From the director ... the need for comparative effectiveness research.(medical practice)(Editorial)

For the last several months I have been hard at work as a member of an Institute of Medicine committee charged by Congress with advising the Secretary of Health & Human Services on how to best spend hundreds of millions of dollars earmarked for comparative effectiveness research (CER). The goal of this type of research is to find out what works and doesn't work in medical practice. Examples include head-to-head comparison of two different drug treatments or a medical treatment versus surgical intervention versus doing nothing. (The article about bladder cancer on the previous page illustrates the need for CER, which would have settled the best-treatment question years ago.)

A significant percentage of the $2.55 trillion Americans will spend for health care in 2009 has no credible evidence of benefit. To help reduce this waste, President Obama has included $1.1 billion for comparative effectiveness research in his stimulus bill. The President's budget director Peter Orzag believes, according to a recent New Yorker profile, "that a government empowered with research on the most effective medical treatments can, using the proper incentives, persuade doctors to become more efficient health-care providers, thus saving billions of dollars."

So why didn't the previous presidents employ a CER strategy to control the inflation and waste that have plagued our health care system for decades? The answer is simple--the politically powerful opposition of drug and device makers, working in concert with anti-government conservatives in Congress. In 1989, Medicare first proposed using CER and cost, in the determination of what new treatments it would pay for. Opposition from industry was so strong that the proposal was quickly withdrawn. In 2000, Medicare tried once more with a proposal that any new medical product would have to show evidence of having an advantage over existing ones as a condition of coverage. And again industry opposition blocked the proposal.

In 2003 Congress picked up the CER mantle. The Medicare Modernization Act authorized $50 million annually for the evaluation of "outcomes, comparative clinical effectiveness, and appropriateness of health care items and services" for Medicare and Medicaid. But, under pressure from the drug industry, Congress prohibited the Center for Medicare and Medicaid Services from using the results of the research to make prescription drug coverage decisions. Congress also forbade Medicare to negotiate drug prices on behalf of its beneficiaries.

While there are bills introduced in both houses to expand CER, the issue of using comparative cost in Medicare coverage decision-making remains highly contentious. In an effort to get the public to join the fight against using CER in Medicare coverage decisions, and especially if comparative cost as well as effectiveness is included, the Republican Party is busy accusing President Obama of pushing the U.S. towards "European socialism." The far from subtle message of the epithet is that if President Obama gets his way, all treatment decisions will be decided by Medicare bureaucrats only on the basis of cost.

I agreed to participate in the Institute of Medicine project because we all stand to benefit from President Obama's efforts to support development of credible evidence to better inform medical decision-making by patients and by their doctors. As for the unsavory "socialized medicine" fear-mongering underway, consider this: all of the European social democracies score higher than the U.S. on almost every measure of health care quality and outcome at one-third the cost.

Arthur A. Levin, MPH, Center for Medical Consumers [c] 2009

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