Doug Brunk

SAN FRANCISCO — The number of invasive group A streptococcal infections in England is on an upsurge, for reasons that remain unclear.

“The current increases in diseases caused by group A streptococcus [GAS] being seen in some regions of England may be attributable to the natural cycle of the disease, with some 'quiet' years followed by a year of high incidence,” Androulla Efstratiou, Ph.D., said at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy. Speaking in an interview after a study about the increase was presented during a poster session, Dr. Efstratiou said that “nonetheless, the Health Protection Agency has been monitoring the situation closely and has launched enhanced surveillance.”

The surveillance includes collecting detailed information on clinical presentations, risk factors, patient outcomes, severity of infection, clustering patterns, and characteristics of the streptococcal strains, said Dr. Efstratiou of the respiratory and systemic infections department at the Health Protection Agency Center for Infections, London. “Information generated from this surveillance may identify new opportunities for preventing the infection, helping clinicians to recognize early signs of the infection and possibly help in the future development of vaccine formulations and clinical guidelines for control, management, and prevention.”

She noted that there is no current evidence of the emergence of a new strain of invasive GAS circulating in England, although an unusual increase in emm3 was observed in the early part of 2009. “This strain is associated with more severe forms of invasive disease, but it's too early to say how significant this strain may be to the overall increase,” she said.

For the study, Dr. Efstratiou and her associates identified 598 invasive GAS infections from isolates submitted to the Health Protection Agency's reference laboratory by hospitals in England between Nov. 1 and March 31, 2008. This represented a 62% increase over the same time period in the previous year. The most common GAS emm types in order of prevalence were emm3, emm89, emm28, and emm6. The number of emm3 cases spiked markedly from 15% in November 2008 to 40% in January 2009.

No atypical patterns of antiomicrobial resistance emerged among the strains; only 3% were resistant to erythromycin.

“Preliminary analysis of enhanced surveillance data found that 30% of cases did not have any underlying illness,” the researchers reported in their poster. “Skin lesions, childbirth, and varicella were the most common acute risk factors.”

Nearly one-quarter of cases (22%) were children younger than age 15 years. Of the 234 cases with outcome information, 22% died within 1 week.

“Clinicians should be mindful of the signs and symptoms of invasive GAS and maintain a high index of suspicion in relevant patients as early recognition and prompt initiation of specific and supportive therapy can be lifesaving,” she said. “The spread of all types of GAS infections may be reduced by use of tissues to help limit the spread of bacteria from coughs and sneezes and thus the potential for spread to others, and by hand washing, especially after coughing and sneezing, and before preparing foods and eating.”

She also emphasized the importance of keeping wounds clean as a way to prevent invasive GAS. Wounds “should be watched for possible signs of infection, which include increasing redness, swelling, and pain at the wound site,” she said. “If these signs occur, especially in a person who also has a fever, they should consult their [physician] immediately.”

Dr. Efstratiou said she had no conflicts to disclose.

SAN FRANCISCO — The number of invasive group A streptococcal infections in England is on an upsurge, for reasons that remain unclear.

“The current increases in diseases caused by group A streptococcus [GAS] being seen in some regions of England may be attributable to the natural cycle of the disease, with some 'quiet' years followed by a year of high incidence,” Androulla Efstratiou, Ph.D., said at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy. Speaking in an interview after a study about the increase was presented during a poster session, Dr. Efstratiou said that “nonetheless, the Health Protection Agency has been monitoring the situation closely and has launched enhanced surveillance.”

The surveillance includes collecting detailed information on clinical presentations, risk factors, patient outcomes, severity of infection, clustering patterns, and characteristics of the streptococcal strains, said Dr. Efstratiou of the respiratory and systemic infections department at the Health Protection Agency Center for Infections, London. “Information generated from this surveillance may identify new opportunities for preventing the infection, helping clinicians to recognize early signs of the infection and possibly help in the future development of vaccine formulations and clinical guidelines for control, management, and prevention.”

She noted that there is no current evidence of the emergence of a new strain of invasive GAS circulating in England, although an unusual increase in emm3 was observed in the early part of 2009. “This strain is associated with more severe forms of invasive disease, but it's too early to say how significant this strain may be to the overall increase,” she said.

For the study, Dr. Efstratiou and her associates identified 598 invasive GAS infections from isolates submitted to the Health Protection Agency's reference laboratory by hospitals in England between Nov. 1 and March 31, 2008. This represented a 62% increase over the same time period in the previous year. The most common GAS emm types in order of prevalence were emm3, emm89, emm28, and emm6. The number of emm3 cases spiked markedly from 15% in November 2008 to 40% in January 2009.

No atypical patterns of antiomicrobial resistance emerged among the strains; only 3% were resistant to erythromycin.

“Preliminary analysis of enhanced surveillance data found that 30% of cases did not have any underlying illness,” the researchers reported in their poster. “Skin lesions, childbirth, and varicella were the most common acute risk factors.”

Nearly one-quarter of cases (22%) were children younger than age 15 years. Of the 234 cases with outcome information, 22% died within 1 week.

“Clinicians should be mindful of the signs and symptoms of invasive GAS and maintain a high index of suspicion in relevant patients as early recognition and prompt initiation of specific and supportive therapy can be lifesaving,” she said. “The spread of all types of GAS infections may be reduced by use of tissues to help limit the spread of bacteria from coughs and sneezes and thus the potential for spread to others, and by hand washing, especially after coughing and sneezing, and before preparing foods and eating.”

She also emphasized the importance of keeping wounds clean as a way to prevent invasive GAS. Wounds “should be watched for possible signs of infection, which include increasing redness, swelling, and pain at the wound site,” she said. “If these signs occur, especially in a person who also has a fever, they should consult their [physician] immediately.”

Dr. Efstratiou said she had no conflicts to disclose.

SAN FRANCISCO — The number of invasive group A streptococcal infections in England is on an upsurge, for reasons that remain unclear.

“The current increases in diseases caused by group A streptococcus [GAS] being seen in some regions of England may be attributable to the natural cycle of the disease, with some 'quiet' years followed by a year of high incidence,” Androulla Efstratiou, Ph.D., said at the annual meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy. Speaking in an interview after a study about the increase was presented during a poster session, Dr. Efstratiou said that “nonetheless, the Health Protection Agency has been monitoring the situation closely and has launched enhanced surveillance.”

The surveillance includes collecting detailed information on clinical presentations, risk factors, patient outcomes, severity of infection, clustering patterns, and characteristics of the streptococcal strains, said Dr. Efstratiou of the respiratory and systemic infections department at the Health Protection Agency Center for Infections, London. “Information generated from this surveillance may identify new opportunities for preventing the infection, helping clinicians to recognize early signs of the infection and possibly help in the future development of vaccine formulations and clinical guidelines for control, management, and prevention.”

She noted that there is no current evidence of the emergence of a new strain of invasive GAS circulating in England, although an unusual increase in emm3 was observed in the early part of 2009. “This strain is associated with more severe forms of invasive disease, but it's too early to say how significant this strain may be to the overall increase,” she said.

For the study, Dr. Efstratiou and her associates identified 598 invasive GAS infections from isolates submitted to the Health Protection Agency's reference laboratory by hospitals in England between Nov. 1 and March 31, 2008. This represented a 62% increase over the same time period in the previous year. The most common GAS emm types in order of prevalence were emm3, emm89, emm28, and emm6. The number of emm3 cases spiked markedly from 15% in November 2008 to 40% in January 2009.

No atypical patterns of antiomicrobial resistance emerged among the strains; only 3% were resistant to erythromycin.

“Preliminary analysis of enhanced surveillance data found that 30% of cases did not have any underlying illness,” the researchers reported in their poster. “Skin lesions, childbirth, and varicella were the most common acute risk factors.”

Nearly one-quarter of cases (22%) were children younger than age 15 years. Of the 234 cases with outcome information, 22% died within 1 week.

“Clinicians should be mindful of the signs and symptoms of invasive GAS and maintain a high index of suspicion in relevant patients as early recognition and prompt initiation of specific and supportive therapy can be lifesaving,” she said. “The spread of all types of GAS infections may be reduced by use of tissues to help limit the spread of bacteria from coughs and sneezes and thus the potential for spread to others, and by hand washing, especially after coughing and sneezing, and before preparing foods and eating.”

She also emphasized the importance of keeping wounds clean as a way to prevent invasive GAS. Wounds “should be watched for possible signs of infection, which include increasing redness, swelling, and pain at the wound site,” she said. “If these signs occur, especially in a person who also has a fever, they should consult their [physician] immediately.”

Dr. Efstratiou said she had no conflicts to disclose.

SAN DIEGO — Postmenopausal women with severe vasomotor symptoms show a circadian rhythm of hot flashes that peaks in the late afternoon and early evening hours, results from a small study showed.

“A lot of women complain about frequency of hot flashes at night,” Lauren Drogos said in an interview after her poster presentation at the annual meeting of the North American Menopause Society. “But we found that women were having the least frequent amount of hot flashes at night.”

For the study, Ms. Drogos and her associates evaluated baseline data from a trial of 29 postmenopausal women who had at least 35 hot flashes per week and were enrolled in a clinical trial comparing the efficacy of hormone therapy, black cohosh, and red clover for menopausal symptoms and cognition.

The women wore ambulatory sternal skin conductance monitors, which recorded their hot flashes over a 24-hour period. Hot flashes were defined as a greater than 2-micromho increase in skin conductance within 30 seconds. The women also kept a diary of perceived hot flashes.

In an effort to reduce the interindividual variability in the time of hot flashes for study participants on different sleep/wake schedules, the researchers normalized the data to each woman's wake time. The mean age of the study participants was 53 years, 61% were African American, 36% were white, and the rest were Asian American.

The women had an average of 19 hot flashes during the 24-hour monitoring period, including 14 during waking hours and 5 during sleeping hours, reported Ms. Drogos, a graduate student in the department of psychology at the University of Illinois at Chicago. “There was a broad peak of hot flash frequency, extending from late afternoon to evening hours, and a nadir that roughly corresponded to the time of the sleep episode,” the investigators wrote in their poster.

Ms. Drogos acknowledged certain limitations of the study, including its small sample size and the fact that it focused on highly symptomatic women.

She reported no conflicts of interest.

SAN DIEGO — Postmenopausal women with severe vasomotor symptoms show a circadian rhythm of hot flashes that peaks in the late afternoon and early evening hours, results from a small study showed.

“A lot of women complain about frequency of hot flashes at night,” Lauren Drogos said in an interview after her poster presentation at the annual meeting of the North American Menopause Society. “But we found that women were having the least frequent amount of hot flashes at night.”

For the study, Ms. Drogos and her associates evaluated baseline data from a trial of 29 postmenopausal women who had at least 35 hot flashes per week and were enrolled in a clinical trial comparing the efficacy of hormone therapy, black cohosh, and red clover for menopausal symptoms and cognition.

The women wore ambulatory sternal skin conductance monitors, which recorded their hot flashes over a 24-hour period. Hot flashes were defined as a greater than 2-micromho increase in skin conductance within 30 seconds. The women also kept a diary of perceived hot flashes.

In an effort to reduce the interindividual variability in the time of hot flashes for study participants on different sleep/wake schedules, the researchers normalized the data to each woman's wake time. The mean age of the study participants was 53 years, 61% were African American, 36% were white, and the rest were Asian American.

The women had an average of 19 hot flashes during the 24-hour monitoring period, including 14 during waking hours and 5 during sleeping hours, reported Ms. Drogos, a graduate student in the department of psychology at the University of Illinois at Chicago. “There was a broad peak of hot flash frequency, extending from late afternoon to evening hours, and a nadir that roughly corresponded to the time of the sleep episode,” the investigators wrote in their poster.

