Doug Brunk

SAN FRANCISCO — The antiviral drug oseltamivir was well tolerated by healthy adults in doses up to 450 mg twice daily, results from a randomized, multicenter, double-blind trial showed.

Oseltamivir (Tamiflu) is Food and Drug Administration–approved for use in adults at a treatment of 75 mg twice daily for 5 days, but “there are some questions about whether or not you might need a higher dose if you a have higher viral load or a more virulent virus,” Regina Dutkowski, Ph.D., said in an interview during a poster session at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Dr. Dutkowski, medical director in virology at Hoffmann-LaRoche Inc., Nutley, N.J., and her associates studied 391 healthy adult volunteers aged 18-65 years from nine medical centers and randomized them to the following twice-daily dosing regimens of oseltamivir for 5 days: placebo (100), 75 mg (95), 225 mg (97), and 450 mg (99). The volunteers were required to be in good general health with normal vital signs, laboratory tests, and electrocardiograms; and have a body mass index within 40% of accepted normal values. Women were required to comprise at least 40% of the study population. The mean age of patients was 34 years, 53% were female, and 81% were white.

All doses of oseltamivir were well tolerated. Headache was the most common adverse event and occurred in 20% of the placebo group, 17% of the 75-mg group, 24% of the 225-mg group, and 23% of the 450-mg group.

Gastrointestinal events, dizziness, and sensations of heat or hot flushes also were observed and appeared to be dose related. For example, nausea occurred in 8% of the placebo group, 8% of the 75- mg group, 26% of the 225-mg group, and 31% of the 450-mg group; vomiting occurred in 2% of the placebo group, 3% of the 75-mg group, 7% of the 225-mg group, and 16% of the 450-mg group, while feelings of heat or hot flushes occurred in 0% of the placebo group, 2% of the 75-mg group, 3% of the 225-mg group, and 5% of the 450-mg group.

“The safety data from this study are reassuring because they support the known profile that indicates that GI events are associated with the drug,” Dr. Dutkowski said. “What we see here are increases in GI events, but they're not limiting.”

Only four patients withdrew from the trial because of adverse events: two in the placebo group (one case of dermatitis and one mistaken case of QT prolongation) and two in the 225-mg group (one case of urticaria and one case of pruritus).

No apparent effects on cardiac or laboratory parameters were observed.

Hoffmann-La Roche Inc. sponsored the study.

SAN FRANCISCO — The antiviral drug oseltamivir was well tolerated by healthy adults in doses up to 450 mg twice daily, results from a randomized, multicenter, double-blind trial showed.

Oseltamivir (Tamiflu) is Food and Drug Administration–approved for use in adults at a treatment of 75 mg twice daily for 5 days, but “there are some questions about whether or not you might need a higher dose if you a have higher viral load or a more virulent virus,” Regina Dutkowski, Ph.D., said in an interview during a poster session at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Dr. Dutkowski, medical director in virology at Hoffmann-LaRoche Inc., Nutley, N.J., and her associates studied 391 healthy adult volunteers aged 18-65 years from nine medical centers and randomized them to the following twice-daily dosing regimens of oseltamivir for 5 days: placebo (100), 75 mg (95), 225 mg (97), and 450 mg (99). The volunteers were required to be in good general health with normal vital signs, laboratory tests, and electrocardiograms; and have a body mass index within 40% of accepted normal values. Women were required to comprise at least 40% of the study population. The mean age of patients was 34 years, 53% were female, and 81% were white.

All doses of oseltamivir were well tolerated. Headache was the most common adverse event and occurred in 20% of the placebo group, 17% of the 75-mg group, 24% of the 225-mg group, and 23% of the 450-mg group.

Gastrointestinal events, dizziness, and sensations of heat or hot flushes also were observed and appeared to be dose related. For example, nausea occurred in 8% of the placebo group, 8% of the 75- mg group, 26% of the 225-mg group, and 31% of the 450-mg group; vomiting occurred in 2% of the placebo group, 3% of the 75-mg group, 7% of the 225-mg group, and 16% of the 450-mg group, while feelings of heat or hot flushes occurred in 0% of the placebo group, 2% of the 75-mg group, 3% of the 225-mg group, and 5% of the 450-mg group.

“The safety data from this study are reassuring because they support the known profile that indicates that GI events are associated with the drug,” Dr. Dutkowski said. “What we see here are increases in GI events, but they're not limiting.”

Only four patients withdrew from the trial because of adverse events: two in the placebo group (one case of dermatitis and one mistaken case of QT prolongation) and two in the 225-mg group (one case of urticaria and one case of pruritus).

No apparent effects on cardiac or laboratory parameters were observed.

Hoffmann-La Roche Inc. sponsored the study.

SAN FRANCISCO — The antiviral drug oseltamivir was well tolerated by healthy adults in doses up to 450 mg twice daily, results from a randomized, multicenter, double-blind trial showed.

Oseltamivir (Tamiflu) is Food and Drug Administration–approved for use in adults at a treatment of 75 mg twice daily for 5 days, but “there are some questions about whether or not you might need a higher dose if you a have higher viral load or a more virulent virus,” Regina Dutkowski, Ph.D., said in an interview during a poster session at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy.

Dr. Dutkowski, medical director in virology at Hoffmann-LaRoche Inc., Nutley, N.J., and her associates studied 391 healthy adult volunteers aged 18-65 years from nine medical centers and randomized them to the following twice-daily dosing regimens of oseltamivir for 5 days: placebo (100), 75 mg (95), 225 mg (97), and 450 mg (99). The volunteers were required to be in good general health with normal vital signs, laboratory tests, and electrocardiograms; and have a body mass index within 40% of accepted normal values. Women were required to comprise at least 40% of the study population. The mean age of patients was 34 years, 53% were female, and 81% were white.

All doses of oseltamivir were well tolerated. Headache was the most common adverse event and occurred in 20% of the placebo group, 17% of the 75-mg group, 24% of the 225-mg group, and 23% of the 450-mg group.

Gastrointestinal events, dizziness, and sensations of heat or hot flushes also were observed and appeared to be dose related. For example, nausea occurred in 8% of the placebo group, 8% of the 75- mg group, 26% of the 225-mg group, and 31% of the 450-mg group; vomiting occurred in 2% of the placebo group, 3% of the 75-mg group, 7% of the 225-mg group, and 16% of the 450-mg group, while feelings of heat or hot flushes occurred in 0% of the placebo group, 2% of the 75-mg group, 3% of the 225-mg group, and 5% of the 450-mg group.

“The safety data from this study are reassuring because they support the known profile that indicates that GI events are associated with the drug,” Dr. Dutkowski said. “What we see here are increases in GI events, but they're not limiting.”

Only four patients withdrew from the trial because of adverse events: two in the placebo group (one case of dermatitis and one mistaken case of QT prolongation) and two in the 225-mg group (one case of urticaria and one case of pruritus).

No apparent effects on cardiac or laboratory parameters were observed.

Hoffmann-La Roche Inc. sponsored the study.

SAN FRANCISCO — Prulifloxacin, a new fluoroquinolone, was superior to placebo in reducing the duration of diarrhea in adult travelers, results from a phase III, randomized, double-blind trial showed.

“This drug is very similar to ciprofloxacin, but we think it has certain advantages, such as its once-a-day dosing,” Brian Walsh, D.V.M., said in an interview during a poster session at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy. “It's also very safe. We think this is as good as ciprofloxacin in that respect.”

Manufactured by Optimer Pharmaceuticals, San Diego, prulifloxacin (Pruli) is currently available in Japan and Italy but not in the United States. The drug's active metabolite, ulifloxacin, has potent activity against gram-negative bacilli, said Dr. Walsh, who is a consultant for the company.

In a trial sponsored by Optimer Pharmaceuticals, he and his associates randomized 268 adults with traveler's diarrhea in India, Guatemala, and Mexico to receive 600 mg prulifloxacin once daily or placebo for 3 days. Study participants recorded stool activity to the test-of-cure visit, which occurred 24-72 hours after the last dose. The primary end point was time to last unformed stool.

The 268 patients comprised the intent-to-treat population. Of these, 200 were eligible for modified intent-to-treat analysis and 173 patients were microbiologically evaluable.

The patients' mean age was 32 years, and 55% were female and 92% were white.

Dr. Walsh and his associates reported that prulifloxacin was superior to placebo for the intent-to-treat, modified intent-to-treat, and microbiologically evaluable patients using a Kaplan-Meier long-rank test for the time to last unformed stool. Among patients treated with prulifloxacin, the median time to last unformed stool was 33 hours in the intent-to-treat group, 33 hours in the modified intent-to-treat group, and 32 hours in the microbiologically evaluable group.

“Because more than half of the subjects given placebo were clinical failures or did not achieve wellness by the end-of-therapy [test of cure] visit, a median time to last unformed stool could not be estimated for the placebo group,” the researchers noted in their poster.

In the modified intent-to-treat population, traveler's diarrhea–associated enteropathogens including enteroaggregative Escherichia coli, Salmonella, Campylobacter, and Shigella species were eradicated in 67% of the patients given prulifloxacin and in 27% of the 103 patients given placebo. In the microbiologically evaluable population, these enteropathogens were eradicated in 67% of the 82 patients given prulifloxacin and in 31% of the 91 patients given placebo.

“For this particular suite of pathogens, this is as good as it gets,” Dr. Walsh said.

Prulifloxacin and placebo had similar safety profiles. Three patients withdrew from the placebo arm of the study because of serious adverse events: one experienced deep vein thrombosis and pulmonary embolism, one experienced worsening of traveler's diarrhea, and one developed pseudomembranous colitis.

Two additional patients withdrew from the trial because of nonserious adverse events: one from the prulifloxacin group who experienced edema and one from the placebo group who experienced asthenia. All events resolved.

Dr. Walsh said that Optimer intends to submit approval documents for prulifloxacin to the Food and Drug Administration during the first quarter of 2010.

Prulifloxacin is very safe. 'We think this is as good as ciprofloxacin in that respect.'

Source DR. WALSH

SAN FRANCISCO — Prulifloxacin, a new fluoroquinolone, was superior to placebo in reducing the duration of diarrhea in adult travelers, results from a phase III, randomized, double-blind trial showed.

“This drug is very similar to ciprofloxacin, but we think it has certain advantages, such as its once-a-day dosing,” Brian Walsh, D.V.M., said in an interview during a poster session at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy. “It's also very safe. We think this is as good as ciprofloxacin in that respect.”

Manufactured by Optimer Pharmaceuticals, San Diego, prulifloxacin (Pruli) is currently available in Japan and Italy but not in the United States. The drug's active metabolite, ulifloxacin, has potent activity against gram-negative bacilli, said Dr. Walsh, who is a consultant for the company.

In a trial sponsored by Optimer Pharmaceuticals, he and his associates randomized 268 adults with traveler's diarrhea in India, Guatemala, and Mexico to receive 600 mg prulifloxacin once daily or placebo for 3 days. Study participants recorded stool activity to the test-of-cure visit, which occurred 24-72 hours after the last dose. The primary end point was time to last unformed stool.

The 268 patients comprised the intent-to-treat population. Of these, 200 were eligible for modified intent-to-treat analysis and 173 patients were microbiologically evaluable.

The patients' mean age was 32 years, and 55% were female and 92% were white.

Dr. Walsh and his associates reported that prulifloxacin was superior to placebo for the intent-to-treat, modified intent-to-treat, and microbiologically evaluable patients using a Kaplan-Meier long-rank test for the time to last unformed stool. Among patients treated with prulifloxacin, the median time to last unformed stool was 33 hours in the intent-to-treat group, 33 hours in the modified intent-to-treat group, and 32 hours in the microbiologically evaluable group.

“Because more than half of the subjects given placebo were clinical failures or did not achieve wellness by the end-of-therapy [test of cure] visit, a median time to last unformed stool could not be estimated for the placebo group,” the researchers noted in their poster.

In the modified intent-to-treat population, traveler's diarrhea–associated enteropathogens including enteroaggregative Escherichia coli, Salmonella, Campylobacter, and Shigella species were eradicated in 67% of the patients given prulifloxacin and in 27% of the 103 patients given placebo. In the microbiologically evaluable population, these enteropathogens were eradicated in 67% of the 82 patients given prulifloxacin and in 31% of the 91 patients given placebo.

“For this particular suite of pathogens, this is as good as it gets,” Dr. Walsh said.

Prulifloxacin and placebo had similar safety profiles. Three patients withdrew from the placebo arm of the study because of serious adverse events: one experienced deep vein thrombosis and pulmonary embolism, one experienced worsening of traveler's diarrhea, and one developed pseudomembranous colitis.

Two additional patients withdrew from the trial because of nonserious adverse events: one from the prulifloxacin group who experienced edema and one from the placebo group who experienced asthenia. All events resolved.

