Betsy Bates

LOS ANGELES — The use of alcohol-based hand-cleaning gels has burgeoned in hospitals, where physicians, nurses, and other medical staff members have embraced them as a convenient alternative to soap and water hand washing.

But because such gels do not have activity against spores, reliance on their use faces further scrutiny in light of nationwide outbreaks of a new resistant strain of Clostridium difficile, according to John M. Boyce, M.D., chief of the infectious diseases section at the Hospital of St. Raphael in New Haven.

Dr. Boyce presented a study at the annual meeting of the Society for Healthcare Epidemiology of America that showed no increase in C. difficile-associated disease at his 500-bed community teaching hospital during the 3 years in which the use of alcohol-based hand rubs increased 10-fold.

Another study discussed at the meeting showed that rates of vancomycin-resistant Enterococcus (VRE) species and methicillin-resistant Staphylococcus aureus (MRSA) decreased in the 27 months following the introduction of alcohol-based hand gels and a hand-washing campaign at Loyola University Medical Center in Maywood, Ill. The reduction in VRE was statistically significant, but the drop in MRSA was not.

Rates of C. difficile were unchanged in the Loyola study, presented by Julie Leischner, M.D., of the department of infectious disease at the university.

Both investigators concluded that the use of alcohol-based hand cleaners did not influence rates of C. difficile infection.

But recent hand-hygiene guidelines written by the Centers for Disease Control and Prevention and a multisociety task force suggest “prudent” precautions during C. difficile outbreaks; the guidelines call for wearing gloves and washing hands with soap and water after removing gloves, because none of the antiseptic hand rubs are “reliably sporicidal” against Clostridium species (MMWR 2002;51(RR16):1–45).

The matter hit close to home for Dr. Boyce when a virulent C. difficile outbreak struck his hospital, months after completion of his study on alcohol-based hand rubs.

Two patients died and three underwent colectomies during a 2-week period—“something I haven't seen in 25 years and hadn't seen in [the] 31/2 years” of the study of alcohol-based hand rubs, he said during a scientific session at the meeting.

Cultures revealed isolates closely related to the highly toxic epidemic strains found in hospitals across the United States and Canada.

Despite his confidence that alcohol-based hand cleaners do not encourage C. difficile outbreaks, he said he believes that soap and water hand washing after diligent use of gloves should be the rule during outbreaks.

“I think it's fair to say a lot of health care workers have gotten used to alcohol-based hand rubs, and now it's hard to get them to go back to using soap and water,” he said.

Dr. Boyce disclosed that he has received funding from Gojo Industries Inc. and has served as a consultant to Mycrocept Corp. and Woodward Laboratories Inc., makers of hand sanitizers and soaps.

LOS ANGELES — The use of alcohol-based hand-cleaning gels has burgeoned in hospitals, where physicians, nurses, and other medical staff members have embraced them as a convenient alternative to soap and water hand washing.

But because such gels do not have activity against spores, reliance on their use faces further scrutiny in light of nationwide outbreaks of a new resistant strain of Clostridium difficile, according to John M. Boyce, M.D., chief of the infectious diseases section at the Hospital of St. Raphael in New Haven.

Dr. Boyce presented a study at the annual meeting of the Society for Healthcare Epidemiology of America that showed no increase in C. difficile-associated disease at his 500-bed community teaching hospital during the 3 years in which the use of alcohol-based hand rubs increased 10-fold.

Another study discussed at the meeting showed that rates of vancomycin-resistant Enterococcus (VRE) species and methicillin-resistant Staphylococcus aureus (MRSA) decreased in the 27 months following the introduction of alcohol-based hand gels and a hand-washing campaign at Loyola University Medical Center in Maywood, Ill. The reduction in VRE was statistically significant, but the drop in MRSA was not.

Rates of C. difficile were unchanged in the Loyola study, presented by Julie Leischner, M.D., of the department of infectious disease at the university.

Both investigators concluded that the use of alcohol-based hand cleaners did not influence rates of C. difficile infection.

But recent hand-hygiene guidelines written by the Centers for Disease Control and Prevention and a multisociety task force suggest “prudent” precautions during C. difficile outbreaks; the guidelines call for wearing gloves and washing hands with soap and water after removing gloves, because none of the antiseptic hand rubs are “reliably sporicidal” against Clostridium species (MMWR 2002;51(RR16):1–45).

The matter hit close to home for Dr. Boyce when a virulent C. difficile outbreak struck his hospital, months after completion of his study on alcohol-based hand rubs.

Two patients died and three underwent colectomies during a 2-week period—“something I haven't seen in 25 years and hadn't seen in [the] 31/2 years” of the study of alcohol-based hand rubs, he said during a scientific session at the meeting.

Cultures revealed isolates closely related to the highly toxic epidemic strains found in hospitals across the United States and Canada.

Despite his confidence that alcohol-based hand cleaners do not encourage C. difficile outbreaks, he said he believes that soap and water hand washing after diligent use of gloves should be the rule during outbreaks.

“I think it's fair to say a lot of health care workers have gotten used to alcohol-based hand rubs, and now it's hard to get them to go back to using soap and water,” he said.

Dr. Boyce disclosed that he has received funding from Gojo Industries Inc. and has served as a consultant to Mycrocept Corp. and Woodward Laboratories Inc., makers of hand sanitizers and soaps.

LOS ANGELES — The use of alcohol-based hand-cleaning gels has burgeoned in hospitals, where physicians, nurses, and other medical staff members have embraced them as a convenient alternative to soap and water hand washing.

But because such gels do not have activity against spores, reliance on their use faces further scrutiny in light of nationwide outbreaks of a new resistant strain of Clostridium difficile, according to John M. Boyce, M.D., chief of the infectious diseases section at the Hospital of St. Raphael in New Haven.

Dr. Boyce presented a study at the annual meeting of the Society for Healthcare Epidemiology of America that showed no increase in C. difficile-associated disease at his 500-bed community teaching hospital during the 3 years in which the use of alcohol-based hand rubs increased 10-fold.

Another study discussed at the meeting showed that rates of vancomycin-resistant Enterococcus (VRE) species and methicillin-resistant Staphylococcus aureus (MRSA) decreased in the 27 months following the introduction of alcohol-based hand gels and a hand-washing campaign at Loyola University Medical Center in Maywood, Ill. The reduction in VRE was statistically significant, but the drop in MRSA was not.

Rates of C. difficile were unchanged in the Loyola study, presented by Julie Leischner, M.D., of the department of infectious disease at the university.

Both investigators concluded that the use of alcohol-based hand cleaners did not influence rates of C. difficile infection.

But recent hand-hygiene guidelines written by the Centers for Disease Control and Prevention and a multisociety task force suggest “prudent” precautions during C. difficile outbreaks; the guidelines call for wearing gloves and washing hands with soap and water after removing gloves, because none of the antiseptic hand rubs are “reliably sporicidal” against Clostridium species (MMWR 2002;51(RR16):1–45).

The matter hit close to home for Dr. Boyce when a virulent C. difficile outbreak struck his hospital, months after completion of his study on alcohol-based hand rubs.

Two patients died and three underwent colectomies during a 2-week period—“something I haven't seen in 25 years and hadn't seen in [the] 31/2 years” of the study of alcohol-based hand rubs, he said during a scientific session at the meeting.

Cultures revealed isolates closely related to the highly toxic epidemic strains found in hospitals across the United States and Canada.

Despite his confidence that alcohol-based hand cleaners do not encourage C. difficile outbreaks, he said he believes that soap and water hand washing after diligent use of gloves should be the rule during outbreaks.

“I think it's fair to say a lot of health care workers have gotten used to alcohol-based hand rubs, and now it's hard to get them to go back to using soap and water,” he said.

Dr. Boyce disclosed that he has received funding from Gojo Industries Inc. and has served as a consultant to Mycrocept Corp. and Woodward Laboratories Inc., makers of hand sanitizers and soaps.

LOS ANGELES — Several hospitals faced with outbreaks of a virulent strain of Clostridium difficile brought the spread of disease under control with stepped-up infection control measures and altered antibiotic prescribing practices.

Early identification of cases, isolation precautions, cleaning of rooms with a bleach solution, replacement of alcohol-based hand rubs with soap and water, and targeted antibiotic restrictions all were cited in institutional success stories described at the annual meeting of the Society for Healthcare Epidemiology of America.

