Byetta, marketed jointly by Amylin Pharmaceuticals and Eli Lilly and Co. , was associated with ``sudden death" in 50 patients.

Byetta, marketed jointly by Amylin Pharmaceuticals and Eli Lilly and Co. ,
was associated with ``sudden death" in 50 patients.

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Website seeks doctors' take on drugs, and firms are crying foul
By Christopher Rowland, Globe Staff | October 14, 2006

A Cambridge 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, 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.

``It's important to study the model of how this site got formed, which is
there were financial rewards for physicians to post to the website," Schuler
said.

Sermo pays doctors $30 to $50 to post observations and says it already has
``several hundred" credentialed contributors. Once doctors are credentialed
and accepted to the Sermo site, their medical observations are ranked for
noteworthiness and credibility by other doctors, who also get paid for their
observations.

While the FDA gathers specific side-effect information that doctors and
companies submit in a government-mandated format, Sermo is a free-wheeling
bulletin board with a broad variety of information, from rants on insurance
reimbursements to reports of medical oddities to questions about the uses
and effects of new and old drugs. Doctors post anonymously, but Sermo knows
who they are and screens them to verify credentials.

Responding to complaints from Pfizer and Lilly, Palestrant, the founder,
said the site is intended to generate debate within the medical community.
He said it acts as a preliminary sounding board for investment firms that
subscribe to the site.

For instance, he said, the physician who anonymously posted the observation
that Byetta was responsible for 50 sudden deaths did not receive any
supporting comments from other physicians. The inference, he said, was that
the posting was of low value. It nonetheless remained on the site, as do all
postings. Regarding Lipitor, Palestrant said the physician reports of a
nightmare link suggest it deserves further study.

Sermo charges subscription fees to its largest subscribers but declined to
disclose the size of the fees. The company said big subscribers are Wall
Street investment companies looking for preliminary information that might
help them anticipate swings in a drug company's stock.

The company hopes to build relationships with federal regulators at the FDA
and Centers for Disease Control and Prevention . Drug companies are not
permitted to subscribe to the site yet, but Palestrant said they will after
details of their participation are negotiated. Drug companies will not have
any authority to quash information on the site, and crucial information will
immediately be reported to the FDA, he added.

Nonetheless, the site has come under criticism from Public Citizen , a
Washington nonprofit consumer advocacy group that frequently petitions the
FDA to have dangerous drugs removed from the market. Public Citizen said
companies should not attempt to supplant the FDA's watchdog role.

``It's a function too important to be left to venture capitalists and the
drug industry," said Dr. Sidney Wolfe , director of Public Citizen's public
health group. ``If you are an investment analyst on Wall Street, you would
love to get the first word on this."

Sermo has about 20 employees. It closed last month on the final portion of
its $3 million capital infusion from Longworth Venture Partners of Waltham
and is seeking another $8 million to $10 million in capital in its next
round, Palestrant said.

Palestrant has experience with healthcare-related start-up companies, having
once led a firm that marketed a medical records-keeping system. He left a
surgical residency at Beth Israel Deaconess Medical Center at the end of
2005 to develop Sermo full time as a forum that would attract investors
interested in tapping into high-quality medical observations.

They key, he said, was ``how do you distinguish the signal from the noise?"

The solution, according to Sermo, is a set of credibility-ranking systems,
in which peers support or debunk observations. It's designed to prevent any
exaggerated or inflated claims from gaining traction, and allow the most
significant patterns to emerge from the thousands of postings, Palestrant
said.

Doctors are not required to disclose connections to drug companies,
including speakers' fees or honoraria they receive, under the assumption
that other doctors will counter claims that seem biased by outside
influences, Palestrant said. ``The critical information is when other
physicians do a scrum and corroborate," he said. A tour through sections of
the site showed that some information is corroborated by doctors, others
were debunked, and many postings appeared to generate little response.

Information about drugs, medical devices, and procedures make for some of
the most interesting discussions, said Dr. Edward A. Cutler , a frequent
Sermo contributor from Columbus, Ohio, who said he posted about 40 times
during the pilot phase leading up to the official launch. ``For a physician,
it's very hard to present unique ideas unless they are double-blind,
controlled studies. Here's a unique opportunity to present unique ideas to
others," Cutler said. ``Every physician has observations that the physician
knows are true but can't prove."

Christopher Rowland can be reached at .

© Copyright 2006 Globe Newspaper Company.