Most physicians and pharmacists have a secret they don’t share with patients. The FDA is in on it and so are drug companies. One out of five of the prescriptions written in this country are for unapproved uses. Some put the number much higher.
Most Americans assume that whenever their doctor prescribes a drug it has been extensively tested and proved to be both safe and effective for their condition. They’re wrong. In reality, many medications are prescribed without this supporting evidence.
When a pharmaceutical company submits a medicine to the FDA for review, it must prove that the compound works and that the benefits outweigh the risks for one particular ailment.
Once that drug receives approval for that particular indication, doctors can prescribe it for anything else, as they see fit. This is called “off-label” prescribing. The FDA does not regulate the practice of medicine, leaving doctors free to make decisions on their own.
Until now, the FDA has not allowed drug companies to promote off-label uses of their products. In fact, some manufacturers have gotten themselves into big trouble when they stepped over the line. Pfizer was slapped with a $430 million fine because it was promoting Neurontin, a drug approved to control epileptic seizures, for a range of other problems, including pain, bipolar disorder, restless legs, ALS, ADD or migraines.
Some medicines commonly prescribed for unauthorized purposes include the schizophrenia drug Risperdal for Alzheimer’s dementia; the antidepressants Prozac and Zoloft for premature ejaculation; and beta blocker heart medicines like atenolol and propranolol for stage fright.
What’s wrong with off-label prescribing? For some conditions, unauthorized prescribing may be appropriate. Without rigorous scientific studies, however, doctors have no way to evaluate the benefits and risks of unauthorized uses. It has been estimated that three quarters of the prescriptions for off-label uses are not backed up by solid evidence (Archives of Internal Medicine, May 8, 2006).
That puts patients in the position of guinea pigs. They are unwitting experimental subjects, but no one is collecting data or protecting their safety. This kind of prescribing can lead to serious adverse reactions or even death. This has happened when anti-psychotic medications are prescribed to older patients with senile dementia.
The FDA is preparing to change the rules that regulate how the pharmaceutical industry promotes off-label indications. Companies will be allowed to give doctors copies of journal articles mentioning drugs for unapproved purposes. With such a green light, manufacturers could easily overwhelm busy doctors with promotional messages about uses for which drugs have not been thoroughly tested.
Drug companies understandably emphasize the positive and downplay bad news. When two studies show contradictory findings, will sales representatives show doctors both of them? The track record is not reassuring.
More alarming, though, is the message that the FDA is sending the pharmaceutical industry. No longer will firms have to fund expensive research to prove their medicines work for off-label purposes. Without such studies patients will be even more vulnerable than they already are.
