Monday, November 30, 2009

Beware the CER Trojan Horse in Senate Reform Bill

I'm a bit late picking up on this important Perspective in the New England Journal:

The co-author is long-time Pharma watcher Alastair J.J. Wood whom many think ought to have been FDA commissioner, if the drug industry did not traditionally have so much veto power over that post.

Selker and Wood basically warn us that there's a serious discrepancy between the House and Senate health reform bills regarding comparative effectiveness research (CER) which could easily be missed since both allocate about the same amount, $600M/year, to CER.

The House went about things in the standard way. The responsibility for CER would be handed over to the Agency for Healthcare Research and Quality (AHRQ), which has a long history of dedication to strict policing of conflicts of interest and following the academic peer review process for funding research. The Senate, however, influenced by drug industry lobbyists, calls for the creation of a new body for CER, with 3 seats on its 15-member governing board being reserved for industry representatives. The industry folks would also have representation on the board's methodology subcommittee.

Most worrisome, as Selker and Wood explain:

"The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not 'within the bounds of and entirely consistent with the evidence.' Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists — and their institutions, 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. This move would be a major retrograde step that would both inhibit the conduct of CER and call its integrity into question. In addition, because researchers and their institutions will seek to avoid such punishment, this provision is likely to result in prolonged arguments, taking place out of public view, regarding which data are acceptable to publish, thereby impeding and delaying publication. The American public, which would be paying for this research, deserves better."

If anyone has been following the CER debate, it seems clear that there is no reason to favor the features that have popped up in the Senate version that were not in the House version, except to give industry assurances that no research or guidelines will be published that might put a serious crimp in its profits. For example, why set up a completely new agency to do CER when AHRQ is all ready to hit the ground running? The prospects of a gag order on any scientist who disagrees with the governing board about what the evidence says is an especially worrisome sign.

See also Roy Poses' commentary on this same issue in his "Health Care Renewal" blog,

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