Healthy Skepticism Library item: 15564

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Nash K.
Opinion: Off-label drug use: Derms weigh in on role of pharmaceutical reps
Modern Medicine 2009 May 1
http://www.modernmedicine.com/modernmedicine/Modern+Medicine+Now/Opinion-Off-label-drug-use-Derms-weigh-in-on-role-/ArticleStandard/Article/detail/596295?contextCategoryId=40160

Full text:

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.

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.

In December 2008, however, President Bush signed a rule change that gave drug makers more flexibility in marketing products for other-than-approved 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.
Disseminating information

Robert D. Durst Jr., M.D., in Topeka, Kan., says manufacturers can disseminate information in a number of ways without drug representatives coming into the office.

“Companies have doctors present information at conferences, or have doctors report in our magazines that they’ve used a drug for a specific purpose.

“That’s not a study, but I can guarantee you that if I’m sitting in the audience and have a problem where I don’t have a good solution, when I go home, the next time I see a patient with that problem, I’m going to try that speaker’s idea,” Dr. Durst says.
In practice for 36 years, Dr. Durst says dermatologists have long used drugs in nontraditional ways, but he thinks they may be better at it now.

“I’m a dinosaur. When I started practicing in ’73, I was with people who practiced through the ’50s and ’60s. They swore by some of their treatments that really didn’t work.

“Someone quoted one time that 80 percent of the drugs dermatologists use are off-label. I would think it’s closer to 50 percent, but we do use a lot of stuff off-label.

“Now, dermatologists are among the brightest and the best, so if you’ve got a medicine that has a mechanism of action, I would guess most dermatologists can figure out from the get-go that it can be used for other things. If you don’t have a knack to figure out how to use something off-label, you’re not being a very effective dermatologist,” Dr. Durst says.

Drawbacks

Deborah A. Englert, M.D., a solo practitioner in Sparks Glencoe, Md., sees drawbacks for marketing drugs off-label for both physicians and the drug companies.

“We, as physicians, are well-equipped to make those decisions on our own. We do not need yet another reason for pharmaceutical reps to come into our office and detail us. We don’t have enough time. They have a hard enough time getting their points across for uses the drugs are approved for,” she says.

“But I also think that if companies start marketing medications without having placebo-controlled trials to back up their reports, the lawyers will have a field day, and that marketing will actually be a liability for them.”

Dr. Englert has a special interest in psoriasis, so she is highly aware of off-label uses.

“But we want to have good, evidence-based medicine to base our clinical judgment on, not just some anecdotal report on some doctor down the road. You could make claims about anything.

“We use biologics off-label, but there are plenty of case reports in the literature that support those uses, and physicians will discuss that information at a lecture or academy meeting. There are plenty of forums where we can have those discussions with other doctors; we don’t need to have it with people who don’t have medical training,” she says.

Flexibility

In Syracuse, N.Y., Lewis A. Dubroff, M.D., doesn’t think doctors should be getting their drug information from company representatives in the first place, but he acknowledges that some doctors do.

Consequently, he doesn’t think it’s a bad idea for reps to have more flexibility in marketing drugs for off-label uses.

“It’s part of a dialogue. I don’t rely on reps’ information, but it’s a discussion with other people which leads to further discussion with other colleagues.

“Drug reps are moderators. They hear what we say and pass it on to the next person. They’re the beginning of the chain letter. We should be smart enough to evaluate what the reps say,” Dr. Dubroff says.

Although many dermatologists are aware of many common off-label drug uses, Dr. Dubroff, a practitioner for 31 years, says there are off-label uses of which doctors aren’t aware.

“We have orphan diseases where there are no approved drugs because the market isn’t big enough to support research. Over the years, I’ve proved that some drugs do have an effect, and the drug rep should be able to talk about these uses because we have a lot of inexperienced dermatologists who haven’t seen these conditions.

“If the drug reps can further the dialogue on some of these less common orphan diseases and doctors can try the off-label drugs, we can go from anecdotal to experiential reports, and that can move these medications through the process faster,” Dr. Dubroff says.

“So, I think there is a place for more relaxed regulations on the marketing,” he adds.