Botox Story Illustrates Danger of Off Label Prescribing
One of my pet peeves--yes, I know, I keep peeves like a crazy old man who keeps hundreds of cats--is off label prescribing. Off label prescribing allows a drug that has been approved for efficacy and safety for one condition, to be used instead to treat a different malady for which it has never been adequately tested. I think it should be illegal as a form of human experimentation, or at the very least, patients should be told as part of informed consent that the treatment is not specifically FDA approved to treat their condition.
Admittedly, some good has come from this. But also some evil, such as this story (perhaps) illustrates of deaths associated with Botox, the drug used in cosmetic procedures to erase wrinkles:
In a public alert issued Friday, the Food and Drug Administration said Botox, along with a similar drug called Myobloc, has been linked to life-threatening symptoms such as strained breathing and severe difficulty in swallowing, which can lead to a form of pneumonia. The FDA is advising doctors to monitor patients for such reactions while it decides whether to strengthen warnings on the drugs' labels.I have always been dubious of purely cosmetic procedures figuring that even an infinitesimal risk of harm isn't worth the false look of youth. In any event, the propriety of off label prescribing needs some pondering.Many of the most serious reactions--deaths and hospitalizations--occurred among children treated for cerebral palsy-associated limb spasticity, the agency said. The drugs are not FDA-approved for that use in children or adults.
FDA-approved drugs often have off-label uses, where physicians take medications approved for one disease to treat another. This practice often benefits patients and drug manufacturers, but can increase risks...
Botox and Myobloc are each forms of a toxin produced by bacteria that can paralyze muscles and lead to botulism, a fatal food poisoning. But in small amounts, the injected toxins can calm muscle spasms. A third product, Botox Cosmetic, is FDA-approved to improve the appearance of wrinkles between the eyebrows.
Labels: Off Label Prescribing
posted by Wesley J. Smith @ 8:43 AM
4 Comments
4 Comments:
I was under the impression that use of Botox to treat spasticity in children with cerebral palsy predated its use for wrinkles. Is that not right? It surely is a much less trivial use of the drug, although if it is not safe it certainly shouldn't be used.
I take 150 mg/day of primidone, an anti-seizure drug, to manage my essential tremor. My neurologist told me that because ET is not a medical problem, only a quality-of-life issue, it doesn't get any direct research. What happens is that patients who are being treated for epilepsy or who get beta blockers for high blood pressure happen to tell their doctors that their hands don't shake anymore, and somebody puts two and two together. This is an off-label use but I would have had to find employment outside the laboratory by now if I couldn't have primidone or another drug like it. But the safety of these drugs was established prior to the off-label use. I've had to have my liver enzymes checked a few times and shouldn't stop taking primidone suddenly but that's about it.
A good friend and supporter disagrees: "Wesley, are you crazy? Off label prescribing is an inherant part of the tools that are usable within the traditional practice of medicine. John Locke engaged in off label prescribing; Thomas Sydenham engaged in off label prescribing; Benjamin Rush engaged in off label prescribing; Horatio Storer engaged in off label prescribing.
The FDA system was created to regulate the mass-production of drugs in the contemporary industrialized world-to control the ugly side of Big Business/Big Medicine and to prevent *drug companies* from trying to immorally influence physicians to give out drugs that they should not give out.
But doctos have *always* in the History of the West since about 1000 A.D. had patients who, under the knowledge of the time, had ailments that no known medical practice/drug/regimen could cure or help.
Yet, when, by past trial-and-error, an uncanny and counter-inuitive cure has proved to be just that, "a cure" for a particular patient, thereby accomplishing what his dignity demands of the physcian: the closest to being cured that he can provide, when that has happened, ALL PHYSICIANS have supported what you call "off label prescribing" or its equivalnent.
It is inherant in those circumstances that, sometimes, in the thoughtful, not capricious, *practice of
medicine* that *includes* some level of
*trial-and-error*, it is inherant in that, that doctors will prescribe from apothecaries something for patients that many saw/see as an uncanny treatment, but that *for that doctor's particular patient/s works*. To take this (somewhat-emergency) power away from doctors is to neuter part of what it is to be a doctor.
Off label prescribing, and its abuse, is already regulated/banned by the Law of Torts and its inexorable correlary: the the theory of Malpractice as an outgrowth of the theory/concept of Negligence. Off label prescribing that is not in the interests of the patient (like this Botox stuff) is probably already contrary to the common law (one of its divisions, the Law of Torts), the of all English-speaking people.
Why the hell you'd want to rip out an essential, inherant, part of the practice of medicine just because you read one bad story on Botox, which may be illegal conduct as is, is beyond me Wesley."
I don't care about the history. These are different times in which there are rules about how we treat human patients. These are different drugs that are created and tailored for very specific ailments. Off label prescribing is human experimentation. Period. At the very least, patients need to be told in informed consent that the medication hasn't been tested or approved for the ailment that is being used to treat them. If there is an indication that drug for ailment A might help ailment Z, get it into testing. Don't let doctors just decide to use it for purposes for which it was never intended or approved. Like I said, it is human experimentation. And I don't think it should be permitted, and moreover, if a drug goes very wrong when prescribed for a non approved purpose, there should be a lawsuit the size of Manhattan.
My name is Diana Lee and i would like to show you my personal experience with Botox.
I have suffered with migraines and neck pain for many years. Botox has given me my life back. I have arthritis in my neck and Botox is the ONLY thing that has given me relief.
Side Effects-
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I hope this information will be useful to others,
Diana Lee
Botox Prescription Medication
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