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Tuesday, November 29, 2005

Dermatologists are among the physicians cited by name in federal court documents exposing an underground network to distribute cutrate botulinum toxin type A to physicians suspected of using it on patients who may have assumed it was Botox.

Four doctors, including the director of oculofacial at University of Kentucky, have been indicted on federal conspiracy charges involving mail and wire fraud and misbranding a drug in connection with what the federal government is calling "a scheme to distribute fake Botox for use on humans."

At least 10 Florida physicians, including several dermatologists, have also had their licenses suspended or restricted because they purchased the unapproved drug, said Lindsay Hodges, a spokeswoman for the Florida Department of Health.

The network was discovered after four South Florida residents were hospitalized in critical condition with botulism, having received catastrophic amounts of improperly diluted raw botulinum toxin purchased from a California laboratory.

The same laboratory also supplied a Tucson, Ariz., company, Toxin Research International (TRI), with 3,081 vials containing botulinum toxin type A, "in a formulation designed to imitate Allergan's Botox" Cosmetic, according to an indictment issued by the U.S. Attorney's Office in the Southern District of Florida.

Botox is the only botulinum toxin type A approved for use in humans in the United States. At least 219 physicians and other health professionals purchased $1.5 million worth of the knockoff botulinum product at about half the price of Botox from TRI, after attending a weekend workshop or being sent promotional postcards or faxes advertising "A Very Stable Clostridium Botulinum Toxin Type A."

In very small print, the $1,250 vials containing 500 IU of toxin noted, "For Research Purposes Only Not for Human Use," according to federal documents.

Assistant U.S. Attorney Carlos B. Castillo said in an interview that physicians who ordered the fake Botox are being investigated by the Centers for Disease Control and Prevention and the Office of Criminal Investigations of the Food and Drug Administration in conjunction with numerous state medical boards.

"This deadly toxin packaged in harmless looking vials, wrapped in the guise of medicine, and used on unsuspecting members of our community, represents a grave threat," said Marcos Daniel Jimenez, U.S. Attorney for the Southern District of Florida in a statement.

A preliminary injunction halted further distribution of the mock Botox in January 2005.

The scandal came to light in late November 2004, when Bach McComb, a 47-year-old Florida osteopath with a suspended medical license, injected himself and three others with improperly diluted amounts of raw toxin obtained directly from List Biological Laboratories, a Northern California research laboratory.

Federal investigators believe the vial contained 20,000 units of botulinum toxin; however, a spokesperson for Allergan said the company's scientists have calculated that the vial may have contained up to 10 million units of botulinum toxin. It is unclear whether Dr. McComb used saline to dilute the product, and if so, by how much.

He and his three patients were hospitalized on ventilators with botulinum poisoning and, months later, are in various stages of recovery. Dr. McComb's girlfriend. Alma "A.J." Hall, remains hospitalized in New Jersey; a Palm Beach County, Fla., couple, Bonnie and Eric Kaplan, are recovering at home, having spent months in the hospital and a rehabilitation center.

Dr. McComb had to use a walker during his arraignment in federal court in Fort Lauderdale in late February 2005, according to the Palm Beach Post.

Also indicted in the case were Chad Livdahl, N.D., and Zarah Karim, N.D., of TRI, and Robert Baker, M.D., professor of ophthalmology, neurology, and pediatrics at the University of Kentucky in Lexington.

The Tucson naturopaths are accused of purchasing thousands of vials of botulinum toxin that were intended for research and then marketing them to physicians, presumably for human use in spite of labeling noting they were research products.

A fax found during a search of TRI headquarters explained to one customer that she could not receive a refund for the botulinum toxin A she returned to the company after she discovered the notation on the vials stating it was not meant for human use. "We must state that for legal purposes to protect ourselves," the fax said. "Our product is simply Botulinum Toxin Type A, which is exactly the same as any Botulinum Toxin Type A that you used in the past."

Federal prosecutors say Dr. Baker promoted and demonstrated the product to physicians at a 2-day workshop in Scottsdale, Ariz., in July 2003. A testimonial letter distributed to physicians bears his name; however, his attorney has told reporters the case is one of identity theft.

A December 2004 affidavit from a special agent for the FDA's Office of Criminal Investigations quotes attendees of the workshop as saying that Dr. McComb injected volunteers with hyaluronic acid, whereas Dr. Baker demonstrated botulinum toxin injections using the TRI product.

A nurse who attended was quoted as saying that Dr. Baker made it a point never to use the word "patients," as if he were avoiding it. Instead, he used the words, "When you inject your specimens."

The affidavit included comments from many physicians who attended the workshop, bought the product, or both.

In Florida, dermatologists, plastic surgeons, family physicians, and a pathologist who performs cosmetic procedures are being investigated by state medical board authorities for allegedly purchasing unapproved product and using it on their patients.

To read the complaint field in U.S. District Court, Southern District of Florida, visit Use search word Botox.

RELATED ARTICLE: 'Fake Botox' Timeline


Early 2003: Dr. Livdahl and Dr. Karim order 3,081 vials of full-strength, raw botulinum toxin from a California laboratory.

April 14, 2003: Dr. McComb's medical license is suspended in Florida for reasons relating to the prescribing of narcotics.

May 2003: Dr. Livdahl and Dr. Karim incorporate TRI in Tucson.

July 19-20, 2003: Health professionals attend TRI-sponsored workshop where botulinum toxin type A is promoted and allegedly demonstrated.


October 2004: Cosmetic surgeon in Tennessee notifies FDA about possible fraudulent TRI business scheme to market a Botox-like product; FDA investigation begins.