Dr. Walsh said that Optimer intends to submit approval documents for prulifloxacin to the Food and Drug Administration during the first quarter of 2010.

Prulifloxacin is very safe. 'We think this is as good as ciprofloxacin in that respect.'

Source DR. WALSH

SAN FRANCISCO — Prulifloxacin, a new fluoroquinolone, was superior to placebo in reducing the duration of diarrhea in adult travelers, results from a phase III, randomized, double-blind trial showed.

“This drug is very similar to ciprofloxacin, but we think it has certain advantages, such as its once-a-day dosing,” Brian Walsh, D.V.M., said in an interview during a poster session at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy. “It's also very safe. We think this is as good as ciprofloxacin in that respect.”

Manufactured by Optimer Pharmaceuticals, San Diego, prulifloxacin (Pruli) is currently available in Japan and Italy but not in the United States. The drug's active metabolite, ulifloxacin, has potent activity against gram-negative bacilli, said Dr. Walsh, who is a consultant for the company.

In a trial sponsored by Optimer Pharmaceuticals, he and his associates randomized 268 adults with traveler's diarrhea in India, Guatemala, and Mexico to receive 600 mg prulifloxacin once daily or placebo for 3 days. Study participants recorded stool activity to the test-of-cure visit, which occurred 24-72 hours after the last dose. The primary end point was time to last unformed stool.

The 268 patients comprised the intent-to-treat population. Of these, 200 were eligible for modified intent-to-treat analysis and 173 patients were microbiologically evaluable.

The patients' mean age was 32 years, and 55% were female and 92% were white.

Dr. Walsh and his associates reported that prulifloxacin was superior to placebo for the intent-to-treat, modified intent-to-treat, and microbiologically evaluable patients using a Kaplan-Meier long-rank test for the time to last unformed stool. Among patients treated with prulifloxacin, the median time to last unformed stool was 33 hours in the intent-to-treat group, 33 hours in the modified intent-to-treat group, and 32 hours in the microbiologically evaluable group.

“Because more than half of the subjects given placebo were clinical failures or did not achieve wellness by the end-of-therapy [test of cure] visit, a median time to last unformed stool could not be estimated for the placebo group,” the researchers noted in their poster.

In the modified intent-to-treat population, traveler's diarrhea–associated enteropathogens including enteroaggregative Escherichia coli, Salmonella, Campylobacter, and Shigella species were eradicated in 67% of the patients given prulifloxacin and in 27% of the 103 patients given placebo. In the microbiologically evaluable population, these enteropathogens were eradicated in 67% of the 82 patients given prulifloxacin and in 31% of the 91 patients given placebo.

“For this particular suite of pathogens, this is as good as it gets,” Dr. Walsh said.

Prulifloxacin and placebo had similar safety profiles. Three patients withdrew from the placebo arm of the study because of serious adverse events: one experienced deep vein thrombosis and pulmonary embolism, one experienced worsening of traveler's diarrhea, and one developed pseudomembranous colitis.

Two additional patients withdrew from the trial because of nonserious adverse events: one from the prulifloxacin group who experienced edema and one from the placebo group who experienced asthenia. All events resolved.

Dr. Walsh said that Optimer intends to submit approval documents for prulifloxacin to the Food and Drug Administration during the first quarter of 2010.

Prulifloxacin is very safe. 'We think this is as good as ciprofloxacin in that respect.'

Source DR. WALSH

SAN DIEGO — Insulin was a surprise among the medications commonly associated with inpatient falls in a large single-center controlled study of 230 patients.

“Previous community studies have found a connection between diabetes and falling. In our study, diabetes was not associated with falling, but use of insulin was. The question is whether insulin is a marker of more severe diabetes, or if these patients have low blood sugars or peripheral neuropathy that is increasing the risk of falling,” said Caroline O'Neil, research coordinator in the infectious diseases division at Washington University, St. Louis.

Patients who fell were more likely than controls who did not fall to be taking hydantoin anticonvulsants (odds ratio 3.6), haloperidol (OR 3.4), benzodiazepines (OR 2.1), and insulin (OR 1.5). Certain combinations of medications increased the risk even more, especially the combination of hydantoins and insulin (OR 11.4) and benzodiazepines and haloperidol (OR 5.7). The data were presented in a poster at the annual meeting of the Society for Healthcare Epidemiology of America.

In the study, led by Dr. Victoria J. Fraser, the researchers evaluated 230 inpatients who had fallen at Barnes Jewish Hospital in St. Louis. The study also included 690 control patients who did not fall. The mean age of patients who fell was 62 years, 54% were male, and their average length of stay was 12 days.

The study was funded with grant support from the National Institutes of Health and the Centers for Disease Control and Prevention. Ms. O'Neil said that she had no financial conflicts to disclose.

Patients taking a combination of hydantoins and insulin had an 11.4-fold increased risk of falling.

Source MS. O'NEIL

SAN DIEGO — Insulin was a surprise among the medications commonly associated with inpatient falls in a large single-center controlled study of 230 patients.

“Previous community studies have found a connection between diabetes and falling. In our study, diabetes was not associated with falling, but use of insulin was. The question is whether insulin is a marker of more severe diabetes, or if these patients have low blood sugars or peripheral neuropathy that is increasing the risk of falling,” said Caroline O'Neil, research coordinator in the infectious diseases division at Washington University, St. Louis.

Patients who fell were more likely than controls who did not fall to be taking hydantoin anticonvulsants (odds ratio 3.6), haloperidol (OR 3.4), benzodiazepines (OR 2.1), and insulin (OR 1.5). Certain combinations of medications increased the risk even more, especially the combination of hydantoins and insulin (OR 11.4) and benzodiazepines and haloperidol (OR 5.7). The data were presented in a poster at the annual meeting of the Society for Healthcare Epidemiology of America.

In the study, led by Dr. Victoria J. Fraser, the researchers evaluated 230 inpatients who had fallen at Barnes Jewish Hospital in St. Louis. The study also included 690 control patients who did not fall. The mean age of patients who fell was 62 years, 54% were male, and their average length of stay was 12 days.

The study was funded with grant support from the National Institutes of Health and the Centers for Disease Control and Prevention. Ms. O'Neil said that she had no financial conflicts to disclose.

Patients taking a combination of hydantoins and insulin had an 11.4-fold increased risk of falling.

Source MS. O'NEIL

SAN DIEGO — Insulin was a surprise among the medications commonly associated with inpatient falls in a large single-center controlled study of 230 patients.

“Previous community studies have found a connection between diabetes and falling. In our study, diabetes was not associated with falling, but use of insulin was. The question is whether insulin is a marker of more severe diabetes, or if these patients have low blood sugars or peripheral neuropathy that is increasing the risk of falling,” said Caroline O'Neil, research coordinator in the infectious diseases division at Washington University, St. Louis.

Patients who fell were more likely than controls who did not fall to be taking hydantoin anticonvulsants (odds ratio 3.6), haloperidol (OR 3.4), benzodiazepines (OR 2.1), and insulin (OR 1.5). Certain combinations of medications increased the risk even more, especially the combination of hydantoins and insulin (OR 11.4) and benzodiazepines and haloperidol (OR 5.7). The data were presented in a poster at the annual meeting of the Society for Healthcare Epidemiology of America.

In the study, led by Dr. Victoria J. Fraser, the researchers evaluated 230 inpatients who had fallen at Barnes Jewish Hospital in St. Louis. The study also included 690 control patients who did not fall. The mean age of patients who fell was 62 years, 54% were male, and their average length of stay was 12 days.

The study was funded with grant support from the National Institutes of Health and the Centers for Disease Control and Prevention. Ms. O'Neil said that she had no financial conflicts to disclose.

Patients taking a combination of hydantoins and insulin had an 11.4-fold increased risk of falling.

Source MS. O'NEIL

Dr. James Barron never took physical fitness seriously until age 30, when he served as the physician for a Marine battalion, but he'd always been intrigued by watching Ironman competitions on television—grueling events that consist of a 2.4-mile swim, a 112-mile bike ride, and a 26-mile run.

“In my mind I would think 'boy, wouldn't it be great to do that some day?'” said Dr. Barron, a 44-year-old internist who practices in Grand Rapids, Mich.

The motivator for his will to ultimately become an Ironman-level triathlete came from a painful life event: the September 2001 death of his 5-year-old niece, Allie Cibulas, from inoperable brain cancer. “She had a horrible course,” Dr. Barron recalled. “I remember visiting her, being so frustrated. I had so much pent-up energy and I wanted to do something to try to make a difference in the lives of other people affected by children with any type of illness.”

So in 2003 he registered for an Ironman competition in Madison, Wis., and asked friends, family, and perfect strangers to champion him by donating money to Allie's Angels—a charity serving terminally ill children and research on pediatric brain cancer that was launched in honor of his niece (www.alliesangels.com

“I thought, 'I'm going to push myself to my limit and do what I can to try to help out,'” he said. “When little children go through chemotherapy, they're not prepared for it. I had never done a triathlon in my life, so it was symbolic that I was going to go do something I'd never done before and fight my own personal battle to complete it.”

After nearly a year of training, when race day arrived he completed the event and helped to raise several thousand dollars for Allie's Angels. “It wasn't a lot of money,” he said. “But for me it was more [about] creating awareness.”

Dr. Barron described feeling like an “imposter” in a crowd of highly trained triathletes. “I remember when I crossed the finish line many hours after the winner, still seeing the winner of the race there to cheer me on,” he said. “It's a feeling of acceptance. It was very emotional, thinking about my niece as I went through the race.”

With his first Ironman behind him, Dr. Barron went on to improve his completion times in subsequent Ironman competitions in Lake Placid, N.Y., and in Louisville, Ky. His ultimate Ironman goal is to compete in Kona, Hawaii, the premier competition in this event.

In addition to his full-time role as a hospitalist for Michigan Medical, P.C., at Spectrum Butterworth in Grand Rapids, Dr. Barron is an essential caretaker of his wife, Dr. Denise Barron-Kraus, and their two teenage sons. Dr. Barron-Kraus left practice in 2000 because she suffers from mental health issues and fibromyalgia that affects her ability to perform activities of daily living. That leaves Dr. Barron precious little time for training.

It's not unusual for Dr. Barron to train in the late evenings until midnight, or to start training at 4:30 a.m. He noted that the Ironman competitions have helped him achieve a “can-do mindset” for whatever challenges come his way.

Dr. James Barron registered for his first Ironman in response to his 5-year-old niece's death from brain cancer.

Source: Courtesy Kyle Barron-Kraus

E-mail us your stories! The purpose of "The Rest of Your Life" is to celebrate the interests and passions of physicians outside of medicine. If you have an idea for this column or would like to tell your story, send an e-mail to d.brunk@elsevier.com.

Dr. James Barron never took physical fitness seriously until age 30, when he served as the physician for a Marine battalion, but he'd always been intrigued by watching Ironman competitions on television—grueling events that consist of a 2.4-mile swim, a 112-mile bike ride, and a 26-mile run.

“In my mind I would think 'boy, wouldn't it be great to do that some day?'” said Dr. Barron, a 44-year-old internist who practices in Grand Rapids, Mich.

The motivator for his will to ultimately become an Ironman-level triathlete came from a painful life event: the September 2001 death of his 5-year-old niece, Allie Cibulas, from inoperable brain cancer. “She had a horrible course,” Dr. Barron recalled. “I remember visiting her, being so frustrated. I had so much pent-up energy and I wanted to do something to try to make a difference in the lives of other people affected by children with any type of illness.”

So in 2003 he registered for an Ironman competition in Madison, Wis., and asked friends, family, and perfect strangers to champion him by donating money to Allie's Angels—a charity serving terminally ill children and research on pediatric brain cancer that was launched in honor of his niece (www.alliesangels.com

“I thought, 'I'm going to push myself to my limit and do what I can to try to help out,'” he said. “When little children go through chemotherapy, they're not prepared for it. I had never done a triathlon in my life, so it was symbolic that I was going to go do something I'd never done before and fight my own personal battle to complete it.”

After nearly a year of training, when race day arrived he completed the event and helped to raise several thousand dollars for Allie's Angels. “It wasn't a lot of money,” he said. “But for me it was more [about] creating awareness.”

Dr. Barron described feeling like an “imposter” in a crowd of highly trained triathletes. “I remember when I crossed the finish line many hours after the winner, still seeing the winner of the race there to cheer me on,” he said. “It's a feeling of acceptance. It was very emotional, thinking about my niece as I went through the race.”

With his first Ironman behind him, Dr. Barron went on to improve his completion times in subsequent Ironman competitions in Lake Placid, N.Y., and in Louisville, Ky. His ultimate Ironman goal is to compete in Kona, Hawaii, the premier competition in this event.

