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Saturday, January 21, 2006

Las Vegas -- Coumadin and other blood thinners should not be discontinued pre- or postoperatively in patients who are having skin surgery, says a professor of dermatology at the University of Rochester School of Medicine.

Speaking at the Fall and Winter Dermatology Conference in October, Dr. Marc Brown says dermatologists should be more concerned with the risk in taking patients off a blood thinner.

"A lot of us (dermatologists) now are keeping our patients on blood thinners like coumadin," Dr. Brown says. "There is a small but significant risk that they could have a stroke or heart attack. Similarly, if a patient were on aspirin for serious reasons, we would keep them on it. There is a greater concern of a serious problem occurring because the patient is not on a blood thinner like coumadin or warfarin than of extensive postoperative bleeding or extensive intra-operative bleeding."

He adds, however, that patients on aspirin who do not have cardiac or cerebral history should be taken off the medication.

Dr. Brown refers to a study published in Plastic Reconstructive Surgery in 2002 that found that cutaneous surgeons were unable to identify, through visual inspection, that patients had taken antithrombotics, based on the amount of intra- operative bleeding.

Dr. Brown estimates that most practicing dermatologists are taking their patients off blood thinners to avoid intra- operative bleeding and postoperative bleeding. Effective counseling, such as advising patients that they need to behave like couch potatoes in the 48 hours following surgery, needs to take place to avoid postoperative bleeding, Dr. Brown stresses.

"They can't undergo the surgery on a Friday and then go ahead and play tennis or golf over the weekend," Dr. Brown says. "They should also avoid bending over or lifting if they have had major excisional procedures performed, such as removal of skin cancers on the face."

Apart from rest, the application of ice packs to the surgical site, and an effective pressure dressing will contribute to minimizing post-operative bleeding, and minimizing ethanol.

In addition to bleeding, major areas of concern in terms of surgical complications are infection, wound dehiscence, and necrosis, Dr. Brown explains. Outpatient surgery is quite safe, with the incidence of complications at 1.6 percent in Mohs micrographic surgery, according to a study published in the Archives of Dermatology in 2003. The complication rate is comparable to complication rates in other surgical specialties, Dr. Brown notes.

If infections do develop following skin surgery, for instance following the removal of a cyst, they would typically occur within a week of surgery. Patients would experience tenderness and pain at the surgical site, as well as redness if an infection develops.

Typically outpatient skin surgery results in an infection rate of between 2 percent and 3 percent. Dermatologic surgeons who perform Mohs surgery and routinely prescribe prophylactic antibiotics to prevent infection should be questioned, Dr. Brown says. About a third of plastic surgeons prescribe antibiotics for graft and flap surgery.

"It's a controversial issue in terms of which patients you should place on antibiotics and which you should not," Dr. Brown says. "If you are performing complex reconstruction, or the patient is immunosuppressed, or the surgical site is around the nose and the ears, I would recommend antibiotics to be prescribed as prophylaxis."

Since the rate of infection is fairly low, Dr. Brown says data do not substantiate prescription of antibiotics as a matter of course in skin surgery.

Proper surgical procedure is one way to avoid possible infection. Taking a nasal swab of medical personnel to ensure there are no asymptomatic carriers of Staph aureus is a judicious measure, Dr. Brown adds. Just as patients should avoid too much activity to prevent infection or postoperative bleeding following skin surgery, minimal activity is recommended to prevent wound dehiscence. Surgeons need to ensure adequate deep closure to avoid wound dehiscence.

COPYRIGHT 2005 Advanstar Communications, Inc.

Friday, January 20, 2006

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 www.usdoj.gov/usao/fls. Use search word Botox.

RELATED ARTICLE: 'Fake Botox' Timeline

2003

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.

2004

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.

2005

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

BY BETSY BATES

Los Angeles Bureau

COPYRIGHT 2005 International Medical News Group