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.....
2 comments:
Eli Lilly needs to get a grip on it's outstanding zyprexa personal injury settlement claims.
Daniel Haszard Bangor Maine zyprexa caused my diabetes http://www.zyprexa-victims.com
The Prevention of Ignorance
Historically, information sources provided to American citizens were limited due to the few methods available to the public. And also this information was subject to being filtered and, in some cases, delayed. This occurred for a number of reasons, which included political ones.
Now, and with great elation, there is the internet.
Soon after the advent of the internet, web logs were created, that are termed ‘blogs’. At that time, about a decade ago, the blogs were referred to as personal journals or diaries visible on line. As time passed, blogs became a media medium, and blog communities evolved on topics that often were not addressed in mainstream media. In addition, blogs provide immediate contributions by others instead of the cumbersomeness of opinion and editorial pieces historically and not always presented in such media forms as newspapers. The authors of blogs vary as far as their backgrounds and intent of what they present are, just as with other media forms. Furthermore, they are not exonerated from the legalities of what is written, such as cases of libel. While we can presume that they like to write, they may not be quality writers.
Yet presently, blogs have become quite a driving force for those with objectives often opposed by others, and are a threat to big business and politics both who presently monitor the progress and content of blogs that provide instant information on events, which might affect their image and activities not yet exposed.
This includes information released from whistleblowers
While one disadvantage of blogs is the potential lack of reliability, blogs however do allow the posting of documents that typically are not created for view of others besides perhaps a select few. For example, blogger Dr. Peter Rost, a whistleblower himself, not long ago posted a newsletter on his blog site given to him by pharmaceutical maker AstraZeneca employees who called themselves the ‘AZ Group of Seven’ to bring to the attention to others the illegal activity of off-label promotion of one of their cancer drugs. Yet this is not what caught the attention of so many with all of the content of this newsletter. It was instead a comment stated by former regional AZ manager Mike Zubalagga, who in this newsletter referred to doctors’ offices as ‘buckets of money’. Again, the statement was authentic and in writing in this newsletter.
Mr. Zubalagga was fired the next day due to this comment. His manager resigned soon afterwards.
And there have been other whistleblower blog cases in addition to this one, so blogs have become a very powerful and threatening medium of information release that does not allow others to prevent such releases. This is true freedom of information, free of alteration or omission. One step closer to social utopia.
Yet again, the information on these blogs should not be taken as absolute truth without proof to verify claims that may be made. Of course, documents that are authentic are in fact proof, as illustrated with the above example. And this, in my opinion, is the blog’s greatest value, combined with the comments on blogs from the growing number of readers who are allowed to contribute to the subject matter so quickly, which fuels the objectives of the blogs.
Because we, the public, have a right to know what we are entitled to know and what we want to know. This is especially true if the information could potentially be adverse to our well-being.
“Information is the seed of an idea, and only grows when it’s watered.” --- Heinz V. Berger
Dan Abshear
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