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Vioxx case and larger implications

yersinia29

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http://www.ncbi.nlm.nih.gov/entrez/...d&dopt=Abstract&list_uids=15713943&query_hl=1


Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial.

Bresalier RS, Sandler RS, Quan H, Bolognese JA, Oxenius B, Horgan K, Lines C, Riddell R, Morton D, Lanas A, Konstam MA, Baron JA; Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators.

Department of Gastrointestinal Medicine and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston 77030-4009, USA. rbresali@mdanderson.org

BACKGROUND: Selective inhibition of cyclooxygenase-2 (COX-2) may be associated with an increased risk of thrombotic events, but only limited long-term data have been available for analysis. We report on the cardiovascular outcomes associated with the use of the selective COX-2 inhibitor rofecoxib in a long-term, multicenter, randomized, placebo-controlled, double-blind trial designed to determine the effect of three years of treatment with rofecoxib on the risk of recurrent neoplastic polyps of the large bowel in patients with a history of colorectal adenomas. METHODS: A total of 2586 patients with a history of colorectal adenomas underwent randomization: 1287 were assigned to receive 25 mg of rofecoxib daily, and 1299 to receive placebo. All investigator-reported serious adverse events that represented potential thrombotic cardiovascular events were adjudicated in a blinded fashion by an external committee. RESULTS: A total of 46 patients in the rofecoxib group had a confirmed thrombotic event during 3059 patient-years of follow-up (1.50 events per 100 patient-years), as compared with 26 patients in the placebo group during 3327 patient-years of follow-up (0.78 event per 100 patient-years); the corresponding relative risk was 1.92 (95 percent confidence interval, 1.19 to 3.11; P=0.008). The increased relative risk became apparent after 18 months of treatment; during the first 18 months, the event rates were similar in the two groups. The results primarily reflect a greater number of myocardial infarctions and ischemic cerebrovascular events in the rofecoxib group. There was earlier separation (at approximately five months) between groups in the incidence of nonadjudicated investigator-reported congestive heart failure, pulmonary edema, or cardiac failure (hazard ratio for the comparison of the rofecoxib group with the placebo group, 4.61; 95 percent confidence interval, 1.50 to 18.83). Overall and cardiovascular mortality was similar in the two groups. CONCLUSIONS: Among patients with a history of colorectal adenomas, the use of rofecoxib was associated with an increased cardiovascular risk. Copyright 2005 Massachusetts Medical Society.
 
OK so lets address the science here and its larger implications.

1. Note that although Vioxx increases risk of cardiovascular events, it does not increase risk of mortality. So for anybody to say that Vioxx "killed" someone is a suspect claim.

2. In this study, 3.5% of Vioxx group had a CV event (2X the risk for the placebo group). What threshold of risk requires a label warning? What if it was 1% or 0.5%? If we start including label warnings for every risk that 3.5% or higher, then you're gonna need about 50 labels for every medication.

3. In the first case against Vioxx that was decided today, the jury awarded 250 million dollars. In this case, a man died due to an apparent arrythmia. There is no evidence that Vioxx increases risk of arrythmias.

4. I think the real screwup by Merck was the internal memos proving that the knew Vioxx increased risk of CV events, but yet failed to put new warnings on the meds or pull the drug from the market until later.
 
I was looking for a thread on this subject and was curious as to what people would have to say about it. Especially in light of the first of the Vioxx case results today:

http://news.yahoo.com/fc/health/anti_inflammatory_drugs

My gut feel about the situation is that drug companies have become increasingly driven to do what it takes to make high profits. And what it takes seems to include political bribes, unethical sales practices, questionable use of the patent system to protect drugs from competition longer than was intended by the patent laws, creation of drug permutations more for marketing reasons than health benefits, and other unsavory schemes.

My biases are almost always against large jury awards which often seem to be a form of unfair crap shoots that end up costing almost everybody except a few winners but I wonder if the Vioxx cases and the costs of them to Merck will not have a beneficial effect on the drug industry.
 
I made my post before I saw yersinia29's second post. I think his item four is the most significant.

