Posted on 09/22/2005 9:56:02 PM PDT by ATOMIC_PUNK
Medical statistics expert: Vioxx can double heart attack risk September 22, 2005 9:56 PM EDT ATLANTIC CITY, New Jersey. - Even short-term use of the painkiller Vioxx can double the risk of heart attack, a medical statistics expert testified Thursday in a product liability trial, a finding that manufacturer Merck & Co. misrepresented.
Testifying on behalf of a postal worker suing Merck, University of Washington biostatistician Richard Kronmal said patients who took the now-withdrawn painkiller in company-sponsored tests suffered serious side effects to blood vessels almost immediately.
"It clearly is a drug that has severe effects on the vascular system," Kronmal said.
But he acknowledged on cross-examination that neither outside scientists who reviewed safety data on the drug nor the U.S. Food and Drug Administration shared his view, and that he had never seen the medical records of Frederick "Mike" Humeston.
Humeston, 60, of Boise, Idaho, is suing Merck, claiming his Sept. 18, 2001 heart attack was caused by Vioxx. His lawyers have told jurors Merck knew of the drug's risks and failed to warn consumers.
Merck, based in Whitehouse Station, contends Humeston's heart attack was because of health problems and that, as a Vioxx user for only two months, he wouldn't have been among those at risk. Merck has said Vioxx only increased cardiac risks after 18 months of use and that it properly disclosed those risks.
The drug, pulled off the market by Merck a year ago, had been a blockbuster, with an estimated 20 million people using it. Many were arthritis sufferers dissatisfied with other prescription pain relievers because they caused stomach pain or bleeding.
In June 2000, Merck released results of a study that found Vioxx users suffered five times as many heart attacks as users of naproxen, an older painkiller. Merck said that was because naproxen protected the heart, not because Vioxx was dangerous.
The Food and Drug Administration rebuked Merck for making that assertion without proof, and Humeston's lawyers have hammered at that point.
Kronmal's testimony came as the trial - which is being closely watched because of a $253 million (euro207 million) liability verdict against Merck last month in Texas - entered its second week.
Merck has yet to begin presenting its side of the case to the seven-woman three-man jury.
Merck faces more than 5,000 lawsuits over Vioxx, nearly half of which have been filed in New Jersey. All 2,475 New Jersey cases have been consolidated under Higbee.
Merck plans to appeal the Texas verdict, which will be reduced to about $26 million (euro21.27 million) because of Texas law capping punitive damages.
The company's shares fell 20 cents to close at $27.60 in trading on the New York Stock Exchange. Shares are down more than $1.50 since the trial started.
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On the Net:
http://www.merck.com
Who's the control group in these studies. People who got aspirin? That wouldn't be a fair study.
Beware of witnesses bearing statistics.
That is what will doom Merck in these lawsuits...it's always the cover-up.
Yes, don't pay any attention to the facts that this patient had only been taking Vioxx for two months and all the data (even "hidden" by Merck and supported by the FDA) shows that only prolonged use of 18 months caused the problems. Since Merck is the evil capitalistic pharmaceutical company (all pharmaceutical companies are evil, anyway, and are getting obscene profits) let's make them pay so that all of our drug cost rise in the long run. Beside, we need to help get these poor underpaid lawyers get off the dole. If Merck actually hid data, they should pay, but it should go to the patients actually affected, not a giant payout scheme for all the sham rip-off artists, which is what it happening. By paying the sham law suits what will happen is that the patients who were the most harmed will end up with less money.
Wow! That was quite a rant. I agree with you entirely about the patients who were actually harmed.
I should have made myself more clear, perhaps. The fact that Merck attempted to deflect concerns about the product, made them the target of these more questionable lawsuits.
The jury sees cover-up evidence...and it's "Katie-bar-the-door" on the awards..no matter how poor the case might be.
I am sure this postal worker was a nonsmoking lifelong vegetarian who exercised every day and had no family history of heart disease. So far as I'm concerned they don't even need a trial to establish that it's all Merck's fault. Except for the part that is Bush's fault.
I've heard others say the same thing. It seems as if Vioxx exacerbated the problem in those who may have already been at a higher risk for heart problems. Like I said, the suppression of some of the test results really turned a molehill into a mountain.
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