Whitney McKnight

Nearly 9 million Americans gained health insurance between 2013 and 2014, data from the U.S. Census Bureau show.

Results from the U.S. Census Bureau Current Population Survey of 98,000 adults showed that 10.4% of Americans – 33 million people – were uninsured in 2014, down from 13.3% in 2013. The survey is the first to compare data from immediately before the law took full effect and the year it did take full effect.

© Catalin205/Thinkstock

Although the Affordable Care Act was passed in 2010, it did not reach its full effect until 2014. Citing similar data from a number of other surveys, both public and private, the Commonwealth Fund says the findings provide “further evidence the law is having its intended effect of reducing the number of Americans who lack health insurance.”

The survey also showed that decreases in the uninsured rate tended to be larger in states that expanded Medicaid eligibility. Texas, Florida, and Alaska, where Medicaid eligibility has not been expanded, topped the list of states with the highest uninsured rates at or above 16%. Overall uninsured rates in states that expanded their Medicaid programs ranged from 3.3% in Massachusetts to 15% in Nevada.

U.S. residents most likely to have benefited from the ACA are young adults, older adults with low to moderate incomes, African Americans, and Latinos, all of whom showed at least 3% gains in coverage.

[email protected]

On Twitter @whitneymcknight

Nearly 9 million Americans gained health insurance between 2013 and 2014, data from the U.S. Census Bureau show.

Results from the U.S. Census Bureau Current Population Survey of 98,000 adults showed that 10.4% of Americans – 33 million people – were uninsured in 2014, down from 13.3% in 2013. The survey is the first to compare data from immediately before the law took full effect and the year it did take full effect.

© Catalin205/Thinkstock

Although the Affordable Care Act was passed in 2010, it did not reach its full effect until 2014. Citing similar data from a number of other surveys, both public and private, the Commonwealth Fund says the findings provide “further evidence the law is having its intended effect of reducing the number of Americans who lack health insurance.”

The survey also showed that decreases in the uninsured rate tended to be larger in states that expanded Medicaid eligibility. Texas, Florida, and Alaska, where Medicaid eligibility has not been expanded, topped the list of states with the highest uninsured rates at or above 16%. Overall uninsured rates in states that expanded their Medicaid programs ranged from 3.3% in Massachusetts to 15% in Nevada.

U.S. residents most likely to have benefited from the ACA are young adults, older adults with low to moderate incomes, African Americans, and Latinos, all of whom showed at least 3% gains in coverage.

[email protected]

On Twitter @whitneymcknight

Nearly 9 million Americans gained health insurance between 2013 and 2014, data from the U.S. Census Bureau show.

Results from the U.S. Census Bureau Current Population Survey of 98,000 adults showed that 10.4% of Americans – 33 million people – were uninsured in 2014, down from 13.3% in 2013. The survey is the first to compare data from immediately before the law took full effect and the year it did take full effect.

© Catalin205/Thinkstock

Although the Affordable Care Act was passed in 2010, it did not reach its full effect until 2014. Citing similar data from a number of other surveys, both public and private, the Commonwealth Fund says the findings provide “further evidence the law is having its intended effect of reducing the number of Americans who lack health insurance.”

The survey also showed that decreases in the uninsured rate tended to be larger in states that expanded Medicaid eligibility. Texas, Florida, and Alaska, where Medicaid eligibility has not been expanded, topped the list of states with the highest uninsured rates at or above 16%. Overall uninsured rates in states that expanded their Medicaid programs ranged from 3.3% in Massachusetts to 15% in Nevada.

U.S. residents most likely to have benefited from the ACA are young adults, older adults with low to moderate incomes, African Americans, and Latinos, all of whom showed at least 3% gains in coverage.

[email protected]

On Twitter @whitneymcknight

In the past 50 years, the introductory cost of cancer drugs has risen over a hundred percent (adjusted for inflation), but Dr. Peter B. Bach wonders, “Are these drugs a hundred times better?”

To answer that question more definitively, Dr. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, New York, and his colleagues have developed a proof of principal tool, the “Drug Abacus”.

The online tool uses a calculus of interactive algorithms that can be set by the individual to determine what a drug’s “true” price should be. Among the values possible to include are a drug’s risks, benefits, cost to develop and manufacture, and the life extension and quality of that extension that it offers. Also considered is how rare a disease is that a specific drug treats and how likely a drug will be able to help lift a public health burden. Although the drug abacus was developed to evaluate the cost of 54 cancer drugs, Dr. Bach believes the tool could be developed for use in evaluating the cost of any drug.

The drug abacus was designed for patients and policymakers alike, which Dr. Bach thinks could help bring about “value-generated prices and a transparent [pharmaceutical] marketplace.”

In a webinar sponsored by the University of Southern California’s Annenberg School for Journalism and the California Endowment for Health Journalism, Dr. Bach presented data from the past 20 years on the benefit of cancer drugs in terms of the survival gains between their time of introduction and their price per year of life gained. The data show that the inflation-adjusted cost for an additional life year earned by a cancer drug goes up by about $8,500. Speaking plainly, Dr. Bach said that means by 1995, buying a year of life cost about $50,000, whereas to do so in 2014 cost $250,000, adjusted for inflation.

“Maybe the drugs are somewhat better, but not enough to justify such a rise in cost,” Dr. Bach said.

In the case of the drug Blincyto (Amgen) approved by the FDA earlier this year to treat Philadelphia chromosome–negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL, the drug abacus cost is calculated as $7,946 when using the following variables: $12,000 for the cost per year added; a toxicity level of 30%; a novelty level of two out of three (it is the second-line FDA-approved therapy); a two out of three for cost of development; and a three out of three for rarity of disease treated. The actual cost of the treatment when it launched in the U.S. market in early 2015 was $64,260.

Were normal market conditions such as competition and demand driving the cost of drugs, Dr. Bach thinks drugs like the immunomodulator Gleevec (Novartis) would not be enjoying the exponential trajectory in revenues it has had since the FDA approved its new formulation in 2003: It has gone from costing an inflation-adjusted less than $100 per day for treatment to over $200. This, despite two other similar treatments (Tasigna, Novartis and Sprycel, Bristol-Myers Squibb) having entered the marketplace, and Gleevec having received multiple indications beyond its original use in leukemia.

“No one can look at this and say the market is working – either that the competition is lowering prices or that this is about recouping the cost of research and investment, Dr. Bach said.

A broken market means that people whose lives could be saved instead go without treatment, particularly if the cost to them is more than their insurance plan will cover, he said. Speaking about Gleevec, “nothing could be more frustrating than to have a drug that is essentially a cure be unavailable to patients because of a broken market.”

And yet, when the pharmaceutical industry does get pushed, interesting things can occur. In 2011, when Sanofi introduced the metastatic colon cancer drug Zaltrap, Dr. Bach and his colleagues at Sloan-Kettering refused to include it in their formulary citing comparative effectiveness data that did not justify its $11,000 per month price tag, double that of Avastin (Genentech) but with no clear additional benefit: Both drugs improved survival by about 6 weeks.

Sanofi immediately cut the cost of the drug in half nationwide.

“This told us two things,” says Dr. Bach. The first is that the market is indeed busted and the second is that there is immense power in comparative effectiveness research.