In addition to his full-time role as a hospitalist for Michigan Medical, P.C., at Spectrum Butterworth in Grand Rapids, Dr. Barron is an essential caretaker of his wife, Dr. Denise Barron-Kraus, and their two teenage sons. Dr. Barron-Kraus left practice in 2000 because she suffers from mental health issues and fibromyalgia that affects her ability to perform activities of daily living. That leaves Dr. Barron precious little time for training.

It's not unusual for Dr. Barron to train in the late evenings until midnight, or to start training at 4:30 a.m. He noted that the Ironman competitions have helped him achieve a “can-do mindset” for whatever challenges come his way.

Dr. James Barron registered for his first Ironman in response to his 5-year-old niece's death from brain cancer.

Source: Courtesy Kyle Barron-Kraus

E-mail us your stories! The purpose of "The Rest of Your Life" is to celebrate the interests and passions of physicians outside of medicine. If you have an idea for this column or would like to tell your story, send an e-mail to d.brunk@elsevier.com.

Dr. James Barron never took physical fitness seriously until age 30, when he served as the physician for a Marine battalion, but he'd always been intrigued by watching Ironman competitions on television—grueling events that consist of a 2.4-mile swim, a 112-mile bike ride, and a 26-mile run.

“In my mind I would think 'boy, wouldn't it be great to do that some day?'” said Dr. Barron, a 44-year-old internist who practices in Grand Rapids, Mich.

The motivator for his will to ultimately become an Ironman-level triathlete came from a painful life event: the September 2001 death of his 5-year-old niece, Allie Cibulas, from inoperable brain cancer. “She had a horrible course,” Dr. Barron recalled. “I remember visiting her, being so frustrated. I had so much pent-up energy and I wanted to do something to try to make a difference in the lives of other people affected by children with any type of illness.”

So in 2003 he registered for an Ironman competition in Madison, Wis., and asked friends, family, and perfect strangers to champion him by donating money to Allie's Angels—a charity serving terminally ill children and research on pediatric brain cancer that was launched in honor of his niece (www.alliesangels.com

“I thought, 'I'm going to push myself to my limit and do what I can to try to help out,'” he said. “When little children go through chemotherapy, they're not prepared for it. I had never done a triathlon in my life, so it was symbolic that I was going to go do something I'd never done before and fight my own personal battle to complete it.”

After nearly a year of training, when race day arrived he completed the event and helped to raise several thousand dollars for Allie's Angels. “It wasn't a lot of money,” he said. “But for me it was more [about] creating awareness.”

Dr. Barron described feeling like an “imposter” in a crowd of highly trained triathletes. “I remember when I crossed the finish line many hours after the winner, still seeing the winner of the race there to cheer me on,” he said. “It's a feeling of acceptance. It was very emotional, thinking about my niece as I went through the race.”

With his first Ironman behind him, Dr. Barron went on to improve his completion times in subsequent Ironman competitions in Lake Placid, N.Y., and in Louisville, Ky. His ultimate Ironman goal is to compete in Kona, Hawaii, the premier competition in this event.

In addition to his full-time role as a hospitalist for Michigan Medical, P.C., at Spectrum Butterworth in Grand Rapids, Dr. Barron is an essential caretaker of his wife, Dr. Denise Barron-Kraus, and their two teenage sons. Dr. Barron-Kraus left practice in 2000 because she suffers from mental health issues and fibromyalgia that affects her ability to perform activities of daily living. That leaves Dr. Barron precious little time for training.

It's not unusual for Dr. Barron to train in the late evenings until midnight, or to start training at 4:30 a.m. He noted that the Ironman competitions have helped him achieve a “can-do mindset” for whatever challenges come his way.

Dr. James Barron registered for his first Ironman in response to his 5-year-old niece's death from brain cancer.

Source: Courtesy Kyle Barron-Kraus

E-mail us your stories! The purpose of "The Rest of Your Life" is to celebrate the interests and passions of physicians outside of medicine. If you have an idea for this column or would like to tell your story, send an e-mail to d.brunk@elsevier.com.

The proliferation of bariatric surgery procedures performed each year in the United States has led to a burgeoning demand for body contouring.

Prior to 2000, it was rare for patients who experienced massive weight loss to seek help from plastic surgeons; in fact, this patient population was almost nonexistent, according to Dr. Al Aly, a board-certified plastic surgeon who practices in Iowa City.

Today, the demand for procedures such as abdominoplasties, upper arm lifts, and thigh lifts has never been higher.

According to the American Society of Plastic Surgeons, between 1992 and 2008 the number of abdominoplasties performed grew by 593%, from 16,810 to 116,512; the number of thigh lifts grew by 731%, from 1,023 to 8,504; and the number of upper arm lifts grew an astounding 2,982%, from 434 to 13,374. Meanwhile, the number of lower body lifts—a procedure that essentially did not exist in 1992—stood at 8,647 in 2008.

Dr. J. Peter Rubin, a board-certified plastic surgeon who directs the multidisciplinary Life After Weight Loss clinical program at the University of Pittsburgh, estimates that 90% of his clinical practice involves body contouring after massive weight loss.

“These are fairly complex and technically challenging procedures that are best done by surgeons who have a strong grounding in plastic surgery principles and strong training in plastic surgery,” said Dr. Rubin, coauthor of “Aesthetic Surgery After Massive Weight Loss” (Elsevier Medical Publishing, 2006).

Dr. Aly evaluates potential body-contouring candidates a minimum of 18 months after they have undergone bariatric surgery.

“We tend to not want to operate on people who are aiming for specific weight levels,” said Dr. Aly, author of “Body Contouring After Massive Weight Loss” (Quality Medical Publishing, 2005). “We want to operate on people who are in a comfortable lifestyle and are not doing heroic things to reach a particular weight level. If you have access to the bariatric surgeon that the patient was referred from, that's one of your best sources. Ask them if they feel that the patient has stabilized their weight loss.”

Dr. Susan Downey, a board-certified plastic surgeon who practices in Los Angeles, addresses goals and expectations with body-contouring candidates up front. She asks them about their cosmetic priorities, how long they've been at their present weight, and whether they've had plateaus with their weight loss. In her practice, abdominoplasty usually tops the list of procedures requested, followed by breast lift/augmentation; arm lift; thigh lift; and lower body lift (belt lipectomy), a combination procedure that includes abdominoplasty, a thigh lift, and a buttock lift.

“What bothers me [from a cosmetic standpoint] may not be what bothers them,” Dr. Downey noted. “I had one patient who wanted her eyes done first because the bags under her eyes got more pronounced as her face got smaller from the weight loss. You can do two or three procedures if a patient is in good medical condition. We usually limit ourselves to about 6-8 hours of surgery.”

Dr. Aly cautioned against combining too many procedures in one sitting. “I understand it would be [more convenient] for patients to combine several procedures, but there are safety reasons and there are also some physical reasons to consider if you want the best result,” he said. “If you have opposing vectors, for example, you tend to not know where things are going to end up. If you combine some of those procedures, you can end up with things looking less than ideal. You cannot shortcut things.”

According to published reports, Dr. Downey said, up to 30% of patients with massive weight loss have complications after body contouring. “I would say it's up to 10% for a major complication and up to 30% for a minor complication,” she estimated. “These patients have a higher rate of hematoma formation, a higher rate of seroma, and wound-healing issues. A lot of it has to do with the fact that the skin is so overstretched at the time that you do the surgery.”

Extensive scarring after the procedures is common, “but the improvement in body contour is quite dramatic and well worth the scars,” she added.

Recovery time varies among patients, Dr. Aly said, and tends to be longer after a belt lipectomy (4-6 weeks) than after other common procedures, including an upper body lift (2-3 weeks), an upper arm lift (2-3 weeks), and a thigh lift (2-4 weeks).

Some medical insurance companies cover the panniculectomy portion of the abdominal contour, including anesthesia, but other procedures generally are not covered. “That's one of the issues with this field: The insurance companies are bound to the criteria of medical necessity,” Dr. Rubin said. “It's sometimes hard to justify true medical necessity by the standard of the insurance company for some of these body-contouring operations, despite the overwhelmingly positive impact it will have on the person's quality of life. With these economic times, I'm not sure we're going to see that getting better quickly.”

Future advances in the field may benefit from adult stem cells. Dr. Rubin and his associates at the University of Pittsburgh's Adipocyte Biology Laboratory are studying stem cells from fat-tissue samples of body-contour patients that “have the potential to be transformed in culture into many different other cell types,” he said. “We are looking at the potential of these cells to aid in the healing process in a variety of disease states and, specifically, how we can use these cells to regenerate new tissue for reconstructive surgery.” Clinical trials are expected to launch in the next 3-5 years.

In the meantime, Dr. Rubin and other experts interviewed for this article expect body contouring to continue maturing as a subspecialty. “We close today considerably faster than we did back in 1998 and 1999, cutting our time by half,” Dr. Aly observed. “Some of that is efficiency, but some of that is also technology. These surgeries will be better from the standpoint of safety, because we will be able to get more efficient in the OR.”

These procedures produce an immeasurable impact on patient self-perception, Dr. Aly stated, recalling that a patient with massive weight loss once told him, “[Bariatric surgery] gave me back my life. It's part of a life transformation. Plastic surgery allows me to enjoy it.”

Body contouring, Dr. Aly said, “is part of a life transformation, and we as surgeons are part of that.”

Source Elsevier Global Medical News

Before and after results of an upper body lift in a male bariatric surgery patient: Experts in the field expect body contouring to mature into a subspecialty.

Source Courtesy Dr. Al Aly

The proliferation of bariatric surgery procedures performed each year in the United States has led to a burgeoning demand for body contouring.

Prior to 2000, it was rare for patients who experienced massive weight loss to seek help from plastic surgeons; in fact, this patient population was almost nonexistent, according to Dr. Al Aly, a board-certified plastic surgeon who practices in Iowa City.

Today, the demand for procedures such as abdominoplasties, upper arm lifts, and thigh lifts has never been higher.

According to the American Society of Plastic Surgeons, between 1992 and 2008 the number of abdominoplasties performed grew by 593%, from 16,810 to 116,512; the number of thigh lifts grew by 731%, from 1,023 to 8,504; and the number of upper arm lifts grew an astounding 2,982%, from 434 to 13,374. Meanwhile, the number of lower body lifts—a procedure that essentially did not exist in 1992—stood at 8,647 in 2008.

Dr. J. Peter Rubin, a board-certified plastic surgeon who directs the multidisciplinary Life After Weight Loss clinical program at the University of Pittsburgh, estimates that 90% of his clinical practice involves body contouring after massive weight loss.

“These are fairly complex and technically challenging procedures that are best done by surgeons who have a strong grounding in plastic surgery principles and strong training in plastic surgery,” said Dr. Rubin, coauthor of “Aesthetic Surgery After Massive Weight Loss” (Elsevier Medical Publishing, 2006).

Dr. Aly evaluates potential body-contouring candidates a minimum of 18 months after they have undergone bariatric surgery.

“We tend to not want to operate on people who are aiming for specific weight levels,” said Dr. Aly, author of “Body Contouring After Massive Weight Loss” (Quality Medical Publishing, 2005). “We want to operate on people who are in a comfortable lifestyle and are not doing heroic things to reach a particular weight level. If you have access to the bariatric surgeon that the patient was referred from, that's one of your best sources. Ask them if they feel that the patient has stabilized their weight loss.”

Dr. Susan Downey, a board-certified plastic surgeon who practices in Los Angeles, addresses goals and expectations with body-contouring candidates up front. She asks them about their cosmetic priorities, how long they've been at their present weight, and whether they've had plateaus with their weight loss. In her practice, abdominoplasty usually tops the list of procedures requested, followed by breast lift/augmentation; arm lift; thigh lift; and lower body lift (belt lipectomy), a combination procedure that includes abdominoplasty, a thigh lift, and a buttock lift.

“What bothers me [from a cosmetic standpoint] may not be what bothers them,” Dr. Downey noted. “I had one patient who wanted her eyes done first because the bags under her eyes got more pronounced as her face got smaller from the weight loss. You can do two or three procedures if a patient is in good medical condition. We usually limit ourselves to about 6-8 hours of surgery.”

Dr. Aly cautioned against combining too many procedures in one sitting. “I understand it would be [more convenient] for patients to combine several procedures, but there are safety reasons and there are also some physical reasons to consider if you want the best result,” he said. “If you have opposing vectors, for example, you tend to not know where things are going to end up. If you combine some of those procedures, you can end up with things looking less than ideal. You cannot shortcut things.”

According to published reports, Dr. Downey said, up to 30% of patients with massive weight loss have complications after body contouring. “I would say it's up to 10% for a major complication and up to 30% for a minor complication,” she estimated. “These patients have a higher rate of hematoma formation, a higher rate of seroma, and wound-healing issues. A lot of it has to do with the fact that the skin is so overstretched at the time that you do the surgery.”

Extensive scarring after the procedures is common, “but the improvement in body contour is quite dramatic and well worth the scars,” she added.

