Legal Issues For Rosacea's Dr. Bitter
Doctor faces sanctions over bogus Botox
By Barbara Feder
Ostrov Mercury News
A prominent Los Gatos dermatologist is facing sanctions from the state medical board for injecting patients, including his wife, with bogus Botox. Dr. Patrick Henry Bitter Jr., was among more than 200 doctors around the country who purchased experimental botulinum toxin, the main ingredient in wrinkle-relaxing Botox, from an Arizona company.
The toxin, which was not approved for human use, came to light in late 2004 when a doctor improperly mixed a batch, causing severe paralysis of four people in Florida. The doctors were customers of Tucson-based Toxin Research International, which illegally marketed the toxin to them as a cheap Botox substitute that would bring in higher profits. The company was shut down in early 2005 and its doctor-owners are in prison.
Bitter, who has appeared on the TV show ``Extreme Makeover'' and is nationally known for inventing the FotoFacial skin-treatment procedure, is one of several California doctors who have been investigated or disciplined by the medical board in recent months for using the unapproved drug. It's unclear what sanctions Bitter will face.
Any remaining unapproved toxin was relinquished to federal investigators, and no other major adverse effects were reported from its use. But experimental botulinum toxin is still being marketed to American doctors, primarily by overseas companies.
Bitter is the inventor of FotoFacial and PhotoFacial, pulsed light treatments for wrinkles, redness and rosacea used by doctors around the country. With his father, Dr. Patrick Bitter Sr., he continues to run the Advanced Aesthetic Dermatology clinic, offering skin treatments, Botox injections and liposuction among other cosmetic services.
He did not return phone calls from the Mercury News. The fallout from the Toxin Research International scandal continues as doctors around the country have been disciplined by regulators, indicted and even imprisoned for passing off the company's Botox knockoff as the real thing.
Use brings prison time In June, a New Mexico doctor was indicted on federal charges of fraud after giving the fake Botox to 120 patients.
Earlier this month, an Oregon doctor was sentenced to 18 months in federal prison for using two kinds of fake Botox, from Toxin Research International and a Chinese company, on more than 800 patients. An Idaho doctor also was sentenced to six months in prison in mid-December for using botulinum toxin from Toxin Research International.
Botox is a huge moneymaker for pharmaceutical firm Allergan, with 2005 sales topping $830 million.
It's a lucrative part of many dermatologists' and plastic surgeons' practices: Botox injections can cost consumers $250 or more per area treated, with the drug lasting only three to five months. A vial costs doctors about $500 and can yield treatment for up to eight areas.
Made from a purified form of the botulinum type A toxin that causes botulism, Botox has become so widely available that it is even injected by nurses in shopping mall ``medi-spas'' supervised by a physician. Botox also is used to treat neurological disorders, migraines and excessive sweating.
Botox works by causing temporary paralysis of facial muscles, relaxing them under the skin and thus smoothing wrinkles. Toxin Research International obtained the botulinum toxin from Campbell-based List Biological Laboratories, but investigators from the U.S. Food and Drug Administration could not establish that List had done anything illegal. List sells products designed to be used in scientific and medical research, and no charges were filed against the company.
While FDA investigators said Botox and the unapproved toxin appeared similar, using unapproved medicine is considered dangerous because there is no monitoring of storage, sterility or manufacturing practices.
The FDA might never have known about the bogus Botox if a Florida doctor with a suspended license hadn't made a nearly fatal error in mixing the potent toxin for injection in himself, his girlfriend and another couple. Within days, all four were paralyzed from a massive overdose causing botulism so severe they depended on ventilators to breathe. They remained hospitalized for weeks.
While three other doctors in California have received public reprimands for dispensing unapproved botulinum toxin -- one Temecula physician injected it into 200 patients -- the stories behind their cases were not made public by the medical board.
The board's accusation against Bitter, the only one made public, alleges that the board-certified dermatologist lied when he told its investigators in January that he did not know the knockoff Botox was not to be used on humans.
In fact, he had admitted months earlier to FDA investigators that he knew the product wasn't intended for human use. Bitter purchased the unapproved toxin from Toxin Research International for more than a decade, at least until February 2004, according to the medical board investigation.
He admitted that he injected the toxin into himself, his wife and four patients between December 2003 and March 2004. There is no information about whether the toxin Bitter administered caused any adverse effects, but typically the medical board would detail such harm if it had occurred.
Bitter also did not tell his patients that he was using a product meant only for research and did not maintain any paperwork on the injections for himself, his wife and one of his patients, the medical board has charged.
Range of penalties To the medical board, those actions constitute ``gross negligence'' and ``extreme departures'' from the standard practice of medicine.
Bitter faces penalties that could include fines, probation or even revocation of his license. He could, however, face only the public reprimand given the other California doctors who used the Botox knockoff.
Bitter is contesting the board's move to sanction him, but a hearing date has not been set. Consumers who stick with FDA-approved Botox shouldn't worry, said Dr. Michael Kane, a Manhattan plastic surgeon and author of ``The Botox Book.'' `
`Botox itself is a tremendously safe product; they have great quality control,'' Kane said. But, he cautioned, research-grade botulinum toxin and counterfeit Botox still are available on the black market and a determined doctor could simply inject a bogus product into an actual Botox vial. Potential patients can research their doctors on the Internet as a basic precaution, he said, but there are no guarantees. ``It's tough to really protect yourself,'' Kane said. `
`If someone is basically evil, you can get the bad stuff.''
Contact Barbara Feder Ostrov at bfeder@mercurynews.com or (408) 920-5064.