Thus was the genesis of the drug abacus, based largely on comparative effectiveness data. Dr. Bach said he thinks such “transparency of data” will help push back on pharmaceutical companies, empowering purchasers to outright refuse to pay arbitrary prices and bring about value-based prices and “rationalize this market.”

[email protected]

On Twitter @whitneymcknight

In the past 50 years, the introductory cost of cancer drugs has risen over a hundred percent (adjusted for inflation), but Dr. Peter B. Bach wonders, “Are these drugs a hundred times better?”

To answer that question more definitively, Dr. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, New York, and his colleagues have developed a proof of principal tool, the “Drug Abacus”.

The online tool uses a calculus of interactive algorithms that can be set by the individual to determine what a drug’s “true” price should be. Among the values possible to include are a drug’s risks, benefits, cost to develop and manufacture, and the life extension and quality of that extension that it offers. Also considered is how rare a disease is that a specific drug treats and how likely a drug will be able to help lift a public health burden. Although the drug abacus was developed to evaluate the cost of 54 cancer drugs, Dr. Bach believes the tool could be developed for use in evaluating the cost of any drug.

The drug abacus was designed for patients and policymakers alike, which Dr. Bach thinks could help bring about “value-generated prices and a transparent [pharmaceutical] marketplace.”

In a webinar sponsored by the University of Southern California’s Annenberg School for Journalism and the California Endowment for Health Journalism, Dr. Bach presented data from the past 20 years on the benefit of cancer drugs in terms of the survival gains between their time of introduction and their price per year of life gained. The data show that the inflation-adjusted cost for an additional life year earned by a cancer drug goes up by about $8,500. Speaking plainly, Dr. Bach said that means by 1995, buying a year of life cost about $50,000, whereas to do so in 2014 cost $250,000, adjusted for inflation.

“Maybe the drugs are somewhat better, but not enough to justify such a rise in cost,” Dr. Bach said.

In the case of the drug Blincyto (Amgen) approved by the FDA earlier this year to treat Philadelphia chromosome–negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL, the drug abacus cost is calculated as $7,946 when using the following variables: $12,000 for the cost per year added; a toxicity level of 30%; a novelty level of two out of three (it is the second-line FDA-approved therapy); a two out of three for cost of development; and a three out of three for rarity of disease treated. The actual cost of the treatment when it launched in the U.S. market in early 2015 was $64,260.

Were normal market conditions such as competition and demand driving the cost of drugs, Dr. Bach thinks drugs like the immunomodulator Gleevec (Novartis) would not be enjoying the exponential trajectory in revenues it has had since the FDA approved its new formulation in 2003: It has gone from costing an inflation-adjusted less than $100 per day for treatment to over $200. This, despite two other similar treatments (Tasigna, Novartis and Sprycel, Bristol-Myers Squibb) having entered the marketplace, and Gleevec having received multiple indications beyond its original use in leukemia.

“No one can look at this and say the market is working – either that the competition is lowering prices or that this is about recouping the cost of research and investment, Dr. Bach said.

A broken market means that people whose lives could be saved instead go without treatment, particularly if the cost to them is more than their insurance plan will cover, he said. Speaking about Gleevec, “nothing could be more frustrating than to have a drug that is essentially a cure be unavailable to patients because of a broken market.”

And yet, when the pharmaceutical industry does get pushed, interesting things can occur. In 2011, when Sanofi introduced the metastatic colon cancer drug Zaltrap, Dr. Bach and his colleagues at Sloan-Kettering refused to include it in their formulary citing comparative effectiveness data that did not justify its $11,000 per month price tag, double that of Avastin (Genentech) but with no clear additional benefit: Both drugs improved survival by about 6 weeks.

Sanofi immediately cut the cost of the drug in half nationwide.

“This told us two things,” says Dr. Bach. The first is that the market is indeed busted and the second is that there is immense power in comparative effectiveness research.

Thus was the genesis of the drug abacus, based largely on comparative effectiveness data. Dr. Bach said he thinks such “transparency of data” will help push back on pharmaceutical companies, empowering purchasers to outright refuse to pay arbitrary prices and bring about value-based prices and “rationalize this market.”

[email protected]

On Twitter @whitneymcknight

In the past 50 years, the introductory cost of cancer drugs has risen over a hundred percent (adjusted for inflation), but Dr. Peter B. Bach wonders, “Are these drugs a hundred times better?”

To answer that question more definitively, Dr. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, New York, and his colleagues have developed a proof of principal tool, the “Drug Abacus”.

The online tool uses a calculus of interactive algorithms that can be set by the individual to determine what a drug’s “true” price should be. Among the values possible to include are a drug’s risks, benefits, cost to develop and manufacture, and the life extension and quality of that extension that it offers. Also considered is how rare a disease is that a specific drug treats and how likely a drug will be able to help lift a public health burden. Although the drug abacus was developed to evaluate the cost of 54 cancer drugs, Dr. Bach believes the tool could be developed for use in evaluating the cost of any drug.

The drug abacus was designed for patients and policymakers alike, which Dr. Bach thinks could help bring about “value-generated prices and a transparent [pharmaceutical] marketplace.”

In a webinar sponsored by the University of Southern California’s Annenberg School for Journalism and the California Endowment for Health Journalism, Dr. Bach presented data from the past 20 years on the benefit of cancer drugs in terms of the survival gains between their time of introduction and their price per year of life gained. The data show that the inflation-adjusted cost for an additional life year earned by a cancer drug goes up by about $8,500. Speaking plainly, Dr. Bach said that means by 1995, buying a year of life cost about $50,000, whereas to do so in 2014 cost $250,000, adjusted for inflation.

“Maybe the drugs are somewhat better, but not enough to justify such a rise in cost,” Dr. Bach said.

In the case of the drug Blincyto (Amgen) approved by the FDA earlier this year to treat Philadelphia chromosome–negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL, the drug abacus cost is calculated as $7,946 when using the following variables: $12,000 for the cost per year added; a toxicity level of 30%; a novelty level of two out of three (it is the second-line FDA-approved therapy); a two out of three for cost of development; and a three out of three for rarity of disease treated. The actual cost of the treatment when it launched in the U.S. market in early 2015 was $64,260.

Were normal market conditions such as competition and demand driving the cost of drugs, Dr. Bach thinks drugs like the immunomodulator Gleevec (Novartis) would not be enjoying the exponential trajectory in revenues it has had since the FDA approved its new formulation in 2003: It has gone from costing an inflation-adjusted less than $100 per day for treatment to over $200. This, despite two other similar treatments (Tasigna, Novartis and Sprycel, Bristol-Myers Squibb) having entered the marketplace, and Gleevec having received multiple indications beyond its original use in leukemia.

“No one can look at this and say the market is working – either that the competition is lowering prices or that this is about recouping the cost of research and investment, Dr. Bach said.

A broken market means that people whose lives could be saved instead go without treatment, particularly if the cost to them is more than their insurance plan will cover, he said. Speaking about Gleevec, “nothing could be more frustrating than to have a drug that is essentially a cure be unavailable to patients because of a broken market.”

And yet, when the pharmaceutical industry does get pushed, interesting things can occur. In 2011, when Sanofi introduced the metastatic colon cancer drug Zaltrap, Dr. Bach and his colleagues at Sloan-Kettering refused to include it in their formulary citing comparative effectiveness data that did not justify its $11,000 per month price tag, double that of Avastin (Genentech) but with no clear additional benefit: Both drugs improved survival by about 6 weeks.

