Mesa Air Cuts 250 Jobs, Including 150 Pilots

Written By: Sam Savage

Published Date: October 8, 2008 Last Edited: October 8, 2008

By Bloomberg News

Mesa Air Group Inc., the regional carrier that operates flights for bigger airlines, cut 250 jobs including pilots partly because of a terminated contract with Delta Air Lines Inc.

About 100 of the positions were at the corporate level, and 150 were pilots, most of whom flew jets for Delta, said Brian Gillman, general counsel for Phoenix-based Mesa. No further job reductions are planned, Gillman said.

The cuts, 6.1 percent of Mesa’s work force, are related to an agreement under which Mesa’s Freedom Airlines unit operated CRJ-900 jets for Delta, Gillman said. Mesa had seven of the 76- seat jets in service, and planned to add seven more next year. The two companies are in a legal dispute over a different accord that covers about a fifth of Mesa’s fleet.

Delta said in August that the flights on the CRJ-900 jets didn’t meet its performance standards, which Mesa disputed.

The companies are in a legal battle over Delta’s plans to end a contract for flying 34 smaller ERJ-145 aircraft. A federal judge in Atlanta has ruled that Delta can’t terminate the contract, and Delta is appealing that decision.

Health

Circumcision May Not Cut Gay Male HIV Risk

Written By: Sam Savage

Published Date: October 8, 2008 Last Edited: October 8, 2008

U.S. researchers found there is little evidence to support the claim that circumcision protects men from getting the AIDS virus during sex with other men.

Researchers from the Centers for Disease Control and Prevention reviewed 15 studies involving 53,567 gay and bisexual men in the United States, Britain, Canada, Australia, India, Taiwan, Peru and the Netherlands and found no benefit for those who were circumcised.

Circumcised men were 14 percent less likely to be infected with the human immunodeficiency virus, or HIV, than those who were uncircumcised, but the finding was not statistically significant, the CDC researchers said.

“You can’t necessarily say with confidence that we’re seeing a true effect there,” said Gregorio Millett of the CDC, who led the study. “Overall, we’re not finding a protective effect associated with circumcision for gay and bisexual men.”

Previous studies in Africa showed that male circumcision cut the risk of female-to-male HIV infection by half.

Experts believe the reduced risk is due to the increased susceptibility of cells on the inside of the foreskin, the area of the penis that is removed during circumcision.

It still remains unclear as to whether circumcision cuts the risk of spreading AIDS in sex between men. Outside of Africa, the HIV epidemic’s center, homosexual and bisexual men player a much larger role is spreading AIDS.

Last week, the CDC reported that 48 percent of the 1.1 million Americans infected with HIV are homosexual or bisexual men, yet three-quarters of men in the U.S. are circumcised.

“We really cannot recommend overall male circumcision as a strategy for men who have sex with men in the United States,” Millett said.

Dr. Peter Kilmarx, of the CDC, said the group is preparing recommendations on circumcision in the U.S. that will be made public next year.

According to Millett, there are signs that circumcision could protect some men depending on their sexual practices.

Previous studies in Peru and Australia showed that men who participated in insertive anal sex, and were not penetrated by partners, saw significant protection from HIV due to being circumcised.

“Of course, if you’re being penetrated by a partner during sex, you being circumcised is not going to protect you from HIV infection,” Millett said.

According to Millett, two previous U.S. studies that occurred before the introduction of HAART, a drug treatment for HIV infections, showed that men who were circumcised were 53 percent less likely to be infected with the HIV virus.

Millett said that the success of HAART, which has turned HIV infection into a chronic disease, might have led some gay and bisexual men to engage in riskier sexual practices.

—

Education

A Higher Education

Written By: Sam Savage

Published Date: October 8, 2008 Last Edited: October 8, 2008

By Delbanco, Andrew

Can the Humanities Survive? Reading Anthony Kronman’s Education’s End: Why Our Coueges and Uni’ versities Have Given Vp on the Meaning of Life (Yale University Press, $17, 320 pp.) reminded me of some advice I once got from a colleague. We were discussing a candidate for a position in the English Department who touted his own work as “revisionist.””Keep in mind,” my colleague said, “if it’s new, it’s probably wrong.”

Kronman, too, is skeptical of the new, and convinced of the enduring value of what many academics today would regard as the hopelessly old. A former dean of the Yale Law School, he teaches now in the “Directed Studies” (Great Books) program of Yale College. Explaining why he spends his time reading old books with young students, he spares us the usual bromides about the value of “critical thinking,” and offers instead a full-throated defense of the humanities as food for the soul. The heart of the college experience, he believes, should be “a disciplined survey of the answers the great writers and artists of the past have given” to the question of how best to live, in order to “aid…students in their own personal encounter with the question of what living is for.” It is unusual these days to hear this kind of talk from a well- credentialed professor, and in order to explain why it has become so rare, Kronman takes us on a historical tour of American higher education.

Most American colleges, he reminds us, began as denominational institutions in which “students were expected to master a common curriculum” and every member of the faculty “was expected to be able to teach the whole of it to them.” Usually the sole administrator (there really was no such thing in the modern sense until after the Civil War) was the president, whose duties included teaching the capstone course in moral philosophy to seniors. The goal of the college was to help students acquire habits of mental and moral discipline. But with the breakdown of the pre-Darwinian synthesis of religion and science, such colleges found themselves struggling to survive in the lengthening shadow of the new research universities- places where undergraduate teaching, if it occurred at all, was secondary to research and to the training of future researchers.

Well into the twentieth century, some colleges continued to consider themselves, in Kronman’s words, “residual legatees” of the older tradition of moral instruction centered in the study of theology and the Greek and Roman classics. These colleges kept alive the mission of teaching young people (at the time, almost exclusively men) what Alexander Meiklejohn, president of Amherst College, called the “art of living”-an educational ideal that eventually established itself in “general education” programs at leading universities, including the Contemporary Civilization Program at Columbia (1919), the Red Book curriculum at Harvard (1945), and Yale’s own Directed Studies Program (1947).

But despite these holding actions, over the course of the twentieth century the “research ideal,” as Kronman calls it, overshadowed and undermined general education almost everywhere. He acknowledges the immense social value of the new knowledge that academic research has produced-advances in medicine and communications, rational management of economies and legal systems, development of new technologies, and so on. At its best, the research ideal is generously collaborative, entailing a devotion to an enterprise unbounded by time and self, in which each individual scientist or scholar makes a contribution based on the work of predecessors, to be extended by successors.

But, like many critics of Enlightenment rationality, Kronman believes that the driving force behind the quest for new knowledge is fundamentally a Faustian urge to exert control over nature and ultimately over death itself-the human desire, as he puts it, “to transform fate into freedom.” When this urge commands the imagination without a countervailing awareness of human fallibility and mortality, it becomes a monstrous folly, and leaves us vulnerable to the rapacious human will. It also leaves us mute before the fundamental question of the meaning of our existence.

For a great many people, it is of course religion that promises deliverance from this spiritual bewilderment. But Kronman considers the promise of “redemption through submission to a perfect power that fulfills by other means the technological fantasy of perfect control” both false and dangerous. In his view, the best alternative to religion in a pluralist society (where relatively few young people attend sectarian colleges) is what he calls “secular humanism,” by which he means the reflective consideration, aided by great writers of the past-including religious writers-of how to shape a moral life. His book is a lament that secular humanism has been marginalized in our colleges and universities too.

Alas, I think he is right. The humanities should be about helping students “stock their souls with the greatest and most lasting images of human striving and fulfillment, as guides to the choices they must face in the years ahead, and as a fund of perennial inspiration.” But, as Kronman points out, the humanities have vitiated themselves by adopting the scientific premise that knowledge is progressive-at best a half-truth, as anyone knows who has seriously studied philosophy, history, literature, or the arts. In a mercifully brief tour of the “culture wars,” Kronman goes on to show how the humanities have lately retreated from the scientific research paradigm and embraced “constructivism”-his word for postmodern relativism. That has only made matters worse, turning professors of the humanities into a “laughingstock” in the eyes of their scientific colleagues, who confirm every day that empirical and experimental inquiry can indeed yield verifiable truths.

But Kronman goes further to say (and here, I suspect, he will raise eyebrows if not hackles) that “the research ideal” brings with it a kind of spiritual disease that enervates the soul of the researcher, who tends “to see things…from the deathless perspective of the discipline to which he or she belongs” and is thereby cut off from the wholeness of life. Kronman even goes on to say that “death casts a more disturbing shadow” over such persons because they cannot evade the dispiriting knowledge that by cultivating only a tiny fragment of knowledge in a vast impersonal system, they condemn themselves to a sort of spiritual isolation.

These are, to put it mildly, contestable claims. Surely we all know scientists and research scholars who feel fulfilled and at peace with themselves. I cannot help but wonder if the person Kronman is writing about when he describes the deprivations of professionalism versus the rewards of undergraduate teaching is, in fact, himself.

I say this not by way of disparagement, but because his passionate commitment to broadly humane education is exactly what makes Kronman’s book worth reading-from the double-entendre of the title to the hortatory conclusion. Still, he is on firmer ground when he steps back from making assertions about the inner lives of researchers, and turns to the real problem-that the research ideal has come to “occupy the whole of the humanities and… dictate the exclusive terms on which the worth of everything that is done in them is measured.” Surely he is right about this too. All the skills and strategies for rising in the academic hierarchy-publishing frequently, performing at conferences, and (most important for raising one’s salary) currying offers from rival institutions-have nothing to do, and are often at odds, with a commitment to undergraduate teaching.

This disjunction, Kronman notes with regret, is increasingly evident “in our liberal-arts colleges too, and even in the country’s community and other two-year colleges.” Just how much he regrets it is clear from his fond recollection of his own touchstone experience of attending a weekly seminar more than forty years ago as a student at Williams College. It took place at the home of the chair of the philosophy department, where teacher and students met to discuss the literature of existentialism while two golden retrievers slept on either side of the fireplace, “like bookends beside the hearth” and, outside the window, the sunset lit the Berkshire hills “in scarlet and gold.”

This pastoral vision of college-an updated version of Mark Hopkins (also a Williams man) conversing with an undergraduate from the opposite end of a log-remains irresistibly appealing. Its point is not to prepare students for graduate school or the I-bank interview (over half the graduating seniors at Harvard now go on to careers in finance), but to invite them into an “ongoing conversation that gives each entrant a weighted and responsible sense of connection to the past” and thereby helps them face the imponderable future. But today even the venerable liberal arts colleges are no longer sanctuaries from “the imperial sprawl” of university culture. With the virtually universal establishment of the PhD degree as a mandatory credential for college teaching, the faculties of such colleges now “begin their [teaching] careers having already internalized the research ideal.” If they happen to encounter during their graduate years a mentor who conveys by example the kind of teaching that Kronman cherishes, it is more likely by happy accident than by design. So what is to be done? It is certainly true that strong forces are arrayed against Kronman’s ideal of humanistic education. There is the general decline of reading in a culture saturated by digitized noise, where few people have the time or concentration to linger with a long or difficult book. There is the pernicious effect of a culture where affluence is both an accepted norm and an elusive goal. Kronman dismisses those who argue against general education on the grounds that it inhibits the specialization that is putatively necessary in our postindustrial society, and he is right that very few professions “require more than a handful of undergraduate courses as preprofessional training…medical school requires a half-dozen; law school none at all.” Still, with every passing year students feel more pressure to impress the professional school admissions committees or corporate hiring committees with a super GPA in some practical subject like economics, at the expense of pursuing learning for its own sake. In this environment, subjects that were once at the heart of a liberal education-literature, art, philosophy, music-are consigned to the dispensable category of “enrichment.”

And then, of course, there is the overweening force of globalization-a word one seems to hear in every speech from every university president every day. The word has many meanings, of which the most salient to Kronman’s book is the international competition that American educational leaders increasingly feel (or at least anticipate) from rising universities in Asia, the Middle East, and, to some extent Europe. Every major institution is expanding-or its leadership is thinking about expanding-in order to accommodate the foreign students who will become the next generation of the international elite, and whom American universities want to be able to call their alumni.

These developments have their positive aspects. A more international student body is less likely to be homogeneous in attitude and provincial in habits; the booming study of non-Western languages and cultures helps to enlarge the intellectual horizons of American students. But it is also true that small-group education of the sort Kronman treasured at Williams becomes harder and harder to sustain-not only because it is extremely expensive (low faculty- student ratios require high instructional budgets) but also because faculties in the humanities are not likely to grow at the same pace as the student body, and because most students from abroad come for some form of technical training, not primarily for the collegiate experience.

Moreover, as Kronman points out, there is growing pressure-both because of faculty ideology and because of the growing numbers of students who are foreign-born or of nonWestern descent-to undercut the “Eurocentric” curriculum and introduce texts from other cultures. The study of other cultures is of course laudable when it supplements the study of the West, but not if it substitutes for it. Kronman is very good on how important it is for students to get some sense of the fundamental ideas that constitute Western culture in its ideal form, that is, the culture we encounter in books:

The ideals of individual freedom and toleration; of democratic government; of respect for the rights of minorities and for human rights generally; a reliance on markets as a mechanism for the organization of economic life and a recognition of the need for markets to be regulated by a supervenient political authority; a reliance, in the political realm, on the methods of bureaucratic administration, with its formal division of functions and legal separation of office from officeholder; an acceptance of the truths of modern science and the ubiquitous employment of its technological products: all these provide, in many parts of the world, the existing foundations of political, social, and economic life, and where they do not, they are viewed as aspirational goals toward which everyone has the strongest moral and material reasons to strive.

Surely anyone who earns a BA from a reputable college or university ought to understand something about the genealogy of these ideas and practices, about the historical processes from which they have emerged, the tragic cost when societies fail to defend them, and yes, about alternative ideas both within the Western tradition and outside it. That’s a tall order for anyone to satisfy on his or her own-and one of the marks of an educated person is the recognition that it can never be adequately done and is therefore all the more worth doing.

I suspect that the problems Kronman describes become more acute the higher one climbs the pyramid of American higher education toward the institutions of peak prestige. It is in the Ivy League and at other “elite” institutions that concern for prestige is most intense, from the trustees, president, and endowment managers through the faculty down to the students themselves. These are not good conditions for humanistic education. Among the leading research universities, only Columbia and Chicago continue to prescribe Great Books courses for all undergraduates. More commonly, “even at our best colleges and universities,” as Kronman puts it, students “spend four years sampling courses with little or no connection, moved by fancy and curiosity but guided by no common organizing principle or theme.” These students are encouraged to think of themselves as “networking” in order to gain entry to some lucrative field where most of their colleagues will come from schools like their own. What is the utility of true humanistic education for such a life plan? What is its market value?

These are, of course, the wrong questions, and I suspect it is the increasing population (mainly outside the Ivies) of “nontraditional” students-adults who have seen life from the vantage point of failure, or who feel unfulfilled after achieving what others deem success-who are asking the better questions. In short, there remains a real constituency for humanistic education-and if we take the broad and long view, it may even be growing. The required courses in philosophy and theology at many Catholic universities and colleges have to some extent upheld this tradition of humanistic education as well.

In fact, one should take heart from some signs that the tide may be slowing if not turning. Despite the pervasiveness of market values in the university, Kronman speaks of a “hunger” for humanistic education among students and young faculty, and here, too, he is surely right-though it should be said that his perspective, like mine, is inevitably skewed by where he teaches. At my university, a steady number of faculty find satisfaction in the series of compulsory small-group discussion classes (the Columbia Core Curriculum) that includes music and art history as well as courses in literature and political and social thought. And many Columbia alumni, recent graduates as well as those who attended college long ago, regard the “core” as having transformed their lives. This is no doubt equally true for Yale’s Directed Studies Program, where students enroll and faculty teach voluntarily.

These are unrepresentative institutions, but what I know of other colleges-from small Ursinus College in Pennsylvania to the honors college of the vast North Carolina State University-convinces me that humanistic education in Kronman’s sense remains alive and well in many places around the nation. Moreover, the straitened discourse that he decries in the contemporary classroom, where buzz words like “race, class, and gender” encourage students “to see themselves as representatives” rather than as autonomous persons, is noticeably loosening.

It is also worth keeping in mind that education of the sort that Kronman values has always been scarce. At the turn of the twentieth century, when “the art of living” was a legitimate subject in college curricula, only about 2 percent of college-age Americans attended any college at all. In short, despite the scandalous limits on educational opportunity in this country, it is arguably the case today that more students than ever before have the chance to experience something like Kronman’s ideal.

Who, then, should read Kronman’s book, and to what end? Being half-polemic and half-manifesto, it invites objections and emendations-as any good teacher would. I found myself dissenting from Kronman’s view of all religion as “fundamentalist,” and pulling back from his own evangelical tone: “We live today in a narcotized stupor, blind to the ways in which our own immense powers and the knowledge that has produced them cuts us off from the knowledge of who we are.” Some academics will read this book with a priori consent, others with the unshakeable sense that the sort of education Kronman wants is quaintly irrelevant in our postmodern, post-Western, posteverything world. Neither of those parties will get much out of it except for the pleasure of confirming what they think they already know.

The readers one hopes for are college and university presidents trying to figure out what’s right and what’s wrong with their institutions. Their authority over academic affairs, as Kronman points out, is much attenuated from what it once was. But they can still be mediators or brokers or, in rare cases, intellectual leaders. Despite the territorial squabbling and the scramble for resources at every institution, small changes can yield big results, and need not be very expensive. Along with taking the customary research seminars, graduate students can be introduced in a serious way to the question of what teaching is all about. Incentives can be put in place to counter the forces that draw faculty away from undergraduates. Leave policies can be enhanced for those who commit themselves to such teaching, so that they can keep up their research as well. Prestige-mongering (How big is our endowment? How many applicants did we turn away from our college?) can be resisted as a poor way of measuring institutional vitality and integrity. All such efforts are uphill battles. But anything that can be done is worth doing on behalf of the inestimable value of Socratic discussion between inquiring students and a challenging interlocutor who compels them to confront deep questions with the aid of great texts. Any education without such engagement is empty at worst, partial at best. The problem with advocating for such education is that its worth is only truly understood by those-like Kronman-who have experienced it for themselves. And unfortunately, he is right that many advocates of the academic humanities, instead of persuading their colleagues in the sciences that they deserve a place at the academic table, “have instead,” by their faddishness and shallowness, “dug a hole and pitched themselves to its bottom.” Taking this book seriously would be a start toward climbing out.

Andrew Delbanco is Levi Professor in the Humanities at Columbia University, where he has taught in the Core Curriculum and is current^ director of American Studies. His most recent book is Melville: His World and Work (Alfred A. Knopf).

Education

Exploring the Relationship Among Cultural Discontinuity, Psychological Distress, and Academic Outcomes With Low-Income, Culturally Diverse Students

Written By: Sam Savage

Published Date: October 8, 2008 Last Edited: October 8, 2008

By Cholewa, Blaire West-Olatunji, Cirecie

School counselors and educators tend to focus on the symptoms of cultural discontinuity and often view these symptoms as root causes for underachievement. In this article we use an ecosystemic paradigm to explore the relationship among cultural discontinuity, psychological distress, and academic achievement. Recommendations include ways in which school counselors can use macrosystemic interventions to forge partnerships between low-income, culturally diverse students’ home culture and that of the school. The U.S. education system is failing our nation’s low-income, culturally diverse students. The persistent achievement gap between low-income African American and Latino American students, in particular, and their middle and upper income White peers has been the focus of investigation by educational researchers (Bazon, Osher, & Fleischman, 2005; Garcia, 1993; Lovelace & Wheeler, 2006; Nieto, 2004). Statistics from the U.S. Department of Education (2006) and the National Assessment of Educational Progress (NAEP; Lee, Grigg, & Donahue, 2007) reveal that low-income children (those eligible for free or reduced lunch), across ethnic groups, underperform in both reading and mathematics at the 4th-, 8th-, and 12th-grade levels, compared to their middle- and upper-income peers (Grigg, Donahue, & Dion, 2007; Lee et al.). Moreover, African American and Latino American students, across all socioeconomic levels, consistently achieve lower scores on reading and mathematics on national standardized tests compared to White students (Grigg et al.; Lee, Grigg, & Dion, 2007; Lee et al.; U.S. Department of Education, 2007). Additionally, 1 out of every 10 African American students and 1 out of every 5 Latino American students drop out of high school (U.S. Department of Education, 2007).

Much of the literature on the achievement gap either focuses on low-income students or on culturally diverse learners. The focus of this paper is on the intersectionality of identity of low-income, culturally diverse students and how this confluence of class and ethnicity significantly contributes to the experience of cultural discontinuity in the classroom. Prior discussion of multiple identities has primarily focused on African American women (Williams, 2005) and sexual minorities (Garrett & Barret, 2003). An additional type of multiple identity, however, is culturally marginalized status and low income, as there appears to be a link between cultural diversity and low income. High-poverty schools have higher percentages of African American and Latino American students, as well as limited English proficiency students (U.S. Department of Education, 2006). According to Frankenberg, Lee, and Orfield (2003), nearly half of the students in schools attended by the average African American or Latino American student are impoverished. Thus, for some culturally diverse students, the intersection of poverty and racial/cultural dynamics influences the quality of their schooling experiences.

The culturally diverse groups most affected by the achievement gap are Native Americans, some Asian American subgroups (specifically, Vietnamese and Pacific Islanders), Latino Americans, and African Americans. Most of the research emphasizes African Americans and Latino Americans as both groups are strongly represented in the United States, while research on Native American, Vietnamese, and Pacific Islander students is not as pervasive. Often viewed as monolithic and the model minority, some Asian Americans subgroups, such as Vietnamese and Pacific Islanders, are often not differentiated from other more successful Asian ethnic groups, such as Japanese and Korean (Kim, 2003). Additionally, the low representation of Native Americans in research samples limits overall educational research on this cultural group as well (Marshall, 2002).

It has been argued that some attempts to close the achievement gap have mistakenly viewed the students’ manifestations of psychological distress as root causes of academic and behavioral problems, rather than as symptoms of more systemic, environmental stressors (Amatea & West-Olatunji, 2007a, 2007b; Butler, 2003; Lee, 1995, 2005). Frequently, school counselor-led interventions to address the underachievement of low-income, culturally diverse youth have had inconsistent results (Cook & Kaffenberger, 2003; Legum & Hoare, 2004; Mitchell, Bush, & Bush, 2002). These mixed outcomes can be partly attributed to a faulty conceptualization in which causes of underachievement are viewed as intrinsic and endemic to low- income, culturally diverse students. A more helpful conceptualization is an ecosystemic approach that provides a useful lens through which the achievement gap can be investigated because of its emphasis on sociocultural factors in assessing, conceptualizing, and intervening with culturally diverse individuals (Amatea & West-Olatunji, 2007b; Anderson, Goolishian, & Winderman, 1986; Bronfenbrenner, 1979; Keys & Lockhart, 1999). The purpose of this article is to use an ecosystemic lens to explore the relationships among cultural discontinuity in education, psychological distress, and academic outcomes for lowincome, culturally diverse students.

BACKGROUND

Low-income, culturally diverse students encounter cultural discontinuity at school on a daily basis (Gay, 2000; Ladson- Billings, 1994; Nieto, 2004). This cultural discontinuity, defined as a cultural disconnection between children’s home environment and that of the school, has an influence on their dispositions and their academic outcomes (Boykin, 2001; Jenks, Lee, & Kanpol, 2001). Additionally, contemporary studies suggest that school-aged children can experience psychological distress, such as symptoms of depression, low levels of mastery, and low levels of life satisfaction, that affect their school performance (Bhatia & Bhatia, 2007; Gosa & Alexander, 2007; Okagaki, Frensch, & Dodson, 1996). Research with adults has shown that similar symptoms of psychological distress have been linked to cultural discontinuity and discrimination (Broman, Mavaddat, & Hsu, 2000; Finch, Hummer, Kol, & Vega, 2001; Gee, Ryan, Laflamme, & Holt, 2006; Kessler, Mickelson, & Williams, 1999). While only limited research has been conducted with children linking cultural discontinuity and psychological distress (Fisher, Wallace, & Fenton, 2000; Smokowski & Bacallao, 2007), we suggest that cultural discontinuity may also contribute to the symptoms of psychological distress seen in low- income, culturally diverse students in schools.

Cultural Discontinuity

Examination of our nation’s public education system reveals that educational hegemony, or ethnocentrism, pervades its structure, practices, and curriculum. As Boykin (2001) points out, schooling consists of more than just reading, writing, and arithmetic, but promotes a particular worldview and way of interpreting reality. The knowledge that is presented in our schools is based on Eurocentric values (Marri, 2005). Therefore, curricular activities often benefit those students whose cultural backgrounds most closely align with Eurocentric norms (Jenks et al., 2001), thus creating a cultural mismatch for culturally diverse students. This phenomenon may be exacerbated when coupled with low-income status. Educators often fail to recognize culturally diverse ways of knowing, speaking, and interacting, and thus invalidate students’ funds of knowledge (Moll & Gonzalez, 2004; Nieto, 2004). These misconceptualizations often hold true regardless of the teachers’ own cultural background as most teacher education programs are also Eurocentrically rooted. Thus, it is the teacher’s pedagogical framework rather than skin color that promotes educational hegemony (Ladson-Billings, 1994).

The culturally based differences in communication styles and language patterns between culturally diverse students and their Eurocentrically oriented teachers can often result in misinterpretations of students’ ways of interacting, students’ intelligence, and students’ academic ability (Coleman, 2000; Delpit, 2004; Lovelace & Wheeler, 2006). Numerous teachers recognize cultural differences and connect students’ home lives and experiences to school. Unfortunately, far too many teachers’ own dispositions toward cultural diversity often prevent them from incorporating children’s funds of knowledge into the teaching and learning experience (Foster, 1997; Gay, 2000; Jenks et al., 2001; King, 2004; Ladson-Billings, 1994).

One example of such a cultural discrepancy is the expectation of some teachers that students will only speak when called upon and not comment on other students’ responses. This expectation is based on Eurocentric cultural language traditions (Lovelace & Wheeler, 2006). However, some African Americans, Latino Americans, and Native Hawaiians typically use a communication style that is participatory- interactive (Gay, 2000). Within this style it is expected that the audience will give encouragement, verbally respond, and even display some movement when they are speaking (Espinosa, 2005; Lovelace & Wheeler). Unfortunately, the teachers often perceive the students calling out and moving in their seats as disrespecting classroom rules. This can result in having students’ names written on the board, singling out students as “problem students,” often in front of their peers. If this happens repeatedly these students can be sent out of the classroom into the hall, placed on suspension, or referred for special education placement. Thus, cultural disconnection with language can lead to less than desired academic outcomes for low-income, culturally diverse students (Bazron et al., 2005). Cultural Discontinuity and Children’s Distress

These daily schisms in the educational environment that discount children’s cultural norms can have deleterious effects on psychological and emotional well-being of children (Nieto, 2004; Phillips, 1993). School children experiencing psychological distress may present symptoms of depression (Bhatia & Bhatia, 2007; Chrisman, Egger, Compton, Curry, & Goldston, 2006; Crundwell & Killu, 2007; Rockhill et al., 2007), low levels of mastery (Gosa & Alexander, 2007), and low levels of life satisfaction (Okagaki et al., 1996). Studies with culturally diverse adults across a variety of ethnic groups have found similar symptoms of psychological distress when reporting greater levels of discrimination (Broman, et al., 2000; Lee, 2003; Moradi & Hasan, 2004; Moradi & Risco, 2006; Schultz et al., 2000; Taylor & Turner, 2002). Additionally, research has linked perceived discrimination across racial and ethnic groups to major depression (Finch et al., 2001; Kessler et al., 1999; Whitbeck, McMorris, Hoyt, Stubben, & Laframboise, 2002) and has been shown to impact overall mental health (Gee, 2002; Gee et al., 2006; Klonoff, Landrine, & Ullman, 1999).

While much of the research conducted has found a link between discrimination and the psychological health in adults, the negative impact of cultural discontinuity and hegemony on children’s psychological well-being and development has also been noted (Bazron et al., 2005; Fisher et al., 2000; Nieto, 2004; Smokowski & Bacallao, 2007). Students who experience disconnection between home and school cultures are more apt to view themselves negatively in terms of their learning, reading, writing, and speaking ability (Garcia, 1993). Nieto stated that this is partially due to policies and practices of schools that support some groups while devaluing others. Students from culturally dominated groups consistently receive and internalize negative messages regarding their culture, ethnic group, class, gender, or language.

As a confounding factor, poverty also can impact psychological well-being (Corcoran, Danziger, & Tolman, 2004; Leventhal & Brooks- Gunn, 2003); this is particularly so for children living in poverty with limited access to health care services (Howell, 2004). Many children in impoverished communities also face multiple stressors such as familial conflict and community violence (Thompson & Massat, 2005) and high mobility (Heinlein & Shinn, 2000) that can impact their psychosocial adjustment and academic achievement (Forehand, Biggar, & Kotchick, 1998; Luster & McAdoo, 1994).

Cultural Discontinuity and Academic Achievement

The disconnection between the school culture and the home culture has been shown to impact the educational experiences of low-income, culturally diverse students. Specifically, both low-income and culturally diverse students are disproportionately placed in special education categories (Blair & Scott, 2002; Skiba et al., 2008). A study by Blair and Scott found that 30% of learning disability placement among boys and 39% of learning disability placements among girls could be attributed to lowsocioeconomic status markers. In 1998, approximately 1.5 million ethnic minority children were identified as having an emotional disturbance, mental retardation, or a specific learning disability (Civil Rights Project, 2002). Once identified, African American as well as Latino students are at higher risk of being segregated from their nondisabled peers, often receiving substandard instruction in separate settings (Civil Rights Project; National Center for Educational Statistics, 2002).

The overrepresentation of culturally diverse students in special education is accompanied by their disproportionate representation in discipline referrals, expulsions, suspensions, and corporal punishment (Cartledge, Tillman, & Johnson, 2001; Skiba, Michael, Nardo, & Peterson, 2002; Townsend, 2000). For example, there is a 13.5% discrepancy in suspensions and a 24.95% discrepancy in expulsions between African American students and their White peers (Skiba et al., 2002). Furthermore, the dropout percentage rates for African American, Latino American, and Native American students are 10.4%, 22.4%, and 14%, respectively, while the dropout rate for White students is 6% (U.S. Department of Education, 2007). Similarly, in 2004, students living in low-income families (defined here as the lowest 20% of all family incomes) were four times more likely to drop out of high school than their peers from high-income families (defined as the top 20% of all family incomes; Laird, DeBell, & Chapman, 2006). The disproportional placement and representation of low-income and culturally diverse students in special education programs, disciplinary action, and dropout rates may be partially accounted for by cultural discontinuity. Educators’ misunderstandings regarding the interaction patterns and culturally based language differences of these students often result in students’ subsequent punishment and referral for special education placement (Bazron et al., 2005; Coleman, 2000). In conjunction, students may unconsciously act out and display symptoms of psychological distress in response to cultural discontinuity.

21st-Century School Counseling

Over the past 2 decades, school counselors have begun to step out of their role as ancillary providers and have moved toward taking on more of a leadership role within schools (Brown & Trusty, 2005; Dollarhide, 2003). The American School Counselor Association (ASCA) further substantiated this push for progress in 2003, when it published the ASCA National Model(R) (2005). The ASCA National Model emphasizes school counselors’ leadership, advocacy, and consultant roles as integral to the academic mission of schools and systemic change in schools. The roles of leader, advocate, and consultant are particularly important with school counselors working in schools with large populations of low-income, culturally diverse students (Amatea & West-Olatunji, 2007a; Bemak, 2000; Bemak & Chung, 2005; Brown & Trusty; Cook & Kaffenberger, 2003; Lee, 2005). Schools with large concentrations of culturally diverse students are often under- resourced and experience a multitude of challenges.

The Ecosystemic Approach

Use of an ecosystemic paradigm for investigating the environmental context in which clients are situated can be useful to school counselors because it can engender client empowerment and collaboration between counselor and client (Amatea & West-Olatunji, 2007b; Chung & Pardeck, 1997). Moreover, an ecosystemic lens permits a consideration of contextual risk and protective factors (Goodman & West-Olatunji, 2008). For culturally diverse families, an understanding of the sociocultural context extends the boundaries of the system of care to include community support systems (Amatea & West-Olatunji, 2007a; Anderson et al., 1986; West-Olatunji & Watson, 1999).

School counselors taking an ecosystemic perspective focus on factors other than the typical individually focused, microsystemic interventions (Bailey & Paisley, 2004; Mitchell et al., 2002). Instead of treating the students’ manifestations of psychological distress as root causes of academic and behavioral problems, counselors using an ecosystemic approach seek to examine macrosystemic factors, including bias, hegemony, and cultural discontinuity (Amatea & West-Olatunji, 2007b).

DISCUSSION

Prior to the call for more advocacy and leadership skill development among school counselors, issues of teacher preparation and classroom dynamics appeared less relevant to the daily performance of professional school counselors. However, given the current mandate, school counselors can transform the experiences and significantly impact achievement outcomes for low-income, culturally diverse students. Specifically, school counselors can augment their awareness of social inequity, incorporate macrosystemic interventions, and provide consultation to teachers.

School counselors can begin by enhancing their awareness of their own biases toward diverse children and families that, albeit unintentional, can negatively impact children’s psychological, emotional, and cognitive development. In particular, we recommend three actions for increased awareness: (a) story circle, (b) multimedia exposure, and (c) multicultural engagement. A story circle group (Williams-Clay, West-Olatunji, & Cooley, 2001) utilizes directed readings, such as “Courageous Conversations About Race” (Singleton & Linton, 2006), “Overcoming Our Racism” (Sue, 2003), and “Can We Talk About Race?” (Tatum, 2007). Counselor-educators, or professional counselors with advanced multicultural competence, can serve as external consultants and facilitate discussions in which school counselors share reflections based on thematic links to other participants’ disclosures.

This critical dialogue provides a safe environment for reflection and growth among a circle of colleagues. The use of documentary films, video clips, music, and contemporary movies can serve to educate school counselors about unfamiliar social and cultural contexts for low-income, culturally diverse students and their parents. Multimedia exposure has been proven as an effective tool for promoting cultural competence among both counselor trainees, as well as professional school counselors. One well-known training video, The Color of Fear (Mun Wah, 1995), is often used to assist counselors in questioning socialized beliefs about culturally diverse individuals. Finally, school counselors can seek out opportunities for multicultural engagement and further their knowledge about diverse communities (ASCA, 2005). They can do so by attending communitywide events like neighborhood meetings, youth athletic events, and religious services. Also whenever possible, they can take the opportunity to make home visits and talk with caregivers on a personal level about their experiences, their lives, and the positive characteristics and talents of their children. Equipped with such awareness and knowledge, school counselors can then assert themselves within the school community as leaders and thereby facilitate cultural competence among other educators in the school community (Amatea & West-Olatunji, 2007a). Such facilitation can begin to lessen the impact of cultural discontinuity within the school, as educators become more adept and comfortable using culturally relevant practices in their interactions with low- income, culturally diverse students.

School counselors also need to apply their unique skill sets by using an ecosystemic approach that utilizes macrosystemic interventions. Effective interventions addressing macrosystemic factors often highlight the need to partner with educators, families, and community stakeholders (Bailey & Paisley, 2004). One successful program, Comite de Padres Latinos (COPLA), emphasizes maintaining Spanishlanguage and Mexican cultural values for starting an interactive dialogue with parents (Barbour, Barbour, & Scully, 2005). Such a program aids parents in inculcating cultural values, such as respect and cooperation. This approach also ensures that youth can participate successfully in Eurocentrically based classrooms. The COPLA model for empowerment also combines the collectivism of the home culture with the individualistic orientation promoted within the classroom. In such a manner, Latino American students can expand their range of language patterns to include those utilized in the classroom (West-Olatunji, 2009).

Another way in which school counselors can collaborate with communities is by establishing more formal, systemic connections through the attainment of federal grants to create out-of-school time programs, such as after-school, weekend, and summer school programs (Pittman, Irby, Yohalem, & Wilson-Ahistrom, 2004). Such programs offer parents the chance to partner in designing developmental initiatives that respond to the social, emotional, and cultural needs of their children. Furthermore, such programs allow educators to increase their knowledge and awareness of the cultural norms of the children and families connected to the school (West- Olatunji, 2009).

In addition to the implementation of macrosystemic interventions, school counselors must also serve as advocates for their socially marginalized students who may suffer from psychological distress. Part of the school counselor’s role of advocate for their low- income, culturally diverse students is to be committed to making certain that all students, regardless of culture or socioeconomic status, have the chance to achieve their academic potential (Lee, 2001). This includes school counselors working to remove barriers that may be present in the school and working to create a climate that promotes learning (Hines & Fields, 2004). Some examples of advocacy include counseling and school program evaluation, assessing school needs, forming advisory groups, problem solving, facilitating teamwork, and sharing resources and information that promote collaboration (Lee, 1995; Pedersen & Carey, 2003).

