NCPA - National Center for Policy Analysis


March 24, 2009

Until this year, most Americans hadn't heard of "comparative effectiveness research" (CER).  But then came the $1.1 billion establishment of the Federal Coordinating Council for Comparative Effectiveness Research and the president's promise that it would "enhance medical decision-making."  This might be the case, but, if mishandled, CER could lead to severe restrictions on the kinds of treatments available to sick Americans, says Peter J. Pitts, president of the Center for Medicine in the Public Interest.

When used properly, CER can help patients and their doctors to make informed health care decisions by providing valuable information about what therapies work best.  But this type of research has a sordid history of being abused by government agencies to lower costs at the expense of patients' health, says Pitts.

Take the case of the United Kingdom's National Institute for Health and Clinical Excellence (NICE):

  • NICE was established in 1999 to appraise various medical treatments and make treatment recommendations to the National Health Service (NHS), Britain's government-run health care provider.
  • Ever since, NICE has frequently judged new medicines to be "not worth the cost;" the government run National Health Service has subsequently taken many of these medicines off its formulary, denying them even to patients who need them to stay alive.
  • What's behind rulings like this is a methodological flaw: if a medicine isn't found to be both cost- and clinically-effective for an "average" patient, NICE advocates against its use.

This practice could easily wind up here, which is why lawmakers should make certain that the U.S. approach to CER sets aside cost considerations and focuses solely on clinical data, says Pitts.

Another way to make sure CER is used properly is to follow the Food and Drug Administration's lead in creating a Critical Path Initiative for CER.  By utilizing the most up-to-date scientific knowledge, treatments could be assessed in a manner that gives the utmost attention to the factors that affect how different patients react to different treatments, adds Pitts.

Source: Peter J. Pitts, "President Obama, health care and 'comparative effectiveness research'," The Star-Ledger, March 23, 2009.

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