Health Highlights: Sept. 1, 2005

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

Prominent Journal Protests FDA''s ''Morning-After'' Pill Delay

One of the nation''s most respected medical journals issued a scathing attack Thursday on last week''s decision by the U.S. Food and Drug Administration to delay allowing over-the-counter sales of the emergency contraception pill known as Plan B.

The perspective piece from the New England Journal of Medicine was released early from its Sept. 22 issue date and followed Wednesday''s resignation of the FDA executive who had headed the Office of Women''s Health. In announcing that she was leaving her job, Susan Wood said the Plan B delay ran "contrary to my core commitment to improving and advancing women''s health."

The FDA last Friday announced that it was delaying for 60 days its long-awaited decision on whether to allow over-the-counter sales of Plan B, often called the "morning-after" pill. It can lower the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sex.

The New England Journal piece, co-authored by the editor-in-chief Dr. Jeffrey Drazen, said postponement of the Plan B decision appeared "to reflect political meddling in the drug-approval process," especially given that an FDA expert advisory panel strongly recommended in December 2003 that Plan B be approved for over-the-counter sales. The full agency normally follows its advisory panel recommendations.

In delaying its decision, the FDA said it was comfortable allowing over-the-counter sales to adults 18 and older, but wanted more time to decide how to keep it out of the hands of young teenagers.

The New England Journal piece said that "the FDA has not pointed to any data to support" its stance questioning the safety of Plan B among younger women, "nor has the agency demanded such evidence in the case of other drugs that have been switched to over-the-counter status."

The American Academy of Pediatrics issued a statement Thursday encouraging more health professionals to discuss emergency contraception with their teen and adult patients, noting that only 20 percent to 25 percent of health care providers now do so.

"Studies show that an increase in availability of emergency contraception does not change rates of sexual activity or increase the frequency of unprotected sex among adolescents," the AAP statement said.

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Hep C Sufferers at Greater Risk of Cirrhosis: Study

Almost 80 percent of people who have chronic hepatitis C for several decades or more will wind up developing cirrhosis or end-stage liver disease, British researchers say.

Some 4 million Americans and more than 170 million people worldwide are believed to have hepatitis C, a liver disease primarily spread by blood transfusion or use of contaminated needles, researchers at the Queen Mary''s School of Medicine and Dentistry in London said. Symptoms include fatigue, poor appetite, and muscle and joint pain.

The longer a person lives with hepatitis C, the more likely they are to develop cirrhosis, the researchers said in a statement. They studied 382 people diagnosed with hepatitis C at three London hospitals between 1992 and 2003.

Study results were published in the September issue of Clinical Gastroenterology and Hepatology.

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FDA: Feds Seize Counterfeit Lipitor

Two drug wholesalers, a repacking business and 11 individuals have been charged with peddling counterfeit Lipitor, the popular cholesterol reducing drug, the U.S. Food and Drug Administration says.

The U.S. Attorney for the Western District of Missouri handed down a 57-count indictment in a case that allegedly involved manufacture of the drug at a secret plant in Central America, the agency said in a prepared statement. In 2003, Kansas City, Mo., wholesaler Albers Medical Distributors and Springfield, Ill.-based H.D. Smith Wholesale Drug Co. allegedly distributed $20 million in illegally imported, stolen, and counterfeit versions of Lipitor, the FDA said. The counterfeit product allegedly was repackaged by Med-Pro of Lexington, Neb.

Most of the counterfeit Lipitor is now believed out of circulation, the agency said.

The FDA said it had no reports of ill health stemming from the fake or illegally imported drugs.

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MS Drug Maker to Ask for Warning Label

The company that makes a multiple sclerosis drug linked to an often-fatal brain disease will be asking U.S. regulators to allow the drug back on the market with additional warning labels.

Biogen Idec Inc.''s CEO, James Mullen, said in an interview with the Associated Press that the Cammbridge, Mass., company will recommend that the drug, Tysabri, include warnings about three cases of progressive multifocal leukoencephalopathy (PML), that were confirmed after clinical trials. Tysabri was withdrawn from the market on Feb. 28, three months after receiving U.S. Food and Drug Administration approval and despite hopes that it would become an important new tool in treating MS.

Mullen said the revised label that the company will propose to the FDA also will warn about risks for patients who have weak immune systems, and therefore could be more susceptible to contracting the disease.

However, Mullen added that the label language his company will suggest will acknowledge that scientists don''t understand precisely how the bioengineered drug put the three patients who contracted PML at risk of contracting the rare disease, the AP reported. Two of those patients died.

Mullen said Biogen Idec and its Irish partner on Tysabri, Elan Corp., plan to submit findings from their review of the drug''s safety to the FDA by the end of September.

After reviewing one year of data from planned two-year trials, federal regulators in November had approved Tysabri for sale to the 350,000 American sufferers of MS, a debilitating and incurable disease in which the body''s immune system turns rebellious, attacking, inflaming and damaging its own nerve tissue.