There are many in Congress who believe that comparative effectiveness research is a science.  Science—in medicine, anyways—is about applying what we know about the biology of disease to the ability to diagnose, treat and prevent illness. That is, research—which links what we do and what we know to address the underlying causes of diseases—will make medicine not only comparatively more effective than what we currently have, but as the essayist and physician Lewis Thomas noted, will lead to preventive technologies that are ultimately cheaper.

Incorporating tools that permit doctors to address illness at this level would be a scientific approach to advancing the goal of comparative effectiveness.  The opportunity to integrate genomic information, predictive tests and data analysis that could improve the ability to select the right treatment for individuals right off the bat—thereby reducing costs—exists if we follow this path. But unfortunately, this is not where Congress is heading.

For instance, the Institute of Medicine (IOM) panel that will advise the new Federal Coordinating Council on Comparative Effectiveness Review (FCCER). It is charged with assessing comparative effectiveness research. But unfortunately, the IOM operates under the assumption that summarizing and reviewing old research that ignores individual differences in response to treatments can save money and improve care. To this extent, the research will not be able to guide physician’s decisions or adequately inform the FCCER. Under these faulty guidelines, how can it do either?

Rather, the goal of the exercise is to justify saying “no” to new technologies.  Advocates want FCCER and the Agency for Healthcare Research and Quality (AHRQ) to be like the United Kingdom’s comparative effectiveness agency, the National Institute for Health and Clinical Excellence (NICE).  Yet, NICE concluded new drugs (which are available in the United States) for cancer, arthritis and multiple sclerosis aren’t cost effective because they are not worth the money for the benefits it provides or the additional life it gives patients. Meanwhile, NICE decided birthing pools and breast reductions for women with self-esteem issues was cost effective.

The IOM panel has only two or three of the committee members, such as former FDA commissioner Mark McClellan, who have looked at how to use predictive markers to improve the evaluation of treatment and outcomes.  The remaining members, such as Mr. Harold Sox, the Chair of the IOM committee and head of the American College of Physicians (ACP), regard comparative effectiveness as a tool for extending government’s control over medical decisions. ACP’s single-payer proposal noted, “Many other countries that have national health insurance programs, such as the United Kingdom and Australia, perform evidence-based evaluations of new drugs and technology…To attain a well-functioning healthcare system, the United States should increase investment in (AHRQ’s) technology assessments, comparative effectiveness, and health services research.”

Other panelists, many of whom have consulted for and receive millions from AHRQ feel the same. Mr. Alan M. Garber of Stanford University claims “cost effectiveness. …simply estimates how much must be spent by using a particular intervention to gain a given health effect, telling us how to achieve the greatest health effect for the dollar.” Yet Mr. Garber regards orphan drugs that control fatal metabolic diseases in children as an example of treatments not worth the “health effect.” In general, he believes the Orphan Drug Act allows the development of drugs that “do not meet traditional cost- effectiveness criteria.”

Indeed, the comparative effectiveness tools they have in mind are those that require more evidence for new technologies instead of discovering which advances work best on specific patients. Sean Tunis, another panelist, runs the Center for Medical Technology Policy. Mr. Tunis evaluated medical technologies for Medicare. He then was dismissed and transferred to AHRQ.  When he left to set up his Center, AHRQ was his first client, paying him to hold a conference on how government should use evidence to make reimbursement decisions. The key, Mr. Tunis suggests, is to demand reasons for justifying improvements provided by a new technology. But to delay access to a medical advance that saves lives is morally irresponsible.

IOM panelist Kay Dickersin of Johns Hopkins University runs an AHRQ funded organization, Consumers United for Evidence Based Care (CUE).

Established to “advocate for local and federal legislative changes,” CUE is an umbrella group of fringe and radical consumer organizations that seek to use comparative effectiveness techniques to advance specific political goals.  CUE includes the National Center for Transgender Health; anti-vaccine groups SAFEMINDS and the National Vaccine Information Center; and left- wing organizations such as Center for Science in the Public Interest.

In 2005, Mr. Dickersin joined the transgender groups in pushing Washington State’s Medicaid program to cover sex-change operations.   Mr. Dickersin wrote the state that research used to deny coverage was unscientific and “that reports used for funding decisions should be held to the same standards as any other scientific report.”

This is not science. The goal of comparative effectiveness research should be to identify–by developing, testing and using the most advanced scientific methods available—which treatments and clinical practices work best in patients who are critically or chronically ill. To ignore the advances in personalized medicine is to institutionalize ignorance and adversely affect the IOM panel, the decisions of Congress and the conduct of comparative effectiveness. By default, an unscientific approach to comparative effectiveness will make all health care choices political.