Sanofi immediately cut the cost of the drug in half nationwide.

“This told us two things,” says Dr. Bach. The first is that the market is indeed busted and the second is that there is immense power in comparative effectiveness research.

Thus was the genesis of the drug abacus, based largely on comparative effectiveness data. Dr. Bach said he thinks such “transparency of data” will help push back on pharmaceutical companies, empowering purchasers to outright refuse to pay arbitrary prices and bring about value-based prices and “rationalize this market.”

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Neurometabolite deficiencies in the dorsolateral prefrontal cortex may contribute to the lack of insight people with severe mental illness have into their condition, a study showed.

Previous studies have shown that insight lives in the prefrontal cortex, which also is involved in cognitive flexibility and executive function, two other functions often impaired in severe mental illness. Previous studies also have shown a relationship between psychosis and reduced N-acetylaspartate (NAA) in the prefrontal cortex, which is thought to indicate impaired brain function or damage.

©Thinkstock.com

Daouia Larabi, a researcher and PhD candidate at the University of Groningen (the Netherlands), and her colleagues administered the Birchwood Insight Scale (BIS) and the Positive and Negative Syndrome Scale (PANSS) to 80 adult patients with severe mental illness to determine their levels of insight into their illness. The results were then correlated with those from each individual participant’s NAA tests done with an imaging technique called proton magnetic resonance spectroscopy, which measures neurometabolite levels and their ratio to creatine in the white matter of the brain, specifically the dorsolateral prefrontal cortex. Illness duration, use of antipsychotics, gray matter content, and cerebrospinal fluid content were covariates.

Ms. Larabi and her colleagues found that patients with poorer insight as scored on the PANSS also had significantly lower levels of NAA in the prefrontal cortex (P = .045), although the investigators did not find a significant correlation between insight and other neurometabolites such as glutamate in the same region of the brain. There also was a significant positive correlation between NAA to creatine levels and the BIS scores (P = .004). Both results indicate that reductions in NAA were associated with poorer insight, Ms. Larabi said at the annual congress of the European Congress of Neuropsychopharmacology.

Although she said this is the first study to show an association between decreased NAA concentrations and impaired insight, the study still does not offer any conclusions about whether one causes the other. However, because poor insight has been linked to treatment nonadherence and more hospitalizations in the severely mentally ill, the findings are exciting, according to Dr. Andreas Meyer-Lindenberg, editor-in-chief of the journal European Neuropsychopharmacology.

“Insight is highly relevant for the prognosis of people with schizophrenia and psychosis, and linking it to dysfunction in a specific brain system, if replicated, may point to new therapeutic or diagnostic approaches in the future,” Dr. Meyer-Lindenberg said in a statement.

Ms. Larabi said she had no conflicts to disclose.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Neurometabolite deficiencies in the dorsolateral prefrontal cortex may contribute to the lack of insight people with severe mental illness have into their condition, a study showed.

Previous studies have shown that insight lives in the prefrontal cortex, which also is involved in cognitive flexibility and executive function, two other functions often impaired in severe mental illness. Previous studies also have shown a relationship between psychosis and reduced N-acetylaspartate (NAA) in the prefrontal cortex, which is thought to indicate impaired brain function or damage.

©Thinkstock.com

Daouia Larabi, a researcher and PhD candidate at the University of Groningen (the Netherlands), and her colleagues administered the Birchwood Insight Scale (BIS) and the Positive and Negative Syndrome Scale (PANSS) to 80 adult patients with severe mental illness to determine their levels of insight into their illness. The results were then correlated with those from each individual participant’s NAA tests done with an imaging technique called proton magnetic resonance spectroscopy, which measures neurometabolite levels and their ratio to creatine in the white matter of the brain, specifically the dorsolateral prefrontal cortex. Illness duration, use of antipsychotics, gray matter content, and cerebrospinal fluid content were covariates.

Ms. Larabi and her colleagues found that patients with poorer insight as scored on the PANSS also had significantly lower levels of NAA in the prefrontal cortex (P = .045), although the investigators did not find a significant correlation between insight and other neurometabolites such as glutamate in the same region of the brain. There also was a significant positive correlation between NAA to creatine levels and the BIS scores (P = .004). Both results indicate that reductions in NAA were associated with poorer insight, Ms. Larabi said at the annual congress of the European Congress of Neuropsychopharmacology.

Although she said this is the first study to show an association between decreased NAA concentrations and impaired insight, the study still does not offer any conclusions about whether one causes the other. However, because poor insight has been linked to treatment nonadherence and more hospitalizations in the severely mentally ill, the findings are exciting, according to Dr. Andreas Meyer-Lindenberg, editor-in-chief of the journal European Neuropsychopharmacology.

“Insight is highly relevant for the prognosis of people with schizophrenia and psychosis, and linking it to dysfunction in a specific brain system, if replicated, may point to new therapeutic or diagnostic approaches in the future,” Dr. Meyer-Lindenberg said in a statement.

Ms. Larabi said she had no conflicts to disclose.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Neurometabolite deficiencies in the dorsolateral prefrontal cortex may contribute to the lack of insight people with severe mental illness have into their condition, a study showed.

Previous studies have shown that insight lives in the prefrontal cortex, which also is involved in cognitive flexibility and executive function, two other functions often impaired in severe mental illness. Previous studies also have shown a relationship between psychosis and reduced N-acetylaspartate (NAA) in the prefrontal cortex, which is thought to indicate impaired brain function or damage.

©Thinkstock.com

Daouia Larabi, a researcher and PhD candidate at the University of Groningen (the Netherlands), and her colleagues administered the Birchwood Insight Scale (BIS) and the Positive and Negative Syndrome Scale (PANSS) to 80 adult patients with severe mental illness to determine their levels of insight into their illness. The results were then correlated with those from each individual participant’s NAA tests done with an imaging technique called proton magnetic resonance spectroscopy, which measures neurometabolite levels and their ratio to creatine in the white matter of the brain, specifically the dorsolateral prefrontal cortex. Illness duration, use of antipsychotics, gray matter content, and cerebrospinal fluid content were covariates.

Ms. Larabi and her colleagues found that patients with poorer insight as scored on the PANSS also had significantly lower levels of NAA in the prefrontal cortex (P = .045), although the investigators did not find a significant correlation between insight and other neurometabolites such as glutamate in the same region of the brain. There also was a significant positive correlation between NAA to creatine levels and the BIS scores (P = .004). Both results indicate that reductions in NAA were associated with poorer insight, Ms. Larabi said at the annual congress of the European Congress of Neuropsychopharmacology.

Although she said this is the first study to show an association between decreased NAA concentrations and impaired insight, the study still does not offer any conclusions about whether one causes the other. However, because poor insight has been linked to treatment nonadherence and more hospitalizations in the severely mentally ill, the findings are exciting, according to Dr. Andreas Meyer-Lindenberg, editor-in-chief of the journal European Neuropsychopharmacology.

“Insight is highly relevant for the prognosis of people with schizophrenia and psychosis, and linking it to dysfunction in a specific brain system, if replicated, may point to new therapeutic or diagnostic approaches in the future,” Dr. Meyer-Lindenberg said in a statement.

