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States Reviewing Drug Safety Themselves

Posted on: Wednesday, 24 November 2004, 03:00 CST

WASHINGTON -- As Congress and others lobby to create an independent board to review the safety of prescription drugs, a dozen states have been doing just that.

State officials who manage billions of dollars in annual drug purchases joined together in a project to help them comparison shop, picking the most effective and safest choices from a slew of competing drugs. Their efforts had an unexpected result.

By taking a closer look at a half-dozen existing studies, the project raised safety questions about Vioxx as early as 2002. Two of the earliest member states - Oregon and Washington - used that independent analysis to remove Vioxx from lists of preferred drugs that doctors use when prescribing medication for Medicaid recipients.

Dr. John Santa, medical director of the Drug Effectiveness Review Project, said the project has developed into virtually an independent office of drug safety.

The project provides information to the states about the drugs it studies. It's then up to the states to decide whether to act in response to the material it gets.

The director of Missouri's Medicaid pharmacy said the states don't want the project to make those sorts of policy recommendations.

Missouri applied the Vioxx warning to a computer program that in fewer than three seconds judges whether the state should pay for prescriptions, said George Oestreich, the program director.

After that, when a pharmacist tapped in prescription information, the computer program knew to block payment for Vioxx if the patient had a history of cardiovascular disease or if the prescribed dose was higher than 25 milligrams and was to be taken longer than five days.

In those cases, an electronic message would flash the answer back to the pharmacy: Missouri won't pay.

The three-year, $4.2 million undertaking provides its now 12 member states credible, systematic and neutral reviews of drug safety and effectiveness, said Santa, assistant director for health projects at the Center for Evidence-Based Policy in Portland, Ore.

The project's members are the states of Alaska, Arkansas, Idaho, Kansas, Minnesota, Missouri, Montana, North Carolina, Oregon, Washington, Wisconsin and Wyoming and two nonprofit health groups, from California and Canada.

In exchange for annual contributions of $96,600, the states have received a dozen reports, including the early warning on Vioxx and a report this fall that compared new-generation antidepressants.

Merck & Co. withdrew its blockbuster painkiller Vioxx from the market in late September because of links to heart problems.

"The data was there. It was there two years ago. It was there three years ago. It was there four years ago," Santa said. "The business model that the industry has, the regulatory model that the FDA has, and the knowledge model that the profession has are flawed."

In testimony last week before the Senate Finance Committee, Food and Drug Administration drug safety reviewer David Graham made similar points and cited the drugs Meridia, Crestor, Accutane, Bextra and Serevent as unsafe. The manufacturers defended the safety of the drugs.

The 15 classes of drugs already reviewed by the project include cox-2 inhibitors, like the arthritis pain drug Bextra, and the anti-cholesterol statins, like Crestor. The project's review of painkillers came before a report this fall that linked Bextra to higher risk of heart attack and stroke, said Dr. Mark Helfand, the project's director and author of a report on that class of drugs.

Reviewing the same data as Graham, the project found a half-dozen trials insufficient for a reliable judgment on the safety of Crestor.

"We didn't think there were enough data to really say what the risk was," Helfand said.

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On the Net:

Drug Effectiveness Review Project

Source: Associated Press/AP Online

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