Fran Lowry

BOCA RATON, FLA. – In an open-label pilot study of 36 marijuana-dependent individuals, 12 weeks of treatment with the catechol O-methyltransferase inhibitor entacapone significantly decreased craving for marijuana in 19 (53%) of the study participants.

These 19 patients were able to abstain from smoking marijuana for the full 12 weeks of the trial, Dr. Rahim Shafa said at the annual meeting of the American Academy of Addiction Psychiatry.

The drug represents a potential safeguard against marijuana addiction in some individuals, said Dr. Shafa of the Metrowest CNS Research Center, Natick, Mass.

Entacapone (Comtan) has been approved by the Food and Drug Administration for use in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy.

In the current study, which was presented as a poster, 30 patients were treated with entacapone 2,000 mg/day for 12 weeks, and 6 patients took 3,000 mg/day. Clinical efficacy was evaluated using the clinical global impression (CGI) improvement scale, which was based on absolute abstinence criteria.

The CGI was divided into four scores, ranging from 0 to 4. Patients who did not improve got a score of 0. Patients who were abstinent for up to 4 weeks got a score of 1, patients who were abstinent for up to 8 weeks got a score of 2, and those who were abstinent for the full 12 weeks of the study got a score of 3.

The patients' ages ranged from 15 to 55 years, with most of them in their mid-20s.

In addition to the 19 patients who were totally abstinent for the 12-week duration of the pilot study, 7 patients were abstinent for 8 weeks, and 3 were abstinent for 4 weeks. There was no improvement noted in the remaining 7 subjects.

The subjects who took up to 3,000 mg/day of entacapone did not report any toxicity and claimed improved efficacy, said Dr. Shafa, who also is in private practice in Natick.

Side effects associated with entacapone in this study were mild, and included palpitations (one patient), somnolence (two patients), sweating (one patient), and nausea (one patient). All of the patients reported urine discoloration.

Dopamine deficiency has been shown to play a major role in drug craving. The catechol O-methyltransferase (COMT) gene plays a pivotal role in regulating homeostatic dopamine neurotransmitter levels. COMT overactivity is related to an increased rate of dopamine degradation, which results in certain disorders, including social withdrawal personality trait, disturbance in attention, and drug abuse.

Drugs that inhibit this overactivity, such as entacapone, may help reduce craving for marijuana by correcting the dopamine imbalance, Dr. Shafa said.

Marijuana is the most commonly used illicit drug in the United States, and first-time use of the drug occurs early.

According to a 2006 National Institute on Drug Abuse survey, 63% of people who used marijuana for the first time were under the age of 18. This is very alarming, Dr. Shafa said.

“The adolescent brain, because of the yet unfulfilled process of myelination, is more vulnerable to permanent structural damage. This makes the increasing problem of tetrahydrocannabinol-containing substance abuse in younger people very worrying,” he said. “As of now, there is no pharmacological treatment recognized for marijuana abuse. COMT-inhibitors may be a promising tool to combat marijuana addiction.”

Dr. Shafa disclosed relationships with AstraZeneca, Bristol-Myers GlaxoSmith- Kline, Janssen, Squibb, and Eli Lilly.

The 19 patients who experienced significantly decreased craving were able to abstain for the full 12 weeks. DR. SHAFA

BOCA RATON, FLA. – In an open-label pilot study of 36 marijuana-dependent individuals, 12 weeks of treatment with the catechol O-methyltransferase inhibitor entacapone significantly decreased craving for marijuana in 19 (53%) of the study participants.

These 19 patients were able to abstain from smoking marijuana for the full 12 weeks of the trial, Dr. Rahim Shafa said at the annual meeting of the American Academy of Addiction Psychiatry.

The drug represents a potential safeguard against marijuana addiction in some individuals, said Dr. Shafa of the Metrowest CNS Research Center, Natick, Mass.

Entacapone (Comtan) has been approved by the Food and Drug Administration for use in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy.

In the current study, which was presented as a poster, 30 patients were treated with entacapone 2,000 mg/day for 12 weeks, and 6 patients took 3,000 mg/day. Clinical efficacy was evaluated using the clinical global impression (CGI) improvement scale, which was based on absolute abstinence criteria.

The CGI was divided into four scores, ranging from 0 to 4. Patients who did not improve got a score of 0. Patients who were abstinent for up to 4 weeks got a score of 1, patients who were abstinent for up to 8 weeks got a score of 2, and those who were abstinent for the full 12 weeks of the study got a score of 3.

The patients' ages ranged from 15 to 55 years, with most of them in their mid-20s.

In addition to the 19 patients who were totally abstinent for the 12-week duration of the pilot study, 7 patients were abstinent for 8 weeks, and 3 were abstinent for 4 weeks. There was no improvement noted in the remaining 7 subjects.

The subjects who took up to 3,000 mg/day of entacapone did not report any toxicity and claimed improved efficacy, said Dr. Shafa, who also is in private practice in Natick.

Side effects associated with entacapone in this study were mild, and included palpitations (one patient), somnolence (two patients), sweating (one patient), and nausea (one patient). All of the patients reported urine discoloration.

Dopamine deficiency has been shown to play a major role in drug craving. The catechol O-methyltransferase (COMT) gene plays a pivotal role in regulating homeostatic dopamine neurotransmitter levels. COMT overactivity is related to an increased rate of dopamine degradation, which results in certain disorders, including social withdrawal personality trait, disturbance in attention, and drug abuse.

Drugs that inhibit this overactivity, such as entacapone, may help reduce craving for marijuana by correcting the dopamine imbalance, Dr. Shafa said.

Marijuana is the most commonly used illicit drug in the United States, and first-time use of the drug occurs early.

According to a 2006 National Institute on Drug Abuse survey, 63% of people who used marijuana for the first time were under the age of 18. This is very alarming, Dr. Shafa said.

“The adolescent brain, because of the yet unfulfilled process of myelination, is more vulnerable to permanent structural damage. This makes the increasing problem of tetrahydrocannabinol-containing substance abuse in younger people very worrying,” he said. “As of now, there is no pharmacological treatment recognized for marijuana abuse. COMT-inhibitors may be a promising tool to combat marijuana addiction.”

Dr. Shafa disclosed relationships with AstraZeneca, Bristol-Myers GlaxoSmith- Kline, Janssen, Squibb, and Eli Lilly.

The 19 patients who experienced significantly decreased craving were able to abstain for the full 12 weeks. DR. SHAFA

BOCA RATON, FLA. – In an open-label pilot study of 36 marijuana-dependent individuals, 12 weeks of treatment with the catechol O-methyltransferase inhibitor entacapone significantly decreased craving for marijuana in 19 (53%) of the study participants.

These 19 patients were able to abstain from smoking marijuana for the full 12 weeks of the trial, Dr. Rahim Shafa said at the annual meeting of the American Academy of Addiction Psychiatry.

The drug represents a potential safeguard against marijuana addiction in some individuals, said Dr. Shafa of the Metrowest CNS Research Center, Natick, Mass.

Entacapone (Comtan) has been approved by the Food and Drug Administration for use in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy.

In the current study, which was presented as a poster, 30 patients were treated with entacapone 2,000 mg/day for 12 weeks, and 6 patients took 3,000 mg/day. Clinical efficacy was evaluated using the clinical global impression (CGI) improvement scale, which was based on absolute abstinence criteria.

The CGI was divided into four scores, ranging from 0 to 4. Patients who did not improve got a score of 0. Patients who were abstinent for up to 4 weeks got a score of 1, patients who were abstinent for up to 8 weeks got a score of 2, and those who were abstinent for the full 12 weeks of the study got a score of 3.

The patients' ages ranged from 15 to 55 years, with most of them in their mid-20s.

In addition to the 19 patients who were totally abstinent for the 12-week duration of the pilot study, 7 patients were abstinent for 8 weeks, and 3 were abstinent for 4 weeks. There was no improvement noted in the remaining 7 subjects.

The subjects who took up to 3,000 mg/day of entacapone did not report any toxicity and claimed improved efficacy, said Dr. Shafa, who also is in private practice in Natick.

Side effects associated with entacapone in this study were mild, and included palpitations (one patient), somnolence (two patients), sweating (one patient), and nausea (one patient). All of the patients reported urine discoloration.

Dopamine deficiency has been shown to play a major role in drug craving. The catechol O-methyltransferase (COMT) gene plays a pivotal role in regulating homeostatic dopamine neurotransmitter levels. COMT overactivity is related to an increased rate of dopamine degradation, which results in certain disorders, including social withdrawal personality trait, disturbance in attention, and drug abuse.

Drugs that inhibit this overactivity, such as entacapone, may help reduce craving for marijuana by correcting the dopamine imbalance, Dr. Shafa said.

Marijuana is the most commonly used illicit drug in the United States, and first-time use of the drug occurs early.

According to a 2006 National Institute on Drug Abuse survey, 63% of people who used marijuana for the first time were under the age of 18. This is very alarming, Dr. Shafa said.

“The adolescent brain, because of the yet unfulfilled process of myelination, is more vulnerable to permanent structural damage. This makes the increasing problem of tetrahydrocannabinol-containing substance abuse in younger people very worrying,” he said. “As of now, there is no pharmacological treatment recognized for marijuana abuse. COMT-inhibitors may be a promising tool to combat marijuana addiction.”

Dr. Shafa disclosed relationships with AstraZeneca, Bristol-Myers GlaxoSmith- Kline, Janssen, Squibb, and Eli Lilly.

The 19 patients who experienced significantly decreased craving were able to abstain for the full 12 weeks. DR. SHAFA

BOCA RATON, FLA. — In a pilot study of pregnant women who continued to smoke cigarettes despite knowing they were pregnant, 11 (37%) of 30 women who received contingency management achieved abstinence, compared with just 2 (10%)) of 23 women who did not.

This result highlights the effectiveness of contingency management as a strategy to help pregnant women stop smoking, Dr. Sarah Heil said at the annual meeting of the American Academy of Addiction Psychiatry.

The women in both the contingent group and noncontingent group were seen every day for the first 5 days of the study.

During this time, abstinence was based on a breath carbon monoxide level of 6 parts per million or less, said Dr. Heil of the University of Vermont, Burlington.

After the first 5 days, the women were seen according to the following schedule:

▸ Twice a week for 7 weeks.

▸ Once a week for the next 11 weeks.

▸ Once every other week until delivery.

▸ Once a week for the first 4 weeks post partum.

▸ Every other week for the next 8 weeks.

Abstinence in this phase of the study was assessed by measuring urine cotinine levels; levels of 80 ng/mL or less were indicative of abstinence.

The women were rewarded with vouchers, which were earned contingent on biochemically verified abstinence.

The voucher value began at $6.25 and escalated at a rate of $1.25 per consecutive negative sample up to a maximum of $45.

“These vouchers are like having a bank account with us. We put their money into an account, and they are allowed to spend it on things we believe are appropriate. So there were a lot of gift certificates, paying of credit card bills, and shopping at Wal-Mart and grocery stores,” Dr. Heil said.

Women who were randomized to noncontingency management got vouchers independent of their smoking status.

The vouchers were a flat $11.50 per antepartum visit, and $20 per each postpartum visit.

The women in the study had been smoking for about 8 years; most of them lived with other smokers.

They smoked approximately one pack of cigarettes a day before pregnancy, but had reduced this amount by roughly 50% by the time they entered the study.

