Open Door for Unproven Drugs Is Unwise

During the 81 years of its existence, the Food and Drug Administration has been under fire from opposite quarters--those who claim it has been holding back in giving the public access to new drugs that could combat serious disease, and those who contend that it subjects the public to great risks by authorizing the use of insufficiently tested new products.

The composition of the FDA staff and the political complexion of the Administration at any given time seem to have been reflected over the years in the way the FDA has responded to these criticisms. At the moment, the tilt appears to be in favor of the pharmaceutical manufacturers. The FDA has now relaxed restrictions against the use of experimental drugs for catastrophically ill patients. The decision to take the drugs would be left mainly to the patients themselves.

In the light of the mass anxiety over AIDS and the growing clamor for the government to take a more vigorous role in combatting the disease, the new regulations are perhaps understandable--even if they are not justifiable. AIDS patients have been bitter about the ease with which supposedly helpful new medicines are made available in France and elsewhere. They blame Washington for being indifferent to their desperate needs.

Meanwhile, the demonstrated fact that the disease is leap-frogging into heterosexual society has increased pressure on the government to take dramatic action in behalf of the victims. Hence the extraordinary FDA decision to make available drugs that may be insufficiently tested--which is the only way the term “experimental” can be defined--and to give patients a much larger role than ever before in the decision about use.

With full sympathy for the plight of AIDS victims, it is nonetheless necessary to separate the political from the scientific. While it is manifestly true that the federal government has not been as innovative or as energetic as it should have been in mounting a war against AIDS, it should be equally obvious that lowering the barriers on experimental drugs is not a responsible answer. Thousands have died and many more thousands today are still paying the price for the use by expectant mothers of the experimental drug thalidomide almost a generation ago.

It was largely as a result of the Kefauver investigation into similar drug abuses that Congress in 1962 passed an act requiring that all new drugs be proved “effective” before being marketed.

Hundreds of drugs, however, that fail to meet the “effectiveness” standard are still being manufactured and sold today. Most people are unaware that enforcement procedures and practices of the FDA are absurdly inadequate.

In October, 1983, the FDA’s own report of an 11-year study showed that only one-third of the chemical ingredients used in nonprescription drugs had been proved to be safe and effective. Despite these findings, the FDA has yet to order removal of the harmful chemicals or to take the products off the market.

One of the most dramatic examples of a drug that has not advanced sufficiently beyond the experimental stage was triparanol, heralded as a magical way of reducing cholesterol levels. The drug had to be withdrawn when the evidence became incontrovertible that it caused cataracts. It later became known that one of the laboratory researchers working on triparanol had informed the FDA at an early stage that experiments on monkeys had produced eye defects.

The present widespread use of chemical additives in food for the purpose of prolonging their life on grocery shelves, or enhancing their taste or appearance, or adding to their bulk, may be a reflection of enforcement inadequacy.

Similarly, the recent revelations about the mass production of carcinogenic chicken are tied in large part to enforcement failures of the FDA. The offensive practices include injection of chemicals that increase weight rapidly, thus disturbing natural growth mechanisms.

It is against this background that many physicians are deeply troubled by the new relaxations of FDA regulations on experimental drugs. They properly fear that a wide new door is being opened through which a large number of new and possibly dangerous drugs will be unloaded on the public.

The fact that these drugs will require prescriptions does not constitute sufficient protection, as the experience with tranquilizers and other addictive drugs has demonstrated. Moreover, it is inevitable that doctors will be under fierce pressure from patients to be given exotic new medications even though the drugs may not have been adequately tested.

No drug is innocuous. A single aspirin tablet can cause internal bleeding. Physicians prescribe aspirin as a blood-thinner in order to avoid life-threatening clots. But its indiscriminate use as a pain-killer without medical advice can be hazardous.

The big need today is for greater care and restraint, not less, in the use of medications. The public needs to be educated in the fact that effective medical care does not always require drugs and that the wise physician works with the body’s own healing system and everything connected with it--and not just the prescription pad. “Our remedies,” Shakespeare wrote, “oft in themselves do lie.”

The current FDA approach may or may not be a reflection of the Administration’s policy in favor of self-policing by industry. In any case, it would be difficult to imagine a more unrealistic or irresponsible extension of such a policy than to the nation’s food and medical supplies. This is an area that calls for continuing and increasing vigilance.