Timothy F. Kirn

SAN FRANCISCO — The expected introduction of the integrase inhibitors will usher in the most exciting time in HIV treatment since the advent of highly active antiretroviral therapy, Dr. George Beatty predicted at a meeting on HIV management sponsored by the University of California, San Francisco.

The drug that is furthest along in trials, MK-0518, is “one of the most potent things I have ever seen,” said Dr. Beatty, commenting on recent trial results. “Clearly, MK-0518 can really kick butt.”

In the initial study in patients, MK-0518 (Merck) reduced viral loads by 2 log10 in just 10 days, a finding consistent with recent, double-blind trials, said Dr. Beatty, director of the HIV clinical trials group at the University of California, San Francisco. He did not participate in the trials and said that he had no conflicts of interest with the manufacturer.

All of the studies were presented at HIV meetings in 2006.

In the most recent of those studies, treatment-experienced patients with serious drug-resistant disease were randomly assigned to one of three doses of the new drug or placebo on top of their optimized background therapy. There were about 40 patients in each group.

At 16 weeks, 50% of those treated with MK-0518 had a viral load below 50 copies/mL, regardless of which dose they received, compared with only about 20% of patients on placebo.

At 24 weeks, 67% of the patients on active therapy had a viral load below 50 copies/mL.

The response rate was even more impressive in the subgroup whose background medications included enfuvirtide, also known as T20, an anti-HIV entry inhibitor. Overall, 90% of those patients achieved a viral load below 50 copies/mL at 24 weeks.

The patients in this trial were difficult to treat, with resistance to at least one drug in each of the three main classes of HIV medication, Dr. Beatty noted.

“It's sexy data,” he said, of all the trials of MK-0518 to date.

Integrase inhibitors prevent DNA created by the retrovirus from becoming incorporated into the host cell DNA, thereby blocking reproduction.

MK-0518 is currently available through an expanded access research program to patients whose infection was previously uncontrolled.

A second integrase inhibitor that is “close on the heels” of MK-0518 in development is GS-9137 (Gilead), Dr. Beatty said.

This drug also has shown the ability to reduce viral load by 2 log10 in about 10 days.

“It appears that Merck has not cornered the market on potency, and that this degree of potency is a class effect,” he said.

One of the differences between the two drugs is that MK-0518 requires twice daily dosing, whereas GS-9137 uses once daily dosing. Another difference between the two is that MK-0518 is metabolized by glucuronidation, so it does not appear to have any significant drug-drug interactions. GS-9137, on the other hand, is metabolized by cytochrome P3A, so it may interact with other drugs. And a third difference between the two is that GS-9137 can be boosted with ritonavir, whereas MK-0518 cannot.

So far, the drugs appear to be very well tolerated, although one patient who was in the MK-0518 trial developed abnormal liver enzymes that appeared to be drug related.

In vitro data suggest that when resistance does develop, it is broad resistance to all of the drugs in the class, Dr. Beatty added.

SAN FRANCISCO — The expected introduction of the integrase inhibitors will usher in the most exciting time in HIV treatment since the advent of highly active antiretroviral therapy, Dr. George Beatty predicted at a meeting on HIV management sponsored by the University of California, San Francisco.

The drug that is furthest along in trials, MK-0518, is “one of the most potent things I have ever seen,” said Dr. Beatty, commenting on recent trial results. “Clearly, MK-0518 can really kick butt.”

In the initial study in patients, MK-0518 (Merck) reduced viral loads by 2 log10 in just 10 days, a finding consistent with recent, double-blind trials, said Dr. Beatty, director of the HIV clinical trials group at the University of California, San Francisco. He did not participate in the trials and said that he had no conflicts of interest with the manufacturer.

All of the studies were presented at HIV meetings in 2006.

In the most recent of those studies, treatment-experienced patients with serious drug-resistant disease were randomly assigned to one of three doses of the new drug or placebo on top of their optimized background therapy. There were about 40 patients in each group.

At 16 weeks, 50% of those treated with MK-0518 had a viral load below 50 copies/mL, regardless of which dose they received, compared with only about 20% of patients on placebo.

At 24 weeks, 67% of the patients on active therapy had a viral load below 50 copies/mL.

The response rate was even more impressive in the subgroup whose background medications included enfuvirtide, also known as T20, an anti-HIV entry inhibitor. Overall, 90% of those patients achieved a viral load below 50 copies/mL at 24 weeks.

The patients in this trial were difficult to treat, with resistance to at least one drug in each of the three main classes of HIV medication, Dr. Beatty noted.

“It's sexy data,” he said, of all the trials of MK-0518 to date.

Integrase inhibitors prevent DNA created by the retrovirus from becoming incorporated into the host cell DNA, thereby blocking reproduction.

MK-0518 is currently available through an expanded access research program to patients whose infection was previously uncontrolled.

A second integrase inhibitor that is “close on the heels” of MK-0518 in development is GS-9137 (Gilead), Dr. Beatty said.

This drug also has shown the ability to reduce viral load by 2 log10 in about 10 days.

“It appears that Merck has not cornered the market on potency, and that this degree of potency is a class effect,” he said.

One of the differences between the two drugs is that MK-0518 requires twice daily dosing, whereas GS-9137 uses once daily dosing. Another difference between the two is that MK-0518 is metabolized by glucuronidation, so it does not appear to have any significant drug-drug interactions. GS-9137, on the other hand, is metabolized by cytochrome P3A, so it may interact with other drugs. And a third difference between the two is that GS-9137 can be boosted with ritonavir, whereas MK-0518 cannot.

So far, the drugs appear to be very well tolerated, although one patient who was in the MK-0518 trial developed abnormal liver enzymes that appeared to be drug related.

In vitro data suggest that when resistance does develop, it is broad resistance to all of the drugs in the class, Dr. Beatty added.

SAN FRANCISCO — The expected introduction of the integrase inhibitors will usher in the most exciting time in HIV treatment since the advent of highly active antiretroviral therapy, Dr. George Beatty predicted at a meeting on HIV management sponsored by the University of California, San Francisco.

The drug that is furthest along in trials, MK-0518, is “one of the most potent things I have ever seen,” said Dr. Beatty, commenting on recent trial results. “Clearly, MK-0518 can really kick butt.”

In the initial study in patients, MK-0518 (Merck) reduced viral loads by 2 log10 in just 10 days, a finding consistent with recent, double-blind trials, said Dr. Beatty, director of the HIV clinical trials group at the University of California, San Francisco. He did not participate in the trials and said that he had no conflicts of interest with the manufacturer.

All of the studies were presented at HIV meetings in 2006.

In the most recent of those studies, treatment-experienced patients with serious drug-resistant disease were randomly assigned to one of three doses of the new drug or placebo on top of their optimized background therapy. There were about 40 patients in each group.

At 16 weeks, 50% of those treated with MK-0518 had a viral load below 50 copies/mL, regardless of which dose they received, compared with only about 20% of patients on placebo.

At 24 weeks, 67% of the patients on active therapy had a viral load below 50 copies/mL.

The response rate was even more impressive in the subgroup whose background medications included enfuvirtide, also known as T20, an anti-HIV entry inhibitor. Overall, 90% of those patients achieved a viral load below 50 copies/mL at 24 weeks.

The patients in this trial were difficult to treat, with resistance to at least one drug in each of the three main classes of HIV medication, Dr. Beatty noted.

“It's sexy data,” he said, of all the trials of MK-0518 to date.

Integrase inhibitors prevent DNA created by the retrovirus from becoming incorporated into the host cell DNA, thereby blocking reproduction.

MK-0518 is currently available through an expanded access research program to patients whose infection was previously uncontrolled.

A second integrase inhibitor that is “close on the heels” of MK-0518 in development is GS-9137 (Gilead), Dr. Beatty said.

This drug also has shown the ability to reduce viral load by 2 log10 in about 10 days.

“It appears that Merck has not cornered the market on potency, and that this degree of potency is a class effect,” he said.

