LAS VEGAS, Nov. 12 /PRNewswire/ — Health Innovations and the Nevada Health Care Coalition (NHCC) announced today the release of a new report on the demographics, costs and quality of care for people with Type 2 diabetes. The inaugural Nevada Type 2 Diabetes Report for 2007 presents an overview of patient demographics, hospital and provider charges, and utilization of clinical services and drug therapy for people with Type 2 Diabetes in key local markets in the state of Nevada. The Report also provides Phoenix, Ariz., and national benchmarks that can help employers and providers better identify opportunities to serve the needs of people with Type 2 diabetes.

“We believe you will find several improvement opportunities in this report,” says Health Innovations principal Jerry Reeves. M.D. “For instance, the proportion of Nevada’s diabetes patients with at least two serious diabetes complications or comorbidities is substantially higher than in Phoenix or the nation as a whole. And the proportion of commercial insurance diabetes patients receiving A1C tests in 2006 is below the national average.”

Six in 10 Nevadans diagnosed with Type 2 diabetes are working age

According to this report, nearly six of every 10 (59.2 percent) people with Type 2 Diabetes in 2006 in Nevada were between the ages of 18 and 64 years old, the prime working ages for most Americans. This was significantly more than the national average of 54.2 percent. Moreover, the percentage of Nevadans diagnosed with Type 2 Diabetes who had two or more complications from the disease is 13.6 percent, sharply higher than the national average of 8.4 percent.

Insulin use is lower among Type 2 diabetes patients in Nevada

The share of people diagnosed with Type 2 diabetes in Nevada using any insulin product was substantially lower than that of the nation. In the state of Nevada, 29.5 percent of people diagnosed with Type 2 diabetes used any insulin product, fractionally higher than the Las Vegas share (29.1 percent), but lower than Reno share (30.4 percent) and especially the national share (34.8 percent).

Quality of care shows positives

The quality of care indicators for Nevadans with Type 2 diabetes, a major concern, heralded more positive signs for employers who want to ensure that their employees receive appropriate care. The Nevada Type 2 Diabetes Report also provides the percentage of people with diabetes receiving recommended services, such as for glucose, Hemoglobin A1C and cholesterol blood tests, as well as eye exams and urine tests for glucose. The percentages for many of these care indicators are much closer to the corresponding national averages. For example, people with Type 2 diabetes in Nevada who received a Hemoglobin A1C test (a key marker for managing diabetes) in 2006 was 74.3 percent compared to the national average of 73.9 percent. But 83.0 percent of people with diabetes received the cholesterol test in Nevada compared to the national average of 83.7 percent.

Next Steps

According to reports from the Centers for Disease Control, more than 17 million Americans have diabetes, with an average of 1 million new cases being diagnosed each year in people over the age of 20. Nine out of ten of these patients have the Type 2 variety. The cost of diabetes in the US was approximately $132 billion in 2002, with $92 billion spent on medical services. The economic loss to the US economy due to higher rates of lost work time, disability and premature mortality associated with diabetes in the working population was approximately $40 billion in 2002. According to reports collated by Centers for Disease Control, the prevalence of obesity in Nevada increased by 28% between 2001 and 2006. And the prevalence of diabetes increased by 32% during the same 5 years. The health of Nevadans is getting worse.

Health Innovations and NHCC hope concerned citizens and stakeholders will develop, implement, and share results of interventions that improve the health status of Nevadans with obesity and diabetes. To indicate your interest in collaborating, contact [email protected].

“We request that members of the health benefits and healthcare provider communities join us in our effort to improve communication about helpful information and resources for patients and their families in their work place, community, and health care sites,” says Dr. Reeves. “We seek to pilot value-based health benefit programs with incentives that decrease barriers to the treatment and care these patients deserve. We intend to review and distribute descriptions of successful diabetes and obesity initiatives in Nevada. And we hope future annual updates of the Nevada Type 2 Diabetes Report will demonstrate that our health improvement interventions are effective.”

About the Nevada Type 2 Diabetes Report for 2007

The Nevada Type 2 Diabetes Report for 2007 helps Health Innovations and NHCC to fulfill their commitment to their community health partners to promote and maintain a high quality, efficient and affordable health care delivery system. The report was produced with assistance from sanofi-aventis. All data are drawn from the Therapeutics Trends Summary(TM), part of the sanofi-aventis Managed Care Digest Series(R). The complete report is available in electronic format on NHCC’s website at http://www.nhccreno.org/ and may be downloaded free of charge.

Health Innovations; Nevada Health Care Coalition

CONTACT: Jerry Reeves MD, Health Innovations LLC, +1-702-873-4943,[email protected]

Web site: http://www.nhccreno.org/

DARIEN, Ill., Nov. 12 /PRNewswire/ — Smart Medical Technology. Inc. has been awarded a five-year contract with Novation, the leading healthcare contracting services company of VHA Inc. and the University HealthSystem Consortium (UHC), two national health care alliances, for its Liftaem(TM) safe-patient-handling system.

The agreement makes Liftaem(TM) available to more than 2,500 health care organizations, effective Jan. 1, 2008. “By using proper equipment such as Liftaem(TM), hospitals not only decrease the risk of injury to patients but they are also helping to protect the health of their staff and decrease the potential for back injuries caused by lifting patients,” said Sandy Wise, Senior Director for Novation.

Liftaem(TM) enables healthcare professionals to easily transfer a patient from a bed to a stretcher or other surface on a single-patient-use inflatable mat — even when the patient weighs up to 1,000 lbs. It’s the only product of its kind featuring single-patient-use mats, which prevent cross-contamination — a priority in health care.

“Our vision is to develop culture-changing innovations to better manage and monitor healthcare environments,” states Smart Medical Technology Chairman and CEO James Patrick. “We believe therapy and safety should always share the same platform.”

The inflatable Liftaem(TM) mats are placed on the patients’ beds when they are admitted and remain with them for the duration of their stay. Carts used for inflation are placed throughout the hospital in areas with high numbers of patient transfers.

Smart Medical Technology developed the Liftaem(TM) to address the serious problems associated with manually lifting, transferring and repositioning patients, including:

   -- Nurses lose a combined average of 750,000 work days each year as a      result of back injury, according to the U.S. Bureau of Labor      Statistics.   -- Patients may suffer pain, skin tears, abrasions, dislocations, tube      dislodgement or even be dropped.   

The system has applications in areas such as bariatrics, maternity wards, operating rooms, intensive care and long-term care facilities.

For additional information on the Liftaem(TM) safe-patient-handling system, contact James Patrick at 630.964.1689 or visit http://www.smartmedtechnology.com/.

Smart Medical Technology, Inc. is a creative design and manufacturing company that develops solutions for the healthcare industry to improve patient care and reduce expenses — http://www.smartmedtechnology.com/.

Novation is the industry’s leading contracting services company delivering savings to more than 2,500 members and affiliates of VHA Inc. and the

University HealthSystem Consortium and over 10,000 Provista customers — http://www.novationco.com/.

   Contact:   James Patrick   [email protected]   phone: 630.964.1689   

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com/.

Smart Medical Technology, Inc.

CONTACT: James Patrick of Smart Medical Technology, Inc., +1-630-964-1689, [email protected]

Web site: http://www.smartmedtechnology.com/http://www.novationco.com/

By Orsega-Smith, Elizabeth M Payne, Laura L; Mowen, Andrew J; Ho, Ching- Hua; Godbey, Geoffrey C

Lack of social support and low self-efficacy are important barriers to regular exercise and physical activity. However, it is unclear whether these resources contribute significantly to CDC recommended physical activity levels and which of these factors (and their associated sub-domains) are more robust in relating to leisure time physical activity (LTPA) among older adults. This study examines the role of social support and self-efficacy in shaping recommended levels of older adult LTPA from five cities across the United States. Results indicated that social support provided by friends (rather than family) and the self-efficacy domain of perceived physical ability were significantly related to LTPA as measured through Metabolic Equivalents (METS). Consistent with prior research, age and health were also significantly related to LTPA. Findings suggest that inter-personal resources and intra-personal resources both play an equal role in shaping LTPA of older adults. Suggestions for promoting LTPA of older adults are discussed. KEYWORDS: Health, leisure time physical activity, social support, self-efficacy, older adults.

Introduction

At a time when the proportion of older adults in the U.S. population is growing rapidly, the need for older adult services and geriatric health care has increased considerably (Himes, 2001). Escalating health care costs have placed pressure on U.S. public finances (Kingson & Williamson, 2001) and the benefits associated with older adult physical activity have drawn increased attention. However, about a quarter of the adult population still reports achieving no leisure time physical activity (LTPA) during the past month (Centers for Disease Control and Prevention, 2005). A growing volume of research is documenting the health-related benefits (e.g., exercise, stress relief) of physical activity participation (Blair, Kohl, Barlow, Paffenbarger, Gibbons, & Macera, 1995; Hull & Michael, 1995; McAuley & Rudolph, 1995; Orsega-Smith, Mowen, Payne, & Godbey, 2004; Orsega-Smith, Payne, & Godbey, 2003; Pate et al., 1995; Penedo & Dahn, 2005; Raymore & Scott, 1998). According to these studies, parks and recreation services provide low-cost and accessible opportunities for increasing LTPA among older adults.

Since leisure is defined and redefined by succeeding cultures, it is natural that the subject matter of such research also evolves. In current society, rapid declines in the level of physical activity required in paid work, housework and personal care have made leisure a more salient arena for physical activity. The contributions of leisure behavior to active living are beginning to be documented and recognized by the medical and health community (c.f., Godbey, Caldwell, Floyd, & Payne, 2005). Thus, leisure research is being influenced by societal trends such as problems associated with sedentary lifestyles. As this happens, leisure and health researchers are collaborating in transdisciplinary efforts. Increasingly these efforts are recognized and leisure behaviors have been incorporated as part of the physical activity milieu.

Although the provision of leisure time physical activity programs and environments is a viable means to promote health and prevent disease, people commonly report constraints or barriers that limit their participation in LTPA (Arnold & Shinew, 1998; Bialeschki & Henderson, 1988; Jackson, 1983; Jackson, 1994; Mowen, Payne, & Scott, 2005; Scott & Munson, 1994; Walker & Virden, 2005). Furthermore, certain segments of the population (e.g., older adults) are more likely to be influenced by such constraints (Booth, Bauman, & Owen, 2002; Schutzer & Graves, 2004; Scott & Jackson, 1996). For these populations, special attention is now being devoted to understanding the intra-personal, inter-personal, and structural resources that can help them facilitate LTPA.

For example, a number of studies from the public health literature have found that self-efficacy and social support are important determinants of exercise and home-based physical activity (Dishman & Sallis, 1994). These concepts have been examined separately across a variety of contexts such as group exercise and home based physical activity programs. However, less is known about the collective effectiveness of these resources in influencing LTPA behaviors and whether such resources are important determinants of recommended LTPA levels for older adults. Therefore, the purpose of this study is to examine social support and self-efficacy in its relationship to leisure time physical activity.

Literature Review

Leisure Constraints and Constraint Negotiation

Leisure constraints and physical activity barriers have been examined in both the leisure studies and in the public health literature.1 With regard to leisure time physical activity (e.g., bowling, walking, exercise), a number of constraints (labeled as barriers in the public health literature) have been found to impact older adults’ physical activity. Generally, these barriers have been categorized as personal and environmental (Clark, 1999; Sallis et al., 1989). Overall, personal barriers include safety concerns, poor health, lack of time, motivation and energy, as well as lack of skill. Environmental barriers have included lack of available places to engage in physical activity, no places to sit and rest during a walk, quality and availability of sidewalks, and inclement weather. However, the leisure studies literature has labeled such barriers as leisure constraints. According to Jackson, leisure constraints are “factors that inhibit people’s ability to participate in leisure activities, to spend more time doing so, to take advantage of leisure services or to achieve a desired level of satisfaction” (Jackson, 1988, p. 203). Constraints are generally categorized into three groups based on a conceptual framework posited by Crawford, Jackson, and Godbey (1991). First, intra-personal constraints are psychological conditions that are internal to the individual (such as personality factors, attitudes, and self-efficacy). Second, inter- personal constraints arise from social interaction with and support from others (such as family members, friends, and co-workers). Finally, structural constraints include such factors as the lack of opportunities, access, or cost of activities that arise from external conditions in the environment.

In addition to understanding leisure non-participation, constraints have been studied with respect to leisure activities/ experiences (Buchanan & Alien, 1983; Jackson, 1983; Jackson, 1994; McCarville & Smale, 1993; Searle & Jackson 1985) and leisure environments such as parks (Arnold & Shinew, 1998; Kerstetter, Zinn, Graefe, & Chen, 2002; Mowen et al., 2005; Scott & Munson, 1994; Scott & Jackson 1996). Much of this work, however, has focused on structural rather than inter-personal and intra-personal constraints and has focused on how such constraints are experienced differently across populations and time periods. For example, Scott and Jackson (1996) found that older women were more likely to be constrained in their park use due to lack of park companionship, poor health, fear of crime, and having no way to get to parks. Using a replication of Scott and Jackson’s study in the same study area, Mowen et al. examined constraint trends and changes in how demographic characteristics related to park use constraints over time. Consistent with earlier constraint studies, they found that lack of time, lack of available companions, and poor health were reported as key constraints to the frequency of park use. However, during both time periods (1991 and 2001), older adults were more likely than younger adults to indicate that having no one with whom to visit parks and poor health were constraints in their use of parks. In a study of former users and non-users of state parks, Kerstetter et al. found that while the lack of time was cited as the most important constraint, lack of knowledge and lack of friends/family with whom to visit state parks were also salient. Findings from both the leisure studies and public health literatures suggest that intra- personal and interpersonal conditions can influence the frequency and enjoyment of older adults’ LTPA. In a 2000 study, Wilcox, Castro, King, Housemann, and Brownson found that perceived barriers were influential factors in shaping LTPA patterns of older, ethnically diverse rural and urban women. Alexandrie, Barkoukis, Tsorbatzoudis, and Grouios (2003) described a pattern of constraints similar to the leisure theory of constraints described by Crawford et al. (1991). In a population of older adults in Greece, they found that psychological/intra-personal constraints as most important in predicting their physical activity. In light of these findings, Jackson (2000) noted that additional research, investigating intra- personal and inter-personal constraint negotiation strategies, is needed.

As a complement to the constraints literature, Raymore (2002) emphasized the importance of examining resources that enable or promote participation. She suggested that constraints represent a “cup half empty” approach to lack of participation and encouraged researchers to adopt a complementary “cup half full” approach to examine conditions that facilitate engagement. She also asserted that social support and self-efficacy are important facilitators of leisure since they are affected by outcome expectations (i.e., the expectation of being able to perform the desired activity) and one’s environment. Therefore, in this study, we frame social support and self-efficacy as potential facilitators of LTPA, while acknowledging they might be perceived by individuals as constraints. Mannell and Loucks-Atkinson (2005) hinted at facilitators when they suggested that future research focus on strategies to enhance self-efficacy and social support resources as a way to mitigate leisure constraints/barriers and thereby facilitate participation in LTPA. A discussion of social support and self-efficacy literature is thus warranted. Social Support and Self-efficacy as Resources to Negotiate LTPA Constraints

Self-efficacy and social support are considered to be important predictive characteristics of exercise and physical activity (Dishman & Sallis, 1994). Improving one’s self-efficacy can be accomplished by starting with small steps, observing others successfully perform the physical activity, and obtaining verbal feedback and persuasion from family members, peers, and leaders (Bandura, 1977). Likewise, social support is an active and cost- effective approach to increase physical activity, and can be provided at an individual level by family, friends, or others who provide encouragement to strengthen an individual’s motives to be physically active. We purport that both social support and self- efficacy are important correlates of older adults’ LTPA.

Social support. The meaning of social support varies greatly, from frequency of interpersonal contact, family size, to living arrangements (Strain & Payne, 1992). For the purpose of the present study, social support is defined as those activities performed by one individual that assist another person toward a desired goal (Caplan, Robinson, French, Caldwell, & Shinn, 1976). House (1981) integrated the views of social support in previous work and divided the construct into four types: instrumental support, informational support, emotional support, and appraisal support. Berkman (1995) further illustrated these four sources of support in terms of support-related exercise behavior: instrumental support (e.g., giving a friend a ride to an exercise class), informational support (e.g., sharing information about exercise classes or programs with a friend), emotional support (e.g., calling a friend to see how his/ her exercise program is going), and appraisal support (e.g., providing encouragement for exercise or learning a new activity).

A growing volume of literature is documenting the importance of social support to exercise behavior for older adults as well as for other age groups. One study assessed types of social support as determinants of exercise adherence for both men and women ages 50 to 65 (Oka, King, & Young, 1995). Social support was an important predictor of exercise adherence among the sample and the authors concluded that social support specific to exercise was an even better predictor than general social support measures. Similarly, in a survey that explored the origins of social support for later life experiences among older women, O’Brien Cousins (1995) suggested that having active friends and/or being encouraged by at least one person were the most influential forces for these women to participate in active types of activities. In a study that examined the relationship between general social support and levels of physical activity of 29,135 individuals from the 1990 Ontario Health Survey, Spanier and Allison (2001) concluded that general social support, in terms of quality and frequency was significantly associated with higher levels of physical activity. Those who had more friends and family members that were contacted frequently also participated in higher levels of physical activity (i.e., frequency or intensity of exercise).

In a 2000 study, Wilcox and colleagues found that social support was an influential factor in shaping the leisure-time physical activity patterns of older, ethnically diverse rural and urban women. In addition, a study of 1803 healthy workers and home-makers aged 18-59 years living in Western Australia also reinforced the importance of social support for increasing levels of physical activity (Giles-Corti & Donovan, 2002). This study examined the influence of individual, social environmental, and physical environmental factors on physical activity. Results of this study demonstrated that the influence of physical environmental determinants to be secondary to individual and social environmental determinants. Respondents with exercise partners or those who were members of sport or recreational clubs were more likely to achieve recommended levels of physical activity than those without such resources. This study reinforced the notion that social support has an important role in facilitating physical activity especially in the domain of LTPA. However, a number of studies are also noting that self-efficacy may also be an important determinant of physical activity.

Self-efficacy. Social cognitive theory is a framework designed to examine human behavior as a reciprocal interaction between interpersonal factors, behavior, and the external environment (Bandura, 1977). Within social cognitive theory, there are several components that are thought to explain an individual’s regulation and motivation in social, cognitive, and behavioral skills. Self- efficacy is one construct in social cognitive theory that is based on the premise that people can self-regulate their own motivations and behaviors (Bandura). Self-efficacy can be defined as the belief in one’s ability to perform a specific task despite obstacles and aversive experiences. An individual with high self-efficacy tends to expend more effort, attempt more challenging tasks, and continue to persist to achieve these tasks in the face of obstacles than an individual with low self-efficacy (Bandura). For example, with respect to physical activity, a person who has high exercise self- efficacy is more likely to attempt to continue to increase minutes of daily physical activity towards achieving 30 minutes per day despite, for example, inclement weather or the loss of an exercise partner.

Self-efficacy has been shown to be a predictor of adoption and adherence to health behaviors in a variety of settings across multiple populations. In healthy adults, self-efficacy has been demonstrated to be a predictor of the adoption and maintenance of dietary health habits in office staff personnel (Sheeshka, Woolcott, & MacKinnon, 1993), the management of weight loss (Weinberg, Hughes, Critelli, England, & Jackson, 1984), the management of diabetes through adherence to diet and exercise (Kavanaugh, Gooley & Wilson, 1993), and of adherence to exercise prescription following coronary angioplasty (Jensen, Banwart, Vehaus, Popkess-Vawter, & Perkins, 1993).

Self-efficacy has been examined in a variety of exercise settings as both a predictor and as an outcome of exercise. However, it has seldom been examined in the context of leisure. Specifically, it has been studied as a predictor of acute single bouts of exercise such as a graded exercise stress test (Ewart, Taylor, Reese, DeBusk, 1983; Rejeski, Craven, Ettinger, McFarlane, & Shumaker, 1996) and in chronic exercise such as an exercise program (Garcia & King, 1991; McAuley & Jacobson, 1991; McAuley, 1993; McAuley, Jerome, Elavsky, Marquez, & Ramsey, 2003; Sallis, Haskell, Fortman, Vranizan, Taylor, & Solomon, 1986). Self-efficacy has also been studied as an outcome of participation in exercise interventions or programs (Kaplan, Atkins, Timms, Reinsch, & Lofback, 1984; McAuley, Courneya, & Lettunich, 1991; Oldridge & Rogowski, 1990). Moreover, self- efficacy has been examined as a mediator between activity and social support (Duncan & McAuley, 1993) and between past exercise behavior and social cognitive theory components (Conn, 1998).

In the area of physical activity promotion, self-efficacy has also been examined in a variety of populations including women and older adults. In a study of African American women and leisure-time physical activity, self-efficacy was a significant predictor of the duration of leisure time physical activity (Sharma, Sargent, & Stacy, 2005). Researchers determined that self-efficacy had a stronger association with physical activity more so than walking in a sample of adults from Queensland, Australia (Duncan & Mummery, 2005). Self-efficacy was also a significant predictor of moderate to vigorous physical activity in a population of randomly selected 50- 65 year olds from Ghent, Belgium (De Bourdeaudhuij & Sallis, 2002). Despite the growing evidence that social support and self-efficacy are important resources in shaping physical activity, few studies have examined their collective influence on leisure time physical activity and whether they are related to recommended levels of physical activity.

Study Purpose

Collectively, leisure studies and public health scholars have attempted to understand the role of constraints (or barriers) in shaping physical activity, leisure experiences, and the use of activity environments (e.g., public parks). While the foci of these studies have varied across disciplines, there is a general consensus that additional research is needed to document the role of individual (intra-personal) and social (inter-personal) resources in negotiating leisure constraints and in shaping leisure time physical activity behaviors. Numerous studies have examined the role of intra- personal (e.g., self-efficacy) and inter-personal (e.g., social support) resources in shaping leisure behavior, exercise, and physical activity (Giles-Corti & Donovan, 2002; Spanier & Allison, 2001; Sharma et al., 2005; Wilcox et al., 2000). However, fewer investigations have examined the collective influence of both kinds of resources in shaping LTPA among our growing older adult population. Such analyses could yield insights into whether social support, self-efficacy, or both contribute significantly to meeting recommended levels of LTPA among older adults. Given these gaps, the present research sought to address the following research questions. (1) What is the level of social support, self-efficacy, leisure time physical activity, and perceived health across a sample of older adults from five cities across the United States?

(2) What is the relative contribution of age, health, social support, and self-efficacy in shaping the level of leisure time physical activity (LTPA) of older adults?

(3) Are there significant differences in the levels of perceived health, social support, and self-efficacy reported by older adults who meet the recommended LTPA guidelines (as determined by the Centers for Disease Control) vs. those who do not meet these guidelines?

Study findings should provide insights into the level and type of social resources and self-efficacy that may be required to overcome social support constraints and stimulate increased LTPA among older adults.

Methods

Study Setting

The data from which this study was derived was part of a larger study that examined the relationship between use of local government park and recreation services (GPRS) and personal health among adults age 50 and over at five cities across the United States. The selection criteria for choosing the study cities were based on city population size, the percentage of the population that consists of ethnic/racial minorities, and climate. Since our objective was to generalize the results as much as possible from studying five cities, we selected one city with a high percentage of ethnic minorities (40% or over), a large population (250,000 or more) and a moderate (non-cold) climate; a second city with a low percentage of ethnic minorities (15% or less), a moderate population and a moderate (non-cold) climate; a third city with a high percentage of ethnic minorities and a small population (under 100,000); a fourth city with a low percentage of ethnic minorities and a small population; and a fifth city was selected specifically because it was a cold climate. Study sites included Minneapolis, Minnesota; Arlington, Virginia; Houston, Texas; San Diego, California; and Peoria, Illinois. Based on the data from this larger study, the current investigation focused on selected concepts from the questionnaire including constructs that measured older adults’ age, health, leisure time physical activity, social support from family and friends, and their self-efficacy.

Data Collection

A systematic sampling technique was utilized for approaching every other group or person who appeared to be 50 and over entering the sampling area. While this selection method was non-intrusive, it may have also skewed the data towards older participants. If the contact initially agreed to participate, research assistants continued the interview process. This systematic sampling strategy was used to increase the chance that the sample could be representative of the population (Frankfort-Nachmias & Nachmias, 1996). For the present study, the sample consisted of survey respondents who were 50 years of age and older (e.g., if a respondent reported being under 50 years of age on the mail-back questionnaire, they were eliminated from subsequent analysis).

Data collection was conducted in two phases. First, a pilot study was conducted in Peoria, Illinois from June to August 2002. During this pilot, data collection procedures were tested and refined. Following the pilot, the survey instrument was slightly revised. However, the data used in this study included only those measures that were identical in both the pilot study questionnaire and the final questionnaire. Data were collected in the other four cities from June to August 2003. Data collection occurred both at public parks and other public places (i.e., supermarkets, shopping centers, malls) where a broad cross section of older adults could be encountered. Sampling occurred three or four days a week during six- hour time intervals, including one weekend day each week. The data collection sites were selected following consultation with each city’s park and recreation agency in order to achieve a sample of both park and non-park users and to closely reflect the demographic profile of the area. Criteria used for park and non-park site selection included: ethnic distribution of the community, type of facilities and programs offered, socioeconomic status of users/ residents, and location of the facilities. The research staff invited each participant to sit for a free blood pressure check, which was used as a strategy to invite participation in the study. In addition, other incentives, such as free products (e.g., bottled water and snacks) and door prizes (e.g., gift certificates) sponsored by local grocery stores and shopping centers were also utilized to encourage participation. Participants were then given the questionnaire to take home and complete. A postcard reminder was sent out seven days after the questionnaire was distributed. A follow-up phone call was then made to non-respondents 10 days after the postcard was mailed (Dillman, 1983).

Based on this sampling procedure, a total of 5,500 surveys were distributed (1,500 in the Peoria pilot study and 1,000 each of other four sites). Refusal rates were determined by calculating the potential participants who refused to be included in the study either at the point of intercept/invitation or at the point when, asked to take a survey home to complete, they refused. Refusal rates varied from 19.8% (Arlington) to 28.9% (Peoria). A total of 1,900 questionnaires were returned, yielding a 34% response rate (Site response rates ranged between 18% and 49%, depending on the city). Lower response rates were due to over-sampling efforts in lower income and racially diverse neighborhoods where the likelihood of non-response was higher than general population surveys. While the initial contacts were more consistent with the neighborhood characteristics, the responses from the mail return survey were skewed to more educated individuals.

Measures

Self-efficacy. Self-efficacy was measured by the physical self- efficacy scale (Ryckmann, Robbins, Thorton, & Cantrell, 1982). Respondents indicated the degree to which they agreed with 21 statements about their physical self-efficacy on a 6-point Likert scale with responses of 1 = “strongly disagree” to 6 = “strongly agree.” This self-efficacy scale included two sub-domains, Perceived Physical Ability (SE-PPA) and Physical Self-presentation Confidence (SE-PSPC). Examples of statements referring to SE-PPA include “My physique is rather strong” and “I can run fast.” Examples of SE- PSPC include “I am embarrassed about my voice” and “I sometimes hold up well under stress.” A composite score was calculated by summing answers for each subscale. This scale has been used extensively in physical activity and exercise behavior research (McAuley, Blissmer, Katula, Duncan & Mihalko, 2000; McAuley, Katula, Mihalko, Blissmer, Duncan, Pena, 1999; Rishel, 2001; Williams & Cash, 2000) and has demonstrated satisfactory internal consistencies (Ryckmann et al., 1982).

Social support. Social support was measured with the social support for exercise behaviors scale (Sallis, Grossman, Pinski, Patterson, & Nader, 1987). Participants were asked to rate 12 support questions on a 6-point Likert scale (1 = “none” to 5 = “very often,” and 6 = “does not apply”) for both family and friends. To aid in interpreting the influence of social support, the item “does not apply” was treated as missing data in the present study (represents 8.1% of the total sample). In this social support scale, “family” referred to anyone living in the household, and “friends” included acquaintances and co-workers. Examples of questions included during the past month, how often has your family and/or friends “exercised with you?,””given you encouragement to stick with your exercise program?,” and “changed their schedule so you can exercise together?” Various types of social support; instrumental, informational, emotional, and appraisal are incorporated into the overall measure. Sallis et al. reported that both reliability (r = .77~.79) and internal consistency (alpha = .84~-.91) were moderately high in their study of perceived social support specific to health- related exercise behaviors.

Social demographics and perceived health. The respondents’ demographic information collected in the larger study included age, gender, educational attainment (grades 7-12, high school graduate, vocational/technical school, associates degree, bachelor’s degree, graduate degree), and marital status (married, widow, divorced, single). These descriptive data are presented in the results section to allow the reader to understand the profile of the sample. Three of these measures, perceived physical health, perceived mental health, and age also served as independent variables in the ANCOVA and multiple regression analyses.

The respondents’ health risk factors were measured by questions associated with self-rated health and health-protective behaviors. Perceived physical health and perceived mental health were derived from sub-scales of the Rand Medical Outcomes Study Health Survey (MOS SF-20). Past use of the SF-20 indicates that it has a moderately high reliability ranging from .81 to .87 for the physical and mental health scales in older adult and general population studies (McDowell & Newell, 1996). In regard to perceived physical health, respondents were asked to describe the extent to which the following four statements were true: (a) “I am somewhat ill,” (b) “I am as healthy as anybody I know,” (c) “my health is excellent,” (d) and “I have been feeling bad lately.” Responses were coded on a five- point scale in which 1 = definitely true and 5 = definitely false. Following the procedures outlined by the scoring manual, we converted this five-point scale into a 100 point scale where 1 = poorest health, and 100 = best health. A mean score was then calculated from the four-item scale. Reliability analysis yielded an acceptable Chronbach’s alpha score of .89. Perceived mental health was measured with a ten-item scale. Participants were asked to respond to ten situations. For example, they were asked, “how much of the time during the past month: (a) has your health limited your social activities (like visiting with friends or close relatives)? and (b) have you been a very nervous person?” Responses were coded on a six-point scale in which O = all of the time, 1 = most of the time, 2 = a good bit of the time, 3 = some of the time, 4 = a little of the time, and 5 = none of the time. Again, following the published protocol (McDowell & Newell, 1996), this scale was also receded into intervals of 20 (from 0-100) where O = 1, 2 = 20, 3 = 40, 4 = 60, 5 = 80 and 6 = 100. A composite score was then computed by averaging the six individual items. The Chronbach’s alpha for this scale was moderately high at .92. Leisure time physical activity. The dependent variable of Leisure Time Physical Activity (LTPA) was calculated based on total METS values (metabolic equivalents) from reported leisure activities reported by study participants. METS represent the energy expenditure whereas 1 MET is associated with energy expended at rest. Participants were asked to list up to 6 leisure time physical activities in which they participated in regularly along with the frequency per week of participation. Each of the six individual leisure activities was assigned a MET level according to the compendium of physical activities by Ainsworth et al., 2000 (i.e., if one reported square dancing it was given a value of 4.5 METS, gardening was 4 METS, general walking was 3.5 METS, playing bridge as 1.5 METS). If there was no specified intensity, then the general level of that activity was assigned (i.e., general walking as 3.5 METS). Then a total of METS for all reported leisure activities was calculated representing the total LTPA level of activity. In addition, calculations were completed to determine if the individual was meeting the CDC recommended level of daily physical activity by examining both the MET level and the frequency of the activity. Both the MET levels and frequencies of reported leisure activity for each individual were then examined. Those who participated in activities of a minimum of 3 METS (at least moderate level of activity) for a minimum of five days were categorized as meeting the CDC recommended level of physical activity (Pate et al., 1995). Those who participated in activities less than 3 METS and/or in moderate-vigorous activities (>3 METS) for less than 5 days per week were classified as not meeting the CDC recommendations.

Analyses

Frequencies and descriptives were used to determine participant characteristics (e.g., age, perceived physical and mental health, social support, self-efficacy, and LTPA). Correlation analysis was completed to examine the relationships between the independent variables. Regression analysis was used to determine the significance and relative strength of age, health, social support, and self-efficacy dimensions in predicting LTPA. Finally, Analysis of Co-Variance (ANCOVA) was used to examine health, social support, and self-efficacy differences based on meeting or not meeting CDC recommended levels of physical activity. The covariates in this analysis included age and physical health as previous research indicates age and health impact leisure time physical activity (CDC, 2004).

Results

Descriptive Findings

The mean age of the sample was 67.7 years old; 61.5% were females and 38.5% were males. Most participants were White (89.2%), over one- half of them were married (59.1%), and 18.5% were widowed. About one- fifth (29.9%) of the participants were high school graduates or less, and about half earned a bachelor’s degree or higher (50.4%). The demographic profile of the sample was skewed toward White, educated female individuals compared to that of the population for those cities surveyed. Specifically, the United States population is 75.1% White and 47.7% are high school graduates or less. In comparing our data collected at each specific site with census demographics of the cities, the data under-represents the Hispanic population found in San Diego (26.8% compared to our 4.8%) and Houston (32% compared to our 13.7%) and the Black populations in Minneapolis (18% compared to our 11.9%), Peoria (26% compared to our 2%), and Arlington (10.3% compared to our 2.6%). Similarly, we had a sample from each site that was slightly higher educated than the census data reports. In examining the percentages of the population having a high school degree or less, our sample under represented those at a lower education level, Arlington (23.9% compared to our 9.1%), Houston (45.4% compared to our 22%), Peoria (36.7% compared to our 29.3%), and San Diego (34.2% compared to our 19.4%). The Minneapolis sample, however, was more representative of the education level of the population (27% compared to our 29.8%).

With respect to health, about one-third of respondents (31.5%, n = 588) rated their health as good (Table 1). The average perceived physical health score was 76.65 (SD = +-20.50) on a scale of 0-100 and the average perceived mental health score was 74.30 (SD = +- 13.50) on a scale of 0-100. Compared to published norms, the mean physical health score was higher than the published norm while the mental health scores were the same as the published norms (Ware, Snow, Kosinski, & Gandek, 1993). The mean self-efficacy construct of perceived physical ability (PPA) was 35.49 (SD = +-11.26) and mean self-efficacy construct of perceived self-presentation confidence (PSPC) was 44.17 (SD = +-12.17). In terms of social support received from family members, the average value was 2.38 (SD = +-1.08) meaning that family members provided support for exercise between rarely and a few times. Social support from friends was reported as a mean score of 2.17 (SD = +- 1.02) meaning that most felt friends rarely provided social support. The average daily total METS was 9.80. Approximately 54.3% of the sample met the CDC recommended levels of physical activity participation.

Correlations between the independent variables were completed as a check for multi-collinearity. The multicollinarity statistics were at recommended thresholds. The variance inflation factor (VIF) statistics ranged between 1.05 and 1.84 (Table 3). Based on these initial results, the authors decided to maintain the initial survey measures as independent predictors in the subsequent regression analyses.

Preliminary analyses of the data through scatter plots allowed the assumption of normality. Multiple regression analyses (simultaneous entry procedure) were conducted to determine how social support, self-efficacy, health and age explained the variance in participation in physically active recreation (Leisure Time Physical Activity). This analysis revealed that the overall model was significantly related physically active recreation participation (R^sup 2^^sub adj^ = .160, F (7, 1219) = 34.53, p

Differences between Those Who Meet CDC Physical Activity Recommendations and Those Who Do Not

Analysis of Covariance (ANCOVA) was used to examine the group differences between older adults who met/did not meet CDC recommendations in regards to perceived health, self-efficacy, and social support. Table 4 presents the means and adjusted (covaried) means. The ANCOVAs were the health (p

Discussion

The principle aim of the study was to document and examine the collective contribution of social support and self-efficacy in relationship to leisure time physical activity among older adults. Respondents from the five cities reported relatively similar levels of social support and self-efficacy compared with prior epidemiological research (Sallis et al., 1987). Not surprisingly, given that some respondents were surveyed in park environments, perceived mental and physical health was slightly higher than previous general population surveys (Ware et al., 1993). Nevertheless, relationships between psycho-social variables and socio-demographic characteristics were consistent with a number of prior investigations in the public health and leisure studies disciplines (Dishman & Sallis, 1994; Wilcox et al., 2000). When examining two of the psychological determinants of physical activity (e.g. social support and self-efficacy), we found modest relationships. As expected, age (a control variable) was also a significant predictor of physical activity. This is consistent with previous literature that shows that, as age increases, there is a decline in LTPA (CDC, 2004). In the exercise and physical activity literature, social support from both friends and family has been shown to be significant predictors of physical activity in adult populations (Bopp, Wilcox, Oberrecht, Kammermann, & McElmurray, 2004; Stahl et al., 2001). In addition, there has been evidence of the impact of self-efficacy on LTPA (Duncan & Mummery, 2005; Sharma et al., 2005). Consistent with prior research, both age and perceived physical health contributed significantly to LTPA (Plotnikoff, Mayhew, Birkett, Loucaides, & Fodor, 2004).

Given that the self-efficacy domain of PPA was significantly related to LTPA, strategies should be identified to help older adults increase their physical self-efficacy, which in turn may increase physical activity participation. These strategies can be used by leisure service organizations target the various sources of efficacy; mastery experience, vicarious experiences, and verbal persuasion (Bandura, 1977). For example, as people are exposed to and are successful at a task, they will likely have a heightened sense of self-efficacy for that task. If an older adult is exposed to an enjoyable leisure activity setting or program and he is with the company of supportive friends, he will likely be more efficacious participating in that activity than someone who never has done so in the past or who has no-one with whom to do those activities. Vicarious experiences can be enhanced by observations of others’ actions in an event and result in the idea that “if he can do it, so can I.” For example, if an older adult observes someone else of similar age, race, and body type successfully walking along a park trail (either in person or in a promotional brochure), then the individual will likely be more efficacious in his ability to complete a half-mile trail walk.

Finally, verbal persuasion can be enhanced by verbal encouragement from someone else (i.e., friends). It can be accomplished through a strong social support system in which friends or family members encourage the individual to continue in their leisure time physical activity participation. Further support could be provided if the friends or family members set time aside to actually engage in the activity with the individual. Leisure service programmers should consider these prompts to encourage program attendance and leisure activity adherence among older adults.

Since occasional support from family and friends played a significant role in affecting older adults’ physical activity participation, it is logical to reason that increases in social support will further increase the frequency of LTPA among older adults, especially as they age. Ways to create and promote social support that increase older adults’ use of local park and recreation services for LTPA, therefore, should be considered and institutionalized in the older adult environmental planning and programming mix. For example, local communities and park and recreation agencies can seek to increase family support and joint participation in park and recreation use by older adults through public service announcements, television and print advertisements. Appeals should be made to families to encourage and support those they care about to use parks for physical activity and to help them accomplish that goal. In addition, park and recreation agencies can offer couple or partner programs at reduced rates, provide ways for multi-generations (i.e. grandparents and grandchildren) to participate in physically active recreation through programs, and promote special events (e.g. jazz along park trails, art in the park) that may bring together older adults and their friends via common cultural interests and hence possibly providing a means for those to develop social support.

