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19 subpoenas issued as botulism probe focuses on improper sales
State prosecutors on Thursday subpoenaed documents from an Oakland Park clinic and four Arizona companies as part of their criminal investigation of how four South Floridians got botulism poisoning from injections of what is thought to be an unapproved anti-wrinkle treatment.
The state Attorney General's Office is trying to find out who was buying botulinum toxin from the Arizona companies, who they were trying to sell it to, and how much customers were paying, according to the subpoenas issued Thursday.
"Who knows how widespread this is," said Attorney General Charlie Crist. "We don't want to alarm people but we want to ensure that they are safe. We are trying to track down this problem and find out where this product was distributed."
The targets of the 19 subpoenas include people associated with Advanced Integrated Medical Center in Oakland Park, and four companies in Arizona. The companies, Z Spa Inc.; Powderz Inc.; Powderz Medical Apothecary; and Toxin Research International Inc. and their registered agents, Chad Livdahl and Karim Zahra, have until Dec. 27 to turn over the documents.
Investigators said in federal court documents that they think one of the companies, Toxic Research International Inc., illegally shipped to the clinic a botulinum toxin that is not intended for human use, with intent to defraud and mislead, and in the expectation that it would be used in humans. The company also lied to the federal Food and Drug Administration, investigators wrote, when it claimed earlier this year that it had not sold the product to doctors who were using it on humans.
Four people are hospitalized in a state of semi-paralysis after they received anti-wrinkle shots at the medical center. They became severely ill over the Thanksgiving holiday weekend.
Chiropractor Eric Kaplan, who was a consultant to the clinic, and his wife Bonnie are hospitalized at Palm Beach Gardens Medical Center. Clinic employees Bach McComb, an osteopathic physician who was suspended last year, accused of overprescribing painkillers, and his girlfriend Alma "AJ" Hall are in a medical center in Bayonne, N.J. All of them are in critical but stable condition.
McComb injected a clear liquid that he said was Botox into the Kaplans at the clinic on Nov. 24, their son Michael told investigators from the federal Food and Drug Administration, according to a federal search warrant affidavit filed in Arizona on Dec. 3. Michael Kaplan, a Palm Beach County resident, said he witnessed the injections being administered.
"Michael Kaplan stated that he observed McComb enter the examination room with a plastic bag containing approximately five to six syringes filled with a clear liquid and capped with an orange cap," wrote Susan J. Leeds, an FDA special agent, in the court documents.
Kaplan also said that McComb told him he had just received a vial of 100 units of "Botox," at a cost of $500, and that he had injected himself and Hall on Nov. 23. He said he was using leftovers from the same vial on the Kaplans, Michael Kaplan said.
So far, investigators have no reason to think that legitimate Botox was used. They suspect that an illegal, unapproved imitation of the popular treatment was used, according to the court documents. It is intended only for animal testing.
McComb also told Tom Toia Jr., the son of the owner of the medical center building, that he had injected himself and his girlfriend with the beauty treatment on Nov. 23, Toia told investigators.
An attorney for Advanced Integrated Medical Center, Neil Garfield, told a state Department of Health investigator earlier this month that he thought the clinic got a batch of the botulinum toxin with a higher dose from a source other than Allergan, the only legal U.S. supplier of Botox for use in humans, according to the federal court documents. That product was then used on all four of the people who have been hospitalized, the attorney said.
Two phone calls to Garfield were not returned on Thursday.
McComb's license to practice medicine is suspended. Between October and December 2002, five of his patients died while under his care. Two people died in Broward County, one in Palm Beach County, and two in the Sarasota area. At least three of those patients' deaths also involved abuse of cocaine. McComb is scheduled to go on trial in February in Sarasota County on charges that he overprescribed painkillers, including OxyContin to several patients. He denies the allegations, according to court records.
When federal agents served a search warrant at the medical center, they found that one of the Tucson, Arizona-based companies, Toxin Research International, which advertises botulinum toxin that is not for human use, had shipped packages to the Oakland Park clinic in October, August and March.
Those packages were shipped to Dr. Al Boyce, a 75-year-old osteopathic physician who told an investigator that he worked only one day per week at the clinic since February.
Boyce told the investigator that he was aware that McComb was administering the anti-wrinkle treatments but that Boyce never had done so. Boyce also said that he did not know that McComb's license to practice had been suspended. Investigators said they found no evidence at the clinic that Boyce had ever administered the controversial treatments.
Boyce's wife on Thursday said that he could not comment because of the ongoing investigation.
Records at the Oakland Park clinic, the investigator wrote, "suggest" that three patients during the past year have received anti-wrinkle treatments from Shelly Wolland, an osteopathic physician whose license has been restricted, prohibiting her from administering or injecting medication.
Wolland, who worked at the clinic, had her license restricted because of allegations that she had injected unlabeled and improperly stored medication. She declined to comment when contacted at her home on Thursday.
Powderz Inc., the Tucson prescription drug wholesaler, surrendered its licenses to the state pharmacy board Thursday morning, five days after federal investigators searched the company for evidence linking it to the botulism poisoning. It is one of the four Tucson businesses owned by Livdahl and Zahra, two licensed naturopathic physicians who were also subpoenaed in the inquiry.
An Arizona State Board of Pharmacy inspector located Livdahl and Zahra on Thursday morning, said Hal Wand, the agency's executive director. "When we got there his [Livdahl's] attorney was called and the attorney talked to our inspector and said he would surrender both permits," Wand said.
While federal investigators have begun a criminal investigation to figure out what happened, Crist, the Florida Attorney General, said he launched a separate investigation to figure out whether there were violations of Florida's Deceptive and Unfair Trade Practices Act. Crist also said he wants to know more about how widely the toxin was being made available and whether it was used on other patients in the state.
"These subpoenas will help us get to the bottom of this sad episode," Crist said.
Jane Erikson of the Arizona Daily Star contributed to this report.
Paula McMahon can be reached at firstname.lastname@example.org or 954-356-4533.