Medicare to help find drug effects

Patient records will be used to detect problems

Vioxx was withdrawn from the market after its public release. (SPENCER PLATT/AFP/GETTY IMAGES/file 2004)

WASHINGTON - US regulators said they will use patient information from Medicare and other sources to monitor harmful side effects of drugs and medical devices to more quickly detect dangers once products are on the market.

The Food and Drug Administration will be able to search computerized medical records to identify dangers once medications and devices are in widespread use, said Health and Human Services Secretary Michael Leavitt yesterday. Medicare is the US healthcare program for the elderly and disabled, and its drug benefits cover 24 million patients.

Regulators now collect voluntary reports by doctors and patients to identify dangers, and the agency says the records often are incomplete and can take a long time to analyze. Legislation signed last year by President Bush called on the FDA to use databases from sources such as Medicare and insurers to detect side effects. The FDA has been criticized by lawmakers who say the agency takes too long to spot dangers.

"We will no longer have to wait years to see how a drug or medical device is affecting millions of people," said FDA commissioner Andrew von Eschenbach.

Data from the Medicare prescription drug program should be available to the FDA in 30 days, Leavitt said. The FDA is in discussions with private insurers to use their computerized medical records as well. The agency's drug chief, Janet Woodcock, declined to identify the companies during a conference call with reporters.

WellPoint Inc., the Indianapolis-based health insurer, last month said it planned to contract with the FDA to provide data from its 35 million members to help regulators detect side effects. No other US company covers more people.

Patient names and personal information won't be included in the information the FDA reviews, officials said.

Before medications are approved for sale by the FDA, drug makers must conduct clinical trials to show the products are safe and effective. Sometimes, harmful side effects aren't detected until medications are widely used in the general population.

The agency's performance has been questioned in handling Vioxx, Merck & Co.'s painkiller that was withdrawn in 2004 after being linked to heart attacks and strokes, and Avandia, GlaxoSmithKline PLC's diabetes pill tied in some studies to a risk of heart attacks.

The Medicare data will link the use of medications to medical care subsequently received by patients. That will help regulators identify patterns of care delivered after medications are used and possibly spot side effects, according to the FDA.

"It allows you to potentially look at very large numbers of events very quickly," said Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, during the conference call.

When the agency suspects a product is a safety risk, it will query the data, Woodcock said. Those queries may result from side effects seen during clinical trials or reports after the products are on the market, she said.

The system may result in more warnings delivered more quickly about products' dangers, according to Woodcock. The data could be used to alert doctors and patients that products pose a particular risk to a specific population of patients, she said.

Leavitt and other officials said they couldn't estimate the cost of the system.