$1.1B outlay for research step closer

The federal government took the first formal step to dole out more than a billion dollars of economic stimulus money to fund research comparing the effectiveness of medical treatments.

The Department of Health and Human Services (HHS), in conjunction with the Department of Veterans Affairs (VA) and the Department of Defense, later this year will begin considering grant applications from academic institutions and other private-sector researchers seeking a piece of the $1.1 billion made available for this comparative effectiveness research.

Federal authorities, in consultation with the Institute of Medicine, industry groups, patient representatives and others, will release their plan for how to distribute the money by July 30.

Proponents of comparative effectiveness research say it can be used to improve medical care by giving physicians and patients information on whether a particular drug, medical device or procedure has shown the best outcomes.

“This is the kind of information that, I can tell you as a physician, is too often lacking,” said Carolyn Clancy, a medical doctor and director of the Agency for Healthcare Research and Quality (AHRQ), which is part of HHS. Clancy said that HHS would move to distribute the money “as expeditiously as possible” given President Obama’s mandate to swiftly utilize funding from the stimulus bill.

The initiative is not without its detractors. Some conservatives, from Republican lawmakers to radio talk show host Rush Limbaugh, have described this new research as a harbinger of a future in which the government and private health insurance companies will dictate what treatments a doctor can provide his or her patients.

The pharmaceutical and medical device industries successfully lobbied during the stimulus deliberations for language specifying that the federal government would not conduct cost-benefit analyses during these studies.

Neera Tanden, a counselor to the office of the HHS secretary, defended comparative effectiveness research and vowed that the Obama administration had no intention to use the results to ration medical care based on cost or any other consideration.

“Just to be very clear about this, the goal of comparative effectiveness research is to empower patients and providers with the best information,” said Tanden, who was a senior policy adviser to Obama’s campaign and a former adviser to Secretary of State Hillary Rodham Clinton, when Clinton was a presidential candidate and a Democratic senator representing New York.

Comparative effectiveness studies are not intended to produce recommendations for how every doctor should treat every patient, Clancy said. “It’s much, much more nuanced than that” because their circumstances vary widely, she said.

The administration also will conduct its work on comparative effectiveness research in the public view, Tanden said, which could allay concerns about how the studies are used.

The council will convene its first public meeting April 14 and provide other avenues for interested parties to submit recommendations on how to distribute the $1.1 billion. “We are extremely committed to ensuring an open and transparent process,” Tanden said. On Thursday, AHRQ announced the 15 members of the coordinating council that will make those determinations. The body includes representatives of HHS agencies including AHRQ, the National Institutes of Health (NIH) and the Food and Drug Administration, as well as the White House Office of Management and Budget, the VA and the Pentagon.

AHRQ, which already maintains a relatively small comparative effectiveness research program, controls $300 million, while the NIH and the HHS secretary control $400 million each. Clancy said the agencies would coordinate with private researchers to avoid funding redundant projects.