Worth Noting GAO Warns of ‘Meaningless’ Genetic Advice on Internet With the growing emphasis on genetic components of various diseases, some Internet sites are urging consumers to send samples of their genetic material in order to receive personalized nutrition and lifestyle guidance to address their genetic health risks. But in a report released July 27, the federal Government Accountability Office (GAO) said the advice being given to consumers by such web sites is "medically unproven and so ambiguous as to be meaningless." To conduct an investigation, the GAO created fictitious consumers and submitted their fictitious genetic information to various web sites. The websites advised the presumed consumers to use expensive dietary supplements, which were generally vitamins and antioxidants that can be found in any grocery store, and made generic recommendations such as "stop smoking" to reduce the risk of diseases such as type 2 diabetes, cancer, osteoporosis, high blood pressure, and heart disease. The GAO report, "Tests Purchased from Four Web Sites Mislead Consumers," GAO-06-9771, can be read and downloaded at www.GAO.gov. Youth Overweight Said to Increase Risk of Bone Fractures, Joint Pain Children and adolescents who are overweight are more likely than their normal-weight counterparts to suffer bone fractures and have joint and muscle pains, according to a study published in the June 2006 issue of the journal Pediatrics. Researchers classified children as "overweight" if they had a body mass index above the 95th percentile for their height and weight and used a technique known as Dual Energy X-Ray Absorptiometry to detect any effect of the overweight on feet, ankles, and knees. The researchers found that overweight youngsters were more likely to report impaired mobility and more likely to experience changes in how the bones of the thigh and leg meet at their knees. Also, the fact that overweight children generally had greater bone density than their normal-weight peers did not protect them from bone fractures in falls, perhaps because overweight boys, in particular may fall harder and have poorer balance predisposing to falls. Researchers advised overweight children and adolescents to engage in modes of physical activity, such as bicycle riding and swimming, that could alleviate the severity of lower extremity joint loading and discomfort. New ADHD Drug Seeks Schedule IV Approval A new drug to succeed the big-selling Adderall XR for treating attention deficit hyperactivity disorder is still awaiting approval by the federal Food and Drug Administration and possible classification as a Schedule IV drug by the federal Drug Enforcement Administration (DEA). Currently called NRP104, the new drug is manufactured by a small biotechnology company, New River Pharmaceuticals, and would be marketed by Shire Pharmaceuticals, makers of Adderall, whose patent on that drug expires in 2010. A Schedule IV classification by the DEA would put NRP104 into the same category as Valium, allowing it to be prescribed for six months at a time. Existing stimulants for attention deficit disorder, including Adderall XR, Concerta, and Ritalin, are Schedule II drugs, the government’s most restrictive category of legal drugs, and require a new prescription every few months. NRP104 is an amphetamine and is claimed by its promoters to be less subject to misuse by people, including college students, who use stimulants to improve concentration and enable longer hours of study. NRP104 consists of a common amphetamine bound to lysine, an amino acid. When the drug is swallowed, enxymes in the digestive tract remove the lysine, freeing the mphetamine. But when NRP104 is snorted—methods that abusers employ to achieve quick highs from amphetamines—the lysine is not removed as easily, so there is less euphoric effect. "You can’t overdose on it," said Dr. Timothy Wilens, a pediatric psychopharmacologist at Massachusetts General Hospital. Shire Pharmaceuticals can be contacted at www.shirepharmaceuticals.com. The following information appeared during the months of June and July 2006 in the News Alerts section of the website of the Center for Health and Health Care in Schools, at www.healthinschools.org. June 2, 2006 June 5, 2006 In a joint statement released today to mark the 25th anniversary of the first reported cases of acquired immunodeficiency syndrome (AIDS), the directors of the National Institutes of Health and the National Institute of Allergy and Infectious Diseases joined with the director of AIDS research in NIH to call for "a sustained global response from all sectors of society" to continuing high rates of AIDS and HIV infection in the Unites States and worldwide. Elias Zerhouni, Anthony Fauci, and Jack Whitescarver said that despite immunology and virology breakthroughs in HIV/AIDS research, "important challenges remain in the area of therapeutics." They noted that many patients receiving antiretroviral therapy "do not fare well on their treatment regimens due to the development of drug resistance, drug toxicities, and side effects" and said NIH is committed to finding therapies that are less toxic and have fewer side effects. They also called for research to develop "the next generation of protective modalities," including topical microbicides that individuals could use to protect themselves against HIV infection and a possible vaccine. NIH currently has clinical trials under way for nearly 50 vaccine candidates, but the virus that causes HIV "is unusually well equipped to elude immune defenses," making vaccine research a complex challenge. The full text of the NIH statement is available online at http://www.nih.gov/news/pr/jun2006/niaid-01.htm.
