NOW THAT federal policymakers have been charged with designing the new comparative effectiveness research program to compare healthcare interventions and determine what works best, they must do so while recognizing that healthcare cannot work without innovation.
Innovation is the engine for growth and advancement. It’s responsible for technological breakthroughs like statins and imaging, for advances in care practices, delivery systems, and benefit design, and for the sharp reduction in mortality from heart disease and cancer in the United States since World War II. Continued innovation is literally a life-and-death issue for patients.
Medical innovation is also a life-and-death issue for the economy. Three out of every four new drug interventions worldwide are made in the United States, and sustaining American leadership in medical innovation is more vital than ever in the current global economic downturn.
It is critical that new comparative studies avoid having a chilling effect on innovation. The comparative effectiveness research program must be designed in a way that identifies interventions that best meet patient needs. And yet, in winnowing out some interventions even as it promotes others, comparative research will inevitably have an impact on innovation – and therein lies the rub.
Responding to these concerns, the New England Healthcare Institute consulted with experts from across the healthcare system on how comparative studies could be structured to optimize innovation. NEHI believes that comparative studies can be designed to not only sustain valuable innovation, but also to promote it, if a few smart policy choices are made by the federal agencies implementing the program.
First, the program should avoid focusing solely on medical technologies such as drugs and devices. New technologies are a moving target for rigorous research because many don’t reveal their true worth (or worthlessness) until doctors and patients use them for an extended period of time. Meanwhile, relatively little is known about the comparative value of a vast number of decisions made by physicians every day.
Dr. Elliott Fisher, a healthcare policy expert, recently suggested the kind of study questions that would address these broader issues: "Is it better to treat severe neck pain with surgery or a combination of physical therapy, exercise, and medications? What is the best combination of ‘talk therapy’ and prescription drugs to treat mild depression?" Studies that go beyond head-to-head comparisons of drugs and devices to examine these tried-but-not-necessarily-true healthcare interventions could have a truly profound and beneficial impact on care and, ultimately, on innovation.
Second, Congress and the administration should make a commitment to fund and develop new ways of conducting comparative research. Much of the data and the methodologies available now were developed for narrow purposes, such as FDA approval. This tends to limit findings to the effects of treatments on "average" patients without other health concerns, while in real life, patients come in endless variations. Comparative studies need to find and validate these subtle differences.
Third, the program must ensure that the findings actually reach patients and physicians in order to make a difference in practice. At least for now, Congress has made a choice that the findings will be purely advisory and not dictate coverage decisions. This will reduce the risks to healthcare innovators but means that federal agencies need to create new pathways for disseminating the findings so they are adopted where they matter most: at the point of patient care. This would be a big improvement, as clinical practice guidelines currently have such low adherence that American adults receive the right medical care only about half the time.
In the long run, everyone should benefit from more and better information on what works and what doesn’t work in healthcare. For now, as policymakers work to structure the new program, they need to find practical ways to make comparative studies a useful tool for patients, physicians, and innovators alike. Designed wisely, comparative effectiveness research can achieve the best of both worlds: vast improvements in the healthcare evidence base along with sustained development and adoption of valuable innovation throughout the healthcare system.
Wendy Everett is president of the New England Healthcare Institute.
