Should the responsible Merck executives go to jail?
 

More on the Vioxx scandal. Vioxx is an antiinflammatory drug like Advil, except in many patients it works better. Too bad, because it causes a greater-than-acceptable increased risk of heart attacks.* When Merck published the safety data in and around 2000, the company intentionally withheld and deleted data on three heart attacks to make the drug look safer. They submitted all the data on a diskette, but failed to include it in the landmark paper that made their drug a huge success.

The nation's top medical journal, the New England Journal of Medicine, called them out on it recently:

http://news.yahoo.com/s/nm/20051209/...oxx_journal_dc

There is no direct article right now. Apparently it was a press release from NEJM.


Merck knew about the heart attacks and failed to put the material in the manuscript. The FDA pulled Vioxx from the market due to an increased risk of heart attacks in 2004. Too bad for some people because for them it really worked. But not so useful if you are dead.

Should the people at Merck be held criminally liable for their actions?



* As for "greater-than-acceptable" risk of death, it is good to be on a forum where people understand probability. The typical knee-jerk response is that no risk of death is tolerable from a medicine. Everyone who says this DRIVES to their doctor's office, often on crowded freeways while using a cell phone. That carries a significant risk of death and yet many a drug with a safety profile better than driving to the doctor's office (like Accutane) get heavily regulated or thrown out. Vioxx is not one of those: the risks of heart attacks remained small, but there were acceptable and available substitues that did not cause the problem. Much of the added risk was unnecessary and not associated with additional gain.


So, again, you are on the jury: the junior exec whose pay and future were tied up in the success of Vioxx knew the data were fudged and submitted the falsified manuscript anyway. Should that junior exec do jail time? How much and what kind? What's red collar crime worth?

Re: Should the responsible Merck executives go to jail?
 

I think so, yes.

Re: Should the responsible Merck executives go to jail?
 

I think they should have to take the [censored] stuff themselves, and give it to their families too.

NT

Re: Should the responsible Merck executives go to jail?
 

this trial you speak of?

it usually consists of more than 200 words and a reuters article.

Re: Should the responsible Merck executives go to jail?
 

Sure they should. But I'm one of the ones who thought Iacocca should have had his career ended over the Pinto instead of become a public institution.

I don't think the issue comes down to necessarily this drug, but very much the principle of the thing. Risk is a subject that shouldn't be decided based on hidden evidence. This is just fundamentally wrong on principle and very dangerous to let drug companies think they can get away with. The stakes to be considered first should be the ones of life and death, not of profit.

Risks will always be taken. But drug companies have no right to make those decisions for doctors and their patients. Doctors and patients need to be able to rely on the value of FDA's approval before they make the decisions on what risks to take. Some risks may well be acceptable. But if they are missing information, an informed decision is impossible for doctor and patient. The drug company that hides information is basically taking the power of choice from both doctor and patient. And this choice involves life and death.

That sort of playing around is not comparable to the usual corporate crime like embezzling, and should be punished severely. It would be a terrible example to corporate America if they were shown both that there are no significant drawbacks to falsifying data and lying to regulatory agencies, nor to playing fast and loose with American lives.

Re: Should the responsible Merck executives go to jail?
 

Vioxx, as I'm sure you in your medical capacities know, is still the best NSAID ever developed. I'm mad at the executives on many accounts--including the fact that because of their unethical behaviour, people who probably SHOULD take this drug---those suffering from rheumatoid arthritis for example--won't anymore because of the stigma attached to it, and their physicians'entirely legitimate fears regarding liability.

Re: Should the responsible Merck executives go to jail?
 

Will the jury decide on the amount of time the person gets or just whether the person is guilty of that crime?

criag

Re: Should the responsible Merck executives go to jail?
 

Neither side has looked very good in this debacle, but I think fully trusting the NEJM and plaintiffs attorneys at this juncture is perhaps unwise.

Re: Should the responsible Merck executives go to jail?
 

Perhaps unwise lapoker, but NEJM has a far tidier reputation than Merck, on many accounts. Sure, innocent until proven guilty, but the two sides should hardly be treated with equal skepticism...

Re: Should the responsible Merck executives go to jail?
 

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Vioxx, as I'm sure you in your medical capacities know

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Resist the urge to be dickless more.

Re: Should the responsible Merck executives go to jail?
 

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this trial you speak of?

it usually consists of more than 200 words and a reuters article.

[/ QUOTE ]

Re: Should the responsible Merck executives go to jail?
 

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Should that junior exec do jail time? How much and what kind? What's red collar crime worth?

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Falsifying risk of death information should be considered murder. Murder for profit is just as unethical as a hitman for hire.

