Inflating the Deficit with Futile Health Therapies
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The Fiscal Times
February 27, 2012

Cynics say Washington is the city where good ideas go to die. A promising strategy for holding down health care costs in the Obama administration’s reform bill – providing patients and doctors with authoritative information on what works best in health care – should provide a classic test of that proposition, assuming the law survives the next election.

Experts estimate anywhere from 10 to 30 percent of the health care that Americans receive is wasted. It is either ineffective or does more harm than good. To put that in perspective, waste costs anywhere from $250 billion and $750 billion a year, or as much as three-fourths of the annual federal deficit.

Yet every effort to curb wasteful spending (health care fraud, though pervasive, is estimated at less than a quarter of the total) has come up short. Neither Medicare and Medicaid’s efforts at government price controls nor the insurance industry’s efforts at managing care has succeeded in stopping health care spending from rising at twice the rate of the overall economy. Only the recent deep recession curbed costs, and that was because people lost their insurance when they lost their jobs and stopped going to the doctor. The bill for that postponed maintenance isn’t in yet.

For over a decade, the health policy world has held out comparative effectiveness research – comparing competing approaches to treating disease – as one possible solution to eliminating waste in the health care delivery system. If only doctors and patients knew what worked best, knew what worked less well than advertised, and knew what didn’t work at all, they would, through better-informed choices, gradually eliminate much of the waste in the system.

The Obama administration and Democrats in Congress placed a big bet on comparative effectiveness research (CER), and paid a heavy political price for doing so. The Affordable Care Act earmarked $500 million a year or $3.5 billion over the life of the bill for such research. It set up the Patient-Centered Outcomes Research Institute (PCORI) to carry it out, and created an independent board made up of the various stakeholders (physicians, patient advocacy groups, providers, and payers) to set priorities.

During the debate leading up to the 2010 passage of the law, Republicans on the Hill made CER and PCORI one of their favorite whipping boys. Sen. Charles Grassley (R-Iowa), normally a trenchant critic of physicians, drug companies and others who use the health care system as a cash cow, accused the administration of trying to set up a “program (that) would be similar to the one in Great Britain and other foreign governments that decide which treatments you can and cannot have.

“The principle of comparative effectiveness research in and of itself is not something that I oppose,” Grassley said on the Senate floor in December 2009. “When it’s used in a way of informing patients and providers about best practices, it’s a good thing to have. But I’m also worried that this could be used as a tool for the government to ration care.”

The CER section of the law went a long way to assuage the critics. It said no government payment decision could be based on the research. The new information would go into the public domain, where doctors and patients could use it. But it could never be used to determine Medicare payment decisions.

But the fact that CER has nothing to do with “pulling the plug on grandma” won’t stop other critics of scientifically evaluating medical technologies from having their say. Medicine is field rife with special interests, each of which is ably represented on the PCORI board and is standing by to lobby the organization. If you’re a radiologist and work in a hospital complex that can offer targeted proton beams from a $100 million cyclotron to treat prostate cancer (there’s more than a half dozen already up and operating in the U.S.), are you really interested in a scientific study that definitively determines whether that, drug therapy or simply “watchful waiting” is the best course for treating that slow-growing tumor?

The clash of special interests started on Monday, when PCORI held a public meeting to discuss its initial call for research proposals. The board, headed by Joe Selby, a family physician formerly with Kaiser Permanente’s internal technology assessment group, put at the top of its priority list determining what works best in preventing, diagnosing and treating specific diseases. The first grants will be made in December – safely after the election.

Marc M. Boutin, chief operating officer of the National Health Council, which is an umbrella group for about 50 patient advocacy organizations, said the board should conduct research that “allows people to make decisions based on their own needs, hopes and desires.” Adolph Falcon, a vice president for the National alliance for Hispanic Health, called for studies that included representation from all demographic groups – Hispanics and women, for instance.

Karen Daley, the president of the American Nurses Association, stressed the need to include “patient defined quality of life outcomes” in every study, and pushed for more research into the effectiveness of team-based care. Helen Darling, the president of the National Business Group on Health, warned the PCORI board not to ignore the needs of the working-age population, the primary concern of the employers in her group. And Richard Smith, the vice president for policy at PhRMA, the drug industry’s trade group, suggested the board pay attention to the negative consequences of patients failing to take their medicines.

In other words, rather than seeing PCORI as a science-based agency that should be trusted to provide the most up-to-date, accurate information about what works best in every field of medicine, most of the stakeholder groups saw its board as another Washington institution to lobby. For them, Monday’s public hearing was just another day at the office.

It was left to Otis Brawley, the chief medical officer of the American Cancer Society, to sound the alarm about the pitfalls that await PCORI studies as they come out of the research institutions that win the agency’s grants. Brawley, who recently released “How We Do Harm: A Doctor Breaks Ranks about Being Sick in America,” said “we have a long history of people subverting the scientific process.”

Though he works for one of the largest and most powerful patient advocacy groups in the country, Brawley has become radicalized over the last few years after one cancer treatment after another has been exposed as not only not helpful, but actually harmful to patients. Bone marrow transplants for breast cancer, screening older men for prostate cancer, anti-anemia drugs for chemotherapy patients – each was given to tens of thousands of people without adequate scientific backing only to discover years later that more died than were saved from the treatments.

Physicians, Brawley said, too often put their own needs over those of their patients, who are often desperate for something that will cure what is likely to be a fatal disease. “We have the greedy feeding the glutinous,” he said. “The problem that PCORI will face is getting people to actually believe the findings of scientific research when you have the greedy and the glutinous conspiring to routinely ignore such findings.”   

spent 25 years as a foreign correspondent, economics writer and investigative business reporter for the Chicago Tribune and other publications. He is the author of the 2004 book, The $800 Million Pill: The Truth Behind the Cost of New Drugs.