Ms. Larabi said she had no conflicts to disclose.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Patients with schizophrenia given the investigational drug cariprazine showed statistical improvements in negative symptoms such as apathy and withdrawal, compared with those given risperidone, results from a phase III clinical trial have shown. The data were presented at the annual congress of the European College of Neuropsychopharmacology.

Both drugs are antipsychotics, but risperidone is a dopaminergic antagonist, and cariprazine is a D2 and D3 receptor partial agonist, tending toward the D3 receptor. Currently, no drugs are on the market with a specific indication for treating the negative symptoms of schizophrenia, although several second-generation antipsychotics reduce negative symptoms as well as positive and general symptoms of schizophrenia. Several pharmacotherapies are available to treat the positive symptoms of the illness.

In this multicenter, international, double-blind study, 230 adults with schizophrenia were randomly assigned to receive cariprazine and 231 were assigned risperidone for 26 weeks, reported Dr. György Németh, one of the study’s lead authors and chief medical officer of the study’s sponsor, Gedeon Richter.

People included in the study had been stable for at least 6 months prior to screening, and for a subsequent 4 weeks prior to randomization. Those with a score of at least 24 or greater on the Negative Factor Scale of the Positive and Negative Syndrome Scale (PANSS-NFS) and a score of at least 4 on two of the three core negative symptoms, along with positive factor scores on the PANSS of at least 19 or more were considered for inclusion in the study. At baseline, both groups had similar PANSS scores: Negative factor scores in the study drug arm were 27.7 and 27.5 in controls. Positive factor scores were also similar: 8.8 in the study arm and 8.6 in controls.

Study participants also were measured at baseline on the Personal and Social Performance Scale. Scores were 48.8 in the study drug arm and 48.1 in the risperidone arm.

After a 2-week period of cross-titration and washout of previous medications, patients were treated with the target dose of 4.5 mg daily of their assigned drug for 24 weeks.

In the 77.4% of enrollees in both cohorts who completed the trial, those treated with cariprazine had the most improvement in both negative symptoms and personal and social performance, compared with the control group. At 26 weeks, the overall change from baseline in the study group for negative factor symptoms was –2.39, compared with –0.53 in controls (95% confidence interval; P = .002). Personal and social performance scores changed at 26 weeks from baseline by 2.71 in the study group and 6.56 in controls (95% CI; P less than .001).

Discontinuation rates were low, and the most common side effects were insomnia and headache (about 10% for each), mostly in the risperidone arm.

Dr. David Pickar, who was not involved in the study, said in an interview that when treating patients with schizophrenia “improvement in negative symptoms occurs a fair amount with improvements in positive symptoms. The problem is the persistence of negative symptoms,” said Dr. Pickar of the department of psychiatry at Johns Hopkins University, Baltimore, and former branch chief of intramural experimental therapeutics at the National Institute of Mental Health.

This trial was sponsored by Gedeon Richter.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Patients with schizophrenia given the investigational drug cariprazine showed statistical improvements in negative symptoms such as apathy and withdrawal, compared with those given risperidone, results from a phase III clinical trial have shown. The data were presented at the annual congress of the European College of Neuropsychopharmacology.

Both drugs are antipsychotics, but risperidone is a dopaminergic antagonist, and cariprazine is a D2 and D3 receptor partial agonist, tending toward the D3 receptor. Currently, no drugs are on the market with a specific indication for treating the negative symptoms of schizophrenia, although several second-generation antipsychotics reduce negative symptoms as well as positive and general symptoms of schizophrenia. Several pharmacotherapies are available to treat the positive symptoms of the illness.

In this multicenter, international, double-blind study, 230 adults with schizophrenia were randomly assigned to receive cariprazine and 231 were assigned risperidone for 26 weeks, reported Dr. György Németh, one of the study’s lead authors and chief medical officer of the study’s sponsor, Gedeon Richter.

People included in the study had been stable for at least 6 months prior to screening, and for a subsequent 4 weeks prior to randomization. Those with a score of at least 24 or greater on the Negative Factor Scale of the Positive and Negative Syndrome Scale (PANSS-NFS) and a score of at least 4 on two of the three core negative symptoms, along with positive factor scores on the PANSS of at least 19 or more were considered for inclusion in the study. At baseline, both groups had similar PANSS scores: Negative factor scores in the study drug arm were 27.7 and 27.5 in controls. Positive factor scores were also similar: 8.8 in the study arm and 8.6 in controls.

Study participants also were measured at baseline on the Personal and Social Performance Scale. Scores were 48.8 in the study drug arm and 48.1 in the risperidone arm.

After a 2-week period of cross-titration and washout of previous medications, patients were treated with the target dose of 4.5 mg daily of their assigned drug for 24 weeks.

In the 77.4% of enrollees in both cohorts who completed the trial, those treated with cariprazine had the most improvement in both negative symptoms and personal and social performance, compared with the control group. At 26 weeks, the overall change from baseline in the study group for negative factor symptoms was –2.39, compared with –0.53 in controls (95% confidence interval; P = .002). Personal and social performance scores changed at 26 weeks from baseline by 2.71 in the study group and 6.56 in controls (95% CI; P less than .001).

Discontinuation rates were low, and the most common side effects were insomnia and headache (about 10% for each), mostly in the risperidone arm.

Dr. David Pickar, who was not involved in the study, said in an interview that when treating patients with schizophrenia “improvement in negative symptoms occurs a fair amount with improvements in positive symptoms. The problem is the persistence of negative symptoms,” said Dr. Pickar of the department of psychiatry at Johns Hopkins University, Baltimore, and former branch chief of intramural experimental therapeutics at the National Institute of Mental Health.

This trial was sponsored by Gedeon Richter.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Patients with schizophrenia given the investigational drug cariprazine showed statistical improvements in negative symptoms such as apathy and withdrawal, compared with those given risperidone, results from a phase III clinical trial have shown. The data were presented at the annual congress of the European College of Neuropsychopharmacology.

Both drugs are antipsychotics, but risperidone is a dopaminergic antagonist, and cariprazine is a D2 and D3 receptor partial agonist, tending toward the D3 receptor. Currently, no drugs are on the market with a specific indication for treating the negative symptoms of schizophrenia, although several second-generation antipsychotics reduce negative symptoms as well as positive and general symptoms of schizophrenia. Several pharmacotherapies are available to treat the positive symptoms of the illness.

In this multicenter, international, double-blind study, 230 adults with schizophrenia were randomly assigned to receive cariprazine and 231 were assigned risperidone for 26 weeks, reported Dr. György Németh, one of the study’s lead authors and chief medical officer of the study’s sponsor, Gedeon Richter.

People included in the study had been stable for at least 6 months prior to screening, and for a subsequent 4 weeks prior to randomization. Those with a score of at least 24 or greater on the Negative Factor Scale of the Positive and Negative Syndrome Scale (PANSS-NFS) and a score of at least 4 on two of the three core negative symptoms, along with positive factor scores on the PANSS of at least 19 or more were considered for inclusion in the study. At baseline, both groups had similar PANSS scores: Negative factor scores in the study drug arm were 27.7 and 27.5 in controls. Positive factor scores were also similar: 8.8 in the study arm and 8.6 in controls.

Study participants also were measured at baseline on the Personal and Social Performance Scale. Scores were 48.8 in the study drug arm and 48.1 in the risperidone arm.

