
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: THURSDAY, October 5, 1995                   TAG: 9510050022
SECTION: EDITORIAL                    PAGE: A-12   EDITION: METRO 
SOURCE: JOHN E. PHILPOTT
DATELINE:                                 LENGTH: Medium

THE FDA IS THE REAL CULPRIT

A SEPT. 19 article in your newspaper (``Hospitals trying to head off new unkillable supergerms'') by the Associated Press laments the problem of the growing resistance of bacteria to various antibiotics. The culprit in this very real problem are our friends and protectors at the Food and Drug Administration.

This all began in the '60s when many best-selling antibiotics were a combination of two or even more compounds. The FDA issued an edict restricting these medications on the grounds of preventing the poor consumer from overpayment. Quite simply, they said, ``if one antibiotic works, why pay for several.''

The result was that top-selling medications found themselves off the market, much to the pharmaceutical industry's dismay. The consequence of this capricious act has led to the current problem. As a college instructor of pharmacology, I consider myself qualified to explain why.

Let us assume that, say, one in a million bacteria are slightly resistant to penicillin. What that means is that penicillin, particularly if given in too small a dose or for too short a time, may allow that one bacterium to survive and to multiply. A subsequent higher dose of the same drug will once more select for that one in a million even more resistant bacterium. The ultimate consequence is a bacterium that's totally resistant to penicillin.

We now treat the patient with erythromycin. The one in a million bacterium with a partial resistance survives and starts the above sequence all over. We then wind up with a bacterium that now resists penicillin and erythromycin.

We now try something else, continually developing the so-called ``super germ'' until, like Enterococcus faecium, major pathogens resist all prescriptions. This is exactly the same method used to create biological weapons!

Let us try again. Suppose we treat the patient initially with a combination of penicillin and erythromycin. The resultant probability of an even partially resistant bacterium surviving becomes one in a million millions or, in short, almost impossible.

The most promising therapy for AIDS patients is a three-way knock-out punch to stay ahead of the mutations of the virus. This has been demonstrated in vitro. Let us hope that clinical applications prove to be as successful. Quite probably, the FDA will act, as it always does, as a barrier to such progress.

Single-drug therapy is almost a prescription for tragedy. Limiting prescriptions of vancomycin won't stop this trend from reaching Dr. Clyde Thornsberry's (director of MRL Pharmaceutical Services) deepest fears. It will only postpone the inevitable.

The FDA does not know what's good for us. If ever a governmental institution has overgrown its usefulness, it's indeed the obstructionist FDA. The medical profession and pharmaceutical companies need to have the shackles removed, so this lamentable trend comes to a halt.

John E. Philpott, of Wirtz, teaches at National Business College in Salem.

by CNB