Naseem S. Miller

ORLANDO – Although current guidelines do not recommend the use of systemic steroids for treatment of psoriasis, dermatologists still prescribe them, according to data presented at the Orlando Dermatology Aesthetic and Clinical Conference.

Researchers at Wake Forest University in Winston-Salem, N.C., analyzed a national database and found that U.S. dermatologists wrote more than 90% of the nearly 660,000 systemic steroid prescriptions for psoriasis over an 11-year period.

The authors concluded that the usefulness of systemic steroids for psoriasis should be reexamined in light of their findings.

"This is an issue that has been buried for a while," said Amir Al-Dabagh, the study’s first author and a fourth-year medical student at Wake Forest University. "Everyone knows it’s there, but it’s not discussed," he said.

Systemic steroids are not recommended for treatment of psoriasis because of evidence that discontinuing the drugs could lead to a rebound flair, sometimes beyond the baseline.

In addition, there are no data that systemic steroids are safe and effective in long-term treatment of psoriasis, said Dr. Joel Gelfand, one of the authors of the American Academy of Dermatology’s psoriasis guidelines, who was not involved in the analysis.

But, in reality, physicians do prescribe systemic steroids from time to time, especially when the patients are acutely flaring, said Dr. Gelfand, of the University of Pennsylvania in Philadelphia. "The general consensus is that it’s not a good thing to do. But sometimes the practitioners are stuck, and there are no other options for patients," he said in an interview.

Also, he added, not everyone follows the guidelines.

To analyze the prescription of steroids, Mr. Al-Dabagh and his colleagues used data from the National Ambulatory Medical Care Survey (NAMCS) from 1989 to 2010. In addition to showing that 90% of the systemic steroid prescriptions for psoriasis were written by dermatologists, the results indicated that three of the nine systemic therapies prescribed were steroids. Prednisone was ranked fourth among the nine therapies, and ranked first among the three systemic steroids, followed by methylprednisolone and dexamethasone.

In addition, no significant change was observed in the use of systemic steroids over the 11-year study period.

The poster’s findings are similar to the results of a 2011 German study that showed that systemic steroids are often used to treat psoriasis, although this treatment is not recommended in the European guidelines. The majority of prescribers in the German study were general practitioners and internists in Europe (J. Dtsch. Dermatol. Ges. 2011;9:833-8).

"If the dogma were true that systemic corticosteroids are frequently associated with severe exacerbations of the disease, then with the wide use of corticosteroids both for psoriasis and for comorbidities of psoriasis, we would expect that large numbers of patients would be seen for major problems such as precipitation, worsening, or rebound of their psoriasis. However, this has not been reported in the literature," Mr. Al-Dabagh and his colleagues wrote.

Academic dermatologists only see patients who aren’t cured by the physicians who prescribe the medications, which results in a selection bias where only the worst cases are seen in academia, the researchers noted. "This phenomenon may explain how steroids may be effective even though ‘everybody knows they don’t work,’ " they added.

Dr. Steven R. Feldman, senior author of the analysis and professor of dermatology at Wake Forest University, said that he and colleagues agreed with the current guidelines, but clinical trials of steroids for psoriasis would be helpful. "Avoiding systemic steroids in psoriasis is dogma, but is not supported by a strong scientific rationale," he said.

"There are long-term side effects from chronic use of systemic steroids, but we can say that about nearly all the treatments we use. The concerns about rebound from short-term use for psoriasis may be overblown as well," he added.

The debate on the use of systemic steroids for treatment of psoriasis is ongoing. Authors of a 2012 European study tried to parse out fact from fiction regarding the treatment and the condition. "There’s a remarkable lack of literature addressing adverse effects such as rebound, pustular, or erythrodermic flares or even new occurrence of psoriasis in patients with a negative disease history," the authors wrote. "A re-evaluation of the treatment of psoriasis and/or psoriatic arthritis with systemic steroids is necessary," the authors concluded (J. Eur. Acad. Dermatol. Venereol. 2012 Jul 25 [doi: 10.1111/j.1468-3083.2012.04656.x]).

More research is needed in the form of double-blind, controlled trials, Mr. Al-Dabagh said.

Mr. Al-Dabagh had no disclosures. Dr. Gelfand had no disclosures. Dr. Feldman said he had relationships with several pharmaceutical companies, but none produced systemic steroids.

ORLANDO – Although current guidelines do not recommend the use of systemic steroids for treatment of psoriasis, dermatologists still prescribe them, according to data presented at the Orlando Dermatology Aesthetic and Clinical Conference.

Researchers at Wake Forest University in Winston-Salem, N.C., analyzed a national database and found that U.S. dermatologists wrote more than 90% of the nearly 660,000 systemic steroid prescriptions for psoriasis over an 11-year period.

The authors concluded that the usefulness of systemic steroids for psoriasis should be reexamined in light of their findings.

"This is an issue that has been buried for a while," said Amir Al-Dabagh, the study’s first author and a fourth-year medical student at Wake Forest University. "Everyone knows it’s there, but it’s not discussed," he said.

Systemic steroids are not recommended for treatment of psoriasis because of evidence that discontinuing the drugs could lead to a rebound flair, sometimes beyond the baseline.

In addition, there are no data that systemic steroids are safe and effective in long-term treatment of psoriasis, said Dr. Joel Gelfand, one of the authors of the American Academy of Dermatology’s psoriasis guidelines, who was not involved in the analysis.

But, in reality, physicians do prescribe systemic steroids from time to time, especially when the patients are acutely flaring, said Dr. Gelfand, of the University of Pennsylvania in Philadelphia. "The general consensus is that it’s not a good thing to do. But sometimes the practitioners are stuck, and there are no other options for patients," he said in an interview.

Also, he added, not everyone follows the guidelines.

To analyze the prescription of steroids, Mr. Al-Dabagh and his colleagues used data from the National Ambulatory Medical Care Survey (NAMCS) from 1989 to 2010. In addition to showing that 90% of the systemic steroid prescriptions for psoriasis were written by dermatologists, the results indicated that three of the nine systemic therapies prescribed were steroids. Prednisone was ranked fourth among the nine therapies, and ranked first among the three systemic steroids, followed by methylprednisolone and dexamethasone.

In addition, no significant change was observed in the use of systemic steroids over the 11-year study period.

The poster’s findings are similar to the results of a 2011 German study that showed that systemic steroids are often used to treat psoriasis, although this treatment is not recommended in the European guidelines. The majority of prescribers in the German study were general practitioners and internists in Europe (J. Dtsch. Dermatol. Ges. 2011;9:833-8).

"If the dogma were true that systemic corticosteroids are frequently associated with severe exacerbations of the disease, then with the wide use of corticosteroids both for psoriasis and for comorbidities of psoriasis, we would expect that large numbers of patients would be seen for major problems such as precipitation, worsening, or rebound of their psoriasis. However, this has not been reported in the literature," Mr. Al-Dabagh and his colleagues wrote.

Academic dermatologists only see patients who aren’t cured by the physicians who prescribe the medications, which results in a selection bias where only the worst cases are seen in academia, the researchers noted. "This phenomenon may explain how steroids may be effective even though ‘everybody knows they don’t work,’ " they added.

Dr. Steven R. Feldman, senior author of the analysis and professor of dermatology at Wake Forest University, said that he and colleagues agreed with the current guidelines, but clinical trials of steroids for psoriasis would be helpful. "Avoiding systemic steroids in psoriasis is dogma, but is not supported by a strong scientific rationale," he said.

"There are long-term side effects from chronic use of systemic steroids, but we can say that about nearly all the treatments we use. The concerns about rebound from short-term use for psoriasis may be overblown as well," he added.

The debate on the use of systemic steroids for treatment of psoriasis is ongoing. Authors of a 2012 European study tried to parse out fact from fiction regarding the treatment and the condition. "There’s a remarkable lack of literature addressing adverse effects such as rebound, pustular, or erythrodermic flares or even new occurrence of psoriasis in patients with a negative disease history," the authors wrote. "A re-evaluation of the treatment of psoriasis and/or psoriatic arthritis with systemic steroids is necessary," the authors concluded (J. Eur. Acad. Dermatol. Venereol. 2012 Jul 25 [doi: 10.1111/j.1468-3083.2012.04656.x]).

More research is needed in the form of double-blind, controlled trials, Mr. Al-Dabagh said.

Mr. Al-Dabagh had no disclosures. Dr. Gelfand had no disclosures. Dr. Feldman said he had relationships with several pharmaceutical companies, but none produced systemic steroids.

ORLANDO – Although current guidelines do not recommend the use of systemic steroids for treatment of psoriasis, dermatologists still prescribe them, according to data presented at the Orlando Dermatology Aesthetic and Clinical Conference.

Researchers at Wake Forest University in Winston-Salem, N.C., analyzed a national database and found that U.S. dermatologists wrote more than 90% of the nearly 660,000 systemic steroid prescriptions for psoriasis over an 11-year period.

The authors concluded that the usefulness of systemic steroids for psoriasis should be reexamined in light of their findings.

"This is an issue that has been buried for a while," said Amir Al-Dabagh, the study’s first author and a fourth-year medical student at Wake Forest University. "Everyone knows it’s there, but it’s not discussed," he said.

Systemic steroids are not recommended for treatment of psoriasis because of evidence that discontinuing the drugs could lead to a rebound flair, sometimes beyond the baseline.

In addition, there are no data that systemic steroids are safe and effective in long-term treatment of psoriasis, said Dr. Joel Gelfand, one of the authors of the American Academy of Dermatology’s psoriasis guidelines, who was not involved in the analysis.

But, in reality, physicians do prescribe systemic steroids from time to time, especially when the patients are acutely flaring, said Dr. Gelfand, of the University of Pennsylvania in Philadelphia. "The general consensus is that it’s not a good thing to do. But sometimes the practitioners are stuck, and there are no other options for patients," he said in an interview.

Also, he added, not everyone follows the guidelines.

To analyze the prescription of steroids, Mr. Al-Dabagh and his colleagues used data from the National Ambulatory Medical Care Survey (NAMCS) from 1989 to 2010. In addition to showing that 90% of the systemic steroid prescriptions for psoriasis were written by dermatologists, the results indicated that three of the nine systemic therapies prescribed were steroids. Prednisone was ranked fourth among the nine therapies, and ranked first among the three systemic steroids, followed by methylprednisolone and dexamethasone.

In addition, no significant change was observed in the use of systemic steroids over the 11-year study period.

The poster’s findings are similar to the results of a 2011 German study that showed that systemic steroids are often used to treat psoriasis, although this treatment is not recommended in the European guidelines. The majority of prescribers in the German study were general practitioners and internists in Europe (J. Dtsch. Dermatol. Ges. 2011;9:833-8).

"If the dogma were true that systemic corticosteroids are frequently associated with severe exacerbations of the disease, then with the wide use of corticosteroids both for psoriasis and for comorbidities of psoriasis, we would expect that large numbers of patients would be seen for major problems such as precipitation, worsening, or rebound of their psoriasis. However, this has not been reported in the literature," Mr. Al-Dabagh and his colleagues wrote.

Academic dermatologists only see patients who aren’t cured by the physicians who prescribe the medications, which results in a selection bias where only the worst cases are seen in academia, the researchers noted. "This phenomenon may explain how steroids may be effective even though ‘everybody knows they don’t work,’ " they added.

Dr. Steven R. Feldman, senior author of the analysis and professor of dermatology at Wake Forest University, said that he and colleagues agreed with the current guidelines, but clinical trials of steroids for psoriasis would be helpful. "Avoiding systemic steroids in psoriasis is dogma, but is not supported by a strong scientific rationale," he said.

"There are long-term side effects from chronic use of systemic steroids, but we can say that about nearly all the treatments we use. The concerns about rebound from short-term use for psoriasis may be overblown as well," he added.

The debate on the use of systemic steroids for treatment of psoriasis is ongoing. Authors of a 2012 European study tried to parse out fact from fiction regarding the treatment and the condition. "There’s a remarkable lack of literature addressing adverse effects such as rebound, pustular, or erythrodermic flares or even new occurrence of psoriasis in patients with a negative disease history," the authors wrote. "A re-evaluation of the treatment of psoriasis and/or psoriatic arthritis with systemic steroids is necessary," the authors concluded (J. Eur. Acad. Dermatol. Venereol. 2012 Jul 25 [doi: 10.1111/j.1468-3083.2012.04656.x]).

