Healthy Skepticism Library item: 13589

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Hensley S.
FDA’s Off-Label Promotion Notion: ‘Good Framework’ vs. ‘Fantasy’
The Wall Street Journal Health Blog 2008 Apr 25
http://blogs.wsj.com/health/2008/04/25/fdas-off-label-promotion-notion-good-framework-v-fantasy/?mod=WSJBlog

Full text:

We’re having flashbacks to James J. Kilpatrick going at it with Shana Alexander on “60 Minutes” after reading the opposing views of ex-FDAer Scott Gottlieb and former New England Journal of Medicine editor Jerome Kassirer on the FDA’s proposal to allow drug and device makers to use journal articles to promote their products for unapproved uses.

Over on the Health Affairs blog, Gottlieb, now at the American Enterprise Institute, sounds off in support of off-label promotion, citing a delay in the adoption of Genentech’s cancer drug Herceptin to treat breast cancer as Exhibit A.

In early 2005, government-funded studies showed that Herceptin could dramatically reduce the risk of relapse for some kinds of early-stage breast cancer in combination with standard chemo.

But some doctors, despite the data and the fanfare, didn’t prescribe the drug to women who could have benefited from it. Worries about heart damage may have weighed on some oncologists, but Gottlieb asserts an “information gap” was a big part of the problem:

[F]or the entire time between the publication of the initial results and FDA approval almost two years later, the drug’s sponsor – Genentech – was prohibited from distributing the findings or educating doctors on the new use through sponsored medical education.

He argues the solution is just what the FDA has in mind. Manufacturers should be able to distribute peer-reviewed articles, setting “a measured standard as to what information could help better inform decisions that doctors make with their patients.”

Kassirer, who knows quite a bit about the strengths and weaknesses of peer review, argues that the process, even with ample disclosure of conflicts, isn’t an adequate shield against improper marketing:

The notion that peer review and disclosure will protect the public is, in my judgment, magical thinking. Anthropologist Philips Stevens Jr. says that magical thinking invests symbols with special powers and forces. Peer review and disclosure are two of these powerful symbols, and, in my opinion, both have been afforded far more credibility than they deserve.

For starters, not all peer-review is equally stringent. Some article rejected by top journals get shopped around until they’re accepted by lesser publications with laxer standards. Even the best journals also publish results from studies whose designs vary. Some may be powerful and sound while others’ main value may be limited to teeing up new questions.

Kassirer concludes:

By requiring peer review, disclosure, and editorial-board expertise, the new FDA guidance offers a veneer of credibility and respectability, but if you scratch this glossy surface, you find more marketing, more inappropriate drug use, more expense, and more adverse consequences.