Mary K. Blank described a multipronged strategy used at the University of Pittsburgh Medical Center that brought the incidence of hospital-acquired C. difficile infection down from a high of 7.2 per 1,000 discharges in 2000 to 4.6 per 1,000 in 2004.

The University of Pittsburgh was one of the first hospitals to report the emergence of a highly toxic strain of C. difficile associated with increased colectomies and patient deaths. A crackdown on C. difficile began in 2000 with active surveillance. At-risk patients were identified on the basis of prolonged length of stay, antibiotic use, high or low white blood cell count, and/or bandemia.

Patients with symptoms suggesting C. difficile infection were isolated and all charts were electronically flagged when the diagnosis was made. Clinicians and other staff members were informed of heightened infection-control requirements maintained throughout the patient's stay. Rooms were cleaned with a 1:10 bleach solution, and alcohol-based hand cleaners were replaced with soap and water.

A C. difficile management team treated each patient, prescribing oral or intravenous metronidazole for most of them, often in conjunction with oral vancomycin for 14 days.

A case-control study linked the use of levofloxacin, clindamycin, and ceftriaxone to the hospital's outbreak, so physicians were required to get prior approval for using those drugs.

At Northwestern University, similar precautions were implemented following the C. difficile-related deaths of two patients in 3 days who had been housed in adjacent rooms in an oncology unit.

An investigation identified 8 patients in the oncology and medical intensive care units colonized with the outbreak strain and 17 patients in those and other units colonized or infected with another toxigenic strain of C. difficile.

Staff alerts, enhanced case identification, intensified infection control and isolation practices, and terminal bleaching of rooms when patients were transferred or discharged brought the outbreak under control, reported Shilpa M. Patel, M.D., a fellow in the department of infectious disease.

LOS ANGELES — Several hospitals faced with outbreaks of a virulent strain of Clostridium difficile brought the spread of disease under control with stepped-up infection control measures and altered antibiotic prescribing practices.

Early identification of cases, isolation precautions, cleaning of rooms with a bleach solution, replacement of alcohol-based hand rubs with soap and water, and targeted antibiotic restrictions all were cited in institutional success stories described at the annual meeting of the Society for Healthcare Epidemiology of America.

Mary K. Blank described a multipronged strategy used at the University of Pittsburgh Medical Center that brought the incidence of hospital-acquired C. difficile infection down from a high of 7.2 per 1,000 discharges in 2000 to 4.6 per 1,000 in 2004.

The University of Pittsburgh was one of the first hospitals to report the emergence of a highly toxic strain of C. difficile associated with increased colectomies and patient deaths. A crackdown on C. difficile began in 2000 with active surveillance. At-risk patients were identified on the basis of prolonged length of stay, antibiotic use, high or low white blood cell count, and/or bandemia.

Patients with symptoms suggesting C. difficile infection were isolated and all charts were electronically flagged when the diagnosis was made. Clinicians and other staff members were informed of heightened infection-control requirements maintained throughout the patient's stay. Rooms were cleaned with a 1:10 bleach solution, and alcohol-based hand cleaners were replaced with soap and water.

A C. difficile management team treated each patient, prescribing oral or intravenous metronidazole for most of them, often in conjunction with oral vancomycin for 14 days.

A case-control study linked the use of levofloxacin, clindamycin, and ceftriaxone to the hospital's outbreak, so physicians were required to get prior approval for using those drugs.

At Northwestern University, similar precautions were implemented following the C. difficile-related deaths of two patients in 3 days who had been housed in adjacent rooms in an oncology unit.

An investigation identified 8 patients in the oncology and medical intensive care units colonized with the outbreak strain and 17 patients in those and other units colonized or infected with another toxigenic strain of C. difficile.

Staff alerts, enhanced case identification, intensified infection control and isolation practices, and terminal bleaching of rooms when patients were transferred or discharged brought the outbreak under control, reported Shilpa M. Patel, M.D., a fellow in the department of infectious disease.

LOS ANGELES — Several hospitals faced with outbreaks of a virulent strain of Clostridium difficile brought the spread of disease under control with stepped-up infection control measures and altered antibiotic prescribing practices.

Early identification of cases, isolation precautions, cleaning of rooms with a bleach solution, replacement of alcohol-based hand rubs with soap and water, and targeted antibiotic restrictions all were cited in institutional success stories described at the annual meeting of the Society for Healthcare Epidemiology of America.

Mary K. Blank described a multipronged strategy used at the University of Pittsburgh Medical Center that brought the incidence of hospital-acquired C. difficile infection down from a high of 7.2 per 1,000 discharges in 2000 to 4.6 per 1,000 in 2004.

The University of Pittsburgh was one of the first hospitals to report the emergence of a highly toxic strain of C. difficile associated with increased colectomies and patient deaths. A crackdown on C. difficile began in 2000 with active surveillance. At-risk patients were identified on the basis of prolonged length of stay, antibiotic use, high or low white blood cell count, and/or bandemia.

Patients with symptoms suggesting C. difficile infection were isolated and all charts were electronically flagged when the diagnosis was made. Clinicians and other staff members were informed of heightened infection-control requirements maintained throughout the patient's stay. Rooms were cleaned with a 1:10 bleach solution, and alcohol-based hand cleaners were replaced with soap and water.

A C. difficile management team treated each patient, prescribing oral or intravenous metronidazole for most of them, often in conjunction with oral vancomycin for 14 days.

A case-control study linked the use of levofloxacin, clindamycin, and ceftriaxone to the hospital's outbreak, so physicians were required to get prior approval for using those drugs.

At Northwestern University, similar precautions were implemented following the C. difficile-related deaths of two patients in 3 days who had been housed in adjacent rooms in an oncology unit.

An investigation identified 8 patients in the oncology and medical intensive care units colonized with the outbreak strain and 17 patients in those and other units colonized or infected with another toxigenic strain of C. difficile.

Staff alerts, enhanced case identification, intensified infection control and isolation practices, and terminal bleaching of rooms when patients were transferred or discharged brought the outbreak under control, reported Shilpa M. Patel, M.D., a fellow in the department of infectious disease.

WAILEA, HAWAII — Ice, vibrators, "talk-esthesia," and sundry topical anesthetic creams and gels were advocated as safe and effective options for relieving pain during a mini-symposium at the annual Hawaii dermatology seminar sponsored by the Skin Disease Education Foundation.

"How much is a happy patient worth? If you hurt them, they won't come back," said Kevin C. Smith, M.D., a dermatologist practicing in Niagara Falls, Ont.

The discussion focused on patients undergoing cosmetic procedures, but the techniques, listed here, can be used on medical dermatology patients as well:

▸ Ice. It's effective and about as cheap as pain relief gets. "We use it a lot," said Alastair Carruthers, M.B., a dermatologist in practice in Vancouver, B.C.

▸ Vibrators. Snickers aside, the Hitachi Magic Wand with a Wonder Wand attachment provides excellent pain relief when applied under a patient's chin during facial procedures by blocking pain signals to the brain, said Dr. Smith.

The devices can be found at the Web site www.drugstore.com

▸ Talk therapy. "It's not enough to put some cream on a patient," Dr. Smith said. From the time a patient first calls the office, the staff and the physician should convey calm reassurance. Patients will have less pain if they feel "confident of your skill and your care."

He said he always uses "talk-esthesia" to talk patients through procedures, even when other forms of pain relief are used.

▸ Analgesics. Some procedures call for up-front pain relief. Dr. Smith sometimes advises patients to take an NSAID in combination with acetaminophen for an additive effect. Patients who do not have asthma may be prescribed propranolol, which provides analgesia but does not interfere with a patient's ability to drive.

▸ L.M.X. 4. This 4% lidocaine cream (formerly ELA-Max 4%) is sold over the counter, does not require occlusion, and provides anesthesia 30 minutes after application, Dr. Carruthers explained.

He tested it against a vehicle cream in 24 patients receiving Botox (botulinum toxin type A) injections for crow's feet.

"I like to think this is not a very painful procedure, so in order to reduce the discomfort, this stuff has to work very well," he said.

The study showed a significant difference in patient visual analogue scale scores and observer ratings of discomfort when L.M.X. 4 was used, with P values in the range of .005.

▸ L.M.X. 5. This anorectal anesthetic cream is more appropriate for use in the mouth than alcohol-containing topical gels, which can cause sloughing of mucous membranes and irritation and stinging if they get in the eyes, Dr. Smith said.

For lip procedures, optimal anesthesia can be obtained by numbing the mucosal surface of the lips, including the anterior mucosae of the anterior labioalveolar sulci down to the gingival sulcus as well as the vermilion and a 1-cm margin around the vermilion border.

