The latest New England Journal of Medicine contains a scathing perspective denouncing the Senate's health care reform bill for giving industry too much control over a new comparative effectiveness research (CER) agency, an issue I tried to call attention to in Health Tech Review (Sept. 28, 2009). The Senate bill guarantees at least three of 15 slots on the new CER agency's board to industry representatives, and would involve those board members in designing studies.

The authors, Harry Selker of Tufts University and Alastair Wood, a long-time drug safety advocate who now moonlights for a venture capital firm, also blast the proposed bill for giving the proposed CER agency's industry-influenced board control over what researchers can publish. Indeed, the bill requires the new agency ban any institution or researcher who publishes unapproved analyses from receiving additional grants for at least five years.

"To allow scientists -- and their instutitions, which receive the support for the conduct of research -- to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome," they wrote.

The troubling section is on pages 1657-58 of the bill. It reads:

REQUIREMENTS FOR PUBLICATION OF RESEARCH.-Any research published under clause (ii)(IV) shall be within the bounds of and entirely consistent with the evidence and findings produced under the contract with the Institute under this subparagraph. If the Institute determines that those requirements are not met, the Institute shall not enter into another contract with the agency, instrumentality, or entity which managed or conducted such research for a period determined appropriate by the Institute (but not less than 5 years).

The negative consequences that will flow from this section will also include long delays in publication, since researchers will wind up engaged in long arguments with agency bureaucrats over what they can and cannot publish. 

"If health care reform legislation does not promote comparative effectiveness research that is free of the potential taint of commercial and political meddling, the public will have little confidence in the results of such research," they conclude.