Ms. Drogos acknowledged certain limitations of the study, including its small sample size and the fact that it focused on highly symptomatic women.

She reported no conflicts of interest.

SAN DIEGO — Postmenopausal women with severe vasomotor symptoms show a circadian rhythm of hot flashes that peaks in the late afternoon and early evening hours, results from a small study showed.

“A lot of women complain about frequency of hot flashes at night,” Lauren Drogos said in an interview after her poster presentation at the annual meeting of the North American Menopause Society. “But we found that women were having the least frequent amount of hot flashes at night.”

For the study, Ms. Drogos and her associates evaluated baseline data from a trial of 29 postmenopausal women who had at least 35 hot flashes per week and were enrolled in a clinical trial comparing the efficacy of hormone therapy, black cohosh, and red clover for menopausal symptoms and cognition.

The women wore ambulatory sternal skin conductance monitors, which recorded their hot flashes over a 24-hour period. Hot flashes were defined as a greater than 2-micromho increase in skin conductance within 30 seconds. The women also kept a diary of perceived hot flashes.

In an effort to reduce the interindividual variability in the time of hot flashes for study participants on different sleep/wake schedules, the researchers normalized the data to each woman's wake time. The mean age of the study participants was 53 years, 61% were African American, 36% were white, and the rest were Asian American.

The women had an average of 19 hot flashes during the 24-hour monitoring period, including 14 during waking hours and 5 during sleeping hours, reported Ms. Drogos, a graduate student in the department of psychology at the University of Illinois at Chicago. “There was a broad peak of hot flash frequency, extending from late afternoon to evening hours, and a nadir that roughly corresponded to the time of the sleep episode,” the investigators wrote in their poster.

Ms. Drogos acknowledged certain limitations of the study, including its small sample size and the fact that it focused on highly symptomatic women.

She reported no conflicts of interest.

SAN DIEGO — The risk of a major depressive episode more than doubles for women during and after the menopausal transition, compared with when they were premenopausal, results from a 9-year follow-up study showed.

The finding suggests that clinicians “need to pay attention to depressive symptoms during this time in a woman's life, and perhaps do a more extensive assessment both in terms of the current presentation and a history of depression, so they have a better understanding of what the overall risk is for a major depressive episode and how they might intervene to prevent it,” the study's principal investigator, Joyce T. Bromberger, Ph.D., said in an interview at the annual meeting of the North American Menopause Society.

She and her associates analyzed 9 years of follow-up data from 221 premenopausal women enrolled at the Pittsburgh site of the Study of Women's Health Across the Nation, a multisite epidemiologic study designed to examine the health of women during midlife. The researchers used the Nonpatient Structured Clinical Interview for DSM-IV Axis I Disorders at baseline to determine lifetime history of major depression and annually to assess current and past-year major depression. They classified the women's status according to self-reported bleeding criteria as premenopausal, perimenopausal, postmenopausal, and postmenopausal on hormones.

Covariates included race, history of major depression at baseline, time-varying age, stressful life events such as the loss of a spouse or a job, use of psychotropic medications, and hot flashes/night sweats. Women who reported a bilateral oophorectomy or hysterectomy were not included in the analyses after the procedure.

At baseline the women were between the ages of 42 and 52, reported Dr. Bromberger, associate professor of epidemiology and psychiatry at the University of Pittsburgh.

Of the 221 women, 129 (58%) transitioned to postmenopause over the 9 years and 69 (31%) experienced at least one major depressive episode. Nearly half of the women with a history of a major depression at baseline (47%) met criteria for current or past-year major depression, compared with 23% of women without a history of major depression at baseline.

Univariate analyses demonstrated that the greatest risk for having a major depressive episode occurred when women were postmenopausal (odds ratio 3.52) or when they were perimenopausal (OR 2.13), compared with when they were premenopausal.

In the fully adjusted multivariate analyses, women remained significantly more likely to have a major depressive episode when they were postmenopausal (OR 3.79) or perimenopausal (OR 2.05). Odd ratios were also significantly greater for African American women (OR 2.10), women with a history of depression (OR 2.97), and women who reported stressful life events (OR 2.90).

“I was surprised by the increased risk during the postmenopause, because the majority of the literature on depressive symptoms has suggested that the increased risk is during the [menopausal] transition, and not after it,” Dr. Bromberger said.

The study was funded by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Nursing Research.

The literature 'has suggested that the increased risk is during the [menopausal] transition, and not after it.'

Source DR. BROMBERGER

SAN DIEGO — The risk of a major depressive episode more than doubles for women during and after the menopausal transition, compared with when they were premenopausal, results from a 9-year follow-up study showed.

The finding suggests that clinicians “need to pay attention to depressive symptoms during this time in a woman's life, and perhaps do a more extensive assessment both in terms of the current presentation and a history of depression, so they have a better understanding of what the overall risk is for a major depressive episode and how they might intervene to prevent it,” the study's principal investigator, Joyce T. Bromberger, Ph.D., said in an interview at the annual meeting of the North American Menopause Society.

She and her associates analyzed 9 years of follow-up data from 221 premenopausal women enrolled at the Pittsburgh site of the Study of Women's Health Across the Nation, a multisite epidemiologic study designed to examine the health of women during midlife. The researchers used the Nonpatient Structured Clinical Interview for DSM-IV Axis I Disorders at baseline to determine lifetime history of major depression and annually to assess current and past-year major depression. They classified the women's status according to self-reported bleeding criteria as premenopausal, perimenopausal, postmenopausal, and postmenopausal on hormones.

Covariates included race, history of major depression at baseline, time-varying age, stressful life events such as the loss of a spouse or a job, use of psychotropic medications, and hot flashes/night sweats. Women who reported a bilateral oophorectomy or hysterectomy were not included in the analyses after the procedure.

At baseline the women were between the ages of 42 and 52, reported Dr. Bromberger, associate professor of epidemiology and psychiatry at the University of Pittsburgh.

Of the 221 women, 129 (58%) transitioned to postmenopause over the 9 years and 69 (31%) experienced at least one major depressive episode. Nearly half of the women with a history of a major depression at baseline (47%) met criteria for current or past-year major depression, compared with 23% of women without a history of major depression at baseline.

Univariate analyses demonstrated that the greatest risk for having a major depressive episode occurred when women were postmenopausal (odds ratio 3.52) or when they were perimenopausal (OR 2.13), compared with when they were premenopausal.

In the fully adjusted multivariate analyses, women remained significantly more likely to have a major depressive episode when they were postmenopausal (OR 3.79) or perimenopausal (OR 2.05). Odd ratios were also significantly greater for African American women (OR 2.10), women with a history of depression (OR 2.97), and women who reported stressful life events (OR 2.90).

“I was surprised by the increased risk during the postmenopause, because the majority of the literature on depressive symptoms has suggested that the increased risk is during the [menopausal] transition, and not after it,” Dr. Bromberger said.

The study was funded by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Nursing Research.

The literature 'has suggested that the increased risk is during the [menopausal] transition, and not after it.'

Source DR. BROMBERGER

SAN DIEGO — The risk of a major depressive episode more than doubles for women during and after the menopausal transition, compared with when they were premenopausal, results from a 9-year follow-up study showed.

The finding suggests that clinicians “need to pay attention to depressive symptoms during this time in a woman's life, and perhaps do a more extensive assessment both in terms of the current presentation and a history of depression, so they have a better understanding of what the overall risk is for a major depressive episode and how they might intervene to prevent it,” the study's principal investigator, Joyce T. Bromberger, Ph.D., said in an interview at the annual meeting of the North American Menopause Society.

She and her associates analyzed 9 years of follow-up data from 221 premenopausal women enrolled at the Pittsburgh site of the Study of Women's Health Across the Nation, a multisite epidemiologic study designed to examine the health of women during midlife. The researchers used the Nonpatient Structured Clinical Interview for DSM-IV Axis I Disorders at baseline to determine lifetime history of major depression and annually to assess current and past-year major depression. They classified the women's status according to self-reported bleeding criteria as premenopausal, perimenopausal, postmenopausal, and postmenopausal on hormones.

Covariates included race, history of major depression at baseline, time-varying age, stressful life events such as the loss of a spouse or a job, use of psychotropic medications, and hot flashes/night sweats. Women who reported a bilateral oophorectomy or hysterectomy were not included in the analyses after the procedure.

At baseline the women were between the ages of 42 and 52, reported Dr. Bromberger, associate professor of epidemiology and psychiatry at the University of Pittsburgh.

Of the 221 women, 129 (58%) transitioned to postmenopause over the 9 years and 69 (31%) experienced at least one major depressive episode. Nearly half of the women with a history of a major depression at baseline (47%) met criteria for current or past-year major depression, compared with 23% of women without a history of major depression at baseline.

Univariate analyses demonstrated that the greatest risk for having a major depressive episode occurred when women were postmenopausal (odds ratio 3.52) or when they were perimenopausal (OR 2.13), compared with when they were premenopausal.

In the fully adjusted multivariate analyses, women remained significantly more likely to have a major depressive episode when they were postmenopausal (OR 3.79) or perimenopausal (OR 2.05). Odd ratios were also significantly greater for African American women (OR 2.10), women with a history of depression (OR 2.97), and women who reported stressful life events (OR 2.90).

“I was surprised by the increased risk during the postmenopause, because the majority of the literature on depressive symptoms has suggested that the increased risk is during the [menopausal] transition, and not after it,” Dr. Bromberger said.

The study was funded by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Nursing Research.

The literature 'has suggested that the increased risk is during the [menopausal] transition, and not after it.'

Source DR. BROMBERGER

The way Dr. Joseph Kim sees it, the field of influenza vaccine development could use an extreme makeover.

“Every year, three flu strains are selected by the flu experts around the world, which determines which strains the vaccine makers should make and stock for the coming fall,” Dr. Kim, president and CEO of San Diego–based Inovio Biomedical Corp., said in an interview. “They can guess right, or they can guess wrong; but every year, you have to change the vaccine. You can't stockpile from the previous year, because the flu strains could change.”

Scientists don't accept this approach for most other common vaccines, he noted, including the one for measles, mumps, and rubella. “That doesn't get changed from year to year, but our society has accepted the fact that the one for influenza does,” he said.

Dr. Kim would like to change that paradigm.

Since 2005, he and his associates at Inovio have been developing DNA-based influenza vaccines capable of providing broad protection against existing as well as newly emerging, unknown seasonal and pandemic influenza strains. To design vaccines, the company developed a process known as SynCon, a way of targeting consensus proteins from multiple strains of H1N1, H2N2, H3N2, and H5N1, “which have collectively caused greater than 90% of all seasonal and pandemic flu events in people in the last 100-plus years,” Dr. Kim said. “We felt that those were very good targets.”

What separates Inovio's SynCon approach from that of other DNA vaccine manufacturers is that the SynCon vaccines demonstrate potential to protect against new strains of influenza that do not specifically match the vaccine.

“So, if the 2009 H1N1 virus mutates, there is no plan B,” Dr. Kim said. “There is no backup option; 2009 swine flu could be a big problem or not. No one can predict accurately.”

Origins of an Alternative

DNA-based influenza vaccines began to draw serious attention about 6 years ago, when infectious diseases experts around the globe expressed concern about a pandemic of H5N1 influenza virus, noted Dr. William Schaffner, chair of the department of preventive medicine at Vanderbilt University, Nashville, Tenn.

“That galvanized the international community,” he said. “Since that time, the United States government and private capital have gone into research to develop more improved influenza vaccines and to improve the vaccine technology. There has been more research into those areas in the past 5 or 6 years than there has been in the previous 50 years. That's stunning.”

The concept of DNA vaccines first emerged in the early 1990s, when researchers discovered that immunizing animals with plasmids—a circular string of DNA that encodes for a specific antigen or vaccine target—generates vaccine responses.