One of the differences between the two drugs is that MK-0518 requires twice daily dosing, whereas GS-9137 uses once daily dosing. Another difference between the two is that MK-0518 is metabolized by glucuronidation, so it does not appear to have any significant drug-drug interactions. GS-9137, on the other hand, is metabolized by cytochrome P3A, so it may interact with other drugs. And a third difference between the two is that GS-9137 can be boosted with ritonavir, whereas MK-0518 cannot.

So far, the drugs appear to be very well tolerated, although one patient who was in the MK-0518 trial developed abnormal liver enzymes that appeared to be drug related.

In vitro data suggest that when resistance does develop, it is broad resistance to all of the drugs in the class, Dr. Beatty added.

SEATTLE – Electronic prescribing may be a way to significantly reduce medication errors, according to a study that reviewed records involving 749 private-practice patients and more than 1,000 prescriptions.

The study found an error rate of 3.9% when physicians used electronic prescribing, Martha Simpson, D.O., said at a conference on rural health sponsored by the WONCA, the World Organization of Family Doctors. That compares with medication error rates from hospital studies that range from 3% to 6%, and error rates from studies in the community that have reached as high as 10%.

“This is significantly lower than other reported rates have been,” said Dr. Simpson of the department of family medicine at Ohio University College of Osteopathic Medicine, Athens.

The study involved four group practices in Ohio, which were given equipment (Rcopia, DrFirst Inc., Rockville, Md.) and training for electronic prescribing to five local pharmacies. The prescriptions were written over a 14-month period. Medical records were then reviewed by a pharmacist, and the patients were telephoned 3 months after their final prescription for an interview to find out if they if they had any adverse events or problems.

The results were not particularly surprising, because a common reason for prescription error is physician handwriting, Dr. Simpson said.

After electronic prescribing becomes more common, it will bring with it unique errors and challenges, she predicted. For example, physicians can easily point their cursors to the wrong box and click, thereby inadvertently canceling a prescription or ordering the wrong one.

The study was sponsored by a grant from the Ohio Medical Quality Foundation.

SEATTLE – Electronic prescribing may be a way to significantly reduce medication errors, according to a study that reviewed records involving 749 private-practice patients and more than 1,000 prescriptions.

The study found an error rate of 3.9% when physicians used electronic prescribing, Martha Simpson, D.O., said at a conference on rural health sponsored by the WONCA, the World Organization of Family Doctors. That compares with medication error rates from hospital studies that range from 3% to 6%, and error rates from studies in the community that have reached as high as 10%.

“This is significantly lower than other reported rates have been,” said Dr. Simpson of the department of family medicine at Ohio University College of Osteopathic Medicine, Athens.

The study involved four group practices in Ohio, which were given equipment (Rcopia, DrFirst Inc., Rockville, Md.) and training for electronic prescribing to five local pharmacies. The prescriptions were written over a 14-month period. Medical records were then reviewed by a pharmacist, and the patients were telephoned 3 months after their final prescription for an interview to find out if they if they had any adverse events or problems.

The results were not particularly surprising, because a common reason for prescription error is physician handwriting, Dr. Simpson said.

After electronic prescribing becomes more common, it will bring with it unique errors and challenges, she predicted. For example, physicians can easily point their cursors to the wrong box and click, thereby inadvertently canceling a prescription or ordering the wrong one.

The study was sponsored by a grant from the Ohio Medical Quality Foundation.

SEATTLE – Electronic prescribing may be a way to significantly reduce medication errors, according to a study that reviewed records involving 749 private-practice patients and more than 1,000 prescriptions.

The study found an error rate of 3.9% when physicians used electronic prescribing, Martha Simpson, D.O., said at a conference on rural health sponsored by the WONCA, the World Organization of Family Doctors. That compares with medication error rates from hospital studies that range from 3% to 6%, and error rates from studies in the community that have reached as high as 10%.

“This is significantly lower than other reported rates have been,” said Dr. Simpson of the department of family medicine at Ohio University College of Osteopathic Medicine, Athens.

The study involved four group practices in Ohio, which were given equipment (Rcopia, DrFirst Inc., Rockville, Md.) and training for electronic prescribing to five local pharmacies. The prescriptions were written over a 14-month period. Medical records were then reviewed by a pharmacist, and the patients were telephoned 3 months after their final prescription for an interview to find out if they if they had any adverse events or problems.

The results were not particularly surprising, because a common reason for prescription error is physician handwriting, Dr. Simpson said.

After electronic prescribing becomes more common, it will bring with it unique errors and challenges, she predicted. For example, physicians can easily point their cursors to the wrong box and click, thereby inadvertently canceling a prescription or ordering the wrong one.

The study was sponsored by a grant from the Ohio Medical Quality Foundation.

SAN FRANCISCO—Antibiotic resistance increased rapidly in nosocomial Acinetobacter infections from 1994 to 2004, growing almost fourfold, according to a report from the Centers for Disease Control and Prevention.

During that 10-year period, 8,537 cases of Acinetobacter infection were reported to the National Nosocomial Infection Surveillance System, of which 3,601 had susceptibility testing results.

The testing results indicate that the number of isolates that were susceptible to only one of four classes of antibiotics rose from 14% to 26%, and the number of isolates resistant to all four classes increased from 4% to 15%, Roberta Carey, Ph.D., reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The classes were β-lactams, fluoroquinolones, aminoglycosides, and carbapenems. Resistance to a β-lactam antibiotic rose from 39% of isolates to 66% during the 10-year period. For fluoroquinolones, resistance rose from 50% to 73% of isolates; for aminoglycosides, from 19% to 31%; and for carbapenems, from 9% to 39%.

The review also indicates that a greater percentage of the resistant infections came from hospitals in the Northeast than from hospitals elsewhere, and that they came from larger hospitals.

Only 24% of the hospitals reporting to the surveillance system were in the Northeast, but 74% of the isolates resistant to all four antibiotic classes came from that region, said Dr. Carey, of the CDC's Division of Health Care Quality Promotion. Only 12% of resistant isolates came from the West.

Less than 1% of the Acinetobacter infections came from hospitals with fewer than 200 beds, while 55% came from hospitals with more than 500 beds. In fact, 99% of isolates resistant to all four classes came from large teaching hospitals, although 83% of the hospitals that report to the system are teaching hospitals.

A preponderance of the Acinetobacter infections came from hospitals in the northern New Jersey and New York City areas, and many were associated with severe burns, Dr. Carey said in an interview after the meeting, which was sponsored by the American Society for Microbiology.

Isolates that were nonsusceptible to all four classes of antibiotics caused pneumonia in 46% of cases, bloodstream infections in 13%, urinary tract infections in 11%, surgical site infections in 10%, and other infections in 20%.

SAN FRANCISCO—Antibiotic resistance increased rapidly in nosocomial Acinetobacter infections from 1994 to 2004, growing almost fourfold, according to a report from the Centers for Disease Control and Prevention.

During that 10-year period, 8,537 cases of Acinetobacter infection were reported to the National Nosocomial Infection Surveillance System, of which 3,601 had susceptibility testing results.

The testing results indicate that the number of isolates that were susceptible to only one of four classes of antibiotics rose from 14% to 26%, and the number of isolates resistant to all four classes increased from 4% to 15%, Roberta Carey, Ph.D., reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The classes were β-lactams, fluoroquinolones, aminoglycosides, and carbapenems. Resistance to a β-lactam antibiotic rose from 39% of isolates to 66% during the 10-year period. For fluoroquinolones, resistance rose from 50% to 73% of isolates; for aminoglycosides, from 19% to 31%; and for carbapenems, from 9% to 39%.

The review also indicates that a greater percentage of the resistant infections came from hospitals in the Northeast than from hospitals elsewhere, and that they came from larger hospitals.

Only 24% of the hospitals reporting to the surveillance system were in the Northeast, but 74% of the isolates resistant to all four antibiotic classes came from that region, said Dr. Carey, of the CDC's Division of Health Care Quality Promotion. Only 12% of resistant isolates came from the West.

Less than 1% of the Acinetobacter infections came from hospitals with fewer than 200 beds, while 55% came from hospitals with more than 500 beds. In fact, 99% of isolates resistant to all four classes came from large teaching hospitals, although 83% of the hospitals that report to the system are teaching hospitals.

