The first federal lawsuit over the anti-inflammatory drug Vioxx ended in a mistrial in the US, even after it was proven that key evidence was withheld in clinical trials.
According to the [The New England Journal of Medicine] authors of the Canadian-led clinical trial on the safety of the arthritis drug Vioxx withheld important information on heart attack risks.
Obtained by subpoena in the Vioxx litigation trial and made available to the Journal, "at least two of the authors [who reported the clinical trials] knew about the three additional myocardial infarctions at least two weeks before the authors submitted the first of two revisions and 4 1/2 months before publication of the article. Given this memorandum, it appears that there was ample time to include the data on these three additional infarctions in the article."
Furthermore, the Journal determined that some of the data from the VIGOR (Vioxx Gastrointestinal Outcomes Research) manuscript was deleted just two days before it was initially submitted to the Journal on May 18, 2000.
The VIGOR study compared the safety of Vioxx to naproxen, a similar anti-inflammatory drug prescribed for rheumatoid arthritis. Merck & Co., the manufacturers of Vioxx, withdrew the drug from the market in 2004 after research indicated that the risk of heart attack doubled in patients taking Vioxx for 18 months or longer.
Obviously, mentioning these three events could prove costly for Vioxx. What appears to be a blatant cover-up by the drug company also puts anyone who was prescribed Vioxx at a greater risk. Currently, the New England Journal of Medicine has asked the authors to submit its corrections.
Coincidentally, Dr. Eric Topol, a cardiologist and the head of Cleveland Clinic at Case Western Reserve University, lost his leadership position at the medical school after testifying at the federal trial that Vioxx posed an "extraordinary risk" of causing heart attacks.
Merck & Co. faces at least 7,000 lawsuits over Vioxx.