The News & Observer, Raleigh, N.C., Under the Dome Column

By Barbara Barrett and Ryan Teague Beckwith, The News & Observer, Raleigh, N.C.

Jul. 29–U.S. Sen. Elizabeth Dole will be a no-show at her party’s big bash in St. Paul, Minn.

Dole spokeswoman Katie Hallaway confirmed Monday that Dole won’t be at the Republican National Convention in September.

“She’s got a busy week scheduled in North Carolina,” Hallaway said. “When there are breaks in the Senate schedule, she spends as much time as possible in North Carolina.”

Hallaway said nothing should be inferred about Dole’s missing the convention — either about her support for Sen. John McCain or about the security of her re-election in November.

Dole is in a tough battle for re-election against Democratic state Sen. Kay Hagan. Dole will be visiting with businesses, organizations and other constituent groups, but Hallaway said the schedule is not final.

She also is one of the bona fide rock stars of the GOP, the type of speaker who could rally the faithful. Dole had a prime time TV speaking role at the last GOP convention in New York City, where she praised President Bush and talked in support of traditional marriage, freedom of religion and the sanctity of life.

A spokeswoman for Hagan said she had not decided whether to attend the Democratic National Convention next month in Denver.

Easley to have surgery

Gov. Mike Easley will undergo shoulder surgery today.

The two-hour surgery will remove bone spurs from his right shoulder area damaged by “extensive use of the shoulder during exercise, sports and physical activities over several years,” said his doctor, Dr. Bill Garrett, in a statement.

“He will be able to work but will be wearing a sling for the next three to four weeks,” Garrett’s statement said. “I am advising the governor to restrict activity for several months and to refrain from high-impact or strenuous activity like contact basketball, golf, shooting shotguns, weight lifting or NASCAR driving until next year. We might suggest he sign bills lefthanded as well. His signature will not be any worse.”

Easley’s activity will be restricted for several months. The surgery at Duke Hospital in Durham will involve only local anesthesia, and Easley will remain governor during the surgery.

Health-care donors

Beverly Perdue has received $98,500 from health-care-related political action committees.

Committees representing drug companies, health-care providers, insurance companies and industry associations were the single largest group of PAC donors to the Democratic gubernatorial candidate, according to campaign finance reports.

They made up about a fourth of the $376,293 she raised from PACs since her re-election in 2004. Other politicians’ campaign committees were a close second, contributing $91,933, with about a third of that coming from other Democratic senators.

The biggest donors were the N.C. Hospital Association and the NP PAC, which represents nurse practitioners. Both gave $8,000. PACs for the Asheville Anesthesia Associates and the Association for Home and Hospice Care of N.C. gave $5,000 apiece.

Drug companies whose PACs donated included GlaxoSmithKline, AstraZeneca, Roche, Eli Lilly, Novartis, Wyeth, Pfizer and Abbott Labs. Pharmacy chains such as Kerr Drug, pharmacist managers Medco Health and Caremark and the PILL PAC, which represents pharmacists, also gave.

Perdue also received money from trade groups: the N.C. Medical Society, the N.C. Health Care Facilities Association, the N.C. Association of Nurse Anesthetists, the N.C. Assisted Living Association, the N.C. Association of Long Term Care Facilities and the N.C. Orthopaedic PAC.

Perdue previously worked at a hospital and has made health care a signature issue.

State employees picks

The State Employees Association of North Carolina has made its endorsements.

The group’s Employees Political Action Committee, also known as EMPAC, made 16 endorsements in statewide races after meeting Saturday.

The group endorsed several incumbents: Attorney General Roy Cooper, Secretary of State Elaine Marshall, Superintendent of Public Instruction June Atkinson and Appeals Court judges John Arrowood, Doug McCullough, Linda Stephens and Jim Wynn.

The others: Perdue for governor, Walter Dalton for lieutenant governor, Wayne Goodwin for insurance commissioner, Ronnie Ansley for agriculture commissioner, Mary Fant Donnan for labor commissioner, Suzanne Reynolds for Supreme Court and Kristin Ruth for Appeals Court.

The list includes one Republican: State Auditor Les Merritt.

[email protected] or (202) 383-0012

By Washington correspondent Barbara Barrett and staff writer Ryan Teague Beckwith.

—–

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Copyright (c) 2008, The News & Observer, Raleigh, N.C.

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Lexicon Pharmaceuticals’ Drug Candidate for Irritable Bowel Syndrome Completes Phase 1 Clinical Trial Showing Positive Results

THE WOODLANDS, Texas, July 29, 2008 (PRIME NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has successfully completed a Phase 1 multiple-dose escalation study in normal volunteers with LX1031, its oral drug candidate for irritable bowel syndrome (IBS). The company plans to progress the new drug candidate into Phase 2 studies in the fourth quarter. LX1031 is one of four programs in human clinical trials as part of Lexicon’s 10TO10 program.

“LX1031 will be our second drug candidate to enter Phase 2 testing,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer. “Our drug discovery strategy is continuing to produce a pipeline of drug candidates working through novel mechanisms that could ultimately enhance the lives of patients worldwide.”

The recently completed trial was a randomized, double-blind, ascending multiple-dose study in which all dose levels were well tolerated over 14 days and no dose limiting toxicities were observed. LX1031 is designed to treat symptoms associated with IBS by decreasing the production of serotonin in the gastrointestinal tract. Serotonin is a key regulator of gastrointestinal sensation and motility. Importantly, the study showed that LX1031 decreased urinary 5-hydroxyindoleacetic acid (5-HIAA), a metabolite of serotonin and biomarker for serotonin production, at all dose levels tested as compared to the placebo group. These results are consistent with a significant reduction in gastrointestinal serotonin synthesis. Doses tested in this study were 250 mg, 500 mg, 750 mg, and 1,000 mg, each administered four times daily. Data from this study will be utilized to select a dosing regime for the Phase 2 proof-of-concept clinical trial.

“LX1031 has demonstrated an excellent safety and tolerability profile in Phase 1 clinical studies, consistent with our observations in preclinical studies,” said Philip M. Brown, M.D., J.D., senior vice president of clinical development at Lexicon. “We are eager to assess LX1031 in patients suffering from IBS, who have limited treatment options.”

Phase 2 Study

Based on the successful outcome of this Phase 1 study, Lexicon expects to initiate a Phase 2 proof-of-concept clinical trial in IBS patients in the fourth quarter of this year. The clinical trial is planned as a four-week, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and effects of LX1031 on symptoms associated with IBS.

About LX1031

LX1031 is an oral drug candidate for IBS and other gastrointestinal disorders. LX1031 was generated by Lexicon medicinal chemists, and its target was internally identified as a key control point for the regulation of peripheral serotonin levels. LX1031 is designed to act locally in the gastrointestinal (GI) tract by reducing the serotonin available for receptor activation, without affecting serotonin levels in the brain or its central nervous system functions. In preclinical studies, LX1031 showed a dose-dependent reduction of serotonin levels in the GI tract.

The target of LX1031 is tryptophan hydroxylase (TPH), a key enzyme in the synthesis of serotonin. Lexicon discovered that mice lacking TPH1, the form of this enzyme found predominantly in the gastrointestinal tract, have virtually no peripheral serotonin but normal levels of brain serotonin.

LX1031 is being developed in a product development collaboration with Symphony Capital Partners, L.P. and its co-investors.

About Irritable Bowel Syndrome

Irritable bowel syndrome is a disorder most commonly characterized by cramping, abdominal pain, bloating, constipation or diarrhea. Symptoms of IBS are believed to be mediated through serotonin, a neurotransmitter that is produced primarily in the GI tract, which has been shown to play an important role in modulating motility and signaling feelings of GI discomfort to the brain.

About Lexicon

Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, cognitive disorders, diabetes and irritable bowel syndrome, all of which were discovered by the company’s research team. The company is using its proprietary gene knockout technology to characterize approximately 5,000 genes in its Genome5000(tm) program, and has discovered more than 100 promising drug targets. Lexicon has applied small molecule chemistry and antibody technology to these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. Lexicon’s goal is to advance 10 drug candidates into human clinical trials by the end of 2010, the strategic objective of its 10TO10 program. For additional information about Lexicon and its programs, please visit www.lexpharma.com.

The Lexicon Pharmaceuticals, Inc. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=4799

Safe Harbor Statement

This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of LX1031, and the potential therapeutic and commercial potential of LX1031. This press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to successfully conduct clinical development of LX1031, and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Factors Affecting Forward-Looking Statements” and “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2007, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

This news release was distributed by PrimeNewswire, www.primenewswire.com

 CONTACT:  Lexicon Pharmaceuticals, Inc.           Bobbie Faulkner, Manager, Investor             and Public Relations           281/863-3503           [email protected] 

“Some Benefit” or “Maximum Benefit”: Does the No Child Left Behind Act Render Greater Educational Entitlement to Students With Disabilities

By Daniel, Philip T K

I. INTRODUCTION The No Child Left Behind Act and the congressional reauthorization of the Individuals with Disabilities Education Improvement Act (IDEA) caused researchers to question whether the provision in the IDEA governing Free Appropriate Public Education should be revised to better serve the interests of special needs children. For each student protected by the IDEA, an instrument must be developed to serve the child’s unique needs, and part of this requirement is the promotion of participation in the general curriculum. As determined by the national government, standards of achievement measured by assessment instruments are cornerstones of this new approach to education. This study examines federal legislation, including statutes, regulations, and case law interpreting whether a student is entitled to “some benefit” or to a maximum benefit in education. A preliminary analysis suggests that the interpretation found in Board of Education of the Hendrick Hudson Central School District v. Rowley1, has changed little over the past quarter century. The United States Office of Education, however, may have a different opinion. Their recent study states that that further guidelines and research are important to establish before school personnel, parents, children, and the attorneys who represent each have a definitive position on this very important topic.

II. THE ROWLEY DECISION

The educational rights of students with special needs are created and protected primarily through the Individuals with Disabilities Education Act (IDEA).2 The Act provides extensive, detailed substantive and procedural rights and protections for disabled children and their parents. The Act’s fundamental premise is that all special needs children are entitled to a free appropriate public education (FAPE). Since the enactment of IDEA, there has been a great deal of litigation regarding what constitutes a FAPE. At the heart of this litigation is the definitive U.S. Supreme Court case of Rowley, which interpreted IDEA’S3 statutory definition of the term. The Court held that the statute does not require that a particular substantive standard be used to measure whether the education provided a special needs child is appropriate. In Rowley, the Court enunciated what it considered to be a “tolerable”4 standard for regulating the content of educational programs:

Insofar as a State is required to provide a handicapped child with a “free appropriate public education,” we hold that it satisfies this requirement by providing personalized instruction with sufficient support services to permit the child to benefit educationally from that instruction. Such instruction and services must be provided at public expense, must meet the State’s educational standards, must approximate the grade levels used in the state’s regular education, and must comport with the child’s IEP [Individualized Education Program]. In addition, the IEP, and therefore the personalized instruction, should be formulated in accordance with the requirements of the Act and, if the child is being educated in the regular classrooms of the public education system, should be reasonably calculated to enable the child to achieve passing marks and advance from grade to grade.5

The Court found that establishing a test for all children covered by the Act would be too difficult6 and therefore confined its analysis to Rowley plaintiff’s unique circumstances. The conclusion that education is appropriate if the child is achieving passing grades and advancing from grade to grade is implicit in the Court’s reasoning. Rowley therefore established that equal access, rather than equal opportunity, was the IDEA’S goal.7 Through its decision in Rowley, the Court established a “basic floor of opportunity” which need only be “individually designed to provide educational benefit to the handicapped child.”8

Unfortunately, as later lower court opinions confirmed, in attempting to set forth a functional standard for the FAPE element of the IDEA, the Rowley Court created more ambiguity than clarity for educators seeking to meet the statutory requirements. Lower courts have been left to struggle with the question of how the benefit is to be measured and how much is required to qualify a disabled child for a free appropriate public education. For example, cases that immediately followed the Rowley decision interpreted the “some educational benefit” test as establishing a standard that does not require a school to provide the best education that money can buy.9 In construing the Rowley educational benefit standard, the trend of cases reflect that special education should produce satisfactory or meaningful progress toward achievement of a disabled child’s unique educational needs.10

III. NATIONAL STANDARDS IN EDUCATION

Given the increasing national focus on standards and educational adequacy requirements, it is argued that Rowley and the “some benefit” language no longer accurately reflect the FAPE requirements in the IDEA.11 The catalyst for such a position is featured in the contemporary American experiment in accountability, based on student achievement, involving universal educational standards for each grade level and high stakes proficiency testing for every student.

Accountability and Testing

At one level, accountability represents a response to poor study and work skills, and substandard overall test scores on the part of all students, especially those representing protected populations. In 2002, the United States Congress, relying on the perceived success of programs in states such as Ohio, Texas, and North Carolina, radically restructured federal education funding by imposing new accountability procedures on every state. This new legislation, entitled the No Child Left Behind Act (NCLB), is a federal spending statute, authorizing and combining under one rubric, those funds to be allocated for K-12 education programs.12 Through the “spending clause” of the United States Constitution,13 the federal government has extended itself into American education on a national level as never before. As a profound shift of authority over educational policy tilted toward the national government and away from the states, this mandate prescribed accountability guidelines for states, districts, and schools. The Act held states accountable by measuring student performance in state tests based on a state’s general curriculum.

Assessment tests, aligned with challenging content and achievement measures for all students, are designed to accomplish accountability. States are required to administer these tests periodically. Within the core of NCLB, a number of measures are designed to drive broad gains in student achievement, and to hold states, school districts, schools and school personnel more accountable for student progress. States must establish “challenging academic content standards” and “student achievement standards” to ensure an adequate education for all students. For example, beginning in the 2002-2003 academic year, states had to furnish annual report cards showing a range of information, including achievement levels for students and targeted ethnic and socioeconomic populations; school-by-school data was also required to demonstrate this report card responsibility.-Furthermore, by the year 2005-2006, states began testing students in grades 3-12 against statewide standards in literacy, mathematics, and science. The tests had to align with state academic standards and each state had to participate in the National Assessment of Educational Progress testing program in reading and math to form year-to-year comparisons of achievement. With the national NCLB mandate, through programming states had to bring all students to a proficient level on state tests. Individual schools must meet state adequate yearly progress targets toward the proficiency level goal (based on a formula spelled out by law) for the student population as and certain demographics.

Students with special needs are a group singled out for protection under NCLB. Early on while enacting the legislation, Congress recognized the need to educate such students using the same standards as those without disabilities. Exposure to the general curriculum was initially required, and determination of progress was assessed with the same testing instruments to determine whether all students were making annual yearly progress.

Organizations supporting the needs of disabled children praised the legislation. The Disability Rights and Education Defense Fund stated that the Act “bolster[ed] the right of special needs students to participate . . . and make progress … in the general education curriculum … It put[s] an end to the processing and hoop jumping that students . . . endure … to improve their chances of getting the support they need.”14 Student disability rights organizations supported the notion that the law had an even stronger incentive than some disability statutes to align the education of special needs students with a state’s general education content.15 This meant that such students would integrate more into regular classrooms beyond social opportunities. Most of these students would be expected to reach the same level of proficiency as their non- disabled peers. This legislation was viewed as significant and as representing a noteworthy cause. Hence, few would disagree with the intent of this statute; to help educators and parents reconcile educational approaches with the needs of all students, particularly those with low-achievement scores, so as to substantially improve the chances of academic success. IV. IDEA 1997 AND 2004 REAUTHORIZATION

The Individuals with Disabilities Education Improvement Act (IDEA) continues to define FAPE as “special education and related services that . . . meet the standards of the state educational agency.”16 The definition is parallel to the original language of the legislation, but today it carries a more academic-centered meaning. At the time the Supreme Court decided Rowley in 1982, most state standards spoke to the process in which services would be provided to students, but did not involve substantive requirements for provision of the educational services. Today state and federal performance objectives address the essence of what students should know and be able to do. The standards-based reform movement has incorporated language in guidelines to educational institutions regarding curriculum content, expected levels of demonstrated achievement, and benchmarks based on assessment measures. Under current mandates, in order to accomplish FAPE, students without special needs must meet state curricular and achievement standards for their respective grade levels.17 These standards are based on content and proficiency standards rooted in a core curriculum which each state must create along with specific assessment measures.

The standards-based approach was integrated into the statute in two reauthorized phases. The 1997 IDEA amendments were the first to require demonstrated assessment of students with disabilities, marking a significant shift from the Supreme Court’s decision in Rowley. These amendments established high expectations for special needs children to achieve real educational results. The amendments changed the focus of IDEA from merely providing access to an education, as the Court noted in Rowley, to requiring measured educational improvement. These changes were made explicit in the House Committee Report:

This Committee believes that the critical issue now is to place greater emphasis on improving student performance and ensuring that children with disabilities receive a quality public education. Educational achievement for children with disabilities, while improving, is still less than satisfactory.

This review and authorization of the IDEA is needed to move to the next step of providing special education and related services to children with disabilities: to improve and increase their educational achievement.18

The No Child Left Behind Act, signed into law in early 2002, emphasized high academic standards for all children. As noted, this included disabled children. Under NCLB, state content standards must: 1) specify what children are expected to know and do; 2) contain rigorous content; and 3) encourage the teaching of advanced skills.19 State achievement standards must be aligned with content standards and must describe two levels of high achievement: proficient and advanced.20 A third level of achievement called “basic” is required to provide complete information about the progress of students towards meeting the proficient or advanced levels.21 NCLB makes it clear that, under federal law, students with disabilities are entitled to and expected to meet the same high academic standards as non-disabled children.

The standards movement assumes that all students can achieve high levels of learning if they receive high expectations, clearly defined standards, and effective teaching to support achievement. These high expectations in state education standards, however, are at odds with the core holding in Rowley that school districts only need to meet the minimalist “some educational benefit” standard. The shift from process to outcome, which is at the heart of the standards-based movement, also contradicts the Rowley finding that the purpose of the IDEA is to provide access to education. The movement’s emphasis on content and proficiency focuses on what students actually learn, not necessarily the process by which they learn. Special education, on the other hand, has traditionally focused on the process of providing services to students. Therefore, it has been hypothesized that it will be necessary for local and state educational agencies to incorporate state educational content and proficiency standards into the statutory definition of FAPE so that high expectations are included in the IEPs of students with disabilities. It has also been suggested that courts may use content and proficiency standards to assess whether a school has provided a child with a FAPE.

In early 2004, the United States Congress again reauthorized IDEA with the latest version entitled the Individuals with Disabilities Education Improvement Act (IDEA) or IDEA04.22 This more recent iteration of the legislation retains the basic foundation, but also illustrates the influence of NCLB requirements of academic proficiency for all disabled students. The statute explicitly mandates that states establish performance goals for children with disabilities consistent with the goals and standards set for all children.23 Specifically, the state must establish goals for the performance of children with disabilities that are the same as the state’s definition of adequate yearly progress. This must include the state’s objective of progress for children with disabilities consistent, to the extent appropriate, with any other goals and standards for children established by the state.24 Furthermore, the state must establish performance indicators that assess progress toward achieving the goals described above, including measurable annual objectives for progress by children with disabilities.25

The United States Department of Education has only recently issued regulations necessary to ensure compliance with the IDEA statute. These final regulations were not complete until summer 2006 and did not take effect until October of the same year. The guidelines follow NCLB legislation and the IDEA statute with the requirement for “highly qualified teachers.” Such teachers must have earned at least a bachelor’s degree at an accredited institution, possess a teacher’s license for the respective state, and be able to demonstrate knowledge of the content areas for subject matter and grade level.26 The regulations extend the statutory requirements permitting states to create “high[ly] objective uniform state standard[s] of evaluation” or HOUSSE standards, “by which special education teachers can demonstrate competency in core academic subjects they teach.”27 One researcher further defined such standards:

[A] single HOUSSE covering multiple subjects is permitted at all grade levels, as long as the separate HOUSSE does not establish a lower standard for content knowledge than is expected of general education teachers. Special educators typically have pedagogical training that is different from that of general educators, and presumably this new standard allows special education methods, assessment procedures, behavior management competencies, and other evidence-based practices to be introduced in a special education HOUSSE. The new standard, however, is unable to address concerns that recruitment and retention of special educators is being harmed by excessively strict academic subject matter competency requirements for special educators.28

Other FAPE-related provisions are equally important. The Code of Federal Regulations makes it clear that a child’s IEP must include a statement of the child’s present levels of academic achievement and functional performance, including how the child’s disability affects involvement and progress in the general education curriculum (i.e., the same curriculum that non-disabled children learn).29 The general education curriculum is presumed to include content and proficiency standards for student achievement; hence, it is necessary for a child’s present levels of academic achievement and functional performance in his/her IEP to directly reference the state content and proficiency standards that are articulated in the general curriculum standards for the school district.

The Regulations also specify that a child’s IEP must include a statement of measurable annual goals, academic and functional, designed to meet the child’s needs that result from the child’s disability. This is to enable the child to make progress in the general education curriculum.30 Again, this language suggests that IEPs now must include a statement of measurable annual goals designed to enable the child to be involved and make progress in the state content and proficiency standards articulated in the general education curriculum.

The Regulations state that an IEP must include a statement of any individual, appropriate accommodations that are necessary to measure the academic achievement and functional performance of the child on state and district-wide assessments. If the IEP team determines that the child must take an alternate assessment other than the state or districtwide assessment of student achievement, a statement of why the child cannot participate in the regular assessment must be clearly articulated.31

Finally, regulations of the No Child Left Behind Act state that “[a]ll children with disabilities are included in all general State and districtwide assessment programs, including assessments described under section . . .[6311 of this title]. . . with appropriate accommodations and alternate assessments where necessary and as indicated in their respective individualized education programs.”32 Almost immediately exceptions were realized for students with the most severe cognitive disabilities.33 These are students with severe cognitive disabilities who are unlikely to meet grade level testing with the assessments measuring nondisabled children. As such, NCLB now permits school districts to use alternate achievement standards to evaluate the performance of these students. Beginning in 2003, schools could include the assessments of such students, said to represent approximately 1% of all students, within their annual yearly progress totals. Just recently, Margaret Spellings, U.S. Secretary of Education, also announced new guidelines to allow an additional 2% of students to be tested alternatively.34 These are the socalled “gap kids” or disabled students with “persistent academic difficulties,” who do not fit into the category of children with “significant cognitive difficulties.” These students can make significant progress, but may not reach grade-level achievement standards within the state’s time frame. Such students are assessed on modified academic standards and take their tests based on these standards. These scores may also be blended in annual yearly progress reports. The two alternative assessments taken together would represent testing for 3% of all students or approximately 30% of students with special needs. Supporters of special education students have raised concerns based on the 1 %/2% testing scheme, suggesting that this would be a facial violation of NCLB and IDEA04 because it could deny students the possibility of participating in the general curriculum. It is more likely, however, that the regulations may alleviate dilemmas for students who could not meet the regular standards other students face. In fact, an argument could be made that the exceptions actually follow the principles established in the legislation, designed for students who need greater intervention; the laws were actually premised upon individualized instruction, and the creation of goals and objectives based on the unique needs of the student.

Concerns about the vast majority of students with special needs, or those presumed to be able to reach state-based achievement standards through educational assessments, represents another story. A real question is whether the new legislation can be interpreted to redefine free appropriate public education where content and proficiency standards of the general curriculum command that special needs students be educated to their maximum abilities. Recall the Supreme Court ruled in the Rowley decision that school districts were only obligated to educate the student so as to achieve “some benefit.”

V. INTERPRETATIONS OF FAPE SINCE ROWLEY

Continued research on interpretations of the standards-based movement, as legislated in NCLB and IDEA, yield the conclusion that emphasizing demonstrated educational accountability does not necessarily translate into an education that enables special needs children to maximize their potential. As noted in previous research, decisions of the courts can be divided into requirements of “meaningful benefit,””some or adequate benefit” and” a mixed standard.”35 Few courts have ruled that that the education statutes and regulations support re-interpretation of Rowley. An analysis of some of the few decided cases follows.

A. “Meaningful Benefit” Standard

In Polk v. Central Susquehanna Intermediate Unit 1636 the Court of Appeals for the Third Circuit interpreted the Rowley standard to require more than a de minimis benefit to a special needs student.37 In Polk, parents of a child with mental and physical disabilities wanted direct handson therapy from a physical therapist, rather than a teacher, as a related service. Agreeing with the parents about the need for professional treatment, the appeals court ruled that the anticipated benefit must be meaningful and, therefore, more than trivial progress must occur.38 The Polk court stated that the standard was more than a “toothless standard” and declared that a FAPE required more than the mere prevention of regression.39 In a very recent decision, Kirby v. Cabell County Board of Education,40 from the Southern District Court of West Virginia, a federal court followed the “meaningful benefit” standard, stating that IDEA “does not require providing every available service necessary to maximize a disabled child’s potential, [and] ‘a school district cannot discharge its duty … by providing a program that provides only de minimis or trivial academic achievement.'”41 The case also notes the importance of students with disabilities participating, as much as possible, in the same activities as students without disabilities. The case involved an eighteen year old student with non-verbal learning disorders: Asperger’s disorder, attention deficit disorder, a speech and language disorder, dysgraphia, and specific learning disabilities. The plaintiff in the case challenged the previous decision of the impartial hearing on an independent evaluation, appropriateness of the defendant’s IEP, private school placement, and reimbursement. In bringing the claim, the plaintiff contended that NCLB “imposes additional obligations on the District in regards to the level of educational benefit required by IDEA.”42 The court rejected the plaintiff’s claim, finding there is “no language in [NCLB] that places additional obligations on the development or assessment of a child’s IEP.”43 Rather, the court found that the statute places responsibility on the state to adopt “challenging academic content standards and challenging student academic achievement standards to carry out the state’s plan under the Act” and that this obligation applies to all students.44 The court found that NCLB “does not contain specific obligations to children with disabilities nor does it alter the Court’s standard of review [of] [IEPs].”45

B. “Some or Adequate Benefit” Standard

Federal courts, especially in recent decisions, interpret the floor of “some benefit” to be below the one provided in Polk and Kirby. In School Board of Lee County v. MM,46 a Florida district court addressed a request for reinterpretation of FAPE in light of NCLB and its impact on IDEA04. The case involved complaints about the adequacy of an IEP for a seven year old student with a specific learning disability, speech and language impairment, attention deficit hyperactivity disorder, and microcephaly. The court followed the “some or adequate benefit” standard, stating that “a child must be provided with ‘a basic floor of opportunity’ that affords ‘some’ educational benefit, but the outcome need not maximize the child’s education.”47 The court also stated that a “student is only entitled to some educational benefit; the benefit need not be maximized to be adequate.”48 The court noted that, in addition to the “some or adequate benefit” standard, education is a fundamental value in Florida and that it is, therefore, “a paramount duty of the state to make adequate provision for the education of all children residing within its borders.”49 The judgment, nevertheless, rejected the argument brought by the student that references to “high quality education” elevates the substantive component of the FAPE for Florida children and that NCLB establishes a higher state standard which requires that a child’s potential be maximized.50 In evaluating whether a higher standard is applicable, the court differentiated cases where a statute requires a state to ensure every child a fair and full opportunity to reach his full potential. The court found that given the well-established nature of the federal standard, an intent to impose an enhanced requirement for IDEA must be more clearly stated in NCLB and that there are no court decisions finding a requirement in Florida that education be maximized in the IDEA context. These cases, according to the court, continue to impose the Rowley standard, followed in Florida precedent, that “there is no requirement to maximize each child’s potential.”51

In Mr. C. v. Maine School Administrative School District52 the Court of Appeals for the First Circuit also applied the “some or adequate benefit” standard with regards to FAPE by declaring that IDEA “does not promise perfect solutions . . . [but rather] sets modest goals . . . emphasiz[ing] an appropriate, rather than ideal, education; requiring] an adequate, rather than an optimal, IEP.”53 “Appropriateness and adequacy,” the court continues, “are terms of moderation.”54 It follows that, although an IEP must afford some educational benefit, the benefit conferred need not reach the highest attainable level or even the level needed to maximize the child’s potential.

In drawing this conclusion the court rejected the plaintiff’s argument that the 1997 and 2004 amendments to IDEA rendered pre- 2004 case law obsolete and raised the bar with respect to the FAPE standard.” The court noted that the plaintiffs relied on J.L. v. Mercer Island School District* and that the First Circuit expressly rejected this argument in 2004. see L.T., T.B. and E.B. ex rel. N.B. v. Warwick School Community District51 (“This court has continued to apply the Rowley standard in cases following the 1997 amendments, as have several of our sister circuits. And that is for good reason. The Rowley standard recognizes that courts are ill-equipped to second-guess reasonable choices that school districts have made among appropriate instructional methods.”)

The court also rejected the plaintiff’s argument that Winkelman v. Parma City School District58 requires that the combination of the 1997 and 2004 amendments supersede the Rowley standard. This claim was rejected because the passage cited from Winkelman “merely noted the unremarkable fact that Rowley happened to have construed the meaning of FAPE in the precursor statute to the IDEA… [t]he court neither stated nor suggested that the standard set forth in the Rowley decision had been superseded by either the 1997 or 2004 amendments to IDEA.”59 C. Mixed Standard of the Seventh Circuit

The Court of Appeals for the Seventh Circuit is alone in its use of a mixed standard to determine the legal criteria for FAPE.60 This is best delineated in Alex R. ex. rel Beth R. v. Forrestville Valley Community Unit School District Number 221 in the following passage:

An IEP passes muster provided that it is “reasonably calculated to enable the child to receive educational benefits,” or in other words, when it is “likely to produce progress, not regression or trivial educational advancement.” The requisite degree of reasonable, likely progress varies, depending on the student’s abilities. Under Rowley, “while one might demand only minimal results in the case of the most severely handicapped children, such results would be insufficient in the case of other children.” Objective factors, such as the regular advancement from grade to grade, and achievement of passing grades, usually show satisfactory progress.61

Board of Ottawa Township High School District 140 v. The United States Department of Education62 in the Northern District of Illinois follows the same reasoning. The plaintiffs in the case were the school boards of the Ottawa Township High School and Elementary School districts, four special education students, and their parents. Collectively they brought complaints against the United States Department of Education, the Illinois State Board of Education, and the leadership of both agencies. Plaintiffs sought a declaration that portions of NCLB violated the IDEA. The District Court disposed of the case on standing grounds, reaching the merits of plaintiffs’ arguments only in dicta. With regard to standing, the court held that the plaintiff school districts failed to allege any current or imminent harm. Id. Specifically, the court held that those sections of NCLB containing corrective measures did not apply to the first of the two plaintiff school districts because it had not accepted Title I funds, and was therefore exempt from those sections of the Act. Id. The court rejected that district’s argument that the State of Illinois’ acceptance of Title I funds forced the district to comply with NCLB. Id.

With regard to the second school district, the court acknowledged that it had accepted Title I funds, but that it still lacked standing because the occurrence of the harms of which it complained- changing curricula and losing local control of the district-were too remote and speculative. Specifically, the school board claimed that NCLB’s creation of adequate yearly progress (“AYP”), used to determine the extent to which a district is meeting a states’ academic achievement standards, violated IDEA’S requirement that all children with disabilities are entitled to a FAPE. Under NCLB, nearly all students (except for a very small percentage with the most serious cognitive disabilities) are held to the same standard- achievement scores. The Plaintiff failed to make AYP because most of their students with disabilities were tested at grade level standards rather than standards established by their IEPs. The board alleged that, had the proficiency scores of the students with disabilities been excluded from the calculation, it would have made AYP.

The court rejected in dicta the argument that NCLB achievement standards harm children with disabilities because those children are held to the same standards as students without disabilities. First, the Court stated that the statutes provide for alternate assessments and alternative academic achievement standards for children with disabilities. second, the court reasoned that NCLB does not force children, protected by IDEA, to do anything contrary to IDEA’S guarantee of a FAPE. The court rejected all of the plaintiffs’ positions, relying heavily on alternative assessment allowances in NCLB:

IDEA requires all disabled children included in statewide assessment programs, including NCLB assessments, to take alternative assessments, if required by their IEPs. 20 U.S.C. [section]1412 (a)(16)(A). Alternative assessments are allowed for “children with disabilities… who cannot participate in regular assessments under subparagraph (A) with accommodations as indicated in their respective individualized education programs ” 20 U.S.C. [section] 1412 (a)(16)(C)(i) (emphasis added). These alternate assessments must be aligned with, not equal, the State’s challenging academic content standards and challenging student academic achievement standards; and also measure the achievement of students with disabilities against alternote academic achievement standards, if the State has adopted such alternate academic achievement standards permitted under the regulated promulgated to carry out [section]6311(b)(l). 20 U.S.C. [section]1412 (a)( 16(C)(ii).63

The court also pointed to the reasonable adaptations and accommodations that are available to students with disabilities as reasons to find NCBL did not violate IDEA. The plaintiffs’ complaint, in addition, asserted that NCLB only allowed alternate assessments for students with the most “serious cognitive disabilities” rather than all students with disabilities, and that this gap in the alignment of the statutes resulted in violation of IDEA’s main purposes. The court rejected this argument because there had been “no showing that holding disabled children to the same achievement standards as non-disabled children is in itself harmful or violative of IDEA’S guarantee of a [FAPE].”64 The Court again points to the inclusion of children with disabilities in alternative assessments and the alignment of alternate assessments with the State’s content standards as consistent with the purposes state in IDEA.

On appeal, the Seventh Circuit similarly failed to reach the merits of whether IDEA and NCLB impose inconsistent obligations upon school districts, although it acknowledged that both plaintiff school districts had standing to sue. The court accepted the argument that the school districts were required to comply with NCLB by virtue of the state’s acceptance of Title I funds, and further reasoned that the districts had standing because satisfying the requirements of NCLB is expensive and may cost more than a district receives in federal grants. The court, nonetheless, declined to address-or to remand for consideration of-the merits of the plaintiffs’ argument regarding the alleged inconsistent obligations imposed on the districts by IDEA and NCLB. The court held, as a matter of statutory interpretation, that any inconsistency between the two statutes must be resolved in favor of NCLB, as it was the statute enacted latest in time.65

D. The United States Office of Civil Rights

Amy June Rowley, the plaintiff in the Supreme Court case by that famous name, was a profoundly deaf student performing at a wellabove- average level even without the accommodation of a sign language interpreter she requested from her school district. Case law above would suggest that not much has changed in 25 years regarding a legal interpretation of FAPE. A recent executive opinion by the United States Department of Education Office of Civil Rights may, however, suggest that students like Amy are entitled to accommodations to meet the achievement levels of NCLB as delineated in their Individualized Education Plans. The opinion originated from a report that some schools and school districts have refused to permit qualified students with disabilities to participate in accelerated and gifted and talented academic programs or that schools condition participation in such programs on the abandonment of special education and related services. The Office of Civil Rights (OCR) found that these practices are inconsistent with section 504 of the Rehabilitation Act of 1973,66 Title II of the Americans with Disabilities Act,67 and the Individuals with Disabilities Improvement Act. Specifically with regard to FAPE, the Office instructed districts where participation by a student with a disability in an accelerated class or program is considered part of the regular education or the regular classes referenced in the section 504 and the IDEA regulations. Thus, if a qualified student with a disability requires related aids and services to participate in a regular education class or program, then a school cannot deny that student the needed related aids and services in an accelerated class or program.

OCR gave the following example: If a student’s IEP or plan under Section 504 provides for Braille materials in order to participate in the regular education program, and she enrolls in an accelerated or advanced history class, then she also must receive Braille materials for that class. The same would be true for other needed related aids and services such as extended time on tests or the use of a computer to take notes. OCR also cautioned school districts that conditioning enrollment in an advanced class or program on the forfeiture of needed special education or related aids and services. OCR noted that this is inconsistent with the principle of individualized determinations, and that the requirement for such determinations is violated when schools ignore the student’s individual needs and automatically deny a qualified student with a disability requisite related aids and services in an accelerated class or program.68

VI. CONCLUSION

The foregoing discussion demonstrates that the Individuals with Disabilities Education Improvement Act and No Child Left Behind support millions of children with special needs in gaining access to public education. It also alerts us that, for the most part, the education provided offers little in the way of promoting intervention leading toward maximum scholastic benefit. Progress has been made but, by and large, little has changed in the interpretation of a free appropriate public education since the landmark decision of Board of Education of the Hendrick Hudson Central School District v. Rowley decided 25 years ago. Congressional action protecting the rights of all students, with particular emphasis on students with special needs, has been necessary and impressive, but reliance on judicial interpretations has resulted in continued burdens on this population, particularly students who can perform at high academic levels. The few court cases addressing whether NCLB has heightened the requirements of FAPE or is violative of IDEA have yielded negative answers. This article has presented information on the Rowley decision, the FAPE standards in IDEA, the national standards fostering a general curriculum, and the NCLB standards for reaching goals, and case law interpreting FAPE. One ray of hope is found in a very recent executive opinion prepared by the United States Office of Education Office of Civil Rights. This executive rendering posits that a possible violation of IDEA, the Americans with Disabilities Act, and section 504 of the Civil Rights Act of 1973 may occur if qualified students with disabilities are refused the opportunity to participate in accelerated and gifted and talented academic programs or that schools condition participation in such programs on the abandonment of special education and related services. Further research in this area must wait until the OCR opinion prevails.

