As you may have heard, President Obama has called for investing in something called Comparative Effectiveness Research. The American Recovery and Reinvestment Act (the so-called stimulus package) included $1.1 billion for CER, about $300 billion going to the Agency for Healthcare Research and Quality and the rest to NIH. The legislation also established the Federal Coordinating Council for Comparative Effectiveness Research to coordinate CER conducted or sponsored by the federal government. (You can learn more about the council here.) Some people like to say "patient-centered outcomes research," instead of CER. Same thing.
The health care reform legislation currently being filibustered, ping ponged and sausage ground in congress also addresses CER, but there's a problem. Harry Selker (who happens to be my boss -- I believe we're supposed to disclose such matters) writes:
Although most observers agree on the value of funding CER, many are unaware that embedded in the legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research. In the currently proposed legislation, there are two general constructs for the conduct of CER. The Senate Finance Committee bill mandates the creation of an entirely new private–public research entity and, owing to industry lobbying, guarantees industry three seats on this entity’s 15-member governing board, as well as representation on its methodology committee (the relevant portion of the bill, which may be found at http://finance.senate.gov/press/Bpress/2009press/prb101909.pdf, begins on page 1129). . . .
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.
Don't worry, conflict of interest or no, I'm not inclined to criticize anything Harry says about this. That's Your Congress At Work, as usual.
Anyway, while the pharmaceutical and medical device industry is scheming to corrupt the process, the extreme right -- i.e., the mainstream of the Republican Party -- is claiming that it's all a plot to murder your grandmother. So what is it really?
As Dr. Hadler suggested, it is a strange liberty claim to demand the right to receive useless or harmful treatments, and to have the rest of us pay for them through our insurance premiums. But that is exactly the claim advanced by opponents of Comparative Effectiveness Research.
To get FDA approval, you don’t have to show that a treatment is better than others – you just have to show that it’s better than placebo. Furthermore, you don’t have to show that it extends life or improves health; you can often get approval by showing an effect on so-called surrogate end points, that is biological states that are presumed to be associated with some health benefit, such as cholesterol levels or blood sugar. Often it turns out not to be true. In spite of the effect on the surrogate end point, the treatment doesn’t really make people better off in the long run, and may even be harmful. Yet the follow-up research to find this out, once a drug or device has been approved, is usually not done.
Comparative Effectiveness Research takes no account of cost. It has nothing to do with rationing. It compares one treatment to another, and determines if one is better. That's all. It does not imply 1-size-fits-all or substitute for clinical judgment. On the contrary, one reason to do more of it is to learn more about what works best for what categories of patients. It does not remotely imply denying effective care to anyone. On the contrary, it is intended to generate the information needed to provide people with the best, most effective care. And yet Obama’s endorsement of modest efforts in this regard has been called “eugenics” and “death panels.” This is the level to which public discourse in this country has descended. Who really hates America?
This is all that the president has proposed: to spend more on this kind of research. The product will only be knowledge, not coercion of clinicians, although one can certainly imagine that reimbursement policies might be changed to favor effective, evidence based medicine. That really isn’t in the legislation, except for small demonstration projects, which I’ll say more about momentarily, but it has nothing to do with death panels or Nazi eugenics, I can assure you.