Recovery time varies among patients, Dr. Aly said, and tends to be longer after a belt lipectomy (4-6 weeks) than after other common procedures, including an upper body lift (2-3 weeks), an upper arm lift (2-3 weeks), and a thigh lift (2-4 weeks).

Some medical insurance companies cover the panniculectomy portion of the abdominal contour, including anesthesia, but other procedures generally are not covered. “That's one of the issues with this field: The insurance companies are bound to the criteria of medical necessity,” Dr. Rubin said. “It's sometimes hard to justify true medical necessity by the standard of the insurance company for some of these body-contouring operations, despite the overwhelmingly positive impact it will have on the person's quality of life. With these economic times, I'm not sure we're going to see that getting better quickly.”

Future advances in the field may benefit from adult stem cells. Dr. Rubin and his associates at the University of Pittsburgh's Adipocyte Biology Laboratory are studying stem cells from fat-tissue samples of body-contour patients that “have the potential to be transformed in culture into many different other cell types,” he said. “We are looking at the potential of these cells to aid in the healing process in a variety of disease states and, specifically, how we can use these cells to regenerate new tissue for reconstructive surgery.” Clinical trials are expected to launch in the next 3-5 years.

In the meantime, Dr. Rubin and other experts interviewed for this article expect body contouring to continue maturing as a subspecialty. “We close today considerably faster than we did back in 1998 and 1999, cutting our time by half,” Dr. Aly observed. “Some of that is efficiency, but some of that is also technology. These surgeries will be better from the standpoint of safety, because we will be able to get more efficient in the OR.”

These procedures produce an immeasurable impact on patient self-perception, Dr. Aly stated, recalling that a patient with massive weight loss once told him, “[Bariatric surgery] gave me back my life. It's part of a life transformation. Plastic surgery allows me to enjoy it.”

Body contouring, Dr. Aly said, “is part of a life transformation, and we as surgeons are part of that.”

Source Elsevier Global Medical News

Before and after results of an upper body lift in a male bariatric surgery patient: Experts in the field expect body contouring to mature into a subspecialty.

Source Courtesy Dr. Al Aly

The proliferation of bariatric surgery procedures performed each year in the United States has led to a burgeoning demand for body contouring.

Prior to 2000, it was rare for patients who experienced massive weight loss to seek help from plastic surgeons; in fact, this patient population was almost nonexistent, according to Dr. Al Aly, a board-certified plastic surgeon who practices in Iowa City.

Today, the demand for procedures such as abdominoplasties, upper arm lifts, and thigh lifts has never been higher.

According to the American Society of Plastic Surgeons, between 1992 and 2008 the number of abdominoplasties performed grew by 593%, from 16,810 to 116,512; the number of thigh lifts grew by 731%, from 1,023 to 8,504; and the number of upper arm lifts grew an astounding 2,982%, from 434 to 13,374. Meanwhile, the number of lower body lifts—a procedure that essentially did not exist in 1992—stood at 8,647 in 2008.

Dr. J. Peter Rubin, a board-certified plastic surgeon who directs the multidisciplinary Life After Weight Loss clinical program at the University of Pittsburgh, estimates that 90% of his clinical practice involves body contouring after massive weight loss.

“These are fairly complex and technically challenging procedures that are best done by surgeons who have a strong grounding in plastic surgery principles and strong training in plastic surgery,” said Dr. Rubin, coauthor of “Aesthetic Surgery After Massive Weight Loss” (Elsevier Medical Publishing, 2006).

Dr. Aly evaluates potential body-contouring candidates a minimum of 18 months after they have undergone bariatric surgery.

“We tend to not want to operate on people who are aiming for specific weight levels,” said Dr. Aly, author of “Body Contouring After Massive Weight Loss” (Quality Medical Publishing, 2005). “We want to operate on people who are in a comfortable lifestyle and are not doing heroic things to reach a particular weight level. If you have access to the bariatric surgeon that the patient was referred from, that's one of your best sources. Ask them if they feel that the patient has stabilized their weight loss.”

Dr. Susan Downey, a board-certified plastic surgeon who practices in Los Angeles, addresses goals and expectations with body-contouring candidates up front. She asks them about their cosmetic priorities, how long they've been at their present weight, and whether they've had plateaus with their weight loss. In her practice, abdominoplasty usually tops the list of procedures requested, followed by breast lift/augmentation; arm lift; thigh lift; and lower body lift (belt lipectomy), a combination procedure that includes abdominoplasty, a thigh lift, and a buttock lift.

“What bothers me [from a cosmetic standpoint] may not be what bothers them,” Dr. Downey noted. “I had one patient who wanted her eyes done first because the bags under her eyes got more pronounced as her face got smaller from the weight loss. You can do two or three procedures if a patient is in good medical condition. We usually limit ourselves to about 6-8 hours of surgery.”

Dr. Aly cautioned against combining too many procedures in one sitting. “I understand it would be [more convenient] for patients to combine several procedures, but there are safety reasons and there are also some physical reasons to consider if you want the best result,” he said. “If you have opposing vectors, for example, you tend to not know where things are going to end up. If you combine some of those procedures, you can end up with things looking less than ideal. You cannot shortcut things.”

According to published reports, Dr. Downey said, up to 30% of patients with massive weight loss have complications after body contouring. “I would say it's up to 10% for a major complication and up to 30% for a minor complication,” she estimated. “These patients have a higher rate of hematoma formation, a higher rate of seroma, and wound-healing issues. A lot of it has to do with the fact that the skin is so overstretched at the time that you do the surgery.”

Extensive scarring after the procedures is common, “but the improvement in body contour is quite dramatic and well worth the scars,” she added.

Recovery time varies among patients, Dr. Aly said, and tends to be longer after a belt lipectomy (4-6 weeks) than after other common procedures, including an upper body lift (2-3 weeks), an upper arm lift (2-3 weeks), and a thigh lift (2-4 weeks).

Some medical insurance companies cover the panniculectomy portion of the abdominal contour, including anesthesia, but other procedures generally are not covered. “That's one of the issues with this field: The insurance companies are bound to the criteria of medical necessity,” Dr. Rubin said. “It's sometimes hard to justify true medical necessity by the standard of the insurance company for some of these body-contouring operations, despite the overwhelmingly positive impact it will have on the person's quality of life. With these economic times, I'm not sure we're going to see that getting better quickly.”

Future advances in the field may benefit from adult stem cells. Dr. Rubin and his associates at the University of Pittsburgh's Adipocyte Biology Laboratory are studying stem cells from fat-tissue samples of body-contour patients that “have the potential to be transformed in culture into many different other cell types,” he said. “We are looking at the potential of these cells to aid in the healing process in a variety of disease states and, specifically, how we can use these cells to regenerate new tissue for reconstructive surgery.” Clinical trials are expected to launch in the next 3-5 years.

In the meantime, Dr. Rubin and other experts interviewed for this article expect body contouring to continue maturing as a subspecialty. “We close today considerably faster than we did back in 1998 and 1999, cutting our time by half,” Dr. Aly observed. “Some of that is efficiency, but some of that is also technology. These surgeries will be better from the standpoint of safety, because we will be able to get more efficient in the OR.”

These procedures produce an immeasurable impact on patient self-perception, Dr. Aly stated, recalling that a patient with massive weight loss once told him, “[Bariatric surgery] gave me back my life. It's part of a life transformation. Plastic surgery allows me to enjoy it.”

Body contouring, Dr. Aly said, “is part of a life transformation, and we as surgeons are part of that.”

Source Elsevier Global Medical News

Before and after results of an upper body lift in a male bariatric surgery patient: Experts in the field expect body contouring to mature into a subspecialty.

Source Courtesy Dr. Al Aly

PORTLAND, ORE. — As the chief of dermatologic surgery at the University of Washington, Seattle, Dr. Daniel Berg likes to have a handful of nontraditional topical hemostatic agents handy.

One is bone wax, a combination of beeswax and isopropyl.

He's had to use it twice in his 15 years of practice to tamponade bleeding of a bone: once on the skull and once in the nasal region.

“You warm up the bone wax, pack it, and stuff it into [the bleeding site] like Silly Putty,” Dr. Berg said at the annual meeting of the Pacific Dermatologic Association. “Consider having a box of it on standby if you do any surgery, particularly on the scalp.”

Possible complications of the agent include a granulomatous reaction, infection, and impediment of osteogenesis. He keeps a box of bone wax packets in his office, and he replaces it every few years when it expires.

A new alternative to bone wax is Ostene, a water-soluble alkylene oxide copolymer manufactured by Ceremed Inc. that dissolves in 24 hours (Dermatol. Surg. 2008;34:431-45).

Dr. Berg also discussed Gelfoam, an absorbable gelatin sponge manufactured by Pharmacia and Upjohn, which he uses for diffuse oozing.

The product promotes clotting and granulation, liquefies in several days, and is degraded over a period of 4-6 weeks. It is applied after being moistened with saline or with a local anesthetic.

“I don't like to put it into wounds that I'm covering over, because although it liquefies and is degraded, it can serve as a nidus for infection,” he said. “A great use is to line forehead flap pedicles with Gelfoam.”

Topical bovine thrombin is another agent Dr. Bergs likes to have at his disposal. Supplied as a sterile powder that has been freeze dried in the final container, along with mannitol and sodium chloride, thrombin directs conversion of fibrinogen to fibrin. It is sprayed on the wound or saturated on Gelfoam.

“I've only used this once in a patient that kept bleeding on aspirin and Plavix [clopidogrel],” he said.

Rare complications include allergy to bovine products, disseminated intravascular coagulation if the product gets into large vessels, and immune-mediated coagulopathies.

Dr. Berg concluded his presentation by discussing hemostatic agents that contain microfibrillar collagen, such as Avitene, manufactured by Davol Inc. These products attract blood platelets and, according to Dr. Berg, tend to be more effective than Gelfoam.

Sticky, powderlike substances, these products are applied directly with surgical gloves and have little immunogenicity; there have been rare reports of allergic or foreign body reactions.

Dr. Berg reported having no conflicts to disclose.

Avitene, a hemostatic agent, is used to control bleeding in a cheek flap.

Use of the agent allowed the defect to be closed with no bleeding.

Source Photos courtesy Dr. Daniel Berg

PORTLAND, ORE. — As the chief of dermatologic surgery at the University of Washington, Seattle, Dr. Daniel Berg likes to have a handful of nontraditional topical hemostatic agents handy.

One is bone wax, a combination of beeswax and isopropyl.

He's had to use it twice in his 15 years of practice to tamponade bleeding of a bone: once on the skull and once in the nasal region.

“You warm up the bone wax, pack it, and stuff it into [the bleeding site] like Silly Putty,” Dr. Berg said at the annual meeting of the Pacific Dermatologic Association. “Consider having a box of it on standby if you do any surgery, particularly on the scalp.”

Possible complications of the agent include a granulomatous reaction, infection, and impediment of osteogenesis. He keeps a box of bone wax packets in his office, and he replaces it every few years when it expires.

A new alternative to bone wax is Ostene, a water-soluble alkylene oxide copolymer manufactured by Ceremed Inc. that dissolves in 24 hours (Dermatol. Surg. 2008;34:431-45).

Dr. Berg also discussed Gelfoam, an absorbable gelatin sponge manufactured by Pharmacia and Upjohn, which he uses for diffuse oozing.

The product promotes clotting and granulation, liquefies in several days, and is degraded over a period of 4-6 weeks. It is applied after being moistened with saline or with a local anesthetic.

“I don't like to put it into wounds that I'm covering over, because although it liquefies and is degraded, it can serve as a nidus for infection,” he said. “A great use is to line forehead flap pedicles with Gelfoam.”

Topical bovine thrombin is another agent Dr. Bergs likes to have at his disposal. Supplied as a sterile powder that has been freeze dried in the final container, along with mannitol and sodium chloride, thrombin directs conversion of fibrinogen to fibrin. It is sprayed on the wound or saturated on Gelfoam.

“I've only used this once in a patient that kept bleeding on aspirin and Plavix [clopidogrel],” he said.

Rare complications include allergy to bovine products, disseminated intravascular coagulation if the product gets into large vessels, and immune-mediated coagulopathies.

Dr. Berg concluded his presentation by discussing hemostatic agents that contain microfibrillar collagen, such as Avitene, manufactured by Davol Inc. These products attract blood platelets and, according to Dr. Berg, tend to be more effective than Gelfoam.

Sticky, powderlike substances, these products are applied directly with surgical gloves and have little immunogenicity; there have been rare reports of allergic or foreign body reactions.

Dr. Berg reported having no conflicts to disclose.

Avitene, a hemostatic agent, is used to control bleeding in a cheek flap.

Use of the agent allowed the defect to be closed with no bleeding.

