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FDA'S Sad Slide: Warnings Went Unheeded

Dec 18, 2004 | Newsday

An Authentic American Hero.

When I last interviewed Dr. Frances O. Kelsey 10 years ago, she was 80, the director of the Office of Scientific Investigations for the Food and Drug Administration, and an authentic American hero. She had a warning for those who were about to weaken the FDA: "Let's not go backwards. We've seen enough tragedy."

What has happened since to the once-proud, independent FDA is tragedy enough for the millions who depend on safe, effective and reasonably priced medicines. But its recent record of anti-consumer malfeasance its campaign to prevent the purchase of cheaper and safe Canadian drugs, the shortage of flu vaccine and the failure to act on the deadly dangers of Vioxx has posed a particular risk to older Americans.

Kelsey knew what she was talking about in 1995, for during more than 60 years as a physician and pharmacologist, she helped remove or keep from druggists' shelves medicines that were worthless or, worse, that maimed and killed.

In 1961, Kelsey fought off criticism within the FDA and pressure from a large American drug company. She refused to grant the company a U.S. license to market a sleeping pill widely used by women in Europe to relieve morning sickness during the early stages of pregnancy. Kelsey had read about disturbing reports of the pill's side effects on fetuses and stopped the drug from coming to the U.S. market.

The drug was thalidomide. Women who took the pill in the early stages of pregnancy gave birth to more than 5,000 deformed babies, most in Germany and Britain. A few were born in the United States to mothers who had gotten the drug from abroad. But Kelsey and the FDA saved thousands of American families from grief. President John F. Kennedy gave her a medal and signed legislation strengthening the FDA.

Kelsey, now retired, personified what the American public then thought of the FDA.

It was the gold standard of trustworthiness, both for the patient and the prescribing physician. Even drug manufacturers impatient with the long process coveted FDA approval, for it meant their drugs were safest; American drugs were the safest in the world.

Lately, however, the FDA's credibility has fallen on hard times. According to a recent CNN-USA Today-Gallup Poll, nearly 40 percent of 1,015 adult respondents said their confidence in the FDA has slipped during the past year. The reason: the FDA failed to anticipate the need for flu vaccine, and the United States was forced to get the vaccine from abroad. At the same time that the agency OK'd emergency importation of flu vaccine from Canada and Germany, saying it was sure the vaccine was safe, the FDA joined U.S. drug companies in warning against the purchase of Canadian drugs, which were made in the United States.

Then came the alarm over Vioxx.

Then came the alarm over Vioxx, and evidence that its manufacturer, Merck, had known for years of studies showing the drug had caused strokes and heart attacks that killed 55,000 Americans. It was pulled from the market, belatedly, by Merck but not the FDA. And at a Senate Finance Committee hearing chaired by Sen. Charles Grassley (R-Iowa), Dr. David Graham, deputy director of the FDA Office of Drug Safety, blasted the FDA for failing to force Merck to withdraw the drug sooner.

Graham told the committee that Merck and the FDA ignored or minimized reports on Vioxx's problems. He said the FDA now sees drug companies as "clients," and is therefore "incapable of protecting America from another Vioxx." He cited other drugs he deemed unsafe or ineffective, including Bextra, Crestor, Meridia, Serevent and Accutane.

FDA officials tried to prevent his testimony, then rejected his criticisms and threatened to force him out of his job. Their denials were included on the agency's Web site, but not his testimony.

Grassley warned the agency against any reprisal and said it had failed in its role as "public watchdog." How did it come to this? Kelsey's warning in 1995 came in response to a campaign led by the new Republican majority in the House of Representatives, and Speaker Newt Gingrich, to strip the FDA of some of its powers. Gingrich had called the FDA the country's "number one job killer" and criticized its aggressive director, David Kessler (a Republican) as a "bully and a thug" for holding up approval of a number of potentially beneficial and profitable drugs.

The campaign was spearheaded by the Progress & Freedom Foundation, run by Gingrich associate Jeffrey Eisenach, and funded by the drug industry, including Bristol-Myers Squibb, Eli Lilly, Glaxo and Marion Merrell Dow. Its stated aim was to loosen the FDA drug approval process to avoid delays. But the Eisenach-Gingrich plan called for turning over much of the approval process to private contractors, paid by drug companies to test their drugs.

FDA spokesman Jim O'Hara said at the time that such a plan would "dismantle many of agency's safeguards that protect the public" adding: "This is basically a proposal that says public health and safety are commodities for the marketplace." Indeed, the Progress & Freedom Foundation and the new Republican House leadership held that the marketplace, not government, could best handle drug approval and safety.

In the decade since, Congress has gradually freed the drug companies from the restrictions of regulation. In turn, the drug companies have spent tens of millions on their allies in Congress. Now, drug companies virtually control the review process, compromising even universities that get fat fees for reviewing drugs. The drug companies reap the benefits of government-sponsored research. They have been permitted to use gimmicks to extend patents on moneymaking brand names. And they have been permitted to spend billions in direct-to-consumer advertising, the better to keep prices high.

Gingrich and company are gone. The drug approval process is certainly faster. But there are consequences. Ask the victims of Vioxx.

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