Friend or enemy?

0 Comments | Insight on the News, August 17, 1998 | by David Wagner

Is the FDA serving the public with its zealous regulation? An eclectic alliance wants to force it to loosen controls on new drugs that may be miracle cures.

The Food and Drug Administration, or FDA, was created as part of the Pure Food and Drug Act in 1906, and it grew at the intersections of two trends. One was the proliferation of "patent medicines" puffed by extravagant claims but often ineffective and sometimes harmful. The other trend was the growing conviction among political elites that America's original constitutional structure, which had no federal administrative agencies and relied on people to look after themselves through private action and local government, was inadequate for the modern world and had to be quietly overthrown through an expanding administrative state.

One of the first administrative agencies founded to protect individual citizens against bad consumer decisions (earlier agencies dealt mainly with interstate commerce and rail rates), the FDA now is being surrounded by a diverse coalition of critics. These include libertarians and antiregulatory regulars, who argue the FDA does more harm than good and is attempting a dangerous expansion of its powers, the growing alternative-medicine community (itself a diverse group of neo-hippies, independent physicians and antiestablishment right-wingers) and even AIDS activists furious about the agency's foot-dragging over alternatives to the approved AIDS "cocktail."

While this informal coalition blasts the FDA for being a stick in the mud, others attack it for sending new medicines to our shelves too quickly, leading to recent high-profile product withdrawals such as the combination of diet drugs known as "phen-fen" and the painkiller Duract.

Between these contradictory critics, the agency and its defenders on Capitol Hill maintain it is searching conscientiously for the balance between the need to bring new medicines to market and the need to protect the public.

Those who criticize the FDA for over-testing drugs also raise a separate set of issues involving bureaucratic imperialism.

Ed Hudgins, policy analyst at the libertarian Cato Institute and the new editor of its highly regarded Regulation magazine, tells Insight: "The FDA regulated a laser-light show in Las Vegas, because it interfered with air navigation. You might think that would be a matter for the Federal Aviation Administration, not the FDA, but you see, lasers are a `medical device,' even when used for public entertainment. Then there was the case where the FDA wanted to ban a kit that parents could use to test their kids for drug use. The FDA publicly stated their reasons as a fear that this kit would lead to `family discord.' Their legal mandate is safety and efficacy of foods and drugs, not federal family therapy, but they were making that claim in all seriousness until bipartisan ridicule forced them to back down."

The most serious indictment of the agency, Hudgins believes, is that it holds back treatments that could cure people now. Hudgins does not dispute that the FDA may have saved lives by keeping harmful medications off the market. But, he says, that has to be weighed against the lives lost because beneficial treatments were kept off shelves by the FDA for unreasonable periods of time.

"The incentive structure of FDA decision-makers is fatally skewed," Hudgins explains. "If they approve a drug and one person in a million dies of it, they get the blame. But if they keep it off the market and a thousand people die for lack of it, they will still be seen as just doing their job, and groups like Public Citizen will still hail them for `protecting Americans from unsafe and ineffective drugs.'" Public Citizen did not return a call from Insight asking for comment.

The wrath of the libertarian policy community pales next to that of the alternative-medicine people. Though wrongly dismissed as cranks, the advocates of vitamins, herbal remedies, homeopathy and new medicines maintain that establishment medicine has grown ossified and self-serving. The FDA has become the establishment's tool, they say, granting approval (however slowly) to the products of the big pharmaceutical companies while barring alternative therapies to the point of initiating criminal prosecutions against those who practice them.

One leader in alternative cancer therapies is Stanislaw Burzynski of Houston. "Burzynski has been the target of a 15-year war by the FDA," says Sue Blevins, a registered nurse and president of the Institute for Health Freedom. "He immigrated here from Poland -- and he has often said that, because of the FDA, he has found less freedom here than in Poland under the communists."

Burzynski is a physician and chemist who treats cancer with an experimental drug called Antineoplaston, which simply means anticancer. "He has treated patients for whom conventional therapy didn't work," writes Blevins, "and he has treated people who opted for Antineoplaston first. Many of them have gone into complete remission. None have reported any serious side effects."