Finally, school counselors can aid in the creation of a culturally responsive climate by acting as a consultant to teachers and school personnel (Lee, 2001). They can also provide professional development to help educators implement instructional interventions that serve to improve academic achievement for low-income, culturally diverse students (Amatea & West-Olatunji, 2007a). Similar to the advisory group described above, one practical way school counselors can act as a consultant is by developing and implementing professional development workshops for the teachers and staff on culturally responsive teaching.

The school counselor would need to assess the needs of his or her particular school prior to the development of such a workshop. Based on the assessed needs, the workshop could include some of the following: activities to increase awareness of teachers’ own biases, presentation of factual information regarding the potential negative impact of solely Eurocentric teaching on the psychological well- being of low-income, culturally diverse students, and presenting culturally responsive education as an alternative by demonstrating culturally responsive lesson plans. In demonstrating their knowledge of some of the literature and their experience in the area through the workshop, teachers may be wiling to work with school counselors on a more individual basis as well. In partnering with educators, school counselors can help teachers to create culturally responsive classrooms that will positively impact students’ psychological well- being and, ultimately, their academic performance.

FUTURE RESEARCH

While much has been written about the need for school counselors to assume a leadership role in schools, there is insufficient empirical evidence to validate specific ways to foster leadership among school counselors. It is important that researchers investigate the role of the school counselors in mediating between the students’ world view and effective teaching practices. Researchers need to focus on outcome evaluations for the increasing number of leadership training programs that are being implemented within the current context of professional school counseling. Empirically based outcome evaluations of leadership training would provide the profession with evidence-based practices that could have a significant impact on instruction and academic outcomes for low- income, culturally diverse students. Research designs that emphasize key stakeholder buy-in and long-term interventions (i.e., training programs that last for 6 months or more) utilizing experimental design are warranted.

Lastly, although much of the literature presented in this article points to the underperformance of low-income, culturally diverse youth, some of these students are achieving well academically. Moreover, there are teachers who are implementing effective, culturally responsive practices within the schools, resulting in academic gains for low-income, culturally diverse students (Foster, 1997; Gay, 2000; Ladson-Billings, 1994). In addition to employing culturally based pedagogical and instructional methods, it appears that effective teachers of low-income, culturally diverse students may also implement psychological interventions within their classrooms. Using a qualitative methodological design, researchers could examine the psychological impact of effective teaching. The outcomes of such a study could inform school counselors of the ways they can consult with teachers to enhance teachers’ ability to apply psychologically beneficial interventions within their classrooms, thereby making the school counselor an even greater resource within schools.

In summary, the school system is failing lowincome, culturally diverse students, as evidenced by the achievement gap. Using an ecosystemic lens, we assert that cultural discontinuity in education has an impact on low-income, culturally diverse students’ levels of psychological distress, thus resulting in academic underachievement. Previous attempts at closing the gap have taken a microsystemic approach addressing the presenting symptoms of psychological distress, not the underlying causes. School counselors can make an impact in closing the achievement gap by (a) using macrosystemic approaches that address the root causes of psychological distress; and (b) utilizing their roles as leader, advocate, and consultant to influence systemic change within their schools to benefit not only low-income, culturally diverse students but all students.

African American and Latino American students, across all socioeconomic levels, consistently achieve lower scores in reading and mathematics on national standardized tests compared to White students.

Low-income, culturally diverse students encounter cultural discontinuity at school on a daily basis.

Schoolchildren experiencing psychological distress may present symptoms of depression, low levels of mastery, and low levels of life satisfaction.

References

Amatea, E., & West-Olatunji, C. (2007a). Joining the conversation about educating our poorest children: New leadership roles for school counselors in high-poverty schools. Professional School Counseling, 11, 81-89.

Amatea, E., & West-Olatunji, C. (2007b). Rethinking how school counselors work with families and schools: An ecosystemic approach. In J. Wittmer & M. Clark (Eds.), Managing your school counseling program: K-12 developmental strategies (3rd ed., pp. 211-222). Minneapolis,MN: Educational Media.

American School Counselor Association. (2005). The ASCA national model: A framework for school counseling programs (2nd ed.). Alexandria,VA: Author.

Anderson, H., Goolishian, H., & Winderman, L. (1986). Problem determined systems: Towards transformation in family systems. Journal of Strategic and Systemic Therapies, 5, 1-14.

Bailey,D. F., & Paisley, P.O. (2004). Developing and nurturing excellence in African American male adolescents. Journal of Counseling and Development, 82, 108-115. Barbour, C., Barbour, N. H., & Scully, P. A. (2005). Families, schools, and communities: Building partnerships for educating children. Upper Saddle River, NJ: Pearson Education, Inc.

Bazron, B., Osher, D., & Fleischman, S. (2005). Creating culturally responsive schools. Educational Leadership, 63, 83-84.

Bemak, F. (2000). Transforming the role of the counselor to provide leadership in educational reform through collaboration. Professional School Counseling, 3, 323-331.

Bemak, F., & Chung, R. C. (2005). Advocacy as a critical role for urban school counselors: Working toward equity and social justice. Professional School Counseling, 8, 196-202.

Bhatia, S. K., & Bhatia, S. C. (2007). Childhood and adolescent depression. American Family Physician, 75, 73-80.

Blair, C., & Scott, G. (2002). Proportion of LD placement associated with low socioeconomic status: Evidence for a gradient? Journal of Special Education, 36, 14-22.

Boykin, W. A. (2001). The challenges of cultural socialization in the schooling of African American elementary school children: Exposing the hidden curriculum. In W. H. Watkins, J. H. Lewis, & V. Chou (Eds.), Race and education: The roles of history and society in educating African American students (pp. 190-199).Needham Heights, MA: Allyn Bacon.

Broman, C. L., Mavaddat, R., & Hsu, S. (2000). The experience and consequences of perceived racial discrimination: A study of African Americans. Journal of Black Psychology, 26, 165-180.

Bronfenbrenner, U. (1979). The ecology of human development: Experiments by nature and design. Cambridge, MA: Harvard University Press.

Brown, D., & Trusty, J. (2005).Designing and leading comprehensive school counseling programs: Promoting student competence and meeting student needs. Belmont, CA: Brooks Cole.

Butler, S. (2003). Helping urban African American high school students to excel academically: The roles of school counselors. High School Journal, 87, 51-57.

Cartledge, G., Tillman, L. C., & Johnson, C. T. (2001). Professional ethics within the context of student discipline and diversity. Teacher Education and Special Education, 24, 25-37.

Chrisman, A., Egger, H., Compton, S. N., Curry, J., & Goldston, D. B. (2006). Assessment of childhood depression. Child & Adolescent Mental Health, 11, 111-116.

Chung, W. S., & Pardeck, J. T. (1997). Treating powerless minorities through an ecosystem approach. Adolescence, 32, 625-634.

Civil Rights Project. (2002, June). Racial inequity in special education: Executive summary for federal policy makers. Retrieved May 1, 2008, from the Civil Rights Project, UCLA website: http:// www.civilrightsproject.ucla.edu/research/specialed/IDEA_paper02.php

Coleman, T. J. (2000). Clinical management of communication disorders in culturally diverse children. Boston: Allyn and Bacon.

Cook, J., & Kaffenberger, C. (2003). Solution Shop: A solutionfocused counseling and study skills program for middle school. Professional School Counseling, 7, 116-123.

Corcoran, M., Danziger, S. K., & Tolman, R. (2004). Long-term employment of African-American and White welfare recipients and the role of persistent health and mental health problems. Women & Health, 39, 21-40.

Crundwell, R. M., & Killu, K. (2007). Understanding and accommodating students with depression in the classroom. Teaching Exceptional Children, 40, 48-54.

Delpit, L. (2004). The silenced dialogue: Power and pedagogy in educating other people’s children. In G. Ladson-Billings & D. Gillborn (Eds.), The RoutledgeFalmer reader in multicultural education (pp. 225-242). New York: RoutledgeFalmer.

Dollarhide, C. (2003). School counselors as program leaders: Applying leadership contexts to school counseling. Professional School Counseling, 6, 304-308.

Espinosa, L. (2005). Curriculum and assessment considerations for young children from culturally, linguistically, and economically diverse backgrounds. Psychology in the Schools, 42, 837-853.

Finch, B. K., Hummer, R. A., Kol, B., & Vega, W. A. (2001).The role of discrimination and acculturative stress in the physical health of Mexican origin adults. Hispanic Journal of Behavioral Sciences, 23, 399-429.

Fisher, C. B., Wallace, S. A., & Fenton, R. E. (2000).Discrimination distress during adolescence. Journal of Youth Adolescence, 29, 679-695.

Forehand, R., Biggar, H., & Kotchick, B. A. (1998). Cumulative risk across family stressors: Short- and long-term effects for adolescents. Journal of Abnormal Child Psychology, 26, 119-128.

Foster, M. (1997). Black teachers on teaching. New York: New Press.

Frankenberg, E., Lee, C., & Orfield, G. (2003). A multiracial society with segregated schools: Are we losing the dream? Retrieved May 1, 2008, from the Civil Rights Project, UCLA website, http:// www.civilrightsproject.ucla.edu/research/reseg03/ resegregation03.php

Garcia, E. E. (1993).The education of linguistically and culturally diverse children. In B. Spodek (Ed.), Handbook of research on the education of young children (pp. 372-384).New York:Macmillan.

Garrett, M.T., & Barret, B. (2003). Two spirit: Counseling Native American gay, lesbian, and bisexual people. Journal of Multicultural Counseling and Development, 31, 131-142.

Gay, G. (2000). Culturally responsive teaching theory, research, and practice. New York: Teachers College Press.

Gee, G. C. (2002). A multilevel analysis of the relationship between institutional racial discrimination and health status. American Journal of Public Health, 92, 615-623.

Gee, G. C., Ryan, A., Laflamme, D. J., & Holt, J. (2006). Selfreported discrimination and mental health status among African descendants,Mexican Americans, and other Latinos in the New Hampshire REACH 2010 Initiative: The added dimension of immigration. American Journal of Public Health, 96, 1821-1828.

Goodman, R.D., & West-Olatunji, C. A. (2008).Transgenerational trauma and resilience: Improving mental health counseling for survivors of Hurricane Katrina. Journal of Mental Health Counseling, 30, 121-136.

Gosa,T. L., & Alexander, K. L. (2007). Family (dis) advantage and the educational prospects of better off African American youth: How race still matters. Teachers College Record, 109, 285-321.

Grigg, W., Donahue, P., & Dion, G. (2007). The nation’s report card: 12th-grade reading and mathematics 2005 (NCES No. 2007-468). U.S. Department of Education, National Center for Education Statistics. Washington, DC: U.S. Government Printing Office.

Heinlein, L. M., & Shinn, M. (2000). School mobility and student achievement in an urban setting. Psychology in the Schools, 37, 349- 357.

Hines, P. & Fields,T. (2004). School counseling and academic achievement. In R. Perusse & G. Goodnaugh (Eds.), Leadership, advocacy, and direct services strategies for professional school counselors (pp. 3-33). Belmont, CA: Brooks Cole.

Howell, E. (2004). Access to children’s mental health services under Medicaid and SCHIP. No. B-60 in series, “New federalism: National survey of America’s families,” Urban Institute. Retrieved December 10, 2007, from http://www.urban.org/url.cfm?ID=311053

Jenks, C., Lee, J. O., & Kanpol, B. (2001). Approaches to multicultural education in preservice teacher education: Philosophical frameworks and models for teaching. The Urban Review, 33, 87-105.

Kessler, R. C., Mickelson, K. D., & Williams, D. R. (1999). The prevalence, distribution, and mental health correlates of perceived discrimination in the United States. Journal of Health and Social Behavior, 40, 208-230.

Keys, S., & Lockhart, E. (1999). The school counselor’s role in facilitating mulitsystemic change. Professional School Counseling, 3, 101-107.

Kim, W. (2003). Ethnic variations in mental health symptoms and functioning among Asian Americans (Doctoral dissertation, University of Washington, 2003). Dissertation Abstracts International Section A: Humanities and Social Sciences, 63 (8-A), 3004.

King, J. E. (2004).Dysconscious racism: Ideology, identity, and the miseducation of teachers. In G. Ladson-Billings & D. Gillborn (Eds.), The RoutledgeFalmer reader in multicultural education (pp. 71-83).New York: RoutledgeFalmer.

Klonoff, E. A., Landrine, H., & Ullman, J. B. (1999). Racial discrimination and psychiatric symptoms among Blacks. Cultural Diversity and Ethnic Minority Psychology, 5, 329-339.

Ladson-Billings, G. (1994). The dreamkeepers: Successful teachers of African American children. San Francisco: Jossey-Bass.

Laird, J., DeBell, M., & Chapman, C. (2006). Dropout rates in the United States: 2004 (NCES No. 2007-024).Washington,DC: U.S.Department of Education,National Center for Education Statistics. Retrieved April 17, 2008, from http://nces.ed.gov/ pubsearch

Lee, C. C. (1995). School counseling and cultural diversity: A framework for effective practice. In C. C. Lee (Ed.), Counseling for diversity: A guide for school counselors and related professionals (pp. 3-17). Boston: Allyn and Bacon.

Lee, C. C. (2001). Culturally responsive school counselors and programs: Addressing the needs of all students. Professional School Counseling, 4, 257-261.

Lee, C. C. (2005).Urban school counseling: Context, characteristics, and competencies. Professional School Counseling, 8, 184-188.

Lee, J., Grigg, W., & Dion, G. (2007). The nation’s report card: Mathematics 2007 (NCES No. 2007-494).Washington,DC: U.S.Department of Education,National Center for Education Statistics. Retrieved November 4, 2007, from http://nces.ed.gov/nationsreportcard/pdf/ main2007/2007494.pdf

Lee, J., Grigg, W., & Donahue, P. (2007). The nation’s report card: Reading 2007 (NCES No. 2007-496). Washington, DC: U.S. Department of Education,National Center for Education Statistics. Retrieved October 17, 2007, from http://nces. ed.gov/ nationsreportcard/pdf/main2007/2007496.pdf

Lee, R. M. (2003).Do ethnic identity and other-group orientation protect against discrimination for Asian Americans? Journal of Counseling Psychology, 50, 133-141. Legum, H. L., & Hoare, C. H. (2004). Impact of a career intervention on at-risk middle school students’ career maturity levels, academic achievement, and self- esteem. Professional School Counseling, 8, 148-155.

Leventhal,T., & Brooks-Gunn, J. (2003). Children and youth in neighborhood contexts. Current Directions in Psychological Science, 12, 27-31.

Lovelace, S., & Wheeler, T. (2006). Cultural discontinuity between home and school language socialization patterns: Implications for teachers. Education, 127, 303-309.

Luster,T., & McAdoo, H. P. (1994). Factors related to the academic achievement and adjustment of young African American children. Child Development, 65, 1080-1094.

Marri, A. (2005). Building a framework for classroom-based multicultural democratic education: Learning from three skilled teachers. Teachers College Record, 107, 1036-1059.

Marshall, P. L. (2002). Cultural diversity in our schools. Belmont, CA:Wadsworth/Thomson Learning.

Mitchell, K., Bush, E., & Bush, L. (2002). Standing in the gap: A model for establishing African American male intervention programs within public schools. Educational Horizons, 80, 140-146.

Moll, L. C., & Gonzalez, N. (2004). Engaging life: A funds- ofknowledge approach to multicultural education. In J. A. Banks & C. A. McGee Banks (Eds.), Handbook of research on multicultural education (pp. 699-715). San Francisco: Jossey Bass, Inc.

Moradi, B., & Hasan, N. T. (2004). Arab American persons’ reported experiences of discrimination and mental health: The mediating role of personal control. Journal of Counseling Psychology, 51, 418-428.

Moradi, B., & Risco, C. (2006). Perceived discrimination experiences and mental health of Latina/o American persons. Journal of Counseling Psychology, 53, 411-421.

Mun Wah, L. (1995). The color of fear [Motion picture].United States: Stir Fry Productions.

National Center for Educational Statistics. (2002). The condition of education 2002.Washington,DC: U.S.Department of Education.

Nieto, S. (2004). Critical multicultural education and students’ perspectives. In G. Ladson-Billings & D. Gillborn (Eds.), The Routledge Falmer reader in multicultural education (pp. 179-200). New York: RoutledgeFalmer.

Okagaki, L., Frensch, P. A., & Dodson,N. E. (1996).Mexican- American children’s perceptions of self and school achievement. Hispanic Journal of Behavioral Sciences, 18, 469-484.

Pedersen, P., & Carey, J. (2003). Multicultural counseling in schools. Boston: Allyn & Bacon.

Phillips, C. B. (1993).The movement of African-American children through sociocultural contexts: A case of conflict resolution. In B.Mallory & R. New (Eds.), Diversity & developmentally appropriate practices (pp. 137-154). New York: Teachers College Press.

Pittman, K., Irby, M., Yohalem, N., & Wilson-Ahistrom, A. (2004). Blurring the lines for learning: The role of out-of-school programs as complements to formal learning. New Directions for Youth Development, 101, 19-41.

Rockhill, C. M., Min-Yu, F., Katon, W. J., McCauley, E., Crick, N. R., & Pleck, J. H. (2007). Friendship interactions in children with and without depressive symptoms:Observation of emotion during game-playing interactions and postgame evaluations. Journal of Abnormal Child Psychology, 35, 429-441.

Schultz, A., Williams, D., Israel, B., Becker, A., Parker, E., James, S. A., et al. (2000).Unfair treatment, neighborhood effects, and mental health in Detroit metropolitan area. Journal of Health and Social Behavior, 41, 314-331.

Singleton, G. E., & Linton, C. (2006). Courageous conversations about race: A field guide for achieving equity in schools. Thousand Oaks, CA: Corwin Press.

Skiba, R. J., Michael, R., Nardo, A., & Peterson, R. (2002).The color of discipline: Sources of racial and gender disproportionality in school punishment. The Urban Review, 34, 317-342.

Skiba, R. J., Simmons, A. B., Ritter, S., Gibb, A. C., Rausch, M. K., Cuadrado, J., et al. (2008). Achieving equity in special education: History, status, and current challenges. Exceptional Children, 74, 264-288.

Smokowski, P. R., & Bacallao, M. L. (2007). Acculturation, internalizing mental health symptoms, and self-esteem: Cultural experiences of Latino adolescents in North Carolina. Child Psychiatry and Human Development, 37, 273-292.

Sue, D. W. (2003).Overcoming our racism: The journey to liberation. San Francisco: Jossey-Bass Publishers.

Tatum, B. D. (2007). Can we talk about race?: And other conversations in an era of school resegregation. Boston: Beacon Press.

Taylor, J., & Turner, R. J. (2002). Perceived discrimination, social stress, and depression in the transition to adulthood. Social Psychology Quarterly, 65, 213-225.

Thompson, T., & Massat, C. R. (2005). Experience of violence, post-traumatic stress, academic achievement, and behavioral problems of urban African American children. Child & Adolescent Social Work Journal, 22, 367-393.

Townsend, B. (2000).Disproportionate discipline of African American children and youth: Culturally responsive strategies for reducing school suspensions and expulsions. Exceptional Children, 66, 381-391.

U.S. Department of Education, National Center for Education Statistics. (2006). The condition of education 2006 (NCES No. 2006- 071). Washington, DC: U.S. Government Printing Office.

U.S. Department of Education, National Center for Education Statistics. (2007). The condition of Education 2007 (NCES No. 2007- 064). Washington, DC: U.S. Government Printing Office. Retrieved November 4, 2007, from http://nces.ed.gov/pubs2007/2007064.pdf

West-Olatunji, C. (2009). Equal access, unequal resources: Appreciating cultural, social, and economic diversity in families. In E. Amatea (Ed.), Building culturally responsive family-school relationships (pp. 144-168).Upper Saddle River, NJ: Pearson Education Inc.

West-Olatunji, C., & Watson, Z. (1999). Community-as-client mental health needs assessment: Use of culturecentered theory & research. The Community Psychologist, 31, 36-38.

Whitbeck, L. B., McMorris, B. J., Hoyt, D. R., Stubben, J.D., & Lafromboise, T. (2002). Perceived discrimination, traditional practices, and depressive symptoms among American Indians in the Upper Midwest. Journal of Health and Social Behavior, 43, 400-418.

Williams, C. B. (2005). Counseling African American women: Multiple identities-multiple constraints. Journal of Counseling and Development, 83, 278-283.

Williams-Clay, L., West-Olatunji, C., & Cooley, C. (2001). Keeping the story alive: Narrative in the African-American church and community. San Antonio,TX: American Counseling Association. (ERIC Document Reproduction Service No. ED462666).

Blaire Cholewa is a doctoral student and Cirecie West-Olatunji, Ph.D., is an assistant professor at the University of Florida, Gainesville. E-mail: [email protected]

The authors gratefully acknowledge the scholarly support from Dr. Michele Foster whose mentorship inspired this line of inquiry.

Science

Hospitality Company Serves Up Sustainability

Written By: Sam Savage

Published Date: October 8, 2008 Last Edited: October 8, 2008

By Yepsen, Rhodes

THINK GLOBAL, ACT REGIONAL Regional company with about 200 restaurants and catering operations actively promotes sustainability, increasing local food purchasing, composting and waste reduction.

EATN Park Hospitality Group (EPHG) was founded in 1949 as a family car-hop restaurant in Pittsburgh, Pennsylvania. It has since grown into a regional chain of about 80 restaurants and over 100 on- site catering locations consisting of 46 Parkhurst Dining Services (universities, business and industry) and 70 Cura Hospitality operations (hospitals and retirement homes).

The family business has broadened its mission to include sustainability initiatives. “Eat’n Park Hospitality group has ‘Positions of Sustainability,’ which establish both corporate and local responsibility standards, including a continual focus on environmental issues,” says Jamie Moore, Director of Sourcing and Sustainability for EPHG. “These comprise commitments to local purchasing, positions on social and ethical consciousness, and positions on environmental awareness, such as composting and alternative fuels.”

EPHG developed FarmSource, an initiative to find and partner with farmers and food producers within 125 miles of local distributors, based on the location of the restaurant or catering operation. In 2007, EPHG spent over $12 million on local food, which consists of about 20 percent of total food purchases.

The company developed “EcoSteps,” a logo used in marketing environmental improvements, i.e., where a specific operation has reduced its ecological footprint. The logo is accompanied by explanations of why the step was taken, such as why Fair Trade practices are followed, or the benefits of organics recycling. In this way, the company is able to target specific decisions that further the overall goal of sustainability. For example, Eat’n Park family restaurants, as a whole, recently decided to eliminate paper placemats. Previously using 25 million placemats/year, Eat’n Park estimates it will save more than 325,000 pounds of paper/year, the equivalent of more than 250 trees.

One of the major benefits of adopting corporate sustainability practices is EPHG’s ability to influence others positively through its buying power. Because it purchases such large quantities of food, if a distributor does not offer local products, or if a farmer uses nonsustainable products, they will often change those practices in order to keep EPHG as a customer. For instance, EPHG purchases milk from Turner Dairy Farms and used its buying power to influence a change in the farm’s milk carton selection. The original carton was lined with plastic, but EPHG said they would only continue purchasing Turner Dairy milk if it switched to a compostable lining. Soon all cartons from Turner Dairy will be compostable.

SHIFT TO COMPOSTING

Six Penn Kitchen, part of the EPHG, is an upscale restaurant in the historic district of downtown Pittsburgh. Mark Broadhurst, Director of Concept Development for EPHG, opened Six Penn in October 2005, wanting it to be a local food restaurant that mixed a fine dining experience with green practices. The menu is seasonal and includes a list of local and sustainable farms that supplied the produce and meat for that season. In March 2008, 50 percent of the food served at Six Penn was locally grown. The restaurant also has a rooftop garden, which uses compost to grow vegetables and herbs.

The restaurant began diverting its organics to composting in December 2007. “Composting had been a discussion point for us for some time, and then the garbage disposal broke, making the decision for us,” says Don Mahaney, Manager of Six Penn Kitchen. Six Penn had already consulted with AgRecycle, one of Pennsylvania’s only fully permitted composting facilities, conveniently located just outside of Pittsburgh.

“We went through the Six Penn and conducted a product audit,” says Carla Castagnero of AgRecycle. “This differs from a waste audit in that we establish characteristics of the waste stream before it’s all mixed in a bin.” For the product audit, AgRecycle makes lists of everything a particular business uses, down to the tea bags and the wrappers they come in. “We then give our new customer two sheets, itemizing which products AgRecycle will accept, and which we won’t,” she continues. “These sheets go above the yellow compost bins.”

An upscale restaurant like Six Penn has a more complicated product list than, for example, a college cafeteria, continues Castagnero. There is a longer list of items, and some are specialty products like pastry paper, which can be tricky to find an alternative for. And, meticulous differentiations need to be made: Although some shellfish are acceptable, clam and oyster shells are not because they won’t decompose in a normal composting cycle. Six Penn now uses compostable products wherever it can, including cocktail straws.

In the kitchen, each prep cook has a scraps bucket. The wait staff is trained to be postconsumer-conscious too. “With 2,000- 2,500 guests per week, it’s important to pay attention to both the food prep and the leftovers,” says Mahaney. “Everyone takes turns spotchecking the organics dumpster. A Green Committee was formed as a way of empowering staff, which has been even more successful than expected: A line cook recently took the initiative to research and advocate energy efficiency measures that could be made in the kitchen.”

AgRecycle runs an independent collection route for new customers during the first two weeks, at its own expense. This allows the waste stream to be isolated, to both limit the possibility of contaminating existing clean windrows, and to characterize the new feedstock. During the first week of organics collection at Six Perm, the loads were perfectly clean, but then plastic gloves started showing up. “This isn’t unusual,” explains Castagnero. “We always make it clear that plastic gloves are not compostable, are on the ‘No’ list, but everyone starts off putting them in the bucket anyway.”

The 2-cubic yard bin behind Six Penn now consistently has clean loads. The volume of trash has been significantly reduced, down to two days/week of collection from five. However, Mahaney says that composting hasn’t necessarily been a money saver. “For an upscale restaurant, composting doesn’t necessarily boost business – it’s not something directly advertised on the menu or website,” he explains. “And, because compostable products are more costly, it hasn’t saved us money.” But composting fits in with Six Penn’s green and local image, as well as EPHG’s overall sustainability mission. “In many ways it’s more about motivating the team,” continues Mahaney. “Sure, our composting efforts spread through word of mouth, and that plays into our image as a green restaurant, but we’re doing it because it’s the right thing to do.”

Restaurant manager and chefs examine herbs and peppers grown with compost on Six Penn Kitchen’s rooftop garden (top). The roof also has a dining terrace with views of downtown Pittsburgh (bottom).

Pre and postconsumer food scraps are collected for composting at Six Penn Kitchen (top), as well as paper and compostable products (bottom).

Health

Methyl-Donor Nutrients Inhibit Breast Cancer Cell Growth

Written By: Sam Savage

Published Date: October 8, 2008 Last Edited: October 8, 2008

By Park, Chung S Cho, Kyongshin; Bae, Dong R; Joo, Nam E; Kim, Hyung H; Mabasa, Lawrence; Fowler, Andrea W

Abstract Lipotropes (methyl group containing nutrients, including methionine, choline, folate, and vitamin B12) are dietary methyl donors and cofactors that are involved in one-carbon metabolism, which is important for genomic DNA methylation reactions and nucleic acid synthesis. One-carbon metabolism provides methyl groups for all biological methylation pathways and is highly dependent on dietary supplementation of methyl nutrients. Nutrition is an important determinant of breast cancer risk and tumor behavior, and dietary intervention may be an effective approach to prevent breast cancer. Apoptosis is important for the regulation of homeostasis and tumorigenesis. The anti-apoptotic protein Bcl-2 may be a regulatory target in cancer therapy; controlling or modulating its expression may be a therapeutic strategy against breast cancer. In this study, the effects of lipotrope supplementation on the growth and death of human breast cancer cell lines T47D and MCF-7 were examined and found to inhibit growth of both T47D and MCF-7 cells. Furthermore, the ratios of apoptotic cells to the total number of cells were approximately 44% and 34% higher in the lipotrope-supplemented treatments of T47D and MCF-7 cancer cells, respectively, compared with the control treatments. More importantly, Bcl-2 protein expression was decreased by approximately 25% from lipotrope supplementation in T47D cells, suggesting that lipotropes can induce breast cancer cell death by direct downregulation of Bcl-2 protein expression. Cancer treatment failure is often correlated with Bcl-2 protein upregulation. These data may be useful in the development of effective nutritional strategies to prevent and reduce breast cancer in humans. Keywords Lipotropes * Apoptosis * MCF-7 * T47D

Lipotropic nutrients (methionine, choline, folate, and vitamin B12) are important dietary methyl donors and cofactors that play key roles in one-carbon metabolism; one-carbon metabolism, which provides methyl groups for all biological methylation pathways, is highly dependent on dietary supplementation of methyl nutrients (Newbeme and Rogers 1986; Institute of Medicine 1998). Methyl nutrients are essential for epigenetic changes (DNA methylation and demethylation, methyl CpG recognition, histone modification, and chromatin remodeling), which are required for cell proliferation and maintenance of tissue integrity (Jones and Laird 1999; Shrubsole et al. 2001). Methyl groups needed for DNA methylation are acquired through the folate and methionine pathways, and DNA methylation patterns may be altered by changes in diet, genetic polymorphisms, and environmental chemicals (Waterland and Jirtle 2004). Dietary lipotropes influence the availability of the chief biological methyl donor, S-adenosylmethionine, and therefore may change genomic DNA methylation patterns and the expression of multiple cancer-related genes (Jones and Laird 1999; Ross 2003). Deficiency of methyl nutrients has been shown to increase chemical carcinogenesis in rodents (Newberne and Rogers 1986; Choi et al. 1993).

While there are some studies on individual dietary methyl nutrients and breast cancer, there are few that address the interplay among these methyl nutrients and their effects on the reduction of breast cancer. We have shown that lipotrope supplementation decreases MCF-7 human breast cancer cell growth by downregulation of Bci-2 gene expression (Kim and Park 2002). This study investigated whether or not lipotrope supplementation changes cancer cell growth and apoptosis. We found that lipotrope supplementation decreased Bcl-2 protein level and, consequently, increased apoptosis of T47D cancer cells.

Three cell lines (two breast cancer cell lines, T47D and MCF-7, and a normal mammary cell line, MCF-10A) were obtained from the American Type Culture Collection (Manassas, VA) and maintained in basal media consisting of Dulbecco’s modified Eagle’s medium (Gibco Invitrogen, Carlsbad, CA) and F12 medium (Gibco Invitrogen) supplemented with 10% heat-inactivated fetal bovine serum (Gibco Invitrogen), 1% antibiotic-antimycotic (Gibco Inviteogen), and 10 [mu]g/ml insulin (Gibco Invitrogen) as recommended by the supplier. For MCF-10A, 20 ng/ml epidermal growth factor (Gibco Invitrogen) and 100 ng/ml cholera toxin (Gibco Invitrogen) were also added. Cells were seeded in 25-cm^sup 2^ culture flasks at a density of 2 x 10^sup 4^ cells/ml and incubated in a 5% CO2-humidified atmosphere at 37[degrees] C in culture media. At 50% confluency, cells were then switched to basal control (normal levels of lipotropes in basal culture medium: 17 mg/1 L-methionine, 9 mg/1 choline, 3 mg/1 folic acid, and 2 mg/1 vitamin B12) and Hpotrope-supplemented media (ten times the level of lipotropes found in the basal control). The chosen dose of lipotropes was based on previous studies (Kim and Park 2002, 2003).

For the cell proliferation assay, cells were seeded into 96-well microplates at a density of 1.0 x 10^sup 5^ cells/ml and grown in culture media until 50% confluent. The cells were then switched to the two treatment media. On days O through 4, growth curves were obtained by a colorimetric [3-(4,5-dimethylthiazol-2-yl)-5-(3- carboxymethoxyphenyl)2-(4-sulfophenyl)-2H-tetrazolium, inner salt; MTS] cell proliferation assay (CellTiter 96 AQueous One Solution Cell Proliferation Assay, Promega, Madison, WI) according to the manufacturer’s instructions. Briefly, 20 [mu]l of AQueous One Solution reagent was added to each well containing 100 [mu]l of cell culture medium. After a 4-h incubation period at 37[degrees] C, the amount of soluble formazan product was measured spectrophotometrically at an absorbance of 490 nm with a plate reader.

For the determination of Bcl-2 protein levels, cells were cultured and treated as described above. On day 4, cells were collected, pelleted (2 x 10^sup 6^ cells/pellet), and stored at 0 – 80[degrees] C until analysis of Bcl-2 protein by enzyme immunometric assay (EIA, TiterZyme EIA kit, Assay Designs, Ann Arbor, MI) according to the manufacturer’s suggestions. Briefly, cell pellets were lysed in a lysis buffer with phenylmethylsulfonyl fluoride and protease inhibitor cocktail (Sigma-Aldrich, St. Louis, MO). The protein concentrations in the supernatant were quantified by bicinchoninic acid protein assay (BCA Protein kit, Sigma-Aldrich). The EIA consists of binding the Bcl-2 in the supernatant to a monoclonal antibody specific to human Bcl-2 protein that was immobilized on a microtiter plate. Then, a biotinylated monoclonal antibody to Bcl-2 was added, followed by streptavidin-conjugated horseradish peroxidase to bind to the biotinylated antibody, and the substrate was added to generate color. The absorbance was measured spectrophotometrically at 450 nm with a plate reader.

4,6-Diamidino-2-phenylindole (DAPI) fluorescent staining was used for observation of apoptotic nuclear morphological changes. Cells (1 x 10^sup 4^ cells/ml) were seeded in polystyrene Labtek-4-chamber slides (Nalgene Nunc, Rochester, NY) and cultured in pre-incubation medium until 50% confluent as described above. The cells were then switched to the two treatment media. On day 4, cells were washed twice and fixed by incubation with DAPI-methanol (1 [mu]g/ml) for 15 min at 37[degrees] C. After the second washing, cells were incubated at room temperature in 1 [mu]g/ml of DAPI solution for 30 min in the dark. The cells were washed with methanol, and a cover-slip was secured to each slide using a fluorescent mounting medium (Gel/ Mount, Biomeda, Foster City, CA). Microscopic analyses were carried out on a Nikon Microphot-FX upright microscope (Nikon, Melville, NY) with Image Pro-Plus Software (Media Cybernetics Inc., Silver Springs, MD). Photomicrographs of five different fields per treatment for each cell line were taken, and the percentage of apoptotic cells to normal cells was evaluated. Apoptotic cells were defined by features such as condensed, fragmented, or hyper- segmented nuclei, and nuclear and cytoplasmic shrinkage (Collins et al. 1997).

One-way analysis of variance followed by Tukey test was conducted to detect differences among groups. All statistical analyses were performed using the SAS program (SAS Institute, Gary, NC). Statistical differences were considered significant at P

This study determined the effect of lipotropes on growth and apoptosis of established human breast cancer cell lines, T47D and MCF-7. Lipotrope supplementation significantly inhibited the growth of both T47D (P

Apoptosis is morphologically defined by cell shrinkage, membrane blebbing, chromatic condensation, and formation of apoptotic bodies (Mooney et al. 2002). The effect of lipotropes on apoptosis in T47D and MCF-7 breast cancer cell lines was assessed by DAPI staining and the observation of nuclear morphology (Fig. 3). In T47D cells, the ratio of apoptotic dead cells was calculated to be approximately 44% higher, compared with that of the control treatment. In MCF-7 cells, the ratio of apoptotic dead cells was approximately 34% higher, compared with that of the control treatment. The increase in apoptotic cells suggests that lipotropes may induce cancer cell death.

DNA methylation is accepted as one of the most important underlying biological mechanisms regulating epigenetic modification of the expression of heritable genes, and transcriptional control by DNA methylation is an important epigenetic mechanism and essential in maintaining cellular function (Jones and Laird 1999). Changes in methylation patterns may contribute to the development of cancer (Davis and Uthus 2004). Evidence indicates that nutrition is an important determinant of cancer risk and tumor behavior, and dietary intervention may be an effective approach to reduce cancer.

Even though further study of DNA methylation of T47D and MCF-7 breast cancer cell lines for a detailed mechanism of anti-cancer effects is needed, lipotropes may alter the gene expression of cancer cells via DNA methylation. Altered DNA methylation is a useful mechanism for the suppression of cancer gene expression (Jones and Laird 1999). In an in vivo study, we found that dietary lipotropes decrease tumor incidence in the nitrosomethylurea- induced cancer model and significantly reduce the expression of ornithine decarboxylase, a marker of cancer cell proliferation (Moon et al. 1998). Moreover, the expression of Bcl-2 gene is decreased in MCF-7 human breast cancer cells growing in lipotrope-suppiemented medium (Kim and Park 2002). It appears that a methyl supplementation- mediated alteration of one-carbon metabolism may act on the expression of genes involved in proliferation and apoptosis thereby suppressing the progression of mammary tumorigenesis.