“They had very high intentions to quit while they are pregnant,” Dr. Heil noted.

Most of the women had less than a high school education, and few of the women were married.

To be considered abstinent at each time point, the women had to self-report that they had not had a cigarette—“not even a puff”—in the last 7 days, as well as the appropriate urine cotinine level.

The effects obtained in the study persisted 3 months after delivery, and for a further 3 months, even though the voucher program was discontinued at 3 months post partum.

This was true for women in the contingent and noncontingent groups, Dr. Heil said.

Importantly, fetuses in the contingent group gained weight faster than those in the noncontingent group. Fetal weight was estimated by measuring fetal length and abdominal circumference by ultrasound.

“We are really excited by these results,” she said.

Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the United States.

Placental abruptions, small gestational age, preterm and still birth, low birth weight, and increased risk for sudden infant death syndrome are all associated with cigarette smoking by the mother.

The adverse effects of smoking on the neonate cost $1,630/birth per year in 2008 dollars.

Dr. Heil said she hopes to extend her research on contingency management to include pregnant smokers who are also opioid dependent.

The women were rewarded with vouchers—earned contingent on biochemically verified abstinence. DR. HEIL

BOCA RATON, FLA. — In a pilot study of pregnant women who continued to smoke cigarettes despite knowing they were pregnant, 11 (37%) of 30 women who received contingency management achieved abstinence, compared with just 2 (10%)) of 23 women who did not.

This result highlights the effectiveness of contingency management as a strategy to help pregnant women stop smoking, Dr. Sarah Heil said at the annual meeting of the American Academy of Addiction Psychiatry.

The women in both the contingent group and noncontingent group were seen every day for the first 5 days of the study.

During this time, abstinence was based on a breath carbon monoxide level of 6 parts per million or less, said Dr. Heil of the University of Vermont, Burlington.

After the first 5 days, the women were seen according to the following schedule:

▸ Twice a week for 7 weeks.

▸ Once a week for the next 11 weeks.

▸ Once every other week until delivery.

▸ Once a week for the first 4 weeks post partum.

▸ Every other week for the next 8 weeks.

Abstinence in this phase of the study was assessed by measuring urine cotinine levels; levels of 80 ng/mL or less were indicative of abstinence.

The women were rewarded with vouchers, which were earned contingent on biochemically verified abstinence.

The voucher value began at $6.25 and escalated at a rate of $1.25 per consecutive negative sample up to a maximum of $45.

“These vouchers are like having a bank account with us. We put their money into an account, and they are allowed to spend it on things we believe are appropriate. So there were a lot of gift certificates, paying of credit card bills, and shopping at Wal-Mart and grocery stores,” Dr. Heil said.

Women who were randomized to noncontingency management got vouchers independent of their smoking status.

The vouchers were a flat $11.50 per antepartum visit, and $20 per each postpartum visit.

The women in the study had been smoking for about 8 years; most of them lived with other smokers.

They smoked approximately one pack of cigarettes a day before pregnancy, but had reduced this amount by roughly 50% by the time they entered the study.

“They had very high intentions to quit while they are pregnant,” Dr. Heil noted.

Most of the women had less than a high school education, and few of the women were married.

To be considered abstinent at each time point, the women had to self-report that they had not had a cigarette—“not even a puff”—in the last 7 days, as well as the appropriate urine cotinine level.

The effects obtained in the study persisted 3 months after delivery, and for a further 3 months, even though the voucher program was discontinued at 3 months post partum.

This was true for women in the contingent and noncontingent groups, Dr. Heil said.

Importantly, fetuses in the contingent group gained weight faster than those in the noncontingent group. Fetal weight was estimated by measuring fetal length and abdominal circumference by ultrasound.

“We are really excited by these results,” she said.

Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the United States.

Placental abruptions, small gestational age, preterm and still birth, low birth weight, and increased risk for sudden infant death syndrome are all associated with cigarette smoking by the mother.

The adverse effects of smoking on the neonate cost $1,630/birth per year in 2008 dollars.

Dr. Heil said she hopes to extend her research on contingency management to include pregnant smokers who are also opioid dependent.

The women were rewarded with vouchers—earned contingent on biochemically verified abstinence. DR. HEIL

BOCA RATON, FLA. — In a pilot study of pregnant women who continued to smoke cigarettes despite knowing they were pregnant, 11 (37%) of 30 women who received contingency management achieved abstinence, compared with just 2 (10%)) of 23 women who did not.

This result highlights the effectiveness of contingency management as a strategy to help pregnant women stop smoking, Dr. Sarah Heil said at the annual meeting of the American Academy of Addiction Psychiatry.

The women in both the contingent group and noncontingent group were seen every day for the first 5 days of the study.

During this time, abstinence was based on a breath carbon monoxide level of 6 parts per million or less, said Dr. Heil of the University of Vermont, Burlington.

After the first 5 days, the women were seen according to the following schedule:

▸ Twice a week for 7 weeks.

▸ Once a week for the next 11 weeks.

▸ Once every other week until delivery.

▸ Once a week for the first 4 weeks post partum.

▸ Every other week for the next 8 weeks.

Abstinence in this phase of the study was assessed by measuring urine cotinine levels; levels of 80 ng/mL or less were indicative of abstinence.

The women were rewarded with vouchers, which were earned contingent on biochemically verified abstinence.

The voucher value began at $6.25 and escalated at a rate of $1.25 per consecutive negative sample up to a maximum of $45.

“These vouchers are like having a bank account with us. We put their money into an account, and they are allowed to spend it on things we believe are appropriate. So there were a lot of gift certificates, paying of credit card bills, and shopping at Wal-Mart and grocery stores,” Dr. Heil said.

Women who were randomized to noncontingency management got vouchers independent of their smoking status.

The vouchers were a flat $11.50 per antepartum visit, and $20 per each postpartum visit.

The women in the study had been smoking for about 8 years; most of them lived with other smokers.

They smoked approximately one pack of cigarettes a day before pregnancy, but had reduced this amount by roughly 50% by the time they entered the study.

“They had very high intentions to quit while they are pregnant,” Dr. Heil noted.

Most of the women had less than a high school education, and few of the women were married.

To be considered abstinent at each time point, the women had to self-report that they had not had a cigarette—“not even a puff”—in the last 7 days, as well as the appropriate urine cotinine level.

The effects obtained in the study persisted 3 months after delivery, and for a further 3 months, even though the voucher program was discontinued at 3 months post partum.

This was true for women in the contingent and noncontingent groups, Dr. Heil said.

Importantly, fetuses in the contingent group gained weight faster than those in the noncontingent group. Fetal weight was estimated by measuring fetal length and abdominal circumference by ultrasound.

“We are really excited by these results,” she said.

Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the United States.

Placental abruptions, small gestational age, preterm and still birth, low birth weight, and increased risk for sudden infant death syndrome are all associated with cigarette smoking by the mother.

The adverse effects of smoking on the neonate cost $1,630/birth per year in 2008 dollars.

Dr. Heil said she hopes to extend her research on contingency management to include pregnant smokers who are also opioid dependent.

The women were rewarded with vouchers—earned contingent on biochemically verified abstinence. DR. HEIL

LAKE BUENA VISTA, FLA. — Trauma patients treated at trauma safety net hospitals—those that care for the highest percentage of uninsured patients—have equivalent in-hospital mortality as trauma patients treated at non-trauma safety net hospitals—those that care for a predominantly insured clientele.

In a retrospective analysis of trauma patients aged 18–64 years included in the National Trauma Data Bank for the years 2001–2005, the adjusted odds ratio of death was 0.93 (95% confidence interval, 0.65–1.32) for both types of facilities.

The result indicates that disparate trauma outcomes because of insurance status are not explained by differences between treating institutions, Dr. Anit S. Vettukattil of Georgetown University Hospital, Washington, said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Trauma safety net hospitals were defined as facilities whose patient population was at least 47% uninsured trauma patients; non-trauma safety net hospitals were facilities with less than 47% uninsured trauma patients. Only adults between the ages of 18 and 64 years with moderate to severe injuries were included. The study adjusted for differences in patients' age, sex, insurance status, injury severity, severe head injury, hypotension upon arrival in the emergency department, and type and mechanism of injury.

A variety of subset analyses also were performed to rule out any possible confounding effect of different trauma center types. These analyses focused on university teaching hospitals, public hospitals, and level 1 trauma centers, Dr. Vettukattil said.

The analysis looked at 36,774 patients treated at 46 trauma safety net hospitals, and 306,279 patients treated at 413 non-trauma safety net hospitals. A mean of 61% of patients were uninsured at the trauma safety net hospitals, and a mean of 26% of patients were uninsured at the non-trauma safety net hospitals.

The majority of patients at both types of hospital were male (78% at trauma safety net vs. 73% at non-trauma safety net hospitals), and the mean ages were also similar (36 years at trauma safety net vs. 38 years at non-trauma safety net hospitals). However, 55% of the patients treated at safety net hospitals were black or Hispanic, compared with 27% of patients treated at non-safety net hospitals.

The unadjusted mortality rate was greater in trauma safety net hospitals, compared with non-trauma safety net hospitals (6.8% vs. 4.6%, P less than .05). However, after controlling for patient and hospital type, patients at both kinds of facility had the same odds ratio of death of 9.3.

Patients treated at hospitals that care for the highest percentage of uninsured patients have been shown to be at risk for worse outcomes. These results show, however, that such disparities are not because of the care these patients receive at safety net hospitals, coauthor Dr. Adil H. Haider said in an interview.

“We were very careful in doing our analysis. Our results were very consistent. Every time we analyzed the data, we got the same result. There is no difference in mortality between safety net and non-safety net hospitals. The fact that this stood up to every single statistical test we could think of makes us very confident in concluding that the disparities in outcome between insured and uninsured patients is not explained by differences between the treating institutions,” said Dr. Haider, who is codirector of the Trauma Outcomes Research Group at Johns Hopkins University, Baltimore.

He added that trauma safety net hospitals must be supported. “These centers are providing excellent care. If they are to close because of financial troubles, we will really be disenfranchising a tremendous number of patients.”

Neither Dr. Vettukattil nor Dr. Haider disclosed any conflicts of interest.

Disparate trauma outcomes due to insurance status are not explained by differences between treating institutions. DR. VETTUKATTIL

'Our results were very consistent. Every time we analyzed the data, we got the same result.' Dr. Haider

LAKE BUENA VISTA, FLA. — Trauma patients treated at trauma safety net hospitals—those that care for the highest percentage of uninsured patients—have equivalent in-hospital mortality as trauma patients treated at non-trauma safety net hospitals—those that care for a predominantly insured clientele.

In a retrospective analysis of trauma patients aged 18–64 years included in the National Trauma Data Bank for the years 2001–2005, the adjusted odds ratio of death was 0.93 (95% confidence interval, 0.65–1.32) for both types of facilities.

The result indicates that disparate trauma outcomes because of insurance status are not explained by differences between treating institutions, Dr. Anit S. Vettukattil of Georgetown University Hospital, Washington, said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Trauma safety net hospitals were defined as facilities whose patient population was at least 47% uninsured trauma patients; non-trauma safety net hospitals were facilities with less than 47% uninsured trauma patients. Only adults between the ages of 18 and 64 years with moderate to severe injuries were included. The study adjusted for differences in patients' age, sex, insurance status, injury severity, severe head injury, hypotension upon arrival in the emergency department, and type and mechanism of injury.