Source Photos courtesy Dr. Daniel Berg

PORTLAND, ORE. — As the chief of dermatologic surgery at the University of Washington, Seattle, Dr. Daniel Berg likes to have a handful of nontraditional topical hemostatic agents handy.

One is bone wax, a combination of beeswax and isopropyl.

He's had to use it twice in his 15 years of practice to tamponade bleeding of a bone: once on the skull and once in the nasal region.

“You warm up the bone wax, pack it, and stuff it into [the bleeding site] like Silly Putty,” Dr. Berg said at the annual meeting of the Pacific Dermatologic Association. “Consider having a box of it on standby if you do any surgery, particularly on the scalp.”

Possible complications of the agent include a granulomatous reaction, infection, and impediment of osteogenesis. He keeps a box of bone wax packets in his office, and he replaces it every few years when it expires.

A new alternative to bone wax is Ostene, a water-soluble alkylene oxide copolymer manufactured by Ceremed Inc. that dissolves in 24 hours (Dermatol. Surg. 2008;34:431-45).

Dr. Berg also discussed Gelfoam, an absorbable gelatin sponge manufactured by Pharmacia and Upjohn, which he uses for diffuse oozing.

The product promotes clotting and granulation, liquefies in several days, and is degraded over a period of 4-6 weeks. It is applied after being moistened with saline or with a local anesthetic.

“I don't like to put it into wounds that I'm covering over, because although it liquefies and is degraded, it can serve as a nidus for infection,” he said. “A great use is to line forehead flap pedicles with Gelfoam.”

Topical bovine thrombin is another agent Dr. Bergs likes to have at his disposal. Supplied as a sterile powder that has been freeze dried in the final container, along with mannitol and sodium chloride, thrombin directs conversion of fibrinogen to fibrin. It is sprayed on the wound or saturated on Gelfoam.

“I've only used this once in a patient that kept bleeding on aspirin and Plavix [clopidogrel],” he said.

Rare complications include allergy to bovine products, disseminated intravascular coagulation if the product gets into large vessels, and immune-mediated coagulopathies.

Dr. Berg concluded his presentation by discussing hemostatic agents that contain microfibrillar collagen, such as Avitene, manufactured by Davol Inc. These products attract blood platelets and, according to Dr. Berg, tend to be more effective than Gelfoam.

Sticky, powderlike substances, these products are applied directly with surgical gloves and have little immunogenicity; there have been rare reports of allergic or foreign body reactions.

Dr. Berg reported having no conflicts to disclose.

Avitene, a hemostatic agent, is used to control bleeding in a cheek flap.

Use of the agent allowed the defect to be closed with no bleeding.

Source Photos courtesy Dr. Daniel Berg

PORTLAND, ORE. — Beginning emollient therapy at birth is a safe and feasible approach to prevent eczema, results from a small pilot study suggest.

"Decades of research on allergen avoidance has not led to any successful strategy so far," Dr. Eric Simpson said at the annual meeting of the Pacific Dermatologic Association.

"There are new genetic data showing that eczema is probably a skin barrier disease, at least in a healthy proportion of patients," he said. "This leads us to the question: Can we focus on skin barrier to prevent eczema?"

The earliest known published study on the topic is from 1991, when researchers in Kenya examined determinants of eczema and whether detergents caused it (Trop. Doct. 1991;21:104-6). They found that the use of petrolatum early in life provided a protective effect.

"This was a case-control study, so it was just one point in time, but it was a surprising finding, and there has not been a follow-up study since that time," commented Dr. Simpson, who is with the department of dermatology at Oregon Health and Science University in Portland.

More recent studies, he added, have found that using Aquaphor (Eucerin) in premature neonates from birth can prevent dermatitis, improve skin barrier function, and reduce mortality and sepsis. "But there have been no studies looking specifically at the skin barrier to prevent atopic dermatitis," he said.

He and his associates were prompted to investigate skin barrier protection after an infant care study at Oregon Health and Science University revealed that 73% of parents and caregivers bathed infants more than three times per week, 91% used soap during bathing, 75% used moisturizers, and 62% regularly used watery lotion.

From that study, Dr. Simpson and his associates concluded that frequent bathing and moisturizer use "is very common in patients who develop eczema," he said. "These skin care practices may be detrimental to the skin. That's concerning in people who are genetically predisposed to developing eczema. Watery lotions and water alone can disrupt the skin barrier."

For the pilot study, the researchers enrolled 22 neonates who received Cetaphil cream daily to all body surfaces from day 7. All of the study participants had at least one sibling with clinically confirmed eczema and were studied for a mean of 447 days and a median of 397 days. They underwent regular clinical exams for the development of eczema and barrier function.

To date, only two of the patients (9%) have developed eczema, and there have been no adverse events related to treatment. Dr. Simpson said that the finding is remarkable because previous studies have demonstrated that 40%-50% of infants with an affected sibling develop eczema.

"We're not really going to know until we have a controlled study, but it is somewhat suggestive that this treatment could be protective against eczema," he said.

"In addition, barrier protection may reduce IgE sensitization that occurs through the skin. We have a lot of questions to answer. Can it prevent atopic dermatitis? Can it prevent asthma and food allergy down the road? What's the best barrier protectant?" Dr. Simpson asked.

The study was funded by the Dermatology Foundation and the National Eczema Association.

Dr. Simpson disclosed that he is a paid consultant for Galderma Laboratories, which makes Cetaphil cream. He also has received a research grant from Ceragenix Pharmaceuticals Inc.

New genetic data 'leads us to the question: Can we focus on skin barrier to prevent eczema?'

Source Dr. Simpson

PORTLAND, ORE. — Beginning emollient therapy at birth is a safe and feasible approach to prevent eczema, results from a small pilot study suggest.

"Decades of research on allergen avoidance has not led to any successful strategy so far," Dr. Eric Simpson said at the annual meeting of the Pacific Dermatologic Association.

"There are new genetic data showing that eczema is probably a skin barrier disease, at least in a healthy proportion of patients," he said. "This leads us to the question: Can we focus on skin barrier to prevent eczema?"

The earliest known published study on the topic is from 1991, when researchers in Kenya examined determinants of eczema and whether detergents caused it (Trop. Doct. 1991;21:104-6). They found that the use of petrolatum early in life provided a protective effect.

"This was a case-control study, so it was just one point in time, but it was a surprising finding, and there has not been a follow-up study since that time," commented Dr. Simpson, who is with the department of dermatology at Oregon Health and Science University in Portland.

More recent studies, he added, have found that using Aquaphor (Eucerin) in premature neonates from birth can prevent dermatitis, improve skin barrier function, and reduce mortality and sepsis. "But there have been no studies looking specifically at the skin barrier to prevent atopic dermatitis," he said.

He and his associates were prompted to investigate skin barrier protection after an infant care study at Oregon Health and Science University revealed that 73% of parents and caregivers bathed infants more than three times per week, 91% used soap during bathing, 75% used moisturizers, and 62% regularly used watery lotion.

From that study, Dr. Simpson and his associates concluded that frequent bathing and moisturizer use "is very common in patients who develop eczema," he said. "These skin care practices may be detrimental to the skin. That's concerning in people who are genetically predisposed to developing eczema. Watery lotions and water alone can disrupt the skin barrier."

For the pilot study, the researchers enrolled 22 neonates who received Cetaphil cream daily to all body surfaces from day 7. All of the study participants had at least one sibling with clinically confirmed eczema and were studied for a mean of 447 days and a median of 397 days. They underwent regular clinical exams for the development of eczema and barrier function.

To date, only two of the patients (9%) have developed eczema, and there have been no adverse events related to treatment. Dr. Simpson said that the finding is remarkable because previous studies have demonstrated that 40%-50% of infants with an affected sibling develop eczema.

"We're not really going to know until we have a controlled study, but it is somewhat suggestive that this treatment could be protective against eczema," he said.

"In addition, barrier protection may reduce IgE sensitization that occurs through the skin. We have a lot of questions to answer. Can it prevent atopic dermatitis? Can it prevent asthma and food allergy down the road? What's the best barrier protectant?" Dr. Simpson asked.

The study was funded by the Dermatology Foundation and the National Eczema Association.

Dr. Simpson disclosed that he is a paid consultant for Galderma Laboratories, which makes Cetaphil cream. He also has received a research grant from Ceragenix Pharmaceuticals Inc.

New genetic data 'leads us to the question: Can we focus on skin barrier to prevent eczema?'

Source Dr. Simpson

PORTLAND, ORE. — Beginning emollient therapy at birth is a safe and feasible approach to prevent eczema, results from a small pilot study suggest.

"Decades of research on allergen avoidance has not led to any successful strategy so far," Dr. Eric Simpson said at the annual meeting of the Pacific Dermatologic Association.

"There are new genetic data showing that eczema is probably a skin barrier disease, at least in a healthy proportion of patients," he said. "This leads us to the question: Can we focus on skin barrier to prevent eczema?"

The earliest known published study on the topic is from 1991, when researchers in Kenya examined determinants of eczema and whether detergents caused it (Trop. Doct. 1991;21:104-6). They found that the use of petrolatum early in life provided a protective effect.

"This was a case-control study, so it was just one point in time, but it was a surprising finding, and there has not been a follow-up study since that time," commented Dr. Simpson, who is with the department of dermatology at Oregon Health and Science University in Portland.

More recent studies, he added, have found that using Aquaphor (Eucerin) in premature neonates from birth can prevent dermatitis, improve skin barrier function, and reduce mortality and sepsis. "But there have been no studies looking specifically at the skin barrier to prevent atopic dermatitis," he said.

He and his associates were prompted to investigate skin barrier protection after an infant care study at Oregon Health and Science University revealed that 73% of parents and caregivers bathed infants more than three times per week, 91% used soap during bathing, 75% used moisturizers, and 62% regularly used watery lotion.

From that study, Dr. Simpson and his associates concluded that frequent bathing and moisturizer use "is very common in patients who develop eczema," he said. "These skin care practices may be detrimental to the skin. That's concerning in people who are genetically predisposed to developing eczema. Watery lotions and water alone can disrupt the skin barrier."

For the pilot study, the researchers enrolled 22 neonates who received Cetaphil cream daily to all body surfaces from day 7. All of the study participants had at least one sibling with clinically confirmed eczema and were studied for a mean of 447 days and a median of 397 days. They underwent regular clinical exams for the development of eczema and barrier function.

To date, only two of the patients (9%) have developed eczema, and there have been no adverse events related to treatment. Dr. Simpson said that the finding is remarkable because previous studies have demonstrated that 40%-50% of infants with an affected sibling develop eczema.

"We're not really going to know until we have a controlled study, but it is somewhat suggestive that this treatment could be protective against eczema," he said.

"In addition, barrier protection may reduce IgE sensitization that occurs through the skin. We have a lot of questions to answer. Can it prevent atopic dermatitis? Can it prevent asthma and food allergy down the road? What's the best barrier protectant?" Dr. Simpson asked.

The study was funded by the Dermatology Foundation and the National Eczema Association.

Dr. Simpson disclosed that he is a paid consultant for Galderma Laboratories, which makes Cetaphil cream. He also has received a research grant from Ceragenix Pharmaceuticals Inc.

New genetic data 'leads us to the question: Can we focus on skin barrier to prevent eczema?'

Source Dr. Simpson

PORTLAND, ORE. — Skin lesions are a hallmark of Merkel cell carcinoma, yet dermatologists often find themselves out of the loop in diagnosing patients with the disease, said Dr. Paul Nghiem.

"These [lesions] are typically biopsied as a cyst and the patient usually has to argue for one, two, or three doctor's visits to have the lesion biopsied," Dr. Nghiem said at the annual meeting of the Pacific Dermatologic Association. "They're usually biopsied by a reluctant primary care physician who thinks they're taking off a cyst. Then they may be referred to medical oncology or to surgical oncology, but rarely to dermatology."

About 1,500 new cases of Merkel cell carcinoma (MCC) are diagnosed in the United States each year (J. Invest. Dermatol. 2007;127:2100-3), which is about the same incidence as cutaneous T-cell lymphoma or dermatofibrosarcoma protuberans, said Dr. Nghiem, an expert on the disease who is associate professor of dermatology, medicine, and pathology at the University of Washington, Seattle.

MCC is significantly more lethal than melanoma (40% vs. 15%, respectively), and its reported incidence has increased threefold since 1986 (J. Surg. Oncol. 2005;89:1-4).

"A big reason for that is that it's not missed as much," Dr. Nghiem said. "There are better tools for pathologists to use to make the diagnosis."

The three main risk factors for MCC are prolonged sun exposure, immune suppression, and age over 50 years. "Ninety-four percent of all MCC cases are in people aged 50 or older," he said. "There is a very strong synergy with age" (J. Am. Acad. Dermatol. 2008;58:375-81).

Dr. Nghiem said that HIV-positive patients had about a 13-fold increase of MCC in one study (Lancet 2002;359:497-8), while another study showed that solid organ transplant recipients have about a 10-fold increase (Transplantation 1999;68:1717-21).

