WebMD Medical News
Daniel J. DeNoon
Louise Chang, MD
Nov. 23, 2009 - Merck should have known Vioxx was deadly years before they
pulled the drug from the market, a study of Merck's own data suggests.
The study, published in the current issue of the Archives of Internal
Medicine, is by Joseph S. Ross, MD, of Mount Sinai School of Medicine, and
colleagues. The study authors were paid consultants to plaintiffs' lawyers in
Vioxx lawsuits -- in which much of the Merck data first was revealed.
"By our analyses, the association is clear that by June 2001 -- more than
three years before the drug was eventually taken off the market -- the risk
could have been known," Ross tells WebMD.
Merck took Vioxx off the market in November 2004, after the "APPROVe" study
conclusively demonstrated that Vioxx users had more heart
attacks and strokes than patients receiving a placebo.
In their study of data from Merck-sponsored clinical trials, Ross and
colleagues found that:
In a written statement and in an interview with WebMD, Merck says the study
is flawed. It maintains that the company acted responsibly both in conducting
safety studies and in pulling the $2 billion per year drug from the market as
soon as it was aware that the drug increased the risk of heart attack and
"We fundamentally disagree with their conclusions that there was an
actionable signal before September 2004," Doug Watson, PhD, senior director of
medical science for Merck Research Laboratories, tells WebMD.
Watson says that when Merck looked at the data, its researchers were much
more thorough than Ross and colleagues. Most importantly, Watson says, the
company used independent evaluators to determine whether adverse events were
truly related to heart attack or stroke, and whether deaths were due to heart
attacks or strokes or to non-Vioxx-related causes such as infections or
"We disagree with their conclusions that there was a finding that should
have resulted in earlier action on our part, because we disagree with the
methods they use," Watson tells WebMD. "We investigated Vioxx while it was on
the market ... based on the most rigorous scientific methods, vetted with the
FDA, and we did not see a signal prior to the APPROVe study."
Ross defends his team's methods as the best way to look for a safety signal.
He notes, for example, that if a patient on Vioxx died due to an accident, it
may very well have been a heart attack that led to the accident. And he points
to the fact that the heart/stroke risk of Vioxx is now a widely accepted
medical fact -- and that Merck's studies failed to detect this risk until some
20 million people had taken the drug.
Ross says the real message of the study is not to point fingers at Merck.
The point, he says, is that routine safety evaluations -- using all clinical
data, not just published data -- should be performed on all new drugs.
"What we are saying is this kind of study should be done routinely,
particularly when there is a known safety concern about a drug," Ross says.
"This safety monitoring is not rocket science. We would be protecting the
publics' health because we would be identifying risks earlier."
Federal law enacted since the Vioxx debacle now requires companies to
disclose clinical trial data to the public within 12 to 24 months of study
In late September, Merck settled more than 3,000 Vioxx lawsuits in a $4.85
billion settlement. That reversed a company policy of fighting each lawsuit one
at a time, even though the company has won most of these suits.
SOURCES:Ross, J.S. Archives of Internal Medicine, Nov. 23, 2009; vol 169: pp
1976-1984.Woloshin, S. and Schwartz, L.M. Archives of Internal Medicine, Nov.
23, 2009; vol 169: pp 1985-1987.Hirsch, L.J. Mayo Clinic Proceedings, September 2009; vol 84: pp
811-821.News release, Merck, Nov. 23, 2009.Joseph S. Ross, MD, MHS, assistant professor of Geriatrics and adult
development, Mount Sinai School of Medicine, N.Y.Doug Watson, PhD, senior director of medical science, Merck Research
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