Vioxx Side Effects
The Killer Painkiller Saga Continues
Merck’s Muck-up
Folks, this Vioxx story keeps peeling like an onion into more and more disturbing layers.
Not long ago, I told you about what I thought was the “seedy underbelly” of the Vioxx heart-risk story (Daily Dose, 10/11) – the fact that the medication’s deadly downsides were discovered in a clinical trial evaluating the use of this drug for a condition far removed from what it was designed to treat.
But I’ve since learned that this fact is but a pimple on the REAL seedy underbelly of the story – the fact that Merck (Vioxx’s manufacturer) knew about Vioxx’s ticker-troubles for MORE THAN FOUR YEARS prior to pulling it from shelves in September.
Yet still their full-page ads claim they took “prompt and decisive action” on behalf of the public!
According to a recent New York Times article, Merck officials convened way back in May of 2000 specifically to discuss whether Vioxx posed a serious heart risk to those taking it. Suggestions of such a possibility had surfaced 2 months before this meeting as results from one of the manufacturer’s clinical trials (for a possible use of the drug other than for arthritis, of course) suggested the need for a serious heart risk study.
Yet instead of doing the right thing and pulling the drug (or at least studying it) a whole presidential administration ago, Merck’s company scientists buckled under pressure from the drug giant’s marketing department – and decided to DO NOTHING, to deadly effect. In the Times piece, a presentation slide from that very meeting is quoted as reading “At present, there is no compelling marketing need for such a study The implied message in not favorable.”
And here’s something even more disturbing (if you can imagine anything more disturbing than marketing gurus playing it fast and loose with your health): According to the Times story, Vioxx has OFTEN AND CONSISTENLY come under fire for heart- and stroke-related risks by outside scientists and doctors since 1999. Keep reading
The New York Times piece cites no less than 5 instances BEFORE the August 2004 Kaiser-Permanente study (the one that finally toppled the drug) in which Merck’s Vioxx came under attack from the scientific and medical community for increasing patients risk of heart attack and stroke:
- In January of 1999, a rheumatoid arthritis study began which ultimately showed that patients taking Vioxx experienced 5 TIMES AS MANY heart attacks as those taking an ordinary pain reliever.
- Then in 2001, a group of cardiologists published an article linking the drug to heart attack and stroke risk in the Journal of the American Medical Association (but not before Merck officials tried to quash the piece).
- And in October of 2002, A Vanderbilt University epidemiologist found that Medicaid patients taking high doses of Vioxx suffered significantly more heart attack and strokes than similar patients not taking the drugs.
- Again in 2002, a Massachusetts research lab concluded that Vioxx damaged blood lipids in such a way as to increase the risk of clotting-a major factor in strokes and coronary events.
- In April of 2004, the journal Circulation published some Harvard Medical School research showing that Vioxx raised heart attack risks relative to other drugs in its class. Later, the same researchers linked the drug to increased hypertension.
So you see, it took a WHOLE LOT OF PRESSURE over an awfully long span of time before Merck “voluntarily” pulled killer Vioxx from the market. In the meantime, the health of potentially thousands of patients may have been affected. Shame on them!
But the glaring question that remains is this: Where was the FDA during all of this? What was the only organization out there designed to protect us from this kind of fiasco up to while all this was going down? The answer in the next Dose
Always peeling the “onion” even if it does make me cry,
William Campbell Douglass II, MD
