Michele G. Sullivan

The same allele that quadruples the risk of Alzheimer’s disease also was associated with some aspects of improved cognition in early adulthood in a prospective study that measured attention during cognitive tasks performed during brain MRI scans.

People who carried the high-risk allele, the apolipoprotein E (apo E) epsilon-4 allele, were more focused – and stayed focused longer – than were non–epsilon-4 carriers. They also showed significantly more activity in brain areas associated with attention- and task-related cognition, Jennifer Rusted, Ph.D., and her colleagues reported (NeuroImage 2013;65:364-73).

"We speculate that [positive epsilon-4 status] may also index genotype differences in cholinergic system activity, for example, higher tonic acetylcholine levels," wrote Dr. Rusted of the University of Sussex, England, and her coauthors.

The study cohort comprised 41 subjects, 21 of whom were epsilon-4 positive. Their mean age was 21 years. They underwent testing with the National Adult Reading Test (which measures verbal IQ), the Rapid Visual Information Processing task (which measures capacity for sustained attention), and a covert attention task (which measures ability to reorient attention). The last two tasks were performed in an MRI scanner.

The study also examined task-related brain activation based on functional MRI measurement of blood oxygenation level dependent according to cognitive test, and included previously obtained white matter imaging.

The epsilon 4–positive subjects significantly outperformed epsilon 4–negative subjects on all components of each attention task, with more correct detections, fewer errors, and a longer attention span.

Those findings correlated with brain activity. The positive subjects showed greater activation of the supplementary motor area, parietal regions, frontal gyrus, medial temporal lobe, and parahippocampus.

Diffusion tensor imaging showed significantly higher axial diffusivity – thought to be a measure of axonal integrity – among epsilon 4–positive than -negative volunteers. "Improved white matter integrity in epsilon 4–positive [subjects] suggests better communication between brain regions, driving increases in the observed functional activity," the authors wrote.

Studies of similar attention tests in mice have shown that superior performance is associated with higher tonic acetylcholine levels, the authors noted. "On this basis, the behavioral advantages we have observed in epsilon 4–positive [subjects] could indicate a difference in acetylcholinesterase tonic activity."

The study was sponsored by a grant from the U.K. Biotechnology and Biological Sciences Research Council. None of the authors declared any financial conflicts.

The same allele that quadruples the risk of Alzheimer’s disease also was associated with some aspects of improved cognition in early adulthood in a prospective study that measured attention during cognitive tasks performed during brain MRI scans.

People who carried the high-risk allele, the apolipoprotein E (apo E) epsilon-4 allele, were more focused – and stayed focused longer – than were non–epsilon-4 carriers. They also showed significantly more activity in brain areas associated with attention- and task-related cognition, Jennifer Rusted, Ph.D., and her colleagues reported (NeuroImage 2013;65:364-73).

"We speculate that [positive epsilon-4 status] may also index genotype differences in cholinergic system activity, for example, higher tonic acetylcholine levels," wrote Dr. Rusted of the University of Sussex, England, and her coauthors.

The study cohort comprised 41 subjects, 21 of whom were epsilon-4 positive. Their mean age was 21 years. They underwent testing with the National Adult Reading Test (which measures verbal IQ), the Rapid Visual Information Processing task (which measures capacity for sustained attention), and a covert attention task (which measures ability to reorient attention). The last two tasks were performed in an MRI scanner.

The study also examined task-related brain activation based on functional MRI measurement of blood oxygenation level dependent according to cognitive test, and included previously obtained white matter imaging.

The epsilon 4–positive subjects significantly outperformed epsilon 4–negative subjects on all components of each attention task, with more correct detections, fewer errors, and a longer attention span.

Those findings correlated with brain activity. The positive subjects showed greater activation of the supplementary motor area, parietal regions, frontal gyrus, medial temporal lobe, and parahippocampus.

Diffusion tensor imaging showed significantly higher axial diffusivity – thought to be a measure of axonal integrity – among epsilon 4–positive than -negative volunteers. "Improved white matter integrity in epsilon 4–positive [subjects] suggests better communication between brain regions, driving increases in the observed functional activity," the authors wrote.

Studies of similar attention tests in mice have shown that superior performance is associated with higher tonic acetylcholine levels, the authors noted. "On this basis, the behavioral advantages we have observed in epsilon 4–positive [subjects] could indicate a difference in acetylcholinesterase tonic activity."

The study was sponsored by a grant from the U.K. Biotechnology and Biological Sciences Research Council. None of the authors declared any financial conflicts.

The same allele that quadruples the risk of Alzheimer’s disease also was associated with some aspects of improved cognition in early adulthood in a prospective study that measured attention during cognitive tasks performed during brain MRI scans.

People who carried the high-risk allele, the apolipoprotein E (apo E) epsilon-4 allele, were more focused – and stayed focused longer – than were non–epsilon-4 carriers. They also showed significantly more activity in brain areas associated with attention- and task-related cognition, Jennifer Rusted, Ph.D., and her colleagues reported (NeuroImage 2013;65:364-73).

"We speculate that [positive epsilon-4 status] may also index genotype differences in cholinergic system activity, for example, higher tonic acetylcholine levels," wrote Dr. Rusted of the University of Sussex, England, and her coauthors.

The study cohort comprised 41 subjects, 21 of whom were epsilon-4 positive. Their mean age was 21 years. They underwent testing with the National Adult Reading Test (which measures verbal IQ), the Rapid Visual Information Processing task (which measures capacity for sustained attention), and a covert attention task (which measures ability to reorient attention). The last two tasks were performed in an MRI scanner.

The study also examined task-related brain activation based on functional MRI measurement of blood oxygenation level dependent according to cognitive test, and included previously obtained white matter imaging.

The epsilon 4–positive subjects significantly outperformed epsilon 4–negative subjects on all components of each attention task, with more correct detections, fewer errors, and a longer attention span.

Those findings correlated with brain activity. The positive subjects showed greater activation of the supplementary motor area, parietal regions, frontal gyrus, medial temporal lobe, and parahippocampus.

Diffusion tensor imaging showed significantly higher axial diffusivity – thought to be a measure of axonal integrity – among epsilon 4–positive than -negative volunteers. "Improved white matter integrity in epsilon 4–positive [subjects] suggests better communication between brain regions, driving increases in the observed functional activity," the authors wrote.

Studies of similar attention tests in mice have shown that superior performance is associated with higher tonic acetylcholine levels, the authors noted. "On this basis, the behavioral advantages we have observed in epsilon 4–positive [subjects] could indicate a difference in acetylcholinesterase tonic activity."

The study was sponsored by a grant from the U.K. Biotechnology and Biological Sciences Research Council. None of the authors declared any financial conflicts.

Over the past 3 decades, screening mammography may have overdiagnosed more than a million clinically insignificant breast tumors, while having virtually no impact on the incidence of metastatic disease.

Compared with the premammography era, routine screening now picks up 122 additional cases of early cancer per 100,000 women – just eight of which would likely have progressed to distant disease, Dr. Archie Bleyer and Dr. Gilbert Welch wrote in the Nov. 22 issue of the New England Journal of Medicine.

Courtesy Rhoda Baer/National Cancer Institute (NCI)

Looking at the results in light of a corresponding 28% decrease in breast cancer mortality puts screening mammography in perspective, the authors said: "Our data show that the true contribution of mammography to decreasing mortality must be at the low end of this range. They suggest that mammography has largely not met the first prerequisite for screening to reduce cancer-specific mortality – a reduction in the number of women who present with late-stage cancer.

Population cancer screening is a doubled-edged sword, wrote Dr. Bleyer of Oregon Health and Science University in Portland, and Dr. Welch of Geisel School of Medicine at Dartmouth in Hanover, N.H. While it’s impossible to say which screen-detected cancers would have caused serious disease or death, "there is certainty about what happens to [these women]. They undergo surgery, radiation therapy, hormonal therapy for 5 years or more, chemotherapy, or (usually) a combination of these treatments for abnormalities that otherwise would not have caused illness."

The authors used the Surveillance , Epidemiology, and End Results (SEER) database to examine screening mammography and breast cancer incidence data from 1976-2008. They considered the incidence baseline to be the number of cancers reported from 1976-1978, and compared it with incidence in 2006-2008. All of the models in the study controlled for an upswing of breast cancer from 1990 to 2005, which was associated with hormone-replacement therapy.

Screening mammography increased from about 30% of women aged 40 or older in the mid-80s to almost 70% by 2008. This was mirrored by an increase in the diagnosis of early-stage breast cancers diagnosed, from 112/100,000 to 234/100,000 per year – representing an absolute increase of 122/100,000 (N. Engl. J. Med. 2012;367:1998-2005 [doi:10.1056/NEJMoa1206809]).

"[This] reflects both the detection of more cases of localized disease and the advent of the detection of [ductal carcinoma in situ] (which was virtually not detected before mammography was available)," the authors said.

There was a much smaller concomitant decrease in late-stage cancers, which fell from 102/100,000 to 94 /100,000 women. This was almost entirely driven by a drop in regional disease, from about 85/100,000 in 1976 to 78/100,000 in 2008. The incidence of distant disease was almost entirely unchanged, hovering around 17/100,000 for the entire study period.

"If a constant underlying disease burden is assumed, only 8 of the 122 additional early diagnoses were destined to progress to advanced disease, implying a detection of 114 excess cases per 100,000 women" – a total of more than 1.5 million over the study period.

The incidence of overdiagnosis held when the authors used other models designed to favor mammography’s impact.

In a "best-guess estimate," they assumed that breast cancer incidence increased by 0.25% over the study period. "This approach suggests that the excess detection attributable to mammography ... involved more than 1.3 million women in the past 30 years."

The "extreme" model assumed that incidence increased by 0.5% each year, an estimate that minimized surplus diagnoses of early-stage disease and maximized the deficit of late-stage cancer. This model found that screening mammography detected an excess of 1.2 million cancers over the study period.

The "very extreme assumption" model assumed that incidence increased by 0.5% each year, and that the baseline incidence of late-stage disease was the highest ever observed (113 cases per 100,000 women, in 1985). Even with this model – the most favorable toward mammography – the authors estimated overdiagnosis of slightly more than 1 million women.

"Our analysis suggests that whatever the mortality benefit, breast-cancer screening involved substantial harm of excess detection of additional early-stage cancers that was not matched by a reduction in late-stage cancers. This imbalance indicates a considerable amount of overdiagnosis involving more than 1 million women in the past 3 decades – and, according to our best-guess estimate, more than 70,000 women in 2008."

SEER breast cancer mortality data help put the findings into perspective, the authors said. There has been a substantial reduction in mortality, which fell from 71/100,000 to 51/100,000 over the study period. "This reduction in mortality is probably due to some combination of the effects of screening mammography and better treatment," they said. But because the absolute reduction in deaths (20/100,000) was larger than the absolute reduction in late-stage cancer (8/100,000), screening mammography can’t be the main driver of change.

"Furthermore ... the small reduction in cases of late-stage cancer that has occurred has been confined to regional (largely node-positive) disease – a stage that can now often be treated successfully, with an expected 5-year survival rate of 85% among women 40 years of age or older. Unfortunately, however, the number of women in the United States who present with distant disease, only 25% of whom survive for 5 years, appears not to have been affected by screening."

Better therapy may even have altered the impact of screening, they added.

"Ironically, improvements in treatment tend to deteriorate the benefit of screening. As treatment of [disease detected by methods other than screening] improves, the benefit of screening diminishes. For example, since pneumonia can be treated successfully, no one would suggest that we screen for pneumonia."

The findings show that there are not absolutes for women considering whether or not to get a mammogram.

"Proponents of screening should provide women with data from a randomized screening trial that reflects improvements in current therapy and includes strategies to mitigate overdiagnosis in the intervention group. Women should recognize that our study does not answer the question, ‘Should I be screened for breast cancer?’ However, they can rest assured that the question has more than one right answer."

Dr. Bleyer disclosed that he is a consultant and speaker for Sigma-Tau Pharmaceuticals. Dr. Welch disclosed that he speaks on the topic of overdiagnosis with universities and medical schools, as well as to the Pharmacy Benefit Management Institute; all honoraria were donated to charitable organizations.

