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Tom Methvin
Tom Methvin
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Merck's 18-Month Myth Is Now Totally Deflated

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Merck & Co. has been playing fast and loose with the truth for years relating to its testing and marketing of Vioxx. Finally, in an admission that undermines its core defense in Vioxx-related lawsuits, Merck has finally decided to tell the truth. Merck now says it erred when it reported in early 2005 that a crucial statistical test showed that Vioxx caused heart problems only after 18 months of continuous use. Merck admits now – after lying for months to the media and even in courts – that a statistical analysis test does not support Merck’s 18-month theory about Vioxx. Merck’s admission, when considered along with the results of other clinical trials of the drug and studies tracking real-world Vioxx use, supports critics’ longstanding contentions that Vioxx causes heart problems quickly. Dr. Alastair J. J. Wood, a drug safety expert at Vanderbilt University, correctly observed, “There never was any evidence for the 18-month story.”

Merck’s cadre of witnesses has been telling courts and juries for months that there was an 18-month use requirement. Clearly, the 18-month issue is crucial for the 20 million Americans who took Vioxx. Taking Vioxx has caused thousands of folks to have heart attacks and strokes. An official with the FDA puts the number at about 40,000. Merck has used the 18-month theory as a defense since Vioxx was withdrawn from the market in September 2004. In defending the lawsuits, Merck, which knew it was scientifically wrong, has consistently taken the position that Vioxx can cause heart problems only if it is used continuously for more than 18 months. Merck has based the 18-month theory largely on data from the APPROVe study, in which the company tracked 2,600 patients in a test to see whether Vioxx could prevent colon polyps. The media was hoodwinked into buying the myth, and I am told that even they now realize it was all a big lie!

In the study, twice as many patients taking Vioxx suffered heart attacks or strokes as those taking a placebo. When it reported the APPROVe results in The New England Journal of Medicine early last year, Merck said that it had performed a statistical test to examine whether Vioxx’s risk changed over time. According to Merck, that test found with almost total certainty that the drug had significantly higher risk than placebo only after the 18-month benchmark — but no extra risk before that time. Now Merck said it had made a mistake in reporting that result last year. In reality, the test that the company said it had used to check the results is proof that Vioxx causes heart attacks both before and after the 18-month benchmark is reached.

Dr. Steven E. Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, says the mistake Merck now admits is just another example of Merck’s mishandling data to make Vioxx seem safer. In this regard, Dr. Nissen says:

They’re acknowledging that they misrepresented the APPROVe data, when they reported that there was a statistically significant difference between the first and the second 18 months. There is no biologically plausible reason to expect an 18-month delay. I never thought it made any sense.

Families who have been hurt by Merck’s lying about Vioxx have a right to be outraged. The federal government should now do a thorough investigation of Merck’s conduct and take appropriate action. Because I have little confidence that the FDA will take any real action because of Merck’s power and influence, it will be up to judges and juries to get to the bottom of all of this.