Tuesday, January 24, 2006

Botox fatwa! 

Malaysian clerical authorities are apparently struggling with the permissibility of Botox:
The National Fatwa Council is yet to determine whether substances used in Botox injections, commonly used for cosmetic treatment, are halal, or acceptable for use by Muslims, the Bernama news agency reported.

The council's chairman, Shukor Husin, said the organisation was still awaiting a report on Botulinum toxin type A, commercially known as Botox. He said the techniques used to inject Botox into the body also needed to be scrutinised to see whether they constituted plastic surgery, which is generally prohibited in Islam.

"We understand that the substance is used for medical purposes and based on that, as of today, we stand by the principle that since it was for medical use, it is okay to use it," Dr Shukor said. "What needs to be looked into is the scope of its use that has expanded from medical to cosmetic purposes."

The fatwa council is struggling with the same question that has long bothered American regulators: under our regulatory regime, at least, once a drug or device is approved for one use, there is nothing to stop a doctor from prescribing it for other, unapproved uses. In the United States, Botox was originally approved for eye muscle disorders and cervical distonia (a neurological disorder that causes neck and shoulder muscles to contract). The product, which is the toxin secreted by the bug that causes botulism, relaxes muscles. Unrelaxed muscles cause wrinkles, so plastic surgeons started using it "off label" to make their patients look younger. Eventually, the FDA cleared the drug for the single cosmetic purpose of improving the appearance of the frown lines between the eyebrows. With that one narrow cosmetic indication Allergan was free to pitch the drug to plastic surgeons, who have used it to smooth wrinkles in all sort of places.

Next up: Botox seems to have a huge impact on migraine headaches. Rumor has it that the drug is on track for approval for that indication within the next couple of years. Some plastic surgeons will inject it for that "off-label" purpose now, but the indication will vastly increase the market because the manufacturer will be able to advertise it for that purpose and will have a reason to call on physicians who more typically treat patients with migraines.

Of course, the next question for the fatwa council is this: if a woman who suffers from migraines gets Botox injections that also happen to smooth her wrinkles, does that cosmetic byproduct vitiate the original medical purpose of the procedure?


By Blogger Mycroft, at Tue Jan 24, 11:11:00 PM:

Lobotomies also cure migraines, I hear.  

By Blogger TigerHawk, at Wed Jan 25, 06:27:00 AM:

Actually, Botox really seems to work. I'd known about this application for a long time, and Monday I met somebody whose wife has benefited from it -- since her plastic surgeon has been injecting her, no migraines.  

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