A variety of subset analyses also were performed to rule out any possible confounding effect of different trauma center types. These analyses focused on university teaching hospitals, public hospitals, and level 1 trauma centers, Dr. Vettukattil said.

The analysis looked at 36,774 patients treated at 46 trauma safety net hospitals, and 306,279 patients treated at 413 non-trauma safety net hospitals. A mean of 61% of patients were uninsured at the trauma safety net hospitals, and a mean of 26% of patients were uninsured at the non-trauma safety net hospitals.

The majority of patients at both types of hospital were male (78% at trauma safety net vs. 73% at non-trauma safety net hospitals), and the mean ages were also similar (36 years at trauma safety net vs. 38 years at non-trauma safety net hospitals). However, 55% of the patients treated at safety net hospitals were black or Hispanic, compared with 27% of patients treated at non-safety net hospitals.

The unadjusted mortality rate was greater in trauma safety net hospitals, compared with non-trauma safety net hospitals (6.8% vs. 4.6%, P less than .05). However, after controlling for patient and hospital type, patients at both kinds of facility had the same odds ratio of death of 9.3.

Patients treated at hospitals that care for the highest percentage of uninsured patients have been shown to be at risk for worse outcomes. These results show, however, that such disparities are not because of the care these patients receive at safety net hospitals, coauthor Dr. Adil H. Haider said in an interview.

“We were very careful in doing our analysis. Our results were very consistent. Every time we analyzed the data, we got the same result. There is no difference in mortality between safety net and non-safety net hospitals. The fact that this stood up to every single statistical test we could think of makes us very confident in concluding that the disparities in outcome between insured and uninsured patients is not explained by differences between the treating institutions,” said Dr. Haider, who is codirector of the Trauma Outcomes Research Group at Johns Hopkins University, Baltimore.

He added that trauma safety net hospitals must be supported. “These centers are providing excellent care. If they are to close because of financial troubles, we will really be disenfranchising a tremendous number of patients.”

Neither Dr. Vettukattil nor Dr. Haider disclosed any conflicts of interest.

Disparate trauma outcomes due to insurance status are not explained by differences between treating institutions. DR. VETTUKATTIL

'Our results were very consistent. Every time we analyzed the data, we got the same result.' Dr. Haider

LAKE BUENA VISTA, FLA. — Trauma patients treated at trauma safety net hospitals—those that care for the highest percentage of uninsured patients—have equivalent in-hospital mortality as trauma patients treated at non-trauma safety net hospitals—those that care for a predominantly insured clientele.

In a retrospective analysis of trauma patients aged 18–64 years included in the National Trauma Data Bank for the years 2001–2005, the adjusted odds ratio of death was 0.93 (95% confidence interval, 0.65–1.32) for both types of facilities.

The result indicates that disparate trauma outcomes because of insurance status are not explained by differences between treating institutions, Dr. Anit S. Vettukattil of Georgetown University Hospital, Washington, said at the annual meeting of the Eastern Association for the Surgery of Trauma.

Trauma safety net hospitals were defined as facilities whose patient population was at least 47% uninsured trauma patients; non-trauma safety net hospitals were facilities with less than 47% uninsured trauma patients. Only adults between the ages of 18 and 64 years with moderate to severe injuries were included. The study adjusted for differences in patients' age, sex, insurance status, injury severity, severe head injury, hypotension upon arrival in the emergency department, and type and mechanism of injury.

A variety of subset analyses also were performed to rule out any possible confounding effect of different trauma center types. These analyses focused on university teaching hospitals, public hospitals, and level 1 trauma centers, Dr. Vettukattil said.

The analysis looked at 36,774 patients treated at 46 trauma safety net hospitals, and 306,279 patients treated at 413 non-trauma safety net hospitals. A mean of 61% of patients were uninsured at the trauma safety net hospitals, and a mean of 26% of patients were uninsured at the non-trauma safety net hospitals.

The majority of patients at both types of hospital were male (78% at trauma safety net vs. 73% at non-trauma safety net hospitals), and the mean ages were also similar (36 years at trauma safety net vs. 38 years at non-trauma safety net hospitals). However, 55% of the patients treated at safety net hospitals were black or Hispanic, compared with 27% of patients treated at non-safety net hospitals.

The unadjusted mortality rate was greater in trauma safety net hospitals, compared with non-trauma safety net hospitals (6.8% vs. 4.6%, P less than .05). However, after controlling for patient and hospital type, patients at both kinds of facility had the same odds ratio of death of 9.3.

Patients treated at hospitals that care for the highest percentage of uninsured patients have been shown to be at risk for worse outcomes. These results show, however, that such disparities are not because of the care these patients receive at safety net hospitals, coauthor Dr. Adil H. Haider said in an interview.

“We were very careful in doing our analysis. Our results were very consistent. Every time we analyzed the data, we got the same result. There is no difference in mortality between safety net and non-safety net hospitals. The fact that this stood up to every single statistical test we could think of makes us very confident in concluding that the disparities in outcome between insured and uninsured patients is not explained by differences between the treating institutions,” said Dr. Haider, who is codirector of the Trauma Outcomes Research Group at Johns Hopkins University, Baltimore.

He added that trauma safety net hospitals must be supported. “These centers are providing excellent care. If they are to close because of financial troubles, we will really be disenfranchising a tremendous number of patients.”

Neither Dr. Vettukattil nor Dr. Haider disclosed any conflicts of interest.

Disparate trauma outcomes due to insurance status are not explained by differences between treating institutions. DR. VETTUKATTIL

'Our results were very consistent. Every time we analyzed the data, we got the same result.' Dr. Haider

ORLANDO — Physicians can expect to have their relationships with the pharmaceutical industry examined increasingly more closely, as government steps up its efforts to scrutinize their links with Big Pharma.

Pharmaceutical company perks, such as travel subsidies to meetings, lavish dinners, and entertainment, are a thing of the past, and full disclosure is now the order of the day, said representatives of the legal, pharmaceutical, and medical profession at the annual meeting of the American Society for Dermatologic Surgery.

Jonah Shacknai, chairman and CEO of Medicis Pharmaceutical Corp., in Scottsdale, Ariz., said he has seen a substantial shift in the past 20 years in what constitutes an appropriate relationship between industry and physicians.

"Scores of companies have been prosecuted by the federal government, and even more have entered into corporate integrity agreements with the feds, whereby virtually every aspect of the commercial program is open to audit and regulated by the feds," Mr. Shacknai said.

In addition, many physicians have been investigated, and several have been prosecuted for malfeasance, such as including lack of disclosure in articles submitted to peer review journals or in relation to speaking engagements, or for accepting gifts from industry, he said.

"During the Bush administration [there has been] an extraordinary increase in enforcement in this area, by about 700%… and it is reasonable to predict that [it] will continue to be of high interest [in an Obama administration]," Mr. Shacknai said.

However, government is not motivated by a moral conviction that close ties between the pharmaceutical industry and the medical profession are wrong, but by a desire to save money, he cautioned.

"They see that certain types of drugs are going to be more advantageous economically for the federal government reimbursement system at a time when there is great fiscal urgency. The country has not awakened to moral reality. What we have awakened to is a new enforcement reality," he explained.

Jeffrey S. Dover, vice president and president-elect of the American Society of Dermatologic Surgery, said that physicians could protect themselves by being transparent about their dealings with industry.

The relationship between industry and the medical profession is very important, he said, noting that medicine needs industry to support research and development, and industry needs physicians for product development, study data, postmarketing surveillance, and advice. But inherent in this relationship are potential conflicts of interest and bias, so that "even with rigorous guidelines, industry will seek ways to influence physicians, especially thought leaders. Doctors must take personal responsibility for their behavior," said Dr. Dover of Yale University, New Haven, Conn., and Dartmouth Medical School, Hanover, N.H.

Robert P. Brady Esq., of the law firm Hogan & Hartson LLP, Washington, DC, agreed. "You have to apply your own personal medical ethics. It's between you and your patient. You cannot be influenced by a mug or cup [from a drug company]—that's absurd. You have to have [a] personal test for whether your financial relationships are appropriate. You have to be providing real services, and you need to be able to look at yourself in the mirror and say, 'Yes, Big Pharma has hired me as a consultant, and I'm providing real services at a reasonable return.'"

He warned of the passage of a law, possibly soon, that would require pharmaceutical and medical device companies to disclose the details of all gifts and payments of over $25 that they make. The disclosures would be posted on company Web sites and on the Department of Health and Human Services site.

"Washington, which tends to look at things simplistically, believes that transparency will cure [much] of what they perceive to be a corrupted relationship between the industry and you," Mr. Brady said. "I think they're dead wrong. Your relationship with industry is vital and their relationship with you is equally vital."

ORLANDO — Physicians can expect to have their relationships with the pharmaceutical industry examined increasingly more closely, as government steps up its efforts to scrutinize their links with Big Pharma.

Pharmaceutical company perks, such as travel subsidies to meetings, lavish dinners, and entertainment, are a thing of the past, and full disclosure is now the order of the day, said representatives of the legal, pharmaceutical, and medical profession at the annual meeting of the American Society for Dermatologic Surgery.

Jonah Shacknai, chairman and CEO of Medicis Pharmaceutical Corp., in Scottsdale, Ariz., said he has seen a substantial shift in the past 20 years in what constitutes an appropriate relationship between industry and physicians.

"Scores of companies have been prosecuted by the federal government, and even more have entered into corporate integrity agreements with the feds, whereby virtually every aspect of the commercial program is open to audit and regulated by the feds," Mr. Shacknai said.

In addition, many physicians have been investigated, and several have been prosecuted for malfeasance, such as including lack of disclosure in articles submitted to peer review journals or in relation to speaking engagements, or for accepting gifts from industry, he said.

"During the Bush administration [there has been] an extraordinary increase in enforcement in this area, by about 700%… and it is reasonable to predict that [it] will continue to be of high interest [in an Obama administration]," Mr. Shacknai said.

However, government is not motivated by a moral conviction that close ties between the pharmaceutical industry and the medical profession are wrong, but by a desire to save money, he cautioned.

"They see that certain types of drugs are going to be more advantageous economically for the federal government reimbursement system at a time when there is great fiscal urgency. The country has not awakened to moral reality. What we have awakened to is a new enforcement reality," he explained.

Jeffrey S. Dover, vice president and president-elect of the American Society of Dermatologic Surgery, said that physicians could protect themselves by being transparent about their dealings with industry.

The relationship between industry and the medical profession is very important, he said, noting that medicine needs industry to support research and development, and industry needs physicians for product development, study data, postmarketing surveillance, and advice. But inherent in this relationship are potential conflicts of interest and bias, so that "even with rigorous guidelines, industry will seek ways to influence physicians, especially thought leaders. Doctors must take personal responsibility for their behavior," said Dr. Dover of Yale University, New Haven, Conn., and Dartmouth Medical School, Hanover, N.H.

Robert P. Brady Esq., of the law firm Hogan & Hartson LLP, Washington, DC, agreed. "You have to apply your own personal medical ethics. It's between you and your patient. You cannot be influenced by a mug or cup [from a drug company]—that's absurd. You have to have [a] personal test for whether your financial relationships are appropriate. You have to be providing real services, and you need to be able to look at yourself in the mirror and say, 'Yes, Big Pharma has hired me as a consultant, and I'm providing real services at a reasonable return.'"

