Medical Minefield of Procedures to be Examined

May 7, 2009
New Effort Reopens a Medical Minefield
By BARRY MEIER
A back-pain researcher, Dr. Richard Deyo recalls the uproar the last time federal officials tried to suggest how doctors should practice their profession.

It was in the mid-1990s, when Dr. Deyo helped develop federal guidelines urging surgeons not to perform spinal fusions to treat acute pain. The reason was simple: There was little evidence that the fusions worked in many patients.

Spine specialists quickly attacked the report, calling it flawed. One medical device maker, Medtronic, sued unsuccessfully to block its release. Republican lawmakers tried to kill the agency that issued the report. It survived, but its funding was drastically cut, and it decided to stop issuing guidelines.

Now, 15 years later, the Obama administration is entering this same medical minefield. And once again, opponents are gearing up for a fight.

The administration plans to spend $1.1 billion over the next few years on studies like the one conducted by Dr. Deyo, to compare the effectiveness of competing treatments for common conditions like back pain, heart disease and prostate cancer. The studies will be publicly released, to help doctors and patients decide which treatment options they want to pursue.

Supporters include many medical researchers, consumer groups, unions and insurers. They say such studies are essential to curbing the widespread use of ineffective treatments and to helping control health care costs, which totaled $2.2 trillion in 2007, or 16 percent of the nation’s gross domestic product.

The New England Journal of Medicine published several articles Wednesday supporting the federal effort and rebutting arguments raised by critics.

But potential opponents — which include medical products companies, some doctors and their political allies — warn that the comparative effectiveness movement could lead to inadequate treatment for some patients and even the rationing of health care.

“It is not difficult to see how you can get on a slippery slope very easily,” said Tony Coelho, a former Democratic congressman who is head of a new industry-backed Washington group called the Partnership to Improve Patient Care, formed to lobby on the comparative effectiveness effort.

The group’s backers include major trade organizations that represent producers of drugs, medical devices and biological treatments.

Critics like Mr. Coelho also point to a British government agency, the National Institute for Health and Clinical Excellence, or NICE, which considers costs in judging a treatment’s effectiveness. Based on NICE’s findings, the British government has denied some patients access to costly drugs like those used to treat cancer.

Whether cost should be a factor in this country was a hot-button issue during the Congressional debate in February, when the comparative-effectiveness funding was approved as part of the economic stimulus package. A legislative report by Congressional lawmakers who negotiated the final version of the bill said that they did not intend the research money to be used to “mandate coverage, reimbursement or other policies for any public or private payer.”

Despite that assurance, even supporters of the effort say one goal in identifying effective medical treatments is to stop wasting money on those of little value.

For now, proponents and critics are warily circling one another, as the first administrative steps of the process unfold.

A panel of government health experts is holding a series of public hearings at which people can suggest medical conditions for comparative effectiveness reviews. Then, in late June, that federal panel and the Institute of Medicine, a part of the National Academies of Science, will issue reports recommending priorities for comparative research. Past combatants like Dr. Deyo expect the fighting to start as soon as such studies start identifying winners and losers.

“If this research is done in a rigorous way and doesn’t pull strings, then a lot of pressure will come to bear,” on the process, said Dr. Deyo, a professor at Oregon Health and Science University in Portland.

Some conservative and libertarian research groups, as well as commentators like Rush Limbaugh, have attacked the comparative effectiveness effort as a step toward socialized medicine. Some medical experts have also raised concerns that the program may slow the drive toward so-called personalized medicine — an approach in which treatments are tailored to a patient’s genetic makeup. But for now, Mr. Coelho’s opposition group and drug and device makers are using more measured rhetoric.

Mr. Coelho, a former House Democratic whip who resigned in 1989 over a controversial junk-bond investment, says his organization does not oppose the concept of comparative effectiveness. But the group is concerned, he said, that such studies could lead to a type of cookbook medicine that will ignore the needs of specific patients, including members of minority groups.

His organization includes patient advocacy groups like the National Alliance for Hispanic Health and the National Alliance on Mental Illness, which also receive financing from medical products companies. Those groups argue that their members are underrepresented in formal clinical trials of drugs and treatments, and so there is not evidence enough on which to draw conclusions on what works for them and what does not, they say.

Mr. Coelho, a driving force behind the Americans with Disabilities Act, points to his own experience with epilepsy, which he has had since he was a teenager, as an example of how patients need to be treated individually.

Under the comparative effectiveness program, the Department of Health and Human Services and two agencies under it —the National Institutes of Health and the Agency for Healthcare Research and Quality — will finance studies that will look at various treatments and will pay for the development of information-gathering tools, like databases of patients being treated for a certain condition.

Right now, “there is no place that helps you sort through a specific option and how that compares to another,” said Dr. Carolyn M. Clancy, the director of the Agency for Healthcare Research and Quality.

The agency, back when it was known as the Agency for Health Care Policy and Research, was the federal body Dr. Deyo worked with in drafting the back-pain guidelines in the mid-90s.

More recently, officials of the Oregon Evidence-Based Practice Center began producing reports a few years ago comparing the effectiveness of competing drugs, both brand-name and generic, in treating specific conditions. The work was meant to help purchasers like state Medicaid programs lower their costs, said Dr. Mark Helfand, director of the center, which is part of the Oregon Health and Science University.

Wherever they went, Dr. Helfand said, he and his colleagues met resistance from drug makers and some patient groups that had rallied to the companies’ side, who raised the same arguments that critics of comparative effectiveness are raising today. The Practice Center’s research, which is continuing, is now used by 14 states. Dr. Helfand said groups representing African-American, Hispanic or elderly patients were right to argue that they were underrepresented in clinical trials. But he added that the whole point of comparative effectiveness was to move medical practice beyond the limits of such trials, by looking at a broader range of evidence that includes the actual experience of patients undergoing treatment.

“Ironically, the motivation for comparative effectiveness is to see what works in practice,” he said, “rather than overgeneralizing from a few unrepresentative studies.”

http://www.nytimes.com/2009/05/07/business/07compare.html?_r=1&th&emc=th

The idea of studying what treatments work is fantastic and, in fact, sorely needed. There have been a couple of unfortunate occasions in my life when I have really wished there was more information on certain treatments that we were considering for my children. All three of them actually! (The wonders of modern medicine mean there are LOTS of opportunities for medical intervention). That being said however, I believe this was put into the same bill which contained a requirement that doctors send all treatment information to the federal government & let the government decide what treatment is appropriate for a given patient. THAT is totally unacceptable. I would liek a database for myself and my husband, in concert with our or our children's doctors to make informed decisions. Not for some bureaucrat to make that decision. There are a lot of hard decisions to be made in the medical field -- that's why it needs to be up to us as individuals to make them for ourselves. Like everything else in life, it all comes down to personal responsibility.

My mom is currently in the hospital undergoing every test known to modern medicine, plus treatments. Medicare and her supplemental insurance take care of all the bills.
Yesterday, one doctor suggested we go to an Urgent Care center as her sodium was very low. The doctor at the center took a listen to her lungs, put her on oxygen, called the paramedics to drive her around the corner to the hospital ER.
Last night they admitted her to the regular hospital and today they are withdrawing fluid from her lungs. While she is doing well, with all the holes they have punched in her withdrawing blood and inserting IVs, I cannot imagine if any of these decisions would have to be run by the government for approval. I know she is in the best hands possible and she is extremely pleased with the care these professionals have shown her.