1. Bd. of Educ. of the Hendrick Hudson Cent. Sch. Dist. v. Rowley, 458 U.S. 176, (1982).

2. 20 U.S.C. [section][section] 1400 et. seq.

3. At the time of the Rowley decision, the statute was called the Education for All Handicapped Children’s Education Act (EAHCA).

4. Rowley 458 U.S. at 203.

5. Id. at 203-204.

6. Id. at 198.

7. Id. at 200.

8. Id. at 201.

9. Lunceford v. Dist. of Columbia Bd. of Educ., 745 F.2d 1577, 1583 (D.C. Cir. 1984) (IDEA “does not secure the best education money can buy;” rather it requires an “appropriate education” for the child); Hessler v. State Bd. of Educ., 700 F.2d 134, 139 (4th Cir. 1983) (education need not be the best education).

10. See, e.g., Burke County Bd. of Educ. v. Denton, 895 F.2d 973, 980 (4th Cir. 1990) (affirming district court finding that day program constituted FAPE because student made good “educational progress” in that setting); Evans v. Dist. No. 17, 841 F.2d 824, 831 (8th Cir. 1988) (Rowley directive to allow school district to choose method of instruction means that “if a child is progressing satisfactorily” with the current method, court is not to question whether another method might work better); Abrahamson v. Hershman, 701 F.2d 223, 228 (1st Cir. 1983) (“educational progress” necessary for FAPE).

11. Scott Johnson, Reexamining Rowley: A New Focus in Special Education Law, 2003 BYU Educ. & L.J. 561 (2003).

12. 20 U.S.C. [section][section] 6301 et. seq.

13. U.S. Const, article I, [section] 8.

14. Stephen Rosenbaum, Aligning or Maligning: Getting Inside a New IDEA, Getting Behind No Child Left Behind and Getting Outside of it All, 15 HASTINGS WOMEN’S L.J. 1, 27-29 (2004).

15. Southern Disability Law Center, http://www.sdlcenter.org/ issues.htm (last visited Feb. 22, 2008).

16. 20 U.S.C. [section] 1401(9) (2006).

17. 20 U.S.C. [section] 1401(9)(B).

18. H.R. Rpt. 105-95, at 83-84 (May 13, 1997).

19. 20 U.S.C. [section]6311 (b)(1)(D).

20. 20 U.S.C. [section] 6311(b)(1)(D)(ii).

21. Id.

22. 20 U.S.C. [section][section] 1400 et. seq.

23. 20 U.S.C. [section] 1412(a)(15).

24. 20 U.S.C. [section] 1412(a)(15) (A)(ii, iv).

25. 20 U.S.C. [section] 1412(a)(15)(B).

26. 20 U.S.C. [section] 1401(10).

27. Dixie S. Huefner, The Final Regulations for the Individuals with Disabilities Education Improvement Act, 217 Educ. L. Rep. 1, 2- 3 (2007).

28. Id.

29. 34 C.F.R. [section] 300.320(a)(1)(i).

30. 34 C.F.R. [section] 300.320(a)(2)(i).

31. 34 C.F.R. [section] 300.320 (a)(6).

32. 20 U.S.C. [section] 1412(16).

33. 34 C.F.R. [section]200.13.

34. “U.S. Department of Education, Secretary Spellings Announces New Regulations to More Accurately Assess Students with Disabilities,” (April 4, 2007), http://www.ed.gov/ print/news/ pressreleases/2007/04/04042007.html. (last visited December 15, 2007).

35. P.T.K. Daniel and Jill Meinhardt, Valuing the Education of Students with Disabilities: Has Government Legislation Caused a Keinterpretation of a Free Appropriate Public Education?, 222 Educ. L. Rep. 515 (2007).

36. 853 F.2d 171 (3d Cir.1988), cert, denied, 488 U.S. 1030 (1989).

37. Id. at 184.

38. Id.

39. Id. at 179.

40. Kirby v. Cabell County Bd. Of Educ, 2006 WL 2691435 (S.D. W. Va., September 19, 2006).

41. Id. at 2, citing Bd. of Educ. of the County of Kanawha v. Michael M., 95 F. Supp.2d 600,607 (S.D. W. Va. 2000) (citations omitted).

42. Id. at 6.

43. Id.

44. Id.

45. Id.

46. Sch. Bd. of Lee County, Fl. v. M.M., 2007 W.L. 983274 (M.D. Fla., March 27, 2007).

47. Id. at 3, citing Walker Co. Sch. Dist. v. Bennett, 203 F. 3d 1293, 1296 n. 10 (11th Cir. 2000).

48. Id. at 3, citing Devine v. Indian River County Sch. Bd, 249 F. 3d 1289, 1292 (11th Cir. 2001).

49. Id. at 3.

50. Id. at 4.

51. Id., citing M.H. v Nassau County Sch. Bd, 918 So. 2d 316, 318 n. 1 (Fla. Dist. Ct. App. 2005).

52. Mr. C. v. Me. Sch. Admin. Dist. No. 6, 2007 W.L. 4206166 (D. Me., Nov. 28, 2007).

53. Id. at 26.

54. Id.

55. Id. at 27, n.31.

56. J.L. v. Mercer Island. Sch. Dist., 2006 W.L. 3628033 (W.D. Wash., Dec. 8, 2006).

57. L.T., T.B. and E.B. ex rel. N.B. v. Warwick Sch. Cmty. Dist., 361 F. 3d 80, 83 (1st Cir., 2004).

58. Winkelman ex. rel. Winkelman v. Parma City Sch. Dist., 127 S. Ct. 1994 (2007).

59. 2007 W.L. 4206166 at 27 n. 31.

60. Lester Aron, Too Much or Not Enough: How Have the Circuit Courts Defined a Free Appropriate Public Education After Rowley, 39 SUFFOLK U. L. REV. 1, 7 (2005).

61. Alex R. ex. rel. Beth R. v. Forrestville Valley Cmty. Unit Sch. Dist. No. 227, 375 F. 3d 603, 615 (7th Cir. 2004), cert, denied, 125 S. Ct. 628 (2004)).

62. Bd. of Ottawa Twp. High Sch. Dist. 140 v U.S. Dept. of Educ., 2007 WL 1017808 (N.D. Ill., March 31, 2007).

63. Id. at 7.

64. Id. at 8.

65. Bd. of Educ. of Ottawa Twp. High Sch. Dist. 140 v. Spellings, 517 F.3d 922, (7th Cir. 2008).

66. 29 U.S.C. [section] 794(a).

67. 42 U.S.C. [section] 12102 et. seq.

68. “United States Office of Education: Office of Civil Rights, Access by Students with Disabilities to Accelerated Programs,” (December 26, 2007). http://www.ed.gov/about/offices/ list/ocr/ letters/colleague-20071226.html (last visited January 2, 2008).

PHILIP T.K. DANIEL*

* Phillip T.K. Daniel is the William and Marie Flesher Professor of Educational Administration and an Adjunct Professor of Law at the Ohio State University in Columbus, Ohio.

Copyright Jefferson Law Book Company Jul 2008

(c) 2008 Journal of Law and Education. Provided by ProQuest Information and Learning. All rights Reserved.

Filtering on the Fly

By O’Hara, Carolyn

It used to be that when a country wanted to block the Internet, it faced an all-or-nothing choice. Pick something offensive, and block it all. The worst offenders-think China, Iran, and Saudi Arabia-spent years building broad, permanent filtering systems. But that kind of wholesale approach might be falling from favor. Eager to avoid the label of Internet pariah, as well as the economic and political costs of sustained blocking, many authoritarian countries are turning to more subtle solutions. This shift may give the appearance that less of the Internet is being filtered. But, experts warn, it really just means that filtering is becoming increasingly difficult to detect-and perhaps even more effective. “[We’re] moving to a situation where filtering is done on a much more ad hoc, on- the-fly basis,” says John Palfrey, a professor at Harvard Law School’s Berkman Center for Internet & Society. Web access in places such as Bahrain or Belarus may be relatively open most of the time. But governments are developing capabilities that allow them to flip the switch on the content they wish to censor. In some cases, governments simply order state-run Internet Service Providers to block sites. This was the case for media and opposition sites in the run-up to recent elections in Bahrain, Tajikistan, and Uganda.

Some regimes, however, are developing far craftier tactics, contracting out the censorship they desire. It appears that many governments are paying hackers-for-hire to overload sites they do not like. Such “denial of service” attacks render the sites dead, yet allow governments to shield themselves from blame. It is, says Ron Deibert, director of the University of Toronto’s Citizen Lab, “a much more sophisticated method in terms of strategy, because it allows you plausible deniability.”

Just after former Russian President Vladimir Putin anointed his political successor last December, the Web site of Russian opposition leader Carry Kasparov was hit by such attacks for nearly two weeks. This type of blocking frequently happens just prior to elections. Many experts, for example, suspect that Kirgiz officials arranged for such services in advance of the country’s 2005 parliamentary vote. Similarly, experts are suspicious of hacker attacks on blogs, media sites, and opposition forums in the weeks immediately before and after the 2006 presidential election in Belarus. The attacks were echoed in April, when the Web site of Radio Free Europe was brought down just as coverage of the 22nd anniversary of the Chernobyl disaster was going online. These attacks, of course, occurred anonymously, and the culprits are nearly impossible to trace. It seems getting snared in the Web has never been easier-or harder to spot.-Carolyn O’Hara

Matt Siegel is a staff writer at the Moscow Times. Lucy Moore is a researcher and Carolyn O’Hara is a senior editor at FOREIGN POLICY.

Copyright Carnegie Endowment for International Peace Jul/Aug 2008

(c) 2008 Foreign Policy. Provided by ProQuest Information and Learning. All rights Reserved.

Evaluation of a Pilot Hospital-Based Community Program Implementing Fitness and Nutrition Education for Overweight Children

By Speroni, Karen Gabel Tea, Christine; Earley, Cynthia; Niehoff, Vonzie; Atherton, Martin

PURPOSE. Evaluate the effect of the Kids Living Fit(TM) hospital- based intervention on body mass index (BMI) percentile, adjusted for age (months) and gender in children ages 8-12 years with BMI percentiles >/= 85. DESIGN AND METHODS. Twelve weekly exercise sessions and three nutrition presentations were held. Nurses recorded BMI and waist circumference at baseline, week 12, and week 24. Participants completed food and activity diaries.

RESULTS. Of the 32 participants enrolled, 16 completed all outcome measures and experienced a decrease in average BMI, BMI percentile, and waist circumference between baseline and weeks 12 and 24.

PRACTICE IMPLICATIONS. Hospitals can offer exercise and nutrition programs to decrease childhood obesity in their communities.

Search terms: Body mass index, child health education, child nutrition, child obesity, nutrition education, physical activity

First received August 27, 2007; Revision received November 11, 2007; Accepted for publication January 11, 2008.

Introduction

Beginning in 1963, surveys have been steadily documenting the obesity epidemic in the United States (Wyllie, 2005). Since that time, the incidence of childhood obesity has tripled (Inge et al., 2004). Overweight, defined as a body mass index (BMI) equal to or greater than the 95th percentile, currently affects 11% of children and adolescents in the United States (Dehghan, Akhtar-Danesh, & Merchant, 2005). When broadened to include the “at risk” for overweight, defined as a BMI of equal to or greater than the 85th percentile, the numbers of affected U.S. children and adolescents increase to 25%. It is estimated that 70% of overweight children will become obese adults (Dehghan et al.).

The long list of diseases associated with obesity in children can affect their health for a lifetime. Type 2 diabetes, rampant among our youth, accelerates the development of cardiovascular disease, stroke, blindness, kidney failure, and limb amputations (North American Association for the Study of Obesity, 2007). Obesity developed in childhood, and particularly in adolescence, is also associated with morbidity and mortality in adulthood from asthma, diabetes (type 2), hypertension, orthopedic complications, psychosocial stigmas and effects, and sleep apnea (American Obesity Association, 2005). Economic costs associated with obesity have been estimated at $117 billion by the United States Surgeon General (Sheehan & Yin, 2006).

Numerous societal trends have contributed to decreased caloric expenditure, one of the major causes of obesity. A notable shift is the increase in sedentary behaviors, such as decreased walking and bicycling and less time spent playing outside (Baker et al., 2005). The increased use of computers and video games, as well as television, has also contributed to decreased activity and greater numbers of obese children (Atherton & Metcalf, 2006).

Sedentary behaviors are further confounded by changes to mandated physical education in schools by the majority of the states in the country. Most states do not require a specific amount of instructional time, and about half allow exemptions, waivers, and/ or substitutions for physical education (Shape of the Nation, n.d.).

Since 1971, the National Health and Nutrition Examination Surveys have been providing documentation of the nation’s increase in mean caloric intake, paralleling the obesity epidemic (Centers for Disease Control and Prevention [CDC], 2004). High-calorie food products, larger portion sizes, meals eaten outside of the home, fast food, and the decline of the “family meal” have all been cited as troubling issues.

A review of the literature reveals many published studies on childhood obesity programs that focus on exercise or nutrition education in the United States (Summerbell et al., 2003). There are fewer that incorporate a two-pronged approach of both exercise and nutrition education (Dreimane et al., 2007).

To facilitate improved lifestyle choices for children regarding activities chosen and foods consumed, nurses at a community hospital designed and tested a series of three Kids Living Fit(TM) (KLF) childhood obesity studies. (KLF is an exercise program designed and offered by Good Sports Fitness, LLC, Leesburg, VA.) The KLF intervention, a two-pronged program incorporating exercise and nutrition education, focused on best lifestyle choices regarding daily activities chosen and foods consumed. In each of the studies the objective was to determine if the KLF exercise and nutrition program could affect change in participants’ BMI percentile, adjusted for age (months) and gender.

Two of the three KLF studies conducted were after-school-based programs (Speroni, 2006; Speroni, Earley, & Atherton, 2007), and one, the study reported below, was a hospital-based program. All three KLF studies included the following: weekly exercise programs, monthly nutrition education, BMI and waist circumference measures, participant completion of food and activity study diaries, and the wearing of pedometers. Parental attendance was encouraged.

The two after-school-based programs that were tested included a pilot study design and a larger comparative study design. In the pilot study, BMI and other obesity-related outcomes were measured for 14 third to fifth graders who participated in an 8-week after- school program at one public elementary school in the community that the hospital serves. Results demonstrated an overall BMI percentile decrease of 0.07% and a 14% increase in “healthy” weight percentiles in this first KLF pilot study (Speroni, 2006). In the larger after- school-based study, BMI and other obesity-related outcomes were compared between a KLF intervention group and a contrast group that received no intervention (Speroni et al., 2007).

There were a total of 185 self-selected participants in the two study groups, KLF intervention group (n = 80) and the no intervention/contrast group (n = 105), all of whom were in the second to fifth grades at one of four elementary schools. According to pairwise change in BMI percentile from baseline to week 24, a paired t-test was conducted for both the KLF and contrast groups. For the KLF groups across all schools, participants experienced a pairwise drop of 2.3 in mean BMI percentile (p

The hospital-based KLF study, also a pilot study, is reported below. The purpose of this study was to evaluate the effect of the KLF intervention on BMI percentile, adjusted for age (months) and gender, and on waist circumference, in children 8-12 years of age who were determined to be “at risk” (BMI 85th-94th percentile) or overweight children (BMI >/= 95th percentile).

Methods

Institutional Review Board approval was obtained for this pilot study. Informed consent was obtained from parents of all study participants, and all study participants (n = 32) provided assent. The KLF program was held at two community hospital sites (site 1 = a 155-bed hospital; site 2 = a 182-bed hospital that includes a Bariatric center). Both are part of a hospital system operating in the geographic region where the study was conducted.

Sample

Study participants were a convenience sample comprised of community members who responded to study advertisements to participate in the KLF study program offered at the hospital. Participants who met the following eligibility criteria were sequentially enrolled in the study: 8-12 years old; BMI for age and gender of > 85th percentile; able to read and write English; able and willing to perform physical fitness activities as required in the KLF exercise component of the program; and able and willing to complete study diaries. There were no children excluded from the study based upon the eligibility screening evaluation conducted at baseline. Participants were charged a $100 fee to participate in the KLF program.

Study Procedures

Overall study procedures are provided in the study procedures flowchart (see Table 1). At baseline, week 12, and week 24, registered nurses measured height, weight, and waist circumference. The CDC’s online BMI child and teen percentile calculator adjusted for age and gender (CDC, 2006) was used to determine the participants’ BMI scores.

Exercise Methodologies

The 1-hr KLF exercise sessions were held once weekly over 12 consecutive weeks (weeks 1-12) at the hospital. Exercise sessions were led by a physical fitness trainer. The exercise component of the KLF intervention focused on physical fitness (e.g., aerobic dance, basic muscle groups, stretching, balancing techniques, and heart rate monitoring associated with exercise), yoga, and relaxation techniques (e.g., meditation, breathing). During the exercise sessions, the trainer also addressed lifestyle choices. Best or healthier lifestyle choices were reinforced by encouraging participants to select more active behaviors (i.e., being active whether running or cycling versus being sedentary by viewing television or playing video games) compared to sedentary behaviors. Participants were also encouraged to make best choices with respect to foods consumed for snacks and meals.

The objective of the exercise sessions was to expose the study participant to a variety of active behaviors that he or she could perform independently following the conclusion of the program. During weeks 1, 4, and 8, the exercise sessions were 30 min to accommodate the 30-min nutrition presentations.

Nutrition Education Methodologies

The dietary/nutritional component included three lectures taught for 30 min once per month by a registered dietitian. The objective of all presentations was to provide information that facilitates children’s abilities to make best choices daily regarding meal and snack selections. The purpose of focusing on best/healthier choices was to expose the participants to thinking in terms of most nutritious or best/healthiest choice versus momentary food desires.

During week 1, balanced nutrition was taught using the United States Department of Agriculture (USDA) food pyramid (USDA, n.d.). Food models were used to provide participants a visual and tangible model of recommended serving sizes, the group to which food belonged, and whether the item represented a “best choice,” OK choice”, or “limited choice” food item. Participants worked together in groups to construct balanced healthy meal and snack selections.

Week 4 focused on the “portion distortion” presentation modified to be age appropriate (Department of Health and Human Services [DHHS], National Heart Lung and Blood Institute, n.d.). The presentation was used to teach calories in simplistic terms. It demonstrated side-by-side comparisons of serving sizes 20 years ago versus serving sizes of today. As part of this interactive teaching, participants guessed how long it would take to perform specific activities to burn the extra energy due to the larger serving sizes (see Figure 1a, b, c). There was an emphasis on making healthy choices also in this presentation.

At week 8, the fast food dietary presentation focused on making best choices at fast food restaurants, with an emphasis on eating fast food in moderation and less than one time per week. The concept of making a healthy versus not healthy choice was taught by providing menus from fast food restaurants and having groups of participants review the menus and present their best choice findings.

Parental attendance was encouraged and recorded for the dietary lectures.

Study Questionnaires and Diaries

Study questionnaires and daily diaries were completed at various time points during the study (see Table 2), to raise study participants’ awareness regarding activities chosen and foods consumed rather than for purposes of analyzing data.

The types of questionnaires and study diaries that participants were asked to complete are as follows:

Food and activity questionnaires completed at screening and at week 12:

1. Participant’s favorite foods and participant’s family’s favorite foods: Delineated by the six food groups per the food group pyramid (e.g., grains, vegetables, dairy, meat, fruit, and fats, oils, sweets) and whether the favorite food is a “best choice,””OK choice,” or “limited choice” item.

2. Participant’s favorite activities: Delineated by whether the activity is a “best choice,””OK choice,” or “limited choice” activity and also whether the choice is active or inactive.

Satisfaction questionnaires completed at screening and at weeks 12 and 24:

1. Evaluation of self: Participant’s satisfaction level regarding food choices and activity levels (very satisfied, satisfied, not satisfied).

2. Evaluation of family: Participant’s satisfaction level regarding family food choices and activity levels (very satisfied, satisfied, not satisfied).

Daily diaries completed during weeks 1, 4, 8, and 12:

1. Daily activities: List of the number of hours/minutes per day of the 10 things the participant did most that day, not including sleeping or going to school.

2. Pedometer totals: Total number of daily steps.

3. Food diary: Number of servings per day by food group and also the number of fast-food restaurant meals.

During the weekly KLF exercise program, study participants were reminded which study documents were to be completed and returned at the next study session.

Participants were followed through week 24; however, there was no intervention after week 12. At week 12, participants were encouraged to make daily best choices with respect to activities chosen and foods consumed during the time of no intervention.

Data analysis for this study was completed by a biostatistician using SAS version 9.1, statistical software. Measures of central tendency (mean and variance) were performed to describe the participant groups.

Results

There were 32 participants who enrolled in the study (site 1 = 10; site 2 = 22) (see Table 2). There was an even distribution by gender; the average age was 10 years; and 69% were Caucasian. Of the 32 enrolled participants, 16 (50%) attended sessions at baseline, week 12, and week 24, when measures of BMI-for-age, BMI-for-age percentile, and waist circumference were taken. The overall BMI mean, BMI percentile, and waist circumference results are for the 32 participants completing baseline measures.

A total of 16 participants completed study measures at baseline, week 12, and week 24 (see Table 3). Those who did not complete all three time points either missed one of the sessions or dropped from the study.

As shown in Table 3, the overall mean BMI decreased between baseline and week 12 (-0.4) and week 24 (-0.6). The overall mean BMI percentile also decreased at these time points (-0.6 and -0.9, respectively). The overall mean waist circumference (inches) also decreased between baseline and week 12 (-0.5”) and week 24 (- 0.7”). Thus, overall, the mean BMI, BMI percentile, and waist circumference decreased between baseline and weeks 12 and 24.

When analyzed by the two groups identified at baseline as “at risk” for overweight (85th-94th percentile) or overweight (95th percentile and above), there were also decreases (see Table 3). At baseline, 2 (12.5%) of the 16 participants were classified as “at risk” for overweight, and 14 (87.5%) were classified as overweight. For those “at risk” for overweight, the mean BMI percentile decreased from baseline to week 24. In the overweight group, the mean BMI decreased between baseline and week 24. For this group, a decrease in BMI percentile and waist circumference was seen at both weeks 12 and 24. The decrease in BMI percentile change was more than twice as large in the “at risk” group (-1.3) compared to the overweight group (-0.5). The number of participants in the overweight group also decreased from baseline to week 24.

The Z scores calculated for all participants indicate that no BMI value for all follow-up periods was more than 2 standard deviations away from the mean (see Table 4). Thus, the data are approximately normally distributed.

Total average steps as measured by participant pedometer recordings increased by more than 45% between week 1 (6,033 steps) and week 12 (8,788 steps). Average steps at weeks 4 and 8 were 7,832 and 6,975, respectively.

The average overall participant attendance at the 12 weekly sessions was 66%. Fifty-three percent of participants attended 75% or more of the weekly sessions. The average parental attendance for the weeks of dietary lecture was 76%.

Table 5 shows participants’ satisfaction regarding self and family food and activity choices. There were increases in the percent satisfied for each of the categories from baseline to weeks 12 and/or 24.

Discussion

The KLF intervention was effective in decreasing BMI and waist circumference in children both “at risk” for becoming overweight and those who were overweight. These findings are consistent with other studies that incorporate both exercise and nutrition education (Dreimane et al., 2007; Summerbell et al., 2003). As concluded by Summerbell et al. (2003), there is limited quality data on the effects of treatment programs, and the extent to which the results of these programs can be generalized is not known. Much of the research has been conducted in populations who are most likely to respond to interventions, such as White, middle class, educated families. In the hospitals’ communities where this research was conducted, the majority met these criteria. Hence, it is difficult to specify the degree to which these results may be generalized to other populations.

The primary limitations of this study included a small sample size and the lack of a control group, both of which are inherent in a pilot study.

Inherent in research on children is the problematic nature of a participant’s ability to attend study sessions due to family social and professional time constraints. A limitation of this study was that 68% of study participants attended only half of the sessions, and just 50% completed all BMI measures. However, there were no notable differences in BMI percentile change by attendance level.

It was noted that the KLF intervention appeared to be more effective in the “at risk” group compared to the overweight group, judging from the size of the decrease in BMI percentile among the “at risk” group compared to the overweight group. In studies that lack a control population, as is the case for this study, the “regression to the mean” effect in the experience of both groups could explain the change in measures over time. It is further notable that the majority of these pilot study participants at baseline were classified as overweight (BMI >/= 95th percentile for age and gender).

Programs, such as the one evaluated in this study, can be conducted as hospital-based or after-school-based programs. The benefit of a hospital-based program may be the ability to target overweight populations that otherwise might not participate in an after-school program for fear of being identified as overweight by their peers. Also, there are disadvantages in after-school-based programs, such as space to hold the exercise programs because other after-school programs compete for the same space. The benefit of a school-based program is the opportunity to work with nurses in the school system to facilitate the provision of a program that teaches exercise and nutrition. The impetus for this study being hospital- based was to offer a program to children in the communities the hospitals serve, regardless of school status, who were overweight or at risk of becoming overweight because there were no other known programs at the time targeting this population. A challenge of a hospital-based program is the requirement for the participants’ round-trip transportation to the weekly sessions and follow-up.

Completion of study diaries can also be problematic in research, particularly when children are charged with task completion. Parents were told not to complete the diaries for their children because the completion of the diary by the children was intended to raise the participants’ awareness regarding activities chosen and foods selected. An example of raised awareness, as seen in this study, was participants wearing pedometers and challenging themselves to walk 10,000 steps per day on days they were not required to wear pedometers.

A control population was not selected and enrolled in this study; participants at both hospitals served as their own controls. The maturation effect is one explanation for the modest improvement that was observed in BMI percentile in both “at risk” and overweight groups.

Another limitation of this study may have been the ability of a family to pay the $100 fee for the child to participate in this study, and thus some at risk or overweight children may not have participated in this study for financial reasons.

The KLF intervention, a two-pronged program incorporating exercise and nutrition education, focused on best lifestyle choices regarding daily activities chosen and foods consumed.

The benefit of a hospital-based program may be the ability to target overweight populations that otherwise might not participate in an after-school program for fear of being identified as overweight by their peers.

How Do I Apply This Information to Nursing Practice?

One important finding of this study is that nurses can spearhead exercise and nutrition-based programs, offered by hospitals, to decrease overweight in children from the hospital’s community. If programs are not available, organizing and implementing exercise and nutrition programs, such as KLF, can be accomplished by registered nurses, registered dietitians, and exercise trainers. Nursing administrators can lend support by providing funding and securing staff hours. Nurses working in pediatrics, emergency, and home health care could provide information to parents of overweight children on programs offered by the hospital and/or available in the community.

Another important finding is that weight loss was sustained by study participants during the time of no intervention. With societal trends of increasing sedentary lifestyles plus caloric intake, an educational approach focusing on exercise and nutrition could empower not only children but also their families to improve daily lifestyle choices with respect to activities chosen and foods consumed to lose weight and to sustain weight loss. Ideally, improvement in lifestyle choices would correlate with improved health over a lifetime.

With $117 billion in healthcare costs associated with obesity and an increasing obesity rate in children, provision of programs focusing on exercise and education is of utmost importance, both for children and their families. As nurses routinely see patients with diabetes, cardiovascular disease, asthma, orthopedic and psychological disorders, they are well poised to be advocates for exercise and nutrition programs to decrease overweight and ultimately to maintain healthy weights for a lifetime.

References

American Obesity Association. (2005). AOA Fact sheet. Obesity in youth. Retrieved August 5, 2007 from http:// obesityl.tempdomainname. com/subs/fastfacts/obesity_youth.shtml

Atherton, M., & Metcalf, J. (2006). Does gender modify the impact of video game playing and television watching on adolescent obesity? American Journal of Health Studies, 21(2), 62-68.

Baker, S., Barlow, S., Cochran, W., Fuchs, G., Klish, W., & Krebs, N. (2005). Overweight children and adolescents: A clinical report of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. Journal of Pediatric Gastroenterology and Nutrition, 40(5), 533-543.

Centers for Disease Control and Prevention (CDC). (2004). Trends in intake of energy and macronutrients-United States 1971-2000. Retrieved August 10, 2007, from http://www.cdc.gov/mmwr/ preview / mm wrhtml / mm5304a3.htm

Centers for Disease Control and Prevention (CDC). (2006). BMI- Body mass index: Child and teen calculator: English. Retrieved November 21, 2006, from http://apps.nccd.cdc.gov/dnpabmi/ Calcula tor.aspx

Dehghan, M., Akhtar-Danesh, N., & Merchant, A. T. (2005). Childhood obesity, prevalence, and prevention. Nutrition Journal, 4(24), 24-32.

Department of Health and Human Services, National Heart Lung and Blood Institute, (n.d.). Portion distortion I slide set. Retrieved January 17, 2007, from http://hp2010.nhlbihin.net/portion/ index.htm

Dreimane, D., Safani, D., MacKenzie, M., Halvorson, M., Braun, S., Conrad, B., et al. (2007). Feasibility of a hospital-based, family-centered intervention to reduce weight gain in overweight children and adolescents. Diabetes Research and Clinical Practice, 75(2), 159-168.

Inge, T. H., Garcia, V., Daniels, S., Langford, L., Kirk, S., Roehrig, H., et al. (2004). A multidisciplinary approach to the adolescent bariatric surgical patient. Journal of Pediatric Surgery, 39(3), 442-447.

North American Association for the Study of Obesity, The Obesity Society. (2007). Obesity fact sheets: Childhood overweight. Retrieved August 6, 2007, from http://www.naaso.org/information/ childhood overweight.asp

Shape of the Nation, (n.d.). Executive summary. Retrieved August 14, 2007, from http://www.aahperd.org/naspe/ShapeOfTheNation/ template.cfm?template=executiveSummary.html

Sheehan, N., & Yin, L. (2006). Childhood obesity: Nursing policy implications. Journal of Pediatric Nursing, 21(4), 308-310.

Speroni, K. G. (2006). A hospital nursing community outreach program on childhood obesity. Nursing Spectrum, 16, 12-13. Retrieved June 19, 2006, from http://community.nursingspectrum.com/ MagazineArticles/article.cfm?AID=22247

Speroni, K. G., Earley, C., & Atherton, M. (2007). A prospective study comparing body mass index for age and gender: Obesity-related outcomes between Kids Living Fit(TM) and elementary school contrast students. Journal of School Nursing, 23(6), 329-336.

Summerbell, C. D., Ashton, V., Campbell, K. J., Edmunds, L., KeUy, S., & Waters, E. (2003). Interventions for treating obesity in children. Cochran Database of Systematic Reviews. Retrieved August 15, 2007, from http://www.thecochranelibrary.com

United States Department of Agriculture, (n.d.). MyPyramid.gov. Retrieved January 25, 2007, from http://www.mypyramid.gov/

Wyllie, R. (2005). Obesity in childhood: An overview. Current Opinion in Pediatrics, 27(5), 632-635.

Karen Gabel Speroni, PhD, RN, Christine Tea, RN, MSN, CNAA-BC, Cynthia Earley, BSN, RN, Vonzie Niehoff, RN, CBN, and Martin Atherton, DrPH

Karen Gabel Speroni, PhD, RN, is Director, Nursing Research, Inova Loudoun Hospital, Leesburg, VA, and Inova Fair Oaks Hospital, Fairfax, VA; Christine Tea, RN, MSN, CNAA-BC, is Service Line Director, Bariatrics and Orthopedics, Inova Fair Oaks Hospital, Fairfax, VA; Cynthia Earley, BSN, RN, is a Staff Nurse, Post- Surgical Unit, Inova Loudoun Hospital, Leesburg, VA; Vonzie Niehoff, RN, CBN, is a Scheduling Coordinator, Bariatrics, Inova Fair Oaks Hospital, Fairfax, VA; and Martin Atherton, DrPH, is a Biostatistician, George Mason University, Fairfax, VA.

Author contacts: [email protected], [email protected], with a copy to the Editor: [email protected]

Copyright Nursecom, Inc. Jul 2008

(c) 2008 Journal for Specialists in Pediatric Nursing. Provided by ProQuest Information and Learning. All rights Reserved.

Ecological Differences in Weight, Length, and Weight for Length of Mexican American Children in the WIC Program

By Reifsnider, Elizabeth Ritsema, Melanie

PURPOSE. Examine factors common in the environments of children who obtain services from a WIC program to determine if differences in ecological/environmental factors can be found in the children who differ in weight, length, and weight for length. DESIGN AND METHODS. Cross-sectional study of 300 children, 100 each who were stunted, normal weight for length, or overweight. Instruments used were NCATS, ARSMA II, 24-hr diet recall, and Baecke Activity Questionnaire.

RESULTS. Significant differences were present in children’s diet, parents’ BMI, parents’ generation in United States, parents’ activity levels, and maternal-child relationship.

PRACTICE IMPLICATIONS. Encourage parents to adopt family approaches to encourage normal body size in children.

Search terms: Child overweight, ecological factors, ecological monitoring, Mexican American children, obesity

First received August 30, 2007; Revision received December 19, 2007; Accepted for publication January 21, 2008.

The length, weight, and weight-for-length ratio of toddlers (children 12-24 months old) have many influences. Prenatal nutrition, early childhood feeding, parents’ sizes, and the larger community environment all contribute to a child’s size. Even when children live in the same neighborhood, are from families with the same socioeconomic status (SES), and claim the same ethnicity, differences persist in children’s weight, length, and weight for length. The purpose of this study was to examine factors common in the environment of children who obtain services from a large metropolitan Supplemental Nutrition Program for Women, Infants, and Children (WIC) to determine if differences in environmental factors can be found in the children who differ in weight, length, and weight-for-length.

Conceptual Framework: Ecological Model of Growth (EMG)

One method to view a child’s environment is through an ecological model. The EMG (see Figure 1) is a heuristic model that explains the levels of a child’s environment that contribute to a child’s growth (Reifsnider, 1995; Reif snider, Gallagher, & Forgione, 2005). Traditionally, an ecological model is shown as a Venn diagram with overlapping circles. The EMG can be drawn in that manner, but it is separated here for ease of presentation.

The EMG is a combination of Human Ecology (Bronfenbrenner, 1979) and epidemiology and illustrates influences at the host (child) and agent (food) levels as they interact in the environment (microsystem and mesosystem). The host variables are those that are characteristics of the child, such as a child’s anthropometric measurements, or a child’s diet and level of activity or inactivity. The agent is viewed as the proximate cause of the problem, in this case nutrition that is not balanced with the child’s needs. The ecological environment is conceived as a set of connected structures, each influencing the other structures within the set.

The microsystem is the immediate setting containing the parent and child. In this study, the family, the family’s home situation, other children in the family, and the interaction between parent and child, are all considered characteristics of the microsystem. Other levels in the system are the mesosystem, exosystem, and macrosystem. This study did not examine the exosystem or macrosystem. The microsystem and mesosystem are settings that have powerful influences on the parents’ parenting practices, and thus affect the child (Bronfenbrenner, 1979).

A mesosystem is composed of a group of microsystems. Whenever a child or parent moves into a new setting or context, a mesosystem is formed or extended. In the mesosystem, a parent is an active participant; therefore, the strength or weakness in the link between the microsystem and mesosystem is important. For this study, the mesosystem was conceived as the parents’ cultural backgrounds and cultural practices. The EMG was used as the framework for this study and directed the choice of conceptual and operational variables to measure.