Re: Should the responsible Merck executives go to jail?
 

lets just put all these bastards in jail the lot of them

who the [censored] is john galt anyways


sorry if i caused the move

Re: Should the responsible Merck executives go to jail?
 

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Quote:
Vioxx, as I'm sure you in your medical capacities know



Resist the urge to be dickless more.

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[censored] you asshat. Do you have any idea how to [censored] read? Matt Flynn is an ACTUAL physician, so I was noting that my comment was not directed AT him in some lecturing tone.

Jesus [censored] christ, pull the bottle of self-righteousness dipshitedness out of your [censored] ass.

Kids these days...no [censored] respect.

The point was that HE ALREADY KNEW THE SUCCESSFUL USES OF VIOXX, but that mental midgets such as yourself where most likely clueless, an implicit comment you felt compelled to prove as quickly as possible.

Re: Should the responsible Merck executives go to jail?
 

Judging any of this based on that wire report with quotes from only one side is just wrong. Thanks to a-holes like kozlowski and ebbers, all big businesses are now presumed guilty far too often. I just don't like when people allow bias to cloud things that should be about facts. When they all come out, if Merck f'd up, I'll be right there with you, but there is far too much money swirling around in this one (go read some articles about the plaintiffs attorneys in Texas) for me to believe either side just yet.

Re: Should the responsible Merck executives go to jail?
 

Okay, then we agree. I certainly don't presumptively think "big business evil, Merck bad" here, though I'm certainly more inclined to trust NEJM, on its face, than a boilerplate denial.

It would be great if there is no wrongdoing here, and hopefully the courts will function effectively. If there is, however, I hope they will also act as punitively towards this offence as they do towards, what are in my view, lighter crimes.

Re: Should the responsible Merck executives go to jail?
 

Yes, they should go to jail.

Falsifying information that leads to death is like murder.

Wether or not Vioxx falls within what you consider acceptable limits is irrelevent, the witholding of information is the crime.

Re: Should the responsible Merck executives go to jail?
 

it is ridiculous on it's face to think that a corporation would have the final say in whether or not a drug is safe enough to go to market. How significant was the inclusion/exlusion of three patients having heart attacks (and it is my understanding is that many vioxx users have existing heart conditions) to the NEJM on vioxx being approved for market? How is FDA approval linked to NEMJ? (I honestly have no idea)

almost every drug worth anything has side effects many potentially fatal. if there is some data that merck is legally obligated to turn over and it is found that they failed to do so, string them up, reckless endangerment all the way. If it is currently an ethics issue it should certainly not be and that would point to a failure of congress.

I don't know much about this story but everything I have learned so far points to incompetence in government regulation and greediness of trial lawyers, nothing too surprising.

Re: Should the responsible Merck executives go to jail?
 

i had a pretty long discussion with my dad about similar stuff today, he works as a statistician in public health trials (mainly stroke medication, some minor work in other neurological things). his attitude, which is what i now believe after hearing him explain it, is that the executives should go to jail. he is well aware that the drug can still greatly benefit a great deal of patients, and can be worth the risks, but the executives need to be held accountable for knowingly lying about the risks of their medication. that is pretty much about as bad as it gets. this is of course if it is proven that the allegations are proven true in public, which they havent been yet.

the FDA may have unnecessarily pulled the drug, but what does that have to do with whether the executives should go to jail?

Re: Should the responsible Merck executives go to jail?
 

I take Blarg's entirely un characteristic silence as a tacit admission that he was, if I were to use the mot du l'année dernière, PZWNED.

Luckily I do not stoop to such internet speech, so I see no need to remind him thoroughly asshatish his unlearned remark was.

Re: Should the responsible Merck executives go to jail?
 

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I take Blarg's entirely un characteristic silence as a tacit admission that he was, if I were to use the mot du l'année dernière, PZWNED.

Luckily I do not stoop to such internet speech, so I see no need to remind him thoroughly asshatish his unlearned remark was.

[/ QUOTE ]

explain to me how anyone got pwned or how this issue is complicated? i skimmed yours and blargs' posts and didnt see much stuff worth debating.

Re: Should the responsible Merck executives go to jail?
 

No, Blarg tried to call me out for being a jerk to Matt Flynn, when I wasn't be a jerk to Matt Flynn, and then disappeared...

Re: Should the responsible Merck executives go to jail?
 

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That sort of playing around is not comparable to the usual corporate crime like embezzling, and should be punished severely. It would be a terrible example to corporate America if they were shown both that there are no significant drawbacks to falsifying data and lying to regulatory agencies, nor to playing fast and loose with American lives.

[/ QUOTE ]

That was my thinking.

Re: Should the responsible Merck executives go to jail?
 

