We Americans are a feisty, independent lot. We don't like to be told what to read, where to pray, or how to bring up our kids. We even resent efforts to make us safer or healthier when those efforts diminish our freedom. And certainly when we're sick, we want to have the final say about our care without hindrance from laws ruling particular treatments out of bounds.
But however much we may want this freedom, we do not at present have it. For what appear to be the very best of reasons, our government currently determines which medical devices may be used and which may not, whether or not a particular drug may be sold, and even the specific illnesses for which a drug may be prescribed.
This system has had its share of successes. Thanks to the vigilance of a Food and Drug Administration scientist, Frances O. Kelsey, backed by a rigorous drug approval process, Americans did not suffer the epidemic of thalidomide-caused birth defects -- missing or malformed limbs -- experienced by western Europeans in the early 1960s.
Other achievements have been less dramatic but not less important. Our regulatory standards, for example, have undoubtedly influenced manufacturers to test drugs more carefully before attempting to market them. Many large-scale tragedies may have been averted in this way, though such successes remain invisible.
But however great its rewards, drug regulation exacts a price, and that price is our freedom of choice. The drug an American takes in Europe and comes to rely upon to relieve menstrual cramps or allergy symptoms may not be available here. Perhaps it will be approved next year or the year after -- our system is often slow -- or perhaps it will be found unsafe or ineffective and rejected. Meanwhile, a patient who wants the drug will have to choose between importing it illicitly or doing without. And if the drug fails to win approval, it will of course remain unavailable -- even to those who would like to have it regardless.
The situation is particularly poignant in the case of purported cancer cures such as laetrile. Despite the repeated failure of efforts to show that the apricot pit extract combats cancer, and notwithstanding numerous pronouncements by scientists to this effect, a small proportion of cancer victims continues to believe that laetrile offers them salvation. Understandably, they will go to almost any lengths to obtain the subtance they believe will keep them alive, and our present system causes them to go to considerable lengths -- to travel to Mexico, for example, despite their often debilitated conditions.
Until recently, some AIDS victims, too, were forced to journey to Mexico because a drug they believed offered them help was unavailable here.
Clearly, then, our drug regulatory system poses problems. But is there a reasonable alternative? If regulation were abandoned and availability became a strictly economic question, some good new drugs might quickly come on the market, but many questionable ones might, too. Neither doctor, pharmacist nor patient could continue to enjoy the degree of confidence in new drugs that they have at present. And in the case of a substance like laetrile, making it as available as penicillin would surely lull some members of the public into believing it equally safe and effective. It is unreasonable to expect untrained individuals to wend their way through the minefields of medicine without assistance and unrealistic to expect that those they consult will all be qualified and responsible.
Thus, some form of drug regulation by the government seems highly desirable. The challenge is to reconcile such regulation with patients' and medical professionals' legitimate desire for autonomy.
One arrangement that could meet this challenge would be the establishment by law of special stores whose only business would be to sell drugs, medical devices and other regulated products that have not received government approval but are not considered highly dangerous. This approach would make unapproved items available to those who really want them, while avoiding the problems that would be created by selling such products in the general marketplace.
The special stores would, of course, serve adults only. They would be clearly marked, government-run, and staffed by personnel qualified to explain the properties and hazards of each item stocked. Descriptive literature would also be made available. Finally, customers would be required to sign a release before making their purchases.
Because of these safeguards, there is every reason to believe that patrons of "disapproved drug stores" would be informed and aware in their decision-making. This is not to say that their decisions would necessarily be wise; on the contrary, it seems likely that many of them would be foolish. But freedom, by its very nature, implies the right to make foolish decisions.
In addition to enhancing freedom, for unapproved substances would lessen political pressure on regulators seeking to ban popular but possibly harmful items such as saccharin. These substances could then be more easily eliminated from the general marketplace, where consumers, including children, may buy them without realizing the hazards involved.
Establishing outlets for unapproved products won't solve all the problems raised by the need to safeguard consumers in a free society. But the arrangement could constitute a significant first step toward reconciling Americans' desire for safety with their yearning for autonomy.