Yes, Steve Nissen has sleepless nights about drug safety, particularly about the misuse of surrogate endpoints to approve drugs (which is why he has developed IVUS to develop a surrogate endpoint for drug approval).
And he compares Avandia's risk of death to that of 9-11 (though even his own meta-analysis did not estimate increased number of deaths only risk of having a heart attack sooner and not death).
He tells Diedtra Henderson of the Boston Globe he doesn't want to be FDA commissioner but tells the NYT he won't rule it out.
He uses the "I give all my money to charity" line but there is nothing about the fact the charities are his own research organizations and the Steven E Nissen Healthy Heart fund that doled out gym memberships and travel money to people at the ACC.
He is described as an "informal advisor to Congress" on drug safety. How about someone who coordinated with Congress to preempt the FDA's own analysis of Avandia in order stoke support for alternative FDA reform proposals. Who was working with Congressman Waxman and the NEJM to release his paper, supposedly told a Glaxo rep he was going to "destroy Avandia" but had the chutzpah to claim to the media he offered Glaxo the chance to co-author a paper.
Nissen's behavior with respect to Avandia and the increasing criticism that has been leveled at his "study" (if all the short term data showed a 40 percent increased risk, why is there no hint of it in long term studies like RECORD) were all neglected in the NYT study.
I predict that when all is said and done Nissen will be revealed as the Michael Nifong of medical research.
http://www.nytimes.com/2007/07/22/business/22nissen.html
And he compares Avandia's risk of death to that of 9-11 (though even his own meta-analysis did not estimate increased number of deaths only risk of having a heart attack sooner and not death).
He tells Diedtra Henderson of the Boston Globe he doesn't want to be FDA commissioner but tells the NYT he won't rule it out.
He uses the "I give all my money to charity" line but there is nothing about the fact the charities are his own research organizations and the Steven E Nissen Healthy Heart fund that doled out gym memberships and travel money to people at the ACC.
He is described as an "informal advisor to Congress" on drug safety. How about someone who coordinated with Congress to preempt the FDA's own analysis of Avandia in order stoke support for alternative FDA reform proposals. Who was working with Congressman Waxman and the NEJM to release his paper, supposedly told a Glaxo rep he was going to "destroy Avandia" but had the chutzpah to claim to the media he offered Glaxo the chance to co-author a paper.
Nissen's behavior with respect to Avandia and the increasing criticism that has been leveled at his "study" (if all the short term data showed a 40 percent increased risk, why is there no hint of it in long term studies like RECORD) were all neglected in the NYT study.
I predict that when all is said and done Nissen will be revealed as the Michael Nifong of medical research.
http://www.nytimes.com/2007/07/22/business/22nissen.html
