Bootleg Botox: a new terror threat?

Take a substance that is sought all over the world for cosmetic purposes, to smooth wrinkles and make people look better. It can be produced without sophisticated equipment, doses are infinitesimal, and there is a huge commercial market.

In pure form it is also one of the deadliest poisons on Earth.

This is botulinum neurotoxin, the active ingredient in Botox. The results of a two-year investigation to be published next week by a team at the James Martin Center for Nonproliferation Studies suggest that counterfeit Botox, as well as counterfeit versions of its competitors, is cropping up around the world and could pose a serious security threat if its producers decide to sell the active ingredient to the wrong people. Writing in the June issue of Scientific American, Ken Coleman and Raymond A. Zilinskas warn that the combination of a deadly toxin, illicit producers, and high global demand for their products spells potential trouble.

They found signs that illegal Botox operations are underway, mainly in China, but also possibly in Russia and India. The producers and middlemen are often difficult to track, but they found a "substantial increase in internet vendors in the last two years." In China alone, they found 20 web sites claiming to be "certified" suppliers of the toxin and offering cosmetic products for sale. "The addresses provided on the sites often proved to be non-existent locations or small offices that appeared to be empty fronts," they write.

Often the bootleg products on the market contain some of the toxin, but in widely varying amounts. Only seven companies in the world have licenses to produce pharamceutical-grade botulinum neurotoxin for use in people. In the United States it is overseen by the Food and Drug Administration and available only by prescription.

Joby Warrick of the Washington Post wrote about the Coleman-Zilinskas investigation in January. While describing the dangers, he also pointed out that Botox, the trade name for the most common commercial formulation, owned by Allergan, is not a weapon. Each vial contains a minuscule amount of the actual toxin, which is secreted by a bacterium called Clostridium botulinum. The amount of poison in a prescribed dose is so small that a determined terrorist would have to obtain hundreds of vials to kill a person.

The FDA first approved Botox in December 1989 as an "orphan drug," those developed for rare medical conditions, for the treatment of two neurological disorders, strabismus (crossed eyes) and blepharospasm (eyelid spasms). In 2002, Botox was first approved by the FDA for cosmetic use, to treat wrinkles (glabellar lines). Since then, Botox has been approved for two additional treatments - hyperhidrosis (excess sweating) and uncontrolled contractions of the neck and shoulder muscles (cervical dystonia). In addition, Zilinskas said, many doctors use Botox for unapproved indications, such as facial spasms, vocal cord problems, and migraine headaches.

But it is not the use of Botox for such medical and cosmetic purposes that poses a security threat. Rather, it is the fact that botulinum neurotoxin, in its pure form, is "the deadliest substance known to science," according to Coleman and Zilinskas. It is grouped with the world's most lethal potential biological weapons agents, sharing "select agent" status with the pathogens that cause smallpox, anthrax and plague. How potent is it? One gram could be lethal to 14,285 people if ingested, 1.25 million people if inhaled, and 8.3 million people if injected. The toxin particles block receptors on nerve endings, silencing the nerves and paralyzing surrounding muscles.

Coleman and Zilinskas fear that terrorists may make the connection between the cosmetic uses and the deadly toxin, and find a way to produce or buy the dangerous stuff on the Internet. "As security analysts, we undertook two years ago to explore the size and nature of this illicit global trade," they write, "and have come away gravely concerned that a deadly, but once relatively inaccessible, weapons agent is now becoming as easy to get or to make as a roadside bomb."

"Manufacturing the minuscule amounts of it that are required to kill takes only equipment standard in biological laboratories worldwide," the authors write. "In less than a month, someone with the equivalent of a masters degree in biology could probably accomplish the necessary steps to produce enough toxin to cause mass casualties."

The fake Botox is cheaper than the real thing. Who buys it? The primary customers are "unscrupulous doctors and cosmetologists who buy from the illicit producers or middlemen, often via the Internet, hoping to pocket the price difference," they say.

Traditional methods to fight the problem may not work. Export controls and weapons interdiction will have limited impact on shadowy traffickers, the authors suggest, because "the commonplace materials needed make the toxin and the bacterium itself are too widespread." While legitimate manufacturers are taking steps against counterfeiting, they lack the expertise, resources, and authority required to track down and prosecute illicit Botox laboratories.

Coleman and Zilinskas suggest a different approach: as a first step, a consortium of governments, industry, and law enforcement should attempt to buy up as many samples of the illicit stuff as possible, and then rigorously analyze it, coming up with a good estimate of how many laboratories are actually out there and what they are producing. Such an effort was made in recent years to fight the counterfeiting of an anti-malaria drug in Southeast Asia. Then a more aggressive effort to stop it could be launched by individual governments where the illicit botulinum neurotoxin producers are at work.

There's a lot that's unknown about this threat. The only case of a non-state actor attempting to use the toxin was a failed effort by the Aum Shinrikyo cult in the early 1990s. But the article by Coleman and Zilinskas suggests the rise of an elusive underworld of counterfeiters and terrorists, who manufacture their toxins in non-descript laboratories and use the internet to market it around the world. Without a signature or a slogan, this face of terrorism could be terrifying, and terribly difficult to confront.

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