To achieve this without getting anesthetic all over the inside of the patient's mouth, he cuts a Telfa pad to mimic a plastic laser shield designed to protect the teeth from laser work performed around the mouth. He cuts a 3-by-4-inch Telfa pad in half, lengthwise, then folds it over and cuts a slit in the middle (to allow the patient to breathe) and slits at the top and bottom to accommodate the frenula.

He inserts the pad into the patient's mouth, against the teeth. He then uses a tongue depressor to apply L.M.X. 5 thickly over the lips and gums and attends to other patients for 30-45 minutes, until his watch alarm sounds to remind him to return to perform the procedure.

At that time, he can inject lidocaine painlessly or, for simple filler procedures, move directly to injections of Restylane (nonanimal stabilized hyaluronic acid gel).

Dr. Smith noted that previous research has determined that the anesthetic mixture in L.M.X. 5 does not produce toxic blood levels, even when applied to mucous membranes.

Dr. Carruthers disclosed that he has financial ties to Allergan Inc., which distributes Botox. Dr. Smith received L.M.X. 5 samples from Ferndale Laboratories Inc. for his research.

The Skin Disease Education Foundation and this newspaper are wholly owned subsidiaries of Elsevier.

WAILEA, HAWAII — Ice, vibrators, "talk-esthesia," and sundry topical anesthetic creams and gels were advocated as safe and effective options for relieving pain during a mini-symposium at the annual Hawaii dermatology seminar sponsored by the Skin Disease Education Foundation.

"How much is a happy patient worth? If you hurt them, they won't come back," said Kevin C. Smith, M.D., a dermatologist practicing in Niagara Falls, Ont.

The discussion focused on patients undergoing cosmetic procedures, but the techniques, listed here, can be used on medical dermatology patients as well:

▸ Ice. It's effective and about as cheap as pain relief gets. "We use it a lot," said Alastair Carruthers, M.B., a dermatologist in practice in Vancouver, B.C.

▸ Vibrators. Snickers aside, the Hitachi Magic Wand with a Wonder Wand attachment provides excellent pain relief when applied under a patient's chin during facial procedures by blocking pain signals to the brain, said Dr. Smith.

The devices can be found at the Web site www.drugstore.com

▸ Talk therapy. "It's not enough to put some cream on a patient," Dr. Smith said. From the time a patient first calls the office, the staff and the physician should convey calm reassurance. Patients will have less pain if they feel "confident of your skill and your care."

He said he always uses "talk-esthesia" to talk patients through procedures, even when other forms of pain relief are used.

▸ Analgesics. Some procedures call for up-front pain relief. Dr. Smith sometimes advises patients to take an NSAID in combination with acetaminophen for an additive effect. Patients who do not have asthma may be prescribed propranolol, which provides analgesia but does not interfere with a patient's ability to drive.

▸ L.M.X. 4. This 4% lidocaine cream (formerly ELA-Max 4%) is sold over the counter, does not require occlusion, and provides anesthesia 30 minutes after application, Dr. Carruthers explained.

He tested it against a vehicle cream in 24 patients receiving Botox (botulinum toxin type A) injections for crow's feet.

"I like to think this is not a very painful procedure, so in order to reduce the discomfort, this stuff has to work very well," he said.

The study showed a significant difference in patient visual analogue scale scores and observer ratings of discomfort when L.M.X. 4 was used, with P values in the range of .005.

▸ L.M.X. 5. This anorectal anesthetic cream is more appropriate for use in the mouth than alcohol-containing topical gels, which can cause sloughing of mucous membranes and irritation and stinging if they get in the eyes, Dr. Smith said.

For lip procedures, optimal anesthesia can be obtained by numbing the mucosal surface of the lips, including the anterior mucosae of the anterior labioalveolar sulci down to the gingival sulcus as well as the vermilion and a 1-cm margin around the vermilion border.

To achieve this without getting anesthetic all over the inside of the patient's mouth, he cuts a Telfa pad to mimic a plastic laser shield designed to protect the teeth from laser work performed around the mouth. He cuts a 3-by-4-inch Telfa pad in half, lengthwise, then folds it over and cuts a slit in the middle (to allow the patient to breathe) and slits at the top and bottom to accommodate the frenula.

He inserts the pad into the patient's mouth, against the teeth. He then uses a tongue depressor to apply L.M.X. 5 thickly over the lips and gums and attends to other patients for 30-45 minutes, until his watch alarm sounds to remind him to return to perform the procedure.

At that time, he can inject lidocaine painlessly or, for simple filler procedures, move directly to injections of Restylane (nonanimal stabilized hyaluronic acid gel).

Dr. Smith noted that previous research has determined that the anesthetic mixture in L.M.X. 5 does not produce toxic blood levels, even when applied to mucous membranes.

Dr. Carruthers disclosed that he has financial ties to Allergan Inc., which distributes Botox. Dr. Smith received L.M.X. 5 samples from Ferndale Laboratories Inc. for his research.

The Skin Disease Education Foundation and this newspaper are wholly owned subsidiaries of Elsevier.

WAILEA, HAWAII — Ice, vibrators, "talk-esthesia," and sundry topical anesthetic creams and gels were advocated as safe and effective options for relieving pain during a mini-symposium at the annual Hawaii dermatology seminar sponsored by the Skin Disease Education Foundation.

"How much is a happy patient worth? If you hurt them, they won't come back," said Kevin C. Smith, M.D., a dermatologist practicing in Niagara Falls, Ont.

The discussion focused on patients undergoing cosmetic procedures, but the techniques, listed here, can be used on medical dermatology patients as well:

▸ Ice. It's effective and about as cheap as pain relief gets. "We use it a lot," said Alastair Carruthers, M.B., a dermatologist in practice in Vancouver, B.C.

▸ Vibrators. Snickers aside, the Hitachi Magic Wand with a Wonder Wand attachment provides excellent pain relief when applied under a patient's chin during facial procedures by blocking pain signals to the brain, said Dr. Smith.

The devices can be found at the Web site www.drugstore.com

▸ Talk therapy. "It's not enough to put some cream on a patient," Dr. Smith said. From the time a patient first calls the office, the staff and the physician should convey calm reassurance. Patients will have less pain if they feel "confident of your skill and your care."

He said he always uses "talk-esthesia" to talk patients through procedures, even when other forms of pain relief are used.

▸ Analgesics. Some procedures call for up-front pain relief. Dr. Smith sometimes advises patients to take an NSAID in combination with acetaminophen for an additive effect. Patients who do not have asthma may be prescribed propranolol, which provides analgesia but does not interfere with a patient's ability to drive.

▸ L.M.X. 4. This 4% lidocaine cream (formerly ELA-Max 4%) is sold over the counter, does not require occlusion, and provides anesthesia 30 minutes after application, Dr. Carruthers explained.

He tested it against a vehicle cream in 24 patients receiving Botox (botulinum toxin type A) injections for crow's feet.

"I like to think this is not a very painful procedure, so in order to reduce the discomfort, this stuff has to work very well," he said.

The study showed a significant difference in patient visual analogue scale scores and observer ratings of discomfort when L.M.X. 4 was used, with P values in the range of .005.

▸ L.M.X. 5. This anorectal anesthetic cream is more appropriate for use in the mouth than alcohol-containing topical gels, which can cause sloughing of mucous membranes and irritation and stinging if they get in the eyes, Dr. Smith said.

For lip procedures, optimal anesthesia can be obtained by numbing the mucosal surface of the lips, including the anterior mucosae of the anterior labioalveolar sulci down to the gingival sulcus as well as the vermilion and a 1-cm margin around the vermilion border.

To achieve this without getting anesthetic all over the inside of the patient's mouth, he cuts a Telfa pad to mimic a plastic laser shield designed to protect the teeth from laser work performed around the mouth. He cuts a 3-by-4-inch Telfa pad in half, lengthwise, then folds it over and cuts a slit in the middle (to allow the patient to breathe) and slits at the top and bottom to accommodate the frenula.

He inserts the pad into the patient's mouth, against the teeth. He then uses a tongue depressor to apply L.M.X. 5 thickly over the lips and gums and attends to other patients for 30-45 minutes, until his watch alarm sounds to remind him to return to perform the procedure.

At that time, he can inject lidocaine painlessly or, for simple filler procedures, move directly to injections of Restylane (nonanimal stabilized hyaluronic acid gel).