Background

Impact of Childhood Overweight

The National Center for Health Statistics at the Centers for Disease Control and Prevention (CDC) recommends that body mass index (BMI) be used to screen for overweight in children more than 2 years of age (CDC, 2007). Normal BMI in children is a BMI 85th percentile and 95th percentile BMI for age and gender. In children younger than 2 years, weight-for-length is the measure that is used to determine body mass. Weight-for-length is interpreted in the same manner, in that a child less than 2 years of age who is above the 95th percentile is considered overweight (CDC). No at-risk-for-overweight category (BMI 85th to 95th percentile) exists for weight-for-length. Stunted growth is length (or height for children more than 2) for age

Overweight during childhood is one of the major risk factors for the development of severe obesity and type 2 diabetes mellitus in adulthood, with all of its attendant risks for cardiovascular diseases (Freedman et al., 2005). It is a particular health problem among Hispanic and African American children. The percentage of overweight preschoolers (ages 2-5 years) has doubled in the past two decades, according to the National Health and Nutrition Examination Survey, increasing from 5% to 10% (Hedley et al., 2004). When preschoolers who are between the 85th and 95th percentile BMI (at risk for overweight) are included, the percentage increases to 23%. Type 2 diabetes, previously considered an adult disease, has increased dramatically in children and adolescents. Eighty percent of persons with diabetes will develop cardiovascular disease, and type 2 diabetes characterizes nearly half of new cases of childhood diabetes (BarrettConnor et al., 2004). Furthermore, obesity has been shown to track from childhood into adulthood (Dietz, 2000). Children who were overweight between the ages of 1 and 6 years have twice the odds for obesity at age 35; children who were overweight at ages 10- 14 have 5-10 times the odds for obesity at age 35 (Dietz).

Growth stunting is a complex child health phenomenon that, if not corrected, can contribute to developmental delay, cognitive deficits, and small constitutional size as an adult. Stunted growth, or height for age below the 5th percentile on the NCHS growth grid, is primarily caused by chronic malnutrition. Malnutrition is broadly defined as insufficient, inadequate, or inappropriate macronutrients and micronutrients. Families of children with stunted growth are often chaotic, characterized by poor supervision of the children and a lack of attention paid to the children’s physical and emotional needs (Heffer & Kelley, 1994). Little is known about the most effective way to treat stunted growth in a community setting, even though the community has been identified as the best place to manage stunted growth (Wright & Talbot, 1996).

Risk factors for overweight in toddlers and preschoolers have been summarized as race/ethnicity, physical activity/inactivity, and dietary intake (Nelson, Carpenter, & Chiasson, 2006). Risk factors for stunted growth other than organic causes are largely based on parenting practices, infections and illness, and malnutrition. As these categories roughly match the EMG framework, they will be summarized in the EMG categories below.

Ethnic Differences and Genetic Influences in Overweight Among Children (Host Factors)

A threefold increase in pediatric overweight has occurred in the last two decades (Ritchie, Ivey, Woodward-Lopez, & Crawford, 2003). Even more worrisome, the prevalence of overweight is higher in minority children, particularly Hispanic and African American children, and among children from low-income families (Lavizzo- Mourey, 2007). The prevalence of overweight among Mexican American preschoolers varies from 15.5% (Warner, Harley, Bradman, Vargas, & Eskenazi, 2006) to 26% (Ariza, Chen, Binns, & Christoffel, 2004); and for African American preschoolers it varies from 16.2% (Ariza et al. 2004) to 42% (Whitaker & Orzol, 2006), with the variation based on location, income of family, and age sampled. Hu et al. (2007) found that Mexican origin nearly tripled the risk of overweight among Head Start students in Minnesota. Stettler, Elliott, Kalian, Auerbach, and Jumanyika (2005) found the prevalence of overweight to be 22% in a nationally representative sample of preschoolers with no difference based on race/ethnicity, and urban, rural, or suburban clinic location.

The effect of allergies on anthropometries is unclear. Researchers in Mexico have shown a lower risk for overweight among children with a history of eczema (Violante et al., 2005), while in Germany, an association was found between airway resistance and overweight (du Prel et al., 2006). In Sweden, a high BMI was associated with wheeze but not with hay fever (Mai et al., 2003). Australian researchers have shown that the increase in BMI from ages 5 to 14 years is associated with asthma, while BMI at age 5 by itself is not associated with asthma (Violante etal. 2005). Some researchers have postulated that overweight and asthma are connected through a common pathway of inflammation, while others doubt this association (Plumb, Brawer, & Brisbon, 2007).

Energy Intake and Sedentary Behavior (Agent Factors) Data collected from 1994 to 1998 indicate that the physical activity of children of all ethnic groups fell short of the Healthy People 2010 goal for strenuous physical activity (Anderson, Crespo, Bartlett, Cheskin, & Pratt, 1998). Studies investigating the factors influencing overweight among Mexican American children have shown birth weight, mother’s BMI, juice intake, TV watching, and sweetened beverage intake as positive correlates to overweight (Ariza et al., 2004; Melgar-Quinonez & Kaiser, 2004). TV exposure increases the odds of overweight by 50% among boys and girls (Fleming-Moran & Thiagarajah, 2005).

Fewer than 20% of U.S. children exercise more than 2 hr of vigorous physical activity weekly, while more than 25% watch more than 4 hr of television daily (Dennison, Erb, & Jenkins, 2002; United States Department of Health and Human Services, 2000). Hernandez etal. (1999) found an average of 4.1 hr of television viewing was reported compared to an average of 2 hr a day of moderate or vigorous activity among children in Mexico City. The risk for obesity was 12% higher for each hour of TV watched and 10% lower for each hour of moderate or vigorous physical activity. Trevino et al. (1999), in a sample from San Antonio, found that Hispanic 9-year-old children were more sedentary at home and watched more television than did nonHispanic White children.

Among young Spanish children, the determinants of obesity found in a cross-sectional study of a random national sample (Perez- Rodrigo, Aranceta Bartrina, Serra-Majem, Moreno, & Delgado Rubio, 2006) were absence of breast-feeding; low consumption of fruit and vegetables; high consumption of sweetened breads, soft drinks, and meat; low physical activity, and high physical inactivity (measured by hours spent watching TV). A prospective longitudinal study of Dutch children showed that children who were breast-fed more than 16 weeks had lower BMI at 1 year of age than did children who were not breast-fed (Scholtens et al., 2007). A prospective longitudinal study of 1,739 Black, Hispanic, and White young children in the United States showed that breast-feeding for four or more months (equivalent to 16 weeks) was associated with a decreased risk of overweight as young children (toddlers or preschoolers) or as older, school-age children (Li, Goran, Kaur, Nollen, & Ahluwalia, 2007).

Home Environment, Parental-Family Influence, and Family-Based Interventions (Microsystem Factors)

How parents feed their children has been shown to have a significant effect on childhood overweight. Maternal child feeding practices that offer restricted food choices result in reduced child BMI percentile (Faith et al., 2003). The authors note that there is an interaction between ethnicity and feeding practices; non- Hispanic White parents/guardians report less monitoring of their children’s food choices than do Hispanic and African American parents/guardians. Close maternal monitoring and verbal prompting to eat at mealtime has been related to undesirable child eating behaviors (Johnson & Birch, 1994). Children who are compliant with maternal directions to eat tend to have a larger BMI (Faith et al., 2003).

A contribution that parents can make to childhood overweight prevention is modeling of healthy behavior at home. Seibold, Knafl, and Grey (2003) interviewed parents and teens to determine the family context of an intervention to prevent type 2 diabetes in high- risk, overweight teens. They identified four themes: child and family eating patterns, rules and control over eating, perspective on obesity, and perspective on weight control. Parents often did not assist teens with weight loss; eating together as a family occurred inconsistently; physical activity was sporadic; and parents did not provide healthy models of eating. Obesity was not seen as something to be avoided.

Children’s weight is significantly and independently associated with high-energy intake of both parents (Mirmiran, Mirbolooki, & Azizi, 2002). Parenting influences health behaviors of children and includes role modeling appropriate behavior and creating the social learning environment wherein the child adopts parental behaviors concerning food and eating. A home environment with low levels of cognitive stimulation, low family income, and maternal obesity results in a twofold increased risk for overweight in children (Strauss & Knight, 1999). Homes with a highly stimulating cognitive environment have the lowest rates of childhood overweight, independent of SES, race, maternal BMI, or marital status. Positive family behaviors, such as eating together and modeling healthy dietary intake, can have an impact on the development and persistence of overweight in childhood (Seibold et al., 2003).

Parental obesity is a major risk factor for child obesity and is the strongest predictor of adult obesity in children before age 3 years (Whitaker, Wright, Pepe, Seidel, & Dietz, 1997). Children with type 2 diabetes usually have a family history of type 2 diabetes, and those of non-European ancestry have a disproportionate share of multigenerational type 2 diabetes (American Diabetes Association, 2000). The majority of the world’s population most likely has genes that allow for survival in times of food scarcity, which would promote obesity in times of abundance (Lobstein, Baur, & Uauy, 2004). Thus, food availability is an example of environmental change that can affect obesity.

Parental modeling of healthy eating and activity behaviors has been associated with less chance for overweight in their children and identified as a useful approach for management of childhood overweight (Ritchie, Welk, Styne, Gerstein, & Crawford, 2005). Polley, Spicer, Knight, and Hartley (2005) demonstrated that African American and Native American parent/ grandparent TV-watching hours were significantly correlated with child TV-watching hours, and child BMI was significantly associated with TV-watching hours.

Family-based interventions for weight management have been recommended for decades (Mahan, 1987). Parents shape the home environment, which includes the children’s toys, play locations, and activities, and they buy the food children consume. Parents’ BMIs are highly correlated to their children’s BMIs (Fogelholm, Nuutinen, Pasanen, Myohanen, & Saatela, 1999). Parents can take a number of steps to change their home environment so that it promotes a healthy lifestyle and reduces the incidence of childhood overweight (Kirk, Scott, & Daniels, 2005; Ritchie et al., 2005). These steps include dietary changes, activity changes, and parental modeling behaviors.

Influence of Acculturation and Community on Overweight (Mesosystem Factors)

In a study of 901 Latino men and women, years lived in the United States was the strongest correlate of obesity (Hubert, Snider, & Winkleby, 2005). Subjects who obtained less exercise, watched TV regularly, and ate fried foods were heavier than subjects with healthier habits. Unger et al. (2004) found in a study of 1,385 Latino and 619 Asian middle-school-age children that acculturation to the United States was positively associated with less physical activity and greater consumption of fast foods. Researchers have demonstrated a fourfold increase in obesity among Latino immigrants to the United States based on length of residence in the United States and shown significant relationships between BMI, fewer hours of physical activity, and years in the United States (Ayala et al., 2004; Himmelgreen et al., 2004; Kaplan, Huguet, Newsom, & McFarland, 2004). They recommend maintaining Mexican cultural practices to reduce obesity among immigrants.

Purpose of Study

In this study, we wanted to determine the differences in weight, length, and weight for length present in the ecological environment of children who participate in a large metropolitan WIC clinic. When the differences are identified, culturally sensitive interventions that model the factors most prevalent in the normal sized children (weight for length or BMI > 5th percentile and

Methods

Design and Procedures

This cross-sectional study collected data based on the EMG. The study was approved by the university’s institutional review board as well as the human subjects protection review board of the health district and occurred across 3 years. Data were obtained from children’s mothers about the children, the mothers, and their families when they were in a WIC clinic sponsored by a large metropolitan health district. All data collection was done at the WIC clinic in a standard manner by all research team members.

After the children had been weighed and measured by WIC personnel, the mothers were approached by a member of the research team and informed of the study. The research team asked for permission to see the children’s anthropometrie measurements to determine if they would qualify for the study. The child was then re- measured by the research personnel. If the child qualified based on criteria discussed below, the study was explained to the mothers and informed consent obtained. Mothers were asked to complete a packet of instruments while their children were being certified for WIC nutrition vouchers and waiting for voucher pickup. It took approximately 30 min to complete the packet. The instruments were in English and Spanish, and the mother was approached by a research team member who spoke her language.

After the questionnaire packet was completed, the research team member asked the mother to review the listing of activities that are included in the NCATS and to teach the child that activity. The resulting motherchild interaction was observed by the team member and scored at its completion. At the completion of the instrument packet and measurement of the child and mother for anthropometries, the mother was given a $20 gift card to a local retailer as compensation for her time. Participants

The sample-size goal was 100 children ages 12 to 24 months in each of the three conditions: stunted, normal-size, and overweight, and their mothers (N = 300). The WIC program in this health district has an average monthly enrollment of 50,000 women and children, and the clinic where the data collection occurred is its largest site. By virtue of qualifying for WIC, all the families were at 185% of federal poverty level or lower. All children had documented residence in the city. To be included in the study, the children had to fit anthropometric criteria for being stunted, normal-sized, or overweight. In addition, they had to live with a parent or guardian (no foster children), not have any metabolic or major illnesses or any neurological or developmental delays, and not have an organic cause for stunted growth or overweight. No inclusion or exclusion criteria existed for the children’s mothers.

Instruments

Anthropometries. For children, height was measured with a length board to the nearest mm, and weight was measured to the nearest 0.1 kg using a balance beam scale with the child wearing only a dry diaper. For mothers, a wall-mounted stadiometer was used for height and a balance beam scale was used for weight, with the mothers wearing only indoor clothing and shoes of no more than 1” in height. All height and weight measures used for research purposes were obtained by research staff, who achieved inter-rater reliability on the measures before data collection began. These measures were used to calculate weight for length, which was entered on the growth charts provided by the National Center for Health Statistics to determine anthropometric percentiles for children and adults. This determined the categories of stunted, normal, and overweight for children and overweight or obesity for adults. All anthropometries were converted to a z score to allow group comparison by gender and age in months.

Dietary data. The 24-hr Diet Recall captured all food intake for the 24 hr of measurement for the child only, both food consumed at home and food consumed away from home. The dietary data were then entered into Food Processor II, a computer-based nutrient analysis system, which then converted the data into multiple levels of analysis. The dietary data were analyzed as individual foods, servings from the food pyramid, as well as macronutrients and micronutrients.

Demographic data. Demographic data consists of personal and family characteristics for each child, his/her parents, and the family situation. It includes items such as income, educational level of parents, parental employment, number and relation of people in the household, receipt of food stamps and monthly amount, receipt of free or reduced lunches for any siblings in the family, length of residence in current house, generation of residence in United States, ethnicity, and language spoken at home.

Acculturation. Acculturation of Hispanic families was measured by the Acculturation Rating Scale for Mexican Americans-II (ARSMA-II) (Cuellar, Arnold, & Maldonado, 1995). ARSMA-II is a 30-item Likert- type scale that measures acculturation along three primary factors: language, ethnic identity, and ethnic interaction. Higher total scores indicate that subjects are acculturated into Anglo-American culture. The authors (Cuellar et al., 1995) report reliability of alpha = .88 and demonstrate validity with lessening ethnic identity (a related but separate process) as acculturation increases (Cuellar, Nyberg, Maldonado, & Roberts, 1997). Sherman, Alexander, Dean, and Kim (1995) used the ARSMA in a study of obesity in Mexican American children and employed total scores as a predictor of obesity.

Parent-child interaction. The variable of parent-child interaction was measured by the Nursing Child Assessment Teaching Scale (NCATS) (Barnard, 1978). The scale consists of 73 items organized into four subscales that measure the parent’s responsibility to the interaction: sensitivity to cues, response to distress, social-emotional growth fostering, cognitive growth fostering; and the scale consists of two subscales that measure the child’s responsibility to the interaction: clarity of cues and responsiveness to caregiver. It is appropriate for children from birth to 36 months. Cronbach’s alpha for the NCATS is reported at .83 for the entire scale, with the parent subscale alpha of .83 and the child subscale alpha of .84 (Barnard et al., 1989). Test-retest reliability is reported as 0.85. Validity was measured by correlation with the HOME of r = .48, and R = .48 with the 24-month Bayley Scale (Barnard et al., 1989). All members of the research team were trained in the use of the scale and obtained inter-rater reliability exceeding .90 before collecting data.

Baecke Questionnaire of habitual physical activity. The Baecke Questionnaire is designed to measure three aspects of an adult’s daily activities: work, leisure, and sports (Baecke & Frijters, 1982). The authors have demonstrated that the questionnaire captures the three types of habitual physical activity, and reliably differentiates between the three types. To demonstrate validity, Florindo and Dias de Oliveira Latorre (2003) compared 21 adult subjects on aerobic fitness, an annual index of physical activity, a weekly walking log, and the Baecke Questionnaire. The subjects who were measured as most fit according to the Baecke Questionnaire also demonstrated fitness on a 12-min aerobic run/walk and were shown to be most active according to a weekly log of physical activity. Six- week test-retest scores on the Baecke Questionnaire demonstrated a significant intraclass correlation of 0.77. The Baecke Questionnaire (available in English and Spanish) was used to measure the mother’s daily habitual physical activities.

Data Analysis

Univariate and multivariate normality were reviewed statistically prior to further data analysis. Statistical analyses were conducted using ANOVA with post hoc tests using Bonferroni correction. Significance was set at p

Results

The genders and ages of the stunted and the normal groups were significantly different. There were no significant differences between the groups for maternal education or employment, or the percentage of mothers who preferred to speak Spanish for data collection. see Table 1 for a description of the sample.

Host Differences

As expected, there were significant differences in the heights, weights, and weight for length of the three groups of children. Of interest is the mean height and weight of the normal sized children was below 0 (z-score), so less than the 50th percentile on the growth grid. The mean height for overweight children was 0 (z- score), which means they were at the 50th percentile on the height growth grid; but at 1.9 z-score mean for weight, they were nearly 2 SD above the mean for weight. For weight for length, no groups were below the mean, but the normal group was closest, followed by the stunted group. The overweight group, as expected, had a z-score of 2.5, indicating they were 2.5 SD above the mean for weight for length. The finding of a significant difference in occurrence of allergies (to environmental sources, as reported by mothers) was not expected (see Table 2).

Agent Differences

The agent variables that showed significant differences were dietary intake, as well as length of time breast-fed and daily ingestion of fluoride. The normal group was breast-fed the longest and the overweight group the shortest length of time. The stunted group received fluoride more often than did either of the other two groups. The overweight group had significantly higher daily intakes of Mexican rice, Kool-Aid, and showed a trend to significance for water and bread, while the normal group had the highest daily intake of American cheese, raw apple with peel, pancakes, and showed a trend to significance for vitamin C. The stunted group showed a trend to significance for the highest daily intake of vegetables (Table 3).

Microsystem Differences

The microsystem differences were analyzed according to the three components of the microsystem: home environment, maternal-child (MC) relationship, and parental factors. There were no significant differences in home environment, but two variables showed a trend to significance, those of sitting with the child at mealtime and a crowded home. For the MC relationship, the total NCATS scale, the child and caregiver subscales, and the subscales of child’s response to distress, mother’s cognitive growth fostering, and child’s response to caregiver showed significant differences by group. The stunted group was significantly higher in child’s response to distress but was the lowest in the other scales and subscales. The normal group was significantly higher in the overall NCATS, caregiver subscale, and tied in the response to caregiver subscale. The overweight group was highest in the cognitive growth fostering and child subscale, and tied with the normal group in response to caregiver.

The maternal and paternal BMIs for the overweight group were significantly higher than for the normal group and the stunted group. The mean parental heights were significantly lower for the stunted group, while they were the same for the normal and overweight groups. The mothers in the overweight group were significantly less likely to sweat during leisure time activity than were the mothers in the stunted group (see Table 4). Mesosystem Differences

The mesosystem differences show a clear and consistent significant increase in the percentage of mothers, maternal grandmothers, and maternal grandfathers who were born in the United States (as opposed to being born in Mexico) from the stunted group to the overweight group. There were no significant differences in fathers, paternal grandmothers, or paternal grandfathers’ places of birth by group (see Table 5).

Discussion

This study supports previous research that shows differences in various factors that contribute to overweight. This study contributes to the fields of child growth and childhood overweight by emphasizing the holistic view that many factors in the child’s environment have an impact on a child’s size and that those differences can be examined through an ecological lens, rather than as a random group of factors.

The cause of the differences in the proportion of boys and girls among the three groups is unknown. The stunted group is significantly different from the normal, with more boys than girls represented in the stunted group. The reason for this disproportion may be due to the significant difference between the stunted and normal groups’ mean ages, with the stunted group being 1.5 months older, or it may be unknown. The mean educational level of the mothers (10th grade) among the children shows no difference between groups, similar to the finding of approximately one third or fewer of the mothers in each group being employed outside the home. The percentage who preferred Spanish is also not significantly different, which was a surprising finding given the significant difference in the percentage of mothers who were born in the United States. However, there were a sizable percentage of mothers in each group who were born in Mexico, and it could be that some of those mothers preferred to complete the instruments in Spanish.

The host differences in weight, length, and weight for length were expected given that those measurements were the inclusion criteria for the study. However, the finding that the mean height and weight for the normal group were below the 50th percentile shows that the children in this population were shorter and lighter than the children in the NCHS growth sample. This may reflect their low- income status because height is associated with better nutrition in a population. Only the overweight group achieved the mean 50th percentile in height, but as increased height is associated with increased weight, this is expected (Dewey et al., 2005). The finding of more reported allergies among the normal group is statistically significant, but its clinical significance is unknown.

The agent differences indicate the length of time breast-fed does contribute to normal growth. This finding was supported by a systematic review by Dewey (2003), who found that the preponderance of studies on breast-feeding show that breast-feeding may influence an infant’s self-regulation of energy intake and metabolic programming in early life. The higher intake of fluoride in the stunted group could indicate supplemental fluoride as the water supply was not fluoridated in this city at this time, so all fluoride the children received was through supplementation given as drops.

The food intake is harder to interpret, but it does indicate that diets featuring dairy protein (American cheese) and fruit (apple with peel and vitamin C) are a characteristic of the normal sized group, while diets featuring starches (Mexican rice, breads) and sweetened beverages (Kool-Aid(R)) are characteristic of the overweight group. Dairy consumption has been inversely associated with components of the metabolic syndrome in adults in several studies (Pfeuffer & Schrezenmeir, 2007). Zemel (2005), in a review on the role of dairy foods in weight management, postulates that high calcium diets reduce fat accumulation and play an important role in maintenance of normal weight and management of overweight. Ariza et al. (2004) found that overweight Hispanic children (ages 5- 6 years) were more likely to consume sweetened beverages (including Kool-Aid(R)) daily. Vegetables are generally low in calories, and the finding that the stunted group ate the most vegetables could indicate their lower caloric intake. The diet differences are only suggestive at this time but do lend support to advising mothers to provide dairy protein and fresh fruit to encourage normal growth and discouraging intake of many servings of starches and sweetened beverages to prevent overweight.

The microsystem is viewed as three components: the home environment, the MC relationship, and the variables pertinent to the parents. Overweight children came from the least crowded homes (five people or fewer in the home) and were least likely to eat by themselves. Both of these findings were only trends so can only provide suggestions, but it may be that in this population, the overweight children receive more attention, and that attention is provided through food. This finding can be interpreted in light of the MC relationship, in that the MC relationship shows that the normal sized and the overweight children have more positive relationships with their mothers on many measures, except for response to distress. In terms of supportive home environments, the stunted children are at a disadvantage compared to normal sized or overweight children. In this population, the structure of home environments and MC relationships that provided individual attention and support may have protected against poor child growth (stunting) but not overweight.

The differences in the parent variables, regarding size of parents, are consistent with previous findings. The BMI of the parents of the overweight children was significantly larger than the BMI of the parents of the normal sized children. Of note is the finding that the mean BMI for all the parents, both mothers and fathers, is in the range considered overweight (BMI > 25), and the BMI of the mothers of the overweight children is in the obese range (BMI > 30). The finding that the mother’s participation in activity during leisure time decreases as the children’s BMI increases has not been previously reported. The finding that more leisure time physical activity is associated with a lower BMI was expected because Mouton, Calmbach, Dhanda, Espino, and Hazuda (2000) have shown that leisure time physical activity is inversely associated with obesity among repeated samples of Mexican American adults from family practice clinics in South Texas. Increasing a mother’s leisure time physical activity could be one way to promote normal child size and decrease risk of overweight in children (Fogelholm et al., 1999).

The increase in percentage of mothers and maternal grandparents born in the United States as the children’s BMI increases mirrors the finding of Duerksen et al. (2007) that parental overweight is associated with eating at American restaurants, while child and parental BMI were lowest in families that predominately ate at Mexican restaurants. However, Ariza et al. (2004) found no association between children’s overweight and the mother’s score on the acculturation scale in their study of 250 kindergarten children who were primarily Mexican American. The effect of acculturation and generation in the United States on health and weight gain is complex, and it calls for models that examine the patterns of health and disease outcomes for distinct ethnic and cultural subgroups, according to Castro (2007).

Limitations

The findings from this study are limited to similar populations of low-income, Hispanic (mostly Mexican American) children who participate in the WIC program. It is unknown if children from other Hispanic populations (Puerto Rican, Central American, etc.) or from other ethnicities/races have similar home environments or growth patterns. As this was a cross sectional study, no conclusions can be drawn about the antecedents for the children’s patterns. Only associations between ecological factors and the size of the children when they were toddlers can be known from this study.

Researchers have demonstrated a fourfold increase in obesity among Latino immigrants to the United States based on length of residence in the United States and shown significant relationships between BMI, fewer hours of physical activity, and years in the United States

The finding that the mother’s participation in activity during leisure time decreases as the children’s BMI increases has not been previously reported.

How Do I Apply This Information to Nursing Practice?

The EMG can be used as a “pathway” by a nurse working with a family that includes a young child who has altered growth patterns, either overweight or stunted growth. The EMG will help the nurse systematically analyze the factors that are contributing to the child’s growth and recommend solutions that are consistent with the family’s culture and background. First the nurse can examine the host contribution by taking careful measurements of the child’s height and weight and graphing them on the appropriate scale. Then consider how many hours of TV the child watches and how many hours the child is physically active. To examine the agent contribution, determine the child’s 24-hr diet intake, whether the child is getting five fruits and vegetables per day and sufficient protein, and inquire about the family’s favorite foods. Is the child getting too many calories or not enough? The microsystem examination will yield information about the number of people in the home, the family’s meal patterns, how the mother responds to the child’s mealtime behaviors, and the parents’ BMI. Then an examination of the family’s cultural background will give meaning about the family’s view of food and child-rearing, type of preferred child activity, and interaction patterns. When the nurse has a systematic view of all the influences surrounding the child that reinforce or discourage childhood growth, the nurse can create a plan that is unique for that child and family and will be more likely to be effective. The EMG is “elastic” in that it will provide a systematic examination of child growth no matter what size the child happens to be. When teaching the parents of a stunted or overweight child about ways to help the child “grow into” the normal weight category, the nurse can discuss foods that support normal growth, such as dairy and fruits and vegetables, and those that encourage overweight, such as sweetened drinks and low-fiber starches. Foods that encourage growth in height contain complete protein, with sufficient calories to maintain accelerated growth. If the nurse is counseling expectant parents, the finding that length of time of breast-feeding is associated with normal growth can provide support for encouraging the expectant parents to choose breast-feeding.

It is important for the nurse to understand the cultural background of the child’s parents, as many more traditional (less Americanized) diets feature more fruits and vegetables and fewer sweets than do contemporary fast-food American diets. Encouraging parents to maintain such cultural diets (if appropriate) can promote normal size growth in an immigrant population. Promoting a nurturing mother-child relationship through teaching a mother how to engage in positive, supportive interactions with her child can also promote normal growth and discourage growth stunting. It is important to teach parenting skills so that parents know how to handle children who throw tantrums if they do not get the sweets they desire. Parents who are physically active during leisure activities can promote a healthy model for their children, and they may involve their children in such activities, promoting normal growth for their children.

This study supports the holistic nursing view that a child’s size is influenced by ecological factors present in the family’s environment. Parents’ exercise patterns, cultural backgrounds, provision of food, and relationships with their children all affect their children’s sizes.

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Elizabeth Reifsnider, PhD, APRN, BC, WHNP, and Melanie Ritsema, RN, IBCLC, MPH

Elizabeth Reifsnider, PhD, APRN, BC, WHNP, is Professor, School of Nursing, University of Texas Medical Branch, Galveston, TX; and Melanie Ritsema, RN, IBCLC, MPH, is WIC Director, San Antonio Metropolitan Health District, San Antonio, TX. (This is where Mrs. Ritsema worked when the study was conducted. She is now living in England.)

Acknowledgments. This research was funded by the National Institute of Nursing Research, Grant No. 5R29NR004882, and a Texas Department of Health, Innovation Grant.

Author contact: [email protected], with a copy to the Editor: [email protected]

Copyright Nursecom, Inc. Jul 2008

(c) 2008 Journal for Specialists in Pediatric Nursing. Provided by ProQuest Information and Learning. All rights Reserved.

Social Implications of Overweight and Obesity in Children

By Edmunds, Laurel D

PURPOSE. To elucidate some of the social impacts that overweight and obesity in children has on families. Healthcare practitioners may be unaware of these impacts if not similarly affected. DESIGN. Qualitative semistructured, interview-based study.

METHODS. A purposive sample of parents (n = 58) with overweight and obese children (n = 48) from three areas in the United Kingdom was used. Analysis was thematic and iterative, underpinned by Grounded Theory.

RESULTS. There are many social situations that have an impact on the child directly (stigmatization), on parents (blame), and on the family in general (being ostracized).

PRACTICE IMPLICATIONS. Seeing the child and his/her family in a broader context with improved understanding of the complexity of raising an overweight child.

Search terms: Child, obesity, overweight, parents’ experiences, qualitative, social impact

First received September 3, 2007; Revision received January 23, 2008; Accepted for publication February 27, 2008.

Obesity in children, from infants to teens, shows few signs of abating, and its effects are increasing globally (Lobstein, Bauer, & Uauy, 2004). In the United Kingdom, primary care personnel, particularly the practice nurses, are the front line for tackling child weight management. School nurses in countries such as the United Kingdom and the United States also have a vital role to play. Most weight management interventions have concentrated on diet and physical activity because these are the main components of published interventions and make sense intuitively. The interventions in the literature, in turn, have been interpreted for national guidelines (e.g., United Kingdom, Australia, Canada, United States, and several other countries). However there are a number of studies that show healthcare practitioners recognize their role in the treatment and prevention of obesity in children but are not sure how to help, and they often feel that it is not a productive use of their time (Jelalian, Boergers, Alday, & Frank, 2003) despite these guidelines.

For children, the worst aspect of overweight and obesity are psychosocial (Dietz, 1998). Some interventions, both prevention and treatment, have included psychological strategies, but treatment interventions also need to consider the personal social circumstances of families, beyond their social demographic, and these are often not explicit. Although awareness of these issues is becoming more accepted, applying this awareness may improve any intervention (Jelalian Wember, Bungeroth, & Birmaher, 2007). Not addressing these “softer” aspects of management may hinder the efficacy of intervening with diet and physical activity.

Healthcare practitioners may not always appreciate the wider impact of having an overweight child in the family and so may not be as supportive as one might wish (Edmunds, 2005). The acceptance, or lack of it, of overweight is likely to vary to some degree culturally in the United Kingdom, and probably in other countries. However, for most, there are negative consequences of being overweight or having an overweight child in the family. This study elucidates some of these wider social impacts of overweight for children and their families. These broader consequences have not been investigated before and may help practitioners understand their plight better when interacting with families coping with overweight children.

Methods

In-depth interviews were chosen as the most appropriate method for exploring the very complex and extremely sensitive subject of childhood obesity. Interviews allowed for greater flexibility and interaction, and allowed novel topics to arise so that themes could be identified. The method of constant comparison was used to refine and revise themes. This approach was underpinned by Grounded Theory, which provided a framework to explore parents’ experiences and their social interactions with health professionals (Strauss & Corbin, 1998). Data were collected and analyzed concurrently, and the emergent themes are detailed below.

Recruitment and Sample

Three geographical areas of England were selected to increase the likelihood of participation as the social stigma associated with childhood obesity was a major barrier to finding a range of parental experiences with children of each gender, from different social backgrounds, and with access to different healthcare provisions. Parents of children (younger than 1-15 years) who had concerns about their children’s weight were included. Within a reasonably homogeneous sample, “data saturation” is achieved within 40 interviews (Pope, Ziebland, & Mays, 2000). Here, 58 parents of 48 children (20 in each of Central and South Western England, and 8 in Northern England) were included in the study.

Parents with any weight concerns about their child(ren) were invited to take part in the research. Parents were recruited via a number of methods, including via health professionals, posters in primary care settings, and advertising in local papers. Recruitment through weight loss groups was added subsequently to improve response rates. Parents were self-selecting, and those interested in taking part received either an information sheet or were invited to telephone the author for more information when responding to advertisements. Parents were recruited via the following sources: 21 from advertisements, 9 (out of 22 who were informed) from pediatric dietitians, 9 from slimming groups, 8 from a weight management clinic, and 1 from a poster in their primary care setting. Forty- four of the children’s parents were White, and the others were of Afro-Caribbean, Indian, and Iranian ethnicities.

Children came from a range of different socioeconomic backgrounds, and 29 were girls. Their shapes were compared with a standardized set of body shapes (Stunkard, Sorensen, & Schulsinger, 1983; see Figure 1) for children over the age of 4 years by the author in conjunction with parent(s). Growth records were used to classify younger children. The aim of using the shapes was to illustrate rather than to provide actual estimates of BMI. Shapes were selected because they did not require the presence of the child and were less intrusive. Recruitment was difficult, and this approach was less likely to result in objections. More importantly, some parents were concerned about raising awareness of overweight in their child(ren) where none existed, or revealing the extent of their concern as parents, particularly in the child’s own home, and so were more willing to participate in these circumstances.

The ages and sizes of the children can be seen in Table 1. Their parents’ socio-economic statuses can be see in Table 2. Categorization was based on the main earners’ incomes in accordance with the U.K. standard occupational classification (Office of Population Censuses and Surveys, 1990).

Interviews

The interview schedule was piloted and included topics such as the child’s weight history from pregnancy in conjunction with the body shapes (see Figure 1) and photographs, together with family weight history, self-help strategies, and societal interactions. In- depth, semi-structured interviews were conducted by the author and audio-tape recorded with the participants’ written consents; 96% were interviewed in their own homes. Thirty-eight interviews were conducted with mothers and 10 with both parents present. Interviews took between 45 and 150 min, with most lasting around 75 min, and they were conducted over a period of 15 months up to January 2002 and from March to November, 2005. Other topics have been published and presented elsewhere (e.g., Edmunds, 2005, 2006; Edmunds, Mulley, & Rudolf, 2007).

To illustrate the starting points for discussion, the following is from the interview schedule:

For any period when the parent describes the child as overweight the interviewer would ask: how the parents felt about it, whether they were aware of the child being bothered about their weight and whether anyone else (such as friends, family, general practitioner, practice nurse, teacher) had commented on the child’s weight. (Did your child say anything to you about it? Do you think they were aware that they were putting on weight? Did anyone else say anything to you about your child? Did this change have any effect on you? Did this change have any effect on your child?).

Many of the issues included here stemmed from these questions.

Analysis

Descriptive data were recorded documenting children’s ages and the current and past shapes of the children and other family members. All the interviews were transcribed verbatim, checked for accuracy by comparing the transcript with the tape, and reread several times. The main, or higher, initial categories were “reactions of others,””learning to cope with their size,””clothes,” and “the impact of teasing and bullying”; these were divided into further subcategories. Themes were discussed with a second qualitative researcher with evidence from the data. Finally, two focus groups were held, one in each of Central and Southern England, to test the veracity of findings with participants. It was not possible to repeat this in Northern England due to lack of funding. Analyses followed a well established social science methodology and findings represent the author’s interpretation of parents’ perceptions. Further details of the methods can be found in an earlier article (Edmunds, 2006). The sex, age, and shape of the children have been used as an identifier for their respective parents’ observations.

Results

The nature of the interviews resulted in very rich, wide-ranging data. The families were diverse in that 11 had only one child, 4 families reported that all the children in the family were overweight, and 33 had just one overweight child. Non-overweight children in some families were still quite young and so could gain excess weight with time. The findings here concern the index child, their families, and any siblings if appropriate.