He and his associates devised the acronym AEIOU to describe the clinical features of Merkel cell carcinoma based on an analysis of 195 patients given the diagnosis between 1980 and 2007 (J. Am. Acad. Dermatol. 2008; 58:375-81). The acronym stands for Asymptomatic, Expanding rapidly, Immune compromised, Older than 50, and UV-exposed, fair skin.

"Under no circumstances do I think that this is a highly specific test," said Dr. Nghiem, whose clinic is based at the Fred Hutchinson Cancer Research Center in Seattle. "It's not going to be up there with the ABCDs of melanoma, but if you see these characteristics together, you may want to think about doing a biopsy."

More than half of the lesions in the 195 patients evaluated (56%) were presumed to be benign at biopsy, and 32% presented on the head and neck, followed by the lower limb (30%), upper limb (20%), trunk (10%), and buttock (8%).

The majority of lesions (81%) presented on sun-exposed skin, but one in six was in a sun-protected site.

Nearly all of the lesions (88%) were asymptomatic ("neither tender nor itchy," he said), 63% doubled in size in the past 3 months, and 8% of the patients were profoundly immune suppressed. "That is a 16-fold increase over the normal population, but still a minority of all Merkel cell cases," he said, noting that 90% of the patients studied were at least 50 years of age and that 98% were fair skinned.

"Taken together, 89% of all Merkel cell carcinomas had three or more of these clinical AEIOU features," he said.

Optimal therapy for MCC is unique among skin cancers, he said, in that sentinel lymph node biopsy (SLNB) is usually indicated and the disease is "exquisitely sensitive" to radiation.

"If I had one modality to treat MCC, it would be radiation," he said.

SLNB is important for prognosis, he added, because it "results in more accurate staging and has therapeutic implications. If it's microscopically positive [the cancer] will very likely develop in that node bed within a few months if you don't do anything."

In Dr. Nghiem's opinion, the best local therapy for MCC is pathologically clear margins when the primary tumor is less than 1 cm, there is no lymphovascular invasion, there is no profound immune suppression, and the SLNB is negative.

"If all of those things are kosher, you are pretty much okay with a negative margin incision," he said. "Otherwise, adjuvant radiation is very helpful."

He described the current staging system for MCC as "a mess." Five staging systems are currently being used, he said, yet all of them are based on studies of fewer than 300 patients and none has been validated.

MCC staging by the American Joint Committee on Cancer is currently performed using the same staging system as for 82 other nonmelanoma skin cancers, including basal cell carcinoma, squamous cell carcinoma, and adnexal neoplasms.

The key histologic feature of MCC is a perinuclear dot pattern of cytokeratin-20, "which is the rule, not the exception," he said.

Dr. Nghiem finds MCC treatment guidelines from the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology to be especially useful. The guidelines are updated annually and are available at www.nccn.org

MCC typically is coded as ICD-9 code 173 (other malignant neoplasm of skin). "Unfortunately, this means that MCC costs can't be tracked at all and, more importantly, patients are denied care," he said. Things should improve on that front shortly, however. Dr. Nghiem said that the CDC is expected to release eight new diagnostic codes specific for MCC this month.

Little is known about MCC biology, but a study from 2008 found that a new polyomavirus is present in the vast majority of cases (Science 2008;319:1096-100). "This is only the sixth example of a virus clearly linked to human cancer," Dr. Nghiem said.

He disclosed that he has received funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the American Cancer Society.

The majority of Merkel cell carcinoma lesions appear on sun-exposed skin, but one in six has been found to appear on sun-protected areas.

Merkel cell carcinoma has a significantly higher mortality rate, compared with melanoma, and reported incidence has increased threefold since 1986.

Source Photos courtesy Dr. Paul Nghiem

PORTLAND, ORE. — Skin lesions are a hallmark of Merkel cell carcinoma, yet dermatologists often find themselves out of the loop in diagnosing patients with the disease, said Dr. Paul Nghiem.

"These [lesions] are typically biopsied as a cyst and the patient usually has to argue for one, two, or three doctor's visits to have the lesion biopsied," Dr. Nghiem said at the annual meeting of the Pacific Dermatologic Association. "They're usually biopsied by a reluctant primary care physician who thinks they're taking off a cyst. Then they may be referred to medical oncology or to surgical oncology, but rarely to dermatology."

About 1,500 new cases of Merkel cell carcinoma (MCC) are diagnosed in the United States each year (J. Invest. Dermatol. 2007;127:2100-3), which is about the same incidence as cutaneous T-cell lymphoma or dermatofibrosarcoma protuberans, said Dr. Nghiem, an expert on the disease who is associate professor of dermatology, medicine, and pathology at the University of Washington, Seattle.

MCC is significantly more lethal than melanoma (40% vs. 15%, respectively), and its reported incidence has increased threefold since 1986 (J. Surg. Oncol. 2005;89:1-4).

"A big reason for that is that it's not missed as much," Dr. Nghiem said. "There are better tools for pathologists to use to make the diagnosis."

The three main risk factors for MCC are prolonged sun exposure, immune suppression, and age over 50 years. "Ninety-four percent of all MCC cases are in people aged 50 or older," he said. "There is a very strong synergy with age" (J. Am. Acad. Dermatol. 2008;58:375-81).

Dr. Nghiem said that HIV-positive patients had about a 13-fold increase of MCC in one study (Lancet 2002;359:497-8), while another study showed that solid organ transplant recipients have about a 10-fold increase (Transplantation 1999;68:1717-21).

He and his associates devised the acronym AEIOU to describe the clinical features of Merkel cell carcinoma based on an analysis of 195 patients given the diagnosis between 1980 and 2007 (J. Am. Acad. Dermatol. 2008; 58:375-81). The acronym stands for Asymptomatic, Expanding rapidly, Immune compromised, Older than 50, and UV-exposed, fair skin.

"Under no circumstances do I think that this is a highly specific test," said Dr. Nghiem, whose clinic is based at the Fred Hutchinson Cancer Research Center in Seattle. "It's not going to be up there with the ABCDs of melanoma, but if you see these characteristics together, you may want to think about doing a biopsy."

More than half of the lesions in the 195 patients evaluated (56%) were presumed to be benign at biopsy, and 32% presented on the head and neck, followed by the lower limb (30%), upper limb (20%), trunk (10%), and buttock (8%).

The majority of lesions (81%) presented on sun-exposed skin, but one in six was in a sun-protected site.

Nearly all of the lesions (88%) were asymptomatic ("neither tender nor itchy," he said), 63% doubled in size in the past 3 months, and 8% of the patients were profoundly immune suppressed. "That is a 16-fold increase over the normal population, but still a minority of all Merkel cell cases," he said, noting that 90% of the patients studied were at least 50 years of age and that 98% were fair skinned.

"Taken together, 89% of all Merkel cell carcinomas had three or more of these clinical AEIOU features," he said.

Optimal therapy for MCC is unique among skin cancers, he said, in that sentinel lymph node biopsy (SLNB) is usually indicated and the disease is "exquisitely sensitive" to radiation.

"If I had one modality to treat MCC, it would be radiation," he said.

SLNB is important for prognosis, he added, because it "results in more accurate staging and has therapeutic implications. If it's microscopically positive [the cancer] will very likely develop in that node bed within a few months if you don't do anything."

In Dr. Nghiem's opinion, the best local therapy for MCC is pathologically clear margins when the primary tumor is less than 1 cm, there is no lymphovascular invasion, there is no profound immune suppression, and the SLNB is negative.

"If all of those things are kosher, you are pretty much okay with a negative margin incision," he said. "Otherwise, adjuvant radiation is very helpful."

He described the current staging system for MCC as "a mess." Five staging systems are currently being used, he said, yet all of them are based on studies of fewer than 300 patients and none has been validated.

MCC staging by the American Joint Committee on Cancer is currently performed using the same staging system as for 82 other nonmelanoma skin cancers, including basal cell carcinoma, squamous cell carcinoma, and adnexal neoplasms.

The key histologic feature of MCC is a perinuclear dot pattern of cytokeratin-20, "which is the rule, not the exception," he said.

Dr. Nghiem finds MCC treatment guidelines from the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology to be especially useful. The guidelines are updated annually and are available at www.nccn.org

MCC typically is coded as ICD-9 code 173 (other malignant neoplasm of skin). "Unfortunately, this means that MCC costs can't be tracked at all and, more importantly, patients are denied care," he said. Things should improve on that front shortly, however. Dr. Nghiem said that the CDC is expected to release eight new diagnostic codes specific for MCC this month.

Little is known about MCC biology, but a study from 2008 found that a new polyomavirus is present in the vast majority of cases (Science 2008;319:1096-100). "This is only the sixth example of a virus clearly linked to human cancer," Dr. Nghiem said.

He disclosed that he has received funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the American Cancer Society.

The majority of Merkel cell carcinoma lesions appear on sun-exposed skin, but one in six has been found to appear on sun-protected areas.

Merkel cell carcinoma has a significantly higher mortality rate, compared with melanoma, and reported incidence has increased threefold since 1986.

Source Photos courtesy Dr. Paul Nghiem

PORTLAND, ORE. — Skin lesions are a hallmark of Merkel cell carcinoma, yet dermatologists often find themselves out of the loop in diagnosing patients with the disease, said Dr. Paul Nghiem.

"These [lesions] are typically biopsied as a cyst and the patient usually has to argue for one, two, or three doctor's visits to have the lesion biopsied," Dr. Nghiem said at the annual meeting of the Pacific Dermatologic Association. "They're usually biopsied by a reluctant primary care physician who thinks they're taking off a cyst. Then they may be referred to medical oncology or to surgical oncology, but rarely to dermatology."

About 1,500 new cases of Merkel cell carcinoma (MCC) are diagnosed in the United States each year (J. Invest. Dermatol. 2007;127:2100-3), which is about the same incidence as cutaneous T-cell lymphoma or dermatofibrosarcoma protuberans, said Dr. Nghiem, an expert on the disease who is associate professor of dermatology, medicine, and pathology at the University of Washington, Seattle.

MCC is significantly more lethal than melanoma (40% vs. 15%, respectively), and its reported incidence has increased threefold since 1986 (J. Surg. Oncol. 2005;89:1-4).

"A big reason for that is that it's not missed as much," Dr. Nghiem said. "There are better tools for pathologists to use to make the diagnosis."

The three main risk factors for MCC are prolonged sun exposure, immune suppression, and age over 50 years. "Ninety-four percent of all MCC cases are in people aged 50 or older," he said. "There is a very strong synergy with age" (J. Am. Acad. Dermatol. 2008;58:375-81).

Dr. Nghiem said that HIV-positive patients had about a 13-fold increase of MCC in one study (Lancet 2002;359:497-8), while another study showed that solid organ transplant recipients have about a 10-fold increase (Transplantation 1999;68:1717-21).

He and his associates devised the acronym AEIOU to describe the clinical features of Merkel cell carcinoma based on an analysis of 195 patients given the diagnosis between 1980 and 2007 (J. Am. Acad. Dermatol. 2008; 58:375-81). The acronym stands for Asymptomatic, Expanding rapidly, Immune compromised, Older than 50, and UV-exposed, fair skin.

"Under no circumstances do I think that this is a highly specific test," said Dr. Nghiem, whose clinic is based at the Fred Hutchinson Cancer Research Center in Seattle. "It's not going to be up there with the ABCDs of melanoma, but if you see these characteristics together, you may want to think about doing a biopsy."

More than half of the lesions in the 195 patients evaluated (56%) were presumed to be benign at biopsy, and 32% presented on the head and neck, followed by the lower limb (30%), upper limb (20%), trunk (10%), and buttock (8%).

The majority of lesions (81%) presented on sun-exposed skin, but one in six was in a sun-protected site.

Nearly all of the lesions (88%) were asymptomatic ("neither tender nor itchy," he said), 63% doubled in size in the past 3 months, and 8% of the patients were profoundly immune suppressed. "That is a 16-fold increase over the normal population, but still a minority of all Merkel cell cases," he said, noting that 90% of the patients studied were at least 50 years of age and that 98% were fair skinned.

"Taken together, 89% of all Merkel cell carcinomas had three or more of these clinical AEIOU features," he said.

Optimal therapy for MCC is unique among skin cancers, he said, in that sentinel lymph node biopsy (SLNB) is usually indicated and the disease is "exquisitely sensitive" to radiation.

"If I had one modality to treat MCC, it would be radiation," he said.

SLNB is important for prognosis, he added, because it "results in more accurate staging and has therapeutic implications. If it's microscopically positive [the cancer] will very likely develop in that node bed within a few months if you don't do anything."

In Dr. Nghiem's opinion, the best local therapy for MCC is pathologically clear margins when the primary tumor is less than 1 cm, there is no lymphovascular invasion, there is no profound immune suppression, and the SLNB is negative.