More research is needed in the form of double-blind, controlled trials, Mr. Al-Dabagh said.

Mr. Al-Dabagh had no disclosures. Dr. Gelfand had no disclosures. Dr. Feldman said he had relationships with several pharmaceutical companies, but none produced systemic steroids.

Atherosclerosis may be an inherent part of aging and not so much the result of diet or lifestyle. At least that's what 4,000 years of human history told through mummies is showing.

The modern human's life expectancy has doubled over the past 200 years, and, during that time, atherosclerotic vascular disease has replaced infectious disease as the leading cause of death in the developed world, according to researchers. But when did this disease begin to leave its mark on human history? Is atherosclerosis the result of hours sitting behind a desk and eating fast food on the way home, or could it be a result of higher socioeconomic status? Or could atherosclerosis just be a disease of aging, having affected humans all along?

Courtesy Wikimedia Commons/Klafubra/Creative Commons License

To find the answer, an international group of scientists selected 137 mummies from four different geographical regions. They called the study Horus, named after one of the oldest and most significant Egyptian deities. The scientists studied whole-body CT scans of 76 mummies from ancient Egypt, 51 from Peru, 5 Ancestral Puebloans of southwest America, and 5 Unangan mummies from the Aleutian Islands of modern day Alaska. The study results were presented at the annual meeting of the American College of Cardiology and published online March 10 in the Lancet (doi: 10.1016/SO140-6736(13)60598-X). 

These hunter-gatherer-farmers not only lived in different parts of the world, and under different conditions, but also had a wide range of diets. For instance, while the Egyptians ate wheat, barley, beans, domesticated cattle, and quail, the Unangans mostly ate seafood.

After seven experienced cardiovascular imaging physicians interpreted the CT scans, looking for presence or absence of calcification in the vessel walls and the heart, they found that 34% of all the mummies had atherosclerosis – 38% of the ancient Egyptians, 25% of the ancient Peruvians, 40% of the Ancestral Peubloans, and 60% of the Unangans.

The findings also found that the older mummies had higher odds of atherosclerosis, and in a more severe form. The mean age of death for mummies with the vascular disease was 43 years old, compared with 32 years old for those without the disease (P less than 0.0001). Also, mummies with a mean age of 42 years had atherosclerosis in one or two vascular beds, while those with a mean age of 44 years old had the disease in three to five beds (P less than 0.0001).

So what does this mean for today's diet-obsessed society? "Our understanding of the causative factors of atherosclerosis is incomplete, and that atherosclerosis could be inherent to the process of human aging," wrote researchers, led by Dr. Randall C. Thompson of University of Missouri-Kansas City School of Medicine, Kansas City, MO.

The findings are also significant because previous research that had uncovered atherosclerosis in Egyptian mummies had proposed that the disease may have been due to higher socioeconomic status, and, hence, diets rich in saturated fat. "The fact that we found similar levels of atherosclerosis in all of the different cultures we studied, all of whom had very different lifestyles and diets, suggests that atherosclerosis may have been far more common in the ancient world than previously thought," said  Dr. Thompson in a news release from the LANCET.

There are caveats and other variables to consider, of course. 

For one, all the populations lived at a time when infection was a major cause of death. And, as found in modern humans, high level of chronic infection and inflammation might have promoted the inflammatory aspects of atherosclerosis, the authors noted. 

Also, researchers used calcification as a marker of atherosclerosis, but didn't have pathological confirmation of the disease. "However, arterial calcifications on imaging studies in patients are deemed characteristic for clinical atherosclerosis," they wrote. In addition, the calcification occurred at the same location as in modern humans and appearance was the same. 

The quality of soft tissue preservation varied among the mummies; some of the mummies, especially those from Egypt, had undergone artificial mummification, a process during which some of their vessels and organs had been removed. 

The authors also acknowledged that their sample size represented a wide cross-section of four cultures, but lacked the "statistical power to adequately compare potential differences in the incidence and severity of atherosclerosis between men and women, and between different cultures."

However, the study has for the first time, shown that the disease was common in several ancient cultures so different from each other, and the "findings greatly increase the number of ancient people known to have atherosclerosis," the researchers wrote.

The study was funded by the National Endowment for the Humanities, the Paleocardiology Foundation, the National Bank of Egypt, Siemens, and St. Luke’s Hospital Foundation of Kansas City. The authors said that they had no conflicts of interest. They said the sponsors of the study had no role in study design, data collection, primary data analysis, data interpretation, or writing of the report. 

--Naseem S. Miller (@NaseemSMiller)

Atherosclerosis may be an inherent part of aging and not so much the result of diet or lifestyle. At least that's what 4,000 years of human history told through mummies is showing.

The modern human's life expectancy has doubled over the past 200 years, and, during that time, atherosclerotic vascular disease has replaced infectious disease as the leading cause of death in the developed world, according to researchers. But when did this disease begin to leave its mark on human history? Is atherosclerosis the result of hours sitting behind a desk and eating fast food on the way home, or could it be a result of higher socioeconomic status? Or could atherosclerosis just be a disease of aging, having affected humans all along?

Courtesy Wikimedia Commons/Klafubra/Creative Commons License

To find the answer, an international group of scientists selected 137 mummies from four different geographical regions. They called the study Horus, named after one of the oldest and most significant Egyptian deities. The scientists studied whole-body CT scans of 76 mummies from ancient Egypt, 51 from Peru, 5 Ancestral Puebloans of southwest America, and 5 Unangan mummies from the Aleutian Islands of modern day Alaska. The study results were presented at the annual meeting of the American College of Cardiology and published online March 10 in the Lancet (doi: 10.1016/SO140-6736(13)60598-X). 

These hunter-gatherer-farmers not only lived in different parts of the world, and under different conditions, but also had a wide range of diets. For instance, while the Egyptians ate wheat, barley, beans, domesticated cattle, and quail, the Unangans mostly ate seafood.

After seven experienced cardiovascular imaging physicians interpreted the CT scans, looking for presence or absence of calcification in the vessel walls and the heart, they found that 34% of all the mummies had atherosclerosis – 38% of the ancient Egyptians, 25% of the ancient Peruvians, 40% of the Ancestral Peubloans, and 60% of the Unangans.

The findings also found that the older mummies had higher odds of atherosclerosis, and in a more severe form. The mean age of death for mummies with the vascular disease was 43 years old, compared with 32 years old for those without the disease (P less than 0.0001). Also, mummies with a mean age of 42 years had atherosclerosis in one or two vascular beds, while those with a mean age of 44 years old had the disease in three to five beds (P less than 0.0001).

So what does this mean for today's diet-obsessed society? "Our understanding of the causative factors of atherosclerosis is incomplete, and that atherosclerosis could be inherent to the process of human aging," wrote researchers, led by Dr. Randall C. Thompson of University of Missouri-Kansas City School of Medicine, Kansas City, MO.

The findings are also significant because previous research that had uncovered atherosclerosis in Egyptian mummies had proposed that the disease may have been due to higher socioeconomic status, and, hence, diets rich in saturated fat. "The fact that we found similar levels of atherosclerosis in all of the different cultures we studied, all of whom had very different lifestyles and diets, suggests that atherosclerosis may have been far more common in the ancient world than previously thought," said  Dr. Thompson in a news release from the LANCET.

There are caveats and other variables to consider, of course. 

For one, all the populations lived at a time when infection was a major cause of death. And, as found in modern humans, high level of chronic infection and inflammation might have promoted the inflammatory aspects of atherosclerosis, the authors noted. 

Also, researchers used calcification as a marker of atherosclerosis, but didn't have pathological confirmation of the disease. "However, arterial calcifications on imaging studies in patients are deemed characteristic for clinical atherosclerosis," they wrote. In addition, the calcification occurred at the same location as in modern humans and appearance was the same. 

The quality of soft tissue preservation varied among the mummies; some of the mummies, especially those from Egypt, had undergone artificial mummification, a process during which some of their vessels and organs had been removed. 

The authors also acknowledged that their sample size represented a wide cross-section of four cultures, but lacked the "statistical power to adequately compare potential differences in the incidence and severity of atherosclerosis between men and women, and between different cultures."

However, the study has for the first time, shown that the disease was common in several ancient cultures so different from each other, and the "findings greatly increase the number of ancient people known to have atherosclerosis," the researchers wrote.

The study was funded by the National Endowment for the Humanities, the Paleocardiology Foundation, the National Bank of Egypt, Siemens, and St. Luke’s Hospital Foundation of Kansas City. The authors said that they had no conflicts of interest. They said the sponsors of the study had no role in study design, data collection, primary data analysis, data interpretation, or writing of the report. 

--Naseem S. Miller (@NaseemSMiller)

Atherosclerosis may be an inherent part of aging and not so much the result of diet or lifestyle. At least that's what 4,000 years of human history told through mummies is showing.

The modern human's life expectancy has doubled over the past 200 years, and, during that time, atherosclerotic vascular disease has replaced infectious disease as the leading cause of death in the developed world, according to researchers. But when did this disease begin to leave its mark on human history? Is atherosclerosis the result of hours sitting behind a desk and eating fast food on the way home, or could it be a result of higher socioeconomic status? Or could atherosclerosis just be a disease of aging, having affected humans all along?

Courtesy Wikimedia Commons/Klafubra/Creative Commons License

To find the answer, an international group of scientists selected 137 mummies from four different geographical regions. They called the study Horus, named after one of the oldest and most significant Egyptian deities. The scientists studied whole-body CT scans of 76 mummies from ancient Egypt, 51 from Peru, 5 Ancestral Puebloans of southwest America, and 5 Unangan mummies from the Aleutian Islands of modern day Alaska. The study results were presented at the annual meeting of the American College of Cardiology and published online March 10 in the Lancet (doi: 10.1016/SO140-6736(13)60598-X). 

These hunter-gatherer-farmers not only lived in different parts of the world, and under different conditions, but also had a wide range of diets. For instance, while the Egyptians ate wheat, barley, beans, domesticated cattle, and quail, the Unangans mostly ate seafood.

After seven experienced cardiovascular imaging physicians interpreted the CT scans, looking for presence or absence of calcification in the vessel walls and the heart, they found that 34% of all the mummies had atherosclerosis – 38% of the ancient Egyptians, 25% of the ancient Peruvians, 40% of the Ancestral Peubloans, and 60% of the Unangans.

The findings also found that the older mummies had higher odds of atherosclerosis, and in a more severe form. The mean age of death for mummies with the vascular disease was 43 years old, compared with 32 years old for those without the disease (P less than 0.0001). Also, mummies with a mean age of 42 years had atherosclerosis in one or two vascular beds, while those with a mean age of 44 years old had the disease in three to five beds (P less than 0.0001).

So what does this mean for today's diet-obsessed society? "Our understanding of the causative factors of atherosclerosis is incomplete, and that atherosclerosis could be inherent to the process of human aging," wrote researchers, led by Dr. Randall C. Thompson of University of Missouri-Kansas City School of Medicine, Kansas City, MO.

The findings are also significant because previous research that had uncovered atherosclerosis in Egyptian mummies had proposed that the disease may have been due to higher socioeconomic status, and, hence, diets rich in saturated fat. "The fact that we found similar levels of atherosclerosis in all of the different cultures we studied, all of whom had very different lifestyles and diets, suggests that atherosclerosis may have been far more common in the ancient world than previously thought," said  Dr. Thompson in a news release from the LANCET.

There are caveats and other variables to consider, of course. 

For one, all the populations lived at a time when infection was a major cause of death. And, as found in modern humans, high level of chronic infection and inflammation might have promoted the inflammatory aspects of atherosclerosis, the authors noted. 

Also, researchers used calcification as a marker of atherosclerosis, but didn't have pathological confirmation of the disease. "However, arterial calcifications on imaging studies in patients are deemed characteristic for clinical atherosclerosis," they wrote. In addition, the calcification occurred at the same location as in modern humans and appearance was the same. 

The quality of soft tissue preservation varied among the mummies; some of the mummies, especially those from Egypt, had undergone artificial mummification, a process during which some of their vessels and organs had been removed. 

The authors also acknowledged that their sample size represented a wide cross-section of four cultures, but lacked the "statistical power to adequately compare potential differences in the incidence and severity of atherosclerosis between men and women, and between different cultures."

However, the study has for the first time, shown that the disease was common in several ancient cultures so different from each other, and the "findings greatly increase the number of ancient people known to have atherosclerosis," the researchers wrote.

