Healthy Skepticism Library item: 14536

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Grogan K.
Off-label use needs more monitoring and heavy fines for offenders
PharmaTimes 2008 Oct 29
http://www.pharmatimes.com/WorldNews/article.aspx?id=14634&src=EWorldNews

Full text:

Off-label use of prescription drugs, while desirable in many cases, needs to be more carefully monitored and especially the way drugmakers get around the law to promote their products.

This is the gist of an article in the October issue of PLoS Medicine in which the authors reveal the tactics employed by companies to get their treatments for uses where there is little evidence of efficacy. The authors of the piece, Adriane Fugh-Berman of Georgetown University, Washington DC and Douglas Melnick, a physician working in North Hollywood, argue that while off-label drug use is “sometimes unavoidable” and sometimes “demonstrably beneficial,” it has also been linked with serious side effects.

Off-label drug use, they say, while legal once a drug is approved for at least one indication, “should be undertaken with care and caution due to the uncontrolled experiment to which a patient is being subjected”. Such uses should be discussed by “unbiased researchers in bona fide medical journals. Promising therapies should be tested in clinical trials. Truly useful off-label benefits of drugs will not remain a secret,” the authors add.

What is not legal of course is the promotion of off-label uses by a drug manufacturer. However, firms have a stake in promoting such use, say the authors, since it means “larger revenues from larger user populations, especially for products with narrow indications”.

In the article, the authors outline some of the ways that drug companies can promote off-label use. The first they cite is the ‘decoy indication’, where pharma firms seek approval for just a narrow indication in order to speed a drug to market. Then they may indulge in an extensive off-label campaign which “is not disclosed to drug regulators”.

Another technique involves reps, even though they are not supposed to detail doctors on off-label uses. The authors quote an article in Medical Marketing and Media in which a pharmaceutical industry attorney says: “Before engaging in off-label promotion, companies should ascertain the risk profile, safety, efficacy, and potential commercial benefits of the use-without committing that last bit to print”. In other words, say Drs Fugh-Berman and Melnick, “illegal promotion may be cost-effective if potential profits trump potential fines”.

They claim that pharmaceutical marketing has “distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown.” In conclusion, companies that engage in off-label promotion “should be heavily fined and their future marketing practices subject to increased scrutiny by regulatory agencies.”