Thursday, December 28, 2006

DR. FRANKENSTEIN'S CURE FOR CROW'S FEET -- BOTULISM: Analysis, Good ol' American greed -- not Islamic terror -- stoked notorious biopoisoning case

Regular readers of DD blog know the government and terror experts excel at pointing out the age of biochemical terror is coming. They insist it is only a matter of time until microorganisms or powerful biotoxins are whipped up by al Qaeda-inspired terrorists to spread mass death in the populace. As proof, they insist biochemical terror is easy to do and point to captured terrorist documents which purport to show that biopoisons, like botulinum toxin, can be created simply from dirt and cow flops or road apples.

With GlobalSecurity.Org Senior Fellow T-shirt on 24/7, DD subscribes to very little if any of these received wisdoms from the war on terror. The truth is more complicated.

The most notorious case of botulism poisoning by man-purified toxin came not from Islamist wannabes. It started life as a simple American scam, a way to make money in the poorly regulated cosmetic surgery industry. Purified research grade botulinum toxin was ordered up fresh -- piping hot, with no questions asked -- from a purifier and seller of microbial toxins and biochemical components in 2003 and 2004 by a small number of people who wished to repackage it as Botox, the FDA-approved botulinum toxin preparation produced by the pharmaceutical company, Allergan.

Botox, of course, is used to treat a number of medical conditions and is used in anti-aging salons by cosmetic surgeons. The scam involved buying purified botulinum toxin cheaply and reselling it to clients at a substantial profit. The clients, cosmetic surgeons, in turn, used it on patients.

The operation fell apart in 2004 when one doctor accidentally overadministered to himself and three patients the knock-off "Botox." Deadly botulism poisoning ensued, putting them all into hospitals. At this point, the FDA and Dept. of Justice stepped in, launching a criminal investigation into the origins and fraudulent rebranding of purified botulinum toxin, produced in California and resold through a number of shell companies based in Arizona. The eventual trial of those involved handed down a variety of guilty verdicts and prison time.

The criminal indictment in the case is lengthy but makes for fascinating reading. It is here.

Parts of this story featured prominently in the national news from Florida in 2004 and 2005. And this past November, the Journal of the American Medical Association published a report on the four botulism cases that resulted in the roll up of the operation.

However, all of the disparate and convoluted pieces of this story have not quite been woven together into a whole, a story which probably could take a thin book. DD lashes much of it together in this new story at El Reg, here.

Crib notes: The JAMA paper, while describing the botulism cases, anonymizes the perpetrator and his patients, as well as the companies involved in the case. In the Reg piece, DD names them all for you, so you can line the data up with what's in the criminal indictment of the knock-off Botox resellers.

The keenly interested should follow the links. They show the preparer of the toxin's botulism formulation and its business as a supplier to researchers and the US counter-terror industry. The purification and distribution of toxins and microorganisms of potential use in biochemical terror is monitored and regulated nationally through the Select Agent Program, a security regulatory function handled by the Centers for Disease Control.

In this case, botulinum toxin was purified and diverted for misuse in 2003-2004 not so much through the failure of technical controls on its production as through the abandoning of common sense and simple credential checking in furtherance of sales of it. No amount of rule-making and agency monitoring can remedy such things. All that can be hoped for is that such lapses remain rare.

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