Stop, You're Killing Me
By Nicholas Regush
ABCNEWS.com
The killers are cutting off blood flow to a federal agency that's entrusted with ensuring the safety and effectiveness of pharmaceuticals, medical devices and other health products, and warning the public about their potential risks.
Congress is crippling the U.S. Food and Drug Administration on behalf of powerful manufacturers who want their products rubber-stamped quickly so they can get them to market. And when some of these highly profitable, hastily evaluated products fail and people die, these same manufacturers can rest assured that the FDA will move like a snail, and sometimes not at all, to ban their further sale.
Sometimes it takes ages before the FDA even gets involved and issues warnings about a troublesome product. A classic recent example of FDA foot-dragging were the delayed warnings, in the face of mounting evidence, about the risky use of Viagra by people with certain heart problems.
Thready Pulse
But since the FDA still has some twitch left, there are occasional desperate cries from within, from employees who still care about the Public Interest. The latest example: when the Washington-based Public Citizen Health Research Group surveyed 19 FDA medical officers anonymously, they identified 27 new drugs that they believed should never have been approved. These FDA employees, who oversee drug safety reviews, attributed the risky-drug OKs to pressure from Congress and manufacturers to speed up the process.
(Only a handful of the scores of drugs approved each year are truly life-saving, giving the lie to the supposed need to speed up drug evaluation rather than carefully consider potential dangers.)
Naturally, the drug industry lit into the Public Citizen survey of FDA medical officers, calling it biased, and thus championing the FDA speed-up policies of their congressional pals whom they help to re-elect.
Risking Jobs And Lives
One product that flew through the FDA “fast-track” process was the diabetes drug Rezulin, now associated with at least 33 deaths in this country and Japan due to liver damage. There is strong medical opinion that the world could have lived without Rezulin or, at least, that its prescription should have been restricted to a small number of special cases. But due to promotional efforts by medical “product champions,” more than 1 million Americans now take Rezulin.
This week, in a two-part series, The Los Angeles Times reported that FDA senior officials dismissed the concerns of a medical reviewer who warned of strong evidence that Rezulin could cause liver damage and opposed its approval. The FDA took the reviewer off the case.
Why am I not surprised? Disputes between product reviewers and senior officials at the FDA are really old news. This agency, which bills itself as the best of its kind in the world, actually has a dubious track record. A number of government oversight reports have blasted the agency for miserably failing to do its job of protecting consumers.
Decline and Fall
In 1991, for example, a 15-member panel headed by Charles Edwards, president of Scripps Clinic and Research Foundation and a former FDA commissioner, concluded that the FDA's problems were so severe that they posed a threat to Americans' health. The panel said the FDA needed stronger enforcement powers, better management, better-trained employees, more funds, improved laboratory equipment and more authority in government.
During 12 years of Reagan and Bush, the FDA had the stuffing knocked out of it. Since the late 1970s, seizures, injunctions and prosecutions by the agency have slowed to a trickle. Its reputation was further tarnished in 1989 when some of its drug reviewers were found to have taken bribes.
By the time Dr. David Kessler settled into running the FDA, senior managers didn't even have proper records of proposed regulations: some 400 — ranging from the size of type on drug packages to standards for defibrilators — had never been acted on.
And a 1992 congressional hearing produced evidence that medical-device reviewers were often undercut or ignored when they failed to recommend approval of a product, because some managers viewed non-approvals as jeopardizing their goal — a high approval rate.
Kessler the (Anti) Hero
For much of his reign, Kessler was viewed as an American hero. Carefully orchestrated FDA media campaigns set in motion several crusades, targeting food safety violations, improper drug advertising, breast implants and tobacco. This did give some new life to the FDA, raising morale and self-confidence half a notch in dealing with certain sectors of industry, which had grown accustomed to having a freer hand.
With the help of key members of Congress, however, industry fought back, arguing that the FDA was, in effect, killing people by moving slowly on the evaluation of drugs and medical devices. This was, and still is, pure bull, but the media and the public bought it and so did numerous organizations of patients with life-threatening diseases, which, in some cases, are funded by drug manufacturers.
Now that Kessler is gone to the Ivory Tower (Yale Medical School) and the White House feeds on its political victory on tobacco and ignores a dying FDA, the agency is in the doldrums, and some of its better employees are looking elsewhere for jobs.
The FDA has a new commissioner, Dr. Jane Henney, but she's not likely to fight the big boys and girls on the Hill. At this rate, the FDA will soon become a corpse.
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