Dr. Smith noted that previous research has determined that the anesthetic mixture in L.M.X. 5 does not produce toxic blood levels, even when applied to mucous membranes.

Dr. Carruthers disclosed that he has financial ties to Allergan Inc., which distributes Botox. Dr. Smith received L.M.X. 5 samples from Ferndale Laboratories Inc. for his research.

The Skin Disease Education Foundation and this newspaper are wholly owned subsidiaries of Elsevier.

FLORENCE, ITALY — Multiple skin leiomyomas may be the first sign of multiple cutaneous and uterine leiomyomatosis, a hereditary disease that can include highly symptomatic uterine fibroids and, in a small percentage of cases, aggressive renal cancer, N. Afrina Alam, M.B., reported at the 13th Congress of the European Academy of Dermatology and Venereology.

Dr. Alam has been working with a multidisciplinary team studying this disease, once thought rare. Just 20 cases had been reported worldwide a few years ago when she began studying multiple cutaneous and uterine leiomyomatosis (MCUL), said Dr. Alam, formerly of the Centre for Cutaneous Research at St. Bartholomew's Hospital and the London.

Cutaneous leiomyomas appear in patients in their teens or 20s, and they are “very variable in their severity,” said Dr. Alam, now of St. John's Institute of Dermatology at St. Thomas Hospital in London. She found 50 index cases herself, and in the ensuing years, significantly more cases have been identified in the United Kingdom and elsewhere.

In a study of 108 patients with MCUL, the mean number of skin leiomyomas was 25. Nearly 90% of patients reported at least one painful skin lesion.

Skin lesions tend to predate other manifestations of the disease by 5ndash;10 years, making them critically important in terms of their diagnostic relevance, Dr. Alam said.

If uterine leiomyomas develop as part of the syndrome, they are histologically indistinguishable from other fibroids but tend to be “very severely symptomatic, with a high risk of hysterectomy,” she said. By age 55, more than half of women with the syndrome had undergone hysterectomies.

The UK team identified aggressive renal cancer in 9 of 89 families carrying the multiple leiomyomatosis gene. One study subject died of metastatic renal carcinoma at age 18 years.

Researchers who have studied the MCUL's genetic profile have found that highly penetrant mutations in an enzyme on chromosome 1 cause the condition, an autosomal dominant disease. A host of mutations has been found in affected families, and certain patterns have emerged.

For example, a mutation dubbed G354R FH appears to be associated with uterine fibroids without skin manifestations. Certain truncating mutations, especially frameshift mutations, appear to be linked to development of renal cancer, which was far more common in females than in males in the MCUL study.

Among 26 males carrying any MCUL mutation, all 26 had skin leiomyomas. Among 67 female mutation carriers, 46 had both skin and uterine leiomyomas, 10 had only skin leiomyomas, and 5 had only uterine leiomyomas. Mutations in six patients were nonpenetrant.

FLORENCE, ITALY — Multiple skin leiomyomas may be the first sign of multiple cutaneous and uterine leiomyomatosis, a hereditary disease that can include highly symptomatic uterine fibroids and, in a small percentage of cases, aggressive renal cancer, N. Afrina Alam, M.B., reported at the 13th Congress of the European Academy of Dermatology and Venereology.

Dr. Alam has been working with a multidisciplinary team studying this disease, once thought rare. Just 20 cases had been reported worldwide a few years ago when she began studying multiple cutaneous and uterine leiomyomatosis (MCUL), said Dr. Alam, formerly of the Centre for Cutaneous Research at St. Bartholomew's Hospital and the London.

Cutaneous leiomyomas appear in patients in their teens or 20s, and they are “very variable in their severity,” said Dr. Alam, now of St. John's Institute of Dermatology at St. Thomas Hospital in London. She found 50 index cases herself, and in the ensuing years, significantly more cases have been identified in the United Kingdom and elsewhere.

In a study of 108 patients with MCUL, the mean number of skin leiomyomas was 25. Nearly 90% of patients reported at least one painful skin lesion.

Skin lesions tend to predate other manifestations of the disease by 5ndash;10 years, making them critically important in terms of their diagnostic relevance, Dr. Alam said.

If uterine leiomyomas develop as part of the syndrome, they are histologically indistinguishable from other fibroids but tend to be “very severely symptomatic, with a high risk of hysterectomy,” she said. By age 55, more than half of women with the syndrome had undergone hysterectomies.

The UK team identified aggressive renal cancer in 9 of 89 families carrying the multiple leiomyomatosis gene. One study subject died of metastatic renal carcinoma at age 18 years.

Researchers who have studied the MCUL's genetic profile have found that highly penetrant mutations in an enzyme on chromosome 1 cause the condition, an autosomal dominant disease. A host of mutations has been found in affected families, and certain patterns have emerged.

For example, a mutation dubbed G354R FH appears to be associated with uterine fibroids without skin manifestations. Certain truncating mutations, especially frameshift mutations, appear to be linked to development of renal cancer, which was far more common in females than in males in the MCUL study.

Among 26 males carrying any MCUL mutation, all 26 had skin leiomyomas. Among 67 female mutation carriers, 46 had both skin and uterine leiomyomas, 10 had only skin leiomyomas, and 5 had only uterine leiomyomas. Mutations in six patients were nonpenetrant.

FLORENCE, ITALY — Multiple skin leiomyomas may be the first sign of multiple cutaneous and uterine leiomyomatosis, a hereditary disease that can include highly symptomatic uterine fibroids and, in a small percentage of cases, aggressive renal cancer, N. Afrina Alam, M.B., reported at the 13th Congress of the European Academy of Dermatology and Venereology.

Dr. Alam has been working with a multidisciplinary team studying this disease, once thought rare. Just 20 cases had been reported worldwide a few years ago when she began studying multiple cutaneous and uterine leiomyomatosis (MCUL), said Dr. Alam, formerly of the Centre for Cutaneous Research at St. Bartholomew's Hospital and the London.

Cutaneous leiomyomas appear in patients in their teens or 20s, and they are “very variable in their severity,” said Dr. Alam, now of St. John's Institute of Dermatology at St. Thomas Hospital in London. She found 50 index cases herself, and in the ensuing years, significantly more cases have been identified in the United Kingdom and elsewhere.

In a study of 108 patients with MCUL, the mean number of skin leiomyomas was 25. Nearly 90% of patients reported at least one painful skin lesion.

Skin lesions tend to predate other manifestations of the disease by 5ndash;10 years, making them critically important in terms of their diagnostic relevance, Dr. Alam said.

If uterine leiomyomas develop as part of the syndrome, they are histologically indistinguishable from other fibroids but tend to be “very severely symptomatic, with a high risk of hysterectomy,” she said. By age 55, more than half of women with the syndrome had undergone hysterectomies.

The UK team identified aggressive renal cancer in 9 of 89 families carrying the multiple leiomyomatosis gene. One study subject died of metastatic renal carcinoma at age 18 years.

Researchers who have studied the MCUL's genetic profile have found that highly penetrant mutations in an enzyme on chromosome 1 cause the condition, an autosomal dominant disease. A host of mutations has been found in affected families, and certain patterns have emerged.

For example, a mutation dubbed G354R FH appears to be associated with uterine fibroids without skin manifestations. Certain truncating mutations, especially frameshift mutations, appear to be linked to development of renal cancer, which was far more common in females than in males in the MCUL study.

Among 26 males carrying any MCUL mutation, all 26 had skin leiomyomas. Among 67 female mutation carriers, 46 had both skin and uterine leiomyomas, 10 had only skin leiomyomas, and 5 had only uterine leiomyomas. Mutations in six patients were nonpenetrant.

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

At least 10 Florida physicians 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 told FAMILY PRACTICE NEWS 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 osteopathic physician 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; but an Allergan spokesperson said company scientists have calculated that it may have contained up to 10 million units. 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, after spending months in a 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 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.

Physicians from Utah and California quoted in the affidavit did not respond to this newspaper's requests for comment.

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

Florida Secretary of Health John O. Agwunobi, M.D., issued a statement saying, “Any practitioner that knowingly purchased unregulated products with the intent to use on their patients should be fully investigated and disciplined accordingly.”

“This company [TRI] skirted Florida's regulations, placing our citizens at risk, simply to make a fast buck; even worse are these abhorrent licensed practitioners who knowingly placed their patients in harm's way,” Dr. Agwunobi said.

