Sanofi contributed more than $5 million to two medical groups and a Duke University researcher that encouraged the FDA to delay approval of a medicine the drugmaker feared would undercut its blockbuster Lovenox bloodthinner, according to a US Senate Finance Committee report released this morning.

The Society of Hospital Medicine, the North American Thrombosis Forum and Duke University thrombosis expert Victor Tapson wrote to the FDA to argue that generic versions of Lovenox may not be as safe as Lovenox, but the letters did not mention any ties to Sanofi, according to the Senate findings, which were first reported by The Wall Street Journal.

Just the same, the FDA last summer approved a generic from Momenta Pharmaceuticals and Sandoz, the Novartis generics unit (back story here and here). Consequently, Lovenox sales, which exceeded $4 billion in 2009, fell sharply last year, according to Sanofi, which unsuccessfully sued the FDA (read this).

The tactics underscore the complex, behind-the-scenes interplay that sometimes exists between the pharmaceutical industry, medical societies, patient advocate groups and academic researchers. Their overlapping efforts sometimes cross lines, according to critics who argue that industry efforts to promote their drugs can have corrosive effects on the practice of medicine and the way drugs are portrayed to the public by organizations that advertise themselves as placing patient interests first.

The issue has generated enormous controversy in recent years amid a slew of investigations and subsequent lawsuits that have peeled back the curtain on how these relationships form and function. To underscore the debate, ProPublica recently created separate databases showing the payments many doctors and medical societies receive from drugmakers (read here and here).

In its report, which is called “Sanofi’s Strategic Use of Third Parties to Influence the FDA,” the Senate Committee says the drugmaker actively enlisted medical experts to conduct what was termed “independent interaction” with the FDA in a bid to protect Lovenox sales. A 2009 slide presentation referred to this as an “imminent threat to (the) Lovenox franchise.” The concern with sales, however, was in contrast to the message sent in an August 2008 letter sent by the medical societies and the Duke researcher to the agency, which was that “untested generic substitution for is not in our patients’ best interest” (go here to read the report, letters, emails and internal documents).

A few numbers: between 2007 and 2010, Sanofi contributed more than $2.6 million to the Society of Hospital Medicine;and Sanofi’s payments to SHM totaled $1.1 million between July 1, 2007 and June 30, 2009, accounting for 8 percent of SHM’s total revenue during those 2 years, the report states. Meanwhile, Sanofi paid more than $2.3 million to the North American Thrombosis Foundation. And from 2007 through 2009, Sanofi’s payments of more than $2 million accounted for 81 percent of NATF’s total revenue during those three years.

And Sanofi paid $260,600 to Duke’s Tapson for consulting services, according to the report. His May 2008 letter from the American College of Chest Physicians to the FDA encouraged the agency ‘‘to learn more of the findings and recommendations’’ of a March 2008 ‘‘scientific interchange roundtable’’ in Huntington Beach, California, which Sanofi paid $190,000 to sponsor, the report states.

The Society of Hospital Medicine was initially reluctant to write the letter, according to emails included in the Senate report, the Journal writes. The society’s director told Sanofi in a June 2008 email that his group “has no history of making similar comments to the FDA” and might not have “the expertise or knowledge to say much about” the issue. But the email did say that “we want to give any issue that is important to our partner careful consideration.” Two months later, the society sent its letter to the FDA. A Sanofi spokesperson later cited the letter in an internal email as a “key accomplishment.”

The society’s director, Larry Wellikson, tells the Journal new policies were adopted to ensure transparency last year. “If we were writing the FDA now, we would be very clear about our relationship with any partner, including financial support,” he says. And Craig Kessler, public policy group chairman of the North American Thrombosis Forum, tells the paper no money from Sanofi “was intended to shape public policy.”

Tapson wrote in an email to the Journal that some portion of the Senate report are “very incorrect,” but did not elaborate other than to write that: “The Citizen’s Petition on Lovenox and the comments of some of the outside experts brought legitimate and important patient safety facts and considerations to the attention of FDA.” UPDATE: The POGO blog letter that Tapson wrote last year to the FDA, imploring the agency to be careful of “dire consequences” that can result from generic Lovenox.

Emails also show Sanofi officials coordinated their media strategy with NATF and were sensitive to how Sanofi’s close relationship with NATF was perceived by the FDA and in the media, according to the report, which cites one instance in which Sanofi officials decided not to quote a scientist affiliated with NATF in a Sanofi press release about a generic version of Lovenox because they were concerned that NATF may lose credibility with the FDA.

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