New "safe harbor" maybe not so safe

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According to this article in the Boston Globe, there's a Web site that allows doctors to post their experiences with various drugs, therapies, and instruments. It sounds sort of like a TripAdvisor, only for the healthcare industry instead of the hospitality world. The rub, it appears, is that the site also lets investment firms peek at the comments. From the article:


    Sermo Inc. , founded by a surgical resident-turned-entrepreneur and backed by $3 million of venture capital, is promoting the website, sermo.com, as a novel Internet community. It's a password-protected private forum where raw postings by doctors can be viewed, for a fee, by Wall Street investment firms.


    Founder and chief executive Daniel Palestrant says the site will serve as an early-warning system about potentially dangerous drug reactions. The site will also be a forum for doctors to share information about so-called off-label uses of drugs, for conditions other than those approved by the Food and Drug Administration.


    The FDA, which is charged with monitoring drug safety, has come under criticism for failing to respond to reports of drug side effects, and for not making manufacturers follow through on pledges to monitor safety after their products are on the market.

    With its debut two weeks ago, the Sermo site generated debate by prominently featuring postings from several doctors saying that Pfizer Inc.'s cholesterol-fighter Lipitor induces vivid and repeated nightmares in some patients as well as a posting by one doctor that said the diabetes drug Byetta, marketed jointly by Amylin Pharmaceuticals and Eli Lilly and Co. , was associated with ``sudden death" in 50 patients.


    There has been almost nothing published about either problem in medical literature. Both drug companies, which reviewed the website after questions from the Globe, said the physicians' anecdotal observations appeared to be inaccurate.


    Pfizer said no scientific studies or clinical trials have shown any link between Lipitor, the world's biggest-selling prescription drug, and nightmares. ``It's not true. This is such a strange situation with this website," said Dr. Gregg Larson , Pfizer's vice president for cardiovascular drugs. ``It's not scientifically based. It's not clinically based."



And so we can expect to see the lawsuits fly. I think it's an interesting idea, if you subtract the investment firm piece. But a private online space where docs can compare notes, much as they do in the hallways at scientific meetings, is not necessarily a bad thing.


Update: I just received this note from a person representing the company:


    We just wanted to make sure you knew that we do not give investment firms complete access to the Sermo community. Our business model is designed to give them access only to the "collective knowledge" of thousands of physicians on the site. Physicians remain anonymous as do individual postings

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