The study was funded by the National Endowment for the Humanities, the Paleocardiology Foundation, the National Bank of Egypt, Siemens, and St. Luke’s Hospital Foundation of Kansas City. The authors said that they had no conflicts of interest. They said the sponsors of the study had no role in study design, data collection, primary data analysis, data interpretation, or writing of the report. 

--Naseem S. Miller (@NaseemSMiller)

ORLANDO – Adding dasatinib to standard-of-care chemotherapy led to a modest delay in skeletal-related events but did not improve overall survival for patients with metastatic castrate-resistant prostate cancer in the READY trial.

Dasatinib, a tyrosine kinase inhibitor, showed promising results in phase I and II studies, but fell short in READY, a multinational randomized double-blinded, placebo-controlled study, sponsored by Bristol-Myers Squibb.

With no difference in overall survival and no meaningful changes in the study\'s secondary endpoints, the search continues for treatments for this group of patients whose current options are mostly palliative with modest improvements in survival. The observed delay in skeletal-related events with dasatinib (Sprycel) is being further investigated, said the study’s lead author, Dr. John C. Araujo of the University of Texas MD Anderson Cancer Center, Houston.

In READY, 1,522 patients were randomized to receive docetaxel (75 mg/m², three times a week) plus prednisone and either 100 mg daily of dasatinib (762 patients), or placebo (760 patients).

There were no meaningful differences in the demographics or disease characteristics of the two study arms. Patients were treated until disease progression or they had unacceptable toxicity.

The primary endpoint of the study was overall survival. The secondary endpoints were objective response rates, time to first skeletal-related event, time to prostate-specific antigen progression, urinary N-telopeptide (uNTx) reduction, pain reduction, progression-free survival, and safety.

Overall survival was 21.5 months in the dasatinib group and 21.2 months in the placebo group (hazard ratio, 0.99; P = .90). Comparably similar outcomes were seen in secondary endpoints for dasatinib vs. placebo arm: objective response rates were 30.5% and 31.9%, respectively; median time to prostate-specific antigen progression was 8 months vs. 7.6 months; uNTx reduction was 66% v. 60.6%; pain reduction was 66.6% v. 71.5%; progression-free survival was 11.8 months v. 11.1 months.

The one exception was median time to first skeletal event, which was not reached in the dasatinib group and was in 31.1 months for the placebo group.

Dr. William Oh, chief of hematology and medical oncology at Tisch Cancer Institute and the Mount Sinai School of Medicine, New York, commented that "about two-thirds of the patients were not on bisphosphonates, which may explain why there was a trend toward a benefit in terms of (skeletal-related events)" in the dasatinib arm.

Dr. Araujo reported there were no unexpected safety findings and no unanticipated events. Patients came off the trial for similar reasons in both arms, including disease progression and maximum clinical benefit. Adverse events related to treatment included diarrhea, fatigue, alopecia, and nausea and occurred in 18% of patients in the dasatinib arm and in 9% in the placebo arm. Grade 3-4 adverse events of interest included anemia (8% vs. 5.9% in placebo), neutropenia (6.2 % vs. 5.5%), hypocalcemia (3.5% vs. 3.1%), gastrointestinal bleeding (2.6% vs. 1.3%), and pleural effusion (1.3 vs. 0.4%).

Dr. Araujo has received research funding from Bristol-Myers Squibb, the maker of Sprycel and sponsor of the trial. Dr. Oh has been consultant or adviser for Amgen, Astellas Pharma, Bayer, Bellicum Pharmaceuticals, Dendreon, Janssen Biotech, Medivation, and Pfizer. He has received research funding from Millennium.

The symposium was sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

ORLANDO – Adding dasatinib to standard-of-care chemotherapy led to a modest delay in skeletal-related events but did not improve overall survival for patients with metastatic castrate-resistant prostate cancer in the READY trial.

Dasatinib, a tyrosine kinase inhibitor, showed promising results in phase I and II studies, but fell short in READY, a multinational randomized double-blinded, placebo-controlled study, sponsored by Bristol-Myers Squibb.

With no difference in overall survival and no meaningful changes in the study\'s secondary endpoints, the search continues for treatments for this group of patients whose current options are mostly palliative with modest improvements in survival. The observed delay in skeletal-related events with dasatinib (Sprycel) is being further investigated, said the study’s lead author, Dr. John C. Araujo of the University of Texas MD Anderson Cancer Center, Houston.

In READY, 1,522 patients were randomized to receive docetaxel (75 mg/m², three times a week) plus prednisone and either 100 mg daily of dasatinib (762 patients), or placebo (760 patients).

There were no meaningful differences in the demographics or disease characteristics of the two study arms. Patients were treated until disease progression or they had unacceptable toxicity.

The primary endpoint of the study was overall survival. The secondary endpoints were objective response rates, time to first skeletal-related event, time to prostate-specific antigen progression, urinary N-telopeptide (uNTx) reduction, pain reduction, progression-free survival, and safety.

Overall survival was 21.5 months in the dasatinib group and 21.2 months in the placebo group (hazard ratio, 0.99; P = .90). Comparably similar outcomes were seen in secondary endpoints for dasatinib vs. placebo arm: objective response rates were 30.5% and 31.9%, respectively; median time to prostate-specific antigen progression was 8 months vs. 7.6 months; uNTx reduction was 66% v. 60.6%; pain reduction was 66.6% v. 71.5%; progression-free survival was 11.8 months v. 11.1 months.

The one exception was median time to first skeletal event, which was not reached in the dasatinib group and was in 31.1 months for the placebo group.

Dr. William Oh, chief of hematology and medical oncology at Tisch Cancer Institute and the Mount Sinai School of Medicine, New York, commented that "about two-thirds of the patients were not on bisphosphonates, which may explain why there was a trend toward a benefit in terms of (skeletal-related events)" in the dasatinib arm.

Dr. Araujo reported there were no unexpected safety findings and no unanticipated events. Patients came off the trial for similar reasons in both arms, including disease progression and maximum clinical benefit. Adverse events related to treatment included diarrhea, fatigue, alopecia, and nausea and occurred in 18% of patients in the dasatinib arm and in 9% in the placebo arm. Grade 3-4 adverse events of interest included anemia (8% vs. 5.9% in placebo), neutropenia (6.2 % vs. 5.5%), hypocalcemia (3.5% vs. 3.1%), gastrointestinal bleeding (2.6% vs. 1.3%), and pleural effusion (1.3 vs. 0.4%).

Dr. Araujo has received research funding from Bristol-Myers Squibb, the maker of Sprycel and sponsor of the trial. Dr. Oh has been consultant or adviser for Amgen, Astellas Pharma, Bayer, Bellicum Pharmaceuticals, Dendreon, Janssen Biotech, Medivation, and Pfizer. He has received research funding from Millennium.

The symposium was sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

ORLANDO – Adding dasatinib to standard-of-care chemotherapy led to a modest delay in skeletal-related events but did not improve overall survival for patients with metastatic castrate-resistant prostate cancer in the READY trial.

Dasatinib, a tyrosine kinase inhibitor, showed promising results in phase I and II studies, but fell short in READY, a multinational randomized double-blinded, placebo-controlled study, sponsored by Bristol-Myers Squibb.

With no difference in overall survival and no meaningful changes in the study\'s secondary endpoints, the search continues for treatments for this group of patients whose current options are mostly palliative with modest improvements in survival. The observed delay in skeletal-related events with dasatinib (Sprycel) is being further investigated, said the study’s lead author, Dr. John C. Araujo of the University of Texas MD Anderson Cancer Center, Houston.

In READY, 1,522 patients were randomized to receive docetaxel (75 mg/m², three times a week) plus prednisone and either 100 mg daily of dasatinib (762 patients), or placebo (760 patients).

There were no meaningful differences in the demographics or disease characteristics of the two study arms. Patients were treated until disease progression or they had unacceptable toxicity.

The primary endpoint of the study was overall survival. The secondary endpoints were objective response rates, time to first skeletal-related event, time to prostate-specific antigen progression, urinary N-telopeptide (uNTx) reduction, pain reduction, progression-free survival, and safety.

Overall survival was 21.5 months in the dasatinib group and 21.2 months in the placebo group (hazard ratio, 0.99; P = .90). Comparably similar outcomes were seen in secondary endpoints for dasatinib vs. placebo arm: objective response rates were 30.5% and 31.9%, respectively; median time to prostate-specific antigen progression was 8 months vs. 7.6 months; uNTx reduction was 66% v. 60.6%; pain reduction was 66.6% v. 71.5%; progression-free survival was 11.8 months v. 11.1 months.

The one exception was median time to first skeletal event, which was not reached in the dasatinib group and was in 31.1 months for the placebo group.

Dr. William Oh, chief of hematology and medical oncology at Tisch Cancer Institute and the Mount Sinai School of Medicine, New York, commented that "about two-thirds of the patients were not on bisphosphonates, which may explain why there was a trend toward a benefit in terms of (skeletal-related events)" in the dasatinib arm.

Dr. Araujo reported there were no unexpected safety findings and no unanticipated events. Patients came off the trial for similar reasons in both arms, including disease progression and maximum clinical benefit. Adverse events related to treatment included diarrhea, fatigue, alopecia, and nausea and occurred in 18% of patients in the dasatinib arm and in 9% in the placebo arm. Grade 3-4 adverse events of interest included anemia (8% vs. 5.9% in placebo), neutropenia (6.2 % vs. 5.5%), hypocalcemia (3.5% vs. 3.1%), gastrointestinal bleeding (2.6% vs. 1.3%), and pleural effusion (1.3 vs. 0.4%).

Dr. Araujo has received research funding from Bristol-Myers Squibb, the maker of Sprycel and sponsor of the trial. Dr. Oh has been consultant or adviser for Amgen, Astellas Pharma, Bayer, Bellicum Pharmaceuticals, Dendreon, Janssen Biotech, Medivation, and Pfizer. He has received research funding from Millennium.

The symposium was sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Urologic Oncology.

Adding aflibercept to docetaxel and prednisone did not boost survival times and nearly doubled the rate of grade 3-4 adverse events, compared with docetaxel and prednisone alone in men with metastatic castration-resistant prostate cancer.

The results of the phase III VENICE trial are yet another negative outcome for a regimen that adds a targeted agent to the standard first-line chemotherapy for metastatic castration-resistant prostate cancer (mCRPC), said lead author Dr. Ian Tannock, professor at the University of Toronto and a medical oncologist at UHN Princess Margaret Cancer Center, Toronto.

Aflibercept is a potent anti-angiogenic agent that binds to VEGF-A, VEGF-B, and placental growth factor (PfGF), he said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology.

Although 866 articles in PubMed have linked VEGF to prostate cancer, targeting VEGF in clinical trials has failed so far, commented Dr. William Oh, who was not involved in the study. Dr. Oh is chief of hematology and medical oncology at Tisch Cancer Institute and Icahn School of Medicine at Mount Sinai, New York.

In the VENICE (Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer) study, researchers randomized 1,224 patients with mCRPC treated with docetaxel (75 mg/m² IV every 3 weeks) and oral prednisone (5 mg, given twice a day) to receive placebo or aflibercept (6 mg/kg every 3 weeks). The aflibercept had a median of seven cycles of therapy and the placebo group had a median of eight cycles.

The patients’ median age was 68 years, and their baseline characteristics were similar in each arm of the study. Most of the patients had a European Cooperative Oncology Group (ECOG) performance status of 0 or 1 and had received three or more hormonal therapies.

The primary end point was overall survival. Secondary end points included PSA response, time to occurrence of skeletal-related events, and progression free survival. By the median follow-up time of 3 years, 873 patients had died.

Overall survival was nearly identical between the two arms: 22.1 months in aflibercept arm vs. 21.2 months in placebo (hazard ratio = 0.94; P = .38).

The secondary end points were either nearly equal between the two arms or favored the placebo arm: PSA response was 68.6% in aflibercept arm vs. 63.5% for placebo (P = 0.075); time to skeletal-related event was 15.3 months for aflibercept vs. 15.0 for placebo (HR = 0.94, P = .31); and progression-free survival was 6.9 months (aflibercept) vs. 6.2 (placebo).

Grade 3-4 adverse events occurred in 77% of the aflibercept group and 48% of the placebo group; adverse events led to discontinuation of therapy for 44% of the aflibercept group and 21% of the placebo group. Fatal adverse events occurred in 5.6% of patients in the aflibercept arm and in 3.3% in the placebo arm.