Over the past 3 decades, screening mammography may have overdiagnosed more than a million clinically insignificant breast tumors, while having virtually no impact on the incidence of metastatic disease.

Compared with the premammography era, routine screening now picks up 122 additional cases of early cancer per 100,000 women – just eight of which would likely have progressed to distant disease, Dr. Archie Bleyer and Dr. Gilbert Welch wrote in the Nov. 22 issue of the New England Journal of Medicine.

Courtesy Rhoda Baer/National Cancer Institute (NCI)

Looking at the results in light of a corresponding 28% decrease in breast cancer mortality puts screening mammography in perspective, the authors said: "Our data show that the true contribution of mammography to decreasing mortality must be at the low end of this range. They suggest that mammography has largely not met the first prerequisite for screening to reduce cancer-specific mortality – a reduction in the number of women who present with late-stage cancer.

Population cancer screening is a doubled-edged sword, wrote Dr. Bleyer of Oregon Health and Science University in Portland, and Dr. Welch of Geisel School of Medicine at Dartmouth in Hanover, N.H. While it’s impossible to say which screen-detected cancers would have caused serious disease or death, "there is certainty about what happens to [these women]. They undergo surgery, radiation therapy, hormonal therapy for 5 years or more, chemotherapy, or (usually) a combination of these treatments for abnormalities that otherwise would not have caused illness."

The authors used the Surveillance , Epidemiology, and End Results (SEER) database to examine screening mammography and breast cancer incidence data from 1976-2008. They considered the incidence baseline to be the number of cancers reported from 1976-1978, and compared it with incidence in 2006-2008. All of the models in the study controlled for an upswing of breast cancer from 1990 to 2005, which was associated with hormone-replacement therapy.

Screening mammography increased from about 30% of women aged 40 or older in the mid-80s to almost 70% by 2008. This was mirrored by an increase in the diagnosis of early-stage breast cancers diagnosed, from 112/100,000 to 234/100,000 per year – representing an absolute increase of 122/100,000 (N. Engl. J. Med. 2012;367:1998-2005 [doi:10.1056/NEJMoa1206809]).

"[This] reflects both the detection of more cases of localized disease and the advent of the detection of [ductal carcinoma in situ] (which was virtually not detected before mammography was available)," the authors said.

There was a much smaller concomitant decrease in late-stage cancers, which fell from 102/100,000 to 94 /100,000 women. This was almost entirely driven by a drop in regional disease, from about 85/100,000 in 1976 to 78/100,000 in 2008. The incidence of distant disease was almost entirely unchanged, hovering around 17/100,000 for the entire study period.

"If a constant underlying disease burden is assumed, only 8 of the 122 additional early diagnoses were destined to progress to advanced disease, implying a detection of 114 excess cases per 100,000 women" – a total of more than 1.5 million over the study period.

The incidence of overdiagnosis held when the authors used other models designed to favor mammography’s impact.

In a "best-guess estimate," they assumed that breast cancer incidence increased by 0.25% over the study period. "This approach suggests that the excess detection attributable to mammography ... involved more than 1.3 million women in the past 30 years."

The "extreme" model assumed that incidence increased by 0.5% each year, an estimate that minimized surplus diagnoses of early-stage disease and maximized the deficit of late-stage cancer. This model found that screening mammography detected an excess of 1.2 million cancers over the study period.

The "very extreme assumption" model assumed that incidence increased by 0.5% each year, and that the baseline incidence of late-stage disease was the highest ever observed (113 cases per 100,000 women, in 1985). Even with this model – the most favorable toward mammography – the authors estimated overdiagnosis of slightly more than 1 million women.

"Our analysis suggests that whatever the mortality benefit, breast-cancer screening involved substantial harm of excess detection of additional early-stage cancers that was not matched by a reduction in late-stage cancers. This imbalance indicates a considerable amount of overdiagnosis involving more than 1 million women in the past 3 decades – and, according to our best-guess estimate, more than 70,000 women in 2008."

SEER breast cancer mortality data help put the findings into perspective, the authors said. There has been a substantial reduction in mortality, which fell from 71/100,000 to 51/100,000 over the study period. "This reduction in mortality is probably due to some combination of the effects of screening mammography and better treatment," they said. But because the absolute reduction in deaths (20/100,000) was larger than the absolute reduction in late-stage cancer (8/100,000), screening mammography can’t be the main driver of change.

"Furthermore ... the small reduction in cases of late-stage cancer that has occurred has been confined to regional (largely node-positive) disease – a stage that can now often be treated successfully, with an expected 5-year survival rate of 85% among women 40 years of age or older. Unfortunately, however, the number of women in the United States who present with distant disease, only 25% of whom survive for 5 years, appears not to have been affected by screening."

Better therapy may even have altered the impact of screening, they added.

"Ironically, improvements in treatment tend to deteriorate the benefit of screening. As treatment of [disease detected by methods other than screening] improves, the benefit of screening diminishes. For example, since pneumonia can be treated successfully, no one would suggest that we screen for pneumonia."

The findings show that there are not absolutes for women considering whether or not to get a mammogram.

"Proponents of screening should provide women with data from a randomized screening trial that reflects improvements in current therapy and includes strategies to mitigate overdiagnosis in the intervention group. Women should recognize that our study does not answer the question, ‘Should I be screened for breast cancer?’ However, they can rest assured that the question has more than one right answer."

Dr. Bleyer disclosed that he is a consultant and speaker for Sigma-Tau Pharmaceuticals. Dr. Welch disclosed that he speaks on the topic of overdiagnosis with universities and medical schools, as well as to the Pharmacy Benefit Management Institute; all honoraria were donated to charitable organizations.

Over the past 3 decades, screening mammography may have overdiagnosed more than a million clinically insignificant breast tumors, while having virtually no impact on the incidence of metastatic disease.

Compared with the premammography era, routine screening now picks up 122 additional cases of early cancer per 100,000 women – just eight of which would likely have progressed to distant disease, Dr. Archie Bleyer and Dr. Gilbert Welch wrote in the Nov. 22 issue of the New England Journal of Medicine.

Courtesy Rhoda Baer/National Cancer Institute (NCI)

Looking at the results in light of a corresponding 28% decrease in breast cancer mortality puts screening mammography in perspective, the authors said: "Our data show that the true contribution of mammography to decreasing mortality must be at the low end of this range. They suggest that mammography has largely not met the first prerequisite for screening to reduce cancer-specific mortality – a reduction in the number of women who present with late-stage cancer.

Population cancer screening is a doubled-edged sword, wrote Dr. Bleyer of Oregon Health and Science University in Portland, and Dr. Welch of Geisel School of Medicine at Dartmouth in Hanover, N.H. While it’s impossible to say which screen-detected cancers would have caused serious disease or death, "there is certainty about what happens to [these women]. They undergo surgery, radiation therapy, hormonal therapy for 5 years or more, chemotherapy, or (usually) a combination of these treatments for abnormalities that otherwise would not have caused illness."

The authors used the Surveillance , Epidemiology, and End Results (SEER) database to examine screening mammography and breast cancer incidence data from 1976-2008. They considered the incidence baseline to be the number of cancers reported from 1976-1978, and compared it with incidence in 2006-2008. All of the models in the study controlled for an upswing of breast cancer from 1990 to 2005, which was associated with hormone-replacement therapy.

Screening mammography increased from about 30% of women aged 40 or older in the mid-80s to almost 70% by 2008. This was mirrored by an increase in the diagnosis of early-stage breast cancers diagnosed, from 112/100,000 to 234/100,000 per year – representing an absolute increase of 122/100,000 (N. Engl. J. Med. 2012;367:1998-2005 [doi:10.1056/NEJMoa1206809]).

"[This] reflects both the detection of more cases of localized disease and the advent of the detection of [ductal carcinoma in situ] (which was virtually not detected before mammography was available)," the authors said.

There was a much smaller concomitant decrease in late-stage cancers, which fell from 102/100,000 to 94 /100,000 women. This was almost entirely driven by a drop in regional disease, from about 85/100,000 in 1976 to 78/100,000 in 2008. The incidence of distant disease was almost entirely unchanged, hovering around 17/100,000 for the entire study period.

"If a constant underlying disease burden is assumed, only 8 of the 122 additional early diagnoses were destined to progress to advanced disease, implying a detection of 114 excess cases per 100,000 women" – a total of more than 1.5 million over the study period.

The incidence of overdiagnosis held when the authors used other models designed to favor mammography’s impact.

In a "best-guess estimate," they assumed that breast cancer incidence increased by 0.25% over the study period. "This approach suggests that the excess detection attributable to mammography ... involved more than 1.3 million women in the past 30 years."

The "extreme" model assumed that incidence increased by 0.5% each year, an estimate that minimized surplus diagnoses of early-stage disease and maximized the deficit of late-stage cancer. This model found that screening mammography detected an excess of 1.2 million cancers over the study period.

The "very extreme assumption" model assumed that incidence increased by 0.5% each year, and that the baseline incidence of late-stage disease was the highest ever observed (113 cases per 100,000 women, in 1985). Even with this model – the most favorable toward mammography – the authors estimated overdiagnosis of slightly more than 1 million women.

"Our analysis suggests that whatever the mortality benefit, breast-cancer screening involved substantial harm of excess detection of additional early-stage cancers that was not matched by a reduction in late-stage cancers. This imbalance indicates a considerable amount of overdiagnosis involving more than 1 million women in the past 3 decades – and, according to our best-guess estimate, more than 70,000 women in 2008."

SEER breast cancer mortality data help put the findings into perspective, the authors said. There has been a substantial reduction in mortality, which fell from 71/100,000 to 51/100,000 over the study period. "This reduction in mortality is probably due to some combination of the effects of screening mammography and better treatment," they said. But because the absolute reduction in deaths (20/100,000) was larger than the absolute reduction in late-stage cancer (8/100,000), screening mammography can’t be the main driver of change.

"Furthermore ... the small reduction in cases of late-stage cancer that has occurred has been confined to regional (largely node-positive) disease – a stage that can now often be treated successfully, with an expected 5-year survival rate of 85% among women 40 years of age or older. Unfortunately, however, the number of women in the United States who present with distant disease, only 25% of whom survive for 5 years, appears not to have been affected by screening."

Better therapy may even have altered the impact of screening, they added.

"Ironically, improvements in treatment tend to deteriorate the benefit of screening. As treatment of [disease detected by methods other than screening] improves, the benefit of screening diminishes. For example, since pneumonia can be treated successfully, no one would suggest that we screen for pneumonia."

The findings show that there are not absolutes for women considering whether or not to get a mammogram.

"Proponents of screening should provide women with data from a randomized screening trial that reflects improvements in current therapy and includes strategies to mitigate overdiagnosis in the intervention group. Women should recognize that our study does not answer the question, ‘Should I be screened for breast cancer?’ However, they can rest assured that the question has more than one right answer."

Dr. Bleyer disclosed that he is a consultant and speaker for Sigma-Tau Pharmaceuticals. Dr. Welch disclosed that he speaks on the topic of overdiagnosis with universities and medical schools, as well as to the Pharmacy Benefit Management Institute; all honoraria were donated to charitable organizations.

In addition to raising the risk of Alzheimer’s disease, the apolipoprotein E e4 allele appears to confer strong risks for Lewy body and Parkinson’s dementia – diseases that do not exhibit Alzheimer’s characteristic beta-amyloid plaques.

The findings suggest that, in addition to causing a toxic buildup of the amyloid protein, the gene could cause neurodegeneration by some other pathway, Dr. Debby Tsuang and her colleagues wrote in the Nov. 19 online issue of Archives of Neurology (doi: 10.1001/jamaneurol.2013.600).

Dr. Tsuang’s case-control study compared ApoE genetic status among 640 patients with dementia and 269 controls, all of whom were deceased. The investigators used both clinical diagnoses and histopathology to identify patients as having either Alzheimer’s disease without Lewy bodies (244), Alzheimer’s with Lewy bodies (224), pure Lewy body dementia (91), or Parkinson’s dementia without Alzheimer’s neuropathology (81).