Four higher categories emerged from the interviews: “reactions of others,””learning to cope with their size,””clothes,” and “the impact of teasing and bullying.” The first, “reactions of others,” was subdivided into family members, strangers, and general societal messages. One important category, healthcare professionals, has been omitted here because these findings have been published elsewhere (Edmunds, 2005). However, one of the respondents from the subsequent data collection in Northern England made a relevant comment: “I’d like them [healthcare practitioners] fo understand just how complicated it [bringing up an overweight child] is” (mother: girl 7 years, shape 6). Coping with the child’s size and clothing received little subdivision, whereas the last category included schools, holidays, and home locations. The main issues for parents have been illustrated; as one mother put it, “It’s all things that other people take for granted every day with their children” (mother: girl 3y, shape 7).

Reactions of Others

The social stigma associated with excess weight was exhibited by everyone from family members to complete strangers. Fathers were more concerned and sensitized if they had been overweight as children, “I’ve suffered all my life” (father: girl 15 years, shape 7). Normal-weight fathers were less concerned and still gave their children treats, “He doesn’t tend to be here evenings and weekends when she’s constantly asking for food … [he] hasn’t had the experience of taking her to the doctor, trying to buy clothes” (mother: girl 8 years, shape 5). Others found having an overweight child difficult: “My husband was so embarrassed and made some comments about it [eating chocolate cake at a party], but L took no notice and just sat down and ate them [2 large pieces]” (mother: boy 15 years, shape 7).

Having an overweight child created potential for discord between parents, further complicating raising an overweight child: “I remember having big arguments with my husband about this [the amount of food the child should eat]” (mother: boy 1 year, shape 6/7). Three mothers felt they had to protect their children from their fathers’ lack of sympathy: “His dad had a tough upbringing in Africa. He thinks I’m being too fussy and I’m making him [son] look silly” (mother: boy 9 years, shape 6/7); He’s so angry… with the NHS [National Health Service] and with the school.. .it just makes thing worse” (mother: girl 12 years, shape 7); “He does moan at A about food …If we take him anywhere and A starts to play up he [father] goes to pieces you know, he just thinks he’s gotta shout at him, tell him, you can’t make him, the more you shout at A the more he’s gonna be like it” (mother: boy 13 years, shape 6/7).

Grandmothers also were not necessarily supportive, but in different ways. Some “nagged” their daughters: LE: “Who was it who told you you’ve got to do something about her weight?””Well me mum’s the one, she goes on about Z’s weight” (mother: girl 13 years, shape 7). Many, however, were responsible for increasing the overweight child’s intake, some with the best of intentions: “She [grandmother] says it’s nice to see kids eat, these kids these days, they don’t eat anything” (mother: boy 11 years, shape 5), or they wanted to feed them “proper” meals (meat, two vegetables, and puddings) or “sweets”: “As soon as we walk through the door, out comes the fairy box [full of sweets]” (mother: girl 9 years, shape 6). Others saw grandmothers’ influences as less helpful: “I always bring my mum into it, she causes the problem. I say to M, you are old enough now to say ‘No nanny, no thank you, I don’t want it'” (mother: girl 9 years, shape 6/7); “My mum-since my dad died, she just can’t be bothered. She … she’ll sit there and she’ll eat packets of crisps and sweets, and she’s always got bagfuls of sweets” (mother: boy 12 years, shape 6/7). Behavior patterns across generations were having an impact on these children.

Overweight children were perceived as “fair game,” and parents recalled comments from strangers that were more or less insulting: “Cor, she likes her chips” (mother: girl 9 years, shape 6); “Look at his legs!” (mother: boy 8 years, shape 7); “What is that child still doing in a pushchair?” (mother: boy 10 years, shape 5); “Has she got a giantism problem?” (mother: girl 13 years, shape 5/6); “Do they have the same father?” (mother: boy 11 years, shape 6). Mothers were often left dumb-founded and further concerned about the messages their children were receiving.

All those interviewed were aware of their children being ostracized because of their weights. Four parents of 7-11 year olds talked about children not being invited to parties. Some mothers were conscious of “people looking at you, judging you” (mother: son 1 year, shape 6/7), being made to feel “out of place” (mother: girl 3 years, shape 7), and “stared at” (mother: girl 14 years, shape 7). As one mother said “I know I shouldn’t worry about what other people think, but we do don’t we” (mother: boy 3 years, shape 7). The plethora of television programs over the last 3-4 years in the United Kingdom raising awareness may be having the unintended effect of “making it worse” (mother: girl 14 years, shape 7). One mother talked about the influence of raising awareness in schools, often in response to bullying incidents: “The headmistress talked about it in circle time. It’s making children more aware of who might be overweight, and they’re being targeted. It’s so unhelpful” (mother: girl 7 years, shape 6). Another mother (girl: 14 years, shape 6/7) summed the situation up “We’re made to feel like lepers.”

Learning to Cope with Their Size

Overweight children without underlying medical causes tended to be tall. Their bodies were more developed than their cognitive and emotional maturity, and children had to learn to cope with the consequences of living in a large body. Many parents described their children as “gentle giants” as they had encouraged them to be caring: “She’s so strong. We had to stop her swinging her friend around. She [friend] is half her [daughter’s] size” (father: girl 7 years, shape 6); “The teacher told us that he’s really good at looking after the younger children in the playground” (mother: boy 8 years, shape 6).

However, this was not always the case. The only grandmother who took part in the interviews said of her granddaughter “I’m worried that when she runs to me, she’s going to knock me over,” and of greater concern, “We need to get her tantrums under control” (grandmother: girl 3 years, shape 7). One mother recalled her son’s story, “They wanted to have him statemented for disruptive behavior in the infants [school for 5-7 years]. He was injuring the other children and crashing into the furniture. He was just being boisterous, but he did look about 8…. and then he was diagnosed with dyspraxia when he was 7” (mother: boy 9 years, shape 6/7). Two of the older children (both large adult size) were encountering the authorities: “He was with a group of friends [and an adult at 1:00 a.m.]. . . . She [policewoman] charged in and got him by his lapels and dragged him to the front of the shop” (mother: boy 15 years, shape 7); “S has been through an anger management course at school, and on Tuesday of this week she was actually arrested . . . there’s a possibility of her being prosecuted” (mother: girl 13 years, shape 5).

Clothes

Buying clothing that fit, was age appropriate, and “looked nice” was problematic for all the parents interviewed and worsened with age and size, especially for girls. For one mother this started in very early: “I couldn’t get a nappy to fit her. She’d outgrown all the ones in the supermarket” (mother: girl 3 years, shape 7). Most of the children in this study were wearing clothes that were sized 2- 3 years above their chronological ages, and some parents were making their children’s clothes: “I’ve had to start making her clothes . . . You can’t even buy clothes off the peg, . . . I can’t have anything with a zip or a button because it just won’t stay up on her, at all” (mother: girl 3 years, shape 7). Mothers (or grandmothers) who could not sew had to resort to other solutions: “I had to buy him dwarf’s trousers” (mother: boy 8 years, shape 7). This was particularly difficult with school uniforms where schools had specified suppliers: “She’s already in the largest size trousers that the school [up to 18 years] suppliers make, and she’s only 12” (mother: girl 12 years, shape 7).

Wanting their children to “look their best” was a topic that most mothers discussed. As children became older, some chose clothes to disguise their sizes: “I know she wears baggy T-shirts to try to hide it” (mother: girl 10 years, shape 6). As children got older and larger, the ubiquitous “baggy sweats” were mainly due to lack of choice: “Obviously it’s hard, ain’t it, when they’re bigger to get really nice clothes” (mother: girl 14 years, shape 7). Younger children wanted to be more fashionable: “She wants to wear fashionable clothes but she won’t look very nice in them so I have to try and talk her out of it” (mother: girl 9 years, shape 6). Looking and being treated as older and so being expected to behave accordingly was commented on frequently in a variety of contexts. However, this was particularly an issue for mothers of preadolescent girls whose clothing could result in their looking adolescent and having to cope with unwanted attentions. The Impact of Teasing and Bullying

Teasing and bullying was particularly notable in the school setting and started at the youngest ages if the children were overweight enough: “I don’t like talking about it in front of her . . . because when she went into reception, she did have a bad time to start off with [suffering name calling, resulting in a lack of confidence when she was 4 years old]. But she says to me “am I fat Mummy?” and she’s only 5 now” (mother: girl 5 years, shape 7). Another, a 5-year-old boy, pleaded with his mother to take him to the doctor because he was being so badly bullied at school: “He used to come home from school crying . . . ‘please take me to the doctor Mummy, I’m too fat'” (mother: boy 5years, currently shape 5). Name- calling started between shapes 4 and 5, usually with taunts: “You wear your mum’s knickers” (mother: girl 7 years, shape 5) and increased in frequency and nastiness with fatness; one boy was exposed on the lavatory at school by a gang of boys (mother: boy 8 years, shape 7).

Parents also thought physical education lessons exacerbated the situation. “The teasing started when he started having to change for PE” (mother: boy 8 years, shape 7). These effects could be long lasting: “Why don’t you want to do PE, its fun? and she said ‘Somebody called me fat’. . . and I think since then it’s stuck in her head” (mother: girl 6 years, shape 6/7). Most parents talked about problems on PE days with “battles” with younger children and older children skipping school, which in one instance was leading to a far worse situation: “At first she only missed school on PE days, now she hardly leaves her room. . . . She’ll only go to the corner shop on her own” (mother: girl 12 years, shape 7). When parents attempted to discuss these situations with teachers, they were often dismissed or made to feel blameworthy, particularly with older children: “You can see they just think it’s your fault and that you’re making a fuss” (mother: boy 12 years, shape 6/7).

When parents tried to increase their children’s physical activity by taking them to school clubs, three mothers reported the following: “He [football coach] thought he would make his team less competitive” (mother: boy 12 years, shape 6/7); “She [dance teacher] made it clear she didn’t really want a big girl in her class” (mother: girl 10 years, shape 6/7); “I know they wouldn’t let her join in the country dancing display ‘cos she’s overweight” (mother: girl 9 years, shape 6).

The presence of an overweight child in the family had wider impacts. For example, in families that were financially able, holiday destinations were chosen where obesity was as prevalent as in the United Kingdom (Greece) “so she doesn’t have to worry about other people looking at her” (mother: girl 10 years, shape 6/7), or more so (United States). One mother also mentioned buying clothes for her daughter in the United States whilst on holiday as she could not buy suitable ones in the United Kingdom: “They cater for big children” (mother: girl 11 years, shape 7). One family invested in a caravan so that they could take their son away more often. Parents saw holidays as a way of alleviating the bullying and name calling their children were subject to at home from local peers. Their aim was to take their children “away” as much as possible to “give them a break.”

Removing their children from bullying also led some parents to not only change schooling for their overweight children, but in two families all the children had been sent to different schools that were usually smaller with tighter behavioral control: “[New school] is very small; there’s about 60 kids there, and there’s much less peer pressure” (mother: boy 11 years, shape 5). In one case this meant going from the state system to the private sector. At even greater cost, three families had relocated to improve the quality of life of all family members, but for the overweight child in particular: “Cs weight has made a difference to us moving” (mother: girl 11 years, shape 7), and “We bought the house in a cul-de-sac because we thought it would encourage him to play out more” (mother: boy 8 years, shape 7). Two other parents mentioned wanting to move, but the cost was prohibitive: “What can you do? You can’t move house can you? We couldn’t afford it even though we’d like to” (mother: boy 8 years, shape 7).

Discussion

These findings represent the views of parents who volunteered to take part in research that remains very socially sensitive. Therefore, the findings may or may not be generalizable, but they illustrate some of the issues that parents have to manage when bringing up an overweight child. The standard occupational classification was used to assess socio-economics status (SES) (Office of Population Censuses and Surveys, 1990), and the sample was dominated by respondents from higher groups. A recent survey in Scotland showed that the inverse relationship between SES and childhood obesity when measured by BMI is being maintained (Cecil et al., 2005); however, the issues discussed by parents revealed consistency of experiences regardless of SES grouping. The main difference for those with more disposable income was that they were in a position to effect larger scale changes such as relocating, or school moves, or more conducive holiday destinations.

Families with an overweight child or children still encountered the usual tribulations of everyday life but with the added burden of these social impacts. Mothers found it particularly difficult negotiating around an unsympathetic partner or their own mothers undermining their efforts to encourage healthy eating strategies. A small number of studies investigated child weight and family functioning in the 1980s, but little has been published recently. However, it has been suggested that taking these aspects of child weight management into account may improve the tailoring of interventions to the needs of the children and their families (Braet, 2005).

Clothing, which may seem relatively frivolous in comparison with the health consequences of obesity in childhood, was a major concern for most, if not all, parents. This was particularly true when they had daughters and as their children got older. “Nice” clothes have been shown to be a significant issue for overweight teen girls (Wills, Backett-Milburn, Gregory, & Lawton, 2006). Apart from the practical need to cover and protect, clothing is an important contributor to appearance and, hence, social currency. The choice for many overweight children may be between “dark and baggy” or more fashionable, but less flattering. Neither is likely to help with making and maintaining friendships. This may be contributing to a lessening of social acceptance and influencing the social marginalization that overweight teens experience (Strauss & Pollack, 2003). Therefore, parents struggled to find suitable clothing or had to take time to make clothing, as well as deal with the increasing consequences of their children’s social isolation.

Children were encouraged to become more careful with others when learning to cope with living in a body that was bigger than their chronological age. These types of behaviors were commendable but not necessarily typical of their age groups, and, again, these behaviors may have been setting them apart from their peers. The extra size and strength enables some children to become bullies, whereas in this sample, children were more likely to be bullied. This was to be expected given that parents volunteered to take part and provide information about their children. There is a growing body of evidence that overweight children are at significant risk of both being bullied and becoming bullies compared with normal-weight children (Griffiths, Wolke, Page, Horwood, & ALSPAC Study Team, 2006; Janssen et al., 2004). These tendencies may have an impact on the emotional, social, and psychological development of overweight and obese children and adolescents, as either end of the bullying continuum are likely to be less psychologically robust. Here two of the teens were not bullying but were expressing their anger forcefully and had already encountered the authorities, with the girl attending an anger management course. Previously, obesity has been shown to be predictive of delinquency in adolescent boys (Pine, Wasserman, Coplan, & Staghezza-Jaramillo, 1996). Perhaps the changes in society and the obesogenic environment have resulted in girls becoming more likely to behave in a similar manner.

The negative societal messages that children receive not only start before the age of 5 years (Musher-Eizenman, Holub, Miller, Goldstein, & Edwards-Leeper, 2004), but they continue to worsen (Latner & Stunkard, 2003). Parents, here, reported experiences in keeping with this. Many were faced with professionals who shared these negative attitudes toward their children and toward them for allowing their children’s weight to develop. Both teachers and healthcare professionals showed a range of attitudes. Teachers were not always helpful, leaving children to fend for themselves in the school environment (Fox & Edmunds, 2000). Parents perceived responses from healthcare practitioners to range from positive, but not necessarily helpful, to negative and sometimes dismissive, making mothers feel blameworthy and guilty-typically in front of the children (Edmunds, 2005). Those professionals involved with careers focused on diet or physical activity may be even more unsympathetic as some have been identified as being at greater risk for body image and eating problems, which may have influenced their career path initially (Yager & O’Dea, 2005).

Persistent obesity is associated with lower educational attainment, poorer employment and relationships, and psychological morbidities, particularly in women. However, these do not have an effect if children are only overweight/obese in childhood (Viner & Cole, 2005), and so intervening appropriately to manage weight during growth remains desirable. In summary, the experience of being an overweight child, or having an overweight child in the family is very complex and very individual. The social consequences of being overweight or obese as a child affected the whole family, particularly mothers who were trying to balance the child’s dietary and physical activity needs with those of the family’s without further stigmatization. There are associated financial and social costs that may not be appreciated by healthcare practitioners and teachers. Some families functioned better than others, and this influenced how well the children coped with their larger sizes. Mothers may have devoted time to looking for help, which was minimal, and the social stigma resulted in a lack of willingness to discuss childhood weight, with one mother describing it as an “open secret.” A better understanding of the family/social context may inform practice and interventions for overweight and obese children.

Acknowledgments. Approval was granted by the Applied Qualitative Research Ethics Committee in Oxford (AQREC No. A00.020), the South West Local Research Ethics Committee (Study No. 2000/4/5Ss), and the Harrogate Local Research Ethics Committee (Study No. 05/Q1107/54).

The study was funded by South East Region NHS Executive Research and Development Fund Grant No. SEO 151 and the University of Warwick Medical School.

Thanks to all the parents who took part and to the health professionals whose help was invaluable; to Rosemary Conley Slimming Clubs and Slimming World for their support in Central and South West England; and to Professor Mary Rudolf and Bernadette Mulley at the University of Leeds for their help with recruiting interviewees in Northern England.

The social stigma associated with excess weight was exhibited by everyone from family members to complete strangers.

The presence of an overweight child in the family had wider impacts. For example, in families that were financially able, holiday destinations were chosen where obesity was as prevalent as in the United Kingdom (Greece) “so she doesn’t have to worry about other people looking at her” (mother: girl 10 years, shape 6/7), or more so (United States).

Clothing, which may seem relatively frivolous in comparison with the health consequences of obesity in childhood, was a major concern for most, if not all, parents.

How Do I Apply This Information to Nursing Practice?

The most appropriate way to incorporate the above into practice is to understand that childhood weight management is about far more than diet and physical activity. Parents raised several issues that may benefit from practical support, such as being directed to counselors (financial or psychological), advice on schooling, suitable clothing outlets, activities where overweight children are not stigmatized, and psychological resilience or self-confidence programs. Additionally, practitioners may appreciate the broader picture and complexity of raising an overweight child. There may be other family issues (e.g., divorce, grief, integrated family) not presented here that also would have an impact on managing the child’s weight. Many parents are likely to have tried self-help approaches before seeking help from a health professional, and it can take a lot of courage to ask for such help. Parents are not solely to blame. The recent Foresight Report (Kopelman, Jebb, & Butland, 2007) highlighted environmental and societal changes that increasingly promote weight gain. However, parents carry most of the responsibility and are best placed to remedy the situation; but for most, support will be required to help them help themselves.

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Viner, R. M., & Cole, T. J. (2005). Adult socioeconomic, educational, social, and psychological outcomes of childhood obesity: A national birth cohort study. British Medical Journal, 330(7504), 1339-1340.

Wills, W., Backett-Milburn, K., Gregory, S., & Lawton, J. (2006). Young teenagers’ perceptions of their own and others’ bodies: A qualitative study of obese, overweight and “normal” weight young people in Scotland. Social Science Medicine, 62, 396-406.

Yager, Z., & O’Dea, J. A. (2005). The role of teachers and other educators in the prevention of eating disorders and child obesity: What are the issues? Eating Disorders, 13, 261-278.

Laurel D. Edmunds, PhD

Laurel D. Edmunds, PhD, is an Obesity Research Psychologist, Head of Research, iOpener Ltd, Oxford, England, United Kingdom.

Author contact: [email protected], with a copy to the Editor: [email protected]

Copyright Nursecom, Inc. Jul 2008

(c) 2008 Journal for Specialists in Pediatric Nursing. Provided by ProQuest Information and Learning. All rights Reserved.

‘Brilliant’ City Welcome for Territorial Medics Back From Afghan War

By KERRA MADDERN

Cheering crowds lined Exeter’s High Street to welcome Territorial Army medics home from a gruelling tour of duty in Afghanistan.

Shoppers applauded the part-time soldiers, who were exercising their rights to march because they have the freedom of the city.

The parade, on Saturday morning, also marked the centenary of the TA. The 100 taking part were from the region’s 243 Field Hospital; 90 of the reservists returned home after three months in Afghanistan last April.

In Helmand province they staffed a newly-opened medical centre, a replacement for a tented field hospital which had been used since 2003.

Ancient city laws say they can march “with drums beating, flags flying and bayonets fixed”, but the soldiers were weapon free as they paraded from the Civic Centre to the Guildhall to be inspected by Lord Mayor Paul Smith. They held their Croix de Guerre, given to the company by the French for bravery during the First World War.

The volunteers, thrilled by the reception they received, hugged each other as they finished the march at the Corn Exchange.

As well as doctors and nurses from all disciplines, 243, which has its headquarters near Bristol, recruits dentists, pathologists, physiotherapists, pharmacists and other medical and special personal, plus cooks, drivers, clerks and combat medical technicians. In Exeter, medical TAs are based at Wyvern Barracks.

Major James Ferguson, an OC in the Exeter B Squadron, is a community psychiatric nurse for the Devon Partnership Trust.

Maj Ferguson, of Beacon Heath, Exeter who has spent 30 years in the TA, worked for the Army’s mental health team.

“The reception we got from the city of Exeter today was just brilliant and it was much appreciated by the whole unit,” he said

While most of the TA volunteers stayed in Camp Bastion, Maj Ferguson was posted out to help different units.

Maj Keith Watkins, a medical liaison officer for mental health services, has also been in the TA for 30 years.

Maj Watkins, from Crediton, said: “You need totally different skills in Afghanistan, but I joined because I wanted to do a public service.”

Captain Bill Tuckett, a modern matron on the Royal Devon & Exeter’s Bramble ward, is a nursing officer in the TA.

In his 21-year career with the TA, Capt Tuckett has also served in Bosnia in 1996; in Iraq in the second Gulf War; and in Afghanistan this year.

“In a previous life I was a long-distance lorry driver and I only trained as a registered nurse when I went into the TA, so it’s changed my life,” he said.

(c) 2008 Express & Echo (Exeter UK). Provided by ProQuest Information and Learning. All rights Reserved.

Most With Colon Cancer Have No Family History of It

By Ask Dr. Ramo BARRY RAMO For the Journal

Days after Tony Snow, President Bush’s former press secretary, died from colon cancer, my 55-year-old patient explained to me that she felt very safe from developing the disease because she didn’t have a single family member with colon cancer.

Snow’s mother died of the disease at age 38 and my patient thought the disease only developed if it ran in the family. She was wrong.

Every year, 100,000 people develop rectal cancer and nearly 50,000 people die from the disease. Of those, the vast majority are like my patient: They have no family history of the disease.

A family history is a significant risk factor if a family member or close relative (parents, brothers, sisters or children) had colorectal cancer at a young age. The risk also goes up if you have a history of cancer of the ovary or breast or ulcerative colitis. But absent those risk factors, my patient had the most important one and that is being over age 50.

Nearly all colon cancers stem from polyps or mushroomlike growths of gland tissue that arise from the colon’s inner lining. During a colonoscopy, a precancerous polyp can usually be cut out before cancer develops and about 30 percent of cancerous polyps can be cured without further surgery.

When detected early, colon cancer is among the most treatable of all cancers and has a five-year survival rate of 90 percent. That survival rate drops to 10 percent when people are diagnosed with the most advanced stage of the disease. Early detection through screening is an extraordinarily effective way to beat colon cancer.

The American Cancer and Gastroenterology societies have developed some easyto-remember guidelines for screening, and New Mexico is one of 26 states that requires that insurance companies pay for colorectal cancer screening.

The guidelines recommend that all men and women have a screening test at age 50. There is a variety of screening tests, but the most definitive is a colonoscopy in which a scope of the entire colon is performed to look for polyps and cancer.

If you have a family member like Tony Snow, you should have a colonoscopy 10 years before the age at which that family member was diagnosed.

Why not just wait for symptoms? Some of my patients believe “if it ain’t broke, don’t fix it.” In the case of colorectal cancer, by the time you’ve learned it’s broken, it could be too late to fix. You should get in for evaluation quickly if you have symptoms.

Any blood in the stool requires immediate evaluation. The polyps can bleed intermittently, so if the bleeding stops, it doesn’t mean the problem has been solved. With the exception of blood in the stool, the other signs of colon cancer appear when the disease is advanced. Signs like alternating constipation and diarrhea, pencil- thin stools, unexplained weight loss and fatigue are late signs and require immediate attention.

One alternative screening test is called virtual colonoscopy, which visualizes your colon after a prep to clean out the colon. At this time, the interpretation takes special expertise and if something is found, then you need a regular colonoscopy anyway. My feeling is that I only want one prep, so I see no virtue in a virtual colonoscopy except in isolated situations.

The prep to clean out your colon is no fun, but neither is developing colon cancer.

I explained all this to my patient, who now has her colonoscopy appointment on her calendar.

Dr. Barry Ramo is a cardiologist with the New Mexico Heart Institute and medical editor for KOAT-TV. E-mail questions to htaylor@abqjournal. com.

(c) 2008 Albuquerque Journal. Provided by ProQuest Information and Learning. All rights Reserved.

Abbott Fund and the Government of Tanzania Celebrate Milestone in Strengthening Nation’s Health Care System

DAR ES SALAAM, Tanzania, July 28 /PRNewswire-FirstCall/ — At a ceremony today, the Ministry of Health and Social Welfare, United Republic of Tanzania, and Abbott Fund commemorated the latest step in a nationwide initiative to upgrade Tanzania’s health care system, laying the cornerstone for the first of 23 hospital laboratories to be built or modernized across the country. The laboratory at Amana Regional Hospital is the first of four laboratories targeted in 2008, with the remaining laboratories scheduled for completion by 2010.

“We have ambitious treatment goals for the more than 2 million people living with HIV in Tanzania, as well as broader challenges in meeting the needs of people who require long-term monitoring and care for diseases like diabetes,” said Hon. David Mwaykusa, Minister of Health and Social Welfare, United Republic of Tanzania. “Modern hospital laboratories are the building blocks for successful treatment, and we are grateful and excited to work with Abbott Fund on this project.”

The Regional Laboratory Modernization Project is an innovative partnership between Abbott Fund and the Government of Tanzania that will construct a flexibly designed, standardized modern lab in 23 regional and district hospitals across Tanzania. These larger laboratories provide support for 77 district hospitals, improving health care for millions of people across the country.

“This laboratory improvement project is an important part of our continued partnership with the Government of Tanzania to make sustainable improvements to the health care system in Tanzania,” said Catherine V. Babington, president, Abbott Fund. “We’re improving the delivery of quality care for Tanzanians by upgrading testing services that are critical for the prevention and treatment of diabetes, heart disease, HIV/AIDS and many other conditions.”

Resource-limited health care systems, including a lack of modern hospital laboratories, continue to be a key barrier to providing quality care for hospital patients across Tanzania. A 2002 public health assessment conducted by the Ministry of Health and the U.S. Centers for Disease Control (CDC) found that the limited capacity of laboratories in Tanzania was one of the weakest links in the provision of quality HIV/AIDS services.

Ground was broken in mid-July to begin construction of the new laboratory at Amana Hospital. More than 1,500 patients are seen each day at this busy city hospital. Space in the existing laboratory is extremely limited, making it difficult to meet growing patient needs and forcing staff to put in significant overtime to process the average daily workload of tests for up to 500 patients. It is estimated that the new laboratory capacity will be tripled following improvements, allowing patients and physicians same-day access to lab results.

In addition to the work being conducted at Amana, it is anticipated that modernization will be completed at regional laboratories in Dodoma, Kagera and Tanga by the end of 2008. The project is estimated to cost more than U.S. $10 million by its 2010 completion.

Public-private partnerships have been an essential part of the program. Abbott Fund and Design 4 Others (D4O), a U.S.-based not-for-profit initiative of the global science and technology design firm CUH2A, are working together with the Government of Tanzania to provide a standardized design that will ensure that patients across the country have the same quality of diagnostic testing. Consulting input is also a key to the program’s success, with important expertise provided by the U.S. CDC – Tanzania and the Association of Public Health Laboratories (APHL).

“The health care system improvements supported by the Abbott Fund will help extend U.S. Government efforts to improve the health of the Tanzanian people,” said Hon. Mark Green, U.S. Ambassador to Tanzania. “The modernized laboratory at Amana will serve patients seen at the new HIV care and treatment center funded by PEPFAR, which is a clear reflection of how governments and the private sector can work together for the common good.”

The nationwide Regional Laboratory Modernization Project expands on extensive earlier lab work by Abbott Fund at Muhimbili National Hospital in Dar es Salaam, and the work completed in 2007 to modernize the laboratory at Mt. Meru Regional Hospital. The improvements and training at Mt. Meru have resulted in a tripling of the laboratory’s testing capacity from 45 to 150 patients per day, a nine-fold increase annually in number of tests processed, a dramatic reduction in turnaround time and increased health worker productivity. The work at Mt. Meru provided a model and proof of concept that a nationwide laboratory modernization program was possible.

About Abbott Fund in Tanzania

Improving hospital laboratories is the latest effort in the ongoing partnership between Abbott Fund and the Government of Tanzania, which began in 2001. To date, Abbott Fund has invested more than $50 million to strengthen Tanzania’s health system.

In 2007, the Global Business Coalition on HIV/AIDS, Tuberculosis and Malaria (GBC) honored Abbott Fund with an Award for Business Excellence for National Action for its public-private partnership with the Government of Tanzania to fight HIV/AIDS. Key results to date include:

   -- At Muhimbili National Hospital, the national teaching and reference      hospital for Tanzania, Abbott Fund built a new outpatient center that      serves hundreds of patients each day and integrates HIV care with other      services, and renovated, automated and computerized the central      pathology laboratory;   -- Trained more than 10,000 health care workers;   -- Provided HIV counseling and testing for more than 150,000 people, and      donated one million rapid HIV tests to the Tanzanian national HIV      testing initiative; and   -- Helped more than 150,000 children and families by providing access to      health services, education and training, and pioneering legal      protection for orphans and widows affected by HIV/AIDS.    

Because of the significant work being conducted in Tanzania, in 2007 Abbott Fund opened its first satellite office in Dar es Salaam.

About Abbott Global AIDS Care Programs

For more than 20 years, Abbott has made a significant contribution to the fight against HIV/AIDS through the development of innovative tests and medicines. Expanding on its scientific contributions, Abbott and Abbott Fund have invested more than $100 million in developing countries to improve the lives of people affected by HIV/AIDS through programs targeting critical areas of need, including strengthening health care systems, supporting children affected by HIV/AIDS, preventing mother-to-child transmission of HIV, and advancing HIV testing and treatment. For more information on these programs, please visit http://www.abbottglobalcare.org/.

About Abbott and Abbott Fund

Abbott Fund is a philanthropic foundation established by Abbott in 1951. Abbott Fund’s mission is to create healthier global communities by investing in creative ideas that promote science, expand access to health care and strengthen communities worldwide. For more information, visit http://www.abbottfund.org/.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries. Abbott’s news releases and other information are available on the company’s Web site at http://www.abbott.com/.

Abbott

CONTACT: East Africa Media, Prateek Patnaik of Cooney Waters Group,+255-786-008-220, for Abbott; or International Media, Scott Gilmore of Abbott,+1-847-936-1192

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

Clinic Would Serve People Without Medical Insurance in Orangeburg, S.C.

By Gene Zaleski, The Times and Democrat, Orangeburg, S.C.

Jul. 24–A group of doctors is looking to establish a free clinic in Orangeburg County to serve individuals without any insurance.

The clinic, which is being championed by Orangeburg doctor Bert Gue, would provide patients with basic medical care.

“We have a work plan and we have done our homework,” RMC Vice President Brenda Williams told The Regional Medical Center Board of Trustees at its July meeting Tuesday.

The RMC has a committee of community members evaluating the effectiveness of establishing the clinic.

The clinic is intended to be solely owned by members of the community and would not be a direct y-product of the hospital, Williams said.

A location for the clinic, types of services provided and costs associated with its establishment have yet to be determined.

“This is very preliminary,” Williams said, explaining that an in-depth needs assessment study is required. Questions about the handling of any malpractice issues and other legal matters are under investigation.

Site visits at similar clinics in Newberry and Kershaw are planned. A meeting has also been held with Jimmie Walker of the South Carolina Hospital Association. Walker has established similar clinics throughout the state. There are currently 26 in South Carolina.

Expectations are the Orangeburg clinic could come online sometime in 2009.

Chairman James Amaker encouraged Williams to receive documentation from all parties involved to ensure all are on the same page.

After some concern was raised by trustees about the conflict of services with Family Health Centers Inc., Williams said FHC Chief Executive Officer Donnie Hilliard has expressed his support for the clinic as long as it is designed for patients without any insurance.

The committee consists of Dr. Gue, Sandy Chaplain R.N, instructor at Orangeburg-Calhoun Technical College; Lisa Tourville, RN; Rebecca Battle-Bryant, OCtech; Dr. Frank Coulter, RMC medical staff; Dr. Lamar Dawkins Jr., RMC medical staff, and Paul Sheler, Family Health Center board member.

CT scanners David Cope, RMC vice president of strategic planning, said the hospital staff has found a more cost-effective way to purchase its desired 64-slice computed tomography scanner.

Trustees Tuesday voted in favor of a purchase package that would include a 64-slice scanner ($706,912) and a new 16-slice CT scanner ($449,829).

Late last year, trustees approved the purchase of a new 64-slice scanner for about $2.3 million, of which $1.265 million was for the scanner and $1.035 million was for construction needed to house the equipment. The project received approval from the S.C. Department of Health and Environmental.

However, negotiations by hospital staff brought the price down on the 64-slice about $108,259, if included with the purchase of the 16-slice.

Hospital officials say the 64-slice scanner will provide patients with a quicker, more efficient, non-invasive procedure, while the technology provides doctors with higher-resolution images.

The hospital would expect to receive the 16-slice scanner by year’s end and the 64-slice by the third quarter of 2009.

The logistics on placement of the 64-slice, which requires a larger footprint and construction of new space, has yet to be determined.

Placement in the hospital’s annex building has been discussed as a way to expedite the scanner coming on-line while a permanent place is constructed.

MONEY MATTERS: Kenneth Rickenbaker, chair of the hospital’s finance committee, informed trustees the remaining $458,678 originally placed in the hospital’s Edisto Health Foundation was reinvested into certificates of deposit at the end of June.

Orangeburg County Council late in 2006 requested the hospital take the $25,458,678 out of its then newly formed EHF and put the money back into the hospital.

The EHF was created in January 2006 to allow the hospital to make investments that it can’t make on its own.

Orangeburg County officials questioned the hospital’s investment strategy in the foundation, saying it was outside the legal requirements of the state of South Carolina for government investments.

The $25.4 million was withdrawn in staggered terms roughly once a month from April 30, 2007, through Aug. 31, 2007, but the $458,678 was not pulled down until June 27 of this year.

Trustee Danny Covington had cited the failure to bring down the monies among 12 of the listed allegations of procedural misconduct and incompetency brought before the board earlier in the week related to Amaker.

But Rickenbaker says the blame for not bringing down the monies sooner falls on the entire board.

Covington questioned this assessment, noting that Orangeburg County Council took issue with the monies being appropriately drawn down when in January it issued its terms and conditions for the hospital to borrow $22 million.

One condition was that the $25 million transferred to Edisto Health Foundation come back to the hospital and that the “funds are invested according to the law of public funding.”

Covington said even when the issue was raised directly, the monies still were not drawn down.

“I got criticized for not saying anything about it, but it has been on the report every month,” Covington said. “I said I want to see how long we will play with it.”

“This is not an issue that has not been discussed,” he said. “This is something that everybody knows about. I can’t figure out in my mind why anybody on this staff would not have got that in day one because we voted to bring it down in six moves.”

Rickenbaker said a report on exactly how the resolution was written will be brought back to the board at the next meeting.

In other business:

–Trustees were updated on the hospital’s engagment with the Dubai-based Jafza International project and its potential impact on the health care industry both in Orangeburg County and the hospital in Bamberg County.

Jafza has conducted the needed interviews, has gathered data and demographic information and is in the process of creating an evaluation of various scenarios that could impact the hospital.

The result of the study and evaluation is expected by the end of August.

–Trustees nominated Dr. Carl Carpenter as RMC Trustee of the Year.

Carpenter will be in line to possibly receive the state honor at the South Carolina Hospital Association’s Trustees, Administrators, and Physicians (TAP) conference in September on Hilton Head Island.

Due to a tie as a result of a late ballot, Trustee Millie Brunson was also given the local honor of being Trustee of the Year. Her name will not be presented for the statewide award.

—–

To see more of The Times and Democrat, or to subscribe to the newspaper, go to http://www.timesanddemocrat.com.

Copyright (c) 2008, The Times and Democrat, Orangeburg, S.C.

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.

Roche and Response Biomedical Corporation Aim to Reduce ‘Vein-to-Brain’ Time With New Point-of-Care Cardiac Tests

INDIANAPOLIS, July 28 /PRNewswire/ — Roche Diagnostics and Response Biomedical have entered into a partnership that will allow Roche to market the first line of cardiovascular tests for Response Biomedical’s new point-of-care platform.