Adverse events included hypertension, stomatitis, appetite disorders, diarrhea, dehydration, epistaxis, dysphonia, cough, headache, and infections.

Dr. Tannock has received research funding from Sanofi, which funded the study along with Regeneron Pharmaceuticals. Dr. Oh has been a consultant or advisor for Amgen, Astellas Pharma, Bayer, Bellicum Pharmaceuticals, Dendreon, Janssen Biotech, Medivation, and Pfizer. He has received research funding from Millennium.

[email protected]

On Twitter @naseemsmiller

Adding aflibercept to docetaxel and prednisone did not boost survival times and nearly doubled the rate of grade 3-4 adverse events, compared with docetaxel and prednisone alone in men with metastatic castration-resistant prostate cancer.

The results of the phase III VENICE trial are yet another negative outcome for a regimen that adds a targeted agent to the standard first-line chemotherapy for metastatic castration-resistant prostate cancer (mCRPC), said lead author Dr. Ian Tannock, professor at the University of Toronto and a medical oncologist at UHN Princess Margaret Cancer Center, Toronto.

Aflibercept is a potent anti-angiogenic agent that binds to VEGF-A, VEGF-B, and placental growth factor (PfGF), he said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology.

Although 866 articles in PubMed have linked VEGF to prostate cancer, targeting VEGF in clinical trials has failed so far, commented Dr. William Oh, who was not involved in the study. Dr. Oh is chief of hematology and medical oncology at Tisch Cancer Institute and Icahn School of Medicine at Mount Sinai, New York.

In the VENICE (Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer) study, researchers randomized 1,224 patients with mCRPC treated with docetaxel (75 mg/m² IV every 3 weeks) and oral prednisone (5 mg, given twice a day) to receive placebo or aflibercept (6 mg/kg every 3 weeks). The aflibercept had a median of seven cycles of therapy and the placebo group had a median of eight cycles.

The patients’ median age was 68 years, and their baseline characteristics were similar in each arm of the study. Most of the patients had a European Cooperative Oncology Group (ECOG) performance status of 0 or 1 and had received three or more hormonal therapies.

The primary end point was overall survival. Secondary end points included PSA response, time to occurrence of skeletal-related events, and progression free survival. By the median follow-up time of 3 years, 873 patients had died.

Overall survival was nearly identical between the two arms: 22.1 months in aflibercept arm vs. 21.2 months in placebo (hazard ratio = 0.94; P = .38).

The secondary end points were either nearly equal between the two arms or favored the placebo arm: PSA response was 68.6% in aflibercept arm vs. 63.5% for placebo (P = 0.075); time to skeletal-related event was 15.3 months for aflibercept vs. 15.0 for placebo (HR = 0.94, P = .31); and progression-free survival was 6.9 months (aflibercept) vs. 6.2 (placebo).

Grade 3-4 adverse events occurred in 77% of the aflibercept group and 48% of the placebo group; adverse events led to discontinuation of therapy for 44% of the aflibercept group and 21% of the placebo group. Fatal adverse events occurred in 5.6% of patients in the aflibercept arm and in 3.3% in the placebo arm.

Adverse events included hypertension, stomatitis, appetite disorders, diarrhea, dehydration, epistaxis, dysphonia, cough, headache, and infections.

Dr. Tannock has received research funding from Sanofi, which funded the study along with Regeneron Pharmaceuticals. Dr. Oh has been a consultant or advisor for Amgen, Astellas Pharma, Bayer, Bellicum Pharmaceuticals, Dendreon, Janssen Biotech, Medivation, and Pfizer. He has received research funding from Millennium.

[email protected]

On Twitter @naseemsmiller

Adding aflibercept to docetaxel and prednisone did not boost survival times and nearly doubled the rate of grade 3-4 adverse events, compared with docetaxel and prednisone alone in men with metastatic castration-resistant prostate cancer.

The results of the phase III VENICE trial are yet another negative outcome for a regimen that adds a targeted agent to the standard first-line chemotherapy for metastatic castration-resistant prostate cancer (mCRPC), said lead author Dr. Ian Tannock, professor at the University of Toronto and a medical oncologist at UHN Princess Margaret Cancer Center, Toronto.

Aflibercept is a potent anti-angiogenic agent that binds to VEGF-A, VEGF-B, and placental growth factor (PfGF), he said at the annual Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology.

Although 866 articles in PubMed have linked VEGF to prostate cancer, targeting VEGF in clinical trials has failed so far, commented Dr. William Oh, who was not involved in the study. Dr. Oh is chief of hematology and medical oncology at Tisch Cancer Institute and Icahn School of Medicine at Mount Sinai, New York.

In the VENICE (Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer) study, researchers randomized 1,224 patients with mCRPC treated with docetaxel (75 mg/m² IV every 3 weeks) and oral prednisone (5 mg, given twice a day) to receive placebo or aflibercept (6 mg/kg every 3 weeks). The aflibercept had a median of seven cycles of therapy and the placebo group had a median of eight cycles.

The patients’ median age was 68 years, and their baseline characteristics were similar in each arm of the study. Most of the patients had a European Cooperative Oncology Group (ECOG) performance status of 0 or 1 and had received three or more hormonal therapies.

The primary end point was overall survival. Secondary end points included PSA response, time to occurrence of skeletal-related events, and progression free survival. By the median follow-up time of 3 years, 873 patients had died.

Overall survival was nearly identical between the two arms: 22.1 months in aflibercept arm vs. 21.2 months in placebo (hazard ratio = 0.94; P = .38).

The secondary end points were either nearly equal between the two arms or favored the placebo arm: PSA response was 68.6% in aflibercept arm vs. 63.5% for placebo (P = 0.075); time to skeletal-related event was 15.3 months for aflibercept vs. 15.0 for placebo (HR = 0.94, P = .31); and progression-free survival was 6.9 months (aflibercept) vs. 6.2 (placebo).

Grade 3-4 adverse events occurred in 77% of the aflibercept group and 48% of the placebo group; adverse events led to discontinuation of therapy for 44% of the aflibercept group and 21% of the placebo group. Fatal adverse events occurred in 5.6% of patients in the aflibercept arm and in 3.3% in the placebo arm.

Adverse events included hypertension, stomatitis, appetite disorders, diarrhea, dehydration, epistaxis, dysphonia, cough, headache, and infections.

Dr. Tannock has received research funding from Sanofi, which funded the study along with Regeneron Pharmaceuticals. Dr. Oh has been a consultant or advisor for Amgen, Astellas Pharma, Bayer, Bellicum Pharmaceuticals, Dendreon, Janssen Biotech, Medivation, and Pfizer. He has received research funding from Millennium.

[email protected]

On Twitter @naseemsmiller

MIAMI BEACH – ICD-11 is a better classification system for skin diseases and dermatologists should take the time now to help shape its final form.

For the 11th revision of the International Classification of Diseases, the chapter on skin diseases has been completely redesigned, said Dr. Robert J. G. Chalmers, co-chair and managing editor of the Dermatology Topic Advisory Group for ICD-11.

Now in its beta version, ICD-11 is assembled as a Wiki-like knowledge base: Its building blocks are "concepts," which may refer to a single disease, disorder or syndrome, or to a group of related disorders.

Each concept will have terms, explicit inclusion and exclusion rules, and hierarchical links to its "parents," "siblings," and "children."

The skin diseases chapter will have 21 major headings, each of which is subdivided into logical groupings and sub-groupings, Dr. Chalmers said at the annual meeting of the American Academy of Dermatology.

Unlike in ICD-10 – slated to be adopted in the United States next year – the web-based view of ICD-11 allows any one concept to have more than one logical parent. For instance, erythema nodosum leprosum can be displayed both as a form of cutaneous vasculitis and as a complication of leprosy. This "polyhierarchy" also enables diseases such as cutaneous infections and neoplasms to be displayed within the skin chapter even though their preferred location may reside within a different chapter.

The revisions will help dermatologists to better document diseases, care for their patients, and assist recruitment for clinical trials. "It’s a better way of capturing information," said Dr. Chalmers.

The ICD was first published in the late 1890s, and included a total of four codes for skin diseases: ulcer, bed-sore; eczema; pemphigus; and other diseases of the skin. But by the 5th edition, eczema and pemphigus had disappeared from the codes, leaving only carbuncle and boils; cellulitis, acute abscess and other diseases of the skin and cellular tissue, Dr. Chalmers said.

ICD-6, which was published in 1948, was entrusted to the newly-formed World Health Organization which continues to publish the code sets.

The 6th edition contained 60 skin diseases, but very little changed from that version until ICD-9, published in 1975.

ICD-9 is still used in the United States, and ICD-10, which was published in 1990 and introduced into clinical practice some 20 years ago in much of the world, is set to replace ICD-9 in the United States next year. The two versions are very similar and "for a dermatologist, ICD-10 remains crude and cumbersome instrument full of bizarre inconsistencies," said Dr. Chalmers, a consultant dermatologist at the University of Manchester, United Kingdom.

Plans for ICD-11 were announced by the WHO in 2007, and the revision is set for release in 2015.

Dr. Chalmers said that it will probably be at least 5 years from now before ICD-11 is available for clinical use. But given the timeline for implementation of ICD-10 in the United States, he said there is no telling when ICD-11 will be available here.

U.S. doctors have challenged the adoption of ICD-10 for several reasons such as having to establish new billing and collection systems, a need for staff training, and an expectation of lower reimbursement.

The American Academy of Dermatology Association, along with the American Medical Association, have urged the Centers for Medicare and Medicaid Services to skip over ICD-10 and wait to update the code set until ICD-11 becomes available. Their request has been declined.

In the meantime, Dr. Chalmers encouraged dermatologists to visit the ICD-11 beta version and share comments, proposals, and definitions, and to participate in field trials.

Dr. Chalmers had no relationships to disclose.

MIAMI BEACH – ICD-11 is a better classification system for skin diseases and dermatologists should take the time now to help shape its final form.

For the 11th revision of the International Classification of Diseases, the chapter on skin diseases has been completely redesigned, said Dr. Robert J. G. Chalmers, co-chair and managing editor of the Dermatology Topic Advisory Group for ICD-11.

Now in its beta version, ICD-11 is assembled as a Wiki-like knowledge base: Its building blocks are "concepts," which may refer to a single disease, disorder or syndrome, or to a group of related disorders.

Each concept will have terms, explicit inclusion and exclusion rules, and hierarchical links to its "parents," "siblings," and "children."

The skin diseases chapter will have 21 major headings, each of which is subdivided into logical groupings and sub-groupings, Dr. Chalmers said at the annual meeting of the American Academy of Dermatology.

Unlike in ICD-10 – slated to be adopted in the United States next year – the web-based view of ICD-11 allows any one concept to have more than one logical parent. For instance, erythema nodosum leprosum can be displayed both as a form of cutaneous vasculitis and as a complication of leprosy. This "polyhierarchy" also enables diseases such as cutaneous infections and neoplasms to be displayed within the skin chapter even though their preferred location may reside within a different chapter.

The revisions will help dermatologists to better document diseases, care for their patients, and assist recruitment for clinical trials. "It’s a better way of capturing information," said Dr. Chalmers.

The ICD was first published in the late 1890s, and included a total of four codes for skin diseases: ulcer, bed-sore; eczema; pemphigus; and other diseases of the skin. But by the 5th edition, eczema and pemphigus had disappeared from the codes, leaving only carbuncle and boils; cellulitis, acute abscess and other diseases of the skin and cellular tissue, Dr. Chalmers said.

ICD-6, which was published in 1948, was entrusted to the newly-formed World Health Organization which continues to publish the code sets.

The 6th edition contained 60 skin diseases, but very little changed from that version until ICD-9, published in 1975.

ICD-9 is still used in the United States, and ICD-10, which was published in 1990 and introduced into clinical practice some 20 years ago in much of the world, is set to replace ICD-9 in the United States next year. The two versions are very similar and "for a dermatologist, ICD-10 remains crude and cumbersome instrument full of bizarre inconsistencies," said Dr. Chalmers, a consultant dermatologist at the University of Manchester, United Kingdom.

Plans for ICD-11 were announced by the WHO in 2007, and the revision is set for release in 2015.

