A drug in search of a disease - Editorial - Picovir

Townsend Letter for Doctors and Patients,  June, 2002  by Alan R. Gaby

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For many years, vitamin E was disparagingly referred to as "the vitamin in search of a disease." Beginning in the 1940s, vitamin E was reported to be effective for the treatment of a wide range of health conditions, but the conventional medical community was not convinced it [vitamin E, that is] was useful for anything; ergo, the label. Today, there is reasonable scientific evidence that vitamin E is useful for the treatment of intermittent claudication, infertility, premenstrual syndrome, childhood epilepsy, and osteoarthritis, and for the prevention of cardiovascular disease and possibly some cancers. So, for vitamin E, the long search is over; it has finally found its diseases.

The story is not as bright for Picovir[R] (pleconaril), an antiviral drug developed by ViroPharma Inc. An FDA advisory panel recently unanimously (15-0) rejected the company's application to have Picovir approved as a treatment for the common cold (see Literature Review, page 30). The panel concluded that the potential risks of the drug (such as the emergence of resistant viral strains and possible drug interactions) outweighed the small beneficial effect it demonstrated against colds. To add insult to rejection, ViroPharma's stock price plunged more than 60% after the advisory panel made its recommendations. And shortly thereafter, at least two law firms filed class action lawsuits against ViroPharma on behalf of stockholders, alleging the company misrepresented the status of the FDA approval process for its drug.

According to a Wall Street Journal report, ViroPharma originally planned to test Picovir as a treatment for meningitis, but was unable to conduct the necessary research. So, instead, it tested the drug against hand, foot and mouth disease, but the results were negative. It was only then that the company switched its attention to the common cold. Despite the setback, ViroPharma has not given up. It plans to work with the FDA to determine what other studies are needed to move its drug along in the approval process. But, at least for now, Picovir remains a drug in search of a disease.

This story provides a disturbing illustration of how the drug-development process may be guided more by corporate interests than by any interest in the public welfare. Drug development has become a high-stakes game, in which a company that owns rights to a particular chemical invests millions of dollars trying to get it past the FDA into the public's mouths. In an altruistic world, the FDA advisory panel's recommendation would have persuaded the company to give up on its drug, at least as a treatment for the common cold. We already have safe treatments that work better than this drug (such as vitamin C, zinc lozenges, and echinacea). And, even if we did not, it is not at all clear that a small amount of symptom relief is worth the risk (however small) of exposing the population to mutated and potentially wicked viruses. However, investments require returns, so the company pushes on.

While the FDA has been accused in the past of being "in bed" with the pharmaceutical industry, the agency should be commended for its handling of this drug application. Nevertheless, the systemic issues that give rise to these situations still need to be addressed: namely, the patent laws and drug-approval regulations that have bred a new era of patent medicines and snake oil salesmen.

COPYRIGHT 2002 The Townsend Letter Group
COPYRIGHT 2002 Gale Group