“The beauty of this technology is speed,” said Vijay B. Samant, president and CEO of San Diego–based Vical, which develops DNA vaccines. “It's not cell culture. It's not egg-based. It's simple fermentation and two purification steps. It does not require the manufacturer to handle the pathogen. All it needs is a gene sequence; that's good enough for us to make the vaccine.”

“Instead of delivering the viruses themselves in some form, you're taking a very simple plasmid, which is a circular string of DNA, and you're putting in a genetic blueprint designed for a specific target, in this case hemagglutinin,” Dr. Kim explained. “Once you inject that into muscle cells or skin cells, it uses our own cellular machinery to manufacture those proteins as antigens, and presents them in a customized way. It's like mimicking viral infection without the side effects and replication. DNA vaccines can never replicate. They do not infect; they do not cause disease, ever.”

Delivery Poses Challenges

Until recently, Dr. Kim and other researchers in the field faced a barrier to the advancement of DNA vaccines: inefficient delivery.

However, a technology developed in the 1990s known as in vivo electroporation is proving to be an effective way to deliver DNA vaccines.

Electroporation works like this: After a DNA vaccine is injected into the upper arm or into skin, a short, controlled electrical pulse is delivered into that tissue, either from the same needle or from a surrounding needle. This brief pulse of current “coaxes the cell membranes to open up their pores,” Dr. Kim said. “That brings in the DNA. We remove the electric field and the pores close up. This has been shown in animal species to be effective in up to a 1,000-fold increase in DNA vaccine uptake. The whole procedure takes a couple of seconds.”

Not all DNA vaccine manufacturers are using electroporation as a delivery method. Vical, the first company to produce a vaccine against the pandemic influenza A(H1N1) virus after initial reports of outbreaks in Mexico, uses a patented adjuvant known as Vaxfectin, “which does an amazing job of protecting the DNA before it enters the skeletal muscle cells,” Mr. Samant said. “Being a proinflammatory, it attracts the immune system toward the site of the injection to facilitate creation of the right immune response and immune memory.”

Phase I Trials Begin

On Oct. 1, 2009, the U.S. Navy awarded Vical a contract to support a phase I clinical trial of its vaccine against H1N1 influenza. “Our goal is to get that trial done by later this year,” Mr. Samant said.

In a virus challenge and protection study of Inovio's SynCon H1N1 vaccine, mice were injected with the H1N1 virus that caused the 1918 Spanish flu. Mice that received the H1N1 vaccine were completely protected from the virus, whereas all of the unvaccinated animals died within 1 week.

In 2010, the SynCon H5N1 vaccine will undergo human testing in healthy volunteers, followed by tests in combination with the SynCon H1N1 vaccine. Addition of H2N2 and other strains could soon follow.

Potential Pitfallr

“If we are correct, we can revolutionize how flu vaccines are made and delivered,” Dr. Kim said.

One potential pitfall of the DNA vaccine technology is the impending backlash from vaccine naysayers, cautioned Dr. Schaffner.

“We have a hardcore group of vaccine skeptics,” he said. “This is a group of people who look askance at vaccines, are dubious about their benefits, and are concerned about how they're manufactured and what's in them. Any innovation, whether it is the addition of an adjuvant, or a new technology such as this, will come to their attention and draw some of their skepticism and opposition. We have to brace for this.”

Dr. Schaffner disclosed that he has been a consultant for various vaccine manufacturers. He also is a member of a data safety committee for Merck for experimental vaccines.

'DNA vaccines can never replicate. They do not infect; they do not cause disease, ever.'

Source DR. KIM

The way Dr. Joseph Kim sees it, the field of influenza vaccine development could use an extreme makeover.

“Every year, three flu strains are selected by the flu experts around the world, which determines which strains the vaccine makers should make and stock for the coming fall,” Dr. Kim, president and CEO of San Diego–based Inovio Biomedical Corp., said in an interview. “They can guess right, or they can guess wrong; but every year, you have to change the vaccine. You can't stockpile from the previous year, because the flu strains could change.”

Scientists don't accept this approach for most other common vaccines, he noted, including the one for measles, mumps, and rubella. “That doesn't get changed from year to year, but our society has accepted the fact that the one for influenza does,” he said.

Dr. Kim would like to change that paradigm.

Since 2005, he and his associates at Inovio have been developing DNA-based influenza vaccines capable of providing broad protection against existing as well as newly emerging, unknown seasonal and pandemic influenza strains. To design vaccines, the company developed a process known as SynCon, a way of targeting consensus proteins from multiple strains of H1N1, H2N2, H3N2, and H5N1, “which have collectively caused greater than 90% of all seasonal and pandemic flu events in people in the last 100-plus years,” Dr. Kim said. “We felt that those were very good targets.”

What separates Inovio's SynCon approach from that of other DNA vaccine manufacturers is that the SynCon vaccines demonstrate potential to protect against new strains of influenza that do not specifically match the vaccine.

“So, if the 2009 H1N1 virus mutates, there is no plan B,” Dr. Kim said. “There is no backup option; 2009 swine flu could be a big problem or not. No one can predict accurately.”

Origins of an Alternative

DNA-based influenza vaccines began to draw serious attention about 6 years ago, when infectious diseases experts around the globe expressed concern about a pandemic of H5N1 influenza virus, noted Dr. William Schaffner, chair of the department of preventive medicine at Vanderbilt University, Nashville, Tenn.

“That galvanized the international community,” he said. “Since that time, the United States government and private capital have gone into research to develop more improved influenza vaccines and to improve the vaccine technology. There has been more research into those areas in the past 5 or 6 years than there has been in the previous 50 years. That's stunning.”

The concept of DNA vaccines first emerged in the early 1990s, when researchers discovered that immunizing animals with plasmids—a circular string of DNA that encodes for a specific antigen or vaccine target—generates vaccine responses.

“The beauty of this technology is speed,” said Vijay B. Samant, president and CEO of San Diego–based Vical, which develops DNA vaccines. “It's not cell culture. It's not egg-based. It's simple fermentation and two purification steps. It does not require the manufacturer to handle the pathogen. All it needs is a gene sequence; that's good enough for us to make the vaccine.”

“Instead of delivering the viruses themselves in some form, you're taking a very simple plasmid, which is a circular string of DNA, and you're putting in a genetic blueprint designed for a specific target, in this case hemagglutinin,” Dr. Kim explained. “Once you inject that into muscle cells or skin cells, it uses our own cellular machinery to manufacture those proteins as antigens, and presents them in a customized way. It's like mimicking viral infection without the side effects and replication. DNA vaccines can never replicate. They do not infect; they do not cause disease, ever.”

Delivery Poses Challenges

Until recently, Dr. Kim and other researchers in the field faced a barrier to the advancement of DNA vaccines: inefficient delivery.

However, a technology developed in the 1990s known as in vivo electroporation is proving to be an effective way to deliver DNA vaccines.

Electroporation works like this: After a DNA vaccine is injected into the upper arm or into skin, a short, controlled electrical pulse is delivered into that tissue, either from the same needle or from a surrounding needle. This brief pulse of current “coaxes the cell membranes to open up their pores,” Dr. Kim said. “That brings in the DNA. We remove the electric field and the pores close up. This has been shown in animal species to be effective in up to a 1,000-fold increase in DNA vaccine uptake. The whole procedure takes a couple of seconds.”

Not all DNA vaccine manufacturers are using electroporation as a delivery method. Vical, the first company to produce a vaccine against the pandemic influenza A(H1N1) virus after initial reports of outbreaks in Mexico, uses a patented adjuvant known as Vaxfectin, “which does an amazing job of protecting the DNA before it enters the skeletal muscle cells,” Mr. Samant said. “Being a proinflammatory, it attracts the immune system toward the site of the injection to facilitate creation of the right immune response and immune memory.”

Phase I Trials Begin

On Oct. 1, 2009, the U.S. Navy awarded Vical a contract to support a phase I clinical trial of its vaccine against H1N1 influenza. “Our goal is to get that trial done by later this year,” Mr. Samant said.

In a virus challenge and protection study of Inovio's SynCon H1N1 vaccine, mice were injected with the H1N1 virus that caused the 1918 Spanish flu. Mice that received the H1N1 vaccine were completely protected from the virus, whereas all of the unvaccinated animals died within 1 week.

In 2010, the SynCon H5N1 vaccine will undergo human testing in healthy volunteers, followed by tests in combination with the SynCon H1N1 vaccine. Addition of H2N2 and other strains could soon follow.

Potential Pitfallr

“If we are correct, we can revolutionize how flu vaccines are made and delivered,” Dr. Kim said.

One potential pitfall of the DNA vaccine technology is the impending backlash from vaccine naysayers, cautioned Dr. Schaffner.

“We have a hardcore group of vaccine skeptics,” he said. “This is a group of people who look askance at vaccines, are dubious about their benefits, and are concerned about how they're manufactured and what's in them. Any innovation, whether it is the addition of an adjuvant, or a new technology such as this, will come to their attention and draw some of their skepticism and opposition. We have to brace for this.”

Dr. Schaffner disclosed that he has been a consultant for various vaccine manufacturers. He also is a member of a data safety committee for Merck for experimental vaccines.

'DNA vaccines can never replicate. They do not infect; they do not cause disease, ever.'

Source DR. KIM

The way Dr. Joseph Kim sees it, the field of influenza vaccine development could use an extreme makeover.

“Every year, three flu strains are selected by the flu experts around the world, which determines which strains the vaccine makers should make and stock for the coming fall,” Dr. Kim, president and CEO of San Diego–based Inovio Biomedical Corp., said in an interview. “They can guess right, or they can guess wrong; but every year, you have to change the vaccine. You can't stockpile from the previous year, because the flu strains could change.”

Scientists don't accept this approach for most other common vaccines, he noted, including the one for measles, mumps, and rubella. “That doesn't get changed from year to year, but our society has accepted the fact that the one for influenza does,” he said.

Dr. Kim would like to change that paradigm.

Since 2005, he and his associates at Inovio have been developing DNA-based influenza vaccines capable of providing broad protection against existing as well as newly emerging, unknown seasonal and pandemic influenza strains. To design vaccines, the company developed a process known as SynCon, a way of targeting consensus proteins from multiple strains of H1N1, H2N2, H3N2, and H5N1, “which have collectively caused greater than 90% of all seasonal and pandemic flu events in people in the last 100-plus years,” Dr. Kim said. “We felt that those were very good targets.”

What separates Inovio's SynCon approach from that of other DNA vaccine manufacturers is that the SynCon vaccines demonstrate potential to protect against new strains of influenza that do not specifically match the vaccine.

“So, if the 2009 H1N1 virus mutates, there is no plan B,” Dr. Kim said. “There is no backup option; 2009 swine flu could be a big problem or not. No one can predict accurately.”

Origins of an Alternative

DNA-based influenza vaccines began to draw serious attention about 6 years ago, when infectious diseases experts around the globe expressed concern about a pandemic of H5N1 influenza virus, noted Dr. William Schaffner, chair of the department of preventive medicine at Vanderbilt University, Nashville, Tenn.

“That galvanized the international community,” he said. “Since that time, the United States government and private capital have gone into research to develop more improved influenza vaccines and to improve the vaccine technology. There has been more research into those areas in the past 5 or 6 years than there has been in the previous 50 years. That's stunning.”

The concept of DNA vaccines first emerged in the early 1990s, when researchers discovered that immunizing animals with plasmids—a circular string of DNA that encodes for a specific antigen or vaccine target—generates vaccine responses.

