Wednesday, April 29, 2009

It's "Peer Reviewed", so It's gotta be right.

The FDA has always taken the attitude of regulating drugs and devices and not the practice of medicine - i.e., doctors can do whatever they want with the controlled materials, even if the product is intended in other ways. I believe cosmetic botox injections started this way. They were originally intended for use in stilling muscles during surgery, but someone got the bright idea that it would be great for removing wrinkles in the face. The drug was not labeled by the manufacturer for this application and it was not legal for the manufacturer to sell it for cosmetic application - the doctor assumed all the risk. This is known as "off-label" useage. That has now changed as the FDA has approved this use of the toxin as well.

But now the regulations in the area are starting to change. It's now permissible for companies to pass out reprints of research articles that studied off-label uses of drugs.

From the FDA document: "A scientific or medical journal article that is distributed should:
  • be published by an organization that has an editorial board that uses experts who have demonstrated expertise in the subject of the article under review by the organization and who are independent of the organization to review and objectively select, reject, or provide comments about proposed articles; and that has a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors, contributors, or editors associated with the journal or organization;

  • be peer-reviewed and published in accordance with the peer-review procedures of the organization; and

  • not be in the form of a special supplement or publication that has been funded in whole or in part by one or more of the manufacturers of the product that is the subject of the article"

So now the FDA is making the assumption that if it is peer-reviewed, it's correct. As if peer-reviewers are short on time (I'm always pressed for time when asked to complete a review, they never seem to come during slow times), ever wrong (I don't think I am, but fortunately I'm not making life-and-death decisions to approve a polymer chemistry paper), or politically connected (I'm too much of a loner for that game). Sure, the papers are already out there, but to use them for promotion is not the original intent of the article (or maybe it is depending on who funded it) but there is no obligation to not cherry pick the articles and only pass out the good results.

1 comment:

اتاق فرار برج میلاد said...

Thank you for such a great post. Best of luck