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14 Mar 2008 11:12:17 | Michael Monheit, Esquire, Monheit Law, PC
Based on an article by THE NEW YORK TIMES, by Alex Berenson,
Gardiner Harris, Barry Meier and Andrew Pollack, "In May 2000,
executives at Merck, the pharmaceutical giant under siege for
its handling of the multibillion-dollar drug Vioxx, made a
fateful decision." The article shows the following timeline of
Merck failures to recall Vioxx:
1998: Vioxx put on the market amid controversy over the safety
of Cox-2 drugs. January 1999: A study of 8,100 rheumatoid
arthritis patients begun in January 1999. February 2001: FDA
members expressed concerns about the heart risks of Vioxx and
doctors on FDA panel argued that the drug's possible harm to the
heart was a real problem. FDA panel felt that more studies
should be done. March 2000: Clinical trial suggested heart risk
concerns. In the study, called Vigor, patients were treated with
either Vioxx or naproxen, an older pain reliever. While Vioxx
reduced the risk of internal bleeding, it also appeared to raise
the incidence of heart problems. Five times as many patients
taking Vioxx had heart attacks as those taking naproxen. March
2000: Company executives were told about the preliminary results
from the Vigor trials that showed increased cardiovascular risk
and were "open to the possibility that Vioxx was at fault."
April 2000: Merck plays down the heart risk findings, with no
basis that has ever been defined by Merck as to why it ignored
the findings. Spring 2000: Merck researchers reviewed safety
data from a study of Vioxx and was unable to find that Vioxx
posed a risk. "But Merck never ran a clinical trial seeking to
scientifically establish the heart-protecting properties of
naproxen or to quantify how powerful an effect might be. In
recent interviews, company officials said they did not believe
there was a reason to conduct such tests because the critical
issue was not proving naproxen's benefits but determining if
Vioxx posed a risk." May 2000: Merck marketing executives
considered whether to directly test Vioxx for heart risk. May
2000: Marck's policy-making group met to discuss ways to defend
Vioxx against competing drug makers' accusations that it posed
cardiac risks. A cardiovascular risk study was considered. May
2000: Merck's marketing executives opposed further cardiac
study. June 2000: Merck executives rejected pursuing a study
focused on Vioxx's cardiovascular risks. Study would require as
many as 50,000 patients. Merck worried that this study would
hurt its marketing. Marketing of Vioxx was the primary concern
for Merck. Many scientists (from the academic community, not
from Merck) repeatedly asked Merck to perform studies of the
cardiovascular risks from Vioxx. For the following years, Merck
took the position that "Vioxx was safe unless proved otherwise."
During this time, "researchers fiercely debated how the question
should be pursued, and some even now question whether the drug
needed to be withdrawn." 2001: "Dr. Deepak L. Bhatt, a
cardiologist at the Cleveland Clinic, proposed to Merck a study
of Vioxx in patients with severe chest pain. Merck declined,
saying the patients proposed for the study did not reflect
typical Vioxx users." September 2001: FDA sent Merck a warning
letter stating that Merck's promotional campaign for Vioxx
"minimizes the potentially serious cardiovascular findings" in
Vigor. Septmeber 2001: Merck required by the FDA to send letters
to physicians across the country "to correct false or misleading
impressions and information." 2001: Merck achieves $2.5 billion
dollars of sales of Vioxx. 2001: Study critical of Vioxx appears
in The Journal of the American Medical Association. Data from
several clinical trials of Vioxx showed that Vioxx may increase
the risk of heart attack and stroke, and that the danger from
Vioxx appeared higher than other Cox-2 drugs. October 2002:
Study by an epidemiologist at Vanderbilt University, found that
high doses of Vioxx caused significantly more heart attacks and
strokes than similar patients who were not taking high doses.
2002: Elucida Research examined Vioxx and found that Vioxx
damaged the lipids and caused an increase in blood clots. Late
2002: Merck faces initial lawsuits from individuals suffering
from strokes and heart attacks April 2004: Harvard Medical
School found that Vioxx raised the risk of heart attacks
relative to Celebrex. June 2004: Researcher showed that Vioxx
increased the risk of hypertension. August 2004: Epidemiological
study F.D.A. researcher based on Kaiser Permanente health care
system data showed an increase cardiovascular risk for Vioxx.
Study showed increased the risk of heart disease 3.7 times
Septmeber 2004: Merck withdraws Vioxx from the market. October
2004: Thousands of people come forward with claims that their
heart attacks and strokes had been caused by Merck's Vioxx.
October 2004: "Dr. David Graham, estimates Vioxx had been
associated with more than 27,000 heart attacks or deaths linked
to cardiac problems." November 2004: SEC announces an
investigation into Merck's misrepresentations to its investors.
November 2004: Congress announces hearings into Merck's failures
and the failures of the FDA to regulate Merck. November 2004:
The Justice Department launches investigations into what Merck
knew and whether there was corporate/criminal malfeasance. Merck
now claims that it took "prompt and decisive action" once it
knew Vioxx was dangerous.
This original of this article can be found at: Monhe
it Law
About Author :
Michael Monheit, Esquire is the managing attorney for Monheit
Law, located in Philadelphia, Pennsylvania Monheit Law, P.C.
concentrates its practice in the field of plaintiff personal
injury cases on a contingency fee basis. They can be found at Monheit Law -
Vioxx lawyer
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