FDA must be made to do its job

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Editorial

 

Article Last Updated: 11/28/2004 11:46:24 AM

http://www.insidebayarea.com/timesstar/ci_2475769

The Alameda Times-Star

 

FDA must be made to do its job

 

A20-YEAR veteran of federal drug safety wars sent shock waves through the

Food and Drug Administration and the pharmaceutical industry when he told

a Senate hearing that regulators are " incapable of protecting America

against another Vioxx. "

 

Dr. David Graham, associate director of the Office of Drug Safety at the

FDA, said, " We are faced with what may be the single greatest drug safety

catastrophe in the history of this country or ... the world. "

 

To emphasize his point, Graham named five other prescription medications

he says should be withdrawn or restricted because of side effects:

cholesterol-lowering drug Crestor, acne medication Accutane, weight-loss

drug Meridia, painkiller Bestra and asthma medication Serevent.

 

Days later, the Journal of the American Medical Association echoed

Graham's conclusions and a recommendation by Sen. Chuck Grassley, R-Iowa,

chair of the powerful Senate Finance Committee, who said an independent

board of drug safety might be needed to review medications after they

receive FDA approval and are marketed.

 

The journal said conflicts of interest among pharmaceutical industry

researchers have suppressed unfavorable drug studies and that the FDA has

failed to respond. Thus, a separate agency is needed to monitor products

after they hit the market: " It is unreasonable to expect that the same

agency that was responsible for approval of drug licensing and labeling

would also ... actively seek evidence to prove itself wrong. "

 

Merck & Co., the manufacturer of Vioxx, withdrew it in September after a

three-year trial found it doubled the risk of heart attacks and strokes.

It had been on the market since 1999. But critics say there were a " lot of

red flags " beforehand indicating that it posed risks.

 

Twenty million Americans had taken Vioxx for such ailments as arthritis.

Two million were taking it at the time of the recall. Graham estimates

between 88,000 and 139,000 Americans may have had heart attacks or strokes

because of Vioxx and that 30 percent to 40 percent possibly died.

 

Dr. Drummond Rennie, professor of medicine at the University of California,

San Francisco, says the FDA has become " a tool of the pharmaceutical

industry it is supposed to regulate. " But there may be alternatives to

creating another layer of bureaucracy to monitor drugs on the market. Part

of the problem may be that tests are not extensive enough to detect

long-term effects.

 

This possibility is reflected by an increase in drug recalls since the

Prescription Drug User Fee Act of 1992 was passed to counter criticism

that the approval process was too slow. By charging companies user fees,

the FDA was able to cut the time in half — from 27 to 14 months. But the

drug recall rate trebled, going from 1.6 percent to 5.4 percent in four

years. That might not be a coincidence.

 

Testing and approving medicines to make sure they're safe is the FDA's top

task. Rather than add bureaucracy, would we be better off reforming the

FDA itself, reinforcing the goal of putting public safety first when

testing and approving drugs? Haste may be deadly. Perhaps longer tests

periods and more intense post-release observation are needed.

 

That is an option the House Energy and Commerce Committee, which has

jurisdiction over public health, should consider as it looks at what went

wrong with Vioxx. Congress can seek changes in how the FDA operates.

Making the agency do its job better, more thoroughly, should be the first

option. If that doesn't work, then consider forming another agency.

 

One thing is certain: We can't let current shortcomings at FDA continue.

It's too soon, however, to add another layer to the review process.

First, Congress, Health and Human Services and other relevant government

arms should determine the FDA's culpability and make it do its job. If

that doesn't work, find another way.