In summary, these findings have shown that lipotrope supplementation suppressed the growth of T47D and MCF7 breast cancer cell lines. Furthermore, lipotropes stimulated the induction of apoptosis and pro-apoptotic Bcl-2 protein expression in the T47D cell line. Cancer treatment failure is often correlated with Bcl-2 protein upregulation. Nutritional strategies for cancer prevention and therapy are low risk and cost effective. This study shows that lipotropes (methyl nutrients) may inhibit the growth of breast cancer cells and downregulate the Bcl-2 protein expression, suggesting that lipotropes may be useful in the development of nutritional strategies to prevent and reduce breast cancer in humans.

Acknowledgment This study was supported by a grant (1 R15 CA098016-01A1) from the National Institutes of Health-National Cancer Institute.

Received: 9 November 2007 /Accepted: 24 March 2008 /Published online: 23 May 2008 / Editor: J. Denry Sato

References

Choi C. B.; Baik M. G.; Keller W. L.; Park C. S. Lipotrope- modified diets enhance nitrosomethylurea-induced mammary carcinogenesis in female rats. Nutr. Cancer 20: 215-221; 1993.

Collins J. A.; Schandl C. A.; Young K. K.; Vesely J.; Willingham M. C. Major DNA fragmentation is a late event in apoptosis. J. Histochem. Cytochem 45: 923-934; 1997.

Davis C. D.; Uthus E. O. DNA methylation, cancer susceptibility, and nutrient interactions. Exp. Biol. Med 229: 988-995; 2004.

Dole M.; Nunez G.; Merchant A. K.; Maybaum J.; Rode C. K.; Bloch C. A.; Castle V. P. Bcl-2 inhibits chemotherapy-induced apoptosis in neuroblastoma. Cancer Res 54: 3253-3259; 1994.

Institute of Medicine, National Academy of Sciences, USA Dietary reference intakes for thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. National Academy Press, Washington, DC 1998.

Jones P. A.; Laird P. W. Cancer epigenetics comes of age. Nat. Genet 21: 163-167; 1999.

Kim H. H.; Park C. S. Lipotropes regulate bcl-2 gene expression in the human breast cancer cell line, MCF-7. In Vitro Cell Dev. Biol. Anim 38: 205-207; 2002.

Kim H. H.; Park C. S. Methionine cytotoxicity in the human breast cancer cell line MCF-7. In Vitro Cell. Dev. Biol. Anim 39: 117-119; 2003.

Moon Y. S.; Keller W. L.; Park C. S. Dietary lipotrope-mediated mammary carcinogenesis in female rats. Nutr. Res 18: 1605-1614; 1998.

Mooney L. M.; Al-Sakkaf K. A.; Brown B. L.; Dobson P. R. M. Apoptotic mechanisms in T47D and MCF-7 human breast cancer cells. Br. J. Cancer 87: 909-917; 2002.

Newberne P. M.; Rogers A. E. Labile methyl groups and the promotion of cancer. Annu. Rev. Nutr 6: 407-432; 1986.

Ottaviano Y. L.; Issa J. P.; Parl F. F.; Smith H. S.; Baylin S. B.; Davidson N. E. Methylation of the estrogen receptor gene CpG island marks loss of estrogen receptor expression in human breast cancer cells. Cancer Res 54: 2552-2555; 1994.

Ross S. A. Diet and DNA methylation interactions in cancer prevention. Ann. NY Acad. Sci 983: 197-207; 2003.

Shrubsole M. J.; Jin F.; Dai Q.; Shu X. O.; Potter J. D.; Herbert J. R.; Gao Y. T.; Zheng W. Dietary folate intake and breast cancer risk: results from the Shanghai Breast Cancer Study. Cancer Res 61: 7136-7141; 2001.

Silvestrini R.; Veneroni S.; Daidone M. G.; Benini E.; Boracchi P.; Mezzetti M.; Di Fronzo G.; Rilke F.; Veronesi U. The Bcl-2 protein: a prognostic indicator strongly related to p53 protein in lymph node-negative breast cancer patients. J. Natl. Cancer fast 86: 499-504; 1994.

Soto A. M.; Murai J. T.; Siiteri P. K.; Sonnenschein C. Control of cell proliferation: evidence for negative control on estrogen- sensitive T47D human breast cancer cells. Cancer Res 46: 2271-2275; 1986.

Soule H. D-; Maloney T. M.; Wolman S. R.; Peterson W. D.; Brenz R. Jr; McGrath C. M.; Russo J.; Pauley R. J.; Jones R. F.; Brooks S. C. Isolation and characterization of a spontaneously immortalized human breast epithelial cell line, MCF-10. Cancer Res 50: 6075- 6086; 1990.

Sumantran V. N.; Ealovega M. W.; Nunez G.; Clarke M. F.; Wicha M. S. Overexpression of Bcl-X^sub s^ sensitizes MCF-7 cells to chemotherapy-induced apoptosis. Cancer Res 55: 2507-2510; 1995.

Waterland R. A.; Jirtle R. L. Early nutrition, epigenetic changes at transposons and imprinted genes, and enhanced susceptibility to adult chronic diseases. Nutrition 20: 63-68; 2004.

Zhang G. J.; Kimijima I.; Onda M.; Kanno M.; Sato H.; Watanabe T.; Tsuchiya A.; Abe R.; Takenoshita S. Tamoxifen-induced apoptosis in breast cancer cells relates to down-regulation of Bcl-2, but not Bax and Bcl-X^sub L^, without alteration of p53 protein levels. Clin. Cancer Res 5: 2971-2977; 1999.

C. S. Park (*) * K. Cho – L. Mabasa * A. W. Fowler

Department of Animal Science, North Dakota State University,

Fargo, ND 58105, USA

e-mail: [email protected]

D. R. Bae

Department of Animal Sciences, The Ohio State University,

Columbus, OH 43210, USA

N. E. Joo

Department of Periodontics/Prevention/Geriatrics,

School of Dentistry, University of Michigan,

Ann Arbor, MI 44109, USA

H. H. Kirn

Abramson Cancer Center, University of Pennsylvania,

Philadelphia, PA 19104, USA

Health

eCardio Launches the eVolution(SM)

Written By: Sam Savage

Published Date: October 8, 2008 Last Edited: October 8, 2008

THE WOODLANDS, Texas, Oct. 8 /PRNewswire/ — eCardio Diagnostics, LLC announced the launch of the eVolution(SM), a single-component cardiac monitoring system that provides instant and accurate patient information through automated data transmissions.

“The eVolution(SM) is the next leap forward in extended daily monitoring,” noted Robert Jordan, Executive Vice President for eCardio. “The simple configuration offers patients a more convenient remote monitoring option while continuing to provide physicians with real-time information about the cardiac health of their patients.”

The eVolution(SM) automatically detects and records cardiac rhythm events and transmits the data to the eLab, eCardio’s 24-hour state-of-the-art monitoring center. The device provides continuous computerized monitoring by means of a micro-processor running an exclusive auto-detecting algorithm. This technology delivers real-time data analysis, allowing physicians to discover both symptomatic and asymptomatic arrhythmias with speed and precision.

In addition, the eVolution(SM) offers:

— A Single Component System, eliminating the cumbersome monitor, modem and base station associated with traditional ambulatory cardiac telemetry systems;

— Flexibility for physicians to remotely program the device while being worn by the patient;

— Customized parameters to more effectively monitor changing patient conditions or specific patient requirements; and

— Convenience for patients with minimal interruptions to the patient’s daily routine.

“Diagnosis and monitoring of cardiac arrhythmias is a complicated and challenging process and timing plays a crucial part,” Nadim Nasir Jr., M.D., F.A.C.C. Director of Clinical Electrophysiology Services and Medical Director of the Cardiac Electrophysiology Lab at Methodist DeBakey Heart Center, commented. “The eVolution’s instant detection and transmission features deliver immediate reports with minimal artifact, which allows me to make more precise treatment decisions for my patients.”

The eVolution(SM) also enhances patient compliance by simplifying the set-up and the extended monitoring process.

As with all of eCardio’s arrhythmia monitoring products, the eVolution(SM) monitors are complimentary to enrolled physicians and monitoring services provided by eCardio are covered by commercial insurance and Medicare.

eCardio will offer hands-on demonstrations of the eVolution(SM) at the upcoming American Heart Association’s Annual Scientific Sessions, November 9-11, 2008 in New Orleans.

About the eVolution(SM)

The eVolution(SM) is a single-component cardiac monitor system that provides instant and accurate patient information through automated data transmissions. The monitor is indicated for diagnostic evaluation of patients who experience transient symptoms such as palpitations or syncope. It is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data wirelessly or over a telephone line to a host PC for review by a licensed physician.

The eVolution(SM) adheres to patient privacy standards and requirements for the electronic transmission of health information, as set forth by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

About eCardio Diagnostics

eCardio Diagnostics LLC, http://www.ecardio.com/, is the nation’s leading provider of comprehensive and advanced technologies, devices, services and solutions for the diagnosis, monitoring, and subsequent clinical management of cardiac arrhythmias, predominantly in the ambulatory setting. eCardio provides leading-edge diagnostic innovations and solutions that optimize the flexibility, speed and accuracy of cardiac arrhythmia diagnoses — contributing to the most timely, effective and appropriate management of cardiac patients.

eCardio Diagnostics, LLC

CONTACT: Rachael Lille Moore, +1-281-465-5210, [email protected], orAndrea Geraci, +1-281-465-5200, [email protected], both of eCardioDiagnostics

Web site: http://www.ecardio.com/

Health

Kampung Folk Go to Surgeons `As Last Resort’

Written By: Sam Savage

Published Date: October 8, 2008 Last Edited: October 8, 2008

By June Ramli

KUALA LUMPUR: Many people prefer to refer their bone ailments to bomoh and sinseh rather than to orthopaedists.

This practice is especially noted in rural areas where such surgeons are almost non-existent.

Asean Orthopaedic Association president Dr Jamal Azmi Mohamad said they knew of this because orthopaedic surgeons had received numerous referrals from traditional medicine men.

“Instead of coming to us first, people in kampung and sometimes even the cities prefer to see these traditional medicine men,” he said at the 28th Asean Orthopaedic Association Congress and the 38th Malaysian Orthopaedic Association (MOA) annual general meeting and scientific meeting at a hotel here recently.

He said it was therefore crucial for the government to post more orthopaedists at rural hospitals.

Most of the 500 orthopaedic surgeons in the country are based in the Klang Valley.

MOA president Dr Robert Penafort suggested that sinseh and bomoh be regulated.

“Because they have no regulations governing them, they are free to do anything with their patients.

“When we get referrals from them, it was already too late for the patient, especially if they have cancer or a tumour,” Dr Penafort said.

“We hope the Health Ministry will take steps to regulate bomoh and sinseh because a lot of people prefer to go to them just because they are scared of going through operations, ” he said, adding that patients were also put off by the three- to six-month waiting period.

Health

Sinseh, Dukun Can Register Online Soon

Written By: Sam Savage

Published Date: October 8, 2008 Last Edited: October 8, 2008

KUALA LUMPUR: Traditional and complementary medicine (TCM) practitioners will soon be able to register online with the Health Ministry through e-Pengamal, a free voluntary registration system.

Minister Datuk Liow Tiong Lai said the system would be available from next month ahead of the mandatory registration of TCM practitioners under the Traditional and Complementary Healthcare Practices Act.

The Act aims to regulate TCM practitioners such as sinseh and dukun by validating their qualifications, enforcing their compulsory registration with the ministry and managing the issuance of practising certificates.

He said a roadshow would be held soon to demonstrate how TCM practitioners can use e-Pengamal, which was developed by the ministry’s TCM division.

Speaking after launching the Golden Horses Health Sanctuary TCM Wellness Centre in Seri Kembangan near here yesterday, Liow said as of May, there were 7,578 TCM practitioners registered under seven umbrella bodies.

They are the Federation of Chinese Physicians and Medicine Dealers Associations of Malaysia, Federation of Chinese Physicians and Acupuncturists Associations of Malaysia, Federation of Malay Traditional Medicine Practitioners, Federation of Indian Traditional Medicine Malaysia, Malaysian Homeopathic Medical Council, Malaysian Society of Complementary Therapies and Chinese Physician’s Association of Malaysia.

Liow said three more hospitals, in Terengganu, Sabah and Sarawak, would offer TCM services.

“The three pilot projects which offered traditional complementary medicine have received overwhelming response.”

The three hospitals currently offering TCM are the Kepala Batas Hospital, Putrajaya Hospital and Hospital Sultan Ismail in Johor.

“In Hospital Putrajaya, appointments have been made up to three months in advance.

“The TCM unit in hospital Kepala Batas has recorded almost 4,000 cases, collectively, for traditional Malay massage, acupuncture and adjunct herbal treatment for cancer patients on chemotherapy,” he said.

Also present at yesterday’s ceremony was Country Heights Holdings founder and deputy chairman Tan Sri Lee Kim Yew.

Health

Art, Culture Help Homeless Rebound

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

By Audra D.S. Burch

MIAMI – In the fifth pew from the back of the Coral Gables Congregational Church, Luanne Allgood sits with four homeless men on one side of her, two on the other, and listens to flutist Eugenia Zukerman’s interpretation of Mozart’s Violin Sonata in F Major. Allgood, who has played the bassoon since she was 11, knows this music, knows its power.

Just two hours earlier, the homeless men she has brought here tonight, 18 in all, had shopped at Burdines, their nickname for the room at the Miami Rescue Mission where donated clothes are available. Some have dressed up for the first time since before their lives fell apart. Every quarter, Allgood introduces a group of men living at the mission – up to 30 at a time and more than 1,000 over 11 years – to the other side of life, to ballets and museums and theater.

“I believe that art and love heal,” Allgood says. “These are men who have every reason to give up. I just hope by surrounding them with beautiful things and trying to change the way they think of their lives, I can make a difference.”

These cultural excursions – Allgood arranges free admission and pays for other expenses – are integral to a 16-week enrichment course she founded called Creative Living, even more than the charitable exercise of a well-intentioned woman facing a roomful of hardened men, gutted by drugs and alcohol and mental illness, looking for a second or third chance.

On the theory that first you clean them up, then you make them whole, more and more rehabilitation centers across the country have begun to incorporate fine art and other cultural components into their recovery programs.

“Our members are seeing the value in artistic expression which helps people reconnect to their lives,” says Phil Rydman of the Association of Gospel Rescue Missions of Kansas City, which represents 300 missions, including the one in Miami. More than a third – including facilities in Seattle, Los Angeles and Atlanta – have launched such programs run by volunteers who believe that the fine arts are as critical as food or faith.

Allgood uses her connections – she has played with chamber ensembles and orchestras in Miami, Atlanta, Cincinnati and Kalamazoo and owns a commercial-production company – to immerse the Miami mission’s clients in environments that cultivate their sense of humanity.

Here she comes this Monday night, popping out of a tiny hybrid automobile across from the mission’s main building, and walking past the homeless souls on the sidewalks who are waiting for three hots and a cot.

Inside a classroom just across the street, Allgood’s students – scarred, like most of the mission’s other clients, by combinations of drink, dope and crime – will be able to escape for a couple of hours from their struggles against anger and emptiness.

“The mission does a wonderful job of getting these men back on their feet again,” Allgood says. “I work to reset their hearts and reactivate their dreams. These men need someone to believe in them and to help them rediscover their special gifts.”

This night, 17 students, including a 21-year-old Miami man hooked on cocaine and alcohol and a Georgia man who has swilled so much cognac that he cannot remember the names of his grandchildren, sit in a semi-circle, singing an old Frank Sinatra standard.

“But he’s got high hopes, he’s got high hopes,” they sing in deep, clumsy bellows and a sweet mix of English and Spanish. “He’s got high apple pie in the sky hopes.” Allgood’s tiny voice floats above their collective bass.

If only for this moment, the men sing as if they believe. And believing – in Allgood, in themselves – is precisely the point.

There’s nothing overtly saintly about Luanne Allgood. She simply sees poetry in the broken and understands the power of escaping time and place – if only for an hour of songs and prayers and painting on a Monday night before lights out at the mission, or for two hours of horseshoes and tug of war at a picnic in Matheson Hammock Park.

“It’s hard to believe a nice lady like that is willing to spend time with a group of losers like us,” whispers Calvin Hartry, the Georgia alcoholic and grandfather of five, snatching at the single tear that streams down the bones and folds of his 58-year-old face. “People normally run from people like us. … Why would anyone invest in us?”

Almost a year ago, after one of his daughters quit speaking to him and he couldn’t afford another bottle of liquor, Hartry showed up at a mission in Atlanta, begging for help. Knowing that he had used up patience and goodwill in that city’s shelters and rehabs, the director gave him a one-way ticket to Miami.

“He told me about the Miami Rescue Mission and said they would give me this last shot to get my life together – what’s left of it,” Hartry says. “After everything I have been through and everything I have learned, seems like the right thing for me to do is go out and preach the gospel of love and kindness, which is all that woman has ever shown us.”

The bus, carrying 18 homeless men on a muggy night, moves slowly from the urban corners of Overtown to the reborn midtown patches vibing with hip energy to the well-manicured, old-moneyed elegance of Coral Gables.

The men quietly stare out the windows as one scene blurs into another until Willie Smith, an alcoholic hoping to become a nurse once he leaves the mission, begins to sing “Victory Is Mine,” an old spiritual. They sing half a dozen more hymns before the bus pulls up to the Coral Gables Congregational Church.

“You guys look so handsome,” Allgood says as the men, some still adjusting their ties, gather outside the church.

“I wanted to look like I belonged,” Ronald McMullen, a 47-year- old truck driver, says softly without making eye contact. “I am pretty excited ’cause I have never heard this kind of music before.”

As the men file into the pews, Allgood reminds them of concert etiquette, of when – and when not – to applaud. She tells them not to clap between the movements listed in the program but at the end of the composition.

“The music is in parts, like chapters in a book,” she says. “You want to be able to hear it with continuity, without clapping. Not making the noise is about creating a pure listening environment and being courteous to your neighbor.”

They listen quietly as Zukerman plays Carl Philipp Emanuel Bach’s “Sonata in A Minor.” Even when some members of the more obviously pedigreed audience applaud out of turn, Allgood’s students sit silently until the music stops, and Zukerman turns slightly and lifts her gaze.

Then the men applaud. And their teacher beams.

“Luanne taught us all about this classical stuff. She talked about how we should be dressed and what to expect,” says Jose Puente, 40, of Hialeah, homeless because he couldn’t kick an 18- year cocaine and crack habit. “The event gives you another perspective, lets you know there is a better life out there.”

It’s better than working small plumbing gigs to earn a paycheck on Friday afternoon and buy drugs by Friday night. “And then start over,” Puente says. “You can’t see anything else but how you are going to get your next high.”

To understand the Luanne Allgood story is to appreciate that she was born bigger than the small Michigan farm town in which she was raised. She grew up on a 40-acre farm in Sturgis, Mich., population 11,000. Her father, a parts manager for the city, died when she was 18; her mother was a secretary. She has known since middle school that music would move her beyond the city’s six square miles. There she is, in a telling first-grade photo, grinning – in that I-march- to-a-different-beat expression she still owns – one front tooth missing, messy bangs and a round collar that refuses to conform.

“Luanne has this free spirit about her. If it wasn’t fun, she would make it fun,” says Gayle Horton, her older sister by two years. “We used to have this three-ring circus on the farm with the other children. It was imaginary, of course, but every year, Luanne was the ringmaster, the one who hosted the show for the parents.”

Allgood’s childhood was clearly demarcated: B.B. and A.B., before and after the bassoon, an odd choice except for this 11-year-old, so drawn to its distinctive voice and towering 4-foot height.

Mary Noday of Fort Lauderdale, a retired music-appreciation professor at Barry University and Broward College, says the bassoon is such a difficult instrument to learn that, typically, students tackle another one first.

Not Allgood. Practicing for countless hours in a room below her sister’s bedroom, she mastered its warm, low-pitched timbre that settles along the bottom of a song.

“My playing the bassoon was a defining moment in my life,” she says. “It just seemed to turn something on inside of me. It is a calling.”

Allgood played through college at Western Michigan University and while studying for her master’s degree at the University of Michigan.

“Effervescent, that is the word to describe Luanne’s personality,” says Phyllis Rappeport, a retired Western Michigan piano professor. “Even back then, she was making the connection between the aesthetic and community. She didn’t know it at the time, but she was preparing for her mission work.”

Allgood’s first job after college was teaching junior high and high school band and orchestra in Battle Creek, Mich. In her study hall, she took on the unruly students, introducing them to the cello. Before the end of the fall semester, the kids, who came to be called the “Dirty Dozen,” had learned to play.

“No one could believe the transformation,” Allgood says. “All of a sudden, these kids blossomed. I got to see what happens when we see and make beautiful things.”

Allgood, who is divorced, arrived in Miami in 1990 to work for a television commercial-production company. Six years later, she started OohLaLa! Productions, with a client roster that includes McDonald’s, Home Depot and State Farm Insurance. She also played with the Miami Symphony Orchestra for six years.

She lives south of downtown in a modern, airy house filled with a mix of contemporary and vintage furnishings and her grandmother’s safe, wash basin and teapot. She lives with two cats and a dog and feeds a flock of neighborhood ducks. And she nurtures a homeless woman who lives in a nearby park.

“She talks about the woman like she is family,” says Horton, a geriatric nurse consultant in Atlanta. “She sees the goodness in everyone.”

During the Christmas holidays in 1996, Allgood volunteered to play music and help distribute toys at Miami Rescue Mission.

“We were talking about how nice it would be if [the homeless men] had the opportunity to go to cultural events,” says Ron Brummitt, executive director. “Before you know it, Luanne was back with the Creative Living class idea.”

Allgood’s students participate in the mission’s Alpha curriculum, which focuses on faith-based education and life and job skills.

“Every person here is broken by something. We have to keep peeling the layers back to get to the core issues,” says Russell Barbour, director of the mission’s centers. “Luanne works on the other side of it to help make them whole.”

Allgood plans a half-dozen outings for each new group. Over the years, her students have been to the Lowe Art Museum and the Miami Art Museum and to plays at Florida International University and the University of Miami. They have visited an Overtown studio to paint abstracts with artist Bayunga. They have listened to professors of drama and acting, the trumpeter who played the opening fanfare for ABC’s “Monday Night Football,” a nutritionist and a professional storyteller.

Still, her commitment isn’t always easy.

Some men are not interested in learning or are too bitter to embrace change.

“There’s been so much ugliness in their lives, and they need so much,” Allgood says. “So, a lot of them come in with their arms folded and staring straight ahead. They don’t want to be there. And some never open up.”

In the last week of class, the men take a field trip to the Everglades.

At Coopertown’s rustic dock and restaurant off Tamiami Trail, they climb aboard two airboats. Half have never been on a boat; only four have ever been to the Everglades; only two have seen a live alligator. Today, they see five.

For every gator sighting, Ron McMullen seems to be transported closer to Charlotte, N.C., which he left when things went bad seven years ago.

“I love this place because it’s so peaceful, maybe what heaven is like,” McMullen says. “It makes me think of back home. I wish my ex- wife could see this.”

He had met his wife at a church dance. She was 12; he was 15. They married as soon as she turned 18. Eventually he strayed, and the marriage fell apart. So did his mind.

“I never forgave myself,” he said. “This class makes you stop beating up yourself so much,” McMullen says, standing at the Coopertown dock where, he has just decided, he will get married, if he ever finds someone who will accept him.

“Before her, there was so much junk and craziness in my head. Luanne taught me to love myself.”

Originally published by McClatchy Newspapers.

Health

Canada Post Foundation for Mental Health Fundraising Stamp on Sale Now

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Canada Post has issued a new stamp that encourages all Canadians to show their support for the one in five Canadians who suffer from mental illness. With the sale of each Mental Health fundraising stamp book, one dollar will be donated to the Canada Post Foundation for Mental Health. The stamp’s issue date coincides with the start of Mental Illness Awareness Week (MIAW), which Canada Post sponsors.

“This stamp advocates change, much-needed change. Change starts by raising awareness and it does its most good when it impacts lives,” said Moya Greene, President and CEO of Canada Post. “The funds raised by this stamp will help patients, their families and the people they turn to for support. It’s a big job for a little stamp, but I’m confident that with the public’s support and 62,000 Canada Post employees acting as ambassadors, we’ll succeed with this ambitious mission,” Greene added.

Canada Post became the first Canadian corporation to adopt mental health as its cause of choice in 2007. With the new Canada Post Foundation for Mental Health, the postal service has created an independent organization dedicated to raising awareness and understanding of mental illness and the millions of Canadians that it affects. Canada Post’s goal is to raise $1 million for the foundation this year.

Guided by an independent board of trustees, the Canada Post Foundation for Mental Health will support front-line organizations serving patients, consumers and caregivers. It will also focus on eliminating the stigma of mental illness, raising awareness of how it affects the lives of all Canadians and to ensuring mental health issues take their rightful place in our country’s health and social policies. The Foundation will receive funds raised by Canada Post and its employees, as well as donations from the public, and expects to begin disbursing funds in mid-2009.

The Mental Health stamp was designed by Paul Haslip of HM&E Design Communication and uses a photograph by Nigel Dickson. Lowe-Martin has been contracted to produce an initial press run of 10 million stamps, in booklets of 10. With the additional surcharge, each booklet will sell for $6.20.

Canada Post has previously issued fundraising stamps from 1974 to 1976 for the Olympic Games in Montreal, and in 1996 to support literacy in Canada.

MULTIMEDIA AVAILABLE:

http://media3.marketwire.com/em/3681

 Contacts: Canada Post Media Relations 613-734-8888 www.canadapost.ca

SOURCE: CANADA POST and Canada’s Top 100 Employers – 2009

Health

Ban Coin-Operated Tanning Salons, Say Health Experts

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

By Madeleine Brindley Health Editor

LEADING health experts have called for coin-operated sun bed salons to be banned as it emerged one company is charging just 30p a minute.

The Chartered Institute of Environmental Health, which has been at the vanguard of the campaign against sunbeds, today branded them “machines that promote cancer”.

The calls come as Consol Suncenter is offering a 30p-a-minute sunbed deal this month in its 12 coin-operated tanning salons in South Wales, to be found from Newport to Llanelli, including three in Cardiff and two each in Swansea and Newport.

A maximum of 16 minutes on the beds at the unmanned shops costs less than pounds 5.

When the Western Mail visited the Pontypridd Consol Suncenter salon it found large signs on the window advertising the 30p- aminute deal.

There was also a smaller sign on the front door and inside stating that the beds were not to be used by under-16s.

But there was no one in the shop to enforce this ruling.

Julie Barratt, director of the Chartered Institute of Environmental Health in Wales, said: “People go into the salons and take advantage of these offers.

“They don’t think about the immediate effects or the long-term potential for skin cancer.

“They just see an opportunity to go from being fairly pale to sunburned and take it.

“The complete absence of any control mechanism means it is very dangerous.

“There is nothing to stop under-16s from using these beds and the risk is that children and older adults will use it to excess.

“Sunbeds are the same as cigarette vending machines – they are machines that effectively promote cancer.”

A report published by the International Agency for Research into Cancer last year found that people who start using sunbeds under the age of 35 increase their risk of malignant melanoma – the most deadly form of skin cancer – by 75%.

The British Photodermatology Group recommends that sunbeds are not used at all, but if they are, usage should be limited to no more than two courses a year of 10 sessions each.

And Cancer Research UK’s website on sunbed use states: “Sunbeds give out UV rays just like the sun.

“Exposure to UV rays, whether from the sun or a sunbed, damages the DNA in your skin cells which can cause cancer. In fact, the intensity of some types of UV rays from sunbeds can be up to 10to 15 times higher than that of the midday sun.”

Dr Richard Lewis, Welsh secretary of the BMA, said: “We believe that there should be a thorough regulation of sunbed operators.

Tighter controls could have a positive impact on skin cancer prevention efforts.

“We have been concerned for some time about rising sunbed use and the effect this may have on levels of skin cancer.”

A spokeswoman for Consol Suncenters said: “During our short 30p- per-minute offer in October, any customer using our studios will do so in the safest possible tanning environment in Wales.

“Consol is the only company in the UK to comply with an EU declaration significantly limiting the output of sunbeds to minimise any risk of burning. Consol limits sunbed session times so that customers cannot take more than 16 minutes before the sunbed automatically shuts down.

“Consol also provides customers with a highly accurate skin tester developed by dermatologists to measure skin type and accurately advise on how long to use a sunbed.

“Anyone determined to use a sunbed in an unsafe way can hire a sunbed at home or move from one studio to the next.

“It is our view that the limited strength and session times of our sunbeds, plus the accuracy of our skin tester and educational information available is the most effective way of reducing inappropriate use of tanning equipment.”

Dr Jodie Moffat, Cancer Research UK’s science information officer, said: “This case highlights the need for legislation banning sunbeds wherever there is no supervision, as has already been done in Scotland.

“Tighter control of the industry will help to ensure young people are protected from putting themselves at increased risk of skin cancer and that adults who choose to use sunbeds are made fully aware of the risks.”

Science

Slowing Economy Could Ease Growth Of Climate Change Emissions

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

A Nobel Prize winning scientist said on Tuesday that the current lagging economy could provide Earth with a much-needed break from climate change-inducing emissions of carbon dioxide.

Atmospheric scientist Paul J Crutzen, known for discussing the possibility of blitzing the stratosphere with sulfur particles to cool the earth, said a global economic slowdown could help slow growth of carbon dioxide emissions.

Furthermore, although the global economic turmoil may also divert focus from efforts to counter climate change, a slowing economy could spur more careful use of energy resources.

“It’s a cruel thing to say … but if we are looking at a slowdown in the economy, there will be less fossil fuels burning, so for the climate it could be an advantage,” said Crutzen, who was awarded the Nobel Prize in Chemistry in 1995 for his work on the depletion of the ozone layer.

“We could have a much slower increase of CO2 emissions in the atmosphere … people will start saving (on energy use) … but things may get worse if there is less money available for research and that would be serious,” Crutzen added.

The U.N. Panel on Climate Change estimates that world temperatures may rise by between 1.8 and 4.0 degrees Celsius (3.2-7.2 degrees Fahrenheit) this century. The Group of Eight industrial nations agreed in July to a goal of halving world emissions by 2050.

Crutzen drew criticism when he authored a paper in 2006 suggesting that injecting the common pollutant sulfur into the stratosphere some 10 miles above the earth could snuff out the greenhouse effect.

He believes that dispersing 1 million tons of sulfur into the stratosphere each year, either on balloons or in rockets, would deflect sunlight and cool the planet.

“I am not saying we should do it, but it is one of the options if we continue under present conditions. We should study it,” he said. “If you look beyond a decade, two decades, and nothing has been done (to counter warming) then we will have a very serious problem on our hands.”

Sulfur is a component of acid rain, which has harmful effects on plants and fish.

“Acid rain is caused by sulfur dioxide emissions from the ground, from the chimneys, and it’s 50 million tons per year. The experiment in the stratosphere would be one million tons of sulfur per year. It’s negligible,” he said.

In a 2007 report, the U.N. climate change panel said such geo-engineering options were largely speculative and unproven, with the risk of unknown side effects. Reliable cost estimates had not been published, it said.

“The price is not a major factor… it’s peanuts,” said Crutzen. “The cost has been estimated by some at 10, 20 million U.S. dollars a year.”

—

Image Caption: Paul J Crutzen (NASA)

—

On the Net:

U.N. Panel on Climate Change

Oddities

Human-Like Robogirl Repliee R-1 Unveiled to Public

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Japanese boffins from Tsukuba University have unveiled the most realistic robot suit to date with plans to distribute it on a mass scale on Friday.

Built after a real five-year-old Japanese girl using flexible silicon skin, the Hybrid Assistive Limb (HAL) suit has 50 sensors and a series of motors to help disabled people move better.

The newly developed robogirl is named Repliee R-1. Its sensors and motors combine to help Repliee R-1 move like a human more than any robot ever created.

Robotics company Cyberdyne Inc said it is preparing to begin distributing the suit on a mass scale on Friday.

At the 2005 World Expo in Japan, the Repliee Q1 appeared showing human-gestures and a lifelike appearance. Q1 was powered by a nearby air compressor, and had 31 points of articulation in its upper body. Q1 was noted to have glitch-related “spasms” at the 2005 expo.

—

On the Net:

Tsukuba University

Health

DuPage’s Only Provider of Head Start Takes Aim at Childhood Obesity in Minorities

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

BENSENVILLE, Ill., Oct. 7 /PRNewswire/ — Lifelink today announced that it has launched an expansive campaign to bring a comprehensive diet and nutrition curriculum to all of its Head Start and Early Head Start classrooms in an effort to have a dramatic impact on lowering childhood obesity and diabetes in minority children. Lifelink also will offer the program in home-based settings to Head Start families and to all families participating in Lifelink’s Healthy Family programs.

Lifelink is the exclusive provider of Head Start and Early Head Start in DuPage County, serving 484 children and 525 parents — at least 95 percent of whom live below the poverty level. Currently, 93 percent of the children it serves are ethnic minorities (77 percent are Latino, 7.7 percent are African American, 1.5 percent are bi-racial and 6.6 percent are Caucasian). A majority of the children come from immigrant families with a variety of languages spoken. One of Lifelink’s Head Start centers has 19 different home-languages spoken.

Statistics indicated that families living below the poverty level are significantly more likely to be overweight or obese. America’s poor families are especially hard hit because of a convergence of factors — lack of neighborhood grocery stores carrying fresh fruits and vegetables, rising cost of nutritious foods, fewer safe parks and play spaces for exercise, and the ease and lower cost of fast foods for family’s daily menu options.

Color Me Healthy(TM)/Salud Primero introduces a healthy nutrition and exercise curriculum to the children alongside a coordinated Health First program for parents, which is a more in-depth curriculum than is already being provided through Head Start parent trainings and Healthy Family curriculums. Lifelink is working alongside DuPage health and mental health providers to bring this comprehensive approach to all of its 14 Head Start/Early Head Start classrooms.

“Childhood obesity and chronic disease are disproportionately affecting African American and Latino children. A lifelong commitment to nutrition and healthy lifestyles is the strongest tool we have to prevent the development of preventable chronic disease in children,” said Kim Perez, Lifelink vice president of Child & Family Services.

Perez notes that the Color Me Healthy(TM)/Salud Primero curriculum has a proven track record. It won an education award from the North Carolina Association of Cooperative Extension Specialists as well as the Dannon Institute Award for Excellence in Community Nutrition. The curriculum was cited for its early intervention in the learning process and its lifelong impact on the participant’s healthy lifestyle choices.

   Color Me Healthy(TM)/Salud Primero curriculum highlights/goals    -- 100 percent of Lifelink Head Start and Healthy Families staff will be      trained in the curriculum   -- 100 percent of children, ages 3-5, will participate in nutrition and      exercise curriculum   -- 90 percent of Head Start teachers will spend at least one hour per week      dedicated solely to nutrition topics and exercise sessions   -- 100 percent of children will be introduced to healthy fruits and      vegetable tastings   -- 100 percent of children will indicate they understand the correlation      between movement, nutrition and health by the end of the program's      inaugural year.   -- 60 percent of parents will attend 15 or more nutrition/exercise      training sessions   -- 100 percent of parents will receive curriculum newsletters and handouts   -- 50 percent of parents will indicate they have made positive changes in      diet and exercise   -- 75 percent of parents will indicated they have been screened for      diabetes and other chronic diseases   -- 90 percent of parents will express knowledge of how to access free      healthcare for their families   -- 85 percent of families will have created an family health plan   -- Lifelink will train 10 bilingual parents to become peer health      ambassadors

Lifelink’s work with parents also will focus on access to annual screenings and affordable or free healthcare to help families prevent chronic disease.

Founded in 1895, Lifelink is a not-for-profit human service organization related to the United Church of Christ. Lifelink’s multi-generational programs include affordable housing for older adults and physically challenged adults, housing management services, home care, Head Start, Early Head Start, Healthy Families, foster care, international adoption, Latino family services and ministries for at-risk youths at its Hoyleton offices in southern Illinois. Lifelink is fully accredited by the national Council on Accreditation. COA accreditation attests that an organization meets the highest national standards of best practice and is delivering the best quality services to the communities it serves.

