Category: Politics and Regulation

Integrating patient experience into research and clinical medicine: Towards true “personalized medicine”

We advocate science-based medicine (SBM) on this blog. However, from time to time, I feel it necessary to point out that science-based medicine is not the same thing as turning medicine into a science. Rather, we argue that what we do as clinicians should be based in science. This is not a distinction without a difference. If we were practicing pure science,...

/ November 8, 2010

Vaccine Wars: the NCCAM Drops the Ball

If you go to the website of the National Center for Complementary and Alternative Medicine (NCCAM), you’ll find that one of its self-identified roles is to “provide information about CAM.” NCCAM Director Josephine Briggs is proud to assert that the website fulfills this expectation. As many readers will recall, three of your bloggers visited the NCCAM last April, after having received an...

/ November 4, 2010

What does “anti-vaccine” really mean?

We write a lot about vaccines here at Science-Based Medicine. Indeed, as I write this, I note that there are 155 posts under the Vaccines category, with this post to make it 156. This is third only to Science and Medicine (which is such a vague, generic category that I’ve been seriously tempted to get rid of it, anyway) and Science and...

/ November 1, 2010

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...

/ September 27, 2010

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...

/ September 20, 2010

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,...

/ September 17, 2010

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...

/ September 8, 2010
avastin

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.

/ August 30, 2010

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...

/ August 19, 2010

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...

/ August 5, 2010