Our guest blogger is Michael Rugnetta, a Research Assistant to Jonathan Moreno for the Progressive Bioethics Initiative.
The roadmap for comparative effectiveness research has become much clearer and detailed these past few days with the release of two new reports. One comes from the Institute of Medicine at the National Academies and the other comes from HHS’s Federal Coordinating Committee for Comparative Effectiveness Research. The IOM released a list of 100 health topics for the Obama administration to prioritize as it spends $1.1 billion in stimulus funds dedicated to CER. More importantly, the Federal Coordinating Committee itself has stated in its report to the President and the Congress that CER should “complement the trend in medicine to develop personalized medicine,” and that it will be “an important partner in helping to bring about this new level of medical effectiveness, personalization, and innovation.” This bold vision of personalized medical innovation based on “patient-centered, pragmatic, ‘real world’ research,” clearly dwarfs the feeble criticisms of CER aired by conservatives in last week’s HELP Committee markup of the “Affordable Health Choices Act.”
While the act incorporates CER as part of its health reform agenda, there is another piece of legislation that will establish a dedicated, rigorously-organized federal Institute for CER.
Formerly known as the “Patient-Centered Outcomes Research Institute,” the creation of this federal body depends on the passage of the “Patient-Centered Outcomes Research Act,” (S. 1213) sponsored by Senators Baucus and Conrad. Upon a close reading of the bill, it is evident that the Patient-Centered Outcomes Research Institute will not just be another meaningless chunk of bureaucracy as its critics claim. The Institute’s goal will not be to simply spit out generic guidelines that your doctor must follow “or else.” Rather, the Institute has been designed to ramp up medical innovation for the common good by championing a new era of personalized medicine.
Taking a close look at the bill there is plenty of language about “evaluating and comparing the clinical effectiveness, risks, and benefits” of various tests, treatments, and devices. More importantly, the bill upholds a commitment to doing the best kind of comparative effectiveness research by making it personalized and reaching out to subpopulations. The bill charges the Institute with conducting “research and evidence synthesis that considers variations in patient subpopulations.” The bill builds upon this by later explaining what “subpopulations” means specifically:
“racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, genetic and molecular subtypes, or quality of life preferences.” This also means that the institute will “include members of such subpopulations as subjects in the research as feasible and appropriate.”