Re: Should the responsible Merck executives go to jail?
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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.
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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.
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