Nov. 26, 2004: Dr. McComb injects himself and three others with raw botulinum toxin from the same lab. All are hospitalized on ventilators within days.

Dec. 4, 2004: Federal agents search TRI offices in Tucson, finding marketing materials and 134 vials of botulinum toxin.

Dec. 15, 2004: Federal agents begin contacting physicians listed in TRI files.


Feb. 3, 2005: Federal grand jury in Florida indicts Dr. McComb, Dr. Livdahl, and Dr. Karim. All later plead not guilty and Dr. McComb is freed on bond.

Feb. 24, 2005: Federal magistrate in Florida denies bond to Dr. Livdahl and Dr. Karim.

March 22, 2005: Dr. Baker is indicted.

March 29, 2005: Dr. Baker pleads not guilty and is released on bond.

Sources: Media reports and documents from U.S. District Court, Southern District of Florida


Los Angeles Bureau

COPYRIGHT 2005 International Medical News Group

Tuesday, November 22, 2005

Las Vegas -- An algorithmic approach to treatment that takes into account anatomic, functional and aesthetic deficits is helpful for optimizing outcomes in patients seeking surgery because of herniated lower eyelid fat pads, said Oscar M. Ramirez, M.D., at the Facial Aesthetic Surgery 2004 meeting, here.

"Given the complexity of the lower eyelid, lower lid blepharoplasty should not be approached in a simple or cookbook fashion," he says. "Successful results are best achieved using an individualized approach that is based on the unique characteristics of each case and appreciation for the features that define a beautiful lid. Those include absence of scleral show, a lateral canthus that is higher than the medial canthus, absence of ciliary tilt, tarsal fullness and a slight infratarsal depression to afford a nice blending between the lower lid and cheek."

Dr. Ramirez is clinical assistant professor of , Johns Hopkins University, Baltimore, and a private practitioner at Esthetique Internationale in Timonium, Md.

Based on variables

The treatment algorithm for patients undergoing surgery for a herniated lower eyelid fat pad is based on the following variables: orbital rim position (the vector), tear trough ("V") deformity, the size of the eye (small, normal, large), and severity of both skin wrinkling/excess and tarsal laxity.

Tarsal laxity is assessed using three tests--the snap test, the distraction test and vertical canthal displacement. A total score [less than or equal to] 10 is considered normal, and in that situation, no additional intervention or only a preventive orbicular suspension is indicated for suspending the lower lid. A score of 11 to 20 represents moderate laxity, which is addressed with plication canthopexy and orbicularis suspension. Patients whose score is [greater than or equal to] 21 are considered to have severe laxity that requires canthoplasty with shortening plus orbicularis suspension. Dr. Ramirez says the orbicular suspension (plication) is done without cutting the orbicularis oculi muscle.

For addressing wrinkles, a trichloroacetic acid peel is the preferred treatment if the wrinkles are minimal. Moderate wrinkling is addressed with laser resurfacing as the first choice, although skin excision can also be performed. Skin excision is the treatment of choice, followed by laser resurfacing to improve the appearance of severe wrinkling.

Vector concerns

Dr. Ramirez notes that the portion of the algorithm that determines treatment based on the vector is more complex, as it takes into account the absence or presence of a tear trough deformity and size of the eye. If the vector is positive and there is no tear trough deformity, the treatment is determined according to eye size. For individuals with small eyes, the fat pads are repositioned inside the orbit. However, if the eyes are normal or large, the fat can be safely removed, and Dr. Ramirez's preferred approach for achieving that is through a transconjunctival incision.

If the patient has a positive vector but a tear trough deformity is present, the fat is maintained within the orbit in patients with small eyes, and the tear trough deformity is treated with fat grafting or a vertical suborbicularis oculi fat (SOOF) lift. When there is a positive vector, tear trough deformity and the eyes are normal or large, the fat pad is slid to improve the tear trough, and then the patient may or may not need a SOOF lift.

Patients with a negative vector--i.e., location of the orbital rim >3 mm behind the corneal plane--are offered an orbital rim implant to convert the vector to positive. If the patient declines the implantation procedure, then canthoplasty is performed. In either case, additional treatment is determined, as described above, according to the absence or presence of a tear trough deformity and size of the eyes.

Orbicularis oculi intact

Dr. Ramirez points out that, in contrast to a traditional blepharoplasty technique, his treatment approach avoids cutting the orbicularis oculi muscle in order to avoid denervation of the lower eyelid and associated complications.

"Although it is controversial among surgeons, I have shown through a number of published studies and presentations that transsection of the muscle denervates the pretarsal portion of the lower orbicularis," he says. "Therefore, I camouflage any tear trough deformity with a vertical SOOF lift and treat the lower eyelid itself with removal of skin and orbicularis suspension/plication only. In avoiding muscle excision, I have been successful in nearly eliminating all of the complications that are often associated with lower eyelid blepharoplasty, including scleral show, ectropion and even corneal damage that can lead to blindness."

Similarly, when performing a facelift for patients who want full-face rejuvenation in addition to treatment for bulging lower eyelids, his technique is also designed to avoid denervation of the lower eyelid. The facelift is divided into two components--the central oval of the face is approached in the subperiosteal plane, while lifting of the lower face and neck is achieved working in the subcutaneous layer.

"The mimetic muscles of the face and the facial nerves lie in the intermediate layer, and facelifts done in that tissue plane also carry a risk for denervation of the lower eyelid and other muscles of the face," Dr. Ramirez says.

COPYRIGHT 2004 Advanstar Communications, Inc.