4. I think the real screwup by Merck was the internal memos proving that the knew Vioxx increased risk of CV events, but yet failed to put new warnings on the meds or pull the drug from the market until later.
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If, indeed Merck, failed to highlight the increased risk of heart problems with its promotion of the drug Merck is not only civiliy liable IMHO but it is criminally liable. The potential for conflict of interest situations between drug prescribers and drug manufacturers is obviously huge. Drug companies seem to push the boundaries of conflict of interest everyday. If Merck did what has been alleged I think they have passed well out of the gray area of ethical drug sales practices and as a result my own view is that a thorough criminal investigation is warranted in addition to the civila trials that are currently pending.
 
davefoc said:
My gut feel about the situation is that drug companies have become increasingly driven to do what it takes to make high profits. And what it takes seems to include political bribes, unethical sales practices, questionable use of the patent system to protect drugs from competition longer than was intended by the patent laws, creation of drug permutations more for marketing reasons than health benefits, and other unsavory schemes.
Click to expand...

My gut feel about the situtation is that the legal industry have become increasingly driven to do what it takes to make astronomical profits on the pitiful amount of capital they put at risk. Rent seeking at its worst.

And what it take seems to be all sort of shady practice, including jurisdiction shopping, distorting truth and fact and making the most base appeal to niave people to punish large faceless evil corporations who are painted as entities that do nothing but break the law and rip off the little people (Dave seems sold on this view).

Towhit, I heard the plaintiff lawyer boldly claim on television that Merck had been found guilty of a criminal act. Leaving aside the absurdity of the claim at a base level (Merck would still exist as an entity even if everyone resigned from the firm. A company is just a pile of legal documents) it is simply factually incorrect. But such a claim does fuel the emotion of the masses. "How dare that nasty company commit these criminal acts". My guess is the lawyer was just getting excited about his upcoming real estate shopping spree.

Also witness the latest ludicrous award - hundreds of millions of dollars for "emotional suffering and loss". Wow, I would have thought that someone who had suffer $200 million in emotional suffeing and loss would have to be institutionalised as a basket case, so great would be the effect on their psychological and emotional state. But no, the plaintiff was there standing next to her hyperactive social parasite, I mean lawyer.

I think this bit says it all:
In this case, a man died due to an apparent arrythmia. There is no evidence that Vioxx increases risk of arrythmias.
Click to expand...

Consider in addition to this that there is no evidence that eating [cornflakes/ice cream/carrots...] inceases risk of arrythmias.

Until they outlaw the practice of payment of punative damages to either plaintiffs or lawyers, this absurdity will continue. Whoever gets a piece of this filthy stash will do alright, but for the rest of us, who rely on the research anf development of drugs like Vioxx that help to improve our quality of life (or perhaps save our lives) will have to watch as hundreds of billions of dollars is syphoned away to Greedy, Sleezy and Filthy Rich LLP instead.
 
What Drooper said.

I don't condone Merck not having publicised a known risk, far from it, but this reaction is way out of all proportion. It's looking as if anyone who has suffered any adverse event at all while on the drug is going to be suing for millions - even though many of the events aren't things the drug has been implicated as causing, and even where an implicated condition is involved, remember that the drug only increases the risk - half of these cases would have happened anyway. It's a feeding frenzy.

Compare and contrast the case of the woman in Brighton who suffered total kidney failure as a result of being given a banned herbal medicine (known as a cause of kidney failure) by a Chinese herbalist. The herbalist was exonerated because she said she had no way of knowing that her supplier was supplying her with a preparation including the banned herb. The patient ended up on dialysis with nothing.

Rolfe.
 
Presumably the case will be appealed.

It seems perverse that a jury can find in favour of the plaintiff in a case like this. Even if he died from one of the known side effects it is irrational to allocate sole causality to the drug. Post hoc ergo propter hoc is a fallacy well bedded into the medical liability legal system.

