Sermo in the Blogsphere

Sermo Inc. Upsets Big Pharma

Pharma Gossip Blog

October, 2006 - A US company that pays doctors to post medical observations on its website, including reports of drug side effects, has quickly incurred the wrath of pharmaceutical makers.

Sermo Inc. , founded by a surgical resident-turned-entrepreneur and backed by $3 million of venture capital, is promoting the website, http://www.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."

Sermo surveyed all its doctors after receiving observations from several physicians about Lipitor. Of 750 doctors surveyed, 33 percent reported they had patients taking Lipitor who also experienced unusual nightmares. Several reported that the nightmares stopped after the patients were switched to another anticholesterol drug, the website reported.

Byetta, which treats diabetes and is derived from the saliva of large lizards known as Gila monsters, has been associated with an undisclosed number of sudden deaths, but has not been proven to be the cause, said an Eli Lilly and Co. spokesman, Jamaison Schuler . But he said the Sermo web posting from a physician saying it was linked to 50 deaths was "significantly inconsistent" with information gathered by the company.

He declined to disclose the number of sudden deaths that the company attributes to Byetta.

More at The Boston Globe

Insider's view: interesting idea! Many clinical observations go on to become reality. However, some turn out to be blind alleys. The old way was for a doctor to collect three similar unusual cases then report them.

Wall Street will love it.

Big Pharma already hates it!

The "signal vs noise" issue is a big one, but Sermo have some plans for handling that.

Let's see.....

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