• 02
  • June
    2011

The Senate Finance Committee issued a report last week in which it accused pharmaceutical manufacturer Sanofi of bribing doctors to lobby the FDA against approving a generic version of the drug. Lovenox, manufactured by Sanofi, brings in around $2 billion per year. Sanofi's attempt to slow down the process of approving cheaper, generic versions of the drug by buying out doctors and physician's groups was the subject of the report.

Lovenox, a blood-thinner used to treat deep vein thrombosis, is one of a number of medications at issue in the report. Deep vein thrombosis is a condition affecting as many as 600,000 Americans, in which blood clots in the leg can be sent to the lungs. Up to 100,000 die every year from the condition.

Last year Senators Max Baucus, chairman of the Senate Finance Committee, and Charles Grassley, urged fellow lawmakers to take action to stop Sanofi from using their financial resources to prevent the approval of generic versions of Lovenox.

At the heart of the lobbying was Sanofi's suggestion that generic versions of the drug were more dangerous than the name brand. The report detailed that Sanofi gave the Society for Hospital Medicine over $2.6 million over a three year period for sponsorship and conferences, urging them to send letters to the FDA calling the safety of generic medications into question. The organization did in fact send two letters to the FDA, saying that untested generic substitutions for the drug were "not in our patients' best interest."

Sanofi also reportedly paid $2.3 million to the North American Thrombosis Foundation, who wrote a letter to the FDA warning of "unanticipated adverse events" associate with generic drugs.

The FDA did eventually approve the generic version of Lovenox in 2010, which caused Lovenox sales to fall 20 percent to $1.9 billion dollars, but two Senators are now urging the FDA to require physicians groups and individual physicians to be transparent about their financial ties with pharmaceutical companies.

While Sanofi defends its action as legitimate efforts to encourage experts to express their professional opinion, others say it is important to foster not only innovation in the pharmaceutical industry but also to maintain independence-not only in fact but also in appearance-among the various bodies of experts in the field.

Source: CBS Evening News, "Senators rail at big pharma's secretive lobbying," Nancy Cordes, 29 May 2011.