A preponderance of the Acinetobacter infections came from hospitals in the northern New Jersey and New York City areas, and many were associated with severe burns, Dr. Carey said in an interview after the meeting, which was sponsored by the American Society for Microbiology.

Isolates that were nonsusceptible to all four classes of antibiotics caused pneumonia in 46% of cases, bloodstream infections in 13%, urinary tract infections in 11%, surgical site infections in 10%, and other infections in 20%.

SAN FRANCISCO—Antibiotic resistance increased rapidly in nosocomial Acinetobacter infections from 1994 to 2004, growing almost fourfold, according to a report from the Centers for Disease Control and Prevention.

During that 10-year period, 8,537 cases of Acinetobacter infection were reported to the National Nosocomial Infection Surveillance System, of which 3,601 had susceptibility testing results.

The testing results indicate that the number of isolates that were susceptible to only one of four classes of antibiotics rose from 14% to 26%, and the number of isolates resistant to all four classes increased from 4% to 15%, Roberta Carey, Ph.D., reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

The classes were β-lactams, fluoroquinolones, aminoglycosides, and carbapenems. Resistance to a β-lactam antibiotic rose from 39% of isolates to 66% during the 10-year period. For fluoroquinolones, resistance rose from 50% to 73% of isolates; for aminoglycosides, from 19% to 31%; and for carbapenems, from 9% to 39%.

The review also indicates that a greater percentage of the resistant infections came from hospitals in the Northeast than from hospitals elsewhere, and that they came from larger hospitals.

Only 24% of the hospitals reporting to the surveillance system were in the Northeast, but 74% of the isolates resistant to all four antibiotic classes came from that region, said Dr. Carey, of the CDC's Division of Health Care Quality Promotion. Only 12% of resistant isolates came from the West.

Less than 1% of the Acinetobacter infections came from hospitals with fewer than 200 beds, while 55% came from hospitals with more than 500 beds. In fact, 99% of isolates resistant to all four classes came from large teaching hospitals, although 83% of the hospitals that report to the system are teaching hospitals.

A preponderance of the Acinetobacter infections came from hospitals in the northern New Jersey and New York City areas, and many were associated with severe burns, Dr. Carey said in an interview after the meeting, which was sponsored by the American Society for Microbiology.

Isolates that were nonsusceptible to all four classes of antibiotics caused pneumonia in 46% of cases, bloodstream infections in 13%, urinary tract infections in 11%, surgical site infections in 10%, and other infections in 20%.

SACRAMENTO—Another medical school has joined what could be a growing movement to ban faculty and residents from accepting gifts from drug company representatives.

The University of California, Davis, Health System decided in late November to forbid its medical staff to accept gifts from drug salesmen, including drug samples, pens, mugs, and meals, however small they might be. Earlier, the school had banned drug company representatives from walking into the clinical areas on a preceptorship.

By taking this action, the school joins a cadre of institutions that includes Yale University, which implemented its policy in 2005, the University of Pennsylvania, which did so in July 2006, and Stanford University, which implemented its policy in October 2006. At UC Davis, the policy goes into effect in July 2007.

The new prohibition "picks off the low-lying fruit" in an attempt by the institution to create a greater distance between its clinical practice and the pharmaceutical industry, said Dr. Timothy E. Albertson, the university system's executive director of clinical care.

The school has plans to look at the issue of conflict of interest in further detail, particularly in regard to relationships with and practices of other vendors. "We're certainly not trying to change capitalism, but we are trying to redefine the ethics of this type of involvement," he said.

The efforts at UC Davis and the other schools were spurred in part by an article in the Journal of the American Medical Association (2006;295:429–33), which noted that many authoritative bodies, including the Pharmaceutical Research and Manufacturers of America and government agencies, have made attempts to curtail practices that constitute a conflict of interest for physicians. But the article also said those actions have largely failed to change the current climate. Thus, the 11 authors of the paper urged academic medical centers to take the lead by, among other things, banning the acceptance of gifts, samples, and payment for time spent at meetings. Academic medical centers need to adopt such policies because the medical profession looks to them for leadership, the proposal said.

The article noted that 90% of the marketing dollars spent by the pharmaceutical industry were directed at doctors, despite the increase in money spent on direct-to-consumer marketing in recent years.

According to IMS Health, a pharmaceutical information and consulting company, drug companies spent $27 billion on product promotion in 2004, of which $16 billion was for free drug samples and $7.3 billion, including gifts and meals, went to sales representative contacts.

The pharmaceutical industry, which adopted strict guidelines on gift giving in 2002, says that limiting the practices and access of their sales representatives will deprive physicians of the best expertise on their medicines. But gifts, however insignificant, establish an unspoken quid pro quo between physicians and pharmaceutical companies. If gifts did not serve this purpose, companies would not give them, the JAMA authors said. They noted that the research bears this out.

According to a 2003 survey of more than 1,000 third-year medical students, an average third-year student receives one gift or attends one company-sponsored activity a week (JAMA 2005;294:1034–42). That is precisely the point of the no-gift policies proposed by the JAMA article, said one of its authors, Dr. Jerome P. Kassirer, former editor-in-chief of the New England Journal of Medicine.

"These meals and gifts give residents and trainees the idea that pharmaceutical largesse is all right and the way things work, but it taints the profession," Dr. Kassirer said in an interview. "They wouldn't pass out these gifts if it didn't matter."

At the academic medical centers, free meals seem to be the biggest issue impeding acceptance by staff. The free meals allow physicians to attend midday meetings they otherwise would not have time to attend. At the UC Davis Cancer Center alone, it is estimated that companies spend $70,000 a year on free lunches. The center will now pick up those costs, and other departments may have to do the same.

At the University of Pennsylvania Health System, the adoption of its policy caused some grumbling at first, along with the loss of some legitimate educational programs that were sponsored. For the most part, however, physicians and other staff members have adjusted, said Dr. Patrick J. Brennan, the chief medical officer of the university health system.

He said there is "much less evidence" of sales representatives around the clinics and school. At one suburban clinic run by the university, sales reps turned in their identification badges in protest; but, he believes, the sales force may have adjusted. He has lately seen an increasing number of medical education programs offered to faculty and staff sponsored by a third party hired by a drug company.

At UC Davis and some of the other institutions, efforts are being made to help low-income patients who previously might have received free drug samples or devices. The university is going to try to purchase some of the equipment that has been donated in the past, such as training inhalers for asthma patients and supplies for diabetes patients, Dr. Albertson noted.

SACRAMENTO—Another medical school has joined what could be a growing movement to ban faculty and residents from accepting gifts from drug company representatives.

The University of California, Davis, Health System decided in late November to forbid its medical staff to accept gifts from drug salesmen, including drug samples, pens, mugs, and meals, however small they might be. Earlier, the school had banned drug company representatives from walking into the clinical areas on a preceptorship.

By taking this action, the school joins a cadre of institutions that includes Yale University, which implemented its policy in 2005, the University of Pennsylvania, which did so in July 2006, and Stanford University, which implemented its policy in October 2006. At UC Davis, the policy goes into effect in July 2007.

The new prohibition "picks off the low-lying fruit" in an attempt by the institution to create a greater distance between its clinical practice and the pharmaceutical industry, said Dr. Timothy E. Albertson, the university system's executive director of clinical care.

The school has plans to look at the issue of conflict of interest in further detail, particularly in regard to relationships with and practices of other vendors. "We're certainly not trying to change capitalism, but we are trying to redefine the ethics of this type of involvement," he said.

The efforts at UC Davis and the other schools were spurred in part by an article in the Journal of the American Medical Association (2006;295:429–33), which noted that many authoritative bodies, including the Pharmaceutical Research and Manufacturers of America and government agencies, have made attempts to curtail practices that constitute a conflict of interest for physicians. But the article also said those actions have largely failed to change the current climate. Thus, the 11 authors of the paper urged academic medical centers to take the lead by, among other things, banning the acceptance of gifts, samples, and payment for time spent at meetings. Academic medical centers need to adopt such policies because the medical profession looks to them for leadership, the proposal said.

