Should the responsible Merck executives go to jail?

[jba]

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this trial you speak of?

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

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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

[Matt Flynn]

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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

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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.

[jba]

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).

[jcx]

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.

[natedogg]

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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.

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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?

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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

[Voltron87]

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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.

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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

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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.

[natedogg]

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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.

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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