Various types of social support can also be created or enhanced via positive approaches. Sallis and colleagues (1998) proposed a variety of environmental and policy interventions to promote physical activity that have implications for local park use and leisure participation. Increasing funding to develop facilities and programs used for exercise purposes is an example. More specifically, local park and recreation agencies could provide interventions, such as provision of evidence based programs and activities and the creation of walking trails specifically for older adults. These initiatives can encourage and facilitate their participation in physically active recreation in order to make connections among older adults. Other interventions could also be provided to encourage physically active leisure participation for older adults in both park settings as well as at specific recreation facilities. These may include Senior Olympics, dance lessons, various team games, and field trips.

Study Limitations and Future Research Directions

Although this study uncovered several significant findings and provided an assessment of both social support and self-efficacy, there are inherent study limitations for the reader to consider when interpreting results. First, our sample was somewhat limited in regards to the ratio of non-park users to park users who were surveyed during the summer months. There were more users of the parks than non-users in this sample, despite efforts to obtain non- participants at local malls and grocery stores. In addition, there may be some non-response bias in this study. Refusal rates varied across study sites (between 19.8% and 29.8%) and those who refused may have different characteristics than those included in the study.

The overall study was designed as a cross-sectional national survey and, thus, it is difficult to establish a cause and effect relationship. In this case either direction is possible. It may be that increases in self-efficacy and social support may lead to increases in LTPA. In contrast, it is possible that increased participation in LTPA in specific programs can lead to the development of a new social support network and enhanced self- efficacy.

In the future, longitudinal studies can add to the body of knowledge. Such studies, which examine the changes in self-efficacy and social support over time in older adults and how those changes affect their use of local parks and recreation may provide additional insight. In addition, future studies of LTPA could incorporate objective measures of activity (i.e. accelerometers). The present study provides important data suggesting that social support and self-efficacy are salient factors in correlating with older adults’ level of leisure time physical activity. More importantly, these constructs are key distinguishing psycho-social characteristics between older adults who meet the recommended guidelines for physical activity and those who do not. Future research should extend our analyses by assessing the role of structural resources (such as proximity, access, and quality of leisure activity environments) along with these intra and inter- personal resources in their relationship to LTPA. As the nation’s older adult population continues to expand, a better understanding of how intra-personal, inter-personal, and structural resources relate to age-appropriate leisure-time physical activity is warranted.

1 Given the volume of leisure constraints and physical activity barrier literature, our intent was to provide an overview of the constraints framework and review those studies that have examined intra-personal and inter-personal constraints and constraint negotiation strategies. A more thorough discussion of leisure constraints, constraint negotiation, constraint research critiques is discussed in Jackson (2005).

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Elizabeth M. Orsega-Smith

Department of Health, Nutrition & Exercise Science

University of Delaware

Laura L. Payne

Department of Recreation, Sport and Tourism

University of Illinois at Urbana-Champaign

Andrew J. Mowen

Department of Recreation, Parks & Tourism Management

The Pennsylvania State University

Ching-Hua Ho

Department of Recreation and Tourism Management

Arizona State University

Geoffrey C. Godbey

Department of Recreation, Parks & Tourism Management

The Pennsylvania State University

Address correspondence to: Elizabeth Orsega-Smith, PhD, Department of Health, Nutrition & Exercise Science, 9 Carpenter Sports Building, University of Delaware, Newark, DE 19716, Phone:302- 831-6681, Fax: 302-831-4261, [email protected].

Copyright National Recreation and Park Association Fourth Quarter 2007

(c) 2007 Journal of Leisure Research. Provided by ProQuest Information and Learning. All rights Reserved.

By Berkley, Eliza Meng, Chen; Rayburn, William F

Abstract Objective. To assess the efficiency of labor induction using low dose misoprostol for cervical ripening among nulliparous patients with severe preeclampsia.

Methods. This retrospective investigation involved cases gathered from our perinatal database for nulliparous women with severe preeclampsia delivering singleton gestations between January 2002 and May 2006. After a review of 229 hospital records, we selected only those cases (N = 145) that were eligible for a trial of labor and were administered intravaginal misoprostol (25 mcg every 3 to 6 h) for an unfavorable cervix. Primary outcomes related to the success and timing of vaginal deliveries. Secondary outcomes involved maternal and neonatal morbidity rates. Statistical evaluations included Chi-square testing and regression analysis.

Results. Vaginal delivery was successful in 95 cases (65.5%). This rate increased from 55.1% in cases at /=37 weeks. Most of those who delivered vaginally did so within 24 h (82 of 95 cases, 86.3%), regardless of gestational age. Vaginal delivery was associated with a shorter postpartum stay (2.5 vs. 3.2 days; p = 0.001) and with less neonatal respiratory distress (4.2% vs. 26.0%; p

Conclusions. Vaginal delivery within 24 h was common, with less morbidity than cesarean delivery, in this nulliparous group presenting with severe preeclampsia and an unfavorable cervix.

Keywords: Severe preeclampsia, induction of labor, misoprostol

Introduction

Preeclampsia affects approximately 8% of all pregnancies, and is one of the main indications for preterm delivery [1]. Timely delivery is warranted, because severe preeclampsia is associated with significant maternal and neonatal morbidity. There is debate, however, about the optimal route of delivery especially when preterm and with an unfavorable cervix. Several investigators recommend cesarean section to avoid prolonged induction, especially when at

It is well known that induction of labor, especially in preterm women with an unfavorable cervix, is difficult and sometimes unsuccessful [7]. Cervical ripening with agents like misoprostol, a synthetic prostaglandin El analog, is often used to enhance success. The American College of Obstetricians and Gynecologists (ACOG) acknowledged the efficacy of misoprostol for pre-induction cervical ripening while recommending a low intravaginal dose (25 mcg) [1]. Nahar and colleagues demonstrated the efficacy of misoprostol for cervical ripening and labor induction in patients with severe preeclampsia [8]. However, they did not reveal the dosing of misoprostol or the parity of their patients.

The objective of this retrospective study was to assess the efficiency of labor induction using low-dose misoprostol for pre- induction cervical ripening for nulliparous patients with an unfavorable cervix and with severe preeclampsia. Efficiency involved the success with vaginal delivery and the duration of labor. This group represents the greatest risk of failure to induction. Secondary outcome measures included maternal and neonatal morbidity.

Methods

Approval for this study was obtained from our human research and review committee. We performed a chart review of 229 consecutive cases of nulliparous patients with the diagnosis of severe preeclampsia. These cases involved singleton gestations obtained from our perinatal database from January 1, 2002 (shortly after release of the ACOG Committee Opinion) to June 1, 2006 [1]. One hundred and forty-five cases met eligibility criteria: (1) diagnosis of severe preeclampsia, (2) singleton gestation, (3) nulliparity, and (4) an unfavorable cervix (Bishop score =4) [9]. Only cases eligible for a trial of labor were included in this study. Exclusion criteria included cases in which a cesarean delivery was necessary before labor: fetal malpresentation, placenta previa, active genital herpes, infection, scarred uterus, rapidly worsening maternal condition, non-reassuring fetal heart rate (FHR) pattern before induction of labor, other active medical or obstetrical complications, and the presence of fetal anomalies.

Criteria for severe preeclampsia followed written ACOG guidelines (Table I) [1]. Confirmation of the diagnosis was made by a maternal- fetal medicine specialist. According to our written protocols, platelet counts and serum liver function tests were obtained every 6 h. Blood pressures were monitored at least every 30 min. Invasive hemodynamic monitoring was required only among women with severe cardiac disease, renal disease, refractory hypertension, pulmonary edema, or unexplained oliguria.

Upon diagnosis, all patients received intravenous magnesium sulfate for seizure prophylaxis using a 4-g bolus followed by 2 g/ h. Betamethasone, 12 mg intramuscularly for two doses, was given to those patients at

Table I. Criteria for severe preeclampsia.

We complied with guidelines from the ACOG Committee on Obstetric Practice on prescribing misoprostol for cervical ripening and labor induction [10]. These guidelines were based on published series and a detailed review of adverse outcomes reported to the Food and Drug Administration (FDA). One quarter of a 100-mcg tablet (Cytotec(R); Searle, Chicago, IL, USA) was the initial intravaginal dose. We anticipated the need to redose every 3-6 h. Oxytocin was infused when a Bishop score became >/=6 or if there were >/=6 contractions per hour. Infusion was started at or beyond 4 h after the last misoprostol dose. The starting dose of oxytocin was 2 mU/min and increased by 2 mU/min every 15 min until contractions came every 2- 3 min lasting 45-60 s [11].

Our written criteria for labor arrest that requires delivery were according to ACOG recommendations [12]. In nearly all cases, an intrauterine pressure catheter was placed. Minimally effective uterine activity was defined as three contractions per 10 min, averaging greater than 25 mmHg above the baseline. A goal of a maximum of five contractions in a 10-min period with resultant cervical dilation was considered adequate. Uterine hyperstimulation was denned either as a persistent pattern of more than five contractions in 10 min, or as contractions lasting 2 min or more [12]. Hyperstimulation syndrome was uterine hyperstimulation accompanied with a non-reassuring FHR recording [13]. An arrest disorder was diagnosed in the first stage of labor using two criteria: (1) the latent phase was completed, and (2) a uterine contraction pattern exceeded 200 Montevideo units for 2 h without cervical change. In our nulliparous women, the diagnosis of a prolonged second stage was considered when the second stage exceeded 3 h if regional anesthesia was administered or 2 h if no regional anesthesia was used.

The cases were divided into three standard subgroups according to gestational age: /=37 weeks 0 days. Maternal demographics included age, ethnicity, and predose Bishop score. The percentage of vaginal deliveries and the duration of labor were calculated for each gestational age group.

The primary outcomes were the success with vaginal deliveries and the duration of labor. As secondary outcomes, we evaluated postpartum morbidities associated with routes of deliveries. Measures of maternal morbidity included post-delivery length of hospital stay, maternal fever (>/=38[degrees]C on two occasions with maternal tachycardia), transfusion, antihypertensive therapy at hospital discharge, and readmission to the hospital. Neonatal morbidity included 5-min Apgar scores =3 and =6, select umbilical artery pH

A sample size of total patients needed to detect a 25% difference in the overall vaginal and cesarean delivery rates was 128, with a power of 0.8 and a type I error probability of 0.05. Statistical analysis was performed using SPSS 13.0 software (SPSS Inc., Chicago, IL, USA). Continuous variables that were normally distributed were compared with Student’s t-tests. Categorical variables were compared with Chi-square tests. For all tests, a p value less than 0.05 was considered to be statistically significant.

Results

During the 53-month study period, 145 women with severe preeclampsia underwent a trial of labor and were eligible for inclusion in this investigation. The numbers of cases in each gestational age group were 49 at between 28 and 33 weeks, 45 at between 34 and 36 weeks, and 51 at >/=37 weeks. Misoprostol was typically administered as two or three doses (range 1-6). Augmentation with oxytocin was used in all cases. No adverse effects from such low doses of local misoprostol (drug reaction, hemorrhage, febrile morbidity, or diarrhea) were recorded. Demographic data for those patients who either underwent a vaginal delivery or a cesarean delivery are shown in Table II. The two groups were not different except for patients at between 34 and 36 weeks of gestation being slightly older when a cesarean delivery was considered necessary. Although pre-induction Bishop scores were higher with increasing gestational age, there was no statistical difference as to the route of delivery for each gestational age subgroup and the pre-induction Bishop score. Elements of labor efficiency are shown in Figures 1 and 2. Vaginal delivery rates ranged from 55.1% in cases at between 28 weeks 0 days and 33 weeks 6 days of gestation to 68.9% of cases at between 34 weeks 0 days and 36 weeks 6 days, and to 72.5% in cases at >/=37 weeks 0 days (Figure 1). Vaginal delivery occurred within 24 h in 86.3% (82 of 95) cases. This 24-h period from initial misoprostol insert until vaginal delivery did not vary significantly between gestational age subgroups (Figure 2). Primary indications for cesarean delivery (N =50) were for fetal intolerance of labor in 34 cases (68%) and for failure to progress in 12 cases (24%).

The postpartum period was associated with gradual recovery and low maternal morbidity. The mean length of hospital stay was shorter after a vaginal than cesarean delivery (2.5 vs. 3.2 days; p = 0.001). The shorter hospital stay after vaginal delivery was most apparent at >/=37 weeks (Table III). Transfusion was necessary in one case (1.1%) after vaginal delivery. No eclamptic seizures were observed with discontinuation of intravenous magnesium sulfate approximately 24 h postpartum. Treatment for a postpartum fever with suspected endomyometritis also occurred less often (5.4% vs. 35.7%; p = 0.013) after a vaginal delivery (at least >/=37 weeks). Approximately one-third of all patients required oral antihypertensive therapy at discharge. There was no significant difference, according to gestational age or route of delivery, in the prescribing of antihypertensive medications at hospital discharge.

Table II. Maternal demographics for those who delivered either vaginally or by cesarean after labor.

Figure 1. Percent deliveries that were vaginal according to gestational age.

Figure 2. Mean time to vaginal delivery according to gestational age.

Neonatal outcomes are shown in Table III. Attendance at delivery by our neonatal team occurred in all cases. A 5-min Apgar score =6 was seen in nine (6.2%) cases, with eight being preterm. There were no cases with an umbilical artery pH /=34 weeks. Antibiotics were prescribed commonly, and reported sepsis was rare.

Table III. Maternal and neonatal morbidity according to gestational age and route of delivery.

Discussion

Consistent with our practice protocols, women with severe preeclampsia who met eligibility criteria underwent a labor induction. Our reported experience comprises the largest number of nulliparas with severe preeclampsia who were eligible for a trial of labor. We chose 145 consecutive nulliparous women, and induction was successful (i.e., resulted in vaginal delivery) in 65.5% of cases. This success rate varied by gestational age, with vaginal delivery occurring in 55.1% of women induced at less than 34 weeks compared with 72.5% induced at or beyond 37 weeks. These rates are similar or better than other reports that failed to distinguish between parity, gestational age group, and condition of the cervix [4-6,8]. Furthermore, those studies used protocols that did not comply with more current ACOG guidelines.

Our data also demonstrate that a large percentage of vaginal deliveries occur within 24 h despite an original unfavorable Bishop score. Although the duration of induction was slightly longer at an earlier gestational age, vaginal delivery occurred within 24 h in 85.2% of cases at

Initiating labor in the third trimester of pregnancy is performed by different methods such as oxytocin administration, hygroscopic balloon dilation of the cervix, extra-amniotic balloon catheters, and the use of prostaglandins and prostaglandin analogs. We chose to investigate outcomes with the use of misoprostol since it is easily available, inexpensive, stable, and easy to store. A feature of the study is compliance with recent ACOG guidelines using a low dose regimen of 25 [mu]g initially and repeated every 3-6 h, knowing that the half-life of misoprostol is 4.5 h [10]. In our experience, we infrequently administered more than three doses consecutively. Misoprostol alone did not achieve effective uterine contractions in many cases, so we often used oxytocin to augment labor.

Studying the effects of labor and routes of delivery on preterm fetuses not only requires a large data set, but also necessitates controlling for several potentially confounding therapies that affect neonatal neurologic morbidity. Uniform intrapartum written protocols were used in the current investigation, and potentially confounding variables were minimized. Magnesium sulfate was used to prevent eclampsia, and all fetuses at

Although our study is limited by its retrospective design, our findings are consistent with others that promote the general safety of induction of labor in cases of severe preeclampsia. Our investigation did not include cases at less than 28 weeks of gestation, since there was a very small number eligible to undergo a trial of labor. In addition, we did not compare overall morbidity with morbidity from elective cesareans performed in a similar group with severe preeclampsia.

Findings reported here should enhance counseling about the relative merits of a trial of labor in this high-risk group who require a timely delivery. Vaginal delivery within 24 h was common, with less morbidity than a cesarean delivery, in this nulliparous group presenting with severe preeclampsia. It appears to be appropriate to employ low-dose misoprostol in the presence of an unfavorable cervix for those cases meeting eligibility criteria to attempt a vaginal delivery. The fetuses appeared to tolerate labor and have less respiratory distress as newborn premature infants. The length of postpartum hospitalization was shortened with vaginal delivery, possibly because of fewer cases of endomyometritis and less anemia requiring transfusion.

Acknowledgements

This research was partially funded by the Seligman Perinatal Research Fund.

References

1. American College of Obstetricians and Gynecologists. Diagnosis and management of preeclampsia and eclampsia. ACOG Practice Bulletin 33. Washington, DC: ACOG; 2002.

2. Magann EF, Roberts WE, Perry KG, Chauhan SP, Blake PG, Martin JN. Factors relevant to mode of preterm delivery with syndrome of HELLP (hemolysis, elevated liver enzymes, and low platelets). Am J Obstet Gynecol 1994;170:1828-1834.

3. Murphy DJ, Stirrat GM. Mortality and morbidity associated with early-onset preeclampsia. Hypertens Pregnancy 2000; 19:221-231.

4. Mashiloane CD, Moodley J. Induction or cesarean section for preterm pre-eclampsia? Obstet Gynecol 2002;22:353-356.

5. Nassar AH, Adra AM, Chakhtoura N, Gomez-Marin O, Beydoun S. Severe preeclampsia remote from term: Labor induction or elective cesarean delivery. Am J Obstet Gynecol 1998;179:1210-1213.

6. Alexander JM, Bloom SL, McIntire DD, Leveno KJ. Severe preeclampsia and the very-low birth weight infant: Is induction of labor harmful? Obstet Gynecol 1999;93:485-488.

7. Coppage KH, Polzin WJ. Severe preeclampsia and delivery outcomes: Is immediate cesarean delivery beneficial? Am J Obstet Gynecol 2002;186:921-923.

8. Nahar S, Choudhury HR, Sayed A, Kashem A, Azim MA. Utility of misoprostol for labor induction in severe preeclampsia and eclampsia. J Obstet Gynecol Res 2004;30: 349-353.

9. Bishop EH. Pelvic scoring for elective induction. Obstet Gynecol 1964;24:266-268.

10. American College of Obstetricians and Gynecologists. Induction of labor with misoprostol. ACOG Committee Opinion 228. Washington, DC: ACOG; 1999.

11. American College of Obstetricians and Gynecologists. Induction of labor. ACOG Practice Bulletin 10. Washington, DC: ACOG; 1999.

12. American College of Obstetricians and Gynecologists. Dystocia and augmentation of labor. ACOG Practice Bulletin 49. Washington, DC: ACOG; 2003. 13. Electronic fetal heart rate monitoring: Research guidelines for interpretation. National Institute of Child Health and Human Development Research Planning Workshop. Am J Obstet Gynecol 1997;177:1385-1390.

14. Chibber RM. Severe preeclampsia and the very-low birth weight infant: The controversy over delivery mode continues. J Reprod Med 2002;47:925-930.

15. Regenstein AC, Laros RK Jr, Wakeley A, Ketterman JA, Tooley WH. Mode of delivery if pregnancies complicated by preeclampsia with very low birth weight infants. J Perinatol 1995;15:2-6.

16. Newton ER, Haering WA, Kennedy JL Jr, Herschel M, Cetrulo CL, Feingold M. Effect of mode of delivery on morbidity and mortality of infants at early gestational age. Obstet Gynecol 1986;67:507-511.

17. Bryan H, Hawrylyshyn P, Hogg-Johnson S, Inwood S, Finley A, D’Costa M, Chipman M. Perinatal factors associated with the respiratory distress syndrome. Am J Obstet Gynecol 1990;162:476- 481.

18. Witlin AG, Saade GR, Mattar F, Sibai BM. Predictors of neonatal outcome in women with severe preeclampsia or eclampsia between 24 and 33 weeks of gestation. Am J Obstet Gynecol 2000;182:607-611.

19. Hall DR, Odendaal HJ, Steyn DW. Delivery of patients with early onset, severe pre-eclampsia. Int J Gynecol Obstet 2001; 74:143- 150.

ELIZA BERKLEY, CHEN MENG, & WILLIAM F. RAYBURN

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, School of Medicine, University of New Mexico, Albuquerque, New Mexico, USA

(Received 12 April 2007; revised 10 July 2007; accepted 16 July 2007)

Correspondence: Eliza Berkley, MD, Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, MSC 10 5580, 1 University of New Mexico, Albuquerque, NM 87131, USA. Tel: +1 505 272 6269. Fax: +1 505 272 3918. E-mail: [email protected]

Copyright Taylor & Francis Ltd. Nov 2007

(c) 2007 Journal of Maternal – Fetal & Neonatal Medicine. Provided by ProQuest Information and Learning. All rights Reserved.

By Lipkin, Christine Sereno, Paul C; Horner, John R

INTRODUCTION OSSIFIED CLAVICLES, either as paired elements or as a median furcula, have been recorded in all major clades of dinosaurs, including ornithischians, sauropodomorphs, and theropods (Bryant and Russell, 1993). Nearly all but the most basal theropods, Eoraptor lunensis and Herrerasaurus ischigualastensis, have an ossified furcula including coelophysids (Downs, 2000; Tykoski et al., 2002; Carrano et al., 2005), allosauroids (Chure and Madsen, 1996), tyrannosaurids (Makovicky and Currie, 1998; Larson and Donnan, 2002; Brochu, 2003; Lipkin and Sereno, 2004; Larson and Rigby, 2005), therizinosaurids (Xu et al., 1999a; Zhang et al., 2001), oviraptorids (Barsbold, 1983; Clark et al., 1999, 2001; Hwang et al., 2002; Osmolska et al., 2004), troodontids (Xu and Norell, 2004), and dromaeosaurids (Norell et al., 1997; Norell and Makovicky, 1999; Xu et al., 1999b; Burnham et al., 2000; Hwang et al., 2002). No ossification of any element beyond the coracoid has been found in the pectoral girdle of the well-preserved primitive theropods, Eoraptor lunensis and Herrerasaurus ischigualastensis.

Although the furcula in tyrannosaurids has been described in several genera (Makovicky and Currie, 1998), the bone has never been found in articulation in any species, and controversy has surrounded the form of the furcula in Tyrannosaurus rex (Larson and Donnan, 2002; Brochu, 2003). We describe the furcula in the spinosaurid, Suchomimus tenerensis, which aids in establishing the basal condition of this bone for tetanuran theropods. We then describe furculae in Tyrannosaurus rex, one of which is preserved in articulation and others of which highlight important variation.

The specimens in this study are housed in the Children’s Museum of Indianapolis (CMI), Field Museum (FMNH), Musee National du Niger (MNN), Museum of the Rockies (MOR), and the University of Chicago Research Collection (UCRC).

DESCRIPTION

Suchomimus tenerensis.-A furcula was recovered in a partially articulated skeleton (MNN GAD513) of the spinosaurid Suchomimus tenerensis (Sereno et al., 1998). The presacral vertebral column was preserved in articulation, whereas the furcula, ribs, gastralia, girdles, and limbs were disarticulated but in close association. The furcula is V-shaped in anterior view with an intrafurcular angle of 111[degrees] (Fig. 1; Table 1). A dorsoventrally-flattened, tongue- shaped hypocleideum projects ventrally in the midline (Fig. 2.1). In anterior view, the hypocleideum is gently concave and displaced somewhat to the left of the midline. The absence of articular rugosities on the hypocleideum suggests that it did not contact other elements of the pectoral girdle. The central ramus has a D- shape in cross-section; anterior and posterior surfaces are convex and nearly flat, respectively (Figs. 1, 2).

The proximal half of each clavicular ramus tapers in dorsoventral width at mid length before expanding as a tongue-shaped epicleideal process (Fig. 1). With the central body held vertically, the epicleideal processes arch gently posteriorly and are marked by striations both anteriorly and posteriorly. The dorsal two-thirds of the epicleideal process is thin; the ventral one-third is thickened posteriorly to form an articular platform for the edge of the acromion. This portion of the process is more strongly fluted for ligament attachment (Fig. 2.2).

Tyrannosaurus rex.-The only undisputed furcula of Tyrannosaurus rex belongs to an articulated postcranial skeleton (UCRC Vl) preserved in a large sandstone concretion from the Lance Formation (Maastrichtian) of eastern Wyoming (Lipkin and Sereno, 2004). The bones of the trunk are preserved in articulation with little transverse or dorsoventral distortion. The furcula is preserved in situ between the right and left coracoids with each clavicular ramus laying near the acrominal process of the scapula (Fig. 3). The distal ends of both clavicular rami are broken away at the edge of the concretion.

The furcula is U-shaped or, more precisely, lyre-shaped in anterior view with an intrafurcular angle of 71[degrees] (Table 1). Unlike other theropod furculae, there is a transversely oriented central body from which extend the clavicular rami (Fig. 4.1). Dorsal and ventral margins of the central body are rounded with no development of a hypocleideal process. The anterior surface has a shallow transverse fossa, whereas the posterior surface is flat. The laterally deflected epicleideal process is preserved on the right side near the acromion of the right scapula. The internal bone texture of the furcula is dense without any development of marrow or pneumatic cavities. This furcula (UCRC V1) most closely resembles that of Gorgosaurus (Makovicky and Currie, 1998, figs. 1, 2), which also lacks any development of a hypocleideum, A rudimentary hypocleideum, in contrast, was reported in specimens referred to the tyrannosaurids Albertosaurus and Daspletosaurus (Makovicky and Currie, 1998, figs. 1, 2).

Another nearly complete furcula (MOR 980) was recovered with a partial skeleton of T. rex. MOR 980 was collected from the upper Hell Creek Formation (uppermost Maastrichtian), east of Fort Peck Lake in Montana (Derstler, 2005). This furcula is U-shaped with an intrafurcular angle of 87[degrees] (Fig. 4.2; Table 1). The central body has a maximum anteroposterior thickness of 19 mm, which is thicker than the others described herein. The unusual thickness is due to pathology on the left posterior-side of the central body. The pathology may have extended all the way up to the dorsal tip of the left epicleideal process. However, the anterior-side of the furcula is missing the outer portion of the clavicular ramus but the epicleideal process is preserved, and it is also pathologic. The right side of the furcula appears to be free of pathology.

Brochu (2003:95, fig. 84) tentatively identified an elongated shaft with a broken end as a “partial furcula” from a well preserved skeleton of T. rex (FMNH PR2081; Fig. 5). He noted its similarity to elements from the gastral basket, which we suggest here, is the correct identification. A bone from the same specimen was tentatively regarded as the proximal portion of a posteriormost dorsal rib (Brochu, 2003, fig. 77). The bone, however, does not match the form of more anterior dorsal ribs or the articular facets on the posteriormost dorsal vertebra. We concur with Larson and Rigby (2005, page 253) that this bone (Fig. 4.3) is a partial furcula, which is very similar in size and form to a fourth furcula found in association with another skeleton of T. rex (CMI 2001.90.1; Fig. 4.4).

FIGURE 1-Stereopairs and line drawings of the furcula in Suchomimus tenerensis (MNN GAD513). I, anterior view and cross- sectional views; 2, posterior view. Cross-hatching indicates broken bone or a cross-sectional surface. Dashed lines indicate missing portions. Abbreviations: cb, central body; ep, epicleideum; he, hypocleideum; la, ligament attachment scars. Scale bar equals 10 cm in Stereopairs; 5 cm in line drawings.

FIGURE 2-Photographs and line drawings of the furcula in Suchomimus tenerensis (MNN GAD513). 1, hypocleideum in anterior view; 2, epicleideal process in posterior view. Dashed lines indicate missing bone. Abbreviations: ep, epicleideum; he, hypocleideum; la, ligament attachment scars. Scale bar equals 5 cm.

TABLE 1-Measurements (mm) of the furcula in Suchomimus tenerensis (MNN GAD513) and furculae from Tyrannosaurus rex (UCRC Vl, MOR 980, and MOR 1125). The length of the clavicular process was taken from the more complete right side of each specimen. Parentheses indicate approximation. Abbreviations: NA, not applicable; NE, not exposed.

The fifth furcula known for T. rex, comes from a skeleton from northeast Montana (MOR 1125; Fig. 4.5). The specimen is approximately three-fourths the size of the large adult F1MNH PR2081 (Homer and Padian, 2004), is approximately 18 years old (Horner and Padian, 2004), and is hypothesized to be a female (Schweitzer et al., 2005). The furcula is broad and U-shaped with an intrafurcular angle of 113[degrees] (Table 1). Articular scars are present on the posterior side of the rami. It most clearly resembles the furcula in the tyrannosaurid Daspletosaurus (Makovicky and Currie, 1998, figs. 1, 2). However, unlike Daspletosaurus, there is no development of a hypocleideum.

CONCLUSION

The V-shaped furcula in Suchomimus documents the presence of an ossified furcula in spinosaurid tetanurans. Its broad V-shape and presence of a short hypocleideum constitute the basal condition within Theropoda, and closely matches the form of the furcula in the coelophysids (Downs, 2000; Tykoski et al., 2002), the allosauroid Allosaurus (Chure and Madsen, 1996), and the therizinosaurid Neimongosaurus (Zhang et al., 2001). The furcula in Suchomimus suggests that the anterior portion of the thorax was transversely narrow as has been preserved in Allosaurus and suggested for tyrannosaurids (Chure and Madsen, 1996; Makovicky and Currie, 1998).

This paper documents marked intraspecific variation in the furcula of T, rex involving its shape and intrafurcular angle. Such variation cautions against the use of subtle changes in furcular shape as character-states in phylogenetic analysis. Microraptor zfiaoianus and Gorgosaurus libratus also show some variation in furcular form, albeit less marked (Hwang et al., 2002). Although variation of the intrafurcular angle in some avians has been correlated with differences in flight function (Hui, 2002), there would seem to be little functional significance to furcular variation in large predators such as T. rex. Nor is it possible to attribute shape differences to sexual dimorphism or ontogeny. The skeleton UCRC V1 is at least of subadult maturity as the neural arches are fused or tightly articulated in the anterior dorsal vertebrae and the long bones are approximately two-thirds the length of those of the large adult FMNH PR2081. As one of only a few large- bodied theropod specimens preserved in three-dimensional articulation, UCRC V1 also documents the narrow proportions of the anterior thorax; maximum width of the thorax (distance between acrominal processes) is only approximately 30 cm. In closing, basal coeluosaurian theropods such as Tyrannosaurus retained a transversely narrow thorax spanned by a furcula with a boomerang, or U-shaped profile. Although this differs from the V-shaped basal tetanuran condition, considerable variation in intraspecific shape may occur. FIGURE 3-Photograph (1) and matching line drawing (2) of the furcula and pectoral girdle of Tyrannosaurus rex (UCRC V1) in anterior view. Cross-hatching indicates broken bone. Dashed lines indicate missing or hidden bone. Abbreviations: ac, acromion; co, coracoid; f, furcula; hu, humerus; se, scapula. Scale bar equals 5 cm.

FIGURE 4-Line drawing of the morphologic variation in the five Tyrannosaurus rex furculae. 1, UCRC V1; 2, MOR 980; 3, FMNH PR 2081; 4, CMI 2001.90.1; 5, MOR 1125. Cross-hatching indicates broken bone. Dashed lines indicate missing bone. Abbreviation: p, pit. Scale bar equals S cm.

ACKNOWLEDGMENTS

We thank M. Benton, S. Braddy, S. Brusatte, J. Conrad, P. Larson, P. Makovicky, and J. Wilson for comments on the manuscript, T. Keillor, B. Masek, and R. Vodden for fossil preparation, and A. Downs for a copy of his paper. For assistance with illustrations and photography, we thank C. Abraczinskas and W. Taylor, respectively. For access to specimens, we are indebted to D. Evans, P. Larson, and P. Makovicky.

FIGURE 5-Line drawing of the mounted furcula of Tyrannosaurus rex (FMNH PR 2081) in anterior view. Dashed lines indicate missing portions. Scale bar equals 5 cm.

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CLARK, J. M., M. A. NORELL, AND R. BARSBOLD. 2001. Two new oviraptorids (Theropoda: Oviraptorosauria), Upper Cretaceous Djadokhta Formation, Ukhaa Tolgod, Mongolia. Journal of Vertebrate Paleontology, 21:209-213.

DERSTLER, K. L. 2005. Taphonomy of the Tyrannosaurus rex “Peck’s rex(R)” from the Hell Creek Formation of Montana. Abstracts from the ” 100 Years of Tyrannosaurus rex” Symposium, Hill City, SD, 19 p.

DOWNS, A. 2000. Coelophysis bauri and Syntarsus rhodesiensis compared, with comments on the preparation and preservation of fossils form the Ghost Ranch Coelophysis Quarry; p. 33-37. In S. G. Lucas and A. B. Heckert (eds.), Dinosaurs of New Mexico. New Mexico Museum of Natural History and Science Bulletin 17, Albuquerque.

HWANG, S. H., M. A. NORELL, AND K. GAO. 2002. New Specimens of Microraptor zhaoianus (Theropoda: Dromaeosauridae) from Northeastern China. American Museum Novitates, Number 3282, 44 p.

HORNER, J. R. AND K. PADIAN. 2004. Age and growth dynamics of Tyrannosaurus rex. Proceeding of the Royal Society of London, Series B, 271: 1875-1880.

HUI, C. A. 2002. Avian furcula morphology may indicate relationships of flight requirements among birds. Journal of Morphology, 251:284-293.

LARSON, P. L. AND K. DONNAN. 2002. Rex Appeal: The Amazing Story of Sue, the Dinosaur that Changed Science, the Law, and My Life. Invisible Cities Press, Montpelier, 389 pp.

LARSON, P. L. AND J. K. RIOBY JR. 2005. Furcula of Tyrannosaurus rex, p. 247-253. In K. Carpenter (ed.), The Carnivorous Dinosaurs. Indiana University Press, Bloomington.

LIPKIN, C. AND P. C. SERENO. 2004. The furcula in Tyrannosaurus rex. Journal of Vertebrate Paleontology, Abstracts of Papers (Supplement to No. 3), 24:83A.

MAKOVICKY, P. AND P. J. CURRIE. 1998. The presence of a furcula in tyrannosaurid theropods, and its phylogenetic and functional implications. Journal of Vertebrate Paleontology, 18:143-149

NORELL, M. A. AND R MAKOVICKY. 1999. Important features of the dromaeosaurid skeleton II: information from newly collected specimens of Velociraptor mongoliensis. American Museum Novitates, Number 3282, 44 p.

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OSMOLSKA, H., P. J. CURRIE, AND R. BARSBOLD. 2004. Oviraptorosauria, p. 165-183. In D. B. Weisampel, R Dodson, and H. Osmolska (eds.), The Dinosauria. University of California Press, Berkeley.

SCHWEITZER, M. H., J. L. WITTMEYER, AND J. R. HORNER. 2005. Genderspecific reproductive tissue in Ratites and Tyrannosaurus rex. Science, 308: 1457-1460.

SERENO, P. C., A. L. BECK, D. B. DUTHEIL, B. GADO, H. C. E. LARSSON, G. H. LYON, J. D. MARCOT, O. W. M. RAUHUT, R. W. SADLEIR, C. A. SIDOR, D. D. VARRICCHIO, G. P. WILSON, AND J. A. WILSON. 1998. A long-snouted predatory dinosaur from Africa and the evolution of spinosaurids. Science, 282:1298-1302.

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ACCEPTED 17 JULY 2006

CHRISTINE LIPKIN,1.2 PAUL C. SERENO,1 AND JOHN R. HORNER3

1Department of Organismal Biology and Anatomy, University of Chicago, 1027 East 57th Street, Chicago, Illinois 60637, , , institut fur Palaontologie, Universitat Bonn, Nussallee 8, D-53115 Bonn, Germany, and ‘Museum of the Rockies, Montana State University, Bozeman 59717,

Copyright Paleontological Society Nov 2007

(c) 2007 Journal of Paleontology. Provided by ProQuest Information and Learning. All rights Reserved.

By Boren, Todd Reyes, Carlos; Montenegro, Raul; Raimer, Karen

Abstract Evan’s syndrome is a rare hematological condition defined as immune thrombocytopenic purpura and hemolytic anemia. We describe herein a case of Evan’s syndrome diagnosed in a term pregnancy that was refractory to primary therapeutic options. We also describe current treatment options in pregnancy and briefly discuss the pathophysiology of Evan’s syndrome and perinatal outcome.

Keywords: Pregnancy, Evan’s syndrome, thrombocytopenia, anemia

Case report

A 34-year-old G1P0 at 38 estimated weeks of gestation presented to our institution as a transfer of care from a nearby hospital. The patient was admitted with elevated blood pressures, elevated liver enzymes (AST 136 U/L and ALT 170 U/L), and thrombocytopenia (platelet count of 8000/mm3). The patient had been placed on a prednisone taper over a three-week period and had received one dose of intravenous immunoglobulin (IVIG) the week before by the transferring obstetrician in efforts to manage the low platelet count. The staff perinatologist was consulted and the decision was made to proceed with cesarean section secondary to HELLP syndrome (hemolysis, elevated liver enzyme levels, and a low platelet count). Magnesium sulfate was started on admission. The patient received a total of 20 units of platelets preoperatively and intraoperatively. The surgery was uncomplicated and a viable male infant was delivered with one- and five-minute Apgar scores of nine and nine.

Postoperatively, the patient was started on solumedrol and transfused two units of packed red blood cells secondary to a postoperative hemoglobin of 6.9 g/dL. The platelets responded to 69 000/mm^sup 3^, and a hematologist was consulted. The patient had no prior knowledge that she had any hematological disorder. The postoperative course was complicated by persistent autohemolysis and severe thrombocytopenia (2000/mm^sup 3^-10 000/mm^sup 3^) despite frequent transfusions, with no evidence of postpartum bleeding. By postoperative day 4, the platelet count continued to decline despite solumedrol, frequent doses of IVIG, and platelet transfusions. The liver enzymes and blood pressure normalized by postoperative day 3. General surgery was consulted and a splenectomy was performed without complications. However, the platelet count did not respond. Multiple labs were ordered by the hematologist including ANA (antinuclear antibodies), RPR (rapid plasmin reagin), thyroid panel, ANCA (antineutrophil cytoplasmic autoantibodies) C and P, Coombs test, EBV (Ebstein Barr Virus), ESR (Erythrocyte Sedimentation Rate), CRP (C-reactive Protein), RF (Ristocetin Factor), AntiDS-DNA (Antidouble-stranded DNA), and haptoglobin. All labs were normal except the elevated C3, which is consistent with autohemolysis. The patient was then started on Rituximab, a chemotherapeutic agent, with no response.

