Botox Inquiry Focuses On Possible Bootleg DrugDec 3, 2004 | Newsday
Unapproved Wrinkle Treatment As The Culprit That Hospitalized Four People.
Investigators are looking at an unapproved wrinkle treatment as the culprit that hospitalized four people with suspected botulism poisoning after they received injections at an Oakland Park clinic, three officials close to the investigation said Thursday.
"The theory is that [the shots] were not real Botox that was contaminated, that they were bogus Botox," one official said. "We don't know for sure yet."
The officials also said they were focusing on suspended physician Bach McComb, who worked at the clinic, as the one they think administered the shots to the four, including himself.
The Florida Department of Health, the lead agency investigating the cases, said it still has not reached any conclusions about what happened at Advanced Integrated Medical Center, where the four people got anti-wrinkle injections last week.
McComb and his girlfriend, Alma AJ Hall, remain hooked to ventilators but are in stable condition at Bayonne Medical Center in New Jersey.
Eric and Bonnie Kaplan, of Palm Beach Gardens, were listed in stable but critical condition Thursday in Palm Beach Gardens Medical Center, also on ventilators.
All four were virtually paralyzed by the suspected botulism, a massive invasion of the bacteria botulinum, which is used to make wrinkle shots such as Botox.
During a half-day search of the clinic that lasted until early Thursday morning, investigators found three empty vials of a wrinkle treatment and a number of used syringes that are now being lab tested, the officials said. The officials would not identify the supplier of the vials or discuss their contents.
State and federal agents found paperwork in the clinic from an Arizona pharmaceutical wholesaler that sells an unlicensed, low-priced Botox-like wrinkle treatment, said the officials, who spoke on the condition of anonymity.
Officials said they found letters from Toxin Research International, a Tucson pharmaceutical distributor that sells a product called Botulinum Neurotoxin Type A. On its Web site, the company says the product is made from the A type of the bacteria.
Officials would not discuss the content of the letters, or whether the company ever supplied any products to the clinic.
TRI's Web site says a 500-unit vial of the product enough to treat 5 to 10 people sells for $1,250.
Brand name Botox sells for about $400 for a 100-unit vial.
The manufacturer of Botox, Allergan Inc. of Irvine, Calif., has complained to the U.S. Food & Drug Administration that TRI's product is illegal and cannot be sold in this country, said company spokeswoman Stephanie Fagan.
"We know about them and we have turned them over to the FDA," Fagan said. "They sell an unapproved version of what they call botulinum toxin type A. It is not legal."
Allergan is the only company approved by the FDA to make and sell a botulinum type A product in this country, an FDA spokeswoman said.
Allergan Sells Only To Physicians.
TRI could not legally obtain Botox to resell because Allergan sells only to physicians, Fagan said. Federal law forbids importing prescription drugs such as Botox from overseas.
Officials said they have not definitively determined whether any TRI products are responsible for the illnesses.
TRI's president, Dr. Chad Livdahl, could not be reached for comment at either of the two pharmaceutical wholesale firms he owns. His office said he was traveling. No one else at the company would comment.
Botox, the leading brand in wrinkle treatment, has been growing in popularity in recent years. Last year, 2.3 million patients were injected. Typically, a patient gets multiple shots around their forehead, eyes and mouth, where the drug paralyzes underlying muscles that cause wrinkles.
Botox-like products have been a growing problem throughout the country, as companies from overseas particularly China and Europe solicit doctors directly by e-mail and faxes offering deep discount prices.
Health officials fear fake Botox could be harmful because it's not made according to FDA standards. Allergan has heard of dozens of cases of fake shots, Fagan said, and the FDA has seized some in South Florida, among other locales.
Agents investigating the Oakland Park clinic including those from the FDA, the state health department and the federal Centers for Disease Control and Prevention asked the clinic's owner for information and documents about the products purchased by the clinic, and who on the center staff gave the shots, the sources said.
Owner Tom P. Toia, a Palm Beach Gardens chiropractor, "is being cooperative in providing as much information as he can," said his Fort Lauderdale attorney, Bruce Zimet. He declined to elaborate on what he or Toia told the investigators.
Zimet said that based on the pointed questions the investigators asked, he thinks they pretty much have concluded how the four became ill.
"I think they certainly have their theories of what happened," Zimet said.
The state suspended McComb's license in April 2003, after he was arrested in Sarasota County on charges of overprescribing painkillers such as OxyContin to patients, including two who died. His trial is scheduled for February.
Toia, as a chiropractor, is not permitted to give injections. The clinic employed two physicians, but one, Dr. Shelly Wolland, is not allowed to dispense or inject prescription medication after state inspectors in 2002 found her Miami office scattered with unrefrigerated syringes filled with unlabeled medications, according to a health department complaint against her.
The clinic lists as its medical director Dr. Alfred Boyce, 75, of Tamarac. His wife says he goes to the clinic about once a week.
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