Physicians soon should have more tools at hand to make good medical decisions. They will be able to compare the effectiveness (and ineffectiveness) of different drugs, devices and treatments, relying on more than their own experience or information provided by drug and device manufacturers.

Under the umbrella of the Department of Health and Human Services, a council of senior officers drawn from seven health-related agencies, half of whom have clinical expertise, has started coordinating a program that would develop unbiased and peer-reviewed, comparative data from a vast array of epidemiological as well as clinical studies. It will make “recommendations on the national priorities for comparative effectiveness research to be conducted or supported” to the president and Congress by June 30, 2009, as spelled out in H.R.1, more commonly known as the economic stimulus package. Once priorities are set, universities and medical centers around the country will vie for contracts. More than a billion dollars will be available to fund the work over several years.

Surprisingly, what bothers some people is not the amount of money spent on this project, but the manner in which this data will be collected and the way it may be used.

The money comes from a relatively small portion of the Obama administration’s first major legislation, the American Recovery and Reinvestment Act of 2009. In it, the U.S. will move from spending at a rate of $15 million a year to more than a billion over three years to collect, compare, and disseminate comparative effectiveness research (CER) in medical treatments.

This type of research is not new, nor is it unique to the U.S. CER for medical treatment is already used in the U.K. and Australia, as well as in France and Germany, all of which have national health care systems that require careful oversight of costs.

In fact, during the Bush administration, Congress asked the Congressional Budget Office to look into comparative research and its implications for health care spending. The Senate Budget and Finance Committees were particularly interested in its use if it would cut costs for health care services, especially those for Medicare and Medicaid.

The resulting 2007 white paper, Research on the Comparative Effectiveness of Medical Treatments, noted that in 2005 the federal government spent about $1.5 billion on all health services research, including $15 million for CER, dispersed through the Agency for Healthcare Research and Quality (AHRQ). Since that time, AHRQ has continued to support similar research at the same funding level.

But in April of last year, long before Obama’s stimulus package was introduced, the Congressional Black Caucus weighed in on the controversial research. At the time, members were concerned that if funding were tied to a Medicare spending package, comparative research could have a negative impact on women and members of minority and disadvantaged populations.

The Caucus warned that if the research was used to come up with a “one-size-fits-all” approach to treating patients, the program would impact negatively anyone outside the majority population, namely white, middle-class males. Women and minorities historically have been left out of many medical studies, and it is only in the last 30 years that major studies of minority populations have been made. The Nurses’ Health Studies, which followed more than 238,000 women since 1976, have provided new insights into women’s health and disease, especially cancer and heart disease. AHRQ-funded studies have done the same for minorities in relation to diabetes and kidney and cardiac diseases.

Fearing that CER data could be used to ration care, Caucus members insisted that any group overseeing government-funded research should not “make decisions or recommendations about which treatments should be covered and available to patients, which treatments are ‘cost-effective’ and which provide ‘value,’ and which do not, based on limited facts that fail to incorporate or recognize the impact of race, ethnicity, gender and geography on health and health care.” They recommend leaving those decisions to the individual health care provider and patient.

Although much of the medical establishment welcomed the idea of government funding for CER when it was introduced earlier this year, critics warned of dire consequences. There was great concern—and still is—that data could be used to control the delivery of health care services, especially to patients in entitlement programs such as Medicare.

Any change in entitlement programs would affect large numbers of women and minorities. Currently, women make up the majority of Medicare beneficiaries, with most living at or near the poverty level. Racial and ethnic minorities make up percentages proportionate to their share of the U.S. population as a whole, but a disproportionate percentage of poor and near-poor Medicare beneficiaries come from minority groups, according to the Kaiser Family Foundation.

Once public payers label medical treatments ineffective or inefficient, they can be expected to refuse to pay for them, say critics. Private payers should be expected to follow.

With this in mind, advocates for minority populations sounded some of the largest concerns. The Congressional Black Caucus was very vocal when H.R. 1 was introduced. Led by Representative Barbara Lee (D-CA), members insisted Congress consider race, ethnicity, geography, and gender in any research the government planned to support. As a result of pressure from the Caucus and other groups, the final bill states “that research conducted with funds appropriated … shall be consistent with [Department of Health and Human Services] polices relating to the inclusion of women and minorities.”

Not only should minorities be included, the Caucus said, but research should be designed to address some medical problems especially troublesome to minority groups. A disproportionate number of members of minority populations suffer from multiple chronic illnesses, such as diabetes and renal and cardiovascular disease. If CER could be designed to provide data for organized systems of care for those with multiple chronic conditions, instead of comparisons of discreet treatments, the Caucus would welcome its use.

Noted health disparities researcher David Williams, the Florence S. Norman and Laura S. Norman Professor of Public Health at Harvard School of Public Health, advocates the inclusion of place-based strategies and research in all levels of health care research and reform. Last year, his work was featured in a public television four-part special report on health disparities, Unnatural Causes: Is Inequality Making Us Sick.

In a recent interview by Madeline Drexler for The American Prospect, Williams said, “I would argue that, given what we know about social determinants of health, the factors that are the largest drivers of the health of a population are outside of what we traditionally define as the health care sector.” Those factors include economic opportunity, race, and geographic location, among others.