I'm all for comparative effectiveness research, as I have made abundantly clear. And I believe at one time or another I may have expressed some mild satisfaction that the otherwise generally crummy health care reform legislation includes some support for CER. A colleague of mine, however, begs to differ:
Currently, scientific research in comparative effectiveness is conducted within the Agency for Healthcare Research and Quality (AHRQ) and within the National Institutes of Health (NIH). Each of these institutions has a long history in this area with appropriate scientific and administrative oversight to carry this out. Topics for review are generated from a panel made up of stakeholders in the process from the patient, payer, provider and industry perspectives and with independent academic and scientific teams to provide an unbiased assessment of relative harms and benefits. This process has been in place for awhile and has resulted in many contributions to evidence on best-practices in healthcare. . . .
The proposed bill would, however, set up a nonprofit Institute unaffiliated with the Federal Government to oversee these duties. We believe that this would create, at great cost and delay, an entity that would not improve upon the structures already available in AHRQ and NIH and would in fact create a confused hierarchy of control and a weakening of the well-functioning groups already present. Furthermore, several of the provisions in the bill mandate oversight antithetical to academic freedom and carrying punitive measures that may scare away many top researchers from these activities.
These measures include the requirement that any research published under contract to the Institute be entirely within the bounds and consistent with the evidence and findings produced in the contract's final report. Failure to abide by this rule will prohibit that researcher from receiving any Institute funds for at least five years. This provision reads as if it could have been written by a totalitarian regime intolerant of any dissent. But one of the hallmarks of the academic process is the freedom to express oneself in civil discourse without fear of retaliation. Such language is certainly not democratic and may in fact be unconstitutional.
A second concerning item in the bill is the requirement that a methodology committee be appointed . . . to establish standards which all researchers would be required to accept. . . Again, this flies in the face of academic freedom and imposes a mandate that may actually at times lead to biased research if the standards are inappropriate. . . .In fact, the Institute of Medicine has already convened a panel of experts representing science, consumers, payers, providers and industry to develop such standards that can serve as a model for future comparative effectiveness reviews.
Third, we object to the composition of a Board of Directors with members from industries whose products will be judged by the results of the reviews undertaken. While industry representatives on advisory panels are desirable, their placement on a Board with authority to allocate the funds, design the studies, and disseminate the results will inevitably lead to conflict of interest and charges of bias. . . .
Yup, looks like the same old song -- the only way Congress is going to do this is to put industry in charge and let them make sure the "scientific" findings don't get in the way of selling useless or dangerous products. This is kind of like -- no, exactly like -- putting drug companies in charge of the FDA.