The article noted that 90% of the marketing dollars spent by the pharmaceutical industry were directed at doctors, despite the increase in money spent on direct-to-consumer marketing in recent years.

According to IMS Health, a pharmaceutical information and consulting company, drug companies spent $27 billion on product promotion in 2004, of which $16 billion was for free drug samples and $7.3 billion, including gifts and meals, went to sales representative contacts.

The pharmaceutical industry, which adopted strict guidelines on gift giving in 2002, says that limiting the practices and access of their sales representatives will deprive physicians of the best expertise on their medicines. But gifts, however insignificant, establish an unspoken quid pro quo between physicians and pharmaceutical companies. If gifts did not serve this purpose, companies would not give them, the JAMA authors said. They noted that the research bears this out.

According to a 2003 survey of more than 1,000 third-year medical students, an average third-year student receives one gift or attends one company-sponsored activity a week (JAMA 2005;294:1034–42). That is precisely the point of the no-gift policies proposed by the JAMA article, said one of its authors, Dr. Jerome P. Kassirer, former editor-in-chief of the New England Journal of Medicine.

"These meals and gifts give residents and trainees the idea that pharmaceutical largesse is all right and the way things work, but it taints the profession," Dr. Kassirer said in an interview. "They wouldn't pass out these gifts if it didn't matter."

At the academic medical centers, free meals seem to be the biggest issue impeding acceptance by staff. The free meals allow physicians to attend midday meetings they otherwise would not have time to attend. At the UC Davis Cancer Center alone, it is estimated that companies spend $70,000 a year on free lunches. The center will now pick up those costs, and other departments may have to do the same.

At the University of Pennsylvania Health System, the adoption of its policy caused some grumbling at first, along with the loss of some legitimate educational programs that were sponsored. For the most part, however, physicians and other staff members have adjusted, said Dr. Patrick J. Brennan, the chief medical officer of the university health system.

He said there is "much less evidence" of sales representatives around the clinics and school. At one suburban clinic run by the university, sales reps turned in their identification badges in protest; but, he believes, the sales force may have adjusted. He has lately seen an increasing number of medical education programs offered to faculty and staff sponsored by a third party hired by a drug company.

At UC Davis and some of the other institutions, efforts are being made to help low-income patients who previously might have received free drug samples or devices. The university is going to try to purchase some of the equipment that has been donated in the past, such as training inhalers for asthma patients and supplies for diabetes patients, Dr. Albertson noted.

SACRAMENTO—Another medical school has joined what could be a growing movement to ban faculty and residents from accepting gifts from drug company representatives.

The University of California, Davis, Health System decided in late November to forbid its medical staff to accept gifts from drug salesmen, including drug samples, pens, mugs, and meals, however small they might be. Earlier, the school had banned drug company representatives from walking into the clinical areas on a preceptorship.

By taking this action, the school joins a cadre of institutions that includes Yale University, which implemented its policy in 2005, the University of Pennsylvania, which did so in July 2006, and Stanford University, which implemented its policy in October 2006. At UC Davis, the policy goes into effect in July 2007.

The new prohibition "picks off the low-lying fruit" in an attempt by the institution to create a greater distance between its clinical practice and the pharmaceutical industry, said Dr. Timothy E. Albertson, the university system's executive director of clinical care.

The school has plans to look at the issue of conflict of interest in further detail, particularly in regard to relationships with and practices of other vendors. "We're certainly not trying to change capitalism, but we are trying to redefine the ethics of this type of involvement," he said.

The efforts at UC Davis and the other schools were spurred in part by an article in the Journal of the American Medical Association (2006;295:429–33), which noted that many authoritative bodies, including the Pharmaceutical Research and Manufacturers of America and government agencies, have made attempts to curtail practices that constitute a conflict of interest for physicians. But the article also said those actions have largely failed to change the current climate. Thus, the 11 authors of the paper urged academic medical centers to take the lead by, among other things, banning the acceptance of gifts, samples, and payment for time spent at meetings. Academic medical centers need to adopt such policies because the medical profession looks to them for leadership, the proposal said.

The article noted that 90% of the marketing dollars spent by the pharmaceutical industry were directed at doctors, despite the increase in money spent on direct-to-consumer marketing in recent years.

According to IMS Health, a pharmaceutical information and consulting company, drug companies spent $27 billion on product promotion in 2004, of which $16 billion was for free drug samples and $7.3 billion, including gifts and meals, went to sales representative contacts.

The pharmaceutical industry, which adopted strict guidelines on gift giving in 2002, says that limiting the practices and access of their sales representatives will deprive physicians of the best expertise on their medicines. But gifts, however insignificant, establish an unspoken quid pro quo between physicians and pharmaceutical companies. If gifts did not serve this purpose, companies would not give them, the JAMA authors said. They noted that the research bears this out.

According to a 2003 survey of more than 1,000 third-year medical students, an average third-year student receives one gift or attends one company-sponsored activity a week (JAMA 2005;294:1034–42). That is precisely the point of the no-gift policies proposed by the JAMA article, said one of its authors, Dr. Jerome P. Kassirer, former editor-in-chief of the New England Journal of Medicine.

"These meals and gifts give residents and trainees the idea that pharmaceutical largesse is all right and the way things work, but it taints the profession," Dr. Kassirer said in an interview. "They wouldn't pass out these gifts if it didn't matter."

At the academic medical centers, free meals seem to be the biggest issue impeding acceptance by staff. The free meals allow physicians to attend midday meetings they otherwise would not have time to attend. At the UC Davis Cancer Center alone, it is estimated that companies spend $70,000 a year on free lunches. The center will now pick up those costs, and other departments may have to do the same.

At the University of Pennsylvania Health System, the adoption of its policy caused some grumbling at first, along with the loss of some legitimate educational programs that were sponsored. For the most part, however, physicians and other staff members have adjusted, said Dr. Patrick J. Brennan, the chief medical officer of the university health system.

He said there is "much less evidence" of sales representatives around the clinics and school. At one suburban clinic run by the university, sales reps turned in their identification badges in protest; but, he believes, the sales force may have adjusted. He has lately seen an increasing number of medical education programs offered to faculty and staff sponsored by a third party hired by a drug company.

At UC Davis and some of the other institutions, efforts are being made to help low-income patients who previously might have received free drug samples or devices. The university is going to try to purchase some of the equipment that has been donated in the past, such as training inhalers for asthma patients and supplies for diabetes patients, Dr. Albertson noted.

PALM DESERT, CALIF.—Is routine antibiotic prophylaxis necessary for patients who are having a surgical procedure on the ear?

Even though almost half of dermatologists surveyed have not adopted this practice, they probably should consider it, according to three experts who spoke at the annual meeting of the American Society for Dermatologic Surgery.

"We should use an antibiotic because we don't know how extensive the surgery is going to be, and we do need to potentially protect against infection and chondritis, which is not successfully done with topical antibiotics," said Dr. Murad Alam, chief of cutaneous and aesthetic surgery at Northwestern University, Chicago.

There are no controlled studies to inform the practice of whether to use antibiotics for ear procedures, nor are any likely to be done in the future, in part because the rate of infection is so low that the study would have to be prohibitively large, Dr. Alam said.

Given this lack of evidence, it's important to weigh the consequences of overusing antibiotics against the welfare of the patient, since an infection could be devastating. In that case, the welfare of the individual patient needs to come first, which often means prescribing an oral antibiotic.

Dr. Alam said he surveyed some dermatologic surgeons about their practice and found that about 60% said they used an antibiotic, mostly ciprofloxacin, to address the possibility of a Pseudomonas infection. The rest did not commonly prescribe an antibiotic. An informal poll taken of the audience members attending Dr. Alam's talk had similar results; about 45% said that they did not usually use an antibiotic.

One study did look at the records of 530 Mohs surgery patients and 517 excisional surgery patients to investigate their infection rates, though the study was retrospective and not controlled, said Dr. Donald J. Grande, a dermatologist who practices in Stoneham, Mass., who was involved in the study while at the Tufts-New England Medical Center, Boston.

The overall infection rate was 2%, but in ears the rate was greater, as 6 of 48 patients developed an infection for a rate of 12.5% (Dermatol. Surg. 1995;21:509–14).

