Sadanand: CER needs regulations to be effective

Yesterday, President Barack Obama signed the Health Care and Education Reconciliation Act, finally putting an end to the interminable legislative battle over health care reform. One of the controversial initiatives in the bill is increased funding for comparative effectiveness research (CER), or large-scale, controlled scientific studies that evaluate which treatments are best for a given medical condition. Some proponents of health care reform have argued that CER would make health care more cost-effective because doctors would no longer feel pressured to prescribe unnecessary treatments or procedures to earn their salaries; insurance premiums would also decrease. Critics counter that treatment guidelines based on CER would limit treatment options for patients and that CER would not be able to keep up with the newest advances in treatment.

While I think that CER is beneficial in the long run, I have concerns about how the government will implement CER.

There is currently little data on which medical treatments are best for a given condition, which is why CER proponents argued for its inclusion in the health care bill. But to their chagrin, the Congressional Budget Office determined that CER would produce no savings in health care costs. And given how ambiguously CER was presented in the bill, the CBO’s assessment was correct.

There are disagreements about how researchers will compare treatments, how the studies will be set up and how the various players in the health care system — particularly patients and health insurance companies — will interpret the results. Furthermore, treatments for the same disease could vary among people because of a wide array of factors, such as age, gender, ethnicity and weight.

It seems unlikely that even the most comprehensive studies could account for all of these factors. In an age where people expect personalized care, can generalized comparisons, even if scientifically based, help improve care, or will they merely marginalize effective treatments that are not broadly useful? The Department of Health & Human Services, doctors, insurers and pharmaceutical companies will need to confront these issues before CER can help to reduce health care costs.

The controversy surrounding a recently issued set of guidelines for breast cancer screenings by the U.S. Preventive Services Task Force, a group of doctors and scientists appointed by the Department of Health & Human Services to perform CER, suggests that the general public might have a harder time accepting scientific comparisons of treatments than CER advocates think. The task force commissioned two studies to evaluate how effective screening procedures were at reducing breast cancer deaths. Based on these studies, the task force recommended in November that women not at high genetic risk for breast cancer start getting mammograms at a later age than previously recommended. Rather than suggesting that women get mammograms every year after the age of 40, the task force determined that mammograms were only necessary every other year after the age of 50. The task force also recommended that doctors should stop teaching women how to conduct breast self-examinations.

To the public, the task force seemed to have made bizarre recommendations: Why would doctors want to discourage self-examinations and postpone mammograms until a later age? The task force’s reasoning was that mammograms are more likely to result in false positives — which can lead to unnecessary surgeries and treatments, in addition to causing a great deal of emotional stress — in women under the age of 50.

Responses to the recommendations were mixed. Some breast cancer patient advocacy groups embraced the guidelines, while other groups said they would continue to recommend annual mammograms. Health and Human Services Secretary Kathleen Sebelius quickly issued a statement distancing the Obama administration from the task force recommendations.

There are several reasons the task force recommendations were met with consternation from many women. Many women have first- and secondhand experience with the value of regular screenings. The task force used clinical data from other countries, such as Sweden and Great Britain, to determine the efficacy of mammograms, which might not have reflected data in the United States. Furthermore, the task force did not do a good job of explaining the potential risks associated with self-examinations; “undue stress” was not a compelling reason for doctors to stop showing women how to conduct breast self-examinations when lives are at stake. Finally, the task force report prompted fears that insurance premiums could go up for women if they wanted their mammograms more often than recommended.

In order for CER to be effective, the government should mandate a list of conditions that all CER studies will be required to meet. While there are many factors that contribute to a patient’s response to treatment, the most obvious ones, such as age or gender, should be controlled for in all studies. More importantly, the government, in conjunction with insurance companies, doctors’ groups and pharmaceutical companies, needs to establish clearly how the results of CER will be applied in treatment. Otherwise, CER will never reach its full potential.

Saheli Sadanand is a third-year student in immunobiology.

Comments

  • Rob69

    The health task force’s insane recommendation that women under 50 should NOT be screened for breast cancer flies in the face of the real-life experiences of thousands of women who are alive today because their cancers were caught in time.
    If this type recommendation is typical of CER’s, it merely highlights yet another huge failing in Obama’s Folly.