Program Aims for Drug, Device Safety

By Rob Stein
Washington Post Staff Writer
Friday, May 23, 2008

Federal health officials yesterday announced plans to begin mining the medical records of millions of patients to try to identify safety problems from drugs and medical devices more quickly.

The Sentinel Initiative will enable the Food and Drug Administration and others to analyze the growing number of databases of health records compiled by the government, health insurers and HMOs to try to identify drug- and device-related problems sooner than does the current system, which relies primarily on voluntary reporting by individual doctors.

"It will be a quantum leap forward in the FDA's capacity to monitor the use of medical products that are currently on the market," said Health and Human Services Secretary Mike Leavitt. "We are moving from reactive dependence on voluntary reporting of product-safety concerns to proactive surveillance of medical products that are currently on the market. The result will be much improved safety."

The agency plans to start by analyzing data collected about the more than 25 million people enrolled in the new Medicare prescription drug program. State agencies and academic researchers will also have access to the data under a new federal regulation that will go into effect in 30 days, officials said.

"The FDA will eventually be able to query databases of tens of millions of patients almost simultaneously," Leavitt said.

The officials stressed that the system will protect patient privacy by keeping all identifying information confidential.

"FDA will not receive information that identifies individual patients, so patient privacy will remain protected," Leavitt said.

The FDA has come under intense criticism in recent years because of safety problems with prescription drugs such as the painkiller Vioxx, which was pulled from the market in 2004 after researchers discovered it was causing heart attacks.

Although drugs and medical devices undergo safety testing before being approved, often the studies are too small or too short to identify harmful side effects that show up when millions of patients start using them. As a result, the FDA primarily relies on doctors to voluntarily report problems they notice among patients. The agency has also recently gotten more authority to require drug companies to conduct follow-up studies of drugs after they have been approved.

"Before Sentinel, tracking drug safety was like looking at the stars in your back yard with the naked eye," Leavitt said. "After Sentinel, it's like giving you the strongest telescope on the market, which allows you to see precise details in great distances."

© 2008 The Washington Post Company