Compared to What?

Jill Wechsler
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."