Dr. Chalmers said that it will probably be at least 5 years from now before ICD-11 is available for clinical use. But given the timeline for implementation of ICD-10 in the United States, he said there is no telling when ICD-11 will be available here.

U.S. doctors have challenged the adoption of ICD-10 for several reasons such as having to establish new billing and collection systems, a need for staff training, and an expectation of lower reimbursement.

The American Academy of Dermatology Association, along with the American Medical Association, have urged the Centers for Medicare and Medicaid Services to skip over ICD-10 and wait to update the code set until ICD-11 becomes available. Their request has been declined.

In the meantime, Dr. Chalmers encouraged dermatologists to visit the ICD-11 beta version and share comments, proposals, and definitions, and to participate in field trials.

Dr. Chalmers had no relationships to disclose.

MIAMI BEACH – ICD-11 is a better classification system for skin diseases and dermatologists should take the time now to help shape its final form.

For the 11th revision of the International Classification of Diseases, the chapter on skin diseases has been completely redesigned, said Dr. Robert J. G. Chalmers, co-chair and managing editor of the Dermatology Topic Advisory Group for ICD-11.

Now in its beta version, ICD-11 is assembled as a Wiki-like knowledge base: Its building blocks are "concepts," which may refer to a single disease, disorder or syndrome, or to a group of related disorders.

Each concept will have terms, explicit inclusion and exclusion rules, and hierarchical links to its "parents," "siblings," and "children."

The skin diseases chapter will have 21 major headings, each of which is subdivided into logical groupings and sub-groupings, Dr. Chalmers said at the annual meeting of the American Academy of Dermatology.

Unlike in ICD-10 – slated to be adopted in the United States next year – the web-based view of ICD-11 allows any one concept to have more than one logical parent. For instance, erythema nodosum leprosum can be displayed both as a form of cutaneous vasculitis and as a complication of leprosy. This "polyhierarchy" also enables diseases such as cutaneous infections and neoplasms to be displayed within the skin chapter even though their preferred location may reside within a different chapter.

The revisions will help dermatologists to better document diseases, care for their patients, and assist recruitment for clinical trials. "It’s a better way of capturing information," said Dr. Chalmers.

The ICD was first published in the late 1890s, and included a total of four codes for skin diseases: ulcer, bed-sore; eczema; pemphigus; and other diseases of the skin. But by the 5th edition, eczema and pemphigus had disappeared from the codes, leaving only carbuncle and boils; cellulitis, acute abscess and other diseases of the skin and cellular tissue, Dr. Chalmers said.

ICD-6, which was published in 1948, was entrusted to the newly-formed World Health Organization which continues to publish the code sets.

The 6th edition contained 60 skin diseases, but very little changed from that version until ICD-9, published in 1975.

ICD-9 is still used in the United States, and ICD-10, which was published in 1990 and introduced into clinical practice some 20 years ago in much of the world, is set to replace ICD-9 in the United States next year. The two versions are very similar and "for a dermatologist, ICD-10 remains crude and cumbersome instrument full of bizarre inconsistencies," said Dr. Chalmers, a consultant dermatologist at the University of Manchester, United Kingdom.

Plans for ICD-11 were announced by the WHO in 2007, and the revision is set for release in 2015.

Dr. Chalmers said that it will probably be at least 5 years from now before ICD-11 is available for clinical use. But given the timeline for implementation of ICD-10 in the United States, he said there is no telling when ICD-11 will be available here.

U.S. doctors have challenged the adoption of ICD-10 for several reasons such as having to establish new billing and collection systems, a need for staff training, and an expectation of lower reimbursement.

The American Academy of Dermatology Association, along with the American Medical Association, have urged the Centers for Medicare and Medicaid Services to skip over ICD-10 and wait to update the code set until ICD-11 becomes available. Their request has been declined.

In the meantime, Dr. Chalmers encouraged dermatologists to visit the ICD-11 beta version and share comments, proposals, and definitions, and to participate in field trials.

Dr. Chalmers had no relationships to disclose.

When patients with metastatic castration-resistant prostate cancer without prior chemotherapy were treated with abiraterone acetate plus prednisone, their risk of disease progression was reduced by almost half, and their risk of death was decreased by almost 20% compared with patients given prednisone alone, based on data from an interim analysis of the phase III trial COU-AA-302.

Treatment with both drugs also delayed times to opiate use and chemotherapy, was associated with improved quality of life measures, and remained safe and well tolerated, said Dr. Dana E. Rathkopf, the study’s lead author, who presented the results at the annual gastrointestinal cancers symposium sponsored by the American Society of Clinical Oncology. Results on quality of life measures were reported at last year’s European Society for Medical Oncology congress.

This was the third planned interim analysis for the randomized trial COU-AA-302, which is designed to evaluate the clinical benefit of abiraterone (Zytiga) and prednisone compared with prednisone alone in mildly symptomatic or asymptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy.

Similar to the findings at a previous interim analysis (43% of total overall survival events) conducted in December 2011, the third analysis (55% of overall survival events) continued to show that the radiographic progression-free survival (rPFS) in the abiraterone plus prednisone arm remained significant. Although overall survival continued to favor the abiraterone plus prednisone arm, it didn’t cross the boundary for significance.

"We may never get the answer to the question of whether prechemotherapy abiraterone can improve overall survival," commented Dr. William Oh, chief of hematology and medical oncology at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. "To me, that is okay as long as we still have evidence that [the drug has] meaningful value to patients" from a quality of life perspective.

For the COU-AA-302 trial, 1,088 patients were randomized to 1,000 mg/day of abiraterone plus 5 mg twice per day of prednisone or to the control arm of placebo plus prednisone. The treatment arms were evenly matched.

Coprimary endpoints were rPFS and overall survival. Secondary endpoints included time to opiate use, time to chemotherapy initiation, time to ECOG-PS (Eastern Cooperative Oncology Group–performance status) deterioration, and time to prostate-specific antigen (PSA) progression

At the third interim analysis, primary endpoints and all secondary endpoints favored the abiraterone and prednisone arm. The time to rPFS was doubled relative to the control arm (16.5 months and 8.3 months; HR = 0.53; P = .0001).

Overall survival was 35.3 months with abiraterone and prednisone versus 30.1 months with placebo and prednisone. The difference was not significantly different (HR = 0.79; P = .0151). Dr. Rathkopf and his colleagues pointed out that the median overall survival of 35.3 months is the longest reported for this mCRPC population.

Abiraterone plus prednisone also doubled the maximal decline in PSA compared with placebo and prednisone (11.1 months and 5.6 months; HR = 0.50; P = .0001). Prednisone is an active control therapy, as 29% of the patients in the control arm had a decline in PSA of greater than or equal to 50%, Dr. Rathkopf said.

The most common adverse event was fatigue. Beyond the 2 years since the study began, no new safety signals have emerged with abiraterone.

At a median follow-up of 27 months, 77% of the patients in the abiraterone and prednisone arm and 89% in the placebo and prednisone arm had discontinued therapy, mainly because of disease progression.

Dr. Rathkopf said he had no financial relationships to disclose. Dr. Oh has been a consultant or adviser to several drug makers including Janssen Biotech, the maker of Zytiga.

[email protected]

On Twitter @naseemsmiller

When patients with metastatic castration-resistant prostate cancer without prior chemotherapy were treated with abiraterone acetate plus prednisone, their risk of disease progression was reduced by almost half, and their risk of death was decreased by almost 20% compared with patients given prednisone alone, based on data from an interim analysis of the phase III trial COU-AA-302.

Treatment with both drugs also delayed times to opiate use and chemotherapy, was associated with improved quality of life measures, and remained safe and well tolerated, said Dr. Dana E. Rathkopf, the study’s lead author, who presented the results at the annual gastrointestinal cancers symposium sponsored by the American Society of Clinical Oncology. Results on quality of life measures were reported at last year’s European Society for Medical Oncology congress.

This was the third planned interim analysis for the randomized trial COU-AA-302, which is designed to evaluate the clinical benefit of abiraterone (Zytiga) and prednisone compared with prednisone alone in mildly symptomatic or asymptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy.

Similar to the findings at a previous interim analysis (43% of total overall survival events) conducted in December 2011, the third analysis (55% of overall survival events) continued to show that the radiographic progression-free survival (rPFS) in the abiraterone plus prednisone arm remained significant. Although overall survival continued to favor the abiraterone plus prednisone arm, it didn’t cross the boundary for significance.

"We may never get the answer to the question of whether prechemotherapy abiraterone can improve overall survival," commented Dr. William Oh, chief of hematology and medical oncology at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. "To me, that is okay as long as we still have evidence that [the drug has] meaningful value to patients" from a quality of life perspective.

For the COU-AA-302 trial, 1,088 patients were randomized to 1,000 mg/day of abiraterone plus 5 mg twice per day of prednisone or to the control arm of placebo plus prednisone. The treatment arms were evenly matched.

Coprimary endpoints were rPFS and overall survival. Secondary endpoints included time to opiate use, time to chemotherapy initiation, time to ECOG-PS (Eastern Cooperative Oncology Group–performance status) deterioration, and time to prostate-specific antigen (PSA) progression

At the third interim analysis, primary endpoints and all secondary endpoints favored the abiraterone and prednisone arm. The time to rPFS was doubled relative to the control arm (16.5 months and 8.3 months; HR = 0.53; P = .0001).

Overall survival was 35.3 months with abiraterone and prednisone versus 30.1 months with placebo and prednisone. The difference was not significantly different (HR = 0.79; P = .0151). Dr. Rathkopf and his colleagues pointed out that the median overall survival of 35.3 months is the longest reported for this mCRPC population.

Abiraterone plus prednisone also doubled the maximal decline in PSA compared with placebo and prednisone (11.1 months and 5.6 months; HR = 0.50; P = .0001). Prednisone is an active control therapy, as 29% of the patients in the control arm had a decline in PSA of greater than or equal to 50%, Dr. Rathkopf said.

The most common adverse event was fatigue. Beyond the 2 years since the study began, no new safety signals have emerged with abiraterone.

At a median follow-up of 27 months, 77% of the patients in the abiraterone and prednisone arm and 89% in the placebo and prednisone arm had discontinued therapy, mainly because of disease progression.

Dr. Rathkopf said he had no financial relationships to disclose. Dr. Oh has been a consultant or adviser to several drug makers including Janssen Biotech, the maker of Zytiga.

[email protected]

On Twitter @naseemsmiller

When patients with metastatic castration-resistant prostate cancer without prior chemotherapy were treated with abiraterone acetate plus prednisone, their risk of disease progression was reduced by almost half, and their risk of death was decreased by almost 20% compared with patients given prednisone alone, based on data from an interim analysis of the phase III trial COU-AA-302.

Treatment with both drugs also delayed times to opiate use and chemotherapy, was associated with improved quality of life measures, and remained safe and well tolerated, said Dr. Dana E. Rathkopf, the study’s lead author, who presented the results at the annual gastrointestinal cancers symposium sponsored by the American Society of Clinical Oncology. Results on quality of life measures were reported at last year’s European Society for Medical Oncology congress.

This was the third planned interim analysis for the randomized trial COU-AA-302, which is designed to evaluate the clinical benefit of abiraterone (Zytiga) and prednisone compared with prednisone alone in mildly symptomatic or asymptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC) without prior chemotherapy.

Similar to the findings at a previous interim analysis (43% of total overall survival events) conducted in December 2011, the third analysis (55% of overall survival events) continued to show that the radiographic progression-free survival (rPFS) in the abiraterone plus prednisone arm remained significant. Although overall survival continued to favor the abiraterone plus prednisone arm, it didn’t cross the boundary for significance.

"We may never get the answer to the question of whether prechemotherapy abiraterone can improve overall survival," commented Dr. William Oh, chief of hematology and medical oncology at the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. "To me, that is okay as long as we still have evidence that [the drug has] meaningful value to patients" from a quality of life perspective.

For the COU-AA-302 trial, 1,088 patients were randomized to 1,000 mg/day of abiraterone plus 5 mg twice per day of prednisone or to the control arm of placebo plus prednisone. The treatment arms were evenly matched.

Coprimary endpoints were rPFS and overall survival. Secondary endpoints included time to opiate use, time to chemotherapy initiation, time to ECOG-PS (Eastern Cooperative Oncology Group–performance status) deterioration, and time to prostate-specific antigen (PSA) progression

At the third interim analysis, primary endpoints and all secondary endpoints favored the abiraterone and prednisone arm. The time to rPFS was doubled relative to the control arm (16.5 months and 8.3 months; HR = 0.53; P = .0001).