After a 2-week period of cross-titration and washout of previous medications, patients were treated with the target dose of 4.5 mg daily of their assigned drug for 24 weeks.

In the 77.4% of enrollees in both cohorts who completed the trial, those treated with cariprazine had the most improvement in both negative symptoms and personal and social performance, compared with the control group. At 26 weeks, the overall change from baseline in the study group for negative factor symptoms was –2.39, compared with –0.53 in controls (95% confidence interval; P = .002). Personal and social performance scores changed at 26 weeks from baseline by 2.71 in the study group and 6.56 in controls (95% CI; P less than .001).

Discontinuation rates were low, and the most common side effects were insomnia and headache (about 10% for each), mostly in the risperidone arm.

Dr. David Pickar, who was not involved in the study, said in an interview that when treating patients with schizophrenia “improvement in negative symptoms occurs a fair amount with improvements in positive symptoms. The problem is the persistence of negative symptoms,” said Dr. Pickar of the department of psychiatry at Johns Hopkins University, Baltimore, and former branch chief of intramural experimental therapeutics at the National Institute of Mental Health.

This trial was sponsored by Gedeon Richter.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Electroconvulsive therapy’s efficacy in rapid relief from depression is well-established, particularly in the elderly, but the best ways to improve the treatment’s overall effectiveness over time remain a puzzle.

“There are still some questions,” said Dr. Willem A. Nolen, an emeritus professor of psychiatry at the University of Groningen (the Netherlands) and chair of a panel of ECT experts at the annual congress of the European College of Neuropsychopharmacology.

Whitney McKnight/Frontline Medical News

“There is a high relapse rate [with ECT]. So, how should we continue treatment? Do we use medication, continuation ECT, or psychological therapies?”

A meta-analysis published in 2013 showed that 27% of people with depression who were given ECT relapsed after 3 months. Just over half did so after 1 year, mostly in the first 6 months (37.7%). After 2 years, 50.2% of those treated with ECT had relapsed. The study also found that in randomized, controlled trials, antidepressants given after ECT cut the risk of relapse in half in the first 6 months, compared with placebo. The most effective antidepressants, according to the study, were tricyclics, but the researchers could not find enough data on other maintenance therapies, including other pharmacotherapies, to offer a definitive conclusion on what therapy best extends ECT’s effectiveness (Neuropsychopharmacology. 2013 Nov;38[12]:2467-74. doi: 10.1038/npp.2013.149). According to Dr. Malek Bajbouj, a presenter at the meeting, and professor of psychiatry and affective neurosciences at Freie Universität Berlin, perhaps a new logic is required when it comes to determining the best combination of ECT and add-on therapies.

This ethos forms the underpinning of an approach Dr. Bajbouj says he and his colleagues in Berlin are using to integrate treatment modalities, seeking ways to successfully overlap psychotherapeutic interventions, brain stimulation techniques, and pharmacological interventions.

But the approach is not without obstacles.

“If you give two interventions, take for example, ECT and medication, you can do it simultaneously or sequentially, or in an interactive manner. The outcome could be that we all think one and one is two, but this is not always true or what we’d expect or wish,” Dr. Bajbouj told the audience.

“It might be that there is a positive synergy, but it might also be that there are negative or neutral effects where one and one is still one.”

Take the recent findings from a study that left him slightly bewildered.

In a prospective randomized, controlled study of 90 inpatients, mostly in their 60s and all with major depressive disorder who were given either medication, medication plus maintenance ECT, or medication and cognitive-behavioral therapy (CBT) after their initial acute intervention with right unilateral ultrabrief ECT, Dr. Bajbouj and his colleagues found that after 1 year, CBT plus medication significantly outperformed the other continuation therapies (Biol Psychiatry. 2014 Aug 1;76[3]:194-202. doi: 10.1016/j.biopsych.2013.11.030).“The findings were against my personal expectations,” Dr. Bajbouj said. Those expectations cost him: In a bet with a coinvestigator who predicted that the talk therapy arm would outperform the others, “I ended up having to buy her a bottle of champagne.”

A third of the initial study group did not respond to the initial acute ECT. But of the 60 who did and who were randomly assigned their add-on therapy, and followed at 6 months and 1 year, 77% of those given CBT plus medication remained in remission at 6 months, and an impressive 65% did so at 1 year. Meanwhile, the medication plus ECT group had a 40% remission rate at 6 months and a 28% remission rate at 1 year. The medication-only arm had a remission rate of 44% at 6 months and 33% at 1 year.

Dr. Bajbouj suggested some factors that might have turned the results against his own calculations.

For example, in the medication arm, patients were not given standardized treatments of nortriptyline and lithium, as established as effective by Harold A. Sackeim, Ph.D., and his colleagues (JAMA. 2001 Mar 14;285[10]:1299-307), but were treated according to current guidelines to both accelerate recruitment rates as well as to avoid any adverse cognitive effects from the interaction of nortriptyline and lithium with ECT.

“We might discuss whether this reduced the likelihood that the people maintained their response rates,” Dr. Bajbouj said. Nearly three-quarters of those in the medication arm were taking two or more antidepressants, more than half were taking an antipsychotic, and a third were taking a mood stabilizer.

An additional factor also could have been the underlying refractory nature of the depression across the cohorts, since after the acute ECT treatment phase, patients in the CBT arm had lower remission rates, compared with the other arms (47% vs. 55% in the ECT plus medication arm, and 64% in the medication-only arm) and had higher Hamilton Rating Scale for Depression scores (24-question version) than the other two groups (8.4 points vs. 5.6 in the ECT plus medication arm and 6.3 in the medication-only arm).

The choice of which type of ECT is best for continuation therapy also is in question. In this single-center study conducted in Berlin between 2004 and 2010, ultrabrief pulse ECT was administered weekly for 4 weeks, biweekly for 8 weeks, and monthly for 3 months, titrated based on the individual seizure threshold established during the first continuation treatment and kept constant thereafter.

In the study, Dr. Bajbouj and his coauthors noted that the results indicated that ultrabrief ECT as a continuation therapy might be less effective than more established forms of ECT with broader pulse widths. “The way we did the continuation ECT therapy is not the way we would do it today,” Dr. Bajbouj said.

So, what of this question of how to factor in possible synergies created when multiple treatments are administered? Dr. Bajbouj pointed to another of his studies, this one done to determine whether the molecular mechanisms of the pretreatments ketamine or lithium used in repetitive transcranial magnetic stimulation affected outcomes (Eur Arch Psychiatry Clin Neurosci. 2012 Feb;262[1]:87-91. doi: 10.1007/s00406-011-0217-3).

Dr. Bajbouj and his colleagues found that pretreatment with ketamine potentiated neuronal cells, while pretreatment with lithium attenuated the cellular response to repetitive magnetic stimulation.

“It’s very oversimplified,” Dr. Bajbouj said. However, a difference in cellular synergies was found, leading Dr. Bajbouj to say that the notion of treatment synergies is “not adequately regarded currently in the field of ECT.”

In the meantime, Dr. Bajbouj laid out a “wish list” for how he’d like to see ECT as well as other brain stimulation techniques become integrated into the mainstream of treatment techniques for depression. Included were the broader use of transcranial magnetic stimulation, more ECT in the depressed elderly and in those with refractory depression, and direct brain stimulation, which he said “might be something for the very severely ill and could prevent relapse.”

