Recently, the Archives of Internal Medicine published an article about the off-label prescribing of drugs by physicians (see “Off-label Prescribing Among Office-Based Physicians“). Here’s the data:
In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (P
First, we as an industry cannot act shocked and claim that off-label promotion is not part of a company’s sales strategy when all indicators and behaviors point to off-label promotion as being a viable strategy.
Second, many pharmaceutical products’ first “approved” indication was not what the compound was originally designated for. Nitrogen oxide research that led to the erectile dysfunction blockbusters were originally meant to generate cardiovascular blockbusters. It just so happened that as scientific serendipity goes, sometimes the industry creates a new class of blockbusters – in this case – lifestyle blockbusters. Off-label prescription often has a scientific origin, albeit poor scientific evidence.
Finally, physicians had always regarded off-label prescribing as their “right” as licensed clinical professionals. Off-label presciption is not just an industry marketing problem: this involves physician behaviors and medical community’s sense of expert entitlement.
What, exactly, ws the “problem” of off-label prescribing? Specialist physicians pay far less attention to labeling than do primary care physicians. Are specialists less informed than generalists? Sure, there are abuses, and companies do sometimes promote off-label based on flimsy data. On the flip side, labeling authorized by the FDA often is behind the frontiers of medicine.
As with your recent blog about the NEJM, when one looks very closely, all parties are likely to have less than pure motives for their publicly held positions.
If you read my blog carefully, you won’t see me saying anything against off-label prescribing. I don’t even think the word “problem” appears in this post.
The issue I discuss is about off-label PROMOTION — soecifically, ILLEGAL off-label promotion — by pharmaceutical companies.
Appreciate your blog,mental health consumers are the least capable of self advocacy,my doctors made me take zyprexa for 4 years which was ineffective for my symptoms.I now have a victims support page against Eli Lilly for it’s Zyprexa product causing my diabetes.–Daniel Haszard http://www.zyprexa-victims.com
Is anyone aware of Pfizer encouraging its sales reps to promote Viagra off label?
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