Comparative Effectiveness Research (CER)—a concept grown out of the idea that comparing different interventions and treatment strategies will inform patients, healthcare providers and decision makers—may be one of the most important steps in the revamping of America’s to-be-determined health care system.
Through the American Recovery and Reinvestment Act (better known as the Stimulus Package), $1.1 billion was appropriated in spending towards CER. Disease advocates are working to ensure that the research is focused on analyzing and informing clinical practice and not used to restrict access to care or therapeutics.
Miriam O’Day, the COPD Foundation’s Senior Director for Public Policy, says that the CER money was split three ways between the Agency for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH) and the Department of Health and Human Services (DHHS). DHHS Secretary Kathleen Sebelius created the Federal Coordinating Council for Comparative Effectiveness Research to make recommendations about how the DHHS funds will be allocated.
“With the stimulus bill, we institutionalized Comparative Effectiveness Research,” O’Day says. “The idea of CER has been long-standing. Now we have funding to implement this concept, and there are concerns about how the research will be used and what the impact will be on specific diseases and disorders.”
O’Day says that CER will be prioritized, and the diseases and disorders that affect the most people and have the greatest financial impact on our system will be dealt with first. Eventually, O’Day said, Americans can expect CER to approach and analyze rare diseases and disorders that have high cost treatments.
“If conducted properly, CER should be an excellent tool to inform clinical decision making,” she adds.
O’Day says a number of provisions have been included in both the House and Senate language that are aimed at using CER to inform clinical decision making—not just cost.
“We want to place language within the health reform legislation that asks to have increased transparency in the process to make sure there are safeguards in place, so we can review the data and make sure we have appropriate experts asking and analyzing the information,” she says.
One of the concerns raised about CER is that the concept may be used to make cost decisions and limit certain types of treatments or procedures.
“In which case, it would be very unfortunate for rare diseases because there are so few experts who know how to properly evaluate that data,” O’Day says. Vlady Rozenbaum, an individual living with COPD, says he is “very skeptical” of CER. He believes that it will have to overcome serious obstacles to help combat his illness.
“As I understand it, CER was not established so that a patient could make a better decision about available treatment,” Rozenbaum says. “In the context of CER, the COPD patient is not really preoccupied with spending as little as possible on treatment that is effective, but whether the decisions on ‘more effective’ drugs and procedures by the government bureaucracy—based on the ‘Comparative Effectiveness” studies—will limit patient’s access to effective treatments and technologies (such as oxygen therapy) that cost more.”
Rozenbaum says the issue has nothing to do with the side effects of drugs. Rather, he says, in comparison with other diseases, there are very few treatments available to COPD patients.
“The few drugs we use are almost exclusively designed for asthmatics, so the choices are very limited,” Rozenbaum adds. “Furthermore, the clinical trials conducted on drugs are limited to certain types of patients, and, thus, they do not affect all COPD patients in the same way. In fact, physicians have commented that the narrow patient populations used in the clinical trials differ from patients seen in daily practice.”
Rozenbaum says that one of the concerns that comes along with CER is that COPD patients may be recommended less expensive drugs that aren’t as effective or cause additional undesirable side effects—while being denied drugs that can be beneficial and are more expensive.
O’Day says that CER is a positive tool, if used properly. The idea can allow patients and physicians to compare the course of treatment in specific diseases.
“The decisions inform clinical decision making with valid information,” she says. “It’s important that patients and allied health professionals as well as physicians are engaged in the process of designing research and making sure the right questions are being asked.”
Dr. Jerry A. Krishnan, the Associate Professor of Medicine and Health Studies and Director of the Asthma and COPD Center at the University of Chicago Medical Center, supports CER.
“I think it provides health care decision makers, clinicians, patients and policy makers the information they desperately need,” he says. “CER serves as an important next step as we identify treatment strategies.”
But he also says CER doesn’t come without criticisms.
“One concern here is that [people will think] one form of treatment is better than another,” Krishnan says. “I think that the underpinnings of CER is to not limit treatment options but provide better options, and have decisions made with the information in hand, as opposed to no information in hand.”
He also says that the stimulus money gives researchers, patients and policy makers a substantial amount of resources to get a COPD program started.
“By no means is current research funding all that is needed,” Krishnan says. “After all, thinking of the total National Institutes of Health budget [which is] many billion of dollars, there’s only $1.1 billion for CER. It’s a narrow slice of the entire biomedical research budget, and an important start, but that isn’t the end of what’s needed.”
As for the future of CER, Krishnan says if the goal is to provide information to effectively treat patients, there needs to be an appropriate representation to study the right questions.
“We need to get the health services resource community engaged and bring them to the table,” Krishnan says. “We need to identify the need, questions and design the most optimal studies. We also need to provide the information health policy makers are looking for in order to improve care. CER is important, and the way to make it relevant is to ensure there are various stakeholders identifying questions and providing the accurate information they’re looking for.”

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