• Defective Drug Side Effects

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A senate hearing regarding Vioxx began Thursday, November 18 following the massive drug recall announced by manufacturer Merck & Co. at the end of September. Inquiries about both the FDA and Merck''s knowledge about Vioxx safety concerns and when they were learned prompted the hearings. FDA scientist David Graham, associate director for science in the FDA''s Office of Drug Safety, created even more controversy when he named five other drugs on the market he believes needs closer scrutiny for possible side effects.

The FDA has been widely criticized for failing to adequately monitor patient safety. Graham had presented his own FDA sponsored study suggesting Vioxx caused heart attacks and stroke in August, a month before the drug was eventually recalled, but alleged senior FDA officials tried to suppress his presentation. After Graham''s testimony Thursday, shares of several makers of the drugs he questioned for safety sharply fell.

According to Graham, Abbott Laboratories'' weight loss drug Meridia, AstraZeneca''s cholesterol- lowering drug Crestor, Roche''s severe acne medication Accutane, Pfizer''s arthritis medicine Bextra (which is in the same drug class as Vioxx) and GlaxoSmithKline''s asthma and chronic obstructive pulmonary disease drug Serevent pose serious safety concerns.

Meridia has been used by 15 million patients worldwide and can cause high blood pressure, according to Graham. He said that when he raised a question about the drug''s usefulness in a report, he was forced to delete it.

Crestor has been prescribed to more than 3.5 million people worldwide and is the “only cholesterol-lowering drug that causes acute kidney failure,” Graham said.

Roche''s Accutane acne drugs was intended to treat severe acne but received a lot of criticism when a growing number of patients were prescribed it for just mild to moderate acne problems. Described as a “20-year regulatory failure” by Graham, Accutane can causer serious birth defects if taken by pregnant women. Though the FDA has implemented efforts to prevent this from occurring, Graham said none of the measures have been effective.

Bextra is part of the class-2 inhibitors that Vioxx belonged to. Since the Vioxx recall, the entire class of drugs has been questioned, and a recent study showed the incidence of heart attacks and strokes among Bextra patients was more than double that of patients taking a placebo.

Even before Serevent was FDA approved, a British study found with 90 percent certainty that it increased the risk of death from serious asthma complication, Graham said.

Graham''s testimony does not appear to reflect the FDA''s opinions, with the deputy director of the Office of New Drugs in the FDA''s Center for Drug Evaluation and Research telling committee members that there is no evidence the five drugs pose any more risk over other drugs.