How did Representative Henry Waxman (Congress' Oversighter-in-Chief) know about the NEJM's clarion call on Avandia before the FDA?
As Scott Gottlieb opines in today's edition of the Wall Street Journal ...
"NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's 'handling' of the drug safety issues. Mr. Waxman is trying to add new restrictions to the FDA's drug approvals. The study's primary author, Cleveland Clinic Cardiologist Steve Nissen, admitted to The Wall Street Journal that he was in touch with Congress while preparing his analysis. Three days after the study was submitted to NEJM, and before it was published, the FDA commissioner received a letter about Avandia from members of the House Energy and Commerce Committee that seemed to reference the NEJM study."
Dr. Steve Galson, the FDA's superb CDER Director, had some pretty unsubtle comments as well (courtesy of BioCentury's Steve Usdin), "What was the compelling public health purpose that justified rushing this study to publication -- an action that resulted in dozens of near-hysterical press reports ... Medical journals need to take their responsibility seriously to patients and physicians to publish information in a responsible and balanced manner. I'm not sure that responsibility was adeqautely executed in this instance."
Steve -- what do you really think?
Dr. Michael Weber, professor of medicine and associate dean at the State University of New York, Downstate College of Medicine, Brooklyn (and Chairman, we are proud to say, of the Center for Medicine in the Public Interest), was equally blunt. He said that Nissens's paper "verged on the sensational ... It is very disappointing that matters like this become opportunities for grandstanding rather than careful and thoughtful analysis of the data."
Michael -- what do you really think?
And, here's another question -- why weren't either of these high-profile experts interviewed for the first round of stories last week?
The Lancet wrote that, "To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed. Alarmist headlines and confident declarations help nobody."
Which begs the question -- what do the experts know that the pols and pundits do not? Could the answer be that science is not a binary right/wrong, safe/unsafe proposition.
But the MSM doesn't like complicated -- there is rarely either the understanding or the space. Politicians certainly don't like complicated -- since it doesn't get headlines. Both groups prefer good guys and bad guys.
So much for not politicizing science.
And the Oversighter-in-Chief? Well, if you've got a hammer, every problem looks like a nail.
As Scott Gottlieb opines in today's edition of the Wall Street Journal ...
"NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's 'handling' of the drug safety issues. Mr. Waxman is trying to add new restrictions to the FDA's drug approvals. The study's primary author, Cleveland Clinic Cardiologist Steve Nissen, admitted to The Wall Street Journal that he was in touch with Congress while preparing his analysis. Three days after the study was submitted to NEJM, and before it was published, the FDA commissioner received a letter about Avandia from members of the House Energy and Commerce Committee that seemed to reference the NEJM study."
Dr. Steve Galson, the FDA's superb CDER Director, had some pretty unsubtle comments as well (courtesy of BioCentury's Steve Usdin), "What was the compelling public health purpose that justified rushing this study to publication -- an action that resulted in dozens of near-hysterical press reports ... Medical journals need to take their responsibility seriously to patients and physicians to publish information in a responsible and balanced manner. I'm not sure that responsibility was adeqautely executed in this instance."
Steve -- what do you really think?
Dr. Michael Weber, professor of medicine and associate dean at the State University of New York, Downstate College of Medicine, Brooklyn (and Chairman, we are proud to say, of the Center for Medicine in the Public Interest), was equally blunt. He said that Nissens's paper "verged on the sensational ... It is very disappointing that matters like this become opportunities for grandstanding rather than careful and thoughtful analysis of the data."
Michael -- what do you really think?
And, here's another question -- why weren't either of these high-profile experts interviewed for the first round of stories last week?
The Lancet wrote that, "To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed. Alarmist headlines and confident declarations help nobody."
Which begs the question -- what do the experts know that the pols and pundits do not? Could the answer be that science is not a binary right/wrong, safe/unsafe proposition.
But the MSM doesn't like complicated -- there is rarely either the understanding or the space. Politicians certainly don't like complicated -- since it doesn't get headlines. Both groups prefer good guys and bad guys.
So much for not politicizing science.
And the Oversighter-in-Chief? Well, if you've got a hammer, every problem looks like a nail.