To read the complaint filed in U.S. District Court, Southern District of Florida, visit www.usdoj.gov/usao/fls

Feds Eyeing Sales of Unauthorized Botox

Leaders in cosmetic dermatology at the annual Hawaii dermatology seminar offered words of caution about the use of unapproved products and cut-rate versions of Food and Drug Administration-approved materials and medications.

“Beware,” warned David J. Goldberg, M.D., J.D., a dermatologist with a specialty practice in New York and New Jersey. A recent scandal in Florida involving the paralysis of four patients with an improperly diluted, unapproved formulation of botulinum toxin type A led to a federal investigation of a network distributing what authorities called “fake Botox” to physicians across the country. (See story on this page.)

Physicians face possible suspension of their licenses following injection of patients with the unapproved toxin, and the repercussions aren't likely to stop there, speakers said at the meeting.

Michael H. Gold, M.D., a dermatologist in a specialty practice in Nashville, Tenn., noted that unapproved products can be “easily obtained” in Canada and elsewhere. “Be careful about where you get your products and how you do it,” he warned his colleagues at the seminar, sponsored by the Skin Disease Education Foundation (SDEF). “Just be reminded that if something goes wrong, you have no leg to stand on.”

Because of recent cases, “the FDA and, more frighteningly, the FBI are considerably more aware of the dangers that can occur to the American people as a result of illegal importation [or use] of material,” noted Alastair Carruthers, M.D., who is credited along with his wife, Jean Carruthers, M.D., with pioneering the cosmetic use of Botox.

Dr. Carruthers, who disclosed financial ties to Allergan Inc., the manufacturer of Botox, said in a later interview that he thinks many physicians may be taking undue risks. “We've lost sight as a group that these regulatory processes are there for a purpose,” said the Vancouver, B.C.-based dermatologic surgeon.

“Thirty-five hundred doctors in the U.S. were using Restylane before it had FDA approval. We have to ask, why are we doing this?” Now that Restylane has been approved, Dr. Carruthers said there is “no justification but greed [for bootlegging Juvederm].” Black market botulinum toxin may pose serious risks to patients, as it did in the Florida case.

The SDEF and this newspaper both are wholly owned subsidiaries of Elsevier.

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

At least 10 Florida physicians 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 told FAMILY PRACTICE NEWS 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 osteopathic physician 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; but an Allergan spokesperson said company scientists have calculated that it may have contained up to 10 million units. 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, after spending months in a 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 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.

Physicians from Utah and California quoted in the affidavit did not respond to this newspaper's requests for comment.

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

Florida Secretary of Health John O. Agwunobi, M.D., issued a statement saying, “Any practitioner that knowingly purchased unregulated products with the intent to use on their patients should be fully investigated and disciplined accordingly.”

“This company [TRI] skirted Florida's regulations, placing our citizens at risk, simply to make a fast buck; even worse are these abhorrent licensed practitioners who knowingly placed their patients in harm's way,” Dr. Agwunobi said.

To read the complaint filed in U.S. District Court, Southern District of Florida, visit www.usdoj.gov/usao/fls

Feds Eyeing Sales of Unauthorized Botox

Leaders in cosmetic dermatology at the annual Hawaii dermatology seminar offered words of caution about the use of unapproved products and cut-rate versions of Food and Drug Administration-approved materials and medications.

“Beware,” warned David J. Goldberg, M.D., J.D., a dermatologist with a specialty practice in New York and New Jersey. A recent scandal in Florida involving the paralysis of four patients with an improperly diluted, unapproved formulation of botulinum toxin type A led to a federal investigation of a network distributing what authorities called “fake Botox” to physicians across the country. (See story on this page.)

Physicians face possible suspension of their licenses following injection of patients with the unapproved toxin, and the repercussions aren't likely to stop there, speakers said at the meeting.

Michael H. Gold, M.D., a dermatologist in a specialty practice in Nashville, Tenn., noted that unapproved products can be “easily obtained” in Canada and elsewhere. “Be careful about where you get your products and how you do it,” he warned his colleagues at the seminar, sponsored by the Skin Disease Education Foundation (SDEF). “Just be reminded that if something goes wrong, you have no leg to stand on.”

Because of recent cases, “the FDA and, more frighteningly, the FBI are considerably more aware of the dangers that can occur to the American people as a result of illegal importation [or use] of material,” noted Alastair Carruthers, M.D., who is credited along with his wife, Jean Carruthers, M.D., with pioneering the cosmetic use of Botox.

Dr. Carruthers, who disclosed financial ties to Allergan Inc., the manufacturer of Botox, said in a later interview that he thinks many physicians may be taking undue risks. “We've lost sight as a group that these regulatory processes are there for a purpose,” said the Vancouver, B.C.-based dermatologic surgeon.

“Thirty-five hundred doctors in the U.S. were using Restylane before it had FDA approval. We have to ask, why are we doing this?” Now that Restylane has been approved, Dr. Carruthers said there is “no justification but greed [for bootlegging Juvederm].” Black market botulinum toxin may pose serious risks to patients, as it did in the Florida case.

The SDEF and this newspaper both are wholly owned subsidiaries of Elsevier.

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

At least 10 Florida physicians 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 told FAMILY PRACTICE NEWS 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 osteopathic physician 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; but an Allergan spokesperson said company scientists have calculated that it may have contained up to 10 million units. 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, after spending months in a 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 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.

Physicians from Utah and California quoted in the affidavit did not respond to this newspaper's requests for comment.

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

Florida Secretary of Health John O. Agwunobi, M.D., issued a statement saying, “Any practitioner that knowingly purchased unregulated products with the intent to use on their patients should be fully investigated and disciplined accordingly.”

“This company [TRI] skirted Florida's regulations, placing our citizens at risk, simply to make a fast buck; even worse are these abhorrent licensed practitioners who knowingly placed their patients in harm's way,” Dr. Agwunobi said.

To read the complaint filed in U.S. District Court, Southern District of Florida, visit www.usdoj.gov/usao/fls

Feds Eyeing Sales of Unauthorized Botox

Leaders in cosmetic dermatology at the annual Hawaii dermatology seminar offered words of caution about the use of unapproved products and cut-rate versions of Food and Drug Administration-approved materials and medications.

“Beware,” warned David J. Goldberg, M.D., J.D., a dermatologist with a specialty practice in New York and New Jersey. A recent scandal in Florida involving the paralysis of four patients with an improperly diluted, unapproved formulation of botulinum toxin type A led to a federal investigation of a network distributing what authorities called “fake Botox” to physicians across the country. (See story on this page.)

Physicians face possible suspension of their licenses following injection of patients with the unapproved toxin, and the repercussions aren't likely to stop there, speakers said at the meeting.

Michael H. Gold, M.D., a dermatologist in a specialty practice in Nashville, Tenn., noted that unapproved products can be “easily obtained” in Canada and elsewhere. “Be careful about where you get your products and how you do it,” he warned his colleagues at the seminar, sponsored by the Skin Disease Education Foundation (SDEF). “Just be reminded that if something goes wrong, you have no leg to stand on.”

Because of recent cases, “the FDA and, more frighteningly, the FBI are considerably more aware of the dangers that can occur to the American people as a result of illegal importation [or use] of material,” noted Alastair Carruthers, M.D., who is credited along with his wife, Jean Carruthers, M.D., with pioneering the cosmetic use of Botox.

Dr. Carruthers, who disclosed financial ties to Allergan Inc., the manufacturer of Botox, said in a later interview that he thinks many physicians may be taking undue risks. “We've lost sight as a group that these regulatory processes are there for a purpose,” said the Vancouver, B.C.-based dermatologic surgeon.

“Thirty-five hundred doctors in the U.S. were using Restylane before it had FDA approval. We have to ask, why are we doing this?” Now that Restylane has been approved, Dr. Carruthers said there is “no justification but greed [for bootlegging Juvederm].” Black market botulinum toxin may pose serious risks to patients, as it did in the Florida case.

The SDEF and this newspaper both are wholly owned subsidiaries of Elsevier.

LOS ANGELES — When cholecystectomy is indicated following gallstone pancreatitis, the severity of the disease should determine timing of the surgery, Nicholas N. Nissen, M.D., said at the 12th International Symposium on Pancreatic and Biliary Endoscopy sponsored by the Cedars-Sinai Medical Center.

Surgical residents are traditionally taught to perform cholecystectomy before hospital discharge—and definitely within 4 weeks of symptom onset—to avoid complications.

That rule still holds for patients with mild or moderate gallstone pancreatitis.