The analysis of those cases indicated that larger defects had been created or more Mohs stages performed, which suggested, in part, that the procedures had taken longer, Dr. Grande said.

The 12.5% rate suggests that patients should receive an antibiotic afterward, particularly those patients with risky features like drainage and crusting of their lesions, a cardiac condition, a prothesis, or a history of immunosuppression or a resistant infection after a previous procedure, Dr. Grande said. He noted that caution also was necessary because of the rising incidence of methicillin-resistant Staphylococcus aureus infections.

He recommends ciprofloxacin, rather than a cephalosporin, because of its efficacy against gram-negative bacteria.

Also making a plea for antibiotic use was Dr. Perry Robins, the moderator of the meeting session at which Dr. Alam and Dr. Grande spoke.

"I do it because the nurses like it, the patients like it, I like it, and my lawyer likes it," said Dr. Robins, chief of the Mohs micrographic surgery unit at New York University Medical Center, New York.

Dr. Perry said he probably has treated 40,000 surgical cases, about 5% of which involved the ear. Only two of those cases developed a Pseudomonas infection, one of which occurred in a patient who did not fill his antibiotic prescription. But that is two cases too many.

"When you are doing an ear case, definitely do Cipro [ciprofloxacin] for your protection," he said. "You don't want to have a case of Pseudomonas. And I have found no allergies or difficulties with the patients taking the medication."

It's important to weigh the consequences of antibiotic overuse against the welfare of the patient. DR. ALAM

PALM DESERT, CALIF.—Is routine antibiotic prophylaxis necessary for patients who are having a surgical procedure on the ear?

Even though almost half of dermatologists surveyed have not adopted this practice, they probably should consider it, according to three experts who spoke at the annual meeting of the American Society for Dermatologic Surgery.

"We should use an antibiotic because we don't know how extensive the surgery is going to be, and we do need to potentially protect against infection and chondritis, which is not successfully done with topical antibiotics," said Dr. Murad Alam, chief of cutaneous and aesthetic surgery at Northwestern University, Chicago.

There are no controlled studies to inform the practice of whether to use antibiotics for ear procedures, nor are any likely to be done in the future, in part because the rate of infection is so low that the study would have to be prohibitively large, Dr. Alam said.

Given this lack of evidence, it's important to weigh the consequences of overusing antibiotics against the welfare of the patient, since an infection could be devastating. In that case, the welfare of the individual patient needs to come first, which often means prescribing an oral antibiotic.

Dr. Alam said he surveyed some dermatologic surgeons about their practice and found that about 60% said they used an antibiotic, mostly ciprofloxacin, to address the possibility of a Pseudomonas infection. The rest did not commonly prescribe an antibiotic. An informal poll taken of the audience members attending Dr. Alam's talk had similar results; about 45% said that they did not usually use an antibiotic.

One study did look at the records of 530 Mohs surgery patients and 517 excisional surgery patients to investigate their infection rates, though the study was retrospective and not controlled, said Dr. Donald J. Grande, a dermatologist who practices in Stoneham, Mass., who was involved in the study while at the Tufts-New England Medical Center, Boston.

The overall infection rate was 2%, but in ears the rate was greater, as 6 of 48 patients developed an infection for a rate of 12.5% (Dermatol. Surg. 1995;21:509–14).

The analysis of those cases indicated that larger defects had been created or more Mohs stages performed, which suggested, in part, that the procedures had taken longer, Dr. Grande said.

The 12.5% rate suggests that patients should receive an antibiotic afterward, particularly those patients with risky features like drainage and crusting of their lesions, a cardiac condition, a prothesis, or a history of immunosuppression or a resistant infection after a previous procedure, Dr. Grande said. He noted that caution also was necessary because of the rising incidence of methicillin-resistant Staphylococcus aureus infections.

He recommends ciprofloxacin, rather than a cephalosporin, because of its efficacy against gram-negative bacteria.

Also making a plea for antibiotic use was Dr. Perry Robins, the moderator of the meeting session at which Dr. Alam and Dr. Grande spoke.

"I do it because the nurses like it, the patients like it, I like it, and my lawyer likes it," said Dr. Robins, chief of the Mohs micrographic surgery unit at New York University Medical Center, New York.

Dr. Perry said he probably has treated 40,000 surgical cases, about 5% of which involved the ear. Only two of those cases developed a Pseudomonas infection, one of which occurred in a patient who did not fill his antibiotic prescription. But that is two cases too many.

"When you are doing an ear case, definitely do Cipro [ciprofloxacin] for your protection," he said. "You don't want to have a case of Pseudomonas. And I have found no allergies or difficulties with the patients taking the medication."

It's important to weigh the consequences of antibiotic overuse against the welfare of the patient. DR. ALAM

PALM DESERT, CALIF.—Is routine antibiotic prophylaxis necessary for patients who are having a surgical procedure on the ear?

Even though almost half of dermatologists surveyed have not adopted this practice, they probably should consider it, according to three experts who spoke at the annual meeting of the American Society for Dermatologic Surgery.

"We should use an antibiotic because we don't know how extensive the surgery is going to be, and we do need to potentially protect against infection and chondritis, which is not successfully done with topical antibiotics," said Dr. Murad Alam, chief of cutaneous and aesthetic surgery at Northwestern University, Chicago.

There are no controlled studies to inform the practice of whether to use antibiotics for ear procedures, nor are any likely to be done in the future, in part because the rate of infection is so low that the study would have to be prohibitively large, Dr. Alam said.

Given this lack of evidence, it's important to weigh the consequences of overusing antibiotics against the welfare of the patient, since an infection could be devastating. In that case, the welfare of the individual patient needs to come first, which often means prescribing an oral antibiotic.

Dr. Alam said he surveyed some dermatologic surgeons about their practice and found that about 60% said they used an antibiotic, mostly ciprofloxacin, to address the possibility of a Pseudomonas infection. The rest did not commonly prescribe an antibiotic. An informal poll taken of the audience members attending Dr. Alam's talk had similar results; about 45% said that they did not usually use an antibiotic.

One study did look at the records of 530 Mohs surgery patients and 517 excisional surgery patients to investigate their infection rates, though the study was retrospective and not controlled, said Dr. Donald J. Grande, a dermatologist who practices in Stoneham, Mass., who was involved in the study while at the Tufts-New England Medical Center, Boston.

The overall infection rate was 2%, but in ears the rate was greater, as 6 of 48 patients developed an infection for a rate of 12.5% (Dermatol. Surg. 1995;21:509–14).

The analysis of those cases indicated that larger defects had been created or more Mohs stages performed, which suggested, in part, that the procedures had taken longer, Dr. Grande said.

The 12.5% rate suggests that patients should receive an antibiotic afterward, particularly those patients with risky features like drainage and crusting of their lesions, a cardiac condition, a prothesis, or a history of immunosuppression or a resistant infection after a previous procedure, Dr. Grande said. He noted that caution also was necessary because of the rising incidence of methicillin-resistant Staphylococcus aureus infections.

He recommends ciprofloxacin, rather than a cephalosporin, because of its efficacy against gram-negative bacteria.

Also making a plea for antibiotic use was Dr. Perry Robins, the moderator of the meeting session at which Dr. Alam and Dr. Grande spoke.

"I do it because the nurses like it, the patients like it, I like it, and my lawyer likes it," said Dr. Robins, chief of the Mohs micrographic surgery unit at New York University Medical Center, New York.

Dr. Perry said he probably has treated 40,000 surgical cases, about 5% of which involved the ear. Only two of those cases developed a Pseudomonas infection, one of which occurred in a patient who did not fill his antibiotic prescription. But that is two cases too many.

"When you are doing an ear case, definitely do Cipro [ciprofloxacin] for your protection," he said. "You don't want to have a case of Pseudomonas. And I have found no allergies or difficulties with the patients taking the medication."

It's important to weigh the consequences of antibiotic overuse against the welfare of the patient. DR. ALAM

SAN DIEGO—Dermatologists should ask patients detailed questions about what medications they are taking before performing a procedure, Dr. Rainer E. Sachse said at a meeting sponsored by the American Society for Mohs Surgery.

