2.11.2009

Drug Makers Fight Stimulus Provision

By ALICIA MUNDY

WASHINGTON -- The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing.

The fight over the provision is highlighting the tensions behind President Barack Obama's plan to overhaul the health-care system. The administration hopes to expand coverage while limiting use of treatments that don't work well, but any efforts that might reduce coverage are politically sensitive.

The House version of the stimulus package sent shudders through the drug and medical-device industry. In a staff report describing the bill, the House said treatments found to be less effective and in some cases more expensive "will no longer be prescribed."

A Senate version backed by Finance Committee Chairman Max Baucus (D., Mont.) doesn't mention cost as a subject to be studied. And the industry won a battle to add the word "clinical" in describing the research -- adding to the implication that the comparison studies won't look at bang for the buck. The final language is likely to be hammered out later this week in a House-Senate conference committee.

Mr. Obama is under pressure to find long-run health-cost savings as projections show that Medicare spending is on track to severely deplete the federal budget. "Without question, we're headed for more of a public and private push for which medicines work best at the lowest cost in particular patients," said Mark McClellan, former Medicare and Medicaid chief under President George W. Bush.

The $1.1 billion in research funding would be doled out to the National Institutes of Health and other government bodies. "We should focus on producing the best unbiased science possible," said Rep. Henry Waxman (D., Calif.), a strong proponent of the House language.

Mr. Obama supported research into comparative effectiveness during his campaign. Administration officials and leading Democrats in Congress say the idea will help government programs direct their dollars to treatments that are worth the money.

Officially, drug and device makers don't object to that sentiment. But they warn of a slippery slope where the government ends up axing useful treatments just because they cost too much. They have lined up patient groups that get industry funding to lobby Capitol Hill.

A coalition called the Partnership to Improve Patient Care includes the lobbying arms of the drug, device and biotechnology industries as well as patient-advocacy groups and medical-professional societies. Coalition spokesman David Di Martino says the research envisioned in the House bill may be used "in an inappropriate manner that may limit treatment options for patients."

A public-relations firm that is part of one of Washington's most influential lobby shops, Barbour Griffith Rogers, is representing the coalition. A major goal is to give industry a seat at the table when federal officials decide what to research with the $1.1 billion.

Companies "want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it," said Harry Selker, a Tufts University professor who directs its clinical-research program.

That also worries Jerry Avorn of Harvard Medical School, a frequent drug-industry critic. Comparative research "has the potential to tell us which drugs and treatments are safe, and which ones work," he said. "This is not information that the private sector will generate on its own, or that the industry wants to share."

Michael Cannon of the libertarian Cato Institute said comparative effectiveness research "isn't going to do any good because the industry will defund it as soon as it presents a threat."

When the government's Agency for Health Research Quality suggested in 1995 that there were too many unnecessary back surgeries, doctors and industry groups attacked the conclusion. Mr. Cannon noted that Congress at the time slashed the agency's budget and stripped its authority to make medicare-payment recommendations.

"They almost killed AHRQ," said Dr. Avorn. "The memory of their near-death experience hasn't been forgotten."

Dr. McClellan, the former Medicare chief, said effectiveness research can be useful but shouldn't assume pricey medicines are automatically bad. "The goal isn't to avoid expensive drugs, it's to get more value for our health-care spending," he said.

—Jacob Goldstein contributed to this article.
Write to Alicia Mundy at alicia.mundy@wsj.com

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