The four people include the doctor who may have administered the injections at his clinic outside Fort Lauderdale, Fla. He and his girlfriend, a clinic employee, remain in a New Jersey hospital. They fell ill after traveling to New Jersey for Thanksgiving. Two others -- a Florida chiropractor and his wife -- are hospitalized in Florida.
Exactly what happened isn't clear. None of the four can yet speak to state and federal officials investigating the case, says Lindsay Hodges, a spokeswoman for the Florida Department of Health. The department is leading the public health investigation; a federal criminal investigation is also under way.
"The patients can't participate in the investigation at this time," Hodges tells WebMD. "They are responsive -- they can indicate 'yes' and 'no' or answer briefly -- but they can't carry on a conversation."
All four patients appear to be suffering from acute poisoning with botulism toxin. Botox contains tiny amounts of this toxin, one of the most poisonous substances on earth. It's made by a common bacterium whose spores live in the soil and bloom under the right conditions.
Botulism toxin works by blocking communication between nerves and muscles, effectively paralyzing affected muscles. There's an antitoxin, but it only prevents further damage. It takes months for the toxin to wear off. People with severe botulism toxin poisoning need mechanical ventilation and intensive hospital care. Recovery is slow.
Botox Is Safe; Shady Product Suspected
According to news reports, investigators suspect that the doctor, identified in news reports as Bach McComb, DO, used an unapproved product made by an Arizona company. [Editors Note: Court documents filed by FDA investigators indicate that the product came from a Northern California firm.] McComb's Florida medical license had been suspended pending charges of trafficking in addictive pain medications.
McComb's clinic, Advanced Integrated Medical Center, in Oakland Park, Fla., did receive two vials of Botox, an approved product often used for cosmetic injections. Botox maker Allergan says there were no safety problems with the Botox lots from which the vials came.
According to news reports, the federal investigation centers on Toxin Research International, a sister company of Powderz Inc. of Tucson, Ariz., which markets a "for experimental use only" botulism toxin called Botulinum Neurotoxin type A. [Editors Note: While court documents filed by FDA investigators report evidence that Toxin Research International may have marketed an experimental botulism toxin for human use, Toxin Research International does not appear to be the source of the botulism toxin used in the Florida cases. According to news reports, that product appears to have come from a Northern California company. According to Botox maker Allergan, the California company's product is shipped in vials containing 10 million units of botulism toxin -- 100,000 times the amount of botulism toxin in authentic Botox, the only botulism toxin product approved for human use.]
Doctors frequently receive flyers advertising these kinds of products as a cheap alternative to Botox, says Peter Fodor, MD, president of the American Society for Aesthetic Plastic Surgery and associate professor of plastic surgery at UCLA.
"We constantly get flyers about various things that are supposed to be alternatives to Botox and other products," Fodor tells WebMD. "This boils down to expense. Botox is not inexpensive, and if somebody can provide something sold under pretext and it does the same thing, well, I cannot comment on who would use these things. No doctor with proper training and proper credentialing would use an unapproved product."
Allergan spokeswoman Stephanie Fagan says the company has received numerous reports of firms advertising bogus Botox.
"It boils down to unethical physicians who take advantage of the brand name to make a profit and put patients' safety at risk," Fagan tells WebMD. "It's really an unfortunate situation."
Rx for Safe Botox Treatment: Find Respectable Doctor
Nobody involved with the Florida case suggests there's anything wrong with Botox. But there's clearly something wrong with a doctor who would use an unapproved Botox substitute. Unfortunately, Fodor says, patients seeking cosmetic surgery are often fooled by marketing gimmicks promising unrealistic results at low cost.
"Some 50 percent of my patients are 'redo' patients who did not have a good outcome from their original procedure," says plastic surgeon Fodor. "And they sit in my office crying about how foolish they were to fall for marketing without checking a person's credentials."
Here's advice from the American Society for Aesthetic Plastic Surgery on how to find the right doctor:
- Check a doctor's board certification. All medical specialties offer certification to recognized specialists. Make sure your doctor is certified in his or her field.
- Check facility accreditation. Make sure that the hospital or clinic in which the procedure takes place has a valid state or Medicare license.
- Check hospital privileges. Hospitals evaluate a doctor's training and competency for specific procedures before granting operating privileges.
- Check reliable sources. Asking your doctor to recommend a cosmetic practitioner is a good way to start. The American Board of Plastic Surgery offers a free referral service.
- Check thoroughness. A doctor should be willing to tell you about the risks of any procedure. If you don't feel a doctor is answering your questions, this isn't the right doctor for you.
- Check rapport. Not every qualified doctor is right for every patient. Find a doctor with whom you can communicate freely.
- Check follow-up care. Ask about a doctor's policy on follow-up visits.