Overall survival was 35.3 months with abiraterone and prednisone versus 30.1 months with placebo and prednisone. The difference was not significantly different (HR = 0.79; P = .0151). Dr. Rathkopf and his colleagues pointed out that the median overall survival of 35.3 months is the longest reported for this mCRPC population.

Abiraterone plus prednisone also doubled the maximal decline in PSA compared with placebo and prednisone (11.1 months and 5.6 months; HR = 0.50; P = .0001). Prednisone is an active control therapy, as 29% of the patients in the control arm had a decline in PSA of greater than or equal to 50%, Dr. Rathkopf said.

The most common adverse event was fatigue. Beyond the 2 years since the study began, no new safety signals have emerged with abiraterone.

At a median follow-up of 27 months, 77% of the patients in the abiraterone and prednisone arm and 89% in the placebo and prednisone arm had discontinued therapy, mainly because of disease progression.

Dr. Rathkopf said he had no financial relationships to disclose. Dr. Oh has been a consultant or adviser to several drug makers including Janssen Biotech, the maker of Zytiga.

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The Centers for Medicare and Medicaid Services is revisiting the National Coverage Determination for ventricular assist devices.

CMS is seeking public comment on the clinical evidence supporting identification of patients whose outcomes would improve with ventricular assist device (VAD) placement, health care teams, and hospital standards that would optimize patient outcomes, including evidence to support the current requirement for certification of hospitals implanting VADs for destination therapy.

CMS added that it is particularly interested in comments that include clinical studies and other scientific information that provides evidence for improvement in short-and long-erm outcomes with VADs.

"My own personal opinion is that it’s a good thing that they’ve reopened the NCD," said Dr. Lee Goldberg, medical director of the heart failure and transplantation program at the University of Pennsylvania, Philadelphia.

"For one, the technology has really changed, the experience of the centers and physicians have changed over time ... and the criteria to certify various centers and surgeons involved is somewhat archaic and arbitrary, so tightening that up in the context of updating evidence and approach makes sense." The challenge, he added, is that there’s not enough clinical data to answer all of the CMS questions and inquiries.

The NCD reopening, announced on Feb. 7, follows a Medicare advisory group meeting in November that aimed to review the available evidence on the management of heart failure using VADs, including the value of VAD-specific certification for various facilities, and patient selection and outcomes.

During the Medicare Advisory (MEDCAC) meeting, heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.

Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.

CMS will accept comments for 30 days on the reopened NCD, and various entities, including the American College of Cardiology, are expected to submit comments. "We want to make sure that we’re putting forth things that are most important to impact CMS decision making," said Dr. Goldberg, chair of the ACC’s heart failure and transplant council. "For instance, the appropriate certification of hospitals, appropriate utilization of a heart care team. ... Also, currently we know transplant is superior to VAD therapy for long-term survival and therefore we want to ensure that patients do have access to transplant evaluation."

The CMS review includes VADs used for bridge-to-transplant and as destination therapy. It does not include devices that are used for temporary, in-hospital use.

The reconsideration was requested by Det Norske Veritas Healthcare Inc. (DNV) to include the DNV mechanical circulatory support certification program as an acceptable credential for facilities that qualify for Medicare reimbursement.

The 140 U.S. centers that place LVADs were expected to implant nearly 3,000 devices in 2012. Nearly 4,600 patients have received an LVAD since 2010.

"I personally think that they’re going to try and tighten up [the requirements] a little bit," said Dr. Goldberg. "And try to understand who’s too sick, and where’s the appropriate cut-off, and to try and maximize or improve long-term outcomes for VAD patients. Whether they’ll be able to come up with something that’s better than what we have, I don’t know." It’s too soon to tell whether the NCD reconsideration will have an impact on procedure volumes, he added.

Dr. Goldberg and Dr. Pinney had no relevant disclosures.

[email protected]

On Twitter @NaseemSMiller

The Centers for Medicare and Medicaid Services is revisiting the National Coverage Determination for ventricular assist devices.

CMS is seeking public comment on the clinical evidence supporting identification of patients whose outcomes would improve with ventricular assist device (VAD) placement, health care teams, and hospital standards that would optimize patient outcomes, including evidence to support the current requirement for certification of hospitals implanting VADs for destination therapy.

CMS added that it is particularly interested in comments that include clinical studies and other scientific information that provides evidence for improvement in short-and long-erm outcomes with VADs.

"My own personal opinion is that it’s a good thing that they’ve reopened the NCD," said Dr. Lee Goldberg, medical director of the heart failure and transplantation program at the University of Pennsylvania, Philadelphia.

"For one, the technology has really changed, the experience of the centers and physicians have changed over time ... and the criteria to certify various centers and surgeons involved is somewhat archaic and arbitrary, so tightening that up in the context of updating evidence and approach makes sense." The challenge, he added, is that there’s not enough clinical data to answer all of the CMS questions and inquiries.

The NCD reopening, announced on Feb. 7, follows a Medicare advisory group meeting in November that aimed to review the available evidence on the management of heart failure using VADs, including the value of VAD-specific certification for various facilities, and patient selection and outcomes.

During the Medicare Advisory (MEDCAC) meeting, heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.

Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.

CMS will accept comments for 30 days on the reopened NCD, and various entities, including the American College of Cardiology, are expected to submit comments. "We want to make sure that we’re putting forth things that are most important to impact CMS decision making," said Dr. Goldberg, chair of the ACC’s heart failure and transplant council. "For instance, the appropriate certification of hospitals, appropriate utilization of a heart care team. ... Also, currently we know transplant is superior to VAD therapy for long-term survival and therefore we want to ensure that patients do have access to transplant evaluation."

The CMS review includes VADs used for bridge-to-transplant and as destination therapy. It does not include devices that are used for temporary, in-hospital use.

The reconsideration was requested by Det Norske Veritas Healthcare Inc. (DNV) to include the DNV mechanical circulatory support certification program as an acceptable credential for facilities that qualify for Medicare reimbursement.

The 140 U.S. centers that place LVADs were expected to implant nearly 3,000 devices in 2012. Nearly 4,600 patients have received an LVAD since 2010.

"I personally think that they’re going to try and tighten up [the requirements] a little bit," said Dr. Goldberg. "And try to understand who’s too sick, and where’s the appropriate cut-off, and to try and maximize or improve long-term outcomes for VAD patients. Whether they’ll be able to come up with something that’s better than what we have, I don’t know." It’s too soon to tell whether the NCD reconsideration will have an impact on procedure volumes, he added.

Dr. Goldberg and Dr. Pinney had no relevant disclosures.

[email protected]

On Twitter @NaseemSMiller

The Centers for Medicare and Medicaid Services is revisiting the National Coverage Determination for ventricular assist devices.

CMS is seeking public comment on the clinical evidence supporting identification of patients whose outcomes would improve with ventricular assist device (VAD) placement, health care teams, and hospital standards that would optimize patient outcomes, including evidence to support the current requirement for certification of hospitals implanting VADs for destination therapy.

CMS added that it is particularly interested in comments that include clinical studies and other scientific information that provides evidence for improvement in short-and long-erm outcomes with VADs.

"My own personal opinion is that it’s a good thing that they’ve reopened the NCD," said Dr. Lee Goldberg, medical director of the heart failure and transplantation program at the University of Pennsylvania, Philadelphia.

"For one, the technology has really changed, the experience of the centers and physicians have changed over time ... and the criteria to certify various centers and surgeons involved is somewhat archaic and arbitrary, so tightening that up in the context of updating evidence and approach makes sense." The challenge, he added, is that there’s not enough clinical data to answer all of the CMS questions and inquiries.

The NCD reopening, announced on Feb. 7, follows a Medicare advisory group meeting in November that aimed to review the available evidence on the management of heart failure using VADs, including the value of VAD-specific certification for various facilities, and patient selection and outcomes.

During the Medicare Advisory (MEDCAC) meeting, heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.

Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.

CMS will accept comments for 30 days on the reopened NCD, and various entities, including the American College of Cardiology, are expected to submit comments. "We want to make sure that we’re putting forth things that are most important to impact CMS decision making," said Dr. Goldberg, chair of the ACC’s heart failure and transplant council. "For instance, the appropriate certification of hospitals, appropriate utilization of a heart care team. ... Also, currently we know transplant is superior to VAD therapy for long-term survival and therefore we want to ensure that patients do have access to transplant evaluation."

The CMS review includes VADs used for bridge-to-transplant and as destination therapy. It does not include devices that are used for temporary, in-hospital use.

The reconsideration was requested by Det Norske Veritas Healthcare Inc. (DNV) to include the DNV mechanical circulatory support certification program as an acceptable credential for facilities that qualify for Medicare reimbursement.

The 140 U.S. centers that place LVADs were expected to implant nearly 3,000 devices in 2012. Nearly 4,600 patients have received an LVAD since 2010.

"I personally think that they’re going to try and tighten up [the requirements] a little bit," said Dr. Goldberg. "And try to understand who’s too sick, and where’s the appropriate cut-off, and to try and maximize or improve long-term outcomes for VAD patients. Whether they’ll be able to come up with something that’s better than what we have, I don’t know." It’s too soon to tell whether the NCD reconsideration will have an impact on procedure volumes, he added.

Dr. Goldberg and Dr. Pinney had no relevant disclosures.

[email protected]

On Twitter @NaseemSMiller

Two heart societies, a device maker, and two federal agencies have collaborated to develop a trial for transcatheter aortic valve replacement, once again extending the concept of teamwork, which is the cornerstone of this technology, far beyond the operating room walls.

During the past year, the Society of Thoracic Surgeons and the American College of Cardiology worked with the Food and Drug Administration, the Centers for Medicare and Medicaid Services (CMS), and Edwards Lifesciences to develop a trial that assesses the safety and efficacy of nontransfemoral approaches for TAVR, using the already-approved Edwards SAPIEN valves.

Copyright ACC

"What makes it unusual is, to the best of our knowledge, this is the first investigational device exemption [IDE] granted by the FDA to medical societies who operate national clinical registries," said ACC President Dr. William Zoghbi.

The societies will run the trial with funding from Edwards, and Medicare will pay for the procedures.

"This allows physicians to get reimbursed for off-label use," said Dr. Michael J. Mack, past president of STS and chair of the STS/ACC TVT (Transcatheter Valvular Therapy) Registry Steering Committee. "And it also allows for controlled off-label use, in which the outcomes can be captured and the sites can be paid while this information is being captured. People should be excited about it."

The goal of the trial is to expand the field and to extend TAVR to a broader group of patients, the societies said.

"A similar mechanism has been used in the past for the implantation of ICDs [implantable cardioverter-defibrillators] for patients who met particular criteria and get the funding as the registry moves forward," said Dr. Sidney Goldstein, professor of medicine at Wayne State University in Detroit, who is not involved in the trial or registry.

But currently, "the ICD Registry is not conducting an IDE to evaluate and reimburse for other possible indications of ICDs," said Dr. Zoghbi.

In the United States, an estimated one in four inoperable patients with severe aortic stenosis is not eligible for TAVR through a transfemoral or transapical approach because of vessel size, vessel disease, or other anatomical restrictions, according to the societies. Alternative routes, such as the transaortic approach, could provide an option for them.

STS and ACC are also working to get FDA approval for two more studies.

"The collaboration and use of registries for research in this pilot can be a model for specialty societies, industry, and federal regulators," Dr. Zoghbi said in a statement. "We have aligned our efforts to ensure patient access to a new technology in a safe and cost-effective way."

The study also stands out in the list of TAVR clinical trials approved by CMS, which began covering TAVR in May 2012: The other five are sponsored by Edwards or Medtronic.

The earlier collaboration of the entities that have developed this trial resulted in the STS/ACC TVT Registry, which captures TAVR-related patient demographics, procedure details, and facility and physician information.

The observational study is conducted in the TVT Registry, and will follow 1,000 patients. Any of the nearly 180 sites using the TVT Registry can participate in the study.

The trial will gather 30-day safety endpoints for patients who undergo alternative access approaches such as transapical and transaortic routes. The lumped data will then be compared with the 30-day outcomes of the transapical approach reported in Cohort A of the PARTNER trial.

