Opinion: Off-label drug use: Derms weigh in on role of pharmaceutical reps

May 1, 2009

If it weren't for off-label drug use, dermatologists might have no medications at all. That may be a facetious statement, but it is one commonly repeated by dermatologists. A study from Stanford University a few years ago indicated that 20 percent of all drugs were prescribed off-label, and with biologics, fillers, immunomodulators and other drugs, dermatology's percentage may be even higher.

Key Points

A study from Stanford University a few years ago indicated that 20 percent of all drugs were prescribed off-label, and with biologics, fillers, immunomodulators and other drugs, dermatology's percentage may be even higher.

Dermatologists generally are aware of off-label uses through presentations, conversations and articles from other dermatologists who have found specific uses for drugs approved by the Food and Drug Administration (FDA) for other purposes. Because of the lack of traditional scientific proof, drug manufacturers have not been permitted to market medications for off-label uses.

On Call wondered if dermatologists would consider it helpful if drug company reps were able to provide more information on off-label uses, or if doctors think it would be a bad idea to permit that type of marketing for non-approved applications.

'Clear-cut' issue

For Betty A. Hinderks Davis, M.D., in Sun City West, Ariz., the issue is clear-cut.

"Unless drug companies have done studies themselves that support the specific use of a drug, they should not be able to market it for off-label use.

"We, as dermatologists, know the mechanisms of action and the pathology of the disease and the disease processes, so if we learn, either by serendipity or in a study, that a medication works for something other than its approved use, we can apply the drug to that condition. That's done a lot," Dr. Davis tells Dermatology Times.

A practitioner of general dermatology and Mohs surgery, Dr. Davis says the problem is with simple anecdotal evidence that's not backed by any studies. "I've seen drugs that may seem to work for a number of people, but then won't work at all for others. There needs to be some evidence," she says.

Blurring the lines

Michael A. Dorman, M.D., in West Bloomfield, Mich., doesn't think additional freedom in marketing is a good idea.

"It's wonderful we learn to treat our patients with unique approaches based on the experience of our colleagues and peers, but to allow paid sales people into the fold I think actually causes more confusion.

"I have much more confidence in what respected colleagues say than drug representatives who come to my office. I take everything they say with a grain of salt," Dr. Dorman says.

On the other hand, Dr. Dorman, chief of dermatology at Huron Valley-Sinai Hospital and a clinical instructor at Wayne State University, Detroit, does think that while there should be limitations, those limits can be too restrictive.

"If I ask the rep if a drug works on a specific condition and they say they can't answer that question, that puts me in an uncomfortable situation. I would prefer they could be a bit more forthcoming.

"The problem is when you release those constraints, it's in the sales reps' best interests to promote their drug for everything, and there are some reps out there who are unscrupulous enough, or without great ethics, who would sell you the emperor's new clothes.

"At the same time, testimony from a paid physician doesn't help me either. I'd rather hear from colleagues who don't have a vested interest in the company and the sale of the drugs, but purely in helping us with adding tools to our armamentarium," Dr. Dorman says.

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