Remember the "super aspirin", Vioxx? You might recall Bruce Jenner or Dorothy Hamill plugging its ability to treat everything from arthritis pain to muscle cramps. No?
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If not, you may still remember the hullabaloo surrounding Merck's abrupt withdrawal of Vioxx in 2004, just five years after it received FDA approval. The accompanying media circus, multi-billion dollar settlement, and FDA refusal to approve any Cox-2 inhibitor drugs since (despite their widespread use in Europe and elsewhere) has dramatically affected the lives of millions of patients. In an attempt to "play" the FDA and the market, Merck reduced healthcare options for every American.
Cox-2 drugs provide all the pain relief of drugs like Aspirin, without the same severe gastrointestinal side effects. Before the fall of Vioxx, approximately 25 million Americans had benefited from the wonder drug. It was a special godsend for those who suffered from GI problems, since approximately 15,000 people a year die of GI-related side effects.
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So what happened between 1999 (when Vioxx was approved) and 2004? A few things. Merck, the producer of Vioxx, released a study designed to confirm the apparent. Known as the VIGOR Study, its objective was to compare the GI effects of pain-relievers Vioxx and Naproxen. True to expectations, the study proved (page 83) that participants taking Naproxen experienced over twice as many adverse GI effects as those taking Vioxx.
In other words, Vioxx was shown to be the safer drug. Nevertheless, Vioxx was removed from the market, while Naproxen is still available. Why?
Conventional wisdom states that Vioxx was removed because, despite the FDA assurance of its safety and effectiveness, it directly causes heart attacks, and that the VIGOR study proves this. You will find that claim in any number of news articles from sources such as the New York Times, Huffington Post, CBS, and others. Just google "Vioxx heart" and no doubt you will be beset by articles touting the dangers of Vioxx. The one place you will not find it is in the New England Journal of Medicine, which published the original VIGOR study in 2000, and released a defense of the study in 2006, in which they fully stood by their original conclusions.
It has never been proven that Vioxx causes heart attacks in a statistically significant way. Yet Merck, in a moment of political posturing, suggested that it did. On September 30, 2004, Merck's Chief Executive Raymond Gilmartin released a statement, claiming that Merck would be withdrawing Vioxx based on inconclusive results from an unfinished study. At that time, Merck released no conclusive evidence, and even the FDA did not have the data necessary to conclude that Vioxx was harmful.
My theory on Merck's poorly conceived strategy is this: Merck was planning to release the "new-and-improved" version of Vioxx, known as Arcoxia. It was being reviewed by the FDA at the time of the Merck press release on Vioxx. If Merck was viewed as being particularly noble in withdrawing a drug out of the deepest concern for its patients, this "sacrifice" would make them look good, provide free publicity for Arcoxia, and allow them to avoid having to contend with generic forms of Vioxx cutting into their sales. This is nothing new: a similar maneuver was used when Seldane was replaced by Allegra in 1997.
Sadly for Merck, they embarrassed the FDA. One of their "safe and effective" drugs was hailed as being unsafe. It consequently did not defend Vioxx, and it certainly did not grant approval to Arcoxia. Merck had to shell out billions of dollars in litigation fees, and received no return on their investment in Arcoxia in the American market. In addition, it withdrew another Cox-2 inhibitor drug, Bextra, leaving Americans patients looking for Cox-2 inhibiting medication with only one option (Celebrex).
In the case of Vioxx, the FDA did not protect patients, nor the drug companies whose medicines it approved from costly litigation. Thanks to Merck and the FDA, individuals suffering from pain and GI problems now have fewer choices than ever. The lives of millions of Americans were thus manipulated by a powerful regulator with little to no concern for its stated mission. The FDA's vindictive refusal to approve Arcoxia may have shown Merck up, but the American people are left holding the bag in these power plays.
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