Because the trial is covered by Medicare, it has to adhere to conditions set by the agency. The requirements will ensure better patient care, Dr. Jeffrey B. Rich, the STS immediate past president, said in a statement, because the "preoperative evaluation, interoperative deployment of the valve, and postoperative care must be jointly shared by cardiologists and cardiothoracic surgeons, utilizing the heart team approach."

Alternative access approaches in the trial include the left ventricular apex (transapical), ascending aorta, subclavian and axillary arteries, and distal aorta, as well as retroperitoneal access to the iliac artery.

The approaches have several advantages, according to the societies. For one, the risks associated with inserting large-caliber catheters into small, diseased femoral arteries are reduced. Also, nonfemoral access sites can provide for better catheter control and safer closure of the access site.

But since some of the alternative approaches, such as the transaortic approach, have not been approved, the operator training lags behind the already-approved transfemoral and transapical approaches. To address this, the societies and Edwards will probably have to create a contract to train the surgeons and cardiologists for the specific purpose of this trial, said Dr. Mack.

The alternative approaches also require additional equipment, and operators may be exposed to greater amounts of radiation. They may also lead to longer recovery and more incisional pain for patients, according to the societies.

Dr. Mack said that the trial will likely be completed in 6 months or less from its start date.

"Using registries for this kind of study has the potential to make new technology available in a timely manner while protecting patient safety," ACC Immediate Past President Dr. David Holmes said in a statement.

None of the physicians had relevant disclosures.

[email protected]

On Twitter @NaseemSMiller

Two heart societies, a device maker, and two federal agencies have collaborated to develop a trial for transcatheter aortic valve replacement, once again extending the concept of teamwork, which is the cornerstone of this technology, far beyond the operating room walls.

During the past year, the Society of Thoracic Surgeons and the American College of Cardiology worked with the Food and Drug Administration, the Centers for Medicare and Medicaid Services (CMS), and Edwards Lifesciences to develop a trial that assesses the safety and efficacy of nontransfemoral approaches for TAVR, using the already-approved Edwards SAPIEN valves.

Copyright ACC

"What makes it unusual is, to the best of our knowledge, this is the first investigational device exemption [IDE] granted by the FDA to medical societies who operate national clinical registries," said ACC President Dr. William Zoghbi.

The societies will run the trial with funding from Edwards, and Medicare will pay for the procedures.

"This allows physicians to get reimbursed for off-label use," said Dr. Michael J. Mack, past president of STS and chair of the STS/ACC TVT (Transcatheter Valvular Therapy) Registry Steering Committee. "And it also allows for controlled off-label use, in which the outcomes can be captured and the sites can be paid while this information is being captured. People should be excited about it."

The goal of the trial is to expand the field and to extend TAVR to a broader group of patients, the societies said.

"A similar mechanism has been used in the past for the implantation of ICDs [implantable cardioverter-defibrillators] for patients who met particular criteria and get the funding as the registry moves forward," said Dr. Sidney Goldstein, professor of medicine at Wayne State University in Detroit, who is not involved in the trial or registry.

But currently, "the ICD Registry is not conducting an IDE to evaluate and reimburse for other possible indications of ICDs," said Dr. Zoghbi.

In the United States, an estimated one in four inoperable patients with severe aortic stenosis is not eligible for TAVR through a transfemoral or transapical approach because of vessel size, vessel disease, or other anatomical restrictions, according to the societies. Alternative routes, such as the transaortic approach, could provide an option for them.

STS and ACC are also working to get FDA approval for two more studies.

"The collaboration and use of registries for research in this pilot can be a model for specialty societies, industry, and federal regulators," Dr. Zoghbi said in a statement. "We have aligned our efforts to ensure patient access to a new technology in a safe and cost-effective way."

The study also stands out in the list of TAVR clinical trials approved by CMS, which began covering TAVR in May 2012: The other five are sponsored by Edwards or Medtronic.

The earlier collaboration of the entities that have developed this trial resulted in the STS/ACC TVT Registry, which captures TAVR-related patient demographics, procedure details, and facility and physician information.

The observational study is conducted in the TVT Registry, and will follow 1,000 patients. Any of the nearly 180 sites using the TVT Registry can participate in the study.

The trial will gather 30-day safety endpoints for patients who undergo alternative access approaches such as transapical and transaortic routes. The lumped data will then be compared with the 30-day outcomes of the transapical approach reported in Cohort A of the PARTNER trial.

Because the trial is covered by Medicare, it has to adhere to conditions set by the agency. The requirements will ensure better patient care, Dr. Jeffrey B. Rich, the STS immediate past president, said in a statement, because the "preoperative evaluation, interoperative deployment of the valve, and postoperative care must be jointly shared by cardiologists and cardiothoracic surgeons, utilizing the heart team approach."

Alternative access approaches in the trial include the left ventricular apex (transapical), ascending aorta, subclavian and axillary arteries, and distal aorta, as well as retroperitoneal access to the iliac artery.

The approaches have several advantages, according to the societies. For one, the risks associated with inserting large-caliber catheters into small, diseased femoral arteries are reduced. Also, nonfemoral access sites can provide for better catheter control and safer closure of the access site.

But since some of the alternative approaches, such as the transaortic approach, have not been approved, the operator training lags behind the already-approved transfemoral and transapical approaches. To address this, the societies and Edwards will probably have to create a contract to train the surgeons and cardiologists for the specific purpose of this trial, said Dr. Mack.

The alternative approaches also require additional equipment, and operators may be exposed to greater amounts of radiation. They may also lead to longer recovery and more incisional pain for patients, according to the societies.

Dr. Mack said that the trial will likely be completed in 6 months or less from its start date.

"Using registries for this kind of study has the potential to make new technology available in a timely manner while protecting patient safety," ACC Immediate Past President Dr. David Holmes said in a statement.

None of the physicians had relevant disclosures.

[email protected]

On Twitter @NaseemSMiller

Two heart societies, a device maker, and two federal agencies have collaborated to develop a trial for transcatheter aortic valve replacement, once again extending the concept of teamwork, which is the cornerstone of this technology, far beyond the operating room walls.

During the past year, the Society of Thoracic Surgeons and the American College of Cardiology worked with the Food and Drug Administration, the Centers for Medicare and Medicaid Services (CMS), and Edwards Lifesciences to develop a trial that assesses the safety and efficacy of nontransfemoral approaches for TAVR, using the already-approved Edwards SAPIEN valves.

Copyright ACC

"What makes it unusual is, to the best of our knowledge, this is the first investigational device exemption [IDE] granted by the FDA to medical societies who operate national clinical registries," said ACC President Dr. William Zoghbi.

The societies will run the trial with funding from Edwards, and Medicare will pay for the procedures.

"This allows physicians to get reimbursed for off-label use," said Dr. Michael J. Mack, past president of STS and chair of the STS/ACC TVT (Transcatheter Valvular Therapy) Registry Steering Committee. "And it also allows for controlled off-label use, in which the outcomes can be captured and the sites can be paid while this information is being captured. People should be excited about it."

The goal of the trial is to expand the field and to extend TAVR to a broader group of patients, the societies said.

"A similar mechanism has been used in the past for the implantation of ICDs [implantable cardioverter-defibrillators] for patients who met particular criteria and get the funding as the registry moves forward," said Dr. Sidney Goldstein, professor of medicine at Wayne State University in Detroit, who is not involved in the trial or registry.

But currently, "the ICD Registry is not conducting an IDE to evaluate and reimburse for other possible indications of ICDs," said Dr. Zoghbi.

In the United States, an estimated one in four inoperable patients with severe aortic stenosis is not eligible for TAVR through a transfemoral or transapical approach because of vessel size, vessel disease, or other anatomical restrictions, according to the societies. Alternative routes, such as the transaortic approach, could provide an option for them.

STS and ACC are also working to get FDA approval for two more studies.

"The collaboration and use of registries for research in this pilot can be a model for specialty societies, industry, and federal regulators," Dr. Zoghbi said in a statement. "We have aligned our efforts to ensure patient access to a new technology in a safe and cost-effective way."

The study also stands out in the list of TAVR clinical trials approved by CMS, which began covering TAVR in May 2012: The other five are sponsored by Edwards or Medtronic.

The earlier collaboration of the entities that have developed this trial resulted in the STS/ACC TVT Registry, which captures TAVR-related patient demographics, procedure details, and facility and physician information.

The observational study is conducted in the TVT Registry, and will follow 1,000 patients. Any of the nearly 180 sites using the TVT Registry can participate in the study.

The trial will gather 30-day safety endpoints for patients who undergo alternative access approaches such as transapical and transaortic routes. The lumped data will then be compared with the 30-day outcomes of the transapical approach reported in Cohort A of the PARTNER trial.

Because the trial is covered by Medicare, it has to adhere to conditions set by the agency. The requirements will ensure better patient care, Dr. Jeffrey B. Rich, the STS immediate past president, said in a statement, because the "preoperative evaluation, interoperative deployment of the valve, and postoperative care must be jointly shared by cardiologists and cardiothoracic surgeons, utilizing the heart team approach."

Alternative access approaches in the trial include the left ventricular apex (transapical), ascending aorta, subclavian and axillary arteries, and distal aorta, as well as retroperitoneal access to the iliac artery.

The approaches have several advantages, according to the societies. For one, the risks associated with inserting large-caliber catheters into small, diseased femoral arteries are reduced. Also, nonfemoral access sites can provide for better catheter control and safer closure of the access site.

But since some of the alternative approaches, such as the transaortic approach, have not been approved, the operator training lags behind the already-approved transfemoral and transapical approaches. To address this, the societies and Edwards will probably have to create a contract to train the surgeons and cardiologists for the specific purpose of this trial, said Dr. Mack.

The alternative approaches also require additional equipment, and operators may be exposed to greater amounts of radiation. They may also lead to longer recovery and more incisional pain for patients, according to the societies.

Dr. Mack said that the trial will likely be completed in 6 months or less from its start date.

"Using registries for this kind of study has the potential to make new technology available in a timely manner while protecting patient safety," ACC Immediate Past President Dr. David Holmes said in a statement.

None of the physicians had relevant disclosures.

[email protected]

On Twitter @NaseemSMiller

ORLANDO – In what might be the first success of its kind, dermatologists at the University of Texas report treating a case of neurotic excoriations with onabotulinumtoxinA.

A 36-year-old man presented with multiple excoriated, crusted erosions on his face and scalp and also complained of tension headaches and an inability to relax.

Images courtesy Dr. Jennifer Gordon

In an attempt to relieve his headaches, Dr. Jennifer Gordon and her colleagues injected his glabella and forehead with 56 units of onabotulinumtoxinA (Botox and Botox Cosmetic).

To their surprise, in 3 weeks he was not only relieved of his headaches, but also of his excoriations.

The patient has been free of symptoms for the past year and receives maintenance injections every 4-6 months, said Dr. Gordon, a second-year dermatology resident at the University of Texas, Austin.

Neurotic excoriations (NE), also known as psychogenic excoriation, dermatillomania, or skin picking syndrome, are the result of compulsive skin picking and scratching. The condition occurs in the absence of a physical pathology and is usually associated with psychological and medical conditions that cause psychological distress.

Some studies suggest that roughly 2% of the patients at dermatology clinics have NE, and there’s a 9% prevalence of NE in patients with pruritus (itching). Researchers believe, however, that the incidence and prevalence of the condition are underreported.

Current treatments for NE include antidepressants and cognitive-behavioral therapy.

Dr. Gordon, who presented a poster at the Orlando Dermatology Aesthetic and Clinical Conference, reported that her patient described "hairs" coming out of his skin, and that twisting his body caused the hairs to coil and pull. As a result, he would pick at these areas on his face and scalp. He also complained of frequent tension headaches.

His lab values were within normal limits, Dr. Gordon reported. He was first treated for folliculitis and was given wound care instructions. He was later started on citalopram, which eliminated complaints about the hairs, but the excoriations persisted. The patient already had been treated for delusions, "and we don’t hesitate to send [the patients] for psych treatment if they need it," said Dr. Gordon, who published the poster with Dr. Jason S. Reichenberg, a faculty member at the university.

The investigators said that they believed the onabotulinumtoxinA might have induced remission in the patient by eliminating tension headaches, which could have been a trigger for his picking. The treatment also might have helped his underlying depression.

Although some statistics show that as many as one-third of NE patients also have tension or migraine headaches and gynecologic symptoms related to menstruation, it is unclear whether this treatment would work on other patients with symptoms similar to this particular patient. It’s also not yet known whether the treatment would work on other sites of the body, or on patients who do not have tension headaches, Dr. Gordon said.