“The beauty of this technology is speed,” said Vijay B. Samant, president and CEO of San Diego–based Vical, which develops DNA vaccines. “It's not cell culture. It's not egg-based. It's simple fermentation and two purification steps. It does not require the manufacturer to handle the pathogen. All it needs is a gene sequence; that's good enough for us to make the vaccine.”

“Instead of delivering the viruses themselves in some form, you're taking a very simple plasmid, which is a circular string of DNA, and you're putting in a genetic blueprint designed for a specific target, in this case hemagglutinin,” Dr. Kim explained. “Once you inject that into muscle cells or skin cells, it uses our own cellular machinery to manufacture those proteins as antigens, and presents them in a customized way. It's like mimicking viral infection without the side effects and replication. DNA vaccines can never replicate. They do not infect; they do not cause disease, ever.”

Delivery Poses Challenges

Until recently, Dr. Kim and other researchers in the field faced a barrier to the advancement of DNA vaccines: inefficient delivery.

However, a technology developed in the 1990s known as in vivo electroporation is proving to be an effective way to deliver DNA vaccines.

Electroporation works like this: After a DNA vaccine is injected into the upper arm or into skin, a short, controlled electrical pulse is delivered into that tissue, either from the same needle or from a surrounding needle. This brief pulse of current “coaxes the cell membranes to open up their pores,” Dr. Kim said. “That brings in the DNA. We remove the electric field and the pores close up. This has been shown in animal species to be effective in up to a 1,000-fold increase in DNA vaccine uptake. The whole procedure takes a couple of seconds.”

Not all DNA vaccine manufacturers are using electroporation as a delivery method. Vical, the first company to produce a vaccine against the pandemic influenza A(H1N1) virus after initial reports of outbreaks in Mexico, uses a patented adjuvant known as Vaxfectin, “which does an amazing job of protecting the DNA before it enters the skeletal muscle cells,” Mr. Samant said. “Being a proinflammatory, it attracts the immune system toward the site of the injection to facilitate creation of the right immune response and immune memory.”

Phase I Trials Begin

On Oct. 1, 2009, the U.S. Navy awarded Vical a contract to support a phase I clinical trial of its vaccine against H1N1 influenza. “Our goal is to get that trial done by later this year,” Mr. Samant said.

In a virus challenge and protection study of Inovio's SynCon H1N1 vaccine, mice were injected with the H1N1 virus that caused the 1918 Spanish flu. Mice that received the H1N1 vaccine were completely protected from the virus, whereas all of the unvaccinated animals died within 1 week.

In 2010, the SynCon H5N1 vaccine will undergo human testing in healthy volunteers, followed by tests in combination with the SynCon H1N1 vaccine. Addition of H2N2 and other strains could soon follow.

Potential Pitfallr

“If we are correct, we can revolutionize how flu vaccines are made and delivered,” Dr. Kim said.

One potential pitfall of the DNA vaccine technology is the impending backlash from vaccine naysayers, cautioned Dr. Schaffner.

“We have a hardcore group of vaccine skeptics,” he said. “This is a group of people who look askance at vaccines, are dubious about their benefits, and are concerned about how they're manufactured and what's in them. Any innovation, whether it is the addition of an adjuvant, or a new technology such as this, will come to their attention and draw some of their skepticism and opposition. We have to brace for this.”

Dr. Schaffner disclosed that he has been a consultant for various vaccine manufacturers. He also is a member of a data safety committee for Merck for experimental vaccines.

'DNA vaccines can never replicate. They do not infect; they do not cause disease, ever.'

Source DR. KIM

SAN DIEGO — The combination of breastfeeding and delaying pregnancy until a woman has acquired the majority of her bone mass appears to have a protective effect on bones, according to study involving more than 600 women.

“Several studies have shown that people who have had many pregnancies have less bone loss than women with no pregnancies,” lead author Dr. Peter F. Schnatz said in an interview.

“Our study is the first to our knowledge looking at the effect of pregnancy during the time of peak bone mineral acquisition and its eventual and ultimate effect on the development of postmenopausal osteoporosis. Most prior adolescent pregnancy studies, for instance, are limited to the immediate postpartum period,” he said at a poster session at the annual meeting of the North American Menopause Society.

Dr. Schnatz, associate chairman and residency program director in the department of obstetrics and gynecology at Reading (Pa.) Hospital and Medical Center and his associates analyzed data from 619 women over 49 years old. They assessed risk factors for osteoporosis, including a previous atraumatic fracture of the hip or spine, pregnancy information, and dual-energy x-ray absorptiometry results. They defined osteoporosis as a T score of −2.5 or lower at the lumbar spine, the femoral neck, or the total femur.

The mean age of the study participants was 62 years and 50% were either current or past smokers. Slightly more than one-quarter (27%) were using or had used a bisphosphonate, 64% were using or had used hormonal therapy, and 5% had used steroids.

Women with any breastfeeding had a significantly lower prevalence of osteoporosis (8%) than women who did not breastfeed (19%), a surprising finding. “It would seem that breastfeeding, which requires acquisition of calcium from the mother to nourish the baby, would cause bone loss,” Dr. Schnatz said.

Among the women who breastfed, those younger than age 27 years at their first pregnancy had a significantly higher prevalence of osteoporosis compared with those who were 27 years of age and older at their first pregnancy (11% vs. 5%, respectively), he reported.

Of the women who were at least 27 years old at first pregnancy, there was a significantly increased prevalence of osteoporosis in those who did not breastfeed, compared with those who did (25% vs. 5%, respectively).

Women who were at least 27 years old at their first pregnancy and who breastfed had a statistically lower prevalence of osteoporosis, compared with their counterparts who had their first pregnancy younger than age 27 and no history of breastfeeding (5% vs. 16%, respectively).

Among women who did not breastfeed, there was little difference in the risk of postmenopausal osteoporosis if the first pregnancy occurred at or after age 22 or 27 years, Dr. Schnatz wrote.

The study was supported by an unrestricted grant from the Alliance for Better Bone Health. Dr. Schnatz and his associates had no other financial conflicts to disclose.

Women with any breastfeeding had a lower prevalence of osteoporosis than women who did not breastfeed.

Source DR. SCHNATZ

SAN DIEGO — The combination of breastfeeding and delaying pregnancy until a woman has acquired the majority of her bone mass appears to have a protective effect on bones, according to study involving more than 600 women.

“Several studies have shown that people who have had many pregnancies have less bone loss than women with no pregnancies,” lead author Dr. Peter F. Schnatz said in an interview.

“Our study is the first to our knowledge looking at the effect of pregnancy during the time of peak bone mineral acquisition and its eventual and ultimate effect on the development of postmenopausal osteoporosis. Most prior adolescent pregnancy studies, for instance, are limited to the immediate postpartum period,” he said at a poster session at the annual meeting of the North American Menopause Society.

Dr. Schnatz, associate chairman and residency program director in the department of obstetrics and gynecology at Reading (Pa.) Hospital and Medical Center and his associates analyzed data from 619 women over 49 years old. They assessed risk factors for osteoporosis, including a previous atraumatic fracture of the hip or spine, pregnancy information, and dual-energy x-ray absorptiometry results. They defined osteoporosis as a T score of −2.5 or lower at the lumbar spine, the femoral neck, or the total femur.

The mean age of the study participants was 62 years and 50% were either current or past smokers. Slightly more than one-quarter (27%) were using or had used a bisphosphonate, 64% were using or had used hormonal therapy, and 5% had used steroids.

Women with any breastfeeding had a significantly lower prevalence of osteoporosis (8%) than women who did not breastfeed (19%), a surprising finding. “It would seem that breastfeeding, which requires acquisition of calcium from the mother to nourish the baby, would cause bone loss,” Dr. Schnatz said.

Among the women who breastfed, those younger than age 27 years at their first pregnancy had a significantly higher prevalence of osteoporosis compared with those who were 27 years of age and older at their first pregnancy (11% vs. 5%, respectively), he reported.

Of the women who were at least 27 years old at first pregnancy, there was a significantly increased prevalence of osteoporosis in those who did not breastfeed, compared with those who did (25% vs. 5%, respectively).

Women who were at least 27 years old at their first pregnancy and who breastfed had a statistically lower prevalence of osteoporosis, compared with their counterparts who had their first pregnancy younger than age 27 and no history of breastfeeding (5% vs. 16%, respectively).

Among women who did not breastfeed, there was little difference in the risk of postmenopausal osteoporosis if the first pregnancy occurred at or after age 22 or 27 years, Dr. Schnatz wrote.

The study was supported by an unrestricted grant from the Alliance for Better Bone Health. Dr. Schnatz and his associates had no other financial conflicts to disclose.

Women with any breastfeeding had a lower prevalence of osteoporosis than women who did not breastfeed.

Source DR. SCHNATZ

SAN DIEGO — The combination of breastfeeding and delaying pregnancy until a woman has acquired the majority of her bone mass appears to have a protective effect on bones, according to study involving more than 600 women.

“Several studies have shown that people who have had many pregnancies have less bone loss than women with no pregnancies,” lead author Dr. Peter F. Schnatz said in an interview.

“Our study is the first to our knowledge looking at the effect of pregnancy during the time of peak bone mineral acquisition and its eventual and ultimate effect on the development of postmenopausal osteoporosis. Most prior adolescent pregnancy studies, for instance, are limited to the immediate postpartum period,” he said at a poster session at the annual meeting of the North American Menopause Society.

Dr. Schnatz, associate chairman and residency program director in the department of obstetrics and gynecology at Reading (Pa.) Hospital and Medical Center and his associates analyzed data from 619 women over 49 years old. They assessed risk factors for osteoporosis, including a previous atraumatic fracture of the hip or spine, pregnancy information, and dual-energy x-ray absorptiometry results. They defined osteoporosis as a T score of −2.5 or lower at the lumbar spine, the femoral neck, or the total femur.

The mean age of the study participants was 62 years and 50% were either current or past smokers. Slightly more than one-quarter (27%) were using or had used a bisphosphonate, 64% were using or had used hormonal therapy, and 5% had used steroids.

Women with any breastfeeding had a significantly lower prevalence of osteoporosis (8%) than women who did not breastfeed (19%), a surprising finding. “It would seem that breastfeeding, which requires acquisition of calcium from the mother to nourish the baby, would cause bone loss,” Dr. Schnatz said.

Among the women who breastfed, those younger than age 27 years at their first pregnancy had a significantly higher prevalence of osteoporosis compared with those who were 27 years of age and older at their first pregnancy (11% vs. 5%, respectively), he reported.

Of the women who were at least 27 years old at first pregnancy, there was a significantly increased prevalence of osteoporosis in those who did not breastfeed, compared with those who did (25% vs. 5%, respectively).

Women who were at least 27 years old at their first pregnancy and who breastfed had a statistically lower prevalence of osteoporosis, compared with their counterparts who had their first pregnancy younger than age 27 and no history of breastfeeding (5% vs. 16%, respectively).

Among women who did not breastfeed, there was little difference in the risk of postmenopausal osteoporosis if the first pregnancy occurred at or after age 22 or 27 years, Dr. Schnatz wrote.

The study was supported by an unrestricted grant from the Alliance for Better Bone Health. Dr. Schnatz and his associates had no other financial conflicts to disclose.

Women with any breastfeeding had a lower prevalence of osteoporosis than women who did not breastfeed.

Source DR. SCHNATZ

SAN DIEGO — Knowledge of correct inhaler administration among hospital-based physicians is relatively poor, with pulmonologists faring no better than general medicine physicians, results from a small study in the United Kingdom showed.

The finding “highlights the need for us as doctors to be able to use the inhalers so we can identify groups of patients that may benefit from them,” Dr. Aldrin Adeni said in an interview during a poster session at the annual meeting of the American Thoracic Society.

“Some devices are better for patients than others. If we don't know how the devices work, then we may prescribe an inhaler that's suboptimal for a patient,” he cautioned.