By Barbara Feder
Ostrov Mercury News
A prominent Los Gatos dermatologist is facing sanctions from the state medical board for injecting patients, including his wife, with bogus Botox. Dr. Patrick Henry Bitter Jr., was among more than 200 doctors around the country who purchased experimental botulinum toxin, the main ingredient in wrinkle-relaxing Botox, from an Arizona company.
The toxin, which was not approved for human use, came to light in late 2004 when a doctor improperly mixed a batch, causing severe paralysis of four people in Florida. The doctors were customers of Tucson-based Toxin Research International, which illegally marketed the toxin to them as a cheap Botox substitute that would bring in higher profits. The company was shut down in early 2005 and its doctor-owners are in prison.
Bitter, who has appeared on the TV show ``Extreme Makeover'' and is nationally known for inventing the FotoFacial skin-treatment procedure, is one of several California doctors who have been investigated or disciplined by the medical board in recent months for using the unapproved drug. It's unclear what sanctions Bitter will face.
Any remaining unapproved toxin was relinquished to federal investigators, and no other major adverse effects were reported from its use. But experimental botulinum toxin is still being marketed to American doctors, primarily by overseas companies.
Bitter is the inventor of FotoFacial and PhotoFacial, pulsed light treatments for wrinkles, redness and rosacea used by doctors around the country. With his father, Dr. Patrick Bitter Sr., he continues to run the Advanced Aesthetic Dermatology clinic, offering skin treatments, Botox injections and liposuction among other cosmetic services.
He did not return phone calls from the Mercury News. The fallout from the Toxin Research International scandal continues as doctors around the country have been disciplined by regulators, indicted and even imprisoned for passing off the company's Botox knockoff as the real thing.
Use brings prison time In June, a New Mexico doctor was indicted on federal charges of fraud after giving the fake Botox to 120 patients.
Earlier this month, an Oregon doctor was sentenced to 18 months in federal prison for using two kinds of fake Botox, from Toxin Research International and a Chinese company, on more than 800 patients. An Idaho doctor also was sentenced to six months in prison in mid-December for using botulinum toxin from Toxin Research International.
Botox is a huge moneymaker for pharmaceutical firm Allergan, with 2005 sales topping $830 million.
It's a lucrative part of many dermatologists' and plastic surgeons' practices: Botox injections can cost consumers $250 or more per area treated, with the drug lasting only three to five months. A vial costs doctors about $500 and can yield treatment for up to eight areas.
Made from a purified form of the botulinum type A toxin that causes botulism, Botox has become so widely available that it is even injected by nurses in shopping mall ``medi-spas'' supervised by a physician. Botox also is used to treat neurological disorders, migraines and excessive sweating.
Botox works by causing temporary paralysis of facial muscles, relaxing them under the skin and thus smoothing wrinkles. Toxin Research International obtained the botulinum toxin from Campbell-based List Biological Laboratories, but investigators from the U.S. Food and Drug Administration could not establish that List had done anything illegal. List sells products designed to be used in scientific and medical research, and no charges were filed against the company.
While FDA investigators said Botox and the unapproved toxin appeared similar, using unapproved medicine is considered dangerous because there is no monitoring of storage, sterility or manufacturing practices.
The FDA might never have known about the bogus Botox if a Florida doctor with a suspended license hadn't made a nearly fatal error in mixing the potent toxin for injection in himself, his girlfriend and another couple. Within days, all four were paralyzed from a massive overdose causing botulism so severe they depended on ventilators to breathe. They remained hospitalized for weeks.
While three other doctors in California have received public reprimands for dispensing unapproved botulinum toxin -- one Temecula physician injected it into 200 patients -- the stories behind their cases were not made public by the medical board.
The board's accusation against Bitter, the only one made public, alleges that the board-certified dermatologist lied when he told its investigators in January that he did not know the knockoff Botox was not to be used on humans.
In fact, he had admitted months earlier to FDA investigators that he knew the product wasn't intended for human use. Bitter purchased the unapproved toxin from Toxin Research International for more than a decade, at least until February 2004, according to the medical board investigation.
He admitted that he injected the toxin into himself, his wife and four patients between December 2003 and March 2004. There is no information about whether the toxin Bitter administered caused any adverse effects, but typically the medical board would detail such harm if it had occurred.
Bitter also did not tell his patients that he was using a product meant only for research and did not maintain any paperwork on the injections for himself, his wife and one of his patients, the medical board has charged.
Range of penalties To the medical board, those actions constitute ``gross negligence'' and ``extreme departures'' from the standard practice of medicine.
Bitter faces penalties that could include fines, probation or even revocation of his license. He could, however, face only the public reprimand given the other California doctors who used the Botox knockoff.
Bitter is contesting the board's move to sanction him, but a hearing date has not been set. Consumers who stick with FDA-approved Botox shouldn't worry, said Dr. Michael Kane, a Manhattan plastic surgeon and author of ``The Botox Book.'' `
`Botox itself is a tremendously safe product; they have great quality control,'' Kane said. But, he cautioned, research-grade botulinum toxin and counterfeit Botox still are available on the black market and a determined doctor could simply inject a bogus product into an actual Botox vial. Potential patients can research their doctors on the Internet as a basic precaution, he said, but there are no guarantees. ``It's tough to really protect yourself,'' Kane said. `
`If someone is basically evil, you can get the bad stuff.''
Contact Barbara Feder Ostrov at bfeder@mercurynews.com or (408) 920-5064.
posted by Madison at 7:22 AM
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