Healthy Skepticism Library item: 16551

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

Goldstein J
New Pharma Guidelines: No Ghostwriting, More Public Info
The Wall Street Journal Blog 2009 Sep 30
http://blogs.wsj.com/health/2009/09/30/new-pharma-guidelines-no-ghostwriting-more-public-info/

Full text:

Clinical trial guidelines from PhRMA, the big drug industry trade group, go into effect tomorrow.

Here are a few interesting details, followed by a big grain of salt:

The guidelines basically ban ghostwriting. That’s noteworthy because of reports over the past few years that several big drugmakers paid professional writers to make major contributions to articles that were published in medical journals under the names of academic physicians.

Anyone who makes “substantial contributions” to a study, writes or revises intellectually important parts of a manuscript and has final approval over what is published should be listed as an author, the guidelines say. People who contribute but don’t qualify as authors should be listed in the acknowledgments. If authors get help, they “should disclose the identity of the people that provided the assistance and any entity that supported it.”

Companies should post “summary results” of all clinical trials of drugs that have been approved for sale, and of drugs that have been dropped from the pipeline, the guidelines say. This is relevant because companies have been criticized for publicizing results that reflect well on their drugs, and burying results that make their drugs look bad.

Trials of experimental drugs that are still in development are exempted because posting trial results could “jeopardize important intellectual property,” the guidelines say. Also worth noting: The guidelines aren’t retroactive, so they’ll apply only to new findings.

A doctor who has an ownership stake in a drug can’t be a clinical investigator in a trial of that drug. So if a doc discovers a drug, then licenses it to a pharma company, the doc can’t be one of the researchers who treats patients in a study of the drug. That would “present an inherent conflict of interest,” the guidelines say. Why is this worth flagging? Ask Chuck Grassley.

The guidelines are purely voluntary. This is the big grain of salt we were talking about. Jeffrey K. Francer, PhRMA’s assistant general counsel, told the Health Blog that the trade group could get into antitrust trouble for making the rules mandatory.

Francer also pointed out that the guidelines were approved unanimously by PhRMA’s board, which includes execs from Pfizer, J&J, Merck, GlaxoSmithKline, Sanofi-Aventis, and most of the other big drug companies you can think of. So can we expect companies whose execs are on the board to follow the guidelines? “I would hope so,” Francer said.