Investment in Comparative Effectiveness Research May Create New Problems

Comparative effectiveness research (CER)… if you’ve been following the health care reform battles, you’ve heard the term — but do you know what it means? CER is a hot topic in health care today, as the federal government has allotted $1.1 billion of the $787 billion stimulus package to research that compares the effectiveness of one type of medical treatment with another.

GOOD IDEA OR NO?

Of course this theoretically makes sense — how else to determine which treatments are most effective and least risky? But critics of the CER program warn that taking this step toward government involvement in health care might move us closer to a system where medical treatment is uniformly dictated by statistics rather than allowing doctors and patients to make choices based on individual needs and preferences. Cost is another worry — even with all the stimulus funds for CER, this is big-ticket reform. How will it be funded once the stimulus funds dry up? And my personal concern is that while the concept certainly makes sense, like certain aspects of health care reform itself, in the real world CER may turn out to be good in theory but untenable in execution.

To gain perspective on comparative effectiveness research, I turned to Edward F. Howard, JD, executive vice president of the nonpartisan, nonprofit Alliance for Health Reform (www.allhealth.org) in Washington, DC.

A SOLUTION — NOT THE SOLUTION

Yes, changes need to be made. As matters now stand, few clinical trials of drugs, devices and treatments evaluate new ones against others that already exist — rather they are merely measured against placebo. Howard points out that drug manufacturers must only establish that a new medicine is safe and effective and better than doing nothing to gain approval by the US Food and Drug Administration — and this offers precious little information to a doctor prescribing a course of treatment. The standards for medical devices are lower yet — manufacturers often must only demonstrate a new one is similar to other devices already in use, again giving patients and doctors no idea which is the “better mousetrap.”

In contrast, comparative effectiveness research directly measures how two or more therapies in current use for a particular medical problem stack up against one another, says Howard. (Of course this can lead to an infinite number of comparisons.) The Institute of Medicine (IOM) has identified 100 key areas for comparative effectiveness research, suggesting highest priority to topics such as health care delivery systems. Other IOM-identified priorities include heart disease, mental disorders (including depression) and cancer.

MORE DOESN’T MEAN BETTER

Other countries already use CER to make decisions about payment rates and which treatment procedures will be covered. This is frightening to drug and device makers, hospitals and doctors, all fighting to protect their incomes by making sure that quality — not cost — remains the key determinant. They warn that head-to-head comparison may result in a situation where insurers try to limit access to certain treatments, at least for those whose medical bills they are paying. The truth is, this happens already.

DO YOUR OWN COMPARATIVE EFFECTIVENESS RESEARCH

Each of us makes health-related decisions every day… small ones, like whether to have blue cheese dressing and fries with a salad at lunch, and other days, larger ones — like whether to address a diagnosis of diabetes with gastric bypass surgery, medication or by eating less and exercising more. On the individual level, comparative effectiveness works very well — and it’s usually quite clear how the analysis of cost and risk versus benefit plays out. As for health care policy, we will have to wait and see how it all turns out.