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Research effectiveness warnings

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Given all that has been written so far about health reform, it is surprising there has not been more attention paid to the idea of a government-sponsored Center for Comparative Effectiveness Research (CCER), which would review the efficacy of various medical treatments and pharmaceuticals.

This is not an insignificant mission. Yes, the idea of studying the effectiveness and costs of various medical treatments sounds good at a time when everyone is concerned with the rapid increases in health care costs. But, let's stop to think about it before our race to reform health care causes us to create a Frankenstein's monster of health care bureaucracy and cost control.

For starters, the American Recovery and Reinvestment Act already provided $1.1 billion in start-up money for the CCER. How many billions will this institute cost over the long term? Federal health care programs, i.e., Medicare and Medicaid, are already broken, and a commitment to support one more permanent -- and expensive -- component of federal health care apparatus will merely compound the funding problems.

Proponents may argue that the private sector will contribute to the CCER. Forgive me if I don't find that argument persuasive. Every dollar a private employer, hospital, pharmaceutical or insurance company pays to support the CCER is one dollar less it spends on employee health benefits, patient care, research or claims reimbursements.

And, frankly, public-private partnerships all have one thing in common: All the money comes from the same place. It comes out of people's pockets through increased taxes, higher prices, premiums or co-payments or reductions in service. But, even more than the financial burden of the CCER, the implications of a government-sponsored entity making judgments about "best practices" should be enough to raise anyone's blood pressure to dangerous levels.

Let's say that the CCER determines that stents are a more effective treatment for heart disease than open-heart surgery. What heart patient wouldn't be happy about a less invasive procedure? Only those who actually need open-heart surgery, which may no longer be covered by insurance, at least not without reams of justifications, because the CCER has determined that stents are the better bargain.

What about a CCER finding that a lower-cost generic drug is effective for a given condition? In many cases, the generic can and should be prescribed. But, can patients still get brand name drugs if the generic formulary doesn't work for them? Additionally, one of the strengths of the American health care system is its ability to innovate. New drugs and devices are constantly being developed. Will the CCER be able to keep pace with rapidly evolving science? And, will the CCER's potential bias toward less costly drugs and devices create disincentives for biomedical research?

What about the effectiveness of spending thousands of dollars on a treatment that may give a patient only a short time to live? At what point does quality of life become a factor in determining effectiveness? Will the CCER wade into these ethical quagmires?

President Obama pledged that health care reform would not interfere with doctor-patient relationships. Yet, if the CCER is intended to compare treatment options, its findings will inevitably influence doctors' recommendations and prescriptions. Even if its powers are only advisory, it will only be a matter of time before private insurance companies, as well as Medicare and Medicaid, adopt the "Book of CCER" as medical gospel.

Treating patients "by the book" is the only way a physician can be sure of reimbursement as well as a way to mitigate malpractice liability. Perhaps this is the real reason behind the American College of Physicians' support for the concept of CCER.

In the end, the CCER will take the place of medical journals, teaching and research hospitals, and a physician's best judgment about appropriate treatments for individual patients. And, when government starts picking up the tab for the uninsured, the government-sponsored CCER will not just evaluate various treatment options. It will become the health cost watchdog that bites.

Kristine Iverson is former assistant secretary of labor (2001-2009).

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