Lifelink

CONTACT: Sylvia Dobbins-Daniels of Lifelink, +1-630-521-8707,[email protected]; or Susana Leyva, +1-312-658-0473,[email protected]

Health

ACSM, AHA Support Federal Physical Activity Guidelines

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

To: NATIONAL EDITORS

Contact: Christa Dickey of American College of Sports Medicine, +1-317- 352-3827, [email protected]; or Katie Bell of American Heart Association, +1-214-706-1345, [email protected]

U.S. recommendations reflect previously published ACSM/AHA

guidelines

INDIANAPOLIS and DALLAS, Oct. 7 /PRNewswire-USNewswire/ — Guidelines for physical activity released today by the U.S. Department of Health and Human Services (HHS) were met with support from the American College of Sports Medicine (ACSM) and the American Heart Association (AHA). The organizations, which jointly published physical activity recommendations last year, attended today’s announcement and said the guidelines effectively support each other and are all based on the most relevant science that links physical activity to improved health and wellness. ACSM/AHA guidelines focus on 30 minutes of moderate-intensity daily physical activity five days a week. HHS guidelines call for a minimum of 150 minutes of moderate physical activity a week, an amount most reasonable on five days a week at a duration of 30 minutes.

The associations note that the core recommendation as it relates to health gains of physical activity are highly consistent. In both the ACSM/AHA guidelines, and those released today by HHS, the latest science was evaluated to understand the physiological mechanisms by which physical activity provides health benefits and the physical activity profile (type, intensity, amount) that is associated with enhanced health and quality of life.

Both sets of recommendations conclude that relatively modest amounts of physical activity will improve health and cardiorespiratory fitness of inactive persons, while expanded health gains, such as weight loss or weight maintenance, may require more than a minimum 30 minutes of moderate activity most days of the week. In general, there are more agreements than differences when it comes to physical activity recommendations. Differences on “minutes- per-day” or “days per week” recommendations appear because they are intended for different groups, and may be age-specific or relevant to overweight or obese individuals.

“Guidelines for physical activity have long been based on research demonstrating that even relatively moderate amounts of physical activity will have positive benefits on health,” said William Haskell, Ph.D., FACSM, lead author of the ACSM/AHA guidelines. “A very important idea, especially for people who are inactive, is that health and physical activity are closely linked. The more days a week that you can be active or accumulate some activity, the higher the value for your health and wellness.”

ACSM and AHA emphasize that beginning an exercise program is the most important public health message when it comes to physical activity guidelines. Physical activity for at least 30 minutes a day, consistent with ACSM/AHA and federal recommendations, or accumulating a minimum of 150 minutes of moderate activity a week, has been shown to have substantial health benefits.

“Numerous studies now suggest that if we can simply move people out of the lowest levels of cardiorespiratory fitness, it can have a profound (and beneficial) impact on public health”, says Barry A. Franklin, Ph.D., national American Heart Association spokesperson and Director of Cardiac Rehabilitation and Exercise Laboratories at William Beaumont Hospital in Royal Oak, Michigan.

AbouttheAmericanCollegeofSportsMedicine

ACSM is the largest sports medicine and exercise science organization in the world. More than 20,000 international, national, and regional members are dedicated to advancing and integrating scientific research to provide educational and practical applications of exercise science and sports medicine.

AbouttheAmericanHeartAssociation

Founded in 1924, the American Heart Association today is the nation’s oldest and largest voluntary health organization dedicated to reducing disability and death from diseases of the heart and stroke. These diseases, America’s No. 1 and No. 3 killers, and all other cardiovascular diseases claim nearly 870,000 lives a year. In fiscal year 2005-06 the association invested over $543 million in research, professional and public education, advocacy and community service programs to help all Americans live longer, healthier lives. To learn more, call 1-800-AHA-USA1 or visit americanheart.org .

Editor’sNote:ACSM/AHA guidelines published jointly in Medicine & Science in Sports and Exercise(R), ACSM’s official journal and Circulation, a journal of the American Heart Association in August 2007. For more information or additional details on the physical activity guidelines, please visit www.americanheart.org/fitnessor www.acsm.org/physicalactivity.

AHAEditor’sNote:In January 2007, the American Heart Association introduced Start!, a national campaign calling on all Americans and their employers to create a culture of physical activity and health to live longer, heart-healthy lives. Through active, year-round participation in walking, Start! supports the mission of the American Heart Association, to reduce the risk of cardiovascular disease and stroke. To learn more, call 1-800-AHA-USA1 or visit americanheart.org/start .

ACSMEditor’sNote:The American College of Sports Medicine has launched new resources, accessible at www.acsm.org/ physicalactivity, to help the public better understand physical activity guidelines and customize a program for their individual activity needs at no cost.

SOURCE American College of Sports Medicine

Health

Medline Announces Exclusive Distribution Agreement for Abaqis(R) Nursing Home Quality Assurance System

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Medline Industries, Inc. announced today a strategic licensing agreement with Nursing Home Quality, LLC, granting Medline exclusive rights to market and distribute the company’s abaqis(R) Nursing Home Quality Assurance System. The Web-based system allows nursing home providers to identify quality concerns and focus their improvement efforts using the same forms, analysis and thresholds used by state surveyors in the new Quality Indicator Survey (QIS).

“The long-term care survey process has changed dramatically with the QIS, and we’re excited to align with a forward-looking company and product that gives healthcare providers a unique ability to improve the quality of resident care,” said Shawn Scott, Medline vice president of healthcare corporate sales. “We are always seeking new technologies that provide targeted solutions, so aligning with Nursing Home Quality was a natural fit.”

Quality assurance and evaluation of our nation’s 15,000 nursing homes — where more than 1.5 million people live — is a growing matter of concern with providers, consumers and the federal government calling for a more consistent and resident-centered survey process. The new QIS process addresses this need through structured protocols that are fully automated on tablet PCs and by obtaining more information from direct questioning of residents and families. As a result, regulatory areas such as quality of life, which were not as fully investigated in the traditional process, are now receiving closer scrutiny.

As the only quality assessment and reporting system for nursing homes tied directly to the QIS, abaqis(R) gives providers the unique opportunity to use QIS tools and approaches for ongoing quality assurance and continuous survey readiness. Users are able to identify quality concerns in the same manner as surveyors and address those concerns before, rather than after, an evaluation. Rich reporting capabilities identify which care areas a facility should target for quality improvement, and drill-down capabilities provide root cause analysis on a facility-wide or individual resident basis, so healthcare providers can focus their interventions for maximum impact.

“Ensuring quality of care and quality of life for residents, as well as being continuously survey-ready, is a challenge for any healthcare organization,” said Andrew Kramer, M.D., CEO of Nursing Home Quality. “With abaqis(R), users will be able to build quality assurance, based on the federal code of regulations, into a nursing home’s daily processes. The results of such an approach will not only be improved survey readiness, but also dramatic improvement in resident care.”

To learn more about the abaqis(R) Nursing Home Quality Assurance System, visit www.medline.com/abaqis or call 1-800-MEDLINE.

About Nursing Home Quality, LLC

Nursing Home Quality assists nursing home operators and staff members in improving the quality of care and quality of life for their residents. Nursing Home Quality trains surveyors and certifies state survey agency trainers in QIS under contract to CMS and provides affordable and reliable QIS training and Web-based systems to nursing homes.

About Medline Industries, Inc.

Medline, the nation’s largest privately held manufacturer and distributor of healthcare products, manufactures and distributes more than 100,000 products to hospitals, extended care facilities, surgery centers, home care dealers and agencies and other markets. Headquartered in Mundelein, IL, Medline has more than 800 dedicated sales representatives nationwide to support its broad product line and cost management services.

Meeting the highest level of national and international quality standards, Medline is FDA QSR compliant and ISO 13485 registered. Medline serves on major industry quality committees to develop guidelines and standards for medical product use, including the FDA Midwest Steering Committee, AAMI Sterilization and Packaging Committee and various ASTM committees. For more information on Medline, visit our Web site, www.medline.com.

Embedded Video Available: http://www2.marketwire.com/mw/release_html_b1?release_id=440939

 Media Contact: Jerreau Beaudoin Office: 847-643-3011 Mobile: 224-213-9878

SOURCE: Medline Industries, Inc.

Business

Somaliland: Plane Carrying Deportees Refused Permission to Land

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Excerpt from report by independent Somaliland newspaper Waaheen on 7 October

A plane from Saudi Arabia which was carrying Somalis who had been deported from that country is said to have been denied clearance to land at Hargeysa airport.

The plane is said to have tried to land at Mogadishu airport but aborted after being informed that Mogadishu airport was insecure. It then proceeded to Hargeysa to offload its human cargo. However, airport officials declined to have it land there forcing it to fly back to Saudi Arabia.

Reports say the plane was carrying Somalis who had been deported from Saudi Arabia and was told about the insecurity at the airport after it was established that it was carrying the Somali deportees.

Somali migrants in Saudi Arabia are usually deported back to the country soon after they are arrested by Saudi police.

Reports say Jeddah prisons are bursting at the seams with illegal Somali migrants who cannot be deported back to the country.

This comes at a time when thousands of migrant Somalis are flocking to the Kingdom of Saudi Arabia. They risk their lives by travelling by sea to Yemen. Hundreds die every year [passage omitted].

Originally published by Waaheen newspaper in Somali 7 Oct 08.

Health

Unraveling the Mysteries of Rett Syndrome and the Brain

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Could new findings about Rett syndrome lead the way in developing new techniques for unraveling other diseases that affect the brain? October is Rett Syndrome Awareness Month, and over 800 of the world’s leading Rett Syndrome researchers, clinicians, organizations and families will meet at the Maison de la Mutualie, Paris October 10 -13 for the 6th World Rett Syndrome Congress hosted by Professor Philippe Evrard, who leads a research department in neurosciences in brain development and neuroprotection and sponsored by the International Rett Syndrome Foundation. This congress is expected to be the largest, most comprehensive meeting of its kind. These distinguished scientists and thought leaders will gather together to discuss the development of treatments and cures for Rett syndrome and other spectrum disorders. Many believe that with an aggressive and focused research strategy, Rett syndrome may be the first brain disorder to be reversed.

“Rett syndrome could indeed prove the Rosetta Stone, allowing scientists to develop techniques for understanding the effects of other mutant proteins that affect neurons,” said Dr. Laura Mamounas, program director for the National Institute of Neurological Diseases and Stroke (NINDS) at the National Institutes of Health. The NINDS is a US federal agency that supports research on Rett syndrome. “People with disorders from autism to Fragile X could benefit from findings in the area of Rett, an autism spectrum disorder affecting mainly females.”

In 1999, Dr. Huda Zoghbi, professor of pediatrics, neurology, neuroscience and molecular and human genetics at Baylor College of Medicine in Houston found the Rett gene responsible for the production of MeCP2, a protein that affects the function of nearly every neuron in the brain.

In 2007, a team of researchers led by Dr, Adrian Bird at Edinburgh University reversed Rett Syndrome symptoms in a mouse bred to display many of the outward signs of the disorder. While his technique is not applicable in the human disease, it did show that it is possible to reverse the damaging symptoms of the disease.

“Since this discovery there has been a sea change in attitude about the way we think about neurological disorders. This seminal discovery supports the view that perhaps Rett is a neurological disorder that could possibly be treated by therapeutic interventions,” said Dr. Mamounas. “Until now, we hoped that was the case, but did not have concrete scientific evidence to support this idea. This has all changed.”

Genetic similarities between Rett and other neurological and brain disorders mean that it may be possible to reverse some neurological conditions thought untreatable before. According to Dr. Tony Horton, Chief Scientific Officer of the International Rett Syndrome Foundation, the world’s largest private funder of Rett syndrome research, “The major challenge now is to lay the foundation for translating these recent exciting discoveries into the development and testing of new therapeutics which could one day be used to treat Rett syndrome and perhaps other related disorders. This is our current focus.”

“The breadth and scope of this congress will be a first for Rett syndrome and related spectrum disorders,” according to Dr. Helen Leonard, an Australian researcher and head of the program committee for the World Congress, “It will extend from a detailed exploration of the neurobiology of Rett syndrome, particularly incorporating the work being done on mouse models to basic clinical and epidemiological research relating clinical presentation to genetic determinants. We have reason to hope.”

About Rett Syndrome

Rett syndrome (RTT), a brain disorder affecting development in childhood, has been identified almost exclusively in females. RTT results in severe movement and communication problems following apparently normal development for the first six months of life. The characteristic features include loss of speech and purposeful hand use, occurrence of repetitive hand movements, abnormal walking, abnormal breathing, and slowing in the rate of head growth. Current treatment for girls with RS includes physical and occupational therapy, speech therapy, and medication for seizures. No cure for Rett syndrome is known. In 2008, researchers heralded a major breakthrough by reversing RTT symptoms in mouse models. Rett syndrome is recognized as the “Rosetta Stone” of other neurological disorders, with genetic links to other disorders like autism and schizophrenia. It is the most physically disabling of the autism spectrum disorders.

About International Rett Syndrome Foundation

IRSF is the world’s leading private funder of basic, translational and clinical Rett syndrome research and is the most comprehensive non-profit organization dedicated to providing thorough and accurate information about Rett syndrome, offering informational and emotional family support, and stimulating research aimed at accelerating treatments and a cure for Rett syndrome and related disorders. To learn more about IRSF and Rett syndrome, visit www.rettsyndrome.org or call IRSF at 1-800-818-RETT.

Health

United Hospital Fund Honors Rear Admiral Robert A. Rosen, NYNM (Ret.) For Creating a Center to Treat “Invisible Wounds” of War Veterans, Law Enforcement Personnel, and Their Families

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

The United Hospital Fund honored Rear Admiral Robert A. Rosen, NYNM (Ret.), with its 2008 Distinguished Community Service Award at its annual black-tie gala, held Monday, October 6, 2008. The award recognizes Admiral Rosen for his leadership in creating the Florence and Robert A. Rosen Family Wellness Center at the North Shore-Long Island Jewish (LIJ) Health System, which addresses the physical and mental health issues of veterans, law enforcement personnel, and their families.

In 2005, after identifying inadequacies in access to mental health services for the veterans returning from Iraq and Afghanistan, Admiral Rosen sought the guidance of his friend and colleague Dr. Lawrence Scherr, former chairman of the medicine at North Shore University Hospital. Admiral and Mrs. Rosen wanted to help those who have served our country and who, as a result, are experiencing a range of problems, from post-traumatic stress disorder, depression, and substance abuse, to marital and other family problems, sleep disorders, and workplace difficulties. Admiral Rosen and Mrs. wanted to help their families, too.

With his wife, Florence, and their family, Admiral Rosen envisioned and then created The Florence and Robert A. Rosen Family Wellness Center for Law Enforcement and Military Personnel and Their Families at the North Shore-LIJ Health System–recognized as the first of its kind and a national model. The center treats what Admiral Rosen calls “the invisible wounds of war,” the psychological and behavioral conditions that are sometimes hidden, but just as serious as bullet wounds. A critical and distinguishing feature of the Center is its emphasis on caring for the entire family, recognizing that dangerous and stressful assignments can have a serious impact on spouses, partners, parents, and children–and that the reintegration of families after long and sometimes multiple deployments brings unique challenges.

Designed to complement, not compete with, government programs, the Rosen Center’s services are entirely confidential and free to those in need. Because the Center is designed to be a resource “without walls,” veterans and their families can enter the program at any of 15 North Shore-LIJ hospitals or right in their own communities. The Center also features research programs to ensure the most responsive, accessible, and effective care.

While the Rosen Center has already provided over 1,500 clinical sessions and reached more than 1,600 attendees through its community education and outreach programs, its ultimate goal is to ensure that all of the 1 million veterans, hundreds of thousands of law enforcement personnel, and family members throughout the New York region know that special care is available.

“We are pleased to recognize Rear Admiral Rosen with the Distinguished Community Service Award,” said James R. Tallon, Jr., president of the United Hospital Fund. “He identified a critical need in the New York community–the need of individuals who put their lives at risk in service to their community and country–and he found a way to address that need, first in concept, then in practice. Like the Fund itself, Admiral Rosen understands that change for the better in health care is more than possible; it is doable. He knows how challenging such change can be, but the rewards are even greater. We at the Fund share his belief that the creation of the Rosen Family Wellness Center will make an important difference in the lives and health of countless New Yorkers. It demonstrates the role that not-for-profit hospitals can play in addressing unmet needs.”

The Distinguished Community Service Award was established by the Fund in 1987 to recognize and promote extraordinary contributions by public-minded citizens to improve health care in New York City. For a third year, the Distinguished Community Service Award has been underwritten by TIAA-CREF, America’s leading provider of retirement services in the medical, academic, research, and cultural fields. Roger W. Ferguson, Jr., president and chief executive officer of TIAA-CREF, presented the award to Rear Admiral Robert A. Rosen, NYNM (Ret.), this year’s recipient.

Mr. Ferguson said, “TIAA-CREF shares the United Hospital Fund’s enthusiasm in recognizing Admiral Robert Rosen, whose work to address the psychological and behavioral wounds of war resulted in a first-of-its-kind wellness center at North Shore-Long Island Jewish Health System that is notable for its holistic approach to mental health treatment for returning veterans and their families. Admiral Rosen, the United Hospital Fund, and TIAA-CREF all believe in serving those who serve others, and TIAA-CREF is pleased to join with the United Hospital Fund tonight to honor Admiral Rosen’s achievement.”

Admiral Rosen is chairman and CEO of Rosen Associates Management Corporation, a real estate company with properties throughout the country. He credits much of his professional and voluntary success to the support he gets from his family–Florence, his wife of 48 years, his four married children, and his 13 grandchildren.

At the gala, the Fund also honored Anthony L. Watson, chairman and chief executive officer of EmblemHealth, Inc., with its Health Care Leadership Award, and The New York Community Trust, one of New York’s preeminent philanthropic leaders, with a Special Tribute.

The gala was held at the Waldorf-Astoria Hotel. The event marks the opening of the Fund’s 130th fund-raising campaign, which supports hospitals and health care in New York and the Fund’s work to shape positive change.

The benefit chairman was J. Barclay Collins II, executive vice president and general counsel of Hess Corporation, who is chairman of the United Hospital Fund.

TIAA-CREF offers a full array of financial products and services to help those in the medical, academic, cultural and research fields plan for and live in retirement.

The United Hospital Fund is a health services research and philanthropic organization whose mission is to shape positive change in health care for the people of New York. For more information, please visit www.uhfnyc.org.

Health

CryoLife Hosts Worldwide Surgical Congress for the Ross Procedure

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

ATLANTA, Oct. 7 /PRNewswire-FirstCall/ — CryoLife, Inc. , a biomaterials, medical device and tissue processing company, announced today that cardiovascular surgeons from around the globe will participate in the Ross Summit 2008, a two-day surgical congress to be held at the Company’s corporate headquarters training facility in Kennesaw, Ga. The program, slated for Oct. 10 and 11, has piqued the interest of the worldwide cardiovascular surgical community with approximately 80 cardiovascular surgeons from 11 countries convening to explore new data supporting the patient advantages of the Ross Procedure in cardiac reconstruction surgeries. In addition, the participants will have the opportunity to perfect their surgical techniques related to the procedure and to learn of new, related technologies now available. Mr. Donald N. Ross, FRCS, consultant surgeon, National Heart Hospital, London, and inventor of the procedure, will be the honored guest at the summit.

The Ross Procedure is a type of specialized aortic valve surgery in which the patient’s diseased aortic valve is replaced with his or her own pulmonary valve. The pulmonary valve is then replaced with a human cryopreserved pulmonary valve. A new decellurized human pulmonary heart valve, CryoValve(R) SG, processed using CryoLife’s SynerGraft(R) technology, was cleared by the FDA in February 2008 for use in cardiac reconstruction procedures including the Ross Procedure.

The Ross Summit’s world renowned faculty, directed by William F. Northrup III, M.D., vice president, medical relations and education at CryoLife, Inc., will be led by Professor Sir Magdi Yacoub, FRS, FRCS, Imperial College, London, Heart Science Center.

“In children and young adults, or older, active patients, the Ross Procedure offers several advantages over other traditional aortic valve replacement options. The most important advantage is improved long-term survival,” said Dr. Northrup. “However, the procedure requires very specific surgical expertise in order to achieve predictable, long-lasting results. The goal of this Summit is to provide the training necessary from acknowledged experts in the field. By doing so, we hope to expand the number of surgeons who can offer this procedure to their patients.”

Additional distinguished cardiovascular surgeons on the Summit faculty include: Prof. Hans Sievers, M.D., FETCS, Klinik fur Herzchirugie, Luebeck, Germany; Emile A. Bacha, M.D., Children’s Hospital Boston, Boston, Mass.; Paul Stelzer, M.D., Mt. Sinai Hospital, New York, N.Y.; Prof. John W. Brown, M.D., Indiana University, Indianapolis, Ind.; Hanneke Takkenberg, M.D., Ph.D., Erasmus University, Rotterdam, Netherlands; Michael F. Teodori, M.D., Phoenix Children’s Hospital, Phoenix, Ariz.; Prof. Francisco da Costa, M.D., Santa Casa De Curitiba, Curitiba, Brazil; Prof. Neal Kon, M.D., Wake Forest University, Winston-Salem, NC.: Prof. Ross Ungerleider, M.D., Oregon Health & Science University, Portland, Ore.; and Giovanni Battista Luciani, M.D., University of Verona, Verona, Italy.

“The Ross Summit will create a unique atmosphere in which to engage in thought-provoking, interactive discussions about this ingenious surgical procedure with leading cardiovascular surgeons in the field,” said Dr. Northrup. “The additional opportunity for hands-on valve implantation in a wet lab environment each day, led by Professors Yacoub and Sievers, offers an invaluable educational opportunity to these surgeons.”

“The outstanding response we’ve received from the worldwide cardiovascular surgical community on this Summit is indicative of the professional interest in the Ross Procedure and in the new technologies and products related to it, such as the CryoValve SG,” added Steven G. Anderson, chairman, president and CEO of CryoLife. “We look forward to hosting these surgeons and in playing a role in honing their technical skills, so that they can offer this surgical option to their patients.”

About CryoLife, Inc.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company recently received FDA clearance for the CryoValve(R) SG pulmonary human heart valve, processed using CryoLife’s proprietary SynerGraft(R) Technology. The Company’s BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. CryoLife distributes Hemostase MPH(R), a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in the United Kingdom, Germany, France and Canada for cardiac, vascular, and general surgery, subject to certain exclusions. The Company also distributes the CryoLife-O’Brien(R) Stentless Porcine Aortic Bioprosthesis, which is CE marked for distribution within the European Community.

For additional information about the company, visit CryoLife’s Web site: http://www.cryolife.com/

   CryoLife Media Contacts:    D. Ashley Lee                                          Katie Brazel   Executive Vice President, Chief Operating Officer      Fleishman-Hillard   and Chief Financial Officer                            Phone: 404-739-0150   CryoLife, Inc.   Phone: 770-419-3355

CryoLife, Inc.

CONTACT: D. Ashley Lee, Executive Vice President, Chief OperatingOfficer and Chief Financial Officer of CryoLife, Inc., +1-770-419-3355; orKatie Brazel of Fleishman-Hillard, +1-404-739-0150

Web site: http://www.cryolife.com/

Health

Wayne County Community College District Hosts Open House at the New Northwest Campus

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

DETROIT, Oct. 7 /PRNewswire/ — Wayne County Community College District (WCCCD) welcomes everyone to a special Community Open House at its New Northwest Campus, on Saturday, October 11, 2008, from 10:00 a.m. to 3:00 p.m., located at 8200 W. Outer Drive, Detroit, MI 48219 (Just off the Southfield Freeway). This event is open to the public and is free of charge.

WCCCD’s New Northwest Campus opened to students for their first day of classes on Monday, August 25, 2008. The opening was a spectacular success and immediately filled to capacity with a total student enrollment of nearly 7,000 students.

“Our new Northwest Campus is a milestone in the District’s history as we continue to ensure that all of our students and communities have access to a high-quality education,” said Dr. Curtis L. Ivery, WCCCD Chancellor. “This new campus has already become our flagship campus by allowing the District to expand course offerings that help people prepare for jobs that are in demand today. We welcome everyone to the open house, to experience this incredible campus and learn about the broad range of programs, courses and amenities that are available to help people build secure and stable careers.”

The community will have an opportunity to tour the campus, enjoy entertainment and live performances by local groups, visit the children’s area for youth activities and receive complimentary refreshment and giveaways. Representatives will be on hand to speak with students, their parents, family and friends regarding the educational opportunities that are available throughout the District, as well as discuss financial aid and the transferring of credited courses.

The New Northwest Campus is located on a 32-acre site and includes the Academic Administration Building, the General Arts Building and the Student Welcome Center. The District’s Health Science Center is also located at this campus and offers students a variety of allied health careers such as Nursing and Dental Programs.

WCCCD is committed to the continued development of new programs, hosting more community-based training sessions, improving student facilities and services, upgrading technologies, making capital investments in massive building expansion projects, training staff members to enhance their skills to maximize efficiency.

This event is open to the public at no cost. For a listing of all special events at the District, please visit http://www.wcccd.edu/ or call 313-496-2704.

Wayne County Community College District

CONTACT: Tina Bassett or Vidya Moorthy, both of Bassett & Bassett,Incorporated, +1-313-965-3010 [24/7/365], for Wayne County Community CollegeDistrict

Web site: http://www.wcccd.edu/

Health

Sunquest Announces $1.5M Sale of Its Laboratory Information Software and Services to the Public Hospitals Authority for Hospitals and Community Clinics in the Commonwealth of The Bahamas

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Sunquest Information Systems, Inc., a market leader in laboratory information systems, today announced a $1.5M sale to the Public Hospitals Authority (PHA) for the purchase of the Sunquest Laboratory Information System (LIS) along with a number of other Sunquest software solutions and services for the Princess Margaret Hospital (PMH), Rand Memorial Hospital (RAND), Sandilands Rehabilitation Center (SRC) and the Department of Public Health (DPH), Ministry of Health.

The Managing Director of the PHA, Mr. Herbert Brown, announced recently that “The PHA has embarked on an aggressive initiative to modernize our Information Technology (IT) infrastructure and install or replace several of our IT-enabled business solutions, one of which is the Laboratory Information System.” The PHA purchased Sunquest Laboratory/Microbiology, Sunquest CoPathPlus, Collection Manager, Encompass, Outreach, and SMART solutions, along with Sunquest Professional Services.

“After researching its current and future needs and IT requirements, the PHA performed a thorough analysis of available laboratory information systems as well as the companies behind the products,” stated Dr. Frank Bartlett, Medical Chief of Staff at the Rand Hospital. “PHA’s decision to go with the Sunquest Laboratory Information System was based on two main points. Firstly, their solution is mature, scalable and has excellent features and functionality. Secondly, and equally important, Sunquest has the industry’s best reputation for service, which is evidenced by their large installed base of satisfied customers and numerous KLAS Awards.”

“The Public Hospital Authority is taking the necessary steps towards building an IT infrastructure foundation that will improve the quality of healthcare service and coverage for its population,” said Richard Atkin, president and CEO of Sunquest Information Systems, Inc. “Sunquest is very pleased that the PHA selected our solution over several competitive offerings. We have proven success with helping many organizations in their missions to bring better healthcare to patients and to improve service to care providers. We are looking forward to working with the PHA in reaching their goal of delivering excellent healthcare services to the people of the Commonwealth.”

The PHA is making additional investments in healthcare information technology, including a new system for the Pharmacy. Aligned with the laboratory project, the pharmacy system is timely since The Bahamas has a government initiative to provide a National Chronic Non-Communicable Disease Prescription Drug Plan for its population of some 350,000 people.

About the Public Hospitals Authority

The Public Hospitals Authority (PHA) was established in July 1999 by an Act of Parliament (1998) as a public corporation responsible for the management and development of the public hospital system in the Commonwealth of The Bahamas. By virtue of this Act, the PHA was vested with the powers, rights, privileges and ownership, of all land, buildings, movable property and undertakings of the hospitals that were previously held by the government. There are three (3) such institutions, namely: Princess Margaret Hospital (PMH) Sandilands Rehabilitation Centre (SRC); and Rand Memorial Hospital (RAND). The PHA is also responsible for the management of the following agencies: The Bahamas National Drug Agency (BNDA) and the Materials Management Directorate (MMD) which procure pharmaceutical drugs and medical/surgical supplies respectively for the entire government healthcare sector; and the National Emergency Medical Services (NEMS). For further information, you may visit the PHA website www.phabahamas.org.

About Sunquest Information Systems, Inc.

Sunquest Information Systems, Inc. is a global market leader in clinical data management solutions with more than 1,200 hospitals and commercial laboratories using its products worldwide. The company is dedicated to providing best-of-suite solutions that enable quality patient care, clinical safety, and operational efficiencies. Its experienced sales and technical service teams deliver 24×7 assistance to customers for their procurement, implementation, and customer care needs. The Sunquest Laboratory(TM) system achieved “Best in KLAS” in the Laboratory Segment for 2007, which was its fourth consecutive year (KLAS Enterprises, LLC, www.KLASresearch.com).

Sunquest’s professional services division provides a wide array of management and technical tools, including lab redesign and optimization, outreach and lab network program development, and operational business and implementation plans. For more information, call 800-748-0692 or visit: www.sunquestinfo.com.

Sunquest is a Trademark of Sunquest Information Systems, Inc. All other product or service names are the property of their respective owners.

Health

Researchers to Evaluate a Once-Daily Investigational Dose of Raltegravir, Merck’s Integrase Inhibitor, in an Investigational Population, Patients Previously Untreated for HIV-1

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

WHITEHOUSE STATION, N.J., Oct. 7 /PRNewswire/ — Merck & Co., Inc. today announced that researchers will conduct a clinical trial to evaluate the use of raltegravir tablets at a once-daily investigational dose in an investigational population, previously untreated (treatment-naive) HIV patients. The once-a-day dose will be compared to a twice-daily regimen, and both will be studied in combination with Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), in treatment-naive HIV patients. The trial, called QDMRK, is a double-blind, randomized, active comparator-controlled clinical trial that aims to enroll 750 patients at 94 centers in 21 countries.

The study will measure the proportion of patients achieving HIV RNA

CD4 cell counts.

Patients interested in taking part in the QDMRK clinical trial are encouraged to speak with their physician. For more information, please visit http://www.benchmrk.com/ and click on QDMRK.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. For more information, visit http://www.merck.com/.

Forward-looking statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking

statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck’s Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company’s periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.

Full prescribing information and patient product information for raltegravir is attached.

   Patient Information   ISENTRESS(TM) (eye sen tris)   (raltegravir)   Tablets

Read the patient information that comes with ISENTRESS(1) before you start taking it and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients. Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is ISENTRESS? -- ISENTRESS is an anti-HIV (antiretroviral) medicine that helps to control HIV infection. The term HIV stands for Human Immunodeficiency Virus. It is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). ISENTRESS is used along with other anti-HIV medicines in patients who are already taking or have taken anti-HIV medicines and the medicines are not controlling their HIV infection. ISENTRESS will NOT cure HIV infection. -- People taking ISENTRESS may still develop infections, including opportunistic infections or other conditions that happen with HIV infection. -- Stay under the care of your doctor during treatment with ISENTRESS. -- The long-term effects of ISENTRESS are not known at this time. -- The safety and effectiveness of ISENTRESS in children less than 16 years of age has not been studied. ISENTRESS must be used with other anti-HIV medicines. How does ISENTRESS work? -- ISENTRESS blocks an enzyme which the virus (HIV) needs in order to make more virus. The enzyme that ISENTRESS blocks is called HIV integrase. -- When used with other anti-HIV medicines, ISENTRESS may do two things: -- It may reduce the amount of HIV in your blood. This is called your "viral load". -- It may also increase the number of white blood cells called CD4 (T) cells that help fight off other infections. -- ISENTRESS may not have these effects in all patients. Does ISENTRESS lower the chance of passing HIV to other people?

No. ISENTRESS does not reduce the chance of passing HIV to others through sexual contact, sharing needles, or being exposed to your blood.

   --  Continue to practice safer sex.   --  Use latex or polyurethane condoms or other barrier methods to lower       the chance of sexual contact with any body fluids. This includes semen       from a man, vaginal secretions from a woman, or blood.   --  Never re-use or share needles.   --  Ask your doctor if you have any questions about safer sex or how to       prevent passing HIV to other people.                                    1. What should I tell my doctor before and                                      during treatment with ISENTRESS?

Tell your doctor about all of your medical conditions. Include any of the following that applies to you:

   --  You have any allergies.   --  You are pregnant or plan to become pregnant.   --  ISENTRESS is not recommended for use during pregnancy. ISENTRESS has       not been studied in pregnant women. If you take ISENTRESS while you       are pregnant, talk to your doctor about how you can be included in the       Antiretroviral Pregnancy Registry.   --  You are breast-feeding or plan to breast-feed.   --  It is recommended that HIV-infected women should not breast-feed their       infants. This is because their babies could be infected with HIV       through their breast milk.   --  Talk with your doctor about the best way to feed your baby.     Tell your doctor about all the medicines you take. Include the following:   --  prescription medicines   --  non-prescription medicines   --  vitamins   --  herbal supplements     Know the medicines you take.   --  Keep a list of your medicines. Show the list to your doctor and       pharmacist when you get a new medicine.     How should I take ISENTRESS?

Take ISENTRESS exactly as your doctor has prescribed. The recommended dose is as follows:

   --  Take only one 400 mg tablet at a time.   --  Take it twice a day.   --  Take it by mouth.   --  Take it with or without food.

Do not change your dose or stop taking ISENTRESS or your other anti-HIV medicines without first talking with your doctor.

IMPORTANT: Take ISENTRESS exactly as your doctor prescribed and at the right times of day because if you don’t:

   --  The amount of virus (HIV) in your blood may increase if the medicine       is stopped for even a short period of time.   --  The virus may develop resistance to ISENTRESS and become harder to       treat.   --  Your medicines may stop working to fight HIV.   --  The activity of ISENTRESS may be reduced (due to resistance).     If you fail to take ISENTRESS the way you should, here's what to do:   --  If you miss a dose, take it as soon as you remember. If you do not       remember until it is time for your next dose, skip the missed dose and       go back to your regular schedule. Do NOT take two tablets of ISENTRESS       at the same time. In other words, do NOT take a double dose.   --  If you take too much ISENTRESS, call your doctor or local Poison       Control Center.     Be sure to keep a supply of your anti-HIV medicines.   --  When your ISENTRESS supply starts to run low, get more from your       doctor or pharmacy.   --  Do not wait until your medicine runs out to get more.       1. What are the possible side effects of ISENTRESS?

When ISENTRESS has been given with other anti-HIV drugs, the most common side effects included:

   --  diarrhea   --  nausea   --  headache     Other side effects include rash and severe skin reactions.

A condition called Immune Reconstitution Syndrome can happen in some patients with advanced HIV infection (AIDS) when combination antiretroviral treatment is started. Signs and symptoms of inflammation from opportunistic infections that a person has or had may occur as the medicines work to control the HIV infection and strengthen the immune system. Call your doctor right away if you notice any signs or symptoms of an infection after starting ISENTRESS with other anti-HIV medicines.

Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the side effects of ISENTRESS. For more information, ask your doctor or pharmacist.

   How should I store ISENTRESS?   --  Store ISENTRESS at room temperature (68 to 77ÃƒÆ’Ã‚“šÃƒ“š°F).   --  Keep ISENTRESS and all medicines out of the reach of children.     General information about the use of ISENTRESS

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

   --  Do not use ISENTRESS for a condition for which it was not prescribed.   --  Do not give ISENTRESS to other people, even if they have the same       symptoms you have. It may harm them.     This leaflet gives you the most important information about ISENTRESS.   --  If you would like to know more, talk with your doctor.   --  You can ask your doctor or pharmacist for additional information about       ISENTRESS that is written for health professionals.   --  For more information go to http://www.isentress.com/ or call 1-800-622-4477.     What are the ingredients in ISENTRESS?    Active ingredient: Each film-coated tablet contains 400 mg of raltegravir.

Inactive ingredients: Microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.

   Manufactured and Distributed by:    MERCK & CO., Inc.   Whitehouse Station, NJ 08889, USA   Revised May 2008   9795101   U.S. Patent Nos. US 7,169,780     HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full prescribing information for ISENTRESS.

   ISENTRESS (raltegravir) Tablets   Initial U.S. Approval: 2007     INDICATIONS AND USAGE

ISENTRESS(TM) is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated:

   --  In combination with other antiretroviral agents for the treatment of       HIV-1 infection in treatment-experienced adult patients who have       evidence of viral replication and HIV-1 strains resistant to multiple       antiretroviral agents (1).

The safety and efficacy of ISENTRESS have not been established in treatment-naive adult patients or pediatric patients (1).