Dr. Adeni and his associates at the Royal Liverpool Hospital, England, asked 42 physicians to demonstrate the correct use of commonly prescribed inhaler devices. A specialist nurse and respiratory consultant jointly assessed hospital physicians of various grades and specialties taking placebo therapy, using six different inhaler devices (the metered-dose inhaler [MDI], Easi-Breathe, Autohaler, Accuhaler, Turbohaler, and HandiHaler) and two spacer devices (the Aerochamber and the Volumatic). A structured assessment sheet was completed for each physician using each device.

All study participants saw acute general medical admissions, including patients with respiratory diseases. More than half of the participants (26) were general medicine physicians, while the rest (16) were respiratory specialists or consultants.

Dr. Adeni reported that there were no significant differences between respiratory and nonrespiratory physicians, or between senior and junior physicians in the correct use of each inhaler.

The number of physicians who knew when inhalers were empty was greatest for the MDI (60%), followed by the Accuhaler (57%), Easi-Breathe (33%), Autohaler (24%), and Turbohaler (12%).

The percentage of physicians who knew how to correctly prepare the MDI and the Accuhaler was relatively high (73% and 86%, respectively), but dropped off sharply for the Turbohaler (38%), Easi-Breathe (29%), Autohaler (26%), MDI plus Volumatic (24%), and Aerochamber (17%).

Errors that were commonly observed with all inhalers included failing to shake, double dosing, breath-holding time, and knowing when the device is empty.

“We believe our findings highlight the need for improved education of all physicians concerning inhaler devices commonly prescribed,” the researchers concluded in their poster.

Dr. Adeni had no relevant conflicts to disclose.

SAN DIEGO — Knowledge of correct inhaler administration among hospital-based physicians is relatively poor, with pulmonologists faring no better than general medicine physicians, results from a small study in the United Kingdom showed.

The finding “highlights the need for us as doctors to be able to use the inhalers so we can identify groups of patients that may benefit from them,” Dr. Aldrin Adeni said in an interview during a poster session at the annual meeting of the American Thoracic Society.

“Some devices are better for patients than others. If we don't know how the devices work, then we may prescribe an inhaler that's suboptimal for a patient,” he cautioned.

Dr. Adeni and his associates at the Royal Liverpool Hospital, England, asked 42 physicians to demonstrate the correct use of commonly prescribed inhaler devices. A specialist nurse and respiratory consultant jointly assessed hospital physicians of various grades and specialties taking placebo therapy, using six different inhaler devices (the metered-dose inhaler [MDI], Easi-Breathe, Autohaler, Accuhaler, Turbohaler, and HandiHaler) and two spacer devices (the Aerochamber and the Volumatic). A structured assessment sheet was completed for each physician using each device.

All study participants saw acute general medical admissions, including patients with respiratory diseases. More than half of the participants (26) were general medicine physicians, while the rest (16) were respiratory specialists or consultants.

Dr. Adeni reported that there were no significant differences between respiratory and nonrespiratory physicians, or between senior and junior physicians in the correct use of each inhaler.

The number of physicians who knew when inhalers were empty was greatest for the MDI (60%), followed by the Accuhaler (57%), Easi-Breathe (33%), Autohaler (24%), and Turbohaler (12%).

The percentage of physicians who knew how to correctly prepare the MDI and the Accuhaler was relatively high (73% and 86%, respectively), but dropped off sharply for the Turbohaler (38%), Easi-Breathe (29%), Autohaler (26%), MDI plus Volumatic (24%), and Aerochamber (17%).

Errors that were commonly observed with all inhalers included failing to shake, double dosing, breath-holding time, and knowing when the device is empty.

“We believe our findings highlight the need for improved education of all physicians concerning inhaler devices commonly prescribed,” the researchers concluded in their poster.

Dr. Adeni had no relevant conflicts to disclose.

SAN DIEGO — Knowledge of correct inhaler administration among hospital-based physicians is relatively poor, with pulmonologists faring no better than general medicine physicians, results from a small study in the United Kingdom showed.

The finding “highlights the need for us as doctors to be able to use the inhalers so we can identify groups of patients that may benefit from them,” Dr. Aldrin Adeni said in an interview during a poster session at the annual meeting of the American Thoracic Society.

“Some devices are better for patients than others. If we don't know how the devices work, then we may prescribe an inhaler that's suboptimal for a patient,” he cautioned.

Dr. Adeni and his associates at the Royal Liverpool Hospital, England, asked 42 physicians to demonstrate the correct use of commonly prescribed inhaler devices. A specialist nurse and respiratory consultant jointly assessed hospital physicians of various grades and specialties taking placebo therapy, using six different inhaler devices (the metered-dose inhaler [MDI], Easi-Breathe, Autohaler, Accuhaler, Turbohaler, and HandiHaler) and two spacer devices (the Aerochamber and the Volumatic). A structured assessment sheet was completed for each physician using each device.

All study participants saw acute general medical admissions, including patients with respiratory diseases. More than half of the participants (26) were general medicine physicians, while the rest (16) were respiratory specialists or consultants.

Dr. Adeni reported that there were no significant differences between respiratory and nonrespiratory physicians, or between senior and junior physicians in the correct use of each inhaler.

The number of physicians who knew when inhalers were empty was greatest for the MDI (60%), followed by the Accuhaler (57%), Easi-Breathe (33%), Autohaler (24%), and Turbohaler (12%).

The percentage of physicians who knew how to correctly prepare the MDI and the Accuhaler was relatively high (73% and 86%, respectively), but dropped off sharply for the Turbohaler (38%), Easi-Breathe (29%), Autohaler (26%), MDI plus Volumatic (24%), and Aerochamber (17%).

Errors that were commonly observed with all inhalers included failing to shake, double dosing, breath-holding time, and knowing when the device is empty.

“We believe our findings highlight the need for improved education of all physicians concerning inhaler devices commonly prescribed,” the researchers concluded in their poster.

Dr. Adeni had no relevant conflicts to disclose.

CORONADO, CALIF. — In his dual roles as an emergency physician and health care lawyer, Dr. Michael Frank has seen an increasing number of patients seeking copies of their medical records—and finding entries that are incomplete, inaccurate, or completely wrong.

“If you want to spend more time with patients to the exclusion of certain documentation, that's fine,” he said at a conference on reimbursement sponsored by the American College of Emergency Physicians. “Just understand that if and when you get sued—even though it may not be fair—if the documentation has suffered, so has your defense.”

Dr. Frank, general counsel and director of risk management for Canton, Ohio–based Emergency Medicine Physicians, discussed the case of a 51-year-old woman who presented to the emergency department complaining of a dog bite laceration to the finger. The laceration was repaired under digital block, and she was discharged.

After receiving a printed version of her medical chart in the mail, the patient wrote notes of correction next to several items and returned it to the physician. For example, the vital signs and physical exam section of the chart indicated no evidence of significant external trauma. But in that section, the patient wrote “dog bite to hand.” According to the chart, she underwent an ENT exam, but the patient wrote that this “did not happen.”

The chart also indicated that there was no evidence of local chest wall tenderness or external injury (patient wrote “never looked or touched”), and that the breath sounds were normal (patient wrote “never listened”).

“We are seeing more complaints from patients who are saying, 'This didn't happen,' that the documentation was wrong,” Dr. Frank said. “This is true, for example, for a review of systems. It has very little to do with our clinical practice, but it's a requirement for certain documentation. So, if we're documenting a review of systems that weren't really done … we are opening ourselves up to fraud allegations.

“You'd better be careful that what you're documenting is exactly what you do, because patients are reading the medical record,” he added.

Physicians who cancel the medical bill of a patient who may be unhappy with services rendered or who threatens to sue don't necessarily put themselves at legal risk. “The issue of whether you cancel the bill or not is not relevant to the issue of whether the care you provided was or was not below the standard of care. There are lots of different reasons for why you might want to cancel a bill,” said Dr. Frank, who is also chairman of the board of trustees and an attending emergency physician at Summa Barberton Hospital in Barberton, Ohio.

If you don't cancel a bill in a case where a patient is really upset, “that might lead that person to pursue a lawsuit,” he added. “If you do cancel a bill, it's possible that they might interpret that as a sign of weakness or that you did something wrong.” If you believe the care you provided was inappropriate, “you should cancel those bills,” he advised. “On the other hand, if you feel you didn't do anything wrong, then it becomes a matter of public relations and customer satisfaction. In the long run, it might be worth your time to foot that bill.”

Dr. Frank had no conflicts of interest to disclose.

CORONADO, CALIF. — In his dual roles as an emergency physician and health care lawyer, Dr. Michael Frank has seen an increasing number of patients seeking copies of their medical records—and finding entries that are incomplete, inaccurate, or completely wrong.

“If you want to spend more time with patients to the exclusion of certain documentation, that's fine,” he said at a conference on reimbursement sponsored by the American College of Emergency Physicians. “Just understand that if and when you get sued—even though it may not be fair—if the documentation has suffered, so has your defense.”

Dr. Frank, general counsel and director of risk management for Canton, Ohio–based Emergency Medicine Physicians, discussed the case of a 51-year-old woman who presented to the emergency department complaining of a dog bite laceration to the finger. The laceration was repaired under digital block, and she was discharged.

After receiving a printed version of her medical chart in the mail, the patient wrote notes of correction next to several items and returned it to the physician. For example, the vital signs and physical exam section of the chart indicated no evidence of significant external trauma. But in that section, the patient wrote “dog bite to hand.” According to the chart, she underwent an ENT exam, but the patient wrote that this “did not happen.”

The chart also indicated that there was no evidence of local chest wall tenderness or external injury (patient wrote “never looked or touched”), and that the breath sounds were normal (patient wrote “never listened”).

“We are seeing more complaints from patients who are saying, 'This didn't happen,' that the documentation was wrong,” Dr. Frank said. “This is true, for example, for a review of systems. It has very little to do with our clinical practice, but it's a requirement for certain documentation. So, if we're documenting a review of systems that weren't really done … we are opening ourselves up to fraud allegations.

“You'd better be careful that what you're documenting is exactly what you do, because patients are reading the medical record,” he added.

Physicians who cancel the medical bill of a patient who may be unhappy with services rendered or who threatens to sue don't necessarily put themselves at legal risk. “The issue of whether you cancel the bill or not is not relevant to the issue of whether the care you provided was or was not below the standard of care. There are lots of different reasons for why you might want to cancel a bill,” said Dr. Frank, who is also chairman of the board of trustees and an attending emergency physician at Summa Barberton Hospital in Barberton, Ohio.

If you don't cancel a bill in a case where a patient is really upset, “that might lead that person to pursue a lawsuit,” he added. “If you do cancel a bill, it's possible that they might interpret that as a sign of weakness or that you did something wrong.” If you believe the care you provided was inappropriate, “you should cancel those bills,” he advised. “On the other hand, if you feel you didn't do anything wrong, then it becomes a matter of public relations and customer satisfaction. In the long run, it might be worth your time to foot that bill.”

Dr. Frank had no conflicts of interest to disclose.

CORONADO, CALIF. — In his dual roles as an emergency physician and health care lawyer, Dr. Michael Frank has seen an increasing number of patients seeking copies of their medical records—and finding entries that are incomplete, inaccurate, or completely wrong.

“If you want to spend more time with patients to the exclusion of certain documentation, that's fine,” he said at a conference on reimbursement sponsored by the American College of Emergency Physicians. “Just understand that if and when you get sued—even though it may not be fair—if the documentation has suffered, so has your defense.”

Dr. Frank, general counsel and director of risk management for Canton, Ohio–based Emergency Medicine Physicians, discussed the case of a 51-year-old woman who presented to the emergency department complaining of a dog bite laceration to the finger. The laceration was repaired under digital block, and she was discharged.