The ApoE e4 genotype was present in 7% of the control subjects, 19% of patients with Parkinson’s dementia, 32% of those with pure Lewy body dementia, 41% of those with Alzheimer’s and Lewy bodies, and 38% of those with pure Alzheimer’s.

Since ApoE e4 increases the risk of Alzheimer’s by up to four times, the investigators were not surprised to find it in a large proportion of patients with Alzheimer’s. However, noted Dr. Tsuang of the Veterans Affairs Puget Sound Health Care System, Seattle, "the finding that e4 was overrepresented in pure Lewy body dementia and pure Parkinson’s dementia was unexpected."

Compared with controls in a model that controlled for gender and age at death, ApoE e4 was associated with a 10-fold increase in the risk of pure Alzheimer’s, a 13-fold increase in the risk of Alzheimer’s with Lewy bodies, a 6-fold increase in the risk of pure Lewy body dementia, and a 3-fold increase in the risk of Parkinson’s dementia.

The finding offers a tantalizing glimpse of what might be a new understanding of ApoE’s influence on neuronal function, the authors said. In Alzheimer’s, the gene is assumed to affect the metabolism of the beta-amyloid protein, slowing clearance and, thus, causing it to clump onto neurons.

"However, our observation of an elevated e4 frequency in the [pure Lewy body] and [Parkinson’s dementia] groups in which the overall brain neuritic plaque burden is low suggests the possibility that ApoE isoforms also might modulate neurodegeneration by nonamyloidogenic mechanisms," they said.

Some early evidence supports this idea. In experimental models, some fragmentary forms of apolipoprotein are directly neurotoxic, perhaps impairing mitochondrial function or disrupting the normal cytoskeleton. The protein also seems to impair neuronal plasticity when it occurs in the presence of lipids.

"Also," the authors noted, "greater microglia-mediated neurotoxicity has been observed in mice expressing human ApoE e4 than other ApoE isoforms."

The study was supported by the National Institutes of Health and the Department of Veterans Affairs. None of the authors had any financial disclosures.

In addition to raising the risk of Alzheimer’s disease, the apolipoprotein E e4 allele appears to confer strong risks for Lewy body and Parkinson’s dementia – diseases that do not exhibit Alzheimer’s characteristic beta-amyloid plaques.

The findings suggest that, in addition to causing a toxic buildup of the amyloid protein, the gene could cause neurodegeneration by some other pathway, Dr. Debby Tsuang and her colleagues wrote in the Nov. 19 online issue of Archives of Neurology (doi: 10.1001/jamaneurol.2013.600).

Dr. Tsuang’s case-control study compared ApoE genetic status among 640 patients with dementia and 269 controls, all of whom were deceased. The investigators used both clinical diagnoses and histopathology to identify patients as having either Alzheimer’s disease without Lewy bodies (244), Alzheimer’s with Lewy bodies (224), pure Lewy body dementia (91), or Parkinson’s dementia without Alzheimer’s neuropathology (81).

The ApoE e4 genotype was present in 7% of the control subjects, 19% of patients with Parkinson’s dementia, 32% of those with pure Lewy body dementia, 41% of those with Alzheimer’s and Lewy bodies, and 38% of those with pure Alzheimer’s.

Since ApoE e4 increases the risk of Alzheimer’s by up to four times, the investigators were not surprised to find it in a large proportion of patients with Alzheimer’s. However, noted Dr. Tsuang of the Veterans Affairs Puget Sound Health Care System, Seattle, "the finding that e4 was overrepresented in pure Lewy body dementia and pure Parkinson’s dementia was unexpected."

Compared with controls in a model that controlled for gender and age at death, ApoE e4 was associated with a 10-fold increase in the risk of pure Alzheimer’s, a 13-fold increase in the risk of Alzheimer’s with Lewy bodies, a 6-fold increase in the risk of pure Lewy body dementia, and a 3-fold increase in the risk of Parkinson’s dementia.

The finding offers a tantalizing glimpse of what might be a new understanding of ApoE’s influence on neuronal function, the authors said. In Alzheimer’s, the gene is assumed to affect the metabolism of the beta-amyloid protein, slowing clearance and, thus, causing it to clump onto neurons.

"However, our observation of an elevated e4 frequency in the [pure Lewy body] and [Parkinson’s dementia] groups in which the overall brain neuritic plaque burden is low suggests the possibility that ApoE isoforms also might modulate neurodegeneration by nonamyloidogenic mechanisms," they said.

Some early evidence supports this idea. In experimental models, some fragmentary forms of apolipoprotein are directly neurotoxic, perhaps impairing mitochondrial function or disrupting the normal cytoskeleton. The protein also seems to impair neuronal plasticity when it occurs in the presence of lipids.

"Also," the authors noted, "greater microglia-mediated neurotoxicity has been observed in mice expressing human ApoE e4 than other ApoE isoforms."

The study was supported by the National Institutes of Health and the Department of Veterans Affairs. None of the authors had any financial disclosures.

In addition to raising the risk of Alzheimer’s disease, the apolipoprotein E e4 allele appears to confer strong risks for Lewy body and Parkinson’s dementia – diseases that do not exhibit Alzheimer’s characteristic beta-amyloid plaques.

The findings suggest that, in addition to causing a toxic buildup of the amyloid protein, the gene could cause neurodegeneration by some other pathway, Dr. Debby Tsuang and her colleagues wrote in the Nov. 19 online issue of Archives of Neurology (doi: 10.1001/jamaneurol.2013.600).

Dr. Tsuang’s case-control study compared ApoE genetic status among 640 patients with dementia and 269 controls, all of whom were deceased. The investigators used both clinical diagnoses and histopathology to identify patients as having either Alzheimer’s disease without Lewy bodies (244), Alzheimer’s with Lewy bodies (224), pure Lewy body dementia (91), or Parkinson’s dementia without Alzheimer’s neuropathology (81).

The ApoE e4 genotype was present in 7% of the control subjects, 19% of patients with Parkinson’s dementia, 32% of those with pure Lewy body dementia, 41% of those with Alzheimer’s and Lewy bodies, and 38% of those with pure Alzheimer’s.

Since ApoE e4 increases the risk of Alzheimer’s by up to four times, the investigators were not surprised to find it in a large proportion of patients with Alzheimer’s. However, noted Dr. Tsuang of the Veterans Affairs Puget Sound Health Care System, Seattle, "the finding that e4 was overrepresented in pure Lewy body dementia and pure Parkinson’s dementia was unexpected."

Compared with controls in a model that controlled for gender and age at death, ApoE e4 was associated with a 10-fold increase in the risk of pure Alzheimer’s, a 13-fold increase in the risk of Alzheimer’s with Lewy bodies, a 6-fold increase in the risk of pure Lewy body dementia, and a 3-fold increase in the risk of Parkinson’s dementia.

The finding offers a tantalizing glimpse of what might be a new understanding of ApoE’s influence on neuronal function, the authors said. In Alzheimer’s, the gene is assumed to affect the metabolism of the beta-amyloid protein, slowing clearance and, thus, causing it to clump onto neurons.

"However, our observation of an elevated e4 frequency in the [pure Lewy body] and [Parkinson’s dementia] groups in which the overall brain neuritic plaque burden is low suggests the possibility that ApoE isoforms also might modulate neurodegeneration by nonamyloidogenic mechanisms," they said.

Some early evidence supports this idea. In experimental models, some fragmentary forms of apolipoprotein are directly neurotoxic, perhaps impairing mitochondrial function or disrupting the normal cytoskeleton. The protein also seems to impair neuronal plasticity when it occurs in the presence of lipids.

"Also," the authors noted, "greater microglia-mediated neurotoxicity has been observed in mice expressing human ApoE e4 than other ApoE isoforms."

The study was supported by the National Institutes of Health and the Department of Veterans Affairs. None of the authors had any financial disclosures.

The Food and Drug Administration has approved a paclitaxel-eluting stent for the treatment of peripheral artery disease.

The Zilver PTX Drug-Eluting Peripheral Stent, manufactured by Cook Medical of Bloomington, Ind., is the first drug-eluting stent to win approval for this indication.

Approval was based on findings from both a randomized controlled trial and a registry study, which together comprised more than 1,200 patients. According to an FDA press statement, the studies indicate that treatment with the stent "is at least as safe as treatment with percutaneous transluminal angioplasty (PTA) and significantly more effective."

The randomized trial included 479 patients with a single stenotic lesion less than 140 mm in one or both of the femoropopliteal arteries. Patients were randomized to the paclitaxel-eluting stent or to PTA. If the transluminal procedure failed, then patients received either the paclitaxel-eluting stent or a bare-metal stent.

After 12 months, 83% of the arteries treated with the drug-eluting stent were still open, compared with 33% of those in the PTA group. In those patients who had the stent placed after a failed PTA, 90% of arteries were open, compared with 73% in those who got the bare metal stent.

In October 2011, the FDA’s Circulatory System Devices Panel voted 11 to 0 that the benefits of the Zilver PTX stent outweighed its risks as a treatment for patients with symptomatic atherosclerotic stenosis of the femoropopliteal arteries on the basis of that trial. This past October, 3-year results were presented at Vascular Interventional Advances 2012 in Las Vegas. The results showed 70.7% primary patency for the paclitaxel-eluting stent, compared with 49.1% for PTA and bare-metal stents.

The registry study followed 767 patients for 24 months. Patients had a maximum of four stents placed; they could be utilized to treat a single lesion or multiple lesions.

At 12 months, the fracture rate was 1.5%; fractures were not associated with any clinical problems. The rate of stent thrombosis was 2.8% at 12 months and 3.5% at 24 months.

"The clinical study demonstrated that the [the paclitaxel-eluting stent] is more effective than balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery," Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the statement. "This approval expands the treatment options for patients suffering from symptomatic peripheral artery disease."

In both studies, the most common major adverse event was restenosis requiring additional treatment to reestablish adequate flow in the artery. 

The device is contraindicated in patients with stenoses that cannot be dilated to permit passage of the catheter or proper placement of the stent; patients who cannot receive recommended drug therapy due to bleeding disorders; or women who are pregnant, breastfeeding, or planning to become pregnant in the next 5 years.

The FDA will now require the manufacturer to conduct a 5-year postapproval study of 900 patients to further evaluate the stent’s safety and efficacy.

The Food and Drug Administration has approved a paclitaxel-eluting stent for the treatment of peripheral artery disease.

The Zilver PTX Drug-Eluting Peripheral Stent, manufactured by Cook Medical of Bloomington, Ind., is the first drug-eluting stent to win approval for this indication.

Approval was based on findings from both a randomized controlled trial and a registry study, which together comprised more than 1,200 patients. According to an FDA press statement, the studies indicate that treatment with the stent "is at least as safe as treatment with percutaneous transluminal angioplasty (PTA) and significantly more effective."

The randomized trial included 479 patients with a single stenotic lesion less than 140 mm in one or both of the femoropopliteal arteries. Patients were randomized to the paclitaxel-eluting stent or to PTA. If the transluminal procedure failed, then patients received either the paclitaxel-eluting stent or a bare-metal stent.

After 12 months, 83% of the arteries treated with the drug-eluting stent were still open, compared with 33% of those in the PTA group. In those patients who had the stent placed after a failed PTA, 90% of arteries were open, compared with 73% in those who got the bare metal stent.

In October 2011, the FDA’s Circulatory System Devices Panel voted 11 to 0 that the benefits of the Zilver PTX stent outweighed its risks as a treatment for patients with symptomatic atherosclerotic stenosis of the femoropopliteal arteries on the basis of that trial. This past October, 3-year results were presented at Vascular Interventional Advances 2012 in Las Vegas. The results showed 70.7% primary patency for the paclitaxel-eluting stent, compared with 49.1% for PTA and bare-metal stents.

The registry study followed 767 patients for 24 months. Patients had a maximum of four stents placed; they could be utilized to treat a single lesion or multiple lesions.

At 12 months, the fracture rate was 1.5%; fractures were not associated with any clinical problems. The rate of stent thrombosis was 2.8% at 12 months and 3.5% at 24 months.

"The clinical study demonstrated that the [the paclitaxel-eluting stent] is more effective than balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery," Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the statement. "This approval expands the treatment options for patients suffering from symptomatic peripheral artery disease."

