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Documents: Merck Tried To Reduce Risks Before Vioxx Hit Market
Documents: Merck Tried To Reduce Risks Before Vioxx Hit Market -- Posted by Roman Bystrianyk on 08-23-05 17:38
"Documents: Merck Tried To Reduce Risks Before Vioxx Hit Market", NBC
30, Connecticut, August 23, 2005,
Link: http://www.nbc30.com/health/4884953/detail.html
Merck & Co. sought patent protection for a way to reduce cardiovascular
problems in Cox-2 inhibitors, the class of drugs that includes Vioxx,
as early as 1998 -- a year before the popular painkiller was
introduced, newly disclosed documents show.
The application suggests that Merck was attempting to reformulate the
drugs targeted for arthritis sufferers two years earlier than had been
previously disclosed. But while the patent was granted in September
1999 by the World Intellectual Property Organization, Merck officials
say no product with those properties was ever introduced.
Instead, Merck began marketing Vioxx in the United States soon after it
was approved by the Food and Drug Administration in May 1999.
Merck stopped selling Vioxx last September after a study showed it
doubled the risk of heart attack and strokes for patients taking it for
at least 18 months. That triggered a stampede to courthouses, with more
than 4,000 lawsuits already filed against the drug maker.
Mark Lanier, the Texas lawyer who last week won a $253.4 million
verdict against Merck at the first Vioxx suit to be tried, said the
1998 patent application provides further evidence that the company knew
about the drug's dangers even before it was introduced -- and marketed
it anyway.
But Merck lawyer Ted Mayer said the company knew that Cox-2 inhibitors
didn't have the cardioprotective properties of other pain relievers
such as aspirin and was trying to enhance the class of drugs, not hide
any defects. Cox-2 inhibitors were designed to be gentler on the
stomach than aspirin and Mayer said Merck sought to create a drug that
would avoid the side effects of gastrointestinal bleeding while still
offering cardioprotective benefits.
"We were not trying to fix a problem," Mayer said.
According to the application, the invention would provide a method for
treating, preventing or reducing the risk of conditions such as heart
attacks, blood clots and strokes in patients taking Cox-2 inhibitors.
Lanier said he didn't introduce evidence about the patent application
at the Texas trial because he didn't know it existed. Mayer countered
that it had been handed over to plaintiff lawyers in discovery and was
entered into evidence, even though it was not mentioned at the trial
that ended last week.
The Associated Press, which earlier reported about attempts in 2000 to
reformulate Vioxx to reduce its cardiovascular risks after its
introduction, learned about the 1998 patent application from a doctor
working with Lanier.
In 2000, Merck researchers privately sought to reformulate the drug
even as the company was publicly playing down a study that highlighted
the pain relief medication's potential heart attack risk, according to
an internal company document.
The widely publicized study in March 2000 found that patients taking
Vioxx were five times more likely to have heart attacks than
individuals using the generic medicine naproxen. Merck insisted at the
time that this was a result of naproxen's cardioprotective properties
and not any defect in Vioxx.
But behind the scenes, company scientists were considering combining
Vioxx with another agent to reduce the risk of heart attacks and
strokes, according to the document obtained by the AP.
That document, a communication between Merck researchers and the
company's patent department, stated that the way Vioxx works to reduce
pain might also increase cardiovascular problems. They suggested a
patent be sought for a combination drug mixing Vioxx with another agent
to lessen the risk. Merck applied for a patent in 2001 but nothing came
of that invention, either.
In 2003, Merck entered into an agreement with Bedford, Mass.-based
NitroMed Inc. to develop nitric oxide medicines that could be used to
treat cardiovascular and inflammatory diseases. Preventing blood clots
is one of nitric oxide's properties, according to Nitromed. Blood clots
can lead to heart attacks.
By 2004, the companies were testing a nitric oxide-enhanced Cox-2
inhibitor using a derivative of rofecoxib, which is the primary
ingredient in Vioxx. The study of that drug was halted after Vioxx was
removed from the market.
After a nearly 10 percent tumble in trading late Friday and early
Monday, Merck shares recovered some in the afternoon. The stock was
down 17 cents to close at $27.89 on the New York Stock Exchange with
heavy volume of 46.3 million shares.
Re: Documents: Merck Tried To Reduce Risks Before Vioxx Hit Market -- Posted by Squiggles on 08-24-05 05:32
"Merck & Co. sought patent protection for a way to reduce
cardiovascular
problems in Cox-2 inhibitors, the class of drugs that includes Vioxx,
as early as 1998 -- a year before the popular painkiller was
introduced, newly disclosed documents show."
The above statement includes
all Cox-2 inhibitors. Do you
know how many of those there
are? Is there a greater number
of lawsuits for non-Vioxx Cox-2 inhibitors or less? And how do these
compare to NSAID related deaths and lawsuits?
Thanks
Squiggles
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