Thursday, December 13, 2007

CRAZED BOTOX DOCTORS (continued): More handy with the business of botulinum toxin A than al Qaeda men

US anti-terror experts love to bang the drum about bioterrorism. One of the threats said to be faced ad nauseum is al Qaeda's potential use of the deadliest poison known to man, botox, to sicken and kill thousands.

However, no al Qaeda man has ever been caught with the capability to make the poison. And none of their voluminous electronic papers wishing for it have shown any scientific savvy in the matter.

On the other hand, unscrupulous American cosmetic surgeons have misused it for their own ends.

Last month, Houston cosmetic surgeon Gayle Rothenberg was convicted on conspiracy and fraud charges stemming from an FBI investigation into her use of lots of the botulinum A toxin not permitted for use as a drug.

The Rothenberg case is fallout from another criminal case which two Arizonans erected a front company called Toxins Research International for the purpose of buying purified botox made only for research purposes.

Chad Livdahl and Zarha Karim then repackaged and resold it around the country, at a profit, to other cosmetic surgeons as a cheap knock-off of Allergan's FDA-approved Botox. Allergan is the only company licensed to sell botulinum toxin for use in medical procedures in the US. The toxin is on the select agent list and the manufacture of it, theoretically, is tightly monitored by the US government.

You see, it just won't do for cosmetic surgeons to be running about commissioning the purification of botulinum toxin from anyone who wishes to make and sell it more cheaply than Allergan. Since they have considerable motivation -- more profit -- to do so, investigating them sequentially for the purchase and reuse of TRI's unlicensed botulinum toxin is the proper thing to do. Willy-nilly production of the toxin would be bad for national security. Very bad.

Cosmetic surgeons may not see it this way. They may be convinced Allergan is unfairly cornering the market for the drug. Your friendly neighborhood GlobalSecurity.Org Senior Fellow says that's just tough cookies.

Livdahl and Karim's Toxin Research International scam came undone when a doctor whose license to practice medicine had been revoked poisoned himself and others with a more concentrated preparation of the botulism toxin, a lot produced by List Labs of Campbell, California. List is a producer of toxins for the biodefense research effort in this country. TRI International had originally also commissioned List to manufacture the material it subsequently resold to cosmetic surgeons.

This lot of botulinum toxin A landed the defrocked doctor and his patients in hospitals with cases of life-threatening botulism. They were put on ventilators for months to keep them alive.

The ramifications of the case and technical details on it were written about for the Reg in Dr. Frankenstein's cure for aging.

Toxins Research sold a great deal of the purified biotoxin, shilled in anti-aging seminars, thus making sure law enforcement and the justice department have a long list of practitioners of cosmetic surgery to work their way through.

Gayle Rothenberg and her husband, Saul Gower, were two more on the government's list. Gower, who was business manager of Rothenberg's cosmetic surgery business, lied to the FBI during the investigation, claiming that the Toxins Research International botulinum toxin had not been used on patients who were told it was Allergan Botox.

Rothenberg and Gower started purchasing TRI's botulinum toxin when Allergan raised the prices of its FDA-approved Botox sometime in 2004, according to the criminal indictment. The doctor then used it to perform de-wrinkling procedures on patients who thought they were getting Allergan Botox. This constituted misbranding of the botulinum toxin and charges addressing this formed the basis of the indictment against them.

That criminal indictment, from March of this year, is here. (pdf)

The original complaint against Rothenberg resulted in a mistrial, caused -- according to news sources -- by a stupid or crazy juror.

The government retried the case and got a jury conviction. That document is here. (pdf)

Original news of indictments against Rothenberg and Gower.

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