In both studies, the most common major adverse event was restenosis requiring additional treatment to reestablish adequate flow in the artery. 

The device is contraindicated in patients with stenoses that cannot be dilated to permit passage of the catheter or proper placement of the stent; patients who cannot receive recommended drug therapy due to bleeding disorders; or women who are pregnant, breastfeeding, or planning to become pregnant in the next 5 years.

The FDA will now require the manufacturer to conduct a 5-year postapproval study of 900 patients to further evaluate the stent’s safety and efficacy.

The Food and Drug Administration has approved a paclitaxel-eluting stent for the treatment of peripheral artery disease.

The Zilver PTX Drug-Eluting Peripheral Stent, manufactured by Cook Medical of Bloomington, Ind., is the first drug-eluting stent to win approval for this indication.

Approval was based on findings from both a randomized controlled trial and a registry study, which together comprised more than 1,200 patients. According to an FDA press statement, the studies indicate that treatment with the stent "is at least as safe as treatment with percutaneous transluminal angioplasty (PTA) and significantly more effective."

The randomized trial included 479 patients with a single stenotic lesion less than 140 mm in one or both of the femoropopliteal arteries. Patients were randomized to the paclitaxel-eluting stent or to PTA. If the transluminal procedure failed, then patients received either the paclitaxel-eluting stent or a bare-metal stent.

After 12 months, 83% of the arteries treated with the drug-eluting stent were still open, compared with 33% of those in the PTA group. In those patients who had the stent placed after a failed PTA, 90% of arteries were open, compared with 73% in those who got the bare metal stent.

In October 2011, the FDA’s Circulatory System Devices Panel voted 11 to 0 that the benefits of the Zilver PTX stent outweighed its risks as a treatment for patients with symptomatic atherosclerotic stenosis of the femoropopliteal arteries on the basis of that trial. This past October, 3-year results were presented at Vascular Interventional Advances 2012 in Las Vegas. The results showed 70.7% primary patency for the paclitaxel-eluting stent, compared with 49.1% for PTA and bare-metal stents.

The registry study followed 767 patients for 24 months. Patients had a maximum of four stents placed; they could be utilized to treat a single lesion or multiple lesions.

At 12 months, the fracture rate was 1.5%; fractures were not associated with any clinical problems. The rate of stent thrombosis was 2.8% at 12 months and 3.5% at 24 months.

"The clinical study demonstrated that the [the paclitaxel-eluting stent] is more effective than balloon angioplasty for the treatment of symptomatic peripheral artery disease in above-the-knee femoropopliteal artery," Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the statement. "This approval expands the treatment options for patients suffering from symptomatic peripheral artery disease."

In both studies, the most common major adverse event was restenosis requiring additional treatment to reestablish adequate flow in the artery. 

The device is contraindicated in patients with stenoses that cannot be dilated to permit passage of the catheter or proper placement of the stent; patients who cannot receive recommended drug therapy due to bleeding disorders; or women who are pregnant, breastfeeding, or planning to become pregnant in the next 5 years.

The FDA will now require the manufacturer to conduct a 5-year postapproval study of 900 patients to further evaluate the stent’s safety and efficacy.

Despite having a lower incidence of breast cancer than white women, black women are 41% more likely to die from the disease.

Black women also are significantly more likely to present with advanced disease than are white women, according to a new federal database review.

"As a public health leader – and as a woman – I find these disparities in breast cancer deaths unacceptable, but they are also avoidable," said Ileana Arias, Ph.D., deputy director of the Centers for Disease Control and Prevention, at a telephone press briefing.

"We’ve achieved significant success in the fight against breast cancer, but we must continue to work together, so that more mothers, daughters, wives, and sisters have the best chance of surviving."

The CDC’s new study, published in the Nov. 13 issue of the Morbidity and Mortality Weekly Report (MMWR 2012; 61:1-6) examined mortality rates among black and white women diagnosed with the disease from 2005-2009. Data were extracted from the National Vital Statistics System, the National Program of Cancer Registries, and the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.

According to the report, an average of 205,246 cases was diagnosed each year. These included 173,970 in white women, at a rate of 122.1/100,000 and 21,942 in black women – at a significantly lower rate of 116.9/100,000.

However, Dr. Arias noted during the briefing, "Black women were 41% more likely to die than were white women. For every 100 diagnoses, black women had nine more deaths than [did] white women [27 deaths in black women vs. 18 in white women]."

The report also found that 45% of black women were diagnosed with advanced disease, compared with 35% of white women, said Dr. Marcus Plescia, director of CDC’s Division of Cancer Prevention and Control.

"Timeliness of care is a challenge as well," he said during the briefing. "For example, studies have shown that 20% of black women experience follow-up times of more than 60 days after an abnormal mammogram compared with 12% of white women." (Am. J. Public Health 2010;100:1769-76).

Studies have also determined that only 69% of black women start treatment within 30 days, compared with 82% of white women, and that significantly fewer black women receive surgery, radiation, and the hormone treatments they need, compared with white women, he said (Breast Cancer Res. Treat. 2008;109:545-57).

"This fatal disparity must end," Dr. Plescia said. "The solutions to address these disparities are within reach, but all parties have to step up to the plate and make equal treatment a priority. There is a shared responsibility for all of us. ... The full benefit of breast cancer screening can only be achieved when we ensure that every woman receives timely follow-up and high-quality treatment."

The report should be seen as a "national call to action," to address these issues, Dr. Arias said.

"Addressing this problem can be complex, but we are closer to a solution with the important passage of the Affordable Care Act, which will dramatically increase access to health care, especially for health screenings, such as mammograms. "

As federal employees, Dr. Arias and Dr. Plescia have no financial disclosures.

Despite having a lower incidence of breast cancer than white women, black women are 41% more likely to die from the disease.

Black women also are significantly more likely to present with advanced disease than are white women, according to a new federal database review.

"As a public health leader – and as a woman – I find these disparities in breast cancer deaths unacceptable, but they are also avoidable," said Ileana Arias, Ph.D., deputy director of the Centers for Disease Control and Prevention, at a telephone press briefing.

"We’ve achieved significant success in the fight against breast cancer, but we must continue to work together, so that more mothers, daughters, wives, and sisters have the best chance of surviving."

The CDC’s new study, published in the Nov. 13 issue of the Morbidity and Mortality Weekly Report (MMWR 2012; 61:1-6) examined mortality rates among black and white women diagnosed with the disease from 2005-2009. Data were extracted from the National Vital Statistics System, the National Program of Cancer Registries, and the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.

According to the report, an average of 205,246 cases was diagnosed each year. These included 173,970 in white women, at a rate of 122.1/100,000 and 21,942 in black women – at a significantly lower rate of 116.9/100,000.

However, Dr. Arias noted during the briefing, "Black women were 41% more likely to die than were white women. For every 100 diagnoses, black women had nine more deaths than [did] white women [27 deaths in black women vs. 18 in white women]."

The report also found that 45% of black women were diagnosed with advanced disease, compared with 35% of white women, said Dr. Marcus Plescia, director of CDC’s Division of Cancer Prevention and Control.

"Timeliness of care is a challenge as well," he said during the briefing. "For example, studies have shown that 20% of black women experience follow-up times of more than 60 days after an abnormal mammogram compared with 12% of white women." (Am. J. Public Health 2010;100:1769-76).

Studies have also determined that only 69% of black women start treatment within 30 days, compared with 82% of white women, and that significantly fewer black women receive surgery, radiation, and the hormone treatments they need, compared with white women, he said (Breast Cancer Res. Treat. 2008;109:545-57).

"This fatal disparity must end," Dr. Plescia said. "The solutions to address these disparities are within reach, but all parties have to step up to the plate and make equal treatment a priority. There is a shared responsibility for all of us. ... The full benefit of breast cancer screening can only be achieved when we ensure that every woman receives timely follow-up and high-quality treatment."

The report should be seen as a "national call to action," to address these issues, Dr. Arias said.

"Addressing this problem can be complex, but we are closer to a solution with the important passage of the Affordable Care Act, which will dramatically increase access to health care, especially for health screenings, such as mammograms. "

As federal employees, Dr. Arias and Dr. Plescia have no financial disclosures.

Despite having a lower incidence of breast cancer than white women, black women are 41% more likely to die from the disease.

Black women also are significantly more likely to present with advanced disease than are white women, according to a new federal database review.

"As a public health leader – and as a woman – I find these disparities in breast cancer deaths unacceptable, but they are also avoidable," said Ileana Arias, Ph.D., deputy director of the Centers for Disease Control and Prevention, at a telephone press briefing.

"We’ve achieved significant success in the fight against breast cancer, but we must continue to work together, so that more mothers, daughters, wives, and sisters have the best chance of surviving."

The CDC’s new study, published in the Nov. 13 issue of the Morbidity and Mortality Weekly Report (MMWR 2012; 61:1-6) examined mortality rates among black and white women diagnosed with the disease from 2005-2009. Data were extracted from the National Vital Statistics System, the National Program of Cancer Registries, and the National Cancer Institute’s Surveillance, Epidemiology, and End Results program.

According to the report, an average of 205,246 cases was diagnosed each year. These included 173,970 in white women, at a rate of 122.1/100,000 and 21,942 in black women – at a significantly lower rate of 116.9/100,000.

However, Dr. Arias noted during the briefing, "Black women were 41% more likely to die than were white women. For every 100 diagnoses, black women had nine more deaths than [did] white women [27 deaths in black women vs. 18 in white women]."

The report also found that 45% of black women were diagnosed with advanced disease, compared with 35% of white women, said Dr. Marcus Plescia, director of CDC’s Division of Cancer Prevention and Control.

"Timeliness of care is a challenge as well," he said during the briefing. "For example, studies have shown that 20% of black women experience follow-up times of more than 60 days after an abnormal mammogram compared with 12% of white women." (Am. J. Public Health 2010;100:1769-76).

Studies have also determined that only 69% of black women start treatment within 30 days, compared with 82% of white women, and that significantly fewer black women receive surgery, radiation, and the hormone treatments they need, compared with white women, he said (Breast Cancer Res. Treat. 2008;109:545-57).

"This fatal disparity must end," Dr. Plescia said. "The solutions to address these disparities are within reach, but all parties have to step up to the plate and make equal treatment a priority. There is a shared responsibility for all of us. ... The full benefit of breast cancer screening can only be achieved when we ensure that every woman receives timely follow-up and high-quality treatment."

The report should be seen as a "national call to action," to address these issues, Dr. Arias said.

"Addressing this problem can be complex, but we are closer to a solution with the important passage of the Affordable Care Act, which will dramatically increase access to health care, especially for health screenings, such as mammograms. "

As federal employees, Dr. Arias and Dr. Plescia have no financial disclosures.

NEW ORLEANS – Protecting children by vaccinating parents comes with some baggage that needs to be sorted out before the idea can become a reality, according to Dr. Herschel Lessin.

There’s no longer any doubt that cocooning, or spinning a cocoon of communicable disease protection around infants and young children, does protect them from illness, said Dr. Lessin, who coauthored the American Academy of Pediatrics 2012 report on the issue (Pediatrics 2012;129:e247-53).

Design Pics

The review found lots of evidence supporting the practice – including one study showing that up to half of infant pertussis cases could have been prevented if parents had been immunized (Pediatr. Infect. Dis. J. 2004;23:985-9).

Two other studies have shown a significantly reduced incidence of influenza among infants whose mothers were vaccinated during pregnancy (Am. J. Obstet. Gynecol. 2011;204[suppl. 1]:S141-8; New Engl. J. Med. 2008;359:1555-64).

Unfortunately, Dr. Lessin said, "adults’ physicians do an awful job of immunizing patients, so most adults are not fully immunized." Obstetricians and neonatal intensive care units "are good at vaccinating mom, but not dad, so these infants are clearly at risk," he added.

The pediatrician’s office can make a difference. "We’re perfectly suited to be a good place to immunize adults," said Dr. Lessin, a pediatrician in private practice in Poughkeepsie, N.Y. In fact, he said, this setup may be particularly attractive to parents who are already taking off time to bring their children in for immunizations.

