Nav: Home

How drug companies covertly promote off-label drug use

October 27, 2008

Off-label prescription of a drug is generally legal, but promotion of off-label uses by a drug manufacturer is illegal. In an article in this week's PLoS Medicine, two physician researchers describe the techniques that drug companies use to covertly promote off-label use, even when such promotion is illegal.

Adriane Fugh-Berman (Georgetown University Medical Center, Washington DC) and Douglas Melnick (a preventive medicine physician working in North Hollywood, California) 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, "should be undertaken with care and caution due to the uncontrolled experiment to which a patient is being subjected".

Nevertheless, drug companies have a stake in promoting such off-label use, say the authors, since increased off-label use means "larger revenues from larger user populations, especially for products with narrow indications".

Based on Dr Melnick's previous experience working in the pharmaceutical industry in medical affairs (supporting drug marketing) and both authors' current contacts within the industry, they outline some of the ways that drug companies can promote such off-label use.

One example is known as the "decoy indication".

In development, say the authors, drugs may be promising for several uses, and companies must choose one or two conditions on which to focus research. Ease of approval is the most important factor in this decision. If extensive off-label use is anticipated, a company may seek approval for just a narrow indication in order to speed a drug to market. In other words, a drug may be approved for this very narrow "decoy indication" while an extensive off-label campaign is not disclosed to drug regulators.

Another technique is to use drug representatives, even though in the US drug reps 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 Fugh-Berman and Melnick, illegal promotion may be cost-effective if potential profits trump potential fines.

Pharmaceutical marketing, they say, 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."

"Companies that engage in off-label promotion should be heavily fined and their future marketing practices subject to increased scrutiny by regulatory agencies."
-end-
Citation: Fugh-Berman A, Melnick D (2008) Off-label promotion, on-target sales. PLoS Med 5(10): e210. doi:10.1371/journal.pmed.0050210

IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE PUBLISHED PAPER: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed0050210

PRESS ONLY PREVIEW OF THE ARTICLE: http://www.plos.org/press/plme-05-10-fugh-berman.pdf

CONTACT:
Adriane Fugh-Berman
Georgetown University
Physiology and Biophysics
Box 571460
Washington, DC 20057-1460
United States of America
+1 202-467-0816
+1 202-687-7407 (fax)
ajf29@georgetown.edu

PLOS

Related Drugs Articles:

Wallflowers could lead to new drugs
Plant-derived chemicals called cardenolides - like digitoxin - have long been used to treat heart disease, and have shown potential as cancer therapies.
Bristol pioneers use of VR for designing new drugs
Researchers at the University of Bristol are pioneering the use of virtual reality (VR) as a tool to design the next generation of drug treatments.
Towards better anti-cancer drugs
The Bayreuth biochemist Dr. Claus-D. Kuhn and his research team have deciphered how the important human oncogene CDK8 is activated in cells of healthy individuals.
Separating drugs with MagLev
The composition of suspicious powders that may contain illicit drugs can be analyzed using a quick and simple method called magneto-Archimedes levitation (MagLev), according to a new study published in the journal Angewandte Chemie.
People are more likely to try drugs for the first time during the summer
American teenagers and adults are more likely to try illegal or recreational drugs for the first time in the summer, a new study shows.
Drugs used to enhance sexual experiences, especially in UK
Combining drugs with sex is common regardless of gender or sexual orientation, reveals new research by UCL and the Global Drug Survey into global trends of substance-linked sex.
Promising new drugs for old pathogen Mtb
UConn researchers are targeting a metabolic pathway, the dihydrofolate reductase pathway, crucial for amino acid synthesis to treat TB infections.
Can psychedelic drugs heal?
Many people think of psychedelics as relics from the hippie generation or something taken by ravers and music festival-goers, but they may one day be used to treat disorders ranging from social anxiety to depression, according to research presented at the annual convention of the American Psychological Association.
New uses for existing antiviral drugs
Broad-spectrum antiviral drugs work against a range of viral diseases, but developing them can be costly and time consuming.
New TB drugs possible with understanding of old antibiotic
Tuberculosis, and other life-threatening microbial diseases, could be more effectively tackled with future drugs, thanks to new research into an old antibiotic by the University of Warwick and the Francis Crick Institute.
More Drugs News and Drugs Current Events

Trending Science News

Current Coronavirus (COVID-19) News

Top Science Podcasts

We have hand picked the top science podcasts of 2020.
Now Playing: TED Radio Hour

TED Radio Wow-er
School's out, but many kids–and their parents–are still stuck at home. Let's keep learning together. Special guest Guy Raz joins Manoush for an hour packed with TED science lessons for everyone.
Now Playing: Science for the People

#565 The Great Wide Indoors
We're all spending a bit more time indoors this summer than we probably figured. But did you ever stop to think about why the places we live and work as designed the way they are? And how they could be designed better? We're talking with Emily Anthes about her new book "The Great Indoors: The Surprising Science of how Buildings Shape our Behavior, Health and Happiness".
Now Playing: Radiolab

The Third. A TED Talk.
Jad gives a TED talk about his life as a journalist and how Radiolab has evolved over the years. Here's how TED described it:How do you end a story? Host of Radiolab Jad Abumrad tells how his search for an answer led him home to the mountains of Tennessee, where he met an unexpected teacher: Dolly Parton.Jad Nicholas Abumrad is a Lebanese-American radio host, composer and producer. He is the founder of the syndicated public radio program Radiolab, which is broadcast on over 600 radio stations nationwide and is downloaded more than 120 million times a year as a podcast. He also created More Perfect, a podcast that tells the stories behind the Supreme Court's most famous decisions. And most recently, Dolly Parton's America, a nine-episode podcast exploring the life and times of the iconic country music star. Abumrad has received three Peabody Awards and was named a MacArthur Fellow in 2011.