AIDS ‘Remedies’: Misguided Compassion

The Food and Drug Administration, apparently acting in response to AIDS activist pressure, has issued a decision formally permitting untested AIDS “remedies” to enter the United States. Dr. Frank Young, commissioner of the FDA, stated that he did not want to be remembered as “the commissioner that robs (AIDS victims) of hope.”

On the face of it, this would seem to be a compassionate and fair solution to a snowballing and, so far as we can see, insoluble problem of limited AIDS treatment availability. After all, what hope does the present AIDS sufferer have? The drug approval process is lengthy while the terminal course of the disease is quite short. Why not give these unfortunate AIDS sufferers any chance, proven or not, at prolonged life? There has been for some time tacit approval of the practice, as AIDS patients were allowed to hand-carry a small supply of “medications” into the country, so why not formalize the process to include mailing of these substances into the United States for “personal use”?

The answers to these questions are at once extremely simple and extremely difficult. The simplicity stems from the scientific basis for pharmaceutical regulatory policy. First, if we were interested only in the well-being of the 30,000 presently symptomatic AIDS victims, few would argue against the new FDA policy. Survival time after diagnosis averages two years; the “rapid” testing and approval of AZT, the primary treatment available for AIDS, took three years.

However, there are an estimated 1.5 million people infected with the virus, most of them asymptomatic, who will need proven and effective treatment during the next 5 to 10 years. If we set foot on the slippery slope of deregulation and interfere with the time-tested policies of drug approval that were in place before the AIDS epidemic, we condemn 1.5 million equally deserving people to a futile, catch-as-catch-can approach to AIDS treatments.

Second, despite vocal opposition and criticism of excessive governmental regulation, no other country may boast the veritable plethora of effective treatments, cures and vaccines with which we are blessed. The random, controlled, double-blind clinical trial has found an unassailable place in scientific research and development . . . because it works.

Attempts to conduct controlled studies for AIDS drugs have already been severely hindered by lack of patient compliance. Subjects of actual studies have ruined promising experiments by taking other available substances that interfered with results or by switching medications among themselves. And this occurred in an environment of relatively low availability of unapproved therapies. What is the chance of obtaining an effective controlled study when anyone can get anything anytime he or she pleases?

The difficult aspect of formulating AIDS drug-testing policy is to maintain a proper balance between compassion for the terminally ill and control of the future course of the epidemic. A historical perspective clearly indicates that expediency is the enemy of progress and that precipitous policy alteration is seldom correct. I plead with Young to reverse his decision and be remembered as the leader who saved a million lives rather than as the man who caved in to political pressure and abandoned real hope based on sound scientific principles.