In fact, off-label prescriptions account for at least 21 percent of pharmaceutical sales, according to a 2006 analysis published in the Archives of Internal Medicine. Critics voice concerns about widespread off-label use, because drugs prescribed off-label haven't gone through rigorous review by the FDA for safety or for effectiveness.  In fact, there may be an almost complete lack of clinical evidence supporting the efficacy of an off-label application.

Dare I say it: Off-label drug usage is based almost exclusively on anecdotal evidence -- just like most herbs and nutraceuticals -- except for the fact that the FDA allows physicians to promote such usage. Physicians typically decide to try an off-label prescription after gleaning anecdotal evidence from a journal article or from talking to colleagues, and based on that information alone, they prescribe the drug for this new, untested application.
And if that's not bad enough (that the FDA applies a double standard when it comes to anecdotal evidence vis-à-vis drugs and alternative remedies), the new FDA proposal will widen the gap by making it even easier for drug manufacturers to market their products directly to physicians for unapproved off-label use. Up until now, drug companies had to submit a new application to the FDA, which would require them to go through clinical trials within three years for the off-label use. Plus, journal articles supporting an off-label application could only be used for marketing when submitted to the FDA first for review and approval.

Not any longer!

The proposed changes would lift these requirements. Pharmaceutical reps would now be able to directly hand doctors articles touting the off-label benefits of any of their products. These articles could come from any peer-reviewed journal that has a conflict-of-interest-disclosure policy -- including publications, for instance, that accept advertising dollars from particular drug manufacturers, or that publish articles written by authors with industry ties. Although the articles would have to cite evidence from studies pointing to the efficacy of the off-label use, the requirements governing where that evidence comes from are rather loosey-goosy. The Draft Guidance reads, "Publications should address adequate and well-controlled clinical investigations that are considered scientifically sound by experts with scientific training and experience." Note the vague wording… "adequate and well-controlled"?  Sure leaves a lot of wiggle room, falling far short of the industry standard of randomized controlled clinical trials.

Let's not mince words here. This is an absolute double-standard. While the FDA is willing to let pharmaceutical companies bypass clinical trials and advertise their products based on just a few months of anecdotal evidence, it grants no such leeway to the alternative health industry -- where certain remedies may have decades of anecdotal evidence to support their use.

• Think grape seed extract and cardiovascular health
• Think green tea and cancer
• Think niacin and cholesterol
• Or as luck would have it, today's announcement from the FDA banning companies from talking about the clinical evidence supporting the health benefits of tart cherries
• And on, and on, and on

Clearly what's good for the pharmaceutical goose isn't good for the nutraceutical gander, at least in the view of the FDA. I guess it pays to be connected with the pharmaceutical industry…big time.

:hc