The key to treatment of NE, she said, "is finding the underlying trigger."

Dr. Gordon said that she had no disclosures.

[email protected]

On Twitter @naseemsmiller

ORLANDO – In what might be the first success of its kind, dermatologists at the University of Texas report treating a case of neurotic excoriations with onabotulinumtoxinA.

A 36-year-old man presented with multiple excoriated, crusted erosions on his face and scalp and also complained of tension headaches and an inability to relax.

Images courtesy Dr. Jennifer Gordon

In an attempt to relieve his headaches, Dr. Jennifer Gordon and her colleagues injected his glabella and forehead with 56 units of onabotulinumtoxinA (Botox and Botox Cosmetic).

To their surprise, in 3 weeks he was not only relieved of his headaches, but also of his excoriations.

The patient has been free of symptoms for the past year and receives maintenance injections every 4-6 months, said Dr. Gordon, a second-year dermatology resident at the University of Texas, Austin.

Neurotic excoriations (NE), also known as psychogenic excoriation, dermatillomania, or skin picking syndrome, are the result of compulsive skin picking and scratching. The condition occurs in the absence of a physical pathology and is usually associated with psychological and medical conditions that cause psychological distress.

Some studies suggest that roughly 2% of the patients at dermatology clinics have NE, and there’s a 9% prevalence of NE in patients with pruritus (itching). Researchers believe, however, that the incidence and prevalence of the condition are underreported.

Current treatments for NE include antidepressants and cognitive-behavioral therapy.

Dr. Gordon, who presented a poster at the Orlando Dermatology Aesthetic and Clinical Conference, reported that her patient described "hairs" coming out of his skin, and that twisting his body caused the hairs to coil and pull. As a result, he would pick at these areas on his face and scalp. He also complained of frequent tension headaches.

His lab values were within normal limits, Dr. Gordon reported. He was first treated for folliculitis and was given wound care instructions. He was later started on citalopram, which eliminated complaints about the hairs, but the excoriations persisted. The patient already had been treated for delusions, "and we don’t hesitate to send [the patients] for psych treatment if they need it," said Dr. Gordon, who published the poster with Dr. Jason S. Reichenberg, a faculty member at the university.

The investigators said that they believed the onabotulinumtoxinA might have induced remission in the patient by eliminating tension headaches, which could have been a trigger for his picking. The treatment also might have helped his underlying depression.

Although some statistics show that as many as one-third of NE patients also have tension or migraine headaches and gynecologic symptoms related to menstruation, it is unclear whether this treatment would work on other patients with symptoms similar to this particular patient. It’s also not yet known whether the treatment would work on other sites of the body, or on patients who do not have tension headaches, Dr. Gordon said.

The key to treatment of NE, she said, "is finding the underlying trigger."

Dr. Gordon said that she had no disclosures.

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On Twitter @naseemsmiller

ORLANDO – In what might be the first success of its kind, dermatologists at the University of Texas report treating a case of neurotic excoriations with onabotulinumtoxinA.

A 36-year-old man presented with multiple excoriated, crusted erosions on his face and scalp and also complained of tension headaches and an inability to relax.

Images courtesy Dr. Jennifer Gordon

In an attempt to relieve his headaches, Dr. Jennifer Gordon and her colleagues injected his glabella and forehead with 56 units of onabotulinumtoxinA (Botox and Botox Cosmetic).

To their surprise, in 3 weeks he was not only relieved of his headaches, but also of his excoriations.

The patient has been free of symptoms for the past year and receives maintenance injections every 4-6 months, said Dr. Gordon, a second-year dermatology resident at the University of Texas, Austin.

Neurotic excoriations (NE), also known as psychogenic excoriation, dermatillomania, or skin picking syndrome, are the result of compulsive skin picking and scratching. The condition occurs in the absence of a physical pathology and is usually associated with psychological and medical conditions that cause psychological distress.

Some studies suggest that roughly 2% of the patients at dermatology clinics have NE, and there’s a 9% prevalence of NE in patients with pruritus (itching). Researchers believe, however, that the incidence and prevalence of the condition are underreported.

Current treatments for NE include antidepressants and cognitive-behavioral therapy.

Dr. Gordon, who presented a poster at the Orlando Dermatology Aesthetic and Clinical Conference, reported that her patient described "hairs" coming out of his skin, and that twisting his body caused the hairs to coil and pull. As a result, he would pick at these areas on his face and scalp. He also complained of frequent tension headaches.

His lab values were within normal limits, Dr. Gordon reported. He was first treated for folliculitis and was given wound care instructions. He was later started on citalopram, which eliminated complaints about the hairs, but the excoriations persisted. The patient already had been treated for delusions, "and we don’t hesitate to send [the patients] for psych treatment if they need it," said Dr. Gordon, who published the poster with Dr. Jason S. Reichenberg, a faculty member at the university.

The investigators said that they believed the onabotulinumtoxinA might have induced remission in the patient by eliminating tension headaches, which could have been a trigger for his picking. The treatment also might have helped his underlying depression.

Although some statistics show that as many as one-third of NE patients also have tension or migraine headaches and gynecologic symptoms related to menstruation, it is unclear whether this treatment would work on other patients with symptoms similar to this particular patient. It’s also not yet known whether the treatment would work on other sites of the body, or on patients who do not have tension headaches, Dr. Gordon said.

The key to treatment of NE, she said, "is finding the underlying trigger."

Dr. Gordon said that she had no disclosures.

[email protected]

On Twitter @naseemsmiller

The Obama administration issued a proposed a rule Feb. 1 clarifying how certain religious organizations could provide copayment free contraceptive coverage under the Affordable Care Act.

The proposed rule comes after months of controversy and several lawsuits from institutions that opposed having to provide contraceptive services based on their religious beliefs. During a press briefing Feb. 1, federal officials would not comment on whether the lawsuits prompted the policy change.

"Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns," Health and Human Services Secretary Kathleen Sebelius said in a statement. "We will continue to work with faith-based organizations, women’s organizations, insurers, and others to achieve these goals."

The Family Research Council came out in strong opposition to the proposed regulation, saying that it did nothing to change the current policy and that it did not protect women’s health.

"The accounting gimmicks HHS is now proposing under the latest [proposed] regulation fail to satisfy the religious freedom protections that exist in other current laws and in the First Amendment of the U.S. Constitution," Anna Higgins, director of FRC’s Center for Human Dignity, said in a statement.

Meanwhile, organizations such as ACLU and Planned Parenthood Federation of America voiced support for the proposed rule.

"This policy delivers on the promise of women having access to birth control without co-pays no matter where they work," said Cecile Richards, president of Planned Parenthood Federation of America, in a statement. "This policy makes it clear that your boss does not get to decide whether you can have birth control."

Under the proposed rule, nonprofit religious organization, including nonprofit religious hospitals and higher education institutions, can receive an accommodation that would provide their employees enrolled in the health plans they sponsor with separate contraceptive coverage, with no copays, and at no cost to the organization.

Religious organizations would provide a notice to their insurer or third-party administrator, and in turn, the insurer or third-party administrator would provide the enrollees with copay-free contraceptive coverage through separate individual health insurance policies.

HHS officials said that they have not estimated the cost of the proposal, but it will be subsidized mostly by user fees that insurers will have to pay to participate in insurance exchanges. They said they didn’t expect the regulation to affect federal funds, because preventive services would lead to overall cost reduction.

Under the proposed rule, religious employers are not required to provide copay-free coverage for contraceptives or other services that violate their beliefs. HHS officials clarified the definition of "religious employer" by using a tax code primarily including churches, other houses of worship, and their affiliated organizations.

The proposed rule is open for public comment through April 8 this year. Comments can be given at www.regulations.gov.

[email protected]

On Twitter @NaseemSMiller

The Obama administration issued a proposed a rule Feb. 1 clarifying how certain religious organizations could provide copayment free contraceptive coverage under the Affordable Care Act.

The proposed rule comes after months of controversy and several lawsuits from institutions that opposed having to provide contraceptive services based on their religious beliefs. During a press briefing Feb. 1, federal officials would not comment on whether the lawsuits prompted the policy change.

"Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns," Health and Human Services Secretary Kathleen Sebelius said in a statement. "We will continue to work with faith-based organizations, women’s organizations, insurers, and others to achieve these goals."

The Family Research Council came out in strong opposition to the proposed regulation, saying that it did nothing to change the current policy and that it did not protect women’s health.

"The accounting gimmicks HHS is now proposing under the latest [proposed] regulation fail to satisfy the religious freedom protections that exist in other current laws and in the First Amendment of the U.S. Constitution," Anna Higgins, director of FRC’s Center for Human Dignity, said in a statement.

Meanwhile, organizations such as ACLU and Planned Parenthood Federation of America voiced support for the proposed rule.

"This policy delivers on the promise of women having access to birth control without co-pays no matter where they work," said Cecile Richards, president of Planned Parenthood Federation of America, in a statement. "This policy makes it clear that your boss does not get to decide whether you can have birth control."

Under the proposed rule, nonprofit religious organization, including nonprofit religious hospitals and higher education institutions, can receive an accommodation that would provide their employees enrolled in the health plans they sponsor with separate contraceptive coverage, with no copays, and at no cost to the organization.

Religious organizations would provide a notice to their insurer or third-party administrator, and in turn, the insurer or third-party administrator would provide the enrollees with copay-free contraceptive coverage through separate individual health insurance policies.

HHS officials said that they have not estimated the cost of the proposal, but it will be subsidized mostly by user fees that insurers will have to pay to participate in insurance exchanges. They said they didn’t expect the regulation to affect federal funds, because preventive services would lead to overall cost reduction.

Under the proposed rule, religious employers are not required to provide copay-free coverage for contraceptives or other services that violate their beliefs. HHS officials clarified the definition of "religious employer" by using a tax code primarily including churches, other houses of worship, and their affiliated organizations.

The proposed rule is open for public comment through April 8 this year. Comments can be given at www.regulations.gov.

[email protected]

On Twitter @NaseemSMiller

The Obama administration issued a proposed a rule Feb. 1 clarifying how certain religious organizations could provide copayment free contraceptive coverage under the Affordable Care Act.

The proposed rule comes after months of controversy and several lawsuits from institutions that opposed having to provide contraceptive services based on their religious beliefs. During a press briefing Feb. 1, federal officials would not comment on whether the lawsuits prompted the policy change.

"Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns," Health and Human Services Secretary Kathleen Sebelius said in a statement. "We will continue to work with faith-based organizations, women’s organizations, insurers, and others to achieve these goals."

The Family Research Council came out in strong opposition to the proposed regulation, saying that it did nothing to change the current policy and that it did not protect women’s health.

"The accounting gimmicks HHS is now proposing under the latest [proposed] regulation fail to satisfy the religious freedom protections that exist in other current laws and in the First Amendment of the U.S. Constitution," Anna Higgins, director of FRC’s Center for Human Dignity, said in a statement.

Meanwhile, organizations such as ACLU and Planned Parenthood Federation of America voiced support for the proposed rule.

"This policy delivers on the promise of women having access to birth control without co-pays no matter where they work," said Cecile Richards, president of Planned Parenthood Federation of America, in a statement. "This policy makes it clear that your boss does not get to decide whether you can have birth control."

Under the proposed rule, nonprofit religious organization, including nonprofit religious hospitals and higher education institutions, can receive an accommodation that would provide their employees enrolled in the health plans they sponsor with separate contraceptive coverage, with no copays, and at no cost to the organization.

Religious organizations would provide a notice to their insurer or third-party administrator, and in turn, the insurer or third-party administrator would provide the enrollees with copay-free contraceptive coverage through separate individual health insurance policies.

HHS officials said that they have not estimated the cost of the proposal, but it will be subsidized mostly by user fees that insurers will have to pay to participate in insurance exchanges. They said they didn’t expect the regulation to affect federal funds, because preventive services would lead to overall cost reduction.

Under the proposed rule, religious employers are not required to provide copay-free coverage for contraceptives or other services that violate their beliefs. HHS officials clarified the definition of "religious employer" by using a tax code primarily including churches, other houses of worship, and their affiliated organizations.

The proposed rule is open for public comment through April 8 this year. Comments can be given at www.regulations.gov.

[email protected]

On Twitter @NaseemSMiller