But for patients with severe disease, it's a different story, noted Dr. Nissen, assistant surgical director of multiorgan transplantation and a specialist in minimally invasive liver and pancreas surgery at the medical center.

“Cholecystectomy in these patients should clearly wait until severe inflammation and organ dysfunction are resolved. It should certainly not be done in the first few weeks [after the onset of symptoms of severe gallstone pancreatitis],” said Dr. Nissen, who also serves on the surgical faculty at the University of California, Los Angeles.

LOS ANGELES — When cholecystectomy is indicated following gallstone pancreatitis, the severity of the disease should determine timing of the surgery, Nicholas N. Nissen, M.D., said at the 12th International Symposium on Pancreatic and Biliary Endoscopy sponsored by the Cedars-Sinai Medical Center.

Surgical residents are traditionally taught to perform cholecystectomy before hospital discharge—and definitely within 4 weeks of symptom onset—to avoid complications.

That rule still holds for patients with mild or moderate gallstone pancreatitis.

But for patients with severe disease, it's a different story, noted Dr. Nissen, assistant surgical director of multiorgan transplantation and a specialist in minimally invasive liver and pancreas surgery at the medical center.

“Cholecystectomy in these patients should clearly wait until severe inflammation and organ dysfunction are resolved. It should certainly not be done in the first few weeks [after the onset of symptoms of severe gallstone pancreatitis],” said Dr. Nissen, who also serves on the surgical faculty at the University of California, Los Angeles.

LOS ANGELES — When cholecystectomy is indicated following gallstone pancreatitis, the severity of the disease should determine timing of the surgery, Nicholas N. Nissen, M.D., said at the 12th International Symposium on Pancreatic and Biliary Endoscopy sponsored by the Cedars-Sinai Medical Center.

Surgical residents are traditionally taught to perform cholecystectomy before hospital discharge—and definitely within 4 weeks of symptom onset—to avoid complications.

That rule still holds for patients with mild or moderate gallstone pancreatitis.

But for patients with severe disease, it's a different story, noted Dr. Nissen, assistant surgical director of multiorgan transplantation and a specialist in minimally invasive liver and pancreas surgery at the medical center.

“Cholecystectomy in these patients should clearly wait until severe inflammation and organ dysfunction are resolved. It should certainly not be done in the first few weeks [after the onset of symptoms of severe gallstone pancreatitis],” said Dr. Nissen, who also serves on the surgical faculty at the University of California, Los Angeles.

PALM SPRINGS, CALIF. — Physicians who doubt that chronic pain patients need and deserve cognitive-behavioral therapy as an adjunct to other treatments need to take an honest look at how well modern medicine treats pain, Dennis C. Turk, Ph.D., said at the annual meeting of the American Academy of Pain Medicine.

Opioids reduce severe, chronic pain by only about a third. Moreover, up to 50% patients discontinue opioid therapy because of a lack of efficacy or because of side effects.

At the end of interventional pain trials, the vast majority of patients have improved so little they would still qualify for a new trial.

Even surgical procedures that sever neurologic pathways believed to be responsible for a patient's pain often fail to alleviate the symptoms.

“Our best efforts still by and large don't cure people,” said Dr. Turk, professor of anesthesiology at the University of Washington, Seattle.

Pain is real, but it is a subjective perception “resulting from the transduction, transmission, and modulation of sensory input filtered through a person's genetic composition and prior learning history and modulated further by [the person's] current physiological status, idiosyncratic appraisals, expectations, current mood state, and sociocultural environment,” he said. In other words, “that arm or neck or shoulder is attached to a human being with a social context and with a history.”

Underlying physical pain are emotional responses: fear, uncertainty, demoralization, and worry about the future. A family is involved, suffering as well.

Offering or referring patients for cognitive-behavioral therapy (CBT) acknowledges that pain may not be curable in every patient and recognizes that life must go on around it. It also gives patients credit for being capable of actively processing information and learning adaptive ways of thinking, feeling, and behaving, Dr. Turk said.

The exact CBT technique used is less important than the characteristics of the approach in general, according to Dr. Turk. All CBT should be:

▸ Problem-oriented.

▸ Time-limited.

▸ Educational.

▸ Collaborative (between patient and provider, and perhaps family members as well).

▸ Practical, using clinic and home exercises to consolidate skills and identify problem areas.

▸ Anticipatory of setbacks and lapses and able to teach patients how to deal with these.

In the context of pain, CBT can be particularly effective in helping patients reconceptualize their problems, making seemingly overwhelming hurdles become manageable.

It can help patients to believe they have the skills necessary to solve problems, transforming them from being passive and helpless to being “active, resourceful, competent,” Dr. Turk said.

By utilizing real examples in a patient's life, CBT can help individuals recognize unhelpful thinking patterns such as overgeneralization, catastrophizing, seeing things in all-or-none terms, jumping to conclusions, selectively focusing on details rather than the big picture, and mind-reading the thoughts of others.

A CBT therapist then helps a patient learn to recognize problems associated with a life of pain and then propose his or her own adaptive solutions. Examples might include feeling bored and restless because of diminished activities, experiencing disharmony in family members due to altered roles, or suffering diminished self-esteem when a patient in chronic pain can no longer work.

A good CBT therapist guides the patient to set realistic solutions approached with step-by-step goals, practiced in sessions and during homework sessions tracked with diaries and charts.

Dr. Turk said he makes success highly attainable from session to session.

For example, if increased mobility is a goal and the patient already believes he can walk 1 block, he sets the bar at walking 8/10 of a block every few days for the first week.

Monitoring, reinforcement, listening, and adapting to changing realities are all key to CBT success. Perhaps most important is the anticipation of nonadherence. Right from the start, a therapist can tell patients to expect flare-ups in pain and “slip-ups” in behavior, and a plan can be devised to deal with those situations before they occur.

Adherence to a CBT Plan

Anticipate nonadherence.

Consider the prescribed regimen from the patient's perspective.

Foster a collaborative relationship based on negotiation.

Prepare for flare-ups.

Customize treatment.

Enlist family support.

Provide a system of continuity and accessibility.

Make use of other health care providers (such as occupational or physical therapists) as well as community resources.

Repeat, repeat, repeat everything.

Don't give up! Pain specialists represent Ellis Island or Lourdes to chronic pain patients. If they were easy patients, “they wouldn't be seeing you.”

Source: Dr. Turk

PALM SPRINGS, CALIF. — Physicians who doubt that chronic pain patients need and deserve cognitive-behavioral therapy as an adjunct to other treatments need to take an honest look at how well modern medicine treats pain, Dennis C. Turk, Ph.D., said at the annual meeting of the American Academy of Pain Medicine.

Opioids reduce severe, chronic pain by only about a third. Moreover, up to 50% patients discontinue opioid therapy because of a lack of efficacy or because of side effects.

At the end of interventional pain trials, the vast majority of patients have improved so little they would still qualify for a new trial.

Even surgical procedures that sever neurologic pathways believed to be responsible for a patient's pain often fail to alleviate the symptoms.

“Our best efforts still by and large don't cure people,” said Dr. Turk, professor of anesthesiology at the University of Washington, Seattle.

Pain is real, but it is a subjective perception “resulting from the transduction, transmission, and modulation of sensory input filtered through a person's genetic composition and prior learning history and modulated further by [the person's] current physiological status, idiosyncratic appraisals, expectations, current mood state, and sociocultural environment,” he said. In other words, “that arm or neck or shoulder is attached to a human being with a social context and with a history.”

Underlying physical pain are emotional responses: fear, uncertainty, demoralization, and worry about the future. A family is involved, suffering as well.

Offering or referring patients for cognitive-behavioral therapy (CBT) acknowledges that pain may not be curable in every patient and recognizes that life must go on around it. It also gives patients credit for being capable of actively processing information and learning adaptive ways of thinking, feeling, and behaving, Dr. Turk said.

The exact CBT technique used is less important than the characteristics of the approach in general, according to Dr. Turk. All CBT should be:

▸ Problem-oriented.

▸ Time-limited.

▸ Educational.

▸ Collaborative (between patient and provider, and perhaps family members as well).

▸ Practical, using clinic and home exercises to consolidate skills and identify problem areas.

▸ Anticipatory of setbacks and lapses and able to teach patients how to deal with these.

In the context of pain, CBT can be particularly effective in helping patients reconceptualize their problems, making seemingly overwhelming hurdles become manageable.

It can help patients to believe they have the skills necessary to solve problems, transforming them from being passive and helpless to being “active, resourceful, competent,” Dr. Turk said.

