Journal expresses Vioxx concerns

Editors at the New England Journal of Medicine said in their Feb. 23, 2006 editorial that they “reaffirm our expression of concern” about Merck’s handling of its Vioxx Gastrointestinal Outcomes Research (VIGOR) study. The concerns focus mainly on the data contained in the study – and that which was left out.

The NEJM published an internal memo dated July 5, 2000 that showed at least two of the authors of the paper knew that not all heart attacks and other cardiovascular risks that occurred during the study had been reported. The results, the editors say, “should have raised concern about potential [heart attack and stroke risks]” and would have made a big difference in the safety rating. The study was published in the NEJM on November 23, 2000, four months after the dated memo.

The problem is that the authors started writing the paper before the actual study was completed. Therefore, the data were not included because they were measured after the “prespecified cutoff date.” To further complicate matters, the cutoff date for cardiovascular side effects was one month before the cutoff date for stomach-related injuries. In other words, the study allowed more time for stomach side effects of naproxen to roll in, but stopped counting the number of heart attacks caused by Vioxx. According to the NEJM, this would have made the conclusions about the safety of Vioxx misleading.

In fact, using all the data from the completed study, the NEJM showed that for every major stomach-related injury Vioxx saved, it caused a major cardiovascular event like a heart attack or stroke. Most experts would agree that the “trade-off risk” between Vioxx and naproxen was not worth it, especially considering that Vioxx cost so much more.

Both the independent authors of the study and the Merck representatives defended the study in unedited letters to the editor published in the same issue of the NEJM. Those from Merck said all coauthors “worked diligently to present the VIGOR data in what we believed to be a scientifically appropriate manner.” The independent authors stated: “We stand by our original article, which was written in line with basic clinical trial principles.”

This may be true, but there are many in the scientific community who question those very principles. It doesn’t take a doctor to realize that if you write the conclusions to a study before the study is finished, you are not going to get the most accurate results. And if important data is left out that could prove a product is unsafe because it happened after the cutoff date… well it may fall in line with basic clinical trial principles as they stand today, but certainly not moral principles.

If you or a loved one has experienced heart attack, stroke, or any other cardiovascular side effect while taking Vioxx, contact Jim S. Adler & Associates today. You may be entitled to compensation to cover your extra medical bills, lost wages, and pain and suffering. Jim S. Adler & Associates has the medical expertise to meet these pharmaceutical companies in court and argue your case before a jury to ensure you get the best compensation package possible. Don’t sign any papers before you talk to us, and don’t settle for less. Call us directly or click on the link below for a free case review.