WASHINGTON — For years, the Food and Drug Administration has struggled with medications that are approved for market but later turn out to have serious side effects its reporting system failed to spot.
Now, a proposal that could be a big step toward solving the problem has been offered by no less an authority than the head of the federal Medicare system. But the response of FDA officials seems lukewarm at best.
For The Record
Los Angeles Times Saturday June 11, 2005 Home Edition Main News Part A Page 2 National Desk 2 inches; 66 words Type of Material: Correction
FDA reporting system -- An article in Sunday's Section A about the U.S. Food and Drug Administration's reporting system for drug side effects identified Dr. Raymond Woosley as vice president of the University of Arizona Health Sciences Center. He recently left that position to become president of the C-Path Institute, a nonprofit organization in Tucson, Ariz., that seeks to improve the process of developing new drugs.
Whether it's a suspected link between Viagra and rare cases of vision loss or heart attacks among arthritis patients using Vioxx, the FDA's current system of voluntary reporting picks up no more than 10% of serious drug reactions.
To help shrink the knowledge gap, Medicare head Mark McClellan, a doctor and an economist who once ran the FDA, has proposed a Medicare-based system to track the safety and effectiveness of medications.
McClellan proposes taking billing data from the prescription program, which will begin in January, and combining it with healthcare information already collected when Medicare users submit claims for hospital and doctors' care. By cross-referencing the information, a computer system could spot signs of trouble.
Patients' personal information would be protected, but the data pool would be so large that problems could be much easier to detect than they are now, he said.
The problem now is that the FDA approves drugs for market on the basis of trials involving a few thousand patients -- and sometimes dangerous side effects don't show up until a prescription is widely used on the open market.
The Medicare data would cover millions of patients and thus create an important warning network.
"One of the main frustrations with Vioxx was that it was on the market for a number of years and used by millions of people, and only later was there a possible association with problems," McClellan said in an interview.
"There is a legitimate reason for the public to be concerned. In an era when we should be depending on electronic systems, it should not take five years and millions of patients before we get to a potential problem."
The FDA, however, has been noncommittal. "It really is too early," a spokeswoman said. "The agencies are exploring this possibility." The FDA declined to make senior medical officers who oversee drug safety available for interviews.
Some outside advisors to the FDA are baffled by what they see as a lack of resolve. The Medicare-based system was one of several ideas discussed at a recent FDA drug safety advisory committee meeting on ways to improve monitoring and reporting.
But after two days of deliberations, "no one at the agency was willing to say, 'OK, this is what we would like to do,' " said Dr. Curt Furberg of Wake Forest University, a member of the advisory panel.
"We thought we had some good ideas, and [using Medicare data] was one of them. It's a little bit frustrating. I really don't understand what their problem is."
The panel's chairman, Dr. Peter Gross of Hackensack University Medical Center, said he thought the Medicare proposal was a good idea, but he "didn't get the sense that [FDA officials] were latching on to it."
"It takes them a long time to come up with decisions," he added.
A large private insurer, UnitedHealth Group Inc., is already creating a monitoring system similar to the one McClellan has proposed. The UnitedHealth system could cover as many as 20 million of its patients; the Medicare plan could cover as many as 43 million people, including some of the sickest and most vulnerable, whom drug companies don't usually enroll in clinical trials.
The prospect of using Medicare to monitor drug safety has generated a buzz of interest among medical and pharmaceutical experts.
"I think it's a huge opportunity," said Dr. Raymond Woosley, vice president of the University of Arizona Health Sciences Center. "We're going to be spending billions of dollars on medications for the elderly, and we're calling it a 'benefit.' But if we don't have a way to monitor outcomes from the use of these medicines, it may not be a benefit."
Woosley, who has testified before Congress on ways to improve drug safety, said he believed the FDA would ultimately endorse the idea.
The centerpiece of the agency's current safety surveillance network is a database called the Adverse Event Reporting System. Doctors and hospitals voluntarily submit reports, and drug companies are required to pass on the ones they receive. Although the system collects about 400,000 reports a year, most experts believe it only scratches the surface.
"We don't know the true extent of underreporting, but we know it's vast," Joyce Weaver, a pharmacologist with the FDA's office of drug safety, told the advisory committee.