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Myrl Weinberg


Published June 11, 2008 04:05 pm - If misused, CER could result in fewer treatment options for sick Americans.

Research should improve delivery of care


By Myrl Weinberg
Guest Columnist

Healthcare costs are through the roof. Last year, national health expenditures totaled $2.3 trillion, or $7,600 per person. That's more than 16 percent of the U.S. economy. A major reason for ballooning medical costs is that too much money is spent on ineffective healthcare. A 2003 study from Dartmouth Medical School found that 30 percent of healthcare spending goes to unneeded or inappropriate treatments.

To rein in those costs, Congressional lawmakers want to establish an agency to run large-scale clinical trials testing the relative performance of drugs and medical procedures.

This type of testing -- known as comparative effectiveness research (CER) -- could help patients and physicians determine which treatments provide the biggest bang for their buck. But there's reason for concern. If misused, CER could result in fewer treatment options for sick Americans.

How can this be? Well, most medical research doesn't tell doctors how different treatments stack up against each other. So, while there may be numerous studies exploring the effects of, say, a particular pharmaceutical drug, there are few that compare that drug to its competitors -- let alone surgery or other treatments. This leaves doctors without conclusive data when it comes time to decide which treatment is best for their patient.

Congress's proposal is intended to remedy this problem by making these comparisons. Ideally, this will get doctors and patients the information they need to make good decisions. But there are some dangers, especially considering how lawmakers make healthcare decisions.

Often, the government looks for treatments that will improve health across large populations of people at the lowest possible cost. That's why public health programs often involve lifestyle recommendations like smoking cessation or eating a balanced diet, since these sorts of steps make the population, as a whole, healthier.

Given this "public health" paradigm, Congress could use CER to determine whether, on average, treatment A is better than treatment B for the majority of people suffering from a particular illness. This, in turn, will determine what gets covered by government-funded healthcare programs like Medicare.

But this application of CER ignores the unique needs of individual patients. Doctors need to know which kind of treatment -- surgical, non-surgical, inpatient, outpatient -- is best given the specific characteristics of the particular person they are treating.

This new research could be misused to restrict doctors' options when making complex health decisions. For instance, if a doctor decides that a brand-new, expensive medication is what her patient on Medicare needs, but the government's research shows that the drug isn't cost-effective for the "average" American, that patient would have to settle for the second or third best treatment.

Sound impossible? That's just what happened in 2001 when British patients were denied access to Gleevec -- a cutting-edge cancer drug -- after the government's comparative effectiveness research concluded that it didn't treat all forms of leukemia as well as other available drugs. This despite the fact that in 65 other nations, licensing authorities approved the drug for both early- and late-phase chronic leukemia patients.

In 2002, U.S. doctors found that Gleevec was also effective in treating a rare stomach cancer. In Britain, however, patients had to wait almost two years before they had access to the drug. There is no doubt that many people lost their lives because of the lag. This is not curbing costs responsibly.

We must consult physicians -- not cost-conscious regulators, and the research must appropriately balance the needs of individual patients with public health goals. It's not only the length of the average patient's life that determines a treatment's effectiveness, but also whether an individual can continue to work, care for a child, or live independently while undergoing care. Doctors need to be given the freedom to tailor their treatments accordingly.

Congress is right to be concerned with the rising cost of health care. A federal CER agency could be a powerful tool for ensuring that patients get the right treatment without wasting money. But Congress must use this new research to improve the delivery of care -- not to cut the budget.

Myrl Weinberg is the president of the National Health Council.



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