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Thursday 12 March 2009

Comparative Effectiveness Research

02:58
"Health Care and the American Recovery and Reinvestment Act," an article today's New England Journal of Medicine, should be read by anyone who has not been following the arcane details of the U.S. stimulus program.

The part of the article I want to focus on in this post is funding for comparative effectiveness research (CER). I've put my comments in bold italics:
On the medical research front, comparative effectiveness studies that directly compare the risks and benefits of different treatments for a particular condition are essential for improving practice and slowing cost escalation. Such studies, however, have been controversial; the pharmaceutical and medical device industries may not fund them, and some are concerned that the government or insurers may use the results to mandate specific approaches to treatment or to deny coverage.

I don't believe there is much public concern about CER. In every other aspect of our lives we compare the effectiveness and relative value of the options we must choose among. We also make personal rationing decisions every day when we decide that our resources require us to forgo a benefit - perhaps just a Latte at Starbucks, but possibly attending a lower cost college than our more costly first choice.

We are already seeing, however, a fear-mongering campaign against CER. Harry and Louise haven't come back yet but they will soon be reincarnated as the bogeyman of a "government bureaucrat getting between you and your doctor." More subtly, we will also see efforts to block research on the cost component of CER and to insert regulatory language that forbids Medicare to make use of CER in its coverage decisions!


...With the money allocated in the stimulus bill, the government will be able to fund many more [CER] trials, as well as clinical registries, clinical data networks, and systematic reviews. Indeed, the $1.1 billion in new funding for comparative effectiveness research dwarfs the current $334 million annual budget of the Agency for Healthcare Research and Quality, which will administer $300 million of the funds; the NIH and the DHHS will administer the rest.

We shouldn't expect CER to drive sensible health coverage on its own - that will require active, and often courageous, management and leadership. But as more and more studies are done an embarassment factor may set in for advocates who plead for expenditure of collective funds (public and private insurance) on costlier alternatives.

In addition, the act includes funds for a contract under which the Institute of Medicine will make recommendations (by June 30, 2009) for “national priorities for comparative effectiveness research.” It establishes a Federal Coordinating Council for Comparative Effectiveness Research, which will be composed of up to 15 federal officials (at least half of whom are physicians or others with clinical expertise) and chaired by the secretary of health and human services. The council will be tasked with recommending and coordinating research but will not be able to establish clinical guidelines or to “mandate coverage, reimbursement, or other policies for any public or private payer.

If the Federal Coordinating Council doesn't get hijacked by industry it has the potential of becoming an honest broker and public educator, much as has happened over time with the Federal Reserve. And having three agencies administer CER funding may make it more difficult for commercial foxes to capture the public chicken coop!
Comparative effectiveness research may seem like a wonky topic, but it is central to improving the disgraceful state of our health care "system." The president understands this. I hope that he will bring his superb communication skills to bear on educating us about the common sense validity of using CER to guide health care and the moral and fiscal necessity for doing this.

As a poignant lesson about what is at stake globally for health care, the article I've quoted is immediately followed by "A Lion in Our Village - The Unconscionable Tragedy of Cholera in Africa." A tiny fraction of the funds that produce no benefit at best and harm at worst could save thousands of lives elsewhere in the world!

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