The Federal Government should have limited, but crucial, role in comparative effectiveness

Jun 18 2009

Federal officials are expected to offer recommendations this month on one of the first installments of health reform - a new initiative to compare the value and merits of competing medical treatments.

Fifteen federal government officials were appointed in March to launch the new federal initiative designed to provide doctors and patients with better information about treatments so they can compare options. The officials, who serve on the Federal Coordinating Council for Comparative Effectiveness Research (CER), have held three "listening sessions" to gather testimony from a broad range of citizens and experts on priorities for future investments in research.

The council will provide guidance on how to use $1.1 billion provided by the economic stimulus act. The effort is controversial in some quarters. While getting better information is needed to achieve better value, many people are concerned about granting the government new power over the medical treatments available to Americans.

Patients, especially those with rare diseases and multiple chronic illnesses, are worried that their unique needs may be disregarded in mega-studies. Doctors fear their clinical expertise will be replaced by formulas. Medical device and pharmaceutical companies are concerned that they may face another layer of government approval that would stifle innovation.

There are also concerns that comparative effectiveness research findings will be used to make spending as well as clinical decisions. House Appropriations Chairman David Obey touched off an uproar when he said that drugs and treatments "found to be less effective and in some cases, more expensive, will no longer be prescribed."

The final legislative language said that the information won't be used to direct "payment, coverage or treatment" decisions. But many believe that the chairman tipped his hand, and described the long-range goals of the effort.

Many people also are concerned that individuals' unique medical needs might not be considered, hurting patients who do not respond well to standard care. Experts in Europe and Canada, where comparative effectiveness systems are established, warn that those who fall outside the mainstream have more difficulty receiving treatment.

Physicians are concerned that experience and knowledge could be replaced by centralized decision making, based on formulas. In the name of protecting their bottom lines, public and private health care plans might refuse to cover treatments and procedures that don't have the approval of this centralized agency.

Physicians and hospitals, fearing the loss of reimbursement and even lawsuits, would also be much less likely to try unapproved treatments - even if early evidence suggests a treatment might work for a particular ailment or set of patients. Our health care system would become more rigid and less innovative as doctors fear repercussions if they go against the official recommendations.

Medical companies would be less likely to pursue research on new and potentially life-saving drugs, biologics, and medical devices when faced with another major bureaucratic hurdle to introducing their products to market. Ultimately, funds for new research would shrivel.

A new study from the Institut économique Molinari in France says that the hurdles to clear comparative effectiveness review boards in Europe are increasingly "tough, heavy-handed and costly … Despite the best intentions, the inevitable consequence of these regulations is to push up the cost of innovation substantially, to undervalue its benefits and to reduce the number of new products by making certain projects unprofitable."

Many hope CER research could be used to lower health spending. But Professor Michael Schlander, a well-respected German physician, medical researcher and economist, found that decisions by the National Institute for Health and Clinical Excellence in the U.K. have actually led to higher spending by the National Health Service. He says that once a treatment is approved for payment, there is a greater incentive for doctors to prescribe it, which carries an increased potential for overuse.

President Obama has assured Americans that "no government bureaucrat will second-guess decisions about your care." Officials designing the CER process would do well to heed his commitment and focus on creating quality information about medical treatments and allow doctors and patients to make decisions.

The CER council has an opportunity to contribute to development of a knowledge-based health care system. Rather than serving as an arbiter that makes final decisions on the value of one treatment over another, the federal government can play a crucial role in aggregating information about the effectiveness of various medicines and treatments and disseminating that information to researchers, clinicians, and patients.

This would allow the process of learning and innovation to continue so a patient-centered health care system could continue to evolve.

By Grace-Marie Turner, President of the Galen Institute

Grace-Marie Turner is president of the Galen Institute, a nonprofit research organization focusing on health reform.