| May 9, 2006
Prescribing in the absence of any evidence occurs about 15 percent of the time. (via a reader tip)
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The final comment in the article exposes the confusion (best interpretation) or the big brother control others wish to apply to the practice of medicine (more likely).
Prescribing off label is not prescribing without evidence. Most off-label uses have quite sufficient evidence of efficacy in the medical literature. One must remember what the Label represents. It is the result of the new drug application that the drug company filed with the FDA. It is costly and time consuming and necessarily an incomplete record of the drug’s efficacy and safety. The gaps are filled in over the subsequent years based on clinical experience and further clinical studies.
It is unusual for generally accepted uses of drugs off-label to be refiled with the FDA because of the expense to the patent holder. Once the clinical evidences are available and physicians are using drugs for newly legitimate purposes then why would the manufacturer spend their dollars on more clinical study and FDA filings?
Off-label prescribing can sometimes be standard care, and failing to prescribe off-label can sometimes constitute poor care. A recent example was the use of Viagra in pulmonary hypertension (the original purpose for its creation). Fail to use it in a PH child or adolescent and standar of care is breached, but it is not a labeled indication; there is however quite ample evidence that it is effective.
Off-label should never be interpreted as indicative of lacking scientific evidence. It merely means the FDA has not caught up with the pace of real medicine.
Gabapentin and Elavil are commonly used for chronic pain or neuropathic pain. I wonder, if any member of the FDA committee develop post herpetic neuralgia, if he/she would refuse Gabapentin because it is off label use.
I wonder how fast anonymous’s wife would call a plaintiff attorney when her husband kills himself while taking zoloft for premature ejaculation…
A couple of things lead to off-label uses of drugs:
1. There is an unmet need. For some conditions, there are no “on-label” drugs. Everything that we use to treat essential tremor, sometimes reasonably effectively, was never approved for treatment of essential tremor. Patients with other conditions may have been tried on everything that is approved without any benefit. This leads to trying other things, not in a random way, but with some idea of the mechanism of action of the drug. Then there is serendipity. A patient may be treated for the on-label use of a drug, but simultaneously it is noted that another condition they have is also improved — this is how treatments for tremor were discovered.
2. You will never see studies done for a new approved use of a generic drug. It costs too much, and there is no significant economic return for any drug company. This is where gabapentin (Neurontin) is at this point.
Troubling article, really. For migraine alone, there are only a handful of FDA approved preventives, yet there are over 100 different medications that headache specialists (and other physicians) use as preventives to treat migraine. Many times, a patient with migraine and another disorder is placed on a med for the other disorder and reports relief of their migraine symptoms. This is found to happen for more and more people, and then a major center decides to try the med with the main purpose of treating migraine. These centers constantly run trials to look at the efficacy of drugs that are not FDA approved to treat migraine, and in many cases, the studies are run with the purpose of getting FDA approval for more meds in this category. Topiramate is one such med that received its FDA approval recently to treat migraine.
I don’t feel the above scenario is practicing bad medicine based on anecdote rather than evidence. If these meds weren’t prescribed “off-label” as it were, then millions who have found relief from them would still be battling disabling pain. To me, it would be practicing bad medicine to deny their treatment on the basis of the reasoning that “this med is not FDA approved for migraine.”
Some insurance companies will not pay for a med if it is prescribed for an off-label use. This was one of the problems I frequently heard of when working with migraine sufferers regarding topiramate. Attaining FDA approval for migraine on that med allowed more people to utilize its treatment. (Have to throw in the cheesy disclaimer that I’m not promoting topamax here! I, personally, had an awful experience with it, but it does provide a good example for the argument above!)
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