Two new articles on the issue of off-label promotion.
The first, courtesy of Bloomberg.com, is far from courteous or unbiased. Consider this quote from Jerry Avorn, a professor at Harvard Medical School and regular critic of the industry:
“Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law.”
Untrue and unfair. That’s a pretty broad brush – but Dr. Avorn has never worried about the unintended consequences of hyperbole.
The Bloomberg article continues, “The widespread off-label promotion of drugs is yet another manifestation of a health-care system that has become dysfunctional.”
That’s outside of any citation – that’s just the reporter talking. Bad journalism.
And then back to Jerry Avorn:
“It’s an unbearable cost to a system that’s going broke. We can’t even afford to pay for effective, safe therapies.”
Now the article is confusing the issue of off-label promotion with off-label use. And that’s a much clearer articulation of the article’s broader agenda.
The complete Bloomberg article can be found here.
A much better omnibus discussion of off-label promotion can be found in the November issue of Nature Biotechnology. An excerpt:
“… on October 2, Allergan, in Irvine, California, filed a lawsuit against the FDA seeking to challenge off-label regulations. Allergan contends that agency rules stop them from sharing safety information about off-label use of approved drug Botox (Clostridium botulinum toxin). The company contends that Botox is effective for as-yet unapproved uses in spasticity, and given that physicians are already using it for that purpose, it is important to communicate information to reduce the risk of adverse events. Indeed, Allergan claims the regulations violate the right to free speech under the First Amendment of the US Constitution. But it also stands to reason that if the information it seeks to communicate was in the literature, Allergan would not have needed to file the suit.”
The complete Nature Biotechnology article can be found here.
Also quoted in the Bloomberg article newbie FDA employee Peter Lurie, who makes an important point, “Most physicians don’t keep track of FDA-approved uses of drugs.”
All the more reason for a robust and expanded “safe use” program by the FDA.
Label detailing aids anyone?
