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Health Highlights: June 18, 2004

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  • Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

    FDA Scientists Disputed Plan B Decision

    Internal U.S. Food and Drug Administration documents show that its own top scientists disagreed with the stated reasons given by the FDA for its rejection of an application to make the emergency contraceptive Plan B available without a prescription.

    The scientists charged that the reasoning used to justify the decision was unfounded, the Washington Post reported.

    In particular, the scientists disputed the FDA suggestion that there was not enough information to assess how easier access to the emergency contraceptive might affect the sexual behavior of teenagers.

    This was the primary reason given by the FDA to explain its refusal of the application, which was announced May 6.

    An FDA spokesperson told the Post that the agency would not comment on internal documents that were part of the decision-making process.

    Following the decision, many critics accused the FDA of caving in to political pressure from social conservatives who opposed easier access to the emergency contraceptive.

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    Rickets Resurges in Canada

    Rickets, a serious childhood disease in which children's bones soften and break, is making an alarming comeback in Canada, according to the Canadian Paediatric Society.

    At least 84 children in Canada have been diagnosed with the disease in the past two years, according to a study released Thursday at the society's annual meeting. Rickets virtually disappeared from the country more than a generation ago, the Globe and Mail of Toronto reported.

    These 84 cases are just the "tip of the iceberg," warned Dr. Leanne Ward, a pediatric endocrinologist at Children's Hospital of Eastern Ontario in Ottawa.

    The study says this resurgence of rickets is caused mainly by two measures meant to improve and protect children's health: breast-feeding and the use of sunscreen.

    Rickets is caused by vitamin D deficiency. By blocking the sun, sunscreen interferes with the natural formation of vitamin D by the body. Breast milk, while rich in many nutrients, does not contain adequate vitamin D, the Globe and Mail reported.

    All breast-fed babies should receive a daily supplement of vitamin D, and nursing mothers should also take a vitamin D supplement, the study authors recommended.

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    Merck Supports Drug Trial Registry

    Merck & Co. Inc., one of the world's leading pharmaceutical companies, supports the concept of a U.S. government-run database to provide public information about clinical drug trials.

    The company revealed its position on the issue in an interview Thursday with the New York Times. This is the first significant indication of drug industry support for this kind of database.

    Recently, both the American Medical Association and the International Committee of Medical Journal Editors called for a clinical trial registry that would include both positive and negative trial results.

    Currently, drug companies do not have to release negative drug trial results.

    Two other major drugmakers told the Times that they were not prepared to take a position on the matter. The drug industry's major trade group said it was too early to make a comment because it had not seen specific proposals for a trial registry.

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    GAO: Drugs Easy to Get on the Net

    The investigative arm of Congress has found that drugs, including narcotic-based painkillers, are easy to buy from Internet-based pharmacies, and that the practice could harm some customers.

    The General Accounting Office (GAO) also found, however, that Web pharmacies in Canada provided safe medications and had much tighter restrictions than most based in the United States, according to a new report it issued Thursday.

    GAO investigators obtained 68 samples of 11 different drugs from pharmacies in Canada, the United States, and several foreign countries. All the Canadian pharmacies required a prescription, while 24 of 29 U.S. pharmacies and all other foreign ones either required none or provided a prescription based on their own questionnaires.

    The drugs themselves weren't problematic when gotten in the United States or Canada. However, many samples from other foreign pharmacies came with no patient instructions or warnings, were shipped at room temperature when they ought to have been insulated, or weren't approved for sale in the United States. Some others appear to have been phony, according to the GAO report.

    Fourteen of the 68 pharmacies -- one sample was obtained from each -- turned out to have been under investigation for regulatory problems, such as shipping counterfeit drugs, the report found.

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    New Growth Drug Shows Promise

    A bioengineered drug for short children has shown promise in a clinical trial, its maker announced Wednesday, and if approved it would be the first new drug to treat short stature in 30 years.

    The New York Times reports that the company, Tercica, Inc., said that patients who received the drug through twice-daily injections grew, on average, an inch more a year than they would have otherwise.

    Tercica expects to use this data to seek U.S. Food and Drug Administration approval for the drug, rhIGF-1, next year. The company used technology and patents it purchased from Genentech, Inc., according to the Times account.

    The study of 65 children found that, upon receiving the drug, they grew 3.15 inches the first year and then by about two inches in subsequent years.

    No price has been set yet for rhIGF-1, but it's expected to cost about the same as growth hormone therapy, about $20,000 a year.

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    Testosterone Patch Boosts Sexual Desire in Women

    A patch delivering small amounts of testosterone greatly enhanced sexual desire and satisfaction in women whose ovaries had been removed.

    Procter & Gamble Pharmaceuticals, developers of the patch, said a new trial showed that the patch increased the frequency of satisfying sexual activity by 50 percent, according to a Newsday account.

    The study of 533 women, with an average age of 49, lasted 24 weeks. All had had their ovaries removed and all had been diagnosed with a lack of sexual desire that causes stress, Newsday reports.

    Testosterone is a male hormone, but women also produce it in their ovaries and adrenal glands. P&G; also plans to test the patch on women who underwent menopause naturally.

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