U.S. Effort to Compare Medical Treatments: Will The Studies be Biased?

As an Orlando Chiropractor, I felt a sinking feeling when I read this NY Times story. One can only hope that patient interests are truly being taken into account.

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A back-pain researcher, Dr. Richard Deyo, recalls the uproar the last time federal officials tried to suggest how doctors should practice their craft.

It was in the mid-1990’s, when Dr. Deyo helped develop federal guidelines urging surgeons not to perform spinal fusions to treat acute pain.

Spine specialists quickly attacked the report, calling it flawed. One medical device maker, Medtronic, sued unsuccessfully to block its release.

Now, 15 years later, the Obama Administration is entering this same medical minefield.

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.

Supporters include many medical researchers, consumer groups, unions and insurers.

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.

Among others, the group is backed by the 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.

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.

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.

“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 think tanks, as well as commentators like Rush Limbaugh, have attacked the comparative effectiveness effort as a step towards socialized medicine.

But for now, both Mr. Coelho’s opposition group, as well as drug and device makers, are using more measured rhetoric.

Coelho, a former House Democratic leader who resigned in 1989 over a controversial junk-bond investment, says his organization does not oppose the concept of comparative effectiveness.

His organization includes patient advocacy groups like the National Alliance for Hispanic Health and the National Alliance on Mental Illness, which also receive funding from medical products companies.

Coelho, who was a driving force behind the Americans with Disabilities Act, points to his own experiences 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 fund studies that will look at various treatments as well as 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-90’s.

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.

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.

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

 

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Full article: http://www.nytimes.com/2009/05/07/business/07compare.html?hpw


 

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