A bone marrow biopsy was performed that only showed schistocytes, also consistent with peripheral destruction. At this time, the diagnosis of Evan’s syndrome was made, which is immune thrombocytopenic purpura (ITP) combined with autoimmune hemolytic anemia. Plasma exchange was initiated with additional transfusions with packed red cells. The patient responded well and on hospital day 15 her hemoglobin was stable at 9.2 g/dL with a platelet count of 22 000/mm^sup 3^. The patient did not experience any signs of postoperative hemorrhage and was discharged home in stable condition. Over the next several weeks the patient received weekly courses of plasma exchange. Four weeks after discharge, her platelet count was 66 000/mm^sup 3^ and stable.

Discussion

Using the MEDLJNE search engine, only three previous articles cite Evan’s syndrome during pregnancy [1-3]. One describes anesthetic complications with performing a second trimester splenectomy in a patient with Evan’s syndrome. The patient responded and went on to deliver a viable infant at term. The second article documents a 19-year-old primigravida who presented at 13 weeks estimated gestational age with thrombocytopenia [1]. Evan’s syndrome had been diagnosed one year earlier. The platelet count responded to prednisolone 20 mg QD, which eventually was increased to 60 mg QD at 31 weeks estimated gestational age with platelet counts ranging from 62 000 to 68 000/mm^sup 3^. The pregnancy was unremarkable until she presented at 35 weeks with a stillborn fetus despite aggressive antenatal surveillance. The autopsy revealed an intracranial subdural hematoma as the cause of death. The patient remained on the same dose of steroids and at six weeks postpartum had a platelet count of 119 000/mm^sup 3^. The third case involved a 26-year-old pregnant patient with Evan’s syndrome treated with high dose corticosteroids for severe thrombocytopenia. The patient developed a disseminated gonococcal infection in the third trimester followed by preterm labor and abruptio placentae. A cesarean delivery was performed at 34 weeks estimated gestational age followed by platelet transfusion. A viable infant was delivered but the mother eventually developed delayed postpartum hemorrhage [3].

Evan’s syndrome involves ITP occurring in sync or sequentially with Coombs positive autoimmune hemolytic anemia (AHA) [4]. This is a rare disease with even fewer patients experiencing associated neutropenia [5]. The diagnosis is one of exclusion, made after all other causes of thrombocytopenia are ruled out. The associated diagnosis of autoimmune hemolytic anemia can be made with a positive Coombs test. Although this test was negative in our case, C3 was elevated. In 10% of cases of AHA, an elevated complement level will be the only abnormal finding [6].

Initial treatment for Evan’s syndrome consists of steroid administration such as prednisone. Other therapies include IVIG, chemotherapeutic agents, splenectomy, and plasmaphoresis for refractory cases [4]. Glucocorticoids such as prednisone decrease sequestration and destruction of antibody-sensitized platelets and red blood cells (RBCs). Splenectomy removes a primary site of sequestrations as well as a major site of antibody production. Plasmaphoresis attempts to replace antibody bound platelets and RBCs with unbound cells while reducing the concentration of IgG. IVIG can lengthen the life span of bound RBCs and platelets by saturating the Fc receptors on macrophages and also by inhibiting sequestration. Immunosuppressive agents such as rituximab have an inhibitory affect on the immune system, affecting B cells and T cells and their antibody production [6].

In the case described herein, the patient was refractory to all therapies except plasmaphoresis, while in the other cases described, the patients responded to either steroids or splenectomy. Complications in this case and the cases above included mild preeclampsia, HELLP syndrome, abruption of placenta, postpartum hemorrhage, and fetal death in utero [1,3]. Other complications include lifethreatening maternal anemia, severe postpartum hemolytic anemia in the infant, and maternal and fetal hemorrhage from severe thrombocytopenia, the latter being the most severe complication [7,8].

ITP in the pregnant patient can cause moderate to severe thrombocytopenia in the fetus and neonate regardless of maternal response to treatment. The fetal thrombocytopenia cannot be prevented. The major risk to the fetus is intracranial hemorrhage with associated neurological impairment, the frequency of which is estimated to be 1-3% [1]. The relative mild maternal thrombocytopenia in the case mentioned above resulted in fetal intracranial hemorrhage, while the patient in this case experienced severe thrombocytopenia with no apparent affect on the fetus.

To date, there is no reliable antenatal measure that can reliably predict fetal platelet status, and maternal response to treatment does not guarantee a desired outcome [9]. Only previous neonatal outcome provides a useful predictor of fetal and neonatal platelet count in a subsequent pregnancy [9,10]. The mode of delivery should be based on obstetrical indications. Hemorrhagic complications, which are rare, are not dependent on the choice of cesarean versus vaginal delivery [8].

Evan’s syndrome is a rare hematological disease and even more rare in pregnancy. Diligent antenatal surveillance of both mother and fetus along with prompt implementation of treatment protocols by a multidisciplinary approach is needed to minimize complications and to improve the chance for a desired outcome for both mother and child.

References

1. Phupong V, Sareepapong W, Witoonpanich P. Evan’s syndrome and pregnancy: A case report. BJOG 2004;111: 274-276.

2. Sherke RR, Rao MS. Anaesthetic management of splenectomy in Evan’s syndrome during pregnancy with pregnancy induced hypertension. J Postgrad Med 2001;47: 196-198.

3. Seluk Tuncer Z, Buyukasik Y, Demirtas E, Tuncer R, Zarakolu P. Pregnancy complicated by Evan’s syndrome. Eur J Obstet Gynecol Reprod Biol 2001 ;100:100-101.

4. Savasan S, Warrier I, Ravindranath Y. The spectrum of Evan’s syndrome. Arch Dis Child 1997;77:245-248.

5. George J, El-Harake M, Aster R. Thrombocytopenia due to enhanced platelet destruction by immunologie mechanisms. In: Beutler E, Lichtman MA, Coller BS, Kipps TJ, editors. William’s hematology. 5th ed. New York: McGraw-Hill; 1995. pp 1315-1325.

6. Schwartz RS, Silberstein LE, Berkman EM. Autoimmune hemolytic anemias. In: Hoffinan R, Benz Jr EJ, Shattil SJ, Furie B, Cohen HJ, Silberstein LE, editors. Hematology: Basic principles and practice. 2nd ed. New York: Churchill Livingstone; 1995. pp 715-721. 7. Chapin H, Cohen R, Bloomberg G, Kaplan HJ, Moore JA, Dorner I. Pregnancy and idiopathic autoimmune hemolytic anemia: A prospective study during six months gestation and 3 months post-partum. Br J Haematol 1973;24:219-229.

8. Gill KK, Kelton JG. Management of idiopathic thrombocytopenic purpura in pregnancy. Semin Hematol 2000;37: 275-314.

9. Cines DB, Blanchette VS. Immune thrombocytopenic purpura. N Engl J Med 2002;346:995-1008.

10. Kelton JG. Idiopathic thrombocytopenic purpura complicating pregnancy. Blood Rev 2002; 16:43-46.

TODD BOREN, CARLOS REYES, RAUL MONTENEGRO, & KAREN RAIMER

Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Bayfront Medical Center, St. Petersburg, Florida, USA

(Received 26 February 2007; revised 5 June 2007; accepted 8 June 2007)

Correspondence: Todd Boren, MD, Bayfront Medical Center, 701, 6th Street South, St Petersburg, Florida, 33701. Tel: 727-385-4644. Fax: 727-893-6917. E-mail: [email protected]

Copyright Taylor & Francis Ltd. Nov 2007

(c) 2007 Journal of Maternal – Fetal & Neonatal Medicine. Provided by ProQuest Information and Learning. All rights Reserved.

MEDICS are urging people on Tyneside to get their mouths checked to spot any early signs of cancer.

Mouth cancer kills one person every five hours in the UK and Gateshead’s oral health promotion team are raising awareness of the importance of early detection.

Throughout Mouth Cancer Awareness Week, which runs until November 17, the team will be out and about explaining how to prevent the illness.

Joanne Robson, oral health co-ordinator for Gateshead Primary Care Trust, said: “Mouth cancer can appear in different forms.

“It is important that you examine your mouth on a regular basis. If you have an ulcer that hasn’t healed after three weeks, or any unusual changes, such as a red or white patch, you should arrange an appointment with your dentist or seek other medical advice.”

Smoking is the most common cause of mouth cancer, and excessive drinking can also increase the risk.

For information on events in Gateshead call (0191) 497 1510 or visit www.mouthcancer.org

(c) 2007 Evening Chronicle – Newcastle-upon-Tyne. Provided by ProQuest Information and Learning. All rights Reserved.

Dear Dr. Gott: I want to tell you of my experience with high cholesterol. I went to the health-food store and bought soy lecithin granules. I take 2 tablespoons every morning in a glass of juice or milk. I have enclosed my results. In three months, my cholesterol went from 250 to 180!

I also use it occasionally on my cereal or put it in meatloaf. I now use it only two or three times a week as maintenance.

Dear Reader: Soy lecithin is new to me as a product to lower cholesterol levels, but your experience is convincing, so I am turning it over to my readers for help.

Dear Dr. Gott: I, like another reader, pass something that can go from a small seed to a needle size. It is generally accompanied by itching and a red, itchy sore. I told my general practitioner about this, and he suggested I take a specimen to the lab within one hour of the passing. I did, and I was told that my stool specimen showed no infection. I am at a quandary as to what to do. My doctor claims that tapeworms and pinworms do not exist in this country.

Dear Reader: If you had intestinal parasites, you would probably be passing these specimens or eggs. I suspect that what you are seeing is evidence of normal digestion and portions of food.

To test my theory, have a stool (one or more) submitted to the lab to test for for ova, cysts and parasites. This will tell the tale.

If your bowel is not harboring parasites, the stool test will be negative. At that point, you may wish to see a gastroenterologist.

Your physician’s claims that this country does not have tapeworms or pinworms is wrong. Pinworms are more common in the warmer southern states than in the cooler northern states, such as Nebraska, where you are located. Tapeworm is very rare in the United States.

Write Dr. Gott c/o United Media, 200 Madison Ave. 4th floor, New York, NY 10016.

Originally published by Staff Reports.

(c) 2007 Tulsa World. Provided by ProQuest Information and Learning. All rights Reserved.

By Albrecht, Uwe Goos, Karl-Heinz; Schneider, Berthold

Key words: Lower urinary tract infections – UTI – Relapses – Tropaeoli majoris herba – Armoraciae rusticanae radix ABSTRACT

Objectives: The aim of this study was to verify the efficacy and safety of a herbal medicinal product containing Tropaeoli majoris herba and Armoraciae rusticanae radix in the prophylactic treatment of chronically recurrent urinary tract infections (UTIs), and to test whether the medicinal product decreases the incidence of relapses over the study period.

Methods: A total of 219 adults aged between 18 and 75 years were screened and 174 patients enrolled. Of these 174 patients, a group of 45 patients were screening failures. Patients were randomised to receive either the study drug or placebo twice daily for 90 days. A UTI is confirmed by defined symptoms together with a laboratory result. The diagnosis of a new episode of a recurrent UTI included urine analysis from a central laboratory. The primary efficacy criterion – the number of recurrent UTIs over the study period – was tested between the treatment groups.

Results: For the per-protocol population, the mean number of recurrent UTIs in the study period was 0.43 versus 0.77 for the placebo group. This result is statistically significant (p = 0.035). A total of 36 patients in the test group and 37 patients in the placebo group reported adverse events. Two serious adverse events were reported in the placebo group and one serious adverse event in the treatment group (not associated with the study medication).

Conclusion:This randomised, double-blind, placebo-controlled trial demonstrates the efficacy and safety of the herbal medicinal product Angocin Anti-Infekt N* in the prophylactic treatment of chronically recurrent UTIs.

Introduction

A urinary tract infection (UTI) is a condition where one or more structures in the urinary tract become infected after bacteria overcome the structures’ strong natural defences. Despite these defences, UTIs are the most common of all infections and can occur at any time in the life of an individual. Almost 95% of UTI cases are caused by bacteria that typically multiply at the opening of the urethra and travel up to the bladder (the ascending route). Much less often, bacteria spread to the kidney from the bloodstream. Chronically recurrent UTIs, in particular, are a significant challenge in daily clinical practice. The common symptoms are dysuria, pollakisuria, suprapubic pain and urine anomalies. Most patients with recurrent UTIs are females. The reason for the predominance of this disease in women is the anatomical structure of the urethra, which is approximately 2-4 cm long in females – compared with 20-25 cm in males. Consequently, bacteria can easily access the bladder. Recurrence is common after both complicated and uncomplicated UTIs. After a single uncomplicated acute urinary tract infection, 27-48% of women will have a recurrence.

Recurrent infections are mostly due to underlying pathological circumstances (for instance, anomalies of the urinary tract) and, also caused by concomitant diseases (for instance diabetes mellitus), chronic trauma to the urinary tract (UTIs due to catheters), reflux of urine (for instance prostate hyperplasia), certain physiological circumstances (such as pregnancy), neurogenic damage, high sexual activity and, most importantly, insufficient hygiene.

Most infections are normally found in the lower urinary tract, the urethra and the bladder. However, such UTIs bear the problem that, in given circumstances, bacteria ascend to the kidney and cause an acute pyelonephritis. The worst possible outcome of such an event is a transition to the blood with resulting urisepsis, which may end in death. Therefore, infections of the lower urinary tract need to be treated carefully in order to avoid potential severe medical problems and also to relieve the uncomfortable symptoms.

Amongst the bacteria causing infections of the lower urinary tract, gram-negative bacteria are predominant. The most important bacterial strain involved is Eschenchia coli. Other bacteria concerned are Proteus spp, Klebsiella spp, Staphylococcus saprophyticus and Enterobacter spp. Gram-positive bacteria play a less important role. This fact is important in the choice of adequate antibiotic therapy which is normally carried out with fluoroquinolones or cotrimoxazole.

At present, the prophylaxis of chronically recurrent UTIs in patients is problematic. In daily practice, lowdose administration of antibiotics is frequently chosen (cotrimoxazole, trimethoprime, nitrofurantoin, fluoroquinolones). These have proven to be efficacious to a certain degree. However, long-term administration of classical antibiotics is associated with the development of resistance of certain bacterial strains. In addition, potential side- effects of long-term treatment, such as neuropathies, may occur. Due to these safety factors, many physicians do not carry out long-term prophylaxis with classical antibiotics.

Angocin Anti-Infekt N is a herbal medicinal product (film-coated tablets) containing two active ingredients: horseradish root (Armoraciae rusticanae radix) 80 mg and nasturtium (Tropaeoli majoris herba) 200 mg. For these two active ingredients an antimicrobial efficacy has been proven in vitro1-12, which is based on the isothiocyanates (mustard oils). The herbs contain different isothiocyanates – in horseradish root, alylisothiocyanate and phenylethylisothiocyanate are the relevant mustard oils; in nasturtium, benzylisothiocyanate is the corresponding mustard oil. In a recent in vitro study13, the investigators confirmed previous reports of the antibacterial properties of mustard oils. The antimicrobial testing of a combination of nasturtium and horseradish revealed broad antibacterial activities against clinically relevant pathogens covering both gram-positive and gramnegative organisms. The study demonstrated that the combination of the two active ingredients leads to an additive activity. The results prove that there is a rational basis for treatment of both UTIs and upper respiratory tract infections with this medicinal product. It is important to emphasize that no bacterial resistance against the isothiocyanates has been observed.

The inactive prodrugs of the mustard oils, glucosinolates, are activated by myrosinase. The routes of excretion for isothiocyanates are the kidneys. Therefore an even higher local concentration can be achieved in the urinary tract and utilized for the treatment of UTIs. Most isothiocyanates are eliminated unchanged and some are metabolized. Pharmacokinetic investigations have shown that a high amount of the administered dose is recovered in the urine3. With regard to the daily dose for prophylactic treatment of chronically recurrent UTIs, a regimen has been chosen based on clinical experience with the medicinal product in the identical composition over decades of use in the daily practice.

There is a vast clinical experience published in the scientific literature for the treatment of bacterial infections with Angocin Anti-Infekt N14-20. However, this trial is the first randomised controlled clinical trial carried out in accordance with the relevant guidelines of the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Guideline for Good Clinical Practice (ICH-GCP).

Patients and methods

Study design

This multicentre study was conducted as a prospective randomised, double-blind, placebo-controlled trial with parallel groups in patients suffering from chronically recurrent UTIs. The goal of the study was to investigate the efficacy and safety of Angocin Anti- Infekt N versus placebo in the prophylactic treatment of chronically recurrent UTIs.

During a screening visit (visit 1, day 1) the inclusion and exclusion criteria were checked and informed consent was obtained. Medical history and demographic data were recorded. The status of an acute UTI was confirmed by urine analysis (stix, investigation of the midstream urine specimen in the central laboratory). Treatment with either cotrimoxazole or ciprofloxacin was initiated. Seven days after visit 1 the patient attended the study site for visit 2. The result of the antibiotic treatment was checked and investigated to establish whether the acute exacerbation of the UTI was cured. If healing was confirmed positively, patients were further randomised to receive either the study medication or placebo. Study medication for the first 30 days was handed out. Further visits to the study site were conducted at intervals of 30 days (visits 3, 4 and 5). At each visit blood pressure, pulse and body temperature were recorded as well as the potential occurrence of adverse events. It was confirmed that no new acute UTI existed (stix and investigation of midstream urine specimen in the central laboratory). Patient satisfaction (satisfaction with the treatment) was recorded on a visual analogue scale ranging from 0 to 10. Study medication was given to the patient at each visit and compliance was recorded in a drug accountability sheet.

In cases where a patient visited the study site between scheduled visits with an acute exacerbation of a UTI, an extra visit was carried out. The patient was then treated according to the decision of the physician and returned to receive study medication after confirmation of healing of the acute exacerbation. The prophylactic treatment with study medication or placebo ended after 90 days and a physical examination, including physical signs (blood pressure, pulse, body temperature), was carried out.

Subsequent to the end of the prophylactic treatment, two further visits were conducted (visit 6 at 120 days and visit 7 at 180 days after visit 2). During these visits the occurrence of a recurrent UTI and potential adverse events were recorded. At study end a physical examination was performed.

The physician recorded all confirmed recurrent UTIs prior to study start. During the course of the study an additional record was completed in which the physician recorded all recurrent UTIs, the treatment administered and the status of the patient.

This study was conducted according to ICH-GCP. The study protocol was approved by the independent ethics committees responsible for the respective study site.

Patients

A total of 219 patients were recruited in 35 active centres in Germany. The inclusion criteria were adults of both genders aged from 18 to 75 years with a medical history of at least three recurrent UTIs according to the records of the physician: two of the recurrent UTIs had to have been recorded during the past 6 months prior to study start. The patient had to present to the study site with an acute exacerbation of a UTI. For safety reasons, females of childbearing potential needed to employ an adequate contraception. The patient was asked to sign an informed consent form as approved by the independent ethics committee. Those noneligible were patients with progression of the infection from the proximal end of the bladder with systemic involvement (pyelonephritis, urisepsis), irritable bladder syndrome, abnormalities or obstruction of the urinary tract, medical history of surgery of the urinary tract, chronic organic dysfunction (for instance, chronic renal insufficiency), acute infection except the UTI, pyelonephritis, acute ulcers of the stomach or duodenum, known hypersensitivity to one of the ingredients, concurrent participation in a clinical trial or participation in a clinical trial in the past 14 days prior to study entry.

Treatment

Patients were randomised to receive either Angocin Anti-Infekt N film-coated tablets in a dosage of 2 tablets twice daily or placebo tablets in the identical dosage. Treatment was initiated at visit 2 after confirmation of successful healing of the acute UTI and was to last until day 90 of the study period. One tablet of the active study medication (Angocin Anti-Infekt N, Repha GmbH, Langenhagen, Germany) contained horseradish root 80 mg and nasturtium 200 mg. The placebo contained inactive ingredients (celluloses, iron oxides and hydroxides E 172, hypromellosis, macrogol, potato starch, sodium carboxy methyl starch, highly dispersed silicon dioxide, stearine acid, talcum, titanium dioxide E 171) only.

Placebo tablets were similar in appearance to the active drug tablets. One box of the study medication was supplied to each patient at the start of treatment and thereafter at visits 3, 4 and 5 for the respective intervals of 30 days each. Tablets were produced in accordance with GMP standards and, for the herbal components, standardised tests for the content were employed. Tablets were packaged into plastic containers according to GMP. The patients were asked to take the tablets after a meal with some fluid.

Randomisation and blinding

Patients were distributed to one of the two treatment groups and allocated randomly generated treatment numbers provided by the independent statistician. Packaging according to the randomisation list was carried out by the contract manufacturer.

Treatment boxes were then transported to the study sites. No interference by the manufacturer was therefore possible. Only the ‘master of the graduated plan’ held a sealed randomisation list for emergencies, but blinding was maintained and the code remained unbroken. Allocation of the treatment numbers to the medication was carried out by the manufacturer according to the randomisation list. The patients received the study drugs in boxes pre-numbered in consecutive order according to the time of their enrolment into the study, always using the lowest number available.

Both patient and physician remained blinded as to which preparation was being administered. The blind could be broken for an individual patient in the event of an emergency; however, no emergencies occurred. Moreover, all other study participants including monitor, auditor, biometrician, principal investigator and sponsor remained blinded throughout the study. The blinding was maintained during review of the complete database for patients’ validity and allocation to the populations of statistical analysis. Thereafter, the database was frozen and the code broken for statistical evaluation.

Safety

Safety variables were clinical signs, frequency and severity of reported adverse events, together with clinical laboratory tests (blood count, AST, ALT gammaGT) as well as body weight, body temperature, blood pressure and pulse rate recorded at each visit. Statistical analysis and sample size It was assumed that the two treatment groups showed identical standard deviations regarding the number of recurrent UTIs during the study period. Should the mean number of recurrences in the test group ([mu]-test) be half of the standard deviation lower as the mean number of recurrences in the placebo group ([mu] placebo) ([mu] test – [mu] placebo)/sigma = – 1/ 2), then a significant result with a probability (power) of 0.8 on the one-tailed level alpha = 0.05 could be expected. In order to achieve this, a sample size of 51 patients per group (total 102 patients) was required. In a clinical trial performed by Tammen21 which include 150 subjects, a standard deviation of approximately one UTI recurrence within 6 months was reported. Assuming the identical standard deviation for this study, a significant result with a power of 0.8 and a sample size of 100 patients was expected to be achieved, if the mean frequency of recurrences in the test group would be 1/2 lower than the mean in the placebo group.

The de-blinding was planned subsequent to a blinded data review and freeze of the database. For the analysis of all data between the treatment groups descriptive statistical methods (calculation of the means, standard deviations for quantitative variables, frequency of the contingency tables for categorical variables) were employed. The baseline values between the groups were compared by applicable statistical methods (t-distribution test, chi^sup 2^-adoption test etc.).

The primary efficacy criterion was chosen to be the difference of the means between the groups regarding the number of clinically confirmed recurrences during the study period tested by the t- distribution test. The nil hypothesis, that the number of recurrences in the test group was not lower than in the placebo group ([mu] test >/= [mu] placebo), was to be tested against the alternative hypothesis that this was not lower ([mu] test

It was laid down to carry out the statistical analysis for the intent-to-treat data set (ITT) as well as for the per-protocol data set (PP). It was determined that into the ITT data set, all patients would be subsumed, who were randomised and were available at least at visit 3. For patients participating in the clinical trial for

The patients’ satisfaction – measured with a visual analogue scale – had to be analysed statistically as secondary efficacy criterion and be compared between the treatment groups by the t- distribution test. For the visual analogue scale, Very bad’ was applicable for the worst and ‘excellent’ for the best judgement, whereas this was related to the general well-being and the satisfaction with the treatment. Satisfaction with the treatment was not a measure for efficacy and safety of the therapy.

Each AE had to be recorded in conjunction with supplementary information (severity, duration, relationship to study drug, action taken, results). The frequency of adverse events had to be compared between the treatment groups.

Results

In 35 active study sites a total of 219 patients were enrolled. One study site (the site of the principal investigator) was the outpatient department of a hospital. All other study sites were private practice. The flow of the patients through the study is shown in Table 1.

A total of 45 patients were not randomised and did not receive study medication. The remaining 174 patients were attributed to the ITT population. Out of these, 84 patients (48.3%) were treated with the active study medication and 90 patients (51.7%) with placebo. According to the protocol, the study was completed by 131 patients. For 28 patients, the acute UTI was not cured at visit 2.

Two patients in the test group (2.4%) and two patients in the placebo group were males (2.2%). All other patients were female. The mean age in the test group was 56.52 years (s = 18.83 years) and in the placebo group 52.32 years (s = 21.56 years). The difference is statistically not significant (p = 0.174, t-test). Means and standard deviations are displayed for height, weight, blood pressure, pulse and body temperature for visit 1 in Table 2. There are no statistical significant differences between the groups. All patients were attributed to the PP population which did not have a UTI at visit 2 (start of prophylactic treatment) and who finished the study according to the protocol. This group comprises a total number of 103 patients. A total of 51 patients (49.5%) were treated with the active medication and 52 (50.5%) received placebo.

Efficacy

Intention-to-treat

In the ITT population, the mean number of UTI relapses from start of prophylaxis until end of the study, was for the test group 0.65 and for the placebo group 0.64. The difference is not statistically significant (p (one-sided) = 0.476, t-test). For the period of 180 days (180 x number/time of observation), the mean number of UTI relapses was 0.74 for the test group and 0.63 for the placebo group (p (one-sided) = 0.260, t-test). For the period of prophylactic treatment (maximum 90 days) the mean number of UTI relapses was 0.44 for the test group and 0.39 for the placebo group (p (onesided) = 0.260, t-test). For 90 days the mean number of UTI relapses for the test group was 0.43 and for the placebo group 0.37 (p (one-sided) = 0.280).

Table 1. Patient flow

Table 2. Data for the ITT population at visit 1

Per protocol

In the PP population, the mean number of UTI relapses during the entire study period was 0.43 for the test group and 0.77 for the placebo group. This difference is statistically significant (p (one- sided) = 0.035, t-test). For 180 days, the mean number of UTI relapses for the test group was 0.43 and for the placebo group 0.75 (p (onesided) = 0.039, t-test). For the period of prophylactic treatment (maximum 90 days) the mean number of UTI relapses for the test group was 0.29 and for the placebo group 0.42 (p (one-sided) = 0.175, t-test). For 90 days the mean number of UTI relapses was 0.28 for the test group and 0.41 for the placebo group (p (one-sided) = 0.167).

Means and standard deviations for UTI relapses for the period of prophylactic treatment (between visits 2 and 5), subsequent to prophylactic treatment (between visit 5 and 7) and in total (between visits 2 and 7) are displayed in Table 3. For all periods the mean number of UTI relapses is lower in the test group compared with the placebo group. On the one-sided level alpha = 0.05 the differences for the period subsequent to prophylactic treatment (visits 5-7) and for the entire period between visit 2 and 7 are statistically significant (p (one-sided = 0.019 respectively 0.035). The nil hypotheses has therefore to be rejected and it has to be assumed that for the treatment with the test medication a lower number of UTI relapses is proven.

Means and standard deviations of days with prophylactic treatment and the entire study duration are displayed in Table 4, those of UTI relapses related to 90 days and 180 days are displayed in Table 5. The difference of the mean duration for the two groups is not statistically significant. The difference in the number of UTI relapses for 180 days is statistically significant on the one-sided level 0.05 significant (p = 0.039).

Patient satisfaction

Patient satisfaction with the therapy was recorded by the patient on a visual analogue scale. In both groups, at all visits, satisfaction with the therapy was judged with a mean score of 0.7. There is no statistical significant difference between the groups.

Safety

In all, 36 patients in the test group and 37 patients in the placebo group reported adverse events. One patient in the test group and two patients in the placebo group recorded serious adverse events (SAEs), none of which were associated with the study medication. One patient in the test group presented with a head wound and commotio cerebri. One patient from the placebo group was diagnosed with cancer of the duodenum. The second SAE in the placebo group was attributed to an episode of arterial hypertension and tachycardia, which made hospitalisation necessary. The adverse events observed were: nausea, flatulence, dysuria, vertigo, edema, hyperhidrosis, elevation of liver enzymes, allergy against test medication, nutritional allergy and laryngitis. There are no statistically significant differences between the treatment groups. The analysis of blood parameters (day -7, day 90), analysed in a central laboratory, did not reveal any adverse events.

Discussion

The data of this clinical study suggest the clinical efficacy and safety of Angocin Anti-Infekt N as a prophylactic treatment for chronically recurrent UTI.

For the PP data set, the mean number of UTI relapses for the entire study period for the test group was 0.43 versus 0.77 for the placebo group. This difference is statistically significant (p (one- sided) = 0.035, t-test). Therefore the clinical efficacy of the prophylactic treatment with Angocin Anti-Infekt N versus placebo is suggested to be proven.

Table 3. Confirmed UTI per patient during, following prophylaxis and total (PP)

Table 4. Duration of prophylactic treatment and entire study duration (PP)

Table 5. Number of UTIs during prophylactic treatment and total per 90 and 180 days (PP)

The primary efficacy criterion – the comparison of the number of relapses over the study period – was chosen in order to prove the efficacy of the medicinal product in a specific patient population. During enrolment of patients it was observed that the number of patients meeting the stringent inclusive and exclusive criteria was limited. This is due to the fact that after diagnosis, treatment with a standard antibiotic was started by the physician and healing was not confirmed as patients did not return for a follow-up visit. Therefore, there is a degree of uncertainty whether patients suffered from reinfections or from a relapse. Approximately 80% of recurring UTIs are reinfections occuring several weeks after antibiotic treatment has cleared up the initial episode. A different bacterial strain from the one that caused the original episode then needs to be treated. In certain circumstances, a long-term treatment with antibiotics is the preferred treatment option. However, this might lead to unwanted medical complications. Moreover, the resistance of bacteria against standard antibiotics is a substantial problem. This is also reflected in the study results, for instance in the ITT data set. The results are different from the analysis of the PP data set. This is due to the fact that for 28 patients at the start of prophylactic treatment (visit 2) the UTI was not completely cured with the standard antibiotics utilised in this study.

As the efficacy of Angocin Anti-Infekt N has been observed over decades in daily practice, it was the goal to verify former clinical investigations in an ICH-GCP clinical study. The sample size calculation for the study was based on published scientific data. The rationale for the assumption of a successful outcome of the trial was supported by recent in vitro studies. These confirmed the excellent antibacterial efficacy of the active ingredients of Angocin Anti-Infekt N. The mustard oils from horseradish root (alylisothiocyanate and phenylethylisothiocyanate) and the corresponding mustard oil contained in nasturtium (benzylisothiocyanate) revealed broad antibacterial activities against clinically relevant pathogens. The in vitro study demonstrated that the combination of the two active ingredients leads to a synergistic activity. Therefore it was important to verify the results in a clinical study.

A potential weakness of the study is that although the study was finalised with a PP data set according to the target sample size, a number of patients failed to enter the treatment phase with active treatment. This was due to the fact that 28 patients were not cured with standard antibiotic treatment at the start of prophylaxis. In total, 219 adults were screened and 174 patients enrolled. Out of these 174 patients, a group of 45 patients were screening failures. The study design to enrol patients who are only present with complete healing after an initial treatment with standard antibiotics is a potential strength of the study as this potentially gave evidence of treatment failures with standard antibiotic treatment.

Conclusion

The results of this prospective randomised placebocontrolled study suggest the efficacy and safety of Angocin Anti-Infekt N as a herbal medicinal product in the prophylactic treatment of chronically recurrent UTIs. The treatment can be regarded as a benefit for this special patient population, mostly women. A dose of 2 tablets twice daily of Angocin Anti-Infekt N is recommended. Based on these results, Angocin Anti-Infekt N may provide physicians with an alternative to long-term treatment with standard antibiotics. This study suggests efficacy and safety for a treatment period of 90 days.

Acknowledgements

Declaration of interest: This study was sponsored by Repha GmbH, Biologische Arzneimittel, Langenhagen, Germany. The authors thank all the physicians who took part in this challenging study for their essential contributions.

* Angocin Anti-Infekt N is a registered trade name of Repha GmbH, Langenhagen, Germany

References

1. Gruia F.S. Moglichkeiten der Infektionsbehandlung in der Praxis. Eine klinische Studie. Erfahrungsheilkunde Acta Medica Empirica 1986;7:486-490

2. Halbeisen T. Untersuchungen uber die antibiotischen Wirkstoffe von Tropaeolum majus. Naturwissenschaften 1954;41:378

3. Halbeisen T. Untersuchung des antibiotischen Wirkstoffes einer hoheren Pflanze (Tropaeolum maius – Kapuzinerkresse). Medizinische 1954;36:1212

4. Halbeisen T. Eine antibiotisch wirksame Substanz aus Cochlearia Armoracia L. Arzneim Forsch Drug Res 1957;7:321

5. Kienholz M. Die antibakterielle Wirkung atherischer Ole aus Meerrettichwurzel. Arzneim Forsch Drug Res 1960;10:917

6. Orzechowski G. Antimikrobiotika in hoheren Pflanzen und die Problematik der Therapie mit Antibiotika. Pharm Rundsch 1961;3:41

7. Rudat KDLJM. Uber die bakterienhemmende Wirkung der in der Kapuzinerkresse enthaltenen antibiotischen Stoffe, insbesondere gegen aerobe Sporenbildner. Pharmazie 1955;10:729 8. Schmidramsl H. Angocin(R) Kresse und Meerrettich bei Atemwegsinfekten. Ergeb Therapiestudie 1998:1-5

9. Thiel H. Erfahrungen mit Angocin in der Praxis. Hippokrates 1958;18:1-7

10. Winter AGWL. Uber Antibiotika. in hoheren Pflanzen: Vl. Mitteilung Gasformige Hemmstoffe aus Tropaeolum majus und ihr Verhalten im menschlichen Korper bei Aufnahme von Tropaeolum-Salat per os. Naturwissenschaften 1952;39:236

11. Winter AG. Antibiotische Therapie mit Arzneipflanzen. Planta Med 1955;3:1

12. Gaase A. Bakteriologische Empfindlichkeitstestung eines Antibiotikums. Arztl Prax 1968;20:667

13. Conrad et al. In-vitro-Untersuchungen zur antibakteriellen Wirksamkeit einer Kombination aus Kapuzinerkressenkraut (Tropaeoli majoris herba) und Meerrettichwurzel (Armoracia rusticanae radix). Arzneim Forsch Drug Res 2006;56(12):842-9

14. Goos KH, Albrecht U, Schneider B. Efficacy and safety profile of a herbal drug containing nasturtium herb and horseradish root in acute sinusitis, acute bronchitis and acute urinary tract infection in comparison with other treatments in the daily practice/results of a prospective cohort study. Arzneim Forsch Drug Res 2006;56:249

15. Gores EKU. Ermittlung der Senfolkonzentration im Probandenharn nach. Gabe von Angocin Anti-Infekt N. Berlin: Prufbericht Biopharm, 1997

16. Schaffer R.J. Untersuchungen zur in vitro-Wirksamkeit von Benzylsenfol gegen pathogene Bakterien und Sprosspilze. Dissertation, Koln. 1980.

17. Winter AGHM. Untersuchungen uber Antibiotika in hoheren Pflanzen: IX. Mitteilung: Gasformige Hemmstoffe aus Cochlearia armoracia (Meerrettich) und ihr Verhalten im menschlichen Korper bei Aufnahme per os. Naturwissenschaften 1953;40:489

18. Germer WD. Ein neues Praparat fur die antibiotische Therapie auf pflanzlicher Grundlage. Dtsch.Med.Wochenschr 1954;79:1445

19. Klesse PLR. Untersuchungen uber die bakteriostatische Wirksamkeit einiger Senfole. Arzneim.-Forsch./ Drug Res 1955;5:505

20. Stickl H. Uber eine antibiotisch wirksame Pflanzensubstanz. Dtsch.Med.Wochenschr. 1954;79:1722

21. Tammen H. Immunobiotherapy with Uro-Vaxom in recurrent urinary tract infections: The German Urinary Tract Infection Study Group. Br J Urol. 1990;65(1):6-9

CrossRef links are available in the online published version of this paper: http://www.cmrojournal.com

Paper CMRO-4047_4, Accepted for publication: 02 August 2007

Published Online: 23 August 2007

doi: 10.1185/03007X233089

Uwe Albrecht(a), Karl-Heinz Goos(b) and Berthold Schneider(c)

a Mediconomics GmbH, Hannover, Germany

b Repha GmbH, Biologische Arzneimittel, Langenhagen, Germany

c Institut fur Biometrie, Medizinische Hochschule Hannover, Germany

Address for correspondence: Dr. Uwe W. Albrecht, Mediconomics GmbH, Hannover, Germany. Tel.: +49 (0) 511 560 998 0; Fax: +49 (0) 511 560 998 20; [email protected]

Copyright Librapharm Oct 2007

(c) 2007 Current Medical Research and Opinion. Provided by ProQuest Information and Learning. All rights Reserved.

HOUSTON, Nov. 9 /PRNewswire-USNewswire/ — The Menninger Clinic, the international specialty psychiatric hospital in Houston, today unveiled plans for The Menninger Mental Health Epicenter — that include The Clinic’s new campus and an international center for mental health research, treatment, training and advocacy.

Menninger will be located within a 10-minute drive from the Texas Medical Center on South Main Street, near South Post Oak Road — moving The Clinic closer to affiliates Baylor College of Medicine and The Methodist Hospital, and collaborating organizations in the Texas Medical Center. The Clinic moved from Topeka in 2003 to its current located at 2801 Gessner Drive in west Houston, with the ultimate goal of relocating near the Texas Medical Center.

Menninger’s Miracles in Mind campaign has raised $69.3 million, and is more than half way to its goal of $125 million. $65.8 million will go toward building the first phase of the Clinic’s new campus. $3.5 million will benefit treatment, research and education programs. Construction on The Epicenter is expected to begin in fall 2008, with a target completion date of summer 2010.

“The Epicenter will be a beacon of hope to persons suffering from mental illness and the people who love them,” says Ian Aitken, Menninger CEO and president. “Thanks to the generosity of our supporters, we will achieve our goal to improve mental health worldwide, prevent mental illness and eliminate stigma.”

One in five Americans suffers from mental illness. The Menninger Mental Health Epicenter will provide much-needed mental health services for the Houston and Texas communities, as well as for individuals nationally and internationally. The Epicenter will also unify mental health research efforts and increase collaboration to develop a greater understanding of brain, behavior and addictive disorders and methods for preventing mental illness.

Research and treatment priorities for The Clinic will include: substance abuse and addictions, personality disorders, mood disorders, anxiety and obsessive-compulsive disorders, trauma-related disorders and neuropsychiatric disorders. The Clinic will also continue to offer comprehensive diagnostic assessments for persons who have complicated symptoms or desire a second opinion.

