M a y 1 5 , 2 0 0 5 • w w w. f a m i l y p r a c t i c e n e w s . c o m Practice Trends 73 Botulism Disaster Uncovers Fake Botox Market B Y B E T S Y B AT E S about half the price of Botox from TRI, af- in; but an Allergan spokesper- Los Angeles Bureau ter attending a weekend workshop or be- ing sent promotional postcards or faxes ad- son said company scientists have calculated that it may Fake Botox Timeline F our doctors, including the director of vertising “A Very Stable Clostridium have contained up to 10 mil- Early 2003: Dr. Livdahl and Dr. Karim order 3,081 oculofacial plastic surgery at the Uni- Botulinum Toxin Type A.” lion units. It is unclear vials of full-strength, raw botulinum toxin from a versity of Kentucky, have been in- In very small print, the $1,250 vials con- whether Dr. McComb used California laboratory. dicted on federal conspiracy charges in- taining 500 IU of toxin noted, “For Re- saline to dilute the product, volving mail and wire fraud and search Purposes Only Not for Human and if so, by how much. April 14, 2003: Dr. McComb's medical license is misbranding a drug in connection with Use,” according to federal documents. He and his three patients suspended in Florida for reasons relating to the what the government is calling “a scheme Assistant U.S. Attorney Carlos B. Castil- were hospitalized on ventila- prescribing of narcotics. to distribute fake Botox for use on hu- lo told FAMILY PRACTICE NEWS that physi- tors with botulinum poison- May 2003: Dr. Livdahl and Dr. Karim incorporate mans.” cians who ordered the fake Botox are be- ing and, months later, are in TRI in Tucson. At least 10 Florida physicians have also ing investigated by the Centers for Disease various stages of recovery. Dr. July 19-20, 2003: Health professionals attend had their licenses suspended or restricted Control and Prevention and the Office of McComb’s girlfriend, Alma TRI-sponsored workshop where botulinum toxin 2003 because they purchased the unapproved Criminal Investigations of the Food and “A.J.” Hall, remains hospital- type A is promoted and allegedly demonstrated. drug, said Lindsay Hodges, a spokes- Drug Administration in conjunction with ized in New Jersey; a Palm woman for the Florida Department of numerous state medical boards. Beach County, Fla., couple, Health. “This deadly toxin packaged in harmless Bonnie and Eric Kaplan, are October 2004: Cosmetic surgeon in Tennessee The network was discovered after four looking vials, wrapped in the guise of recovering at home, after notifies FDA about possible fraudulent TRI South Florida residents were hospitalized medicine, and used on unsuspecting mem- spending months in a hospi- business scheme to market a Botox-like product; in critical condition with botulism, having bers of our community represents a grave tal and a rehabilitation center. FDA investigation begins. received catastrophic amounts of im- threat,” said Marcos Daniel Jimenez, U.S. Dr. McComb had to use a properly diluted raw botulinum toxin pur- Attorney for the Southern District of walker during his arraign- Nov. 26, 2004: Dr. McComb injects himself and chased from a California laboratory. Florida in a statement. ment in federal court in Fort three others with raw botulinum toxin from the The same laboratory also supplied a A preliminary injunction halted further Lauderdale in late February same lab. All are hospitalized on ventilators Tucson, Ariz., company, Toxin Research distribution of the mock Botox in January 2005, according to the Palm within days. International (TRI), with 3,081 vials con- 2005. Beach Post. Dec. 4, 2004: Federal agents search TRI offices taining botulinum toxin type A, “in a for- The scandal came to light in late No- Also indicted were Chad in Tucson, finding marketing materials and 134 mulation designed to imitate Allergan’s vember 2004, when Bach McComb, a 47- Livdahl, N.D., and Zarah vials of botulinum toxin. 2004 Botox” Cosmetic, according to an indict- year-old Florida osteopathic physician Karim, N.D., of TRI, and Dec. 15, 2004: Federal agents begin contacting ment issued by the U.S. Attorney’s Office with a suspended medical license, inject- Robert Baker, M.D., professor physicians listed in TRI files. in the Southern District of Florida. ed himself and three others with improp- of ophthalmology, neurology, Botox is the only botulinum toxin type erly diluted amounts of raw toxin ob- and pediatrics at the Universi- A approved for use in humans in the Unit- tained directly from List Biological ty of Kentucky in Lexington. Feb. 3, 2005: Federal grand jury in Florida ed States. Laboratories, a Northern California re- The Tucson naturopaths indicts Dr. McComb, Dr. Livdahl, and Dr. Karim. At least 219 physicians and other health search laboratory. are accused of purchasing All later plead not guilty and Dr. McComb is freed professionals purchased $1.5 million worth Federal investigators believe the vial thousands of vials of botu- on bond. of the knockoff botulinum product at contained 20,000 units of botulinum tox- linum toxin that were intend- Feb. 24, 2005: Federal magistrate in Florida