Health Highlights: March 4, 2006
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
Drug Companies’ Promised Trials Not Yet Started
Drug companies have not even started two-thirds of the follow-up studies that they agreed to undertake once their medicines were approved for the market, according to a government report.
The drugs often received expedited approval from federal regulators on condition that the studies be carried out, the Associated Press reported.
The Food and Drug Administration said in an annual report that, as of Sept. 30, 65 percent of the 1,231 so-called “post-marketing” drug studies that companies had pledged to carry out were still pending.
“That doesn’t mean they will never be started,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs, explaining that 116 of the 797 studies were committed to during the 12 months ending in September. The clinical trials required under the commitments can take six months to a year to design and launch, he added.
Other studies had been committed to years earlier, but the FDA didn’t provide a breakdown.
FDA spokeswoman Kathleen Quinn said the agency feels that “these numbers show drug companies are taking this thing seriously.”
But Dr. Jerry Avorn, a Harvard Medical School professor and author of Powerful Medicines, in which he criticizes the FDA’s post-marketing system, said the numbers show the system is broken.
“This new information is an embarrassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has ‘mandated’ drug manufacturers to perform. It is scandalous that of the supposedly active studies, about two-thirds haven’t even been started yet,” Avorn said.
The report, posted to the FDA Web site, lists 231 studies as ongoing, 28 as delayed and three as terminated as of Sept. 30. Another 172 studies are listed as completed or terminated, with a final report submitted to the agency.
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Wal-Mart Agrees to Sell Plan B Contraception Pill
Wal-Mart Stores announced Friday that that it would begin carrying Plan B, the emergency contraception pill, in all of its United States pharmacies by the end of the month.
But in a move that rankled some women’s groups, the company also said that it would allow pharmacists who object to filling a Plan B prescription to refer customers to another pharmacist and, in some cases, to another pharmacy, The New York Times reported.
Wal-Mart, which has 3,700 pharmacies, had been the only major chain that refused to sell the so-called morning-after pill, which can prevent pregnancy when taken within 72 hours of intercourse.
The retailer’s policy provoked criticism from groups like Naral Pro-Choice America and the Planned Parenthood Federation of America, which argued that because Wal-Mart was the only pharmacy in some areas, its decision to not carry the pill deprived women of access to a federally approved emergency contraceptive.
Responding to a lawsuit filed by three women, Massachusetts ordered Wal-Mart last month to carry Plan B in its pharmacies. Wal-Mart said it expected Connecticut and New York to enforce similar mandates.
Ron Chomiuk, vice president for Wal-Mart’s pharmacy business, said in a statement that given the impending state action and the fact that Plan B was approved by the Food and Drug Administration, “we feel it is difficult to justify” not selling the drug.
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Pesticides Found in Nearly All U.S. Rivers and Streams
Nearly all rivers and streams in the United States are contaminated with pesticides linked to cancer, birth defects and neurological disorders, said a U.S. Geological Survey (U