He warned of the passage of a law, possibly soon, that would require pharmaceutical and medical device companies to disclose the details of all gifts and payments of over $25 that they make. The disclosures would be posted on company Web sites and on the Department of Health and Human Services site.

"Washington, which tends to look at things simplistically, believes that transparency will cure [much] of what they perceive to be a corrupted relationship between the industry and you," Mr. Brady said. "I think they're dead wrong. Your relationship with industry is vital and their relationship with you is equally vital."

ORLANDO — Physicians can expect to have their relationships with the pharmaceutical industry examined increasingly more closely, as government steps up its efforts to scrutinize their links with Big Pharma.

Pharmaceutical company perks, such as travel subsidies to meetings, lavish dinners, and entertainment, are a thing of the past, and full disclosure is now the order of the day, said representatives of the legal, pharmaceutical, and medical profession at the annual meeting of the American Society for Dermatologic Surgery.

Jonah Shacknai, chairman and CEO of Medicis Pharmaceutical Corp., in Scottsdale, Ariz., said he has seen a substantial shift in the past 20 years in what constitutes an appropriate relationship between industry and physicians.

"Scores of companies have been prosecuted by the federal government, and even more have entered into corporate integrity agreements with the feds, whereby virtually every aspect of the commercial program is open to audit and regulated by the feds," Mr. Shacknai said.

In addition, many physicians have been investigated, and several have been prosecuted for malfeasance, such as including lack of disclosure in articles submitted to peer review journals or in relation to speaking engagements, or for accepting gifts from industry, he said.

"During the Bush administration [there has been] an extraordinary increase in enforcement in this area, by about 700%… and it is reasonable to predict that [it] will continue to be of high interest [in an Obama administration]," Mr. Shacknai said.

However, government is not motivated by a moral conviction that close ties between the pharmaceutical industry and the medical profession are wrong, but by a desire to save money, he cautioned.

"They see that certain types of drugs are going to be more advantageous economically for the federal government reimbursement system at a time when there is great fiscal urgency. The country has not awakened to moral reality. What we have awakened to is a new enforcement reality," he explained.

Jeffrey S. Dover, vice president and president-elect of the American Society of Dermatologic Surgery, said that physicians could protect themselves by being transparent about their dealings with industry.

The relationship between industry and the medical profession is very important, he said, noting that medicine needs industry to support research and development, and industry needs physicians for product development, study data, postmarketing surveillance, and advice. But inherent in this relationship are potential conflicts of interest and bias, so that "even with rigorous guidelines, industry will seek ways to influence physicians, especially thought leaders. Doctors must take personal responsibility for their behavior," said Dr. Dover of Yale University, New Haven, Conn., and Dartmouth Medical School, Hanover, N.H.

Robert P. Brady Esq., of the law firm Hogan & Hartson LLP, Washington, DC, agreed. "You have to apply your own personal medical ethics. It's between you and your patient. You cannot be influenced by a mug or cup [from a drug company]—that's absurd. You have to have [a] personal test for whether your financial relationships are appropriate. You have to be providing real services, and you need to be able to look at yourself in the mirror and say, 'Yes, Big Pharma has hired me as a consultant, and I'm providing real services at a reasonable return.'"

He warned of the passage of a law, possibly soon, that would require pharmaceutical and medical device companies to disclose the details of all gifts and payments of over $25 that they make. The disclosures would be posted on company Web sites and on the Department of Health and Human Services site.

"Washington, which tends to look at things simplistically, believes that transparency will cure [much] of what they perceive to be a corrupted relationship between the industry and you," Mr. Brady said. "I think they're dead wrong. Your relationship with industry is vital and their relationship with you is equally vital."

ORLANDO — It is possible that the presence of micrometastases on sentinel lymph node biopsy may have little clinical prognostic value when predicting the survival of patients with malignant melanoma, according to a review of 415 patients.

The overall survival of those who had micrometastases less than 1 cm was similar to the overall survival achieved by patients with no metastases, Dr. Arun P. Venkat reported at the annual meeting of the American Society for Dermatologic Surgery.

In contrast, overall survival was significantly worse in patients who had macrometastases greater than 1 cm, said Dr. Venkat.

Micrometastases are most often detected with sentinel lymph node biopsy (SLNB), whereas macrometastases can be detected clinically or with positron emission tomography/computed tomography (PET/CT).

"Improved immunohistologic techniques are making it easier to find micrometastases in malignant melanoma, so the real question is whether micrometastases are an accurate predictor of recurrences and prognosis or are we unnecessarily upstaging patients by finding more micrometastases?" said Dr. Venkat, who is a dermatology resident at the University of Iowa Hospitals and Clinics in Iowa City.

The prognostic relevance of micrometastases versus macrometastases "has not been clearly differentiated," he noted.

The 415 patients had been followed for at least 3 months: 73 were deemed to have micrometastases, as evidenced by SLNB, and 81 had macrometastases as evidenced by PET/CT. Patients with macrometastases had a significantly lower probability of survival. Their hazard ratio for all causes of death was 3.73, compared with 2.03 in patients with micrometastastes.

The survival difference between macrometastases versus micrometastases and macrometastases versus no metastases was significant, but the difference between micrometastases and no metastases was not significant, he noted.

"The statistically significant difference in survival using the log-rank test had the following P values: P equal to .029 for macrometastases versus micrometastases, and P less than .0001 for macrometastases versus micrometastases," he said. Adding that "The difference in survival between micrometastases and no metastases was not statistically significant, with a P value of .148."

He offered some explanations as to why micro- and macrometastases would differ prognostically.

"Micrometastases may actually be false positives, as benign nevi can have nevus rests in lymph nodes. Additionally, they might also act as an antigen to activate the immune system to fight against the cutaneous malignant melanoma," he said.

"A few malignant cells in the sentinel lymph nodes may not mean that the prognosis is poor," he added. "The melanoma cells in the lymph nodes may activate the immune system and actually cause an immune response."

Dr. Venkat said he had no conflicts of interest to declare relevant to his presentation.

He noted that the study was funded by an American Society of Dermatologic Surgery Cutting Edge Research Grant.

'Micrometastases may actually be false positives, as benign nevi can have nevus rests in lymph nodes.' DR. VENKAT

ORLANDO — It is possible that the presence of micrometastases on sentinel lymph node biopsy may have little clinical prognostic value when predicting the survival of patients with malignant melanoma, according to a review of 415 patients.

The overall survival of those who had micrometastases less than 1 cm was similar to the overall survival achieved by patients with no metastases, Dr. Arun P. Venkat reported at the annual meeting of the American Society for Dermatologic Surgery.

In contrast, overall survival was significantly worse in patients who had macrometastases greater than 1 cm, said Dr. Venkat.

Micrometastases are most often detected with sentinel lymph node biopsy (SLNB), whereas macrometastases can be detected clinically or with positron emission tomography/computed tomography (PET/CT).

"Improved immunohistologic techniques are making it easier to find micrometastases in malignant melanoma, so the real question is whether micrometastases are an accurate predictor of recurrences and prognosis or are we unnecessarily upstaging patients by finding more micrometastases?" said Dr. Venkat, who is a dermatology resident at the University of Iowa Hospitals and Clinics in Iowa City.

The prognostic relevance of micrometastases versus macrometastases "has not been clearly differentiated," he noted.

The 415 patients had been followed for at least 3 months: 73 were deemed to have micrometastases, as evidenced by SLNB, and 81 had macrometastases as evidenced by PET/CT. Patients with macrometastases had a significantly lower probability of survival. Their hazard ratio for all causes of death was 3.73, compared with 2.03 in patients with micrometastastes.

The survival difference between macrometastases versus micrometastases and macrometastases versus no metastases was significant, but the difference between micrometastases and no metastases was not significant, he noted.

"The statistically significant difference in survival using the log-rank test had the following P values: P equal to .029 for macrometastases versus micrometastases, and P less than .0001 for macrometastases versus micrometastases," he said. Adding that "The difference in survival between micrometastases and no metastases was not statistically significant, with a P value of .148."

He offered some explanations as to why micro- and macrometastases would differ prognostically.

"Micrometastases may actually be false positives, as benign nevi can have nevus rests in lymph nodes. Additionally, they might also act as an antigen to activate the immune system to fight against the cutaneous malignant melanoma," he said.

"A few malignant cells in the sentinel lymph nodes may not mean that the prognosis is poor," he added. "The melanoma cells in the lymph nodes may activate the immune system and actually cause an immune response."

Dr. Venkat said he had no conflicts of interest to declare relevant to his presentation.

He noted that the study was funded by an American Society of Dermatologic Surgery Cutting Edge Research Grant.

'Micrometastases may actually be false positives, as benign nevi can have nevus rests in lymph nodes.' DR. VENKAT

ORLANDO — It is possible that the presence of micrometastases on sentinel lymph node biopsy may have little clinical prognostic value when predicting the survival of patients with malignant melanoma, according to a review of 415 patients.

The overall survival of those who had micrometastases less than 1 cm was similar to the overall survival achieved by patients with no metastases, Dr. Arun P. Venkat reported at the annual meeting of the American Society for Dermatologic Surgery.

In contrast, overall survival was significantly worse in patients who had macrometastases greater than 1 cm, said Dr. Venkat.

Micrometastases are most often detected with sentinel lymph node biopsy (SLNB), whereas macrometastases can be detected clinically or with positron emission tomography/computed tomography (PET/CT).

"Improved immunohistologic techniques are making it easier to find micrometastases in malignant melanoma, so the real question is whether micrometastases are an accurate predictor of recurrences and prognosis or are we unnecessarily upstaging patients by finding more micrometastases?" said Dr. Venkat, who is a dermatology resident at the University of Iowa Hospitals and Clinics in Iowa City.

The prognostic relevance of micrometastases versus macrometastases "has not been clearly differentiated," he noted.

The 415 patients had been followed for at least 3 months: 73 were deemed to have micrometastases, as evidenced by SLNB, and 81 had macrometastases as evidenced by PET/CT. Patients with macrometastases had a significantly lower probability of survival. Their hazard ratio for all causes of death was 3.73, compared with 2.03 in patients with micrometastastes.

The survival difference between macrometastases versus micrometastases and macrometastases versus no metastases was significant, but the difference between micrometastases and no metastases was not significant, he noted.

"The statistically significant difference in survival using the log-rank test had the following P values: P equal to .029 for macrometastases versus micrometastases, and P less than .0001 for macrometastases versus micrometastases," he said. Adding that "The difference in survival between micrometastases and no metastases was not statistically significant, with a P value of .148."

He offered some explanations as to why micro- and macrometastases would differ prognostically.

"Micrometastases may actually be false positives, as benign nevi can have nevus rests in lymph nodes. Additionally, they might also act as an antigen to activate the immune system to fight against the cutaneous malignant melanoma," he said.

"A few malignant cells in the sentinel lymph nodes may not mean that the prognosis is poor," he added. "The melanoma cells in the lymph nodes may activate the immune system and actually cause an immune response."

Dr. Venkat said he had no conflicts of interest to declare relevant to his presentation.

He noted that the study was funded by an American Society of Dermatologic Surgery Cutting Edge Research Grant.