denies bond to Dr. Livdahl and Dr. Karim. ed for research and then mar- keting them to physicians, March 22, 2005: Dr. Baker is indicted. Feds Eyeing Sales of Unauthorized Botox presumably for human use in spite of labeling noting they March 29, 2005: Dr. Baker pleads not guilty and is released on bond. L eaders in cosmetic dermatology at the annual Hawaii dermatology reminded that if something goes wrong, you have no leg to stand on.” were research products. A fax found during a search 2005 seminar offered words of caution Because of recent cases, “the FDA of TRI headquarters ex- Sources: Media reports and documents from U.S. about the use of unapproved products and, more frighteningly, the FBI are plained to one customer that District Court, Southern District of Florida and cut-rate versions of Food and considerably more aware of the dan- she could not receive a refund Drug Administration–approved mate- gers that can occur to the American for the botulinum toxin A she rials and medications. people as a result of illegal importa- returned to the company after she discov- many physicians who attended the work- “Beware,” warned David J. Gold- tion [or use] of material,” noted ered the notation on the vials stating it was shop, bought the product, or both. berg, M.D., J.D., a dermatologist with Alastair Carruthers, M.D., who is cred- not meant for human use. Physicians from Utah and California a specialty practice in New York and ited along with his wife, Jean Car- “We must state that for legal purposes to quoted in the affidavit did not respond to New Jersey. A recent scandal in Florida ruthers, M.D., with pioneering the protect ourselves,” the fax said. “Our prod- this newspaper’s requests for comment. involving the paralysis of four patients cosmetic use of Botox. uct is simply Botulinum Toxin Type A In Florida, dermatologists, plastic sur- with an improperly diluted, unap- Dr. Carruthers, who disclosed finan- which is exactly the same as any Botulinum geons, family physicians, and a pathologist proved formulation of botulinum tox- cial ties to Allergan Inc., the manufac- Toxin Type A that you used in the past.” who performs cosmetic procedures are in type A led to a federal investigation turer of Botox, said in a later inter- Federal prosecutors say Dr. Baker pro- under investigation by state medical board of a network distributing what author- view that he thinks many physicians moted and demonstrated the product to authorities for allegedly purchasing the un- ities called “fake Botox” to physicians may be taking undue risks. “We’ve lost physicians at a 2-day workshop in Scotts- approved product and using it on patients. across the country. (See story on this sight as a group that these regulatory dale, Ariz., in July 2003. Florida Secretary of Health John O. Ag- page.) processes are there for a purpose,” said A testimonial letter distributed to physi- wunobi, M.D., issued a statement saying, Physicians face possible suspension of the Vancouver, B.C.–based dermato- cians bears his name; however, his attor- “Any practitioner that knowingly pur- their licenses following injection of pa- logic surgeon. ney has told reporters the case is one of chased unregulated products with the tients with the unapproved toxin, and “Thirty-five hundred doctors in the identity theft. intent to use on their patients should the repercussions aren’t likely to stop U.S. were using Restylane before it had A December 2004 affidavit from a special be fully investigated and disciplined there, speakers said at the meeting. FDA approval. We have to ask, why agent for the FDA’s Office of Criminal In- accordingly.” Michael H. Gold, M.D., a dermatol- are we doing this?” Now that Resty- vestigations quotes attendees of the work- “This company [TRI] skirted Florida’s ogist in a specialty practice in lane has been approved, Dr. Car- shop as saying that Dr. McComb injected regulations, placing our citizens at risk, Nashville, Tenn., noted that unap- ruthers said there is “no justification volunteers with hyaluronic acid, whereas simply to make a fast buck; even worse are proved products can be “easily ob- but greed [for bootlegging Juved- Dr. Baker demonstrated botulinum toxin these abhorrent licensed practitioners who tained” in Canada and elsewhere. “Be erm].” Black market botulinum toxin injections using the TRI product. knowingly placed their patients in harm’s careful about where you get your may pose serious risks to patients, as it A nurse who attended was quoted as way,” Dr. Agwunobi said. s products and how you do it,” he did in the Florida case. saying that Dr. Baker made it a point nev- warned his colleagues at the seminar, The SDEF and this newspaper both er to use the word “patients,” as if he were To read the complaint filed in U.S. District sponsored by the Skin Disease Educa- are wholly owned subsidiaries of avoiding it. Instead, he used the words, Court, Southern District of Florida, visit tion Foundation (SDEF). “Just be Elsevier. “When you inject your specimens.” www.usdoj.gov/usao/fls. Use search word The affidavit included comments from Botox.