"These visits represent an opportunity to immunize parents or other adult caregivers with minimal disruption for both the adults and the practice," Dr. Lessin and his colleagues wrote in the AAP report. "Immunizations represent a major focus for pediatric care, and many educational opportunities exist for the pediatrician to explain the benefits of immunization for the child and for close family contacts. Thus, convenience, physician vaccine knowledge and encouragement, and vaccine availability are strong factors for immunizing parents and close family contacts in the pediatric office."

In theory, this sounds great, Dr. Lessin said at the annual meeting of the American Academy of Pediatrics. In practice, immunizing parents can be challenging and even somewhat risky. Questions about liability, how much vaccine to purchase and administer to adults, documentation, and reimbursement remain.

He addressed each of these issues:

• Liability. The Vaccine Injury Compensation Program covers all vaccines recommended for routine use in children, regardless of the age of the person being vaccinated. Since the Tdap and influenza vaccines are recommended for children, the pediatrician who also gives them to adults would be covered.

• Vaccine supply. Offering adult immunizations would mean walking a fine line between having enough vaccine and wasting money on too much. The problem could be exacerbated in years of influenza vaccine shortage. In addition, the AAP report noted that "because nearly all privately supplied influenza vaccine is preordered months in advance, there is a risk of using the ordered supply too quickly when immunizing both close family contacts and children. ... Alternatively, too much vaccine might be ordered ... leaving practices at economic risk of unused doses. This is a significant concern, given the narrow financial margins for immunizations."

• Documentation. The pediatric office would have to document these immunizations, which would entail creating some kind of brief medical record – perhaps a vaccination card. There should probably be some communication with the adult’s primary care provider as well.

• Reimbursement. Some offices that provide adult immunizations require up-front payment, and leave insurance filing to the individual. "You need to ask yourself if you’re willing to get into the insurance hassle because you’re not the adult’s primary care doctor. It’s up to you," he said.

The AAP report also offered a few warnings about adult vaccine billing: "In most states, vaccines supplied to pediatricians by the Vaccines for Children Program may not be used for adults and certainly cannot be billed. If a practice chooses to involve itself in the insurance coverage of parents and close family contacts, it will produce a significantly increased burden that may make the provision of such services nonviable."

Dr. Lessin disclosed that he is on the speakers board of GlaxoSmithKline and the advisory boards of Merck, Novartis, and Pfizer. He is also a senior consultant for the Verden Group, a practice management company.

NEW ORLEANS – Protecting children by vaccinating parents comes with some baggage that needs to be sorted out before the idea can become a reality, according to Dr. Herschel Lessin.

There’s no longer any doubt that cocooning, or spinning a cocoon of communicable disease protection around infants and young children, does protect them from illness, said Dr. Lessin, who coauthored the American Academy of Pediatrics 2012 report on the issue (Pediatrics 2012;129:e247-53).

Design Pics

The review found lots of evidence supporting the practice – including one study showing that up to half of infant pertussis cases could have been prevented if parents had been immunized (Pediatr. Infect. Dis. J. 2004;23:985-9).

Two other studies have shown a significantly reduced incidence of influenza among infants whose mothers were vaccinated during pregnancy (Am. J. Obstet. Gynecol. 2011;204[suppl. 1]:S141-8; New Engl. J. Med. 2008;359:1555-64).

Unfortunately, Dr. Lessin said, "adults’ physicians do an awful job of immunizing patients, so most adults are not fully immunized." Obstetricians and neonatal intensive care units "are good at vaccinating mom, but not dad, so these infants are clearly at risk," he added.

The pediatrician’s office can make a difference. "We’re perfectly suited to be a good place to immunize adults," said Dr. Lessin, a pediatrician in private practice in Poughkeepsie, N.Y. In fact, he said, this setup may be particularly attractive to parents who are already taking off time to bring their children in for immunizations.

"These visits represent an opportunity to immunize parents or other adult caregivers with minimal disruption for both the adults and the practice," Dr. Lessin and his colleagues wrote in the AAP report. "Immunizations represent a major focus for pediatric care, and many educational opportunities exist for the pediatrician to explain the benefits of immunization for the child and for close family contacts. Thus, convenience, physician vaccine knowledge and encouragement, and vaccine availability are strong factors for immunizing parents and close family contacts in the pediatric office."

In theory, this sounds great, Dr. Lessin said at the annual meeting of the American Academy of Pediatrics. In practice, immunizing parents can be challenging and even somewhat risky. Questions about liability, how much vaccine to purchase and administer to adults, documentation, and reimbursement remain.

He addressed each of these issues:

• Liability. The Vaccine Injury Compensation Program covers all vaccines recommended for routine use in children, regardless of the age of the person being vaccinated. Since the Tdap and influenza vaccines are recommended for children, the pediatrician who also gives them to adults would be covered.

• Vaccine supply. Offering adult immunizations would mean walking a fine line between having enough vaccine and wasting money on too much. The problem could be exacerbated in years of influenza vaccine shortage. In addition, the AAP report noted that "because nearly all privately supplied influenza vaccine is preordered months in advance, there is a risk of using the ordered supply too quickly when immunizing both close family contacts and children. ... Alternatively, too much vaccine might be ordered ... leaving practices at economic risk of unused doses. This is a significant concern, given the narrow financial margins for immunizations."

• Documentation. The pediatric office would have to document these immunizations, which would entail creating some kind of brief medical record – perhaps a vaccination card. There should probably be some communication with the adult’s primary care provider as well.

• Reimbursement. Some offices that provide adult immunizations require up-front payment, and leave insurance filing to the individual. "You need to ask yourself if you’re willing to get into the insurance hassle because you’re not the adult’s primary care doctor. It’s up to you," he said.

The AAP report also offered a few warnings about adult vaccine billing: "In most states, vaccines supplied to pediatricians by the Vaccines for Children Program may not be used for adults and certainly cannot be billed. If a practice chooses to involve itself in the insurance coverage of parents and close family contacts, it will produce a significantly increased burden that may make the provision of such services nonviable."

Dr. Lessin disclosed that he is on the speakers board of GlaxoSmithKline and the advisory boards of Merck, Novartis, and Pfizer. He is also a senior consultant for the Verden Group, a practice management company.

NEW ORLEANS – Protecting children by vaccinating parents comes with some baggage that needs to be sorted out before the idea can become a reality, according to Dr. Herschel Lessin.

There’s no longer any doubt that cocooning, or spinning a cocoon of communicable disease protection around infants and young children, does protect them from illness, said Dr. Lessin, who coauthored the American Academy of Pediatrics 2012 report on the issue (Pediatrics 2012;129:e247-53).

Design Pics

The review found lots of evidence supporting the practice – including one study showing that up to half of infant pertussis cases could have been prevented if parents had been immunized (Pediatr. Infect. Dis. J. 2004;23:985-9).

Two other studies have shown a significantly reduced incidence of influenza among infants whose mothers were vaccinated during pregnancy (Am. J. Obstet. Gynecol. 2011;204[suppl. 1]:S141-8; New Engl. J. Med. 2008;359:1555-64).

Unfortunately, Dr. Lessin said, "adults’ physicians do an awful job of immunizing patients, so most adults are not fully immunized." Obstetricians and neonatal intensive care units "are good at vaccinating mom, but not dad, so these infants are clearly at risk," he added.

The pediatrician’s office can make a difference. "We’re perfectly suited to be a good place to immunize adults," said Dr. Lessin, a pediatrician in private practice in Poughkeepsie, N.Y. In fact, he said, this setup may be particularly attractive to parents who are already taking off time to bring their children in for immunizations.

"These visits represent an opportunity to immunize parents or other adult caregivers with minimal disruption for both the adults and the practice," Dr. Lessin and his colleagues wrote in the AAP report. "Immunizations represent a major focus for pediatric care, and many educational opportunities exist for the pediatrician to explain the benefits of immunization for the child and for close family contacts. Thus, convenience, physician vaccine knowledge and encouragement, and vaccine availability are strong factors for immunizing parents and close family contacts in the pediatric office."

In theory, this sounds great, Dr. Lessin said at the annual meeting of the American Academy of Pediatrics. In practice, immunizing parents can be challenging and even somewhat risky. Questions about liability, how much vaccine to purchase and administer to adults, documentation, and reimbursement remain.

He addressed each of these issues:

• Liability. The Vaccine Injury Compensation Program covers all vaccines recommended for routine use in children, regardless of the age of the person being vaccinated. Since the Tdap and influenza vaccines are recommended for children, the pediatrician who also gives them to adults would be covered.

• Vaccine supply. Offering adult immunizations would mean walking a fine line between having enough vaccine and wasting money on too much. The problem could be exacerbated in years of influenza vaccine shortage. In addition, the AAP report noted that "because nearly all privately supplied influenza vaccine is preordered months in advance, there is a risk of using the ordered supply too quickly when immunizing both close family contacts and children. ... Alternatively, too much vaccine might be ordered ... leaving practices at economic risk of unused doses. This is a significant concern, given the narrow financial margins for immunizations."

• Documentation. The pediatric office would have to document these immunizations, which would entail creating some kind of brief medical record – perhaps a vaccination card. There should probably be some communication with the adult’s primary care provider as well.

• Reimbursement. Some offices that provide adult immunizations require up-front payment, and leave insurance filing to the individual. "You need to ask yourself if you’re willing to get into the insurance hassle because you’re not the adult’s primary care doctor. It’s up to you," he said.

The AAP report also offered a few warnings about adult vaccine billing: "In most states, vaccines supplied to pediatricians by the Vaccines for Children Program may not be used for adults and certainly cannot be billed. If a practice chooses to involve itself in the insurance coverage of parents and close family contacts, it will produce a significantly increased burden that may make the provision of such services nonviable."

Dr. Lessin disclosed that he is on the speakers board of GlaxoSmithKline and the advisory boards of Merck, Novartis, and Pfizer. He is also a senior consultant for the Verden Group, a practice management company.

NEW ORLEANS – While vaccinations are certainly a health benefit to pediatric patients, they may be a financial risk for pediatricians, according to Dr. Herschel R. Lessin.

"Vaccines are expensive, complicated, and require a lot of time-consuming communication with parents. If they’re not managed correctly, they can bankrupt your business," he said at the annual meeting of the American Academy of Pediatrics. "Vaccines are the second-largest budget item in your business, after payroll, and can tie up enormous amounts of capital. You need to be smart about how you use them and how you buy them."

©Design Pics

It’s hard to judge how much vaccines really cost a practice, said Dr. Lessin, a pediatrician in private practice in Poughkeepsie, N.Y. In addition to the actual cost of the product, the equation has to include the cost of time spent on counseling about vaccines’ risks and benefits, defusing the popular mythology attached to them, and taking calls about reactions. Add to that the equipment necessary to administer and store them, and you have a situation that may very well be costing more than it brings in.

"It’s a question of opportunity cost," he said. "Ask yourself, ‘What other things could I have done with that money?’ "

Purchasing is the biggest up-front outlay. "The absolute worst way to buy these is to purchase them on your own from the drug company. It’s a little bit more economical if you’re part of a practice group and you share the cost with your colleagues. Or you can team up with other practices in your area and create a group purchase organization [GPO]."

But this kind of business relationship works only if the group provides enough financial incentive to offset the headaches of joining.

GPOs combine buying power from multiple members to get better prices on vaccine. The organizations deal directly with vaccine manufacturers to negotiate what usually turn out to be the best prices. Another benefit is that orders are placed individually. Practices can order just what they need and not be forced to order a large volume to get a discount.

But they almost always come with rules designed to keep a practice connected with the group, and with the manufacturers who participate. "All GPOs have rules you must abide by and products you must use to get the savings. If you see a good price on a vaccine and switch to it, you might be financially punished" for buying it, by being forced to pay list price on the vaccine you do order through the group, he said.

Another option is to collaborate with other practices in the community to negotiate deals directly with the manufacturer. Dr. Lessin said his practice did just that a few years ago. Although collaborating with a competitor was initially uncomfortable, it actually became a first step toward improving relations between the two businesses.

"We found out they weren’t quite the ogre that we thought they were," he said.