Menninger’s collaboration with Texas Medical Center institutions and national and international experts in mental health will give patients access to the latest research interventions and medical specialty care.

“The Epicenter will help advance Houston as a center for excellence in mental health treatment, education and research and to continue to attract leading scientists and clinical specialists to Houston,” says Stuart Yudofsky, MD, D.C. and Irene Ellwood Professor and chairman of the Menninger Department of Psychiatry and Behavioral Sciences at Baylor College of Medicine, and chairman of Psychiatry at The Methodist Hospital. “By encouraging collaboration across disciplines, The Epicenter will be a catalyst for exciting new discoveries about the brain and behavior.”

The Epicenter will significantly increase the number of mental health professionals Menninger will train to help alleviate shortages locally and nationally.

Educating the public about mental health and effectiveness of treatments for mental illness will also be a major focus of The Epicenter, helping to erase the stigma that prevents many people from seeking treatment.

Plans for Phase I of The Epicenter include a 144-bed inpatient specialty psychiatric hospital, a brain and behavior research center, administrative buildings, educational facilities, wellness center, nondenominational chapel, dining center and features including meditation and sculpture gardens. The Clinic will cover approximately half of the 50-acre campus.

Phase II building plans include facilities for aftercare services for patients, headquarters for mental health organizations, training and education, and international leadership program.

The Menninger Clinic is an international specialty psychiatric center, providing treatment, research and education. Founded in 1925 in Kansas, Menninger relocated to Houston in 2003 and is affiliated with Baylor College of Medicine and The Methodist Hospital. For 17 consecutive years, Menninger has been named among the leading psychiatric hospitals in U.S.News & World Report’s annual ranking of “America’s Best Hospitals.”

Newsroom: http://www.menningerclinic.com/newsroom/

The Menninger Clinic

CONTACT: Anissa Orr, work: +1-713-275-5038, cell: +1-832-434-8928,[email protected], Nancy Trowbridge, work: +1-713-275-5030,[email protected]

Web Site: http://www.menningerclinic.com/

By Matthias Gafni, Contra Costa Times, Walnut Creek, Calif.

Nov. 9–BAY POINT — Contra Costa County sheriff’s deputies arrested a man Thursday in connection with a string of suspicious activities involving at least four girls and possibly a number of others near two Bay Point elementary schools.

Brent Bockover, 39, of Oakley was arrested on suspicion of attempted kidnapping and attempted child molestation, sheriff’s spokesman Jimmy Lee said.

Bockover was being held in lieu of $1 million bail at County Jail in Martinez.

Someone called the sheriff’s office about 11:15 a.m. Thursday and reported that a man in a car was harassing a woman who was walking in the area of Hanlon Way and Loftus Road in Bay Point.

A special enforcement team of deputies responded and stopped Bockover in Pittsburg.

The arrest of a suspect is significant, said sheriff’s Capt. Dan Terry. “In identifying him and taking him off the streets, the Bay Point community is safer today,” he said.

The investigation began when a man attempted to lure the girls into his red pickup by asking for directions with his passenger door open. The man, who in one instance exposed himself to a girl, has sought out girls ages 6 to 13, from 5 to 7 p.m. in the Shore Acres neighborhood, officials said.

The sheriff’s office distributed composite sketches of the suspect to the media and notified schools nearby of the incidents, and Terry thanked residents for helping in the investigation.

The investigation is continuing, including work with other agencies to determine

whether Bockover is linked to any other cases.

Meanwhile, Sherree Gilmour, a Bay Point mother of three and Shore Acres resident, is helping organize a community march Saturday to keep parents vigilant.

“If you walk down the street you don’t see any kids out, and we have a lot of kids here. People just don’t know what to do,” she said.

Gilmour expects about 300 people to march through the neighborhood as part of Shore Acres Community March for Awareness. She has passed out fliers in English and Spanish throughout the largely Latino neighborhood.

“The most effective thing a community can do is come together to face these challenges. If everyone was in a vacuum and no one reported anything, we couldn’t do anything about it,” Lee said.

The first suspicious report came Oct. 17, when four girls in the Bay Point area reported that a man attempted to lure them into his vehicle. Two days later, the man was spotted speaking to a 6-year-old near Rio Vista Elementary School. On Oct. 24, the man approached two girls near Shore Acres Elementary School.

Since an initial media report appeared, Lee said more individuals came forward reporting similar incidents.

Reach Matthias Gafni at 925-779-7174 or [email protected].

COMMUNITY MARCH

–WHAT: Shore Acres Community March for Awareness

–WHEN: 6 p.m. Saturday

–WHERE: Starts at Shop & Save parking lot, 620 Port Chicago Highway; ends at Wharf Drive near Rio Vista Elementary

–WHO: Open to the public; march will be held rain or shine

–CONTACT: 925-705-1106 or 925-261-0931

—–

To see more of the Contra Costa Times, or to subscribe to the newspaper, go to http://www.contracostatimes.com/.

Copyright (c) 2007, Contra Costa Times, Walnut Creek, Calif.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

By Thompson, Sharon H

Abstract. The Female Athlete Triad is a life-threatening syndrome defined by disordered eating, amenorrhea, and osteoporosis. Objective and Participants: The author’s purpose in this study was to examine female cross-country runners’ (N = 300) calcium consumption, along with the prevalence of 2 components of the triad: disordered eating and menstrual dysfunction. Methods: The author used measures including the Orientation to Exercise Questionnaire, Calcium Rapid Assessment Method, and questions related to height, weight, exercise time, perceptions of eating disorders, and menstrual status. Previous or current eating disorders were reported by 19.4% of the women, 23.0% had irregular menstrual cycles, and 29.1% had inadequate calcium intake. Results: Those athletes perceiving a previous/current eating disorder scored higher on the Orientation to Exercise questionnaire than did those who did not perceive such. Conclusion: The author recommends educational efforts for the prevention of components of the Female Athlete Triad. Keywords: body image, eating disorders, female athletes, menstrual dysfunction

The American College of Sports Medicine first described the Female Athlete Triad a decade ago.1 It is a life-threatening syndrome that is defined by disordered eating, amenorrhea, and osteoporosis.2 Female athletes at the elite level, those involved in appearance or endurance sports,3 and those with a low body weight are particularly susceptible to developing the triad.1 Data on the prevalence of the triad is needed to improve prevention efforts.4 The researchers who composed a position stand for the American College of Sports Medicine advised further study to better understand the triad areas.5

Although physical exercise has many benefits, too much exercise can negatively affect the female athlete, causing amenorrhea (defined as the absence of 3 to 6 consecutive menstrual cycles), one of the components of the triad.6,7 When athletes restrict food and train hard, hormonal changes can affect the reproductive system and cause menstrual dysfunction. 8 Menstrual dysfunction is more prevalent among female athletes than it is among nonathletes6 and is especially common among women who participate in sports where a thin build may improve performance.1 Several forms of menstrual dysfunction have been found in female athletes, the most severe form being amenorrhea.8,9 Athletic amenorrhea is most common among long- distance runners and ballet dancers, with a prevalence of up to 66%.10 Amenorrhea is also a primary characteristic of anorexia, an eating disorder marked by low body weight and excessive dieting.11 Athletes who appear to be at the greatest risk of developing menstrual dysfunction usually begin training prior to menarche (first menstrual bleeding), have an extremely intense training regimen, consume few calories, and have a low body weight.12

A second component of the triad, disordered eating, is more common among women who participate in certain sports. Researchers1,13 have previously reported that 15% to 65% of those women in thin build sports have pathogenic eating patterns, a fact that may influence the history, development, and course of eating disorders. When studying risk factors for eating problems, Macleod13 found that the same personality characteristics that are required for success in sport, such as perfectionism, persistence, high self- expectation, and independence, are risk factors for eating disorders. Furthermore, athletes who perceive that they have no control over their environments often compensate for this lack of control by controlling food intake. They might also view excessive exercise as a method to control weight and improve performance9; however, these practices are ultimately self-defeating and actually weaken athletic performance.14

Although anorexia and bulimia nervosa are the most commonly researched clinical eating disorders, Eating Disorders Not Otherwise Specified (EDNOS), or subclinical eating disorders, account for 50% of all eating disorders.15 A diagnosis of EDNOS applies when symptoms for anorexia or bulimia are only partially met. People with EDNOS are preoccupied with eating, engage in excessive exercise, and may experience some depression and low-self esteem.16 Beals and Manore17 have reported increases in subclinical eating disorders among active women with rates that may exceed that of clinical eating disorders. Although active women with subclinical eating disorders might not suffer the life-threatening medical complications of those with clinical eating disorders, they have poor nutritional status and health.17

The third component of the triad, osteoporosis, has serious health effects. Amenorrhea and low body weight are 2 factors that are significant predictors of osteoporosis,18 a condition characterized by low bone mass and fragility fractures of the hip, wrist, and spine.19 Numerous researchers8,18,20 have confirmed the development of osteoporosis among eating-disordered women. Poor nutrition from disordered eating and menstrual dysfunction negatively affects the skeletal system.6,7 Adequate calcium and vitamin D intake, along with balanced nutrition, are recommended as part of the preventive guidelines against osteoporosis.20 On the basis of the Reference Dietary Intakes, the daily calcium recommendation for women aged 19-30 years with normal menstrual cycles is 1,000 mg,21 whereas those with oligomenorrhea or amenorrhea are advised to consume 1,500 mg.22

My purpose in this study was to examine the prevalence of characteristics of the Female Athlete Triad in a study of National Collegiate Athletic Association (NCAA) Division I, II, and III cross- country female athletes. Because women in this sport are considered to be at risk for developing components of the Female Athlete Triad,5 I examined their perceptions of a previous/current eating disorder, exercise time, subclinical eating disorder characteristics, current calcium consumption, current menstrual status, and body mass index (BMI).

METHODS

Procedure

I mailed packets containing 20 copies of self-report paper surveys for female collegiate cross-country runners to 85 randomly selected coaches of NCAA United States teams. Included with the surveys was a stamped, self-addressed envelope for survey return. In the coaches’ cover letter, I asked them to have someone other than themselves distribute the surveys to the runners and return them. As an incentive for participation, I offered coaches osteoporosis educational materials I developed for the athletes (brochures and prepared transparencies). I distributed these materials to the coaches when I received the completed surveys. Participation was voluntary, anonymous, and in accordance with university guidelines for human participants.

Participants

Twenty-nine collegiate teams (34.12% return rate) from 22 states completed the survey. From these teams, 300 female collegiate cross- country runners from 44 states and 1 foreign country returned their completed surveys. Mean age for the athletes was 19.64 years (SD = 1.56). A majority reported their race as white (90.3%).

Measurements

Demographic Information

Race, age, height, and weight were self-reported. I used height and weight measures to calculate BMI, a standard acceptable measure of body size. (BMI is measured in kg/m2.) BMI is a function of weight adjusted for height and is one of the most commonly used methods of weight categorization.23 Thomas et al24 found that BMI is related to problem eating and body dissatisfaction.

Perception of Previous/Current Eating Disorder

I assessed the athletes’ perceptions of previous/current eating disorders with the question, “Have you ever been told or perceived that you had an eating disorder?” Thompson et al25 obtained a 1- week test-retest reliability coefficient of 1.0 for this question with a sample of young women. Those who answered “yes” were also asked, “What age were you at the onset?”

Current Menstrual Status

Participants were asked their age at menarche, and they then indicated their current menstrual status by choosing between these responses: have not started menstruation, have not had a menstrual period for 6 months (amenorrhea), have a menstrual period every 6 weeks (oligomenorrhea), or have menstrual periods every 25-35 days.6

Exercise Time

I asked the women, “How many times a week do you engage in vigorous physical activity long enough to work up a sweat?” and also “How many minutes a day do you usually exercise?” I multiplied their reported minutes of exercise a day by the number of times they reported exercising each week to determine their total minutes of weekly exercise. I also asked the women their age when they first became involved in competitive athletics.

Orientation to Exercise

Yates et al26 derived this 27-item questionnaire, the Orientation to Exercise Questionnaire [OEQ], from statements made by athletes and eating disordered patients about sports and investment in exercise. They designed it to determine patterns of risk for progression toward subclinical and clinical eating disorders among athletes and nonathletes. The 6 subscales within the questionnaire and a sample of questions for each factor include: self-control (“I feel better after I exercise”), orientation to exercise (“I follow a controlled training regimen”), self-loathing (“I hate my body when it won’t do what I want”), weight reduction (“I would like a lower percent body fat”), identity (“I am a serious athlete”), and competition (“If I make one goal, I shoot for a harder one”). The alpha coefficients for these factors indicated reliability from .74 to .87, with .92 for the total score.26 Participants indicated agreement or disagreement with statements by checking responses on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree).26 Current Calcium Intake

Hertzler and Frary27 developed a Rapid Assessment Method (RAM) to estimate usual calcium intake on the basis of correlations with a 24- hour recall for adults and students. Similar to other RAMs, dietary calcium tends to be overreported; however, the relationship for this RAM and Dietary Records was in an acceptable range (r = .68) for a large proportion (85%) of the test population. The RAM portion of the survey included a listing of calcium-rich foods for participants to estimate their consumption on a typical day in the past week. The assessment then provided estimates of daily calcium intake (mg) from 6 categories of foods: milk, yogurt, and cheese; breads, cereals, rice, and pasta; fruits and vegetables; meat, fish, poultry, beans, and nuts; and fat, sugar, and alcohol.

Data Analysis

I manually coded the surveys, entered, and crossvalidated into EPI: INFO, Version 6: A Word-processing, Database, and Statistics Program (Centers for Disease Control and Prevention, Geneva, Switzerland). The data set was then exported to the Statistical Analysis System v. 6.12 (SAS Inc, Cary, NC) and prepared for analysis. I required a probability value of p

Independent variables included perception of a previous/current eating disorder (yes or no) and BMI. Dependent variables were age at menarche, exercise time (minutes per week), current calcium consumption (RAM) items, and Orientation to Exercise items. To assess interactions between these independent variables and test for equal BMI slopes, I used the General Linear Model (GLM) Analysis of Variance procedure. I initially ran the model with interaction terms for the independent variables, and if I could not find these to be significant, I removed them and reanalyzed the model. I calculated least square means to adjust each dependent variable for independent variables.

RESULTS

Table 1 shows participants’ demographic information. Most respondents (83.3%) were of an average weight based on their BMI, which I calculated from their self-reported height and weight (average weight BMI = 18.5-

Perception of Previous/Current Eating Disorder

When asked, “Have you ever perceived or been told that you have an eating disorder?” 19.3% (n = 58) answered “yes.” Those who answered yes reported that their eating disorder began at a mean age of 15.76 years (SD = 1.86, range 11-20 years). Of those individuals, 15 (26.3%) said they had received treatment for eating disorders (see Table 2).

Current Menstrual Status

Participants reported menarche to be at the age of 13.46 (SD = 1.65). When examining rates of menstrual dysfunction, 77% reported normal cycles, 5.3% reported amenorrhea, and 17.7% reported oligomenorrhea. When using the GLM to examine differences in age at menarche by perception of a previous/current eating disorder (yes or no) and BMI, I found no significant differences.

Exercise Time

The women reported a total exercise time each week of 544.72 minutes (SD = 343.45). They became involved in competitive athletics at the age of 11 (M = 11.37, SD = 3.22) and had been competitive athletes for an average of 8 years (M = 8.26, SD = 3.54). Using the GLM, I did not find minutes of exercise time per week to be significantly different on the basis of perception of a past/ current eating disorder (yes or no) or by BMI.

Current Calcium Intake

To determine the effects of BMI and the athletes’ reports of previous/current eating disorders on calcium consumption, I used the GLM. Reported calcium intake (mg) from milk products with intake decreased by 39% for each unit increase in BMI (p = .0221, slope = – .3880; see Table 3). Calcium intake from bread products was also significant by BMI. For each unit increase in BMI, calcium from bread products decreased by 62% (p = .0258, slope = -.6261). In addition, calcium intake from the fats and sweets group was significant by BMI. For each unit increase in BMI, scores decreased (less calcium from fats and sweets) by 49.9% (p = .0152, slope = – .4986. I found no differences in calcium intake for the independent variables in the fruit and vegetable or meat group. Overall scores for the calcium screener were significantly different by BMI. For each unit increase in BMI, scores on the calcium screener decreased by 58.64% (ie, less calcium intake reported) (p = .0081, slope = – .5864).

I next examined the percentage of women who consumed less than recommended amounts of calcium on the basis of the calcium RAM results.27 Young women with menstrual dysfunction should consume 1,500 mg/d calcium.22 I found 50.72% (n = 35) of those athletes reporting amenorrhea and oligomenorrhea had scores lower than this amount on the calcium screener. I found 22.51% (n = 52) of the women who reported normal menstrual status consumed less than this recommended amount.

Orientation to Exercise

To determine the effects of BMI and the athletes’ reports of previous/current eating disorders on subscales within and on the entire OEQ (a measure of patterns of risk for subclinical and clinical eating disorders), I used the GLM (see Table 4).

Those who perceived they had previous/current eating disorders had significantly higher scores on self-loathing (M = 12.60, SD = 3.57, p

The athletes who reported a previous/current eating disorder also had significantly higher scores for using exercise as a method of weight reduction (M = 11.98, SD = 2.26, p = .0028) than did those with no reported eating disorder (M = 10.94, SD = 2.94). For BMI, scores for exercise as a means of reducing weight increased by 41.75% for each unit increase in BMI (p

For identity to exercise, only BMI was significant. Scores decreased by 19.43% for each unit increase in BMI, meaning the athletes reported less of an identity to exercise as their weight increased (p = .0005, slope = -.1944).

I found no significant differences by BMI or for perceptions of previous/current eating disorders for the OEQ subscales of competition, self-control, or orientation to exercise.

When examining overall scores for the OEQ, I found significant differences for those who perceived having a previous/current eating disorder because they obtained higher scores (ie, greater risk of having subclinical or clinical eating disorders) (yes: M = 88.59, SD = 8.95; no: M = 83.39, SD = 9.45, p = .0002) than did those who did not report eating disorders. I also found BMI to be significant. For each unit increase in BMI, scores on this questionnaire increased by 71.39% (p = .0087, slope = .7139).

Female Athlete Triad Components

In 1998, Otis2 cited disordered eating, osteoporosis, and menstrual dysfunction as components of the Female Athlete Triad. I examined the components of disordered eating and menstrual dysfunction on the basis of the athletes’ reports of previous/ current eating disorders and reports of their menstrual status. Although inadequate calcium intake is not a direct measure of osteoporosis, it is one of the risk factors for osteoporosis20; therefore, I used the final calcium RAM scores as one measure of risk for osteoporosis. (I defined low calcium consumption as less than 1,500 mg/d for those with menstrual dysfunction22 and 1,000 mg/ d for those with normal menstrual periods.21) To summarize the results provided previously, 19.4% of the women reported previous/ current eating disorders, 23.0% had irregular menstrual cycles, and 29.1% had inadequate calcium intake.

COMMENT

Although sports participation should be promoted among girls and women for health benefits and enjoyment, education and counseling should be provided for collegeage women regarding components of the Female Athlete Triad.29 Noted in the results are several important findings for college health professionals.

Approximately one-fifth (19.3%) of the female athletes said they perceived or had been told that they had an eating disorder. Although the self-reported responses to this question cannot be equated to clinical diagnoses of eating disorders, the rates were higher than the lifetime prevalence of anorexia and bulimia among women in general, which is estimated to be 3.7% and 4.2%, respectively.30 However, the rates of eating disorders were lower than previous estimates of 36% to 55% for women involved in running and endurance team sports.6,31 Similar to previous findings on age of eating disorder initiation,32 the collegiate runners in this study reported their eating disorders began at age 15 years.

Most athletes’ (83.3%) BMI was in the average-weight category, which I found encouraging because a BMI > 17.5 is a diagnostic criteria for anorexia nervosa.15 Also, a low body weight is a risk factor for the Female Athlete Triad1 and is believed to be a stronger influence on menstrual function than is body fat.8

Menstrual dysfunction is common among female athletes who are involved in intensive athletic activity or are consuming inadequate calories (ie, energy); however, determining the prevalence of menstrual dysfunction is difficult because of the variations in the definition of amenorrhea and the limitations in assessing history of menstrual dysfunction.32 Among these cross-country runners, 23% of the women reported current menstrual dysfunction, a percentage which is higher than the rate of 2% to 5% for women in general,9 yet lower than the rates of 25% to 66% previously reported for female runners.1,6,33 My findings reiterate the importance of screening collegiate cross-country runners for menstrual irregularities because women who suffer from prolonged amenorrhea may never achieve ageappropriate bone mineral densities.33 A weakness of this study was my not identifying those athletes who were using hormone replacement therapy to regulate menstrual cycles or for other medical reasons. There is currently controversy regarding whether hormone therapy will prevent or reverse bone mineral deficits.20 Investigators should conduct further research to determine the role this medication plays in athletes’ health. Because the athletes in this study were physically active but calcium intake was not known, I used calcium intake scores on the RAM to determine one of the risk factors for osteoporosis: low calcium consumption. Approximately 29% of all athletes did not consume adequate calcium, and more than 50% of the women reporting irregular menstrual cycles did not consume the recommended 1,500 mg/d of calcium. Because there is a positive relationship between calcium intake and premenopausal bone density, interventions are needed to encourage female athletes to increase calcium to retard bone loss.34,35 Nutrition education is needed for these athletes to provide information on food choices from the milk, cheese, and yogurt group, which will keep calcium consumption at an adequate level and not promote the weight gain they feel could hinder athletic performance.

My findings were difficult to compare with previous findings because there is limited research on the prevalence of the components of the Female Athlete Triad.9 Researchers have noted that when examining self-reported exercise, eating problems, and body dissatisfaction, investigators should be concerned with social desirability effects.36,37 Because many individuals with disordered eating carefully guard this secret, actual prevalence rates of those with at least 1 component of the triad could be higher.

Future Directions

One aspect that deserves further examination is that of EDNOS. Because it is believed that approximately 50% of those with eating disorders fall into this category,15 further research is warranted to determine specific identifying features. In this study, those women perceiving a previous/current eating disorder had significantly higher scores than did the others on the 2 OEQ subscales related to eating problems: self-loathing and use of exercise for weight reduction, and also on their total OEQ score. The higher scores of those with perceptions of eating disorders could indicate warning signs for body dissatisfaction, obligatory exercise, and possible eating problems. The OEQ seems to be a useful tool to assist in screening athletes for subclinical or clinical eating disorders.

Another item of interest was the effect of BMI on the OEQ scores. Similar to the results discussed previously for those women with a history of eating disorders, as BMI increased there were significant increases in self-loathing and using exercise as a method of weight control. Shame and starvation initiate self-loathing and other destructive behaviors38; therefore, those with higher BMIs in this sport could be at an increased risk for subclinical eating disorders. However, unlike those women who perceived they had eating disorders, there was an inverse relationship between identity to exercise as BMI increased. This means that as BMI increased, the women were less likely to identify themselves as athletes. I speculate that these women feel the need to exercise to lose weight to achieve the usual thin ideal body size for competitive collegiate runners, yet, at the same time, could psychologically try to disassociate themselves from the sport. Also, although I used the wording “higher BMI,” this is probably a misnomer because only 3.7% of the women fell into the overweight or obese categories. This finding is one that experts should note for future study; cross- country runners on the higher end of the average-weight BMI category may be at an increased risk for eating problems.

Limitations

Important deficits exist in knowledge about the triad among active women; therefore, investigators involved in future research in this area should address the following limitations of this study. First, although the surveys were anonymous and I instructed coaches to have someone else collect the surveys and return them via mail, the women could have thought that their coaches or teammates would examine their self-reported information. Those who perceived their BMI to be high could have been overly sensitive about being involved in a sport where a thin body size is considered ideal, and this sensitivity could have influenced their responses. Second, responses about weight, dieting, and body dissatisfaction could have been inaccurate because of social desirability bias or the secretive nature of eating problems. Last, the method of survey distribution and low return rate of the surveys are causes for concern.

Additional studies, particularly those of a longitudinal nature, are needed to better determine how training intensity, hormone replacement therapy, body fat, and body weight influence menstrual irregularities and health of competitive female runners. Thrash and Anderson4 indicated that nutrition education of female athletes should receive greater attention, and the results of this study confirm this recommendation. Coaches should place greater emphasis on prevention of components of the Female Athlete Triad by not promoting disordered eating behaviors and the pursuit of low body weight when working with these athletes. Increased awareness and educational efforts among college health professionals, collegiate coaches, athletes, trainers, athletic department directors, health educators, parents, and physicians are needed to insure optimal physical and mental health among these athletes.

ACKNOWLEDGMENT

The author thanks Presley Smith, Melissa Gabriel, and Lindsey Grainger for assistance in gathering the data.

This study was funded by a grant from the South Carolina Osteoporosis Coalition and the South Carolina Department of Health and Environmental Control, Columbia, SC.

REFERENCES

1. Warren MP, Shantha S. The female athlete. Baillieres Clin Endocrinol Metab. 2000;14:37-53.

2. Otis CL. Too slim, amenorrheic, fracture-prone: the female athlete triad. ACSM Health Fitness J. 1998;2:20-25.

3. Yeager KK, Agostini R, Nattiv A, Drinkwater B. The female athlete triad: disordered eating, amenorrhea, osteoporosis. Med Sci Sports Exerc. 1993;25:775-777.

4. Thrash LE, Anderson JJB. The female athlete triad: nutrition, menstrual disturbances, and low bone mass. Nutr Today. 2000;35:168- 174.

5. American College of Sports Medicine. The female athlete triad: position stand. Med Sci Sports Exerc. 1997;29:i-ix.

6. Henriksson BG, Schnell C, Hirschberg AL. Women endurance runners with menstrual dysfunction have prolonged interruption of training due to injury. Gynecol Obstet Invest. 2000;49:41-46.

7. Wolman RL, Clark P, McNally E, Harries M, Reeve J. Menstrual state and exercise as determinants of spinal trabecular bone density in female athletes. Br Med J. 1990;301:516-518.

8. Fruth SJ, Worrell TW. Factors associated with menstrual irregularities and decreased bone mineral density in female athletes. J Orthop Sports Phys Ther. 1995;22:26-38.

9. Nattiv A, Agostini R, Drinkwater B, Yeager KK. The female athlete triad: the inter-relatedness of disordered eating, amenorrhea, and osteoporosis. Clin Sports Med. 1994;13:405-418.

10. Hirschberg AL, Hagenfeldt K. Athletic amenorrhea and its consequences. Hard physical training at an early age can cause serious bone damage [abstract]. Lakartidningen. 1998;95:5765-5770.

11. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Arlington, VA: American Psychiatric Association; 1994.

12. Snow-Harter CM. Bone health and prevention of osteoporosis in active and athletic women. Clin Sports Med.1994;13:389-404.

13. Macleod AD. Sport psychiatry. Aust N Z J Psychiatry. 1998;32:860-866.

14. Beals KA. Subclinical eating disorders in female athletes. J Phys Educ Recreation Dance. 2000;71:23-29.

15. American Dietetic Association. Position of the American Dietetic Association: nutrition intervention in the treatment of anorexia nervosa, bulimia nervosa, and eating disorders not otherwise specified. J Amer Diet Assoc. 2001;101:810. Retrieved October 31, 2001, from InfoTrac OneFile database.

16. Schwitzer AM, Rodriguez LE, Thomas C, Salimi L. The eating disorders NOS diagnostic profile among college women. J Am Coll Health. 2001;49:157. Retrieved October 31, 2001, from InfoTrac OneFile database.

17. Beals KA, Manore MM. Subclinical eating disorders in physically active women. Top Clin Nutr. 1999;14:14-29.

18. Baker D, Roberts R, Towell T. Factors predictive of bone mineral density in eating-disordered women: a longitudinal study. Int J Eat Disord. 2000;27:29-35.

19. Lane JM. Osteoporosis: medical prevention and treatment. Spine. 1997;22:32S-37S.

20. Gordon CM. Bone density issues in the adolescent gynecology patient. J Pediatr Adolesc Gynecol. 2000;13:157-161.

21. Food and Nutrition Board of the National Academy of Science. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington, DC: National Academy Press; 1997.

22. National Collegiate Athletic Association. Sports Science Newsletter [online]. The female athlete triad. The NCAA News. April 20, 1998. Retrieved July 25, 2007, from Sport Discus.

23. US Department of Health and Human Services. The Surgeon Ggeneral’s Report on Nutrition and Health. Washington, DC: US Government Printing Office; 1988. DHHS (PHS) Publication No. 88- 50210 24. Thomas K, Ricciardelli LA, Williams RJ. Gender traits and self-concept: indicators of problem eating and body dissatisfaction among children. Sex Roles. 2000;43:441-458. Retrieved October 31, 2001, from InfoTrac OneFile database.

25. Thompson SH, Sargent RG, Case A. Factors influencing performance-related injuries among group exercise instructors. Women Sport Phys Act J. 2001;10:125-142.

26. Yates A, Edman JD, Crago M, Crowell D, Zimmerman R. Measurement of exercise orientation in normal subjects: Gender and age differences. Pers Individ Dif. 1999;27:199-209.

27. Hertzler AA, Frary RB. A dietary calcium rapid assessment method (RAM). Top Clin Nutr. 1994;9:76-85.

28. National Institutes of Health. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report. Washington, DC: NHLBI Obesity Education Initiative Task Force Members; 1998.

29. American Academy of Pediatrics. Medical concerns in the female athlete. Pediatrics. 2000;106:610-613.

30. Deering S. Eating disorders: recognition, evaluation, and implications for obstetrician/gynecologists. Prim Care Update Ob Gyns. 2001;8:31-35.

31. National Collegiate Athletic Association. Sports Science Newsletter [online]. Women and nutrition. The NCAA News. April 12, 1999. Retrieved July 25, 2007, from Sport Discus.

32. Ressler A. “A body to die for”: eating disorders and body- image distortion in women. Int J Fertil. 1998;43:133-138.

33. Puffer JC. Athletic amenorrhea and its influence on skeletal integrity. Bull Rheum Dis. 1994;43:5-6.

34. Peterson BA, Klesges RC, Kaufman EM, Cooper TV, Vukadinovich CM. The effects of an educational intervention on calcium intake and bone mineral content in young women with low calcium intake. Am J Health Promot. 2000;14:149-156.

35. Rourke K, Bowering J, Turkki P, Buckenmeyer P, Keller B, Sforzo G. Effect of calcium supplementation on bone mineral density in female athletes. Nutr Res. 1998;18:775-783.

36. Johnson C, Powers PS, Dick R. Athletes and eating disorders: The National Collegiate Association Study. Int J Eat Disord. 1999;26:179-188.

37. Krane V, Waldron J, Stiles-Shipley JA, Michalenok J. Relationships among body satisfaction, social physique anxiety, and eating behaviors in female athletes and exercisers. J Sport Behav. 2001;24:247. Retrieved October 23, 2001, from InfoTrac OneFile database.

38. Mansfield MJ, Emans SJ. Anorexia nervosa, athletics, and amenorrhea. Pediatr Clin North Am. 1989;36:533-549.

Sharon H. Thompson, EdD, CHES

Dr Thompson is with Coastal Carolina University’s Health, Physical Education, and Recreation Department.

Copyright (c) 2007 Heldref Publications

NOTE

For comments and further information, please address correspondence to Dr Sharon H. Thompson, Health, Physical Education, and Recreation Department, College of Education, Coastal Carolina University, PO Box 261954, Conway, SC 29528 (email: [email protected].).

Copyright Heldref Publications Sep/Oct 2007

(c) 2007 Journal of American College Health. Provided by ProQuest Information and Learning. All rights Reserved.

ShiftWise, the nation’s leading provider of healthcare supplemental staffing management services, today announced that Jackson Health System has selected ShiftWise Vendor Management Service (VMS) to manage both its clinical and non-clinical staffing agency programs at all Miami area locations. ShiftWise will manage all temporary labor regardless of labor type or location across the organization.

By consolidating all staffing agency programs Jackson will be able to standardize policies and procedures, improve quality, enhance reporting and simplify the agency billing and invoicing process.

“ShiftWise will allow Jackson Health System to regulate staffing activity across a very large organization and to more effectively track and control costs related to their temporary labor usage,” says Jeff Niles, Regional Director of Sales for ShiftWise. “We believe that the evaluation tools built into the ShiftWise system will also enhance their ability to share information between facilities which will improve staff quality.”

ShiftWise will also replace existing paper processes for agency timekeeping and invoicing with electronic timecards and an inverted consolidated invoice. “The move to the ShiftWise paperless invoicing process will free up administrative and accounting resources and provide Jackson a more efficient method for paying vendors,” says Niles.

For ShiftWise the expansion into Non-clinical VMS for Jackson is a result of past success and a natural progression. “We are comfortable in the clinical world and have succeeded in mastering the convoluted nature of clinical VMS that keeps traditional VMS companies out of this space,” says ShiftWise founder Jason Lander. “Our success in managing the most intricate clinical specialties has our customers demanding more. We are happy to oblige and we do not anticipate the struggles that traditional VMS companies have when trying to enter the more complex clinical setting.”

About Jackson Health System

Jackson Health System, an integrated healthcare delivery system, consists of its centerpiece, Jackson Memorial Hospital; 12 primary care centers and two primary care mobile vans; 16 school-based clinics; two long-term care nursing facilities; a network of mental health facilities; Holtz Children’s Hospital, Jackson Rehabilitation Hospital, Jackson North Medical Center and Jackson South Community Hospital. Governed by the Public Health Trust, a dedicated team of citizen volunteers acting on behalf of the Miami-Dade Board of County Commissioners, Jackson Health System ensures that all residents of Miami-Dade County receive a single high standard of care regardless of their ability to pay.

About ShiftWise

Based in Portland, Ore., ShiftWise combines healthcare specific web-based management software with customized client support services to deliver a comprehensive solution that reduces costs, improves quality, ensures compliance and enhances reporting. ShiftWise services more than 400 healthcare organizations in 23 states for both clinical and non-clinical staffing. ShiftWise clients rely on VMS and IRP services as an alternative solution to the complicated and expensive manual processes often in use for supplemental staffing. To learn more about ShiftWise call 866-399-2220. http://www.shiftwise.net

ARCADIA, Calif. and DUARTE, Calif., Nov. 8 /PRNewswire/ — The National Marrow Donor Program (NMDP) has selected an abstract written by Dr. Auayporn Nademanee, physician and professor in the Division of Hematology & Hematopoietic Cell Transplantation at City of Hope, and Dr. Robert Chow, Founder and Global Medical Director for StemCyte, as one of four best abstracts at its annual Council Meeting in Minneapolis, MN. The abstract, “Adult Patients with Malignancies Transplanted with Plasma Depleted Cord Blood (PD CB) — A Retrospective Audited Analysis of 107 Patients” was presented by Dr. Nademanee at the NMDP Council Meeting and has several other co-authors.

The abstract describes the safety and effectiveness of transplanting single or double plasma-depleted umbilical cord blood units into adult patients with cancers of the blood. All of the plasma-depleted cord blood was processed and shipped from the StemCyte International Cord Blood Center in Arcadia, CA. Dr. Nademanee says, “Patients treated with plasma-depleted cord blood demonstrated excellent outcomes in terms of overall survival, transplant-related mortality, and the absence of complications such as graft-versus-host disease. We believe that plasma-depleted cord blood will continue to be an effective treatment for patients with leukemia, lymphoma, and other malignant indications.”

Dr. Chow says, “We thank NMDP for selecting ours as one of their Best Abstracts. We are heartened to see the outstanding patient outcomes using StemCyte’s plasma-depleted cord blood products. However, none of these results would be possible without the tremendous care given to patients by physicians like Dr. Nademanee at City of Hope. We are gratified to have the support and confidence of physicians at City of Hope and other leading transplant centers around the world.” StemCyte has shipped cord blood products to over 140 of the leading transplant centers in 32 countries around the world.

About StemCyte

StemCyte, Inc. operates as both an international umbilical stem cell storage bank and a therapeutics company. Stem cells are used to replace or initiate the production of other cells that are damaged or missing due to disease. StemCyte collects, processes and banks umbilical cord blood (“UCB”) stem cells to be used as therapeutic treatments. The Company currently operates UCB storage banks in California and Taiwan and is expanding its locations into other regions around the globe. In addition, the Company is pursuing collaborations with a number of leading stem cell researchers to improve and expand the treatment opportunities using stem cells.

UCB stem cells are a non-controversial and readily available source of stem cells, harvested from umbilical cords that would otherwise be discarded. To date, UCB stem cells have been used in approximately 8,000 transplants worldwide and have successfully treated certain cancers (e.g., leukemia, lymphoma and myeloma), blood disorders (e.g., thalassemia, sickle cell anemia and Fanconi anemia) and immune deficiency diseases. StemCyte and its scientific founder have developed proprietary processes to ensure that the least number of stem cells are lost post-collection and post-thaw. Studies have shown that successful patient engraftment and survival outcome are directly correlated to the number of stem cells provided. StemCyte’s stem cells are currently being used to treat three to four patients per week and the Company recently released its 600th cord blood stem cell shipment for transplant. With an inventory of over 25,000 units, the Company’s stem cell banks represent one of the largest and most ethnically diverse sources of unrelated (allogeneic) UCB stem cells.

StemCyte’s therapeutic activities involve expanding the use of UCB stem cells in indications where stem cells are already an FDA-approved therapy, validating the engraftment and survival benefits of its proprietary stem cell processing technology and participating in clinical trials for new transplant indications. New indications include thalassemia, a devastating red blood cell deficiency diagnosed in over 150,000 babies each year with severe forms of the disease, and non-blood-based disorders, including neurodegenerative diseases.

StemCyte has received accreditation from the American Association of Blood Banks (AABB), the National Marrow Donor Program (NMDP), the College of American Pathologists (CAP), and Foundation for the Accreditation of Cellular Therapy (FACT) for allogeneic donations and has the only cord blood bank in the world accredited by FACT for autologous donations. StemCyte is one of only six banks to have been selected to participate in the C.W. Bill Young Cell Transplantation Program under the initial $79 million authorized by Congress in the Stem Cell Therapeutic and Research Act of 2005.

StemCyte is privately-held. Visit http://www.stemcyte.com/ for more information.

About City of Hope

City of Hope is a leading research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as a Comprehensive Cancer Center, the highest honor bestowed by the National Cancer Institute, and a founding member of the National Comprehensive Cancer Network, City of Hope’s research and treatment protocols advance care throughout the nation. City of Hope is located in Duarte, Calif., just northeast of Los Angeles, and is ranked as one of “America’s Best Hospitals” in cancer and urology by U.S.News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation and genetics. For more information, visit http://www.cityofhope.org/.

   Contact:   David Carmel   StemCyte, Inc.   917-414-4121  

StemCyte, Inc.

