Worth Noting FDA Requires HIV Warning on Popular Contraceptives In an effort to correct what it calls "misconceptions" the federal Food and Drug Administration (FDA) warned in December that widely used over-the-counter contraceptives containing the ingredient nonoxynol 9 (N9) do not protect against HIV, the virus that causes AIDS, or other sexually transmitted diseases. The FDA said it is now requiring gels, foams, films, or inserts containing N9 to carry labels warning that they provide no protection from infection by an infected partner and may in fact increase the possibility of infection by irritating vaginal tissues. Labels must carry the caution: "Do not use if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control." The full text of the final rule is posted at www.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0003.pdf. -------------------------------- Hib-Containing Vaccines RecalledDrug manufacturer Merck & Co., Inc. announced December 13 that it has recalled certain lots of two Haemophilus influenzae type b (Hib) conjugate vaccines because the company "cannot assure the sterility of equipment used during manufacture of these lots." The recommended schedule for Hib-containing vaccines is a primary series of two or three doses administered beginning at age 2 months and a booster shot at 12 to 15 months of age, but because of the recall, Merck and the Advisory Committee on Immunization Practices are recommending that practitioners temporarily defer administration of the 12-to-15-month dose, except to high-risk children. Hib disease can occur in any age group, especially among persons with compromised immune systems, but it is one of the most commonly occurring bacterial infections in very young children. The disease is transmitted through contact with mucus or droplets from the nose and throat of an infected person. Further information on the recall is available from the federal Food and Drug Administration (FDA), at www.fda.gov/consumer/updates/hib121307.html. -------------------------------- First Recommendations on Genetic Testing The Centers for Disease Control and Prevention (CDC) has issued the first recommendations for genetic testing by health care providers in clinical practice, focusing on testing in adults with depression. "With the expected increase in the number of genetic tests in practice, this recommendation statement … marks the beginning of a sustained public health approach to independent assessment of genomic applications in clinical and public health practice," the CDC said. "Reliable, evidence-based information is urgently needed by health care providers, consumers, policy makers, and others to help determine which genetic tests are safe and effective, and to provide guidance on their appropriate use." Information on CDC's work on genetics and public health is available at www.cdc.gov/genomics. -------------------------------- The following information appeared during the month of December 2007 in the News Alerts section of the website of the Center for Health and Health Care in Schools, at www.healthinschools.org. FDA Launches New E-Mail Alerts Health care professionals who need up-to-date information about medical products and the food supply have a new resource. The federal Food and Drug Administration (FDA) today announced day it's inaugurating an e-mail service that will alert subscribers whenever information is updated on certain FDA web pages, with subscribers able to specify the kinds of information they want to receive. The new service "strengthens FDA's ability to keep its audiences informed quickly and effectively," said Commissioner of Food and Drugs Andrew von Eschenbach. To receive e-mail alerts, subscribers need only click on a red envelope icon on an FDA web page; each e-mail update will include a link to the web page that has been updated. A list of currently available topics can be found at www.fda.gov/emaillist.html. December 6, 2007 Teen Birth Rate Rose in 2006 For the first time since 1991, the rate of births to teenagers rose last year, increasing to 41.9 live births per 1000 females ages 15 to 19 years old. The 3 percent increase follows a 14-year downward trend in which teen births had fallen from an all-time peak of 61.8 births per 1000 in 1991. "It's way too early to know if this is the start of a new trend," said Stephanie Ventura, head of the Reproductive Statistics Branch of the Centers for Disease Control and Prevention (CDC), which compiled the report. "But given the long-term progress we've witnessed, this change is notable." The largest increases in teen births were to non-Hispanic black teens, whose overall rate rose 5 percent in 2006. The rate of increase was 2 percent for Hispanic teens, 3 percent for non-Hispanic white teens, and 4 percent for American Indian teens. The full report, which includes data on total births in the United States in 2006, is available online at www.cdc.gov/nchs. December 11, 2007 Survey Finds Declines in Smoking, Drugs at Eighth Grade This year’s Monitoring the Future survey found encouraging drops in both smoking and illicit drug use by eighth graders, and the director of the National Institutes of Health (NIH) credited the declines to "a large science-based effort throughout the public health community to drive down the rates of smoking, illicit drug, and alcohol use among teens." The director of NIH's National Institute on Drug Abuse (NIDA) Nora Volkow said her agency will be watching closely over the next two years to see if the decline will stick as the kids get older. "If this change in attitude is carried with them throughout the rest of their teen years, we could see a dramatic drop in smoking-related deaths in their generation," Volkow said. The Monitoring the Future survey, now in its 33rd year, is a series of independent surveys of 8th, 10th, and 12th graders conducted by researchers at the University of Michigan under a grant from the NIDA. This year's findings, while encouraging for eighth graders, revealed other problems, including that prescription drug abuse remains high, with Vicodin one of the most commonly abused drugs among 12th graders. Also of concern is a softening of attitudes toward MDMA (Ecstasy) and LSD in the younger grades, with a decrease in perceived harmfulness at 10th grade and an increase in Ecstasy use by 10th and 12th graders over the past two years. Information about the Monitoring the Future survey is available online at http://monitoringthefuture.org. December 13, 2007 Bush Vetoes Second SCHIP Bill As he had promised to do, President Bush yesterday vetoed a bill reauthorizing the State Children’s Health Insurance Program (SCHIP). The vetoed legislation was the second try by Congress at a reauthorization; Bush had previously vetoed the first SCHIP bill Congress passed, and the new proposal was intended to meet some of the President’s objections to that original proposal. On its second try, however, Congress maintained a $35 billion additional federal contribution to SCHIP over the next five years, to enable states to enroll more children, which is more funding than the administration wants and apparently led to the veto. Negotiations in the House and Senate over a possible third SCHIP bill appear to have broken down, making it likely SCHIP will survive only at current funding levels and only for an indefinite time in the coming calendar year. December 17, 2007 Senate Drops School Food from Farm Bill Under pressure to enact a multi-billion-dollar bill of farm supports, the Senate late on Thursday evening dropped a series of amendments that had been proposed to the bill, including a proposal to limit the food that can be sold in schools. The amendment would have banned certain high-sugar, high-fat drinks and snacks from vending machines and a la carte cafeteria lines in schools. The amendment's major sponsor, Senator Harkin (D-IA), while conceding the need to drop the amendment in order to facilitate passage of the farm bill, vowed to bring the subject of school food up again in the new session of Congress that will convene in January. December 19, 2007 Senate Reauthorizes SCHIP to 2009 In a bill that has not yet been passed by the House or signed by the President, the United States Senate yesterday reauthorized the State Children's Health Insurance Program (SCHIP) through March 2009. The Senate-passed bill, S. 2499, also extends and makes changes in other federal health programs, including Medicare and Medicaid. Among other things, the bill would delay implementation of recently released regulations limiting Medicaid reimbursements to schools. The full text of S. 2499 and information about action on the legislation in the House will be available at http://thomas.loc.gov. December 20, 2007 House Agrees to Short-Term SCHIP Reauthorization The U.S. House of Representatives voted nearly unanimously yesterday to reauthorize the expiring State Children's Health Insurance Program (SCHIP) until March 2009. The reauthorization had been approved by the Senate earlier and the House action now clears the bill, S. 2499, for signature by President Bush. Further action on a longer-term reauthorization of the popular child health insurance initiative was promised by Senate supporters, and SCHIP is expected to be a major issue in the new Congress. The President twice vetoed earlier reauthorizations passed by Congress because of disagreement over the level of funding for the program. |
