And so, the Vioxx saga continues. Nearly eight years after Merck withdrew the controversial painkiller over links to heart attacks and strokes, a new paper indicates the drugmaker hid evidence that Vioxx tripled the risk of cardiovascular death for more than three years before taking the pill off the market in 2004. During the same period, the paper in the American Heart Journal notes, Merck had regularly insisted such an increased did not exist.
The authors came to this conclusion after running an intent-to-treat analysis of three placebo-controlled studies that Merck conducted to determine whether Vioxx was useful in preventing or treating Alzheimer’s disease. Merck, however, did not publish such an analysis; instead, the drugmaker relied on so-called on-treatment analysis, which is not the preferred method for ferreting out potentially harmful side effects that may occur in a clinical trial (here is the abstract).
Simply put, an intent-to-treat analysis will examine patients who were on the study drug, as well as time spent off the drug, but still enrolled in the study. The on-treatment approach used by Merck will not capture as many side effects. If a drug causes people to get sick and drop out of a study, then counting only the results that occur on treatment can bias results to favor the drug being studied, since the placebo arm is unlikely to cause as many patients to drop out.
More
DelMarVa's Premier Source for News, Opinion, Analysis, and Human Interest Contact Publisher Joe Albero at alberobutzo@wmconnect.com or 410-430-5349
EVEYONE in charge of the FDA should be fired. They are SUPPOSED to give these new drugs 5 YEARS of trials before they are allowed to give them to the genmeral population. BUT, the pharma companies have successfully BRIBED them and members of Congress to "fast track" approvals. Thats why you see ads on TV for attorneys seeking individuals who have been killed or injured by all these drugs that were going to cure arthritis, blood pressure problems, joint pain, depression, etc. While we are firing FDA idiots, go on over to the Senate and take a few of them (ok, ALL of them), too. Still think they are "looking out for you"? You (we, the people) are insignificant pawns, not worth enough to worry about when it comes to profits. Wake the hell up!
ReplyDelete