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Published online: 25
January 2005; | doi:10.1038/news050124-4
Painkiller blamed for heart-disease
epidemicGeoff
Brumfiel
Arthritis drug was over-prescribed
and under-regulated, say researchers.
A study of the arthritis drug Vioxx
has shown that it may have caused up to 140,000 cases of heart
disease in the United States before it was withdrawn from sale.
A separate study finds that many of the victims may have received
the drug unnecessarily.
The estimate comes
from David Graham, a researcher at the US Food and Drug
Administration (FDA) in Rockville, Maryland, and his
colleagues. The painkiller rofecoxib, sold under the name
Vioxx by New Jersey-based manufacturer Merck, was pulled from
the market in September 2004. The decision was made after a
study of Vioxx's effect on colorectal cancer revealed that it
increased patients' risk of heart attacks.
In
their study, published in The Lancet1,
Graham and his team examined the medical records of 1.4
million Californians who had used anti-inflammatory drugs.
Users of Vioxx, were between 1.6 and 3.6 times more likely to
experience heart trouble than users of a rival drug,
celecoxib, which Pfizer manufactures under the name
Celebrex.
Graham's group estimated the number
of incidents likely to have occurred between the drug's debut
in 1999 and its withdrawal from the market. By combining data
from Merck's clinical trials with data on how many patients
took Vioxx, the group concluded that the drug had caused
between 88,000 and 140,000 cases of coronary heart disease or
heart attacks.
Many of these complications could
have been avoided if FDA regulators had done more when
problems with the drug surfaced in 2000, says Graham. At the
time, they recommended simply that a warning be added about
the drug's possible complications. "This new study shows the
societal cost of not taking appropriate regulatory action,"
Graham says.
Newer not better
In a
related study, a group led by Randall Stafford of Stanford
University's Prevention Research Centre in Palo Alto,
California, found that many patients taking Vioxx did not even
need the drug.
 There is a perception that newer
drugs are better.  |
Randall Stafford
Stanford University,
California | | |
|
| Vioxx and other drugs in its class were initially
developed as alternatives to pain relievers that caused
internal bleeding in some patients. But by studying two
federal surveys, Stafford and his colleagues found that almost
two-thirds of new prescriptions written between 1999 and 2002
went to patients who were not at risk of internal bleeding. By
2002 only 39% of patients receiving the class of drugs that
includes Vioxx actually needed that type, rather than earlier
types of painkiller.
"From the perspective of both the
patient and the doctor I think there is a perception that
newer drugs are better," Stafford says. Aggressive marketing
by drug companies, combined with faith in more recent
discoveries, meant that far more people were taking the drug
than actually needed it, he says. His research is published in
the Archives of Internal Medicine2.
Both
Stafford and Graham agree that the FDA needs to be more
vigilant about watching drugs after they have been approved
and controlling the advertising blitz that often occurs after
they go to market. "It is time that we learn from these
lessons," Stafford says.
References
- Graham, D. J. et al. Lancet Published
online January 25 (2005). View article
- Dai, C., Stafford, R. S. & Alexander, G. C.
Arch. Int Med 165, 171−177 (2005).
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Story from
news@nature.com:
http://news.nature.com//news/2005/050124/050124-4.html | |
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