Sales/Marketing Sway In Educational Grants Under Scrutiny By Senate

The Senate Finance Committee is asking drug companies to explain the role sales and marketing executives play in educational grants bestowed to professional societies.

"We are concerned that sales and marketing professionals may influence the awarding of a grant in a way that favors those individuals and organizations that are known to advocate use of specific products," committee leaders state in Jan. 9 letters to 23 drug companies.

Signed by Chairman Chuck Grassley (R-Iowa) and Ranking Member Max Baucus (D-Mont.), the letters mark the most recent development in the committee's investigation into pharmaceutical manufacturers' use of educational grants.

In addition to requesting descriptions of the "role(s) of marketing and/or sales personnel in receiving, processing and/or evaluating grants," the committee asks for lists of all grants or other payments to "medical/physician/professional organizations," patient education or advocacy groups, "medical specialty societies," academic institutions and state agencies in fiscal 2003 and 2004.

The letters request details such as the amount, date and purpose of the grant and a "description of the activity funded." The committee also asks whether the grant led to the "development and/or dissemination" of journal articles, practice or treatment guidelines or "medication algorithms." Responses are due Feb. 6.

"If drug companies are crossing the line with these grants, and influencing providers to make treatment decisions they might not otherwise make, that's a problem and we're going to tackle that," Baucus said in a Jan. 11 statement.

Baucus and Grassley fear that companies are trying to cultivate relationships with "key opinion leaders" capable of influencing other practitioners. They also are concerned that reliance on educational grants may jeopardize the independence of professional groups.

"Some professional and patient advocacy groups have learned that their very survival depends on drug company money," Grassley said. "In that case, it seems pretty obvious that their independence may be compromised. We need to look at just how beholden these groups are to the money they're getting."

The investigation follows an inquiry initiated last year. In June 2005, the committee requested information from the 23 manufacturers on their policies for distinguishing between marketing and educational grants. The committee then drafted a July letter to Johnson & Johnson addressing company-funded education activities specific to heartburn drug Propulsid (¹ 'The Pink Sheet' July 11, 2005, In Brief).

Propulsid was again singled out in a Jan. 9 letter to J&J, while the other 22 companies received a more generalized versions. The other recipients were: Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Bristol-Myers Squibb, Novartis, Amgen, Wyeth, Lilly, Sanofi-Aventis, Eisai, Boehringer Ingelheim, Schering-Plough, Hoffman-LaRoche, Forest, Abbott, Genentech, Biogen Idec, Genzyme, Chiron, Serono and TAP.

In the letter to J&J, Grassley and Baucus specifically cite off-label pediatrician use of Propulsid (cisapride) as an example of potential misuse of educational grants.

The senators suggest that J&J strategically offered grants and attempted "to build 'key opinion leaders,' who influence their peers' medical practice, including but not limited to prescribing behavior."

Specifically, the committee notes that from 1997 through 1999, J&J provided 117 research and education grant payments for Propulsid. Related documentation included references to J&J executives with titles suggesting sales/marketing roles, such as "product director," "Propulsid product manager," "senior brand director" and "director of market development, gastroenterology," the letter states.

"The apparently significant role played by marketing in approving these grants suggests that education may have been secondary to the promotion of Propulsid," Grassley and Baucus state.

Hearings on the investigation have yet to be scheduled. Committee staff will decide whether they are necessary based on the information received in response to the letters.