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Published: Sunday, 11/28/2004

The FDA loses its luster just when we need it most

WASHINGTON - In this season of homage to food, worry over flu vaccine and nightmares over drug prices, one's thoughts fly quickly to the Food and Drug Administration.

For years, I covered the FDA as part of my consumer beat and used to prowl the dingy halls of its headquarters, poking my head into offices to talk to scientists and bureaucrats. I found some who were just marking time until retirement. But I also found many to be truly dedicated men and women, driven by a conviction that their frustration and relatively low pay compared to their industry counterparts were offset by their satisfaction that they were helping real people in real ways.

The agency has changed.

It has become politicized, marginalized, and temporized. Some think it should be vaporized.

The job of the agency is basically the same as the job journalists have - comfort the afflicted and afflict the comfortable. It is supposed to protect us from bad, ineffective, and unsafe drugs and unhealthful food. It is supposed to ride herd on new products made by giant companies to be ingested by humans.

These days FDA rules upset everyone. Companies say new drugs take too long to be approved and that the testing required is too arduous and too costly, delaying products that are approved in Europe in much less time. Consumer activists say the testing is not thorough enough. Doctors complain they are developing safer medical procedures but find getting them approved too difficult.

The FDA is one of those alphabet-soup agencies that have enormous impact on Americans, whether they realize it, but which are like sand gnats to the White House.

In 2003, when a nail gun at a construction site accidentally fired, a nearby teenager was struck in the heart by a nail and almost died. He was saved by an on-the-spot innovative technique developed by the boy's cardiologist involving stem cells from the teenager's own bone marrow. The FDA said that for the technique to be approved, years of expensive tests had to be required which the cardiologist could not afford. And even if he could, the technique could not be patented and he would never get his money back.

In 2003, when there was evidence that the plant in England used by a company making half of the flu vaccine used in the United States was dirty and had bacterial contamination, the Food and Drug Administration did not follow through to make sure the plant was cleaned up to its standards. The British government closed the plant this year and that's why there is not enough flu vaccine.

With thousands of American seniors getting prescription drugs from Canada at a fraction of the cost they would pay in the United States, the FDA has launched a fusillade against dozens of Canadian pharmacies, attacking their safety practices, even as drug makers are threatening to stop shipping their drugs to the pharmacies.

A year ago, a thousand people got sick from Hepatitis A carried on green onions and three died. Produce is regulated by the FDA. The FDA failed to issue a public health advisory for nearly two months while people in Pennsylvania were getting sick. It is widely agreed that the FDA lacks both the resources and the proper authority to monitor the safety of imported food.

After the FDA approved the use of irradiation in food to prevent bacterial contamination, Europe vehemently disagreed and banned such foods, saying the FDA did not consider studies that indicated substances formed when fat is irradiated might lead to colon cancer.

The FDA is asking companies to submit voluntary safety evaluations of bioengineered food crops that may cross-pollinate with other plants. Food-safety activists say there should be mandatory safety testing of scientifically engineered crops before they become widely available.

Earlier this month, David Graham, a drug safety reviewer for the FDA for the past 20 years, testified before a congressional hearing on Vioxx, the arthritis painkiller pulled from the market in September because of cardiovascular risks.

He testified his agency was "virtually incapable" of protecting the American public from unsafe drugs. Within days his reputation was being denounced by anonymous phone calls thought to be from FDA managers. He sought help from a group that tries to protect whistleblowers from being fired or harassed. He said he was worried about retaliation.

But the public is not worried. A new Gallup poll of 1,015 Americans finds that 70 percent are confident the FDA is doing its job.

After all, Lester Crawford, the acting commissioner of the FDA, says everything is fine.



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