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...

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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…