After receiving a printed version of her medical chart in the mail, the patient wrote notes of correction next to several items and returned it to the physician. For example, the vital signs and physical exam section of the chart indicated no evidence of significant external trauma. But in that section, the patient wrote “dog bite to hand.” According to the chart, she underwent an ENT exam, but the patient wrote that this “did not happen.”

The chart also indicated that there was no evidence of local chest wall tenderness or external injury (patient wrote “never looked or touched”), and that the breath sounds were normal (patient wrote “never listened”).

“We are seeing more complaints from patients who are saying, 'This didn't happen,' that the documentation was wrong,” Dr. Frank said. “This is true, for example, for a review of systems. It has very little to do with our clinical practice, but it's a requirement for certain documentation. So, if we're documenting a review of systems that weren't really done … we are opening ourselves up to fraud allegations.

“You'd better be careful that what you're documenting is exactly what you do, because patients are reading the medical record,” he added.

Physicians who cancel the medical bill of a patient who may be unhappy with services rendered or who threatens to sue don't necessarily put themselves at legal risk. “The issue of whether you cancel the bill or not is not relevant to the issue of whether the care you provided was or was not below the standard of care. There are lots of different reasons for why you might want to cancel a bill,” said Dr. Frank, who is also chairman of the board of trustees and an attending emergency physician at Summa Barberton Hospital in Barberton, Ohio.

If you don't cancel a bill in a case where a patient is really upset, “that might lead that person to pursue a lawsuit,” he added. “If you do cancel a bill, it's possible that they might interpret that as a sign of weakness or that you did something wrong.” If you believe the care you provided was inappropriate, “you should cancel those bills,” he advised. “On the other hand, if you feel you didn't do anything wrong, then it becomes a matter of public relations and customer satisfaction. In the long run, it might be worth your time to foot that bill.”

Dr. Frank had no conflicts of interest to disclose.

CORONADO, CALIF. — As general counsel and director of risk management for Canton, Ohio–based Emergency Medicine Physicians, Dr. Michael Frank fields his share of calls from partner groups asking for insight on how to keep a lid on malpractice insurance costs.

“Any time you see another patient, that's going to expose you to more risk,” Dr. Michael Frank said at a meeting on reimbursement sponsored by the American College of Emergency Physicians. “The only sure way to eliminate your risk is to stop taking care of patients. But that's not going to be a very good solution.”

He offered three ways to save money on medical malpractice insurance:

▸ Sign up with the insurance carrier that offers the lowest premiums. “Be careful about doing that, because the history of medical malpractice insurance companies is littered with the stories of companies that tried to buy business by charging too low of a premium, and they're now bankrupt,” he said. “What do you wind up with? No coverage or coverage by a state guarantee association.”

▸ Set up shop in a state with effective tort reform. Each year, the American Tort Reform Association publishes “Judicial Hellholes,” a list of some of the nation's most “unfair” civil court jurisdictions in which to be sued (www.atra.org

According to the 2008–2009 edition, the current leading “judicial hellholes” include West Virginia; South Florida; Cook County, Ill.; Atlantic County, N.J.; Montgomery and Macon counties, Ala.; Los Angeles County, Calif.; and Clark County, Nev.

The publication's “watch list” includes Rio Grande Valley and the Gulf Coast of Texas; Madison County, Ill.; Baltimore; the city of St. Louis, as well as St. Louis and Jackson counties, Mo.

“Does tort reform really decrease medical malpractice premiums?” Dr. Frank asked. “California has one of the best tort reforms, limiting noneconomic damages to $250,000. The Las Vegas premiums we charge are about three times that of California. That's mostly because of what tort reform has done.”

▸ Start your own insurance company. Options include a “group captive,” an insurance company that is primarily owned and controlled by its policyholders, or a risk retention group, which is a type of captive authorized under the Liability Risk Retention Act of 1986. Captives can be created by either small practices or larger groups.

Risk retention groups are not subject to individual state laws that ordinarily apply to insurance companies. In addition, “once you are chartered in one state, you don't have to get permission to operate in any other state,” said Dr. Frank, who is also chairman of the board of trustees and an attending emergency physician at Summa Barberton (Ohio) Hospital.

He went on to note that, regardless of your business model, one surefire way to lose money on medical malpractice insurance is to not report claims promptly. “One of the first things the insurance company will do is to look for a way to deny coverage,” he said. “Try reporting after you should have done so. Almost every medical malpractice policy requires prompt reporting.”

Another way to lose money on medical malpractice insurance is to lose control of underwriting expenses. He spoke of one risk retention group that applies 60 cents of every dollar it earns from premiums into operating expenses. “Sooner or later that [group] is going to have to start charging higher premiums,” he said.

Buying too much coverage is another common way to lose money on medical malpractice insurance. Higher limits “are as much a target as they are a shield,” Dr. Frank said. “You have to be very careful about how policy limits are allocated, whether you have shared limits or individual limits. In our policy we have shared limits. Let's say Dr. X and Y were our employees and were named in a lawsuit. In our policy there would be $1 million in coverage for both. If they decided to name the medical group as well, it would still be only $1 million in coverage.”

On the other hand, if the policy limits were stacked, “that's like blood in the water to sharks,” he said. “The plaintiff attorneys who might be looking to settle for policy limits of $1 million would see coverage of $3 million and think, 'There's $3 million in coverage, and so that's what the case is worth.'”

Dr. Frank had no conflicts of interest to disclose.

'One of the first things the insurance company will do is to look for a way to deny coverage.'

Source Dr. Frank

CORONADO, CALIF. — As general counsel and director of risk management for Canton, Ohio–based Emergency Medicine Physicians, Dr. Michael Frank fields his share of calls from partner groups asking for insight on how to keep a lid on malpractice insurance costs.

“Any time you see another patient, that's going to expose you to more risk,” Dr. Michael Frank said at a meeting on reimbursement sponsored by the American College of Emergency Physicians. “The only sure way to eliminate your risk is to stop taking care of patients. But that's not going to be a very good solution.”

He offered three ways to save money on medical malpractice insurance:

▸ Sign up with the insurance carrier that offers the lowest premiums. “Be careful about doing that, because the history of medical malpractice insurance companies is littered with the stories of companies that tried to buy business by charging too low of a premium, and they're now bankrupt,” he said. “What do you wind up with? No coverage or coverage by a state guarantee association.”

▸ Set up shop in a state with effective tort reform. Each year, the American Tort Reform Association publishes “Judicial Hellholes,” a list of some of the nation's most “unfair” civil court jurisdictions in which to be sued (www.atra.org

According to the 2008–2009 edition, the current leading “judicial hellholes” include West Virginia; South Florida; Cook County, Ill.; Atlantic County, N.J.; Montgomery and Macon counties, Ala.; Los Angeles County, Calif.; and Clark County, Nev.

The publication's “watch list” includes Rio Grande Valley and the Gulf Coast of Texas; Madison County, Ill.; Baltimore; the city of St. Louis, as well as St. Louis and Jackson counties, Mo.

“Does tort reform really decrease medical malpractice premiums?” Dr. Frank asked. “California has one of the best tort reforms, limiting noneconomic damages to $250,000. The Las Vegas premiums we charge are about three times that of California. That's mostly because of what tort reform has done.”

▸ Start your own insurance company. Options include a “group captive,” an insurance company that is primarily owned and controlled by its policyholders, or a risk retention group, which is a type of captive authorized under the Liability Risk Retention Act of 1986. Captives can be created by either small practices or larger groups.

Risk retention groups are not subject to individual state laws that ordinarily apply to insurance companies. In addition, “once you are chartered in one state, you don't have to get permission to operate in any other state,” said Dr. Frank, who is also chairman of the board of trustees and an attending emergency physician at Summa Barberton (Ohio) Hospital.

He went on to note that, regardless of your business model, one surefire way to lose money on medical malpractice insurance is to not report claims promptly. “One of the first things the insurance company will do is to look for a way to deny coverage,” he said. “Try reporting after you should have done so. Almost every medical malpractice policy requires prompt reporting.”

Another way to lose money on medical malpractice insurance is to lose control of underwriting expenses. He spoke of one risk retention group that applies 60 cents of every dollar it earns from premiums into operating expenses. “Sooner or later that [group] is going to have to start charging higher premiums,” he said.

Buying too much coverage is another common way to lose money on medical malpractice insurance. Higher limits “are as much a target as they are a shield,” Dr. Frank said. “You have to be very careful about how policy limits are allocated, whether you have shared limits or individual limits. In our policy we have shared limits. Let's say Dr. X and Y were our employees and were named in a lawsuit. In our policy there would be $1 million in coverage for both. If they decided to name the medical group as well, it would still be only $1 million in coverage.”

On the other hand, if the policy limits were stacked, “that's like blood in the water to sharks,” he said. “The plaintiff attorneys who might be looking to settle for policy limits of $1 million would see coverage of $3 million and think, 'There's $3 million in coverage, and so that's what the case is worth.'”

Dr. Frank had no conflicts of interest to disclose.

'One of the first things the insurance company will do is to look for a way to deny coverage.'

Source Dr. Frank

CORONADO, CALIF. — As general counsel and director of risk management for Canton, Ohio–based Emergency Medicine Physicians, Dr. Michael Frank fields his share of calls from partner groups asking for insight on how to keep a lid on malpractice insurance costs.

“Any time you see another patient, that's going to expose you to more risk,” Dr. Michael Frank said at a meeting on reimbursement sponsored by the American College of Emergency Physicians. “The only sure way to eliminate your risk is to stop taking care of patients. But that's not going to be a very good solution.”

He offered three ways to save money on medical malpractice insurance:

▸ Sign up with the insurance carrier that offers the lowest premiums. “Be careful about doing that, because the history of medical malpractice insurance companies is littered with the stories of companies that tried to buy business by charging too low of a premium, and they're now bankrupt,” he said. “What do you wind up with? No coverage or coverage by a state guarantee association.”

▸ Set up shop in a state with effective tort reform. Each year, the American Tort Reform Association publishes “Judicial Hellholes,” a list of some of the nation's most “unfair” civil court jurisdictions in which to be sued (www.atra.org

According to the 2008–2009 edition, the current leading “judicial hellholes” include West Virginia; South Florida; Cook County, Ill.; Atlantic County, N.J.; Montgomery and Macon counties, Ala.; Los Angeles County, Calif.; and Clark County, Nev.

The publication's “watch list” includes Rio Grande Valley and the Gulf Coast of Texas; Madison County, Ill.; Baltimore; the city of St. Louis, as well as St. Louis and Jackson counties, Mo.

“Does tort reform really decrease medical malpractice premiums?” Dr. Frank asked. “California has one of the best tort reforms, limiting noneconomic damages to $250,000. The Las Vegas premiums we charge are about three times that of California. That's mostly because of what tort reform has done.”

▸ Start your own insurance company. Options include a “group captive,” an insurance company that is primarily owned and controlled by its policyholders, or a risk retention group, which is a type of captive authorized under the Liability Risk Retention Act of 1986. Captives can be created by either small practices or larger groups.

Risk retention groups are not subject to individual state laws that ordinarily apply to insurance companies. In addition, “once you are chartered in one state, you don't have to get permission to operate in any other state,” said Dr. Frank, who is also chairman of the board of trustees and an attending emergency physician at Summa Barberton (Ohio) Hospital.

He went on to note that, regardless of your business model, one surefire way to lose money on medical malpractice insurance is to not report claims promptly. “One of the first things the insurance company will do is to look for a way to deny coverage,” he said. “Try reporting after you should have done so. Almost every medical malpractice policy requires prompt reporting.”

