Thursday, October 15, 2009
An oldie but goodie
http://www.center4research.org/news/fda-app-safety.html
2006 study of the practices of the advisory panels for the FDA which are the front lines of the approval process for new drugs and devices
The results indicate that advisory committees recommended approval for 76% of new drugs and 82% of new medical devices. Some committees are more discriminating than others. Many panel members and some committee members recommended approval for every product they considered year after year. For example, 98% of the votes by members of the advisory committee reviewing arthritis drugs over the eight years of the study recommended approval; almost all, like Vioxx®, were recommended unanimously. The committee reviewing medical devices for vision correction and eye diseases unanimously recommended approval for every medical device they considered for the last six years of the study. About 96% of these drugs and devices were subsequently approved by the FDA.
2006 study of the practices of the advisory panels for the FDA which are the front lines of the approval process for new drugs and devices
The results indicate that advisory committees recommended approval for 76% of new drugs and 82% of new medical devices. Some committees are more discriminating than others. Many panel members and some committee members recommended approval for every product they considered year after year. For example, 98% of the votes by members of the advisory committee reviewing arthritis drugs over the eight years of the study recommended approval; almost all, like Vioxx®, were recommended unanimously. The committee reviewing medical devices for vision correction and eye diseases unanimously recommended approval for every medical device they considered for the last six years of the study. About 96% of these drugs and devices were subsequently approved by the FDA.
Tuesday, October 13, 2009
10/13/09
Thanks to Joel I've gone twitter crazy. There's still time for people to push back against this mindless swine flu vaccination campaign. There's still the forums to get started (finally) but between seeing sick children and doing sports physicals, I've been working on ways to encourage debate over the swine flu mandates throughout the health care industry. Most of you are aware of Memorial Hospital's decision to force all their clinicians to accept an untested bio pharmaceutical or suffer the consequence of wearing a mask on hospital property for 5 months: A very public questioning of their individual clinical judgement.
I have a slide show to get published looking at the CDC data on the swine flu epidemic.
Join twitter if you haven't already to participate in spreading the knowledge.
http://twitter.com/doctorcrafts
Any of you who want to sit down and talk about anything, I'm an email away. I've enjoyed the meetings I've had with folks so far.
I have a slide show to get published looking at the CDC data on the swine flu epidemic.
Join twitter if you haven't already to participate in spreading the knowledge.
http://twitter.com/doctorcrafts
Any of you who want to sit down and talk about anything, I'm an email away. I've enjoyed the meetings I've had with folks so far.
Wednesday, October 7, 2009
Wed 10/7/09
I'll be in a cardiology conference most of today; don't know if i'll have internet access there but I bet I will
will be out of that thing and home by 630 if not
still working on the forums deal, getting closer
thanks for all of the great advice and assistance
will be out of that thing and home by 630 if not
still working on the forums deal, getting closer
thanks for all of the great advice and assistance
Monday, October 5, 2009
Slow Money
http://friendsofslowmoney.com/
Slow Money's Mission
• To steer significant new sources of capital to small food enterprises, appropriate-scale organic farming and local food systems; and,
• To catalyze the emergence of the nurture capital industry— entrepreneurial finance supporting soil fertility, carrying capacity, sense of place, cultural and ecological diversity, and nonviolence.
Slow Money's Mission
• To steer significant new sources of capital to small food enterprises, appropriate-scale organic farming and local food systems; and,
• To catalyze the emergence of the nurture capital industry— entrepreneurial finance supporting soil fertility, carrying capacity, sense of place, cultural and ecological diversity, and nonviolence.
Sunday, October 4, 2009
Conflict of interest
http://www.nybooks.com/articles/22237
The problems I've discussed are not limited to psychiatry, although they reach their most florid form there. Similar conflicts of interest and biases exist in virtually every field of medicine, particularly those that rely heavily on drugs or devices. It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of TheNew England Journal of Medicine.
--Marcia Angell, M.D. (born 1939) is an American physician, author, and the first woman to serve as editor-in-chief of the New England Journal of Medicine (NEJM). She currently is a Senior Lecturer in the Department of Social Medicine at Harvard Medical School, in Boston, Massachusetts
The problems I've discussed are not limited to psychiatry, although they reach their most florid form there. Similar conflicts of interest and biases exist in virtually every field of medicine, particularly those that rely heavily on drugs or devices. It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of TheNew England Journal of Medicine.
--Marcia Angell, M.D. (born 1939) is an American physician, author, and the first woman to serve as editor-in-chief of the New England Journal of Medicine (NEJM). She currently is a Senior Lecturer in the Department of Social Medicine at Harvard Medical School, in Boston, Massachusetts
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