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Botulism Disaster Uncovers Fake

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					   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.

				
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