Another way to lose money on medical malpractice insurance is to lose control of underwriting expenses. He spoke of one risk retention group that applies 60 cents of every dollar it earns from premiums into operating expenses. “Sooner or later that [group] is going to have to start charging higher premiums,” he said.

Buying too much coverage is another common way to lose money on medical malpractice insurance. Higher limits “are as much a target as they are a shield,” Dr. Frank said. “You have to be very careful about how policy limits are allocated, whether you have shared limits or individual limits. In our policy we have shared limits. Let's say Dr. X and Y were our employees and were named in a lawsuit. In our policy there would be $1 million in coverage for both. If they decided to name the medical group as well, it would still be only $1 million in coverage.”

On the other hand, if the policy limits were stacked, “that's like blood in the water to sharks,” he said. “The plaintiff attorneys who might be looking to settle for policy limits of $1 million would see coverage of $3 million and think, 'There's $3 million in coverage, and so that's what the case is worth.'”

Dr. Frank had no conflicts of interest to disclose.

'One of the first things the insurance company will do is to look for a way to deny coverage.'

Source Dr. Frank

PORTLAND, ORE. — Psoriasis patients face an increased risk of comorbidities ranging from depression to MI, but most don't know that.

“People don't know what you don't tell them, so please educate your patients about these risk factors,” Dr. Theresa Devere said at the annual meeting of the Pacific Dermatologic Association. “We should all be educating and screening people for comorbidities of psoriasis. At the least, perhaps make a handout that lists what they may be at risk for.”

Psoriatic Arthritis

A common comorbidity is psoriatic arthritis, which occurs in 11%–31% of patients before, concurrently, or after the onset of psoriasis, according to Dr. Devere. Telltale symptoms that warrant referral to a rheumatologist include pitting and discoloration of the nails, swollen finger joints, sausage finger or toe (dactylitis), and swollen heel at the Achilles tendon.

“Axial psoriatic arthritis can be a little more difficult to ascertain whether it's arthritis or not, but people with this condition will complain of lower back pain and hip pain,” said Dr. Devere of the department of dermatology at Oregon Health and Science University, Portland.

Depression

In a 1998 National Psoriasis Foundation survey of 17,350 people with psoriasis, 54% reported feeling depressed (Arch. Dermatol. 2001;137:280–4). An earlier study found that 81% of psoriasis patients reported that having the disease led to feelings of embarrassment and shame, 19% had experienced social rejection, and 6% of younger patients reported suicidal ideation (Br. J. Dermatol. 1998;139:846–50).

“We ask psoriasis patients to fill out a sheet that asks them if they've been feeling sad for the past couple of weeks and if they've had any suicidal ideation,” Dr. Devere said. “It's almost easier to get them to say yes or no on paper rather than asking them outright.”

Another study found that successful treatment of psoriasis with PUVA reduced disability and stress related to psoriasis, but did not impact anxiety, depression, and worrying (Br. J. Dermatol. 2004;151:1219–26). “Treatment of psoriasis may or may not improve depression and anxiety,” she said. “Screening and referral to a mental health professional may be helpful.”

Smoking

The Nurses' Health Study II, which followed more than 78,000 women over 14 years, found that current smokers were at higher risk for developing psoriasis, compared with past smokers (risk ratios of 1.87 and 1.37, respectively). It concluded that the risk of psoriasis increased with duration, intensity, and pack-years of smoking (Am. J. Med. 2007;120:953–9).

Another study found that patients who smoked more than 20 cigarettes per day had a twofold increased risk of clinical severe psoriasis, compared with those who smoked 10 or fewer cigarettes per day; the association was stronger among women (Arch. Dermatol. 2005;141:1580–4).

“Why does this happen? Nicotinic cholinergic receptors have been demonstrated on keratinocytes, which may control keratinocyte adhesion and upward migration in the epidermis,” Dr. Devere said. “Nicotine also alters immune responses by directly interacting with T cells and dendritic cells.”

She added that smoking induces “an overproduction of inflammatory cytokines, which may be associated with psoriasis severity.”

Alcohol Intake

Large cohort studies have showed a higher incidence of alcoholism in psoriasis patients. One reported that 17%–30% of patients with moderate to severe psoriasis have problems with alcohol (Br. J. Dermatol. 2008;158:138–40). Another study suggested that alcohol use is associated with decreased response to treatment in men (J. Am. Acad. Dermatol. 1993;28:730–2). “I have three male alcoholic patients that I cannot get better on any drug,” she said.

Obesity

One large, case-control study found that the risk of psoriasis had a 1.6 odds ratio for individuals with a body mass index of 25–30 kg/m

Other studies have found that leptin levels are increased in obesity and in the serum and tissue of severe psoriatic patients, and that leptin increases T-cell proliferation and stimulates TNF alpha production, which may link psoriasis and obesity, she said.

Dr. Devere also noted two case reports of psoriasis remission after gastric bypass surgery (Obes. Surg. 2004;14:1132–4; 2006;16:94–7). “Both patients had severe psoriasis for 15 and 39 years, respectively, without remission on multiple treatments,” she said. “After gastric bypass surgery and significant weight loss, both patients had complete remission of their psoriasis.”

Atherosclerotic Conditions

Psoriasis has also been shown to heighten the risk of a full range of atherosclerotic conditions.

A recent Veteran Affairs study showed that overall mortality (OR 1.86) and the following vascular diseases were significantly increased among patients with psoriasis: ischemic heart disease (OR 1.78), cerebrovascular disease (OR 1.70), and peripheral vascular disease (OR 1.98) (Arch. Dermatol. 2009;145:700–3). “Patients with psoriasis should be encouraged to identify and manage their modifiable cardiovascular risk factors,” Dr. Devere said.

She recommended that screening of patients with psoriasis include measures of blood pressure and weight, and questions about smoking, alcohol intake, depression and anxiety, and family history of cardiovascular disease.

Dr. Devere reported having no conflicts to disclose.

Patients with psoriasis should 'identify and manage their modifiable cardiovascular risk factors.'

Source Dr. Devere

PORTLAND, ORE. — Psoriasis patients face an increased risk of comorbidities ranging from depression to MI, but most don't know that.

“People don't know what you don't tell them, so please educate your patients about these risk factors,” Dr. Theresa Devere said at the annual meeting of the Pacific Dermatologic Association. “We should all be educating and screening people for comorbidities of psoriasis. At the least, perhaps make a handout that lists what they may be at risk for.”

Psoriatic Arthritis

A common comorbidity is psoriatic arthritis, which occurs in 11%–31% of patients before, concurrently, or after the onset of psoriasis, according to Dr. Devere. Telltale symptoms that warrant referral to a rheumatologist include pitting and discoloration of the nails, swollen finger joints, sausage finger or toe (dactylitis), and swollen heel at the Achilles tendon.

“Axial psoriatic arthritis can be a little more difficult to ascertain whether it's arthritis or not, but people with this condition will complain of lower back pain and hip pain,” said Dr. Devere of the department of dermatology at Oregon Health and Science University, Portland.

Depression

In a 1998 National Psoriasis Foundation survey of 17,350 people with psoriasis, 54% reported feeling depressed (Arch. Dermatol. 2001;137:280–4). An earlier study found that 81% of psoriasis patients reported that having the disease led to feelings of embarrassment and shame, 19% had experienced social rejection, and 6% of younger patients reported suicidal ideation (Br. J. Dermatol. 1998;139:846–50).

“We ask psoriasis patients to fill out a sheet that asks them if they've been feeling sad for the past couple of weeks and if they've had any suicidal ideation,” Dr. Devere said. “It's almost easier to get them to say yes or no on paper rather than asking them outright.”

Another study found that successful treatment of psoriasis with PUVA reduced disability and stress related to psoriasis, but did not impact anxiety, depression, and worrying (Br. J. Dermatol. 2004;151:1219–26). “Treatment of psoriasis may or may not improve depression and anxiety,” she said. “Screening and referral to a mental health professional may be helpful.”

Smoking

The Nurses' Health Study II, which followed more than 78,000 women over 14 years, found that current smokers were at higher risk for developing psoriasis, compared with past smokers (risk ratios of 1.87 and 1.37, respectively). It concluded that the risk of psoriasis increased with duration, intensity, and pack-years of smoking (Am. J. Med. 2007;120:953–9).

Another study found that patients who smoked more than 20 cigarettes per day had a twofold increased risk of clinical severe psoriasis, compared with those who smoked 10 or fewer cigarettes per day; the association was stronger among women (Arch. Dermatol. 2005;141:1580–4).

“Why does this happen? Nicotinic cholinergic receptors have been demonstrated on keratinocytes, which may control keratinocyte adhesion and upward migration in the epidermis,” Dr. Devere said. “Nicotine also alters immune responses by directly interacting with T cells and dendritic cells.”

She added that smoking induces “an overproduction of inflammatory cytokines, which may be associated with psoriasis severity.”

Alcohol Intake

Large cohort studies have showed a higher incidence of alcoholism in psoriasis patients. One reported that 17%–30% of patients with moderate to severe psoriasis have problems with alcohol (Br. J. Dermatol. 2008;158:138–40). Another study suggested that alcohol use is associated with decreased response to treatment in men (J. Am. Acad. Dermatol. 1993;28:730–2). “I have three male alcoholic patients that I cannot get better on any drug,” she said.

Obesity

One large, case-control study found that the risk of psoriasis had a 1.6 odds ratio for individuals with a body mass index of 25–30 kg/m

Other studies have found that leptin levels are increased in obesity and in the serum and tissue of severe psoriatic patients, and that leptin increases T-cell proliferation and stimulates TNF alpha production, which may link psoriasis and obesity, she said.

Dr. Devere also noted two case reports of psoriasis remission after gastric bypass surgery (Obes. Surg. 2004;14:1132–4; 2006;16:94–7). “Both patients had severe psoriasis for 15 and 39 years, respectively, without remission on multiple treatments,” she said. “After gastric bypass surgery and significant weight loss, both patients had complete remission of their psoriasis.”

Atherosclerotic Conditions

Psoriasis has also been shown to heighten the risk of a full range of atherosclerotic conditions.

A recent Veteran Affairs study showed that overall mortality (OR 1.86) and the following vascular diseases were significantly increased among patients with psoriasis: ischemic heart disease (OR 1.78), cerebrovascular disease (OR 1.70), and peripheral vascular disease (OR 1.98) (Arch. Dermatol. 2009;145:700–3). “Patients with psoriasis should be encouraged to identify and manage their modifiable cardiovascular risk factors,” Dr. Devere said.

She recommended that screening of patients with psoriasis include measures of blood pressure and weight, and questions about smoking, alcohol intake, depression and anxiety, and family history of cardiovascular disease.

Dr. Devere reported having no conflicts to disclose.

Patients with psoriasis should 'identify and manage their modifiable cardiovascular risk factors.'

Source Dr. Devere

PORTLAND, ORE. — Psoriasis patients face an increased risk of comorbidities ranging from depression to MI, but most don't know that.

“People don't know what you don't tell them, so please educate your patients about these risk factors,” Dr. Theresa Devere said at the annual meeting of the Pacific Dermatologic Association. “We should all be educating and screening people for comorbidities of psoriasis. At the least, perhaps make a handout that lists what they may be at risk for.”

Psoriatic Arthritis

A common comorbidity is psoriatic arthritis, which occurs in 11%–31% of patients before, concurrently, or after the onset of psoriasis, according to Dr. Devere. Telltale symptoms that warrant referral to a rheumatologist include pitting and discoloration of the nails, swollen finger joints, sausage finger or toe (dactylitis), and swollen heel at the Achilles tendon.

“Axial psoriatic arthritis can be a little more difficult to ascertain whether it's arthritis or not, but people with this condition will complain of lower back pain and hip pain,” said Dr. Devere of the department of dermatology at Oregon Health and Science University, Portland.

