Reason to Frown?
Botox is made from a very small dose of botulinum toxin, the single most poisonous substance known. The toxin comes from soil but can be ingested through food that comes in contact with contaminated dirt. The poison paralyzes muscles and may prevent victims from being able to breathe on their own.
Diagnosis and treatment of botulism can be both time-consuming and a strain on hospital resources. This is the reason why the CDC has labeled the toxin as a "Category A" substance in its list of agents of concern, says Gigi Kwik, PhD, a fellow for the Johns Hopkins Center for Civilian Biodefense Strategies. Other Category A agents include smallpox and anthrax.
The Johns Hopkins center even considers the botulinum toxin as a potential major bioweapons threat. Kwik readily points out, however, that there is an extremely tiny amount of the poison in Botox, so the chances that it could be used as a biological weapon are slim.
"Unfortunately, while you can envision all kinds of threats that come from everywhere, you have to look at something more likely," says Kwik, who notes that Botox is not the only place in the world where one could get a hold of the toxin. "Anybody who was going to make it as a weapon would have a much easier time if they weren't to use Botox."
Botox's maker, Allergan, says it takes precautions to safeguard the drug as it does with all its other products.
In terms of cosmetic use, the FDA has only approved Botox for treatment of the brow furrow, the vertical crease frequently seen between the eyebrows, but Allergan spokeswoman Christine Cassiano says the company is now in talks with the agency regarding the treatment of forehead lines and crow's feet.
Yet the company is pitching more than just facial remedies. Allergan is now completing a U.S. study on the drug's effect on stroke injuries. Research has reportedly found that Botox relaxes clenched hands and other muscles that may have been injured after a stroke. Cassiano says the medicine is approved for such use in 23 countries, including Canada and a good portion of Europe.
Canada is also one of nearly a dozen countries that has given its formal nod to use Botox for sweaty palms (palmar hyperhidrosis). U.S. studies are now under way, and Allergan expects to file for approval in mid-2003.
In earlier-stage development is work on using the drug for migraine headaches and back pain. Cassiano estimates that the company probably will not be able to file for approval for treatment of headaches until at least 2006.
Stephen Silberstein, MD, FACP, professor of neurology and director of the Thomas Jefferson University Headache Center in Philadelphia, conducted a study on the effectiveness of Botox in preventing migraine headaches. His research, published in the June 2000 issue of the journal Headache, found that Botox significantly reduced migraine frequency and severity and use of migraine medication. It also cut down on migraine-related vomiting.
"We know it's effective, but we can't predict for which patients," says Silberstein. This is why he is setting up another nationwide study on Botox and migraine headaches.
Other studies have found that Botox potentially relieves pain associated with many ailments such as serious bladder problems, hemorrhoid surgery, and cerebral palsy.