"If all of those things are kosher, you are pretty much okay with a negative margin incision," he said. "Otherwise, adjuvant radiation is very helpful."

He described the current staging system for MCC as "a mess." Five staging systems are currently being used, he said, yet all of them are based on studies of fewer than 300 patients and none has been validated.

MCC staging by the American Joint Committee on Cancer is currently performed using the same staging system as for 82 other nonmelanoma skin cancers, including basal cell carcinoma, squamous cell carcinoma, and adnexal neoplasms.

The key histologic feature of MCC is a perinuclear dot pattern of cytokeratin-20, "which is the rule, not the exception," he said.

Dr. Nghiem finds MCC treatment guidelines from the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology to be especially useful. The guidelines are updated annually and are available at www.nccn.org

MCC typically is coded as ICD-9 code 173 (other malignant neoplasm of skin). "Unfortunately, this means that MCC costs can't be tracked at all and, more importantly, patients are denied care," he said. Things should improve on that front shortly, however. Dr. Nghiem said that the CDC is expected to release eight new diagnostic codes specific for MCC this month.

Little is known about MCC biology, but a study from 2008 found that a new polyomavirus is present in the vast majority of cases (Science 2008;319:1096-100). "This is only the sixth example of a virus clearly linked to human cancer," Dr. Nghiem said.

He disclosed that he has received funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the American Cancer Society.

The majority of Merkel cell carcinoma lesions appear on sun-exposed skin, but one in six has been found to appear on sun-protected areas.

Merkel cell carcinoma has a significantly higher mortality rate, compared with melanoma, and reported incidence has increased threefold since 1986.

Source Photos courtesy Dr. Paul Nghiem

PORTLAND, ORE. — Its ability to provide volume and spare tissue makes the island pedicle flap a valuable technique for deep facial defects.

"When you can just about close a defect primarily and have concerns that doing so might cause unnecessary contour deformity or free margin retraction, an island pedicle flap taken from the standing cutaneous cone will rescue the repair and provide excellent cosmesis with minimal tissue loss," Dr. Roberta Sengelmann said at the annual meeting of the Pacific Dermatologic Association.

Also known as the B-to-Y flap or the kite flap, the island pedicle flap "has a rich vascular supply which comes from the underlying subcutaneous and muscular pedicle," said Dr. Sengelmann, a cosmetic dermatologic surgeon who practices in Santa Barbara, Calif., and St. Louis. "It is a terrifically viable flap and has surprisingly good mobility."

She uses it for deep defects, in areas where cosmetic junction lines and relaxed skin tension lines can camouflage the flap's kite-shaped design, to advance hair-bearing skin in cases when like skin is needed where there is a limited tissue reservoir within the cosmetic subunit.

She described the technique at the meeting. First, design the flap so that the primary and secondary flap movement will not cause anatomic distortion. Designs may be pentagonal, curved, or tapered. "These designs are used to preserve adjacent anatomical structures so as to avoid tissue distortion, but you maximize gain of the soft tissues that you have available," Dr. Sengelmann explained. "You take advantage of tissue laxity and relaxed skin tension lines."

Movement of the island pedicle flap is usually linear, "but you can rotate it [30-90 degrees], flip it [90-180 degrees], or tunnel it," she said.

Incise the flap vertically to the full thickness of the skin, free the advancing edge a few millimeters to prevent tethering down of the leading edge, and free a distal third or so of the flap to prevent limitation of movement.

Next, use a vertical spreading technique to undermine the flap. "The goal here is to maintain the vascular and muscular pedicle and provide enough stretch to allow adequate movement," she said. Advance the flap into place and secure the leading edge with the key suture. Undermine the defect wound margins in the mid-fat, close the secondary defect, achieve hemostasis, and approximate the flap slightly below the plane of the surrounding skin while providing perfect wound edge coaptation and eversion.

"Flaps should not be oversized," she cautioned. "When the flap is oversized, it tends to buckle up during the wound-healing process and can leave a 'pincushion-like' deformity."

To achieve optimal results, "be sure that the secondary defect can be easily closed side-to-side without distortion of anatomic structures," she added.

Other clinical pearls she shared were to "slightly undersize the flap, keeping in mind the area you are moving it to and being sure that you have enough primary movement to close the defect without compromising contour at that site."

Dr. Sengelmann acknowledged certain limitations of the island pedicle flap, including "trapdooring" and the potential for poor outcomes in areas with inadequate subdermal tissue and/or poor mobility, such as radiated, burned, or scarred skin; the nasal dorsum; and helical rim.

Even so, she concluded that the tissue-sparing aspect of this flap is "unsurpassed." There is a learning curve to "getting it right," but once the execution is mastered it provides an exceptional option for reconstruction of facial cutaneous defects.

Dr. Sengelmann disclosed no relevant conflicts of interest.

There's a learning curve to 'getting it right,' but once mastered it provides an exceptional option.

Source Dr. Sengelmann

PORTLAND, ORE. — Its ability to provide volume and spare tissue makes the island pedicle flap a valuable technique for deep facial defects.

"When you can just about close a defect primarily and have concerns that doing so might cause unnecessary contour deformity or free margin retraction, an island pedicle flap taken from the standing cutaneous cone will rescue the repair and provide excellent cosmesis with minimal tissue loss," Dr. Roberta Sengelmann said at the annual meeting of the Pacific Dermatologic Association.

Also known as the B-to-Y flap or the kite flap, the island pedicle flap "has a rich vascular supply which comes from the underlying subcutaneous and muscular pedicle," said Dr. Sengelmann, a cosmetic dermatologic surgeon who practices in Santa Barbara, Calif., and St. Louis. "It is a terrifically viable flap and has surprisingly good mobility."

She uses it for deep defects, in areas where cosmetic junction lines and relaxed skin tension lines can camouflage the flap's kite-shaped design, to advance hair-bearing skin in cases when like skin is needed where there is a limited tissue reservoir within the cosmetic subunit.

She described the technique at the meeting. First, design the flap so that the primary and secondary flap movement will not cause anatomic distortion. Designs may be pentagonal, curved, or tapered. "These designs are used to preserve adjacent anatomical structures so as to avoid tissue distortion, but you maximize gain of the soft tissues that you have available," Dr. Sengelmann explained. "You take advantage of tissue laxity and relaxed skin tension lines."

Movement of the island pedicle flap is usually linear, "but you can rotate it [30-90 degrees], flip it [90-180 degrees], or tunnel it," she said.

Incise the flap vertically to the full thickness of the skin, free the advancing edge a few millimeters to prevent tethering down of the leading edge, and free a distal third or so of the flap to prevent limitation of movement.

Next, use a vertical spreading technique to undermine the flap. "The goal here is to maintain the vascular and muscular pedicle and provide enough stretch to allow adequate movement," she said. Advance the flap into place and secure the leading edge with the key suture. Undermine the defect wound margins in the mid-fat, close the secondary defect, achieve hemostasis, and approximate the flap slightly below the plane of the surrounding skin while providing perfect wound edge coaptation and eversion.

"Flaps should not be oversized," she cautioned. "When the flap is oversized, it tends to buckle up during the wound-healing process and can leave a 'pincushion-like' deformity."

To achieve optimal results, "be sure that the secondary defect can be easily closed side-to-side without distortion of anatomic structures," she added.

Other clinical pearls she shared were to "slightly undersize the flap, keeping in mind the area you are moving it to and being sure that you have enough primary movement to close the defect without compromising contour at that site."

Dr. Sengelmann acknowledged certain limitations of the island pedicle flap, including "trapdooring" and the potential for poor outcomes in areas with inadequate subdermal tissue and/or poor mobility, such as radiated, burned, or scarred skin; the nasal dorsum; and helical rim.

Even so, she concluded that the tissue-sparing aspect of this flap is "unsurpassed." There is a learning curve to "getting it right," but once the execution is mastered it provides an exceptional option for reconstruction of facial cutaneous defects.

Dr. Sengelmann disclosed no relevant conflicts of interest.

There's a learning curve to 'getting it right,' but once mastered it provides an exceptional option.

Source Dr. Sengelmann

PORTLAND, ORE. — Its ability to provide volume and spare tissue makes the island pedicle flap a valuable technique for deep facial defects.

"When you can just about close a defect primarily and have concerns that doing so might cause unnecessary contour deformity or free margin retraction, an island pedicle flap taken from the standing cutaneous cone will rescue the repair and provide excellent cosmesis with minimal tissue loss," Dr. Roberta Sengelmann said at the annual meeting of the Pacific Dermatologic Association.

Also known as the B-to-Y flap or the kite flap, the island pedicle flap "has a rich vascular supply which comes from the underlying subcutaneous and muscular pedicle," said Dr. Sengelmann, a cosmetic dermatologic surgeon who practices in Santa Barbara, Calif., and St. Louis. "It is a terrifically viable flap and has surprisingly good mobility."

She uses it for deep defects, in areas where cosmetic junction lines and relaxed skin tension lines can camouflage the flap's kite-shaped design, to advance hair-bearing skin in cases when like skin is needed where there is a limited tissue reservoir within the cosmetic subunit.

She described the technique at the meeting. First, design the flap so that the primary and secondary flap movement will not cause anatomic distortion. Designs may be pentagonal, curved, or tapered. "These designs are used to preserve adjacent anatomical structures so as to avoid tissue distortion, but you maximize gain of the soft tissues that you have available," Dr. Sengelmann explained. "You take advantage of tissue laxity and relaxed skin tension lines."

Movement of the island pedicle flap is usually linear, "but you can rotate it [30-90 degrees], flip it [90-180 degrees], or tunnel it," she said.

Incise the flap vertically to the full thickness of the skin, free the advancing edge a few millimeters to prevent tethering down of the leading edge, and free a distal third or so of the flap to prevent limitation of movement.

Next, use a vertical spreading technique to undermine the flap. "The goal here is to maintain the vascular and muscular pedicle and provide enough stretch to allow adequate movement," she said. Advance the flap into place and secure the leading edge with the key suture. Undermine the defect wound margins in the mid-fat, close the secondary defect, achieve hemostasis, and approximate the flap slightly below the plane of the surrounding skin while providing perfect wound edge coaptation and eversion.

"Flaps should not be oversized," she cautioned. "When the flap is oversized, it tends to buckle up during the wound-healing process and can leave a 'pincushion-like' deformity."

To achieve optimal results, "be sure that the secondary defect can be easily closed side-to-side without distortion of anatomic structures," she added.

Other clinical pearls she shared were to "slightly undersize the flap, keeping in mind the area you are moving it to and being sure that you have enough primary movement to close the defect without compromising contour at that site."

Dr. Sengelmann acknowledged certain limitations of the island pedicle flap, including "trapdooring" and the potential for poor outcomes in areas with inadequate subdermal tissue and/or poor mobility, such as radiated, burned, or scarred skin; the nasal dorsum; and helical rim.

Even so, she concluded that the tissue-sparing aspect of this flap is "unsurpassed." There is a learning curve to "getting it right," but once the execution is mastered it provides an exceptional option for reconstruction of facial cutaneous defects.

Dr. Sengelmann disclosed no relevant conflicts of interest.

There's a learning curve to 'getting it right,' but once mastered it provides an exceptional option.

Source Dr. Sengelmann

Two years after the American Academy of Dermatology's Seal of Recognition program was launched, six products have been recognized for their sun protection benefits.

In an interview, Dr. James M. Spencer, who oversees the program, said that he expected the list of recognized products “to be somewhat larger” by now. He acknowledged that part of the slow start may stem from controversy the program generated at the AAD's annual meeting in 2008, most notably by the late dermatopathologist A. Bernard Ackerman.

“He did not feel that sunlight causes melanoma,” recalled Dr. Spencer, who also chairs the AAD's Melanoma/Skin Cancer Committee. “If you have that position, why would you want to encourage people to wear sun protection products? He also felt that [the Seal of Recognition program] was a conflict of interest financially; that it tainted the AAD. We're all sensitive to that. Potential conflicts of interest come up in practice all the time. Professionalism means putting your duty ahead of your personal benefit.”

Dr. Spencer of Mount Sinai School of Medicine, New York, went on to emphasize that while he is sensitive to the arguments against the program, “at the end of the day it's like giving a medication: We weigh the risks versus the benefits. The benefits are, if we can get people to use effective sun protection products more, that's a benefit. The risks are that it may make us appear like we've sold out somehow. We have to weigh those two against each other. To me, the benefits to society of driving sun protection products outweigh any potential risks. Life's full of decisions like that, isn't it?”

To have a product considered for the program, the manufacturer must pay a $5,000 application fee, followed by a $10,000 annual license fee upon approval of the application.

“This program was never intended to be a fund-raiser,” said Dr. Spencer. “If there's any money left over [from the application fees] after program expenses, it goes solely to public education for skin cancer.”

