Is It Botox, or Is It Bogus?

September 20, 2016 / Botox, neuromodulators

TO millions of Americans, Botox is a magic bullet. A few pinpricks and in a day the face is returned to an approximation of its teenage self, unlined and uninjured by the relentless insult of adult life.

But devotees of the youth potion were dismayed last week to learn that four people who went for wrinkle-smoothing treatments had been hospitalized for possible botulism poisoning.

Close up of woman receiving botox injection under eye

There are many unanswered questions in the case. Investigators want to know whether a former osteopath in South Florida gave patients and himself injections of a bogus Botox, either homemade or illegally imported. (The former osteopath also fell ill.)

Botox, a toxin derivative that temporarily paralyzes tiny muscles that cause wrinkles, is manufactured by Allergan Inc., a California company. But doctors say there is a growing underground market for do-it-yourself and illegally imported or manufactured anti-aging compounds that are supposed to do what Botox does — at a fraction of the cost — but have not been approved for use in this country.

The Centers for Disease Control and Prevention, with New Jersey and Florida state health departments, are testing a Florida couple and the former doctor, along with an employee of the clinic for botulism poisoning. Tim O’Connor, the spokesman for the Palm Beach County Health Department, said that the Florida couple “exhibited all the signs of botulism” and had been treated with a botulism antidote.

Dr. Leonard Hochstein, a plastic surgeon in Aventura, Fla., has administered Botox for five years and has not suspended its use because of the recent cases. He added, however: “I think there will be a reduction in interest in Botox, at least for a while. Anytime we have one of these nightmare knock-off do-it-yourself surgery scares, it affects all of us.”

Allergan defended its popular product last week. A company spokeswoman, Stephanie Fagan, issued a statement saying that only two vials of Botox had been sold to the Advanced Integrated Medical Center in the last 12 months, enough for two to eight treatments. (A standard treatment in New York City would cost anywhere from $400 to $1,000.) In an e-mail message, Ms. Fagan wrote that the company had investigated all the manufacturing and quality assurance processes and found no irregularities. No other doctors or patients have reported any other adverse events, she said.

The case came to the public’s attention when Eric S. Kaplan, a South Florida chiropractor and his wife, Bonnie, told doctors that they fell ill after they received shots they thought were Botox at the clinic in Oakland Park during Thanksgiving week. The Kaplans, who were admitted to Palm Beach Gardens Medical Center Nov. 26, were in serious but stable condition on Thursday.

Bach McComb, 47, the man they said injected them, was also hospitalized along with his companion, Alma Hall. Mr. McComb, who has worked at the clinic, and Ms. Hall were admitted to the Bayonne Medical Center in Bayonne, N.J. (Mr. McComb, who lives in Florida, had come to New Jersey to visit his mother.) Both spent at least part of last week on respirators. A man answering the phone at Mr. McComb’s mother’s house in Bayonne said she was too upset to speak. Mr. McComb was not available for comment.

Mr. O’Connor said that Florida’s health agency and the Centers for Disease Control were investigating what Mr. McComb might have injected the patients and himself with, whether Botox, a black-market or home-made formulation of botulinum, or something else.

Florence Evermon, Ms. Hall’s sister, said on Thursday from her home in Georgia that The doctors are optimistic. “She is young and healthy,” she said. “And they think she’s going to get well.”

Mr. McComb had been licensed as an osteopathic physician, but his medical license was suspended by Florida in April 2003 after he was arrested by the Sarasota County sheriff’s office on felony charges of trafficking in addictive pain medications, including oxycodone. He is scheduled to face trial in Florida in February on the charges.

He is known in cosmetic-surgery circles as an entrepreneur who has taught at seminars that claim to instruct doctors and others how to make their own cosmetic formulations like collagen, a wrinkle filler, and botulinum toxin Type A, the toxin that is used in Botox, which is the trademark name for the formulation distributed by Allergan. “No need for fancy equipment, sterile rooms, etc., most physicians already have all they need,” proclaimed one flier sent to plastic surgeons in New York City last year, outlining promises for quick and easy profits.

The fliers invited doctors and any of their staff members to two-day seminars where for $1,150 they would learn to formulate anti-aging medications. The seminars promised to teach “simple, safe and profitable” methods. “You can prepare 100’s of cc’s of injectables at 1 time, in under an hour,” the pamphlet reads, at costs of as little as $1 a dose.

Zahra Karim and Chad Livdahl, naturopathic physicians who organized the conferences did not respond to messages left with a receptionist at Powderz Inc., the Arizona company they founded.

In New York, Dr. Michael A. C. Kane, a plastic surgeon and the author of “The Botox Book” (St. Martin’s Press, 2002), bristled at the idea that people without medical degrees would attempt to make botulinum toxin or collagen.

“It’s insane,” Dr. Kane said. The environment and procedures used to make such pharmaceutical products, he added, “is far beyond the capabilities of a medical office, let alone people without medical degrees.”

Although it is not known whether the four who fell ill were injected with a compound of Mr. McComb’s making, they were clearly seeking a youthful appearance through pharmaceutical compounds. Since Botox was approved by the Food and Drug Administration in 2002 for cosmetic use in treating specific forehead wrinkles, sales have rocketed. In 2003, Allergan sold $564 million worth of Botox.

As its popularity has grown so has the illegal market: Last year, an investigation by the Food and Drug Administration found black-market botulinum shipments coming from all over the world. Much comes from China, where botulinum toxin is sold under the brand names BTX-A and Botutox.

Reposted from: The New York Times