[ QUOTE ]
Vioxx, as I'm sure you in your medical capacities know, is still the best NSAID ever developed. I'm mad at the executives on many accounts--including the fact that because of their unethical behaviour, people who probably SHOULD take this drug---those suffering from rheumatoid arthritis for example--won't anymore because of the stigma attached to it, and their physicians'entirely legitimate fears regarding liability.

[/ QUOTE ]

The FDA often seems to be in the business of avoiding egg on the face. Plus they make ridiculous moves to falsely address problems. E.g., they wil soon require all pregnancy tests done for monitoring on Accutane to be done in a certified lab instead of with over-the-counter urine tests in the doctor's office. Somebody thought it was a bright idea to make sure the tests were good, never bothering to calculate that the move would cost over $4 billion and millions of patient-hours miminum per birth defect prevented. I conclude that FDA panels should be required to be at least a third people with math or epidemiology degrees, and that law should require the panel to do a simple cost-per-event-prevented analysis and sign off on spending other people's money.

Many people who benefitted tremendously from Vioxx but not other antiinflammatories would glady and rationally take the extra risk.

Re: Should the responsible Merck executives go to jail?
 

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[ QUOTE ]
Should that junior exec do jail time? How much and what kind? What's red collar crime worth?

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Falsifying risk of death information should be considered murder. Murder for profit is just as unethical as a hitman for hire.

[/ QUOTE ]

It seems a little less than murder to me, but still something to punish harshly to deter others and encourage whistle-blowing.

Re: Should the responsible Merck executives go to jail?
 

[ QUOTE ]
[ QUOTE ]
this trial you speak of?

it usually consists of more than 200 words and a reuters article.

[/ QUOTE ]

[/ QUOTE ]

NEJM 2000 article. You can google it.

Re: Should the responsible Merck executives go to jail?
 

[ QUOTE ]
[ QUOTE ]
Quote:
Vioxx, as I'm sure you in your medical capacities know



Resist the urge to be dickless more.

[/ QUOTE ]


[censored] you asshat. Do you have any idea how to [censored] read? Matt Flynn is an ACTUAL physician, so I was noting that my comment was not directed AT him in some lecturing tone.

Jesus [censored] christ, pull the bottle of self-righteousness dipshitedness out of your [censored] ass.

Kids these days...no [censored] respect.

The point was that HE ALREADY KNEW THE SUCCESSFUL USES OF VIOXX, but that mental midgets such as yourself where most likely clueless, an implicit comment you felt compelled to prove as quickly as possible.

[/ QUOTE ]

Inchoate,

No offense even considered - I read it as you intended.

Blarg,

Thanks for the response anyway.



Very entertaining read here.

Matt

Re: Should the responsible Merck executives go to jail?
 

Fudging data is unacceptable. Criminal charges, as well as civil liability, are definitely in order.

Re: Should the responsible Merck executives go to jail?
 

[ QUOTE ]
Will the jury decide on the amount of time the person gets or just whether the person is guilty of that crime?

criag

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With the notable exception of death penalty cases, in th US, usually the jury determines guilt or innocence, and the judge sets the sentence if the defendant is found guilty.

Re: Should the responsible Merck executives go to jail?
 

[ QUOTE ]
it is ridiculous on it's face to think that a corporation would have the final say in whether or not a drug is safe enough to go to market. How significant was the inclusion/exlusion of three patients having heart attacks (and it is my understanding is that many vioxx users have existing heart conditions) to the NEJM on vioxx being approved for market? How is FDA approval linked to NEMJ? (I honestly have no idea)

almost every drug worth anything has side effects many potentially fatal. if there is some data that merck is legally obligated to turn over and it is found that they failed to do so, string them up, reckless endangerment all the way. If it is currently an ethics issue it should certainly not be and that would point to a failure of congress.

I don't know much about this story but everything I have learned so far points to incompetence in government regulation and greediness of trial lawyers, nothing too surprising.

[/ QUOTE ]

NEJM publishes what they get. The articles are reviewed by other doctors prior to publication, but data are not verified - really no way to do that.

FDA approved the med based on the studies done by the company. Adverse event rules require reporting of heart attacks. I do not know if the FDA got full disclosure, but it is a serious infraction if they did not.

With full knowledge of the heart attack risks, presumably the drug would have had much lower sales, but I do not know that.

Re: Should the responsible Merck executives go to jail?
 

[ QUOTE ]
[ QUOTE ]
[ QUOTE ]
this trial you speak of?

it usually consists of more than 200 words and a reuters article.

[/ QUOTE ]

[/ QUOTE ]

NEJM 2000 article. You can google it.

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Hi Matt,

you're missing the point: you're pointing us to only one side of the issue. In a trial, the other side is allowed to put up a defense.

jba

Re: Should the responsible Merck executives go to jail?
 

