Does the FDA Know Best?

A storm over providing advice on drugs

Soon after Lewis Carroll's Alice tumbles down the rabbit hole, she finds a little bottle with a label tied round its neck. Printed on it is a short, direct message: DRINK ME. Prudently, Alice looks to make sure there is no additional marking saying POISON, mindful that imbibing toxic liquids "is almost certain to disagree with you, sooner or later." Discovering none, she obeys the command--and shrinks to a height of ten inches.

Much like the unsuspecting Alice, today's patients frequently feel they are falling into a drug Wonderland. All too often the powerful pills and potions prescribed by doctors come with nothing more than the pharmacist's typed label bearing the drug's name and the unedifying command: "Take as directed." Even if the physician has provided added information in his office, it may be woefully inadequate. Given hurriedly, short on detail, with possible harmful consequences glossed over or even omitted, the instructions frequently seem to be following the hoary 16th century precept of England's Royal College of Physicians: "Let no one teach the people about medicines or even tell them the names of medicines."

Last year, under pressure from consumer groups, the Food and Drug Administration (FDA) decided to remedy such patient ignorance. It proposed that 375 prescription medications be accompanied by simply written instructional leaflets about the drugs. These patient package inserts, or PPIs, would explain, among other things, what the drug is used for, how it should be taken and for how long, its possible side effects, even how to store it. The PPIs would also include special caveats, such as warnings to avoid alcohol or certain foods and medications that could dangerously alter the drug's potency as well as certain activities, like sunbathing and driving, that might be harmful to a person taking the drug.

The idea seemed innocent enough; nonprescription over-the-counter drugs, which are generally less powerful, have long come with printed consumer information. But the FDA's proposal quickly brought a storm of controversy. Drug manufacturers are worried about legal repercussions should a drug user develop a rare side effect unmentioned in a PPI. Though the FDA figures that the cost of preparing, storing and distributing leaflets would add only an average of 6 1/4-c- to each prescription, professional groups reckon the extra tab at 22-c- to 35-c-. Pharmacists are afraid that the leaflets will provoke a rash of time-consuming questions from customers. Some say that they may be put in the uncomfortable position of seeming to second-guess the doctors. Gripes a Virginia pharmacist: "If the medical profession were doing its job, there wouldn't be a consumer need for these PPIs."

Many physicians contend that the leaflets will interfere with the doctor-patient relationship. Some contend that there are patients--for instance, some of those suffering from schizophrenia or cancer--who would be better off not knowing the precise nature of their ailments; yet they would probably be able to deduce the diagnosis from the insert. Still other doctors fear that PPIs could be seen as quasi-legal documents defining minimal standards of care, and thus expose them to more malpractice suits. Perhaps the most serious concern (shared by doctors, drug manufacturers and the FDA) is that a laundry list of possible adverse effects could scare off patients from needed medication.

Partly in response to the furor, the FDA now plans to require inserts for only ten drugs, one of them probably the popular tranquilizer Valium. FDA Commissioner Jere Goyan, a pharmacist, supports this truth-in-prescription experiment, but acknowledges that PPIs may have surprising side effects. He cites the case of a friend's wife who underwent a hysterectomy, or removal of the uterus. Later she was given a prescription for estrogen, for which the FDA has required PPIs since 1977. After reading the leaflet, she immediately wanted to stop taking the hormone. Her reason: she was afraid of developing cancer of the uterus.

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