We have long been writing that the financial relationships between the drug and medical device industries and the health care industry have led to enormous controversy. Critics maintain that such relationships create conflicts of interest and could unduly influence everything from research findings to prescribing practices.
The Wall Street Journal just reported that according to an emerging Senate Finance Committee report, drug maker Sanofi SA contributed over $5 million to a couple of medical groups and one researcher for the purposes of urging U.S. regulators to delay approving a generic version of the brand name fast-acting anti-clotting drug, <"http://www.yourlawyer.com/practice_areas/defective_drugs">Lovenox.
It seems that both the Society of Hospital Medicine and the North American Thrombosis Forum and Victor Tapson, a Duke University thrombosis expert, wrote to the U.S. Food and Drug Administration (FDA), stating that generic versions of Lovenox might not be as safe as the brand, according to the Senate Finance Committee report, wrote the Journal. The letters never mention the financial links to Sanofi, said the report, entitled “Sanofi’s Strategic Use of Third Parties to Influence the FDA.”
In July 2010, the FDA approved generics, sold by Momenta Pharmaceuticals Inc. and Sandoz, a Novartis AG unit, in spite of the letters; two other versions seeking agency approval are also pending, said the Journal.
According to the report, Sanofi recruited experts to manage so-called “independent interaction” with the FDA in its efforts to maintain its corner on the brand-name blood thinner, wrote the Journal.
From 2007 through 2010, Sanofi gave over $2.6 million to the Society of Hospital Medicine; in excess of $2.3 million to the North American Thrombosis Foundation, and more than $260,000 to Dr. Tapson, said the Journal, citing the Senate report. “Pharmaceutical companies simply cannot be allowed to spend millions of dollars to buy medical opinions that claim objectivity but instead favor their products,” said Senator Max Baucus (Democrat-Montana), chairman of the Finance Committee said, quoted the Journal.
We recently cited a study that highlighted potential pitfalls when doctors maintain close financial ties with drug and medical device makers. The study, published in the Archives of Internal Medicine, said most doctors who served on panels charged with writing heart treatment guidelines also have financial relationships with companies that market medical products.
Last month, we wrote that according to another study, fewer than half of all Americans diagnosed with stable heart disease receive guideline-recommended medicines before undergoing angioplasty with coronary stentsâ€”a procedure also known as percutaneous coronary intervention (PCI). An investigation by ProPublica suggested that the rush to use stents by many doctors could be the result of heavy financial influence from the makers of stents. It seems that guidelines instituted after a 2007 landmark study are largely ignored in favor of heavily touted stents, despite that the guidelines showed that intensive drug treatment in nonemergency patients with chest pain worked just as well as angioplasty and also suggested that many of those given drugs first would never need an eventual angioplasty.