by Brett Coughlin
May 18, 2011


  PCORI Keeps Close Eye on Misuse of Research

NEW YORK — To do its job well, the Patient-Centered Outcomes Research Institute will have to keep a close eye on how comparative effectiveness research is done — and make sure it’s used in the right ways.

The big question is how to keep the research from being misused. Judging from the feedback the board of governors heard from patients and other stakeholders in New York this week, the institute is a long way from answering the question.

By law, the institute can’t consider cost in its research priorities. Yet that’s exactly what the leader of an advocacy group for people with chronic conditions — who suffers from a severe form of arthritis himself — worries will happen.

There’s a broad concern that comparative effectiveness research may be “misused” to focus on cost containment rather than delivering “optimal, individualized care,” Seth Ginsberg, co-founder of the Global Healthy Living Foundation, told the board in testimony Monday.

Up until now, Ginsberg said, the kind of test that typically is used to pick research topics — and determine how to conduct the research — is based on “questions that will help payers control costs.”

Joe Selby, the institute’s new executive director and a former researcher for Kaiser Permanente, insisted that the law will prevent the research from veering into the kind of cost considerations Ginsberg is worried about.

“We exist to address questions brought by patients, endorsed by patients. That’s the hallmark of these questions. They will provide new evidence that patients and providers will use in making decisions.”

But by its very nature, Ginsberg said, comparative effectiveness research is often described as “finding out which treatment is best and only paying for that.”

To serve patients well, the research should go beyond just comparing one treatment to another, and focus on larger questions such as how to reduce or eliminate regional variations in care, he said.

The cost issue isn’t the only sensitive topic the institute will have to navigate in the months ahead. Some consumer advocates are also needling the board about the Methodology Committee — which will determine the standards and help identify research gaps — because they think its priorities could be skewed toward the health industry’s interests.

John Santa, an internist who works for Consumers Union and writes about comparative health care coverage, warned the board Tuesday that “we’re going to watch the methodology committee — more than the board — very closely, because they are important to consumers.”

Santa told POLITICO he’s skeptical, despite the votes of confidence from other patients and advocates, that the committee can produce research policies that aren’t driven by drug makers, device makers, insurers and the other members of the health care industry.

Still, board members made a point of gathering a range of views from patients in a late-night listening session Monday. And those conversations convinced the board members that they’ll have to find ways to keep patients involved over the long run.

“What I heard, in terms of our priorities, is, we gotta figure out how we engage the patients,” said PCORI Chairman Eugene Washington.

Harlan Krumholz, a PCORI board member, said he heard frustration from patients who say there is not enough information available about treatment options that can best help them.

“They didn’t express to us that the research will be misused by others. They were expressing to us that they are often adrift, at sea, because they lack information that puts them into a position to make the kind of decisions they need,” Krumholz said.


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