Covert Promotion Of Off-Label Drug Use

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Main Category: Pharma Industry / Biotech Industry
Also Included In: Clinical Trials / Drug Trials;  Pregnancy / Obstetrics;  Pediatrics / Children's Health
Article Date: 28 Oct 2008 - 0:00 PST

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Several techniques are often employed by drug companies to secretly promote off-label use, according to a piece released on October 27, 2008 in the open-access journal PLoS Medicine.

For most drugs, it is legal to prescribe them for off-label uses, which are not specified in the original approval of the drug. These uses are sometimes unavoidable -- for instance, most approvals do not include pregnant women, who may need medication. However, it is illegal for a drug manufacturer to promote these off-label uses, because they have not necessarily been proven effective and may have serious side effects.

Adriane Fugh-Berman, of Georgetown University Medical Center, and Douglas Melnick, a preventive medicine physician in North Hollywood, California emphasize that these off-label drug use, though "sometimes unavoidable" and sometimes "demonstrably beneficial," they add that this "should be undertaken with care and caution due to the uncontrolled experiment to which a patient is being subjected." Even so, drug companies have a potential benefit from promoting off-label use thanks to "larger revenues from larger user populations, especially for products with narrow indications."

They subsequently describe the techniques that are employed by these drug companies to covertly promote the off-label use of their drugs. One such technique is "decoy indication." In this process, drugs may be initially promising for many different uses, but companies choose a limited number of conditions on which they focus research for efficient approval of the drug. By pursuing a narrower indication, the drug may be sent to market more quickly, but this "decoy indication" simply masks the other uses from drug regulators.

Drug representatives may also pass on the information. In the United States, drug representatives are not permitted to inform doctors of off-label uses. The authors quote a pharmaceutical industry attorney in a second paper from Medical Marketing and Media: "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." That is, if the potential profits of the action overcome the potential fines, it may be worth a company's consideration. Thus, doctors and patients are often encouraged to engage in off-label use, as 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."

The authors conclude: "Companies that engage in off-label promotion should be heavily fined and their future marketing practices subject to increased scrutiny by
regulatory agencies."

Off-label promotion, on-target sales.
Fugh-Berman A, Melnick D
PLoS Med 5(10): e210.
doi:10.1371/journal.pmed.0050210
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Written by Anna Sophia McKenney
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