[ QUOTE ]
Hi Matt,

you're missing the point: you're pointing us to only one side of the issue. In a trial, the other side is allowed to put up a defense.

jba

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Not sure what I left out? The only contention - made by the New England Journal of Medicine's board - is three serious adverse events* were left out of the landmark paper that gave rise to the success of Vioxx. Merck has acknowledged that fact.


* By definition an adverse event is any bad medical event that occurs while taking a drug and does not mean it was caused by the drug.

Re: Should the responsible Merck executives go to jail?
 

Matt,

I have no idea how or why these were left out, that seems like a very important point, doesn't it?

Also, I see nothing in your post or the reuters article that indicates that the exclusion of this information caused people to lose their lives (nor anything that would indicate that it didn't, of course).

Re: Should the responsible Merck executives go to jail?
 

If the FDA did not exist there could have been full disclosure and people could have made up their own mind as to the risks. As it was, Merck likely realized the drug would not be approved and the hundreds of millions spent developing the drug would be flushed down the toilet. Not wanting to explain this to shareholders, info was witheld to gain approval. Certainly unethical, but I understand the motivation. The upshot? Merck will cough up barrels of cash paying off lawsuits and people willing to take a calculated risk in exchange for relief from debilitating arthritis won't have access to what has been a miracle drug for so many.

Re: Should the responsible Merck executives go to jail?
 

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Should the people at Merck be held criminally liable for their actions.

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Yes, absolutely.

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because it causes a greater-than-acceptable increased risk of heart attacks.*

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I would only ask, "greater than acceptable" to whom? Everyone has their own levels of risk they are willing to take as a trade-off for treating debilitating arthritic pain, for instance. The risks should be published honestly of course, but the decision on whether the risks are greater than acceptible or not should be made by each patient for themselves.

[ QUOTE ]
So, again, you are on the jury: the junior exec whose pay and future were tied up in the success of Vioxx knew the data were fudged and submitted the falsified manuscript anyway. Should that junior exec do jail time? How much and what kind? What's red collar crime worth?

[/ QUOTE ]

He committed criminal fraud at the least. The risks were still quite negligible so I wouldn't go so far as to call him a murderer, but it's close. He intentionally lied to people about the risks posed for those who consumed Vioxx.

Personally I blame the FDA for this. Seriously. Ok maybe not directly the perverse incentives caused by the FDA indirectly led to the pressures that caused this lie to take place.

If we americans were treated like grownups this wouldn't have happened.

natedogg

Re: Should the responsible Merck executives go to jail?
 

[ QUOTE ]

I would only ask, "greater than acceptable" to whom? Everyone has their own levels of risk they are willing to take as a trade-off for treating debilitating arthritic pain, for instance. The risks should be published honestly of course, but the decision on whether the risks are greater than acceptible or not should be made by each patient for themselves.

[/ QUOTE ]

wow, this is insane, do you realize what a system like this would look like?

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Personally I blame the FDA for this. Seriously. Ok maybe not directly the perverse incentives caused by the FDA indirectly led to the pressures that caused this lie to take place.

If we americans were treated like grownups this wouldn't have happened.

natedogg

[/ QUOTE ]

this is crazy sauce, the FDA is responsible??? vioxx should never have been released to the market in the first place, that is the source of this problem. the drug got ingrained to the public through direct to consumer ads, and people started gushing about the drug. this is of course an awful way of evaluating the drug, because the thousands of people who died from taking it dont really voice an opinion.

it was tested in a small sample of patients, then the FDA approved it. it was one of the first drugs to be a part of direct to consumer ads, which made the situation worse. then after a while on the market, everyone at merck realizes that the drug is unsafe and is killing people. merck lies about this and tries to cover it up. the FDA finally realizes this, and takes the drug off the market. when the drug is tested or taken in a large sample, then the dangerous side effects become much more apparent than they did when they were initially tested in the small sample. the drug was incorrectly released to the public in the first place because it was badly tested and the results may have been fudged. the makes the situation 10x worse since the public has been taking the drug and now we have people who are angry it is being taken off the market. not to mention the thousands of peole who have died from taking it.

Re: Should the responsible Merck executives go to jail?
 

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[ QUOTE ]

I would only ask, "greater than acceptable" to whom? Everyone has their own levels of risk they are willing to take as a trade-off for treating debilitating arthritic pain, for instance. The risks should be published honestly of course, but the decision on whether the risks are greater than acceptible or not should be made by each patient for themselves.

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wow, this is insane, do you realize what a system like this would look like?



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Yes, but do you? Because it sounds like you haven't put much thought into the issue.

The FDA is the epitome of everything wrong with the relationship between citizen and government here in America.

Your further comments reveal to me that you are an inveterate paternalist. That's really a shame. God forbig someone see an ad for a drug. What is the world coming to?

natedogg