July 3, 2006 Federal FDA, USDA Mark 100th Anniversaries Two federal laws that were enacted in 1906 are celebrating their 100th anniversaries this year. The Food and Drugs Act of June 30, 1906, created the Food and Drug Administration (FDA), the oldest consumer protection agency in the United States with responsibility for assuring the safety of food, human and veterinary drugs, medical devices, and cosmetics. In a resolution passed in June, Congress noted that the FDA "has been a pioneer in promoting the health and safety of citizens in the United States" and around the world. Also marking a 100th anniversary this year is the Federal Meat Inspection Act (FMIA), which is administered by the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). Signed into law by then-President Theodore Roosevelt on the same day as the FDA legislation, the FMIA is charged with inspecting meat products and assuring that slaughter houses and processing plants are operated under sanitary conditions. Impetus for the two laws is generally credited to books such as Upton Sinclair’s The Jungle, published in the early 1900s that exposed conditions in food, drug, and cosmetics industries and in meat processing plants. July 5, 2006 Medicaid Recipients Must Show Proof of Citizenship In a letter to state Medicaid directors, the U.S. Centers for Medicare and Medicaid Services has called attention to a provision of the 2005 Deficit Reduction Act that requires individuals to provide "satisfactory documentary evidence of citizenship or nationality" when initially applying for Medicaid or upon a first Medicaid re-determination. Specific documents that will be recognized as satisfactory documentary evidence of citizenship or nationality include:
The letter to state Medicaid directors can be downloaded from http://www.cms.hhs.gov/MedicaidEligibility/05_ProofofCitizenship.asp. July 10, 2006 Children Are Exposed to Lung-Damaging Air Pollution Air pollution and children are an unhealthy mix, according to a research report and accompanying editorial in the July 6, 2006, issue of the New England Journal of Medicine. Carbon particles similar to those found in ambient air have been found in the airways of children, and increased levels of carbon correlate with decreased lung function in children, whose lungs develop steadily during childhood. In the past half-century, "we have learned a great deal about the effects of air pollution on health, through both controlled trials and epidemiologic studies," researcher point out, and although overall air quality in urban environments has improved as the result of vehicle emission controls and cleaner-burning fuels, children are often exposed to particularly dangerous levels of air contamination in schools built near busy roadways or other sources of pollution. The editorial concludes that currently ongoing research into the specific components of air pollution that are responsible for health effects may enable policymakers to institute more specific control strategies. "Our children’s health depends on it," the editorial summarizes. The research report, "Carbon in Airway Macrophages and Lung Function in Children," and the editorial, "Air Pollution and Children—An Unhealthy Mix," are published in the June 6, 2006, issue of the New England Journal of Medicine. July 12, 2006 Mumps, Pertussis Cited as Re-Emerging Diseases Low immunization coverage and waning immunity may be responsible for recent outbreaks of childhood diseases that were thought to have been eliminated, according to a report released today by the National Foundation for Infectious Diseases. While immunization is at the highest level ever recorded and the number of diseases targeted for prevention through routinely recommended childhood vaccinations increased to 15 as of early this year, outbreaks of forgotten diseases such as mumps and whooping cough are occurring in the United States, and on the international front, there has been a resurgence of paralytic polio in previously polio-free countries. The resurgence of these three vaccine-preventable diseases is a signal that "We can never become complacent, but must maintain strong programs and public confidence in vaccines and our immunization system," said Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC) July 14, 2006 Varicella Outbreak Raises Questions about Vaccination, Surveillance After a school nurse notified the Nebraska Health and Human Services System of an outbreak of chickenpox in an elementary school in 2004, the state initiated a retrospective study to determine the extent of the outbreak and the severity of the illness in vaccinated and unvaccinated children. In a summary published in this week’s issue of the Morbidity and Mortality Weekly Report, the federal Centers for Disease Control and Prevention (CDC) notes that there has been a dramatic decline in cases of chickenpox since licensure of a vaccine in 1995 and implementation of a variety of school-entry varicella vaccination requirements in most states. To reduce additional virus transmission during an outbreak, the Advisory Council on Immunization Practices in 2005 recommended a second dose of varicella vaccine in outbreak settings for those who had previously received one dose of the vaccine. In addition, the Council of State and Territorial Epidemiologists recommended that by 2005, all states should established case-based varicella reporting by using either statewide surveillance or surveillance in sentinel sites. As demonstrated in the Nebraska outbreak, "schools are an ideal setting for varicella sentinel surveillance because of their readily available vaccination records and populations that can be surveyed easily," the CDC said. The report, "Varicella Outbreak Among Vaccinated Children—Nebraska, 2004," appears in the July 14, 2006, issue of Morbidity and Mortality Weekly Report at http://www.cdc.gov/mmwr. July 18, 2006 Survey Finds Methamphetamine Number-One Drug Problem Across U.S. In a survey released today by the National Association of Counties (NACo), county officials reported that methamphetamine continues to be the number-one drug problem in states including Arizona, California, Idaho, Nevada, New Mexico, Utah, Washington, and Wyoming, and that use of the drug is rapidly spreading across the country from west to east. Meth is increasingly linked to crimes such as robberies and