'Micrometastases may actually be false positives, as benign nevi can have nevus rests in lymph nodes.' DR. VENKAT

ORLANDO — Patients who receive multiple solid organ transplants appear to be at significantly higher risk of developing cutaneous malignancy—specifically melanoma and nonmelanoma skin cancer—after their transplants, compared with patients who have had only one transplant.

A total of 6 (26%) of 23 patients who received two or more transplants reported having at least one posttransplant skin cancer, compared with 23 (8%) of 297 patients who had only one transplant. This difference between multiple and single organ transplant recipients was statistically significant, Dr. Murad Alam said at the annual meeting of the American Society for Dermatologic Surgery.

Using a database that was jointly developed by the departments of organ transplantation and dermatology at Northwestern University, Chicago, Dr. Alam and colleagues contacted 320 patients (mean age, 54 years) who received transplanted organs more than 4 years previously. Their transplants included kidney, liver, heart, lung, and pancreas.

The patients were interviewed for 30 minutes by telephone, and asked about their medical and surgical history, including whether they had diabetes. "We postulated that the patients with diabetes who may have had prolonged immunosuppression prior to their transplant might also have a greater incidence of skin cancers after their transplants," explained Dr. Alam of Northwestern.

The patients also provided dates and type of skin cancer, if any, that had developed since their transplants.

Diabetes was not a factor in developing a subsequent skin cancer. Of 91 patients with diabetes, 10 (11%) developed skin cancer, compared with 19 (8%) of 229 patients without diabetes, Dr. Alam said.

The finding that multiple organ transplant is associated with a higher rate of subsequent skin cancer than single organ transplant raises other questions that cannot be answered by a study cohort of this size, he added.

A study with a larger cohort might be able to answer these questions:

▸ Is there a causal link between multiple organ transplants and skin cancer?

▸ Are the risks different for different types of cancer?

▸ Do other comorbidities or medications have an impact on the likelihood of skin cancer in multiple organ transplant recipients?

▸ Which is more likely to increase the risk of skin cancer, concurrent transplants or sequential transplants?

▸ Are there specific types of transplants or specific pairs of transplants that produce greater risk for skin cancer?

"If we can find answers to these questions, we will then be able to tell which patients need to undergo the closest scrutiny for early management of their cancers," Dr. Alam concluded. He disclosed having no conflicts of interest.

The study also found that diabetes was not a factor in developing a subsequent skin cancer. DR. ALAM

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Patients who receive multiple solid organ transplants appear to be at significantly higher risk of developing cutaneous malignancy—specifically melanoma and nonmelanoma skin cancer—after their transplants, compared with patients who have had only one transplant.

A total of 6 (26%) of 23 patients who received two or more transplants reported having at least one posttransplant skin cancer, compared with 23 (8%) of 297 patients who had only one transplant. This difference between multiple and single organ transplant recipients was statistically significant, Dr. Murad Alam said at the annual meeting of the American Society for Dermatologic Surgery.

Using a database that was jointly developed by the departments of organ transplantation and dermatology at Northwestern University, Chicago, Dr. Alam and colleagues contacted 320 patients (mean age, 54 years) who received transplanted organs more than 4 years previously. Their transplants included kidney, liver, heart, lung, and pancreas.

The patients were interviewed for 30 minutes by telephone, and asked about their medical and surgical history, including whether they had diabetes. "We postulated that the patients with diabetes who may have had prolonged immunosuppression prior to their transplant might also have a greater incidence of skin cancers after their transplants," explained Dr. Alam of Northwestern.

The patients also provided dates and type of skin cancer, if any, that had developed since their transplants.

Diabetes was not a factor in developing a subsequent skin cancer. Of 91 patients with diabetes, 10 (11%) developed skin cancer, compared with 19 (8%) of 229 patients without diabetes, Dr. Alam said.

The finding that multiple organ transplant is associated with a higher rate of subsequent skin cancer than single organ transplant raises other questions that cannot be answered by a study cohort of this size, he added.

A study with a larger cohort might be able to answer these questions:

▸ Is there a causal link between multiple organ transplants and skin cancer?

▸ Are the risks different for different types of cancer?

▸ Do other comorbidities or medications have an impact on the likelihood of skin cancer in multiple organ transplant recipients?

▸ Which is more likely to increase the risk of skin cancer, concurrent transplants or sequential transplants?

▸ Are there specific types of transplants or specific pairs of transplants that produce greater risk for skin cancer?

"If we can find answers to these questions, we will then be able to tell which patients need to undergo the closest scrutiny for early management of their cancers," Dr. Alam concluded. He disclosed having no conflicts of interest.

The study also found that diabetes was not a factor in developing a subsequent skin cancer. DR. ALAM

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Patients who receive multiple solid organ transplants appear to be at significantly higher risk of developing cutaneous malignancy—specifically melanoma and nonmelanoma skin cancer—after their transplants, compared with patients who have had only one transplant.

A total of 6 (26%) of 23 patients who received two or more transplants reported having at least one posttransplant skin cancer, compared with 23 (8%) of 297 patients who had only one transplant. This difference between multiple and single organ transplant recipients was statistically significant, Dr. Murad Alam said at the annual meeting of the American Society for Dermatologic Surgery.

Using a database that was jointly developed by the departments of organ transplantation and dermatology at Northwestern University, Chicago, Dr. Alam and colleagues contacted 320 patients (mean age, 54 years) who received transplanted organs more than 4 years previously. Their transplants included kidney, liver, heart, lung, and pancreas.

The patients were interviewed for 30 minutes by telephone, and asked about their medical and surgical history, including whether they had diabetes. "We postulated that the patients with diabetes who may have had prolonged immunosuppression prior to their transplant might also have a greater incidence of skin cancers after their transplants," explained Dr. Alam of Northwestern.

The patients also provided dates and type of skin cancer, if any, that had developed since their transplants.

Diabetes was not a factor in developing a subsequent skin cancer. Of 91 patients with diabetes, 10 (11%) developed skin cancer, compared with 19 (8%) of 229 patients without diabetes, Dr. Alam said.

The finding that multiple organ transplant is associated with a higher rate of subsequent skin cancer than single organ transplant raises other questions that cannot be answered by a study cohort of this size, he added.

A study with a larger cohort might be able to answer these questions:

▸ Is there a causal link between multiple organ transplants and skin cancer?

▸ Are the risks different for different types of cancer?

▸ Do other comorbidities or medications have an impact on the likelihood of skin cancer in multiple organ transplant recipients?

▸ Which is more likely to increase the risk of skin cancer, concurrent transplants or sequential transplants?

▸ Are there specific types of transplants or specific pairs of transplants that produce greater risk for skin cancer?

"If we can find answers to these questions, we will then be able to tell which patients need to undergo the closest scrutiny for early management of their cancers," Dr. Alam concluded. He disclosed having no conflicts of interest.

The study also found that diabetes was not a factor in developing a subsequent skin cancer. DR. ALAM

ELSEVIER GLOBAL MEDICAL NEWS

ORLANDO — Patients getting an investigational hyaluronic acid gel filler for lip augmentation reported less pain and greater satisfaction with a 24-mg/mL dose than with a 20-mg/mL dose, interim study results have shown.

Patients who received the 24-mg/mL hyaluronic acid gel filler required fewer touch-ups and trended toward less severe injection-site reactions than did patients treated with the 20-mg/mL dose, reported Dr. William Philip Werschler in a poster at the annual meeting of the American Society for Dermatologic Surgery.

Sponsored by Allergan Inc., the randomized, double-blind (to the patient and evaluator) parallel study included 30 women aged 30 years or older (mean age, 51 years) whose lips were rated as 0 (none) or 1 (mild) on a fullness assessment scale by the treating investigator.

All participants had to agree not to undergo other antiwrinkle or augmentation procedures in the lower two-thirds of the face during the 6-month study, said Dr. Werschler of the University of Washington, Seattle. He coauthored the study with Dr. Steven Fagien, who is in private practice in Boca Raton, Fla.

A total of 12 patients were treated with the 24-mg/mL hyaluronic acid gel filler and received a mean injection volume of 0.88 mL in their upper lip and 0.78 mL in their lower lip. The 18 patients treated with the 20-mg/mL formulation received a mean injection volume of 0.97 mL in their upper lip and 0.85 mL in their lower lip.

Slight injection-site swelling occurred in 6 (50%) of the patients receiving the 24-mg/mL injection, compared with 10 (56%) of the patients receiving the 20-mg/mL dose. Two patients receiving the lower-dose treatment also had mild or severe swelling.

The patients returned for follow-up at weeks 1 and 2 and months 2, 4, and 6. Touch-up treatments were permitted at week 2 and were limited to half of the amount of the previous treatment.

Two (17%) of the patients treated with the 24-mg/mL hyaluronic acid gel filler received touch-up treatment, compared with 10 (56%) of the patients treated with the 20-mg/mL hyaluronic acid gel filler.

Two weeks after treatment, investigators and expert reviewers indicated that the 24-mg/mL hyaluronic acid gel filler was associated with a higher percentage of patients with no lines or shallow lines in the perioral area, Dr. Werschler said.

In addition, more investigators reported being "very satisfied" or "satisfied" with overall appearance, lip fullness, perioral or lipstick lines, curvature of the upper and lower lip, smile lines, and marionette lines associated with the 24-mg/mL hyaluronic acid gel filler.

Similarly, more patients receiving the higher dose reported that they were "satisfied" or "very satisfied," compared with those who received the 20-mg/mL hyaluronic acid gel filler.

The treatment effect lasted up to 216 days for patients receiving the 24-mg/mL injection (mean, 193 days) and for up to 178 days (mean, 158 days) for those receiving the 20-mg/mL dose.

Dr. Werschler said that full results of the study will be reported in late 2009.

Asked to comment on why the 24-mg/mL filler was superior, he cautioned that these are interim results. However, "the data points were clearly distinguished," he added. "Perhaps in the final results, this will be discussed further."

Dr. Werschler is a speaker, consultant, and clinical investigator for Allergan Inc. and Medicis Aesthetics Inc. Dr. Fagien is a consultant and clinical investigator for Allergan Inc. and Medicis Aesthetics.

Patients who received a higher dose of the investigational hyaluronic acid gel required fewer touch-ups. DR. WERSCHLER

ORLANDO — Patients getting an investigational hyaluronic acid gel filler for lip augmentation reported less pain and greater satisfaction with a 24-mg/mL dose than with a 20-mg/mL dose, interim study results have shown.

Patients who received the 24-mg/mL hyaluronic acid gel filler required fewer touch-ups and trended toward less severe injection-site reactions than did patients treated with the 20-mg/mL dose, reported Dr. William Philip Werschler in a poster at the annual meeting of the American Society for Dermatologic Surgery.

Sponsored by Allergan Inc., the randomized, double-blind (to the patient and evaluator) parallel study included 30 women aged 30 years or older (mean age, 51 years) whose lips were rated as 0 (none) or 1 (mild) on a fullness assessment scale by the treating investigator.

All participants had to agree not to undergo other antiwrinkle or augmentation procedures in the lower two-thirds of the face during the 6-month study, said Dr. Werschler of the University of Washington, Seattle. He coauthored the study with Dr. Steven Fagien, who is in private practice in Boca Raton, Fla.

A total of 12 patients were treated with the 24-mg/mL hyaluronic acid gel filler and received a mean injection volume of 0.88 mL in their upper lip and 0.78 mL in their lower lip. The 18 patients treated with the 20-mg/mL formulation received a mean injection volume of 0.97 mL in their upper lip and 0.85 mL in their lower lip.