Cost concerns don’t evaporate even after the vaccine is delivered and safely tucked in the refrigerator. That’s when some of the thorniest issues arise, he said. Vaccines don’t administer themselves. They require equipment, providers, and communication that are specialized.

"The real cost of vaccines is much, much more than the price," Dr. Lessin said. The hidden costs include equipment, syringes, waste handling, and simple things such as gloves, swabs, and Band-Aid strips. Other less-tangible costs are time spent preparing the vaccine, counseling the parents, and documenting the procedure.

The usual per-patient profit for an office visit ranges from 30% to 50%, but drops off sharply when vaccines are figured into the mix, Dr. Lessin said. "If it’s your second-biggest expense, you better be making a profit of it. Vaccine is a product and we are selling product." Some practices have decided to increase their fees in order to cover the cost of vaccine administration.

"You deserve to make a profit margin on administrative costs," he said.

The American Academy of Pediatrics offers several free resources on building a successful vaccine practice model.

Dr. Lessin disclosed that he is on the speakers board of GlaxoSmithKline and the advisory boards of Merck, Novartis, and Pfizer. He is also a senior consultant for the Verden Group, a practice management company.

NEW ORLEANS – While vaccinations are certainly a health benefit to pediatric patients, they may be a financial risk for pediatricians, according to Dr. Herschel R. Lessin.

"Vaccines are expensive, complicated, and require a lot of time-consuming communication with parents. If they’re not managed correctly, they can bankrupt your business," he said at the annual meeting of the American Academy of Pediatrics. "Vaccines are the second-largest budget item in your business, after payroll, and can tie up enormous amounts of capital. You need to be smart about how you use them and how you buy them."

©Design Pics

It’s hard to judge how much vaccines really cost a practice, said Dr. Lessin, a pediatrician in private practice in Poughkeepsie, N.Y. In addition to the actual cost of the product, the equation has to include the cost of time spent on counseling about vaccines’ risks and benefits, defusing the popular mythology attached to them, and taking calls about reactions. Add to that the equipment necessary to administer and store them, and you have a situation that may very well be costing more than it brings in.

"It’s a question of opportunity cost," he said. "Ask yourself, ‘What other things could I have done with that money?’ "

Purchasing is the biggest up-front outlay. "The absolute worst way to buy these is to purchase them on your own from the drug company. It’s a little bit more economical if you’re part of a practice group and you share the cost with your colleagues. Or you can team up with other practices in your area and create a group purchase organization [GPO]."

But this kind of business relationship works only if the group provides enough financial incentive to offset the headaches of joining.

GPOs combine buying power from multiple members to get better prices on vaccine. The organizations deal directly with vaccine manufacturers to negotiate what usually turn out to be the best prices. Another benefit is that orders are placed individually. Practices can order just what they need and not be forced to order a large volume to get a discount.

But they almost always come with rules designed to keep a practice connected with the group, and with the manufacturers who participate. "All GPOs have rules you must abide by and products you must use to get the savings. If you see a good price on a vaccine and switch to it, you might be financially punished" for buying it, by being forced to pay list price on the vaccine you do order through the group, he said.

Another option is to collaborate with other practices in the community to negotiate deals directly with the manufacturer. Dr. Lessin said his practice did just that a few years ago. Although collaborating with a competitor was initially uncomfortable, it actually became a first step toward improving relations between the two businesses.

"We found out they weren’t quite the ogre that we thought they were," he said.

Cost concerns don’t evaporate even after the vaccine is delivered and safely tucked in the refrigerator. That’s when some of the thorniest issues arise, he said. Vaccines don’t administer themselves. They require equipment, providers, and communication that are specialized.

"The real cost of vaccines is much, much more than the price," Dr. Lessin said. The hidden costs include equipment, syringes, waste handling, and simple things such as gloves, swabs, and Band-Aid strips. Other less-tangible costs are time spent preparing the vaccine, counseling the parents, and documenting the procedure.

The usual per-patient profit for an office visit ranges from 30% to 50%, but drops off sharply when vaccines are figured into the mix, Dr. Lessin said. "If it’s your second-biggest expense, you better be making a profit of it. Vaccine is a product and we are selling product." Some practices have decided to increase their fees in order to cover the cost of vaccine administration.

"You deserve to make a profit margin on administrative costs," he said.

The American Academy of Pediatrics offers several free resources on building a successful vaccine practice model.

Dr. Lessin disclosed that he is on the speakers board of GlaxoSmithKline and the advisory boards of Merck, Novartis, and Pfizer. He is also a senior consultant for the Verden Group, a practice management company.

NEW ORLEANS – While vaccinations are certainly a health benefit to pediatric patients, they may be a financial risk for pediatricians, according to Dr. Herschel R. Lessin.

"Vaccines are expensive, complicated, and require a lot of time-consuming communication with parents. If they’re not managed correctly, they can bankrupt your business," he said at the annual meeting of the American Academy of Pediatrics. "Vaccines are the second-largest budget item in your business, after payroll, and can tie up enormous amounts of capital. You need to be smart about how you use them and how you buy them."

©Design Pics

It’s hard to judge how much vaccines really cost a practice, said Dr. Lessin, a pediatrician in private practice in Poughkeepsie, N.Y. In addition to the actual cost of the product, the equation has to include the cost of time spent on counseling about vaccines’ risks and benefits, defusing the popular mythology attached to them, and taking calls about reactions. Add to that the equipment necessary to administer and store them, and you have a situation that may very well be costing more than it brings in.

"It’s a question of opportunity cost," he said. "Ask yourself, ‘What other things could I have done with that money?’ "

Purchasing is the biggest up-front outlay. "The absolute worst way to buy these is to purchase them on your own from the drug company. It’s a little bit more economical if you’re part of a practice group and you share the cost with your colleagues. Or you can team up with other practices in your area and create a group purchase organization [GPO]."

But this kind of business relationship works only if the group provides enough financial incentive to offset the headaches of joining.

GPOs combine buying power from multiple members to get better prices on vaccine. The organizations deal directly with vaccine manufacturers to negotiate what usually turn out to be the best prices. Another benefit is that orders are placed individually. Practices can order just what they need and not be forced to order a large volume to get a discount.

But they almost always come with rules designed to keep a practice connected with the group, and with the manufacturers who participate. "All GPOs have rules you must abide by and products you must use to get the savings. If you see a good price on a vaccine and switch to it, you might be financially punished" for buying it, by being forced to pay list price on the vaccine you do order through the group, he said.

Another option is to collaborate with other practices in the community to negotiate deals directly with the manufacturer. Dr. Lessin said his practice did just that a few years ago. Although collaborating with a competitor was initially uncomfortable, it actually became a first step toward improving relations between the two businesses.

"We found out they weren’t quite the ogre that we thought they were," he said.

Cost concerns don’t evaporate even after the vaccine is delivered and safely tucked in the refrigerator. That’s when some of the thorniest issues arise, he said. Vaccines don’t administer themselves. They require equipment, providers, and communication that are specialized.

"The real cost of vaccines is much, much more than the price," Dr. Lessin said. The hidden costs include equipment, syringes, waste handling, and simple things such as gloves, swabs, and Band-Aid strips. Other less-tangible costs are time spent preparing the vaccine, counseling the parents, and documenting the procedure.

The usual per-patient profit for an office visit ranges from 30% to 50%, but drops off sharply when vaccines are figured into the mix, Dr. Lessin said. "If it’s your second-biggest expense, you better be making a profit of it. Vaccine is a product and we are selling product." Some practices have decided to increase their fees in order to cover the cost of vaccine administration.

"You deserve to make a profit margin on administrative costs," he said.

The American Academy of Pediatrics offers several free resources on building a successful vaccine practice model.

Dr. Lessin disclosed that he is on the speakers board of GlaxoSmithKline and the advisory boards of Merck, Novartis, and Pfizer. He is also a senior consultant for the Verden Group, a practice management company.

NEW ORLEANS  – It’s time for more pediatricians to step into the digital world.

Facebook pages, Twitter accounts, and direct e-mail to patients are nothing to be scared of, according to Dr. Todd Wolynn. In fact, if your practice isn’t connecting with families over the Internet, competitors are, he said at the annual meeting of the American Academy of Pediatrics.

"Pediatrics is rapidly changing, facing threats on all sides," said Dr. Wolynn, a pediatrician in group practice in Pittsburgh. "When I started, I did everything for my patients, from NICU visits to inpatient care and house calls. But our practice size is shrinking. Now most general pediatricians just see outpatient, sick calls, and well calls. There’s even increasing competition for those from urgent care facilities, and even clinics in retail stores and pharmacies."

Before the age of constant connection, pediatricians were part of an extended family centered on the patient and parents, and sometimes grandparents as well. "It was a trust-based relationship based on ties with several generations," he said. Now, young "Generation Y" parents are likely to pay more attention to their virtual friends than to their real parents, Dr. Wolynn said.

"Your target audience is GenY. These are the parents making decisions now, and if you don’t know them, you will quickly become meaningless and fail to reach their children," he said.

Connectedness can be a double-edged sword. "It’s not just Facebook. It’s like Facebook on steroids," capable of generating medical myths so entrenched they become almost impossible to expunge. On the other hand, Facebook and its "ADHD relative" Twitter, can spread positive feedback about your practice like never before.

For the pediatrician who’s open to it, this paradigm shift can be a grand moment of expansion. "Now, 50% of our new patient visits are related to some sort of social media. This is where you can really begin to grow your practice."

He offered some tips for getting started:

• Start slow. "Don’t waste the time if your parents aren’t interested. Do a simple paper-and-pencil survey in your office. Find out if people are interested in e-mail, Twitter, Facebook, or a Web page for your practice. Once you figure that out, you can target your efforts," Dr. Wolynn advised.

©audioundwerbung/iStockphoto

• If you can afford it, hire someone to create your Web page. It should be full of colorful graphics, easy to navigate, and constantly refreshed with new offerings – blogs, conversations about seasonal health issues, links that allow parents to "meet" staff, and even general information about the larger community. "We have even added a jobs page [with openings at our practice] for parents, and a link to the local center for breastfeeding."

• Consider video. "In 2012, 50% of Internet traffic was driven by video. GenY wants to see it – not read it. We use YouTube as a way of introducing our doctors. We do pay someone to do the videos, but the investment pays for itself," Dr. Wolynn said. Videos introducing our physicians are especially popular with parents. "You can offer general parenting tips as well, not just medical information." Dr. Wolynn said a video he did on "five places to cool off for free" in Pittsburgh was one of the most popular on the site.

• Allow parents to ask general questions and to expect a timely response. "It has to be clear that this isn’t intended for emergency use, and you do need to vet the information you provide. But it’s perfect for general things like, ‘My baby has a fever – what can I give?’ This can actually start taking away some of your triage nurse’s calls. Other parents will jump in as well, responding to the post," he said.

• Don’t simply wait for families to come to you – push your information to them. "They can make an agreement, and your information will come to them in their preferred media," he said.

• Be clear with staff about the site’s use and limits. "You don’t want your staff posting things like, ‘We were really overworked today.’ They can say things like that on their own site – that’s their right. But not on the practice site. We have never had a negative employee comment posted," Dr. Wolynn said.

• Consider privacy laws and seek advice if you need to. It’s always best to err on the side of caution when parents ask specific questions. "We have someone monitor the site. If something acute comes up, we call the person as quickly as possible," he said. Patient privacy law for Internet communication is "evolving as we go along. We’ve talked to our lawyer and been told that ‘precedent on this is being set daily,’ " Dr. Wolynn noted.

He said he had no relevant financial disclosures.

NEW ORLEANS  – It’s time for more pediatricians to step into the digital world.

Facebook pages, Twitter accounts, and direct e-mail to patients are nothing to be scared of, according to Dr. Todd Wolynn. In fact, if your practice isn’t connecting with families over the Internet, competitors are, he said at the annual meeting of the American Academy of Pediatrics.

"Pediatrics is rapidly changing, facing threats on all sides," said Dr. Wolynn, a pediatrician in group practice in Pittsburgh. "When I started, I did everything for my patients, from NICU visits to inpatient care and house calls. But our practice size is shrinking. Now most general pediatricians just see outpatient, sick calls, and well calls. There’s even increasing competition for those from urgent care facilities, and even clinics in retail stores and pharmacies."

