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Prescribing drugs ‘off-label’: an ethical prescription

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More than one in five of the prescriptions U.S. doctors write for 160 common drugs is for a use other than that approved by the Food and Drug Administration. The practice is perfectly legal, though patients are largely in the dark about what ‘indications’ or uses the FDA has approved for different prescription medications. (You can, however, always check the FDA-approved product labels for a prescription drug here.).

These ‘off-label uses’ have not been scrutinized by the FDA for safety and effectiveness. It’s not legal for drug companies actively to promote a drug for ‘off-label’ purposes. But the practice means big money for drug makers, and some do it anyway (just last month, Pfizer agreed to plead guilty to promoting off-label uses for some of its medications and was fined $2.3 billion by the Justice Department, according to the Justice Department website).

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So, while it’s legal, the practice is controversial.

That leaves doctors, who often feel immense pressure to offer something--anything--to relieve a patient’s suffering, in uncharted ethical waters. In some cases, the ‘off-label’ use of a drug might be just the treatment the patient needed. But it might just as likely be a waste of time and money--or worse, pose unpredictable dangers to the patient. When ‘everybody’s doing it’ (and, yes, even physicians say stuff like that sometimes), what’s a physician to do?

In a commentary in the latest issue of Archives of Internal Medicine, three writers from the National Institutes of Health make it pretty simple: do a little research before writing off-label; think twice before offering something that’s new to the market, carries risks of dangerous side effects or is very expensive; in most cases, acknowledge uncertainties to the patient; and share what you’ve learned with other doctors, especially if the patient did poorly on the medication.

In some cases, a welter of clinical trials has established the safety and effectiveness of a drug’s off-label use, and professional societies have recommended the practice: Though the FDA has never approved the use of beta blockers for congestive heart failure, for instance, they are formally acknowledged by cardiology groups as standard in the treatment of the condition.

When there’s not a lot of evidence, when the drug in question has been in wide use for less than three to five years or when the drug is being prescribed quite differently from its FDA-approved use (at higher doses, for longer times, or as part of a cocktail of drugs, for instance), a doctor should consider the treatment ‘suppositional,’ write the commentators. And in those cases, a doctor should tell a patient explicitly why she is proposing the drug, what the medical community knows about the risks of its use and what alternatives exist (and you can look here for a list of drug therapies the FDA has approved for various common conditions).

Finally, whenever a doctor prescribes a drug off-label without solid evidence that it works, he has a responsibility to help build a body of evidence about the drug’s safety and effectiveness. If it proves ineffective or the patient suffers notable side effects, the physician should make a report to the FDA’s MedWatch system, the NIH writers assert. Beyond that, physicians should press drug makers, their specialty associations and the FDA to organize registries that track how well a drug fares in off-label treatments.

-- Melissa Healy

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