Why PCORI Should Be Very Wary of Studying Medical Devices

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.

7 replies »

  1. Device and software manufacturers don’t like regulation, but they do want doctors to recommend their products and they want insurers to pay for them. They may be drawn into compromise if they realize that they’ll have a much more gigantic market once these institutions trust that their products actually produce value. They need to learn that they need quality control and validation.

  2. I’m afraid there is no happy solution. Given the current political climate, to do anything to satisfy this diverse, “Republican and Democrat, patients and providers, device manufacturers and insurance companies” are almost certainly impossible. While working on a Federal Agency’s role is not to incite political battles, they cannot avoid producing quality research on important topics, just because they’re not going to invite everyone to participate in. Sometimes, all you have to do what’s right even though it is the political risk is very high, even if it leads to dispersion of your organization. Too many see PCORI to produce quality scientific important (even though the political risk is very high) than it produces research, but everyone can agree on, it almost certainly will not produce the kind of results will in fact lead to large changes in the health care sector.

  3. Interestingly, private industry is taking the end run around government here once again. A company called Shared Clarity is doing device-focused analysis to determine which subset of devices in each category is “best” and will direct their many affiliated hospitals on both quality and cost through group purchasing. Worth noting this may get done better and faster outside the political world.

  4. I agree NIH is not safe, but it is much, much safer. And as for PCORI taking political risks, if it is too risky too soon, it won’t do any good science. We need to sometimes balance ideals and reality.

  5. Peter, I think we’re on the same page. I have argued, even in THCB) that CER is only as valid as the degree to which clinically meaningful efficacy is demonstrable in any subset. Otherwise one is likely to be doing comparative ineffective research and then massaging the data. The limiting factor is the demonstration of clinically meaningful efficacy, regardless of who does the demonstrating.

    I was a consultant to the AHCPR committee developing guidelines for the diagnosis and treatment of acute low back pain. I detail the object lesson in http://uncpress.unc.edu/books/T-9058.html. The more recent saga of CMS and vertebroplasty is a replay (Health Affairs 2011;30:2269-76).

    All of these considerations merit transparency and wide dissemination.

  6. Disagree with you about the NIH being safe:


    I fear that there is no solution that pleases everyone. Based on the current political climate, doing ANYTHING that satisfies this diverse group of people, “Republicans and Democrats, patients and providers, device manufacturers and insurance companies”, is almost certainly impossible. While the role of a federal agency that funds research is not to instigate political battles, they cannot shy away from producing quality research about important topics simply because they won’t please everyone involved. Sometimes, you must do what is right, even if it is politically risky and even if it leads to dispersal of your organization. I’d much rather see PCORI produce high-quality science that is important (even if politically risky) than to see it produce studies that only everyone can agree upon, which will almost certainly not yield the kind of results that will actually lead to large change in the health care sector.