The economic stimulus package approved by Congress in February set off a firestorm of speculation that comparative studies
will block patient access to necessary treatment. Although the $1.1 billion allocated for research comparing medical products
and procedures is just a tiny piece of the $789 billion American Recovery and Reinvestment Act of 2009 (ARRA), it has already
prompted cries of "government rationing" and "cookbook medicine" from conservative legislators and commentators.
Comparative studies aim to identify the treatments that will be most beneficial for the largest number of people, in contrast
to personalized treatments for small patient populations. Comparative-effectiveness research (CER) enthusiasts insist that
better information on medical products and procedures can improve care and cut unnecessary spending, but pharma companies
have raised the specter of limiting coverage for targeted therapies essential to personalized medicine.
The final report on the stimulus bill sought to diffuse this controversy by asserting that Congress does not intend CER to
be used to "mandate coverage, reimbursement, or other policies for any public or private payer." Senate Republicans tried
to insert similar limitations in the 2010 budget resolution, but Democrats objected to specific curbs on CER use. Even if
public programs are constrained from basing coverage on comparative studies, there's nothing to stop private insurers and
payers from using the data as they see fit. As a Congressional Budget Office (CBO) white paper stated last year, CER can "provide
a basis for applying costly new technologies only when they are likely to confer added benefits."
What's clear is that the federal government will play a large role in selecting treatments and topics to be analyzed, as well
as the methods for conducting comparative studies. (See "Better Methods,".) Instead of creating a new, multi-billion dollar
CER operation, the stimulus package divides the $1.1 billion among three arms of the Department of Health and Human Services
(HHS). The HHS secretary gets $400 million to run the program and build infrastructure for future CER, including registries
and data networks. The Agency for Healthcare Research and Quality (AHRQ) adds $300 million to its $50 million outcomes and
effectiveness research program. And $400 million goes to the National Institutes of Health (NIH). That's just a drop in the
bucket when compared to the $10 billion ARRA funds for NIH scientific research and facilities improvement.
How these agencies dole out the money will be determined by a June 30 report from the Institute of Medicine recommending CER
priorities. The IOM panel is considering the needs of populations most served by federal programs, such as the elderly and
children, as well as subpopulations such as women and minorities.
A new Federal Coordinating Council for CER will weigh in on investments, monitor how well HHS grants fit the IOM priorities,
and coordinate government-funded initiatives. This 15-member council includes top officials from HHS, NIH, AHRQ, FDA, and
other federal agencies. HHS will publish information on grants and contracts awarded under the program, disseminate research
findings, and report to Congress each year.