Slight injection-site swelling occurred in 6 (50%) of the patients receiving the 24-mg/mL injection, compared with 10 (56%) of the patients receiving the 20-mg/mL dose. Two patients receiving the lower-dose treatment also had mild or severe swelling.

The patients returned for follow-up at weeks 1 and 2 and months 2, 4, and 6. Touch-up treatments were permitted at week 2 and were limited to half of the amount of the previous treatment.

Two (17%) of the patients treated with the 24-mg/mL hyaluronic acid gel filler received touch-up treatment, compared with 10 (56%) of the patients treated with the 20-mg/mL hyaluronic acid gel filler.

Two weeks after treatment, investigators and expert reviewers indicated that the 24-mg/mL hyaluronic acid gel filler was associated with a higher percentage of patients with no lines or shallow lines in the perioral area, Dr. Werschler said.

In addition, more investigators reported being "very satisfied" or "satisfied" with overall appearance, lip fullness, perioral or lipstick lines, curvature of the upper and lower lip, smile lines, and marionette lines associated with the 24-mg/mL hyaluronic acid gel filler.

Similarly, more patients receiving the higher dose reported that they were "satisfied" or "very satisfied," compared with those who received the 20-mg/mL hyaluronic acid gel filler.

The treatment effect lasted up to 216 days for patients receiving the 24-mg/mL injection (mean, 193 days) and for up to 178 days (mean, 158 days) for those receiving the 20-mg/mL dose.

Dr. Werschler said that full results of the study will be reported in late 2009.

Asked to comment on why the 24-mg/mL filler was superior, he cautioned that these are interim results. However, "the data points were clearly distinguished," he added. "Perhaps in the final results, this will be discussed further."

Dr. Werschler is a speaker, consultant, and clinical investigator for Allergan Inc. and Medicis Aesthetics Inc. Dr. Fagien is a consultant and clinical investigator for Allergan Inc. and Medicis Aesthetics.

Patients who received a higher dose of the investigational hyaluronic acid gel required fewer touch-ups. DR. WERSCHLER

ORLANDO — Patients getting an investigational hyaluronic acid gel filler for lip augmentation reported less pain and greater satisfaction with a 24-mg/mL dose than with a 20-mg/mL dose, interim study results have shown.

Patients who received the 24-mg/mL hyaluronic acid gel filler required fewer touch-ups and trended toward less severe injection-site reactions than did patients treated with the 20-mg/mL dose, reported Dr. William Philip Werschler in a poster at the annual meeting of the American Society for Dermatologic Surgery.

Sponsored by Allergan Inc., the randomized, double-blind (to the patient and evaluator) parallel study included 30 women aged 30 years or older (mean age, 51 years) whose lips were rated as 0 (none) or 1 (mild) on a fullness assessment scale by the treating investigator.

All participants had to agree not to undergo other antiwrinkle or augmentation procedures in the lower two-thirds of the face during the 6-month study, said Dr. Werschler of the University of Washington, Seattle. He coauthored the study with Dr. Steven Fagien, who is in private practice in Boca Raton, Fla.

A total of 12 patients were treated with the 24-mg/mL hyaluronic acid gel filler and received a mean injection volume of 0.88 mL in their upper lip and 0.78 mL in their lower lip. The 18 patients treated with the 20-mg/mL formulation received a mean injection volume of 0.97 mL in their upper lip and 0.85 mL in their lower lip.

Slight injection-site swelling occurred in 6 (50%) of the patients receiving the 24-mg/mL injection, compared with 10 (56%) of the patients receiving the 20-mg/mL dose. Two patients receiving the lower-dose treatment also had mild or severe swelling.

The patients returned for follow-up at weeks 1 and 2 and months 2, 4, and 6. Touch-up treatments were permitted at week 2 and were limited to half of the amount of the previous treatment.

Two (17%) of the patients treated with the 24-mg/mL hyaluronic acid gel filler received touch-up treatment, compared with 10 (56%) of the patients treated with the 20-mg/mL hyaluronic acid gel filler.

Two weeks after treatment, investigators and expert reviewers indicated that the 24-mg/mL hyaluronic acid gel filler was associated with a higher percentage of patients with no lines or shallow lines in the perioral area, Dr. Werschler said.

In addition, more investigators reported being "very satisfied" or "satisfied" with overall appearance, lip fullness, perioral or lipstick lines, curvature of the upper and lower lip, smile lines, and marionette lines associated with the 24-mg/mL hyaluronic acid gel filler.

Similarly, more patients receiving the higher dose reported that they were "satisfied" or "very satisfied," compared with those who received the 20-mg/mL hyaluronic acid gel filler.

The treatment effect lasted up to 216 days for patients receiving the 24-mg/mL injection (mean, 193 days) and for up to 178 days (mean, 158 days) for those receiving the 20-mg/mL dose.

Dr. Werschler said that full results of the study will be reported in late 2009.

Asked to comment on why the 24-mg/mL filler was superior, he cautioned that these are interim results. However, "the data points were clearly distinguished," he added. "Perhaps in the final results, this will be discussed further."

Dr. Werschler is a speaker, consultant, and clinical investigator for Allergan Inc. and Medicis Aesthetics Inc. Dr. Fagien is a consultant and clinical investigator for Allergan Inc. and Medicis Aesthetics.

Patients who received a higher dose of the investigational hyaluronic acid gel required fewer touch-ups. DR. WERSCHLER

ORLANDO — Consider turning dermatology patients into aesthetic ones, to help stay afloat during these tough economic times.

Patients may come into your office needing a medical procedure, but will return for a cosmetic procedure if you educate them, said Dr. Mark S. Nestor, a dermatologist in private practice in Aventura, Fla.

Dr. Nestor said he always has educational videos for patients to watch as they sit in his waiting room. "A mother who brings her child in for acne treatment learns about cosmetic procedures that I do, and she will come back for Botox. The thing is to start small, let your patients walk into it slowly, especially if they've never had aesthetic procedures," he said at the annual meeting of the American Society for Dermatologic Surgery.

Dr. Laurie J. Polis, who was part of a panel with Dr. Nestor that discussed dermatology marketing practices, suggested that a crucial part of the education process is to reassure patients about your expertise.

This can be done by displaying your diplomas and awards prominently on the wall, said Dr. Polis, a dermatologist in private practice in New York.

Developing good relationships with the media is also key to marketing and promoting your practice. You can spend money on advertising, or you can become known as an expert by being interviewed for magazine articles. "If you give good interviews … and you get yourself quoted in an article, that will work better than any dollar that you can spend," Dr. Polis said.

Frame any articles and display them on your walls.

"If you are lucky enough to get editorial coverage, don't be shy. Make sure your patients know about it. It will make them proud of you," she said.

Keep in touch with your patients through regular e-mails and newsletters informing them of your services, Dr. Polis said.

"If I had to give just one take-home message, it would be this: Inundate your patients with awareness of what you do. Send e-mail blasts monthly or quarterly, whatever you are comfortable with. List all the things you do in your office. The worst thing to hear is, 'I didn't know you had a spa upstairs,' or 'I didn't know you did fillers and Botox,' so awareness is key," she said.

Keep these communications to patients educational, Dr. Polis said. "If they are educationally flavored, it does not sound like a sales pitch. Instead, it opens up questions, inquiries, and interest, and that will lead to sales of those procedures."

Buff up your Web presence and use HTML so that you can be found on the Web. Also, make sure your Web site is listed on every letter and collateral you send out to patients.

First impressions are vital. Make sure your office environment conveys a professional but relaxed and inviting atmosphere.

Pay attention to your office staff. Everyone connected with your practice—from your receptionists to your aestheticians—should be well spoken, well groomed, and polite.

"Remember that your patients are coming to you for an aesthetic service.

Pay attention to how your staff answers the phone. Are there messages when patients and clients are on hold? How long are they on hold? Think about how you want to project yourself and your practice from the minute your patient walks into your office," she said.

Remember that tough economic times mean that advertising dollars are scarce. Now is a great time to negotiate for reduced rates with different advertising venues, from print to radio to TV, Dr. Polis advised.

ORLANDO — Consider turning dermatology patients into aesthetic ones, to help stay afloat during these tough economic times.

Patients may come into your office needing a medical procedure, but will return for a cosmetic procedure if you educate them, said Dr. Mark S. Nestor, a dermatologist in private practice in Aventura, Fla.

Dr. Nestor said he always has educational videos for patients to watch as they sit in his waiting room. "A mother who brings her child in for acne treatment learns about cosmetic procedures that I do, and she will come back for Botox. The thing is to start small, let your patients walk into it slowly, especially if they've never had aesthetic procedures," he said at the annual meeting of the American Society for Dermatologic Surgery.

Dr. Laurie J. Polis, who was part of a panel with Dr. Nestor that discussed dermatology marketing practices, suggested that a crucial part of the education process is to reassure patients about your expertise.

This can be done by displaying your diplomas and awards prominently on the wall, said Dr. Polis, a dermatologist in private practice in New York.

Developing good relationships with the media is also key to marketing and promoting your practice. You can spend money on advertising, or you can become known as an expert by being interviewed for magazine articles. "If you give good interviews … and you get yourself quoted in an article, that will work better than any dollar that you can spend," Dr. Polis said.

Frame any articles and display them on your walls.

"If you are lucky enough to get editorial coverage, don't be shy. Make sure your patients know about it. It will make them proud of you," she said.

Keep in touch with your patients through regular e-mails and newsletters informing them of your services, Dr. Polis said.

"If I had to give just one take-home message, it would be this: Inundate your patients with awareness of what you do. Send e-mail blasts monthly or quarterly, whatever you are comfortable with. List all the things you do in your office. The worst thing to hear is, 'I didn't know you had a spa upstairs,' or 'I didn't know you did fillers and Botox,' so awareness is key," she said.

Keep these communications to patients educational, Dr. Polis said. "If they are educationally flavored, it does not sound like a sales pitch. Instead, it opens up questions, inquiries, and interest, and that will lead to sales of those procedures."

Buff up your Web presence and use HTML so that you can be found on the Web. Also, make sure your Web site is listed on every letter and collateral you send out to patients.

First impressions are vital. Make sure your office environment conveys a professional but relaxed and inviting atmosphere.

Pay attention to your office staff. Everyone connected with your practice—from your receptionists to your aestheticians—should be well spoken, well groomed, and polite.

"Remember that your patients are coming to you for an aesthetic service.

Pay attention to how your staff answers the phone. Are there messages when patients and clients are on hold? How long are they on hold? Think about how you want to project yourself and your practice from the minute your patient walks into your office," she said.

Remember that tough economic times mean that advertising dollars are scarce. Now is a great time to negotiate for reduced rates with different advertising venues, from print to radio to TV, Dr. Polis advised.

ORLANDO — Consider turning dermatology patients into aesthetic ones, to help stay afloat during these tough economic times.

Patients may come into your office needing a medical procedure, but will return for a cosmetic procedure if you educate them, said Dr. Mark S. Nestor, a dermatologist in private practice in Aventura, Fla.

Dr. Nestor said he always has educational videos for patients to watch as they sit in his waiting room. "A mother who brings her child in for acne treatment learns about cosmetic procedures that I do, and she will come back for Botox. The thing is to start small, let your patients walk into it slowly, especially if they've never had aesthetic procedures," he said at the annual meeting of the American Society for Dermatologic Surgery.

