Category: Politics and Regulation
What does “anti-vaccine” really mean?
We frequently use terms like "antivaccine," "antivax," and "antivaxxers." Critics think it's a "gotcha" to ask how we define "antivax." It's not. There are gray areas, but not so gray that the word is never appropriate.
The mammography wars heat up again
PRELUDE: THE PROBLEM WITH SCREENING If there’s one aspect of science-based medicine (SBM) that makes it hard, particularly for practitioners, it’s SBM’s continual requirement that we adjust what we do based on new information from science and clinical trials. It’s not easy for patients, either. To lay people, SBM’s greatest strength, its continual improvement and evolution as new evidence becomes available, can...
Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2
NB: If you haven’t yet read Part 1 of this blog, please do so now; Part 2 will not summarize it. … At the end of Part 1, I wrote: We do not need formal statistics or a new, randomized trial with a larger sample size to justify dismissing the Gonzalez regimen. In his editorial for the JCO, Mark Levine made a...
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...