By utilizing real examples in a patient's life, CBT can help individuals recognize unhelpful thinking patterns such as overgeneralization, catastrophizing, seeing things in all-or-none terms, jumping to conclusions, selectively focusing on details rather than the big picture, and mind-reading the thoughts of others.

A CBT therapist then helps a patient learn to recognize problems associated with a life of pain and then propose his or her own adaptive solutions. Examples might include feeling bored and restless because of diminished activities, experiencing disharmony in family members due to altered roles, or suffering diminished self-esteem when a patient in chronic pain can no longer work.

A good CBT therapist guides the patient to set realistic solutions approached with step-by-step goals, practiced in sessions and during homework sessions tracked with diaries and charts.

Dr. Turk said he makes success highly attainable from session to session.

For example, if increased mobility is a goal and the patient already believes he can walk 1 block, he sets the bar at walking 8/10 of a block every few days for the first week.

Monitoring, reinforcement, listening, and adapting to changing realities are all key to CBT success. Perhaps most important is the anticipation of nonadherence. Right from the start, a therapist can tell patients to expect flare-ups in pain and “slip-ups” in behavior, and a plan can be devised to deal with those situations before they occur.

Adherence to a CBT Plan

Anticipate nonadherence.

Consider the prescribed regimen from the patient's perspective.

Foster a collaborative relationship based on negotiation.

Prepare for flare-ups.

Customize treatment.

Enlist family support.

Provide a system of continuity and accessibility.

Make use of other health care providers (such as occupational or physical therapists) as well as community resources.

Repeat, repeat, repeat everything.

Don't give up! Pain specialists represent Ellis Island or Lourdes to chronic pain patients. If they were easy patients, “they wouldn't be seeing you.”

Source: Dr. Turk

PALM SPRINGS, CALIF. — Physicians who doubt that chronic pain patients need and deserve cognitive-behavioral therapy as an adjunct to other treatments need to take an honest look at how well modern medicine treats pain, Dennis C. Turk, Ph.D., said at the annual meeting of the American Academy of Pain Medicine.

Opioids reduce severe, chronic pain by only about a third. Moreover, up to 50% patients discontinue opioid therapy because of a lack of efficacy or because of side effects.

At the end of interventional pain trials, the vast majority of patients have improved so little they would still qualify for a new trial.

Even surgical procedures that sever neurologic pathways believed to be responsible for a patient's pain often fail to alleviate the symptoms.

“Our best efforts still by and large don't cure people,” said Dr. Turk, professor of anesthesiology at the University of Washington, Seattle.

Pain is real, but it is a subjective perception “resulting from the transduction, transmission, and modulation of sensory input filtered through a person's genetic composition and prior learning history and modulated further by [the person's] current physiological status, idiosyncratic appraisals, expectations, current mood state, and sociocultural environment,” he said. In other words, “that arm or neck or shoulder is attached to a human being with a social context and with a history.”

Underlying physical pain are emotional responses: fear, uncertainty, demoralization, and worry about the future. A family is involved, suffering as well.

Offering or referring patients for cognitive-behavioral therapy (CBT) acknowledges that pain may not be curable in every patient and recognizes that life must go on around it. It also gives patients credit for being capable of actively processing information and learning adaptive ways of thinking, feeling, and behaving, Dr. Turk said.

The exact CBT technique used is less important than the characteristics of the approach in general, according to Dr. Turk. All CBT should be:

▸ Problem-oriented.

▸ Time-limited.

▸ Educational.

▸ Collaborative (between patient and provider, and perhaps family members as well).

▸ Practical, using clinic and home exercises to consolidate skills and identify problem areas.

▸ Anticipatory of setbacks and lapses and able to teach patients how to deal with these.

In the context of pain, CBT can be particularly effective in helping patients reconceptualize their problems, making seemingly overwhelming hurdles become manageable.

It can help patients to believe they have the skills necessary to solve problems, transforming them from being passive and helpless to being “active, resourceful, competent,” Dr. Turk said.

By utilizing real examples in a patient's life, CBT can help individuals recognize unhelpful thinking patterns such as overgeneralization, catastrophizing, seeing things in all-or-none terms, jumping to conclusions, selectively focusing on details rather than the big picture, and mind-reading the thoughts of others.

A CBT therapist then helps a patient learn to recognize problems associated with a life of pain and then propose his or her own adaptive solutions. Examples might include feeling bored and restless because of diminished activities, experiencing disharmony in family members due to altered roles, or suffering diminished self-esteem when a patient in chronic pain can no longer work.

A good CBT therapist guides the patient to set realistic solutions approached with step-by-step goals, practiced in sessions and during homework sessions tracked with diaries and charts.

Dr. Turk said he makes success highly attainable from session to session.

For example, if increased mobility is a goal and the patient already believes he can walk 1 block, he sets the bar at walking 8/10 of a block every few days for the first week.

Monitoring, reinforcement, listening, and adapting to changing realities are all key to CBT success. Perhaps most important is the anticipation of nonadherence. Right from the start, a therapist can tell patients to expect flare-ups in pain and “slip-ups” in behavior, and a plan can be devised to deal with those situations before they occur.

Adherence to a CBT Plan

Anticipate nonadherence.

Consider the prescribed regimen from the patient's perspective.

Foster a collaborative relationship based on negotiation.

Prepare for flare-ups.

Customize treatment.

Enlist family support.

Provide a system of continuity and accessibility.

Make use of other health care providers (such as occupational or physical therapists) as well as community resources.

Repeat, repeat, repeat everything.

Don't give up! Pain specialists represent Ellis Island or Lourdes to chronic pain patients. If they were easy patients, “they wouldn't be seeing you.”

Source: Dr. Turk

WAILEA, HAWAII — Leaders in cosmetic dermatology at the annual Hawaii dermatology seminar offered words of caution about the use of unapproved products and cut-rate versions of Food and Drug Administration-approved materials and medications.

“Beware,” warned David J. Goldberg, M.D., J.D., a dermatologist with a specialty practice in New York and New Jersey. A recent scandal in Florida involving the paralysis of four patients with an improperly diluted, unapproved formulation of botulinum toxin type A led to a federal investigation of a network distributing what authorities called “fake Botox” to physicians across the country. (See story on this page.)

Physicians face possible suspension of their licenses following injection of patients with the unapproved toxin, and the repercussions aren't likely to stop there, speakers said at the meeting.

Michael H. Gold, M.D., a dermatologist in a specialty practice in Nashville, Tenn., noted that unapproved products can be “easily obtained” in Canada and elsewhere. “Be careful about where you get your products and how you do it,” he warned his colleagues at the seminar, sponsored by the Skin Disease Education Foundation (SDEF). “Just be reminded that if something goes wrong, you have no leg to stand on.”

Because of recent cases, “the FDA and, more frighteningly, the FBI are considerably more aware of the dangers that can occur to the American people as a result of illegal importation [or use] of material,” noted Alastair Carruthers, M.D., who is credited along with his wife, Jean Carruthers, M.D., with pioneering the cosmetic use of Botox.

Dr. Carruthers, who disclosed financial ties to Allergan Inc., the manufacturer of Botox, said in a later interview that he thinks many physicians may be taking undue risks. “We've lost sight as a group that these regulatory processes are there for a purpose,” said the Vancouver, B.C.-based dermatologic surgeon.

The SDEF and this newspaper both are wholly owned subsidiaries of Elsevier.

WAILEA, HAWAII — Leaders in cosmetic dermatology at the annual Hawaii dermatology seminar offered words of caution about the use of unapproved products and cut-rate versions of Food and Drug Administration-approved materials and medications.

“Beware,” warned David J. Goldberg, M.D., J.D., a dermatologist with a specialty practice in New York and New Jersey. A recent scandal in Florida involving the paralysis of four patients with an improperly diluted, unapproved formulation of botulinum toxin type A led to a federal investigation of a network distributing what authorities called “fake Botox” to physicians across the country. (See story on this page.)

Physicians face possible suspension of their licenses following injection of patients with the unapproved toxin, and the repercussions aren't likely to stop there, speakers said at the meeting.

Michael H. Gold, M.D., a dermatologist in a specialty practice in Nashville, Tenn., noted that unapproved products can be “easily obtained” in Canada and elsewhere. “Be careful about where you get your products and how you do it,” he warned his colleagues at the seminar, sponsored by the Skin Disease Education Foundation (SDEF). “Just be reminded that if something goes wrong, you have no leg to stand on.”