Loosely modeled after product endorsement programs established by the American Dental Association and the Skin Cancer Foundation, the AAD's Seal of Recognition program has a twofold purpose, Dr. Spencer said: to let consumers know that the product they're buying has a sun protection benefit, and “to raise awareness about the importance of sun protection. According to recent surveys the use of sunscreen is going down.”

Each product undergoes a review every 2 years to ensure that it still meets evidence-based criteria as set forth by the AAD. “It is a fairly high hurdle for a product to have these independent studies, to be reviewed and accepted,” Dr. Spencer said.

The Seal of Recognition program reflects the academy's efforts “to do everything possible to reduce the incidence of skin cancer on all fronts. Among those fronts is to encourage the use of effective sun protection products. That's the genesis of this effort,” he said.

The ongoing debate about the benefits of vitamin D and the call by some clinicians to seek out unprotected exposure to the sun is not helping the Seal of Recognition program from a public relations standpoint, either. “Dermatologists need to be aware that sun protection has become a controversial issue, specifically because of vitamin D,” he said. “Weighing the evidence overall, our advocacy of regular sun protection is still the way to go, and I would encourage our colleagues to continue their advocacy for sun protection.”

By accepting application fees from companies that manufacture sun protection products, the Seal of Recognition program “can be misinterpreted as a conflict of interest by the medical or general public,” said Dr. Peter C. Lombardo of the department of dermatology at Columbia University, New York. A recent article about professional medical associations and their relationships with industry calls the propriety of endorsing commercial products “highly suspect” (JAMA 2009;301:1367-72).

“My objection is that money is involved in the granting of the seal, and this is where the misconception of the AAD's motives arises,” said Dr. Lombardo. “If this were not the case, I would have no objection to [the program]. I believe the AAD is the premier academic institution of America's dermatologists and as such it should be 'like Caesar's wife': above reproach.”

Ron Cummings, founder and owner of Newport Beach, Calif.–based AminoGenesis Skin Care, called the Seal of Recognition program a “long-overdue” development. “What made this good is that it was a third-party verification process, extremely documented and very rigorous,” he said. “You had to put together a formula that was great, and we were able to do that. Consumers have responded very well, because when they use a product with this AAD seal, they know that it has some level of credibility behind it. It's a certain level of assurance.”

The manufacturer must contract with an independent laboratory to test the product in accordance with stringent, evidence-based criteria, including UVA protection, which is not yet required by the Food and Drug Administration. The independent laboratory test results are reviewed by an independent scientist who holds a PhD degree in photobiology and is based in New York City. (The AAD would not disclose the name of this person to ensure that the review of products being considered for the seal remains independent.) That person provides a recommendation about whether the product meets the program's criteria to the AAD's Melanoma/Skin Cancer Committee, which makes the final call on acceptance.

Dr. Spencer disclosed that he is a consultant for L'Oréal, Neutrogena, and IVAX.

Products Bearing AAD Seal of Recognition

AminoGenesis Anti-Aging Day Cream with SPF 18

AminoGenesis Derma Scyne Wrinkle Arrest with SPF 18

Coolibar Sun Protection Clothing UPF 50+

Aveeno Continuous Protection Sunblock SPF 55

Aveeno Baby Continuous Protection Sunblock SPF 55

Mederma Cream plus SPF 30

Two years after the American Academy of Dermatology's Seal of Recognition program was launched, six products have been recognized for their sun protection benefits.

In an interview, Dr. James M. Spencer, who oversees the program, said that he expected the list of recognized products “to be somewhat larger” by now. He acknowledged that part of the slow start may stem from controversy the program generated at the AAD's annual meeting in 2008, most notably by the late dermatopathologist A. Bernard Ackerman.

“He did not feel that sunlight causes melanoma,” recalled Dr. Spencer, who also chairs the AAD's Melanoma/Skin Cancer Committee. “If you have that position, why would you want to encourage people to wear sun protection products? He also felt that [the Seal of Recognition program] was a conflict of interest financially; that it tainted the AAD. We're all sensitive to that. Potential conflicts of interest come up in practice all the time. Professionalism means putting your duty ahead of your personal benefit.”

Dr. Spencer of Mount Sinai School of Medicine, New York, went on to emphasize that while he is sensitive to the arguments against the program, “at the end of the day it's like giving a medication: We weigh the risks versus the benefits. The benefits are, if we can get people to use effective sun protection products more, that's a benefit. The risks are that it may make us appear like we've sold out somehow. We have to weigh those two against each other. To me, the benefits to society of driving sun protection products outweigh any potential risks. Life's full of decisions like that, isn't it?”

To have a product considered for the program, the manufacturer must pay a $5,000 application fee, followed by a $10,000 annual license fee upon approval of the application.

“This program was never intended to be a fund-raiser,” said Dr. Spencer. “If there's any money left over [from the application fees] after program expenses, it goes solely to public education for skin cancer.”

Loosely modeled after product endorsement programs established by the American Dental Association and the Skin Cancer Foundation, the AAD's Seal of Recognition program has a twofold purpose, Dr. Spencer said: to let consumers know that the product they're buying has a sun protection benefit, and “to raise awareness about the importance of sun protection. According to recent surveys the use of sunscreen is going down.”

Each product undergoes a review every 2 years to ensure that it still meets evidence-based criteria as set forth by the AAD. “It is a fairly high hurdle for a product to have these independent studies, to be reviewed and accepted,” Dr. Spencer said.

The Seal of Recognition program reflects the academy's efforts “to do everything possible to reduce the incidence of skin cancer on all fronts. Among those fronts is to encourage the use of effective sun protection products. That's the genesis of this effort,” he said.

The ongoing debate about the benefits of vitamin D and the call by some clinicians to seek out unprotected exposure to the sun is not helping the Seal of Recognition program from a public relations standpoint, either. “Dermatologists need to be aware that sun protection has become a controversial issue, specifically because of vitamin D,” he said. “Weighing the evidence overall, our advocacy of regular sun protection is still the way to go, and I would encourage our colleagues to continue their advocacy for sun protection.”

By accepting application fees from companies that manufacture sun protection products, the Seal of Recognition program “can be misinterpreted as a conflict of interest by the medical or general public,” said Dr. Peter C. Lombardo of the department of dermatology at Columbia University, New York. A recent article about professional medical associations and their relationships with industry calls the propriety of endorsing commercial products “highly suspect” (JAMA 2009;301:1367-72).

“My objection is that money is involved in the granting of the seal, and this is where the misconception of the AAD's motives arises,” said Dr. Lombardo. “If this were not the case, I would have no objection to [the program]. I believe the AAD is the premier academic institution of America's dermatologists and as such it should be 'like Caesar's wife': above reproach.”

Ron Cummings, founder and owner of Newport Beach, Calif.–based AminoGenesis Skin Care, called the Seal of Recognition program a “long-overdue” development. “What made this good is that it was a third-party verification process, extremely documented and very rigorous,” he said. “You had to put together a formula that was great, and we were able to do that. Consumers have responded very well, because when they use a product with this AAD seal, they know that it has some level of credibility behind it. It's a certain level of assurance.”

The manufacturer must contract with an independent laboratory to test the product in accordance with stringent, evidence-based criteria, including UVA protection, which is not yet required by the Food and Drug Administration. The independent laboratory test results are reviewed by an independent scientist who holds a PhD degree in photobiology and is based in New York City. (The AAD would not disclose the name of this person to ensure that the review of products being considered for the seal remains independent.) That person provides a recommendation about whether the product meets the program's criteria to the AAD's Melanoma/Skin Cancer Committee, which makes the final call on acceptance.

Dr. Spencer disclosed that he is a consultant for L'Oréal, Neutrogena, and IVAX.

Products Bearing AAD Seal of Recognition

AminoGenesis Anti-Aging Day Cream with SPF 18

AminoGenesis Derma Scyne Wrinkle Arrest with SPF 18

Coolibar Sun Protection Clothing UPF 50+

Aveeno Continuous Protection Sunblock SPF 55

Aveeno Baby Continuous Protection Sunblock SPF 55

Mederma Cream plus SPF 30

Two years after the American Academy of Dermatology's Seal of Recognition program was launched, six products have been recognized for their sun protection benefits.

In an interview, Dr. James M. Spencer, who oversees the program, said that he expected the list of recognized products “to be somewhat larger” by now. He acknowledged that part of the slow start may stem from controversy the program generated at the AAD's annual meeting in 2008, most notably by the late dermatopathologist A. Bernard Ackerman.

“He did not feel that sunlight causes melanoma,” recalled Dr. Spencer, who also chairs the AAD's Melanoma/Skin Cancer Committee. “If you have that position, why would you want to encourage people to wear sun protection products? He also felt that [the Seal of Recognition program] was a conflict of interest financially; that it tainted the AAD. We're all sensitive to that. Potential conflicts of interest come up in practice all the time. Professionalism means putting your duty ahead of your personal benefit.”

Dr. Spencer of Mount Sinai School of Medicine, New York, went on to emphasize that while he is sensitive to the arguments against the program, “at the end of the day it's like giving a medication: We weigh the risks versus the benefits. The benefits are, if we can get people to use effective sun protection products more, that's a benefit. The risks are that it may make us appear like we've sold out somehow. We have to weigh those two against each other. To me, the benefits to society of driving sun protection products outweigh any potential risks. Life's full of decisions like that, isn't it?”

To have a product considered for the program, the manufacturer must pay a $5,000 application fee, followed by a $10,000 annual license fee upon approval of the application.

“This program was never intended to be a fund-raiser,” said Dr. Spencer. “If there's any money left over [from the application fees] after program expenses, it goes solely to public education for skin cancer.”

Loosely modeled after product endorsement programs established by the American Dental Association and the Skin Cancer Foundation, the AAD's Seal of Recognition program has a twofold purpose, Dr. Spencer said: to let consumers know that the product they're buying has a sun protection benefit, and “to raise awareness about the importance of sun protection. According to recent surveys the use of sunscreen is going down.”

Each product undergoes a review every 2 years to ensure that it still meets evidence-based criteria as set forth by the AAD. “It is a fairly high hurdle for a product to have these independent studies, to be reviewed and accepted,” Dr. Spencer said.

The Seal of Recognition program reflects the academy's efforts “to do everything possible to reduce the incidence of skin cancer on all fronts. Among those fronts is to encourage the use of effective sun protection products. That's the genesis of this effort,” he said.

The ongoing debate about the benefits of vitamin D and the call by some clinicians to seek out unprotected exposure to the sun is not helping the Seal of Recognition program from a public relations standpoint, either. “Dermatologists need to be aware that sun protection has become a controversial issue, specifically because of vitamin D,” he said. “Weighing the evidence overall, our advocacy of regular sun protection is still the way to go, and I would encourage our colleagues to continue their advocacy for sun protection.”

By accepting application fees from companies that manufacture sun protection products, the Seal of Recognition program “can be misinterpreted as a conflict of interest by the medical or general public,” said Dr. Peter C. Lombardo of the department of dermatology at Columbia University, New York. A recent article about professional medical associations and their relationships with industry calls the propriety of endorsing commercial products “highly suspect” (JAMA 2009;301:1367-72).

“My objection is that money is involved in the granting of the seal, and this is where the misconception of the AAD's motives arises,” said Dr. Lombardo. “If this were not the case, I would have no objection to [the program]. I believe the AAD is the premier academic institution of America's dermatologists and as such it should be 'like Caesar's wife': above reproach.”

Ron Cummings, founder and owner of Newport Beach, Calif.–based AminoGenesis Skin Care, called the Seal of Recognition program a “long-overdue” development. “What made this good is that it was a third-party verification process, extremely documented and very rigorous,” he said. “You had to put together a formula that was great, and we were able to do that. Consumers have responded very well, because when they use a product with this AAD seal, they know that it has some level of credibility behind it. It's a certain level of assurance.”

The manufacturer must contract with an independent laboratory to test the product in accordance with stringent, evidence-based criteria, including UVA protection, which is not yet required by the Food and Drug Administration. The independent laboratory test results are reviewed by an independent scientist who holds a PhD degree in photobiology and is based in New York City. (The AAD would not disclose the name of this person to ensure that the review of products being considered for the seal remains independent.) That person provides a recommendation about whether the product meets the program's criteria to the AAD's Melanoma/Skin Cancer Committee, which makes the final call on acceptance.

Dr. Spencer disclosed that he is a consultant for L'Oréal, Neutrogena, and IVAX.

Products Bearing AAD Seal of Recognition

AminoGenesis Anti-Aging Day Cream with SPF 18

AminoGenesis Derma Scyne Wrinkle Arrest with SPF 18

Coolibar Sun Protection Clothing UPF 50+

Aveeno Continuous Protection Sunblock SPF 55

Aveeno Baby Continuous Protection Sunblock SPF 55

Mederma Cream plus SPF 30