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Vioxx Scandal Didn't Lead To Changes At FDA

Dec 9, 2009 | Parker Waichman LLP

The Vioxx scandal, and the Food & Drug Administration's (FDA) role in it, has not brought about much change at the agency, according to a new government report.

Vioxx was approved for use in 1999, and quickly became a bestseller for Merck, with annual sales of $2.5 billion; however, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Most recently we wrote that a study found that evidence of cardiovascular risks linked to Vioxx might have been realized almost four years before Merck pulled the drug from the market.  

Now, the Associated Press (AP) points out that the FDA  has not yet changed how it monitors drug safety, years after the issues with Vioxx began hitting front pages.

According to the AP, congressional investigators learned that the agency has not yet “followed through” with suggested changes from 2006 meant to better enable the FDA to find medication problems. Although some changes—for instance, some oversight responsibility has been changed—the majority of responsibility for decision makers still resides with scientists and not those who monitor drug side effects, said the AP. "It is not yet clear if or when FDA's decision-making process will be substantially improved as a result of its efforts," according to the Government Accountability Office (GAO) report, a copy of which was obtained by the AP.

External experts believe that not separating responsibilities from the scientists who cleared the medications, is risky. "There's this desire on the part of the people who first approved the drug to say, 'We predicted everything and it's fine,'" said Dr. Diana Zuckerman of the National Research Center for Women and Families in Washington, quoted the AP. The GAO, the Institute of Medicine, and other experts have suggested that the Office of Surveillance and Epidemiology receive equal drug safety authority in conjunction with the FDA’s Office of New Drugs, said the AP, which notes this has not yet been done.

Since the Vioxx withdrawal, revelations about the way Merck marketed the drug have raised serious questions about the firm's conduct.  For instance, a recent Australian Vioxx trial revealed that Merck, the maker of the controversial drug, paid nurses to look through medical records in search of potential Vioxx patients—without obtaining physician permission—in the hopes of garnering 100 patients per doctor, explained BNET previously. Merck apparently put on a year-end “skit” in which sales reps mocked the Journal of the American Medical Association, which published an article discussing Vioxx and issues with its cardiovascular side effects, said BNET.

One of the most shocking tactics used by Merck to push Vioxx in Australia involved the use of a fake medical journal, published by Elsevier, offering it like other peer-reviewed medical journals. The articles reprinted or summarized articles, all presenting Merck products, including Vioxx, favorably.


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