The "Off-Label" Paradox

We MedEd providers are truly facing a programming dilemma. How can one provide state-of-the-art medicine and information while fearing presentation of "off-label" indications?

Twenty years ago, prior to this extensive questioning of "off-label" concerns, Projects In Knowledge, the MedEd firm I'm founder and president of, conducted a non-accredited tele-symposium on a certain cancer disease state.

Our recruitment rate was terrible and the event itself was let's just say, not a showstopper.

At the end of the program, in our post-conference with the faculty, we discussed the disappointing news on attendance. The entire faculty had the same response, "we are not surprised." The faculty (which had expressed its concern early on) went on to discuss that by limiting the discussion to "on-label" indications we portrayed the program, and in fact the faculty, as not knowledgeable of the state of the art in cancer treatment. The key problem, the medications discussed were never prescribed as labeled by the manufacturer. Our audience was not served and moreover the patient was not benefiting from the training of the physician specialty we were targeting.

"Off-Label" has become the most feared term in MedEd. Science, of which medicine is an art form, is about exploring, investigation and trying out new therapies based on reputable and well-documented research. Much of what was once "off-label" has become “on-label”.

"Pharma funding juxtaposed with an off-label activity to many means a promotional workaround and a significant marketing opportunity for Pharma."

So what to do?

If the "off-label" indications are truly the state-of-the-art they must be backed by evidence. The faculty must stand behind their representations. Projects In Knowledge has insisted and documented faculties' framing of "off-label" discussions. Following documentation and confirmation of the evidence, MedEd must follow the thread of the "off-label" story throughout the presentation. Is it heavy-handed, demanding and far-reaching, or is it balanced against approved therapies? “Off-label” must be clearly indicated and use instructions illustrated. Ultimately, again and again the question of the science and the benefit to a positive patient outcome must be answered while creating the content.

As in the earlier example of our cancer tele-symposium, if the specialty can see that the activity has no value because the state of the art is not being discussed, no one has been positively served.

MedEd must take a leadership position here, not because Pharma funders are not served but because the profession of medicine is underserved. Surely we can create an environment through documentation and fair balance that shows that good medicine has been taught and that we observed the first principal of good clinical practice “first do no harm."

Comments

[Richard Veryard]

You describe some of the difficulties involved in disseminating Off-Label research data. There are clearly some potential conflicts of interest, and doubtless sometimes there is natural suspicion of the motives of the drug companies.

In another post, you quote your mother's physician as saying "Often the drug companies will under-dose their labeling to get it through the FDA." Does this mean the physician has some other way of finding out an appropriate dose, or is it all done by trial and error?

If the official channels are blocked or sticky, how does the medical community share practical knowledge about Off-Label. Is this partly done by unofficial samizdat and word-of-mouth?