Healthy Skepticism Library item: 13408

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Publication type: news

Dixon K.
ANALYSIS-US may compare medical products; companies wary
Reuters 2008 Mar 31
http://www.forbes.com/reuters/feeds/reuters/2008/03/31/2008-03-31T193238Z_01_N31419471_RTRIDST_0_DRUGS-COMPARISONS-ANALYSIS.html

Full text:

WASHINGTON (Reuters) – New evidence that best-selling cholesterol fighter Vytorin is no better than older, cheaper medicines at slowing heart disease comes as two U.S. lawmakers prepare legislation to launch studies comparing specific treatments.

The idea of the federal government funding independent comparative effectiveness studies has drug and medical device makers jittery. They fear such information would influence insurance coverage and jeopardize billions of dollars worth of sales for their newest and most lucrative treatments.

“We don’t want a situation where we’re going to a kind of ‘cheapest is best’ approach to medicine,” said David Nexon, a policy expert at the trade group AdvaMed.

The group lobbies for medical device makers including giants like Medtronic Inc (nyse: MDT – news – people ), which sells surgical devices to prop open arteries, among other products.

The idea, though, has many backers, including economists, insurers and the nation’s large employers.

U.S. health care spending has tripled over the past four decades, and is now more than $2 trillion a year. Half of all long-term health spending growth is linked to technological advances such as new drugs and medical devices, according to the Congressional Budget Office.

At the same time, myriad reports have detailed how the quality of U.S. health care trails other developed nations.

“There is frustration that we are spending a lot and not seeming to get as much as we would like from that,” said Gail Wilensky, a health economist and former head of the Medicare and Medicaid programs under President George H. W. Bush.

Legislation to be proposed soon by Democratic Senators Max Baucus of Montana and Kent Conrad of North Dakota would establish an independent institute to systematically compare the effectiveness of drugs and devices.

Manufacturers in general have no incentive to conduct such studies, experts say, because the Food and Drug Administration does not require them. Manufacturers typically must only prove their products are superior to a placebo such as a sugar pill.

IS NEWER BETTER?

The U.S. insurance system pays more for more care, encouraging doctors to use new and expensive products, experts said. Doctors and patients are also influenced by advertising, which the industry reserves for its most lucrative products.

In a startling example of what comparative studies can turn up, researchers on Sunday confirmed findings that Vytorin, a heavily marketed cholesterol drug with billions in annual sales, was no better than a cheaper generic at keeping heart disease at bay.

Vytorin makers, Merck (nyse: MRK – news – people ) & Co and Schering-Plough Corp (nyse: SGP – news – people ) , said the results could be explained because patients had been treated aggressively with other cholesterol-lowering drugs, leaving little room for improvement.

A separate New England Journal of Medicine study compared U.S. and Canadian prescribing practices for Zetia, a component of Vytorin. It suggested heavy advertising greatly boosted U.S. sales. “We spent a lot of money on this thing and I think honestly we don’t have any idea whether or not, net-net, patients benefited,” said Harlan Krumholz, a Yale researcher on the study.

But industry is worried that such comparative research could stifle innovation, if it turned into a treatment-denying mechanism. The Pharmaceutical Research and Manufacturers of America trade group said in a statement that it could back such research in concept as long as the results did not make “centralized value judgments” or be used to deny patient care.

An analysis by the Lewin Group for the Commonwealth Fund found that comparative effectiveness research, used appropriately by doctors and insurers to guide decisions, could cut national health spending by $370 billion over 10 years.

“One of the requirements for a market to work is that you have good information and we don’t have a lot of that right now,” said Stuart Guterman, an economist at the nonprofit Commonwealth Fund.

To be sure, that proposal assumes insurers and doctors take the information and use it — a big if, Guterman said.

COSTS

A key sticking point for industry is whether the federally-funded comparisons would take costs into account, as is done in Europe. Lawmakers have said treatment costs would not be used initially by the institute, but these factors might be considered at some point in the future.

“We really think the entity should stay away from cost-effectiveness,” said Kathy Buto, vice president of health policy at Johnson & Johnson. “We’d recommend against an entity that would make up or down decisions.”

The Democrats’ bill is expected to propose funding of $200 million annually within five years. The institute would be governed by a board with officials from government, nonprofit groups, doctors, patients and industry.

“Ultimately it’s better to target our health care dollars using comparative effectiveness rather than just cutting back because it’s so expensive,” Steve Wojcik, policy advisor for the National Business Group on Health.

Some Republicans also embrace the idea. A House bill introduced last year was sponsored by Democrat Tom Allen of Maine and Republican Jo Ann Emerson of Missouri. Former Senate Republican leader Bill Frist, a physician, had also backed it.

Wilensky, the former Republican official, said it’s wiser for drug and device makers to embrace an evidence-based research institute now, than to risk more random cost-cutting methods that insurers could employ.

As health care costs take a bigger bite of national spending — now 16 percent of gross domestic product and headed for 20 percent within a decade — payers will be forced to make hard choices of what treatments to cover, experts said.

“Information can always be misused,” Wilensky said. “Learning how to spend smarter is so much better for them than the kind of crude mechanisms (insurers) will feel forced to turned to if we don’t go in this direction,” she said. (Additional reporting by Julie Steenhuysen; Editing by Tim Dobbyn)