PharmaGossip: “Inverse benefit law” explains how drug marketing undermines patient safety --- bmj.com

“Inverse benefit law” explains how drug marketing undermines patient safety

Janice Hopkins Tanne

+ Author Affiliations

¹New York

Drug companies show a clear, repeated pattern in which “drugs discovered with good science for a specific set of patients are marketed to a larger population” for whom they are less appropriate and less safe, says Howard Brody, professor and director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston.

The “inverse benefit law” was published online in the American Journal of Public Health (doi:10.2105/AJPH.2010.199844).

Dr Brody told the BMJ, “You have to be really sceptical and careful not be seduced by research findings that are apparently very valid scientifically, but if you drill down they are really industry marketing disguised as research rather than scientifically valid research . . . Scientists in [industry] laboratories never make a move without somebody from marketing being there while they’re planning their research.”

The inverse benefit law echoes Julian Tudor Hart’s “inverse care law,” which says that availability of good medical care varies inversely with the need for it in the population (Lancet 1971;i:405-12).

The inverse benefit law says that patients with the most severe symptoms or the highest level of risk will receive the greatest benefit from treatment with a drug. The risk of an adverse event, however, is spread among all people receiving the drug.

Because only a few people would receive the drug on the basis of evidence based treatment, marketing from drug companies seeks to increase the number of people who should be treated, using six mechanisms:

• Reducing the threshold for diagnosing disease, such as lowering the level for diagnosing type 2 diabetes and hypertension

• Relying on surrogate end points, such as glucose concentrations and blood pressure levels, rather than patient outcomes such as myocardial infarction, stroke, and death

• Exaggerating safety claims (so that doctors prescribed newer antipsychotics more often, for example)

• exaggerating effectiveness claims—as with cyclo-oxygenase-2 inhibitors, which were no better as analgesics than older non-steroidal anti-inflammatory drugs, had only a modestly lower risk of gastrointestinal bleeding, and were later found to raise cardiovascular risks

• creating new diseases, such as social phobia, pre-diabetes, and pre-hypertension; and

• encouraging unapproved uses—such as through continuing education campaigns, talks by physicians, and ghostwritten articles.

To counter the “inverse benefit,” Dr Brody and his coauthor, David Light of the University of Medicine and Dentistry of New Jersey, suggest that writing treatment guidelines should be restricted to groups free of commercial interest. A neutral agency such as a branch of the National Institutes of Health or the Agency for Healthcare Research and Quality should conduct drug trials and comparative effectiveness research.

Creation of “new diseases” could be lessened by restricting drug companies’ input in clinical guidelines. Marketing by drug company sales people would be reduced if most US doctors didn’t see them—but now 94% of US doctors do.

Notes

Cite this as: BMJ 2011;342:d598