FDA proposes to pad drug reps’ briefcases with off-label studies
This week, the FDA issued a draft guidance that could, if adopted, change the contents of the drug rep’s briefcase. It will free up the industry to distribute studies of drugs for off-label indications. That’s a concern.
Of course, many off-label uses are medically appropriate. Once a drug is on the market, there is nothing to stop a clinician for prescribing it for any indication he or she sees fit. Providing there is good evidence to support those prescriptions, we support that. But do we really want pharmaceutical marketing mavens pumping up the volume?
Right now, drug reps are prevented from promoting drugs for off-label uses. So whatever the quality of the information they provide, we at least know that the FDA has established that this particular use of the drug has some merit.
The argument for changing the system, presumably, is that companies can play a role in “educating” doctors about peer reviewed studies. But peer review is no guarantee of quality.
As a general rule (very, very general), the most important, best-designed studies show up in first- and second-tier journals. But a slew of minor peer-reviewed rags exist to snap up the remaining vast quantity of unbelievable rubbish. We’re talking about studies that are badly designed, lacking appropriate endpoints, outcomes, comparators, randomization, blinding, follow-up, analyses and conclusions – sometimes all at once. The good news is that nobody reads most of this junk. It gets published in minor journals and serves mostly to pad out CVs and grant applications.
But what if America’s 100-thousand-or-so drug reps were to load up the trunks of their cars with these studies and start driving around, handing them out to doctors? That would be bad — especially if they were using these studies to promote off-label uses of their drugs (that is, indications that the FDA has not reviewed or approved). And yet, that is precisely what the FDA’s new draft guidance is proposing to allow.
What on earth would prompt the guardians of the nation’s drug safety system to invite industry to reach into the Pandora’s box of crap studies for unapproved uses and, well, start selling?
That’s the question that Representative Henry Waxman is asking. We await the answer.