By Peter Ubel, MD
In the New York Times on Thursday, October 17, Topher Spiro wrote an important op-ed expressing why we need to hold onto the medical device tax that helps pay for parts of the Affordable Care Act. Spiro backs up his argument by pointing out how profitable the device industry is. To his argument I would also add the fact that this will provide the industry with more paying customers. Certainly it can afford to pay the taxes.
But I diverge from Spiro on a proposal he floated near the end of his piece:
“To complement these efforts, the new Patient-Centered Outcomes Research Institute [PCORI], a non-governmental body created by the Affordable Care Act, should pay for research that compares the effectiveness of devices so physicians can make informed choices. (Three years into its existence, the institute has initiated few, if any, studies of medical devices.”
Listen to me PCORI. Don't follow this advice, unless you plan not to survive to celebrate your fourth birthday.
Consider what happened to the Agency for Healthcare Policy Research (AHCPR), when it tried to help physicians figure out the best way to treat low back pain. AHCPR was created as a stand-alone research institute, akin to the NIH, but one that would focus not on the basic science of treating disease, but instead on evaluating how well existing treatments worked.
By the early 90's, the folks at AHCPR decided that scientists had learned enough about low back pain treatment that it was time to convene experts and put out treatment guidelines. The AHCPR guidelines were state of the art (or state of the science, I guess). Where knowledge was lacking, the guidelines said we needed more research. Where findings were clear, the guidelines gave strong advice to clinicians on how they should take care of their patients.
The AHCPR experts boldly concluded that spinal fusion– one of the most common and lucrative treatments given to patients with low back pain– was of no proven benefit. In reaching this conclusion, the people at AHCPR had convened a wide array of experts, many of whom disagreed with each other at the outset about the best ways to treat problems like low back pain.
Playing by the rules of science, these experts collaborated with each other to analyze available data. And when they conducted new studies, they pushed for the kind of randomized clinical trials that would best inform their research questions. They had tackled this challenging clinical problem with the best available scientific methods of the day.
Only one little problem: The North American Spine Society (NASS), a professional organization made up of the very surgeons who have made their millions performing spinal fusion operations, decided to wield its political power to thwart the AHCPR guidelines.
Few things are more motivating than mortgage payments, and these surgeons were highly motivated to fight back against any federal agency that questioned the medical value of their treatments.
So the spine surgeons quickly formed a lobbying group, cleverly named the "Center for Patient Advocacy," and used this lobbying organization to recruit powerful politicians. The surgeons were out for blood, bureaucratic blood. They decided not only to discredit the AHCPR guidelines, but to try to convince legislators to eliminate the entire agency.
AHCPR, by trying to use good science to inform public policy, found itself on the legislative chopping block. PCORI risks facing the same fate if it tackles the kind of clinical questions that will raise the ire of powerful interest groups. And the device industry is clearly one such group. Look at all the resources it has marshaled to combat the device tax, and the success it has gained in gathering support from legislators on both sides of the aisle.
PCORI needs to conduct the kind of research that everyone — Republicans and Democrats, patients and providers, device manufacturers and insurance companies — will support, at least until the point where it has proven its value to enough people that it won't be one controversial topic away from the chopping block.
It's a shame that the people who put together the Affordable Care Act didn't make PCORI part of the NIH. If it had done this, the Institute would have been on more solid ground. No one is going to eliminate the NIH. Housing comparative effectiveness research within the NIH is a much better way of making sure such research is immune to political pressures.
That's why I disagree with Spiro that PCORI ought to study devices. Instead, I would give that job to the National Heart, Lung, and Blood Institute (NHLBI), the Institute at the NIH that deals with cardiovascular disease, so it could study things like pacemakers, defibrillators and artificial heart valves. Or I would give the job to the National Institute of Arthritis and Muscoskeletal and Skin Diseases (NIAMS), the Institute at the NIH that deals with joint diseases, so it could study things like artificial hips and knees.
If we want to inform healthcare practice with good science, we need to make sure that the people who do the science won't be vulnerable to special interest groups.
Peter Ubel, MD is a physician, behavioral scientist and author of Pricing Life: Why It's Time for Health Care Rationing and Free Market Madness and his new book Critical Decisions. He teaches business and public policy at Duke University. You can follow him on his personal blog.
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