I have delayed posting about this matter and as a result can simply point to several earlier posts by our various colleagues:
--as well as Alicia Mundy's report in the Wall Street Journal (subscription required):
Short version: Sanofi-Aventis makes a drug called Lovenox (enoxaparin), given by injection. This drug is one of a class called "low-molecular-weight heparins." Heparin is a drug to prevent clotting (a so-called "blood thinner" which is a misnomer as it does not thin the blood) that also carries with it a number of problems, including a need to have its effect on the body closely monitored. Lovenox and its cousins can be given safely without that close monitoring, meaning that some conditions that used to require hospital stays now can be handled in an outpatient setting. Lovenox is one of the relatively small number of drugs that could legitimately be argued to have saved money, even though the drug itself is very expensive--if it keeps people out of the hospital and allows home treatment instead.
But all good things must come to an end, and in this case the good thing, for Sanofi-Aventis, is Lovenox's patent. The possibility of competition from cheaper generic drugs cutting into Lovenox's $4B in global sales had the usual effect on the company. Their response has been to launch a massive PR campaign aimed at the FDA, arguing that the data do not demonstrate the safety of the generic versions, raising the fear that patients might die if given cheaper drugs.
As Roy Poses noted in the Health Care Renewal post, a typical PR move in such circumstances is to play the "third-party tactic"-- send the company's message to the FDA but as if it was coming spontaneously from another party entirely, without any prompting from the firm. Now, enter the Senate Finance Committee, where drug industry foe Sen. Charles Grassley hangs out. The committee has issued a report naming two medical societies (Society of Hospital Medicine (SHM), North American Thrombosis Forum (NATF)) and Duke University prof Dr. Victor Tapson as accepting large payments from the company and then sending supposedly independent letters to the FDA challenging the safety of the generic drugs. Internal company memos clearly indicate that the company, at least, thought that it had a quid pro quo from these folks. Between 2007 and 2010, Sanofi-Aventis contributed more than $2.6M to SHM, $2.3M to NATF, and $260,000 to Dr. Tapson. Dr. Tapson was apparently a bargain for the company; he wrote multiple letters to the FDA. Paul Thacker at Project on Government Oversight reports that Dr. Tapson, in an e-mail to the Wall Street Journal, characterized the Senate Finance report as "very incorrect," but did not explain in what way. Thacker throws in as a bonus a copy of one of the letters Dr. Tapson wrote to the FDA (http://pogoarchives.org/m/ph/lovenox-senate-report/tapson-letter-duke-letterhead-20100528.pdf).
And of course in none of the communications from the above three parties was any mention made of receiving funding from Sanofi-Aventis. Earlier, before the Senate Finance report, leaders of one of the medical societies explicitly denied any relationship between the company funding and their letters to the FDA.
Monday, June 13, 2011
When "Professional" Societies Become an Industry PR Apparatus
Posted by Howard Brody at 3:57 PM
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