   DOSAGE AND ADMINISTRATION   --  400 mg administered orally, twice daily with or without food (2.1).    DOSAGE FORMS AND STRENGTHS   Tablets: 400 mg (3).    CONTRAINDICATIONS   None    WARNINGS AND PRECAUTIONS   Monitor for Immune Reconstitution Syndrome (5.1)     Drug Interactions   --  Caution should be used when coadministering ISENTRESS with strong       inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1       (e.g., rifampin) due to reduced plasma concentrations of raltegravir       (5.2).    ADVERSE REACTIONS   --  The most common adverse reactions (>10%) of all intensities, reported       in subjects in either the ISENTRESS or the placebo treatment group,       regardless of causality were: nausea, headache, diarrhea and pyrexia       (6.1).   --  Creatine kinase elevations were observed in subjects who received       ISENTRESS. Myopathy and rhabdomyolysis have been reported; however,       the relationship of ISENTRESS to these events is not known. Use with       caution in patients at increased risk of myopathy or rhabdomyolysis,       such as patients receiving concomitant medications known to cause       these conditions (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

   USE IN SPECIFIC POPULATIONS   Pregnancy:   --  ISENTRESS should be used during pregnancy only if the potential       benefit justifies the potential risk to the fetus. Physicians are       encouraged to register pregnant women exposed to ISENTRESS by calling       1-800-258-4263 so that Merck can monitor maternal and fetal outcomes       (8.1).   Nursing Mothers:           --  Breast-feeding is not recommended while taking ISENTRESS               (8.3).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

   Revised: 05/2008    FULL PRESCRIBING INFORMATION: CONTENTS*    1  INDICATIONS AND USAGE   2  DOSAGE AND ADMINISTRATION   2.1  Dosing Information   3  DOSAGE FORMS AND STRENGTHS   4  CONTRAINDICATIONS   5  WARNINGS AND PRECAUTIONS   5.1  Immune Reconstitution Syndrome   5.2  Drug Interactions   6  ADVERSE REACTIONS   6.1  Clinical Trials Experience   6.2  Postmarketing Experience   7  DRUG INTERACTIONS   7.1  Effect of Raltegravir on the Pharmacokinetics of Other Agents   7.2  Effect of Other Agents on the Pharmacokinetics of Raltegravir   8  USE IN SPECIFIC POPULATIONS   8.1  Pregnancy   8.3  Nursing Mothers   8.4  Pediatric Use   8.5  Geriatric Use   8.6  Use in Patients with Hepatic Impairment   8.7  Use in Patients with Renal Impairment   10  OVERDOSAGE   11  DESCRIPTION   12  CLINICAL PHARMACOLOGY   12.1  Mechanism of Action   12.2  Pharmacodynamics   12.3  Pharmacokinetics   12.4  Microbiology   13  NONCLINICAL TOXICOLOGY   13.1  Carcinogenesis, Mutagenesis, Impairment of Fertility   14  CLINICAL STUDIES   16  HOW SUPPLIED/STORAGE AND HANDLING   17  PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the Full Prescribing Information are not listed.

   full prescribing information    1  INDICATIONS AND USAGE

ISENTRESS(2) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

This indication is based on analyses of plasma HIV-1 RNA levels up through 24 weeks in two controlled studies of ISENTRESS. These studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults.

The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies (14)].

The safety and efficacy of ISENTRESS have not been established in treatment-naive adult patients or pediatric patients.

There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.

   2  DOSAGE AND ADMINISTRATION   2.1  Dosing Information

For the treatment of patients with HIV-1 infection, the dosage of ISENTRESS is 400 mg administered orally, twice daily with or without food.

   3  DOSAGE FORMS AND STRENGTHS    400 mg pink, ovalshaped, filmcoated tablets with "227" on one side.    4  CONTRAINDICATIONS   None    5  WARNINGS AND precautions    5.1  Immune Reconstitution Syndrome

During the initial phase of treatment, patients responding to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium complex, cytomegalovirus, Pneumocystis jiroveci pneumonia, Mycobacterium tuberculosis, or reactivation of varicella zoster virus), which may necessitate further evaluation and treatment.

5.2 Drug Interactions

Caution should be used when coadministering ISENTRESS with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 (e.g., rifampin) due to reduced plasma concentrations of raltegravir [see Drug Interactions (7)].

   1. ADVERSE REACTIONS        a. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

TreatmentExperienced Studies

The safety assessment of ISENTRESS in treatmentexperienced subjects is based on the pooled safety data from the randomized, double-blind, placebo-controlled trials, BENCHMRK 1 and BENCHMRK 2 (Protocols 018 and 019), and the randomized, double-blind, placebo-controlled, dose-ranging trial (Protocol 005) in antiretroviral treatment-experienced HIV-1 infected adult subjects reported using the recommended dose of ISENTRESS 400 mg twice daily in combination with optimized background therapy (OBT) in 507 subjects, in comparison to 282 subjects taking placebo in combination with OBT. During double-blind treatment, the total follow-up was 332.2 patient-years in the ISENTRESS 400 mg twice daily group and 150.2 patient-years in the placebo group.

The most commonly (>10%) reported adverse reactions, of all intensities, regardless of causality in subjects treated with ISENTRESS and OBT versus placebo and OBT are presented in Table 1.

Table 1: Percentage of Subjects with the Most Commonly Reported (>10%) Adverse Reactions of All Intensities and Regardless of Causality Occurring in

   TreatmentExperienced Adult Subjects        System Organ Class,             Adverse              Randomized Studies P005, P018 and P019            Reactions              ISENTRESS 400 mg        Placebo + OBT                                  twice daily + OBT        (n=282)(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š )                                    (n=507)(  ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š )                %                                          %   Gastrointestinal Disorders     Diarrhea                           16.6                 19.5     Nausea                              9.9                 14.2   Nervous System Disorders     Headache                            9.7                 11.7   General Disorders and Administration Site Conditions     Pyrexia                             4.9                 10.3   -------------------------             ---                 ----         Intensities are defined as follows: Mild (awareness of sign or          symptom, but easily tolerated); Moderate (discomfort enough to          cause interference with usual activity); Severe (incapacitating          with inability to work or do usual activity).        (ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š )n=total number of subjects per treatment group.

The clinical adverse reactions listed below were considered by investigators to be of moderate to severe intensity and causally related to any drug in the combination regimen (ISENTRESS/placebo alone or in combination with OBT, or OBT alone):

Common Adverse Reactions

Drug-related clinical adverse reactions of moderate to severe intensity occurring in >=2% of subjects treated with ISENTRESS + OBT are presented in Table 2.

Table 2: Percentage of Subjects with Drug-Related* Adverse Reactions of Moderate to Severe IntensityÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š Occurring in >=2% of TreatmentExperienced Adult Subjects

   System Organ Class,        Randomized Studies P005, P018 and P019   Adverse Reactions    ISENTRESS 400 mg Twice Daily       Placebo + OBT                                 + OBT                              (n = 282)(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡)              (n = 507)(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡)                                   %                           %   Gastrointestinal Disorders      Diarrhea                     3.7                        4.6      Nausea                       2.2                        3.2   Nervous System Disorders      Headache                     2.4                        1.4   -----------------               ---                        ---        *Includes adverse reactions at least possibly, probably, or very         likely related to the drug.         (ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š )Intensities are defined as follows: Moderate (discomfort         enough to cause interference with usual activity); Severe         (incapacitating with inability to work or do usual activity).        (ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡)n=total number of subjects per treatment group.     Less Common Adverse Reactions

Drugrelated adverse reactions occurring in at least 1% but less than 2% of treatmentexperienced subjects (n=507) receiving ISENTRESS + OBT and of moderate (discomfort enough to cause interference with usual activity) to severe (incapacitating with inability to work or do usual activity) intensity are listed below by system organ class:

   Gastrointestinal Disorders: abdominal pain, vomiting   General Disorders and Administration Site Conditions: asthenia, fatigue   Nervous System Disorders: dizziness   Skin and Subcutaneous Tissue Disorders: lipodystrophy acquired    Discontinuations

In the pooled analyses for studies P005, P018 and P019, the rates of discontinuation of therapy due to adverse reactions were 2.0% in subjects receiving ISENTRESS + OBT and 1.4% in subjects receiving placebo + OBT.

   Serious Events    Drug Related

The following serious drugrelated reactions were reported in the clinical studies, P005, P018 and P019: hypersensitivity (hypersensitivity was seen in 2 subjects with ISENTRESS; therapy was interrupted and upon rechallenge the subjects were able to resume drug), anemia, neutropenia, myocardial infarction, gastritis, hepatitis, herpes simplex, toxic nephropathy, renal failure, chronic renal failure and renal tubular necrosis.

Regardless of Drug Relationship

Cancers were reported in treatmentexperienced subjects who initiated ISENTRESS with OBT; several were recurrent. The types and rates of specific cancers were those expected in a highly immunodeficient population (many had CD4+ cell counts below 50 cells/mm3 and most had prior AIDS diagnoses). The cancers included Kaposi’s sarcoma, lymphoma, squamous cell carcinoma, hepatocellular carcinoma and anal cancer. Most subjects had other risk factors for cancer including tobacco use, papillomavirus and active hepatitis B virus infection. It is unknown if these cancer diagnoses were related to ISENTRESS use.

Grade 2-4 creatine kinase laboratory abnormalities were observed in subjects treated with ISENTRESS (see Table 3). Myopathy and rhabdomyolysis have been reported; however, the relationship of ISENTRESS to these events is not known. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions.

   Patients with Co-existing Conditions    Patients Co-infected with Hepatitis B and/or Hepatitis C Virus

In the clinical studies, P018 and P019, subjects with chronic (but not acute) active hepatitis B and/or hepatitis C virus co-infection (N = 113/699 or 16.2%) were permitted to enroll provided that baseline liver function tests did not exceed 5 times the upper limit of normal (ULN). The rates of AST and ALT abnormalities were somewhat higher in the subgroup of subjects with hepatitis B and/or hepatitis C virus co-infection for both treatment groups. In general the safety profile of ISENTRESS in subjects with hepatitis B and/or hepatitis C virus co-infection was similar to subjects without hepatitis B and/or hepatitis C virus co-infection. Grade 2 or higher laboratory abnormalities that represent a worsening from baseline of AST, ALT or total bilirubin occurred in 26%, 27% and 12%, respectively, of raltegravir-treated coinfected subjects as compared to 9%, 8% and 7% of all other raltegravir-treated subjects.

Laboratory Abnormalities

The percentages of adult subjects treated with ISENTRESS 400 mg twice daily in P005, P018 and P019 with selected Grades 2 to 4 laboratory abnormalities that represent a worsening from baseline are presented in Table 3.

Table 3: Selected Grade 2 to 4 Laboratory Abnormalities Reported in TreatmentExperienced Subjects

                                                 Randomized Studies P005,                                                       P018 and P019       Laboratory               Limit              ISENTRESS        Placebo        Parameter                                   400 mg            +     Preferred Term                             Twice Daily          OBT         (Unit)                                    + OBT          (N = 282)                                                 (N = 507)      Hematology      Absolute neutrophil count (10(3)/L)        Grade 2                 0.75 - 0.999        3.7%            7.4%        Grade 3                 0.50 - 0.749        2.4%            2.5%        Grade 4                                  0.0%            0.0%      Total serum bilirubin        Grade 2                 1.6 - 2.5 x ULN     5.3%            6.7%        Grade 3                 2.6 - 5.0 x ULN     3.2%            2.5%        Grade 4                  >5.0 x ULN         0.8%            0.0%      Serum aspartate aminotransferase        Grade 2                 2.6 - 5.0 x ULN     9.1%            5.7%        Grade 3                5.1 - 10.0 x ULN     2.2%            2.1%        Grade 4                  >10.0 x ULN        0.4%            0.7%      Serum alanine aminotransferase        Grade 2                 2.6 - 5.0 x ULN     6.9%            7.8%        Grade 3                5.1 - 10.0 x ULN     3.0%            1.4%        Grade 4                  >10.0 x ULN        0.6%            1.1%      Serum alkaline phosphatase        Grade 2                 2.6 - 5.0 x ULN     2.0%            0.4%        Grade 3                5.1 - 10.0 x ULN     0.4%            1.1%        Grade 4                  >10.0 x ULN        0.4%            0.4%      Serum pancreatic amylase test        Grade 2                1.6 - 2.0 x ULN      1.4%            0.7%        Grade 3                2.1 - 5.0 x ULN      3.6%            2.1%        Grade 4                    >5.0 x ULN       0.2%            0.0%      Serum lipase test        Grade 2                1.6 - 3.0 x ULN      3.4%            1.8%        Grade 3                3.1 - 5.0 x ULN      0.6%            0.4%        Grade 4                   >5.0 x ULN        0.2%            0.0%      Serum creatine kinase        Grade 2                6.0 - 9.9 x ULN      2.2%            1.4%        Grade 3              10.0 - 19.9 x ULN      2.4%            1.8%        Grade 4                  >=20.0 x ULN        2.2%            0.7%      ULN = Upper limit of normal range     6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ISENTRESS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

   Skin and Subcutaneous Tissue Disorders: rash, Stevens-Johnson syndrome    7 DRUG INTERACTIONS    7.1 Effect of Raltegravir on the Pharmacokinetics of Other Agents

Raltegravir does not inhibit (IC50>100 ÃƒÆ’Ã‚“šÃƒ“šÃ‚µM) CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A in vitro. Moreover, in vitro, raltegravir did not induce CYP3A4. A midazolam drug interaction study confirmed the low propensity of raltegravir to alter the pharmacokinetics of agents metabolized by CYP3A4 in vivo by demonstrating a lack of effect of raltegravir on the pharmacokinetics of midazolam, a sensitive CYP3A4 substrate. Similarly, raltegravir is not an inhibitor (IC50>50 ÃƒÆ’Ã‚“šÃƒ“šÃ‚µM) of the UDP-glucuronosyltransferases (UGT) tested (UGT1A1, UGT2B7), and raltegravir does not inhibit P-glycoprotein-mediated transport. Based on these data, ISENTRESS is not expected to affect the pharmacokinetics of drugs that are substrates of these enzymes or P-glycoprotein (e.g., protease inhibitors, NNRTIs, methadone, opioid analgesics, statins, azole antifungals, proton pump inhibitors, oral contraceptives, and anti-erectile dysfunction agents).

In drug interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of the following: lamivudine, tenofovir.

7.2 Effect of Other Agents on the Pharmacokinetics of Raltegravir

Raltegravir is not a substrate of cytochrome P450 (CYP) enzymes. Based on in vivo and in vitro studies, raltegravir is eliminated mainly by metabolism via a UGT1A1-mediated glucuronidation pathway.

Rifampin, a strong inducer of UGT1A1, reduces plasma concentrations of ISENTRESS. Therefore, caution should be used when coadministering ISENTRESS with rifampin or other strong inducers of UGT1A1 [see Warnings and Precautions (5.2)]. The impact of other inducers of drug metabolizing enzymes, such as phenytoin and phenobarbital, on UGT1A1 is unknown. Other less strong inducers (e.g., efavirenz, nevirapine, rifabutin, St. John’s wort) may be used with the recommended dose of ISENTRESS.

Similar to rifampin, tipranavir/ritonavir reduces plasma concentrations of ISENTRESS. However, approximately 100 subjects received raltegravir in combination with tipranavir/ritonavir in Protocols 018 and 019. Comparable efficacy was observed in this subgroup relative to subjects not receiving tipranavir/ritonavir. Based on these data, tipranavir/ritonavir may be coadministered with ISENTRESS without dose adjustment of ISENTRESS.

Atazanavir, a strong inhibitor of UGT1A1, and atazanavir/ritonavir increase plasma concentrations of raltegravir. However, concomitant use of ISENTRESS and atazanavir/ritonavir did not result in a unique safety signal in Protocol 005 and Protocols 018 and 019. Based on these data, atazanavir/ritonavir may be coadministered with ISENTRESS without dose adjustment of ISENTRESS.

Coadministration of ISENTRESS with other drugs that inhibit UGT1A1 may increase plasma levels of raltegravir.

   7 USE IN SPECIFIC POPULATIONS    8.1  Pregnancy    Pregnancy Category C

ISENTRESS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. In addition, there have been no pharmacokinetic studies conducted in pregnant patients.

Developmental toxicity studies were performed in rabbits (at oral doses up to 1000 mg/kg/day) and rats (at oral doses up to 600 mg/kg/day). The reproductive toxicity study in rats was performed with pre-, peri-, and postnatal evaluation. The highest doses in these studies produced systemic exposures in these species approximately 3- to 4fold the exposure at the recommended human dose. In both rabbits and rats, no treatment-related effects on embryonic/fetal survival or fetal weights were observed. In addition, no treatment-related external, visceral, or skeletal changes were observed in rabbits. However, treatment-related increases over controls in the incidence of supernumerary ribs were seen in rats at 600 mg/kg/day (exposures 3fold the exposure at the recommended human dose).

Placenta transfer of drug was demonstrated in both rats and rabbits. At a maternal dose of 600 mg/kg/day in rats, mean drug concentrations in fetal plasma were approximately 1.5- to 2.5-fold greater than in maternal plasma at 1 hour and 24 hours postdose, respectively. Mean drug concentrations in fetal plasma were approximately 2% of the mean maternal concentration at both 1 and 24 hours postdose at a maternal dose of 1000 mg/kg/day in rabbits.

Antiretroviral Pregnancy Registry

To monitor maternal-fetal outcomes of pregnant patients exposed to ISENTRESS, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.

8.3 Nursing Mothers

Breast-feeding is not recommended while taking ISENTRESS. In addition, it is recommended that HIV-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV.

It is not known whether raltegravir is secreted in human milk. However, raltegravir is secreted in the milk of lactating rats. Mean drug concentrations in milk were approximately 3fold greater than those in maternal plasma at a maternal dose of 600 mg/kg/day in rats. There were no effects in rat offspring attributable to exposure of ISENTRESS through the milk.

8.4 Pediatric Use

Safety and effectiveness of ISENTRESS in pediatric patients less than 16 years of age have not been established.

8.5 Geriatric Use

Clinical studies of ISENTRESS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Use in Patients with Hepatic Impairment

No clinically important pharmacokinetic differences between subjects with moderate hepatic impairment and healthy subjects were observed. No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. The effect of severe hepatic impairment on the pharmacokinetics of raltegravir has not been studied [see Clinical Pharmacology (12.3)].

8.7 Use in Patients with Renal Impairment

No clinically important pharmacokinetic differences between subjects with severe renal impairment and healthy subjects were observed. No dosage adjustment is necessary [see Clinical Pharmacology (12.3)].

10 OVERDOSAGE

No specific information is available on the treatment of overdosage with ISENTRESS. Doses as high as 1600-mg single dose and 800-mg twice-daily multiple doses were studied in healthy volunteers without evidence of toxicity. Occasional doses of up to 1800 mg per day were taken in the P005/P018 & P019 studies without evidence of toxicity.

In the event of an overdose, it is reasonable to employ the standard supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required. The extent to which ISENTRESS may be dialyzable is unknown.

11 DESCRIPTION

ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-m ethyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt.

   The empirical formula is C20H20FKN6O5 and the molecular weight is 482.51.    The structural formula is:

Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol.

Each film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir potassium (as salt), equivalent to 400 mg of raltegravir (free phenol) and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, red iron oxide and black iron oxide.

   12  CLINICAL PHARMACOLOGY    12.1 Mechanism of Action    Raltegravir is an HIV-1 antiviral drug [see Clinical Pharmacology (12.4)].        a. Pharmacodynamics

In a monotherapy study raltegravir (400 mg twice daily) demonstrated rapid antiviral activity with mean viral load reduction of 1.66 log10 copies/mL by Day 10.

In Protocol 005 and Protocols 018 and 019, antiviral responses were similar among subjects regardless of dose.

Effects on Electrocardiogram

In a randomized, placebo-controlled, crossover study, 31 healthy subjects were administered a single oral supratherapeutic dose of raltegravir 1600 mg and placebo. Peak raltegravir plasma concentrations were approximately 4-fold higher than the peak concentrations following a 400 mg dose. ISENTRESS did not appear to prolong the QTc interval for 12 hours postdose. After baseline and placebo adjustment, the maximum mean QTc change was -0.4 msec (1-sided 95% upper Cl: 3.1 msec).

   12.3 Pharmacokinetics    Absorption

Raltegravir is absorbed with a Tmax of approximately 3 hours postdose in the fasted state. Raltegravir AUC and Cmax increase dose proportionally over the dose range 100 mg to 1600 mg. Raltegravir C12hr increases dose proportionally over the dose range of 100 to 800 mg and increases slightly less than dose proportionally over the dose range 100 mg to 1600 mg. With twice-daily dosing, pharmacokinetic steady state is achieved within approximately the first 2 days of dosing. There is little to no accumulation in AUC and Cmax. The average accumulation ratio for C12hr ranged from approximately 1.2 to 1.6.

The absolute bioavailability of raltegravir has not been established.

In subjects who received 400 mg twice daily alone, raltegravir drug exposures were characterized by a geometric mean AUC0-12hr of 14.3 M?hr and C12hr of 142 nM.

Considerable variability was observed in the pharmacokinetics of raltegravir. For observed C12hr in Protocols 018 and 019, the coefficient of variation (CV) for inter-subject variability = 212% and the CV for intra-subject variability = 122%.

Effect of Food on Oral Absorption

ISENTRESS may be administered without regard to food. Administration of raltegravir following a high-fat meal increased raltegravir AUC by approximately 19%. A high-fat meal slowed the rate of absorption resulting in an approximately 34% decrease in Cmax, an 8.5-fold increase in C12hr, and a delay in Tmax following a single 400 mg dose. The effect of consumption of a range of food types on steady-state pharmacokinetics is not known. Raltegravir was administered without regard to food in the pivotal safety and efficacy studies in HIV-1 positive subjects.

Distribution

Raltegravir is approximately 83% bound to human plasma protein over the concentration range of 2 to 10 ÃƒÆ’Ã‚“šÃƒ“šÃ‚µM.

Metabolism and Excretion

The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter -phase half-life (~1 hour) accounting for much of the AUC. Following administration of an oral dose of radiolabeled raltegravir, approximately 51 and 32% of the dose was excreted in feces and urine, respectively. In feces, only raltegravir was present, most of which is likely derived from hydrolysis of raltegravir-glucuronide secreted in bile as observed in preclinical species. Two components, namely raltegravir and raltegravir-glucuronide, were detected in urine and accounted for approximately 9 and 23% of the dose, respectively. The major circulating entity was raltegravir and represented approximately 70% of the total radioactivity; the remaining radioactivity in plasma was accounted for by raltegravir-glucuronide. Studies using isoform-selective chemical inhibitors and cDNAexpressed UDP-glucuronosyltransferases (UGT) show that UGT1A1 is the main enzyme responsible for the formation of raltegravir-glucuronide. Thus, the data indicate that the major mechanism of clearance of raltegravir in humans is UGT1A1-mediated glucuronidation.

   Special Populations    Pediatric

The pharmacokinetics of raltegravir in pediatric patients has not been established.

Age

The effect of age on the pharmacokinetics of raltegravir was evaluated in the composite analysis. No dosage adjustment is necessary.

Race

The effect of race on the pharmacokinetics of raltegravir was evaluated in the composite analysis. No dosage adjustment is necessary.

Gender

A study of the pharmacokinetics of raltegravir was performed in young healthy males and females. Additionally, the effect of gender was evaluated in a composite analysis of pharmacokinetic data from 103 healthy subjects and 28 HIV-1 infected subjects receiving raltegravir monotherapy with fasted administration. No dosage adjustment is necessary.

Hepatic Impairment

Raltegravir is eliminated primarily by glucuronidation in the liver. A study of the pharmacokinetics of raltegravir was performed in subjects with moderate hepatic impairment. Additionally, hepatic impairment was evaluated in the composite pharmacokinetic analysis. There were no clinically important pharmacokinetic differences between subjects with moderate hepatic impairment and healthy subjects. No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. The effect of severe hepatic impairment on the pharmacokinetics of raltegravir has not been studied.

Renal Impairment

Renal clearance of unchanged drug is a minor pathway of elimination. A study of the pharmacokinetics of raltegravir was performed in subjects with severe renal impairment. Additionally, renal impairment was evaluated in the composite pharmacokinetic analysis. There were no clinically important pharmacokinetic differences between subjects with severe renal impairment and healthy subjects. No dosage adjustment is necessary. Because the extent to which ISENTRESS may be dialyzable is unknown, dosing before a dialysis session should be avoided.

UGT1A1 Polymorphism

Data currently available are not sufficient to determine the impact of UGT1A1 polymorphism on raltegravir pharmacokinetics.

   Drug Interactions [see Drug Interactions (7)].    Table 4: Effect of Other Agents on the Pharmacokinetics of Raltegravir                                                             Ratio (90%                                                            Confidence                                                           Interval) of                                                            Raltegravir                                                         Pharmacokinetic                                                            Parameters                                                            with/without                                                          Coadministered                                                              Drug;   Co-administered     Co-administered    Raltegravir     No Effect = 1.00     Drug                 Drug              Dose/                       Dose/Schedule      Schedule   n  Cmax    AUC    Cmin   Atazanavir           400 mg             100 mg   10  1.53    1.72   1.95                         daily         single dose     (1.11,  (1.47  (1.30,                                                        2.12)   2.02)  2.92)   atazanavir/        300 mg/100 mg    400 mg twice 10  1.24   1.41    1.77   ritonavir             daily             daily       (0.87, (1.12,  (1.39,                                                        1.77)  1.78)   2.25)   efavirenz          600 mg daily      400 mg      9   0.64   0.64    0.79                                      single dose      (0.41, (0.52,  (0.49,                                                        0.98)  0.80)   1.28)   rifampin           600 mg daily      400 mg      9   0.62   0.60    0.39                                      single dose      (0.37, (0.30,  (0.39,                                                        1.04)  0.91)   0.51)   ritonavir          100 mg twice     400 mg      10   0.76   0.84    0.99                        daily         single dose      (0.55, (0.70,  (0.70,                                                        1.04)  1.01)   1.40)   tenofovir         300 mg daily      400 mg       9   1.64   1.49    1.03                                      twice daily      (1.16, (1.15,  (0.73,                                                        2.32)  1.94)   1.45)   tipranavir/     500 mg/200 mg     400 mg        15   0.82   0.76    0.45 ritonavir       twice daily       twice daily  (14  (0.46, (0.49,  (0.31,                                                  for   1.46)  1.19)   0.66)                                                  Cmin)         a. Microbiology    Mechanism of Action

Raltegravir inhibits the catalytic activity of HIV-1 integrase, an HIV-1 encoded enzyme that is required for viral replication. Inhibition of integrase prevents the covalent insertion, or integration, of unintegrated linear HIV-1 DNA into the host cell genome preventing the formation of the HIV-1 provirus. The provirus is required to direct the production of progeny virus, so inhibiting integration prevents propagation of the viral infection. Raltegravir did not significantly inhibit human phosphoryltransferases including DNA polymerases ÃƒÆ’Ã‚Å½Ãƒ“šÃ‚±, ÃƒÆ’Ã‚Å½Ãƒ“šÃ‚², and ÃƒÆ’Ã‚Å½Ãƒ“šÃ‚³.

Antiviral Activity in Cell Culture

Raltegravir at concentrations of 31 20 nM resulted in 95% inhibition (EC95) of viral spread (relative to an untreated virus-infected culture) in human T-lymphoid cell cultures infected with the cell-line adapted HIV-1 variant H9IIIB. In addition, raltegravir at concentrations of 6 to 50 nM resulted in 95% inhibition of viral spread in cultures of mitogen-activated human peripheral blood mononuclear cells infected with diverse, primary clinical isolates of HIV-1, including isolates resistant to reverse transcriptase inhibitors and protease inhibitors. Raltegravir also inhibited replication of an HIV-2 isolate when tested in CEMx174 cells (EC95 value = 6 nM). Additive to synergistic antiretroviral activity was observed when human T-lymphoid cells infected with the H9IIIB variant of HIV-1 were incubated with raltegravir in combination with non-nucleoside reverse transcriptase inhibitors (delavirdine, efavirenz, or nevirapine); nucleoside analog reverse transcriptase inhibitors (abacavir, didanosine, lamivudine, stavudine, tenofovir, zalcitabine, or zidovudine); protease inhibitors (amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, or saquinavir); or the entry inhibitor enfuvirtide.

Resistance

The mutations observed in the HIV-1 integrase coding sequence that contributed to raltegravir resistance (evolved either in cell culture or in subjects treated with raltegravir) generally included an amino acid substitution at either Q148 (changed to H, K, or R) or N155 (changed to H) plus one or more additional substitutions (i.e., L74M/R, E92Q, T97A, E138A/K, G140A/S, V151I, G163R, H183P, Y226D/F/H, S230R and D232N). Amino acid substitution at Y143C/H/R is another pathway to raltegravir resistance.

   13  NONCLINICAL TOXICOLOGY    13.1       Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term (2-year) carcinogenicity studies of raltegravir in rodents are ongoing.

No evidence of mutagenicity or genotoxicity was observed in in vitro microbial mutagenesis (Ames) tests, in vitro alkaline elution assays for DNA breakage and in vitro and in vivo chromosomal aberration studies.

No effect on fertility was seen in male and female rats at doses up to 600 mg/kg/day which resulted in a 3-fold exposure above the exposure at the recommended human dose.

   14  Clinical Studies    Description of Clinical Studies

The evidence of efficacy of ISENTRESS is based on the analyses of 24-week data from 2 ongoing, randomized, double-blind, placebo-controlled trials, BENCHMRK 1 and BENCHMRK 2 (Protocols 018 and 019), in antiretroviral treatment-experienced HIV-1 infected adult subjects. These efficacy results were supported by the 48-week analysis of a randomized, double-blind, controlled, dose-ranging trial, Protocol 005, in antiretroviral treatment-experienced HIV-1 infected adult subjects.

Treatment-Experienced Subjects

BENCHMRK 1 and BENCHMRK 2 are Phase III studies to evaluate the safety and antiretroviral activity of ISENTRESS 400 mg twice daily in combination with an optimized background therapy (OBT), versus OBT alone, in HIV-infected subjects, 16 years or older, with documented resistance to at least 1 drug in each of 3 Classes (NNRTIs, NRTIs, PIs) of antiretroviral therapies. Randomization was stratified by degree of resistance to PI (1PI vs. >1PI) and the use of enfuvirtide in the OBT. Prior to randomization, OBT was selected by the investigator based on genotypic/phenotypic resistance testing and prior ART history.

Table 5 shows the demographic characteristics of subjects in the ISENTRESS 400 mg twice daily arm and subjects in the placebo arm.

   Table 5: Baseline Characteristics                                  ISENTRESS 400 mg                                             Twice Daily            Placebo   BENCHMRK 1 and 2 Pooled                      + OBT                + OBT                                                (N = 462)           (N = 237)   Gender n (%)     Male                                      405 (87.7)          210 (88.6)     Female                                     57 (12.3)           27 (11.4)   Race n (%)     White                                     301 (65.2)          173 (73.0)     Black                                      66 (14.3)           26 (11.0)     Asian                                       16 (3.5)             6 (2.5)     Hispanic                                   53 (11.5)            19 (8.0)     Others                                      26 (5.6)            13 (5.5)   Age (years)     Median (min, max)                    45.0 (16 to 74)     45.0 (17 to 70)   CD4+ Cell Count     Median (min, max), cells/mm(3)        119 (1 to 792)      123 (0 to 759)     =2 PI                   447 (96.8)          226 (95.4)     *Hepatitis B virus surface antigen positive or hepatitis C virus antibody positive.

Table 6 compares the characteristics of optimized background therapy at baseline in the ISENTRESS 400 mg twice daily arm and subjects in the control arm.

   Table 6: Characteristics of Optimized Background Therapy at Baseline                                  ISENTRESS 400 mg                                    Twice Daily            Placebo     BENCHMRK 1 and 2 Pooled           + OBT                + OBT                                    (N = 462)            (N = 237)       Number of ARTs in OBT         Median (min, max)              4.0 (1 to 7)        4.0 (2 to 7)      Number of Active PI in OBT by       Phenotypic Resistance Test*                       0                 166 (35.9)           97 (40.9)                    1 or more            278 (60.2)          137 (57.8)      Phenotypic Sensitivity Score (PSS)(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š )                       0                  67 (14.5)           44 (18.6)                       1                 145 (31.4)           71 (30.0)                       2                 142 (30.7)           66 (27.8)                    3 or more             85 (18.4)           48 (20.3)      Genotypic Sensitivity Score (GSS)(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š )                       0                 115 (24.9)           65 (27.4)                       1                 178 (38.5)           96 (40.5)                       2                 111 (24.0)           49 (20.7)                    3 or more             51 (11.0)            23 (9.7)     *Darunavir use in OBT in darunavir naive subjects was counted           as one active PI.    (ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š )The Phenotypic Sensitivity Score (PSS) and the Genotypic Sensitivity Score (GSS) were defined as the total oral ARTs in OBT to which a subject's viral isolate showed phenotypic sensitivity and genotypic sensitivity, respectively, based upon phenotypic and genotypic resistance   tests. Enfuvirtide use in OBT in enfuvirtide-naive subjects was counted as one active drug in OBT in the GSS and PSS. Similarly, darunavir use in OBT in darunavir-naive subjects was counted as one active drug in OBT.

Week 24 outcomes for subjects on the recommended dose of ISENTRESS 400 mg twice daily from the pooled studies BENCHMRK 1 and 2 are shown in Table 7. The efficacy responses were evaluated based upon the 436 subjects from the pooled studies BENCHMRK 1 and 2 who had completed 24 weeks of treatment or discontinued earlier. All other outcomes were based upon the total 699 subjects who were randomized and treated.

   Table 7: Outcomes by Treatment Group through Week 24                                           ISENTRESS 400 mg                                            Twice Daily        Placebo         BENCHMRK 1 and 2 Pooled               + OBT              + OBT                   n (%)                     (N = 462)         (N = 237)            Outcome at Week 24                  n (%)             n (%)     Subjects with Week 24 data                 286                150     Subjects with HIV-1 RNA less than       400 copies/mL*                        216 (75.5)         59 (39.3)     Subjects with HIV-1 RNA less than       50 copies/mL*                         179 (62.6)         50 (33.3)     Virologic Failure (confirmed)(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š ,ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡)       74 (16.0)        121 (51.1)       Non-responder(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š ,ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡)                     13 (2.8)      78 (32.9)       Rebound(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š ,ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡)                           61 (13.2)      43 (18.1)     Death(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡,ÃƒÆ’Ã‚“šÃƒ“šÃ‚§)                                 6 (1.3)        3 (1.3)     Discontinuation due to       adverse experiences(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡,ÃƒÆ’Ã‚“šÃƒ“šÃ‚§)                 9 (1.9)        5 (2.1)     Discontinuation due to other       reasons(ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡,ÃƒÆ’Ã‚“šÃƒ“šÃ‚§,ÃƒÆ’Ã‚“šÃƒ“šÃ‚Â¶)                           6 (1.3)        1 (0.4)    *Based upon the 436 subjects with Week 24 data    (ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“š )Virologic failure: defined as non-responders who did not achieve >1.0 log10 HIV-1 RNA reduction and 400 copies/mL (on 2 consecutive measurements at least 1 week apart) after initial response with HIV-1 RNA 1.0 log10 increase in HIV-1 RNA above nadir level (on 2 consecutive measurements at least 1 week apart).    (ÃƒÆ’Ã‚¢Ãƒ“šÃ‚Ãƒ“šÃ‚¡)Based upon the total 699 subjects randomized and treated, not all subjects complete to Week 24    (ÃƒÆ’Ã‚“šÃƒ“šÃ‚§)Includes available data beyond Week 24    (ÃƒÆ’Ã‚“šÃƒ“šÃ‚Â¶)Includes loss to follow-up, subjects withdrew consent, noncompliance, protocol violation and other reasons.

The mean changes in plasma HIV-1 RNA from baseline were -1.85 log10 copies/mL in the ISENTRESS 400 mg twice daily arm and -0.84 log10 copies/mL for the control arm. The mean increase from baseline in CD4+ cell counts was higher in the arm receiving ISENTRESS 400 mg twice daily (89 cells/mm3) than in the control arm (35 cells/mm3).

Virologic responses at Week 24 by baseline genotypic and phenotypic sensitivity score are shown in Table 8.

Table 8: Virologic Response at Week 24 by Baseline Genotypic/Phenotypic Sensitivity Score

BENCHMRK Percent with Percent with HIV 1 and 2 HIV RNA RNA Pooled

ISENTRESS tablets 400 mg are pink, oval-shaped, film-coated tablets with "227" on one side. They are supplied as follows:

   NDC 0006-0227-61 unit-of-use bottles of 60.    No. 3894    Storage and Handling

Store at 20-25ÃƒÆ’Ã‚“šÃƒ“š°C (68-77ÃƒÆ’Ã‚“šÃƒ“š°F); excursions permitted to 15-30ÃƒÆ’Ã‚“šÃƒ“š°C (59-86ÃƒÆ’Ã‚“šÃƒ“š°F). See USP Controlled Room Temperature.

   17  PATIENT COUNSELING INFORMATION    [See FDA-Approved Patient Labeling].

Patients should be informed that ISENTRESS is not a cure for HIV infection or AIDS. They should also be told that people taking ISENTRESS may still get infections or other conditions common in people with HIV (opportunistic infections). In addition, patients should be told that the long-term effects of ISENTRESS are not known at this time. Patients should also be told that it is very important that they stay under a physician's care during treatment with ISENTRESS.