It might be a while, though. Despite plenty of data in support of ECT and Dr. Bajbouj’s own data in favor of combining CBT with pharmacotherapy after ECT, the results from an Internet survey showed that, “If you were to ask patients in Germany what they would do if they were depressed, ECT doesn’t even appear.” In the survey, psychotherapy ranked first. “Take antidepressants” ranked between “eat chocolate” and “go on vacation.”

Dr. Bajbouj did not have any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Electroconvulsive therapy’s efficacy in rapid relief from depression is well-established, particularly in the elderly, but the best ways to improve the treatment’s overall effectiveness over time remain a puzzle.

“There are still some questions,” said Dr. Willem A. Nolen, an emeritus professor of psychiatry at the University of Groningen (the Netherlands) and chair of a panel of ECT experts at the annual congress of the European College of Neuropsychopharmacology.

Whitney McKnight/Frontline Medical News

“There is a high relapse rate [with ECT]. So, how should we continue treatment? Do we use medication, continuation ECT, or psychological therapies?”

A meta-analysis published in 2013 showed that 27% of people with depression who were given ECT relapsed after 3 months. Just over half did so after 1 year, mostly in the first 6 months (37.7%). After 2 years, 50.2% of those treated with ECT had relapsed. The study also found that in randomized, controlled trials, antidepressants given after ECT cut the risk of relapse in half in the first 6 months, compared with placebo. The most effective antidepressants, according to the study, were tricyclics, but the researchers could not find enough data on other maintenance therapies, including other pharmacotherapies, to offer a definitive conclusion on what therapy best extends ECT’s effectiveness (Neuropsychopharmacology. 2013 Nov;38[12]:2467-74. doi: 10.1038/npp.2013.149). According to Dr. Malek Bajbouj, a presenter at the meeting, and professor of psychiatry and affective neurosciences at Freie Universität Berlin, perhaps a new logic is required when it comes to determining the best combination of ECT and add-on therapies.

This ethos forms the underpinning of an approach Dr. Bajbouj says he and his colleagues in Berlin are using to integrate treatment modalities, seeking ways to successfully overlap psychotherapeutic interventions, brain stimulation techniques, and pharmacological interventions.

But the approach is not without obstacles.

“If you give two interventions, take for example, ECT and medication, you can do it simultaneously or sequentially, or in an interactive manner. The outcome could be that we all think one and one is two, but this is not always true or what we’d expect or wish,” Dr. Bajbouj told the audience.

“It might be that there is a positive synergy, but it might also be that there are negative or neutral effects where one and one is still one.”

Take the recent findings from a study that left him slightly bewildered.

In a prospective randomized, controlled study of 90 inpatients, mostly in their 60s and all with major depressive disorder who were given either medication, medication plus maintenance ECT, or medication and cognitive-behavioral therapy (CBT) after their initial acute intervention with right unilateral ultrabrief ECT, Dr. Bajbouj and his colleagues found that after 1 year, CBT plus medication significantly outperformed the other continuation therapies (Biol Psychiatry. 2014 Aug 1;76[3]:194-202. doi: 10.1016/j.biopsych.2013.11.030).“The findings were against my personal expectations,” Dr. Bajbouj said. Those expectations cost him: In a bet with a coinvestigator who predicted that the talk therapy arm would outperform the others, “I ended up having to buy her a bottle of champagne.”

A third of the initial study group did not respond to the initial acute ECT. But of the 60 who did and who were randomly assigned their add-on therapy, and followed at 6 months and 1 year, 77% of those given CBT plus medication remained in remission at 6 months, and an impressive 65% did so at 1 year. Meanwhile, the medication plus ECT group had a 40% remission rate at 6 months and a 28% remission rate at 1 year. The medication-only arm had a remission rate of 44% at 6 months and 33% at 1 year.

Dr. Bajbouj suggested some factors that might have turned the results against his own calculations.

For example, in the medication arm, patients were not given standardized treatments of nortriptyline and lithium, as established as effective by Harold A. Sackeim, Ph.D., and his colleagues (JAMA. 2001 Mar 14;285[10]:1299-307), but were treated according to current guidelines to both accelerate recruitment rates as well as to avoid any adverse cognitive effects from the interaction of nortriptyline and lithium with ECT.

“We might discuss whether this reduced the likelihood that the people maintained their response rates,” Dr. Bajbouj said. Nearly three-quarters of those in the medication arm were taking two or more antidepressants, more than half were taking an antipsychotic, and a third were taking a mood stabilizer.

An additional factor also could have been the underlying refractory nature of the depression across the cohorts, since after the acute ECT treatment phase, patients in the CBT arm had lower remission rates, compared with the other arms (47% vs. 55% in the ECT plus medication arm, and 64% in the medication-only arm) and had higher Hamilton Rating Scale for Depression scores (24-question version) than the other two groups (8.4 points vs. 5.6 in the ECT plus medication arm and 6.3 in the medication-only arm).

The choice of which type of ECT is best for continuation therapy also is in question. In this single-center study conducted in Berlin between 2004 and 2010, ultrabrief pulse ECT was administered weekly for 4 weeks, biweekly for 8 weeks, and monthly for 3 months, titrated based on the individual seizure threshold established during the first continuation treatment and kept constant thereafter.

In the study, Dr. Bajbouj and his coauthors noted that the results indicated that ultrabrief ECT as a continuation therapy might be less effective than more established forms of ECT with broader pulse widths. “The way we did the continuation ECT therapy is not the way we would do it today,” Dr. Bajbouj said.

So, what of this question of how to factor in possible synergies created when multiple treatments are administered? Dr. Bajbouj pointed to another of his studies, this one done to determine whether the molecular mechanisms of the pretreatments ketamine or lithium used in repetitive transcranial magnetic stimulation affected outcomes (Eur Arch Psychiatry Clin Neurosci. 2012 Feb;262[1]:87-91. doi: 10.1007/s00406-011-0217-3).

Dr. Bajbouj and his colleagues found that pretreatment with ketamine potentiated neuronal cells, while pretreatment with lithium attenuated the cellular response to repetitive magnetic stimulation.

“It’s very oversimplified,” Dr. Bajbouj said. However, a difference in cellular synergies was found, leading Dr. Bajbouj to say that the notion of treatment synergies is “not adequately regarded currently in the field of ECT.”

In the meantime, Dr. Bajbouj laid out a “wish list” for how he’d like to see ECT as well as other brain stimulation techniques become integrated into the mainstream of treatment techniques for depression. Included were the broader use of transcranial magnetic stimulation, more ECT in the depressed elderly and in those with refractory depression, and direct brain stimulation, which he said “might be something for the very severely ill and could prevent relapse.”

It might be a while, though. Despite plenty of data in support of ECT and Dr. Bajbouj’s own data in favor of combining CBT with pharmacotherapy after ECT, the results from an Internet survey showed that, “If you were to ask patients in Germany what they would do if they were depressed, ECT doesn’t even appear.” In the survey, psychotherapy ranked first. “Take antidepressants” ranked between “eat chocolate” and “go on vacation.”

Dr. Bajbouj did not have any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Electroconvulsive therapy’s efficacy in rapid relief from depression is well-established, particularly in the elderly, but the best ways to improve the treatment’s overall effectiveness over time remain a puzzle.

