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Merck hid Vioxx data from FDA
Merck hid Vioxx data from FDA -- Posted by outrider on 07-03-05 22:23
2000 study by Merck showed Vioxx risk Results not given to FDA
Sunday, July 03, 2005
BY ED SILVERMAN
Star-Ledger Staff
Merck officials five years ago conducted an internal analysis that
revealed patients taking Vioxx were twice as likely to suffer heart
attacks as those on similar painkillers, but the giant drug maker never
reported its finding to federal regulators.
Merck's analysis included the review of more than 20,000 study patients
from five trials. Other findings from the study were provided to the
Food and Drug Administration in January 2001 in preparation for a
regulatory meeting. Merck, however, did not include the portion that
measured the rate at which Vioxx users suffered heart attacks.
Ted Mayer, an attorney who represents Merck, said the analysis was not
given to the FDA because it was not statistically sound. He also said
regulators were given a broader overall analysis that, at the time,
found no excessive risk associated with Vioxx.
"It was not a statistically valid pooling," Mayer said. "You don't
disclose every single piece of data or the way you think about it. You
disclose your best analysis of the data."
The existence of this previously unreported analysis surfaced last week
when it was disclosed during a hearing in state court in Atlantic City,
where more than 2,000 lawsuits have been filed against the Whitehouse
Station drug maker over Vioxx.
The company's findings five years ago were part of a larger scientific
review of Vioxx called a meta-analysis -- a common practice in the
pharmaceutical industry in which companies pool results from previous
patient trials and study the combined data. Merck launched its
meta-analysis of Vioxx after concerns were raised in 2000 that the
medicine was linked to heart attacks.
The result places Merck's own review among the first scientific
confirmations that Vioxx held a greater risk than competing medicines.
The drug, which once was used by millions of Americans, ultimately was
pulled from the market last fall, and the company now faces billions of
dollars in potential damages from lawsuits.
A spokeswoman for the FDA, Laura Alvey, said a company isn't required
to submit every single analysis, but the agency would want to see a
danger signal.
LEGAL FIGHT TAKING SHAPE
The disclosure is the latest episode in a mounting battle between Merck
and a cadre of lawyers from around the country who claim the company
failed to properly disclose cardiovascular side effects caused by
Vioxx.
"You don't find this (analysis) on the product label," David Buchanan,
a lawyer who represents a union that claims it was overcharged for an
unsafe drug, said during a hearing last week. He cited the previously
undisclosed analysis in his argument.
The first trial is slated to begin later this month in Texas, where a
60-year-old woman says Vioxx caused her husband's heart attack and
death. The implications for Merck are enormous.
Many Wall Street analysts estimate Merck faces liability from $4
billion to $30 billion, depending upon the outcome of the first few
trials. If Merck loses those trials, analysts say, others may be
encouraged to file lawsuits.
To make their point, lawyers are expected to argue that Merck
manipulated clinical trial designs and outcomes, concealed unfavorable
findings, improperly promoted the drug to doctors and attempted to
silence critics, such as academics who raised safety questions.
For its part, Merck maintains it promptly investigated questions about
heart problems linked to Vioxx and disclosed all pertinent material to
the FDA. The company also argues that internal memos are being leaked
to the media and taken out of context.
THE NAPROXEN EFFECT
In discussing the newly disclosed analysis and why it wasn't submitted
to the FDA, Mayer explained the trial results included some studies
that were skewed by the use of naproxen by some patients.
Since questions about Vioxx first arose, Merck has explained that
clinical trials showed a higher incidence of cardiovascular side
effects among Vioxx patients, compared with those given naproxen, an
older painkiller. Merck hypothesized that naproxen benefits the heart.
This explanation was cited when in 2000 the company reported the
results of its so-called Vigor trial, which found that Vioxx patients
were five times as likely to suffer heart attacks as were patients on
naproxen, which is another type of non-steroidal anti-inflammatory.
For this reason, Mayer said, using the newly disclosed analysis to
measure the risk of heart attacks among all clinical-trial patients was
not useful. He said this conclusion was backed by a team of outside
consultants, although he declined to identify them.
"This analysis was done in the course of doing a reality check," Mayer
said. "They went where the statistical rules told them to go. But the
tests showed you couldn't combine (the different Vioxx trials) and get
proper results" due to the naproxen effect.
Chris Seeger, another attorney who represents the union as well as
individuals suing Merck, said this wasn't the only instance in which
Merck didn't disclose the five-year-old analysis. He pointed to an
October 2001 article in Circulation, a medical journal that discussed
risks but not the specific findings.
Several authors were Merck employees.
"If the findings were so benign, why didn't they just disclose it to
the FDA?" Seeger said. "If Merck thought it was meaningful for their
scientists to run data on only heart attacks, I think that data would
also have been meaningful to the FDA and doctors."
RESPONDING TO RED FLAGS
Experts note that large-scale reviews of clinical trials -- the
meta-analyses -- can be imperfect, likening the effect to mixing apples
and oranges. But these experts also said the results can be meaningful
and that worrisome signals shouldn't be ignored.
"There's no reason why a company can't play around with its internal
data for its own benefit," said Sheldon Krimsky, a science policy
expert at Tufts University. "But if there was evidence the drug was
dangerous and they didn't report it, they violated their fiduciary
responsibility to consumers."
The issue, he added, is an extension of the recent debate over
disclosing clinical-trial data. A controversy arose last year after it
became known that some drug makers failed to report adverse events in
their clinical trials for antidepressants.
Another expert, Arthur Caplan, who heads the Center for Bioethics at
the University of Pennsylvania, noted that such concerns should extend
to a drug maker's meta-analysis, even though current FDA regulations do
not require a company to report such findings.
"In this case," Caplan said, Merck had "an ethical duty to report the
data. If we're talking about deaths, it's serious. The stakes are
higher."
Ed Silverman may be reached at (973) 392-1542 or
esilverman@starledger.com.
=A9 2005 The Star Ledger
=A9 2005 NJ.com All Rights Reserved.
FAIR USE NOTICE: This may contain copyrighted (=A9 ) material the use of
which has not always been specifically authorized by the copyright
owner. Such material is made available for educational purposes, to
advance understanding of human rights, democracy, scientific, moral,
ethical, and social justice issues, etc. It is believed that this
constitutes a 'fair use' of any such copyrighted material as provided
for in Title 17 U.S.C. section 107 of the US Copyright Law. This
material is distributed without profit.
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