Patients should be informed that ISENTRESS does not reduce the chance of passing HIV to others through sexual contact, sharing needles, or being exposed to blood. Patients should be advised to continue to practice safer sex and to use latex or polyurethane condoms or other barrier methods to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood. Patients should also be advised to never re-use or share needles.

Physicians should instruct their patients that if they miss a dose, they should take it as soon as they remember. If they do not remember until it is time for the next dose, they should be instructed to skip the missed dose and go back to the regular schedule. Patients should not take two tablets of ISENTRESS at the same time.

Physicians should instruct their patients to read the Patient Package Insert before starting ISENTRESS therapy and to reread each time the prescription is renewed. Patients should be instructed to inform their physician or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.

   Manufactured and Distributed by:    MERCK & CO., INC., Whitehouse Station, NJ 08889, USA    Printed in USA    9795101    U.S. Patent Nos. US 7,169,780    (1) Trademark of MERCK & CO., Inc.   COPYRIGHT (C) 2007 MERCK & CO., Inc.   All rights reserved    (2) Trademark of MERCK & CO., Inc.   COPYRIGHT (C) 2007 MERCK & CO., Inc.   All rights reserved

Cohn & Wolfe Healthcare

CONTACT: Amy Rose, +1-908-423-6537, or Lynn Kenney, +1-908-423-4188,both of Merck & Co., Inc.; or Investor Relations, Eva Boratto,+1-908-423-5185

Web Site: http://www.benchmrk.com/http://www.merck.com/

Health

Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientific Meeting

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

ORLANDO, Fla., Oct. 7 /PRNewswire/ — Alba Therapeutics Corporation presented results from two clinical studies this week at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting. Data from study CLIN 1001-004, the first Phase IIa trial conducted in celiac disease and the first to assess the prevention of immunologic changes in celiac disease, showed that larazotide acetate (AT-1001) successfully demonstrated prevention of gluten-induced immunologic changes in celiac patients.

Results from the study showed that larazotide acetate is the first pharmacologic agent to prevent changes in blood mononuclear cell populations (specifically T-reg cells and B Cells) and other markers of immunological change associated with active celiac disease. This data suggests that larazotide acetate offers potential as a future treatment of celiac disease. Results from a second poster presented at ACG showed that larazotide acetate also inhibited the effect of inflammatory cytokines, including tumor necrosis factor (TNF-alpha) and interleukin (IL-4) on intestinal epithelial permeability, in vitro, further suggesting that the product offers potential as a future treatment for inflammatory bowel disease (IBD).

Larazotide Acetate is a novel, non-absorbed peptide currently being studied in Phase IIb trials for the treatment of celiac disease. Larazotide acetate has the potential to become the first approved medicine to treat celiac disease and has been granted “Fast Track” designation from the U.S. Food and Drug Administration (FDA) for this indication.

Celiac disease affects approximately one percent of individuals in the United States and Europe, or approximately 6.5 million individuals. The only accepted management for the disease is a strict gluten-free diet; however, the response to therapy is poor or incomplete in up to 30 percent of patients. These facts suggest that there is a need for therapeutic modalities beyond dietary modification.

Related data presented in a third poster at ACG include results from a qualitative study conducted to investigate the validity of the Gastrointestinal Symptom Rating Scale (GSRS) in patients with celiac disease. The GSRS is a validated measure used in clinical trials for irritable bowel syndrome and peptic ulcer disease. GSRS has been utilized in studies to assess larazotide acetate, including CLIN 1001-004 and CLIN 1001-006. Results from the poster presentation suggest that certain subscales of the GSRS may have relevance for use in establishing the efficacy of novel treatments for celiac disease. This is the first time the validity of the GSRS clinical scale has been studied in celiac disease to assess efficacy of treatments.

“There are currently no products approved by the FDA to treat celiac disease and a clear need exists for a therapeutic option,” said Daniel Leffler, MD, gastroenterologist, Beth Israel Deaconess Medical Center and one of the lead investigators for CLIN 1001-004. “This study showed that larazotide acetate prevented immunologic changes induced by gluten in patients with celiac disease. In addition, studies to establish the validity of scales such as GSRS are an important step forward in the development of effective treatments for celiac disease.”

“Alba is excited to be advancing the first therapy for celiac disease and we are encouraged by these breakthrough findings,” said Dr. Francisco Leon, head of Clinical Research and Development at Alba Therapeutics, Inc. “These results will be further tested in Phase III clinical trials to evaluate safety, efficacy, and maintenance of effect of larazotide acetate in treating celiac disease. In addition, we are excited by early preclinical study results showing signs of efficacy in inflammatory bowel disease targets and look forward to future research to uncover the product’s potential in this important therapeutic area.”

About the Studies

Results from CLIN 1001-004 were presented at ACG in a poster entitled “Larazotide Acetate Prevents Immunologic Changes Induced by Gluten Challenge in Celiac Disease Patients” (Poster 446). The randomized, double-blind, placebo-controlled study was designed to evaluate the effects of larazotide acetate on the systemic immunologic changes induced by a two week gluten challenge in patients with celiac disease. Study results showed that larazotide acetate was well tolerated and showed signs of efficacy in preventing immunologic changes induced by gluten challenge in patients with celiac disease, consistent with the beneficial effects observed on intestinal permeability, signs and symptoms. Clinical findings included:

— Gluten challenge in the placebo (control) group resulted in an increase in circulating regulatory T cells (CD4, CD25, FOX-P3+) and a decrease in B cells (CD3, CD19+). These changes were completely prevented in the group on larazotide acetate.

— There was a small, not statistically significant increase in the anti-tTG titer in the placebo (control) group, which was prevented in the group on larazotide acetate.

— Other trends in specific monocyte populations induced by gluten challenge were also prevented to varying extents by larazotide acetate.

The second presentation, “Larazotide Acetate, a Tight Junction Inhibitor Peptide, Inhibits Epithelial Permeability Induced by TNF-alpha and IL-4” (Poster 1052) included results from a study investigating the effect of larazotide acetate on tumor necrosis factor (TNF-alpha) and interleukin (IL-4) induced permeability. The study showed that larazotide acetate inhibited increased permeability mediated with TNF-alpha and IL-4, which suggests the potential of larazotide acetate as a therapeutic agent for the treatment of celiac disease and IBD.

The third poster presentation, “Relevance of the Gastrointestinal Symptom Rating Scale (GSRS) in Patients with Celiac Disease” (Poster 1023), includes results from a qualitative study conducted to investigate the validity of the GSRS in patients with celiac disease and to explore if the GSRS would constitute an appropriate and relevant scale to demonstrating the efficacy of novel treatments for celiac disease. Results showed that relevant subscales of the GSRS may be useful in clinical trials of novel treatments for celiac disease.

About Celiac Disease

Celiac disease (CD) is an inherited, lifelong T-cell mediated auto-immune disorder where the environmental trigger has been identified as gluten, which is found in wheat, barley, and rye. It is characterized by small intestinal inflammation and injury. CD is a growing public health concern, affecting approximately 3 million people in the United States and over 6.5 million people worldwide. The ingestion of gluten causes an immune response which triggers an inflammatory reaction in the small intestine. This then causes damage to the villi in the small intestine and can lead to total villous atrophy in CD. This results in varying symptoms such as fatigue, skin rash, anemia, fertility issues, stillborn births, joint pain, weight loss, pale sores inside the mouth, tooth discoloration or loss of enamel, depression, chronic diarrhea or constipation, and abdominal pain and bloating. The immunology and nutritional abnormalities in celiac disease can potentially result in long-term complications such as osteoporosis, refractory sprue, small intestinal cancer, and lymphoma. The only current management of CD is complete elimination of gluten from the diet, which can be very difficult to implement in practice.

About “Larazotide Acetate”

Larazotide acetate is an experimental medicine and an inhibitor of barrier dysfunction that has been shown to block abnormally increased intestinal permeability and the genesis of some autoimmune diseases, either as a result of reduction of antigen presentation to the body’s immune system, or through inhibitory, direct effects on gastrointestinal associated lymphoid tissue. Larazotide acetate is a non-absorbed peptide which improves mucosal barrier function by inhibiting cytoskeletal reorganization and tight junction disassembly. Larazotide acetate is orally formulated, has been granted “Fast Track” designation by the U.S. Food and Drug Administration for the treatment of Celiac disease, and is also being evaluated for the treatment of Crohn’s Disease. Results of the Company’s first study in patients with celiac disease are available online at: http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-2036.2007.03413.x

For more information about Alba’s clinical trials, please visit the http://www.clinicaltrials.gov/ web site and search for Alba Therapeutics.

About Alba Therapeutics Corporation

Alba Therapeutics Corporation is a privately held, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of therapies to treat auto-immune, immune mediated and inflammatory diseases and is located in Baltimore, Maryland. Alba’s technology platform is based upon a key pathway that regulates the assembly and disassembly of tight junctions in cell barriers throughout the body. As a result of its unique technology platform, Alba is a leader in mucosal biology and has developed a pipeline of innovative therapeutic candidates that has the potential to modify the course of disease and significantly improve upon existing treatments for a wide range of diseases such as Celiac disease, Crohn’s disease, and Asthma/COPD or acute lung injury.

    Media: Mariesa Kemble    Sam Brown Communications    608-850-4745    [email protected]     Corporate: Wendy Perrow    Alba Therapeutics Corporation    410-878-9850

Alba Therapeutics Corporation

CONTACT: Media, Mariesa Kemble of Sam Brown Communications,+1-608-850-4745, [email protected]; or Corporate, Wendy Perrow of AlbaTherapeutics Corporation, +1-410-878-9850

Web site: http://www.albatherapeutics.com/http://www.clinicaltrials.gov/

Health

‘Breakthrough’ Test Could Lead to New Treatments for MS Sufferers Scottish Scientists to Present Findings in US

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

By JULIA HORTON

SCOTTISH scientists claim to have developed a “breakthrough” test that could lead to new medication for thousands of multiple sclerosis patients whose condition is currently untreatable.

Researchers at life sciences company Glasgow Health Solutions (GHS) revealed yesterday they have devised a blood test that detects levels of nitrotyrosine, a “bio marker” whose presence indicates chemical activity hat causes the nerve-cell damage that results in MS.

Early detection of the less obvious signs of the disease through such blood tests every three or six months could lead to new drugs to stop nerve damage in progressive forms of MS, for which there is currently no treatment.

GHS said he new test could also give doctors a cheap, easy alternative to the invasive, costly MRI scans and lumbar punctures hat are currently used to assess a patient’s condition.

The MS Society Scotland warned, however, that while a simple blood test would be far better than the existing assessments, there was no firm proof yet that measuring nitrotyrosine was an accurate way of tracking the progression of the disease.

GHS research laboratory head Dr Thomas Gilhooly aims to prove the blood test’s validity through further trials, for which he hopes to secure funding after presenting the findings at a key conference in America this week.

He said: “This blood test offers fresh hope to MS sufferers as it can detect when a patient is entering the active phases of the disease. It therefore could be a way of ensuring accurate and timely treatment of patients with the progressive forms of MS.

“This has the potential to unlock treatment for this group of patients and massively improve their quality of life. The terrifying aspect of MS for most sufferers is that they do not know how quickly, and how far, it will progress.

“This test gives them the certainty of diagnosis and the ability to begin effective treatment at a very early stage.”

Dr Gilhooly admitted that the team was in the early stages of work on the test, developed through preparations for a trial of a potential MS treatment known as Low Dose Naltrexone.

Dr Gilhooly was optimistic that the test would prove successful as he prepared to go to Los Angeles to speak at the 4th Annual Low Dose Naltrexone Conference there on Saturday.

But an MS Society Scotland spokesman said: “There is some science that suggests nitrotyrosine levels are raised in people with MS, but its value as a biomarker simply has not been validated and therefore interpretation of the results would be open to question.

“It’s also worth remembering that nitrotyrosine levels could be induced by a number of different things, including infections. Patients with progressive MS are more likely to get infections, particularly urinary tract infections, and this would confuse the results.”

He added that there were no proven biomarkers for predicting MS itself and no drugs to suppress its progression, “so a positive result would not lead to a change in treatment or diagnosis”.

Scotland has the highest incidence of MS in the world with an estimated 10,500, or one in every 500, people thought to have the unpredictable disease – and rates are still rising.

Originally published by Newsquest Media Group.

Health

Power3 Medical Products in Talks With Industry Leaders to License and Market Its Proprietary Technology for Diagnostic, Disease Detection Blood Tests for Breast Cancer, Alzheimer’s and Parkinson’s Disease

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Power3 Medical Products, Inc. (OTCBB:PWRM), (www.power3medical.com), today announced that the Company has been contacted by and is currently in talks with leading marketers of early disease detection tests and is confident that the ongoing talks and negotiations will insure the future of the company’s primary focus, the commercialization of its proprietary intellectual property, and to enhance shareholder value through product sales and new revenue streams.

“The fruits of our labors are beginning to pay off, in what I would consider to be an unprecedented interest in our diagnostic blood test technologies, especially our early diagnostic test for breast cancer,” stated Dr. Ira Goldknopf, President and Chief Scientific Officer of Power3. The company attributes the recent increase of interest in its products to a lecture given by Dr. Goldknopf on Oct. 1, 2008 at a CHI Biomarker Discovery Summit, which addressed technologies for the early detection of breast cancer, as well as Alzheimer’s and Parkinson’s diseases, utilizing Power3’s proprietary protein biomarker technology.

“In addition, October is Breast Cancer Awareness Month and there is a heightened awareness of the need for products such as ours that can detect the disease early and thereby help give the patient opportunities for earlier treatment and reassurance,” stated Helen R. Park, Interim CEO of Power3.

About Power3 Medical Products, Inc.

Power3 Medical Products, Inc. (OTCBB:PWRM) (www.Power3Medical.com), is a leading Bio Medical company engaged in the commercialization of cancer and neurodegenerative disease biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets. Power3’s patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and prognosis of disease, identify protein biomarkers, and drug targets. Power3 operates a state-of-the-art CLIA certified laboratory in The Woodlands (Houston), Texas. The Company continues to evolve and enhance its IP portfolio.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. With the exception of historical information contained herein, the matters discussed in this press release involve risk and uncertainties. Actual results could differ materially from those expressed in any forward-looking statement.

Health

Microwaves Not Meant For Cooking Raw Foods

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Using the microwave to heat up your food is a great, simple way to enjoy a meal, but if not done properly, it can make you sick.

This is a problem that is not receiving much notice, even though there were numerous illnesses last year caused from improperly microwaved frozen foods.

“Given how people use microwaves, it’s great for reheating, but maybe not so good for cooking,” said Doug Powell, scientific director of the International Food Safety Network.

The government issued a word of warning on Sunday advising consumers to meticulously cook frozen chicken dinners after 32 people were struck with salmonella poisoning.

The issue is that microwaves heat unequally and can leave cold spots in the food that can foster bacteria, like E. coli, salmonella or listeria.
Consequently, microwaving anything that includes raw meat, whether it’s frozen or thawed, can be unwise.

“I think most food-safety experts probably would have said it’s not a good idea to microwave anything that’s from a raw state,” said Michael Davidson, a University of Tennessee food microbiologist.

Many people incorrectly assume all frozen meals are precooked and simply need to be re-heated. It’s a fallacy supported by foods that are made to appear prepared, such as chicken that has been breaded or pre-browned.

“I haven’t worried about the safety of frozen food. Maybe I should,” consumer Kathy Tewhill told the ASsociated Press in an interview.

In truth, there are several meals intended to be microwaved that can still be dangerous if they are not heated thoroughly enough, or are prepared using directions that are meant for a microwave with different voltage.

The government does not track microwave-related food-borne illnesses, but annually more than 325,000 people are hospitalized for food-related sicknesses.

Last fall, hundreds became unwell when Banquet brand pot pies produced by ConAgra Foods were connected to a salmonella outbreak, and frozen pizzas prepared by General Mills were tied to an E. coli outbreak. Both products were eventually recalled.

Since the outbreaks, food companies have renovated the cooking instructions on their frozen foods to guarantee they are satisfactory enough for destroying any dangerous bacteria, stated Leslie Sarasin, head of the American Frozen Food Institute trade group.

ConAgra and Nestle Prepared Foods, two of the biggest frozen foods producers, have introduced the modified instructions on several of their brands, including Stouffer’s, Lean Cuisine, Banquet and Healthy Choice.

However, preparing frozen foods securely could involve a change in consumers’ personal microwave habits. In the midst of the latest outbreak of illness, some of the meals were only microwaved even though the merchandise clearly wasn’t meant to be.

Microwaves generate short radio waves that infiltrate food about 1 inch and excite water, fat and sugar molecules to create heat. Food safety experts note that the heating method used causes more of a threat than a stove or oven because microwaves heats food unevenly.

To be completely secure, they advise getting a food thermometer and using it to confirm the temperature of microwaved food in several places, principally if the product has raw ingredients.

“If you were going to make one of these things for a kid, you’d definitely want to be checking the temperatures on the things or using your (conventional) oven,” Davidson said.

Nevertheless, finding the raw ingredients isn’t always straightforward, because the only hint most companies give is the two words “COOK THOROUGHLY” on the front of the package.

Consumers also should to become more familiar with the technical terms of their microwaves. The unit’s wattage influences how powerful it is and how well it heats food.

Microwaves do lose power over time, and a number of smaller microwaves do not generate enough power to carefully cook some products.

Kathy Barges, another consumer, states that she attempts to follow the instructions on her Lean Cuisine meals closely, but did not notice the package’s advice to correct cooking time if she doesn’t have a 1,100-watt microwave.

“I’m not sure what mine is,” Barges said. “It’s an expensive microwave, so I assume it’s got the most wattage on it.”

College student Jordan Sullivan stated he frequently eats frozen pizza and pizza rolls, but has not given much consideration to the safety of the cooking process.

“I just toss them in and wait till they look good,” Sullivan said of the rolls.

While following directions is ideal, experts say plainly that cooking raw food should be left to stovetops, grills and ovens.

—

On the Net:

Health

Marinus Pharmaceuticals, Inc., Completes Two Phase 2 Milestones for Ganaxolone in Epilepsy

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

BRANFORD, Conn., Oct. 7 /PRNewswire/ — Marinus Pharmaceuticals, a developer of specialty therapeutics to treat neurological and psychiatric disorders, today announced that it has completed its Phase 2 clinical trial of ganaxolone for the treatment of infantile spasms (also called West syndrome) and that the final patient has completed enrollment for its Phase 2 clinical trial of ganaxolone for the treatment of adult partial complex seizures.

“Completion of the infantile spasms study and the completion of recruitment in the adult partial seizure trial are significant milestones for the ganaxolone program,” said John Krayacich, CEO of Marinus. “We are anxious to review the unblinded data in the infantile spasms study and hope to present the data to the medical community early in 2009. We anticipate the data in the adult study to be available in the first half of 2009 and to present the data in the second half of 2009.”

“We would like to thank the patients, parents, investigators, and Marinus colleagues who have made this program possible. We believe ganaxolone represents a potential important new therapy for the treatment of various forms of epilepsy.” Krayacich continued.

Previous Phase 1 and proof of concept studies of ganaxolone have demonstrated safety and efficacy in refractive epilepsy. The ganaxolone program currently consists of four clinical studies, one infantile spasms and one adult partial seizure study as well as open label extensions for each study. Approximately 2.5 million Americans suffer from epilepsy.

About Ganaxolone

Ganaxolone is a synthetic neurosteroid and is being investigated as a first in class drug for the treatment of epilepsy. Ganaxolone has been administered to more than 700 healthy adult volunteers and patients, 214 in Phase 1 studies, and approximately 500 patients in Phase 2 epilepsy and migraine studies. The epilepsy studies involved more than 100 patients and generated data supportive of ganaxolone’s efficacy and safety in the treatment of both children and adults suffering from refractory epilepsy (patients who continue to have seizures even when taking multiple anticonvulsant drugs).

In December 2006, Marinus successfully completed a performance study of a proprietary new liquid suspension formulation of ganaxolone developed by Marinus specifically for its Phase 2b clinical studies.

About Marinus Pharmaceuticals

Marinus is a specialty pharmaceutical company dedicated to the reformulation, development, and commercialization of novel drugs to treat serious neurological, psychiatric, and pain disorders. Marinus is located in Branford, Connecticut and its investors include Domain Associates, Canaan Partners, Sofinnova Ventures and Foundation Medical Partners. For additional information, please visit the company’s website at http://www.marinuspharma.com/.

    Company Contact:    John Krayacich, President and CEO    Marinus Pharmaceuticals    [email protected]    (203) 315-5809     Media Contact:    Shirley Chow    Porter Novelli Life Sciences    [email protected]    (212) 601-8308

Marinus Pharmaceuticals

CONTACT: John Krayacich, President and CEO of Marinus Pharmaceuticals,+1-203-315-5809, [email protected]; or Media, Shirley Chow ofPorter Novelli Life Sciences, +1-212-601-8308, [email protected],for Marinus Pharmaceuticals

Web site: http://www.marinuspharma.com/

Health

China Medical Technologies Acquires HPV-DNA Biosensor Chip and SPR System

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

China Medical Technologies has entered into a definitive asset acquisition agreement with Molecular Diagnostics Technologies to purchase its HPV-DNA biosensor chip and surface plasmon resonance based analysis system for the detection of human papillomavirus, which causes cervical cancer and sexually transmitted disorders.

Under the terms of the asset acquisition agreement, the company will pay an aggregate cash consideration of $345 million in installments with the final payment to be made one year after the closing of the acquisition.

The company expects to use its existing available cash to pay for the acquisition. The closing of the acquisition is subject to customary closing conditions and is expected to occur in December 2008 or January 2009. No regulatory approvals are needed for the consummation of the acquisition.

HPV-DNA biosensor chip is a label-free DNA chip for the diagnosis of human papillomavirus (HPV) infection and genotyping of HPV. The HPV chip can identify each of 24 distinctive common HPV genotypes, including 16 high-risk genotypes and eight low-risk genotypes. It can also identify mixed HPV infection and can be used to guide individual therapy and vaccination. The HPV chip is expected to be used in the gynecology and dermatology departments of hospitals.

The surface plasmon resonance based analysis system (SPR System) utilizes surface plasmon resonance technology, a biosensor technology in molecular biology. HPV can be detected by adding pathological samples on the HPV chip which is analyzed with the SPR System. The SPR System is reported to be label-free with high throughput, high speed and a high degree of automation. The detection results can be displayed on a real-time and online basis.

The SPR System can be used in various clinical diagnostic applications, such as the detection of biomarkers related to infectious diseases, cancers, cardiovascular disorders and immune system disorders. The company plans to develop and introduce more products for such applications.

Xiaodong Wu, chairman and CEO of China Medical Technologies, said: “We expect the acquisition to broaden our range of molecular diagnostic product offerings, increase our high margin recurring revenues and provide an additional growth engine. We expect the integration process for the acquisition to be smooth and plan to begin offering the HPV chip and the SPR System in the first quarter of 2009.”

Health

Ivivi Technologies Reports FDA Decision to Reopen SofPulse 510(K); Rescission of NSE Letter

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

MONTVALE, N.J., Oct. 7, 2008 (GLOBE NEWSWIRE) — Ivivi Technologies, Inc. (Nasdaq:IVVI), a leader in non-invasive, electrotherapy systems, today announced that in response to the Company’s appeal of the U.S. Food and Drug Administration’s (FDA) “Not Substantially Equivalent” (NSE) decision on its SofPulse 510(k) submission, the FDA has reopened the submission for an additional round of review. The reopening of the 510(k) overrides and supersedes the prior NSE decision. In addition to the information previously submitted to the FDA, the Company will be submitting supplemental data to the FDA as requested by them, during our current fiscal third quarter.

“We are extremely pleased that the FDA has taken the time to review the data submitted in support of our appeal, and has agreed to reopen our 510(k) covering the SofPulse M-10, Roma(3) and Torino II targeted pulsed electromagnetic field (tPEMF(tm)) products,” commented Steven Gluckstern, Chairman, President and Chief Executive Officer. “This is a significant positive development for the Company and we will continue to work closely with the FDA to enable us to expand distribution of our technology in our target markets through our various partners.”

Andre’ DiMino, Executive Vice President and Chief Technical Officer added, “We are pleased the FDA has given us the opportunity to work with it to provide certain limited additional animal and other data to support substantial equivalence of our technology in the 510(k). The requested animal study should be completed within our current fiscal third quarter. While we await a final decision, we believe all our products are covered by the FDA clearance provided in 1991.”

About Ivivi Technologies, Inc.

Based in Montvale, N.J., Ivivi Technologies, Inc. is a medical technology company focusing on designing, developing and commercializing its proprietary electrotherapeutic technology platform, with a primary focus on developing treatments for cardiovascular disease. Ivivi’s research and development activities are focused specifically on targeted pulsed electromagnetic field, or tPEMF(tm), technology, which, by creating a therapeutic electrical current in injured soft tissue, is believed to modulate biochemical and physiological healing processes to help reduce related pain and inflammation. The Company’s most recent clinical studies have shown reductions in anginal pain and increases in blood flow to the heart in certain cardiac patients; however, additional studies will be focused in this area. The Company also expects to seek strategic partners to pursue other markets, such as osteoarthritis, neurology and other inflammatory-related conditions if FDA marketing approvals or clearances can be achieved in these areas.

Forward-Looking Statements

This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to our ability to achieve FDA clearance of our 510(k) submission, current and future studies, regulatory clearance and approvals, strategic partnerships and future sales. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the Company’s limited operating history, history of significant and continued operating losses and substantial accumulated earnings deficit, difficulties with its financial accounting controls, the failure of the market for the Company’s products to continue to develop, the inability for customers to receive third party reimbursement, the inability to obtain additional capital, the inability to protect the Company’s intellectual property, the loss of any executive officers or key personnel or consultants, competition, changes in the regulatory landscape or the imposition of regulations that affect the Company’s products and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission, including the Company’s Form 10-KSB for the fiscal year ended March 31, 2008. The Company assumes no obligation to update the information contained in this press release.

This news release was distributed by GlobeNewswire, www.globenewswire.com

 CONTACT:  Ivivi Technologies, Inc.           Investor Relations Contact:           Cameron Associates             Alison Ziegler or Lester Rosenkrantz             212-554-5469             [email protected]           Deanne Eagle for Media             212-554-5463             [email protected]

Health

Eli Lilly and Company Resolves Investigation Involving Numerous States

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

INDIANAPOLIS, Ind., Oct. 7 /PRNewswire-FirstCall/ — Eli Lilly and Company today announced that it has resolved a multi-state investigation involving 32 states and the District of Columbia (DC) related to the sales, marketing and promotion of its antipsychotic medication Zyprexa(R) (olanzapine).

“We believe all of the parties involved share an interest in putting this dispute behind us,” said Robert A. Armitage, Lilly’s senior vice president and general counsel. “From our standpoint, it’s certainly in the best interests of the company and the patients, care-givers and healthcare professionals who continue to rely on this life-saving medication,” he said, adding that Zyprexa remains available to patients and on formularies for Medicaid programs in all 50 states and DC.

The Agreement

While there is no finding that Lilly has violated any provision of the state laws under which the investigations were conducted, the company will pay $62 million to be divided among the settling states. This payment will result in a charge in the third quarter of $.04 per share. In addition, Lilly will undertake certain commitments regarding Zyprexa for a period of six years following the agreement via consent decrees filed in the various states. These commitments relate to the company’s promotional practices, dissemination of medical information, funding of continuing medical education (CME) and grants related to Zyprexa, and continued disclosure of Zyprexa clinical trials and their results. Lilly would also agree to provide signatory attorneys general with information related to compensation made to healthcare professionals who have received more than $100 annually from the company for promotional speaking or consulting regarding Zyprexa in the U.S.

“Lilly’s policies and practices already mirror most of the provisions included in the proposed consent decrees. This resolution reflects our commitment to continually build on a foundation of compliance, accuracy and transparency,” said Armitage.

Lilly’s Commitment to Compliance

Lilly has implemented and continues to review and enhance a broadly based compliance program that includes comprehensive compliance-related activities designed to ensure that its marketing and promotional practices comply with promotional laws and regulations. Lilly’s compliance program includes the elements of compliance guidelines issued by the Department of Health and Human Services, Office of Inspector General, for the pharmaceutical industry. The company has a vice president and chief compliance officer, who reports directly to Lilly’s Chairman and its Board of Directors; corporate compliance committee; a code of conduct; policies and procedures specific to promotion and marketing; extensive training; auditing, monitoring and reporting programs, including a compliance hotline; and disciplinary and corrective action processes.

Participating States

The 32 states participating in the agreement are Alabama, Arizona, California, Delaware, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin, as well as the District of Columbia. The company previously disclosed these state investigations, which were brought under those states’ various consumer protection laws, in May 2007, in a quarterly filing with the U.S. Securities and Exchange Commission.

Eleven other states (Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, West Virginia, Connecticut, Arkansas and Idaho) have filed lawsuits over Zyprexa and are not covered by this agreement. In March, Lilly entered into a $15 million settlement with the State of Alaska, which concluded an ongoing trial involving various issues surrounding Zyprexa. In addition, since 2005, Lilly has settled approximately 31,000 individual product liability lawsuits alleging that certain adverse events are associated with Zyprexa.

Since its initial approval by the FDA in 1996, Zyprexa has been prescribed for more than an estimated 26 million patients around the world, and is regularly used in the U.S. and in more than 80 other countries.

Zyprexa Background

Zyprexa is indicated in the United States for the short- and long-term treatment of schizophrenia, acute mixed or manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder. Since Zyprexa was introduced in 1996, it has been prescribed more than 26 million times by physicians around the world. Zyprexa is not approved for patients under 18 years of age.

Zyprexa is not approved for the treatment of patients with dementia- related psychosis. Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with those patients taking a placebo. In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with Zyprexa.

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Zyprexa.

While relative risk estimates are inconsistent, the association between atypical antipsychotics and increases in glucose levels appears to fall on a continuum and olanzapine appears to have a greater association than some other atypical antipsychotics. Physicians should consider the risks and benefits when prescribing olanzapine to patients with an established diagnosis of diabetes mellitus, or who have borderline increased blood glucose levels. Patients taking olanzapine should be monitored regularly for worsening of glucose control. Persons with risk factors for diabetes who are starting on atypical antipsychotics should undergo baseline and periodic fasting blood glucose testing. Patients who develop symptoms of hyperglycemia during treatment should undergo fasting blood glucose testing.

Undesirable alterations in lipids have been observed with olanzapine use. Clinical monitoring, including baseline and follow-up lipid evaluations in patients using olanzapine, is advised. Significant, and sometimes very high, elevations in triglyceride levels have been observed with olanzapine use.

Potential consequences of weight gain should be considered prior to starting olanzapine. Patients receiving olanzapine should receive regular monitoring of weight.

As with all antipsychotic medications, a rare and potentially fatal condition knows as Neuroleptic Malignant Syndrome NMS has been reported with Zyprexa. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

Also, as with all antipsychotic treatments, prescribing should be consistent with the need to minimize Tardive Dyskinesia (TD). The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Other potentially serious adverse events include low blood pressure, seizures, elevated prolactin levels, elevated liver enzymes, cognitive and motor impairment, body temperature elevation, and trouble swallowing.

The most common treatment-emergent adverse event associated with Zyprexa in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonagressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite and tremor.

Full prescribing information, including a boxed warning, is available at http://www.zyprexa.com/.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com/ .

C-LLY

Eli Lilly and Company

CONTACT: Marni Lemons, +1-317-433-8990, mobile, +1-317-532-7826,[email protected], Phil Belt, +1-317-276-2506, mobile, +1-317-748-3915,[email protected]

Web site: http://www.lilly.com/

Health

Great Basin Scientific, Inc. Closes $3.9 Million in Equity Funding

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

SALT LAKE CITY, Oct. 7 /PRNewswire/ — Great Basin Scientific, Inc., a privately held life sciences company developing novel, point-of-care molecular diagnostic solutions, today announced it had closed a $3.9 million financing round. New and returning investors participated in the funding for this round.

The new round of financing will fund the company through the spring of 2009 as it completes the design of its rapid molecular diagnostic testing platform and brings a methicillin-resistant Staphylococcus aureus (MRSA) test into clinical trials. The silicon chip based technology is simple, cost-effective and improves on the highly complex, traditional Polymerase Chain Reaction (PCR) method that requires the skills of highly-trained technicians and often times multiple rooms to avoid cross contamination of tests. The company’s highly-sensitive, easy-to-use integrated cartridge system which can be performed in a CLIA-rated moderately complex or waived laboratory, will give healthcare providers and their patients the benefit of point-of-care test results within a 20 – 60 minute time frame at costs much lower than current molecular solutions.

“This financing coincides with an exciting time for our company as we begin to develop important technology that will bring rapid disease diagnosis nearer to the patient to improve clinical outcomes and reduce treatment cost,” said Ryan Ashton, president and CEO, Great Basin Scientific. “This commitment by our investors shows a strong indication of confidence in our innovation, use of technology, strategy and leadership team. “

About Great Basin Scientific

Great Basin Scientific, Inc. is a privately held life sciences company that commercializes breakthrough technologies for the molecular, rapid diagnostic testing market. The company is dedicated to development of simple yet powerful point-of-care technology and products that improve automation, throughput, scalability, reliability and ease of use of rapid diagnostic testing for point-of-care settings such as physician’s office labs, small-medium hospital labs and other moderately complex laboratory facilities.

The company was founded in 2003 by David Ward, Ph.D., deputy director of the Nevada Cancer Institute, formerly of Yale University of Medicine, and Anthony R. Torres, M.D., senior scientist and director of the Immunogenetics Laboratory, Utah State University. More information can be found on the company’s Web site at http://www.gbscience.com/.

Great Basin Scientific, Inc.

CONTACT: Mary-Katharine Juric of Edelman, +1-415-486-3269,[email protected], for Great Basin Scientific, Inc.

Web site: http://www.gbscience.com/

Business

Customers Recognize the Power of Solar Tracking By Selecting RayTracker GC for Their PV Installations

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Energy Innovations, Inc., manufacturer of commercial solar products that maximize usable energy from the sun, announced today that the company’s RayTracker GC product has been installed by several new customers and will be included in installations representing over 2MW of clean, renewable solar energy starting this month. RayTracker GC is a single-axis solar tracker for ground-mount and carport-mount applications that maximizes the energy yield of a photovoltaic system and supports a wide range of the leading, available PV panel types.

According to Paula Mints, Principal Analyst, PV Services Program and Associate Director, Energy Practice at Navigant Consulting, projections show tracking systems being used in at least 85% of commercial installations greater than 1MW in 2009 – 2012.

“Single-axis tracking is one of the most straightforward ways to improve the performance and economics of a commercial solar installation,” said Bill Gross, CEO of Energy Innovations. “Energy Innovations has assembled a talented team to focus on this tracking category, to apply best practices across all disciplines and bring a new level of sophistication in product design, engineering, manufacturing, delivery and service to the solar tracking marketplace.”

The installations utilizing RayTracker GC are systems being deployed by leading companies such as the North American headquarters of British Telecom located in El Segundo, CA, and the West Coast distribution center of The North Face located in Visalia, Calif. The locations and site types for each installation presented different challenges and benefited from RayTracker GC’s rugged, versatile design. The British Telecom site’s carport design, for example, will provide maximum system capacity and shade for cars parked underneath, while The North Face system will be constructed over a storm water retention area located on the property, allowing for dual use and providing a buffer to adjacent properties. Outfitted with a combined 7,445 Suntech (NYSE:STP) solar modules, these innovative systems will gain increased efficiency and accelerated ROI by using RayTracker GC. Both installations are currently under construction by Suntech Energy Solutions (formerly EI Solutions) and are scheduled to go online in the coming months. RayTracker GC will also be a part of several additional, undisclosed, installations also being deployed in 2008.

“RayTracker has quickly become a recognized leader in quality, innovation and customer support,” said Mark Henderson, General Manager of RayTracker at Energy Innovations. “In the few short months since the RayTracker product was introduced, we’ve seen an overwhelming market demand for our RayTracker GC product from customers looking to increase the return on their solar investment and lower the overall cost of energy produced.”

RayTracker was designed from the start to be cost-effective while also maximizing efficiency and reliability. PV panels mounted on a RayTracker system can yield an up to 38% increase in annual energy production compared to fixed flat PV panels and up to 25% more than fixed tilted (30-degree), thus increasing the overall return on investment of an installation. RayTracker GC’s precision distributed actuation design provides for increased system availability and no scheduled maintenance, while removing the actuator single point of failure which can be found in other tracker designs. RayTracker also requires little field welding and comes with many components pre-assembled from the factory.

About Energy Innovations, Inc.