Before the age of constant connection, pediatricians were part of an extended family centered on the patient and parents, and sometimes grandparents as well. "It was a trust-based relationship based on ties with several generations," he said. Now, young "Generation Y" parents are likely to pay more attention to their virtual friends than to their real parents, Dr. Wolynn said.

"Your target audience is GenY. These are the parents making decisions now, and if you don’t know them, you will quickly become meaningless and fail to reach their children," he said.

Connectedness can be a double-edged sword. "It’s not just Facebook. It’s like Facebook on steroids," capable of generating medical myths so entrenched they become almost impossible to expunge. On the other hand, Facebook and its "ADHD relative" Twitter, can spread positive feedback about your practice like never before.

For the pediatrician who’s open to it, this paradigm shift can be a grand moment of expansion. "Now, 50% of our new patient visits are related to some sort of social media. This is where you can really begin to grow your practice."

He offered some tips for getting started:

• Start slow. "Don’t waste the time if your parents aren’t interested. Do a simple paper-and-pencil survey in your office. Find out if people are interested in e-mail, Twitter, Facebook, or a Web page for your practice. Once you figure that out, you can target your efforts," Dr. Wolynn advised.

©audioundwerbung/iStockphoto

• If you can afford it, hire someone to create your Web page. It should be full of colorful graphics, easy to navigate, and constantly refreshed with new offerings – blogs, conversations about seasonal health issues, links that allow parents to "meet" staff, and even general information about the larger community. "We have even added a jobs page [with openings at our practice] for parents, and a link to the local center for breastfeeding."

• Consider video. "In 2012, 50% of Internet traffic was driven by video. GenY wants to see it – not read it. We use YouTube as a way of introducing our doctors. We do pay someone to do the videos, but the investment pays for itself," Dr. Wolynn said. Videos introducing our physicians are especially popular with parents. "You can offer general parenting tips as well, not just medical information." Dr. Wolynn said a video he did on "five places to cool off for free" in Pittsburgh was one of the most popular on the site.

• Allow parents to ask general questions and to expect a timely response. "It has to be clear that this isn’t intended for emergency use, and you do need to vet the information you provide. But it’s perfect for general things like, ‘My baby has a fever – what can I give?’ This can actually start taking away some of your triage nurse’s calls. Other parents will jump in as well, responding to the post," he said.

• Don’t simply wait for families to come to you – push your information to them. "They can make an agreement, and your information will come to them in their preferred media," he said.

• Be clear with staff about the site’s use and limits. "You don’t want your staff posting things like, ‘We were really overworked today.’ They can say things like that on their own site – that’s their right. But not on the practice site. We have never had a negative employee comment posted," Dr. Wolynn said.

• Consider privacy laws and seek advice if you need to. It’s always best to err on the side of caution when parents ask specific questions. "We have someone monitor the site. If something acute comes up, we call the person as quickly as possible," he said. Patient privacy law for Internet communication is "evolving as we go along. We’ve talked to our lawyer and been told that ‘precedent on this is being set daily,’ " Dr. Wolynn noted.

He said he had no relevant financial disclosures.

NEW ORLEANS  – It’s time for more pediatricians to step into the digital world.

Facebook pages, Twitter accounts, and direct e-mail to patients are nothing to be scared of, according to Dr. Todd Wolynn. In fact, if your practice isn’t connecting with families over the Internet, competitors are, he said at the annual meeting of the American Academy of Pediatrics.

"Pediatrics is rapidly changing, facing threats on all sides," said Dr. Wolynn, a pediatrician in group practice in Pittsburgh. "When I started, I did everything for my patients, from NICU visits to inpatient care and house calls. But our practice size is shrinking. Now most general pediatricians just see outpatient, sick calls, and well calls. There’s even increasing competition for those from urgent care facilities, and even clinics in retail stores and pharmacies."

Before the age of constant connection, pediatricians were part of an extended family centered on the patient and parents, and sometimes grandparents as well. "It was a trust-based relationship based on ties with several generations," he said. Now, young "Generation Y" parents are likely to pay more attention to their virtual friends than to their real parents, Dr. Wolynn said.

"Your target audience is GenY. These are the parents making decisions now, and if you don’t know them, you will quickly become meaningless and fail to reach their children," he said.

Connectedness can be a double-edged sword. "It’s not just Facebook. It’s like Facebook on steroids," capable of generating medical myths so entrenched they become almost impossible to expunge. On the other hand, Facebook and its "ADHD relative" Twitter, can spread positive feedback about your practice like never before.

For the pediatrician who’s open to it, this paradigm shift can be a grand moment of expansion. "Now, 50% of our new patient visits are related to some sort of social media. This is where you can really begin to grow your practice."

He offered some tips for getting started:

• Start slow. "Don’t waste the time if your parents aren’t interested. Do a simple paper-and-pencil survey in your office. Find out if people are interested in e-mail, Twitter, Facebook, or a Web page for your practice. Once you figure that out, you can target your efforts," Dr. Wolynn advised.

©audioundwerbung/iStockphoto

• If you can afford it, hire someone to create your Web page. It should be full of colorful graphics, easy to navigate, and constantly refreshed with new offerings – blogs, conversations about seasonal health issues, links that allow parents to "meet" staff, and even general information about the larger community. "We have even added a jobs page [with openings at our practice] for parents, and a link to the local center for breastfeeding."

• Consider video. "In 2012, 50% of Internet traffic was driven by video. GenY wants to see it – not read it. We use YouTube as a way of introducing our doctors. We do pay someone to do the videos, but the investment pays for itself," Dr. Wolynn said. Videos introducing our physicians are especially popular with parents. "You can offer general parenting tips as well, not just medical information." Dr. Wolynn said a video he did on "five places to cool off for free" in Pittsburgh was one of the most popular on the site.

• Allow parents to ask general questions and to expect a timely response. "It has to be clear that this isn’t intended for emergency use, and you do need to vet the information you provide. But it’s perfect for general things like, ‘My baby has a fever – what can I give?’ This can actually start taking away some of your triage nurse’s calls. Other parents will jump in as well, responding to the post," he said.

• Don’t simply wait for families to come to you – push your information to them. "They can make an agreement, and your information will come to them in their preferred media," he said.

• Be clear with staff about the site’s use and limits. "You don’t want your staff posting things like, ‘We were really overworked today.’ They can say things like that on their own site – that’s their right. But not on the practice site. We have never had a negative employee comment posted," Dr. Wolynn said.

• Consider privacy laws and seek advice if you need to. It’s always best to err on the side of caution when parents ask specific questions. "We have someone monitor the site. If something acute comes up, we call the person as quickly as possible," he said. Patient privacy law for Internet communication is "evolving as we go along. We’ve talked to our lawyer and been told that ‘precedent on this is being set daily,’ " Dr. Wolynn noted.

He said he had no relevant financial disclosures.

Adjusting antiplatelet therapy on the basis of platelet function doesn’t confer any significant clinical benefits over a course of standard antiplatelet therapy for patients undergoing coronary stenting.

By the end of 1 year, about a third of patients in each group had died or experienced a heart attack, stent thrombosis, cerebrovascular accident, or urgent revascularization, Dr. Gilles Montalescot and his colleagues reported simultaneously at the annual scientific sessions of the American Heart Association and in the Nov. 4 issue of the New England Journal of Medicine (2012 [doi:10.1056/NEJMoa12099979]).

"We observed no hint of improvement in ischemic outcomes and no better safety outcomes with a strategy of monitoring and drug adjustment as compared with a conventional strategy," wrote Dr. Montalescot of the University Pierre and Marie Curie, Paris, and his co-investigators in the ARCTIC trial (Assessment by a Double Randomization of a Conventional Antiplatelet Strategy vs. a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption vs. Continuation 1 Year After Stenting).

ARCTIC comprised 2,440 patients about to undergo coronary stenting. They were randomized to either conventional antiplatelet therapy, or to flexible antiplatelet treatment guided by platelet-function monitoring.

The patients were a mean of 63 years old; about 80% were men. About a quarter (27%) presented with an acute coronary syndrome without ST-segment elevation.

At the time of stenting, patients in the monitoring group underwent platelet function measuring for both aspirin and P2Y12 inhibitors. (The P2Y12 inhibitors clopidogrel and prasugrel, both thienopyridines, were used in the study.) These assays were repeated 2-4 weeks after stenting, and drug therapy was adjusted according to the results.

If the initial assay indicated aspirin reactivity, these patients received an aspirin bolus before stenting. If reactivity with clopidogrel was detected, the patient received either glycoprotein IIb/IIIa inhibitors and a loading dose of at least 600 mg clopidogrel, or a loading dose of 60 mg prasugrel, followed by a daily maintenance dose of 150 mg clopidogrel or 10 mg prasugrel.

At the 2- to 4-week follow-up visit, patients who showed high platelet reactivity with clopidogrel were switched to 10 mg prasugrel or had a 75-mg increase in their daily clopidogrel.

If, during treatment, patients had low platelet reactivity with thienopyridine, they were switched to daily clopidogrel at 75 mg if they were already getting 10 mg prasugrel or 150 mg clopidogrel.

Patients in the standard therapy group received the stents without any platelet function tests. The use of GP IIb/IIIa inhibitors was left up to the treating physicians.

Before stenting, 34% of the monitoring group had high clopidogrel platelet reactivity; 80% of those received the clopidogrel bolus and 3% the additional prasugrel. High aspirin reactivity was seen in 8%; of those, 85% had the additional aspirin dose.

At the follow-up visit, 16% of the monitoring group showed high platelet reactivity to thienopyridine; 43% of those then received an increase in their maintenance clopidogrel dose. A total of 4% of the monitoring group showed aspirin reactivity at the follow-up visit; 46% of these received an increase in their maintenance dose.

At 1 year after stenting, the primary composite end point had occurred in 35% of the monitoring group and 31% of the standard therapy group, a nonsignificant difference. There were no significant between-group differences when the component end points were individually examined. Bleeding rates were less than 5% and similar in both groups.

The study was largely sponsored by Allies in Cardiovascular Trials Initiatives and Organized Networks, and included funding from Sanofi-Aventis, Cordis, Medtronic, and Boston Scientific.

Dr. Montalescot disclosed that he is a consultant with Atrium, Bayer, and Bristol-Myers Squibb. Several of the coauthors reported financial relationships with multiple pharmaceutical and device companies.

Adjusting antiplatelet therapy on the basis of platelet function doesn’t confer any significant clinical benefits over a course of standard antiplatelet therapy for patients undergoing coronary stenting.

By the end of 1 year, about a third of patients in each group had died or experienced a heart attack, stent thrombosis, cerebrovascular accident, or urgent revascularization, Dr. Gilles Montalescot and his colleagues reported simultaneously at the annual scientific sessions of the American Heart Association and in the Nov. 4 issue of the New England Journal of Medicine (2012 [doi:10.1056/NEJMoa12099979]).

"We observed no hint of improvement in ischemic outcomes and no better safety outcomes with a strategy of monitoring and drug adjustment as compared with a conventional strategy," wrote Dr. Montalescot of the University Pierre and Marie Curie, Paris, and his co-investigators in the ARCTIC trial (Assessment by a Double Randomization of a Conventional Antiplatelet Strategy vs. a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption vs. Continuation 1 Year After Stenting).

ARCTIC comprised 2,440 patients about to undergo coronary stenting. They were randomized to either conventional antiplatelet therapy, or to flexible antiplatelet treatment guided by platelet-function monitoring.

The patients were a mean of 63 years old; about 80% were men. About a quarter (27%) presented with an acute coronary syndrome without ST-segment elevation.

At the time of stenting, patients in the monitoring group underwent platelet function measuring for both aspirin and P2Y12 inhibitors. (The P2Y12 inhibitors clopidogrel and prasugrel, both thienopyridines, were used in the study.) These assays were repeated 2-4 weeks after stenting, and drug therapy was adjusted according to the results.