Dr. Laurie J. Polis, who was part of a panel with Dr. Nestor that discussed dermatology marketing practices, suggested that a crucial part of the education process is to reassure patients about your expertise.

This can be done by displaying your diplomas and awards prominently on the wall, said Dr. Polis, a dermatologist in private practice in New York.

Developing good relationships with the media is also key to marketing and promoting your practice. You can spend money on advertising, or you can become known as an expert by being interviewed for magazine articles. "If you give good interviews … and you get yourself quoted in an article, that will work better than any dollar that you can spend," Dr. Polis said.

Frame any articles and display them on your walls.

"If you are lucky enough to get editorial coverage, don't be shy. Make sure your patients know about it. It will make them proud of you," she said.

Keep in touch with your patients through regular e-mails and newsletters informing them of your services, Dr. Polis said.

"If I had to give just one take-home message, it would be this: Inundate your patients with awareness of what you do. Send e-mail blasts monthly or quarterly, whatever you are comfortable with. List all the things you do in your office. The worst thing to hear is, 'I didn't know you had a spa upstairs,' or 'I didn't know you did fillers and Botox,' so awareness is key," she said.

Keep these communications to patients educational, Dr. Polis said. "If they are educationally flavored, it does not sound like a sales pitch. Instead, it opens up questions, inquiries, and interest, and that will lead to sales of those procedures."

Buff up your Web presence and use HTML so that you can be found on the Web. Also, make sure your Web site is listed on every letter and collateral you send out to patients.

First impressions are vital. Make sure your office environment conveys a professional but relaxed and inviting atmosphere.

Pay attention to your office staff. Everyone connected with your practice—from your receptionists to your aestheticians—should be well spoken, well groomed, and polite.

"Remember that your patients are coming to you for an aesthetic service.

Pay attention to how your staff answers the phone. Are there messages when patients and clients are on hold? How long are they on hold? Think about how you want to project yourself and your practice from the minute your patient walks into your office," she said.

Remember that tough economic times mean that advertising dollars are scarce. Now is a great time to negotiate for reduced rates with different advertising venues, from print to radio to TV, Dr. Polis advised.

ORLANDO — Reviewing the original biopsy slides of patients before they undergo Mohs surgery could result in a change of diagnosis, which in some cases could avert unnecessary surgery, according to Dr. Suzy T. Butler.

In a retrospective study of 3,345 patients, a second review of the original biopsy slide resulted in 74 changed diagnoses. Of these, 45 patients had a change in their management and 25 avoided an unnecessary surgery, Dr. Butler said at the annual meeting of the American Society for Dermatologic Surgery. The study reviewed all patients referred to the cutaneous oncology unit for Mohs surgery at St. Louis University from January 2003 to March 2007.

In one case, a 76-year-old white female presented to her dermatologist with a pink papule on her right cheek that had been previously treated with liquid nitrogen. A shaved biopsy showed an atypical spindle cell proliferation that was read as a desmoplastic malignant melanoma.

A review of the biopsy slides, however, diagnosed the patient as having dermal scar, said Dr. Butler of St. Louis University. Because of this discrepancy, additional biopsies were performed. These confirmed the diagnosis of scar. An s100 stain showed a few spindle cells in the dermis. Surgery was cancelled, and close observation was planned.

In another case, a 74-year-old white male presented with a 1-year history of pink scaly plaques at the suprapubic area. A punch biopsy was originally read as superficial spreading melanoma in situ.

A review of the biopsy before surgery, however, suggested extramammary Paget disease, which was confirmed with additional biopsies. The patient underwent "slow Mohs" surgery with permanent section histology, as well as a thorough malignancy work-up that was negative.

"These cases illustrate how second-opinion review of histopathology before treatment can either avoid potentially disfiguring, unnecessary surgery or direct a different surgical approach and guide the need for other testing," said Dr. Butler.

In addition to recording the number of cases in which the diagnosis changed, the investigators noted how the diagnosis changed and then reviewed the patient's chart to see how that change affected the patient's management. They also recorded the board certification of the original pathologist. Nearly half (48%) of the slides that were rediagnosed had been read by certified dermatopathologists, Dr. Butler said.

The most common change in diagnosis was from one malignant tumor to another in 43% of the patients. Most commonly, a basal cell carcinoma (BCC) diagnosis changed to squamous cell carcinoma (SCC), or a melanoma went from in situ to invasive or vice versa, Dr. Butler said.

The next most common change in diagnosis was from malignant to benign in 36% of the patients. This was often a seborrheic keratosis or a verruca vulgaris being misdiagnosed as SCC.

BCC was most likely to be misdiagnosed, followed by SCC, and then by melanoma and melanoma in situ, Dr. Butler noted. Seventeen percent of discordant diagnoses involved melanoma and melanoma in situ.

"Misdiagnoses involving basal cells are likely related to their high representation in our population, as opposed to any diagnostic challenge," she said. "On the flip side, considering the small proportion of total tumors that melanoma and melanomas in situ represent in our population, they comprise a surprisingly substantial proportion of the misdiagnosed tumors."

She suggested that the diagnoses of melanoma or melanoma in situ might be the most cost-effective diseases to target with second-opinion review.

The most common change in patient management was cancellation of surgery in 25 patients. The planned surgical approach was changed in another 10 patients, and 1 patient had to be scheduled for surgery as a result of the second biopsy reading, Dr. Butler said.

The cost of taking a second look at biopsy slides is considerable, however. "We did a cost analysis and found that the estimated cost of reviewing the biopsy slides would be approximately $93,000 a year at our university based on the number of slides we look at per year. That is significant, but it has to be weighed against the other benefits," she said.

Surgeons gain much useful information regarding the nature of the tumor, particularly useful when there are deeply infiltrating, aggressive tumors or in cases of perineural involvement, said Dr. Butler, who disclosed having no conflicts of interest relevant to her presentation.

Melanoma and melanoma in situ might be the most cost-effective diseases to target with second-opinion review. DR. BUTLER

ORLANDO — Reviewing the original biopsy slides of patients before they undergo Mohs surgery could result in a change of diagnosis, which in some cases could avert unnecessary surgery, according to Dr. Suzy T. Butler.

In a retrospective study of 3,345 patients, a second review of the original biopsy slide resulted in 74 changed diagnoses. Of these, 45 patients had a change in their management and 25 avoided an unnecessary surgery, Dr. Butler said at the annual meeting of the American Society for Dermatologic Surgery. The study reviewed all patients referred to the cutaneous oncology unit for Mohs surgery at St. Louis University from January 2003 to March 2007.

In one case, a 76-year-old white female presented to her dermatologist with a pink papule on her right cheek that had been previously treated with liquid nitrogen. A shaved biopsy showed an atypical spindle cell proliferation that was read as a desmoplastic malignant melanoma.

A review of the biopsy slides, however, diagnosed the patient as having dermal scar, said Dr. Butler of St. Louis University. Because of this discrepancy, additional biopsies were performed. These confirmed the diagnosis of scar. An s100 stain showed a few spindle cells in the dermis. Surgery was cancelled, and close observation was planned.

In another case, a 74-year-old white male presented with a 1-year history of pink scaly plaques at the suprapubic area. A punch biopsy was originally read as superficial spreading melanoma in situ.

A review of the biopsy before surgery, however, suggested extramammary Paget disease, which was confirmed with additional biopsies. The patient underwent "slow Mohs" surgery with permanent section histology, as well as a thorough malignancy work-up that was negative.

"These cases illustrate how second-opinion review of histopathology before treatment can either avoid potentially disfiguring, unnecessary surgery or direct a different surgical approach and guide the need for other testing," said Dr. Butler.

In addition to recording the number of cases in which the diagnosis changed, the investigators noted how the diagnosis changed and then reviewed the patient's chart to see how that change affected the patient's management. They also recorded the board certification of the original pathologist. Nearly half (48%) of the slides that were rediagnosed had been read by certified dermatopathologists, Dr. Butler said.

The most common change in diagnosis was from one malignant tumor to another in 43% of the patients. Most commonly, a basal cell carcinoma (BCC) diagnosis changed to squamous cell carcinoma (SCC), or a melanoma went from in situ to invasive or vice versa, Dr. Butler said.

The next most common change in diagnosis was from malignant to benign in 36% of the patients. This was often a seborrheic keratosis or a verruca vulgaris being misdiagnosed as SCC.

BCC was most likely to be misdiagnosed, followed by SCC, and then by melanoma and melanoma in situ, Dr. Butler noted. Seventeen percent of discordant diagnoses involved melanoma and melanoma in situ.

"Misdiagnoses involving basal cells are likely related to their high representation in our population, as opposed to any diagnostic challenge," she said. "On the flip side, considering the small proportion of total tumors that melanoma and melanomas in situ represent in our population, they comprise a surprisingly substantial proportion of the misdiagnosed tumors."

She suggested that the diagnoses of melanoma or melanoma in situ might be the most cost-effective diseases to target with second-opinion review.

The most common change in patient management was cancellation of surgery in 25 patients. The planned surgical approach was changed in another 10 patients, and 1 patient had to be scheduled for surgery as a result of the second biopsy reading, Dr. Butler said.

The cost of taking a second look at biopsy slides is considerable, however. "We did a cost analysis and found that the estimated cost of reviewing the biopsy slides would be approximately $93,000 a year at our university based on the number of slides we look at per year. That is significant, but it has to be weighed against the other benefits," she said.

Surgeons gain much useful information regarding the nature of the tumor, particularly useful when there are deeply infiltrating, aggressive tumors or in cases of perineural involvement, said Dr. Butler, who disclosed having no conflicts of interest relevant to her presentation.

Melanoma and melanoma in situ might be the most cost-effective diseases to target with second-opinion review. DR. BUTLER

ORLANDO — Reviewing the original biopsy slides of patients before they undergo Mohs surgery could result in a change of diagnosis, which in some cases could avert unnecessary surgery, according to Dr. Suzy T. Butler.

In a retrospective study of 3,345 patients, a second review of the original biopsy slide resulted in 74 changed diagnoses. Of these, 45 patients had a change in their management and 25 avoided an unnecessary surgery, Dr. Butler said at the annual meeting of the American Society for Dermatologic Surgery. The study reviewed all patients referred to the cutaneous oncology unit for Mohs surgery at St. Louis University from January 2003 to March 2007.

In one case, a 76-year-old white female presented to her dermatologist with a pink papule on her right cheek that had been previously treated with liquid nitrogen. A shaved biopsy showed an atypical spindle cell proliferation that was read as a desmoplastic malignant melanoma.

A review of the biopsy slides, however, diagnosed the patient as having dermal scar, said Dr. Butler of St. Louis University. Because of this discrepancy, additional biopsies were performed. These confirmed the diagnosis of scar. An s100 stain showed a few spindle cells in the dermis. Surgery was cancelled, and close observation was planned.

In another case, a 74-year-old white male presented with a 1-year history of pink scaly plaques at the suprapubic area. A punch biopsy was originally read as superficial spreading melanoma in situ.

A review of the biopsy before surgery, however, suggested extramammary Paget disease, which was confirmed with additional biopsies. The patient underwent "slow Mohs" surgery with permanent section histology, as well as a thorough malignancy work-up that was negative.