Almost half of patients who undergo a dermatologic procedure are taking some type of anticoagulant, according to a recent survey. However, this scenario may not preclude surgery, Dr. Sachse said.

Patients may be taking an alternative medicine that has anticoagulant properties, such as garlic, fish oil, niacin, or vitamin E. Similarly, many patients routinely take aspirin each day, noted Dr. Sachse, a facial plastic surgeon who practices Mohs surgery in Fort Lauderdale, Fla.

If a patient can stop the anticoagulant, Dr. Sachse asks them to do so for at least 1 week before the procedure. But because of the possible risk involved in stopping that therapy, he has the patient consult with the doctor who prescribed the medication.

For patients who are taking warfarin (Coumadin), dermatologists should know the international normalized ratio before performing the procedure. A patient on any type of anticoagulant should keep the pressure dressing on longer and avoid a lot of activity afterward to prevent bruising, other physicians at the meeting said.

SAN DIEGO—Dermatologists should ask patients detailed questions about what medications they are taking before performing a procedure, Dr. Rainer E. Sachse said at a meeting sponsored by the American Society for Mohs Surgery.

Almost half of patients who undergo a dermatologic procedure are taking some type of anticoagulant, according to a recent survey. However, this scenario may not preclude surgery, Dr. Sachse said.

Patients may be taking an alternative medicine that has anticoagulant properties, such as garlic, fish oil, niacin, or vitamin E. Similarly, many patients routinely take aspirin each day, noted Dr. Sachse, a facial plastic surgeon who practices Mohs surgery in Fort Lauderdale, Fla.

If a patient can stop the anticoagulant, Dr. Sachse asks them to do so for at least 1 week before the procedure. But because of the possible risk involved in stopping that therapy, he has the patient consult with the doctor who prescribed the medication.

For patients who are taking warfarin (Coumadin), dermatologists should know the international normalized ratio before performing the procedure. A patient on any type of anticoagulant should keep the pressure dressing on longer and avoid a lot of activity afterward to prevent bruising, other physicians at the meeting said.

SAN DIEGO—Dermatologists should ask patients detailed questions about what medications they are taking before performing a procedure, Dr. Rainer E. Sachse said at a meeting sponsored by the American Society for Mohs Surgery.

Almost half of patients who undergo a dermatologic procedure are taking some type of anticoagulant, according to a recent survey. However, this scenario may not preclude surgery, Dr. Sachse said.

Patients may be taking an alternative medicine that has anticoagulant properties, such as garlic, fish oil, niacin, or vitamin E. Similarly, many patients routinely take aspirin each day, noted Dr. Sachse, a facial plastic surgeon who practices Mohs surgery in Fort Lauderdale, Fla.

If a patient can stop the anticoagulant, Dr. Sachse asks them to do so for at least 1 week before the procedure. But because of the possible risk involved in stopping that therapy, he has the patient consult with the doctor who prescribed the medication.

For patients who are taking warfarin (Coumadin), dermatologists should know the international normalized ratio before performing the procedure. A patient on any type of anticoagulant should keep the pressure dressing on longer and avoid a lot of activity afterward to prevent bruising, other physicians at the meeting said.

PALM DESERT, CALIF.—The larger particle-sized hyaluronic acid product called Perlane has been shown in a trial to be as safe as another approved filler, and the data have been submitted to the Food and Drug Administration as part of the approval process.

"Perlane provides excellent volume correction, with a single injection, and lasts over 6 months in most patients," said Dr. Jeffrey S. Dover, who presented the trial data at the annual meeting of the American Society for Dermatologic Surgery.

The 6-month trial found no significant difference between Restylane, an FDA-approved hyaluronic acid, and Perlane, said Dr. Dover, a dermatologic surgeon in Chestnut Hill, Mass.

The sole distinction between the two products appeared to be that slightly less Perlane was needed, on average, for the wrinkle corrections.

Perlane and Restylane are both hyaluronic acids made from streptococcus by the same company, Q-Med Esthetics of Uppsala, Sweden. Both products contain the same concentration of hyaluronic acid, 20 mg/mL. The sole difference is the particle size, which is larger for Perlane (700–1,000 mum, vs. 250–500 mum for Restylane), which makes it more viscous and better suited for larger corrections.

Patients in the trial had mesolabial and/or nasolabial folds corrected.

Of the patients in the trial, who were treated at 17 different centers, 141 received the Perlane and 142 received Restylane.

At 2 weeks after treatment, 96% of the subjects who received Perlane had an improvement in their folds of at least one grade according to a wrinkle severity rating score, compared with 92% of those who received Restylane.

At 24 weeks, 63% of Perlane-treated subjects had at least a single grade improvement, vs. 74% of Restylane-treated subjects. The difference was not statistically significant, "despite the large numbers in the trial," Dr. Dover said.

The average amount of each product used per nasolabial fold was 1.1 mL for Perlane and 1.2 mL for Restylane.

Extensive immunogenicity tests were performed during the trial and included skin testing at 24 weeks after the corrections, in which the test area was biopsied a few days later for examination.

"Both of these products are completely nonimmunogenic," Dr. Dover said of all the testing.

Side effects were similar between the two products. The most commonly reported side effect was itching, experienced by about 90% of the subjects.

The itching, as well as any pain, redness, or bruising experienced by patients, "dropped off quickly," Dr. Dover said.

Restylane is distributed in this country by Medicis, which sponsored the trial and would also distribute Perlane. Dr. Dover reported no financial interest in the study.

PALM DESERT, CALIF.—The larger particle-sized hyaluronic acid product called Perlane has been shown in a trial to be as safe as another approved filler, and the data have been submitted to the Food and Drug Administration as part of the approval process.

"Perlane provides excellent volume correction, with a single injection, and lasts over 6 months in most patients," said Dr. Jeffrey S. Dover, who presented the trial data at the annual meeting of the American Society for Dermatologic Surgery.

The 6-month trial found no significant difference between Restylane, an FDA-approved hyaluronic acid, and Perlane, said Dr. Dover, a dermatologic surgeon in Chestnut Hill, Mass.

The sole distinction between the two products appeared to be that slightly less Perlane was needed, on average, for the wrinkle corrections.

Perlane and Restylane are both hyaluronic acids made from streptococcus by the same company, Q-Med Esthetics of Uppsala, Sweden. Both products contain the same concentration of hyaluronic acid, 20 mg/mL. The sole difference is the particle size, which is larger for Perlane (700–1,000 mum, vs. 250–500 mum for Restylane), which makes it more viscous and better suited for larger corrections.

Patients in the trial had mesolabial and/or nasolabial folds corrected.

Of the patients in the trial, who were treated at 17 different centers, 141 received the Perlane and 142 received Restylane.

At 2 weeks after treatment, 96% of the subjects who received Perlane had an improvement in their folds of at least one grade according to a wrinkle severity rating score, compared with 92% of those who received Restylane.

At 24 weeks, 63% of Perlane-treated subjects had at least a single grade improvement, vs. 74% of Restylane-treated subjects. The difference was not statistically significant, "despite the large numbers in the trial," Dr. Dover said.

The average amount of each product used per nasolabial fold was 1.1 mL for Perlane and 1.2 mL for Restylane.

Extensive immunogenicity tests were performed during the trial and included skin testing at 24 weeks after the corrections, in which the test area was biopsied a few days later for examination.

"Both of these products are completely nonimmunogenic," Dr. Dover said of all the testing.

Side effects were similar between the two products. The most commonly reported side effect was itching, experienced by about 90% of the subjects.

The itching, as well as any pain, redness, or bruising experienced by patients, "dropped off quickly," Dr. Dover said.

Restylane is distributed in this country by Medicis, which sponsored the trial and would also distribute Perlane. Dr. Dover reported no financial interest in the study.

PALM DESERT, CALIF.—The larger particle-sized hyaluronic acid product called Perlane has been shown in a trial to be as safe as another approved filler, and the data have been submitted to the Food and Drug Administration as part of the approval process.

"Perlane provides excellent volume correction, with a single injection, and lasts over 6 months in most patients," said Dr. Jeffrey S. Dover, who presented the trial data at the annual meeting of the American Society for Dermatologic Surgery.

