AIDS TREATMENT NEWS No. 052 - March 11, 1988
John S. James
Ribavirin By Prescription?
Ribavirin has been available in the U.S. by prescription for some time, but the only FDA-approved use has been for aerosol treatment of respiratory syncytial virus in infants. Physicians are, however, allowed to use an approved drug for other than approved uses. (An excellent discussion of this issue appeared in the FDA Drug Bulletin Volume 12 Number 1, April 1982. It points out that gaining FDA approval for legitimate medical advances "may take time and, without the initiative of the drug manufacturer whose product is involved, may never occur. For that reason, accepted medical practice often includes drug use that is not reflected in approved drug labeling." (You can get the FDA Drug Bulletin from a Federal depository library--which can be found in most cities.)
Recently we heard from a pharmacist that he could fill prescriptions for ribavirin if the physician specified that it be used "as directed". This would be the official ribavirin, not an imitation product.
However we have not heard from anyone who has actually obtained and used the drug in this way. And according to Martin Delaney of Project Inform, ribavirin is sold onlythrough hospitals, since the aerosol treatment for infants is not suitable for home use.
If a pharmacy does have the drug, we suspect that the words "as directed" get the pharmacist off the hook, leaving the issue of prescribing ribavirin for treatment of AIDS or ARC between the physician and the FDA. And physicians as a group have long been protective of their right to practice medicine as they see fit; they have considerable political power when they use it, and when the laws were written they were careful to guard their professional sphere against intrusions. Pharmacists in this country do not have the same protections. The phrase "as directed" apparently works its magic by not giving notice to the pharmacist of the non-approved use.
Ribavirin is of course a special case, in that a state of war has developed between ICN, the manufacturer, and the FDA. ICN has not always played by the rules--rules of a game which has grown to be rigged against small to medium companies like ICN, in favor of giants like Burroughs-Wellcome. We don't know who will win this war, but tragically we do know who will lose it. No one knows for sure whether ribavirin does any good for persons with ARC or AIDS, but few could have confidence in the system currently in place for finding out.
We should add that ICN had nothing to do with our comments here, and knew nothing about them in advance. While physicians are allowed to prescribe approved drugs for non-approved uses, drug manufacturers are strictly forbidden to do anything to encourage them to do so.
And physicians have been reluctant to exercise or even discuss the rights they have--possibly from fear of losing professional flexibility if the issue came to a head. Physicians have already lost influence and freedom in the face of Federal efforts to control medical costs. The big money in medicine, which so enriched U.S. allopathic physicians by legislating rival systems out of existence earlier in the twentieth century, may turn against its beneficiaries now that bigger money is involved.
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