The platform, the RAMP(R) 200 (Rapid Analyte Measurement Platform), is based on RAMP technology that is already used in laboratories worldwide for West Nile Virus, biodefense tests and the recently FDA-cleared RAMP Flu A/B Test.

The RAMP cardiovascular product line includes Troponin-I, CK-MB, Myoglobin and NT-proBNP. Roche has exclusive rights to market the cardiovascular line in the United States, Canada and other global markets.

“Having the test menu at the patient’s bedside may provide physicians with the improved ‘vein-to-brain’ time that is often critical when treating patients with potentially life-threatening cardiovascular conditions,” said Rodney Cotton, Senior Vice President of Roche Diagnostics’ Point of Care division. “The RAMP 200 will allow physicians to treat patients faster because it can help reduce the amount of time from when a patient presents with symptoms to when treatment begins.”

The RAMP 200 cardiovascular line is expected to be launched in the first quarter of 2009. The test system uses whole blood and can perform 18 to 36 tests per hour. Up to six tests of all one type or a mixture of tests may be run simultaneously. Results appear in as little as 15 minutes.

The RAMP cardiac tests are simple to use and may be placed in a variety of hospital locations, which provides the hospital with more staffing flexibility, and reduces potential delays due to sample transportation and processing.

Guidelines from the American College of Cardiology and the American Heart Association require or recommend a patient presenting with a potential AMI (acute myocardial infarction, or heart attack) be diagnosed within 60 minutes, and preferably within 30 minutes.

“One of the advantages of this system for critical care is that all of the RAMP cardiac tests correlate to the same tests on larger analyzers in the lab, such as the cobas 6000 series,” said Ken Levy, Director of Strategic Business Development for Roche Diagnostics’ Point of Care division. “This way, physicians can be confident that the results they get in the ER and in the lab are consistent, so they can provide better treatment to the patient.”

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007, sales by the Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested more than 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at http://www.roche.com/.

About Response Biomedical

Response Biomedical develops, manufactures and markets rapid on-site diagnostic tests for use with its RAMP Platform for clinical and environmental applications. RAMP represents a new paradigm in diagnostics that provides high sensitivity and reliable information in minutes. It is ideally suited to both point-of-care testing and laboratory use. Response Biomedical is a publicly traded company, listed on the TSX under the trading symbol “RBM” and quoted on the OTC Bulletin Board under the symbol “RPBIF.” For further information, please visit the company’s website at http://www.responsebio.com/.

All trademarks used or mentioned in this release are legally protected by law.

   For further information, please contact:    Media:   Lori McLaughlin   Corporate Communications   Roche Diagnostics Corporation   Indianapolis, Ind.   Phone: 317-521-3112   [email protected]  

Roche Diagnostics

CONTACT: Lori McLaughlin, Corporate Communications of Roche DiagnosticsCorporation, +1-317-521-3112, [email protected]

Web site: http://www.roche.com/http://www.responsebio.com/

Scots GP Should Be Struck Off, Panel is Told Doctor to Learn Fate Today

By HELEN PUTTICK HEALTH CORRESPONDENT

A SCOTTISH GP who prescribed sleeping tablets to a patient so she could end her life should be struck off, a panel of the General Medical Council was told yesterday.

Suzanne Goddard, QC, counsel for the GMC who presented the case against Dr Iain Kerr, said providing the drugs to the elderly woman was “akin to handing her a noose”.

She said erasing his name from the medical register was necessary to “maintain confidence in the profession and to safeguard the public interest”.

However, the panel, which will make the final decision on Dr Kerr’s future, was also handed a file of testimonies from colleagues and patients praising the Glasgow GP, who has worked for 30 years.

One consultant, who had known the doctor for 28 years, said he would be delighted if Dr Kerr cared for one of his own relatives. Another specialist said he first encountered the GP as a locum and described how a patient had compared him unfavourably with Dr Kerr. Patients wrote about the time and attention Dr Kerr had given their elderly parents on home visits.

Michael Mylonas, counsel for Dr Kerr, presented these accounts and proposed the 61year-old continued working subject to a set of conditions.

The hearing into Dr Kerr’s fitness to practise has been running in Manchester since Monday last week.

The panel has already found he prescribed a pensioner, known as Patient A, sleeping pills called sodium amytal in 1998 so she could take her life. They have also criticised his conduct in 2005, when the retired businesswoman killed herself using different drugs prescribed by Dr Kerr – although he has stressed he did not give her these tablets for the purpose of suicide.

Five other cases when he prescribed sodium amytal – which official guidance says should only be given to patients with severe intractable insomnia – have also been examined, and his use of the drug in three of these criticised.

Yesterday, panel chairman John Donnelly told the GP, who works in Williamwood Medical Centre, Clarkston: “Your actions and omissions amount to persistent and serious failures to meet many of the fundamental principles and standards of professional conduct as set out in Good Medical Practice.”

He added that they found his fitness to practise medicine had been impaired by his misconduct and then invited submissions about what sanctions – if any – should be imposed.

Ms Goddard said: “The fact that Patient A did not in fact use that prescription (of sodium amytal) but destroyed it some years later, does not in our submission lessen the seriousness of the initial flawed judgment shown by Dr Kerr.” She then went on to say it was “akin to handing her a noose with which to hang herself at a time of her choosing”.

The panel is expected to reach a decision today.

Originally published by Newsquest Media Group.

(c) 2008 Herald, The; Glasgow (UK). Provided by ProQuest Information and Learning. All rights Reserved.

AorTech Shares Heartened By Elast-Eon Clinical Advance

By DOUGLAS HAMILTON

AORTECH International, an AIM-listed biomaterials and medical device development company, saw its shares rise by almost 4per cent yesterday after it said its early-stage clinical use of a proprietary biostable co-polymer, Elast-Eon, in pulmonary support tubes (known as cannulae) has been successful.

Elast-Eon was used in a device intended to help provide life- saving lung support to patients suffering from acute lung failure. AorTech said it developed Elast-Eon, which was designed and manufactured by the privately held Avalon Laboratories, a major supplier of cardiopulmonary vascular cannulae. Cannulae are disposable components that connect patients to heart and lung machines and other circulatory support devices.

The first human use of these products has occurred in the UK. Preparations are being made for introducing them to the US market after they win approval from the Federal Drug Administration.

This first clinical use follows the exclusive licence granted to Avalon for the use of Elast-Eon in cardiac and pulmonary cannulae products in December 2006.

AorTech also said ElastEon is being assessed for a range of additional applications including morbid obesity, neurostimulation, diabetes, women’s health and cardiovascular devices.

AorTech shares, which are widely held in Scotland and elsewhere, closed 10p higher at 265p – an advance of 3.9per cent.

Originally published by Newsquest Media Group.

(c) 2008 Herald, The; Glasgow (UK). Provided by ProQuest Information and Learning. All rights Reserved.

Why Athletes Take Caffeine To Boost Performance

New research exploring the placebo effects of caffeine highlight competitive athletes who believe caffeine gives them an edge, despite doubts that it works.

The World Anti-Doping Agency (WADA) removed caffeine from its list of banned substances in sport 4 years ago, just before the Athens Olympics.

“This was presumably because WADA considered (caffeine’s) performance-enhancing effects to be insignificant,” said Mark Stuart, in the journal BMJ Clinical Evidence.

Stuart has worked with doping control for past Olympic Games and helped train medical staff for the upcoming Beijing Olympics.

He said studies indicate that many athletes still use the stimulant.

Researchers found that of 193 UK track-and-field athletes they surveyed, one-third used caffeine to enhance performance — as did 60 percent of 287 competitive cyclists, according to the study last month.

It’s possible that the placebo effect plays a role in why so many athletes continue to pop caffeine pills, Stuart told Reuters Health.

Meaning athletes may perform slightly better after taking caffeine because they believe it works.

Two small studies specifically addressed the placebo effect as it relates to caffeine and athletic performance, Stuart said.

In one, seven male cyclists were told that they would be given either caffeine or a placebo, but in fact none received caffeine. The researchers found that cyclists who believed they had taken the placebo showed a decline in their cycling performance compared with their baseline tests. In contrast, cyclists who believed they had been given caffeine improved their performance.

A similar study of 14 male cyclists published this year showed what seemed to be a “nocebo” effect: athletes who knew they were being given a placebo instead of caffeine showed a decrease in their performance. In other words, their performance may have suffered because they knew they were not getting caffeine.

However, Stuart said given the small stature of the studies, “results should be interpreted with extreme caution.”

But “the placebo effect does offer a possible explanation to ponder as to why some athletes continue to use (caffeine),” Stuart said.

“There is an obvious difference in the perception of caffeine as a performance-enhancing substance between WADA and the many elite athletes who continue to use it.”

He added: “Regardless of this difference and given the evidence-driven backing of WADA from the scientific community, the potential for widespread caffeine use at this month’s Olympics will, hopefully, not threaten the integrity of fair play in sport.”

On the Net:

Design Studio Opens in Carrboro

By The Chapel Hill News, N.C.

Jul. 27–12 Grain Studio, Inc., a creative services firm that specializes in web and graphic design, web and marketing copy, illustration, and animation, recently opened in Carrboro.

Laura Sargent, freelance copywriter and former editorial journalist, and Matt Duquette, freelance illustrator and former art director and senior designer, run the business.

“We are transplants from the ‘City of Good Neighbors’ — Buffalo, but have already decided that Carrboro is more worthy of that title,” Duquette said. “We knew right away it was the right move to bring our business here and hope to grow with, and within, the Carrboro-Chapel Hill community.”

One of 12 Grain Studio’s aspirations is a desire to collaborate work with other artists in the community.

To learn more about 12 Grain Studio, see or call (716) 359-4950.

CHIROPRACTOR OPENS OFFICE IN PITTTSBORO: Jacqulyn L. Nygren has opened New Branch Chiropractic & Health Center at 120 Lowes Drive, Suite 105 in Pittsboro.

Nygren is a 2006 graduate of Sherman College of Straight Chiropractic in Spartanburg, S.C. She and her family moved to the Triangle area after falling in love with the greenery.

Nygren is a member of the Chatham County United Chamber of Commerce, the International Chiropractic Association and the NC Chiropractic Association.

Nygren focuses her practice on activator instrument adjusting and diversified/Thompson techniques. Her office is off U.S. 15-501 next to Lowes Home Improvement and the Carolina Brewery.

“I come from a rural background, and I have a sincere appreciation for the people who reside here,” Nygren said. “I am excited about meeting the people of Pittsboro and working with them to ensure their present and future well-being.”

While chiropractic care is the foundation of her practice, she also will offer other services such as massage and wellness care.

For information, call 642-0555 or see www.newbranchchiro.com.

YMCA HIRES NEW HEALTH DIRECTOR: The Chapel Hill-Carrboro YMCA has hired Abby Dennis as health enhancement director.

She has been serving as assistant director of campus recreation at Elon University. She received her bachelor’s degree in therapeutic recreation at the University of Arkansas and completed her master’s degree in health promotion and wellness management.

She will be responsible for management of all health and wellness programs at the YMCA, as well as outreach to the community.

INN UNDER NEW MANAGEMENT: Destination Hotels & Resorts is the new manager of the Carolina Inn. The 184-room Carolina Inn, owned by the University of North Carolina, was previously managed by Aramark Harrison Lodging.

DOWNTOWN HOTEL WINS READER AWARD: Metro magazine has awarded The Franklin Hotel in Chapel Hill a 2008 Metro Bravo Award in the category of Best City Hotel.

This is the second time the Franklin Hotel has won the award. The Metro Bravo Awards are determined by voting among the magazine’s readers.

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Copyright (c) 2008, The Chapel Hill News, N.C.

Distributed by McClatchy-Tribune Information Services.

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The Implications of Health-Care Reform

With the U.S. presidential election coming this November, health care reform is becoming a political priority in a way it hasn’t since the Clinton Administration in the early 1990s. What are the implications for health care companies payers, providers, and manufacturers? While it’s too early to say for sure, most of the solutions presented so far share underlying principles that we think enable realistic discussion.

We believe an ongoing flow of statistics underscores the current health care system’s flaws: In 2006, about 47 million Americans lacked health insurance, up 8.6 million from 2000, according to The Commonwealth Fund, a health care policy think tank. A Commonwealth study released in June 2008 noted that the number of underinsured American adults rose nearly 60% to 25 million in 2007, from 16 million in 2003. The underinsured have health coverage, but still face access and financial constraints similar to uninsured people.

At the same time, total costs are rising: In 2007, the nations health care spending was $2.7 trillion, up from $2.1 trillion in 2006, according to the Centers for Medicare and Medicaid Services [CMS]. Employer-sponsored health insurance premiums rose 10 times faster than family income between 2001 and 2005, according to the Robert Wood Johnson Foundation. Medicare trustees project that Medicares chief financing vehicle, the Health Insurance Trust Fund, will be exhausted by 2019.

Details vary, but in broad terms, most groups Democrats and Republicans, the private and public sectors, big corporations, and individuals agree that solutions must include broader access to health insurance through more affordable, simpler insurance plans, greater efficiencies, and cost containment measures. Proposals to achieve these aims typically center around a greater emphasis on value-based medicine, that is, closer correlation of reimbursement to effectiveness, more cost sharing between payers and consumers, greater pricing transparency for medical services and products, and development of reliable, independent measures of quality and cost-effectiveness of health care services and products.

In general, we think companies that are involved in initiatives of the kind mentioned above stand to benefit. Most large managed care organizations [MCOs], for example, are rapidly diversifying their customer base and product portfolios, moving into the small group and individual markets, which until recently they considered niches with modest potential. Coventry Health (CVH), Cigna (CI), WellPoint (WLP), and others are offering a bevy of new kinds of health plans at different price points that appeal to people who are struggling to afford health insurance premiums. While their main motivation is to offset slowing growth in their core large group businesses, theyre also addressing the uninsured population problem.

These niche markets remain, however, only a small part of their business, and their potential is uncertain. As of the end of the first quarter of 2008, companies offering lower-cost plans struggled to increase enrollment; a Kaiser Family Foundation [KFF] study released in April found that most uninsured households can’t afford high-deductible health plans. One reason is the faltering economy, which is forcing consumers to make hard choices; another reason is, for a certain subset of people, the premiums are still too high. “The question is how low can the companies bring the price point and still provide meaningful coverage in the face of rising medical costs?” asks Phillip Seligman, a Standard & Poor’s equity analyst.

Companies with larger exposure to Medicare and government-financed programs also may be more vulnerable to health care reform proposals, as government programs often lead the way in changing the health care payments and reforms. Pharmaceutical companies have benefited greatly from Medicares new prescription drug plan [PDP], but they could be at risk if the government takes steps to better control costs of this expensive program, in our view.

Among pharmaceutical companies, those with a large proportion of drugs that are widely used by seniors and thus recipients of significant PDP funds include Merck (MRK), Pfizer (PFE), and Eli Lilly (LLY). Others, like Wyeth (WYE) have less exposure to Medicare PDP, in our view. Among device companies, those that make products widely used by seniors are also at risk of changes to Medicare funding. These include implantable device makers St. Jude Medical (STJ), Zimmer (ZMH), Boston Scientific (BSX), and Medtronic (MDT).

That being said, health care reforms are likely to play out in unintended ways because Democrats and Republicans hold widely disparate views on how to achieve greater access to health care insurance and how to fund a system that is beset by spiraling costs. Democrats would guarantee access to affordable health insurance by replacing individual insurance policies with new group options, offered by both private and public payers, and, in some cases, by expanding government programs, including Medicaid.

Republicans, in contrast, favor tax credits for individuals to encourage them to buy insurance on the private market, while removing existing tax incentives for employers that offer health insurance. Employer-sponsored health insurance is the backbone of the current system, but many Republicans believe it discourages competition and disconnects costs from utilization and effectiveness.

No matter which partys candidate wins the presidential election in November, most experts agree that incremental reforms are much more likely to occur in the near term and substantial nation-wide reform remains a long-term proposition. In the absence of national consensus, states are undertaking some high-profile but small reforms on their own. Massachusetts, Maine, and Vermont have come closest to instituting near-universal health insurance coverage for their residents. Another 14 states are in the process of developing comprehensive reform plans, according to the KFF.

The two-year-old Massachusetts plan, in particular, is in the spotlight as a potential harbinger for more sweeping, nationwide change. As of July 2007, the state has mandated that all residents purchase health insurance or, beginning in 2008, face financial penalties. To help low-income people, it offers subsidies and premium fees based on a sliding scale. At the same time, all employers with 11 or more employees have to offer health insurance or pay into a fund set up to subsidize individual policy purchases. A public-private organization, the Commonwealth Health Insurance Connector Authority, administers the program. As of March 2008, some 350,000 of an estimated 600,000 previously uninsured people had obtained health insurance, KFF reports; Maine’s and Vermont’s programs are a fraction of the size and scope.

While state governments are driving these initiatives, some involve the private sector. Companies, however, can’t yet estimate how much they will benefit, if at all.

In Massachusetts, the enrollment numbers seem impressive. However, none of the large MCOs that dominate national markets were willing to offer their services; the participating private carriers are small, regional players. Also, the Massachusetts program’s costs are greater than expected, while efforts to contain medical spending are stalled in the legislature. Thus, other states may be reluctant to duplicate the effort.

Geneva Offers First Cardiovascular Technology Graduate Program in the Nation

BEAVER FALLS, Pa., July 28 /PRNewswire/ — Anticipating the needs of the future, Geneva College will launch the first Cardiovascular Technology (CVT) graduate degree program in the nation.

Drawing on Geneva’s long-standing affiliation with INOVA Fairfax Hospital in Falls Church, Va., the program offers students a M.S. degree in Cardiovascular Sciences. Geneva’s incoming freshmen will now have the option of obtaining a B.S. (in four years) or a B.S./M.S. degree (in five years) in CVT. Students coming into the program with another B.S. degree can complete the M.S. in two years. The program will launch in the fall 2008 semester.

Cardiovascular technologists are allied health professionals who work directly with cardiologists to perform diagnostic and therapeutic procedures in the laboratory setting. Their assistance has become vital in the growing trend toward non-surgical solutions for a variety of cardiovascular diseases. “The burden on cardiologists and their support staff will only increase as the baby boomer generation ages and cardiovascular disease continues to be among the leading killers in our nation,” says Dr. Daryl Sas, chair of Geneva’s Department of Biology.

A major goal of the program, according to CVT Program Coordinator Dr. David Essig, is that the M.S. trained student will become recognized as “cardiologist’s assistant” much like the physician’s assistant.

Geneva has offered a bachelor’s of science degree in CVT through INOVA for the past 30 years. In the current program, students who earn the B.S. work with cardiologists to diagnose and perform therapeutic procedures on diseased blood vessels. Most procedures are directed towards coronary arteries which, when occluded by advanced atherosclerosis, can lead to heart attack and death. The effectiveness of these procedures has not only saved lives but has lessened dependence on the coronary bypass surgery. Under this program, which is one of two in the nation granting B.S. degrees, students from Geneva have enjoyed a very high rate of job placement.

The new M.S. degree builds on this program, offering training in electrophysiology, an area of cardiology. Considered by many to be the fastest-growing area in cardiology today, electrophysiology deals with the insertion of pacemakers and laser surgery on the electrical system of the heart muscle. Electrophysiological procedures are in high demand, yet there are no professional programs devoted to formal training in this area of CVT. Geneva’s new MS program is designed to meet that need.

INOVA has been an outstanding training environment for Geneva College students. Many of the same students who graduated from the program have been employed by INOVA, some for as long as 20 years. The cardiology unit in the hospital has grown in national prominence and now ranks 21st out of 1,500 hospitals in the latest US News and World Report rankings. These facilities and staff were also a critical component in the recent 10 year re-accreditation of the Geneva College Program in CVT earlier this year.

Geneva College is a comprehensive Christian college of the arts, sciences and professional studies. Founded in the tradition of the Reformed Christian faith, Geneva prepares students to serve Christ in all areas of society: work, family and the church. Geneva is a founding member of the Council for Christian Colleges & Universities (CCCU).

Geneva College

CONTACT: Cheryl Johnston, Director of Public Relations of GenevaCollege, +1-724-847-6577, [email protected]

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

In Motion Technology and Physio-Control Provide Critical Cardiac Information From the Field to Doctors Anywhere

In Motion Technology, a leader in multi-network mobility management systems for in-vehicle use, today announced that emergency medical personnel in vehicles equipped with In Motion’s onBoard(TM) Mobile Gateway and Physio-Control’s LIFEPAK(R) 12 defibrillator/monitor can now send, via the Internet, diagnostic-quality cardiac information seamlessly from the field to hospital care teams anywhere via the LIFENET STEMI Management Solution–a capability that helps reduce the time to treatment for STEMI (ST-segment elevation myocardial infarction) patients, thereby improving outcomes and saving lives.

In Motion Technology’s onBoard(TM) Mobile Gateway is installed in emergency vehicles to create a “vehicle area network” that provides connectivity for all on-board data communications, including vehicle locating and dispatch systems, patient care recording technology and other medical monitoring devices such as the LIFEPAK 12 defibrillator/monitor. The Gateway senses and selects the best available wireless network to ensure data from these systems in transmitted reliably and securely to headquarters staff, other first responders and area hospitals. In Motion Technology solutions also provide operations command with powerful tools to allow remote monitoring and troubleshooting of vehicles, onboard systems and communications networks.

Physio-Control’s LIFENET STEMI Management Solution is a web-based system that allows emergency personnel to quickly transmit and distribute pre-hospital 12-lead ECGs to hospital based care teams via the Internet. For STEMI patients, time to treatment is critical. The American Heart Association recommends that STEMI patients receive angioplasty or other coronary intervention within 90 minutes of arriving at a hospital. Having the ability to transmit patient data while the patient is still in transit reduces the time to treatment by alerting care teams of a STEMI patient and ensuring that they are transported to a facility capable of providing the appropriate treatment.

In Motion Technology’s onBoard(TM) Mobile Gateway provides field-based internet connectivity used by Physio-Control’s LIFENET STEMI Management Solution. The Gateway senses and selects the best available wireless network to ensure these lifesaving communications get through with unparalleled reliability. And because the Gateway is equipped with GPS, emergency personnel and dispatchers can track the vehicle while monitoring the patient.

“The LIFENET STEMI Management Solution delivers lifesaving information when and where it is needed. But this information can only be used to save lives when the wireless data from the field can get through,” said Randy Merry, Physio-Control’s Vice President of Smart Services. “That’s where In Motion Technology comes in. In Motion provides us with a reliable connection to the Internet, allowing paramedics to focus on the patient while the pre-hospital 12-lead ECG is delivered to hospital care teams.”

“In Motion Technology solutions have been used by more than 130 emergency organizations across North America to improve communications, operations and response times,” said Kirk Moir, CEO of In Motion Technology. “Working with Physio-Control will allow healthcare providers to monitor and share critical information while the patient is in transit. We believe the combination of the onBoard(TM) Mobile Gateway and the LIFENET STEMI Management Solution demonstrates the power and lifesaving possibilities of providing reliable internet connectivity to EMS.”

Both In Motion and Physio-Control will attend the Pinnacle 2008 EMS Leadership meeting in San Diego July 29-31, 2008 and will demonstrate this technology.

About In Motion Technology

In Motion Technology provides multi-network mobility management systems for in-vehicle use that enable mobile workforces to simply and cost-effectively stay connected while in motion. Leveraging patented technology, the mobility management system ensures that any device can be immediately useful in the field without modification, and provides the ability to seamlessly roam across current and future wireless networks. In Motion Technology products have been successfully deployed in over 130 healthcare, government, public safety, utility and transportation organizations across North America. Founded in 2002, In Motion Technology is based in Vancouver, BC. For more information, please call Louise Labuda (In Motion Technology) at (604) 523-2371 ext. 538 or Michael Rubin (Rubin | Meyer) at (202) 898-0995, or visit www.inmotiontechnology.com.

GOING FOR THE CHOP ; Forget Fatty Takeaways. The Real Chinese Diet is so Healthy It Could Solve the West’s Obesity Crisis. Sophie Morris Explains How It Works — and the Nutritionists’ Verdict

By Sophie Morris

Chinese food has a bad reputation in the UK. The rice-heavy meals and fatty meat dishes are thought to lead straight to obesity and heart disease. But properly prepared, says Chinese food expert Lorraine Clissold, the very opposite is true: the Chinese way of eating is healthy and fulfilling, fights illness and prolongs life.

She also insists, in her book Why the Chinese Don’t Count Calories, that a real Chinese diet won’t make you fat, and that the rising levels of obesity observable in China are in fact caused by sugary, overprocessed Western food. Here are some of her Chinese dietary secrets – and the verdict of two Western nutrition experts, Patrick Holford and Ian Marber.

Stop counting calories

The Chinese don’t have a word for ‘calories’. They view food as nourishment, not potential weight gain. A 1990 survey found that Chinese people consumed 30% more calories than Americans, but were not necessarily more active. Clissold says their secret is avoiding the empty calories of sugary, nutrient-free foods.

Holford says: “The latest research into weight loss shows that calorie-controlled, low-fat diets are less effective than low glycemic load diets, which is exactly what a traditional Chinese diet is.”

Marber says: “There is one calorie in a Diet Coke, and 340 calories in an avocado. Which one is actually good for you? It’s a no-brainer. The avocado supplies you with monounsaturated fats and omega-6, which actually help increase metabolic rate.”

Think of vegetables as dishes

Rather than an uninspiring accompaniment to meat or fish, the Chinese treat vegetables as meals in their own right, rather than add-ons, as in the West.

Marber says: “I’m a great believer in combining protein and carbohydrate. There aren’t many complex carbohydrates in vegetables, but they should count as a dish. If the majority of your meal is vegetables, and you add some protein, you’ll always have a perfect meal.”

Holford says: “Vegetables should make up half of what’s on your plate in any given meal, so this fits perfectly with the Chinese diet.”

Fill up on staple foods

Without rice, which is low in fat and high in nutrients and fibre, claims Clissold, it is impossible to eat until you are full. Low-carb diets promise to burn fat, but Clissold says that replacing carbs with food that is higher in fat and lower in nutrients is not a long-term answer to weight loss.

Marber says: “I don’t agree. That Chinese person shovelling rice down is slightly pudgy because they eat too much rice. But from a financial point of view it’s very useful, because Atkins-style diets are very expensive.”

Eat until you are full

The Chinese eat until they are full, and then stop. Westerners often take a feast-and-famine approach to eating that is ridden with guilt – purging during the week and binging over the weekend, or skipping lunch to make room for cake. The Chinese tend to eat three good meals every day.

Holford says: “Provided that a meal has a high intake of fibre- rich vegetables and a balance of protein and carbohydrate, which a typical Chinese meal would, then you should eat until you are full. But the combination of high sugar, refined carbs (the white stuff) and high fat allows for more food to be eaten in a short space of time before the body’s ‘appestat’ kicks in and tells you to stop.”

Marber says: “What does ‘full’ mean? I think so much of that message is lost in the conspicuous consumption of the Western world. But be careful: it takes a while for the brain to recognise CCK, the hormone released when you are full, so you’re actually full quite a lot earlier than you realise.”

Take liquid food

Soup, or a soup-based dish, is present at every Chinese meal, often in the form of a watery porridge, zhou. Western diets can be very dry, and nutritionists compensate by urging us to drink more water, which the Chinese would never do with a meal. Instead, they make a nourishing liquid food part of the meal. And it’s a great way of using up leftovers.

Holford says: “Thirst is often confused with hunger. Also, drinking does tend to fill you up. So soups help you control your appetite.”

Marber says: “I’m a great believer in soups before food. Miso soup, for instance, or anything fermented – these are probiotics, which help release nutrients from the food you are about to eat.”

Bring yin and yang into your kitchen

A good Chinese diet balances yin (wet and moist) and yang (dry and crisp) ingredients. Yin foods cool the body down, while yang foods – meat, spicy dishes, wine, coffee – heat it up. The sharing, multi-dish approach to eating in China means most meals contain yin and yang in equilibrium.

Marber says: “You should have complex carbs, a protein and a grain together for many different reasons, one of which is the experience of eating. The typical English bastardisation of Chinese food, chicken and cashew nuts, is a good example: you’ve got the softness of the chicken, the crunch of the nut and the satisfying rice.”

Holford says: “Most protein foods are seen as yang, carbohydrates as yin. The combination of these two helps stabilise blood sugar, which is the key to good energy and minimising weight gain.”

Raw power? Not necessarily

Chinese people don’t eat raw salad. While raw food has a higher concentration of vitamins than cooked food, Clissold says the research ignores that lightly cooking food makes its nutrients easier for the body to take on. This way, it can conserve energy for other tasks. The stomach is unable to digest too much raw food; this can lead to bloating and weight gain.

Holford says: “The rawer the better. In almost all cases, raw food has more nutrients, though lightly cooking some vegetables can make those nutrients more bio-available.”

Marber says: “I don’t hold with this one. Eating a big salad with lots of different raw vegetables in it is very satisfying, and I can’t believe your average Briton is going to blanch salad.”

Use food to keep fit

Chinese medicine prescribes various foods as medical treatments: chillies to promote digestion and dispel cold; garlic to counteract toxins. The ultimate purpose is to ensure all the organs are working correctly to allow energy, or chi, to circulate smoothly around the body.

Holford says: “Two thousand years ago, Hippocrates said, ‘Let food be your medicine.’ But we in the West forgot. Peasant communities tend to have more respect for the cycle of food and how it supports life.”

Drink green tea

Green tea eliminates toxins, aids digestion and allays hunger. Scientists have found that it also fights free radicals, which cause cancer and heart disease.

Marber says: “I’m a great believer in green and herbal teas. Green tea is an important antioxidant, but it will only help you lose weight if you drink 40 cups a day. I’m also a great believer in a skinny latte once in a while – or every morning, in my case.”

Holford says: “Traditionally, when the Chinese want another cup of tea, they’ll keep the same leaves and add water to the pot. That’s like only using one teabag a day – which means much less caffeine.”

Take restorative exercise

Try regular, gentle exercise such as tai chi. A sweaty workout might shed fat, but it is stressful for your body. Energetic, aerobic workouts are yang – since they heat us up – while breathing exercises are yin.

Holford says: “Exercise after a meal promotes an active metabolism and helps control appetite. Although no one has worked out how to measure chi, the vital energy that these exercises promote, it’s a real thing that can easily be experienced. Many trials now show benefits to energy levels and immunity from these chi-generating exercises.”

Marber says: “Tai chi gives you a sense of balance, calm and peacefulness. Sweating it out at the gym is the precise opposite, but I can’t help it – I’m vain, shallow and modern. I think we’ve got a really f**ked-up view of how the body should look, and that it’s how we look, rather than how we feel, that matters.”

Why the Chinese Don’t Count Calories, Constable, Pounds 8.99. Log on to www.thefooddoctor.com or www.patrickholford.com

(c) 2008 Belfast Telegraph. Provided by ProQuest Information and Learning. All rights Reserved.

Genaera Reports Positive Interim Data From Phase I Diabetes Trial

Genaera has announced interim Phase I safety and pharmacokinetic data and new preclinical data on trodusquemine, its lead drug candidate for the treatment of type 2 diabetes and obesity.

Interim results from Genaera’s second Phase I clinical trial of MSI-1436, a novel inhibitor of PTP1B, demonstrated that the drug was well-tolerated by the overweight and obese volunteers with type 2 diabetes at anticipated therapeutic dose levels with a very low level of adverse events and no evidence of serious adverse events.

Moreover, pharmacokinetic (PK) profiles of MSI-1436 in the four cohorts of the study showed a consistent pattern with minimal subject-to-subject variability. Linearity of peak trodusquemine concentration was observed across the range of doses studied. Values for a wide range of endocrine and metabolic biomarkers as well as evaluations of mood and cognition were also found to be stable in subjects receiving all levels of the drug or placebo during the trial.

These positive study MSI-1436C-103 results are expected to enable further study to fully validate proof-of-concept of MSI-1436 in an ascending multiple-dose clinical trial planned to begin later this year.

Data were also presented from preclinical studies which demonstrated that systemically administered MSI-1436 crossed the blood-brain barrier and functionally inhibited PTP1B in the hypothalamus.

In this study, rats were administered a single dose of MSI-1436 one day prior to receiving insulin; 30 minutes post-insulin, hypothalami were harvested to determine the level of phosphorylated-insulin receptor beta (IR-beta), a target of PTP1B. Previous studies had shown that MSI-1436 is a reversible, noncompetitive inhibitor of PTP1B with the ability to cross the blood brain barrier.

In the hypothalamus, MSI-1436 enhanced the insulin-induced phosphorylative state of the insulin receptor, which confirms the functionality of MSI-1436 in this key regulatory center of the brain. According to the company, the combination of central and peripheral inhibition makes MSI-1436 a promising therapeutic candidate for both obesity and type 2 diabetes.

‘Hooked’ Uncovers the Hidden Dangers of Teen Sex

Pop culture tells young people that sex is an act of self-expression, a personal choice for physical pleasure that can be summed up in the ubiquitous phrase, “hooking up.” They are told that as long as they use protection and avoid STDs or out-of-wedlock pregnancies, there are no consequences. But what happens when those relationships end? “Hooked: New Science on How Casual Sex is Affecting Our Children” uncovers new research on the impact that sex, even “safe” sex, can have on the adolescent brain. Written by physicians Joe S. McIlhaney, Jr., M.D. and Freda McKissic Bush, M.D., “Hooked” is a journey of exploration into the mind, the most powerful sex organ of all.

Based on studies and data from the Medical Institute for Sexual Health, a nonprofit medical, educational, and research organization, “Hooked” reveals groundbreaking evidence showing that when couples become sexually active, they release a series of brain chemicals that can result in powerful emotional bonding. Once “hooked,” the couple has a bond that is not easily broken. When separation does occur, it has a chemical and biological impact on the brain – an impact that affects future behavior and happiness.

“Millions of American teenagers and young adults are finding that the psychological baggage of casual sex is affecting their lives,” said Gary Rose, MD, President and CEO of the Medical Institute. “They are discovering that ‘hooking up’ is the easy part, but ‘unhooking’ from a sexual relationship is a lot harder and can have serious consequences.”

The risks of unprotected sex and unhealthy sexual behavior are widely known. More than 700,000 unplanned pregnancies and 19 million new Sexually Transmitted Infections (STIs) occur in the United States each year. But too few young people consider the emotional and psychological risks of casual sex – bonds that are certain to be formed, regardless of precautionary measures. When these bonds are broken, the trauma can create negative patterns in their behavior and thinking that last a lifetime. More than just stern warning about teenage sex, “Hooked” is a journey of discovery into the human brain when we are at our most vulnerable, and speaks to every parent and child who must consider the true consequences of sex.

On the Net:

Faith In Practice Honors Dr. Rafael Espada, Guatemalan Vice President and Former Houston Cardiac Surgeon

This Fall, Faith In Practice will honor the work of Dr. Rafael Espada, Vice President of Guatemala, former Houston cardiac surgeon and Faith In Practice Board Member at its annual Gala “A Heart For Mission” Tuesday, October 14, 2008 from 5:30-9:00 p.m. at the Westin Galleria Houston.

Dr. Espada practiced in Houston for over 30 years at the Methodist DeBakey Heart Center and was a professor of cardiothoracic surgery at the Baylor College of Medicine. Most recently he was elected Vice President of Guatemala in January of 2008 and has said this position will allow him to concentrate on the overall health care and economic conditions in his native country. Until his recent election, Espada traveled monthly from his home in Houston to Guatemala to treat underprivileged patients and to teach. Through his work and the collaboration of other US surgeons, Dr. Espada built UNICAR, a state-of-the-art cardiothoracic surgery facility, in Guatemala City.

“Dr. Espada’s willingness to forgo a comfortable retirement in the United States and return to his homeland of Guatemala to help his people is inspiring and encouraging to all of us who work in the health field in Guatemala,” said Vera Wiatt, co-founder of Faith In Practice. “He brings unquestionable ethics, high ideals and years of experience in providing quality medical care to a country in great need of innovative ideas and restructuring of the medical care delivery system.”

In addition to honoring Dr. Espada, the Gala will honor Faith In Practice volunteer and Guatemalan native, Armando Najera. A former beneficiary of donated medical services, Armando works and lives in rural Guatemala and now volunteers as a Faith In Practice community leader, bringing health and wholeness to his remote village. Armando’s testament as a Faith In Practice volunteer is evidence to the life changing medical mission work that happens all over the country.