The 6-month trial found no significant difference between Restylane, an FDA-approved hyaluronic acid, and Perlane, said Dr. Dover, a dermatologic surgeon in Chestnut Hill, Mass.

The sole distinction between the two products appeared to be that slightly less Perlane was needed, on average, for the wrinkle corrections.

Perlane and Restylane are both hyaluronic acids made from streptococcus by the same company, Q-Med Esthetics of Uppsala, Sweden. Both products contain the same concentration of hyaluronic acid, 20 mg/mL. The sole difference is the particle size, which is larger for Perlane (700–1,000 mum, vs. 250–500 mum for Restylane), which makes it more viscous and better suited for larger corrections.

Patients in the trial had mesolabial and/or nasolabial folds corrected.

Of the patients in the trial, who were treated at 17 different centers, 141 received the Perlane and 142 received Restylane.

At 2 weeks after treatment, 96% of the subjects who received Perlane had an improvement in their folds of at least one grade according to a wrinkle severity rating score, compared with 92% of those who received Restylane.

At 24 weeks, 63% of Perlane-treated subjects had at least a single grade improvement, vs. 74% of Restylane-treated subjects. The difference was not statistically significant, "despite the large numbers in the trial," Dr. Dover said.

The average amount of each product used per nasolabial fold was 1.1 mL for Perlane and 1.2 mL for Restylane.

Extensive immunogenicity tests were performed during the trial and included skin testing at 24 weeks after the corrections, in which the test area was biopsied a few days later for examination.

"Both of these products are completely nonimmunogenic," Dr. Dover said of all the testing.

Side effects were similar between the two products. The most commonly reported side effect was itching, experienced by about 90% of the subjects.

The itching, as well as any pain, redness, or bruising experienced by patients, "dropped off quickly," Dr. Dover said.

Restylane is distributed in this country by Medicis, which sponsored the trial and would also distribute Perlane. Dr. Dover reported no financial interest in the study.

PALM DESERT, CALIF.—The new, overriding concept in cosmetic procedures is that what the aging face often needs is new volume.

It is the view that the aging face is a "deflated" face, Dr. Gary D. Monheit said at the annual meeting of the American Society for Dermatologic Surgery.

"It is the volume loss as much as the ptosis," said Dr. Monheit, immediate past president of the ASDS. "It is the volume loss in the face that has become the new concept, the volume loss of bone, fat structure, and muscles, and we now have some new handles in order to rejuvenate." Such "handles" include using fillers like hyaluronic acid to enhance hollow cheeks, and barbed sutures used to lift the malar area to smooth out nasolabial folds and create an impression of high cheekbones.

Dr. Monheit, who practices in Birmingham, Ala., said this approach follows the precepts articulated by Dr. Richard Glogau of the University of California, San Francisco. Dr. Glogau said there are four features of the aging face that can be addressed by the cosmetic dermatologist. He calls them the four Rs: rebuild, relax, resurface, and redrape.

For rebuilding, there are fillers. For relaxing, there is botulinum toxin. For resurfacing, there are lasers and cosmeceuticals. And, for redraping, there are the barbed threads. But, all of these options also are making cosmetic dermatology much more complex than it has ever been.

The new challenge for cosmetic dermatology is the number of products now available for rejuvenation, with many more probably coming soon, an almost bewildering array, Dr. Monheit said.

The field will have to be careful in evaluating and embracing these products as they come onto the market, he warned.

PALM DESERT, CALIF.—The new, overriding concept in cosmetic procedures is that what the aging face often needs is new volume.

It is the view that the aging face is a "deflated" face, Dr. Gary D. Monheit said at the annual meeting of the American Society for Dermatologic Surgery.

"It is the volume loss as much as the ptosis," said Dr. Monheit, immediate past president of the ASDS. "It is the volume loss in the face that has become the new concept, the volume loss of bone, fat structure, and muscles, and we now have some new handles in order to rejuvenate." Such "handles" include using fillers like hyaluronic acid to enhance hollow cheeks, and barbed sutures used to lift the malar area to smooth out nasolabial folds and create an impression of high cheekbones.

Dr. Monheit, who practices in Birmingham, Ala., said this approach follows the precepts articulated by Dr. Richard Glogau of the University of California, San Francisco. Dr. Glogau said there are four features of the aging face that can be addressed by the cosmetic dermatologist. He calls them the four Rs: rebuild, relax, resurface, and redrape.

For rebuilding, there are fillers. For relaxing, there is botulinum toxin. For resurfacing, there are lasers and cosmeceuticals. And, for redraping, there are the barbed threads. But, all of these options also are making cosmetic dermatology much more complex than it has ever been.

The new challenge for cosmetic dermatology is the number of products now available for rejuvenation, with many more probably coming soon, an almost bewildering array, Dr. Monheit said.

The field will have to be careful in evaluating and embracing these products as they come onto the market, he warned.

PALM DESERT, CALIF.—The new, overriding concept in cosmetic procedures is that what the aging face often needs is new volume.

It is the view that the aging face is a "deflated" face, Dr. Gary D. Monheit said at the annual meeting of the American Society for Dermatologic Surgery.

"It is the volume loss as much as the ptosis," said Dr. Monheit, immediate past president of the ASDS. "It is the volume loss in the face that has become the new concept, the volume loss of bone, fat structure, and muscles, and we now have some new handles in order to rejuvenate." Such "handles" include using fillers like hyaluronic acid to enhance hollow cheeks, and barbed sutures used to lift the malar area to smooth out nasolabial folds and create an impression of high cheekbones.

Dr. Monheit, who practices in Birmingham, Ala., said this approach follows the precepts articulated by Dr. Richard Glogau of the University of California, San Francisco. Dr. Glogau said there are four features of the aging face that can be addressed by the cosmetic dermatologist. He calls them the four Rs: rebuild, relax, resurface, and redrape.

For rebuilding, there are fillers. For relaxing, there is botulinum toxin. For resurfacing, there are lasers and cosmeceuticals. And, for redraping, there are the barbed threads. But, all of these options also are making cosmetic dermatology much more complex than it has ever been.

The new challenge for cosmetic dermatology is the number of products now available for rejuvenation, with many more probably coming soon, an almost bewildering array, Dr. Monheit said.

The field will have to be careful in evaluating and embracing these products as they come onto the market, he warned.

PALM DESERT, CALIF.—Thermage radiofrequency treatment can be combined with liposuction to shrink loose skin in the abdomen, Dr. Victoria G. Belo said at the annual meeting of the American Society for Dermatologic Surgery.

"By virtue of its noninvasive nature combined with its excellent safety profile, this complementary use of Thermage and liposuction provides an attractive alternative to surgical procedures for patients who want to treat skin laxity," said Dr. Belo, who practices in Manila.

Dr. Belo presented an investigation of 30 patients undergoing liposuction: Ten underwent a Thermage procedure at the time of their liposuction, 10 received a Thermage treatment 1 month after liposuction, and 10 served as controls.

Dr. Belo said that she treated an area of the abdomen that was 20 cm by 14 cm in all the patients, using a 50% overlapping technique, and followed the patients once a month for 6 months.

In all the patients, the area marked out but not treated measured an average of 280 cm

In the group treated immediately with Thermage, however, the area began to contract at about 3 months, and by the fourth month the average size of the area was about 200 cm

The group treated 1 month after liposuction had about half the improvement of the immediate-treatment group. "It is really not until the fourth to sixth month that you can see a difference," Dr. Belo said.

Dr. Belo speculated that those who were treated 1 month after their liposuction might not have had a response because fibrotic tissue from the liposuction procedure had already formed. Alternatively, there may have been a positive interplay between the inflammation stimulated by the liposuction procedure and the Thermage treatment, enhancing the effect, she said.

"It is possible that you have some scar tissue from liposuction at 1 month that is unresponsive to Thermage," she said.

Dr. Belo indicated that she has no financial ties to Thermage Inc.

PALM DESERT, CALIF.—Thermage radiofrequency treatment can be combined with liposuction to shrink loose skin in the abdomen, Dr. Victoria G. Belo said at the annual meeting of the American Society for Dermatologic Surgery.