“There are still some questions,” said Dr. Willem A. Nolen, an emeritus professor of psychiatry at the University of Groningen (the Netherlands) and chair of a panel of ECT experts at the annual congress of the European College of Neuropsychopharmacology.

Whitney McKnight/Frontline Medical News

“There is a high relapse rate [with ECT]. So, how should we continue treatment? Do we use medication, continuation ECT, or psychological therapies?”

A meta-analysis published in 2013 showed that 27% of people with depression who were given ECT relapsed after 3 months. Just over half did so after 1 year, mostly in the first 6 months (37.7%). After 2 years, 50.2% of those treated with ECT had relapsed. The study also found that in randomized, controlled trials, antidepressants given after ECT cut the risk of relapse in half in the first 6 months, compared with placebo. The most effective antidepressants, according to the study, were tricyclics, but the researchers could not find enough data on other maintenance therapies, including other pharmacotherapies, to offer a definitive conclusion on what therapy best extends ECT’s effectiveness (Neuropsychopharmacology. 2013 Nov;38[12]:2467-74. doi: 10.1038/npp.2013.149). According to Dr. Malek Bajbouj, a presenter at the meeting, and professor of psychiatry and affective neurosciences at Freie Universität Berlin, perhaps a new logic is required when it comes to determining the best combination of ECT and add-on therapies.

This ethos forms the underpinning of an approach Dr. Bajbouj says he and his colleagues in Berlin are using to integrate treatment modalities, seeking ways to successfully overlap psychotherapeutic interventions, brain stimulation techniques, and pharmacological interventions.

But the approach is not without obstacles.

“If you give two interventions, take for example, ECT and medication, you can do it simultaneously or sequentially, or in an interactive manner. The outcome could be that we all think one and one is two, but this is not always true or what we’d expect or wish,” Dr. Bajbouj told the audience.

“It might be that there is a positive synergy, but it might also be that there are negative or neutral effects where one and one is still one.”

Take the recent findings from a study that left him slightly bewildered.

In a prospective randomized, controlled study of 90 inpatients, mostly in their 60s and all with major depressive disorder who were given either medication, medication plus maintenance ECT, or medication and cognitive-behavioral therapy (CBT) after their initial acute intervention with right unilateral ultrabrief ECT, Dr. Bajbouj and his colleagues found that after 1 year, CBT plus medication significantly outperformed the other continuation therapies (Biol Psychiatry. 2014 Aug 1;76[3]:194-202. doi: 10.1016/j.biopsych.2013.11.030).“The findings were against my personal expectations,” Dr. Bajbouj said. Those expectations cost him: In a bet with a coinvestigator who predicted that the talk therapy arm would outperform the others, “I ended up having to buy her a bottle of champagne.”

A third of the initial study group did not respond to the initial acute ECT. But of the 60 who did and who were randomly assigned their add-on therapy, and followed at 6 months and 1 year, 77% of those given CBT plus medication remained in remission at 6 months, and an impressive 65% did so at 1 year. Meanwhile, the medication plus ECT group had a 40% remission rate at 6 months and a 28% remission rate at 1 year. The medication-only arm had a remission rate of 44% at 6 months and 33% at 1 year.

Dr. Bajbouj suggested some factors that might have turned the results against his own calculations.

For example, in the medication arm, patients were not given standardized treatments of nortriptyline and lithium, as established as effective by Harold A. Sackeim, Ph.D., and his colleagues (JAMA. 2001 Mar 14;285[10]:1299-307), but were treated according to current guidelines to both accelerate recruitment rates as well as to avoid any adverse cognitive effects from the interaction of nortriptyline and lithium with ECT.

“We might discuss whether this reduced the likelihood that the people maintained their response rates,” Dr. Bajbouj said. Nearly three-quarters of those in the medication arm were taking two or more antidepressants, more than half were taking an antipsychotic, and a third were taking a mood stabilizer.

An additional factor also could have been the underlying refractory nature of the depression across the cohorts, since after the acute ECT treatment phase, patients in the CBT arm had lower remission rates, compared with the other arms (47% vs. 55% in the ECT plus medication arm, and 64% in the medication-only arm) and had higher Hamilton Rating Scale for Depression scores (24-question version) than the other two groups (8.4 points vs. 5.6 in the ECT plus medication arm and 6.3 in the medication-only arm).

The choice of which type of ECT is best for continuation therapy also is in question. In this single-center study conducted in Berlin between 2004 and 2010, ultrabrief pulse ECT was administered weekly for 4 weeks, biweekly for 8 weeks, and monthly for 3 months, titrated based on the individual seizure threshold established during the first continuation treatment and kept constant thereafter.

In the study, Dr. Bajbouj and his coauthors noted that the results indicated that ultrabrief ECT as a continuation therapy might be less effective than more established forms of ECT with broader pulse widths. “The way we did the continuation ECT therapy is not the way we would do it today,” Dr. Bajbouj said.

So, what of this question of how to factor in possible synergies created when multiple treatments are administered? Dr. Bajbouj pointed to another of his studies, this one done to determine whether the molecular mechanisms of the pretreatments ketamine or lithium used in repetitive transcranial magnetic stimulation affected outcomes (Eur Arch Psychiatry Clin Neurosci. 2012 Feb;262[1]:87-91. doi: 10.1007/s00406-011-0217-3).

Dr. Bajbouj and his colleagues found that pretreatment with ketamine potentiated neuronal cells, while pretreatment with lithium attenuated the cellular response to repetitive magnetic stimulation.

“It’s very oversimplified,” Dr. Bajbouj said. However, a difference in cellular synergies was found, leading Dr. Bajbouj to say that the notion of treatment synergies is “not adequately regarded currently in the field of ECT.”

In the meantime, Dr. Bajbouj laid out a “wish list” for how he’d like to see ECT as well as other brain stimulation techniques become integrated into the mainstream of treatment techniques for depression. Included were the broader use of transcranial magnetic stimulation, more ECT in the depressed elderly and in those with refractory depression, and direct brain stimulation, which he said “might be something for the very severely ill and could prevent relapse.”

It might be a while, though. Despite plenty of data in support of ECT and Dr. Bajbouj’s own data in favor of combining CBT with pharmacotherapy after ECT, the results from an Internet survey showed that, “If you were to ask patients in Germany what they would do if they were depressed, ECT doesn’t even appear.” In the survey, psychotherapy ranked first. “Take antidepressants” ranked between “eat chocolate” and “go on vacation.”

Dr. Bajbouj did not have any relevant disclosures.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Despite persistent stigma, electroconvulsive therapy endures as an effective treatment for depression, particularly when applied with a patient-specific approach, according to several study results presented at the annual congress of the European College of Neuropsychopharmacology.

Dr. Charles Kellner, professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, said ECT is well established as effective in elderly populations with depression and is notable for its ability to rapidly curb suicidal ideation, as shown by unpublished data from his PRIDE study (Prolonging Remission in Depressed Elderly, NCT01028508). That study showed an 85% drop in suicidality in patients by the end of their ECT treatment course.

“ECT would be one of the very best treatments in all of medicine” if not for several factors, Dr. Kellner said. ECT cannot prevent relapse in depression unless it is used as maintenance therapy, and varying degrees of negative cognitive impact can come with the procedure, he said. In addition, ECT has been stigmatized by the popular media and others in the profession, and by the antipsychiatry movement, he said.