Guests at the Gala will participate in a live auction and the “Mercado” featuring beautiful Guatemalan handicrafts and art. Proceeds from the event will help to support this life changing work.

Since its inception in 1992, Faith In Practice has developed rich and rewarding partnerships throughout Guatemala, including the Obras Sociales del Hermano Pedro Hospital and Orphanage in Antigua, and in the remote villages of Retalhuheu, San Benito, Patzun and Sarstoon. Working alongside the medical staff, administrative staff and the Franciscan clergy, Faith In Practice volunteers donate a week of their time and pay their own travel expenses to provide healthcare services to the poor of Guatemala. Faith In Practice provides housing at the Casa de Fe in Antigua, a guest house for patients and their families while they await their surgeries and then begin recovery. Faith In Practice has also begun its Women’s Health Initiative, with the VIA/Cryo program, a medical teaching program educating local Guatemalan practitioners how to identify and treat precancerous cervical cells.

For more information about opportunities with Faith In Practice or to purchase tickets for the Gala, please contact Faith In Practice at 713/484-5555, [email protected] or online at www.faithinpractice.org.

South Florida Proton Center to Partner With University of Miami

MIAMI, July 28 /PRNewswire/ — The South Florida Proton Center and University of Miami Miller School of Medicine announce the first university affiliated proton treatment facility in South Florida. The $85-100 million facility, officially “The South Florida Proton Center at The University of Miami,” will be located at the new UM Life Sciences Park and will be a LEED certified green building.

Proton therapy uses a sophisticated system with a particle accelerator to precisely deposit radiation directly within tumors while sparing adjacent healthy tissues and organs. According to South Florida Proton Center Executive Director, James G. Schwade, M.D., FACR, FACRO, FASTRO, “Our goal is to make proton therapy affordable and accessible to cancer patients across the region.” Using new technology from Varian Medical Systems, Inc. of Palo Alto, California, the planned center will offer cancer patients the most advanced and precise proton therapy in the world.

The South Florida Proton Center has also secured participation from physicians within the regional community so that continuity of care will be maximized. “This will serve our patients and also potentially help with our discovery mission and lab work,” said Dr. Bart Chernow, VP for special programs and resource strategy at UM’s Miller School of Medicine. “UM physicians would have the opportunity to work there and help to provide medical leadership.”

“By working with Varian, the world leader in radiotherapy technology, we intend to build a more affordable facility capable of delivering intensity modulated proton therapy utilizing scanning beam technology, the most advanced form of this type of therapy,” said Dr. Schwade.

Unlike other proton therapy facilities, the South Florida Proton Center plans to proceed with a second facility in Northern Palm Beach County, as well. According to Schwade, this will facilitate access by a greater number of patients and physicians. Said Schwade, “We’ve shown with our previous projects, such as the two regional Cyberknife sites, that giving access to the maximum number of qualified physicians ensures access for the maximum number of patients.”

Construction is planned to commence in July of 2009, and SFPC is actively exploring sites in Palm Beach County for the second facility.

For more information please visit http://southfloridaprotoncenter.com/.

The South Florida Proton Center

CONTACT: Susan Nefzger of Susan Nefzger PR & Web Marketing for The SouthFlorida Proton Center, +1-561-632-9525

Web site: http://southfloridaprotoncenter.com/

Head-to-Head Study Results Demonstrated No Significant Difference Between NicoDerm(R) CQ(R) and Chantix (Varenicline Tartrate) in Long Term Quit Rates

PITTSBURGH, July 28 /PRNewswire/ — New data published today in the August issue of Thorax shows no significant differences in 6-month and 1-year quit rates between the NicoDerm(R) CQ(R) Clear Patch and Chantix (varenicline tartrate) despite statistically higher quit rates for Chantix (varenicline tartrate) at 12 weeks. According to the official 2008 U.S. Public Health Service Guideline, longer-term quit rates at the 6-month milestone are the most predictive of long-term success.

The Thorax paper, entitled, “Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial”, reports on a 52-week study that is the first-ever direct comparison of the NicoDerm CQ Clear Patch to Chantix (varenicline tartrate). The study was conducted using an “open-label” design, meaning that subjects knew what medication they were taking. Though this design may have favored the new pill, Chantix (varenicline tartrate) did not demonstrate long-term superiority to NicoDerm CQ.

“This study confirms that there is no magic bullet when it comes to smoking cessation and that both therapeutic nicotine and Chantix (varenicline tartrate) demonstrate long-term effectiveness,” stated Dr. Howard Marsh, vice president of Worldwide Medical Affairs for GlaxoSmithKline Consumer Healthcare. “There is also no single approach that will work for everyone. For example, a substantial proportion of quit attempts are made spontaneously, without much planning. Therapeutic nicotine is widely available without the need for a prescription or a visit to a doctor’s office.”

Each smoking cessation medicine has been proven effective. In separate double blind placebo-controlled studies for NicoDerm CQ and Chantix (varenicline tartrate), NicoDerm CQ patch had a 45 percent success rate (vs. 18 percent for placebo) at the end of 10-week treatment and Chantix (varenicline tartrate) had a success rate of 44 percent (vs. 18 percent for placebo) at the end of 12-week treatment.

In fact, the recently updated 2008 U.S. Public Health Service Guideline recommends these products as well as Commit(R) lozenge and Nicorette(R) gum as first-line therapy for quitting, as they significantly increase rates of long-term smoking abstinence.

Dr. Howard Marsh continued, “The aim of all quitters is to quit for good, so although short-term quit rates are useful indicators of efficacy, long-term abstinence will prolong improved health. These results confirm that NicoDerm CQ patch enables a significant proportion of patients to quit for a year.”

Over-the-counter therapeutic nicotine products like NicoDerm CQ patch, Nicorette gum and Commit lozenge are first-line treatments for smoking cessation and are thoroughly researched, well-understood and highly accessible stop smoking therapies. Unfortunately, the majority of smokers try to quit with no assistance at all and only 3-5 percent of smokers who quit “cold turkey” are successful long-term.

GlaxoSmithKline Consumer Healthcare’s family of over-the-counter therapeutic nicotine products, NicoDerm CQ patch, Nicorette gum and Commit lozenge have helped more than six million smokers around the world quit successfully. Of these smokers, over three million have successfully quit smoking specifically with the help of the NicoDerm CQ patch.

Consistent with their FDA-approved labeling, the GlaxoSmithKline Consumer Healthcare’s therapeutic nicotine products help reduce nicotine withdrawal symptoms, including nicotine craving, associated with quitting smoking. Therapeutic nicotine products are designed to allow smokers to wean off nicotine gradually and safely. GlaxoSmithKline Consumer Healthcare’s therapeutic nicotine products are available without a doctor’s prescription, in flexible dosing options at over 35,000 retail outlets across the country. So a smoker who wants to quit doesn’t have to wait to see a doctor to get help.

With more than 10 years of experience in smoking cessation therapy, GlaxoSmithKline Consumer Healthcare understands successful quitting requires breaking the dependence on tobacco and changing behaviors associated with smoking. GlaxoSmithKline Consumer Healthcare recommends that quitters wanting to improve their chances of success use our individually-tailored Committed Quitters(R) program or other behavioral support programs in combination with our therapeutic nicotine products. Our tailored Committed Quitters program is available to anyone, and further increases a smoker’s chances of quitting.

For more information on the Committed Quitters program and managing both the physical and psychological aspects of smoking dependence, visit http://www.way2quit.com/, a comprehensive smoking cessation resource offered by GlaxoSmithKline Consumer Healthcare.

Notes to editors:

“Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial”. The head to head study was a 52 week, open-label, randomised, multicenter trial conducted in Belgium, France, the Netherlands, UK and U.S.A. Seven hundred and forty-six participants were eligible for primary analysis. Participants were randomly assigned to receive Chantix (varenicline tartrate) for 12 weeks or transdermal therapeutic nicotine for 10 weeks. The primary endpoint was confirmed abstinence for the last four weeks of treatment and secondary endpoints were 24 and 52 week confirmed abstinence, and effect on craving and withdrawal symptoms.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world’s largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette(R) and NicoDerm(R)CQ(R), and Commit(R), as well as many medicine cabinet staples — alli(R), Aquafresh(R), Sensodyne(R), and TUMS(R) — which are trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.About

GlaxoSmithKline

GlaxoSmithKline — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com/.

GlaxoSmithKline

CONTACT: Mark Polisky, of GolinHarris, +1-312-729-4417,[email protected], for GlaxoSmithKline; or Jennifer May ofGlaxoSmithKline Consumer Healthcare, +1-412-200-3729, [email protected]

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

Genomas Presents New Findings on Statin Safety and Patient Adherence at the American Association For Clinical Chemistry Annual Meeting and Symposium With Leading Experts in Cardiovascular Pharmacogenetics

WASHINGTON, July 28 /PRNewswire/ — Genomas(R), a biomedical company advancing DNA-guided medicine and personalized healthcare, announced its participation in the symposium to be held today entitled Pharmacogenomics of Statin Safety and Efficacy at the Annual Meeting of the American Association for Clinical Chemistry (AACC). Gualberto Ruano, MD, PhD, President and CEO of Genomas, is the symposium’s chairman and will talk about The Pathway to DNA-Guided Statin Therapy.

   The symposium participants are:   Ronald M. Krauss, MD   Children's Hospital and   Oakland Research Institute    Stewart H. Lecker, MD, PhD   Beth Israel Deaconess Medical Center and   Harvard Medical School    Georgirene Vladutiu, PhD   School of Medicine and   Biomedical Sciences   SUNY at Buffalo   

Statins are the most prescribed drugs in the world. These drugs offer effective strategies to reduce cardiovascular disease and improve survival. Drugs in this class include atorvastatin, rosuvastatin, and simvastatin.

However, there are clinically relevant safety risks for some patients. Statin-induced neuromyopathy (SINM) may present as muscle aches (myalgia), cramps, weakness, and muscle injury (myositis, monitored in serum by elevation of certain enzymes). SINM is more frequent at the higher doses required for treating advanced heart disease and varies in extent between individual statins and from patient to patient.

The symposium will describe the progress of DNA-guided medicine with respect to statin therapy. The participants will describe class-wide and drug- specific genetic associations with statin lipid lowering and neuromyopathy, explore clinical relevance, and survey directions for future research, particularly the utilization of total genome arrays.

New research from an actuarial analysis supported by Genomas of over 4 million commercially insured persons from 2004 to 2006 will be presented by Dr. Ruano. The incidence of SINM in new high-risk patients was 17% and the incidence of SINM in new and existing patients with coronary artery disease was 21%. Dr. Ruano will also discuss statin pharmacogenetic results from the consortium including Genomas, Hartford Hospital, University of California San Francisco and Rogosin Institute, which is funded by a recently awarded $1.2 million NIH grant.

“We are seriously motivated about the role we can play in addressing what has been an underappreciated health issue that affects millions of people,” said Dr. Ruano. “This presentation at AACC is part of a series of upcoming forums for Genomas to present its research and product development efforts, and to engage with international thought leaders.” The AACC Annual Meeting is one of the premiere international forums for laboratory medicine and the clinical diagnostics industry.

ABOUT GENOMAS

Genomas(R) Inc. is a biomedical company advancing DNA-guided medicine and personalized healthcare. The company develops revolutionary PhyzioType(TM) Systems for DNA-guided diagnosis and prevention of metabolic disorders induced by drugs in cardiovascular and psychiatric medicine. PhyzioType Systems provide physicians with the unprecedented capability to select for each patient the safest drug treatment to enhance compliance. Please access http://www.genomas.net/ .

Genomas

CONTACT: Gualberto Ruano, MD, PhD, President and CEO of Genomas, Inc.,+1-860-545-3774

Web site: http://www.genomas.net/

Cytomedix Retains Dr. David F. Counts, Inventor of Company’s Anti-Inflammatory Peptide Patent; Dr. Counts to Assist Dr. Peter Clausen, Lead Biochemist, in Further Development of CT-112 Peptide

ROCKVILLE, Md., July 28, 2008 (PRIME NEWSWIRE) — Cytomedix, Inc. (AMEX:GTF) today announced that David F. Counts Ph.D., a leading pharmacologist and medical researcher who discovered the Company’s anti-inflammatory peptide, CT-112, has been retained as a consultant to assist the Company with the further development of the peptide, as the Company prepares to file an Investigational New Drug (IND) submission with the FDA and move into a Phase I Clinical trial. Dr. Counts discovered the anti-inflammatory properties of the CT-112 peptide in the mid 90s during his research of platelet derived growth factors, which contributed to the development of the Company’s AutoloGel(tm) System. Dr. Counts will be working with Dr. Peter Clausen, a leading biochemist, who was also recently retained by the Company to oversee the CT-112 development effort.

Pre-clinical animal studies led by Dr. Counts indicated the CT-112 peptide may be active for the treatment of inflammatory diseases such as Rheumatoid Arthritis, Crohn’s Disease, Tissue Reperfusion Injury and other related medical conditions. The studies further indicated that CT-112 may be administered orally, unlike other anti-inflammatory drugs currently on the market which are administered via injection or infusion.

“I remain dedicated to the advancement of the CT-112 peptide as a potential breakthrough drug that could benefit patients suffering from inflammatory diseases without causing the serious side effects that have plagued other therapies. Advancements in peptide manufacturing and a greater understanding of the technology have now made it feasible to move ahead with the development of CT-112. Based on the pre-clinical data which has been gathered to date, I believe the Company is well-positioned to prepare an IND application, and I am looking forward to working with Dr. Clausen on this important project,” said Dr. Counts.

“Dr. Counts’ expertise as the developer of the CT-112 peptide and his commitment to seeing it brought to fruition, will be invaluable as we prepare to take it through the regulatory process,'” stated Martin Rosendale, Chief Executive Officer of Cytomedix. “This represents an exciting new stage for the Company and we are pleased to have Dr. Counts and Dr. Clausen as a part of our team in the further development of CT-112.”

Dr. Counts is a renowned pharmacologist with more than 30 years experience in academia, industry and economic development organizations. Dr. Counts is currently a Director (Life Sciences) for Angle Technology Ventures, a Philadelphia-based international consulting, management and venture creation company. He is also an Adjunct Clinical Assistant Professor in the Department of Dermatological Surgery at the State University of New York at Stony Brook Medical School. Previously, he was the co-founder of Avogen, a Los Angeles-based specialty chemicals company that markets exclusive cosmetic materials.

Prior to Avogen, Dr. Counts was a Director of Preclinical Research at Curative Technologies, Inc., where he managed more than 25 research contracts with universities, contract research organizations and individual consultants. It was during his tenure at Curative Technologies where Dr. Counts discovered the anti-inflammatory properties of the CT-112 peptide while conducting research of platelet derived growth factors. Dr. Counts also held senior positions with Marion Merrell Dow Inc., a Kansas City, Mo. based pharmaceutical company, Eli Lilly and Company, where he was a senior biochemist, and was a Research Associate at Gillette Research Institute. During the early 1980s, Dr. Counts was also a Research Assistant Professor in the Biochemistry department of the University of Vermont’s School of Medicine. He holds a Bachelor of Science degree in Chemistry from Tulane University and a Ph.D. in Cell and Molecular Biology from the Medical College of Georgia.

Dr. Clausen is a seasoned biochemist with nearly 15 years experience in the biotechnology industry. Dr. Clausen was a founding member, Vice President of Research and Development, and inventor of core intellectual property at Marligen Biosciences, an Ijamsville, Md.-based company that develops, manufactures and markets innovative products for the life sciences market. Prior to Marligen Biosciences, he was the Manager of New Purification Technologies developing novel DNA and protein purification technologies for commercialization at Invitrogen Corporation, a Rockville, MD-based biotechnology company that provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Dr. Clausen also worked to develop small molecule and peptide therapeutics as a Scientist at Pro-Neuron Inc., a Maryland-based Biotechnology company focused in therapeutic areas including Oncology, Neurology, Dermatology, and Metabolic Disease. Dr. Clausen held a fellowship in the Laboratory of Molecular Oncology at the National Cancer Institute where he contributed research in the areas of oncology, hematopoiesis and gene therapy. He holds a Bachelor of Science degree in Biochemistry from Beloit College and a Ph.D. in Biochemistry from Rush University where his research focused on inflammation and the pathogenesis of inflammatory arthritides.

ABOUT CYTOMEDIX

Cytomedix, Inc. is a biotechnology company specializing in processes and products derived from platelet releasates for use on wounds and other applications. The current offering is the AutoloGel(tm) System, a process that utilizes an autologous platelet gel composed of multiple growth factors, other platelet releasates, and fibrin matrix. Additional information regarding Cytomedix is available at: http://www.cytomedix.com.

SAFE HARBOR STATEMENT

Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix’s actual results may differ materially due to a number of factors, many of which are beyond Cytomedix’s ability to predict or control, including among others, the outcome of development or regulatory review of CT-112, commercial success or acceptance by the medical community, and competitive responses. CT-112 was introduced as a therapeutic candidate with an FDA Pre-IND meeting in 1995. It is uncertain whether the company will obtain the funds necessary for development, or whether current market conditions will support a renewed effort to develop CT-112. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.

This news release was distributed by PrimeNewswire, www.primenewswire.com

 CONTACT:  The Wall Street Group, Inc.           Ron Stabiner           212-888-4848                      Cytomedix, Inc.            Martin Rosendale, Chief Executive Officer           240-499-2680 

Nventa Announces Final Data From HspE7 Phase 1 Cervical Dysplasia Trial

SAN DIEGO, July 28 /PRNewswire-FirstCall/ — Nventa Biopharmaceuticals Corporation (TSX: NVN) today announced that it has completed analysis of immunological data from all four cohorts of its Phase 1 clinical trial for HspE7, its lead product candidate. HspE7 is a therapeutic treatment for patients with cervical intraepithelial neoplasia, or CIN, a precursor to cervical cancer. The primary cause of CIN is infection with certain human papillomavirus (HPV) types, of which HPV16 is the most common. Based on an analysis of HPV16 E7-specific T-cell responses across all cohorts, Nventa has identified a dose regimen of 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC, a toll-like receptor 3 (TLR3) adjuvant, for subsequent Phase 2 trials.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080303/LAM023LOGO)

The purpose of the Phase 1 trial was to determine the safety, tolerability and immunogenicity of HspE7 plus escalating doses of adjuvant (50, 500, 1,000 and 2,000 mcg of Poly-ICLC). All dose regimens were found to be safe and well tolerated. Immunogenicity analysis demonstrated that the adjuvant potently enhanced HPV16 E7-specific T-cell responses in subjects who demonstrated no or low responses at baseline.

“This Phase 1 trial has not only demonstrated HspE7’s excellent safety profile, it has also provided compelling data to support the immunologic activity of the compound and identified the appropriate dose regimen for our future trials,” said Gregory M. McKee, president and chief executive officer at Nventa. “We are very encouraged by these results and believe that HspE7 may offer an important therapeutic benefit for the millions of women with CIN.”

In the first cohort (500 mcg of HspE7 and 50 mcg of Poly-ICLC), which was designed to establish a baseline for the study, there was limited HPV16 E7-specific T-cell responses. In cohort 2 (500 mcg of HspE7 and 500 mcg of Poly-ICLC), three out of four patients showed HPV16 E7-specific T-cell responses. In the third cohort (500 mcg of HspE7 and 1,000 mcg of Poly-ICLC), HPV16 E7-specific T-cell responses were elicited in all four subjects and all of these T-cell responses represented significant changes from baseline, indicating that the responses were a direct result of treatment with HspE7. In the trial’s fourth and final cohort (500 mcg of HspE7 and 2,000 mcg of Poly-ICLC), two of five patients had significant increases in HPV16 E7-specific T-cells from baseline while the remaining three patients maintained high levels of HPV16 E7-specific T-cells that were already present at baseline. The absolute levels of HPV16 E7-specific T-cells in patients in the fourth cohort were similar to levels observed in the third cohort. The data, therefore, support doses of 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC as appropriate for advancing into Phase 2 studies.

Findings from this trial verify the company’s predicted mechanism of action for HspE7 as demonstrated by early preclinical models and support the compound’s potential to treat HPV16- induced CIN. HPV16 is the most common subtype of the HPV virus and is responsible for a significant percentage of cases of CIN.

Phase 2 Development Plan Update:

Following discussions with, and input from, the U.S. Food and Drug Administration (FDA), Nventa has finalized its protocol for a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial of HspE7 in patients with high-grade cervical dysplasia (CIN 2/3). Preparations have been made at approximately 40 clinical investigational sites in the U.S., Canada and Latin America. The company has also designed a Phase 2 trial of HspE7 in patients with low-grade cervical dysplasia (CIN 1). Evaluation of clinical investigational sites in Europe and Latin America are underway. The company intends to initiate one or both of these Phase 2 trials once it has secured necessary financing.

About Cervical Intraepithelial Neoplasia (CIN):

CIN, also known as cervical dysplasia, is characterized by the presence in the cervix of abnormal cells that precede and can develop into cervical cancer. The primary cause of such abnormalities is infection with certain human papillomavirus (HPV) types, of which HPV16 is the most common. In the U.S., these infections are typically discovered through nearly 60 million Pap screens completed each year, at a cost of up to $6 billion. Each year in the U.S., an estimated 1.2 million women are diagnosed with low-grade cervical dysplasia (CIN 1), 300,000 with high-grade dysplasia (CIN 2/3) and 2.4 million with atypical squamous cells of undetermined significance (ASCUS). No therapies other than surgery are currently approved by the FDA for the treatment of any type of CIN.

About HspE7:

The company’s lead product candidate, HspE7, is a novel therapeutic candidate intended for the treatment of precancerous and cancerous lesions caused by the human papillomavirus (HPV), one of the most common sexually transmitted diseases in the world. HspE7 incorporates the proprietary adjuvant, Poly-ICLC, a toll-like receptor-3 (TLR3) agonist. An adjuvant is a substance added to vaccines to improve immune responses against target antigens. HspE7 is derived from Nventa’s proprietary CoVal(TM) fusion platform, which uses recombinant DNA technology to covalently fuse stress proteins to target antigens, thereby stimulating cellular immune system responses. Nventa is developing HspE7 for multiple indications.

About Nventa Corporation:

Nventa is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by HPV. The company is publicly traded on the Toronto Stock Exchange under the symbol “NVN”. For more information about Nventa, please visit http://www.nventacorp.com/.

This press release contains statements which may constitute forward-looking information under applicable Canadian securities legislation or forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Such forward-looking statements or information may include statements regarding the company’s future plans, objectives, performance, growth or the company’s underlying assumptions. The words “may”, “would”, “will”, “expect”, “intend”, “plan”, “estimate” and “believe” or other similar words and phrases may identify forward-looking statements or information. Persons reading this press release are cautioned that such statements or information are only expectations, and that the company’s actual future results or performance may be materially different.

Forward-looking statements or information in this press release include, but are not limited to, statements or information concerning: our intent to use 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC in our Phase 2 trials; that 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC is the optimal dose regimen for advancing into Phase 2 trials; that HspE7 may offer an important therapeutic benefit for the millions of women with CIN; the potential of HspE7 to treat HPV16 induced CIN; and our intent to initiate a Phase 2 clinical trial in patients with CIN 2/3 and/or a Phase 2 clinical trial in patients with CIN 1 once we have secured necessary financing.

Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments to be materially different from results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, the possibility that 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC is not the optimal dose regimen; the possibility that immunology responses may not be a predictor of clinical benefit; that immunological findings in our Phase 1 trial may not be consistent with findings from future clinical trials; that safety and tolerability findings in our Phase 1 trial may not be consistent with findings from future clinical trials; that results from future clinical trials will not be consistent with our expectations; that we will not be able to recruit patients for our planned trials in a timely manner; our need for capital, which may not be available on a timely basis, or at all; risks associated with requirements for approvals by government agencies such as the FDA before products can be tested in clinical trials; the possibility that such government agency approvals will not be obtained in a timely manner or at all or will be conditioned in a manner that would impair our ability to advance development; risks associated with the requirement that a drug candidate be found safe and effective after extensive clinical trials; our dependence on suppliers, collaborative partners and other third parties and the prospects and timing for obtaining clinical supply materials; our ability to attract and retain key personnel; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at http://www.sedar.com/.

Assumptions underlying our expectations regarding forward-looking statements or information contained in this press release include, among others, that 500 mcg of HspE7 and 1,000-2,000 mcg of Poly-ICLC is the optimal dose regimen; that immunology responses are a predictor of clinical benefit; that immunological findings in our Phase 1 trial will be consistent with findings from future clinical trials; that safety and tolerability findings in our Phase 1 trial will be consistent with findings from future clinical trials; that results from future clinical trials will be consistent with our expectations; that we will raise enough capital, on reasonable terms and in a timely manner; that we will retain our key personnel; that we will obtain the necessary regulatory approvals related to HspE7 and Poly-ICLC in a timely manner; that sufficient HspE7 and Poly-ICLC will be available to conduct our planned clinical trials; that we will obtain timely approval from additional Investigational Review Boards; that the results from additional preclinical and clinical work, if any, will be consistent with the results we have already obtained; that a sufficient number of patients will be available to conduct our planned trials; and that sufficient data will be generated to support our Biologics License Application.

In the event that any of these assumptions prove to be incorrect, or in the event that we are impacted by any of the risks identified above, we may not be able to continue in our business as planned.

For a complete discussion of the assumptions, risks and uncertainties related to our business, you are encouraged to review our filings with Canadian securities regulatory authorities, including our 2007 Annual Information Form filed on SEDAR at http://www.sedar.com/.

All forward-looking statements and information made herein are based on our current expectations as of the date hereof and we disclaim any intention or obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20080303/LAM023LOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, [email protected]

Nventa Biopharmaceuticals Corporation

CONTACT: Donna Slade, Director, Investor Relations of NventaBiopharmaceuticals Corporation, +1-858-202-4945, [email protected]; Media,Tim Brons, +1-415-675-7402, [email protected], of VidaCommunication for Nventa Biopharmaceuticals Corporation; Michael Moore,+1-416-815-0700, ext. 241, [email protected], of The Equicom Group forNventa Biopharmaceuticals Corporation

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

Doctor’s Persistence Saves CEO’s Life

ROSEVILLE, Calif., July 28 /PRNewswire/ — Guy A. Archbold, CEO of El Dorado Hills, California based Chapeau Inc. d/b/a: Blue Point Energy credits the thoroughness of his new doctor with saving his life and his company money. Doctors save lives all the time, but, what is unique about Guy’s situation was that he had an undetected melanoma (cancerous mole) on his skin which other doctors had missed. According to Guy, “It was during the most thorough examination I’ve ever had, that Robert S. Taylor, M.D. discovered a suspicious mole. We got it out and three days later the report came back as a Level-1 melanoma. He is no ordinary doctor, he is extraordinary; Dr. Taylor saved my life!”

Guy has become an enthusiastic advocate for Dr. Taylor and his “Direct Access” Medical Practice. He also recognized the value of having this level of medical care as an employee fringe benefit — he signed up five of his company’s top executives as members of Dr. Taylor’s innovative medical practice. The results have been very impressive reports Guy, “Predictably, it’s a much-appreciated fringe benefit. I can unequivocally argue that the cost to benefit ratio is superb. The preventive health care reduced sick time and saved us money. A bonus has been the positive impact it’s had on morale!”

Typically, the back of the one’s calf is rarely checked during an initial examination. However, Dr. Taylor is anything but your average General Practitioner. He is one of a few physicians in Northern California that render services directly to his member patients. Dr. Taylor always wanted to practice medicine this way — with all of the new medical technology coupled with caring service. Guy A. Archbold originally chose Dr. Taylor because he limits his practice to fewer patients, is very accessible and devotes more time to his patients. Dr. Taylor explains, “On the average, doctors assess patients in an eight to twelve-minute visit, but we provide generous visits so we can be more thorough. In Guy’s case, we caught the melanoma early.” Dr. Taylor will even make house calls as needed and provides patients his personal cell phone for 24/7 access and peace of mind.

Dr. Taylor offers same day appointments, minimal waiting, comprehensive exams, customized wellness plans, an enhanced referral network, affiliation with the Sutter Health system and prompt prescription refills. He is also a Federal Aviation Administration (FAA) Senior Aviation Medical Examiner (AME) and conducts comprehensive flight physical examinations for pilots. Dr. Taylor is a member of the Society for Innovative Medical Practice Design (SIMPD). For interviews with Robert S. Taylor, M.D. call Lourdes Cruz of CruzMark, Inc. at (916)791-1535, or email her at: [email protected]. To learn more about Dr. Taylor’s practice, visit: http://www.drbobtaylor.net/ located at 2550 Douglas Blvd., Suite 160, Roseville, CA 95661, Phone: (916) 784-9575, Fax: (916) 784-9577, Email: [email protected] For more information on Blue Point Energy go to: http://www.bluepointenergy.com/

Dr. Taylor

CONTACT: Lourdes Cruz of CruzMark, Inc. +1-916-791-1535,[email protected], for Dr. Taylor

Web site: http://www.drbobtaylor.net/

AIM Pharmakon to Introduce Next Generation of Cardiovascular Health and Longevity Products With New Premium Quality Natural Liquid Concentrates

NEW YORK, July 28 /PRNewswire/ — AIM Pharmakon, Inc. (API), a New York-based company, announced today the introduction of the next generation of high-level cardiovascular health and longevity products starting with Aim Endurance(TM), a new premium quality liquid concentrate. The product will be available the first week of August 2008.

“Unhealthy diet, lifestyle-related stress, stage of life, and genetic predispositions are among the contributing factors of cardiovascular diseases. These risk factors are escalating the related incidences at an alarming pace. There is a distinct need for integrative and holistic approaches to address the effects of these triggers. Cardiovascular disease develops either with stealth or sudden onset and is often debilitating, affecting the quality of life or fatal. Aim Endurance(TM) in a liquid concentrate matrix is a product of choice for cardiovascular health and longevity due to its efficacy, ease of intake, high bioavailability, and palatability,” commented Vijay Puntambekar, President of AIM Pharmakon.

Aim Endurance(TM) contains Toyo-FVG(TM) (from Toyo Bio-Pharma), which has exceptionally high OPC content contributing to elevated ORAC H Rate: 12,784 (micromoleTE/g). Toyo-FVG(TM) has high Superoxide Elimination Activity (Units/gram): 2.6×105 (Japan Food Research Laboratory). Additionally, human clinical studies demonstrate that Toyo-FVG(TM) prevents oxidative stress of DNA. The biomarker 8-hydroxy-2-deoxyguanosine (8-OHdG) is an oxidized metabolite of deoxyguanosine excreted after digestion of DNA repairing enzyme. Measurement of 8-OhdG is an effective method in determining the oxidative stress at DNA level. Decrease in 8-OHdG concentration by Toyo-FVG(TM) indicated that it possessed inhibitory effect on the oxidative damage of DNA. It helps to reduce serum lipid level and lower bad cholesterol. There is a supporting evidence of impact on reduction on idiopathic swelling, improved peripheral microcirculation, rapid athletic recovery and decreased hypertension. It may also help in myocardial microcirculation. Decrease in lactic acid values, suppression of muscle damage and an increase in blood mobility all indicate that the product possesses great capability for athletic recovery after extended exertion. The product has a low glycemic value and is suitable for diabetic people. By neutralizing free radicals — the by-product of cell metabolism, stress, busy lifestyle choices — it can support the entire circulatory system and rejuvenate overall health. The product contains exclusive high-end, premium quality ionized mineral complexes from Japan in the form of a proprietary bioenhancing mix. The synergistic balance of mineral and soluble fiber helps achieve the optimum cardiovascular health advantages of Aim Endurance(TM) with regular diet and exercise.

“The development of the innovative products for the baby-boomer generation and seniors was strategically planned,” added Vijay. “While developing the products for seniors, our scientists formulated the concentrate matrix that is convenient for ingestion, resulting in better product compliance. Our core competence and aim is: Formulating Innovation,” he continued. The product line will be available through the physician care market and also available through select quality health stores.

AIM Pharmakon develops and markets preservative-free, natural products. The company was incorporated in 2005 and has in-house R&D and manufacturing capability. The company is also launching an ultra-premium, completely natural and preservative-free cosmetic product line in the Japanese market in the fourth quarter of 2008. It will include specialty hair care and facial skin care products. AIM Pharmakon (http://www.aimpharmakon.com/) offers diversified services in product development, marketing, and project management in the areas of pharmaceuticals, natural products, consulting, and has offices in Long Island, New York, Tokyo and Mumbai. Recently, API and Global Life Science, LLC USA (http://www.globallifescienceusa.com/) agreed to have a strategic partnership in marketing and project development and management.

   For further information, please contact:    Vijay Puntambekar   631-506-8430   [email protected]    

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

AIM Pharmakon, Inc.

CONTACT: Vijay Puntambekar of AIM Pharmakon, Inc., +1-631-506-8430,[email protected]

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

Exforge(R) Helps Nearly Twice As Many Patients Control Their High Blood Pressure Compared to Amlodipine Alone

EAST HANOVER, N.J., July 28 /PRNewswire/ — New data show Exforge(R) (amlodipine and valsartan), a single-pill combination of the world’s leading high blood pressure medicines Diovan(R) (valsartan) and amlodipine, gets nearly twice as many patients with high baseline blood pressure to a healthier blood pressure goal compared to amlodipine alone.

Results of a study in patients with baseline systolic blood pressure greater than or equal to 160 mmHg published in The Journal of the American Society of Hypertension, showed that 51.8% of patients on Exforge achieved systolic blood pressure control, defined as

The primary endpoint of the study was the change from baseline Mean Sitting Systolic Blood Pressure (MSSBP) at week four. Results showed that on average, patients on Exforge experienced a significant 30.1 mmHg reduction in systolic blood pressure compared to a 23.5 mmHg reduction in patients on amlodipine alone.

In the same study, patients with systolic blood pressure greater than or equal to 180 mmHg treated with Exforge experienced significant systolic blood pressure reductions of up to 40.1 mmHg, compared with 31.7 mmHg for those treated with amlodipine alone. High blood pressure is estimated to affect one in three adults in the US — approximately 73 million adults.

“All patients who received Exforge achieved significant blood pressure drops, with the bigger blood pressure drops of up to 40 mmHg being seen in those patients with a higher baseline level,” said Maurizio Destro, MD, the lead investigator from the Azienda Ospedaliera di Pavia in Italy. “In addition, Exforge was well tolerated which is important for patients in managing their blood pressure.”

Treatment guidelines recommend that patients with high blood pressure greater than or equal to 160/100 mmHg should be considered for a combination of two medicines from different drug classes.

Exforge also demonstrated significantly better blood pressure-lowering efficacy than amlodipine alone across certain difficult-to-treat patient groups, including the elderly (over 65 years), obese people and those with diabetes.

“Exforge has shown significant benefit in difficult-to-treat patients with high blood pressure,” said Marjorie Gatlin, MD, Vice President and Head of Cardiovascular and Metabolism Medical Franchise, US Medical and Drug Regulatory Affairs at Novartis Pharmaceuticals Corporation. “This is important as high blood pressure remains a highly prevalent condition and underlying cause of cardiovascular disease.”

The study was designed to investigate and compare the efficacy and safety of Exforge with amlodipine in patients with stage 2 high blood pressure (a more severe stage of the disease, with systolic blood pressure between 160 and 200 mmHg). It was a randomized, double-blind, multi-center parallel-group study carried out in 75 centers across Europe and the US. In total, 646 patients were randomized to receive treatment with Exforge 5-10/160 mg (n=322) or amlodipine 5-10 mg (n=324). Demographic and high blood pressure baseline characteristics were similar for both groups.

Overall blood pressure measurements consist of two values, both expressed in millimeters of mercury (mmHg). The first is the systolic blood pressure when the heart beats and the second is the diastolic pressure when the heart relaxes between beats. In this study, overall blood pressure control rates (

Novartis is focused on improving the lives of the hundreds of millions of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programs to treat high blood pressure and diabetes — both major public health issues.

The core of the Novartis portfolio is its cardiovascular medications for the treatment of high blood pressure and diabetes. These include the world’s most-prescribed angiotensin receptor blocker, the first and only approved direct renin inhibitor, and a single pill combining two leading high blood pressure medicines. Novartis is dedicated to helping physicians and patients improve cardiovascular and metabolic health through effective medicines, programs and an ongoing commitment to research.