Civil liability "on the balance of probabilities" would be more reasonable if the patient died of something that almost never happened without the suspect agent being involved, e.g. mesothelioma and asbestos exposure, but death from a myocardial infarction would not represent such a cause of death. The decision in the case at issue is made more ridiculous by the apparent absence of evidence to establish any link between the cause of death and the drug.

As to the ludicrous amount, does this derive from the award being judged against the depths of the defendants pockets rather than any measure of proportionality to the suffering of the particular plaintiff?

As I remind my family members who are in the legal profession, they now use lawyers instead of rats in laboratories, the technicians don't get so attached to them and there are some things even a rat won't do.
 
I think Merck was clearly in the wrong for trying to hide the risks of CV events. I think as soon as the jury heard about that, nothing else mattered to them and they found Merck guilty on the spot because of that.

I think this illustrates a larger problem though. Layperson juries cant be trusted to wade through this stuff. This case should have been decided on medical science. Layperson juries dont understand those intricacies. They are not capable of understanding the VIGOR and APPROVE trials and what they really mean in terms of increased risk and assigning causality to Vioxx
 
Another note about arrythmias. Mr. Ernst was supposedly in pretty good health with no CV risk factors. So I bet the plaintiff lawyer played that up in court: "ladies and gentlemen, this was a healthy man, so the fact that he died from a CV event is proof that it was the drug that caused it"

But actually, athletes and others who run a lot or play sports can develop arrythmias even if they have no other CV risk factors. For whatever reason, sometimes people's hearts that are exposed to a lot of athletic stress change their conduction pathways over time, leading to the possibility of developing an arrythmia
 
Hi Drooper,
I was moderately confused by your post but I think it is possible we agree.

I think our view is that there are scum bag lawyers out there who produce nothing of value for society and who attempt to feed off the hardwork and capital of individuals and companies by bringing bogus lawsuits.

However, every now and then one of these scumbag lawyers or perhaps even a non-scumbag lawyer takes on a cause that has social value beyiond the aggrandizement of themselves.

It is conceivable that the Vioxx case might be one of those causes.
 
Hi Rolfe,
Since I was confused by what Drooper meant I was a little confused about what you meant when you implied that you agreed wtih him.

However based on your post I think we disagree a little.

I don't like to see large corporations get savaged by questionable lawsuits. For instance the breast implant lawsuits against Corning.

But in this case, it appears that Merck made an effort to promote their product without adequately discussing the hazards. Drug companies shouldn't do this in my view and about the only way that I see to discourage them from doing this is to punish them financially to the point that they won't do it.

I listened to the Merck CEO on TV defending his company and IMHO he didn't have a clue as to the ethics of this situation and it is pretty clear to me that the only thing that gets the attention of somebody like that is the potential for massive financial loss. If Merck survives this thing with only minor losses it will not have any imparct on their practices when it comes to honestly discussing risks associated with their drugs.

I am completely in sync with the idea that there is a risk associated with every effective drug and we would have no drug companies if we made them liable for every problem that might be caused by the use of their drug. For me, it is about disclosure. A drug company that promotes their product with full disclosure of the risks based on due diligence research should not be liable for problems linked to their product. But, in this case, it appears that Merck attempted to promote their product without full disclosure and if that is the case I don't have any problem with seeming them get financially ripped.
 
Rolfe said:
Compare and contrast the case of the woman in Brighton who suffered total kidney failure as a result of being given a banned herbal medicine (known as a cause of kidney failure) by a Chinese herbalist. The herbalist was exonerated because she said she had no way of knowing that her supplier was supplying her with a preparation including the banned herb. The patient ended up on dialysis with nothing.
Click to expand...
I was wondering if you had a cite for that? I'd be interested to read it.
 
yersinia29 said:
I think Merck was clearly in the wrong for trying to hide the risks of CV events. I think as soon as the jury heard about that, nothing else mattered to them and they found Merck guilty on the spot because of that.

I think this illustrates a larger problem though. Layperson juries cant be trusted to wade through this stuff. This case should have been decided on medical science. Layperson juries dont understand those intricacies. They are not capable of understanding the VIGOR and APPROVE trials and what they really mean in terms of increased risk and assigning causality to Vioxx
Click to expand...

