Bogus Botox sounds wake-up call

National report - The recent Florida case of four people paralyzed by botulism after receiving massive doses of unapproved bulk botulinum toxin type A may represent the tip of the iceberg regarding bogus Botox.

"It's a problem that has been growing for probably about a year," says Michael A. C. Kane, M.D., attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital.

A frequent lecturer at academic meetings and training sessions sponsored by Allergan, the maker of Botox, Dr. Kane spoke at 40 gatherings during 2004.

Allergan's Botox is the only botulinum toxin type A product approved for human use by the U.S. Food and Drug Administration (FDA). TRI-tox and Botutox are unapproved.

Dr. Kane says the questioners were "semi-reputable people" who approached him one-on-one rather than risking repercussions during group sessions.

On the rise In 2003, FDA investigators uncovered black-market botulinum toxin shipments originating from around the globe, with China representing a hot spot. Since 2002, Allergan also has witnessed an increase in the manufacture of ersatz botulinum toxin products.

"Every time we become aware of unlicensed products - and we do monitor closely for them - we inform the appropriate federal and state authorities," says Caroline Van Hove, Allergan's senior manager, corporate communications.

Along with the previously mentioned knockoffs, Van Hove says, the company has noticed the unlicensed Chinese product Quick Star as well as Linurase (Prollenium Medical Technologies) being marketed to U.S. physicians.

"There are seminars here that brag about teaching you how to inject as well as mix your own products," adds Kenneth Beer, M.D., director, Palm Beach Esthetic Institute, and clinical instructor in dermatology, University of Miami. Family practice and OB/GYN meeting programs are rife with such seminars, while backers of these products have attempted to purchase mailing lists from medical societies.

"The other problem that is incredibly prevalent is what I call gray-market Botox," Dr. Kane says. "Pharmacies in Canada solicit U.S. physicians all the time, and I know a lot of people who buy from Canada. It's about 20 percent cheaper, but the thing with Botox is that it's got to be handled properly. There are many requirements. And once you buy not from Allergan but from some intermediary, you don't really know how it's been handled and how potent it's going to be."

This may explain why knockoff products' results don't seem to last as long as those achieved with the genuine article, and why physicians using bogus Botox often encounter dosing problems.

Four poisoned in Fla. Federal court documents released in late December assert that an osteopath based in Oakland Park, Fla., mixed and injected himself, his girlfriend and two other patients with an undiluted, highly concentrated research toxin as though it were FDA-approved Botox. A witness says the osteopath, whose license was already suspended, represented the toxin as Botox to the patients involved. However, the vial, whose manufacturer claims it contained 20,000 units of botulinum toxin (while Allergan contends the vial may have contained as many as 10 million units), was marked "not for human use."

At press time, the osteopath and two of the recipients remained paralyzed, while the fourth was able to walk with assistance.

"The important thing to keep in mind is that this is not a counterfeiting issue where a physician was using something that he thought was Botox while in reality he was using something else," Ms. Van Hove says. "The fact is that the success of Botox has unfortunately led to unethical manufacturers who are illegally exploiting the Botox brand name to make money, and thereby dispensing unlicensed, unregulated products to unscrupulous physicians who have the audacity to use such products on patients."