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FDA's method of tracking side-effects called outdated

Oct 30, 2006 | Star Ledger The Food and Drug Administration's system of tracking serious side effects of new medicines is badly outdated, health experts inside and outside the FDA said.

That critical lapse, experts said in interviews, hampers the government's ability to protect the public and is among a series of safety issues Congress is expected to debate next year, when FDA reform legislation will be on the agenda.

Under the current system, manufacturers of new drugs are required to report serious "adverse events" to the FDA within 15 days of learning about them. In 2004, the last year for which data were available, the FDA received more than 400,000 reports of suspected adverse events.

But Curt Furberg, a member of the FDA's drug safety and risk management advisory committee, estimates the reported events represent only about 10 percent of the serious side effects that occur each year, and only about 1 percent of total side effects.

"Fundamentally, it is a 1950s-era approach," said Furberg, a professor of public health sciences at Wake Forest University. "There is enormous underreporting of adverse events, which leads to delays in detecting problems, and many of the types of adverse events reported are not really relevant."

Arthur Levin, director of the Center for Medical Consumers and the consumer representative on the FDA's drug safety advisory committee, said the system is set up to "react to bad things that have already happened," and, in most cases, reacts too slowly. This explains how a once-popular medicine like Vioxx was suddenly pulled off the market two years ago because of mounting evidence it caused heart attacks and strokes.

"They are waiting for problems to come in as data, not looking proactively, and there is vast underreporting, which everyone acknowledges," Levin said. "They need to have real-time monitoring of large populations that are real users of drugs."

The FDA acknowledges it has a problem and is exploring ways to expand its limited reporting system by tapping into outside databases of large health care providers to detect patterns of drug usage and serious drug reactions. But the projects are in their infancy, and the FDA has limited resources for the task.

The FDA acknowledges it has a problem and is exploring ways to expand its limited reporting system by tapping into outside databases of large health care providers to detect patterns of drug usage and serious drug reactions. But the projects are in their infancy, and the FDA has limited resources for the task.

"Our systems for learning about new medications after they are approved have too often remained old school," FDA Deputy Commissioner Scott Gottlieb said during a speech this summer. "We need to do more to actively collect information, and not just rely on passive databases that report information sometimes months and maybe years after actual events have occurred."

Prescription medicines are approved by the FDA as safe and effective based on data from clinical studies sponsored by the drug companies. The clinical trials ordinarily involve only a few hundred to a few thousand participants.

But once a drug is on the market and used by millions of people, it is common for unexpected and sometimes serious side effects to occur. The FDA received 422,889 reports of suspected drug-related adverse events in 2004.

Most of the reports are filed by the drugmakers themselves. In addition to the requirement they report serious side effects within 15 days, manufacturers must report other problems quarterly for the first three years a drug is on the market, and annually thereafter.

Doctors, hospitals and patients can separately submit so-called adverse event reports to the FDA on a voluntary basis. But in 2004, only 21,493 reports or about 5 percent of the total came from the health-care community and patients.

David Swee, a New Brunswick family physician and chairman of the New Jersey Medical Society's council on medical services, said doctors generally have to "go out of their way" to file adverse event reports with the FDA, and "most of the time end up not reporting" because of uncertainties, their busy schedules or a belief the FDA knows about the problems.

"There is a sense it is really not worth it," Swee said.

Even when the FDA has clear evidence of serious side-effect problems, it still must negotiate with the drug companies before changes can be made in warning and prescribing labels or before a drug can be withdrawn from the market. There have been 10 drug withdrawals for safety reasons since 2000, and every year there are dozens of warning label changes.

In a report issued earlier this year, the Government Accountability Office said the adverse-event reporting system can serve a useful purpose by signaling some rare serious problems, but the FDA relies on a small staff of less than 50 pharmacists and epidemiologists to interpret the limited data.

The GAO said the FDA "cannot establish the true frequency of adverse events in the population" with the data it receives, making it "hard to establish the true magnitude of a safety problem."

"In addition, it can be difficult to attribute adverse events to particular drugs when there is a relatively high incidence rate in the population for a medical condition," the GAO said.

As an example, the GAO said the FDA staff analyzed adverse event reports of heart attacks among users of the anti-inflammatory drug Vioxx in 2001. Vioxx, made by Merck, was used to treat arthritis, which occurs frequently among older adults who also have a high rate of heart attacks and strokes. The GAO said that because of these factors, the FDA staff concluded the data was not sufficient to establish that Vioxx was causally related to the heart attacks it was seeing in the reports.

Four years later, Merck removed Vioxx from the market after follow-up studies showed a relationship between the use of the painkiller and serious cardiovascular events. Some researchers and FDA staff, however, told the GAO that previous studies supported an earlier withdrawal, but were ignored.

Brian Strom, a University of Pennsylvania professor of public health and a former member of the FDA drug safety committee, said the current reporting system generates signals that can be useful, but added that the real question is "what do you do with them and how do you follow up."

"That is where the system breaks down," said Strom.

Strom recently joined Furberg, Levin and other physicians in an Archives of Internal Medicine article that concluded the system of regulating drugs after they reach the market is in disrepair and in need of major reform. The same conclusion was reached in September in a report by the prestigious National Institute of Medicine.

The Institute of Medicine report found the FDA lacks the tools to monitor and assess the safety of newly marketed drugs; does not have the capacity or legal authority to rapidly respond to and act on safety problems that are discovered; and does not quickly or effectively communicate the appropriate information to the public.

It called for stronger enforcement powers, clearer drug-labeling requirements, limitations on advertising for new medications, mandatory post-market clinical studies by drugmakers, a large boost in funding for the agency and creation of a new entity within the FDA to gather and analyze data on medications' risks and benefits after they have been approved for market.

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