CONTACT: David Carmel of StemCyte, Inc., +1-917-414-4121

Web site: http://www.stemcyte.com/http://www.cityofhope.org/

CHICAGO and CONCORD, N.C., Nov. 8 /PRNewswire-FirstCall/ — Allscripts, the leading provider of clinical software, connectivity and information solutions that physicians use to improve healthcare, today announced that Carolinas Medical Center — NorthEast (CMC-NorthEast) has selected HealthMatics(R) ED Emergency Department Information System (EDIS) from Allscripts to automate emergency room operations and improve access to clinical information. CMC-NorthEast currently has 160 physicians in 40 clinics using Allscripts Electronic Health Record (EHR) solutions.

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A regional 457-bed, not-for-profit medical center, CMC-NorthEast has a reputation for excellence built on advanced technology, medical staff talent, quality, and compassionate care. The Allscripts EDIS will replace paper charts and an electronic patient tracking system in CMC-NorthEast’s Emergency Care Center — whose 25 physicians handle nearly 80,000 patient visits each year — with a fully connected electronic system that shares information from multiple systems, including Allscripts Electronic Health Records.

“Information technology is critical to enhancing the quality and safety of patient care provided in Carolinas Medical Center-NorthEast’s Emergency Care Center,” said Keith McNeice, Chief Information Officer of CMC-NorthEast. “Allscripts has been a solid partner for our Electronic Health Record initiative and was the logical choice to help us accelerate our efforts in this mission critical area of our organization. We believe the EDIS is the best way to share information between the hospital, ECC and the NorthEast Physician Network providers to deliver all the information our providers need to make sound, real-time clinical decisions at the point of care.”

Physicians, nurses and other Emergency Care Center staff will benefit from the Allscripts solution’s single-screen view of all ED activity with comprehensive patient tracking, electronic records, real-time views of all lab orders and test results, and patient-specific decision support information to enhance safety. The EDIS also features remote chart access for community caregivers and hospital staff, so they can securely access an ED patient’s chart via the Web without logging into the ED solution. Additionally, its sophisticated analytics identifies workflow bottlenecks that slow care delivery, and monitors quality outcomes to ensure better care.

CMC-NorthEast will implement HealthMatics ED Version 6.0, the latest release of the Allscripts EDIS, which includes the new Form Builder functionality to improve the care process. Form Builder enables caregivers at CMC-NorthEast to create new forms within the EDIS or transfer existing paper forms into the system, making it easier for physicians to transition from paper to electronic record-keeping. Form Builder also lets users incorporate clinical decision support tools that guide physicians through patient encounters.

“Physicians and caregivers inside the Emergency Department need instant access to the right information at the right time,” said Allscripts Chief Executive Officer Glen Tullman. “The very definition of emergency speaks to speed, quick access, and the ability to document and share information quickly. We’re proud that Carolinas Medical Center — NorthEast has selected Allscripts to help fulfill their mission of providing comprehensive and connected health care to their community”.

CMC-NorthEast conducted a systematic analysis of EDIS vendors and selected Allscripts for its comprehensive functionality, ease of customization, and proven success at the nation’s leading hospitals, where the Allscripts solution handles millions of Emergency Department visits each year. Allscripts will connect the HealthMatics EDIS system and the company’s Electronic Health Records, which are used by physicians outside the hospital to document patient care, manage chronic disease and electronic prescribing. CMC-NorthEast will integrate the EDIS with its hospital inpatient information system, enabling interoperability of all clinical and financial information between the Emergency Care Center and the hospital.

“In addition to the many benefits of automating emergency operations, our vision for an integrated healthcare network includes physician access and interoperability between the Allscripts systems,” said McNeice. “Our ED physicians and hospitalists, who frequently access the Electronic Health Record, will now be able to see a patient’s medical problems and care plans as well as active medications without having to rely on patients for that information.”

About Carolinas Medical Center — NorthEast

Carolinas Medical Center-NorthEast, http://www.cmc-northeast.org/, is a regional 457-bed, not-for-profit medical center with a reputation for excellence built on advanced technology, medical staff talent, quality, and compassionate care. Four years in a row, Solucient, http://www.solucient.com/, a leading healthcare information company, named CMC-NorthEast to its 100 Top Hospitals(R) list under the “Teaching Hospitals” category. The Jeff Gordon Children’s Hospital, http://www.jeffgordonchildrenshospital.org/, opened on the main medical campus for its first patients early this year, followed by the dedication of a new Batte Cancer Center in May. HealthGrades, http://www.healthgrades.com/ a leading, independent healthcare ratings company named CMC — NorthEast “Best in North Carolina” for cardiac services resulting from a three-year quality study involving virtually all 5,000 hospitals now located in the U.S. Based in Concord, NC, CMC — NorthEast has 4200 employees serving in more than 30 facilities located throughout the region.

CMC-NorthEast is now part of Charlotte-based Carolinas HealthCare System, http://www.carolinashealthcare.org/ an organization with more than 33,000 employees working in both North and South Carolina that share similar values, cultures and commitments to patients. The organization now includes 21 hospitals supported through more than 200 locations and staffed by 1,100 physicians.

About Allscripts

Allscripts is the leading provider of clinical software, connectivity and information solutions that physicians use to improve healthcare. The Company’s business units provide unique solutions that inform, connect and transform healthcare. Allscripts award-winning software applications include Electronic Health Records, practice management, e-prescribing, document imaging, emergency department, and care management solutions, all offered through the Company’s Clinical Solutions units. Additionally, Allscripts provides clinical product education and connectivity solutions for physicians and patients through its Physicians Interactive(TM) unit, and medication fulfillment services through its Medication Services unit. To learn more, visit Allscripts on the Web at http://www.allscripts.com/.

This announcement may contain forward-looking statements about Allscripts Healthcare Solutions that involve risks and uncertainties. These statements are developed by combining currently available information with Allscripts beliefs and assumptions. Forward-looking statements do not guarantee future performance. Because Allscripts cannot predict all of the risks and uncertainties that may affect it, or control the ones it does predict, Allscripts’ actual results may be materially different from the results expressed in its forward-looking statements. For a more complete discussion of the risks, uncertainties and assumptions that may affect Allscripts, see the Company’s 2006 Annual Report on Form 10-K, available through the Web site maintained by the Securities and Exchange Commission at http://www.sec.gov/.

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Allscripts

CONTACT: Todd Stein, Senior Manager|Public Relations, +1-312-506-1216,[email protected], or Dan Michelson, Chief Marketing Officer,+1-312-506-1217, [email protected], both of Allscripts; or LeeBrower, Director of Communications, Carolinas Medical Center, +1-704-783-1449,[email protected]

Web site: http://www.allscripts.com/http://www.carolinashealthcare.org/http://www.healthgrades.com/http://www.jeffgordonchildrenshospital.org/

BIRMINGHAM, Ala., Nov. 8 /PRNewswire/ — Diagnostic Health Corporation (DHC) announced today the appointment of Lucy C. Hicks as senior vice president and general counsel. In this role, Hicks will coordinate matters regarding DHC’s legal affairs at the newly independent diagnostic imaging company.

“We are pleased to bring someone with Lucy’s experience to the company,” said Diane Munson, DHC’s president and chief executive officer. “Her experience within the healthcare industry and familiarity with our business model will be invaluable as we continue to position the company for future growth. I know that she will be a great asset to our leadership team.”

Ms. Hicks has extensive legal expertise in the healthcare industry, most recently serving as senior vice president and deputy general counsel for HealthSouth Corporation. Prior to joining HealthSouth, she served as the legal counsel to the University of Alabama System for its operating division, the University of Alabama at Birmingham (UAB), and to the director of the UAB Research Foundation, the technology transfer operation for UAB. Before working with UAB, Ms. Hicks was vice president of legal services for Caremark Rx, formerly known as MedPartners, Inc. In the beginning of her career, she also served as a certified cytogenetic technologist in the UAB Laboratory of Genetics and in the Toxicology and Pharmacology Division of Southern Research Institute. Ms. Hicks earned a bachelor’s degree in biology from Huntingdon College and a law degree from Cumberland School of Law.

About Diagnostic Health Corporation

Diagnostic Health Corporation is a stand-alone provider of diagnostic imaging services with more than 50 freestanding locations across the country. Formerly a division of HealthSouth Corporation, DHC is a fully owned subsidiary of The Gores Group. DHC facilities offer a combination of outpatient diagnostic imaging services, including MRI, CT, X-ray, ultrasound, mammography, fluoroscopy, and nuclear medicine services. For more information, please visit http://www.dxhealthcorp.com/.

About The Gores Group

Founded in 1987, The Gores Group is a private equity firm focused on acquiring controlling interests in mature and growing businesses which can benefit from the firm’s operating experience and flexible capital base. The Gores Group has become a leading investor, having demonstrated over time a reliable track record of creating substantial value in its portfolio companies alongside management. Headquartered in Los Angeles, California, The Gores Group maintains offices in Boulder, Colorado and London. For more information, please visit http://www.gores.com/.

Diagnostic Health Corporation

CONTACT: Diagnostic Health Corporation, 1-866-621-4057

Web site: http://www.dxhealthcorp.com/http://www.gores.com/

Melissa Stark, television host and anchor, hosted the 33rd Annual FREDDIE Awards, MediMedia’s black-tie gala honoring the best in the year’s health and medical productions, it was announced today. Known as the “Oscars of Health and Medicine,” the 2007 ceremony was held at Philadelphia’s elegant Crystal Tea Room.

In addition to the 31 awards bestowed for excellence in a variety of categories, The FREDDIE Awards presented their prestigious 2007 Lifetime Achievement Award, the organization’s highest honor to Bob and Leila Macauley, Founders of AmeriCares. The 2007 Special Awards for Public Service were presented to Vincent T. DeVita, Jr., M.D. for his global leadership in cancer research and treatment, Dan and Claire Marino and the Dan Marino Foundation for their long-term efforts to support the challenges of Autism, and the Fidelco Guide Dog Foundation for their years of support to the visually impaired.

“These honorees have made an immeasurable contribution to the field of health and medical productions and, perhaps more importantly, to the personal lives of countless individuals,” said Steve Simcox, CEO, MediMedia, USA. “Our hope is that this spotlight placed on their work will further increase contributions to support their efforts in the health and medical communities.”

“The mission of the FREDDIE Awards is to provide encouragement and acknowledgment to the producers of health and medical electronic media. We are proud to share their accomplishments with a world that will benefit greatly from the knowledge they provide,” said Donna Hill Howes, Executive Producer of the FREDDIE Awards.

The 2007 Lifetime Achievement Award and Special Award Recipients joined the luminous ranks of past winners including, Bill and Melinda Gates, Christopher Reeve, Marlo Thomas, Jerry Lewis, Jack LaLanne, Mary Tyler Moore, Doctors Without Borders, Jonas Salk, M.D., Senators John Glenn, Bob and Elizabeth Dole, and basketball legend Magic Johnson, to name a few.

About: AmeriCares

AmeriCares is a nonprofit disaster relief and humanitarian aid organization founded by Bob and Leila Macauley, providing immediate response to emergency medical needs, as well as supporting long-term humanitarian assistance programs for all people around the world, irrespective of race, creed or political persuasion. AmeriCares solicits donations of medicines, medical supplies and other relief materials from U.S. and international manufacturers, and delivers them quickly and efficiently to healthcare and welfare professionals around the world. To accomplish these results, AmeriCares assembles product donations from the private sector, determines the most urgent needs and solicits the funding to send the aid via airlift or ocean cargo to health and welfare professionals on the ground. AmeriCares works with international and local non-governmental organizations, hospitals, health networks and government ministries. Historically, each $100 in cash contribution enables AmeriCares to deliver more than $3,000 in emergency relief, including medicines, medical supplies and nutritional supplements.

About: Vincent T. DeVita, Jr., M.D.

Vincent T. DeVita, Jr., M.D., has improved the lives of countless people around the globe through his outstanding contributions to cancer research and treatment. He is Chairman of the Yale Cancer Center Advisory Board and Professor of Internal Medicine and Professor of Epidemiology and Public Health at Yale University School of Medicine. Dr. DeVita is the first appointee to the post of “The Amy and Joseph Perella Professor of Medicine” at Yale University. Dr. DeVita was appointed by the President of the United States as Director of the National Cancer Institute (NCI) and the National Cancer Program. Along with colleagues at the NCI, Dr. DeVita was instrumental in developing combination chemotherapy programs which led to the curative chemotherapy for Hodgkin’s disease and diffuse large-cell lymphomas. These experiments were paramount in proving that drugs could cure advanced cancer. Dr. DeVita is one of the three editors of Cancer: Principles and Practice of Oncology, the most popular cancer textbook in the world.

About: Fidelco Guide Dog Foundation

Charles and Roberta Kaman’s intuitive knowledge of how German shepherd guide dogs could help people with visual disabilities live more normal lives was the genesis of the Fidelco Guide Dog Foundation. Beginning in 1960, the work done by the Kamans and an ever-growing group of dedicated and tireless staff, volunteers and supporters, has reached out and touched thousands of clients’ and family members lives. Today, Fidelco is an accredited member of the International Guide Dog Federation and a recognized leader in the guide dog industry. The non-profit organization places superbly trained German shepherds throughout the U.S. and Canada, and its clients run the gamut from business people to college students. Fidelco has a national focus but every placement is local. Their instructor-trainers travel to their clients’ homes and places of work to help them take the first important step toward freedom and independence. Fidelco pioneered this “In-community Placement” process in the U.S.

About: The Dan Marino Foundation

Motivated by experiences in raising their second son, Michael, who has autism, Dan and Claire Marino created the Dan Marino Foundation in 1992. The Marinos realized the need for comprehensive and integrated treatment programs for children with developmental disabilities and chronic medical problems. In 1998, the Marinos, along with Miami Children’s Hospital, built the Dan Marino Center in Weston, Florida, a free-standing pediatric subspecialty center providing the most comprehensive and integrated diagnostics and treatments for children with developmental disabilities, autism, and chronic medical problems. The Center serves more than 25,000 children annually. The Marinos understand that not all individuals with autism and their families have access to services. In 2004, the Foundation launched Childnett.tv, a 24-hour free web TV channel that is dedicated to autism and other neurodevelopmental disorders and showcases personal stories, therapies, and the latest medical breakthroughs. In 2006, the Marinos introduced the Marino Autism Research Institute (MARI). MARI is a “Virtual Institute” designed to sponsor cross-university collaborative research in understanding, treating and preventing autism. As the Marino family has matured — Michael is now in college studying Communications — so has Dan and Claire’s vision for the Foundation. Once young adults with special needs graduate from high school, their options become alarmingly narrow. The Foundation is now engaged in supporting training and employment programs for teens and young adults with special needs.

About: Melissa Stark

This year’s host, Melissa Stark, has served as the TODAY SHOW National Correspondent since 2003. Melissa has also served as host on WEEKEND TODAY and anchor on MSNBC. Melissa Stark is well known for her three years as sideline reporter for MONDAY NIGHT FOOTBALL, including Super Bowl XXXVI. While at ABC, Melissa also covered celebrity golf events, figure skating, and appeared as a guest co-host on THE VIEW.

About: The FREDDIES

Thirty-three years ago, FREDDIE’s Founder Dr. Fredrick Gottlieb brought the worlds of medical science, education and the arts together in what has become the preeminent international media competition devoted to educational health and medical productions. Each year, the competition attracts hundreds of submissions from around the world–documentaries, series, shorts, videos, web sites, and CD-ROMs–in 31 categories. These include Oncology, Diabetes, Fitness/Wellness, Infectious Disease, Prevention, and Women’s Health. All of the submitted media aim to help people live healthier, longer lives. They provide answers for consumers as well as health professionals, and raise important questions, too. The stories they tell are courageous and inspirational, often documenting the lives of those who have overcome tremendous medical struggles and those who have helped them to do so. Go to www.thefreddies.com for more information.

About: 2007 FREDDIE Award winners by category

 

ADOLESCENT HEALTH

Real Talk: Blueprint for a Safer Philadelphia

MEE Productions, Inc., Philadelphia, PA

 

ADVERTISING & PUBLIC RELATIONS

Why Planetree?

Planetree, Derby, CT

 

ALLERGIES & ASTHMA

Real Sports with Bryant Gumbel: The Air We Breathe

Home Box Office, Santa Monica, CA

 

BASIC & CLINICAL SCIENCE

Laser in Dentistry

Quintessenz.tv, Berlin, Germany

 

BEHAVIORAL DISEASES

Addiction

Home Box Office, Santa Monica, CA

 

CAREGIVING

Alzheimer’s Disease: Helping Yourself Help a Loved One

Alliance for Aging Research, Washington, DC

 

CHILDREN’S HEALTH

Reading and the Brain

WETA–Reading Rockets, Arlington, VA

 

COMMUNICATIONS

Iraq: Front Line ER

Discovery Health Media Enterprises, Silver Spring, MD

 

COMMUNITY HEALTH

Prometheus Bound: The Epidemic of Hepatitis C

Banyan Communications, St. Charles, MO

 

COPING

Moving OnTM: Tools for Breast Cancer Survivors

HealthMark Multimedia, Washington, DC

 

DIABETES

GYST: Life Guide for Young People on the Move

The Royal Children’s Hospital, Parkville, Victoria, Australia

 

HEALTH & WELLNESS

Action Hero Makeover

Mozark Productions, Studio City, CA

 

HEALTH EDUCATION

Max & Buddy the Bear in “The Bear Facts About CT Scans”

Florida Hospital Celebration Health, Celebration, FL

 

HEALTH SERIES

Mystery Diagnosis

Discovery Health Media Enterprises, Silver Spring, MD

 

INFECTIOUS DISEASES

www.poz.com

Smart + Strong, New York, NY

 

INFLAMMATORY DISEASES

True Guts

Dream Realization Media, Boston, MA

 

ISSUES & ETHICS

Scope of Practice

Kaiser Permanente, Los Angeles, CA

 

MEN’S HEALTH

Hormone Therapy: When the PSA Rises After Prostate Cancer Treatment

Health Dialog, Boston, MA

 

NEUROLOGICAL DISORDERS

Epilepsy Defined

Information Television Network, Boca Raton, FL

 

NUTRITION & DIET

Small Steps to a Healthier America

McCann Erickson, New York, NY

 

ONCOLOGY

Reflections on Psalm 23 for People with Cancer

Vision Video, Inc., Worcester, PA

 

PATIENT CARE

Influenza

Medfilms, Inc., Tucson, AZ

 

PREVENTION

A Little More Time…What’s It Worth to You?

Glendale Adventist Medical Center, Glendale, CA

 

PSYCHIATRY

Surviving Trauma & Tragedy

Michigan Victim Alliance, East Lansing, MI

 

PUBLIC SERVICE ANNOUNCEMENTS

The Appointment

HealthMedia, Inc., Ann Arbor, MI

 

SENIOR HEALTH

The Art of Aging

Aquarius Health Care Media, Sherborn, MA

 

SPECIAL PEOPLE

The Boy Inside

Fanlight Productions, Boston, MA

 

STROKE & HEART DISEASE

A.D.A.M. Specialty Centers: Stroke and Heart Disease

A.D.A.M., Inc., Atlanta, GA

 

SURGERY

AO Surgery Reference

AO Foundation, Davos, Switzerland

 

WEB SITES

ChefMD.com

Marx Creative, Glendale, WI

 

WOMEN’S HEALTH

The Promise and Power

Hurd Studios, New York, NY

About MediMedia

MediMedia offers some of the best-known brands in healthcare communications to both industry professionals and patients. In addition to its leading consumer health content sources, MediMedia is the preeminent provider of solutions for pharmaceutical companies along their entire marketing continuum, targeting physicians, payers and patients with our content and applications. The company’s attention to content quality, accuracy and ease of comprehension, as well as its experience in delivering specialized information to targeted audiences, has earned the trust and respect of healthcare organizations, pharmaceutical companies, physicians, employers and consumers throughout the country. For more information about MediMedia USA, please visit www.medimedia.com.

For more information about THE FREDDIES, please contact 650-244-4553

By Joan Reminick, Newsday, Melville, N.Y.

Nov. 7–Sometimes, it’s just not feasible to hold Thanksgiving dinner at home. Here are some restaurants serving special dinners:

Nassau County

Bistro M, 70 Glen Head Rd., Glen Head, 516-671-2498. Three-course prix fixe, $52 a person, 2 to 8 p.m.

Carltun on the Park, Eisenhower Park, East Meadow, 516-542-0700. Price-fixed dinner, $65 a person ($30 for children 3 to 10), noon to 8 p.m.; also buffet, $47 a person ($30 for children 3 to 10), 1 to 6 p.m.

Chas. Rothmann’s Steakhouse, 6319 Northern Blvd., East Norwich, 516-922-2500. Traditional turkey dinner, $28; also regular steak-house menu; 1 to 9 p.m.

CoolFish, 6800 Jericho Tpke., Syosset, 516-921-3250. Three-course menu, $38; regular dinner menu also available; 2 to 8 p.m.

Glen Cove Mansion Hotel & Conference Center, 200 Dosoris Lane, Glen Cove, 516-674-2990. Thanksgiving buffet, $45 a person ($25 for children 4 to 13). Discounted hotel rates offered to dinner guests. Seatings at 1, 4 and 7 p.m.

George Washington Manor, 1305 Old Northern Blvd., Roslyn, 516-621-1200. Thanksgiving buffet, $36.95 for adults; $14.95 for children 12 and younger; noon to 6 p.m.

Maine Maid Inn, 4 Old Jericho Tpke., Jericho, 516-935-6400. Three-course Thanksgiving dinner, $42 for adults; children younger than 10 can get downsized adult dinner at $20 or special kids’ menu at $15; 11 a.m. to 8 p.m.

Polo Restaurant, The Garden City Hotel, 45 Seventh St., Garden City, 516-877-9353. Fixed-price four-course menu, $75 for adults, half-price for children younger than 12. Three seatings: 11:30 a.m., 2:30 and 5:30 p.m.

Ruth’s Chris Steak House, 600 Old Country Rd., Garden City, 516-222-0220. Three-course dinner, $39.95 for adults, $19.95 for children younger than 10; regular menu also available; 2 to 8 p.m.

Suffolk County

Elk Street Grille, 201 Main St., Port Jefferson; 631-331-0960. Fixed-price $39.95 menu; children 12 and younger can have smaller adult dinner at $19.95 or special kids’ menu at $15.95; 1 to 7 p.m.

The Gatsby, 712 Main St., Islip, 631-581-1900. Three-course fixed-price dinner, $39.95 a person; noon to 7 p.m.

Jedediah’s, 400 S. Jamesport Ave., Jamesport; 631-722-2900. Fixed-price three-course menu with multiple choices, $65; 1, 3, 5 and 7 p.m.

Jonathan’s Ristorante, 15 Wall St., Huntington, 631-549-0055. A la carte menu with some traditional Thanksgiving specials; 4 to 9 p.m.

Panama Hatties, 872 E. Jericho Tpke., Huntington Station, 631-351-1727. Three-course dinner, $59 a person ($29 for children 10 and younger). Private rooms available for parties of 18 or more. 2 to 7 p.m.

Stonebridge Country Club, 2000 Raynors Way, Smithtown, 631-724-1600. Thanksgiving buffet at $38.95 for adults ($20 for children ages 3 to 12). One seating, 2:30 p.m.

Three Village Inn, 150 Main St., Stony Brook; 631-751-0555. Fixed-price menu, $47 for adults and half-price for children younger than 10; also special $15 children’s menu. Seatings at noon, 3 and 6 p.m.

Thanksgiving at home — with help

Caterer Alexandra Troy of Culinary Architect Catering, 28 Chestnut St., Greenvale, will hold two preholiday classes. The first, which runs tonight from 7:30 to 9, deals with creating a make-ahead holiday buffet party. The second, on Friday night, will cover hors d’oeuvres and drinks for festive holiday gatherings. The cost of each class is $35 (an additional $5 for those who are not Manhasset residents). For more information, or to register, call Scope Education Services, 631-881-9625.

Ready, Set, Cook, 244E Glen Cove Ave., Glen Cove, is a service offering the option of ordering Thanksgiving side dishes that are ready for stove-top or oven. Choose from a roster that includes old-fashioned bread stuffing, fresh cranberry relish, sweet-potato casserole, Brussels sprouts with bacon-lemon dressing, creamy corn pudding and roasted acorn squash with shallots and rosemary. Place your order by Friday, Nov. 16 and pick it up Tuesday or Wednesday, Nov. 20 and 21. For information, or to order, call 516-584-2079 or visit rscli.com.

—–

To see more of Newsday, or to subscribe to the newspaper, go to http://www.newsday.com

Copyright (c) 2007, Newsday, Melville, N.Y.

Distributed by McClatchy-Tribune Information Services.

For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

NASDAQ-NMS:RUTH,

IRVINE, Calif., Nov. 7 /PRNewswire-FirstCall/ — Endocare, Inc. , an innovative medical device company focused on the development of minimally invasive technologies for tissue and tumor ablation, announced that the Centers for Medicare and Medicaid Services (CMS) have accepted the recommendation received from the American Medical Association’s (AMA) Specialty Society Relative Value Update Committee (RUC) and created a clinical reimbursement code and rate for percutaneous renal cryoablation. The new rate will go into effect January 1, 2008.

The new code is CPT 50593 which will be paid an adjusted average in the $440 range and is the first time there is a specific code and reimbursement rate for this procedure. Percutaneous renal cryoablation is a minimally invasive procedure that allows physicians to destroy small tumors in the kidney by inserting a probe directly through the skin and freezing the cancerous tissue.

Endocare Chairman, CEO and President Craig T. Davenport said: “This represents a significant milestone for Endocare and for cryoablation as a cancer therapy. Recent data showing the safety and effectiveness of renal cryoablation have made a positive impression on the American Medical Association Committee that establishes clinical CPT codes. The new renal cryoablation reimbursement rate, paid at a higher rate than other percutaneous ablation modalities, provides patients and their physicians with a powerful new option when choosing a therapy to treat a dangerous disease.”

About Endocare

Endocare, Inc. — http://www.endocare.com/ — is an innovative medical device company providing minimally invasive technologies for tissue and tumor ablation. Endocare has initially concentrated on developing technologies for the treatment of prostate cancer and believes that its proprietary technologies have broad applications across a number of markets, including the ablation of tumors in the kidney, lung and liver and palliative intervention (treatment of pain associated with metastases).

Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties, including, without limitation, the effects of the new CPT code described above. Among the important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, those discussed in “Risk Factors” in the Company’s Forms 10-K, Forms 10-Q and other filings with the Securities and Exchange Commission. Such risk factors include, but are not limited to, the following items: the Company may incur significant expenses in the future as a result of the Company’s obligation to pay legal fees for and otherwise indemnify former officers and former directors in connection with the ongoing investigation and legal proceedings involving them; the Company has a limited operating history with significant losses and losses may continue in the future; the Company may require additional financing to sustain its operations and without it the Company may not be able to continue operations; the sale of the Company’s common stock to Fusion Capital may cause dilution, and the sale of the shares of common stock acquired by Fusion Capital or Frazier Healthcare Ventures could cause the price of the Company’s common stock to decline; the Company’s business may be materially and adversely impacted by the loss of the Company’s largest customer or the reduction, delay or cancellation of orders from this customer or if this customer delays payment or fails to make payment; the Company may be required to make state and local tax payments that exceed the Company’s settlement estimates; uncertainty relating to third party reimbursement; uncertainty regarding the ability to convince health care professionals and third party payers of the medical and economic benefits of the Company’s products; the risk that intense competition and rapid technological and industry change may make it more difficult for the Company to achieve significant market penetration; and uncertainty regarding the ability to secure and protect intellectual property rights relating to the Company’s technology. The actual results that the Company achieves may differ materially from any forward-looking statements due to such risks and uncertainties. The Company undertakes no obligation to revise, or update publicly, any forward- looking statements for any reason.

   Investor Contact:      Media Contact:         For Additional Information:   Matt Clawson           Len Hall               Craig T. Davenport, CEO   Allen & Caron, Inc.    Allen & Caron, Inc.    Michael R. Rodriguez, CFO   (949) 474-4300         (949) 474-4300         Endocare, Inc.   [email protected]    [email protected]     (949) 450-5400  

Endocare, Inc.

CONTACT: Investors, Matt Clawson, +1-949-474-4300, [email protected],or Media, Len Hall, +1-949-474-4300, [email protected], both of Allen &Caron, Inc.; or Craig T. Davenport, CEO, or Michael R. Rodriguez, CFO, both ofEndocare, Inc., +1-949-450-5400

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

BIO-Europe 2007 takes place November 12-14, 2007 at the Congress Center Hamburg. Listed below are BIO-Europe exhibitor profiles. For in-depth information about the event, visit http://www.ebdgroup.com/bioeurope/.

Business Wire is the official news wire for BIO-Europe 2007. Breaking news releases and photos are available at http://www.tradeshownews.com, Business Wire’s trade show, conference, and event news resource.

Company:

AAIPharma

Stand:

53

Media Contact:

Dr. John M. Hall

Phone:

44 7802 207 307

E-mail:

[email protected]

Web:

www.aaipharma.com

 

AAIPharma’s scientific and professional teams have provided best-in-class product development expertise since 1979. Our business is founded on partnership and delivery of value. We deliver services ranging from a single test to integrated drug development: consulting, preclinical (oncology), pharmaceutical sciences (CMC), clinical trial supplies manufacturing and distribution and Ph I-IV international clinical development. We focus on medical and clinical relevance from well-founded First-in-Man and Proof of Concept packages through delivery of cost and time effective dose-defining and pivotal trials, to post-registration support. These services are integrated through international regulatory affairs and project management and supported by state-of-the-art data systems.

 

 

 

Company:

Acambis plc

Ticker Symbol & Exchange:

ACM, London Stock Exchange

Media Contact:

Lyndsay Wright

Phone:

44 01223 275 300

E-mail:

[email protected]

Web:

www.acambis.com

 

Acambis is a leading vaccine company developing novel vaccines, based in Cambridge, UK and Cambridge, Massachusetts, US. ChimeriVax platform vaccine candidates include: ChimeriVax-JE (partnered with sanofi pasteur and Bharat Biotech, excellent safety and efficacy profile shown in Phase 3), ChimeriVax-West Nile (in Phase 2), and ChimeriVax-Dengue, sanofi pasteur’s tetravalent dengue vaccine (100% seroconversion to four dengue virus serotypes demonstrated in Phase 2). Acambis has the only vaccine in development against Clostridium difficile bacteria. Influenza programme targets a universal vaccine, for which a universal ‘A’ strain vaccine is in Phase 1. The US FDA licensed ACAM2000 smallpox vaccine in August 2007.

 

 

 

Company:

Adhesives Research

Media Contact:

Andrea Jackson

Phone:

717-227-3309

E-mail:

[email protected]

Web:

www.adhesivesresearch.com

 

Adhesives Research (AR) is a leading developer and manufacturer of custom adhesives, dissolvable films and laminates for the pharmaceutical and medical markets. We offer formulation, process development and analytical support for the development of components for transdermal and oral/mucosal delivery systems. Adhesives Research has developed custom-coated technology to create unique dissolvable films and custom adhesive systems for the delivery of functional ingredients found in pharmaceutical prescription and over-the-counter (OTC) products. We have the ability to manufacture clinical and commercial quantities in our cGMP compliant facilities located in Glen Rock, Pa and Limerick, Ireland.

 

 

Company:

Akruti Nirman Limited

Ticker Symbol & Exchange:

AKRUTI & BSE

Media Contact:

Mr. Ajay M. Pawar

Phone:

91-22-67037515

E-mail:

[email protected]

Web:

www.akrutiestate.com

 

Akruti Nirman Limited is a leading player in the Real Estate Sector in India, involved in the creation of various sector specific infrastructure such as IT Parks, BT Parks, Commercial and Residential properties. It is presently involved in the development of India’s largest BT Park in Gujarat with an aim to provide the impetus for a Biotech led Socio-Economic revolution in the State of Gujarat, by giving access to the most modern technologies & infrastructure, which ultimately fosters entrepreneurship, innovation and growth. The Park comprises Built to suit plots ( plug & play ), Loaded wet labs, Bioincubation centre, Animal House, pilot plant facility, microbiological labs, tissue culture labs, green house, logistic centre etc and also will house a residential/commercial township with modern amenities.

 

 

 

Company:

Almac Group Ltd

Stand:

42

Media Contact:

Stakeholder Communications

Phone:

44(0)28 3833 2200

E-mail:

[email protected]

Web:

www.almacgroup.com

 

Almac employs over 2,000 people throughout our extensive facilities in Europe and North America. Our integrated development services range from: Comprehensive genomic and bioinformatics services; Cancer genomics contract research; Route design & synthesis of APIs (including potent, peptide and chiral compounds); Synthesis and formulation of labelled compounds (pre-clinical and clinical) Formulation development; Manufacturing/blinding, packaging, randomized labelling and distribution of clinical supplies; Clinical trial technology solutions based on IVRS, Web and EDC; Commercial scale manufacture and distribution; Comprehensive analytical services; EU import testing and QP release for clinical and commercial product.

 

 

Company:

alphaGEN Co., Ltd.

Media Contact:

Iwao Nozawa, Ph.D.

Phone:

81 3-3518-2838

E-mail:

[email protected]

Web:

http://www.alphagen.jp/e-index.html

 

alphaGEN is a biopharmaceutical company which is focusing its R&D activities on siRNA drug for the treatment of ischemic diseases (such as PAD) and cancers. It has developed DNA/RNA chimeric double-stranded oligonucleotides (siChimera™), which has enhanced stability, minimized off-target effects and immunostimulatory innate immune reactions without sacrifice of gene silencing efficiency. Its lead ALG-00412 is a siRNA targeting Int6 mRNA to induce HIF-2alpha-dependent angiogenesis for the treatment of a variety of ischemic diseases. It has been shown that ALG-00412 can be administered intramuscularly without carrier systems to generate arterioles and improve walking disability in intermittent claudication-like rat model.

 

 

Company:

Alston & Bird

Media Contact:

Philippe Bennett

Phone:

001-212-210-9559

E-mail:

[email protected]

Web:

www.alston.com

 

Philippe’s practice over the past twenty-five years has focused on litigation and licensing of intellectual property rights, trade secret and employee non-compete litigation, technology transfer transactions, and the negotiation of patent and trademark contracts and agreements. He has been trial counsel before various federal and state courts, and the International Trade Commission in a diverse range of cases involving pharmaceutical chemistry, classical chemistry, drug delivery systems, medical imaging and injector devices, cardiac pacemakers, and in biotechnology. Philippe has also developed in-house patent programs and contributed to the development of corporate IP strategies, and has been involved in numerous international mergers and acquisitions and directed extensive due diligence projects, and IP portfolio valuations.

 

 

 

Company:

Ambrilia Biopharma Inc.

Ticker Symbol & Exchange:

TSX:AMB

Media Contact:

Julie M. Thibodeau

Phone:

(514) 751-2003

E-mail:

[email protected]

Web:

www.ambrilia.com

 

Ambrilia Biopharma Inc. (TSX:AMB) is a biopharmaceutical company dedicated to the discovery and development of novel treatments for viral diseases and cancer. Ambrilia’s product portfolio includes an HIV protease inhibitor program (with lead compound PPL-100), an HIV integrase inhibitor program, two new formulations of existing peptides (Octreotide and Goserelin), other tumor targeted peptides such as PCK3145 and the Tumor and tumor Vasculature Targeting (TVT) technology platform, as well as other anti-viral programs. Exclusive worldwide rights to PPL-100 and its related compounds have been granted to Merck & Co., Inc. in return for milestone payments and royalties. Ambrilia’s head office, research and development and manufacturing facilities are located in Montreal with a regional office in France.

 

 

Company:

Aquapharm Biodiscovery

Stand:

SDI

Media Contact:

Dr. Jason Cleaversmith

Phone:

44 1631 559391

E-mail:

[email protected]

Web:

www.aquapharm.co.uk

 

Aquapharm Biodiscovery is the UK’s premier marine biotechnology company, pioneering the discovery and development of novel bioactives & innovative production systems from marine microbes. The company has a substantial collection of unique marine bacteria and fungi (> 6,500) isolated from diverse and extreme environmental habitats. Through the use of proprietary technology, Aquapharm derives and develops new biologically active natural products from this collection, which have commercial applications in the nutraceutical, cosmeceutical and pharmaceutical sectors. Aquapharm focuses on the development of anti-infectives, anti-inflammatories, natural carotenoids and anti-oxidants through innovative fermentation based technology.

 

 

 

Company:

aRigen Pharmaceuticals, Inc.

Media Contact:

Dr. Kyaw Min Oo

Phone:

81-3-5771-4532

E-mail:

[email protected]

Web:

www.arigen.jp

 

aRigen Pharmaceuticals, Inc. is a leading Japanese drug discovery and development company working on NMEs for infectious diseases. With a vision of “Discovered in Japan for Global Health” we discover pharmaceutical compounds in Japan in co-operation with leading Japanese life scientists, and develop them into novel drugs for the global population. aRigen is the only biomedical venture in Japan advancing toward a specialty pharmaceutical company with a strong focus on infectious diseases. aRigen has currently 6 NMEs in clinical and clinical-ready stages.

 

 

Company:

Assign Group

Stand:

52

Media Contact:

Klaus Fischer, PhD

Phone:

43-1-403 3805-18

E-mail:

[email protected]

Web:

http://www.assigngroup.com

 

As a mid-sized European CRO we offer the full range of services in the development and conduct of clinical trials across the whole of Central, Eastern & Western Europe (clinical research, data management, biostatistics, medical writing and study drug management incl. QP release). Through our offices in Berlin, Vienna, Gliwice and Budapest, our multi-national professionals deliver highest quality in accordance with ICH-GCP, local, national and international legislation. Our customer-focus, reliability and responsiveness have led to stable and continuous growth over the past years. The Assign Group stands for tailor-made solutions in clinical research.

 

 

 

Company:

BAC BV

Media Contact:

Kathryn Robertson

Phone:

01260 296 506

E-mail:

[email protected]

Web:

www.bac.nl

 

Based in The Netherlands, BAC BV offers products and services for the affinity purification of biological materials from complex media. The Company’s proprietary CaptureSelect® affinity ligands have been proven in a wide range of biological applications, including Life Science Research and Biomanufacturing. The CaptureSelect® technology, based on single chain antibody fragments, enables the design of ligands for almost any target, with high specificity, affinity and stability. The ligands are produced through an efficient animal-free Saccharomyces cerevisiae-based process. The unique properties of the products provide competitive benefits to their users in terms of reduced cost of purification, higher quality product, and increased flexibility in the purification process.