burglaries and is more popular in many places than cocaine, marijuana, and heroin combined. A particular concern to many county law enforcement officials is an increase in meth-related identity theft, which is up 27 percent since 2005. The full text of the NACo survey is available www.naco.org. July 19, 2006 Women’s Medical Group Opposes ‘Teen Endangerment’ Bills The 13,00-member American Medical Women’s Association (AMWA) this week called attention to two bills pending in the United States Congress that the organization charged will, if enacted, "endanger the lives of girls and young women." The AMWA has signed on to a letter to federal lawmakers urging them to vote against the Child Custody Protection Act (S. 403) in the Senate and the Child Interstate Abortion Notification Act (H.R. 748) in the House of Representatives. S. 403 would make it a federal crime for anyone other than a parent to accompany a young woman to an out-of-state doctor for abortion if the home state’s parental-involvement requirement has not been met; and H.R. 748 imposes a complex patchwork of parental involvement laws on women and doctors that the AMWA calls "both complicated and unconstitutional." The full text of both laws and their current status in Congress are available at http://thomas.loc.gov. Research Confirms Gene Variant Increases Diabetes Likelihood In a report published in today’s issue of the New England Journal of Medicine, researchers are confirming that a variant in one gene predisposes people to type 2 diabetes. But the good news, researchers said, is that people at the highest genetic risk benefit as much as or perhaps more than those without the variant from changes in life style, including losing weight, reducing calories in diet, and increasing physical activity. "This finding emphasizes that people at risk of diabetes, whether they’re overweight, have elevated blood glucose levels, or have this particular genetic variant, can benefit greatly by implementing a healthy life style," said lead author Dr. Jose Florez of Massachusetts General Hospital in Boston. The study that found the genetic predisposition to diabetes began in 1995 and was ended a year earlier than planned because the results were so clear, according to the National Institute of Diabetes and Digestive and Kidney Disease in the National Institutes of Health, which sponsored the study. The study population consisted of adults with blood glucose readings higher than normal but not yet in the diabetic range and reflected the racial and ethnic diversity typical of the U.S. population. July 21, 2006 Senate Bill Would Continue Medicaid to Schools for Transportation, Administrative Expenses for Children with Disabilities Legislation introduced in the Senate July 20 would continue Medicaid reimbursements to schools for the special costs they incur in transporting children with disabilities to school and for administrative expenses that schools incur in connection with Medicaid-reimbursable services for children with developmental, physical, or mental health needs. Noting that the Bush administration is proposing to deny Medicaid funding to schools for transportation or administration, Senator Ted Kennedy (D-MA) and co-sponsors said their Protecting Children’s Health Act "recognizes the importance of schools as a site of delivery of health care." Kennedy noted that the estimated value of Medicaid reimbursements to schools for transportation and administration is expected to be $3.6 billion over the next five years, and he said the decision by the administration to try to eliminate those payments "follows years of resisting Medicaid reimbursements, without clear guidance on how schools should appropriately seek reimbursement." The Senate bill, S. 3705, and similar legislation expected to be introduced in the House of Representatives, can be accessed at http://thomas.loc.gov. July 24, 2006 FDA Approves New Implantable Contraceptive The federal Food and Drug Administration July 17 approved an implantable contraceptive described as "about the size of a matchstick," which is inserted just under the skin of a woman’s upper arm, where it releases a low but steady dose of progestogen (etonogestrel) for a period of up to three years. Removal can occur at any time at the woman’s request, after which her fertility returns to pre-existing levels. The contraceptive, called Implanon, has been used by some 2.5 million women in more than 30 countries, according to the manufacturer, the pharmaceutical company Organon, which has offices in New Jersey and the Netherlands. Organon says it will now launch a nationwide training program in the U.S. to train healthcare professionals in insertion and removal procedures, and only professionals who have completed the training will be able to prescribe implantation for their patients. The manufacturer can be contacted at http://www.organon.com. July 26, 2006 Senate Passes Bill Restricting Out-of-State Teen Abortion The United States Senate yesterday passed legislation that makes it a federal crime for a person other than a parent to transport a minor across state lines for the purpose of obtaining an abortion, if the minor’s home state has a parental consent or notification law. During lengthy debate on the bill, S. 403, the Senate agreed to one amendment and rejected another. In a narrow limitation on parental rights, the Senate approved an amendment to "punish incestuous fathers" by imposing fines and imprisonment on any father who has "committed an act of incest" with a minor and then transports the minor across a state line for the purpose of obtaining an abortion. On the only other amendment proposed, the Senate rejected on a party-line vote a proposal to provide $100 million to localities for comprehensive sex education programs that would include information about contraception. The Senate bill does not mention whether the ban on interstate transportation for abortion applies if the health of a pregnant minor is at stake, a point on which state abortion bills have been found unconstitutional, but it does allow a minor to ask a court for permission for an interstate abortion without parental consent. Before the legislation passed yesterday can go to President Bush for signature, the Senate must confer with the House of Representatives, which passed a similar but not identical bill more than a year ago. |