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Big pharma deploys doctors to lobby FDA


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How does the FDA make its decisions? Big pharma pays doctors to send letters promoting its interests.


Senators rail at big pharma's secretive lobbying


Sen. Baucus seeks to force doctors and medical associations who lobby the FDA to disclose their pharmaceutical company ties


By Nancy Cordes May 29, 2011 (CBS News)


Two influential U.S. senators have urged the FDA to require physicians groups and doctors to disclose their financial ties with drug-makers.



[the senators detailed] how one pharmaceutical giant urged doctors to contact the FDA and raise concerns about a cheaper generic version of one of their drugs.


One of the drugs at the center of the controversy is Lovenox, a blood-thinner injections used to combat deep vein thrombosis. It is a condition that sends dangerous blood clots from the leg to the lungs. Up to 600,000 Americans are afflicted every year, and as many as 100,000 die.


Lovenox earned its maker - the French company Sanofi - more than $2 billion per year. So when the FDA began considering a cheaper, generic version of the costly drug in 2007, Sanofi sprang into action to try and slow the process.


....[sen. Max Baucus (D-MT)] chairs the Senate Finance Committee, which issued a report this week accusing Sanofi of "paying off doctors to lobby the FDA against generics."


According to the report, the Society for Hospital Medicine received more than $2.6 million over 3 years from Sanofi for sponsorship and conferences. Sanofi urged them to send letters to the FDA questioning the safety of generics.


In an internal email, an executive at the society admitted it "has no history of making similar comments to the FDA" and lacked "the expertise and knowledge" to weigh in on the matter.


But the society sent two letters anyway. Warning in one, "an untested generic substitution...is not in our patients' best interest"


Baucus said of the incident: "I think if the FDA receives letter recommendations from the medical companies, from doctors, they should have a disclosure requirement. That is, tell us Mr. Doctor, tell us Mr. Medical Association, are you bought and sold?"


Sanofi paid $2.3 million to the North American Thrombosis Foundation, which also wrote to the FDA to warn of the "potential for unanticipated adverse events" from generic drugs.


Sanofi stands by its actions, telling CBS News: "Where there is an appropriate forum for public discourse, we may encourage experts in the field to express their own opinions....Each made their own decisions to submit comments to the FDA".


But the Society of Hospital Medicine says it has reshaped its transparency policies, telling CBS News: "We have learned from this experience."



The FDA did approve the generic version of the drug in 2010, causing sales of Lovenox to drop 20 percent to a still healthy $1.9 billion dollars.



This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

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