 

 

Company:

Bayer Schering Pharma AG

Stand:

59

Media Contact:

Oliver Renner

Phone:

49 172 328 3112

E-mail:

[email protected]

Web:

www.bayerscheringpharma.de

 

Bayer Schering Pharma AG is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women’s Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. The company employs more than 40,000 people and markets its products in over 100 countries. Pro forma sales in 2006 totaled EUR 10 billion. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.

 

 

Company:

BIOALVO, SA

Media Contact:

Luis Amado

Phone:

3.51218E+11

E-mail:

[email protected]

Web:

www.bioalvo.com

 

BIOALVO is the first Portuguese biotech company working on early stages of drug discovery. BIOALVO designs and develops innovative drug development programmes that generate potent and efficient drugs aimed at CNS and neurodegenerative disorders. Using its proprietary and flexible HTS systems, based on engineered living yeast cells with a human target, BIOALVO can accelerate and increase the efficiency of drug discovery in a cost competitive way (savings more than 60% of costs up to the pre-lead stage, when compared to lower values in specialized publications) generating potent drug candidates (narrowing of the hit list of potential drugs to 20% of those identified by common platforms) for its pipeline and for its partners.

 

 

Company:

Bio-Link Australia Pty. Ltd.

Media Contact:

Paul Field, CEO, Bio-Link

Phone:

61.2.9209.4397

E-mail:

[email protected]

Web:

www.bio-link.com.au

 

Bio-Link is a business development company based in Australia but working globally to support the commercialization of therapeutics and diagnostics. Clients are invited to select from a range of service modules including technology assessment; project management; identification and engagement of partners, benchmarking and full negotiation of deals. The Bio-Link portfolio of opportunities includes small molecule and peptide drug candidates, genetic and protein biomarkers and other technologies. Bio-Link has a valuable mix of technical and commercial skills developed at companies and institutions where members of the team have been previously employed in the USA, Europe and Australia, including Schering Plough, Novartis, Cytopia, Cellabs, Exlixis, Ascenion and other organizations.

 

 

Company:

BioMarck Pharmaceuticals, Ltd.

Media Contact:

Scott Yates

Phone:

919-459-6452

E-mail:

[email protected]

Web:

www.biomarck.com

 

BioMarck Pharmaceuticals, Ltd. is a private biopharmaceutical company dedicated to the discovery and development of new drugs for the treatment of pulmonary diseases and disorders associated with the over-secretion of mucus and pulmonary inflammation in patients with chronic obstructive pulmonary disease (COPD), asthma, chronic rhinitis and cystic fibrosis. The company is developing a first-in-class drug specifically targeting the over-secretion process. The new product is based on scientific concepts developed by Dr. Kenneth Adler, Professor of Cell Biology at North Carolina State University and a recipient of The American Thoracic Society’s Scientific Achievement Award. For more information, please visit www.biomarck.com

 

 

Company:

BIOPHARM GmbH

Media Contact:

Dr. B. Merz

Phone:

49 173 6683396

E-mail:

[email protected]

Web:

www.biopharm.de

 

BIOPHARM GmbH operates internationally, offering licenses and co-development opportunities to our partners for more than 20 years. Our proprietary human growth and differentiation factor rhGDF-5 shows very promising results in treating orthopaedic defects, rebuilding blood vessels and repair nerve lesions. Currently we develop an innovative cosmetic product against skin-aging. Furthermore we provide services to our customers: The analysis of classical and recombinant active substances and drugs and the implementation or development of various cell culture projects. We offer to our customers efficient job processing, professionalism, punctuality and the suitable infrastructure.

 

 

Company:

BioQuanta

Media Contact:

Jean-Michel Mauclaire

Phone:

336 1316 7415

E-mail:

[email protected]

Web:

www.bioquanta.net

 

BioQuanta offers biopharmaceutical companies expert molecular modelling capabilities for design, validation and optimization of compounds and screened molecule libraries. Partnering with hospital laboratories, we offer a comprehensive approach combining in-silico and NMR with in-vitro and in-vivo experimental data generation. Our gold standard service relies on standardized quantum chemistry, molecular dynamics protocols and proprietary software tools that enable rationalization of highly reliable structure-activity prediction for proteins and receptors, target identification for a given effect, lead optimization and toxicity prediction. The fast delivery of reliable data on a drug and its interaction mechanisms with its target saves time and resources while reducing risks of failure during clinical development. Such data is required to regulatory approval for new drug application filing

 

 

Company:

BioSciences Research Institute, India.

Phone:

91 98410 84810

E-mail:

[email protected]

Web:

www.bri.in

 

BioSciences Research Institute (BRI) has been setup as a premier Institute for conducting Research and Advanced Training, in the field of BioSciences. The institute has been promoted as a Not-for-Profit organization for promoting the growth of BioSciences in India. The aim and vision of the institute is to provide a platform for individuals, professionals, R&D Organizations, Pharmaceutical & Software companies to utilize and harness the Indian biotechnology Potential. BRI is engaged in Bioinformatics Training, Research and Development, Offshore R&D Support and Bio utilities simulation and development. Our R&D Team specializes in improving and inventing techniques, methodologies and environments for research in Biotechnology.

 

 

 

Company:

CAS

Phone:

614-447-3600

E-mail:

[email protected]

Web:

www.cas.org

 

CAS produces the world’s largest databases for chemistry and related sciences. About 40% of CAS’s content is biological. The CAS Registry, the world’s largest substance database, contains records not only for organic and inorganic chemicals but also sequences from literature, patents, and Genbank. CAS produces Chemical AbstractsT, a family of databases available through the STN® network, the SciFinder® desktop research tool for scientists, SciFinder ScholarT for students, and STN AnaVistT for analysis and visualization, among other electronic search services. CAS records provide links to full-text articles and patents. In addition, CAS’ ScienceIP® staff are available to provide expert searching.

 

 

Company:

Cellectricon

Media Contact:

Susanne Fagerlund

Phone:

46 31 760 35 15

E-mail:

[email protected]

Web:

www.cellectricon.com

 

Cellectricon is a key innovator and solutions provider of advanced cell-based screening products to accelerate biotechnology and drug discovery. Cellectricon’s cell-based screening solutions and product pipeline are aimed at critical bottlenecks in the drug discovery where today’s products are inadequate. The company’s launched products has received outstanding market acceptance including 9 of the 10 largest pharmaceutical companies. At Bio-Europe Cellectricon will present their cutting-edge screening systems that will transform drug discovery:

–Cellaxess-HT — The world’s first high throughput RNAi screening system

–Dynaflow-HT — Next generation high throughput APC system for ion channel screening

 

 

Company:

Cellerix S.L.

Media Contact:

Maria Pascual

Phone:

34918049264

E-mail:

[email protected]

Web:

www.cellerix.com

 

Cellerix is a clinical biopharmaceutical company that develops and produces innovative medicines based on the use of adult stem cells. It currently has two products undergoing clinical trials: Cx401 for the treatment of perianal fistulas (Phase III) and Cx501, for skin regeneration (Phase II). Cx401 and Cx501 are the two first cellular products to obtain orphan status by EMEA. The new generation of Cellerix products is based in the employment of allogeneic stem cells and is represented by Cx601 and Cx611, currently undergoing preclinical development for the treatment of fistulas and different alterations of the immune system. On August 6th, Cellerix announced the closing of a series B round, led by LSP, Ventech and YSIOS with co-investment by Novartis and Roche Venture Funds. On October 2nd, Cellerix also announced that it has outlicensed North American rights to Cx401 to Axcan Pharma.

 

 

Company:

ChemCon GmbH

Media Contact:

[email protected]

Phone:

49 (0) 761 5597 440

E-mail:

[email protected]

Web:

www.chemcon.com

 

ChemCon is specialized in contract research and custom synthesis in the field of small molecular organic and inorganic chemistry. Our core competence is the development of synthetic routes and small scale manufacturing (mg to multi kg) of fine chemicals and Active Pharmaceutical Ingredients (APIs) from pre-clinical and all clinical phases to commercial material. We are equipped with excellent R&D- and production laboratories, FDA inspected clean-room facilities, and microbiological / chemical analytics. ChemCon is your expert partner for process transfer from R&D to cGMP compliant commercial production (with full GMP-documentation and Drug Master Files Type II).

 

 

Company:

CLEAN CELLS

Stand:

Hall H, Booth 86

Media Contact:

Rolf CUYPERS

Phone:

33 2 51 09 27 57

E-mail:

[email protected]

Web:

www.clean-cells.fr

 

Clean Cells is a French CRO offering a comprehensive biosafety testing program of in vitro and in vivo services supporting the process development of bioproducts (recombinant proteins, monoclonal antibodies, vaccines, cell and gene therapy products…) from initial R&D stages through clinical trials. Clean Cells has at its disposal over 4300 square feet of laboratory space in full compliance with American and European Pharmacopeia regulatory specifications at biosafety level II and III. This state of the art facility is designed to meet all requirements for biosafety controls (mycoplasma, sterility, viruses, residual DNA, endotoxins…) and cell characterization (isoenzymes, DNA finger printing, karyology…) Clean Cells differs from its larger competitors in its ability to offer very personalized services to its customers with a fast response time at a competitive cost.

 

 

 

Company:

Cobra Biomanufacturing Plc

Ticker Symbol & Exchange:

CBF

Media Contact:

Philip Ridley-Smith

Phone:

44 (0)1782 877298

E-mail:

[email protected]

Web:

www.cobrabio.com

 

Cobra Biomanufacturing is a company focused on a solution-led approach to biomanufacturing for the production of biopharmaceuticals, including recombinant proteins, protein conjugation, virus and plasmid DNA products up to Phase III. The company provides world-class process development solutions, cGMP contract manufacturing and a high level of analytical capabilities for the development of products from pre-clinical evaluation through to clinical trial manufacture. Cobra has an international base with major accounts in Europe, the U.S., Africa and Australasia. Our mission is to work in partnership with our customers to accelerate the clinical development of their products and to add significant value to their business.

 

 

 

Company:

CytRx Corporation

Ticker Symbol & Exchange:

Nasdaq: CYTR

Media Contact:

David Haen

Phone:

(310) 826-5648 ext. 304

E-mail:

[email protected]

Web:

www.CytRx.com

 

CytRx Corporation is engaged in the development of human therapeutics based on its small molecule “molecular chaperone” amplification technology and RNAi therapeutics. The Company plans to start a Phase IIb trial in ALS with Arimoclomol, its lead small molecule candidate, by year end 2007. CytRx expects to start Phase II trials with Arimoclomol for stroke recovery and Iroxanadine for diabetic foot ulcers in the first half of 2008, subject to FDA clearance. CytRx intends to issue a dividend of shares of RXi Pharmaceuticals, its majority owned RNAi therapeutics subsidiary, and expects RXi will trade as a separate listed company.

 

 

Company:

DSM Biologics

Media Contact:

Kevin Lesnewski

Phone:

973-257-8011

E-mail:

[email protected]

Web:

www.dsmpharmaceuticals.com

 

DSM Biologics, a business unit of DSM Pharmaceutical Products, is a global provider of manufacturing technologies & services to the biopharmaceutical industry. Along with manufacturing services, DSM offers license and process development services utilizing PER.C6® human cell line as a production platform for recombinant proteins and monoclonal antibodies. The PER.C6® Technology Platform used in combination with DSM’s XD™ process can achieve yields in excess of 10 g/l. This expertise provides biopharmaceutical companies pipelines with a turn-key biologic manufacturing solution, reducing cost, risk and drastically shorting time to first-in-man clinical trials. Contact DSM Biologics and see why more companies are licensing The PER.C6® human cell line than ever before.

 

 

Company:

Dynogen Pharmaceuticals, Inc.

Media Contact:

Heather Savelle, Manager, Corporate Comm

Phone:

781.839.5149

E-mail:

[email protected]

Web:

www.dynogen.com

 

Dynogen is a clinical stage company developing a portfolio of treatments for gastrointestinal and genitourinary disorders. The Company is focused on large and untapped markets in disease areas that severely impair a patient’s quality of life, such as irritable bowel syndrome, gastroesophageal reflux disease and overactive bladder. The Company leverages its development expertise to identify promising clinical compounds and rapidly advance them towards registration.

 

 

Company:

Eden Biodesign

Media Contact:

Sylvie Berrebi (De Facto Communications)

Phone:

44 20 7861 3838

E-mail:

[email protected]

Web:

http://www.edenbiodesign.com/

 

Eden Biodesign is a world leader in the provision of biopharmaceutical development and manufacturing expertise and now operates the new world class UK National Biomanufacturing Centre. The combination of the advanced facility and the expertise found in its people, mean Eden Biodesign has the scope and the capacity to handle over 95% of the products and processes found within the biopharmaceutical pipeline.

–Recombinant protein therapies (antibodies and fragments)

–Natural proteins

–Gene therapies

–Cell therapies

–Vaccines (VLP, Cancer vaccines, whole cell vaccines)

–Tissue engineering

 

 

Company:

Eurogentec SA – Biologics Division

Media Contact:

Philippe Cronet, Business Unit Director

Phone:

32 4 366 6111

E-mail:

[email protected]

Web:

http://biologics.eurogentec.com

 

Antibiotic free GMP plasmid DNA manufacturing.

Eurogentec has been selected by Delphi Genetics as the exclusive CMO for its antibiotic free StabyTM technology. Delphi’s technology responds to the FDA’s and EMEA’s strong recommendations to move towards systems that are completely free from antibiotic resistance genes. The combination of Delphi’s technology and Eurogentec’s GMP biologics manufacturing experience will offer those developing plasmid DNA based drugs the latest in plasmid manufacturing technology. Eurogentec SA, based in Seraing, Belgium, offers services to the research, diagnostic and therapeutic markets. http://www.eurogentec.com. Delphi Genetics, based in Gosselies, Belgium, offers patented technology for DNA engineering and protein production. http://www.delphigenetics.com

 

 

 

Company:

European Patent Office

Stand:

77

Media Contact:

Mr. Rainer Osterwalder

Phone:

49 2399 1820

E-mail:

[email protected]

Web:

www.epo.org

 

The European Patent Office (EPO) is an international authority set up on the basis of the European Patent Convention to grant European patents using a unitary and centralized procedure. A single patent application in any of the three official languages – English, French or German – can provide patent protection in 32 states. The European patent system also offers a high level of legal certainty, as European patents are only granted following an in-depth examination and a comprehensive novelty search based on a collection of over 60 million documents.

 

 

 

Company:

FHR Consult

Media Contact:

Dr. Fritz Rudert

Phone:

49-8106-995161

E-mail:

[email protected]

Web:

www.fhrconsult.com

 

FHR Consult offers a diversified range of expert and hands-on consulting support in the areas of partnering, licensing, strategy, management, financing and competitive intelligence. We identify the most promising opportunities, help you with due diligence and commercial terms and actively support your negotiations to closing the deal. A particular focus is applied to all aspects of research, development and commercialization of biologics, like antibodies, and other targeted medicines. With our international network of partners and experts we give you the broad coverage, quality advice and tangible support for risk-balanced, fast decision making in complex corporate processes.

 

 

 

Company:

Foley & Lardner LLP

Stand:

76

Media Contact:

Richard C. Peet

Phone:

202.672.5483

E-mail:

[email protected]

Web:

www.foley.com

 

The Life Sciences Industry Team of Foley & Lardner LLP brings together experienced attorneys with knowledge of intellectual property (IP), venture capital, securities, tax, corporate and regulatory affairs, health care, antitrust, and international trade issues affecting all areas of biotechnology, pharmaceutical development, chemical, medical devices, and medicine. Our attorneys draw on the full resources of the firm’s 19 offices across the United States, in Europe and Asia, assisting with all stages of a life-sciences business, from company formation and IP asset building to accessing capital and achieving commercial success. For more information, please visit our Web site at Foley.com.

 

 

Company:

Genzyme Pharmaceuticals

Ticker Symbol & Exchange:

GENZ

Media Contact:

Matthew Roe

Phone:

44 144 071 6204

E-mail:

[email protected]

Web:

www.genzymepharmaceuticals.com

 

Genzyme Pharmaceuticals, a division of Genzyme Corporation, provides an integrated resource of custom manufacturing, value-added technologies, and strategic relationships focused in the lipid, peptide, amino acid derivative, and drug delivery markets. Genzyme Pharmaceuticals and Pharmidex have formed a collaboration of science and skill to develop CerenseSM, a unique integrated solution to release the value of your CNS portfolio by unlocking the blood-brain barrier and measuring brain penetration. This is achieved through the combination of Genzyme Pharmaceuticals’ patented CNS drug delivery technology and the unique expertise of Pharmidex to determine neuro-pharmacokinetics. Visit www.cerense.com to learn more.

 

 

 

Company:

Hana Biosciences

Ticker Symbol & Exchange:

HNAB, NASDAQ

Media Contact:

Remy Bernarda

Phone:

650-228-2769

E-mail:

[email protected]

Web:

www.hanabiosciences.com

 

Hana Biosciences is a development stage biopharmaceutical company engaged in the acquisition, development, and commercialization of products to strengthen the foundation of cancer care. The company has an oncology pipeline that includes four cancer therapeutics and one supportive care product candidate. The company’s therapeutic products include three compounds that utilize their OPTISOME™ Nanoparticle Technology: Marqibo® (vincristine), Alocrest™ (vinorelbine) and Brakiva™ (topotecan). Marqibo is currently in a registration study in adult relapsed acute lymphoblastic leukemia, the rALLy study. Hana’s supportive care product is Menadione for the treatment of skin rash associated with the use of epidermal growth factor receptor (EGFR) inhibitors.

 

 

Company:

HungaroTrial CRO

Stand:

4

Media Contact:

Dr. Lajos Sárosi

Phone:

36-1-203-21-34

E-mail:

[email protected]

Web:

www.hungarotrial.hu

 

HungaroTrial Contract Research Organization’s declared goal is to join the human research programs of Pharmaceutical companies and Biotech companies by organizing and managing clinical operations in Central and Eastern Europe. We are conducting Phase I-IV clinical trials, medical device studies.

Services:

–Feasibility Analysis

–Site Selection

–Regulatory and EC Affairs

–Hospital and Investigator Grant Consulting and Negotiation

–Monitoring

–Data management and Statistics

–QA Site Audit

To learn more about our activities, please visit our web site: www.hungarotrial.hu. Or send your questions or requests to [email protected].

 

 

Company:

InterMed Discovery

Media Contact:

Erik H. Metz

Phone:

49 231 9742 6072

E-mail:

[email protected]

Web:

http://www.intermed-discovery.com/

 

InterMed Discovery, a MBO from BAYER HealthCare, is an independent company dedicated to the discovery and development based on Natural Products and endeavors to become the premiere company in discovering innovative lead compounds based on or derived from natural sources. We offer the broadest collection of genetic source material, a unique technology platform and comprehensive databases around chemical and biological data. InterMed Discovery provides products for therapeutic applications in the pharmaceutical industry, for the food industry and other life science areas. While focusing on developing our own discovery project portfolio for the food and pharmaceutical industry, we also offer excellent Natural Product research and discovery services.

 

 

 

Company:

Intertek ASG

Media Contact:

Dr. Nick Crabb

Phone:

44 (0)161 721 1051

E-mail:

[email protected]

Web:

www.intertekasg.com

 

Intertek ASG is a specialist CRO providing a broad range of advanced analytical and characterization services to pharmaceutical and biopharmaceutical clients. Services include method development, validation, and batch release analysis (e.g. for product and process related impurities) and regulatory characterization work (e.g. proof of structure, impurity characterization, detailed biopharmaceutical comparability studies, biopharmaceutical aggregation studies etc). Intertek ASG has experience across a diverse range of products including small molecule therapeutics, oligonucleotides, peptides, recombinant proteins, antibodies, vaccines and viral vectors. The laboratory has been inspected to GLP and GMP by the UK MHRA and to GMP by the US FDA.

 

 

Company:

IP Bewertungs AG (IPB)

Stand:

CCH Hall/Booth no:32

Media Contact:

Juliane Ostler

Phone:

49 40 8787 90-00

E-mail:

[email protected]

Web:

www.ipb-ag.com

 

IP Bewertungs AG (IPB) is one of Europe’s leading consulting firms for intellectual property services such as patent evaluation, patent monetisation and patent management. On this year’s Bio-Europe IPB presents various innovationsa, eg. a comprehensive system for the production of active ingredients such as for pharmaceutical products and technical enzymes, where the whole intact bacteria cell is utilized (whole cell catalyst) and a biotechnological basic technology for the production of pharmacological relevant active substances.

aThe patents are the property of ZYRUS Beteiligungsgesellschaft mbH & Co. Patente I KG.

 

 

Company:

Italian Institute for Foreign Trade

Stand:

60

Media Contact:

Francesca Mondello

Phone:

39 06 5992 6606

E-mail:

[email protected]

Web:

http://www.italtrade.com/countries/europe/germany/

 

The Italian Institute for Foreign Trade – ICE, is the Government Agency that helps Italian SMEs to develop business and export opportunities worldwide. ICE organizes, in collaboration with Assobiotec, the Italian participation at BIO-Europe 2007, within the framework of the Special Project for Biotechnology and Nanotechnology, financed by the Ministry for International Trade. Please come and visit the Italian Pavilion (booth 60) and find out more about the Italian biotechnology sector! If you are interested in meeting our 15 Italian participants (http://www.italtrade.com/bioeurope.htm) don’t hesitate to get in contact with all Italian companies by using the official partnering system.

 

 

 

Company:

Keryx Biopharmaceuticals

Ticker Symbol & Exchange:

KERX

Media Contact:

Lauren Fischer

Phone:

212-531-5965

E-mail:

[email protected]

Web:

www.kery.com

 

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes, diabetes related diseases, cancer and nervous system disorders. Keryx pipeline includes:

–Sulonex, for the treatment of diabetic nephropathy, presently in a pivotal Phase III and Phase IV program.

–Perifosine, an oral anticancer agent that modulates AKT and other key signal transduction pathways in Phase 2.

–Zerenex, an oral, iron-based phosphate binder in Phase II for hyperphosphatemia.

–KRX-0701, for neuropathic conditions, phase II planned for 2008.

–KRX-0501 is an orally available small molecule in phase I with the potential to treat neurological disorders via its ability to enhance nerve growth factor.

 

 

Company:

LAB Research

Stand:

19

Ticker Symbol & Exchange:

LRI

Media Contact:

Cecilia Ponzi

Phone:

(1) 450-973-2240

E-mail:

[email protected]

Web:

www.labresearch.com

 

LAB Research Inc., (LRI) is a leading in-vivo nonclinical contract research organization with facilities in Canada, Hungary and Denmark. We provide contract research services to the pharmaceutical, biotechnology, industrial chemical, agrochemical and medical device industries. LAB Research offers the full range of nonclinical studies necessary for the development of drugs intended for the treatment of human conditions or diseases or required for the certification or registration of products of non-medicament products. From discovery to IND/NDA, LAB Research provides unparalleled research excellence.

 

 

 

Company:

MacroGenics, Inc.

Media Contact:

Sarah Kurz

Phone:

301-251-5172

E-mail:

[email protected]

Web:

www.macrogenics.com

 

Founded in 2000, MacroGenics is a private, venture-backed biotechnology company that focuses on the development, manufacture, and commercialization of immunotherapeutics for autoimmune disorders, cancer, and infectious diseases. With an experienced management team and a spectrum of fully integrated capabilities in monoclonal antibody product development, MacroGenics has developed technology platforms and a diverse product portfolio with several drugs currently in clinical testing, and others to enter clinical trials in the near future.

 

 

Company:

Marinomed Biotechnologie GmbH

Media Contact:

Dr. Eva Prieschl-Grassauer

Phone:

0043/1/25077 4460

E-mail:

[email protected]

Web:

www.marinomed.com

 

Marinomed is specialized in biotechnological research on marine organisms as source for new therapies. The company develops innovative drugs from natural resources for the treatment of diseases that have a high degree of unmet medical need. Marinomed cultivates marine organisms such as stony corals, soft corals, anemones, and sponges in aquaculture and in cell culture. This guarantees the reproducible source for any extraction and allows the induction of substance production in the animals or culture systems. Extracts from the organisms will be subjected to a screening program focussing on the therapeutic field of immunology and infectious diseases.

 

 

Company:

Mayer Brown LLP

Stand:

71

Media Contact:

Dr. Rdiger Herrmann

Phone:

49 69 7941 1421

E-mail:

[email protected]

Web:

www.mayerbrown.com

 

Mayer Brown is among the leading international business law firms, with more than 1,500 lawyers practicing in key business centers in North America, Europe and Asia. We providing comprehensive legal services to companies from the biotech, pharma, medical device and life science industries. Our representation ranges from some of the largest biotech and pharma corporations to start-up biotech, life science and bioinformatics companies. We also represent a significant number of financial investors, including banks, private equity and venture capital companies, as well as credit institutions and investment banks. Please visit our website for comprehensive contact information for all offices.

 

 

Company:

Millipore Corporation

Ticker Symbol & Exchange:

MIL

Media Contact:

Karen Marinella Hall

Phone:

978-715-1567

E-mail:

[email protected]

Web:

www.millipore.com

 

Millipore is a Life Science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. Established in 1954 as a high performance filtration products and services company, Millipore has grown into a partner for Life Science customers through R&D investment, organic growth and acquisitions. Companies acquired include Chemicon, Upstate, Linco, and NovaSeptic AB, allowing Millipore to offer cell biology, life science research, drug target screening and upstream biomanufacturing tools and services. As a result, Millipore is able to provide solutions across the workflow continuum — from research to development to production. Millipore is an S&P 500 company with more than 6,100 employees worldwide and operations in 47 countries.

 

 

Company:

Moberg Derma AB

Media Contact:

Peter Wolpert and Tommy Nilsson

Phone:

46 522 307 00

E-mail:

[email protected]

Web:

www.mobergderma.se

 

Moberg Derma develops a portfolio of late-stage pharmaceuticals for skin diseases based on the Kaprolac® principle. The two lead products are in phase III clinical trials – K101 for Onychomycosis and K301 for Seborrheic Eczema. The first market approval is expected late 2009. The company will market and sell its products in the Nordic markets and in-license additional product rights to complement the portfolio. International commercialization will be through partners and discussions are ongoing with the aim to close a deal during first half of 2008. The company aims for an IPO at OMX Nordic Exchange in Stockholm in 2008/2009.

 

 

 

Company:

Movetis

Media Contact:

Dirk Reyn

Phone:

32 475 96 52 57

E-mail:

[email protected]

Web:

www.movetis.com

 

Movetis NV, based in Turnhout, Belgium, is a specialty pharmaceutical company focused on GI diseases. Movetis has a broad portfolio with four products in clinical development, including its lead product, Resolor® which is in Phase III, and four in preclinical, addressing important areas of unmet medical need, including Chronic Constipation, ascites, paediatric reflux, diabetic gastroparesis, severe dyspepsia and secretory diarrhoea. The current portfolio was licensed from Janssen Pharmaceutica NV, Belgium and Ortho-McNeil Pharmaceutical Inc. In 2006, Movetis secured a 49 million Euros series ‘A’ financing from major European and US investors — one of the biggest series ‘A’ rounds in Europe.

 

 

Company:

MPI Research

Media Contact:

Lisa Lambertsen

Phone:

269.668.3336

E-mail:

[email protected]

Web:

www.mpiresearch.com

 

MPI Research is a full service Contract Research Organization that serves the biotech and the pharmaceutical industries in meeting their preclinical and early clinical drug development research needs, from discovery to regulatory submission. Known for our state-of-the-art facilities, excellent study quality, regulatory experience, AAALAC accreditation, and GLP compliance, we partner with our Sponsors in delivering on time, high quality, innovative and cost-effective solutions. From single study protocols to multiple projects across our broad scope of services, we have the capacity and resources to start you studies promptly so that you can achieve your project milestones. For complete information, visit our website at www.mpiresearch.com.

 

 

Company:

Nereus Pharmaceuticals, Inc.

Media Contact:

Pam Lord, Porter Novelli Life Sciences

Phone:

619-849-6003

E-mail:

[email protected]

Web:

www.nereuspharm.com

 

Nereus Pharmaceuticals pursues novel sources of chemical diversity to discover and develop new therapeutics. Using its unmatched expertise in marine microbiology to identify unique biologically active compounds, the Company has placed two oncology drug candidates in Phase I clinical trials. NPI-2358, a tumor vascular disrupting agent, is being evaluated in patients with solid tumors and lymphomas, and the proteasome inhibitor NPI-0052 is being developed in patients with solid tumors, lymphomas and multiple myeloma. Nereus’s discovery portfolio also includes potential drug candidates for cancer, infectious diseases and inflammation. For more information, visit www.nereuspharm.com.

 

 

Company:

Novozymes A/S

Ticker Symbol & Exchange:

NZYMb; OMX Copenhagen

Media Contact:

David Mead

Phone:

44 115 9553355

E-mail:

[email protected]

Web:

www.novozymes.com

 

Novozymes offers:

–flexible licensing packages for protein expression, albufuse™ and cGMP manufacture of proteins.

–Albufuse™ technology enables genetic fusion of a client’s target protein to albumin at the molecular level: a cost effective, scalable system for the production of fully functional peptides and proteins.

–for out-licensing a variety of antimicrobial peptides active against a number of serious bacterial and fungal infections. The lead compound Plectasin NZ2114 enters clinical phase I in 2008.

–contract manufacturing services to the biopharmaceutical industry, Cell Bank preparation, GMP adaptation and scale-up of bioprocesses and GMP production for clinical trial and commercial products.

 

 

Company:

Oncolytics Biotech Inc.

Ticker Symbol & Exchange:

ONC:TSX, NASDAQ:ONCY

Media Contact:

Cathy Ward

Phone:

403.670.7370

E-mail:

[email protected]

Web:

www.oncolyticsbiotech.com

 

Oncolytics Biotech Inc. was formed in 1998 to develop its proprietary product, REOLYSIN®, as a potential therapeutic for a wide variety of human cancers. Oncolytics has completed six clinical trials with REOLYSIN® in Canada, the U.K. and the U.S. and is currently conducting seven Phase I or Phase II REOLYSIN® trials in the U.K. and the U.S. The current clinical program includes local or systemic delivery of REOLYSIN® as a monotherapy, and local or systemic delivery of REOLYSIN® in combination with radiation or chemotherapy for patients with advanced cancers.

 

 

Company:

Optimata Ltd.

Media Contact:

Guy Malchi, CEO

Phone:

972-3-7519226

E-mail:

[email protected]

Web:

www.optimata.com

 

Optimata Ltd. is a modeling based biopharmaceutical company that develops computerized tools, Virtual Patient engines, for Navigating Drug Development towards better drugs at lower attrition rates. Optimata’s predictive bio-simulation technology enables the identification of discontinued drug candidates and redirecting their path to market. Optimata Virtual Patient® (OVP) engine is a powerful, interactive, clinical trial optimization tool, enabling significant reductions in time-to-market and development costs from the pre-clinical phase through treatment personalization.

Optimata’s Technology Enables:

–Drug repurposing

–Enhanced drug competitive profile

–Early “GO/NO-GO” development decisions

–Drug safety profile

–Optimal dosing schedules

–Clinical indication selection/expansion

 

 

Company:

Oryzon Genomics

Media Contact:

Group Inforpress

Phone:

0034 93 419 06 30

E-mail:

[email protected]

Web:

www.oryzon.com

 

Oryzon Genomics is the first Spanish company in functional genomics and a paradigm of high growth in the emergent Spanish Biotech Sector. Based in Barcelona and launched in 2001 as a spin-off of the Spanish National Research Council (CSIC) and the University of Barcelona, Oryzon has an international staff of highly qualified scientists and is developing projects that are aimed at identify biomarkers focused on oncology and neurological disorders and, for certain uses, in Agrobiotechnology. The company is extending his activity from diagnostics to therapy through biologics, identifying and validating possible new therapeutic targets that could be used as a starting point for further development of new drugs based on a biological approach.

 

 

Company:

Oy Jurilab Ltd.

Media Contact:

Tim Kirk

Phone:

358207219200

E-mail:

[email protected]

Web:

www.jurilab.com

 

Jurilab is a Genetic Discovery company dedicated to applying its proprietary discoveries of genes and genetic markers associated with the root cause of common diseases and drug response across healthcare. The current focus of Jurilab’s work is in the genetic background of metabolic diseases, often described under the umbrella of Metabolic Syndrome, including hypertension, type 2 diabetes, obesity and dyslipidemia. The product emphasis is on disease predisposition tests, which will support the advent of personalized medicine and nutrition, and on human-validated drug targets.

 

 

Company:

PAION AG

Ticker Symbol & Exchange:

PA8, FSE

Media Contact:

Dr. Peer Nils Schroeder

Phone:

49 241 4453-152

E-mail:

[email protected]

Web:

www.paion.de

 

PAION, a biopharmaceutical company based in Aachen, Germany, aims to become a leader in developing and commercializing innovative drugs for the treatment of diseases for which there is a substantial unmet medical need, e.g. stroke and other thrombotic diseases. Since 11 February 2005, PAION is listed at the Frankfurt Stock Exchange (Prime Standard Official Market, Stock Symbol PA8, ISIN DE000A0B65S3). PAION’s focus is currently on Desmoteplase, a plasminogen activator in PhIII development for ischaemic stroke. It was partnered with Forest Labs. and H. Lundbeck, but in 08/2007 Forest decided to return the license. PAION is now actively looking for a new partner for North America.

 

 

Company:

Pieris AG

Media Contact:

Dr. Birgit Zech – Business Development

Phone:

49 8161 141 1400

E-mail:

[email protected]

Web:

www.pieris-ag.com

 

Pieris is a biopharmaceutical company engaged in the discovery and development of Anticalins®, a novel class of targeted human proteins designed to diagnose and treat serious human disorders. Anticalins are engineered by Pieris from the scaffold of human lipocalins, a family of natural ligand binding proteins. Anticalins are selected to have prescribed binding properties with selectivity and affinity fundamentally similar to that of monoclonal antibodies. Being human in origin, Anticalins are predicted to have minimal immunogenicity in man. Where Anticalins benefit compared to conventional antibodies is in their small size (20 kDa), their robust physicochemical properties and their simple composition that together allow highly soluble, predictably stable products to be manufactured from bacteria.

 

 

Company:

Pharmahungary™ Group

Stand:

4

Media Contact:

Peter Ferdinandy, MD, PhD, MBA

Phone:

36 30 9250498

E-mail:

[email protected]

Web:

www.pharmahungary.com, www.cardiovasc.com

 

Pharmahungary is an emerging preclinical and clinical CRO providing innovative and cost-effective preclinical and clinical R&D solutions for pharma/biotech companies, focusing on cardiovascular (cardiovasc™) and metabolic diseases (diabetes, hyperlipidemia, atherosclerosis, obesity etc). Our custom designed innovative R&D systems (innoRD™) significantly reduce the duration of drug development. Quality is ensured by highly trained management with top scientific excellence. Pharmahungary runs some in-house R&D projects currently focusing on the development of inhibitors of peroxynitrite and its downstream cellular target matrix metalloproteinases (www.mmpharma.com), as well as activators of biglycan for cardiovascular indications. Pharmahungary is seeking for partners to develop joint venture projects.

 

 

Company:

Pharmalicensing Ltd.

Media Contact:

Pete Tan

Phone:

44 (0)1904 520 460

E-mail:

[email protected]

Web:

www.pharmalicensing.com

 

Pharmalicensing is the leading online global resource for partnering, licensing and business development within the life science and biopharmaceutical industry. Our unique partnering services complement and enhance business development activity throughout the deal making process, from finding partners to making the deal. Attracting an audience of over 60,000 visitors per month, Pharmalicensing provides a central meeting point for potential partners, offering company profiles to promote licensing opportunities, flexible consultancy services, business intelligence, and up to date industry news. Pharmalicensing also offers advertising and sponsorship opportunities on its website and in its newsletters. Visit www.pharmalicensing.com

 

 

Company:

Pharmarama

Stand:

35

Media Contact:

Paul Sagan, Sharon Merrill Associates

Phone:

1 617 542 5300

E-mail:

[email protected]

Web:

www.pharmarama.com

 

Pharmarama is a licensed wholesaler and importer of licensed and unlicensed medicines, based in London, England, with offices located in the United States and Germany. The company was founded in 2006 by Ben Rabin, Chairman of BR Pharma, to work in collaboration with BR Pharma as a single point of contact for the sourcing, repacking, blinding and distribution of comparator drugs worldwide. BR Pharma has more than a decade of experience working with the world’s leading pharmaceutical companies and clinical research organizations sourcing and procuring pharmaceutical products for clinical trials as well as in providing services for named patient programs.

 

 

Company:

PHOTO DYNAMIC THERAPY LLC / PDT®

Media Contact:

Gnther HOFMANN

Phone:

43 664 33 7777 5

E-mail:

[email protected]

Web:

www.pdt.at

 

PHOTONIC TUMOR THERAPY is intelligent controlled laser light adapted to patients’ individual needs. FOTESI® docks on tumor cells and the laser light matching the properties of both causing the least cytotoxic tumor cell switch-off but protecting healthy cells. Treatment in the curative and palliative setting at bile duct, bladder, cardia, cervix, colon, esophagus, lung, pancreas and rectum. PDT® provides a clinical service on cost per treatment with procedural advice, SOPs, hands-on support and the PDT® SYSTEM to ensure treatment quality. The strong demand of PDT®’s non-invasive tumor treatment requires the capacity upscale by strategic partnerships for worldwide roll out.

 

 

Company:

Poniard Pharmaceuticals

Ticker Symbol & Exchange:

Nasdaq:PARD

Media Contact:

Brendan Doherty

Phone:

650-745-4425

E-mail:

[email protected]

Web:

www.poniard.com

 

Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. Picoplatin, the Company’s lead platform product candidate, is a new generation platinum therapy with an improved safety profile designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell lung cancer and Phase 2 trials in metastatic colorectal and hormone-refractory prostate cancer, as well as a Phase 1 clinical trial of oral picoplatin in solid tumors. For more information, visit www.poniard.com.

 

 

Company:

Premier Research Group

Ticker Symbol & Exchange:

PRG (AIM London)

Media Contact:

Jessica Barag

Phone:

1 (215) 282-5391

E-mail:

[email protected]

Web:

www.premier-research.com

 

Premier Research is a leading solutions-driven CRO leveraging our commitment to therapeutic focus and scientific expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies. We operate in more than 30 countries across Europe and North America. We offer a comprehensive selection of services, including clinical trial management, medical and safety management, data management, biostatistics, medical writing, IVRS, regulatory affairs, quality assurance, and dedicated clinical sites. We are a leader in clinical research for Analgesia, Neuroscience, Oncology, and Infectious Disease and have a breadth of experience in medical device and pediatric clinical research.

 

 

Company:

Pyxis Discovery B.V.