About Diovan, Tekturna(R) (aliskiren), and Exforge

Diovan, Tekturna, and Exforge are prescription medications for adults used to treat high blood pressure. They can be used alone or in combination with other high blood pressure medications. It is not known whether additional blood pressure reductions are present when Tekturna is used in combination with ACE inhibitors or beta blockers.

Important Considerations:

IMPORTANT WARNING: Taking Diovan, Tekturna or Exforge during pregnancy can cause injury and even death to your unborn baby. If you get pregnant, stop taking Diovan, Tekturna or Exforge and call your doctor right away. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.

Do not take Diovan, Tekturna or Exforge if you are allergic to any of the ingredients in the product you are taking. Additionally, do not take Tekturna if you take cyclosporine. If you take Tekturna or Exforge, tell your doctor if you have kidney problems.

If you take Tekturna and have an allergic reaction involving swelling of the face, lips, throat, and/or tongue, which may cause difficulty in breathing and swallowing, stop taking Tekturna and contact your doctor immediately.

The most serious side effect with Diovan, Tekturna and Exforge is low blood pressure, and additionally with Diovan kidney problems.

In clinical studies, diarrhea was experienced by more patients taking Tekturna than patients taking a sugar pill. Other less common reactions to Tekturna include cough and rash. Side effects that occur more frequently with Exforge than placebo are swelling of the hands, ankles, or feet; nasal congestion or sore throat; head or chest cold; and dizziness.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “will,””may,””potential,””could,” or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Exforge or regarding potential future revenues from Exforge. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Exforge to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Exforge will be approved for any additional indications or labelling in any market. Nor can there be any guarantee that Exforge will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Exforge could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com/.

Novartis Pharmaceuticals Corporation

CONTACT: US: Novartis Media Relations, Julissa Viana, +1-862-778-2648(direct), or +1-862-926-9449 (cell), [email protected], or SherryPudloski, +1-862-778-1271 (direct), or +1-917-620-4446 (cell),[email protected], both of NPC Communications; Novartis InvestorRelations, Ruth Metzler-Arnold, +41-61-324-9980, or Katharina Ambuehl,+41-61-324-5316, or Pierre-Michel Bringer, +41-61-324-1065, or John Gilardi,+41-61-324-3018, or Thomas Hungerbuehler, +41-61-324-8425, or Isabella Zinck,+41-61-324-7188; Central phone: +41-61-324-7944, Fax: +41-61-324-8444,[email protected]; North America Office, or Richard Jarvis,+1-212-830-2433, or Jill Pozarek, +1-212-830-2445, or Edwin Valeriano,+1-212-830-2456, Fax: +1-212-830-2405, [email protected]

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

Island of Sun, Sea and Surgery

By Kate Foster

DOZENS of Scots seeking cut-price cosmetic surgery are making the trip to Cyprus, lured by low prices at private clinics which also offer recuperation by the Mediterranean.

The number of patients seen at one clinic has doubled in the past year with others also reporting a rise in Scots undergoing tummy tucks, breast implants and liposuction.

Cosmetic surgery experts said yesterday that the island was one of the fastest-growing destinations for medical tourism because of its low prices and high standards of care.

Average prices in clinics on the island are two-thirds of those charged by UK clinics, and also include a two-week recuperation period in the sun, flights and transfers.

Cosmetic surgery holidays are becoming increasingly popular to destinations such as India, Poland and South Africa. But Keith Pollard, managing director of Treatment Abroad, a website for patients considering treatment outside the UK, said Cyprus was closer to home and also offered a holiday in the sun.

He said: “Cyprus is a fast-growing, up-and-coming destination. It has a nice climate, good English speakers, an advanced healthcare system with good accreditation that you would hope for in any EC country.”

Several firms have sprung up on the island in recent years, offering cosmetic surgery and recuperation packages to UK patients.

A marketing campaign by the island’s tourist board, promoting Cyprus as a destination for medical procedures, was also launched last year.

Some 60 per cent of the island’s private hospitals now treat patients from overseas with cosmetic surgery the most common type of procedure.

Hellyn Fairbrother, who runs BFN Cosmetic Tourism in Kyrenia, Northern Cyprus, said that when she launched her service five years ago she had just one Scottish client. But last year she saw 17 and this year she expects around 30.

Fairbrother uses surgeons who charge less than British doctors because of the relatively cheaper cost of living in Northern Cyprus.

She said: “Our hospitals don’t have MRSA or C Difficile and they don’t use contract cleaners. I have had a tummy tuck myself here so I have been through what the clients are going through.

“The number of clients from Scotland is growing year on year. It is largely a word-of-mouth thing and we are hoping to expand even further.

“I think that for many years Scottish women didn’t really take great care of themselves but now they are really taking stock. We have a lot of older women who come to us. We have very stringent health tests but if they pass them they can have the surgery.”

Her firm charges around two-thirds of UK prices for cosmetic procedures including the cost of flights, transfers, medications, follow-up checks and a two-week stay in a local four-star hotel.

This amounts to around GBP 3,600 for a tummy tuck compared with up to GBP 5,200 in the UK and GBP 3,900 for breast implants compared with up to GBP 5,000 in the UK.

Susan O’Connell, who runs tourism firm Cosmedicare4u in the island’s capital, Nicosia, said she had seen a similar rise in Scottish patients and now also treats around 30 each year.

“The prices in the UK are outrageous and we are seeing quite a few patients from Scotland,” she said.

“I get patients returning for more treatment and I get a lot of patients having combined procedures such as a tummy tuck, face lift and breast implants.”

One patient, Patricia McAuley, from East Kilbride, had a tummy tuck at the age of 69 with BFN Cosmetic Tourism after being unhappy with her body for years.

McAuley, now 72, said she was delighted with the results of the procedure: “I went over to the clinic and said I wanted them to do the operation before I changed my mind. But now my stomach is flat, I have dropped two dress sizes and it has stayed that way.”

(c) 2008 Scotland on Sunday. Provided by ProQuest Information and Learning. All rights Reserved.

Broward Healthy Start Coalition and MomCare Program in Conjunction With Community Partners Host 1st Annual Countywide Baby Shower (August 1, 2008)

FORT LAUDERDALE, Fla., July 28 /PRNewswire/ — Broward Healthy Start Coalition, the MomCare Program and Community Partners will host their inaugural countywide baby shower for expectant and new parents, Friday August 1, 2008 from 11:00 am – 3:00 pm at Central Broward Regional Park, 3700 NW 11th Place, Lauderhill, FL located on the corner of Sunrise Blvd & State Road 7.

Parents are encouraged to attend and receive education and information about family health, prenatal health and infant child care. This is a “Shower to Empower”. Eligible participants will receive car seats, baby bags and lots of other giveaways in addition to free lunch and activities for the kids.

Broward Healthy Start Coalition is one of eight Healthy Start Agencies, statewide, that was selected to participate in the Black Infant Health Practice Initiative to study the high incident of black infant deaths in the state of Florida. In April, Healthy Mother’s, Healthy Babies, hosted a countywide Call-to Action meeting at the African American Research Library and Cultural Center to enlighten community partners and other stakeholders about the startling statistics involving black fetal and infant deaths and assist with educating the community about prevention, and services that are available for expecting and new mothers. As a part of the Black Infant Health Practice Initiative, Broward Healthy Start Coalition has introduced the Care Campaign, to educate the Broward County community about the importance of being a healthy mother, which will result in a healthy baby.

The inaugural “Shower to Empower” is the beginning of the community education program that will include community workshops, and other programs that will educate the community about Interconceptional Care, prenatal Care, Dental Care, and Fatherhood initiatives to improve the lives of black families, and lower the black fetal and infant mortality rates in Broward County.

The “Shower to Empower” is being presented in part by Broward Healthy Start Coalition, Inc., Florida Department of Health, MomCare, Black Infant Health Practice Initiative, Staywell, Children Services Council of Broward County, Healthy Families Broward, Healthy Mothers, Healthy Babies Coalition of Broward County, Memorial Healthcare System, Broward County Parks & Recreation, JK Harris Publications, Inc., HealthEase

For information about the Countywide Baby Shower, or to get involved with the Black Infant Health Practice Initiative, contact Annette Gardiner at the Broward Healthy Start Coalition office at (954) 563-7583.

Broward Healthy Start Coalition Inc. is a non-profit organization whose mission is to ensure that services are available to promote and protect the health and well-being of pregnant women and children from birth to three years of age. We strive to accomplish our mission through strong community partnerships with private and public sectors, maternal and child health providers, and consumers of services. Our goal is to reduce infant mortality and morbidity, to improve pregnancy outcomes, and to enhance the health and health and development of children.

   Contact: The Marome Agency            Anthony Jackson            (954) 765-1995            [email protected]  

Broward Healthy Start Coalition Inc.

CONTACT: Anthony Jackson, The Marome Agency, +1-954-765-1995,[email protected]

Settlement Reached in Lawsuit Against Baltimore Hospital and Doctor

By Danny Jacobs

A Dundalk woman reached a confidential settlement earlier this month in a medical malpractice lawsuit against her doctor and a Baltimore hospital, claiming they did not properly diagnose a heart ailment.

Donna Jankowiak, Dr. Diaa Mikhail and Franklin Square Hospital Center came to an agreement July 18 during the fifth day of a trial in Baltimore County Circuit Court before Judge Dana M. Levitz. Joyce M. Notarius of Cadeaux, Taglieri & Notarius P.C. in Washington, D.C., who represented Jankowiak, declined to comment because the settlement was confidential.

Jankowiak felt “arm pain radiating to her chest” the morning of Nov. 19, 2004, and went to see Mikhail, according to her complaint filed in April 2007. According to the complaint, Mikhail performed an electrocardiogram, or EKG, which he found normal, and prescribed her medication.

After Jankowiak’s pain continued, she went to the emergency room at Franklin Square where another EKG was performed before 1 p.m. and again found to be normal, according to the complaint. It was only when a second hospital EKG performed six hours later came back abnormal that a cardiologist was called to treat Jankowiak, according to the complaint.

Jankowiak suffered a myocardial infarction — an interrupted supply of blood to the heart — causing permanent heart damage and leading to additional medical treatments, including surgeries, the complaint stated.

Trace G. Krueger of Baxter, Baker, Sidle, Conn & Jones P.A. in Baltimore, who represented Mikhail, and David A. Levin of Wharton Levin Ehrmantraut & Klein P.A. in Annapolis, who represented Franklin Square, did not return calls seeking comment.

Originally published by Danny Jacobs.

(c) 2008 The Daily Record (Baltimore). Provided by ProQuest Information and Learning. All rights Reserved.

InCode BioPharmaceutics, Inc. Announces Key Safety Data for rC3-1: A New Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

SAN FRANCISCO, July 28 /PRNewswire/ — InCode BioPharmaceutics, Inc. today announced favorable results of its preclinical primate toxicity study demonstrating no adverse events and reduction of key markers of potency for its lead drug candidate, rC3-1.

In the study, escalating doses of rC3-1 were delivered directly to the pulmonary artery of non-human primates. The lung is considered to be the target organ for potential toxicity. All doses recorded no clinically significant changes in direct systemic blood pressure, pulmonary arterial pressure, lung resistance and dynamic compliance, respiratory rate, tidal volume and airway pressure.

“rC3-1 was well tolerated and shows strong indications that it could be a new treatment alternative for complement mediated diseases,” commented Bill St. John, CEO of InCode. “The aggressive design of this study supports additional studies of this drug candidate. Complete results will be presented at the XXII International Complement Workshop in Basel, Switzerland, September 28, 2008.”

rC3-1 is being developed for the treatment of the rare chronic blood disease Paroxysmal Nocturnal Hemoglobinuria (PNH) and Age-related Macular Degeneration. InCode plans to begin PNH clinical trials in the near future. The only treatment currently available for PNH patients is an anti-C5 antibody Soliris(TM) (eculizumab) sold by Alexion Pharmaceuticals, Inc.

rC3-1 promotes the enzymatic partial depletion of C3, the hub of the complement cascade. Complement protein C3 is the master regulator of complement protein C5 that mediates red blood cell damage in PNH patients and tissue injury in Macular Degeneration animal models.

InCode BioParmaceutics, Inc. is an emerging biotechnology company that is developing a new class of recombinant proteins for the controlled depletion of complement protein C3. The therapeutic potential for C3 depletion has been demonstrated in Macular Degeneration, Asthma, Rheumatoid Arthritis, and autoimmune and inflammatory disease models. C3 depletion has also been demonstrated as a useful adjuvant to surgery, transplantation and cancer therapy. InCode is pursuing a progressive clinical development plan focused on proof of concept trials.

InCode BioParmaceutics, Inc.

CONTACT: William St. John, President and CEO of InCode BioPharmaceutics,Inc., +1-808-268-9803, [email protected]

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

Controversy About Lack of Placebo Group Decline in Alzheimer’s Clinical Trials

CHICAGO, July 28 /PRNewswire-USNewswire/ — Lack of measureable decline in memory and thinking processes among placebo groups in Alzheimer’s disease clinical trials might reduce the ability to show the effectiveness of new Alzheimer therapies, according to new research reported today at the 2008 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD 2008) in Chicago.

Alzheimer clinical trials seek to show that those who received the treatment improved over the course of the study when compared to those who received the placebo, or that they got worse to a lesser degree. A complication that is emerging in Alzheimer clinical trials is the perception that participants with Alzheimer’s in the placebo arms of the trials are showing less worsening over the time period of current studies. It has been speculated that this may be due to:

— Inadequate sensitivity of the standard scales used for measuring cognition in these trials.

— Differences in disease severity and co-existing medical conditions between the populations being recruited now compared with previous trials.

— The relatively common use of the currently approved Alzheimer drugs (cholinesterase inhibitors and memantine) by populations involved in the clinical trials.

“In Alzheimer trials, if the placebo group does not worsen over the course of the trial then it might be very difficult, or even impossible, to show that a drug is effective,” said William Thies, PhD, vice president for Medical & Scientific Relations at the Alzheimer’s Association.

Two scientific presentations from ICAD 2008 address the issue head on — one through a review of 87 Alzheimer clinical trials conducted between 1991 and 2005, and the second by specifically looking at trials of the drug donepezil from 1990 to 1999.

Analysis of Multiple Studies Reveals Process to Ensure Placebo Group Decline

Lon S. Schneider, MD, professor of psychiatry and neurology at the University of Southern California Keck School of Medicine, and professor of gerontology at the USC Leonard Davis School of Gerontology and colleagues searched published and unpublished sources for six months or longer randomized, double-blind, placebo-controlled Alzheimer clinical trials. They found 103 trials conducted between 1991 and 2005 and obtained information from 87. From these they extracted information about trial size, countries, number of sites, treatment allocation ratios, enrollment dates, age, gender, and scores on two standard measures of cognition — the Mini-Mental State Examination (MMSE) and the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog).

The researchers found no changes in amounts of cognitive decline across the 15-year time period of the trials. They found that smaller placebo groups were associated with less likelihood of cognitive worsening over the course of the trial. Placebo group sample sizes less than 100 had a 37 percent chance of not showing significant change, while samples greater then 200 all showed significant worsening at six months. In 12-month studies, 95 percent of placebo group sample sizes greater then 100 showed significant decline.

Several other factors were found to be associated with whether or not there was cognitive decline in the placebo group. Studies with non-English speaking trial sites were associated with less cognitive worsening over the course of the clinical trial. Use of more frequent cognitive assessments reduced the amount of variance in the amount of worsening. Use of cholinesterase inhibitors was not associated with less cognitive decline during clinical trials.

“Experts have no need to worry that people with Alzheimer’s in clinical trials are less likely to worsen than they have before, or that cholinesterase inhibitors are lessening decline of placebo treated patients in recent trials,” Schneider said. “Based on our analysis, the most reliable approach to maximize the likelihood for demonstrating efficacy is to have a placebo group size greater than 200 and to use the ADAS-cog at least four times and in English.”

Scientific Review of Donepezil Trials Shows Slowing Rates of Placebo Group Decline

Professor Roy Jones, Director of RICE — The Research Institute for the Care of Older People, based at the Royal United Hospital in Bath, England, and colleagues conducted a meta-analysis using individual patient data from randomized, double-blind, placebo-controlled studies of donepezil (Aricept) for Alzheimer’s between 1990 and 1999. The work stemmed from discussions and analyses undertaken through an expert working group initiated and funded by Eisai and Pfizer, makers and marketers of donepezil.

“Our results indicate that patients with Alzheimer’s entering the later clinical trials appear to be experiencing a slower rate of decline in memory and thinking processes,” Jones said. “These observations are potentially important for the future design of clinical trials in people with Alzheimer’s. For example, it may be necessary to conduct longer duration research studies — more than 24 weeks — to ensure any effects of treatment can be fully evaluated.”

Data were available from 3,403 patients who participated in 13 randomized, double-blind, placebo-controlled Alzheimer trials. Data were grouped according to the year of initiation of the trials. Group 1: studies initiated in 1990-1994; Group 2: studies initiated in 1996-1999. This cut-off was associated with the timing of donepezil registration. Changes from baseline MMSE and ADAS-cog scores up to week 24 were compared between groups 1 and 2 for placebo only, and then between donepezil and placebo.

Decline on the MMSE from baseline to week 24 was significantly greater among placebo patients in group 1 (-1.28 points) compared with group 2 (-0.56 points; P = 0.024). Placebo decline on the ADAS-cog was also greater in group 1 than group 2, but the difference was nonsignificant.

About ICAD

The 2008 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD 2008) is the largest gathering of international leaders in Alzheimer research and care ever convened. At ICAD 2008, more than 5,000 researchers from 60 countries will share groundbreaking information and resources on the cause, diagnosis, treatment and prevention of Alzheimer’s and related disorders. As a part of the Association’s research program, ICAD serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community. ICAD 2008 will be held in Chicago at McCormick Place, Lake Side Center from July 26-31.

About the Alzheimer’s Association

The Alzheimer’s Association, the nonprofit world leader in Alzheimer’s research and support, is the first and largest U.S. voluntary health organization dedicated to finding prevention methods, treatments and an eventual cure for Alzheimer’s. For more than 25 years, the donor-supported Alzheimer’s Association has provided reliable information and care consultation; created supportive services for families; increased funding for dementia research; and influenced public policy changes. For more information, call (800) 272-3900 or visit http://www.alz.org/.

— Lon S. Schneider. “No secular trend and high variability for ADAS-cog change among placebo groups from clinical trials.” (Funders: None)

— Roy Jones. “Variation in placebo decline across a decade of Alzheimer’s disease trials.” (Funders: Eisai, Pfizer)

All materials to be presented at the 2008 Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD 2008) are embargoed for publication and broadcast until the date and time of presentation at the International Conference on Alzheimer’s Disease, unless the Alzheimer’s Association provides written notice of change of date/time in advance.

Alzheimer’s Association

CONTACT: Alzheimer’s Association media line: +1-312-335-4078,[email protected], ICAD 2008 press room, July 27-31: +1-312-949-3253

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

Barrier Therapeutics Introduces Dual-Component Xolegel CorePak(TM) for Seborrheic Dermatitis

Barrier Therapeutics, Inc. (NASDAQ: BTRX) announced today the introduction of Xolegel CorePak(TM) for the treatment of seborrheic dermatitis. Now, patients with this chronic skin condition need only one prescription to get quick itch relief and to safely manage the overall condition long term.

The two products in Xolegel CorePak are new Xebcort(TM) Gel, a 1% hydrocortisone gel, and Xolegel(R) (ketoconazole, USP) Gel, 2%. Xebcort Gel provides quick symptom relief and is presented as a 0.8 ounce tube designed for short term use to relieve itch. Xolegel CorePak contains 45 grams of Xolegel Gel provided in three 15 gram tubes. In a long-term safety trial with Xolegel Gel, patients remained symptom free for up to 8 weeks post-treatment.

“By providing the hydrocortisone and ketoconazole gels separately in one prescription, Xolegel CorePak encourages patients to comply with their physician’s recommendations to better manage this chronic and common inflammatory skin condition,” explained Al Altomari, Chief Executive Officer of Barrier Therapeutics.

More About the Xolegel Family of Products

With the addition of Xolegel CorePak, there is now a family of Xolegel products available to treat the variety of seborrheic dermatitis patient types.

Xolegel Gel is a cosmetically elegant treatment which offers powerful relief for seborrheic dermatitis of the face and body in immunocompetent adults and children 12 years of age and older. Xolegel Gel is a patented topical formulation of 2% ketoconazole in a translucent, non-greasy gel. Xolegel Gel applies smoothly and dries clear. With its unique gel formulation, Xolegel Gel provides patients with a dosing regimen of a once daily application for only 14 days, thus reducing by approximately 75 percent the number of applications required by other topical antifungal seborrheic dermatitis therapies. Xolegel Gel was approved by the FDA in July 2006 and is the first and only FDA-approved prescription gel formulation of ketoconazole.

Xolegel Duo(TM), available by prescription, also consists of 45 grams of Xolegel (ketoconazole, USP) Gel, 2% provided in 15 gram tubes, and one 1.7 ounce bottle of Head & Shoulders(R) (pyrithione zinc 1%) anti-dandruff shampoo. It is designed to provide a more complete treatment option for effectively managing seborrheic dermatitis by providing a prescription gel formulation of ketoconazole for the face and body plus a medicated shampoo for the scalp in one convenient package. All Xolegel products are covered under the company’s Patient 1st Program. The program allows most commercial insurance patients to receive their prescription for one $10 copay. For additional information on the entire family of Xolegel products, visit www.xolegel.com

About Seborrheic Dermatitis

Seborrheic dermatitis is a common inflammatory skin condition characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and torso. Seborrheic dermatitis affects approximately three to five percent of the U.S. population, or 8.5 million people. An estimated 90% of seborrheic dermatitis patients reportedly have affected areas on the scalp as well as on the face and/or body. There is no known cause, cure or way of preventing seborrheic dermatitis but it can be effectively managed. Traditional prescription therapies for this condition have consisted primarily of shampoos, topical antifungal creams and topical steroids that typically require two or more applications per day over periods of up to four weeks to be effective.

About Barrier Therapeutics

Barrier Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of products in the field of dermatology. Barrier Therapeutics currently markets three prescription pharmaceutical products in the United States: Xolegel(R) (ketoconazole, USP) Gel, 2%, for seborrheic dermatitis; Vusion(R) (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment, for diaper dermatitis complicated by documented candidiasis; and Solage(R) (mequinol 2.0%, tretinoin 0.01%) Topical Solution, for solar lentigines. Barrier Therapeutics has other product candidates in various stages of clinical development for the treatment of a range of dermatological conditions, including onychomycosis, psoriasis, acne, skin allergies, and superficial fungal infections. The company is headquartered in Princeton, New Jersey and has a wholly-owned subsidiary in Geel, Belgium. More information about Barrier Therapeutics can be found on its corporate website at: www.barriertherapeutics.com. Xolegel, Vusion, Solage, Xolegel CorePak and Xolegel Duo are all trademarks of Barrier Therapeutics, Inc.

Safe Harbor Statement

In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the “Safe Harbor” provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Barrier’s current expectations or forecasts of future events. Barrier’s performance and financial results could differ materially from those reflected in these forward-looking statements due to the marketplace acceptance of Barrier’s products, Barrier’s ability to execute its commercial and clinical strategy, the decisions of regulatory authorities, the results of clinical trials, and strategic decisions regarding its pipeline, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 which is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Barrier undertakes no obligation to update publicly any forward-looking statement.

 Contact: Lazar Partners Ltd. Erich Sandoval, Public Relations (212) 867-1762  Barrier Therapeutics, Inc. Michael Laferrera VP, Marketing & Commercial Planning (609) 945-1242  

SOURCE: Barrier Therapeutics, Inc.

Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants

CLINTON, N.J., July 28 /PRNewswire/ — Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and severity of delayed graft function (DGF) in patients undergoing solid organ transplantation.

Ralf Rosskamp, M.D., Executive Vice President of Research and Development for Ikaria, commented, “The designation of orphan drug status is a significant step that will greatly facilitate the development of inhaled carbon monoxide as a potential treatment for DGF in solid organ transplants. Pre-clinical data has demonstrated that the compound may possess anti-inflammatory, cytoprotective and anti-apoptotic properties that could potentially improve ischemic-reperfusion mediated malfunction in transplanted organs and allow for an important advance in solid organ transplantation. We look forward to advancing our research of inhaled carbon monoxide as part of our overall goal of delivering new therapies for the underserved critical care market.”

Ikaria is currently conducting a single-blind, placebo controlled, dose-escalating Phase 2 study of inhaled carbon monoxide in patients receiving renal transplants. The primary endpoint of the study is to evaluate the safety and tolerability of increasing carbon monoxide dose levels when administered as an inhaled gas to kidney transplant patients over the course of one hour in an acute hospital setting. The study was initiated in August 2007 and is currently enrolling patients.

Delayed graft function following kidney transplantation represents an unmet medical need with considerable health burdens. DGF occurs when the kidney does not function sufficiently after transplantation, often requiring dialysis to support the patient. The underlying cause of DGF is ischemia-reperfusion injury, which occurs when blood flow is returned to damaged tissue, leading to an inflammatory response that could result in poor organ function. In the United States, approximately 28,000 patients received a solid organ transplant in 2007.

Orphan drug designation provides an accelerated FDA review process, tax advantages and a seven-year period of market exclusivity in the US upon product approval.

About Ikaria Holdings, Inc.

Ikaria Holdings, Inc. is a fully integrated biotherapeutics company focused on the development and commercialization of innovative pharmaceutical and biological products and drug/device combinations for the critically ill in the hospital and ICU setting. The company’s product, INOmax(R) (nitric oxide) for inhalation, is an FDA-approved drug for the treatment of hypoxic respiratory failure in term and near-term newborns. The drug also is approved by regulatory authorities and used in Canada, Europe, Australia and Latin America. In addition to the ongoing clinical development as well as the marketing and selling of its INOmax product, Ikaria is engaged in a number of Phase 2 trials with Covox(R) (carbon monoxide) for inhalation and Phase 1 trials with hydrogen sulfide (H2S) for various critical care indications. Ikaria has a staff of approximately 400 people and is headquartered in Clinton, NJ, with research facilities in Seattle, WA and Madison, WI and manufacturing in Port Allen, LA. For more information on Ikaria, please visit http://www.ikaria.com/.

CONTACTS: Matthew Bennett, Ikaria, (908) 238-6673, [email protected]; or Jason Rando, The Ruth Group, 646-536-7025, [email protected]

Ikaria Holdings, Inc.

CONTACT: Matthew Bennett of Ikaria, +1-908-238-6673,[email protected]; or Jason Rando of The Ruth Group for Ikaria,+1-646-536-7025, [email protected]

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

Lonely Divorcee Plied Girls With Drugs and Drink

By Neil Hunter

A LONELY divorcee who plied teenage girls with alcohol and drugs at his home has been jailed for two years.

Grant Glaister, 47, was told by a judge yesterday: ?The public will be outraged if I take the step of a non-custodial sentence. ? Teesside Crown Court was told how two 16-year-olds visited Glaister?s home in Ferryhill to take cannabis and amphetamine.

It was suggested that Glaister ? three-timesmarried, but living alone last November ? was flattered by their presence at his home.

During his trial, it was made clear there was no sexual motive for inviting the girls, and Glaister made no money from the drugs.

Rodney Ferm, mitigating, said that Glaister simply gave the drugs to the girls when they called at his home.

MrFerm said the former plasterer, a long-term user of cannabis and heavy drinker, was lonely and was ?showing off?.

Judge Les Spittle said:

?There is no question here of you using alcohol and drugs to entice those young girls for other reasons.

?You were giving those young girls drugs, but you didn?t face up to that and you didn?t accept your responsibility, and had a trial. ? Glaister, of Gladstone Terrace, admitted possessing Class B and Class C drugs, but denied supplying them to the teenagers.

He was convicted after a trial of four counts of supplying amphetamine and cannabis after the jury heard the girls? accounts.

Judge Spittle told Glaister he would receive no credit for forcing the youngsters to give evidence in front of the court.

He added: ?A lthough itmay have been very flattering for you to have these young girls coming to your premises, it was the supply of drugs that brought them.

?Those who are users ought to know the potential danger of drugs themselves and have a responsibility to warn young people. You should not be encouraging, you should be discouraging.

?You should be using your experience of years of drugtaking to dissuade them, but you did the opposite. ? Mr Ferm failed in an attempt to persuade the judge to impose a suspended prison sentence, so Glaister could continue to support his son?s business.

(c) 2008 Northern Echo. Provided by ProQuest Information and Learning. All rights Reserved.

Corgenix Announces Collaboration With SpectraCell Laboratories

DENVER, July 28 /PRNewswire-FirstCall/ — Corgenix Medical Corporation (BULLETIN BOARD: CONX) , a worldwide developer and marketer of diagnostic test kits, has announced its collaboration with SpectraCell Corporation, a Houston, Texas-based specialized clinical testing laboratory company providing cardiovascular and nutritional testing nationwide.

Under terms of the relationship Corgenix’ AspirinWorks(R) product will be used to assess aspirin effect as part of SpectraCell’s extensive cardiovascular risk assessment services.

“SpectraCell is increasingly recognized as a major lab in the U.S. for individualized cardiovascular testing and risk assessment. Their unique approach to cardiovascular medicine provides a perfect fit for aspirin effect testing,” said Douglass Simpson, Corgenix’ President and Chief Executive Officer. “This new association, combined with their physician-directed sales force, is an important step for Corgenix, and we look forward to a long-term relationship.”

The collaboration will allow SpectraCell to take advantage of Corgenix’ unique diagnostic assay that determines the effect of aspirin on platelets in apparently healthy individuals by measuring the level of thromboxane production (aspirin’s target). The higher the levels of thromboxane, the stickier the blood platelets, and the less impact the aspirin is having. Clinical studies suggest that more than 25 percent of all patients taking aspirin are not sufficiently protected from suffering a cardiovascular event.

“This arrangement further expands our functional testing capabilities to include aspirin effect,” said Dr. Fred Crawford, VP of Operations and Technical Director at SpectraCell Laboratories. “Partnering with Corgenix helps insure that SpectraCell continues to deliver the most advanced technology and highest quality service to our physician clients nationwide.”

Physicians interested in learning more about SpectraCell’s advanced clinical testing may call 800-227-5227 or e-mail [email protected].

About Corgenix Medical Corporation

Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders, including the world’s only non-blood-based test for aspirin non-responsiveness. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network. More information is available at http://www.corgenix.com/.

About SpectraCell Laboratories

SpectraCell is a CLIA accredited laboratory that services healthcare providers nationwide by providing an innovative assessment of a patient’s nutritional and cardiovascular status. Unlike traditional serum, hair and urine tests, SpectraCell’s patented FIA(TM) (Functional Intracellular Analysis) measures how an individual’s white blood cells respond to varied environments of vitamins, minerals, amino acids and antioxidants. By evaluating the functionality of specific nutrients in a patient’s own cells, individual differences in metabolism, age, genetics, health, prescription drug usage, absorption rate or other factors are taken into consideration, opening a true “window on intracellular function.” Unlike traditional cholesterol tests, SpectraCell’s LPP(TM) directly measures both the size and number of several classes of lipoprotein particles, including critical risk factors as cited by the National Cholesterol Education Program, giving an accurate assessment of cardiovascular risk.

Statements in this press release that are not strictly historical facts are “forward-looking” statements (identified by the words “believe”, “estimate”, “project”, “expect” or similar expressions) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products and services in the marketplace, competitive factors, changes in the regulatory environment, and other risks detailed in the Company’s periodic report filings with the Securities and Exchange Commission. The statements in this press release are made as of today, based upon information currently known to management, and the Company does not undertake any obligation to publicly update or revise any forward-looking statements.

Corgenix Medical Corporation

CONTACT: William Critchfield, Senior VP and CFO of Corgenix MedicalCorp., +1-303-453-8903, [email protected]; or Dan Snyders, VicePresident and Public Relations Supervisor of Armada Medical Marketing,+1-303-623-1190, ext. 230, fax, +1-303-623-1191, [email protected], forCorgenix Medical Corporation

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

New Inter-Lakes CEO to Be Welcomed

By Lohr McKinstry, The Press-Republican, Plattsburgh, N.Y.

Jul. 28–TICONDEROGA — The community can meet and talk with new Inter-Lakes Health Chief Executive Officer Roger Masse at a welcoming reception from 2 p.m. to 5 p.m. Thursday.

Masse, whose first day on the job will be July 28, will be greeting guests after delivering introductory remarks at 3:30 p.m.

“I am looking forward to starting work and to meeting as many members of the Ticonderoga community as possible,” Masse said in a release.

“Inter-Lakes has been an integral part of Ticonderoga for 100 years now, and I believe the hospital CEO should be one of the most accessible and involved people in the community.”

Masse comes to Inter-Lakes after five years of leading Clifton-Fine Hospital in Star Lake. He replaces Kevin Haughney, who remains as chief financial officer.

He is chairman of the Northern New York Hospital Association, an offshoot of the Healthcare Association of New York State. The group meets regularly throughout the year to review common agendas and goals of the state’s rural health-care providers.

“Health care is not easy to provide anywhere, but in smaller towns it is even more important,” Masse said.

“That’s the challenge everywhere, and I am looking forward to hearing about the challenges here and working with the staff and the community to rise to those challenges.”

Masse has an master’s of business administration in healthcare management from Boston University,

Masse’s wife, Annice, is a registered nurse at Mary Imogene Bassett Hospital in Cooperstown. They have five children ranging in age from 21 to 29.

The reception will be at the Heritage Commons Residential Healthcare facility on the Inter-Lakes campus off Wicker Street. Light food and soft drinks will be available.

Inter-Lakes includes Moses-Ludington Hospital and Heritage Commons nursing home.

[email protected]

—–

To see more of The Press-Republican or to subscribe to the newspaper, go to http://www.pressrepublican.com/.

Copyright (c) 2008, The Press-Republican, Plattsburgh, 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.

Career Students Get a Taste of College

By Elizabeth Benton, New Haven Register, Conn.

Jul. 28–NEW HAVEN — Najeia Mention knows she’s headed to college.

“It’s not even a question,” she said. “My stepmom always told me ‘You’re going to college.’ It just sunk in.”

This summer, Najeia, 15, and 46 of her Career High School classmates spent three weeks studying and rooming together at Yale University, getting an advance look at the type of place they’ll be in a few years.

The Science Collaborative for Hands-On Learning and Research program, known as SCHOLAR, now in its 10th year, is a rigorous three weeks of science classes, college admissions guidance and interdisciplinary courses, including a class this year on Africa. Rising seniors also write their college application essays during the program.

All students in the tuition-free program have gone on to attend college, and two students have attended Yale. For half of the students in the program, they will be the first in their family to go to college.

Eleven years ago, Yale opened a partnership with Career, a science/ health and business/technology magnet school. At that inception, a team of educators visited Xavier University in New Orleans, a historically black Catholic university with a record of getting 97 percent of its students into medical school. The team looked at Xavier’s feeder high schools and noticed a trend, that almost all of their students were attending summer programs.

From that trip, SCHOLAR was born.

“The original intent was to give students a nugget of what students would be doing the following year in science classes,” said Claudia Merson, director of Public School Partnerships in the Yale Office of New Haven and State Affairs.

With Career’s science teachers in class with university professors, the program also has developed into a more “organic” form of professional development, Merson said.

This year master’s students in Yale’s Urban Teaching Program also taught classes, in addition to SCHOLAR’s core science curriculum.

Erin Ahearn-Leger, 16, of West Haven, has her heart set on attending UCLA. So much so that at one point, she thought she wouldn’t apply anywhere else. “I want to go away,” she said.

She’s still got to sell her parents on the distance. “They’re thinking no,” she said, but dorm life this summer only has her more convinced.

“I got over the shared bathrooms,” said Ahearn-Leger. “Living on campus is so great. It’s like having sisters. We sit and we talk and watch movies, gossiping. … One night we stayed up and cleaned the bathroom together. It was the greatest bonding experience.”

From 6 to 9 p.m., after a full day of classes, the SCHOLAR students study together. “We can help each other along,” said Ahearn-Leger. “I learned a lot more than I thought I would.”

Beyond dorm bonding, the program’s goal is to prepare students for their high school courses in the fall. “Across the board, they go back to their classrooms and become leaders, and it’s only because they’ve been exposed,” said Mount Holyoke College chemistry professor Connie Allen.

