An off-label prescription is one that a doctor has written to treat a condition that the FDA has approved it for, but is not the condition that you have. Twenty percent of all prescriptions written today are off-label prescriptions.

     For psychiatric drugs, that number increases to thirty-one percent.

     Off-label prescriptions are a way for pharmaceutical companies to increase their already outrageous profits by expanding the market beyond what the drug was originally intended for. It’s not illegal — and by those statistics it is obviously commonplace — but the practice raises one more red flag for the collusion between Big Pharma, the FDA and psychiatry.

     Surprisingly, a doctor prescribing an off-label drug is not legally obligated to get informed contest from a patient, as is the case with any on-label prescriptions. So this practice also hints at a less than perfect application of the Hippocratic Oath by a doctor to protect one’s patient.

     Drugs that are approved by the FDA have to undergo a series of clinical trials that show that the drug is safe and effective for the condition it is designed to treat. Off-label drugs do not have any such research pedigree behind them. Their effectiveness in treating a condition is often merely anecdotal…particularly with psychiatric drugs.

     A 2010 article in the The Journal of Developmental and Behavioral Pediatrics found that seventy-seven percent of pediatric antidepressant prescriptions were off-label. Because the “disorders” listed in psychiatry’s Diagnostic and Statistical Manuals are merely a description of symptoms – not physical causes — in the first place, off-label use of the antidepressants used to treat them is more prone to influence by anecdotal, unscientific conjecture.

     The FDA does prohibit the misbranding of medications, which would include the listing of off-label use for a medication, but no court has ruled that a physician must disclose through the informed consent process the potential consequences of off-label use of a drug. That too puts patients at risk.

     Most people, in fact, are unaware of the dangers of off-label prescriptions. In one 2006 poll half of all respondents believed that a drug could only be prescribed for its primary, on-label use, as approved by the FDA after successful clinical trials. Two-thirds of those polled then felt that off-label drug use should be banned except for their use in the clinical trials alone.

     A sensible viewpoint, but one not shared by the FDA.

     The number of psychiatrists who are on the advisory boards of the FDA, and who are also financially connected to and on the boards of pharmaceutical companies is not insignificant. The profit of pharmaceutical companies from off-label prescriptions because of that collusion is also not insignificant.

     In 2013, for instance, four pharmaceutical companies – Eli Lilly, GSK, Hoffman-LaRoche and Abbvie — had a profit margin greater than twenty percent. Pfizer had a profit margin of an astounding forty-two percent.

     How is it that off-label drug use — with its inherent risks undisclosed to patients through otherwise mandatory informed consent law — still accounts for twenty percent of all prescriptions written?

     Follow the money.

Archives of Internal Medicine 2006 article