Media Contact:

Alexandrine Cheronet

Phone:

31 15 2600972

E-mail:

[email protected]

Web:

www.pyxis-discovery.com

 

Pyxis Discovery is a knowledge based company focusing on novel small molecules to accelerate drug discovery programs. Pyxis Discovery develops proprietary tools to explore the bioactive chemical space, design and identify novel small molecules and to select optimal properties for early stage drug candidates. Pyxis Discovery offers lead discovery services: proprietary screening platform for Proteases (MMPs, Serines, Cysteines and Aspartyls). Smart Libraries: small molecule screening sets specifically designed to address the current need of the drug discovery industry (high quality, stringent pysico-chemical properties, medicinal chemistry fast follow-up…) Fragment Libraries: fragment molecule screening sets designed for NMR screening.

 

 

Company:

QUALITY ASSISTANCE

Media Contact:

Ms. Caroline Cajot

Phone:

32 71 53 47 81

E-mail:

[email protected]

Web:

www.quality-assistance.com

 

Quality Assistance is a leading European Contract Research Organisation assisting the (bio)pharmaceutical industries with the development of their products. We can provide a full service package compliant with the highest quality standards required by the FDA and EMEA. Our objective is to help our customers bring their products to the market efficiently.

Our assets:

•25 years experience

•90 highly-qualified employees

•3 200 m² of laboratories (5 000 m² by end 2007), including environmental chambers, and cell culture and BL2 & BL3 facilities

•Accredited ISO 17025, recognized GMP, certified GLP and inspected by the FDA (no 483s issued)

 

 

Company:

Richter-Helm BioTec

Stand:

No. 5

Media Contact:

Dr. Astrid Brammer

Phone:

49-40-55905-801

E-mail:

[email protected]

Web:

www.richter-helm-biotec.eu

 

Richter-Helm BioTec, formerly known as Strathmann Biotec, is a dynamic and expanding biotechnology company based in Hamburg, Germany. Richter-Helm offers highly specialized contract development and manufacturing services for microbial production of biopharmaceuticals, namely recombinant proteins and plasmid DNA and vaccines. Additionally to our contract development and manufacturing business, Richter-Helm is seeking for interesting biopharmaceutical development projects for its own pipeline and for co-development with partners. Based on long standing experience in the area of protein expression systems, plasmid-DNA technologies, fermentation as well as downstream processing Richter-Helm is in the position to offer first class services to our clients and partners.

 

 

Company:

Rottapharm S.p.A.

Media Contact:

Dr. Marliese Annefeld

Phone:

0039 039 7390 308

E-mail:

[email protected]

Web:

www.rottapharm.com

 

Rottapharm is an Italian multinational pharmaceutical group, headquartered in Monza, with branches in over 80 countries worldwide. Since its inception, Rottapharm has been primarily focusing on research. The group’s traditional research fields in the gastrointestinal/digestive area and in the osteo-articular/rheumatology area have been extended, through intensive activity, to include the fields of hormone replacement therapy/women’s health/gynaecology and, more recently, the cardiovascular, respiratory tract and central nervous system areas. In August 2007, Rottapharm acquired the pharmaceutical company Madaus Pharma; this acquisition represents an important turning point for Rottapharm, in terms of R&D synergies and marketing growth.

 

 

Company:

SciClone Pharmaceuticals, Inc.

Ticker Symbol & Exchange:

NASDAQ:SCLN

Media Contact:

Angela Bitting

Phone:

US: 925-462-1106

E-mail:

[email protected]

Web:

www.sciclone.com

 

SciClone Pharmaceuticals is a biopharmaceutical company engaged in developing therapeutics to treat life-threatening diseases. SciClone’s lead product ZADAXIN® (thymalfasin) is in late-stage trials for malignant melanoma and hepatitis C virus (HCV). ZADAXIN is approved for sale in select markets internationally, principally in China where SciClone has an established sales and marketing operation. A key part of SciClone’s strategy is to leverage its advantage and broaden its portfolio in China by in-licensing or acquiring the rights to other products, such as DC BeadTM. For the U.S., SciClone’s clinical-stage drug development candidates are RP101 for pancreatic cancer and SCV-07 for HCV.

 

 

Company:

Select Greater Philadelphia

Media Contact:

Nicole Blatcher

Phone:

215.240.0076

E-mail:

[email protected]

Web:

http://www.selectgreaterphila.com

 

Select Greater Philadelphia (Select) is an economic development organization dedicated to marketing the Greater Philadelphia region as a premier business location. Select serves as a support system and information resource for companies in the United States and abroad as they consider a new location on the Northeastern Seaboard. Select is a private, non-profit organization that focuses its resources on

CHF Technologies, Inc., d/b/a BioVentrix, San Ramon, California, announced the appointment of Kenneth Miller as the new President and Chief Executive Officer. Mr. Miller replaces Acting CEO, Arthur Bertolero, who co-founded BioVentrix and remains a member of the Company’s Board of Directors.

Mr. Miller brings to BioVentrix an outstanding track record of general management experience and research and development success. He is accomplished at securing financing, setting and executing strategies and exceeding revenue and profit objectives. His most recent success was as VP of Sales and Marketing for Cholestech, a global diagnostics company focused on coronary heart disease and diabetes. During his tenure there, Cholestech was acquired by Inverness for $317 million. Prior to that, Mr. Miller served as COO of R2 Technology, a diagnostic imaging company, where he helped grow revenues from $3 million to $58 million in three years.

“Ken has the perfect credentials for this position,” said Gerald Grayson, BioVentrix Board Member. “We are very fortunate to have his leadership skills and vision for the future.”

“I am intrigued with the technology and direction that BioVentrix is taking in the treatment of Heart Failure,” said Mr. Miller. “The products in our pipeline will address the underserved needs of thousands of patients suffering from this debilitating disease. With over $30 billion spent annually on heart failure, BioVentrix is poised to capture a generous market share.”

Mr. Miller received his MBA in Pharmaceutical Marketing from Fairleigh Dickinson University in Teaneck, New Jersey, and a BS from Rutgers University. He resides with his family in Danville, CA.

About BioVentrix:

BioVentrix is a private corporation based in San Ramon, California. Its mission is to improve and expand on the surgical treatment of heart failure by left ventricular reconstruction, primarily through the development of less invasive approaches, and ultimately, catheter-based procedures. BioVentrix’s Scientific Advisory Board and associated physicians include some of the country’s leading surgeons and cardiologists. For more information, please visit www.bioventrix.com

 Media Contact: Kent Richards 925-830-1000 [email protected]

SOURCE: BioVentrix

CHICAGO, Nov. 6/PRNewswire-USNewswire/ — This November, Southeastern Conference football legend, Frank Broyles of the Arkansas Razorbacks, and the Alzheimer’s Association, the leading resource for Alzheimer’s care, are teaming up to teach Alzheimer’s caregivers sometimes the best defense is a good offense. For the almost 10 million Americans caring for someone with Alzheimer’s disease or another dementia, the sooner they are educated about the disease and can utilize resources, the sooner they can more effectively take care of their loved one and themselves. November is both National Alzheimer’s Disease Awareness Month and National Family Caregivers Month.

Beginning November 1, 2007, anyone can request a free copy of Coach Broyles’ Playbook for Alzheimer’s Caregivers on alz.org or by visiting their local Alzheimer’s Association chapter. The Playbook is a football-themed, practical guide that addresses “Pre-Game Planning,””Coaches and Special Teams,””Playing Offense,””Playing Defense” and the “Training Table” for each stage of the disease.

“When my wife was diagnosed with Alzheimer’s disease I was at a loss,” said Broyles, athletic director and former coach of the Arkansas Razorbacks. “My family and I collaborated with many great partners like the Alzheimer’s Association along her journey and we want to share our collective insight to help ease the caregiving of those still facing this immense challenge.”

Caring for a person with Alzheimer’s disease poses special challenges. Although memory loss is the most widely known symptom, as the disease progresses it also causes confusion, loss of orientation, and frequently, changes in personality and behavior. Individuals with Alzheimer’s require increasing levels of care, supervision and provision for their safety.

The Alzheimer’s Association, already provides a number of programs and services that help people affected by Alzheimer’s at every stage of the disease including a toll-free help line 24/7, 7-days-a-week (800.272.3900), informative web site alz.org, and local services including information and referral, care consultation, peer- and professional-support groups, and educational material resources.

In addition to offering complimentary copies of Coach Broyles’ Playbook for Alzheimer’s Caregivers, the Alzheimer’s Association is launching its enhanced MedicAlert + Safe Return program to ensure medical history is immediately available during wandering incidents, as well as its new online suite of services called CareSource, this November.

CareSource includes the new Senior Housing Finder database to locate dementia-specific housing nationwide and Lotsa Helping Hands community calendars to help organize in-home caregivers. CareSource also includes the existing CareFinder tool to help people understand what type of care is appropriate given their needs and preference.

“The most important thing caregivers can do it take care of themselves,” says Peter Reed, Ph.D., senior director of programs for the Alzheimer’s Association. “From Coach’s Playbook to the new online CareSource, the Alzheimer’s Association is dedicated to helping caregivers by offering them the best resources possible.”

If you have been touched by Alzheimer’s or are a caregiver to someone with the disease, there is help. For more helpful information and resources, visit CareSource at alz.org or call 800-272-3900.

The Alzheimer’s Association

The Alzheimer’s Association is the leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimer’s disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer’s. For more information, visit http://www.alz.org/.

Alzheimer’s Association

CONTACT: Katie Kyle of the Alzheimer’s Association, +1-312-335-5293,[email protected]

Web Site: http://www.alz.org/

In a move that brings lower drug prices to nearly half of its 4.6 million Medicare members, Humana (NYSE: HUM) has announced it will offer zero-dollar copayments for eligible Humana Medicare members ordering Tier 1 (preferred generic) drugs from RightSourceSM starting in January 2008. RightSource is the company’s preferred prescription home delivery service. RightSource sends up to a 90-day supply of medications directly to members’ homes and offers an opportunity to manage and reduce prescription drug costs.

This savings opportunity will be available for members in Humana’s Enhanced and Complete stand-alone Medicare Prescription Drug Plans as well as most members in the company’s Medicare Advantage plans.

Humana’s zero-dollar copayment benefit includes over 2,200 generic prescriptions in a variety of dosages and solid or in liquid forms. The generic drugs, known as Tier 1 (preferred generics), includes many well-known drug types and are prescribed for numerous chronic conditions such as high cholesterol, high blood pressure, and diabetes. Using RightSource may also offer members additional savings opportunities for drugs in Tiers 2 and 3, which include covered brand-name drugs with higher copayments.

“The zero-dollar copayment for preferred generic drugs could potentially help millions of our Medicare members,” said William Fleming, Humana’s vice president of pharmacy. He noted that about 60 percent of Humana’s Medicare prescription drug claims are for Tier 1 drugs, adding, “Generics contain the same active ingredients as ‘brand-name’ counterparts, and are equally effective. Including RightSource for prescription drug home delivery can save Humana’s Medicare members money, particularly as they get into the coverage gap,” he said, referring to the Medicare prescription drug benefit gap between the initial coverage limit and the catastrophic coverage threshold.

For members using RightSource in 2008:

Medicare PDP Complete Plan members pay zero-dollar copayments for preferred generics during the first two stages of the prescription drug plan, and a zero-dollar copayment in the coverage gap. During the catastrophic coverage stage, members pay whichever is greater — five percent co-insurance, or $2.25 for a preferred generic drug.

Medicare PDP Enhanced members and most MAPD plan members pay zero-dollar copayments for preferred generics during the first two stages of the prescription drug plan. Members pay 100 percent in the coverage gap until the yearly out-of-pocket drug costs reach the catastrophic coverage stage. At that point, members pay whichever is greater — five percent co-insurance, or $2.25 for a preferred generic drug.

Humana’s plans and services offer guidance to help members choose, manage, and use health benefits with confidence and success. In 2006, Humana opened RightSource, its state-of-the-art mail-order facility. Members benefit from RightSource’s strong buying power where savings are passed along to them.

Humana’s list of 2008 Tier 1 (preferred generics) may be found at Humana’s website, www.humana-medicare.com.

Treatment options, including generic prescription drugs, should be discussed with a doctor.

About Humana

Humana Inc., headquartered in Louisville, Kentucky, is one of the nation’s largest publicly traded health benefits companies, with more than 11.3 million medical members. Humana offers a diversified portfolio of health insurance products and related services — through traditional and consumer-choice plans — to employer groups, government-sponsored plans, and individuals.

Over its 46-year history, Humana has consistently seized opportunities to meet changing customer needs. Today, the company is a leader in consumer engagement, providing guidance that leads to lower costs and a better health plan experience throughout its diversified customer portfolio.

More information regarding Humana is available to investors via the Investor Relations page of the company’s web site at www.humana.com, including copies of:

Annual reports to stockholders;

Securities and Exchange Commission filings;

Most recent investor conference presentations;

Quarterly earnings news releases;

Replays of most recent earnings release conference calls;

Calendar of events (includes upcoming earnings conference call dates and times, as well as planned interaction with research analysts and institutional investors);

Corporate Governance information

IntelGenx Corporation (OTCBB: IGXT) (“IntelGenx” or the “Company”) and Cary Pharmaceuticals (“Cary Pharma”) today announce the signing of a Definitive Agreement (“Agreement”) to jointly develop and commercialize Cary Pharma’s oral antidepressant (“CPI-300” or the “Product”) using IntelGenx’s proprietary oral delivery technology.

Under the terms of the Agreement, IntelGenx will provide funding and development support for the Product and will be entitled to profit sharing. The transaction is expected to close by the end of 2007. The parties anticipate that a New Drug Application (“NDA”) will be filed with the United States Food and Drug Administration (“FDA”) during the third quarter of 2008. Commercial launch of the Product is expected upon FDA approval in 2009.

Horst G. Zerbe, President and CEO of IntelGenx, said, “This strategic relationship is of significant importance to the future growth of both companies. CPI-300 represents a novel treatment for depression and IntelGenx has developed the drug delivery technology that creates a unique and effective addition to the marketplace. We expect that the compatibility of the two companies will lead to further opportunities for collaboration.”

“We are excited about expanding our relationship with IntelGenx,” said Douglas D. Cary, President of Cary Pharmaceuticals. “Combining our collective experience and resources will enable us to efficiently complete the development of CPI-300. We look forward to commercializing CPI-300 and making it available as a new treatment option for patients who suffer from depression.”

About IntelGenx Corp.

IntelGenx Corp. is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. The company uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. The company’s research and development pipeline includes products for the treatment of osteoarthritis, pain management, hypertension, and depression.

About Cary Pharmaceuticals Inc.

Cary Pharmaceuticals Inc. is a privately held pharmaceutical company based in Great Falls, Virginia. The Company is developing novel treatments for depression, hypertension, and smoking cessation.

Forward-Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties that could cause IntelGenx’s actual results and experiences to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as anticipates, expects, plans, believes, intends, and similar words or phrases. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that all of the conditions for closing the transaction with Cary Pharmaceuticals Inc. will be satisfied in a timely manner or at all, which may prevent IntelGenx from completing the transaction. In addition, this press release also includes forward-looking statements regarding the timing, progress and results of the clinical development, regulatory processes, potential clinical trial initiations, NDA filings and commercialization efforts for CPI-300. These statements are subject to various risks and uncertainties and include the possibility that the results of clinical trials will not support CPI-300 claims, the possibility that the development efforts of Cary Pharmaceuticals and IntelGenx related to CPI-300, will not be successful, the inability to obtain regulatory approval for CPI-300, and reliance on third-party manufacturers to produce the product. Additional risks are described in IntelGenx’s Annual Report on Form 10-KSB for the year ended December 31, 2006. IntelGenx assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

 Contacts: IntelGenx Corp. Dr. Horst G. Zerbe President and CEO (514) 331-7440, ext. 201 (514) 331-0436 (FAX) Email: [email protected] Website: www.intelgenx.com  Cary Pharmaceuticals Inc. Douglas D. Cary President (703) 771-8540 (703) 759-6492 (FAX) Email: [email protected] Website: www.carypharma.com  Investor Relations for IntelGenx Corp Consulting for Strategic Growth 1 Stanley Wunderlich, CEO 1-800-625-2236 (212) 337-8089 (FAX) Email: [email protected] Website: www.cfsg1.com  Media Relations for IntelGenx Corp. Consulting for Strategic Growth 1 Daniel Stepanek (212) 896-1202 (212) 697-0910 (FAX) Email: [email protected] Website: www.cfsg1.com

SOURCE: IntelGenx Corp.

COLUMBIA, S.C., Nov. 5 /PRNewswire/ — Palmetto GBA, a leading provider of technical and administrative services for the federal government, today announced it has been selected by the federal Centers for Medicare & Medicaid Services (CMS) to process fee-for-service Medicare claims and perform related duties for California, Hawaii, Nevada, American Samoa, Guam and the Northern Mariana Islands.

CMS awarded Palmetto GBA a contract with a base period of one year and four one-year options to serve as the Medicare Administrative Contractor (MAC) for those states and U.S. territories, known as MAC Jurisdiction 1. The contract has a potential value of approximately $400 million. As the MAC, Palmetto GBA will process claims for both Parts A and B of the Medicare benefit program.

To support the contract, Palmetto GBA and its two largest subcontractors, TrailBlazer Health Enterprises and First Coast Service Options, will add approximately 750 full-time jobs. The majority of those positions will be at Palmetto GBA’s existing locations in Columbia, S.C. and Columbus, Ohio; at TrailBlazer’s office in Dallas, Texas; and First Coast’s office in Jacksonville, Fla.

Palmetto GBA will begin implementation activities immediately. It will assume full responsibility for claims in Jurisdiction 1 no later than June 2008.

“This very significant award is a reflection of the dedication our employees have shown in providing outstanding service to Medicare beneficiaries and providers since the Medicare program was created,” Palmetto GBA President Bruce Hughes said. “We are excited about the opportunity to serve the people with Medicare and the physicians and providers who care for them in the states and territories of Jurisdiction 1.”

Acting CMS Administrator Kerry Weems said Palmetto GBA was chosen as the Jurisdiction 1 MAC because the company “offered the best overall value to the government, from both a cost and technical perspective.”

CMS is in the process of selecting 15 MACs to process claims for both Parts A and B of Medicare. The MACs will replace fiscal intermediaries, which currently process Part A claims, and carriers, which currently process Part B claims. Medicare Part A helps cover fees from hospitals, skilled nursing facilities and other institutional providers. Part B covers fees from physicians, laboratories and other practitioners. The Medicare Modernization Act of 2003 mandated creation of the MACs, which were established to increase efficiency and improve service by giving beneficiaries and providers a single point of contact for the Medicare program.

About Palmetto GBA

Based in Columbia, S.C., Palmetto GBA is a wholly owned subsidiary of BlueCross BlueShield of South Carolina. Palmetto GBA’s principal business is providing administrative services for the Medicare health benefit program. The company has offices in South Carolina, Florida, Georgia, Ohio and Illinois. Palmetto GBA and BlueCross BlueShield of South Carolina are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans.

About TrailBlazer Health Enterprises

Based in Dallas, TrailBlazer Health Enterprises, LLC is a wholly owned subsidiary of BlueCross BlueShield of South Carolina. TrailBlazer is a diversified government contractor, providing services to Medicare and other government programs. In addition to its Dallas headquarters, the company has offices in Denison, Texas; San Antonio, Texas; and Timonium, Md. TrailBlazer Health Enterprises and BlueCross BlueShield of South Carolina are independent licensees of the Blue Cross and Blue Shield Association.

About First Coast Service Options

FCSO contracts with the Centers for Medicare & Medicaid Services and the Blue Cross and Blue Shield Association to provide quality Medicare administrative services to more than 3 million beneficiaries and the health care providers who care for them in Florida and Connecticut. One of the nation’s largest Medicare administrators, the company has more than 1,200 staff at the company’s headquarters in Jacksonville, Fla., and field offices in Miami, Orlando, Tampa and Meriden, Conn. FCSO is a wholly owned subsidiary of Blue Cross and Blue Shield of Florida, and both are independent licensees of the Blue Cross and Blue Shield Association.

Palmetto GBA

CONTACT: Billy Quarles of BlueCross BlueShield of South Carolina,+1-803-264-5779

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

By Tan Choe Choe

ABOUT 300,000 Malaysians are `trembling’ their way to health. TAN CHOE CHOE checks out the Waitankung phenomenon.

You’ve probably seen them in a park or garden around your neighbourhood – a group of people, generally elderly, shaking their hands or feet as if partaking in some ritual.

If they sport beige or brown pants with collared white tees, then you’re spot on – they are Waitankung practitioners.

It is hard to give a literal translation of “Waitankung”, but it loosely means exterior body exercise. It is a form of meditative exercise practised by the Chinese in the imperial courts more than 2,000 years ago.

The original form of the exercise is very intricate and difficult to master, but Ali Chang Chih-Tung remodelled and simplified the motions in the 1970s and reintroduced it to the public in Taiwan in 1976.

It is said to be able to help strengthen and exercise vital organs and normalise the functions of the heart and lungs.

The focus of the exercise is to generate internal qi (energy) in the body through a series of controlled shaking motions of various body parts, from head to toe.

This is based on the belief that there is a pre-born internal energy in us which is called xian tian qi. Strengthening this internal qi will make a person healthier.

“To activate this qi, we have to systematically shake our body parts. The qi makes the organs healthy, relaxed, working and functioning,” says Petaling Jaya Waitankung branch publicity chairman Albert Chua, 62.

Practitioners often refer to these shaking motions as “trembling” because many claim that over time and with regular practice, the shaking becomes automatic, almost like involuntary “trembling”.

Those who practise the exercise correctly and regularly – about two or three times a week – say the exercise promotes blood circulation, helps strengthen the immune system, loosens tendons, muscles and joints, and reduces stress and hypertension.

It is also said to help alleviate rheumatism, arthritis, insomnia, digestive problems and constipation.

“You can do it while standing, sitting, crouching or slouching on the couch. If you do it right, your body will feel warm, like there’s a kind of energy flowing through it,” says Waitankung practitioner and Petaling Jaya Waitankung branch chairman Lee Sak Yon, 64.

There are about 30 branches with about 300 Waitankung centres in Malaysia, and about 300,000 practitioners from all walks of life.

“In Petaling Jaya alone, there are eight branches. Waitankung is the largest exercise group in Malaysia now. It is bigger than tai chi,” says Lee.

This is no small feat indeed, since the exercise was only brought here about 26 years ago by Dr Kok Chi Kai. In 1984, the Waitankung Research Society was established and later, the Waitankung and Neitankung Society Malaysia was registered, with its national headquarters in Puchong, Kuala Lumpur.

“We are not just an exercise group, we are also a social group. We organise get-togethers, charitable activities, karaoke sessions and trips for our members, whom we refer to as `brothers’ and `sisters’,” says Chua.

To the uninitiated, a regular Waitankung exercise routine starts with a seven-step induction or warm-up exercises.

There’s a quirky tradition here: practitioners inhale deeply and shout heng has when they initiate each step, followed by murmurs of shih wu as they exhale.

“It helps to regulate their breathing. The forceful heng has helps to energise their motions and the subsequent shih wu helps them to de-stress and exhale the stale air.”

The warm-up steps are then followed by the exercise proper which consists of 12 steps of “trembling” motions, with fanciful names like “Big Crane Walk”.

Lee says Waitankung is suitable for both the young and the elderly.

Classes are conducted by experienced trainers.

“They teach for free. We also have English and Malay classes because our students are multi-racial.”

To join, you only need to get a pair of Waitankung uniform and chip in RM10 or RM20 a month to help pay the rental of an exercise centre, utilities and refreshments.

(c) 2007 New Straits Times. Provided by ProQuest Information and Learning. All rights Reserved.

By Maria Halkias, The Dallas Morning News

Nov. 3–Girl power will be on display this weekend at the Dallas Galleria.

About 6,000 shoppers from throughout the Southwest are expected to show up for the grand opening of the American Girl Boutique and Bistro.

This is more than a toy store. Girls not only can buy high-end, historically accurate dolls with names like Felicity, Molly and Kaya for $87, but they also can buy a doll that looks like them for the same price.

The store is stocked with doll furniture and accessories, historical paperback novels that tell the dolls’ stories, and matching outfits for the dolls’ owners, starting at about $20.

Girls can get their dolls’ hair and nails done in the salon and host a tea party in the bistro.

Some Dallas-area girls who previewed the pink-themed store — only the fifth in the U.S. — this week called it magical.

“I think it’s so fancy,” said Anna Roberts, 7, surrounded by friends who were among the first to experience a two-hour birthday party. “And write that I want Nicki.”

Leaving the party, excited guests jumped up and down to show a reporter the crafts they made and to have their wish lists included in an article they were certain their parents would read.

“They felt like royalty,” said hosting mom Becky Connet of Mansfield, whose daughter Kylie was the birthday girl and got to sit in the oversized pink chair.

“The store has a lot of energy to it. And we like the books because they’re more educational,” Mrs. Connet said.

American Girl has a publishing arm that has sold more than 117 million books, and its magazine has a circulation of 650,000 — more than many grown-up periodicals.

It’s all about pink

In the second-level bistro, with a nice view of North Dallas’ high-rises, a three-course meal is $14.50, and a banana split that feeds four to six costs $21.

Entrees include heart-shaped grilled cheese sandwiches and pink ravioli. Birthday cakes are decorated with pink polka dots. Pink is everywhere, including the lemonade.

The store has fun and thoughtful features, including holders for dolls in the bathroom stalls and small flickering lights in the pavement in the grand entrance.

“I thought it was just going to be another store at the mall,” said Megan Scott, 6, who talked her mother into buying twin Bitty dolls ($87 for the pair) that she’ll be sharing with her big sister Brittany, 8.

Even girls past the target 7- to 12-year-old age group say they’re up for a visit down memory lane.

Thirteen-year-old Emily Lyons of Richardson said she and her friends, who used to play together with their American Girl dolls, have been talking about going to the store for old time’s sake.

“We want to take them to get their hair done,” Emily said. “When I heard they opened the first store in Chicago, I wanted to go bad.

“We all had them and played together. It’s a special thing we did together for a long time, and it was fun.”

‘A perfect fit’ for Galleria

The first American Girl store opened in Chicago in 1998. A second flagship is on Fifth Avenue in New York, and the third opened in April at the Grove in Los Angeles. Those stores include a theater and are larger than the Boutique and Bistros in Dallas and Atlanta.

Although it’s smaller than a department store, an American Girl store generates similar sales, from $30 million to more than $100 million, depending on the store.

Galleria general manager Peggy Weaver said the Dallas mall started courting the store in 2004, “before we even had any idea whether they were interested in expanding.”

“We just thought it was a perfect fit for us, since we have the ice rink and the hotel and they’re such an experiential store,” Ms. Weaver said. “Ice skating and sleepovers at the Westin just go together with the magic of this store.”

Wade Opland, American Girl’s vice president of retail, said there are no plans for another store, except for the relocation of the Chicago flagship, which is moving a few blocks next year into a larger space in the Water Tower Place.

In time for Christmas

American Girl, a top seller in the much-sought-after “tween” market, is hoping it can boost sales by opening new stores without diluting the exclusivity of the brand.

It may just work — the Dallas store’s bistro is nearly booked through the end of the year for weekend birthday parties.

Owned by Mattel Inc. since 1998, American Girl saw sales soar from just under $300 million in 1999 to $440 million last year. More than 13 million dolls have been sold since the company was founded by an educator in 1986.

But sales are soft this year, despite a new store that opened in Atlanta in August and its first new historical doll in five years — Julie, who lived in San Francisco in 1974.

Like most toy retailers, Christmas is American Girl’s biggest season, and the rest of the year can pull it out of a slump.

“We’re hopeful about the holiday season now with five stores open and the new character doll,” Mr. Opland said.

Ironically, like most toys sold in the U.S., American Girl dolls and toys are made in China.

But while Mattel has experienced some of the biggest recalls for unsafe lead content in toys made in China, American Girl has escaped that scene.

“We know that girls love us, and moms trust us,” Mr. Opland said. “Safety is our No. 1 promise.”

AMERICAN GIRL ENSEMBLE

$87 –Julie Albright, historical doll from the 1970s, with a period outfit and Meet Julie book

$20 –Julie’s hat, necklace and shoulder bag

$39.95 –Julie’s set of six paperback books

$24 –Julie’s casual outfit with boots

$185 –Julie’s Bedroom Collection, a 24-piece set that includes bed and pajamas

$355.95 –Total

20 years later: Handed down to daughter

XBOX 360 AND PERIPHERALS

$349 –Xbox 360 Pro console (including two bundled games)

$49 –Second wireless controller

$99 –Wi-Fi adapter for connecting wirelessly to the Internet

$50 –One-year subscription to Xbox Live Gold online service

$59 –Halo 3 game

$606 –Total

20 years later: Obsolete

SOURCE: Dallas Morning News research

—–

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Copyright (c) 2007, The Dallas Morning News

Distributed by McClatchy-Tribune Information Services.

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NYSE:MAT,

Aetna (NYSE: AET) today announced that it has sent out $250,000 in financial rewards to Maine primary care physicians for delivering high-quality care to Aetna members during 2006. The payments were made to 255 in-network physician practices that participate in the Maine Health Management Coalition’s (MHMC) Pathways to Excellence — Primary Care initiative, which is Aetna’s pay-for-performance partner for primary care practices in Maine.

“We commend the MHMC for driving the effective collaboration among employers, physicians and payers that lead to this program, and we thank and congratulate the physicians who have earned blue ribbons and financial rewards for high-quality care,” said Michael Hudson, president for Aetna’s Northeast Region. “Aetna believes very strongly that pay-for-performance programs — which are programs designed to recognize, both publicly and financially, physician practices that demonstrate high-quality care — can definitively move the needle in improving the quality and efficiency of health care for our members.”

The Pathways to Excellence (PTE) — Primary Care Initiative has two goals: to measure health care quality and share that information with employer plan sponsors and health care consumers; and to recognize and reward physician practices that offer high-quality care that leads to better health outcomes. More than 275 primary care practice locations across Maine submitted data on three main performance measurements, and were ranked on the MHMC public website with “blue ribbon” achievements in each category, as warranted by their performance.

“What makes this program successful is the collaborative nature of the process that developed and oversees the measurement and reporting system,” said Tara Ryan, marketing and member services manager of MHMC. “Physicians, insurers and employers who purchase healthcare reached consensus on the measures and how they would be used. The website was developed through numerous focus groups and testing with consumers over several years.”

“Aetna’s support and acknowledgement of Blue Ribbon practices is essential for their continued improvement of the care they deliver to the people of Maine.” said Stephen Ryan, president/CEO Maine Network for Health. “These small practices are struggling to provide needed services to chronically ill individuals, often in rural areas of the state. Aetna’s payments help these practices to continue the work they have begun. Everyone — patients, purchasers and providers — benefits from a program like this.”

Maine employers are also enthusiastic in support of rewarding physicians for providing quality care.

“Aetna has been a great partner to Hannaford. They are really helping us to offer health benefits that make it easy for our members to get high quality health care very efficiently which improves the outcomes for both Hannaford and our members,” says Peter Hayes, director of associate health and wellness at Hannaford Brothers. “We really appreciate the support of the primary care practices. We think high quality primary care is a key strategy to help improve the health of our communities.”

According to a new study by the Milken Institute, “An Unhealthy America: The Economic Burden of Chronic Disease,” the annual economic impact on the U.S. economy of the most common chronic diseases is calculated to be more than $1 trillion, largely due to lost productivity. However, the study says reorienting the health care system toward prevention could avert 40 million cases of seven common chronic conditions, including stroke, heart disease, cancers and diabetes, in the year 2023.

In rewarding top performers for 2006, the PTE initiative used the following performance measurements, applied specific criteria to determine achievement in each area and designated a “blue ribbon” in each of the three areas as warranted. Information on physician performance is available at www.mhmc.info. Aetna issued financial rewards to top performers who received two or three blue ribbons, taking into consideration the number of fully insured Aetna members who selected a given practice as their primary care physician.

1. Use of office systems to manage chronic disease: During 2006, primary care practices across Maine were asked to complete an office systems survey on the clinical office information systems in their practices.

2. Adherence to standard clinical care guidelines: During 2006, primary care practices across Maine were asked to provide information about how well their practice followed clinical guidelines for diabetes and ischemic vascular disease (for adult practices) and asthma (for pediatric practices).

3. Measurement of patient care results: During 2006, primary care practices across Maine were asked to provide selected measurements of the results of their patient care for diabetes (for adult practices) and immunizations (for pediatric practices).

About MHMC

The Maine Health Management Coalition is a non-profit organization whose over 60 members include public, private and non-profit employers, hospitals, health plans and doctors working together to measure and report healthcare quality and use this information to drive quality improvement. Currently, more than 200,000 member employees and thousands of others are benefiting from the Maine Health Management Coalition’s work.

About Aetna

Aetna is one of the nation’s leading diversified health care benefits companies, serving approximately 36.4 million people with information and resources to help them make better informed decisions about their health care. Aetna offers a broad range of traditional and consumer-directed health insurance products and related services, including medical, pharmacy, dental, behavioral health, group life and disability plans, and medical management capabilities and health care management services for Medicaid plans. Our customers include employer groups, individuals, college students, part-time and hourly workers, health plans, government-sponsored plans and expatriates. www.aetna.com

NEW YORK, Nov. 1 /PRNewswire/ — On yesterday’s Oprah Winfrey show, themed “What the Stylemakers Can’t Live Without,” supermodel and supermom Cindy Crawford revealed that homeopathic medicines are must-haves in her life.

“I am the doctor of our family and I’m a big fan of homeopathy,” she said. “If I have the kids, for sure, I always take this with me,” she explained, holding up a plastic kit containing small vials of homeopathic medicines. Cindy said she carries these medicines in case of bee stings, mosquito bites, and bruises. “You need like 5 of those little pellets,” she said, adding that they “taste sweet so the kids will take them.”

Millions of parents across the country, like Cindy, are now using homeopathic medicines because of their reliability and safety. According to Nathalie Stern, MD, a Manhattan-based pediatrician and mother of two, parents are turning to homeopathic medicines because they have no known side effects or drug interactions.

“I always recommend that parents include homeopathic medicines in their family’s first aid kits,” Dr. Stern said. “For instance, arnica pellets are ideal to safely treat kids at the playground or on the sports field. Arnica words especially well for pain, swelling and bruising, which is inevitable with active kids.”

Dana Ullman, MPH, author of The Homeopathic Revolution: Why Famous People and Cultural Heroes Choose Homeopathy (North Atlantic Books, October 16), says he is not surprised that celebrity parents are looking to homeopathy to meet their families’ health needs.

“Homeopathy is the #1 alternative medicine in Europe, and has been popular there for over 200 years,” Ullman said. “There is a good reason why celebrities have used and advocated for homeopathic treatments for themselves and their families — homeopathy works!”

Ullman’s book includes references to Cindy Crawford’s interest in homeopathy on page 180. He said that she, along with 11 American presidents, seven popes, Charles Darwin, J.D. Rockefeller, Tina Turner, David Beckham and Mother Teresa, are among the famous who have used and endorsed homeopathic medicine.

Dana Ullman

CONTACT: Dean Draznin of Dean Draznin Communications, Inc.,+1-641-472-2257, [email protected], for Dana Ullman

Tenet Healthcare Corporation (NYSE:THC) today announced that a subsidiary has completed the purchase of the assets of Stanislaus Behavioral Health Center, a 67-bed county behavioral health hospital located in Modesto, Calif. It will continue to operate as a department of Doctor’s Medical Center of Modesto and will be renamed Doctor’s Behavioral Health Center. The approximate purchase price is $10.9 million and is subject to normal post-closing adjustments.

Doctor’s Medical Center of Modesto has been working with the Stanislaus County for the past 24 months to complete this deal. The transaction ensures a dedicated mental health facility in Stanislaus County and offers employment to approximately 75 county employees working at the center.

The newly renamed Doctor’s Behavioral Health Center provides the only services of its kind in the county. Data show a shortfall, with an additional 60 beds needed to fully meet the needs of the mental health community. With a need for more dedicated behavioral healthcare beds in the area, the center is planning to add two more psychiatrists to the staff and increase its bed count.

Stephen L. Newman, M.D., Tenet’s chief operating officer, said, “Through this integrated approach Tenet can provide comprehensive, cost-effective mental health care services to the Modesto area.”

Doctor’s Medical Center of Modesto expects approximately 3,000 annual acute psychiatric admissions from this transaction.

Tenet Healthcare Corporation, through its subsidiaries, owns and operates acute care hospitals and related health care services. Tenet’s hospitals aim to provide the best possible care to every patient who comes through their doors, with a clear focus on quality and service. Tenet can be found on the World Wide Web at www.tenethealth.com.

Some of the statements in this release may constitute forward-looking statements. Such statements are based on our current expectations and could be affected by numerous factors and are subject to various risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended Dec. 31, 2006, our quarterly reports on Form 10-Q and periodic reports on Form 8-K. Do not rely on any forward-looking statement, as we cannot predict or control many of the factors that ultimately may affect our ability to achieve the results estimated. We make no promise to update any forward-looking statement, whether as a result of changes in underlying factors, new information, future events or otherwise.

INGLEWOOD, Calif., Oct. 31 /PRNewswire/ — Prime Healthcare Services, Inc. (PHS), the owner and operator of eight acute care hospitals in Southern California, announced today that Prime Healthcare Centinela, one of its subsidiaries, has acquired Centinela Hospital Medical Center (CHMC), a 369-bed full-service acute care facility in Inglewood, California, from Centinela Freeman HealthSystems Holdings, Inc.

(Logo: http://www.newscom.com/cgi-bin/prnh/20071031/AQW228LOGO)

Representatives for both PHS and CHMC said the acquisition will bring much-needed long-term financial stability to the hospital and assure that its doors remain open and all of its services remain available to the people of Inglewood and other local communities.

PHS has pledged to expand the Emergency Department to relieve overcrowding, to maintain all currently-offered services and to invest $20 million in new infrastructure improvements over the next year. It will also keep its ongoing commitment to serving the poor and uninsured.

“We look forward to working with Centinela’s medical staff and employees, as well as community leaders, to maintain this hospital’s long and storied tradition of medical excellence and of providing quality healthcare services to patients regardless of economic status,” said Prem Reddy, MD, FACC, FCCP, Chairman of the Board of PHS.

“We are 100-percent committed to delivering a financial shot-in-the-arm to this hospital and providing the very best, most compassionate health care to the people of this community,” said Reddy.

CHMC is a premier and critical hospital serving Inglewood and the greater Los Angeles communities. Recognized nationally and internationally for its work in the area of orthopedic medicine, it is the official hospital for the Los Angeles Dodgers, Lakers, Clippers, Sparks, Galaxy and Avengers sports teams and the home of the renowned Tommy Lasorda Heart Institute.