If the initial assay indicated aspirin reactivity, these patients received an aspirin bolus before stenting. If reactivity with clopidogrel was detected, the patient received either glycoprotein IIb/IIIa inhibitors and a loading dose of at least 600 mg clopidogrel, or a loading dose of 60 mg prasugrel, followed by a daily maintenance dose of 150 mg clopidogrel or 10 mg prasugrel.

At the 2- to 4-week follow-up visit, patients who showed high platelet reactivity with clopidogrel were switched to 10 mg prasugrel or had a 75-mg increase in their daily clopidogrel.

If, during treatment, patients had low platelet reactivity with thienopyridine, they were switched to daily clopidogrel at 75 mg if they were already getting 10 mg prasugrel or 150 mg clopidogrel.

Patients in the standard therapy group received the stents without any platelet function tests. The use of GP IIb/IIIa inhibitors was left up to the treating physicians.

Before stenting, 34% of the monitoring group had high clopidogrel platelet reactivity; 80% of those received the clopidogrel bolus and 3% the additional prasugrel. High aspirin reactivity was seen in 8%; of those, 85% had the additional aspirin dose.

At the follow-up visit, 16% of the monitoring group showed high platelet reactivity to thienopyridine; 43% of those then received an increase in their maintenance clopidogrel dose. A total of 4% of the monitoring group showed aspirin reactivity at the follow-up visit; 46% of these received an increase in their maintenance dose.

At 1 year after stenting, the primary composite end point had occurred in 35% of the monitoring group and 31% of the standard therapy group, a nonsignificant difference. There were no significant between-group differences when the component end points were individually examined. Bleeding rates were less than 5% and similar in both groups.

The study was largely sponsored by Allies in Cardiovascular Trials Initiatives and Organized Networks, and included funding from Sanofi-Aventis, Cordis, Medtronic, and Boston Scientific.

Dr. Montalescot disclosed that he is a consultant with Atrium, Bayer, and Bristol-Myers Squibb. Several of the coauthors reported financial relationships with multiple pharmaceutical and device companies.

Adjusting antiplatelet therapy on the basis of platelet function doesn’t confer any significant clinical benefits over a course of standard antiplatelet therapy for patients undergoing coronary stenting.

By the end of 1 year, about a third of patients in each group had died or experienced a heart attack, stent thrombosis, cerebrovascular accident, or urgent revascularization, Dr. Gilles Montalescot and his colleagues reported simultaneously at the annual scientific sessions of the American Heart Association and in the Nov. 4 issue of the New England Journal of Medicine (2012 [doi:10.1056/NEJMoa12099979]).

"We observed no hint of improvement in ischemic outcomes and no better safety outcomes with a strategy of monitoring and drug adjustment as compared with a conventional strategy," wrote Dr. Montalescot of the University Pierre and Marie Curie, Paris, and his co-investigators in the ARCTIC trial (Assessment by a Double Randomization of a Conventional Antiplatelet Strategy vs. a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption vs. Continuation 1 Year After Stenting).

ARCTIC comprised 2,440 patients about to undergo coronary stenting. They were randomized to either conventional antiplatelet therapy, or to flexible antiplatelet treatment guided by platelet-function monitoring.

The patients were a mean of 63 years old; about 80% were men. About a quarter (27%) presented with an acute coronary syndrome without ST-segment elevation.

At the time of stenting, patients in the monitoring group underwent platelet function measuring for both aspirin and P2Y12 inhibitors. (The P2Y12 inhibitors clopidogrel and prasugrel, both thienopyridines, were used in the study.) These assays were repeated 2-4 weeks after stenting, and drug therapy was adjusted according to the results.

If the initial assay indicated aspirin reactivity, these patients received an aspirin bolus before stenting. If reactivity with clopidogrel was detected, the patient received either glycoprotein IIb/IIIa inhibitors and a loading dose of at least 600 mg clopidogrel, or a loading dose of 60 mg prasugrel, followed by a daily maintenance dose of 150 mg clopidogrel or 10 mg prasugrel.

At the 2- to 4-week follow-up visit, patients who showed high platelet reactivity with clopidogrel were switched to 10 mg prasugrel or had a 75-mg increase in their daily clopidogrel.

If, during treatment, patients had low platelet reactivity with thienopyridine, they were switched to daily clopidogrel at 75 mg if they were already getting 10 mg prasugrel or 150 mg clopidogrel.

Patients in the standard therapy group received the stents without any platelet function tests. The use of GP IIb/IIIa inhibitors was left up to the treating physicians.

Before stenting, 34% of the monitoring group had high clopidogrel platelet reactivity; 80% of those received the clopidogrel bolus and 3% the additional prasugrel. High aspirin reactivity was seen in 8%; of those, 85% had the additional aspirin dose.

At the follow-up visit, 16% of the monitoring group showed high platelet reactivity to thienopyridine; 43% of those then received an increase in their maintenance clopidogrel dose. A total of 4% of the monitoring group showed aspirin reactivity at the follow-up visit; 46% of these received an increase in their maintenance dose.

At 1 year after stenting, the primary composite end point had occurred in 35% of the monitoring group and 31% of the standard therapy group, a nonsignificant difference. There were no significant between-group differences when the component end points were individually examined. Bleeding rates were less than 5% and similar in both groups.

The study was largely sponsored by Allies in Cardiovascular Trials Initiatives and Organized Networks, and included funding from Sanofi-Aventis, Cordis, Medtronic, and Boston Scientific.

Dr. Montalescot disclosed that he is a consultant with Atrium, Bayer, and Bristol-Myers Squibb. Several of the coauthors reported financial relationships with multiple pharmaceutical and device companies.

Listeria and Salmonella infections in patients with rheumatoid arthritis decreased by 73% after they received updated advice about consuming foods likely to carry those pathogens.

The incidence of these infections dropped from 5/10,000 person-years to 1/10,000 after the 2006 educational campaign, Ms. Rebecca Davies reported.

Courtesy CDC/Janice Haney Carr

"Although it may not be possible to eliminate this infection risk entirely, this ... shows the positive impact of informing patients of how to modify their risk of adverse events," wrote Ms. Davies, a research assistant at the University of Manchester, England, and her colleagues.

Because tumor necrosis factor is important in controlling intracellular bacterial infections, suppressing the protein can increase the risk of such infections. The British Society for Rheumatology’s Rheumatoid Arthritis Register tracks such events. In 2006, recognizing an early signal of increased infections by food-borne pathogens, the group advised patients taking the drugs to avoid high-risk foods, including raw eggs and raw poultry, unpasteurized milk, and some cheeses.

Ms. Davies and her colleagues reviewed the records of almost 12,000 patients enrolled in the registry – 9,376 of whom were taking anti-TNF-alpha drugs before 2006, and 2,347 of whom were taking them afterward. All were followed until death, last recorded visit, or through March 31, 2011. The review included data on all listeria and salmonella infections in the patients.

Nine patients who had ever taken one of the drugs experienced an infection before 2006 (four taking etanercept, three taking infliximab, and two taking adalimumab). Six patients experienced infections after 2006 (two etanercept, two infliximab, and two adalimumab). The crude incidence rates were 5/10,000 before 2006 and 1.4/10,000 afterward – a rate ratio of 0.27 and a 73% reduction.

The investigators found a similar result when they examined rates only in patients who were on therapy during the times in question. The incidence ratio was 4.6/10,000 before 2006, and 1.2 after 2006 – a rate ratio of 0.26 (74% reduction).

"This reduction was also found when allowing for a 90-day ‘lag window’ following treatment, accounting for any residual effect of the drug," the investigators noted.

The British Society for Rheumatology funded the study. The society receives funding from Abbott Laboratories, Merck, Pfizer, Roche, Swedish Orphan Biovitrum, and UCB. The society also contributes to rheumatology research at the University of Manchester. The paper did not note financial declarations from any of the individual authors.

Listeria and Salmonella infections in patients with rheumatoid arthritis decreased by 73% after they received updated advice about consuming foods likely to carry those pathogens.

The incidence of these infections dropped from 5/10,000 person-years to 1/10,000 after the 2006 educational campaign, Ms. Rebecca Davies reported.

Courtesy CDC/Janice Haney Carr

"Although it may not be possible to eliminate this infection risk entirely, this ... shows the positive impact of informing patients of how to modify their risk of adverse events," wrote Ms. Davies, a research assistant at the University of Manchester, England, and her colleagues.

Because tumor necrosis factor is important in controlling intracellular bacterial infections, suppressing the protein can increase the risk of such infections. The British Society for Rheumatology’s Rheumatoid Arthritis Register tracks such events. In 2006, recognizing an early signal of increased infections by food-borne pathogens, the group advised patients taking the drugs to avoid high-risk foods, including raw eggs and raw poultry, unpasteurized milk, and some cheeses.

Ms. Davies and her colleagues reviewed the records of almost 12,000 patients enrolled in the registry – 9,376 of whom were taking anti-TNF-alpha drugs before 2006, and 2,347 of whom were taking them afterward. All were followed until death, last recorded visit, or through March 31, 2011. The review included data on all listeria and salmonella infections in the patients.

Nine patients who had ever taken one of the drugs experienced an infection before 2006 (four taking etanercept, three taking infliximab, and two taking adalimumab). Six patients experienced infections after 2006 (two etanercept, two infliximab, and two adalimumab). The crude incidence rates were 5/10,000 before 2006 and 1.4/10,000 afterward – a rate ratio of 0.27 and a 73% reduction.

The investigators found a similar result when they examined rates only in patients who were on therapy during the times in question. The incidence ratio was 4.6/10,000 before 2006, and 1.2 after 2006 – a rate ratio of 0.26 (74% reduction).

"This reduction was also found when allowing for a 90-day ‘lag window’ following treatment, accounting for any residual effect of the drug," the investigators noted.

The British Society for Rheumatology funded the study. The society receives funding from Abbott Laboratories, Merck, Pfizer, Roche, Swedish Orphan Biovitrum, and UCB. The society also contributes to rheumatology research at the University of Manchester. The paper did not note financial declarations from any of the individual authors.

Listeria and Salmonella infections in patients with rheumatoid arthritis decreased by 73% after they received updated advice about consuming foods likely to carry those pathogens.

The incidence of these infections dropped from 5/10,000 person-years to 1/10,000 after the 2006 educational campaign, Ms. Rebecca Davies reported.

Courtesy CDC/Janice Haney Carr

"Although it may not be possible to eliminate this infection risk entirely, this ... shows the positive impact of informing patients of how to modify their risk of adverse events," wrote Ms. Davies, a research assistant at the University of Manchester, England, and her colleagues.

Because tumor necrosis factor is important in controlling intracellular bacterial infections, suppressing the protein can increase the risk of such infections. The British Society for Rheumatology’s Rheumatoid Arthritis Register tracks such events. In 2006, recognizing an early signal of increased infections by food-borne pathogens, the group advised patients taking the drugs to avoid high-risk foods, including raw eggs and raw poultry, unpasteurized milk, and some cheeses.

Ms. Davies and her colleagues reviewed the records of almost 12,000 patients enrolled in the registry – 9,376 of whom were taking anti-TNF-alpha drugs before 2006, and 2,347 of whom were taking them afterward. All were followed until death, last recorded visit, or through March 31, 2011. The review included data on all listeria and salmonella infections in the patients.

Nine patients who had ever taken one of the drugs experienced an infection before 2006 (four taking etanercept, three taking infliximab, and two taking adalimumab). Six patients experienced infections after 2006 (two etanercept, two infliximab, and two adalimumab). The crude incidence rates were 5/10,000 before 2006 and 1.4/10,000 afterward – a rate ratio of 0.27 and a 73% reduction.

The investigators found a similar result when they examined rates only in patients who were on therapy during the times in question. The incidence ratio was 4.6/10,000 before 2006, and 1.2 after 2006 – a rate ratio of 0.26 (74% reduction).

"This reduction was also found when allowing for a 90-day ‘lag window’ following treatment, accounting for any residual effect of the drug," the investigators noted.

The British Society for Rheumatology funded the study. The society receives funding from Abbott Laboratories, Merck, Pfizer, Roche, Swedish Orphan Biovitrum, and UCB. The society also contributes to rheumatology research at the University of Manchester. The paper did not note financial declarations from any of the individual authors.