Stimulus funds set aside to study competing medical treatments



Is it better to operate on a bad knee or get an injection of the joint fluid known as Visco?

To help doctors and patients decide, President Obama has dedicated $1.1 billion in the economic stimulus package for federal health agencies to oversee scientific studies on the merits of competing medical treatments.

The approach, known as comparative effectiveness research, is aimed at finding the best treatments at the best prices. Proponents say reducing ineffective or unproven care is one way to rein in health costs, which consume nearly 18 percent of the gross domestic product, straining family budgets, company profits and the federal government.

Skeptics, however, say Obama's decision to invest heavily in such research will lead to European-style rationing in which patients are denied lifesaving therapies to save money. Obama's push also has alarmed some drug companies and medical device manufacturers, which fear that a system of winners and losers is bound to reduce their bottom lines.

The stimulus bill "treats health care the way European governments do: as a cost problem instead of a growth industry," wrote Betsy McCaughey, a fellow at the conservative Hudson Institute who serves on the board of a medical-device company. "Imagine limiting growth and innovation in the electronics or auto industry during this downturn. This stimulus is dangerous to your health and the economy."

But the idea of determining which treatment works best -- and then steering patients toward it -- has been employed for years by state Medicaid programs, the Veterans Health Administration and many private health plans.

Systematic reviews of the mind-boggling array of drugs and treatments on the market has helped California-based Kaiser Permanente save hundreds of millions of dollars. Comparative effectiveness research has allowed the state of Washington to trim its Medicaid drug bill by $40 million a year and shielded officials from aggressive lobbying by drugmakers, said Siri Childs, pharmacy administrator for that state.

"If the whole nation used such an approach, just imagine what the savings would be," she said.

The nerdy-sounding concept is even gaining cache with the public. Today, the independent Consumer Reports, better known for its car-buying guides and appliance ratings, will release "Best Drugs for Less." It details the pros and cons of drugs and lists "best buys" for treating conditions such as migraines, diabetes, depression and hyperactive children. For insomnia, it recommends Zolpidem, a low-cost generic Ambien.

"Many patients and doctors are under the impression that newer drugs are better," said John Santa, a physician and director of the Health Ratings Center at Consumer Reports. "There are many, many, many good drugs that are a lot cheaper and just as effective."

But medical decisions are often more nuanced than choosing between two pills and depend heavily on patient preference.

"Our medicines very often work better on some people than on other people," said W. J. "Billy" Tauzin, president of the trade group Pharmaceutical Research and Manufacturers of America.

Industry officials publicly say they welcome the reviews. They are less enthusiastic about programs in Europe and at the Veterans Administration that link quality and cost.

"Used incorrectly, it allows government payers to literally ban and keep medicines from patients who need them," Tauzin said. He noted that many veterans have purchased Medicare drug coverage because of the restrictions in the VA plan.

For now, Obama has stopped short of advocating coverage decisions that combine clinical findings with cost effectiveness.

"We're not saying, 'Do X or Y,' " said Carolyn Clancy, head of the Agency for Healthcare Research and Quality, which will receive $300 million under the stimulus package. "We're saying, 'Here are the facts, and you should have a conversation with your doctor.' "

The remaining stimulus money will be divided between the National Institutes of Health and the Department of Health and Human Services. Experts at the Institute of Medicine will spend the next several months prioritizing the research, with some of it likely to fund clinical trials.

Many health-care purchasers already combine clinical and cost effectiveness.

Most of the research today occurs at a handful of academic centers, such as the Oregon Health and Science University in Portland.

Consumers Union, publisher of Consumer Reports, and 15 state Medicaid programs contract with Oregon's Drug Effectiveness Review Project for reports on common diagnoses such as high blood pressure and asthma.

The center's findings on cholesterol-lowering drugs prompted the Missouri Medicaid program to switch most patients from the expensive brand-name drug Lipitor to a generic named Simvastatin, saving the state nearly $4 million a year, said George Oestreich, director of pharmacy programs at the Missouri Division of Medical Services. A computer program tracks patient usage, and if a patient's cholesterol remains high on the generic, it automatically allows the physician to prescribe another medication, including Lipitor, he said.

"What we're doing is a microcosm of what could be done across the nation," he said. "You can effectively use the best medical evidence to change the way we buy and deliver health care in our country."

The Oregon center warned states that the Terbutaline pump -- marketed heavily to Medicaid directors and state legislators -- had little or no effect on reducing preterm births but serious side effects, said Mark Gibson, the center's deputy director.

The research, he said, "gave states the ability to say, 'That's not something we're going to cover.' "

At Kaiser, a team of pharmacists, doctors and other researchers takes a similar approach, "scouring the globe" for data on how well medications, devices and procedures work.

"The goal is to figure out under what circumstances is a given therapy best for certain patients," said Sharon Levine, Kaiser's associate executive medical director. The assessments are refined as new data evolves and as researchers learn more about the effect of a given medication on sub-groups such as women or minorities.

Often, Kaiser researchers are able to identify "an equally effective drug at a fraction of the cost," she said. "This is how we can begin to make value choices."

Kaiser estimates it has saved $70 million on high blood pressure treatments, $80 million on anti-depressants and about $100 million on cholesterol-lowering medicines.

Sometimes, comparativeness effectiveness researchers are ahead of the Food and Drug Administration, as when they raised concerns about the anti-inflammatory drug Vioxx four years before it was pulled from the market. Kaiser researchers branded Vioxx no better than its lower-priced cousins, noting that in some cases it appeared to pose an increased risk of stomach bleeding or heart trouble.

In 2003, when about half of all patients with pain were prescribed Vioxx , less than 5 percent of eligible Kaiser patients were taking it. The decision, Levine said, protected Kaiser members from severe, even life-threatening heart complications and saved the health plan $100 million.


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