Energy Innovations was founded in 2001 by entrepreneur and current CEO, Bill Gross, and has assembled a world-class team of experts in the fields of solar concentration and tracking to deliver cost-effective, grid-competitive solar electric power. The company is developing the Sunflower line of concentrated photovoltaic products as well as the RayTracker line of solar tracking products, all with a focus on bringing the cost of solar below that of utility-supplied electricity. Information about RayTracker GC can be found at http://www.raytracker.com. Energy Innovations is an operating company of Idealab, a creator and operator of technology businesses. http://www.energyinnovations.com

(C) 2008 Energy Innovations, Inc. All rights reserved. Energy Innovations, RayTracker and Sunflower are trademarks or registered trademarks of Energy Innovations, Inc. All other trademarks are the property of their respective owners.

Health

NCCN, Abraxis BioScience and AstraZeneca Announce Collaboration to Conduct Anti-Cancer Drug Studies

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

The National Comprehensive Cancer Network (NCCN), Abraxis BioScience (NASDAQ:ABII), and AstraZeneca (NYSE:AZN) today announced that they have entered into a collaboration to conduct multiple investigator-initiated studies of Abraxis BioScience’s anti-cancer drug ABRAXANE(R) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound), which is based on the company’s proprietary tumor targeting technology known as the nab(TM) platform.

The NCCN studies will evaluate ABRAXANE in the treatment of breast, non-small cell lung, head and neck, melanoma and ovarian cancers. The clinical research will include investigations of tumor gene expression by microarray and the expression of SPARC, (secreted protein acidic and rich in cysteine), a protein that is over expressed and secreted in many cancers. SPARC, a known prognostic factor for poor survival in a number of tumor types(1), is an albumin binding protein that may mediate an enhanced anti-tumor effect of ABRAXANE via a SPARC- albumin interaction(2).

“Collaborating with NCCN Member Institutions allows us to tap into their collective expertise to develop safer and more effective treatments for cancer. ABRAXANE has become a leading treatment option for metastatic breast cancer, and we are pleased to support this critical research designed to investigate ABRAXANE in several oncology indications,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “The research will also evaluate whether SPARC expression leads to increased clinical response with ABRAXANE due to the interaction of SPARC and albumin.”

Abraxis and AstraZeneca, which have a co-promotion agreement for marketing ABRAXANE in the United States, are providing funding in support of the clinical studies. Investigators at seven NCCN Member Institutions are recipients of awards from NCCN for the clinical studies conducted at their centers.

“AstraZeneca is pleased to support the NCCN Oncology Research Program in collaboration with Abraxis Oncology,” said Lisa Schoenberg, Vice President of Specialty Care, AstraZeneca. “This program can be beneficial by providing a better understanding of ABRAXANE in different tumor types. Support of the NCCN program is further evidence of AstraZeneca’s commitment to oncology research.”

The NCCN Oncology Research Program (ORP) facilitates all phases of clinical research by identifying clinical investigators and initiating trials at NCCN Member Institutions. The NCCN ORP draws on the expertise of investigators at 21 of the world’s leading cancer centers and helps to establish collaborations with pharmaceutical and biotech companies in order to advance therapeutic options for patients with cancer.

About ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin bound)

In the United States, ABRAXANE is currently indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

For the ABRAXANE full prescribing information (including boxed WARNING), please visit www.abraxane.com.

IMPORTANT SAFETY INFORMATION

WARNING: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE.

Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin greater than 1.5 mg/dL or baseline serum creatinine greater than 2 mg/dL.

ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.

Men should be advised to not father a child while receiving treatment with ABRAXANE.

It is recommended that nursing be discontinued when receiving ABRAXANE therapy.

ABRAXANE contains albumin (human), a derivative of human blood.

Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.

ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level greater than 1,500 cells/mm3 and platelets recover to a level greater than 100,000 cells/mm3.

In the case of severe neutropenia (less than 500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, a dose reduction for subsequent courses is recommended.

Sensory neuropathy occurs frequently with ABRAXANE.

If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE.

Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary emboli, and hypertension.

In the randomized metastatic breast cancer study, the most important adverse events included alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), asthenia (any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), anemia (all 33%; severe 1%), infections (24%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 27%; severe less than 1%), and mucositis (any 7%; severe less than 1%).

Other adverse reactions have included ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST (SGOT) 39%), renal dysfunction (any 11%; severe 1%), thrombocytopenia (any 2%; severe less than 1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (less than 1%). During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with ABRAXANE.

About Abraxis BioScience

Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company’s portfolio includes the world’s first and only protein-bound chemotherapeutic compound (ABRAXANE), which is based on the company’s proprietary tumor targeting technology known as the nab(TM) platform. The first FDA approved product to use this nab(TM) platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people’s lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca-us.com.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 21 of the world’s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives. For more information, visit www.nccn.org.

The NCCN Member Institutions are: City of Hope, Los Angeles, CA; Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Comprehensive Cancer Center, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; Arthur G. James Cancer Hospital & Richard J. Solove Research Institute at The Ohio State University, Columbus, OH; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Memorial Sloan-Kettering Cancer Center, New York, NY; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute, Memphis, TN; Stanford Comprehensive Cancer Center, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; UNMC Eppley Cancer Center at The Nebraska Medical Center, Omaha, NE; The University of Texas M. D. Anderson Cancer Center, Houston, TX; and Vanderbilt-Ingram Cancer Center, Nashville, TN.

Literature References

1. Podhajcer OL, Benedetti LG, Girotti MR, et al: The role of the matricellular protein SPARC in the dynamic interaction between the tumor and the host. Cancer Metastasis Rev, 2008

2. Trieu V, Hwang J, Desai N: Nanoparticle Albumin-bound (nab) technology may enhance antitumor activity via targeting of SPARC protein (abstr 53), New Targets and Delivery System for Cancer Diagnosis and Treatment (SKCC). San Diego, CA, 2007

Health

FoldRx Announces Rapid Progress With Development Program for Lead Candidate

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

FoldRx Pharmaceuticals, Inc. (FoldRx) today announced that enrollment is underway in an open-label Phase II clinical study with its lead drug candidate, Fx-1006A, for patients suffering from TTR Amyloid Cardiomyopathy (ATTR-CM). The company also announced progress in several other ongoing studies that are part of a larger development program evaluating its lead candidate. Fx-1006A is designed to stop the progression of TTR amyloidosis caused by the ‘misfolding’ of a protein called transthyretin (TTR) and the subsequent accumulation of amyloid fibrils in various tissues, such as the heart and peripheral nerve tissue, with resultant cardiomyopathy and neuropathy, respectively.

Enrollment is complete in a previously announced pivotal multinational Phase II/III clinical trial of Fx-1006A for TTR amyloid polyneuropathy. Patients having completed this 18-month Phase II/III pivotal study are being enrolled in a one-year open-label follow-up study with Fx-1006A. Additionally, recruitment is underway in an open-label Phase II study for ATTR polyneuropathy patients with various TTR mutations not included in our Phase II/III trial.

“The launch of this latest study constitutes our first interventional study for cardiomyopathy stemming from TTR misfolding and the fourth study with our lead drug candidate, Fx-1006A, since initiating the development program only two years ago,” noted FoldRx President and CEO Richard Labaudiniere, Ph.D. “Together, these studies will serve as the pivotal efficacy and safety data supporting registration of Fx-1006A for the treatment of TTR amyloid polyneuropathy and we anticipate results from the fully enrolled pivotal multinational Phase II/III clinical for TTR amyloid polyneuropathy by July 2009.”

In ATTR-CM, a fatal, under-diagnosed disorder, amyloid fibrils are deposited in the myocardium (the muscular layer of the heart), resulting in diastolic dysfunction (reduction in the heart’s ability to relax and fill with blood) that may progress to restrictive cardiomyopathy and symptomatic heart failure. ATTR-CM is caused by either specific point mutations in the TTR gene or age-associated TTR deposition.

“TTR amyloid cardiomyopathy is emerging as a significant cause of heart failure in the elderly population and in carriers of TTR mutations,” said Mathew Maurer, M.D., associate professor of clinical medicine, Columbia University Medical Center and director of the Clinical Cardiovascular Research Laboratory for the Elderly at the Allen Pavilion of NewYork-Presbyterian Hospital, who is the principal investigator for the CUMC trial site. “The ability to halt the deposition of TTR amyloid in ATTR-CM, for which there is currently no treatment, would represent a significant clinical advance in the care of patients with heart failure. As a clinical trial site, we at Columbia have administered the first-in-the-world trial dose of this novel drug candidate and we look forward to evaluating its efficacy as a potential benefit to patients with this rare, but serious disease.”

This open-label Phase II study is evaluating the safety and efficacy of orally-administered Fx-1006A in up to 40 patients with confirmed TTR cardiac amyloidosis. Participants will undergo a one-year treatment regimen with once a day 20mg dosing of Fx-1006A. The primary and secondary endpoints will measure TTR stabilization, safety, functional assessments including New York Heart Association Classification, clinical laboratory measurements of cardiac function, as well as ECG, Echocardiogram and Cardiac MRI measurements. These endpoints were chosen based on the findings of the TRACS study (Transthyretin Cardiac Amyloid Study), an observational study conducted by FoldRx which followed 29 patients with ATTR-CM every 6 months for up to two years. TRACS evaluated the natural history of ATTR-CM, and documented the change of various cardiac assessments in this patient population.

Labaudiniere also noted, “2008 has also seen significant progress in our other ongoing programs such as our relationship with Cystic Fibrosis Foundation Therapeutics where we reached a key development milestone, discovering a series of novel drug prototypes that have shown potential in vitro to correct the protein-folding defect associated with cystic fibrosis.”

About Fx-1006A

Fx-1006A is a first-in-class, disease-modifying, small-molecule compound that stabilizes wild-type and variant TTR, prevents misfolding and inhibits the formation of TTR amyloid fibrils. The stabilization effect of Fx-1006A has been demonstrated ex-vivo in plasma samples of healthy volunteers and patients with TTR amyloidosis. In a dose escalating Phase I study in healthy volunteers, Fx-1006A was found to be safe and well-tolerated. None of the study participants discontinued dosing due to adverse events. Additionally, Fx-1006A demonstrated strong TTR stabilization effects in plasma of study participants, even 24 hours after oral administration of the drug. Fx-1006A has orphan drug designation in both the U.S. and European Union (EU) and Fast Track designation in the U.S. for the treatment of TTR amyloid polyneuropathy.

About Transthyretin Amyloidosis

TTR is a hormone-carrying protein that is produced in the liver and circulates in the blood. In patients with certain genetic mutations or due to the aging process, TTR is destabilized and misfolds, resulting in amyloid deposits in various tissues. TTR misfolding is associated with TTR amyloidosis, occurring in patients aged 30 and above. Stabilization of transthyretin by Fx-1006A should inhibit further amyloid deposition and stop progression of ATTR, including the neuropathy and cardiomyopathy.

In patients with ATTR-CM, TTR amyloid fibrils infiltrate the myocardium of the heart, leading to diastolic dysfunction progressing to restrictive cardiomyopathy and heart failure. The predominant mutation in ATTR-CM, V122I, is present in nearly four percent of the U.S. African American population. A mutation in transthyretin is not a prerequisite for the development of transthyretin amyloid cardiomyopathy. In the elderly, wild-type (normal) transthyretin may become structurally unstable resulting ultimately in the formation of amyloid fibrils, primarily in heart tissues. There are currently no treatments available for ATTR-CM.

In patients with ATTR-PN, deposition of TTR amyloid occurs in the peripheral nerve tissue and results in a length dependent sensorimotor neuropathy (symptoms starting in the lower extremities) and autonomic neuropathy. Liver transplantation is currently the only treatment available for these patients.

About FoldRx Pharmaceuticals, Inc.

FoldRx Pharmaceuticals is a development and discovery company focusing on first-in-class, disease-modifying, small molecule therapeutics to treat diseases of protein misfolding and aggregation (amyloidosis). Protein misfolding is increasingly being recognized as an underlying cause of many chronic degenerative diseases. By applying FoldRx’s proprietary expertise in protein folding and its platform for drug and target discovery, the company is building a pipeline, initially for neurodegenerative and cardiovascular conditions. FoldRx’s initial pipeline includes a program in clinical development to treat genetic neurologic and cardiovascular disorders, TTR Amyloid Polyneuropathy and TTR Amyloid Cardiomyopathy, and discovery programs in Cystic Fibrosis and neurodegenerative diseases, including Parkinson’s disease, based on its broad, proprietary, yeast-based drug discovery platform. For more information on FoldRx, please visit the company’s web site at www.foldrx.com.

Health

Pipex Pharmaceuticals’ Oral Flupirtine Receives IRB Approval to Initiate Phase II Clinical Trial for Fibromyalgia

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

ANN ARBOR, Mich., Oct. 7, 2008 (GLOBE NEWSWIRE) — Pipex Pharmaceuticals, Inc. (AMEX:PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of central nervous system and autoimmune diseases, today announced that its double-blind, randomized, placebo-controlled phase II clinical trial of oral flupirtine for the treatment of fibromyalgia has received ethics committee approval to initiate the clinical trial.

Fibromyalgia is a rheumatic pain disease which affects an estimated six million Americans with only one FDA-approved therapy, Lyrica(r). During its second full year of in-market sales, Lyrica(r) recorded $1.8 billion in sales during 2007, with 47-percent annual growth.

Oral flupirtine has been approved as a treatment of pain in Europe since 1984 but has never been approval for any indication in the U.S. Flupirtine, a non-opiate analgesic, has been used in Europe for post-surgical pain, cancer pain, trauma pain, pain associated with liver disease, and other nocioceptive pain states. According to post-marketing surveillance, flupirtine has been given to more than 1.5 million patients and 2,776 patients have been studied in various controlled clinical trials with flupirtine.

Dr. Andrew L. Stoll, director of the Psychopharmacology Research Laboratory at McLean Hospital, a Harvard University-affiliated teaching hospital and inventor of this new use for the drug, commented, “The Institutional Review Board (the Committee charged with oversight of all human subjects research at McLean) has approved the initiation of a formal phase II clinical study using flupirtine as a therapeutic agent in treatment-refractory fibromyalgia patients. Due to its rapid onset of action and high response rate, I believe flupirtine may represent a new therapeutic modality for the treatment of this debilitating disease which affects more than six million Americans. There is a strong scientific rationale supporting the development of flupirtine for the treatment of fibromyalgia.”

Nicholas Stergis, Pipex’s chief executive officer, stated, “We are pleased to have received this approval to initiate the double-blind, placebo-controlled phase II clinical trial with oral flupirtine for the treatment of fibromyalgia, a pain disorder seen by rheumatologists. This program complements our rheumatic disease franchise, which includes our lead molecule, oral dnaJP1 for the treatment of rheumatoid arthritis (RA) which has completed a 160 patient, double-blind, placebo-controlled phase II clinical trial. Later this month, at the American College of Rheumatology (ACR) meeting, we intend to release additional data regarding oral dnaJP1.”

Phase II Clinical Trial of Oral Flupirtine in Fibromyalgia

This phase II clinical trial is designed as a double-blind, placebo-controlled phase II trial which would evaluate safety and efficacy of oral flupirtine vs. placebo in fibromyalgia patients. This phase II clinical trial is intended to enroll up to 90 subjects and treat subjects for up to 90 days; the primary endpoint will be a reduction in musculoskeletal pain and the overall symptoms of fibromyalgia. Secondary outcomes of the study will be a reduction in the severity of mood, fatigue, cognitive symptoms, and sleep disturbance, as well as improvement in overall level of functioning. During April 2008, oral flupirtine received an IND from the FDA to initiate this clinical trial.

Preclinical data and clinical experience suggests that flupirtine should also be effective for treating neuropathic pain since it acts in the central nervous system. Flupirtine is especially attractive as a treatment for neuropathic pain because it operates through non-opiate pain pathways, exhibits no known abuse potential, and lacks withdrawal effects. In addition, no tolerance to its antinocioceptive effects has been observed. One common link between neuroprotection, nocioception, and flupirtine may be the NMDA (N-methyl-D-aspartate) glutamate system, a major receptor subtype for the excitotoxic neurotransmitter glutamate.

Pipex has an exclusive worldwide license to issued U.S. patent 6,610,324 and pending international patents from McLean Hospital, a Harvard University-affiliated teaching hospital, relating to flupirtine’s use to treat fibromyalgia syndrome.

About Fibromyalgia

Fibromyalgia is an arthritis-related condition that is characterized by generalized muscular pain and fatigue. It is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. It is estimated to affect between two and four percent of the world’s population and, after osteoarthritis, is the most commonly diagnosed disorder in rheumatology clinics.

About Pipex Pharmaceuticals, Inc.

Pipex Pharmaceuticals, Inc. (“Pipex”) is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of central nervous system and autoimmune diseases. Pipex’s strategy is to exclusively in-license clinical-stage drug candidates for the treatment of unmet medical diseases. Pipex is focused on developing products to treat rheumatoid arthritis, dry age-related macular degeneration (AMD), multiple sclerosis, and fibromyalgia. For further information, please visit www.pipexinc.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc.’s current expectations about its future results, performance, prospects and opportunities, including statements regarding the ethics committee approval for oral flupirtine, initiating a phase II clinical trial for flupirtine, as well as clinical data in glaucoma, retinitis pigmentosa, diabetes retinopathy and Dr. Stoll’s belief that flupirtine may represent a new therapeutic modality for the treatment of fibromyalgia. Where possible, the Company has tried to identify these forward-looking statements by using words such as “anticipates,””believes,””intends,” or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements including the risks set forth in our Form 10-Q and other filings with the Securities and Exchange Commission. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including, dnaJP1, TRIMESTA, Zinthionein, oral flupirtine, SOLOVAX, oral TTM, or CD4 inhibitors, particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals, and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise.

Lyrica(r) is a registered trademark of Pfizer, Inc.

This news release was distributed by GlobeNewswire, www.globenewswire.com

 CONTACT:  Pipex Pharmaceuticals, Inc.           Nicholas Stergis, Chief Executive Officer           (734) 332-7800            Redington, Inc.           Investor Relations           Thomas Redington           (203) 222-7399

Health

Arbios Sells HepatAssist Bioartificial Liver System to HepaLife Technologies, Inc.

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

PASADENA, Calif., Oct. 7 /PRNewswire-FirstCall/ — Arbios Systems, Inc. (BULLETIN BOARD: ABOS) today announced that it has sold all its rights and interest in its bioartificial liver system, HepatAssist, to HepaLife Technologies, Inc. (BULLETIN BOARD: HPLF) , a Boston-based biotechnology company developing proprietary cell-based medical technologies to improve, protect and save lives, addressing prevalent human health concerns.

The terms of the deal included $450,000 in cash and a five year warrant to purchase 750,000 shares of HepaLife’s common stock. Arbios has received $250,000 at the closing and will receive an additional $200,000 on the earlier to occur of; i) the date on which HepaLife, in the aggregate, raises $4 million of gross proceeds from debt or equity financings, or ii) the 18-month anniversary of the closing of this transaction.

“The cash proceeds received upon the closing of this transaction will be used to continue our efforts to obtain financing or a strategic partnership for SEPET, our liver assist device, and/or another transaction that will maximize value for our shareholders,” commented Shawn Cain, Interim President and CEO. “We will be continuing our efforts by reaching out to potential additional interested parties, however, there can be no assurances that we will generate any offers, and if offers are obtained, that they will be deemed acceptable by the Company and its shareholders.”

The Company has also entered into a three month consulting agreement with Shawn Cain, pursuant to which Mr. Cain will seek to identify and engage prospective purchasers, licensors and investors and negotiate the terms of any potential transactions.

About Arbios’ SEPET(TM) Liver Assist Device

The SEPET(TM) Liver Assist Device is an extracorporeal (outside the body) liver assist device for blood purification of patients suffering from cirrhosis due to chronic liver disease and who are hospitalized with acute complications due to worsening liver dysfunction and portal hypertension. The SEPET(TM) device is a sterile, disposable cartridge containing microporous hollow fibers with proprietary permeability characteristics. When a patient’s blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities (e.g., hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration). These substances would otherwise progressively accumulate in the patient’s bloodstream during liver failure, causing hypotension, increasing risk of sepsis development and accelerating damage to the liver, lungs and other organs, including the brain and kidneys, and suppressing the function and regeneration of the liver. SEPET(TM) is designed for use with standard blood dialysis systems available in hospital intensive care units.

According to the American Liver Foundation, liver disease is among the top seven causes of death in adults in the United States between the ages of 25 – 64. In fact, one out of every 10 Americans has some form of liver disease. There is currently no satisfactory therapy available to treat patients in liver failure, other than maintenance and monitoring of vital functions and keeping patients stable through provision of intravenous fluids and blood products, administration of antibiotics and support of vital functions, such as respiration.

About Arbios Systems

Arbios Systems, Inc. is developing proprietary medical devices to enhance the survival of millions of patients each year who experience, or are at risk for, life-threatening episodes of liver failure. Arbios’ SEPET(TM) Liver Assist Device is a novel blood purification therapy that provides enhanced “liver dialysis”. For more information on the Company, please visit http://www.arbios.com/.

This press release contains forward-looking statements that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the Company’s ability to attract future financing, to enter into strategic partnerships, to dispose of its remaining assets, or to further develop its SEPET product and technology. These statements represent the current goals and judgment of Arbios’ management as of this date and are subject to risks and uncertainties that could adversely affect the Company or its abilities to achieve its goals. Arbios cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements. Please refer to our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2007, and to our subsequent Quarterly Reports on Form 10-Q, for a description of risks that may affect our results or business conditions. The Company does not undertake any obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events except as required by law. SEPET(TM) is a trademark of Arbios Systems, Inc.

Arbios Systems, Inc.

CONTACT: Shawn Cain, Interim President and CEO, +1-626-356-3105, orScott Hayashi, Interim CFO, +1-626-356-3105, both of Arbios Systems, Inc.

Web Site: http://www.arbios.com/

Health

Music Therapy Reduces Stress During Pregnancy

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

Simple technique is easy and inexpensive, but effective

Music therapy can reduce psychological stress among pregnant women, according to research just published in a special complementary and alternative therapy medicine issue of the Journal of Clinical Nursing.

Researchers from the College of Nursing at Kaohsiung Medical University, Taiwan, randomly assigned 116 pregnant women to a music group and 120 to a control group.

“The music group showed significant reductions in stress, anxiety and depression after just two weeks, using three established measurement scales” says Professor Chung-Hey Chen, who is now based at the National Cheng Kung University.

“In comparison, the control group showed a much smaller reduction in stress, while their anxiety and depression scores showed little or no improvement.

“Women in the music group also expressed preferences for the type of music they listened to, with lullabies, nature and crystal sounds proving more popular than classical music.”

The women who took part in the study had an average age of 30 years, were between 18 to 34 weeks’ pregnant and expected to have uncomplicated vaginal deliveries. All but five of the 241 women, who were recruited from the antenatal clinic at a medical centre in southern Taiwan, completed the pre and post-test assessments.

The demographic profiles of the two groups were very similar when it came to factors like education, occupation, social class and happiness with their marriage.

Half of the women were pregnant for the first time and just over half of the pregnancies were planned. The number of women in their second and third trimesters were more or less equal.

Four pre-recorded 30-minute music CDs were created for the study and each featured music that mimicked the human heart rate, with between 60 and 80 beats per minute.

The lullaby CD included songs like Brahms’ Lullaby and Twinkle Twinkle Little Star and composers like Beethoven and Debussy were included on the classic CD. The nature sounds included Tropical Mystery and Friendly Natives and the crystals’ CD comprised Chinese children’s rhymes and songs, like Little Honey-Bee and Jasmine.

Women taking part in the music group were given copies of the CDs and asked to listen to them for 30 minutes a day for two weeks. They then completed a diary saying which CD they had listened to and what they were doing at the time. Most of them listened to the music while they were resting, at bedtime or performing chores.

The control group did not listen to the CDs.

Participants in both groups were asked to complete three well-established scales, which are used to measure stress, anxiety and depression, before and after the music intervention.

The results showed that:

Before they took part in the study, women in the music group scored 17.44 on the Perceived Stress Scale, which ranges from zero to 30. After the intervention their stress levels had dropped by an average of 2.15, which is statistically significant. Women in the control group reported a much smaller fall of 0.92.
Anxiety was measured by the State Scale of the State-Trait Anxiety Inventory, which ranges from 20 to 80. It fell by 2.13 from 37.92 in the music group and rose by 0.71 in the control group.
Depression was measured by the Edinburgh Postnatal Depression scale, which ranges from zero to 30. The music group reported an average level of 12.11 before the intervention and a reduction of 1.84 at the end of the two-week period. The score was almost constant in the control group, falling by an insignificant 0.03.

“Pregnancy is a unique and stressful period for many expectant mothers and they suffer anxiety and depression because of the long time period involved” says Professor Chen. “In fact, anxiety and depression during pregnancy is a similar health problem to postnatal depression.

“Any intervention that reduces these problems is to be welcomed. Our study shows that listening to suitable music provides a simple, cost-effective and non-invasive way of reducing stress, anxiety and depression during pregnancy.

“The value of music therapy is slowly being realized by nurses in a number of clinical settings and we hope that our findings will encourage healthcare professionals to consider it when treating pregnant women.”

Complementary and alternative therapies (CAM) are increasingly being used, according to Dr Graeme D Smith, Senior Lecturer at the University of Edinburgh and editor of the special October issue.

“There are many potential health benefits that can be gained from close integration of CAM therapies into nursing practice and conventional health care” he says. “In the UK, for example, approximately one in five people have tried at least one form of CAM and one in five family doctors are actively involved in providing them. It is also good to see that the National Health Service is incorporating more types of CAM as part of its delivery of integrated services.

“The beauty of the CAM technique described by Professor Chen is that patients saw immediate and significant benefits simply by including half an hours’ relaxing music into their daily routine. In a world of sophisticated medical advances, it is good to see that something so easy and inexpensive can be so effective.”

* Effects of music therapy on psychological health of women during pregnancy. Chang et al. Journal of Clinical Nursing. 17, pp 2580-2587 (October 2008).

—

On the Net:

Journal of Clinical Nursing

Health

Mommy’s ER Provides Natural Relief for Sniffles, Fever, Allergies and More

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

AUSTIN, Texas, Oct. 7 /PRNewswire/ — It’s 3 am, your child has a fever, and that dose of ibuprofen hasn’t kicked in yet. You wish there was something safe and simple you could do to make her feel better, but what? Mommy’s ER is a 3-part DVD library of safe, simple, natural remedies parents can use to offer relief at any time. Each DVD is packed with easy-to-understand segments and demos that educate users on everything from how to teach yourself (and your child!) simple acupressure treatments, nutritional information even facts on the healing powers of herbs. The first DVD focuses on acute conditions, such as fever or sore throat. The second reviews chronic conditions, such as ear infections and allergies. The third DVD examines ways to support overall health and well-being. The best part? All of the treatments can be used alone or in conjunction with a pediatrician’s recommendations.

Mommy’s ER is a unique combination of Eastern medicine, Western sensibilities, and good-old fashioned common sense. Austin mom Jennifer Crain, a licensed acupuncturist and former public health researcher and virologist, created the DVDs. “Mommy’s ER was born out of personal experience,” says Crain. “When my son was one, he had an ear infection he just couldn’t shake. After three unsuccessful attempts with antibiotics, I drew from my knowledge of Chinese medicine. He hasn’t had ear trouble since.” Crain specializes in treating complicated children’s health conditions by using acupressure, Japanese-style acupuncture and nutritional healing. She holds a Masters Degree in Acupuncture & Oriental Medicine from the Academy of Oriental Medicine at Austin.

Mommy’s ER comes in a 3 volume set for $79.95 and is available at http://www.mommyser.com/. Jennifer Crain is available for press interviews and as an expert on Eastern medicine and acupuncture for children and adults.

Mommy’s ER

CONTACT: Dorre Fox of Mommy’s ER, +1-512-300-5148, [email protected]

Web site: http://www.mommyser.com/

Health

New National Report Reveals the High Price of Low Self-Esteem

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

ENGLEWOOD CLIFFS, N.J., Oct. 7 /PRNewswire/ — Self-esteem has become a national crisis in this country. The majority of girls (seven in ten) feel they do not measure up in some way including their looks, performance in school and relationships. Most disturbing is that girls with low self-esteem are engaging in harmful and destructive behavior that can leave a lasting imprint on their lives. These new findings come from Real Girls, Real Pressure: A National Report on the State of Self-Esteem(1), conducted with girls between eight and 17 and commissioned by the Dove Self-Esteem Fund. In response, Dove is launching its largest effort yet to bring self-esteem programming to girls across the country and to encourage everyone to make a difference in the lives of girls. This new initiative is part of the Dove Self-Esteem Fund goal to reach 5 million girls globally by 2010 with self-esteem programming.

Destructive Behaviors

An alarming number of girls are turning to destructive action when feeling insecure, and girls with low self-esteem are three times more likely to participate in dangerous behaviors during these times.

   --  75 percent of girls with low self-esteem reported engaging in negative       and potentially harmful activities, such as disordered eating,       cutting, bullying, smoking or drinking, when feeling badly about       themselves -- compared with 25 percent of girls with high self-esteem.   --  61 percent of teen girls with low self-esteem admit to talking badly       about themselves (Compared to 15 percent of girls with high       self-esteem)    --  25 percent of teen girls with low self-esteem resort to injuring       themselves on purpose or cutting when feeling badly about themselves       (Compared to 4 percent of girls with high self-esteem)    --  25 percent of teen girls with low self-esteem practice disordered       eating, such as starving themselves, refusing to eat, or over-eating       and throwing up, when feeling badly about themselves (Compared to 7       percent of girls with high self-esteem)

“Low self-esteem among girls and young women has reached a crisis level,” said Dr. Ann Kearney-Cooke, Ph.D., a psychologist and self-esteem expert who collaborated on Real Girls, Real Pressure. “The new report from Dove confirms the importance of healthy self-esteem and the dangerous consequences that can arise when hang-ups about looks, academics and popularity erode a girl’s sense of self-worth and self-acceptance.”

Self-Esteem Tipping Point

Girls are also craving better communication with adult figures as they struggle with challenges in their lives. The top wish among girls is for their parents to communicate better with them, including more frequent and more open conversations, as well as discussions about what is happening in her life. However, as girls enter their teenage years there is a significant loss of trust and communication with adults, particularly when they are feeling badly about themselves.

   --  67 percent of girls ages 13 - 17 turn to their mother as a resource       when feeling badly about themselves compared to 91 percent of girls       ages 8 - 12    --  Only 27 percent of girls ages 13 - 17 will turn to their father for       help when feeling badly about themselves compared to 54 percent of       girls ages 8-12.  Interestingly, at 16, girls become more likely to       seek support from male peers than from their own dads.

“We cannot underestimate just how vital the words and actions of parents are in fostering positive self-esteem in girls. However, it can be challenging because adolescence is not typically a time when girls are reaching out to their parents and speaking candidly,” said self-esteem expert Jess Weiner, a best-selling author and the Global Ambassador for the Dove Self-Esteem Fund. “The good news is that if parents and other role models are willing to create a steady conversation of encouragement, honesty and openness it can definitely help girls gain confidence and reach their full potential.”

Making a Difference

This fall, the Dove Self-Esteem Fund is extending its outreach in an effort to tackle the self-esteem crisis among girls. As part of its largest efforts to date, Dove is continuing to support uniquely ME!, a long-term partnership with the Girls Scouts of the USA that helps build confidence in girls 8-17 with after school programs, self-esteem building events and educational resources. The brand is also embarking on a new partnership with the Boys and Girls Club of America to conduct educational workshops in 20 cities across the country for both girls and the adults who influence them.

The Dove Self-Esteem Workshops for girls have been developed to empower them and promote new ways of thinking about beauty, body image and self-esteem. Separate “Train the Trainer” workshops will also be held in each city for mentors and educators to provide them with the skills and information they need to host workshops with girls in their own organizations.

“We know that if you spend time giving girls new ways to think about beauty, body image and self-esteem it can make a real difference,” said Kathy O’Brien, Dove marketing director. “This program has been developed to provide the resources necessary to create positive change and ensure the next generation of young women grows up feeling good about themselves and appreciating their own unique beauty.”

To ensure everyone has access to self-esteem resources, Dove has developed a range of powerful and engaging self-esteem online tools, workbooks and facilitator training guides for girls, moms and mentors that can be downloaded for free on the Dove Web site. To learn more visit campaignforrealbeauty.com.

About Real Girls, Real Pressure: A National Report on the State of Self-Esteem

Real Girls, Real Pressure: A National Report on the State of Self-Esteem was conducted nationally online among 1,029 girls 8 – 17, and is representative of the U.S. based on census indicators (region, ethnicity and parental education.) An additional 3,344 girls 8 – 17 were surveyed in a targeted study that was conducted in 20 major U.S. cities representative of each DMA based on ethnicity and parental education. The research was conducted by StrategyOne, an applied research consulting firm, in collaboration with Ann Kearney-Cooke, PhD.

Methodology: Interviews averaged 15 minutes and were conducted between May 6 and May 28, 2008 using the online field services of ResearchNow.

About the Dove Self-Esteem Awareness Measurement

The Dove Self-Esteem Awareness Measurement was developed to provide an indicator of self-esteem encompassing an overall sense of self-acceptance, confidence and emotional orientation among American girls. Each girl surveyed was assigned a score based on how she rated herself in each of these areas. Based on their individual scores, girls were classified into three groups: high, average and low self-esteem. The high self-esteem group was comprised of girls whose scores fell within the top third of the distribution, the average self-esteem group included girls whose scores fell within the middle third of the distribution and the low self-esteem group included girls whose scores fell within the bottom third of the distribution.

About the Dove Self-Esteem Fund

The Dove Self-Esteem Fund was established as an agent of change to inspire and educate girls and young women about a wider definition of beauty. It is committed to help girls build positive self-esteem and a healthy body image, with a goal of reaching 5 million girls globally by 2010. The Fund is part of the Dove Campaign for Real Beauty, a global effort designed to widen today’s stereotypical view of beauty.

The Dove Self-Esteem Fund is a global project, which consists of a network of local country initiatives linked in strategy and direction by a global steering group. In each country, the Dove Self-Esteem Fund supports a specific charitable organization to help foster self-esteem. In the U.S., it supports the Boys and Girls Club of America and the Girls Scouts of the USA to help build confidence in girls 8-17 with after-school programs, self-esteem building events and educational resources.

About Dove

The Dove mission is to make women feel more beautiful every day by challenging today’s stereotypical view of beauty and inspiring women to take great care of themselves. Dove, manufactured by Unilever, is the No. 1 personal wash brand nationwide. One in every three households uses a Dove product(2), which includes beauty bars, body washes, face care, anti-perspirant/deodorants, body mists, hair care and styling aids. Dove is available nationwide in food, drug and mass outlet stores.

About Unilever

Unilever’s mission is to add vitality to life. We meet everyday needs for nutrition, hygiene and personal care with brands that help people feel good, look good and get more out of life. Each day, around the world, consumers make 160 million decisions to purchase Unilever products.

In the United States, the portfolio includes major brand icons such as: Axe, Ben & Jerry’s, Bertolli, Breyers, Caress, Country Crock, Degree, Dove personal care products, Hellmann’s, Klondike, Knorr, Lipton, Popsicle, Promise, Q-Tips, Skippy, Slim-Fast, Suave, Sunsilk and Vaseline. All of the preceding brand names are registered trademarks of the Unilever Group of Companies. Dedicated to serving consumers and the communities where we live, work and play, Unilever employs more than 14,000 people in both the United States and Puerto Rico – generating nearly $11 billion in sales in 2007. For more information, visit http://www.unileverusa.com/.

(1) Real Girls, Real Pressure: A National Report on the State of Self-Esteem (commissioned June 2008)

(2) AC Nielsen (2004)

Dove

CONTACT: Alison Dunning of Edelman, +1-212-704-4452,[email protected], for Unilever; or Stacie Bright of Unilever,+1-201-894-6531, [email protected]

Web Site: http://campaignforrealbeauty.com/http://www.unileverusa.com/

Business

Orbital Sciences Coming to Huntington

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

By Beighley, Dan

MANUFACTURING: Rocket, satellite maker set to hire local, Boeing engineers Virginia’s Orbital Sciences Corp. is looking to tap into Orange County’s engineering workforce by opening a Huntington Beach office.

The Dulles, Va.-based maker of rockets and satellites wants to hire as many as 40 people in its first year here, and could eventually employ as many as 150.

“Huntington Beach is fertile ground for aerospace engineers,” said Barron Beneski, a spokesman for the company.

Orbital Sciences chose Huntington Beach despite its higher costs when it couldn’t recruit engineers to its Chandler, Ariz., location.

“Some people just don’t want to move, so we had to go to them,” Beneski said.

The office is expected to open this fall, but the company won’t announce the location until it’s signed a lease, he said.

The Huntington Beach location also will keep the company closer to many of its suppliers and customers in the area, which include Boeing Co., Northrop Grumman Corp., the California Institute of Technology’s Jet Propulsion Laboratory in Pasadena and the Air Force’s Missile Systems Center at its Los Angeles base.

