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FDA Allows Publication of Blocked Vioxx Study

Jan 25, 2005 | Los Angeles Times

A report on Vioxx risks previously blocked by the Food and Drug Administration was published online Monday after the agency withdrew its opposition. The study found that as many as 140,000 extra cases of heart disease in the United States and as many as 56,000 deaths were caused by the painkiller during the five years that it was on the market.

The study’s findings were announced last fall at a meeting in France and in Senate testimony by its lead author, Dr. David Graham of the FDA’s Center for Drug Evaluation and Research. Graham has been an outspoken critic of FDA’s regulatory policies for new drugs.

Like other research released last year, the study of 1.4 million patients found that low doses of Vioxx increased the risk of heart disease by about 50 percent, while higher doses increased it by 358 percent.

The study, published online by the journal Lancet, was sponsored by FDA and used data collected from patients of Kaiser Permanente California over three years.

The report was accepted by the Lancet last year and scheduled for publication in November, about the same time that Graham was to testify to a Senate committee about its findings.

“On Nov. 16, I was ordered to withdraw the paper or ‘face severe consequences’ – which I interpreted to mean that I would be fired,†Graham said. “With a gun to my head, I called Lancet and withdrew the article.â€

The spate of bad publicity about the drug led its manufacturer, Merck & Co., to withdraw it from the market on Sept. 30. The FDA cleared Graham’s paper for publication earlier this month.

The study identified about 40,000 people who used Vioxx, nearly a million who used ibuprofen, about 435,000 who used naproxen and 27,000 who used Celebrex, a drug from the same family as Vioxx.

Graham’s study found 8,143 cases of serious coronary heart disease among the painkiller users and 1,508 deaths. Although the risk of heart disease and death was substantially higher for those taking Vioxx, the study found no increased risk associated with use of Celebrex.

Graham and his colleagues estimated that Vioxx use was responsible for 88,000 to 140,000 excess cases of heart disease.


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