Federal agencies begin to prioritize comparative effectiveness research dollars

Washington -- Federal authorities charged with supervising a major expansion of comparative effectiveness research have begun holding public forums and gathering input in advance of carrying out their work.

The American Recovery and Reinvestment Act enacted in February includes $1.1 billion for comparative effectiveness research. Such studies evaluate of the effectiveness of different drugs, devices and procedures on the same medical condition. The money is available through Sept. 30, 2011 -- the end of fiscal 2010 -- and is divided three ways:

• $400 million for the Office of the Secretary of Health and Human Services.
• $400 million for the National Institutes of Health.
• $300 million for the Agency for Healthcare Research and Quality.

AHRQ and NIH have funded comparative effectiveness research in recent years, but within a much more limited scope. For example, AHRQ is authorized to spend about $50 million a year for such work, said Jean Slutsky, director of the agency's Center for Outcomes and Evidence.

All three major funding recipients are working together to make sure they are not duplicating each other's efforts, Slutsky said. "Clearly the interest is having a coordinated response."

The federal stimulus act also created the 15-member Federal Coordinating Council for Comparative Effectiveness Research to help federal agencies harmonize their efforts. The council held a public listening session April 14 and plans to hold additional sessions in May, said HHS spokesman Nick Papas. The group includes senior members of several federal agencies, including nine physicians.

More than 40 individuals and organizations also offered their advice at an April 3 AHRQ forum on comparative effectiveness research, including American Academy of Pediatrics President David Tayloe Jr., MD. He suggested that AHRQ should consider ways to improve enrollment of children, especially minority children, in randomized controlled trials.

The National Institutes of Health appears to be moving the fastest on the issue. NIH in March released grant application guidelines for 69 topics related to comparative effectiveness research, according to NIH spokesman Don Ralbovsky. They include studying advanced imaging procedures and treatments for age-related macular degeneration.

The HHS secretary's office, however, is new to the table. The recovery act specified that HHS's portion of the funding should be used not only to pay for comparative effectiveness research, but also to make its results easily accessible. The act also directed the Institute of Medicine to recommend priorities for the HHS portion of the funding by June 30. The IOM solicited public comments at a March 20 forum.

The American Medical Association strongly supports comparative effectiveness research, wrote AMA President Nancy H. Nielsen, MD, PhD, in a letter to the Institute of Medicine in advance of its March 20 public meeting. But Dr. Nielsen said physician perception that cost-containment is the primary focus of comparative effectiveness research could undermine support for national health system reform among doctors.

The AMA also believes that research should focus on the prevention, management and treatment of preventable disease and include analyses of high-volume, high-cost treatments for which there are significant practice variations.

Comparative effectiveness research also should examine different methods for delivering care -- not just medical devices and drugs -- suggested Lawrence Casalino, MD, PhD, chief of the Division of Outcomes and Effectiveness Research in the Dept. of Public Health at Weill Cornell Medical College in New York. For example, is it more effective for a physician to verbally remind female patients to have mammograms or for staff to track when women need them and call or send them reminders? "This all could be done without the doctor having to spend time on it at all," Dr. Casalino said.

The stimulus act's comparative effectiveness funding has sparked controversy. Conservatives have expressed concern that the $1.1 billion in the act will be used by the coordinating council to consider cost as a primary measure when considering the effectiveness of treatments or devices and that the panel will instruct federal agencies to limit more expensive treatments. The recovery act language did not specify nor exclude cost as one of the criteria for funding recipients.

A coalition of a dozen pharmaceutical companies, device manufacturers, patient advocates and others sent a joint statement to AHRQ for the April 3 meeting, suggesting in part that cost containment must not be the primary focus of comparative effectiveness research. The statement also said such research must not restrict the practice of medicine nor patients' access to necessary treatments.