Allen is familiar with challenges some minority and first-generation college students face when they arrive on campus through her role as an academic dean at Mount Holyoke.

This year, she will transfer those skills to the high school level at the Academic Success Program in Dallas, where she will work to prepare minority and first-generation college applicants for attendance at top-tier schools.

“It’s these students we have to tap early on, to get them excited, and also to let them know they can succeed,” she said.

The SCHOLAR program is one of two residential programs at Yale specifically for New Haven students. There also are 12 Schafer Scholars taking Yale summer courses and boarding in the dorms.

SCHOLAR is limited to Career students, but Merson said there are preliminary plans to open a similar program for Cooperative Arts and Humanities High School students, with an arts focus.

—–

To see more of New Haven Register, or to subscribe to the newspaper, go to http://www.nhregister.com.

Copyright (c) 2008, New Haven Register, Conn.

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.

Verizon FiOS TV Delivers 100 High-Definition Channels to New Yorkers – on the Network Built for HD

NEW YORK, July 28 /PRNewswire/ — America’s biggest city now has the biggest high-definition (HD) TV lineup as Verizon today begins selling FiOS TV service to customers in New York City. As FiOS TV is launched here, the service will offer 100 HD channels, giving customers more HD than Time Warner or Cablevision.

The new channel lineup will also be offered to existing FiOS TV markets in the New York metropolitan area, including parts of Long Island, the suburbs just north of the city, and northern New Jersey.

(Note: See separate Verizon news release announcing Verizon’s launch of FiOS TV in the New York metropolitan area. Also a press kit is available at http://newscenter.verizon.com/kit/fios-in-nyc/)

FiOS TV is delivered over the nation’s most advanced fiber-optic network straight to customers’ homes and businesses, providing stunning picture and sound quality, more HD and video-on-demand (VOD) choices, a broad spectrum of content diversity, and interactive features that create the ultimate home entertainment experience.

“There’s HD on FiOS and then there’s everything else,” said Shawn Strickland, vice president of video solutions for Verizon. “The immense capacity of our advanced network means FiOS TV customers receive HD signals just as Verizon receives them, without the additional compression that some cable companies perform. This means stunning picture-and-sound quality that’s noticeably better, delivered on the network that’s made for HD.”

With 100 HD channels and 400 HD VOD titles offered each month, FiOS TV customers in the New York metro area now have more than 500 HD choices available at any time. The company plans to increase its monthly HD VOD titles to more than 1,000 by year-end. In addition, Verizon will continue expanding its HD channel lineup and by year-end will offer all available major HD programming.

Customers in the New York metro area who are FiOS TV-eligible can order FiOS TV by calling their local Verizon sales office or 888-438-3467 or visiting http://www.verizon.com/fiostv online. Customers in this market can bundle FiOS TV service with FiOS Internet service and the Verizon Freedom Essentials unlimited calling plan, with packages priced as low as $94.99 per month.

FiOS TV’s New HD Channels Span Wide Diversity of Content

“Verizon’s commitment to HD leadership is about more than just the large number of HD titles we offer; it’s also about picture quality and providing a wide diversity of content,” said Terry Denson, vice president – FiOS TV content and programming. “New York City is the nation’s melting pot, and FiOS TV delivers an incredible range of programming that’s global in scope.”

FiOS TV customers in the New York metro area will get to see their favorite channels in HD, including Animal Planet, TLC, FX, USA, Bravo, TBS, History Channel, Weather Channel, Science Channel, SCI FI and Smithsonian Channel.

For those who want the best in news, Verizon is adding CNN, CNBC, Fox Business Network and Fox News Channel in HD. Viewers who watch home and leisure programming can now enjoy QVC, the Travel Channel and Planet Green, while kids can enjoy their favorite shows on the Disney Channel and Toon Disney – all in HD.

In addition, movie buffs now can get 11 new channels from Cinemax and 13 new channels from HBO in HD plus FiOS TV’s Movie Package, which now includes 13 new HD channels from The Movie Channel, Starz and Showtime, including The Movie Channel Xtra, Starz Edge, Starz Comedy, Starz Kids and Family, Showtime, Showtime Showcase, Showtime Extreme and Showtime 2.

Sports fans will also get the best programming with four new HD sports channels:

— Big Ten Network, which features top college basketball and football action.

— Versus/Golf Channel, which features live events and original programming from Versus as well as PGA Tour and additional golf coverage.

— Outdoor Channel 2, which provides programming that promotes traditional outdoor activities like fishing, hunting and shooting sports.

— World Fishing Network, which provides recreational and sport fishing enthusiasts with an entertaining and comprehensive lineup that covers a wide range of programming.

New Standard-Definition Channels, Including Multicultural Content

In addition to the new HD content, Verizon has launched 7 new standard-definition channels in the New York metro area. New content includes RFD TV, Reelz, Current TV, Veria TV, WAPA TV and more. Verizon also is now offering a new standard-definition sports channel with Setanta Sports, a premium channel dedicated to bringing European and International soccer and rugby to U.S.-based fans. Currently, no other cable provider offers Setanta.

Verizon also soon will offer New York metro area customers 14 new multicultural channels, including leading channels for Arabic, Portuguese and Russian audiences, among others. These new channels continue to make FiOS TV an outlet for emerging and independent networks to showcase their diverse programming.

This content comes from WorldTV, a division of content management and delivery company GlobeCast, which previously signed a distribution deal with Verizon for top-tier international channels. The new GlobeCast WorldTV international television channels include MBT (Arabic), RTPI (Portuguese) and RTR Planeta (Russian). In addition to the WorldTV content, Verizon will also offer Filipino channel GMA Pinoy TV.

Verizon is in the process of launching new content in each of its FiOS TV markets, with many new channels already available in Oregon and Indiana. During the next few months, Verizon will be rolling out new content, region by region, in areas where FiOS TV is available.

Verizon Communications Inc. , headquartered in New York, is a leader in delivering broadband and other wireline and wireless communication innovations to mass market, business, government and wholesale customers. Verizon Wireless operates America’s most reliable wireless network, serving more than 67 million customers nationwide. Verizon’s Wireline operations include Verizon Business, which delivers innovative and seamless business solutions to customers around the world, and Verizon Telecom, which brings customers the benefits of converged communications, information and entertainment services over the nation’s most advanced fiber-optic network. A Dow 30 company, Verizon employed a diverse workforce of approximately 232,000 as of the end of the first quarter 2008 and last year generated consolidated operating revenues of $93.5 billion. For more information, visit http://www.verizon.com/.

VERIZON’S ONLINE NEWS CENTER: Verizon news releases, executive speeches and biographies, media contacts, high-quality video and images, and other information are available at Verizon’s News Center on the World Wide Web at http://www.verizon.com/news. To receive news releases by e-mail, visit the News Center and register for customized automatic delivery of Verizon news releases.

Verizon

CONTACT: National, Heather Wilner, Verizon – FiOS TV, +1-212-321-8333,[email protected], or Bobbi Henson, Verizon – FiOS TV,+1-214-789-6483, [email protected]; or Local, Rich Young, Verizon – NewJersey, +1-973-649-2279, [email protected], or John Bonomo, Verizon-New York, +1-212-321-8033, [email protected]

Web Site: http://newscenter.verizon.com/kit/fios-in-nyc

Company News On-Call: http://www.prnewswire.com/comp/094251.html

The IVF Baby Grows Up

By Emma Pomfet; Barry Nelson report

What was once science fiction became science fact 30 years ago today when a remarkable baby was born. Emma Pomfet and Barry Nelson report

AMID the popping of champagne corks and global praise for the doctors who rewrote infertility history, the world?s very first ?testtube? baby, Louise Brown, will celebrate her 30th birthday today.

However, despite huge technological advances and the publication of Government guidelines on state-funded IVF treatment in 2004, many patients still face a postcode lottery in the very country that pioneered this life-changing procedure 30 years ago.

Infertility now affects a staggering one in six couples in the UK, but on top of the obvious suffering and deep emotional distress this condition brings, many of these couples will also have to fight the on-going battle of unequal access to NHS treatment.

?The recent National Infertility Day recognised how IVF treatments, which 30 years ago were seen as possibly going beyond the mark, are now recognised treatments for infertility, ? says Clare Brown, chief executive of Infertility Network UK. ?It?s a shame that inmany areas the NHS still, after 30 years, does not seem to see them as such. ? Indeed, the NICE guidance issued four years ago recommends that all eligible couples should receive up to three cycles of NHS treatment each, including frozen embryo transfers. In the North-East every primary care trust has agreed to pay for two NHS cycles of IVF treatment, but North Yorkshire PCT will still only pay for one.

?Sadly, the PCTs are currently following their own rules meaning that access to treatment very often depends on where you live, and in some cases couples can find themselves receiving just one cycle while others attending the same clinic could have access to three, ? explains Susan Seenan of the National Infertility Awareness Campaign (NIAC).

?In addition to this, some PCTs do not fund frozen embryo transfers at all, but with the recent move towards single embryo transfer (SET), it is even more important to allow patients access to the treatment promised to them by the Government. ? IVF ? In Vitro Fertilisation ? literallymeans ?in glass?, and is amethod of assisted reproduction that involves combining an egg with a sperm in a laboratory dish.

If the egg fertilises and begins to divide, the resulting embryo is transferred back into the woman?s uterus where it will hopefully implant and develop. ?Happily, we can treat the majority of couples with IVF these days, ? explains Dr Simon Fishel, managing director of CARE Fertility Group. ?The only really impossible cases are mainly men who do notmanufacture sperm, because if even the basic stem cells for sperm are not there they cannot be treated for their own genetic child.

?Similarly, we can make women whose ovaries have stopped functioning, or who are in the menopause, pregnant with donor eggs, but not with their own genetic eggs.

?What to expect from IVF largely depends on the type of infertility that is being treated and the age of the woman, because at 30 years old the chances of conception are 50 per cent and above per attempt, but at 40 years old this drops to around 12 per cent per attempt.

?The clinic which they attend is also very important as experience, techniques available and how treatment is practised varies widely, as do the results, sadly, ? he adds.

?Ethics, regulation and legislation have evolved dramatically, and very differently, across the world and the improvements in IVF treatment over the last 30 years have been significant. ? For example, IVF patients used to spend ten days in the clinic doing urine samples eight times a day in order to pinpoint the timing of ovulation, according to Dr Fishel. ?Now this is simply an outpatient procedure where the patient may spend just an hour in the clinic for egg retrieval, ? he reveals.

?In our early work the natural cycle was used, and Louise Brown was born as a result of this, but it meant that ovulation could occur anytime of the day or night ? and it did!

?These days, however, we can programme cycles so that a patient knows within one or two days when egg retrieval is likely to occur, months or even a year in advance. ? In addition to this, embryology methods have also improved dramatically and the entire procedure for egg harvesting has become much easier over the years, according to Dr Fishel.

?Egg collection has changed from aninvasive and much more debilitating laparoscopy, to using ultrasound to collect the eggs which ismuch simpler, ? he explains.

Dr Fishel estimates that problems concerning low sperm counts and immobile sperm represent roughly half of all the infertility cases that CARE sees every year. ?However, ICSI ? intracytoplasmic sperm injection ? has revolutionised the treatment of the vastmajority ofmale factor cases, ? he says.

Before 1992, 95 per cent ofmen only had donor sperm as an option for their partners to conceive, whereas now around 95 per cent of men have the opportunity to have their own genetic child. ? Dr Fishel believes that the use of egg, sperm, embryo donation and surrogacy provide the opportunity to treat nearly all cases of infertility, even the more difficult cases such as women with absent wombs, severe heart conditions, or malfunctioning ovaries.

?Now we can also use alternative, advanced technologies such as ?embryo screening? to help patients who have immune problems relating to their reproductive processes or those with chromosome problems which can reduce the chance of conceiving a ?normal? child, ? he explains.

?More recently considerable advances have also been made in eggfreezing technology that makes it almost as successful as using ?fresh? eggs and embryos.

?This not only provides great opportunities for fertility preservation for clinically imperative cases, such asthe effects of cancer or surgery, but also for women to preserve their fertility for lifestyle options. ? Professor Alison Murdoch, head of the Newcastle Fertility Centre at the Centre for Life, says her work is deeply satisfying, but challenging.

?It combines the most stressful times with the most happy times. Because having babies is such a fundamental thing and not every one is successful, we have to help patients through the difficult times as well as celebrate success, ? she says.

The time it takes to get IVF treatment varies in the North-East, with some couples still facing waits of two to three years, but extra investment by the NHS in the last year means that the waiting list should be down to an incredible 18 weeks at the Newcastle treatment centre by the end of the year.

Philip Taylor, consultant gynaecologist and obstetrician at the assisted conception unit at James Cook University Hospital in Middlesbrough says the results from IVF treatment have gradually crept up by about one per cent a year.

During 2006 the success rate for under 35s at James Cook was an impressive 34.9 per cent.

ButMr Taylor believes thatmay decline as a result of new rules designed to prevent too many multiple births which willmean that IVF doctors will only be allowed to put a single fertilised embryo back into the woman?s womb, rather than two at present.

?Currently about 30 per cent of our patients have twins, but that is likely to reduce, ? he adds.

One of the happiest occasions was when dozens of successful IVF patients brought their babies back to the hospital for a party.

?We had a party for our IVF patients a few years ago, ? recalls Mr Taylor.

?Of course it is lovely to see them, but the people who remain as patients are the ones who haven?t got pregnant. ?

(c) 2008 Northern Echo. Provided by ProQuest Information and Learning. All rights Reserved.

Major Moves to Keep More Patients on Home Turf

By Wall, J K

Nearly three-quarters of orthopedics patients in Shelby County have gone to an Indianapolis hospital to receive care. Now, Major Hospital in Shelbyville wants to keep more of those patients at home.

By next June, the hospital will build a $7 million orthopedics center that will house two orthopedic surgeons. They will begin building their practices in Shelbyville next month.

The play for orthopedics patients throws Major into a pitched battle among Indianapolis-area hospitals. Surging numbers of patients need new hips and knees. And providing them is one of the most profitable things hospitals do these days.

Major’s orthopedics gambit shows up how Major is working to convince Shelby County’s 44,000 residents that they can get nearly all their health care close to home.

Major is renaming itself Major Health Partners so it can remind Shelby County residents of all the kinds of medical care the Major system provides. For example, Major’s Shelbyville pharmacy now will refer to itself as MedWorks Pharmacy, a Major Health Partner.

A marketing campaign to promote the new name will begin the week of July 7.

“One of the biggest challenges for the doughnut hospitals around Indianapolis is to try to keep our specialty patients and not have them sucked up to Indy,” said Major CEO Tony Lennen. He added, “There’s still a lot of people in the Shelbyville area that don’t really know what we do.”

Lennen is trying to do even more, especially in the three key specialty areas: cancer, heart and orthopedics.

Two years ago, Lennen persuaded Dr. Kevin Lemme and Dr. Sean Garringer to set up shop in Shelbyville once they end their residencies at the Indiana University School of Medicine. They both will start Aug. 18.

Major already offers orthopedic care to its patients. But physicians there have to refer patients to other hospitals when they need surgery. Now, Lemme and Garringer can provide surgery in Shelbyville, which sits 25 minutes southeast of Indianapolis on Interstate 74.

Orthopedics is a smart area to go after. As of 2005, hospitals earned nearly 50 percent profit margins on orthopedic surgery procedures, according to Phase 2 Consulting in Austin, Texas. That meant hospitals pulled in nearly $9,000 in profit for each surgery.

And the need for new joints keeps growing. The average age for joint replacement surgery is 67. The eldest of the 70 million baby boomers is 62.

“Orthopedics is a very hot topic,” said Ed Abel, director of health care services at Blue & Co., an Indianapolis accounting firm. He added, “Virtually all Indianapolis hospitals have tried to develop orthopedic services.”

Indianapolis even has one hospital dedicated entirely to orthopedics – the Indianapolis Orthopedic Hospital, which is owned by the OrthoIndy group of physicians. That 37-bed hospital sits in the northwest corner of Indianapolis.

But Major also will face strong competition from hospitals that serve the southern and eastern outskirts of the Indianapolis area. For example, St. Francis Hospital & Health Centers has 23 orthopedic surgeons working at its hospitals in Beech Grove, Indianapolis and Mooresville.

Also, Hancock Regional Hospital in Greenfield has offered orthopedic surgery for years via its affiliation with a physicians group called the Indiana Orthopaedic Center Physicians. And Community Health Network offers orthopedic surgery at three hospitals just off the east and south legs of Interstate 465.

Keith Jewell, St. Francis’ chief operating officer, praised Major’s move as good for patients. But he said the Shelbyville hospital’s strategy “absolutely” would draw patients away from St. Francis.

Even so, he said, “Our volume in orthopedics has continued to grow year after year for several years now,” he said. “I still think we’ll … have a nice, strong, growing program.”

Orthopedics is not the first specialty Major has gone after. In 2005, Major opened the Benesse Oncology Center in Shelbyville. Two physicians treat cancer patients at the center, along with a team of nurses, physical therapists, nutritionists, pathologists and other health care professionals.

Benesse is one of many outside practice groups and service centers that Major owns. Others include physician groups in obstetrics, sports medicine, surgery and family practice, as well as a physician-management services firm.

Tying them all under one brand name should help promote Major not only to Shelby County families, but also to local employers, Lennen said.

That’s the best way for Major to protect its turf and, maybe one day, even broaden it, Lennen said. “If we can rebrand ourselves, and deliver on the promise, then the reach will just take care of itself.”

Major Health

Partners

Address: 150 W. Washington St., Shelbyville

Beds: 54

Opened: 1924 CEO: Tony Lennen

2007 financials: earned $7.6 million on revenue of $80.4 million

Subsidiaries: Southeast OB/GYN, Major Sports & Musculoskeletal Care, Shelby Surgical Associates, MedWorks Pharmacy, Shelby County Family Practice, Internal Medicine of Shelby County Inc., MDSolutions.

Source: Major Hospital

Copyright IBJ Corporation Jul 7, 2008

(c) 2008 Indianapolis Business Journal. Provided by ProQuest Information and Learning. All rights Reserved.

Amid Leadership Changes, JPS Board Tackles Budget

By Anthony Spangler, Fort Worth Star-Telegram, Texas

Jul. 27–FORT WORTH — After years of increased demand on the Tarrant County Hospital District and correlating expansion of its clinics, offices and hospitals, the board of managers for the taxpayer-supported system is wanting to slow growth and focus on ensuring that patients are getting the services they need.

Although most board members want to continue adding school-based clinics, some want to bolster staffing at community clinics and identify other ways to improve patient access to the district, which operates as the JPS Health Network.

“Instead of focusing on how many clinic doors can we open, we should focus on how many patients can we get in on a timely basis and referrals done in a timely manner, while still tending to growth,” JPS Board Chairman Steve Montgomery said.

A series of consultant reports in 2007, which cost about $800,000 and were kept from the board of managers, depict JPS as a system riddled with bottlenecks, long waits for appointments and inadequate housekeeping. After a series of stories by the Star-Telegram that included some of the consultant’s findings, state health officials and an agency that accredits JPS to receive federal funds conducted surprise inspections that revealed dozens of problems.

The JPS board will meet Saturday for its annual budget retreat. In preliminary budget discussions, some board members have said the budget needs to ensure those problems are addressed and do not resurface.

By the numbers 4 percent: Growth projected in hospital admissions

23 cents: Current tax rate

$77 million: Projected surplus this year

6,932: Estimated number of births next year

31,190: Projected school-based clinic visits this year

What’s proposed

JPS administrators are proposing a $603 million budget that would include employee raises and $6.6 million in new spending initiatives to bolster staffing, hire more interpreters, start a school-based psychiatric program and expand cardiac services.

The budget recommendations project a $77 million surplus by the end of the current fiscal year Sept. 30 and another smaller surplus in 2008-09, even with a 1/4 -cent to 1-cent reduction in its tax rate, which stands at 23.0397 cents per $100 of assessed value or about $230 for a $100,000 home.

Montgomery said he wants JPS to consider a zero-based budget next year. He said that in previous years the board may have relied too heavily on the administration regarding budget details.

“The board has to step up and provide some management oversight,” he said. “While I’d like to start a zero-based budgeting process, it would be reckless with a new CEO, CFO and a couple of new board members. The budget process already started in the middle of our turmoil.”

Physician concerns

Dr. G. Sealy Massingill, an obstetrics/gynecology physician and president of the JPS medical staff, said that next year’s budget should emphasize quality of care and pour money into the network’s community clinics.

“Mainly, we think there are problems with access to primary-care physicians because we don’t have enough,” he said. “We need to make sure physicians have enough resources so they can see 25 patients a day rather than 20 patients a day.”

Other doctors at JPS have recommended studying the impact of reducing patient co-payments and suggested that JPS either eliminate or reduce them.

Board concerns

JPS board members have suggested slowing growth of its facilities, studying whether more staffing is needed throughout the network and continuing the expansion of school-based clinics.

Board member Martha Walker echoed concerns of medical staff regarding co-payments.

“We’re talking about people who are making little or no money at all and have to pay $20 per doctor visits,” she said. “It is the repeat business that is really troubling. If they have an illness and have treatment where they have to come back again and again and have to pay $20 each time, I think it is a burden. I want to know how the charges are affecting them.”

Board member Tonya Veasey wants to scrutinize whether clinics have adequate support staff.

“If they don’t have the support staff they need to move the patient along, the patient is waiting longer than they need to for service,” she said.

Tax rate cut urged

When JPS administrators briefed Tarrant County commissioners recently regarding the surprise inspections by state health officials, a majority of the commissioners said they want to see the hospital board cut its tax rate given JPS’s sound financial position.

Commissioners J.D. Johnson and Gary Fickes have urged JPS to consider cutting its tax rate following years of surpluses.

“I think JPS, in the past, has had a positive cash-flow situation that is better than the alternative,” said Fickes, whose district encompasses Northeast Tarrant County. “It is prudent to keep reserves up to a point. I would like the JPS board to work on increasing access, which is going to cost some money. We just want them to use their dollars prudently.”

Series of changes

After criticism from its own physicians and some community groups that JPS leadership was more concerned with commercially insured patients than serving the needy, the JPS board replaced two of its top administrators.

The board accepted the resignation of Chief Executive Officer David Cecero and named JPS’s former head of community affairs, Robert Earley, as interim CEO. Shortly after Cecero’s departure, the district’s chief financial officer resigned. Former budget director Randy Rogers was named interim chief financial officer. And the JPS board fired its environmental-services contractor, which is responsible for keeping JPS facilities clean.

Under the new administrative leadership, a majority of the JPS board indicates they will work toward a budget that pumps more of its surpluses into patient care instead of brick-and-mortar.

Sound financial position

Last year, JPS brought in about $97 million more than it spent and continues to acquire land and buildings, construct new facilities and build its cash reserves and investments — touting more than $400 million in its portfolio.

JPS recently moved its emergency department, surgical rooms and intensive-care unit to a new, five-story, $96 million patient pavilion. Also opened this year were an urgent-care clinic in Arlington, a community health clinic in Watauga and three school-based clinics, with two more expected by year’s end.

As interim chief executive, Earley said he does not want to tamper drastically with the budget but wants the board to revisit the budget in midyear, when the fate of some federal funding is determined, to be realistic about surplus expectations. In the past, JPS has not factored in tens of millions in federal funding and then pocketed those funds at the end of the fiscal year.

“If we get those funds in midyear, I want us to consider putting that money toward programs that won’t make it into the budget,” Earley said. “We still need to run a surplus, maintain our reserves and to fund future capital projects. But we’re not going to pretend like those federal dollars aren’t coming in and then when they do show another large profit.”

—–

To see more of the Fort Worth Star-Telegram, or to subscribe to the newspaper, go to http://www.dfw.com.

Copyright (c) 2008, Fort Worth Star-Telegram, Texas

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.

HIV Prevention Expert Dr. Timothy Mastro Speaks on Future of Pre-Exposure Prophylaxis at International AIDS Conference

RESEARCH TRIANGLE PARK, N.C., July 27 /PRNewswire/ — Timothy Mastro, MD, FACP, DTM&H, who joins Family Health International (FHI) on August 1st as Senior Director of Research, will share information on promising research into pre-exposure prophylaxis (PrEP) for HIV prevention at the International AIDS Conference in Mexico City.

Dr. Mastro’s presentation, titled “Pre-Exposure Prophylaxis: Current and Planned Trials,” will examine ongoing and upcoming clinical trials that suggest oral doses of certain antiretroviral therapies taken daily may prove effective in protecting people from HIV infection. The successful development of PrEP would be especially useful to women and others who may not be empowered to negotiate consistent condom use with their sexual partners.

Dr. Mastro, who joins FHI from the Centers for Disease Control and Prevention (CDC), is one of the leading experts on HIV/AIDS prevention. During his tenure at the CDC, Dr. Mastro oversaw HIV prevention research activities, including a landmark study on mother-to-child HIV transmission, trials of microbicides for women, and the first international HIV vaccine efficacy trial. He has also served as chief of the CDC HIV Vaccine Section and directed CDC’s participation in the President’s Emergency Plan for AIDS Relief (PEPFAR). At FHI, Dr. Mastro will support the organization’s commitment to continue to expand its global leadership role in public health and development, particularly in HIV/AIDS prevention and treatment research and programs.

   WHAT:   FHI's Dr. Timothy Mastro Presents on "Pre-Exposure Prophylaxis:           Current and Planned Trials"    WHERE:  XVII International AIDS Conference           Centro Banamex, Mexico City Session Room 9    WHEN:   Thursday, August 7, 2008           2:30-4:00 p.m.    

Dr. Mastro’s presentation is part of a symposium titled “The Future of Microbicides: from Vaginal ART to PREP,” which will examine the road forward for research on female-controlled HIV prevention methods in the face of negative results from some recent clinical trials. Other presentations at the session will include “Future Promising Microbicidal Products: What to Learn from the In Vitro Work,””ART-Containing Vaginal Microbicides in the Clinical Pipeline: A Status of the Studies,” and “The Use of Oral and Topical PREP at Population Level: What Are the Issues?”

Other notable FHI presentations at the International AIDS Conference include:

“Meeting the Sexual and Reproductive Health Needs of People Living with HIV: Critical to Human Rights and Prevention” by Ms. Rose Wilcher

   Sunday, August 3, 2008   3:45-5:45 p.m. in Skills Building Room 5   

“Vaccines and Microbicides: Where Do We Go From Here?” by Dr. Lut Van Damme

   Monday, August 4, 2008   11:00 a.m.-1:00 p.m. in Session Room 1     Family Health International  

Family Health International (FHI) has been at the forefront of international public health initiatives since 1971. With a staff of 2,200 working in more than 65 countries, FHI leads and supports research and programs that address the most pressing public health needs of the developing world – HIV/AIDS prevention, care, and treatment; reproductive health; malaria; tuberculosis; and avian influenza as well as other chronic and infectious diseases. FHI’s work is made possible by close relationships with funding partners, host-country governments, non-governmental organizations, research institutions and universities, community and faith-based groups, and private-sector organizations.

   Contact: Tae Crotty            Director of Communications            1-571-225-5819            [email protected]  

Family Health International

CONTACT: Tae Crotty, Director of Communications, +1-571-225-5819,[email protected]

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

National Medical Association Honors Visionaries in Health Care and Opens 2008 Convention With Leadership Awards

ATLANTA, July 27 /PRNewswire-USNewswire/ — The National Medical Association (NMA) celebrated a host of leaders and organizations for outstanding achievement in the elimination of health disparities at its Opening and Awards Ceremony on Saturday July 26. Special guests, Former Health and Human Services Secretary, Dr. Louis Sullivan and Democratic National Committee Chair, Dr. Howard Dean, praised the distinguished honorees, concluding a day of opening festivities for the NMA 2008 Convention.

The nation’s foremost conference devoted to medical science and African American health, the NMA’s Annual Conference and Scientific Assembly convenes in Atlanta from July 26-31 and brings together the most prominent medical scholars, scientists, practitioners, government experts and health care advocates in the country.

Each year the NMA Opening Awards Ceremony recognizes those who exemplify visionary leadership, service and extraordinary achievement in health care for African Americans. President of the National Medical Association, Dr. Nelson L. Adams, III, said, “We celebrate our colleagues and friends in furthering the goals and objectives of the National Medical Association.”

This year’s honorees include:

— David Satcher, M.D., Ph.D., Former Surgeon General and Director of the Center for Excellence on Health Disparities

— Robert J. Smith, M.D., Chief Surgeon, Middle Tennessee Medical Center and Associate Professor, Meharry Medical College

— Henry W. Foster, Jr., M.D.- Professor Emeritus and Former Dean of Meharry School of Medicine and Clinical Professor, Vanderbilt University

— Frederick N. Quarles, M.D., dermatology expert and consultant, Principal, Quarles Dermatology, co-author of “Skin Deep: A History of Black Dermatology.”

— Rebat M. Halder, M.D., Chairman, Department of Dermatology, Howard University College of Medicine

— Michael R. DeBaun, M.D., M.P.H., hematology-oncology expert and Professor of Pediatrics, Biostatics and Neurology

— Olufijnmilayo (Funmi) Olopade, M.D., MBBS, FACP, cancer specialist and Founding Director, Center for Clinical Genetics, University of Chicago

— State Senator Frederica S. Wilson, (D-CA), public education advocate and Democratic Leader Pro Tempore, Florida Senate

— AstraZeneca US-NMA Corporate Circle Partner, global leader in pharmaceuticals

— Medtronic-NMA Corporate Circle Partner and global leader in medical technology

— The James Wilson Bridges, M.D. Medical Society – NMA Affiliate, (Miami, Florida)

The awards conferred included the Scroll of Merit, the National Medical Association’s highest award, Cobb Lifetime Achievement Award; Practitioner of the Year, Distinguished Service, Meritorious Achievement, Corporate Circle Partner and Medical Society of the Year.

“We are grateful to work with an organization so committed to working with patients and improving health outcomes,” said Lisa Davis, Vice-President of Communications who accepted the award on behalf of AstraZeneca, a NMA Corporate Circle Partner.

This year’s NMA Opening Awards presented Atlanta’s own, David Satcher, M.D., Ph.D. with the esteemed Cobb Lifetime Achievement Award, named after one of NMA’s past presidents, Dr. William Montague Cobb for extraordinary achievement in research and advocacy for health care.

Nedra H. Joyner, M.D., Chair of the Board of Trustees of the NMA said, “The Opening and Award Ceremony is an opportunity to recognize the contributions of our pioneers in medicine. We continue a legacy of paying homage to our leaders.”

About the National Medical Association

Founded in 1895, the NMA is a nonprofit organization that is the nation’s oldest and largest medical association representing the interest of more 30,000 African American physicians and their patients. The NMA advocates health care for policies that would assure equitable and quality health care for all.

National Medical Association

CONTACT: Lanni Thomas, +1-404-502-9109, Alisa Mosley,+1-240-350-7531

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

Steel Sinks Sculpture

By VICTORIA McMAHON

ROCKETING steel prices have thrown plans for a landmark sculpture on the scrap heap.

The 45metre-high Trillian steel sculpture, was to form an iconic part of Belfast’s emerging skyline but skyhigh steel prices have pushed the project up 50 per cent to pounds 600,000.

It means that, after three years and thousands of pounds already spent on consultation and planning stages, Belfast City Council, the driving has been forced back to the drawing board.

After a worldwide search in 2005 Oregon artist Ed Carpenter’s “wild flower” was chosen from 400 entries to become the landmark centre piece at Broadway Roundabout.

It was due to take up its new home later this year at the head of the recently improved Westlink.

It was described at the time as a “breathtaking symbol of regeneration and renewal”.

After dark, the installation was designed to be visible for miles with rays of light projected from the tips of its leaves into the night sky. But the problem lay with the materials in the Trillian design with the polycarbonate material being backed with costly steel trusses, and reinforced steel cables holding the artwork in place.

Belfast City Council has now launched another hunt for an artist to replace the Trillian design and one which keeps within its hefty pounds 400,000 budget.

South Belfast councillor Bob Stoker admitted: “It is disappointing to go back to the drawing board again.

It’s just one of those things, we just didn’t have the money.”

A steering panel will now be set up with representatives from community organisations as well as politicians and representatives from the Department of Social Development, the Arts Council of Northern Ireland, and Roads Service – who are stumping up the bulk of the cash for the project.

(c) 2008 Sunday Mirror; London. Provided by ProQuest Information and Learning. All rights Reserved.

Expert: Bipolar Disorder Often Unrecognized

By Christine Phelan, The Sun, Lowell, Mass.

Jul. 27–The announcement that state Sen. J. James Marzilli Jr. suffers from bipolar disorder, following his arrest, has some shaking their heads in bewilderment, some in disgust.

But not psychiatrist Gary Sachs, who directs Massachusetts General Hospital’s Bipolar Clinic and Research Program. For Sachs, Marzilli’s erratic behavior during his June 3 visit to Lowell — during which he was accused of accosting four women in as many hours, followed by a foot chase and ultimately his arrest in a city parking garage — is well within the boundaries of the disease that affects some 9 million Americans.

“It’s an equal-opportunity condition,” Sachs said, noting that the average age of onset is ages 15 to 19, and that half of his clinic’s patients are 18 or younger.

Marzilli faces two court hearings this week. Tomorrow, he will be in Lowell Superior Court for a hearing into charges lodged in the downtown Lowell incidents. On Thursday, he faces another hearing in Middlesex Superior Court in Woburn, on a civil complaint filed by three women who say they were harassed by Marzilli in other incidents.

Following his arrest, Marzilli was admitted to McLean Hospital, a psychiatric hospital in Belmont. His attorney said Marzilli was diagnosed with bipolar disorder.

“Jane,” a Massachusetts Trial Court employee who did not want her real name used, said she was diagnosed as bipolar about seven years ago at age 35, but had been diagnosed years earlier as suffering from

either depression or manic episodes depending on the phase she was in.

Jane, who is married and has always maintained employment, is now being treated by drugs and therapy to level her moods.

What she doesn’t understand is how Marzilli, who as a politician leads a very public life, could show no signs of the disorder until age 50.

“I never did anything crazy, but If you talked to anyone who knows me, they would tell you they knew something was wrong from early on,” Jane said.

Sachs said, “There are people who’ve had episodes that’ve gone undetected, and those that have their first episode later in life. I don’t know Sen. Marzilli, but the kind of multiple incidents where he was using very poor judgment, that is something that, during an episode, is a common symptom. There’s no doubt about that.”

While just under 3 percent of Americans have bipolar disorder, Sachs said fewer than one in three cases are recognized, despite reliable methods to diagnose the disease. And because it’s so often diagnosed in tandem with other mental illnesses, like depression and anxiety disorder, early treatment is critical.

Bipolar patients on average live dramatically briefer lives — sometimes by as much as two decades — due to alcohol and drug abuse, or suicide.

Bipolar disorder is characterized by dramatic and uncontrollable shifts in mood, ranging from euphoric highs to, more frequently, debilitating depressive episodes. While its exact origins are unknown, major emotional events — like death or divorce — can ignite bipolar mania, as can an overabundance of the stress hormone cortisol, produced by the adrenal gland, and even bodily inflammation, both of which may affect brain circuitry, Sachs said.

Biological stressors of an episode — especially the lack of sleep — can exacerbate the intensity of an existing episode.

Treatment usually involves both drugs and talk therapy.

But what makes bipolar disorder — previously called manic depression — distinct is patients’ almost incredible disconnect with reality, Sachs said.

“With depression, we don’t appreciate what is missing: the capacity to experience pleasure,” he explained. “But when we get to mood elevation, it’s the opposite — we don’t appreciate the downside of anything. You can’t make perceptions accurately. It’s a kind of colorblindness. You can’t see those red lights, and you’re going to get a lot of tickets if you get caught.”

And while there’s intense debate about over-diagnosis, Sachs said there is a larger issue.

“We do have reliable ways to make diagnoses,” Sachs said. “But there are a lot of inaccurate diagnoses, we miss cases, or we conclude that because we saw one or another star that the whole dipper is there. We have an absolute duty to our patient to give them a systematic diagnosis.”

Sun reporter Lisa Redmond contributed to this story.

—–

To see more of The Sun, or to subscribe to the newspaper, go to http://www.lowellsun.com.

Copyright (c) 2008, The Sun, Lowell, Mass.

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.