Because of recent cases, “the FDA and, more frighteningly, the FBI are considerably more aware of the dangers that can occur to the American people as a result of illegal importation [or use] of material,” noted Alastair Carruthers, M.D., who is credited along with his wife, Jean Carruthers, M.D., with pioneering the cosmetic use of Botox.

Dr. Carruthers, who disclosed financial ties to Allergan Inc., the manufacturer of Botox, said in a later interview that he thinks many physicians may be taking undue risks. “We've lost sight as a group that these regulatory processes are there for a purpose,” said the Vancouver, B.C.-based dermatologic surgeon.

The SDEF and this newspaper both are wholly owned subsidiaries of Elsevier.

WAILEA, HAWAII — Leaders in cosmetic dermatology at the annual Hawaii dermatology seminar offered words of caution about the use of unapproved products and cut-rate versions of Food and Drug Administration-approved materials and medications.

“Beware,” warned David J. Goldberg, M.D., J.D., a dermatologist with a specialty practice in New York and New Jersey. A recent scandal in Florida involving the paralysis of four patients with an improperly diluted, unapproved formulation of botulinum toxin type A led to a federal investigation of a network distributing what authorities called “fake Botox” to physicians across the country. (See story on this page.)

Physicians face possible suspension of their licenses following injection of patients with the unapproved toxin, and the repercussions aren't likely to stop there, speakers said at the meeting.

Michael H. Gold, M.D., a dermatologist in a specialty practice in Nashville, Tenn., noted that unapproved products can be “easily obtained” in Canada and elsewhere. “Be careful about where you get your products and how you do it,” he warned his colleagues at the seminar, sponsored by the Skin Disease Education Foundation (SDEF). “Just be reminded that if something goes wrong, you have no leg to stand on.”

Because of recent cases, “the FDA and, more frighteningly, the FBI are considerably more aware of the dangers that can occur to the American people as a result of illegal importation [or use] of material,” noted Alastair Carruthers, M.D., who is credited along with his wife, Jean Carruthers, M.D., with pioneering the cosmetic use of Botox.

Dr. Carruthers, who disclosed financial ties to Allergan Inc., the manufacturer of Botox, said in a later interview that he thinks many physicians may be taking undue risks. “We've lost sight as a group that these regulatory processes are there for a purpose,” said the Vancouver, B.C.-based dermatologic surgeon.

The SDEF and this newspaper both are wholly owned subsidiaries of Elsevier.

Dermatologists are among the physicians cited by name in federal court documents exposing an underground network to distribute cut-rate 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 plastic surgery 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 filed in U.S. District Court, Southern District of Florida, visit www.usdoj.gov/usao/fls

Dermatologists are among the physicians cited by name in federal court documents exposing an underground network to distribute cut-rate 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 plastic surgery 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 filed in U.S. District Court, Southern District of Florida, visit www.usdoj.gov/usao/fls

Dermatologists are among the physicians cited by name in federal court documents exposing an underground network to distribute cut-rate 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 plastic surgery 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 filed in U.S. District Court, Southern District of Florida, visit www.usdoj.gov/usao/fls

PALM SPRINGS, CALIF. — Pain scores declined by half and opioid use significantly declined in a small number of patients treated with spinal cord stimulation for chronic visceral pelvic pain at the Cleveland Clinic Foundation.

Nagy Mekhail, M.D., chairman of pain management, and his associate Leonardo Kapural, M.D., conducted a small clinical study of spinal cord stimulation for pelvic pain based on recent studies implicating dorsal column pathways in the transmission of visceral pelvic pain.

Six patients were enrolled in the study Dr. Mekhail presented at the annual meeting of the American Academy of Pain Medicine.

All had long-standing histories of chronic pelvic pain of a mean duration of nearly 15 years. All had pelvic adhesions and had undergone multiple surgical explorations for endometriosis and other diagnoses. Their clinical diagnoses included chronic pelvic inflammatory disease, adenomyosis, urinary retention, dyspareunia, vaginal prolapse and vulvodynia, and vulvar vestibulitis. Multiple surgical and medical therapies, including antidepressants and opioids, failed to relieve their pain for long.

After psychological evaluation and approval by an implantable devices committee, each patient underwent a spinal cord stimulation trial of 7-14 days and was implanted with two dual compact or dual quad leads connected to a generator. The lead tip was at the T11 or T12 level.

After an average follow-up of more than 30 months, the patients' mean visual analog score declined from 8 to 3, with all patients reporting a 50% or greater decrease in pain. Mean Pain Disability Index scores declined from 57.7 to 19.5, and mean opioid use was reduced from 22.5 mg morphine equivalent per day to 6.6 mg per day.

Dr. Mekhail acknowledged that the study was very small and the results were preliminary. However, he said these encouraging results suggest that spinal cord stimulation may offer “significant therapeutic potential” for difficult to treat patients with severe, long-standing visceral pelvic pain.

PALM SPRINGS, CALIF. — Pain scores declined by half and opioid use significantly declined in a small number of patients treated with spinal cord stimulation for chronic visceral pelvic pain at the Cleveland Clinic Foundation.

Nagy Mekhail, M.D., chairman of pain management, and his associate Leonardo Kapural, M.D., conducted a small clinical study of spinal cord stimulation for pelvic pain based on recent studies implicating dorsal column pathways in the transmission of visceral pelvic pain.

Six patients were enrolled in the study Dr. Mekhail presented at the annual meeting of the American Academy of Pain Medicine.

All had long-standing histories of chronic pelvic pain of a mean duration of nearly 15 years. All had pelvic adhesions and had undergone multiple surgical explorations for endometriosis and other diagnoses. Their clinical diagnoses included chronic pelvic inflammatory disease, adenomyosis, urinary retention, dyspareunia, vaginal prolapse and vulvodynia, and vulvar vestibulitis. Multiple surgical and medical therapies, including antidepressants and opioids, failed to relieve their pain for long.

After psychological evaluation and approval by an implantable devices committee, each patient underwent a spinal cord stimulation trial of 7-14 days and was implanted with two dual compact or dual quad leads connected to a generator. The lead tip was at the T11 or T12 level.

After an average follow-up of more than 30 months, the patients' mean visual analog score declined from 8 to 3, with all patients reporting a 50% or greater decrease in pain. Mean Pain Disability Index scores declined from 57.7 to 19.5, and mean opioid use was reduced from 22.5 mg morphine equivalent per day to 6.6 mg per day.

Dr. Mekhail acknowledged that the study was very small and the results were preliminary. However, he said these encouraging results suggest that spinal cord stimulation may offer “significant therapeutic potential” for difficult to treat patients with severe, long-standing visceral pelvic pain.

PALM SPRINGS, CALIF. — Pain scores declined by half and opioid use significantly declined in a small number of patients treated with spinal cord stimulation for chronic visceral pelvic pain at the Cleveland Clinic Foundation.

Nagy Mekhail, M.D., chairman of pain management, and his associate Leonardo Kapural, M.D., conducted a small clinical study of spinal cord stimulation for pelvic pain based on recent studies implicating dorsal column pathways in the transmission of visceral pelvic pain.

Six patients were enrolled in the study Dr. Mekhail presented at the annual meeting of the American Academy of Pain Medicine.

All had long-standing histories of chronic pelvic pain of a mean duration of nearly 15 years. All had pelvic adhesions and had undergone multiple surgical explorations for endometriosis and other diagnoses. Their clinical diagnoses included chronic pelvic inflammatory disease, adenomyosis, urinary retention, dyspareunia, vaginal prolapse and vulvodynia, and vulvar vestibulitis. Multiple surgical and medical therapies, including antidepressants and opioids, failed to relieve their pain for long.

After psychological evaluation and approval by an implantable devices committee, each patient underwent a spinal cord stimulation trial of 7-14 days and was implanted with two dual compact or dual quad leads connected to a generator. The lead tip was at the T11 or T12 level.

After an average follow-up of more than 30 months, the patients' mean visual analog score declined from 8 to 3, with all patients reporting a 50% or greater decrease in pain. Mean Pain Disability Index scores declined from 57.7 to 19.5, and mean opioid use was reduced from 22.5 mg morphine equivalent per day to 6.6 mg per day.

Dr. Mekhail acknowledged that the study was very small and the results were preliminary. However, he said these encouraging results suggest that spinal cord stimulation may offer “significant therapeutic potential” for difficult to treat patients with severe, long-standing visceral pelvic pain.