Category: Politics and Regulation
Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1
Background: the distinction between EBM and SBM An important theme on the Science-Based Medicine blog, and the very reason for its name, has been its emphasis on examining all the evidence—not merely the results of clinical trials—for various claims, particularly for those that are implausible. We’ve discussed the distinction between Science-Based Medicine (SBM) and the more limited Evidence-Based Medicine (EBM) several times,...
Ghostwriting As Marketing Tool
An article in the latest issue of PLOS Medicine, The Haunting of Medical Journals: How Ghostwriting Sold “HRT”, details the use of ghostwriting as a marketing tool for pharmaceutical companies. It is a chilling discussion of how at least one pharmaceutical company, Wyeth, used the peer-reviewed literature as a method of distributing marketing messages to physicians. The author, Adriane J. Fugh-Berman, details...
Avastin and metastatic breast cancer: When science-based medicine collides with FDA regulation
Not all drugs that prevent progression of cancer prolong the patient's survival. The case of Avastin and metastatic breast cancer reminds us of that simple, unfortunate fact once again.
Medical Science and Public Opinion: The Avandia Story
The week of 12-16 July saw an FDA Advisory Panel meet to decide the fate of an important drug. Along the way, the FDA charted new territory in using drug comparisons to judge safety, amidst external allegations of corporate malfeasance and patient harm. Avandia, or rosiglitazone, is one of a new class of anti-diabetes drugs approved for marketing by the FDA in...
Supplement Regulation: Be Careful What You Wish For
A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls...
NCCAM Director Dr. Josephine Briggs and the American Association of Naturopathic Physicians
On Friday, one of my partners in crime here at Science-Based Medicine, Dr. Kimball Atwood, wrote an excellent Open Letter to Dr. Josephine Briggs. Dr. Briggs, as most regular readers of SBM know, is the Director of the National Center for Complementary and Alternative Medicine (NCCAM). As most regular readers of SBM also know, we at SBM have been quite critical of...
Open Letter to Dr. Josephine Briggs
Josephine P. Briggs, M.D. Director, National Center for Complementary and Alternative Medicine Dear Dr. Briggs, As you know, we’ve met twice. The first time was at the Yale “Integrative Medicine” Symposium in March. The second was in April, when Drs. Novella, Gorski and I met with you for an hour at the NCCAM in Bethesda. At the time I concluded that you...
The Texas Medical Board acts in the case of the Winkler County whistle blowing nurses
I can’t speak for anyone else who blogs here at Science-Based Medicine, but there’s one thing I like to emphasize to people who complain that we exist only to “bash ‘alternative’ medicine.” We don’t. We exist to champion medicine based on science against all manner of dubious practices. Part of that mandate involves understanding and accepting that science-based medicine is not perfect....
Bought and Sold: Who Should Pay for CME
There are two topics about which I am a crank. The first, as you might have guessed, is alternative medicine. The other is pharmaceutical reps. Drug companies are somewhat schizophrenic. They have amazing scientists who invent drugs that treat an astounding array of diseases. Then, they take these drugs and turn them over to marketing, to be sold with all the enthusiasm...
New CMS Chief Donald Berwick: a Trojan Horse for Quackery?
NB: I posted this on Health Care Renewal a couple of days ago, figuring that Dr. Gorski’s post would suffice for the SBM readership (he and I had discussed the topic while at TAM8 last week). But Managing Editor Gorski has asked me to repost it here, which I’m happy to do. I am especially pleased to demonstrate that I am capable...