Monday, August 22, 20056
Vioxx and Merck: Monday update
Forbes.com: How to defend Merck
"One of Merck's main goals will have to be to limit the number of patients who can claim they are owed money. In clinical trials, Vioxx was linked to an increase in heart attacks, strokes and some other heart problems. But it never was linked to arrhythmias, the cause of death written on the death certificate of Robert Ernst, the victim in the first Vioxx lawsuit. By one line of logic, that should have made it easy for Merck to argue that Vioxx did not cause his death.
Unfortunately, Birnbaum says, getting science across to a jury can be incredibly difficult. 'It takes some very good lawyering to do that, because laypeople, it's hard for them to differentiate between arrhythmias and heart attacks,' says Birnbaum."
BBC: Widow 'encouraged' by Vioxx case
"A south Wales widow who alleges the painkiller Vioxx killed her husband has welcomed the £141m awarded by a US jury to an American woman.
Maureen Watt, from Bargoed, is one of hundreds in the UK hoping to take legal action against the US firm Merck."
NY Times: Vioxx Verdict Raises Profile of Texas Lawyer
"To jurors, Mr. Lanier's performance may have appeared unscripted, but he meticulously planned the trial's smallest details, down to his choice of wedding band. Outside the courtroom Mr. Lanier wears a heavy band engraved with Hebrew and Greek lettering, but in front of jurors he prefers a simple gold band so they will not be distracted. For the same reason, he wore the same blue suit each day. He also hired a private investigator to examine the jurors' criminal records in search of potential hidden biases.
With the help of a 13-member shadow jury that was paid to watch the trial and report to consultants hired by Dr. Robert Leone, his in-house jury psychologist, Mr. Lanier refined his arguments each evening in Suite 922 at the Four Seasons hotel in downtown Houston, where he and several members of his team stayed during the trial."
Corante: In the Pipeline:
"You would think, to hear the way some people talk, that no one at Merck ever took Vioxx. That they just launched it onto the market with an evil cackle and a shout of 'Caveat emptor', then sat back to watch the money roll in. Actually, employees of Merck very likely took Vioxx at a rate above that of their cohorts in the general population - employee discounts, you know. I've no doubt that this applies to Merck's marketing department, to their clinical development groups, and to their toxicologists. Why shouldn't they take their own company's drug if they're in need of a COX-2 inhibitor?"
"One of Merck's main goals will have to be to limit the number of patients who can claim they are owed money. In clinical trials, Vioxx was linked to an increase in heart attacks, strokes and some other heart problems. But it never was linked to arrhythmias, the cause of death written on the death certificate of Robert Ernst, the victim in the first Vioxx lawsuit. By one line of logic, that should have made it easy for Merck to argue that Vioxx did not cause his death.
Unfortunately, Birnbaum says, getting science across to a jury can be incredibly difficult. 'It takes some very good lawyering to do that, because laypeople, it's hard for them to differentiate between arrhythmias and heart attacks,' says Birnbaum."
BBC: Widow 'encouraged' by Vioxx case
"A south Wales widow who alleges the painkiller Vioxx killed her husband has welcomed the £141m awarded by a US jury to an American woman.
Maureen Watt, from Bargoed, is one of hundreds in the UK hoping to take legal action against the US firm Merck."
NY Times: Vioxx Verdict Raises Profile of Texas Lawyer
"To jurors, Mr. Lanier's performance may have appeared unscripted, but he meticulously planned the trial's smallest details, down to his choice of wedding band. Outside the courtroom Mr. Lanier wears a heavy band engraved with Hebrew and Greek lettering, but in front of jurors he prefers a simple gold band so they will not be distracted. For the same reason, he wore the same blue suit each day. He also hired a private investigator to examine the jurors' criminal records in search of potential hidden biases.
With the help of a 13-member shadow jury that was paid to watch the trial and report to consultants hired by Dr. Robert Leone, his in-house jury psychologist, Mr. Lanier refined his arguments each evening in Suite 922 at the Four Seasons hotel in downtown Houston, where he and several members of his team stayed during the trial."
Corante: In the Pipeline:
"You would think, to hear the way some people talk, that no one at Merck ever took Vioxx. That they just launched it onto the market with an evil cackle and a shout of 'Caveat emptor', then sat back to watch the money roll in. Actually, employees of Merck very likely took Vioxx at a rate above that of their cohorts in the general population - employee discounts, you know. I've no doubt that this applies to Merck's marketing department, to their clinical development groups, and to their toxicologists. Why shouldn't they take their own company's drug if they're in need of a COX-2 inhibitor?"






Comments
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GG
The Forbes article makes two common mistakes. First, they say Merck failed to get "science across to a jury." But the comments from jury members shows that they understood the difference between a heart attack and an arrythmia. The pathologist testified that the arrythmia was caused by a temporary blockage in a constricted artery, probably by an embolus that broke free during CPR. Second, the point is raised that the deceased took Vioxx for less than 18 months. Remember that 18 months is when a significant diffence is achieved, so these are events which have occured BY that time point; thus, these deaths all occured previous to the time point. Some will have occured much earlier than others, because all people don't suddenly drop dead at exactly 18 months. So the study in fact says nothing about those who take the drug for OVER 18 months, since it was stopped when the adverse risk became significantly greater at that time point.
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wpwavnrt
Consider the following--
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drexelmed
The jurists in the case appear to disparage the marketing practices and documents hidden by Merck, rather than the actual cause of death. Documents were introduced that demonstrated early warnings by Merck scientists of CV risks as well as attempts to delay FDA knowledge of these risks. Evidence, including videotapes, also demonstrated that sales reps were prepped to avoid physician questions on CV risks to their patients. I enjoy a pubmed search as much as anyone else, but it's a problem when the majority of scientific evidence I am receiving about a drug is from the biased company itself.
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Rich, MD
By the way it is "arrhythmia" not "arrythmia."
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Anonymous
"The pathologist testified that the arrythmia was caused by a temporary blockage in a constricted artery, probably by an embolus that broke free during CPR"
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Greg
No, anon, you probably can't sue over your grandmother's death, because of the statute of limitations.
Post a Comment »10:55 PM
Vioxx, the offending drug--worked too well. It removed the deterent to carry out activities that proved to be detrimental to the patient's health. To wit, if I have significant pain I can't perform a level of exercise that was inappropriate and would put me at risk for an underlying cardiac proble not previously detected. Hence, the untoward event was, in fact, an accident waiting to happen! This could easily account for the unfortunate assumption that the drug caused the illness when it actually revealed it!
By the way it is "arrhythmia" not "arrythmia."
11:37 PM
1:41 PM
# posted by wpwavnrt : 12:37 AM
LOL!
7:54 PM
Is that like "if a tree falls in the woods, and nobody's there to hear it, does it make a noise?" Where did the embolus go? Lungs, Brain, did it to to Bob's Big Burger? Wendy's? Didn't it know it was worth 250 million big ones? Can I sue because my grandma died of a heart attack (in 1972) she took alot of NSAIDS, which apparently cause the same inhibition of coronary vessel collateralization?
8:08 PM
Interestingly, the $229 mil punitive part was the amount of money Merck said they could make by delaying the FDA warning on heart risks.
11:02 AM