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Vertebroplasty Debate Cited As Cautionary Tale

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The new Patient-Centered Outcomes Research Institute (PCORI) will get more than $3 billion over the next decade to conduct “comparative effectiveness” research and suggest the best ways to treat various illnesses. Will anybody listen?

Don’t bet on it, suggests a Kaiser Health News article. Writer Julie Appleby cites the example of vertebroplasty—the injection of medical cement into compression fractures of the spine in order to relieve pain (at a cost of $5,000 or more). In 2009, two studies said it didn’t work.

The studies, published in the August 6, 2009, issue of the New England Journal of Medicine (click here and here), said vertebroplasty, often done by interventional radiologists, produced no more pain relief than sham injections.

In November 2009, the Society of Interventional Radiologists issued a statement that picked apart the studies and concluded, “We believe it is premature—and possibly incorrect—to conclude that vertebroplasty is no better than a control sham procedure.”

Today, more than two years later, Medicare and most other insurers still cover vertebroplasty.

The Kaiser article also mentions the controversies that followed an October 2011 recommendation by the U.S. Preventive Services Task Force against routine screening for prostate cancer and the Food and Drug Administration’s reversal in November of its approval of Avastin for breast cancer treatment.

Some see such reactions as evidence that financial self-interest, consumer confusion, resistance to change, and other powerful forces will prevail against attempts to reduce health care costs. The article quotes Sean Tunis, MD, founder and director of the nonprofit Center for Medical Technology Policy in Baltimore, concerning the prostate screening and Avastin cases:

If we’re ever going to have a hope of spending less money on medicine, we’re going to have to stop paying for things that don’t work, or hurt people. You could not ask for two more clear examples.

On the other hand, the very fact that the FDA initially approved Avastin before changing its mind demonstrates that there are good reasons for questioning the conclusiveness of research about the effectiveness of a particular procedure. Said Jennifer Jaff, executive director of the Connecticut-based Advocacy for Patients with Chronic Illness:

If you find a medical journal article that says ‘no,’ I can find you one that says ‘yes.’

The PCORI (get used to those initials; you’ll be seeing them a lot) is an independent, nongovernmental board set up by the Patient Protection and Affordable Care Act and funded by a small annual fee on health insurance policies, including Medicare. Its 21-member board represents a broad range of health care stakeholders, including consumers, government agencies, insurers, and makers of drugs and medical devices.

But it’s purely an advisory body, with no power to enforce its recommendations. So it risks becoming an example of what it is trying to eliminate: an expensive procedure that provides no benefit to patients or the health care system.

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How has the American Board of Radiology reacted to last week’s CNN report accusing radiologists of cheating on the ABR qualifying exams? We take a look in today’s Facebook post.

Related seminar: Interventional Radiology Review

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