Unfortunately, CHMC has been experiencing financial difficulties over the past few years. With the recent closure of Martin Luther King Jr. – Harbor Hospital, the Emergency Department has seen an increase in indigent and uninsured patients. In addition to the growing volume of uncompensated care, the ever-increasing costs of healthcare delivery and decreasing reimbursements have resulted in financial stress for the hospital.

“This sale of Centinela Hospital to Prime Healthcare Services is designed to meet the long-term needs of our patients and employees by stabilizing the delivery of health care services in Inglewood and the surrounding communities,” said Von Crockett, President and CEO of CFHS. “This is very good news indeed both for this facility and for the many people we serve.”

Prime Healthcare Services has become a respected industry leader by acquiring financially distressed and/or failing hospitals and strengthening operations through proven operational protocols: adequate capital infusion, physician driven and patient focused clinical pathways, and outcome oriented management protocols.

As is the case in all eight of the hospitals it has acquired throughout Southern California, PHS maintains open emergency departments that rarely, if ever, go on saturation/bypass.

What’s more, PHS’ hospitals offer more charity care compared to other not-for-profit and for-profit competitors. Its hospitals are award-winning facilities which consistently rank near the top of respected hospital quality assurance and accreditation agencies.

Prime Healthcare Services will operate CHMC as an acute-care facility with all services presently provided including Emergency Department services, Medical/Surgical services, Obstetric services and specialty-care services such as orthopedic/sports medicine and cardiovascular services operated as Centers of Excellence.

Under the management of PHS, it is anticipated that emergency services will be improved with increased efficiencies. Therefore, the Emergency Department will be open all the time for the patients of the catchment area, as well as for ambulance transfers from outside the catchment area that have been affected by the recent closure of Martin Luther King Jr.-Harbor Hospital.

Current employees will be retained under the new management. The current medical staff will continue to operate as an independent and autonomous entity with its elected leadership. PHS has assumed the existing contracts of health plans and physicians. CHMC will also continue its contracts with Medicare, Medi-Cal and the County of Los Angeles.

CFHS will continue to operate the Marina campus hospital, a 76-bed acute care facility in Marina Del Rey.

About Prime Healthcare Services

Prime Healthcare Services is a progressive, innovative and rapidly-expanding hospital management company in Southern California. With over 5,000 employees, PHS currently owns and operates nine acute care facilities: Desert Valley Hospital in Victorville (83-beds), Centinela Hospital Medical Center (369-beds) in Inglewood, Chino Valley Medical Center in Chino (126-beds), Sherman Oaks Hospital and the Grossman Burn Center in Sherman Oaks (153-beds), Montclair Hospital Medical Center in Montclair (102-beds), Huntington Beach Hospital in Huntington Beach (141-beds), La Palma Intercommunity Hospital in La Palma (131-beds), West Anaheim Medical Center in Anaheim (219-beds) and Paradise Valley Hospital in San Diego (301-beds), California. The PHS’ mission is to provide comprehensive quality healthcare in a compassionate, convenient and cost-effective manner. For more information, visit http://www.primehealthcare.com/

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20071031/AQW228LOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, [email protected]

Prime Healthcare Services, Inc.

CONTACT: Jana Retes of PHS, +1-760-792-9389, [email protected];or Deborah Ettinger of CFHS, +1-310-680-8098,[email protected]

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

PITTSBURGH, Oct. 31 /PRNewswire/ — Much of today’s chronic disease and disability is directly linked to lifestyle. In fact, half of the two million premature deaths that occur each year can be linked to modifiable behaviors. Unhealthy lifestyles — smoking, poor nutrition, and lack of exercise — are a primary reason for rising health care costs, absenteeism and lost productivity in the workplace.

As companies across the country look for ways to control ever-rising health care costs among their employees and help them get and stay healthier, many are turning to company-sponsored employee wellness programs. In fact, research shows that effective employee health management significantly decreases health risks and its associated costs. Solutions to the rising costs of health care are clear and simple — keep employees who are low to moderate risk from progressing to high risk status, by providing effective, evidence- based interventions. Return on Investment (ROI) studies indicate a potential ROI of $2 to $5 in health care costs for every dollar spent.

Lifestyle Returns Outcomes, Highmark Blue Cross Blue Shield’s latest consumer-driven program, is just one more way Highmark is helping members live longer, healthier lives. This program enhances Highmark’s continued commitment to wellness and its consumerism strategy. Consumerism is the demand for information that helps members take more responsibility and make more educated health care decisions.

Highmark’s original Lifestyle Returns program was created in 2005, and has now developed the Lifestyle Returns Outcomes Program. Members earn points toward employer-set rewards by participating in the program, reaching defined progress, and achieving target health goals.

“Employers and employees are taking a more active role in health care,” said Donald Fischer, M.D., Highmark’s senior vice president and chief medical officer. “Highmark Blue Cross Blue Shield is taking a multi-faceted approach, built around incentives, to help our members make the right lifestyle choices and get the right medical care.”

Lifestyle Returns Outcomes specifics

The program begins with an online pledge at the Highmark member Web site. Employees promise to be more involved in their health by taking a comprehensive self-health evaluation. They then complete a personal online health profile, and based on the results, will generate an individual Wellness Profile Report for better health. Recommendations may include participating in lifestyle improvement programs through worksite health promotion classes, online programs, or wellness programs offered through Highmark’s community network at local YMCAs and hospitals.

In addition to the pledge and profile, the program encourages members to receive preventive exams applicable to their age and gender and participate in activities. It also encourages members to receive worksite health screenings for the following key health status measures: LDL cholesterol, systolic blood pressure, Body Mass Index, tobacco use, and an HbA1C screen for self- identified diabetics. Each of these screenings has a target health goal based on medical standards and personal health data provided in the Wellness Profile. Participants who are unable to meet goals due to a medical condition, or if it is medically inadvisable to attempt to satisfy the goals, are offered reasonable alternatives to earn points.

“The merits of preventive exams and health screenings are clear,” said Fischer. “Annual exams and health screenings can help members stay on top of their health, better manage illnesses, and even save lives through early detection of serious diseases. By making health care information available by phone, online, at the worksite and in the community, Highmark is striving to provide relevant information that will allow consumers to make more informed health care decisions.”

Employers provide rewards or incentives to promote employee participation and to complete the Lifestyle Returns program. Some employers offer a cash reward, a contribution toward employees’ health savings account, a reduction in employee health coverage contributions, or offer higher level of benefits.

“The Lifestyle Returns Outcomes Program is critical in the evolution of Highmark’s Lifestyle Returns and consumerism programs,” said Fischer. “The screenings help to identify health issues and areas in need of improvement, making participants more involved and educated health care consumers. Highmark has more than 30 programs and initiatives available that can be tailored to help change lifestyles towards better health — a reward that lasts a lifetime.”

About Highmark Blue Cross Blue Shield

As one of the state’s leading health insurers and with nearly 70 years of community involvement, Pittsburgh-based Highmark Blue Cross Blue Shield serves 3.1 million members. The company’s mission is to provide access to affordable, quality health care enabling individuals to live longer, healthier lives. Highmark exerts an enormous economic impact throughout Pennsylvania. A recent study states that Highmark’s positive impact exceeded $2.5 billion. Highmark Blue Cross Blue Shield employs more than 5,000 people in the region and provides the resources to give its members a greater hand in their health.

Highmark Blue Cross Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. For more information about Highmark Blue Cross Blue Shield, visit http://www.highmark.com/.

Highmark Blue Cross Blue Shield

CONTACT: Kimberly Scanish of Highmark Blue Cross Blue Shield,+1-717-302-4244, [email protected]

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

DETROIT, Oct. 31 /PRNewswire-USNewswire/ — Health Alliance Plan (HAP) announced new statewide Medicare Supplements (or Medigap Plans) and Prescription Drug Plans (PDP) for Medicare-eligible beneficiaries who reside in Michigan.

“Our customers and Medicare beneficiaries throughout Michigan have been asking for these plans,” said Karen Wintringham, Vice President, HAP Medicare Programs. “HAP now has more options to meet the needs of individuals who want the security of having Medicare coverage beyond their basic Medicare benefits.”

Alliance Medicare Rx is a stand-alone Prescription Drug Plan that provides Medicare Part D prescription drug coverage, with benefits that offer more coverage than the standard Medicare Part D benefit. Monthly premiums range from $24.80 to $55.20.

Alliance Medicare Supplements are Medigap plans that offer protection against the gaps that exist in Original Medicare, including protection in the case of catastrophic illness.

“With Original Medicare, you’re covered for many hospital and medical expenses, but there are some gaps in that coverage that you may be paying like deductibles, coinsurance and copayments,” said Wintringham. “Medigap plans protect against what can be costly coverage gaps.”

In 2008, for example, the gaps include a $1,024 upfront deductible for hospitalization, which Medicare beneficiaries must pay before coverage begins. After 60 days of hospitalization, they begin paying $256 per day, or $512 per day after 90 days. In catastrophic circumstances there may be no additional coverage for hospitalization. Beneficiaries also pay portions of their outpatient bills and skilled nursing care. These gaps can create significant financial risk.

“When choosing a Medicare plan, it’s important to consider what’s most important to you,” advised Wintringham. “For example, if you spend more than six continuous months a year in warmer climates, then a Medicare Supplement Plan with a Prescription Drug Plan are great options to consider. If you prefer being able to seek routine services from any Medicare participating physician anywhere in the United States, then the best Medicare solution for you is probably the Alliance Medicare Supplement combined with the Alliance Medicare Rx.”

The Medicare Annual Enrollment Period for Alliance Medicare Rx runs from November 15 through December 31, 2007. Coverage for individuals who enroll during this period begins January 1, 2008. Beneficiaries may enroll in Alliance Medicare Supplement throughout the year.

To be eligible for either product, covered beneficiaries must reside in Michigan. For the Alliance Medicare Rx, beneficiaries must have Medicare Part A or Part B. For Alliance Medicare Supplement, they must have both Part A and Part B.

Individuals who have health benefits covered through an employer should ask their former company or union for advice before signing up for any plan.

About HAP

Headquartered in Detroit, the Michigan-based Health Alliance Plan is a nonprofit health plan serving more than 540,000 members and 2,000 employer groups. Alliance Medicare Rx and Alliance Medicare Supplement Plans are products of Alliance Health and Life Insurance Company, a wholly owned subsidiary of HAP. Medicare Supplement Plans are regulated and approved by the Michigan Office of Financial and Insurance Services. Alliance Medicare Rx plans are Medicare-approved health plans. The National Committee for Quality Assurance awarded HAP’s commercial HMO and HAP Senior Plus, its Medicare Advantage HMO, with Excellent Accreditation.

   IMPORTANT CONSUMER INFORMATION FOR BENEFICIARIES:    -- Now is the time for Medicare beneficiaries who do not receive coverage      through an employer to review their current medical and prescription      drug coverage for 2008.    -- Those who have health benefits from an employer group plan should ask      the company or union for advice before signing up for any plan.    -- For more information about Alliance Medicare Supplement or Alliance      Medicare Rx plans, call 800-971-7878.    -- For a free copy of an educational booklet, "Making Sense of Medicare,"      call (800) 211-3965. The booklet was published by HAP as a public      service; the general content does not promote HAP Medicare plans.    -- You may also call (800) MEDICARE or visit http://www.medicare.gov/ to compare      plans.  

Health Alliance Plan

CONTACT: Tiffany Baker, MA, Public Relations Specialist,+1-248-443-1072, [email protected], or Susan Schwandt, APR, Public RelationsDirector, +1-248-443-1076, or [email protected], both of Health Alliance Plan

Web Site: http://www.hap.org/

COSTA MESA, Calif., Oct. 31 /PRNewswire-FirstCall/ — CNS Response, Inc. (BULLETIN BOARD: CNSO) announced today that Henry T. Harbin, MD has been appointed to the Company’s Board of Directors. A psychiatrist with over 30- years experience in the behavioral health field, Dr. Harbin has served as the CEO of two national behavioral health care companies and has held numerous senior positions in both the public and private mental health sectors.

Len Brandt, chairman and CEO of CNS Response, commented, “CNS Response is extremely fortunate to add Dr. Harbin’s experience and acumen to our Board of Directors. I simply don’t know anyone who has been more at the forefront of advancing behavioral healthcare management these past twenty-five years. Beyond that, Dr. Harbin is a creative force who has already influenced our thinking on initiatives to accelerate the impact that the objective guidance of rEEG(SM) can make for patients and payers alike.”

Among his past accomplishments, Dr. Harbin served as Commissioner of the President’s New Freedom Commission on Mental Health from 2002 to 2003, chairing the subcommittee for the Interface between Mental Health and General Medicine. In addition to his Federal government experience, Dr. Harbin also spent 10 years in the public mental health system in Maryland, serving as Director of the State Mental Health Authority for three of those years.

As the chairman, CEO and President of Magellan Health Services, the country’s leading behavioral managed care organization, Dr. Harbin led a company with approximately 6,500 employees and revenues of $1.7 billion. During his tenure from 1998 to 2004, Magellan managed the mental health and substance abuse benefits of approximately 70 million Americans including persons who were insured by private employers, Medicaid and Medicare. Prior to Magellan, Dr. Harbin worked for Green Spring Health Services, Inc., one of the largest managed behavioral health organizations in the country. Dr. Harbin held several executive positions at the company, including five years as its president and CEO.

Among his achievements in research, Dr. Harbin was a principal investigator and project director for multiple studies at the University of Maryland’s Institute of Psychiatry and Human Behavior, and has served as a reviewer for the American Journal of Psychiatry, Journal of Nervous and Mental Disease, and Hospital & Community Psychiatry. Dr. Harbin has also been published in over 10 peer-reviewed articles.

Dave Jones, Managing Partner of Sail Venture Capital and a member of the CNS Response Board of Directors, remarked, “The experience and enthusiasm of the people becoming associated with CNS Response, including Dr. Henry Harbin, our new President, George Carpenter, the new Chief Medical Officer, Daniel Hoffman, MD, and others joining Len, combined with the core team, allows this company to capitalize on its extraordinary vision and opportunity.”

About CNS Response

CNS Response is a life-sciences data company focused on the commercialization of the first patented commercial system that guides psychiatrists and other physicians to determine proper treatments for patients with behavioral (mental or addictive) disorders. This technology allows CNS Response to create and provide simple reports (“rEEG(SM) Reports”) that specifically guide physicians to treatment strategies based on the patient’s own physiology.

rEEG(SM) utilizes traditional electroencephalography (EEG) in conjunction with a normative database and a proprietary clinical (symptomatic) database to identify the following: (1) medication classes most likely to be needed; and (2) medications within these classes with the most probable treatment potential for each patient. Reports are provided to physicians in a relationship analogous to that of a reference laboratory. Prospective, retrospective and field studies of treatment-resistant patients have reported treatment success of 70% or greater in managed care, outpatient psychiatric and residential substance abuse clinical settings.

In addition to providing analytical support to physicians, CNS Response is also an aide to pharmaceutical developers, who can use rEEG(SM) to (1) stratify study populations to improve the success of FDA clinical trials; (2) provide insight on effective therapeutic dosing of investigational drugs; (3) identify additional indications for psychiatric medications; (4) provide insight into effective drug combinations; and (5) discover opportunities for decision analytics and support. In addition to these applications, CNS Response continues to investigate the use of rEEG analysis for development of proprietary pharmaceutical opportunities.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995

Except for the historical information contained herein, the matters discussed are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements involve risks and uncertainties as set forth in the Company’s filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from any forward-looking statements made herein.

    Contacts:     Investor Relations:    Sara Ephraim    (646) 536-7002    [email protected]     Media:    Janine McCargo / Jason Rando    (646) 536-7033 / 7025    [email protected]    [email protected]  

CNS Response, Inc.

CONTACT: Investor Relations: Sara Ephraim, +1-646-536-7002,[email protected], or Media: Janine McCargo, +1-646-536-7033,[email protected], or Jason Rando, +1-646-536-7025,[email protected], all of The Ruth Group, for CNS Response, Inc.

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

PHNS Inc. (PHNS) announced a new long-term agreement to provide information technology services (IT) and health information management (HIM) services (including medical records, transcription and coding) to POH Regional Medical Center (POH), Pontiac, Michigan. POH, a 338 bed hospital located in Pontiac, Michigan, recently became the newest subsidiary of McLaren Health Care, a large, fully integrated health care delivery system in Michigan that owns seven other hospitals in Flint, Lansing, Bay City, Mount Clemens and Lapeer, Michigan. McLaren Health Care has outsourced all of its IT and HIM services to PHNS since 2000.

“POH expects significant benefits for its patient service capabilities through the IT and HIM services from PHNS that are enjoyed by the other McLaren Health Care hospitals,” said Patrick E. Lamberti, president and CEO of POH.

“POH and McLaren Health Care have a similar vision for delivering high quality health care at the best value possible, which will be enhanced by integrating POH into McLaren Health Care’s infrastructure that includes the excellent IT and HIM services that PHNS provides to all of our regional medical centers and locations,” said Phil Incarnati, president and CEO of McLaren Health Care.

“PHNS is excited about providing improved and cost efficient IT and HIM services for POH to help POH deliver high quality health care services,” stated Chick Young, president and CEO of PHNS.

About POH Regional Medical Center: POH, a 338-bed hospital located in downtown Pontiac, Michigan, provides primary and specialty health care services guided by the principles of Osteopathic Medicine and the values of excellence, integrity, diversity and compassion. Founded in 1953, POH has grown from one small clinic to a full-fledged medical community that includes more than 300 physicians, an inpatient hospital in downtown Pontiac and eight satellite facilities throughout north Oakland County. POH is the newest subsidiary of McLaren Health Care.

About McLaren Health Care: McLaren Health Care (MHC) is a fully integrated health care delivery system committed to meeting the health care needs of Michigan residents and to enhancing their health status. The mission of MHC is to be Michigan’s best value in health care, as defined by quality outcomes and cost. MHC has been ranked for eight consecutive years among the Top 25 Integrated Health Systems in the United States. Subsidiaries of MHC include Bay Regional Medical Center, Bay Special Care Hospital, Ingham Regional Medical Center, Ingham Regional Orthopedic Hospital, Lapeer Regional Medical Center, McLaren Regional Medical Center, McLaren Health Plan, McLaren Medical Management, Inc., Mount Clemens Regional Medical Center, POH Regional Medical Center, Visiting Nurse Services of Michigan, and Great Lakes Cancer Institute.

About PHNS: PHNS provides comprehensive healthcaring solutions for hospitals including information technology, health information management (including medical record management and storage, transcription, coding, release of information and electronic medical record services), advisory services and receivables management services. Serving more than 425 U.S. hospitals, PHNS creates business-healthy hospitals by improving operations, enhancing technology and increasing cash on hand. This allows hospitals to focus on their core competency–patient care. PHNS is a national healthcare services company headquartered in Dallas, Texas. See www.phns.com for additional information about PHNS.

IntraOp Medical Corporation (OTCBB: IOPM), a provider of innovative technology solutions for the treatment and eradication of cancer, announced today that St. Joseph Hospital in Orange, CA has selected its Mobetron® device. Mobetron directly delivers intraoperative electron radiation therapy (“IOERT”) to patients as they undergo surgery in a highly safe and efficient manner.

St. Joseph Hospital is one of 14 hospitals in the St. Joseph Health System, with facilities located throughout California and Texas. The St. Joseph Hospital Cancer Center, established in 1987, is the only center in Orange County to provide comprehensive cancer care, including a full range of diagnostic services, chemotherapy, radiation therapy, surgery, clinical trials, and stem cell transplants.

Recently, the center became one of 16 hospitals named by the National Cancer Institute (NCI) to participate in a three-year pilot for the NCI Community Cancer Centers Program (NCCCP), to deliver the most advanced cancer care to a greater number of Americans in the communities in which they live. St. Joseph Hospital was the only hospital on the West Coast named for the NCCCP pilot. The hospital currently treats more than 1,500 new cancer patients each year.

Mobetron will be used at St. Joseph Hospital to safely and efficiently treat a wide variety of cancers, including breast, colorectal, head and neck, and abdominal cancers. With Mobetron, radiation and surgical oncologists can pinpoint the exact area that requires radiation and immediately deliver high doses directly to the affected tissue during cancer surgery. Hospitals can wheel Mobetron between existing operating rooms without investing in costly renovations to accommodate traditional radiation therapy devices. Key patient benefits of this early and powerful start to radiation therapy include: better local tumor control, increased survival rates, shorter treatment cycles and fewer side effects.

“We are pleased to be able to offer Mobetron as an integral part of our cancer treatment program,” said Dr. Robert Ash, Radiation Oncologist at St. Joseph Hospital. “The acquisition of this important cancer-fighting device strengthens our efforts to be a world-class treatment facility and supports the hospital’s mission to continue to improve the health and quality of life of the people in the communities we serve.”

John Powers, CEO of IntraOp Medical said, “Mobetron is fundamentally changing the way cancer patients are being treated today and positively impacting their survival. We look forward to working closely with St. Joseph Hospital to provide the most advanced medical technology available to effectively and efficiently treat cancer. The hospital’s decision to use Mobetron demonstrates St. Joseph’s commitment to provide the very best medical care to its patients.”

Other U.S. institutions currently using Mobetron include: Clarion Methodist Hospital Indianapolis, Mayo Clinic Phoenix, Ohio State University, St. Vincent Indianapolis Hospital, University Hospital Cleveland, University of California San Francisco, University of Louisville and University of North Carolina.

For more information on St. Joseph Hospital, please visit: www.sjo.org.

About IntraOp

IntraOp Medical Corporation provides innovative technology solutions for the treatment and eradication of cancer. Founded in 1993, IntraOp is committed to providing the tools doctors need to administer radiation therapy safely and effectively — for all cancer patients. The company’s flagship product, Mobetron, is the first fully portable, self-shielding intraoperative electron radiation therapy device designed for use in any operating room. Key Mobetron benefits include: increased survival rates, better local tumor control, shorter treatment cycles, and fewer side effects. Leading hospitals, from university research centers to specialized cancer clinics in North America, Europe and Asia, use Mobetron as a vital part of their comprehensive cancer program.

For more information on IntraOp Medical Corporation, please visit www.intraopmedical.com.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the 1933 Securities Act and Section 21E of the 1934 Securities Exchange Act. Actual results could differ materially, as the result of such factors as competition in the markets for the company’s products and services and the ability of the Company to execute its plans. By making these forward-looking statements, the Company can give no assurances that transactions described in this press release will be successfully completed, and undertakes no obligation to update these statements for revisions or changes after the date of this press release.

By Orenstein, Beth W

In early September, Paulette Nish, clinical director of women’s and children’s services, looked at the neonatal intensive care unit at Community Medical Center (CMC) in Scranton and said,”Today, I have 10 babies.”

None of the neonates were born at CMC.The hospital dosed its labor and delivery department in August.All the babies in CMC’s neonatal intensive care are transfers.

Nish does not expect the situation to change. CMC will continue to operate a Level 3 neonatal intensive care unit, but it will rely strictly on transfers for its tiny patients.

About the same time, Mercy Hospital in Scranton closed its obstetrical services as well.

Moses Taylor Hospital (MTH), a third hospital in Scranton, is the only one in Lackawanna County to offer obstetrical services.

Nish said CMC dosed its maternity floor because it did not have enough obstetricians to deliver babies.

“We had a group of five plus we had a few independent practitioners,” she said.”One by one, they left, and if you don’t have enough physicians, you have to depend on physicians who will come to work in an area, and from a patient satisfaction perspective, that isn’t good.The patient might see five different doctors five appointments in a row. That’s not a quality way to run a service, Nish said.

CMC has a protocol in place should a woman arrive at the emergency room and be ready to deliver imminently. However, the mother and baby would be transferred to Moses Taylor for post- delivery care.

MTH has 26 private mom/baby and 11 private labor/birth suites. In 2005, it spent about $10 million to upgrade its birthing suites and family and clinical space.

MTH offers two obstetricians and a neonatologist in-hospital 24/ 7, and is adding perinatology services. Moses Taylor also has a Level 3 Neonatal Intensive Care Unit (NICU) with 15 beds.

CMC’s decision to dose its maternity unit comes as it and MTH have sought to form an operational and financial alliance.

The hospitals applied to the state for approval for their collaborative agreement about a year ago and still are awaiting a decision.

“We’re waiting for the regulatory approvals, said Karen Murphy, vice president of planning for MTH. “We have not proceeded on anything except what is required for the regulatory approvals.”

Nish was not sure how long it would take for the agreement to be completed. “We thought the whole process would be completed by the end of the summer, maybe the beginning of September. But right now there is no timeframe that we’re talking about.”

Nish said if the two hospitals forge an affiliation, it would be good for the community. Very often, she said, with neighboring hospitals, some services are offered at one and some services are offered at the other.

“Many facilities are run that way,” she said. “Other facilities throughout the United States have done this and have many campuses that have offered different services”

The success, she said, depends on communicating with the public so that patients know where they need to go for what service.

Nish said the arrangement “optimizes care for the patient. If you look at integrating offering all subspecialties in grating one area, it’s a benefit because ….It maximizes what we can offer to the community.”

Murphy agreed.

About 30 people from the labor and delivery staff at CMC are working at Moses Taylor.

“We’re sharing resources a little, Nish said. “We have an arrangement so they’re able to work at that campus. They’re just working at the other site.”

The Family Birthing Suites at Moses Taylor Hospital have been ranked in the top 1 percent of hospitals in the nation with obstetrics services for patient satisfaction, according to Press Ganey surveys.

Statewide, 33 obstetrics units have closed since 1997; in 20 just the OB closed, in 13 it was the entire hospital that closed.

Every year, more than 145,000 babies are born in hospitals in Pennsylvania, according to Hospital Association of Pennsylvania (HAP) About 2,500 to 3,000 babies had been born annually at the three hospitals in Scranton.

Moses Taylor now expects roughly 2,900 births a year at its Family Birthing Suites. Last year, it delivered 2,000 babies.

Wayne Memorial Hospital in Honesdale reports its maternity unit anticipates a surge in deliveries due to Scranton’s obstetric shuffle.”The local Ob/Gyn group added another nurse midwife this summer, bringing-their total of nurse mid-wives to three, in addition to three obstetricians,” says Heather Holmes,Wayne Memorial’s New Beginnings Unit (maternity unit) coordinator. On our maternity unit, we hired a new head nurse who has extensive experience with neonatal care. We also have state of the art monitoring equipment, which allows our nurses to spend more time with mothers and less time on paperwork. We consistently score high on patient satisfaction surveys. In short, when the surge hits, we’ll be ready,” she said.

The New Beginnings unit has 14 beds at present and births between 400 and 500 babies a year “We record extremely good outcomes in the wake of what’s happening in Scranton; Holmes said.

HAP’s recent report said that the birth rate has remained stable but that the percentage of low birth weight (2500 grams or less) babies needing more specialized care has been increasing.

Copyright Northeast Pennsylvania Business Journal Oct 2007

(c) 2007 Northeast Pennsylvania Business Journal. Provided by ProQuest Information and Learning. All rights Reserved.

By Simchak, Margery

Complete Childbirth Class PowerPoint Presentation 4-CD program. $495

One-time customization fee. $99.95

Each additional user license, $99.95

Ages 13-adult

Released 2006

AVAILABLE FROM:

Injoy Videos

7107 La Vista Place, J4

Longmont, Colorado 80503 USA

800/326-2082

www.injoyvideos.com

Childbirth Education is being revolutionized by Injoy’s recent production, Complete Childbirth Education Power Point Presentation. No longer does the childbirth educator have to drag charts, posters, videos cassettes, models, or even notes to the childbirth education classroom. The educator only needs a small case containing 4 CDs and a laptop computer. Of course, the facility must have the necessary equipment so that the information on the computer screen can be projected to a screen that is large enough to be viewed by several people at one time. With this program, those who manage and direct childbirth education programs will know exactly what is being presented in class, and, most of all, that the information being presented is correct.

Even though this program standardizes the class content, it still allows and mandates individual input from the educator and much opportunity for class participants to ask questions and input their thoughts. This presentation is information-rich as its name implies and yet sprinkled with laugh breaks, color cartoons, sound effects, dancing, pop-up and fading words, fun facts, and cultural diversity. There are no perineal shots and no actual birth scenes. Babies are shown breastfeeding, but little of the breasts are seen.

CD 1 : Pregnancy Topics, Pain Theories, Pre-Labor Signs

The first disk contains information on pregnancy topics, pain theories, and pre-labor signs. It begins with information that one would include in every first childbirth class – housekeeping information such as information about breaks, locations of supplies, and location of the bathrooms. Then there are a couple of cute ice breakers and the mission statement is presented: to learn about childbirth topics in a fun, comfortable, and respectful class environment. The program then moves into the curriculum: labor pain and pain theories, pre-labor, breathing and relaxation, and anatomy, explaining changes in pregnancy. At this point there is a little icon in the lower right corner noting that a one-minute, fifteen- second video is available for viewing that explains with more detail the last point, changes in pregnancy with moving graphics and narration. The educator can show it with a click on the icon. There are sound effects throughout the presentation, but narration is only heard when video is being shown.

The next topic is nutrition in pregnancy. Cartoons are used to demonstrate healthy foods. The pregnant woman only needs 300 more calories a day. The screen shows what kinds of foods equal 300 calories. Weight gain and fluid intake is covered. Danger signs are then presented in list format. The educator must click for each additional danger sign to be shown on the screen. The educator should read the list and make additional comments if appropriate. Rupture of membranes is one of the danger signs. The acronym COAT is given to the viewer as a reminder of what to report to the caregiver when reporting rupture of membranes: color, odor, amount, and time. A little cartoon picture of a coat appears on the screen to help the viewer remember the acronym. Facts about proper body mechanics appear on the screen. Optional: three 1 -minute videos are offered in the lower corner that include moving from bed and furniture, traveling in a car, and working at a desk. Advantages of Kegels appear on the screen, but no description of how to do them. The educator would have to describe how to do Kegels.

The next screen is Pregnane/ Topics Review and then Group Discussion with two discussion topics. The discussion topics are: 1 .) What is your previous experience with pain? and 2.) How do you imagine labor pain will be different from previous pain? The educator would facilitate the discussion and then click for the next topic. The cycle of fear, tension, and pain is shown with colorful letters. The educator must explain the screen. Another acronym is presented PAIN: purposeful, anticipated, intermittent, and normal.

The Four Ps of labor are shown: passageway, passenger, powers, and psyche. Great graphics accompany this topic. Early signs of labor, lightening, show, and prenatal bonding are well-reviewed. The educator has two options to explain prenatal bonding through visualization. The narrator can present the image in a less than 2- minute video or the educator can click on the “music only” icon and describe the imagery herself with soothing music in the background. The same option is available for the topic, progressive relaxation. The guided exercise is 5 minutes; the music only is 4 minutes. The first CD concludes with several breathing styles, again with wonderful graphics and sound effects. The cleansing breathe is mentioned, but not described.

Each CD ends with a short slide show of wonderful pictures of nature, mothers, babies, dads, and even grandmothers accompanied by soothing background music. Each picture has a heartfelt message, some from famous writers and some from unknown writers. The slide show is such a peaceful and positive way to end a childbirth class.

CD 2: Stages of Labor, Comfort Measures. Labor Positions

The second CD opens with a welcome exercise as an ice breaker. The topics for this class are listed. Onset of labor is described. As with the previous CD, the educator must read the screen and click after each point. Labor characteristics and its stages are easy to explain as the program proceeds because the facts listed are logical and complete and the accompanying graphics are excellent. Nature of contractions, sensations, support people’s roles, best environment, length of labor, and emotions are presented. What to pack for labor is shown. The group members are asked about their support teams. The educator would again facilitate that discussion. A “Questions?” slide with cute babies is presented between basic topics. The videos on this CD include thoughts and advice from new mothers and fathers, and scenes with women in various labor positions being supported by the health care team and others.

Gate control theory is described as a preface to comfort techniques. Touch relaxation includes two videos. Again, a 3-minute one is narrated and a 4-minute one is music only. A massage video shows different types of massage and explains why massage comforts the laboring woman.

Attention focusing and distraction are both well-validated with two 30-second videos. One just shows a clock ticking away – 30 seconds which seems like forever. The second 30-second video shows various relaxing scenes of nature such as moving clouds in a beautiful blue sky and peaceful waterfalls. The second 30-second video seems to be much shorter.

The class content proceeds with a visual imagery exercise, focal point ideas, hydrotherapy, and tips for support partners. Slow breathing is reviewed with graphics and sound effects. Many labor positions are shown and avoidance of back-lying is emphasized. Labor positions are shown and described with a discussion of how certain positions can even enhance labor. Paced breathing and patterned breathing are shown with graphics suggesting when each would work best. Discussion of how to use a birthing ball is included. The last part of CD 2 includes tips for coping with back labor, breathing during pushing, and positions for pushing.

The CD ends again with another wonderful short slide show. One slide show message is “breast milk is soul food” and another is “a father carries pictures where his money used to be.”

CD 3: Interventions, Pain Medications, Cesarean Birth

Another welcoming exercise opens this CD and then presents the topic of this CD: what a birth plan is and is not. Group discussion follows: Have you prepared a birth plan?

Interventions may be necessary, but questions should be asked before they are done. An excellent list is presented to the viewers, which includes the risks and benefits and what would happen if one decided to wait. Inductions should not be for anyone’s convenience. Additional topics on this CD that are presented well are augmentation, amniotomy, intravenous fluids, external and internal electronic fetal monitoring, fetal scalp sampling, vacuum extraction, forceps, analgesics, and epidural anesthesia. Not all sub-topics are described perfectly, but each has excellent graphics so the educator could easily fill the informational gaps. Benefits and risks are listed for each.

Extended time is spent on epidural anesthesia as well it should be because of its worldwide popularity. A 4-minute video shows the administration position with excellent graphics. The needle insertion is not shown on the laboring mother during the video; the injection is only shown on the graphic. Epidurals should not be administrated before 4-5 cms vaginal dilation. The viewer is advised to wait a bit after full dilation before pushing. Risks and benefits are presented with this intervention also.

Cesarean is also well-covered with information, graphics, and videos. There are two videos, one of an unplanned cesarean and the other of a planned cesarean. One suggestion given on how to avoid a cesarean is hiring a doula. The slide show at the end of this CD is especially appreciated by this grandma reviewer as one of the slides shows a grandma with a baby and a quote from Theresa Bloomingdale, “If your baby is beautiful and perfect, never cries or fusses, sleeps on schedule, burps on demand, an angel all the time… you’re the grandma.”

CD 4: Postpartum, Newborn Procedures and Appearance, Basic Breastfeeding

Another welcoming exercise opens this video along with information about the topics included on this CD. Postpartum physical and emotional characteristics are covered well. Comfort measures are included; including ice packs the first day and then Sitz baths. Two short videos are optional that well explain postpartum blues which occurs in 80% of new mothers and another on the more serious postpartum depression. Dads can also feel blue after the baby is born. Excellent advice is given to those women who feel depressed or frustrated with the overwhelming new responsibilities that go along with caring for a newborn. Newborn appearance and required newborn medical procedures are reviewed. A baby’s innate ability to respond to the environment is nicely explained. The six stages of baby consciousness are reviewed using movies of babies. A baby is shown trying to shut down the surrounding stimuli.

Shaken baby syndrome is presented outstandingly. One suggestion given for the caretaker is to hug a pillow when frustrated, and to pray or breathe deeply. Of course, the best suggestion is to ask for help in caring for a new baby and move out of the environment if necessary until one has calmed down. Recommendations for preventing sudden infant death syndrome (SIDS) are listed.

Breastfeeding begins with a group discussion about the knowledge and the attitude that the group already has. Then basics facts are covered well. Again, using graphics, proper latch-on and positioning methods are reviewed. Advantages of breastfeeding, when to feed, and positioning for feeding are nicely covered. A fun fact that is mentioned is that holding a baby for more than two hours skin-to- skin after birth can increase breastfeeding success by 80%.

The last CD concludes with a refresher labor rehearsal, reviewing each type of breathing pattern and when they can best be used. Comfort measures and encouragement are emphasized. A final slide show of cute babies and sweet messages are the very last of the fourth and final CD.

The PowerPoint presentation solves so many of the previous unsolvable problems of educators. Having appropriate posters in order while lecturing has always been difficult; so too is comparing one poster to another. Frequently, when explaining anatomy, the educator would use one or two 2-dimensional posters plus the educator’s own body and then a three-dimensional model. How confusing that could be to the learner! The mechanics of moving from lecture to group discussion to videos could often result in loss of the learners’ attention. All educators know that it is difficult for a term pregnant woman to sit for 20- to 30-minute movies and yet much information was best understood if it could be presented in moving picture form. Educators want their class members to see a real person in labor using suggested comfort techniques. Pregnant couples want advice from new parents as well as health professionals.

The video clips in this CD package are not longer than 5 minutes, yet every necessary scene is shown during the PowerPoint presentation. Because posters are cumbersome, educators use them only if necessary and yet research tells us that most people are visual learners. This PowerPoint presentation lists every fact on the screen. As the educator reads it, the viewer reads it in their mind and sees it. The more senses used, the more that is learned. Because the educator has power over the click to move to the next fact, the educator determines the unique pace of that particular class. The extroverts in the class will probably ask questions any time, but the introverts will probably wait until the cute baby “Questions?” or “Review” slide comes up, especially if the educator waits and allows silence for a few seconds at this time. The educator can give the class a break at any time. Instead of asking vis a vis questions during class breaks, many educators are preparing to show a video or coordinate other visual aids for the second half of class content. This will not happen with this media package. Breaks can become a time for answering one-on-one questions from learners with unique problems. The class resumes with a simple click.

There were a few graphics that were too dark and at one time the words were out of sync with the talker in a video. Perhaps Injoy can fix those small defects. Injoy is also available to customize this program to fit your teaching needs for a one-time fee of $99.95. If more than one person is using the program a facility can purchase an additional user license for $99.95. An excellent facilitator’s guide comes with the CD package which includes pictures of all the slides and PowerPoint tips.

This is not a “take home” audiovisual birth preparation media. Although it covers all the necessary information of a childbirth education class, it still needs a knowledgeable educator to present it. This is a very expensive program to produce and it is one that could only be produced by experts in the media field. All efforts should be made to avoid copyright infringement. Injoy deserves to recover its production costs plus a profit so that they will continue to offer educators quality, current media.

This reviewer has reviewed hundreds of childbirth education audiovisual aids and has never been as excited about using a new educational media as she is about using this one. Most childbirth educators will delight in using this new media.

Most childbirth educators will delight in using this new media.

Copyright INTERNATIONAL CHILDBIRTH EDUCATION ASSOCIATION Sep 2007

(c) 2007 International Journal of Childbirth Education. Provided by ProQuest Information and Learning. All rights Reserved.