Botox Inquiry Focuses On
Possible Bootleg Drug

From Patricia Doyle, PhD
From ProMED-mail
By Bob LaMendola
South Florida Sun-Sentinal
Investigators are looking at an unapproved wrinkle treatment as the culprit that hospitalized 4 people with suspected botulism poisoning after they received injections at an Oakland Park, FL clinic, 3 officials close to the investigation said Thu, 2 Dec 2004.
"The theory is that [the shots] were not real Botox that was contaminated, that they were bogus Botox," an official said. "We don't know for sure yet." The officials also said they were focusing on a suspended physician who worked at the clinic as the one they think administered the shots to the 4, 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 4 people got anti-wrinkle injections last week.
The physician and his girlfriend remain on ventilators but are in stable condition at Bayonne Medical Center in NJ. Another couple, of Palm Beach Gardens, FL, were listed in stable but critical condition Thu, 2 Dec 2004, in Palm Beach Gardens Medical Center, also on ventilators.
During a half-day search of the clinic, investigators found 3 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 USD $1250. Brand-name Botox sells for about USA $400 for a 100-unit vial.
The manufacturer of Botox, Allergan Inc. of Irvine, Calif., has complained to the USA 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.
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.
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.,0,
Assuming that the affected individuals indeed have botulism -- very few
neuromuscular illnesses occur in clusters -- a possible etiology involving
a nonstandardized product (with higher amounts of toxin) looms large. We
await the formal results of the CDC/FDA/State of Florida investigation. -
Patricia A. Doyle, PhD
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Zhan le Devlesa tai sastimasa
Go with God and in Good Health



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