Orbital did more than $1 billion in sales last year, about double what it was doing five years ago.

It had a recent publicly traded market value of about $1.5 billion.

It’s also doubled its workforce, growing at an average of 300 employees each year, bringing its total number of employees to 3,600.

Orbital will be competing with other local companies who have struggled to find engineers for some programs.

The company already has hired a handful of people for the office since announcing the move in August; it doesn’t anticipate having a hard time finding people.

“We’re not looking for quantity, but quality,” Beneski said.

Many of its new hires are likely to come from Boeing.

Boeing announced earlier in the year that it was laying off some of its workforce related to its satellite business in Seal Beach that failed to win some contracts.

Boeing, which accounts for 40% of all aerospace and defense employees in OC, or 9,700 workers, showed a 7.3% drop off in total workers in the past year.

Excluding Boeing’s reduction, the top 25 employers in the industry had a 2% increase in their workforce to 1.3 million jobs.

Like Orbital, Boeing had a similar problem in luring OC engineers outside of the area for work.

Last year, half of the 900 workers at Boeing’s United Launch Alliance, a joint venture with Lockheed Martin Corp, passed on moving with the company to Denver.

Most of the workers stayed for family reasons, according to the company.

Engineers at Orbital’s Huntington Beach office will be working primarily on the company’s Taurus II rocket program, which ferries cargo to the International Space Station.

Orbital doesn’t have plans to bring its satellite business here, but it is looking to tap rocket engineers in the area.

Some also will work on missile defense systems and help the company with customers and suppliers in Southern California.

The location will just have offices, not test facilities, Beneski said.

Huntington Beach won’t be Orbital’s first California location. It currently employs about 150 at Vandenberg Air Force Base in Santa Barbara County and NASA’s Ames Research Center in Santa Clara County. More are likely to be added in the future, according to the company.

Orbital has been in business since 1982, and markets its products as being smaller and cheaper than competitors’.

Over the past few years the company has sold off parts of its business outside its core aerospace and defense industry, such as its transportation management division.

In June it said it would invest $45 million for a test and launch facility for its Taurus II program, adding about 125 jobs in Duties and its Wallops Island, Va., locations.

Health

The Historian As Time Traveller

Written By: Sam Savage

Published Date: October 7, 2008 Last Edited: October 7, 2008

By Mortimer, Ian

Ian Mortimer, who has been an archivist and a poet before becoming a medieval historian and biographer, describes why a blend of empathy and evidence is the key to getting the most out of history. I was about ten years of age, standing alone in the ruined hall of Grosmont Castle in South Wales. The wand rustled the leaves of the nearby trees as I looked up at the empty space where Maud, mother of the great Duke of Lancaster (who was born in this castle), had sat in the early fourteenth century. I pictured the decoration on the walls, the table on the dais, the tablecloth, the dishes with rich sauces, the salt, and the servants bustling over the dinner. I imagined Lady Lancaster’s expression in the weeks after the birth, coming unsteadily into the hall from her solar chamber, smiling, receiving visitors and messengers. In my mind’s ear I heard her speaking to the chaplain seated beside her during a meal, and her conversation with her husband, Henry, Lord Lancaster, after his return from a hunting trip. Then I looked at the guidebook. On the page, these people were as dead as the stones of the ruined castle.

That day in the late 1970s I began to realize that my vision of the past was a little different from other people’s. It seemed that the dead were treated as if they were just so many exotic species, pinned out and labelled like butterflies in a museum case. The flaxen-haired Harold II was a shortlived tragic specimen; the Richard II a brilliantly coloured, equally short-lived one. The iridescent Elizabeth I was doomed to extinction due to her reluctance to marry.

It was not that this was all wrong; it just somehow seemed to be flat. Two-dimensional. There was no point in there being a dead Elizabeth I or a dead Richard II. It was their lives I needed to see, if I was to have any chance of understanding why they did what they did. There was little or no value in seeing a ruined hall as a pile of stone; I needed to see it as a living space. I wanted to know the answer to questions such as: how did people greet each other in the past? What did they do if they were ill? How did they cope with the deaths of so many loved ones?

As I grew up, the propensity to treat the dead as lifeless increasingly seemed to me to be a distortion of past reality. The historical Henry V – refracted through Shakespeare’s hero-worship – was treated as if he had been a political and military genius from birth, with every success of his father’s reign was due to him and every failure due to his father. Perhaps the most disturbing distortion was the way historians in the early twentieth century spoke about the ‘therapeutic’ effects of the Black Death. The illness may well have had a catalytic effect on society – and marked the beginnings of a shift to a free-market economy and democratic parliament. But what about the traumatic effect on the people of seeing nearly half their children, their neighbours and their friends die miserably? To say this terrible fate was in any way ‘therapeutic’ was a wilful disengagement from reality. It was also based on the assumption that government by political parties is somehow ‘healthier’ than feudalism. Even if it is, who in their right mind could sensibly refer to the suffering of millions of people as therapeutic? It was not a view to which I wished to subscribe.

Over the years, that day at Grosmont has often come to mind. Through it I have gradually come to terms with my frustration with traditional history. I can see now that, while history is ‘the study of the past’ in the public sphere, in its more specific educational and academic dimensions it is the study of evidence. The two are not the same: one is a matter of human understanding; the other is a scholarly process. Knowing the difference, I have begun to harness the tension between the two in what I hope is a constructive manner, using each as a corrective to the other. The human understanding element is necessary to correct the tedious excesses of scholarship; and scholarship is necessary to impose boundaries on the speculation inherent in any direct consideration of the human past.

Most people want to know ‘what the past was like’, or they want to know ‘what actually happened’. So it is inevitable that the academic reluctance to answer these questions except in an oblique way, using unemotive and undramatic language, alienates a great many potential readers and pushes them towards historical fiction. In this respect, traditional scholarship has lost out on the popular front. It has lost out intellectually, too. Since the early 1970s postmodernism and critical theory have attacked the authority of historians and undermined their claims to be able to say anything true about the past. According to the most ardent postmodernists, the practice of history is an academic ritual: a personal selection of subjective inferences drawn from a small sample of artificially constructed facts, purveyed to the public in a form subject to the historian’s own prejudices, and no more meaningful than historical fiction.

Although postmodernism has proved useful in challenging certain historical assumptions, it has done little or nothing to facilitate the closing of the gap between historical scholarship and the public. Indeed, it could be said to have made it wider by criticizing the authority of the historian without regard to why that authority exists in the first place. Historians have authority to write about the past because society as a whole is curious about it. If people want to know ‘what the past was like’, then historians have a public responsibility which gives meaning to their work. Such a response not only answers the challenge of postmodernism but also the unarticulated criticism of the popular reader, who feels alienated by academia and driven to read historical fiction. Historians may justify what they do, both intellectually and socially, through re-engaging with public interests and rediscovering the balance between history as the direct study of the past (through human understanding) and the study of the evidence.

This is the philosophical platform on which I have based my books. With regard to my sequence of historical biographies, it is necessary for me to try to understand the living people at the heart of the unfolding story. I do not believe I have any special right to sit in judgement on Edward III or Henry IV – any more than I recognize the right of someone in the distant future to sit in judgement on me – but I can try to understand them in the context of late medieval English society. This requires a conscious sympathy for them as living, developing individuals. Without a close-up, sympathetic view of the challenges they faced at each stage of their lives, how can one begin to consider the Tightness or wrongness of their actions? And what purpose would my judgement serve anyway? The purpose of history is to reveal human nature and behaviour, not to attempt to judge it.

The Time Traveller’s Guide to Medieval England is the logical extension of this philosophy into social history. I started with the most fundamental historical question – ‘what was life like?’ – and tried to answer it in a way which is both informed by scholarship and balanced by human understanding. A whole host of secondary questions followed. If you really could visit fourteenth-century England, where might you stay? What might you wear? What might you eat? What sicknesses might you suffer and how might contemporary physicians treat them? This Virtual time travel’ is instructive. Merely asking certain questions draws attention to themes which have not previously been explored. For example, if the median age in twenty-first-century Britain is thirty-eight, and in medieval England it was twenty-one, does this help to explain why medieval society was so much more violent than our own? Indeed, are we really all ‘basically the same/ as so many light-entertainment TV shows blithely state?

The ultimate value of this approach is a glimpse of history’s deeper meanings. It allows us to juxtapose our own culture with another, and to compare English society across the centuries. The hope is that a view over seven hundred years will be thought- provoking and perhaps even inspiring. This is not because of a wish to celebrate the virtues of ‘progress’, which are not always clear- cut; nor is it a nostalgic look at a way of life which was often ‘nasty, brutish and short”. But it is an attempt to show how Mankind can change and how we ourselves can be the agents of that change. History has many philosopher’s stones, but a view of how we ourselves have developed over 700 years must surely be one of the most desirable.

“historians have a public responsibility which gives meaning to their work”

Ian Mortimer has written biographies of Sir Roger Mortimer, Edward III and Henry IV. His latest book The Time Traveller’s Guide to Medieval England is published this month by Bodley Head, price Pounds 20.

Health

Ambulances Now Carry Forced-Air Breathing Devices

Written By: Sam Savage

Published Date: October 6, 2008 Last Edited: October 6, 2008

By Eric Eyre

A portable machine that helps people stop snoring and breathe easier at night is now being used in Kanawha County ambulances to treat patients on their way to the hospital emergency room.

About 15 Kanawha County Emergency Ambulance Authority trucks have been equipped with Continuous Positive Airway Pressure, or C-PAP, devices in recent weeks.

The noninvasive machines get air into the lungs faster, pushing in oxygen and pushing out fluid.

“These machines have been around for years, but we’ve just never had them on ambulances before,” said Kanawha paramedic Wayne Harmon. “It gives positive pressure and pushes away fluid.”

Harmon believes the Kanawha Ambulance Authority and the Charleston Fire Department are the first two agencies in West Virginia to equip ambulances with C-PAP machines. Ambulance companies in other states also are using them.

The ambulance authority plans to put C-PAP machines in all 35 of its vehicles by the end of the year. Each machine costs about $800.

“It’s an extension of the ER into the field, so we can provide the most appropriate treatment,” said Dr. John Burdette, the authority’s medical director and an E.R. doctor at St. Francis Hospital in Charleston. “The earlier we get to them, the better.”

C-PAP machines are most commonly used by people with sleep apnea, which occurs when the upper airway narrows and throat muscles relax during sleep. That reduces oxygen in the blood and prompts people to wake up at night.

Harmon demonstrated a C-PAP machine one morning last week. He likened the device’s air pressure to the sensation of trying to breathe while sticking your head out of the window of a speeding car.

The machine features a mask placed over the nose and mouth. An attached air hose is connected to an oxygen tank. Air pressure can be adjusted with the turn of a switch.

Paramedics use the machines on people having trouble breathing because of congestive heart failure, cardio obstructive pulmonary disease, emphysema and asthma attacks.

Patients treated with C-PAP machines in ambulances are transferred to another C-PAP machine when they arrive at the hospital.

In the past, patients with severe breathing problems often had to be sedated and intubated with a breathing tube in the ambulance, and then hooked up to a ventilator at the hospital. That increases the risk of infection and usually results in longer stays in the hospital’s intensive care unit. It’s sometimes difficult to wean people off ventilators.

“Anytime you can stop someone from going on a ventilator, you’re better off,” Harmon said.

With the C-PAP machines, if patients’ breathing improves after a few minutes, they are less likely to need a ventilator later.

“This is just another tool to help patients,” Harmon said. “It’s going to take off and become a standard of care.”

Reach Eric Eyre at [email protected] or 348-4869.

Originally published by Staff writer.

Health

Bug-Hit Wards Close

Written By: Sam Savage

Published Date: October 6, 2008 Last Edited: October 6, 2008

By Alison Dayani

THREE wards at two Birmingham hospitals were today shut down to new patients and visitors after a fresh outbreak of the winter sickness bug norovirus.

Heart of England Trust bosses said the outbreaks were reported over the weekend with two wards at Heartlands and one at Sutton Coldfield’s Good Hope remaining closed this morning.

They are still waiting for lab results to confirm how many patients are suffering with norovirus which causes severe vomiting and diarrhoea and can be dangerous to the elderly, very young and sick.

Cait Allen, spokeswoman for both hospitals said: “Two wards were affected at the weekend and we are waiting to hear when they will be reopened and how many patients are affected.

“We urge anyone who has suffered with diarrhoea and vomiting in the past 48 hours to stay away from the hospital, in a bid to stop the bug spreading.”

Over the past three weeks, the bug has swept through hospitals in the region forcing dozens of wards to be sealed off, patients isolated and visitors banned.

More than 130 patients were hit across 14 wards at Worcestershire Acute Hospitals Trust, which includes Redditch’s Alexandra Hospital and Kidderminster Hospital.

All non-urgent planned surgery was cancelled and visitors turned away at the height of the problem when five wards alone were closed off in Redditch.

An elderly care ward, Ward C3, at Russells Hall Hospital, in Dudley, was affected last week.

While Ward D11 at City Hospital, in Winson Green, was closed off when six patients were diagnosed with the virus on September 21.

That ward reopened late last week.

The Health Protection Agency (HPA) warned that norovirus cases will only continue to rise as they usually start to appear during the autumn, peaking in January.

Advice is to wash hands thoroughly after using the toilet and coming into contact with contaminated surfaces.

Health

First Florida Use of New AccuBoost Breast Cancer Treatment

Written By: Sam Savage

Published Date: October 6, 2008 Last Edited: October 6, 2008

TAMPA, Fla., Oct. 6, 2008 (GLOBE NEWSWIRE) — More that 13,000 women in Florida will be diagnosed with breast cancer this year, a number that is increasing every year. Thousands of them annually will undergo radiation therapy as part of their treatment. The AccuBoost procedure is a new image-guided radiation therapy technique for concentrating the radiation dose to the portion of the breast containing the highest concentration of cancer cells. The AccuBoost has recently been cleared by the Federal Drug Administration (FDA) for use in women with early stage breast cancer. The Center for Radiation Oncology (CRO) prides itself on providing the best treatment choices for cancer patients in the Tampa metro area. In that spirit, they are the first in the state to receive and use AccuBoost.

AccuBoost is a noninvasive imaging and radiation delivery system that focuses radiation from Iridium-192 sources into the portion of the woman’s breast that harbored her tumor. The size and location of the radiation beam is determined by a radiation oncologist using real-time mammography to pinpoint the tissue that needs to be irradiated. Dr. Kathryn Kepes, a board-certified medical oncologist and radiation oncologist at the Center for Radiation Oncology stated that “the AccuBoost design delivers a conformal dose to the target tissue, sparing the remainder of the breast and underlying lung and heart from adverse radiation effects.”

Media will be welcomed for a press conference on Tuesday October 7th at 5:20 pm. The first AccuBoost patients, CRO physicians and staff, and an AccuBoost company representative will be available for interview. The treatment process and how it differs from prior care will be demonstrated. Press kits with information about the system and CRO will be available on site or by request via mail.

Dr. Kepes founded the Center for Radiation Oncology, in 1993 and has expanded to provide care in five locations, including Brandon, Plant City, Sun City Center, Tampa and Zephyrhills. Other radiation oncologists at the Center for Radiation Oncology include Drs. Robert Lavey, Nagy Elssayad and Virginia Goytia. Together, they provide: 3D Simulation, External Beam Radiation, IMRT, HDR Brachytherapy (including MammoSite), Prostate Seed Implants, and Interstitial Breast Brachytherapy at the facilities of CRO. Their friendly and knowledgeable staff is always ready to help and answer questions at www.centerforradiation.com or (813) 661-6339.

Please visit www.AccuBoost.com for additional information on the system and visit the News page for links to prior news stories and releases. Breast cancer affects over 240,000 women each year, and is one of the topics of most interest for women and men of all ages.

The AccuBoost(tm) logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3939

This news release was distributed by GlobeNewswire, www.globenewswire.com

 CONTACT:  Center for Radiation Oncology           Cheryl Deppert           813-661-6339            Advanced Radiation Therapy            Bruce Taylor, Vice President of Marketing and Business             Development           (978) 663-7300           [email protected]           www.AccuBoost.com

Health

Using a Fan During Sleep May Reduce Infants’ SIDS Risk, Kaiser Permanente Study Shows

Written By: Sam Savage

Published Date: October 6, 2008 Last Edited: October 6, 2008

OAKLAND, Calif., Oct. 6 /PRNewswire/ — Infants who slept in a bedroom with a fan ventilating the air had a 72 percent lower risk of Sudden Infant Death Syndrome compared to infants who slept in a bedroom without a fan, according to a new study by the Kaiser Permanente Division of Research. The study appears in the October issue of the Archives of Pediatric & Adolescent Medicine.

This is the first study to examine an association between better air ventilation in infants’ bedrooms and reduced SIDS risk.

The finding is consistent with previous research that showed factors influencing a baby’s sleep environment may change SIDS risk. Among those factors are sleeping on the stomach and soft bedding, both of which may limit air ventilation around an infant’s breathing pathway and thus increase the chance of re-breathing exhaled carbon dioxide, said the researchers.

They explained that fan use is no substitute for practices known to reduce the risk for sudden infant death syndrome, which include: always placing infants to sleep on their backs, putting infants to sleep on firm mattresses and avoiding soft bedding materials like comforters and quilts, providing a separate sleep environment, preventing infants from overheating, and not smoking around infants.

“Although this is the first finding linking fan use to SIDS, concerned parents can take measures to improve ventilation of infants sleep environment, by adding fans in rooms or opening windows. Other studies have found that parents can also reduce the chance of re-breathing carbon dioxide by putting infants to sleep on their back, avoiding soft bedding and overheating, and by using a pacifier,” said study author Dr. De-Kun Li, a reproductive and perinatal epidemiologist at Kaiser Permanente’s Division of Research in Oakland.

The study also found that opening a window in infant’s room reduced the risk of SIDS by 36 percent compared to babies who slept in a room with closed windows, though this connection was not statistically significant according to the researchers.

“More studies need to be done to determine the exact relationship between the types of ventilation and the risks of SIDS,” said Li, who also authored a 2006 study in the British Medical Journal that found that using a pacifier can reduce SIDS risk by 90 percent.

Funded by the National Institutes of Health, this latest study looked at 185 babies who died from SIDS in 10 Northern California counties and Los Angeles County from 1997 to 2000. They were compared to 312 infants of a similar age and from similar socio-economic and ethnic backgrounds in the same counties. Researchers identified SIDS cases through records from the California Department of Health Services and the Los Angeles County coroner’s office and interviewed participating mothers by trained interviewers in English and Spanish with an average of 3.8 months after the baby’s death.

The study found that if an infant was in a high-risk sleep environment such as sleeping on their stomach or without a pacifier, or sharing a bed with someone other than parents or in an overheated room, using a fan to improve room ventilation was particularly beneficial.

SIDS is the leading cause of death among infants aged 1 to 12 months, and the third leading cause of overall infant mortality in the United States. SIDS is defined as sudden death of an infant under the age of 1, which remains unexplained after a thorough case investigation, including an autopsy, examination of the death scene and a review of clinical history.

“Though this needs to be studied further before we can make clinical recommendations, this finding is consistent with the other factors that we know impact the SIDS risk by influencing sleeping environment, such as prone sleep position, soft bedding, and use of a pacifier,” said Dr. Fern Hauck of the University of Virginia Health Systems, who is a SIDS researcher and an American Academy of Pediatrics SIDS Task Force member.

“The finding that better ventilation had a greater reduced risk of SIDS in the presence of other risk factors affecting sleep environment (prone sleep position, bed sharing — other than parents — , high temperature, and not using pacifiers) further supports the hypothesis that environmental factors play a major role in SIDS risk,” Hauck said. Hauck was not involved in this Kaiser Permanente research study.

Because of the difficult nature of the study (interviewing mothers whose babies had died suddenly), participation was relatively low. Also, in a case-control study, recall bias is always a potential concern.

The study involved infants and their mothers from Alameda, Contra Costa, Fresno, Marin, Monterey, Sacramento, San Francisco, San Joaquin, San Mateo, Santa Clara and Los Angeles counties.

Other authors on the study included: Kimberly Coleman-Phox, MPH, of the Kaiser Permanente Division of Research and the University of California, Berkeley, School of Public Health; and Roxana Odouli, MSPH, of the Kaiser Permanente Division of Research.

More information on reducing the risk of SIDS is available from National Institutes of Health’s Back to Sleep Campaign, http://www.nichd.nih.gov/sids/.

About the Kaiser Permanente Division of Research (http://www.dor.kaiser.org/)

The Kaiser Permanente Division of Research conducts, publishes, and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and the society at large. It seeks to understand the determinants of illness and well being and to improve the quality and cost-effectiveness of health care. Currently, the center’s 400-plus staff is working on more than 250 epidemiological and health services research projects.

About Kaiser Permanente Research

Kaiser Permanente’s eight research centers comprise one of the largest research programs in the United States and engage in work designed to improve the health of individuals everywhere. KP HealthConnect(TM), Kaiser Permanente’s electronic health record, and other resources provide population data for research, and in turn, research findings are fed into KP HealthConnect to arm physicians with research and clinical data. Kaiser Permanente’s research program works with national and local health agencies and community organizations to share and widely disseminate its research data. Kaiser Permanente’s research program is funded in part by Kaiser Permanente’s Community Benefit division, which in 2007 directed an estimated $1 billion in health services, technology, and funding toward total community health.

About Kaiser Permanente

Kaiser Permanente is America’s leading integrated health plan. Founded in 1945, the program is headquartered in Oakland, Calif. Kaiser Permanente serves 8.7 million members in nine states and the District of Columbia. Today it encompasses Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals and their subsidiaries, and the Permanente Medical Groups. Nationwide, Kaiser Permanente includes approximately 159,000 technical, administrative and clerical employees and caregivers, and 14,000 physicians representing all specialties. The organization’s Labor Management Partnership is the largest such health care partnership in the United States. It governs how more than 130,000 workers, managers, physicians and dentists work together to make Kaiser Permanente the best place to receive care, and the best place to work. For more Kaiser Permanente news, visit the KP News Center at: http://xnet.kp.org/newscenter

http://www.kaiserpermanente.org/

Kaiser Permanente

CONTACT: Danielle Cass, +1-510-267-5354, [email protected], orFarra Levin, +1-510-267-7364, [email protected], or Maureen McInaney,+1-510-710-7322, [email protected], all of Kaiser Permanente

Web site: http://www.kaiserpermanente.org/http://www.nichd.nih.gov/sidshttp://www.dor.kaiser.org/http://xnet.kp.org/newscenter

Health

Cannabis Spray Use May Be Made Legal

Written By: Sam Savage

Published Date: October 6, 2008 Last Edited: October 6, 2008

By CHALMERS, Anna

CANNABIS products could soon be used legally for medical purposes, after an application by a leading drug company to market a liquid version for pain relief.

Medsafe is considering whether to allow the marketing and sale of cannabis spray, Sativex, after an application from its British maker.

It comes as the Government faces increasing pressure from some patients and scientists to legalise cannabis use to alleviate chronic pain for accident victims and some sufferers of multiple sclerosis and cancer.

Cannabis is a class C drug and cannabis preparations are class B drugs, but the Medicines Act allows the drug to be used with ministerial approval.

The Health Ministry said approval to use Sativex had been granted for three patients, and a further application was pending.

The spray, which is administered under the tongue, was developed by British firm GW Pharmaceuticals for multiple sclerosis patients and has been legal in Canada since 2005.

Rose Wall, the ministry’s quality and safety manager, said the Medsafe application to market Sativex as a medicine was still being considered.

In a briefing paper to former health minister Pete Hodgson, issued by the ministry last year, officials said there was “sufficient evidence of safety and efficacy of cannabis in some medical conditions” to support consideration of compassionate, controlled use.

A group of medicinal cannabis users presented a petition with 3000 signatures to the health select committee in July, urging law reform for medical purposes.

Billy McKee, who appeared before the committee and is the director of GreenCross, a patients’ medicinal cannabis support group, said patients who used cannabis medicinally faced many risks in buying it on the black market.

He smoked cannabis to control chronic nerve pain dating from car crash injuries sustained 15 years ago and would welcome Sativex if he could “easily access and afford it”.

But he believed users could face costs of $150 to $300 weekly as it was not subsidised by Pharmac.

Mr McKee said users faced obstacles growing the drug, including arrest. His home had been burgled 20 times by thieves trying to remove plants.

Multiple Sclerosis Society national director Graham Billings said the agency supported the use of Sativex in New Zealand. “But until it’s been made legal we can’t really comment.”

Otago University Pharmacology professor Paul Smith said the drug, which contained two cannabis strands — THC and cannabidiol — would not work for all chronic pain sufferers but initial results in multiple sclerosis patients showed about 30 per cent success, including reducing symptoms in some patients.

He believed the evidence was compelling and the drug should be allowed as, unlike cannabis plant and oil, it did not have to be smoked.

“The fact that it happens to be cannabis, from a pharmacologist point of view, is irrelevant.”

GW Pharmaceuticals could not be contacted yesterday. In its application to Medsafe it says that in therapeutic doses, Sativex may produce side-effects “interpreted as a euphoria or cannabis- like high”.

——————–

Health

Scaling New Heights After Cancer Treatment, Talking to Kids About Cancer, Coping With Cancer Through Music and Breast Cancer Awareness Are Topics of October Shows

Written By: Sam Savage

Published Date: October 6, 2008 Last Edited: October 6, 2008

To: NATIONAL EDITORS

Contact: Shannon Pao of The Wellness Community, +1-202-659-9709, [email protected]

Frankly Speaking About Cancer with The Wellness Community airs Tuesdays on VoiceAmerica

WASHINGTON, Oct. 6 /PRNewswire-USNewswire/ — Kim Thiboldeaux, President & CEO of The Wellness Community (TWC), the nations leader in providing empowering support and educational programs for people with cancer and their loved ones, will address a broad range of issues in the October line-up of Frankly Speaking About Cancer with The Wellness Community,a new Internet talk radio program. Topics includehow to talk to children about cancer, how to set goals and achieve great physical accomplishments after treatment, staying positive through music, and advice for breast cancer patients and survivors on what they can do to better cope with social and emotional issues. Frankly Speaking About Cancer with The Wellness Communityairs every Tuesday at 1:00 pm PST/4:00 pm EDT on the VoiceAmerica network at http://www.modavox.com/voiceamericacms/ WebModules/HostModaview.aspx?HostId=546&ChannelId=5&Flag=1.

The Wellness Community offers people living with cancer and their loved ones free social and emotional support programs to empower them to take charge of their lives, said Kim Thiboldeaux, President & CEO of The Wellness Community, headquartered in Washington, D.C. and host of the program. Connecting listeners who need hope and information with other cancer survivors and caregivers from all over the country is tremendously rewarding, and another way The Wellness Community is helping people meet the challenge of cancer.

Frankly Speaking About Cancer with The Wellness Communitylaunched on September 9 and is the first Internet talk radio show on the VoiceAmerica Networks Health & Wellness Channel to focus specifically on how to live a better life with cancer. The radio program features patients, physicians, researchers, social workers and caregivers with whom listeners can connect and draw inspiration. The program can also be downloaded as a podcast at www.voiceamerica.com.

The October Line-up

October 7, 2008: How to Talk to Kids About Cancer

The fifth episode will feature The Childrens Treehouse Foundation, the nations only organization providing hospital-based, cancer-focused, psychosocial intervention training and programming to improve the emotional health of children whose parents have cancer. Guests will give specific advice about how to talk to kids and reveal common misconceptions children have about cancer. Guests include:

— Peter vander Noot, Executive Director, The Childrens Treehouse Foundation, Denver, CO

— Heather Hogoboom, caregiver and parent participant at The

Childrens Treehouse Foundation, Denver, CO

October 14, 2008: Beating the Odds: An Amazing Story of Cancer Survival

The sixth episode will feature Sean Swarner, the only person in the world ever recorded to have been diagnosed with Hodgkin’s lymphoma and Askin’s sarcoma. However, the story is not about his illness, but how he overcame it to climb the seven tallest peaks in the world, founding the CancerClimber Association. Guests will discuss advice for those who feel physical limitations after cancer treatment and whether every cancer patient should attempt a physical goal as well as the kind of support cancer patients need to cope. Guests include:

— Sean Swarner, Hodgkin’s lymphoma and Askin’s sarcoma survivor, Founder of the CancerClimber Association

— Peter D. Eisenberg, MD, California Cancer Care

October 21, 2008: Bret Martin, The Cancer Crooner: Providing the Ultimate Pep Talk Through Music

The seventh episode will highlight survivor Bret Martin. A father and husband who battled cancer as his wife was pregnant with their son, he turned to music to express what he was experiencing. The show will discuss the social and emotional issues cancer patients face, and how song, music, and other creative outlets can improve quality of life. The episode will also highlight the importance of a positive patient-doctor relationship. Guests include:

— Bret Martin, cancer survivor, singer and songwriter, Sebastopol, CA

— Marek J. Bozdech, MD, Redwood Regional Oncology Center, Santa

Rosa, CA

October 28, 2008: Women Living Their Best Lives in the Face of Breast Cancer

The eighth and final episode of October will highlight the compelling stories of three breast cancer survivors from around the country. In honor of Breast Cancer Awareness month, guests will discuss the important medical, social and emotional issues the estimated 2.5 million breast cancers survivors living in the United States face everyday. Guests include:

— Mel Majaros, cancer survivor, TWC Online Support Group participant, Producer of the Vic MacCarty Show, Petoskey, MI

— Maria Padilla, cancer survivor and TWC-San Francisco/East Bay

participant, Concord, CA

— Tonia Hines, cancer survivor and TWC-Greater Boston

participant, Malden, MA

ABOUT THE WELLNESS COMMUNITY

Founded in 1982, The Wellness Community is an international non- profit organization dedicated to providing free support, education and hope to people with cancer and their loved ones. Through participation in professionally-led support groups, educational workshops, nutrition and exercise programs, and stress-reduction classes, people affected by cancer learn vital skills that enable them to regain control, reduce isolation and restore hope regardless of the stage of their disease. The Wellness Community provides such programs, free of charge at more than 100 locations worldwide including 24 U.S. based and 2 international centers with 73 satellite and off-site programs and online at www.thewellnesscommunity.org.

ABOUT VOICEAMERICA

Since 1999, VoiceAmerica Networkhas been providing internet talk radio programs featuring more than 100 hosts broadcasting on four genre based channels: its flagship VoiceAmerica Channel, VoiceAmerica Health & Wellness Channel, VoiceAmerica Business Channel, and the newest, 7th Wave Network. VoiceAmerica is the single largest producer of Internet talk radio programming in the world, with over 5 million unique listeners and an average of 300,000 unique listeners a month on its Health & Wellness Channel. For more information about VoiceAmerica, visit www.voiceamerica.com.

SOURCE The Wellness Community

Health

Lou Gehrig’s Disease Now ‘Compensable’ Illness for Active-Duty Vets ; HBO to Air Program on Arlington’s ‘Saddest Acre’

Written By: Sam Savage

Published Date: October 6, 2008 Last Edited: October 6, 2008

Veterans with amyotrophic lateral sclerosis (ALS) may receive badly needed support for themselves and their families after the Department of Veterans Affairs announcement on Sept. 23 that ALS will become a presumptively compensable illness for all veterans with 90 days or more of continuous active service.

VA Secretary Dr. James Peake based his decision primarily on a November 2006 report by the National Academy of Sciences’ Institute of Medicine that concluded there is a link between military service and ALS.

The report, titled Amyotrophic Lateral Sclerosis in Veterans: Review of the Scientific Literature, analyzed numerous previous studies on the issue and concluded “there is limited and suggestive evidence of an association between military service and later development of ALS.”

Since ALS is a disease that progresses rapidly once diagnosed, Peake realized that an easier and faster claims process was in order.

ALS, also called Lou Gehrig’s disease, is a neuromuscular disease that affects about 20,000 to 30,000 people of all races and ethnicities in the United States. It is almost always fatal. It causes degeneration of nerve cells in the brain and spinal cord that leads to muscle weakness, muscle atrophy, and spontaneous muscle activity. The cause of ALS is not yet known, and there is no effective treatment.

The new regulation applies to all applications for benefits received by VA on or after Sept. 23 or that are pending on that date before the VA, the U.S .Court of Appeals for Veterans Claims, or the U.S. Circuit Court of Appeals.

Also, VA will work to identify and contact veterans with ALS, including those whose claims were previously denied, through direct mailings and other outreach programs. To view the entire regulation published in the Federal Register, go online to www.federalregister.gov/OFRUpload/OFRData/2008-21998_PI.pdf.

For more information on VA’s disability compensation program, go online to www.va.gov or call (800) 827-1000.

Next Monday, HBO will air Section 60: Arlington National Cemetery. Section 60, the final resting place for those who died fighting in Iraq and Afghanistan, is often called “the saddest acre in America.”

Unobtrusively chronicling the most intimate moments of relatives and friends mourning and honoring their loved ones at those graves, Section 60 is a powerful account of those left behind.

A family sings “Happy Birthday” to a father who would have turned 30 on that day. A father camps out on his son’s grave with a quilt, a bottle of bourbon and one of two cigars his son had sent from Iraq. Two mothers take turns mourning at the graves of their sons, killed when they were 20 and 21. A man kneels at the grave of his fiancee, a nurse killed three months earlier. A widow and her young children lay candy canes on each grave, wishing each soldier a Merry Christmas.

The documentary, by Emmy Award-winning filmmakers Jon Alpert and Matthew O’Neill, was created with the respect and professionalism evident in their previous works and, in the words of the sister of a fallen soldier, portrays Section 60 as “one of the most honorable places in America.”

Recheck beneficiaries

Veterans who receive military retirement account statements should review the back of the statement and verify their designated beneficiary. Some veterans, especially those in the Military Officers Association of America, have complained to the Department of Defense that beneficiary changes have been made without their knowledge or permission.

– U.S. Submarine Veterans

SUBVETS Groton will hold its monthly meeting at 6:30 p.m. today in the group’s clubhouse, at 40 School St. The monthly Subvet World War II social and luncheon is set for tomorrow at 10:30 a.m. in the clubhouse. The dinner of the month for members and guests will be held on Oct. 18, from 6 to 8:30 p.m., and the Holland Club luncheon will be held on Oct. 21 at 11:30 a.m., both at the clubhouse. For reservations call (860) 445-5262.

– American Legion

Post 15 meets tonight at 7 at 1016 Main St. in East Greenwich. Post 39 will meet Thursday at 7 p.m. at 1958 Kingstown Rd., Peace Dale. Fierlit-Korzen Post, 46 Central St., Central Falls will hold a yard sale on Sunday at 9 a.m., with proceeds benefiting community and Legion programs.

– Fleet Reserve Association

Blackstone Valley Branch 132 meets this evening at 7 in VFW Post 306, 171 Fountain St., Pawtucket.

– Veterans of Foreign Wars

Gilbert Auxiliary Unit 4487 will conduct a bingo at the Rhode Island Veterans Home, on Metacom Avenue in Bristol, at 1 p.m. tomorrow. Kelley-Gazzerro Post 2812, 1418 Plainfield St., Cranston, will meet Sunday at 9:30 a.m. Gatchell Auxiliary Unit 306 will hold a bingo Sunday at 171 Fountain St., Pawtucket, at 1 p.m.

– Disabled Veterans

Maurice Pion Chapter 17 will meet tomorrow at 7:30 p.m. at the Crompton Veterans Organization, on Hepburn Street in West Warwick. Mount Pleasant Chapter 21 will meet Thursday at 7 p.m. in VFW Post 10011, at 354 Fruit Hill Ave. in North Providence.

– Korean War Veterans

Northern Rhode Island Chapter 3 will meet Wednesday at 7 p.m. in the Chepachet Senior Center, 1210 Putnam Pike.

– Coast Guard Auxiliary

Flotilla 78 and guests will meet Wednesday at 7:30 p.m. in the Aspray Boathouse, Pawtuxet Village, Warwick. For more information go to www.cgaux0708.org or call (401) 884-5638.

– Reserve Officers

The Rhode Island Department’s executive committee will meet at 7 p.m. Thursday in the Harwood Army Reserve Center, 385 Niagara St., Providence.

– Military Officers’ Assn.

Narragansett Bay Chapter will hold a dinner meeting Friday at My Mary’s restaurant, 336 Post Rd., Westerly; reservations must be made by today by phoning Bob at (401) 294-4824. New members are welcome; eligible are those who were commissioned or warrant officers in active service, the Guard or Reserve or NOAA and the Public Health Service, as well as their surviving spouses. Call Bud Cooney, chapter president, at (401) 364-8969 or send e-mail to [email protected].

– Retired Enlisted Assn.

Narragansett Bay Chapter 79 will meet at 1 p.m. Saturday at Brewski’s restaurant, 10 Maple Ave., Middletown.

George W. Reilly can be reached at [email protected] or by writing to The Providence Journal, 75 Fountain St., Providence, RI 02902.