"These cases illustrate how second-opinion review of histopathology before treatment can either avoid potentially disfiguring, unnecessary surgery or direct a different surgical approach and guide the need for other testing," said Dr. Butler.

In addition to recording the number of cases in which the diagnosis changed, the investigators noted how the diagnosis changed and then reviewed the patient's chart to see how that change affected the patient's management. They also recorded the board certification of the original pathologist. Nearly half (48%) of the slides that were rediagnosed had been read by certified dermatopathologists, Dr. Butler said.

The most common change in diagnosis was from one malignant tumor to another in 43% of the patients. Most commonly, a basal cell carcinoma (BCC) diagnosis changed to squamous cell carcinoma (SCC), or a melanoma went from in situ to invasive or vice versa, Dr. Butler said.

The next most common change in diagnosis was from malignant to benign in 36% of the patients. This was often a seborrheic keratosis or a verruca vulgaris being misdiagnosed as SCC.

BCC was most likely to be misdiagnosed, followed by SCC, and then by melanoma and melanoma in situ, Dr. Butler noted. Seventeen percent of discordant diagnoses involved melanoma and melanoma in situ.

"Misdiagnoses involving basal cells are likely related to their high representation in our population, as opposed to any diagnostic challenge," she said. "On the flip side, considering the small proportion of total tumors that melanoma and melanomas in situ represent in our population, they comprise a surprisingly substantial proportion of the misdiagnosed tumors."

She suggested that the diagnoses of melanoma or melanoma in situ might be the most cost-effective diseases to target with second-opinion review.

The most common change in patient management was cancellation of surgery in 25 patients. The planned surgical approach was changed in another 10 patients, and 1 patient had to be scheduled for surgery as a result of the second biopsy reading, Dr. Butler said.

The cost of taking a second look at biopsy slides is considerable, however. "We did a cost analysis and found that the estimated cost of reviewing the biopsy slides would be approximately $93,000 a year at our university based on the number of slides we look at per year. That is significant, but it has to be weighed against the other benefits," she said.

Surgeons gain much useful information regarding the nature of the tumor, particularly useful when there are deeply infiltrating, aggressive tumors or in cases of perineural involvement, said Dr. Butler, who disclosed having no conflicts of interest relevant to her presentation.

Melanoma and melanoma in situ might be the most cost-effective diseases to target with second-opinion review. DR. BUTLER

ORLANDO — Once-daily application of topical fluorouracil cream 0.5% for 4 weeks significantly reduced the number of visible and palpable actinic keratosis lesions on the posterior scalp, ears, neck, lips, arms, and hands by 8 weeks in an open-label, multicenter study of 277 patients.

The effect of the cream was greatest for AK lesions on the lips, ears, and neck. By week 8, 79% of patients with AK lesions on the lips, 62% of patients with AK lesions on the ears, and 65% of patients with AK lesions on the neck, achieved total clearance of their lesions, Dr. Dow Stough reported in a poster at the annual meeting of the American Society of Dermatologic Surgery.

Almost half (48%) of patients were clear of lesions on the posterior scalp, 37% of patients were clear of lesions on the arms, and 31% were clear on the hands. Fourteen percent of patients experienced clearance of AK lesions on all designated treatment areas, wrote Dr. Stough of Burke Pharmaceutical Research and the University of Arkansas, Hot Springs, and his associates.

These results were accomplished with a low incidence of treatment-emergent adverse events, aside from expected application site reactions and eye irritation, according to the investigators.

Topical fluorouracil cream 0.5% is a lower concentration of topical 5-fluourouracil, which has long been used to treat actinic keratoses.

The formulation was developed by Dermik Laboratories, which sponsored the study, and is applied to the AK lesions via the patented Microsponge technology, which permits its controlled release. It is currently approved by the Food and Drug Administration for the treatment of multiple AKs on the face and anterior scalp.

The study was conducted at 25 centers throughout the United States. Patients had at least five lesions on the face or anterior scalp, and at least five lesions on the posterior scalp, ears, neck, lips, arms, or hands. Their mean age was 67 years and 81% were men.

The efficacy and safety of fluorouracil cream 0.5% on facial and anterior scalp AK lesions have already been shown in two randomized, double-blind, vehicle-controlled phase III trials (Cutis 2002;70:335–9; Cutis 2002;70[2 suppl]:22–9). The results of this subanalysis are about the effects of fluorouracil cream 0.5% on AK lesions on sites other than the face, the investigators explained.

Fluorouracil cream 0.5% was applied by the patient to designated lesions once a day for up to 4 weeks, as tolerated. Four weeks after the last application, the patients returned for a follow-up assessment.

There were statistically significant percentage decreases from baseline in the number of AK lesions at the 8-week assessment (P less than .0001). AK lesions decreased by 77% on the lips, 80% on the ears, 79% on the neck, 63% on the arms, 56% on the hands, and 77% on the posterior scalp, Dr. Stough and his associates reported.

The most common adverse event was skin irritation. Symptoms included dryness, erythema, burning, erosion, pruritus, edema, and pain at the application site, they noted.

Patients also reported experiencing symptoms of eye irritation, which included watering, burning, itching, sensitivity, and stinging. One patient was discontinued from the study because of moderate conjunctivitis, and one patient was discontinued because of pancreatitis, which was unrelated to the treatment medication.

Dr. Stough disclosed that his travel expenses to the ASDS annual meeting were funded by Dermik Laboratories.

ORLANDO — Once-daily application of topical fluorouracil cream 0.5% for 4 weeks significantly reduced the number of visible and palpable actinic keratosis lesions on the posterior scalp, ears, neck, lips, arms, and hands by 8 weeks in an open-label, multicenter study of 277 patients.

The effect of the cream was greatest for AK lesions on the lips, ears, and neck. By week 8, 79% of patients with AK lesions on the lips, 62% of patients with AK lesions on the ears, and 65% of patients with AK lesions on the neck, achieved total clearance of their lesions, Dr. Dow Stough reported in a poster at the annual meeting of the American Society of Dermatologic Surgery.

Almost half (48%) of patients were clear of lesions on the posterior scalp, 37% of patients were clear of lesions on the arms, and 31% were clear on the hands. Fourteen percent of patients experienced clearance of AK lesions on all designated treatment areas, wrote Dr. Stough of Burke Pharmaceutical Research and the University of Arkansas, Hot Springs, and his associates.

These results were accomplished with a low incidence of treatment-emergent adverse events, aside from expected application site reactions and eye irritation, according to the investigators.

Topical fluorouracil cream 0.5% is a lower concentration of topical 5-fluourouracil, which has long been used to treat actinic keratoses.

The formulation was developed by Dermik Laboratories, which sponsored the study, and is applied to the AK lesions via the patented Microsponge technology, which permits its controlled release. It is currently approved by the Food and Drug Administration for the treatment of multiple AKs on the face and anterior scalp.

The study was conducted at 25 centers throughout the United States. Patients had at least five lesions on the face or anterior scalp, and at least five lesions on the posterior scalp, ears, neck, lips, arms, or hands. Their mean age was 67 years and 81% were men.

The efficacy and safety of fluorouracil cream 0.5% on facial and anterior scalp AK lesions have already been shown in two randomized, double-blind, vehicle-controlled phase III trials (Cutis 2002;70:335–9; Cutis 2002;70[2 suppl]:22–9). The results of this subanalysis are about the effects of fluorouracil cream 0.5% on AK lesions on sites other than the face, the investigators explained.

Fluorouracil cream 0.5% was applied by the patient to designated lesions once a day for up to 4 weeks, as tolerated. Four weeks after the last application, the patients returned for a follow-up assessment.

There were statistically significant percentage decreases from baseline in the number of AK lesions at the 8-week assessment (P less than .0001). AK lesions decreased by 77% on the lips, 80% on the ears, 79% on the neck, 63% on the arms, 56% on the hands, and 77% on the posterior scalp, Dr. Stough and his associates reported.

The most common adverse event was skin irritation. Symptoms included dryness, erythema, burning, erosion, pruritus, edema, and pain at the application site, they noted.

Patients also reported experiencing symptoms of eye irritation, which included watering, burning, itching, sensitivity, and stinging. One patient was discontinued from the study because of moderate conjunctivitis, and one patient was discontinued because of pancreatitis, which was unrelated to the treatment medication.

Dr. Stough disclosed that his travel expenses to the ASDS annual meeting were funded by Dermik Laboratories.

ORLANDO — Once-daily application of topical fluorouracil cream 0.5% for 4 weeks significantly reduced the number of visible and palpable actinic keratosis lesions on the posterior scalp, ears, neck, lips, arms, and hands by 8 weeks in an open-label, multicenter study of 277 patients.

The effect of the cream was greatest for AK lesions on the lips, ears, and neck. By week 8, 79% of patients with AK lesions on the lips, 62% of patients with AK lesions on the ears, and 65% of patients with AK lesions on the neck, achieved total clearance of their lesions, Dr. Dow Stough reported in a poster at the annual meeting of the American Society of Dermatologic Surgery.

Almost half (48%) of patients were clear of lesions on the posterior scalp, 37% of patients were clear of lesions on the arms, and 31% were clear on the hands. Fourteen percent of patients experienced clearance of AK lesions on all designated treatment areas, wrote Dr. Stough of Burke Pharmaceutical Research and the University of Arkansas, Hot Springs, and his associates.

These results were accomplished with a low incidence of treatment-emergent adverse events, aside from expected application site reactions and eye irritation, according to the investigators.

Topical fluorouracil cream 0.5% is a lower concentration of topical 5-fluourouracil, which has long been used to treat actinic keratoses.

The formulation was developed by Dermik Laboratories, which sponsored the study, and is applied to the AK lesions via the patented Microsponge technology, which permits its controlled release. It is currently approved by the Food and Drug Administration for the treatment of multiple AKs on the face and anterior scalp.

The study was conducted at 25 centers throughout the United States. Patients had at least five lesions on the face or anterior scalp, and at least five lesions on the posterior scalp, ears, neck, lips, arms, or hands. Their mean age was 67 years and 81% were men.

The efficacy and safety of fluorouracil cream 0.5% on facial and anterior scalp AK lesions have already been shown in two randomized, double-blind, vehicle-controlled phase III trials (Cutis 2002;70:335–9; Cutis 2002;70[2 suppl]:22–9). The results of this subanalysis are about the effects of fluorouracil cream 0.5% on AK lesions on sites other than the face, the investigators explained.

Fluorouracil cream 0.5% was applied by the patient to designated lesions once a day for up to 4 weeks, as tolerated. Four weeks after the last application, the patients returned for a follow-up assessment.

There were statistically significant percentage decreases from baseline in the number of AK lesions at the 8-week assessment (P less than .0001). AK lesions decreased by 77% on the lips, 80% on the ears, 79% on the neck, 63% on the arms, 56% on the hands, and 77% on the posterior scalp, Dr. Stough and his associates reported.

The most common adverse event was skin irritation. Symptoms included dryness, erythema, burning, erosion, pruritus, edema, and pain at the application site, they noted.

Patients also reported experiencing symptoms of eye irritation, which included watering, burning, itching, sensitivity, and stinging. One patient was discontinued from the study because of moderate conjunctivitis, and one patient was discontinued because of pancreatitis, which was unrelated to the treatment medication.

Dr. Stough disclosed that his travel expenses to the ASDS annual meeting were funded by Dermik Laboratories.