- Sep 29, 2004
- 18,656
- 68
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Vioxx outcome
- Thread starter IHateMyJob2004
- Start date
That'd be a let down, but it sounds appropriate.All these people having supposedly Vioxx-related heart attacks.. I have to ask... how old are they? are they fat? do they smoke? are they diabetic? do they have heart disease?
Arthritis is, for the most part, a disease of the old. Old people have heart attacks.. these guys are 60 and 77. OLD!
Arthritis is, for the most part, a disease of the old. Old people have heart attacks.. these guys are 60 and 77. OLD!
Unless you're a physician qualified to comment on the evidence presented, congratulations on not breaking your string of frivolous posts.
Did you know Merck actively worked to suppress evidence of the fatal side effects of Vioxx?
NPR Report, Part 1.
NPR Report, Part 2.
More NPR Reports.
zendari -- Usually, I just think you're the dumbest troll on P&N, but I'm beginning to think you're simply malicious. Remind me to be extremely suprised on the day you say anything with even a hint of intelligence. :roll:
And remind me to be extremely surprised on the day you go after Dave for the exact same silliness. :roll: indeed.
The problem is that the consumer advertisement and total ignorance in the U.S. somehow gives people the impression that drugs cannot have side effects.
If the people in the Merck administration didn't do the exquisitely stupid thing and alter the studies... and instead just put a damn warning on the label, they might have lost a few million in sales, but they wouldn't be facing multi-million dollar lawsuits, a press crucible, and a drop in stock price.
the problem with these lawsuits is that all of the people taking vioxx already have predisposing conditions for heart attacks. studies have shown at most a doubling of risk of a cardiovascular event. even in a healthy person without predispositions, this is low. for other people who are already predisposed including diabetics, smokers, and people high cholesterol, the drug may not have helped and a better warning would have been prudent.
It would also have been more prudent if Merck hadn't actively worked to suppress the data they had from research studies long before they recalled Vioxx showing increased incidents of heart attacks and strokes.
It would have been more prudent to be open about it, and they are paying for it with the lawsuits. On the other hand vioxx was a wonder drug and unfortunately because of this mess will never see the market again unless the generics take up production after the patent expires.
My mom had issues with Vioxx.....she is 47. Every time she took the medication her chest would hurt for a bit and she felt dizzy. She only took it for 4 days.
AreaCode707
Lifer
- Sep 21, 2001
- 18,447
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Actually, rheumatoid arthritis, one of the primary forms of arthritis treated by Vioxx, most often strikes women between the ages of 25 and 55. Children can get this too, called Junior Rheumatoid arthritis. The arthritis most older people have is osteoarthritis and is frequently treated with regular anti imflammatories rather than heavier duty drugs like Vioxx.
Do a little research next time. I'm not defending the lawsuit happy, but your comment about arthritis being a disease for the old undermined the rest of your argument.
<---- has had arthritis since age 17
Love this line from Mr Cona's (the guy who was awarded the $45) lawyer:
Yeah.......only the lawyer was in it for the money!! :roll:
Yeah.......only the lawyer was in it for the money!! :roll:
The thing is that treating arthritis with NSAIDs is dangerous, because the patients get ulcers and gastric cancer, since NSAIDs suppress the ability of gastric cells to secrete protective mucus, and they're literally burned away by the acid.
Of course, one can use steroidal anti-inflammatories, but their side effects are far more severe than Vioxx's.
That's why COX2 inhibitors (like Vioxx, Celebrex, Celecoxib) are good drugs. They do, however, carry some risk. It was stupid and irresponsible on the part of Merck to pretend that they are perfect drugs, but as horrible as it sounds, a few deaths is not a good enough reason to take the drug off the market.
Plus, the reason some of these deaths happened in the study, was that the group that was taking Vioxx were deliberately deprived of their aspirin, which they needed for cardiovascular health, rather than analgesia. In the real world, nothing is stopping people from taking 80mg aspirin as well.
I am not exactly sure what you meant. I understand that Merck wanted a clean clinical trial, but the fact that the Vioxx group did not receive low-dose aspirin was a huge medical oversight, not to mention an ethical violation. It would have certainly introduced a confounding variable into the clinical trial, but I don't think that depriving patients of a proven treatment is appropriate.
That being said, if they agreed to it...
It depends on which trial you are talking about. For the pre-market trials as an "alternative" to other NSAIDS Merck would be forbidden to give low-dose aspirin AND rofecoxib b/c the presumptive benefit was going to be improved efficacy for the treatment of pain AND lower GI side effects. After it was approved for short term use, Merck continued trials looking at longer timepoints (VIGOR) comparing rofecoxib to naproxen. Again, it wouldn't make sense to add a non-selective COX inhibitor b/c it would defeat the purpose of reducing NSAID-induced GI side effects. It was during this trial (and Pfizer's equivalent CLASS) that the increase in serious adverse events became undeniable.
Merck tried to claim naproxen was cardioprotective but FDA gave them the Heisman. There's a bit of conflict between Merck's recollection that they were REFUSED permission to put additional warnings on Vioxx and FDA's position.
There was no ethical oversight with regards to low-dose aspirin. In essence, people with ANY significant risk factors for cardiovascular or cerebrovascular events shouldn't have participated in the long term trials. Merck had enough evidence from Phase III to have that exclusion criterium. Then again, maybe they did exclude those people and STILL produced an increase in serious adverse events.
Merck didn't run VIGOR with low-dose ASA b/c it would have mitigated the very effect that Merck was trying to prove . . . long-term efficacy for pain and GI superiority to other NSAIDS. They didn't care about cardiac/brain issues. In the absence of evidence that low-dose ASA is useful in combination with COX-2 inhibitors it wouldn't pass scientific muster to run VIGOR in that manner . . . except for the purpose of proving SAFETY.
Technically, Merck is an amoral entity and under no obligation to prove safety beyond the edicts of FDA. Merck would have been compelled to do the low-ASA+rofecoxib study looking at a variety of AEs (GI, heart, brain, etc). After dropping 8-figures and several years . . . the study could have easily produced equivocal results. Big Pharma doesn't gamble like that.
Your point about the gen pop is spot on, though. Prescribing physicians should be held responsible for their "eagerness" to dispense Vioxx . . . particularly in patients with significant risk factors. But just adding low-dose ASA may not be the answer since I doubt there's much evidence that it is cardioprotective in the context of chronic COX-2I use. Then again, it's still FAR from settled that rofecoxib really has fewer serious GI issues compared to other NSAIDs.
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