Depression

In a 1998 National Psoriasis Foundation survey of 17,350 people with psoriasis, 54% reported feeling depressed (Arch. Dermatol. 2001;137:280–4). An earlier study found that 81% of psoriasis patients reported that having the disease led to feelings of embarrassment and shame, 19% had experienced social rejection, and 6% of younger patients reported suicidal ideation (Br. J. Dermatol. 1998;139:846–50).

“We ask psoriasis patients to fill out a sheet that asks them if they've been feeling sad for the past couple of weeks and if they've had any suicidal ideation,” Dr. Devere said. “It's almost easier to get them to say yes or no on paper rather than asking them outright.”

Another study found that successful treatment of psoriasis with PUVA reduced disability and stress related to psoriasis, but did not impact anxiety, depression, and worrying (Br. J. Dermatol. 2004;151:1219–26). “Treatment of psoriasis may or may not improve depression and anxiety,” she said. “Screening and referral to a mental health professional may be helpful.”

Smoking

The Nurses' Health Study II, which followed more than 78,000 women over 14 years, found that current smokers were at higher risk for developing psoriasis, compared with past smokers (risk ratios of 1.87 and 1.37, respectively). It concluded that the risk of psoriasis increased with duration, intensity, and pack-years of smoking (Am. J. Med. 2007;120:953–9).

Another study found that patients who smoked more than 20 cigarettes per day had a twofold increased risk of clinical severe psoriasis, compared with those who smoked 10 or fewer cigarettes per day; the association was stronger among women (Arch. Dermatol. 2005;141:1580–4).

“Why does this happen? Nicotinic cholinergic receptors have been demonstrated on keratinocytes, which may control keratinocyte adhesion and upward migration in the epidermis,” Dr. Devere said. “Nicotine also alters immune responses by directly interacting with T cells and dendritic cells.”

She added that smoking induces “an overproduction of inflammatory cytokines, which may be associated with psoriasis severity.”

Alcohol Intake

Large cohort studies have showed a higher incidence of alcoholism in psoriasis patients. One reported that 17%–30% of patients with moderate to severe psoriasis have problems with alcohol (Br. J. Dermatol. 2008;158:138–40). Another study suggested that alcohol use is associated with decreased response to treatment in men (J. Am. Acad. Dermatol. 1993;28:730–2). “I have three male alcoholic patients that I cannot get better on any drug,” she said.

Obesity

One large, case-control study found that the risk of psoriasis had a 1.6 odds ratio for individuals with a body mass index of 25–30 kg/m

Other studies have found that leptin levels are increased in obesity and in the serum and tissue of severe psoriatic patients, and that leptin increases T-cell proliferation and stimulates TNF alpha production, which may link psoriasis and obesity, she said.

Dr. Devere also noted two case reports of psoriasis remission after gastric bypass surgery (Obes. Surg. 2004;14:1132–4; 2006;16:94–7). “Both patients had severe psoriasis for 15 and 39 years, respectively, without remission on multiple treatments,” she said. “After gastric bypass surgery and significant weight loss, both patients had complete remission of their psoriasis.”

Atherosclerotic Conditions

Psoriasis has also been shown to heighten the risk of a full range of atherosclerotic conditions.

A recent Veteran Affairs study showed that overall mortality (OR 1.86) and the following vascular diseases were significantly increased among patients with psoriasis: ischemic heart disease (OR 1.78), cerebrovascular disease (OR 1.70), and peripheral vascular disease (OR 1.98) (Arch. Dermatol. 2009;145:700–3). “Patients with psoriasis should be encouraged to identify and manage their modifiable cardiovascular risk factors,” Dr. Devere said.

She recommended that screening of patients with psoriasis include measures of blood pressure and weight, and questions about smoking, alcohol intake, depression and anxiety, and family history of cardiovascular disease.

Dr. Devere reported having no conflicts to disclose.

Patients with psoriasis should 'identify and manage their modifiable cardiovascular risk factors.'

Source Dr. Devere

SAN DIEGO — The risk of a major depressive episode more than doubles for women during and after the menopausal transition, compared with when they were premenopausal, results from a 9-year follow-up study showed.

The finding suggests that clinicians “need to pay attention to depressive symptoms during this time in a woman's life, and perhaps do a more extensive assessment both in terms of the current presentation and a history of depression, so they have a better understanding of what the overall risk is for a major depressive episode and how they might intervene to prevent it,” the study's principal investigator, Joyce T. Bromberger, Ph.D., said in an interview at the annual meeting of the North American Menopause Society.

She and her associates analyzed 9 years of follow-up data from 221 premenopausal women enrolled at the Pittsburgh site of the Study of Women's Health Across the Nation, a multisite epidemiologic study designed to examine the health of women during midlife. The researchers used the Nonpatient Structured Clinical Interview for DSM-IV Axis I Disorders at baseline to determine lifetime history of major depression and annually to assess current and past-year major depression. They classified the women's status according to self-reported bleeding criteria as premenopausal, perimenopausal, postmenopausal, and postmenopausal on hormones.

Covariates included race, history of major depression at baseline, time-varying age, stressful life events such as the loss of a spouse or a job, use of psychotropic medications, and hot flashes/night sweats. Women who reported a bilateral oophorectomy or hysterectomy were not included in the analyses after the procedure.

At baseline the women were between the ages of 42 and 52, reported Dr. Bromberger, associate professor of epidemiology and psychiatry at the University of Pittsburgh. Of the 221 women, 129 (58%) transitioned to post menopause over the 9 years and 69 (31%) experienced at least one major depressive episode. Nearly half of women with a history of a major depression at baseline (47%) met criteria for current or past-year major depression, compared with 23% of women without a history of major depression at baseline.

Univariate analyses demonstrated that the greatest risk for having a major depressive episode occurred when women were postmenopausal (odds ratio 3.52) or when they were perimenopausal (OR 2.13), compared with when they were premenopausal.

In the fully adjusted multivariate analyses, women remained significantly more likely to have a major depressive episode when they were postmenopausal (OR 3.79) or perimenopausal (OR 2.05). Odd ratios were also significantly greater for African American women (OR 2.10), women with a history of depression (OR 2.97), and women who reported stressful life events (OR 2.90).

“I was surprised by the increased risk during the postmenopause, because the majority of the literature on depressive symptoms has suggested that the increased risk is during the [menopausal] transition, and not after it,” Dr. Bromberger said.

The study was funded by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Nursing Research.

The literature has suggested that the increased risk is during the menopausal transition, and not after it.

Source Dr. Bromberger

SAN DIEGO — The risk of a major depressive episode more than doubles for women during and after the menopausal transition, compared with when they were premenopausal, results from a 9-year follow-up study showed.

The finding suggests that clinicians “need to pay attention to depressive symptoms during this time in a woman's life, and perhaps do a more extensive assessment both in terms of the current presentation and a history of depression, so they have a better understanding of what the overall risk is for a major depressive episode and how they might intervene to prevent it,” the study's principal investigator, Joyce T. Bromberger, Ph.D., said in an interview at the annual meeting of the North American Menopause Society.

She and her associates analyzed 9 years of follow-up data from 221 premenopausal women enrolled at the Pittsburgh site of the Study of Women's Health Across the Nation, a multisite epidemiologic study designed to examine the health of women during midlife. The researchers used the Nonpatient Structured Clinical Interview for DSM-IV Axis I Disorders at baseline to determine lifetime history of major depression and annually to assess current and past-year major depression. They classified the women's status according to self-reported bleeding criteria as premenopausal, perimenopausal, postmenopausal, and postmenopausal on hormones.

Covariates included race, history of major depression at baseline, time-varying age, stressful life events such as the loss of a spouse or a job, use of psychotropic medications, and hot flashes/night sweats. Women who reported a bilateral oophorectomy or hysterectomy were not included in the analyses after the procedure.

At baseline the women were between the ages of 42 and 52, reported Dr. Bromberger, associate professor of epidemiology and psychiatry at the University of Pittsburgh. Of the 221 women, 129 (58%) transitioned to post menopause over the 9 years and 69 (31%) experienced at least one major depressive episode. Nearly half of women with a history of a major depression at baseline (47%) met criteria for current or past-year major depression, compared with 23% of women without a history of major depression at baseline.

Univariate analyses demonstrated that the greatest risk for having a major depressive episode occurred when women were postmenopausal (odds ratio 3.52) or when they were perimenopausal (OR 2.13), compared with when they were premenopausal.

In the fully adjusted multivariate analyses, women remained significantly more likely to have a major depressive episode when they were postmenopausal (OR 3.79) or perimenopausal (OR 2.05). Odd ratios were also significantly greater for African American women (OR 2.10), women with a history of depression (OR 2.97), and women who reported stressful life events (OR 2.90).

“I was surprised by the increased risk during the postmenopause, because the majority of the literature on depressive symptoms has suggested that the increased risk is during the [menopausal] transition, and not after it,” Dr. Bromberger said.

The study was funded by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Nursing Research.

The literature has suggested that the increased risk is during the menopausal transition, and not after it.

Source Dr. Bromberger

SAN DIEGO — The risk of a major depressive episode more than doubles for women during and after the menopausal transition, compared with when they were premenopausal, results from a 9-year follow-up study showed.

The finding suggests that clinicians “need to pay attention to depressive symptoms during this time in a woman's life, and perhaps do a more extensive assessment both in terms of the current presentation and a history of depression, so they have a better understanding of what the overall risk is for a major depressive episode and how they might intervene to prevent it,” the study's principal investigator, Joyce T. Bromberger, Ph.D., said in an interview at the annual meeting of the North American Menopause Society.

She and her associates analyzed 9 years of follow-up data from 221 premenopausal women enrolled at the Pittsburgh site of the Study of Women's Health Across the Nation, a multisite epidemiologic study designed to examine the health of women during midlife. The researchers used the Nonpatient Structured Clinical Interview for DSM-IV Axis I Disorders at baseline to determine lifetime history of major depression and annually to assess current and past-year major depression. They classified the women's status according to self-reported bleeding criteria as premenopausal, perimenopausal, postmenopausal, and postmenopausal on hormones.

Covariates included race, history of major depression at baseline, time-varying age, stressful life events such as the loss of a spouse or a job, use of psychotropic medications, and hot flashes/night sweats. Women who reported a bilateral oophorectomy or hysterectomy were not included in the analyses after the procedure.

At baseline the women were between the ages of 42 and 52, reported Dr. Bromberger, associate professor of epidemiology and psychiatry at the University of Pittsburgh. Of the 221 women, 129 (58%) transitioned to post menopause over the 9 years and 69 (31%) experienced at least one major depressive episode. Nearly half of women with a history of a major depression at baseline (47%) met criteria for current or past-year major depression, compared with 23% of women without a history of major depression at baseline.

Univariate analyses demonstrated that the greatest risk for having a major depressive episode occurred when women were postmenopausal (odds ratio 3.52) or when they were perimenopausal (OR 2.13), compared with when they were premenopausal.

In the fully adjusted multivariate analyses, women remained significantly more likely to have a major depressive episode when they were postmenopausal (OR 3.79) or perimenopausal (OR 2.05). Odd ratios were also significantly greater for African American women (OR 2.10), women with a history of depression (OR 2.97), and women who reported stressful life events (OR 2.90).

“I was surprised by the increased risk during the postmenopause, because the majority of the literature on depressive symptoms has suggested that the increased risk is during the [menopausal] transition, and not after it,” Dr. Bromberger said.

The study was funded by the National Institute on Aging, the National Institute of Mental Health, and the National Institute of Nursing Research.

The literature has suggested that the increased risk is during the menopausal transition, and not after it.

Source Dr. Bromberger