My guess is that Viagra would be a much riskier drug, but try keeping that out of people's, (mens?) hands.

They were undoubtedly guilty of guilding the lilly, and should pay. They were also incredibly stupid, to think they would get away with it. The problems with the drug were always going to come out.

My guess, the short term, "we've bumped our bottom line this year" was was made the policy.

250 million, though, is ridiculous, except that it makes all the other drug companies take note that they had better make sure they tell people exactly what they are buying.

All drugs have side effects. Patients have to be told what they are, and make an informed choice, with their doctor, on what they should do with the condition that is being treated.

However, for $250, it almost makes it worth dying.
 
a_unique_person said:

250 million, though, is ridiculous, except that it makes all the other drug companies take note that they had better make sure they tell people exactly what they are buying.
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Well, that's the point. Punitive damages are supposed to discourage people from doing whatever the tortuious act under discussion is.

I would like you to imagine the following discussion happening at the LargePharmoInc board of directors meeting :

- "I think we're on to a real winner here; it's a diet drug that really works. Our estimates are that we will make a billion dollars a year until the patents run out, and we have a stream of enough other variations and claims that we can keep the patents going for fifty years."

- "Great! Let's go with it!"

- "Just one problem, though. It causes one percent of the people who take it to enter an irreversable persistant vegetative state."

- "Not a problem. Don't even tell them about it. By the time word gets out, we'll have enough in the bank to settle their claims from the interest on the profits."

- "Um, no, sir. Do you remember the Vioxx case? If word gets out that we've been covering up risks, the jury might slap us with a several hundred million dollar charge for punitive damages, and all the profits will evaporate. We can't afford to cover up those risks."

What part of this conversation do you think is a bad thing?


My guess, the short term, "we've bumped our bottom line this year" was was made the policy.
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And since that policy demonstrably hurt someone (as was jury by the jury), the jury decided to make that policy demonstrably ineffective.
 
new drkitten said:
What part of this conversation do you think is a bad thing?



And since that policy demonstrably hurt someone (as was jury by the jury), the jury decided to make that policy demonstrably ineffective.
Click to expand...

Which is fine except that the jury were wrong to come to that conclusion.

I don't disagree that Big Pharma should be held to account with serious financial penalties against serious wrong-doing it's just that this particular individual does not seem likely to have suffered from Merck's wrong-doing and the way the system works in the US creates a giant honey pot to attract lawyers. As I have already said, I don't see how it is logically feasible to decide that an individual patient has suffered from an individual drug when the background risk of what they have suffered from is high.

The fair way for the system to work would be for large groups of cases to be heard together on a more epidemiological basis that could genuinely provide evidence that the group as a whole has suffered damage on average and for the punitive damages to be taken by the government not the plaintiffs, while the plaintiffs share the damages payable for their losses. The problem is that the law is all about single individuals and there is a clash of paradigms. Another problem is that implicit in what I have said is that certain medical liabilities can be logically decided on a single-case basis, like asbestosis. Drawing the line between the need for single-case decisions and a mass-case decision would be hard, but you could leave a jury to decide- if lawyers present a single-case claim under these rules it may be thrown out if a jury cannot adequately link effect to cause. What seems to be absent at the moment is any mechanism to help juries make that decision and they are left to make decisions that would only be appropriate to a mass-case claim based on a single-case claim.
 
Badly Shaved Monkey said:
The fair way for the system to work would be for large groups of cases to be heard together on a more epidemiological basis that could genuinely provide evidence that the group as a whole has suffered damage on average and for the punitive damages to be taken by the government not the plaintiffs, while the plaintiffs share the damages payable for their losses.
Click to expand...

That sounds like a really good idea to me. Do the tobacco law suits provide any sort of a model for this kind of thing?

Why haven't the Vioxx law suits been handled via a class action law suit?

It seems like the Corning law silicon breast implant law suits were handled like this. The only problem was that the jury made a decision unsupported by the science and one of the premier companies in the world was almost destroyed for something where they were blameless.
 
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