"By virtue of its noninvasive nature combined with its excellent safety profile, this complementary use of Thermage and liposuction provides an attractive alternative to surgical procedures for patients who want to treat skin laxity," said Dr. Belo, who practices in Manila.

Dr. Belo presented an investigation of 30 patients undergoing liposuction: Ten underwent a Thermage procedure at the time of their liposuction, 10 received a Thermage treatment 1 month after liposuction, and 10 served as controls.

Dr. Belo said that she treated an area of the abdomen that was 20 cm by 14 cm in all the patients, using a 50% overlapping technique, and followed the patients once a month for 6 months.

In all the patients, the area marked out but not treated measured an average of 280 cm

In the group treated immediately with Thermage, however, the area began to contract at about 3 months, and by the fourth month the average size of the area was about 200 cm

The group treated 1 month after liposuction had about half the improvement of the immediate-treatment group. "It is really not until the fourth to sixth month that you can see a difference," Dr. Belo said.

Dr. Belo speculated that those who were treated 1 month after their liposuction might not have had a response because fibrotic tissue from the liposuction procedure had already formed. Alternatively, there may have been a positive interplay between the inflammation stimulated by the liposuction procedure and the Thermage treatment, enhancing the effect, she said.

"It is possible that you have some scar tissue from liposuction at 1 month that is unresponsive to Thermage," she said.

Dr. Belo indicated that she has no financial ties to Thermage Inc.

PALM DESERT, CALIF.—Thermage radiofrequency treatment can be combined with liposuction to shrink loose skin in the abdomen, Dr. Victoria G. Belo said at the annual meeting of the American Society for Dermatologic Surgery.

"By virtue of its noninvasive nature combined with its excellent safety profile, this complementary use of Thermage and liposuction provides an attractive alternative to surgical procedures for patients who want to treat skin laxity," said Dr. Belo, who practices in Manila.

Dr. Belo presented an investigation of 30 patients undergoing liposuction: Ten underwent a Thermage procedure at the time of their liposuction, 10 received a Thermage treatment 1 month after liposuction, and 10 served as controls.

Dr. Belo said that she treated an area of the abdomen that was 20 cm by 14 cm in all the patients, using a 50% overlapping technique, and followed the patients once a month for 6 months.

In all the patients, the area marked out but not treated measured an average of 280 cm

In the group treated immediately with Thermage, however, the area began to contract at about 3 months, and by the fourth month the average size of the area was about 200 cm

The group treated 1 month after liposuction had about half the improvement of the immediate-treatment group. "It is really not until the fourth to sixth month that you can see a difference," Dr. Belo said.

Dr. Belo speculated that those who were treated 1 month after their liposuction might not have had a response because fibrotic tissue from the liposuction procedure had already formed. Alternatively, there may have been a positive interplay between the inflammation stimulated by the liposuction procedure and the Thermage treatment, enhancing the effect, she said.

"It is possible that you have some scar tissue from liposuction at 1 month that is unresponsive to Thermage," she said.

Dr. Belo indicated that she has no financial ties to Thermage Inc.

PALM DESERT, CALIF.—An immunoperoxidase stain for cytokeratin 7 can be extremely helpful for reducing recurrences when performing Mohs surgery on patients with extramammary Paget's disease, Dr. John Zitelli said at the annual meeting of the American Society for Dermatologic Surgery.

"Although I don't have enough patients in the last 2 years to give you long-term follow-up, there is no doubt in my mind that this is the way to go," Dr. Zitelli said.

Without the stain, a review that included his own patients treated over a period of 20 years showed a recurrence rate of about 20%, said Dr. Zitelli, a former president of the American College of Mohs Micrographic Surgery and Cutaneous Oncology who practices in Pittsburgh.

Although all of the patients who had recurrences did well eventually, the recurrence rate probably indicates that he was missing individual Paget cells around the nests of tumor of the main lesion. The stain makes those individual cells in a frozen section easy to see without extra magnification, he said.

Cytokeratin 7 is a filament protein expressed by cancers in the epithelia.

"My kids could see it," he said of stained, individual cells in a section.

The staining technique using the cytokeratin 7 stain requires only 1 hour, so a case requiring multiple stages can be done in a single day, he added.

To remove Paget's disease using the Mohs technique, Dr. Zitelli uses the exact same method he helped develop for MART(melanoma antigen recognized by T cells)-1 staining of melanoma (Dermatol. Surg. 2004;30:403–8).

He also uses a "strip technique" in part because the lesions tend to be rather large (20–30 mm in diameter), which can make them difficult to section. With this technique, he outlines the lesion before cutting. His first stage is to take the margin around where he has marked. Once the margins are clear, he goes back and takes the central island of tissue, and all tissue is taken down to the fat.

PALM DESERT, CALIF.—An immunoperoxidase stain for cytokeratin 7 can be extremely helpful for reducing recurrences when performing Mohs surgery on patients with extramammary Paget's disease, Dr. John Zitelli said at the annual meeting of the American Society for Dermatologic Surgery.

"Although I don't have enough patients in the last 2 years to give you long-term follow-up, there is no doubt in my mind that this is the way to go," Dr. Zitelli said.

Without the stain, a review that included his own patients treated over a period of 20 years showed a recurrence rate of about 20%, said Dr. Zitelli, a former president of the American College of Mohs Micrographic Surgery and Cutaneous Oncology who practices in Pittsburgh.

Although all of the patients who had recurrences did well eventually, the recurrence rate probably indicates that he was missing individual Paget cells around the nests of tumor of the main lesion. The stain makes those individual cells in a frozen section easy to see without extra magnification, he said.

Cytokeratin 7 is a filament protein expressed by cancers in the epithelia.

"My kids could see it," he said of stained, individual cells in a section.

The staining technique using the cytokeratin 7 stain requires only 1 hour, so a case requiring multiple stages can be done in a single day, he added.

To remove Paget's disease using the Mohs technique, Dr. Zitelli uses the exact same method he helped develop for MART(melanoma antigen recognized by T cells)-1 staining of melanoma (Dermatol. Surg. 2004;30:403–8).

He also uses a "strip technique" in part because the lesions tend to be rather large (20–30 mm in diameter), which can make them difficult to section. With this technique, he outlines the lesion before cutting. His first stage is to take the margin around where he has marked. Once the margins are clear, he goes back and takes the central island of tissue, and all tissue is taken down to the fat.

PALM DESERT, CALIF.—An immunoperoxidase stain for cytokeratin 7 can be extremely helpful for reducing recurrences when performing Mohs surgery on patients with extramammary Paget's disease, Dr. John Zitelli said at the annual meeting of the American Society for Dermatologic Surgery.

"Although I don't have enough patients in the last 2 years to give you long-term follow-up, there is no doubt in my mind that this is the way to go," Dr. Zitelli said.

Without the stain, a review that included his own patients treated over a period of 20 years showed a recurrence rate of about 20%, said Dr. Zitelli, a former president of the American College of Mohs Micrographic Surgery and Cutaneous Oncology who practices in Pittsburgh.

Although all of the patients who had recurrences did well eventually, the recurrence rate probably indicates that he was missing individual Paget cells around the nests of tumor of the main lesion. The stain makes those individual cells in a frozen section easy to see without extra magnification, he said.

Cytokeratin 7 is a filament protein expressed by cancers in the epithelia.

"My kids could see it," he said of stained, individual cells in a section.

The staining technique using the cytokeratin 7 stain requires only 1 hour, so a case requiring multiple stages can be done in a single day, he added.

To remove Paget's disease using the Mohs technique, Dr. Zitelli uses the exact same method he helped develop for MART(melanoma antigen recognized by T cells)-1 staining of melanoma (Dermatol. Surg. 2004;30:403–8).

He also uses a "strip technique" in part because the lesions tend to be rather large (20–30 mm in diameter), which can make them difficult to section. With this technique, he outlines the lesion before cutting. His first stage is to take the margin around where he has marked. Once the margins are clear, he goes back and takes the central island of tissue, and all tissue is taken down to the fat.