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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. http://www.boston.com/business/healt... crying_foul/ a.. Home b.. Business c.. Healthcare 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. |
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