- 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
- 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
- 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
- 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.
- Assuming that the affected individuals indeed have botulism
-- very few
- neuromuscular illnesses occur in clusters -- a possible
- a nonstandardized product (with higher amounts of toxin)
looms large. We
- await the formal results of the CDC/FDA/State of Florida
- Patricia A. Doyle, PhD
- Please visit my "Emerging Diseases" message
board at: http://www.clickitnews.com/ubbthreads/postlist.php?
- Zhan le Devlesa tai sastimasa
- Go with God and in Good Health