READER RESPONSE:Merck & Co responds to report on the withdrawal of Vioxx
Re: Vioxx risks known before withdrawal, Healthplus, November 24th
Dear Sir,
Your recent column "Vioxx risks known before withdrawal" described an article published in the Archives of Internal Medicine, but it did not include discussion of some of the important limitations in that article.
It is important to recognise that the article was authored by paid consultants of plaintiffs’ attorneys involved in litigation against Merck & Co.
Their analysis included no new data and used unreliable methods and reached incorrect conclusions.
For example, while the authors purported to conduct an analysis designed to look at the safety of Vioxx with respect to thrombotic events, they ignored the results of a rigorous adjudication procedure designed to determine whether or not events were in fact thrombotic, and they included a number of events – including electrocutions, infections and traumas – that were clearly not.
The authors also included a number of events that occurred long after patients had stopped taking any medicine. The authors’ methodology was less reliable than the methodology Merck itself used when evaluating Vioxx’s safety.
The scientific exercise of examining what the data showed about Vioxx’s cardiovascular safety over time is an important one, and Merck scientists did exactly that, in real time while Vioxx was on the market.
These regularly updated analyses of a large body of data from randomised clinical trials, conducted in consultation with outside experts and with regulatory agencies, did not demonstrate an increased risk of thrombotic events when Vioxx was compared to placebo.
The first time Merck observed a difference in a placebo-controlled study was when it learned the results of the APPROVe study in September 2004. We voluntarily withdrew Vioxx from the market within a week of those results.
Since that time, additional analyses have supported the conclusion that Vioxx’s cardiovascular safety is no different from that of other Cox-2 selective inhibitors and traditional NSAIDs that remain on the market throughout the world.
The fact is, nothing is more important to Merck than patient safety. Merck acted responsibly – from researching Vioxx prior to approval in studies with approximately 10,000 patients, to monitoring the medicine while it was on the market, to voluntarily withdrawing the medicine when it did.
Yours etc,
Ron Rogers,
Global Communications,
Merck Co Inc.