Last week, a newly released study showed that half of all American doctors who responded to a nationwide survey say they regularly prescribe placebos to patients. This news captured a lot of media attention and elicited a round of ethical hand-wringing with many experts wondering if systematically deceiving patients by giving them placebos without telling them was right. But ironically, there is a paper out this week in Public Library of Science Journal that is getting nowhere near the same attention as the placebo study, but raises a far more serious concern: Doctors prescribing off-label medicines that may not work.
In 2001, the last year for which data is available, American physicians wrote 150 million prescriptions off-label to treat conditions for reasons other than the ones for which the drugs were approved. This represents 21 percent of all prescriptions written for 160 of the most common medications used in the United States. About three-quarters of all off-label prescriptions were written for conditions for which there was little or no scientific support to show that they worked.
The manufacturers of these drugs apparently believe the practice is ethical. In the article, two physician researchers, Dr. Adriane Fugh-Berman and Dr. Douglas Melnick, say that despite the fact that it is illegal for pharmaceutical companies to promote drugs for off-label uses, drugmakers still find ways to do so — primarily because there is so much money to be made from the practice.
Drug companies sometimes seek approval from the U.S. Food and Drug Administration for an obscure use for a new drug knowing that it is likely it will be picked up for much wider use off-label. A “decoy” indication for a rare or unusual condition may get a drug approved quickly while the company gears up a subtle campaign to suggest off-label uses for which no data has been given to the FDA.
Doctors not bound by same rules
The key to encouraging off-label use is to make sure no one working for the company suggests any such thing. But if prominent, respected physicians can be recruited to give talks for the company concerning a drug, they are free to say what they want about possible off-label uses.
Flooding medical meetings with abstracts, posters and other additions to programs that are not obviously sponsored by industry creates more buzz for possible off-label uses. These practices are so lucrative that some drug companies pursue them even at the risk of huge fines. In the past few years, Schering Plough, Cell Therapeutics, Purdue-Pharma, Cephalon and many other companies have paid billions in fines even as the practice of surreptitiously promoting off-label uses flourishes.
What we now have is a huge amount of money being spent on what are often placebos. The system for regulating off-label use is not working and needs to be toughened. And it makes sense for the next presidential administration to consider creating an agency that can serve as an independent, publicly funded source of data on the safety and efficacy of off-label use of drugs.
Until changes are made, what you really need to know from your doctors is not whether they are using placebos but whether the drugs they prescribe for you are off-label and why.