- - Tuesday, June 19, 2012

ANALYSIS/OPINION:

If Obamacare is ruled unconstitutional, Secretary of Health and Human Services Kathleen Sebelius asserted that she would keep it alive in other ways. One of these is the development and use of comparative effectiveness research (CER) - studies that compare products or treatments to decide which is the most effective for the money - to decide which new technologies government health programs like Medicare should cover.

Under the new health care law, CER must be employed before we can use new technologies. Even if Obamacare is overturned, HHS will spend billions creating and marketing CER to health plans and doctors even as it limits private-sector discussion of innovation.

CER proponents claim it will be used to give people access to the best care they deserve. That’s not how CER is used. Last year, the Food and Drug Administration approved Benlysta, the first new treatment for lupus in 50 years. A friend of mine has been taking it for six months. For the first time in a decade she wakes up pain-free. She is painting and teaching nearly fully time.

If she lived in London, Berlin or Syndey, she would still be suffering. Benlysta is not covered by health systems in Germany, Britain, Australia and Canada.

The same goes for Avastin for breast cancer, Revlimid for multiple myeloma, and Yervoy, the first new drug for skin cancer in a decade. Those countries said “no” years after American patients got them. As another friend of mine who’s on Revlimid told me: “If I were living in England, I’d be dead.”

Under Mrs. Sebelius, HHS is already using CER to limit access. Medicare won’t pay for a genetic test that reduces the risk of internal bleeding from blood thinners. The Centers for Disease Control and Prevention has used CER to suggest that a meningitis vaccine that could prevent 4,000 babies each year from dying or suffering brain damage might not be worth paying for. The U.S. Preventive Services Task Force, the agency determining which preventive services will be covered under the new health care law, used CER to conclude mammograms for women younger than 50 and prostate-specific antigen screening of adult men for prostate cancer don’t save enough lives to warrant the expense.

Yet cancer mortality has declined each year since 1990, and in 2005, overall deaths from cancer declined despite the larger and older U.S. population. In 2007, the rate of decline actually doubled.

The reason? Since the early 1990s, cancer has been increasingly treated with products tailored to specific types of genetic mutations, individual risk factors and cancer progression. Personalized medicine is making the treatment of cancer and other diseases more effective, less invasive and less costly. Contrary to the CER-driven decisions of the U.S. Preventive Services Task Force (USPST), it makes screening imperative.

CER discounts the value of targeted and personalized medicine at a time when its promise is finally being realized. Congress just passed an FDA appropriations bill that requires the agency to speed up approval of targeted therapies. Yet CER, which is performed afterFood and Drug Administration approval, would delay access and discourage investment in personalized medicine. CER would add two to three years and billions of dollars to the commercialization of medical technologies. The additional cost and uncertainty of CER could reduce drug investment by $32 billion over 10 years. That translates into 60 fewer new medicines. By losing those innovations, we’d also lose 81 million life years and $4 trillion in health value.

Most of that value flows directly to us. Revlimid replaces blood transfusions and stem-cell transplants with a pill that’s tailored to the biology of the patient. CER ignores how such a shift reduces pain and saves time and money, and it dismisses the value of longer, healthier lives.

We should incorporate consumer and stakeholder preferences into the design of new products. Such value-driven approaches can reduce the complexity and cost of health care as technologies are being developed, and accelerate the commercialization of personalized medicine.

More targeted treatments are on the way. By next year, cancer patients could go to the doctor, have their genome sequenced and begin a treatment strategy tailored to their genetic profile, individual needs and conditions all in the same day. But we will have to wait for such preventive screening and treatment because USPST, insurers and other government agencies will delay decisions until CER is conducted.

Comparative effectiveness research will survive any court decision. It will continue to control the way health care dollars are spent, monopolize what we know about our care and shape how doctors practice medicine. Rapid advances in the science and individual control over medical information improve our health and prosperity. CER undermines both.

Robert Goldberg is co-founder and vice president of the Center for Medicine in the Public Interest.

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