Fda Faces Major Surgery But Officials Say Proposed Changes Would Imperil Public Health
Tombstones flank the grim headline: “If a murderer kills you, it’s homicide. If the FDA kills you, it’s just being cautious.”
The full-page newspaper ads are part of a campaign mounted by conservative critics to try to persuade Congress to dramatically restructure - or even dismantle - the U.S. Food and Drug Administration, saying it kills Americans by over-regulating medicine.
“This is going to be a serious effort,” said Brent Bahler of Citizens for a Sound Economy, which is dedicating a large portion of its $10 million budget to the battle. “The FDA may be doing more harm than good.”
While the agency that filters out deadly drugs and quack cures has withstood such accusations before, the unprecedented strength of the latest attacks has FDA defenders worried.
“It is very serious,” said Rep. Ron Wyden, D-Ore. “The far right is trying to work up a real frenzy out there.”
“These are inflammatory campaigns meant to terrify people into believing the government is their enemy as opposed to some organization that has protected the public from things that are clearly dangerous,” said Dr. Sidney Wolfe of the advocacy group Public Citizen.
The FDA long has walked a tightrope between critics who say it is too cautious, pointing to multiple-year delays of drug approvals, and consumer advocates who blast it as not being strict enough. But the anti-regulatory mood of the new Republican Congress - including House Speaker Newt Gingrich, a harsh FDA critic - has given FDA opponents new prominence.
Gingrich’s own Progress and Freedom Foundation is spending $500,000 to design a drug-approval process that would privatize the FDA’s job. Overseeing the project is a high-profile panel including former Department of Health and Human Services Secretary Louis Sullivan.
Other critics have spent hundreds of thousands of dollars on anti-FDA advertising, and eight conservative think tanks and activist groups hope to begin sending proposals to Congress as early as next month.
“It’s a basic question: If the government approves a drug that will start saving lives tomorrow, how many people died yesterday waiting for the government to act?” asked Sam Kazman of the Competitive Enterprise Institute.
No legislation is pending, but among critics’ suggestions are ones to allow any medical product on the market and simply label whether it is FDA-approved so patients can choose to risk taking it; force the FDA to approve drugs sold in other countries; and give industry the FDA’s job.
“We are talking about … who lives and who dies, and no unelected regulator should be allowed to have that power,” argued Washington Legal Foundation attorney Daniel Popeo.
But others say the plans are dangerous.
Wolfe points to thalidomide, which caused massive birth defects in Europe but which the FDA blocked in the United States. The FDA cites a beta blocker for heart disease that it recently blocked when it uncovered liver toxicity, prompting the manufacturer to pull the drug in Europe.
Some therapies “would leave bodies in the streets,” said FDA drug chief Dr. Robert Temple. “Europeans don’t take the position that if something’s approved in the United States, it ought to be approved there.”
The FDA also says critics are using false propaganda.
Bahler’s group charges, for example, that the FDA stops companies from revealing that aspirin helps prevent a second heart attack. In fact, companies can market aspirin on that basis to doctors - the firms merely can’t mass-advertise because daily aspirin can hurt some people, who shouldn’t self-medicate, Temple said.
The Washington Legal Foundation’s tombstone ads blame thousands of deaths on the FDA’s delay in approving drugs such as Interleukin-2 for kidney cancer and the clotbuster TPA for heart attacks. But IL-2’s manufacturer says the FDA was right to reassess the drug’s risks after it killed some patients. And the FDA notes a competing clot-buster, streptokinase, was in wide use years before TPA.
Meanwhile, the FDA says it is improving it speeded up overall drug approval 21 percent last year and quickened approval of novel drugs by almost 50 percent.
Outsiders hope Congress can strike a
balance.
“There may well be some good questions to be asked,” said Sheila Shulman, a drug expert at Tufts University.
But “it’s wise to be a little circumspect about deregulation. These are experimental drugs, … and the agency does have as its major overriding mandate protection of public health.”
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