Despite all this, burgeoning data indicate clinicians have a variety of effective and efficacious ECT methods from which to choose. The overall calculus for which ECT method is best in a specific case “is severity of illness,” Dr. Kellner said in an interview. “It’s usually driven by suicidality and how dysfunctional the patient has become.”

In Dr. Kellner’s PRIDE phase I study, data indicated that 40% of 240 consenting patients with a mean age of 70 years and unipolar depression, given ultrabrief pulse right unilateral ECT three times weekly until remission, and augmented by a low dose of the selective serotonin reuptake inhibitor venlafaxine (up to 225 mg per day after any previous medication washout), were successfully treated for their depression after 1 week.

The response criteria was a 50% or greater reduction from baseline in at least 21 of 24 items on the Hamilton Rating Scale for Depression (HAM-D-24) after 1 week, while remission was defined as scoring 10 or less on the HAM-D-24 at two consecutive follow-up points each week. After two treatments, 8% of responders achieved remission, and nearly 18% remitted after a full week.

Meanwhile, patients who did not complete the study or meet the response and remission criteria still benefited, Dr. Kellner said. “Nonremitters [about 28% of the study] and dropouts [about 10%] get considerably better from whatever ECT they are able to have.”

ECT with a pulse width of less than 0.5 milliseconds is considered ultrabrief pulse ECT. Pulse widths of 0.5 msec or higher are considered standard ECT. Seizures induced by any pulse width are the theorized mechanism of action for reducing depression with ECT, but correlates between higher levels of energy and greater levels of negative cognitive effects are well established in the literature. Presenter Dr. Pascal Sienaert, a psychiatrist and director of the ECT program at the Catholic University of Leuven (Belgium), said that because the “ideal stimulus to depolarize a group of neurons would be 0.1 or 0.2 milliseconds,” ultrabrief pulse ECT should “theoretically” be the most effective with the least cognitive burden.

Whitney McKnight/Frontline Medical News

In the PRIDE study, nearly 85% of participants seized at the lowest stimulus dose during their first treatment when ultralow doses were used to determine each patient’s seizure threshold. Given the age of the cohort, this was a fortunate surprise, Dr. Kellner said, since it allowed subsequent dosing at six times the seizure threshold at low absolute stimulus charges. “This is a very efficient form of ECT for inducing a seizure,” Dr. Kellner said in his presentation.

About 10% of responders in the study experienced more than a 50% drop in their HAM-D scores after one treatment at the ultralow dose, which has created some debate over whether it was a placebo response. Dr. Kellner rejected this theory. “I think ECT is such a powerful biological treatment, it’s very hard to ascribe this to placebo.”

Rates of remission varied greatly in the PRIDE study, ranging from 20% remitting after 4 treatments, to 26% remitting after 10 treatments. “This speaks to the point that you can’t tell a patient how long their treatment will be. Some need fewer treatments; some need prolonged courses.”

But Dr. Sienaert’s own findings cast doubt on the ability of ultrabrief pulse ECT to ensure fewer cognitive burdens than standard ECT.

In a randomized comparison of ultrabrief bifrontal and unilateral ECT for patients with refractory depression, no significant differences were found in response and remission rates. However, the cohort treated with right unilateral ultrabrief pulse ECT required fewer treatments to reach response and remission (J Affect Disord. 2010 Apr;122[1-2]:60-7. doi: 10.1016/j.jad.2009.06.011).

Although all patients had baseline deficits across the cognitive domains, Dr. Sienaert’s study did not find any additional declines in cognition following ECT in either arm. Because the entire study group overall remained cognitively impaired, Dr. Sienaert theorized the sample was either previously cognitively scarred, putting them at risk for depression, or that the inverse was true: their depression left them vulnerable to cognitive deficits.

Taken with the results of a second study by Dr. Sienaert, there doesn’t seem to be any notable cognitive advantage to ultrabrief pulse ECT.

In the second study, a randomized, controlled comparison of right unilateral ultrabrief pulse ECT with right unilateral standard pulse ECT in 116 patients, standard pulse ECT performed significantly better than did ultrabrief pulse ECT, and had similar relapse rates at 3 and 6 months. Most of the patients in the study were women in their early 60s who were taking medication for their depression (J Affect Disord. 2015 Sep 15;184:137-44. doi: 10.1016/j.jad.2015.05.22).

Remission rates in both those who dropped out (58%) of the standard group and those who completed the standard ECT treatments (68.4%) were higher, compared with the ultrabrief intention-to-treat (41.4%) and completion (49%) groups. The standard ECT group also needed, on average, two fewer treatments to reach remission (7 vs. 9). Cognitive burdens in the two therapies were comparable.

However, a recently published meta-analysis of both standard and ultrabrief pulse ECT found that while ultrabrief pulse ECT has lower remission rates than standard ECT, it is associated with having less of a cognitive impact (J Clin Psychiatry. 2015 Jul 21).

Even though, according to Dr. Sienaert, many clinicians have changed their practice, adopting ultrabrief pulse ECT for all patients, he told the audience: “I don’t think it should be the standard of care. There is not one single technique that should be ... the data give us possibilities to tailor treatment to our patients.”

Having a range of treatments also helps to persuade patients who might be put off by near sadistic depictions of “shock therapy” in popular culture such as in the movie “One Flew Over the Cuckoo’s Nest” based on the novel by Ken Kesey and released in 1975. “It’s still responsible for the vast majority of stigma surrounding ECT,” Dr. Kellner said.

In an interview, Dr. Sienaert said having more options means, “You can choose treatments with less cognitive side effects for patients who are either afraid of [experiencing cognitive deficits] or who already have cognitive issues, such as might be in the elderly.”

Data presented by Dr. Declan McLoughlin, a research professor of psychiatry at Trinity College Dublin, considered the question of whether a specific ECT treatment’s efficacy might be outweighed by a lack of effectiveness.

Whitney McKnight/Frontline Medical News

Previous trials have tested whether standard bitemporal ECT has better efficacy than that of high-dose unilateral ECT, but whether a cognitive impact was too great proved unclear.

In a currently unpublished study, Dr. McLoughlin and his associates showed that both forms of treatment were efficacious and effective. The upshot was that high-dose ECT was not inferior and offered some cognitive advantages, “Particularly if cognitive side effects are an issue to begin with,” he said.

The study randomly assigned 138 patients with severe depression, two-thirds of whom were women primarily in their late 50s, to receive standard bitemporal ECT at 1.5 times the patient’s established seizure threshold twice weekly, or high-dose right unilateral ECT at 6.0 times the patient’s seizure threshold twice weekly. Patients received up to 12 sessions depending upon the treatment recommended by the individual clinician. All participants, except for the clinicians administering the treatments, were blinded. Patients were rated for their response and remission rates after every second ECT treatment and were followed for 12 months after their last treatment.

Nearly 51% of patients in the low-dose group met the primary clinical outcome with a 60% or greater change from baseline on their HAM-D-24, scoring 16 or less. Just under 61% of patients met the response criteria in the high-dose group.

Forty-two percent of patients in the low-dose group met remission criteria of at least a 60% decrease in their baseline HAM-D with a score of 10 or less on two consecutive rating sessions, while just over 46% did in the high-dose group.

“Over time, the unilateral group did slightly better, including at 6 months’ follow-up,” Dr. McLoughlin said.

The higher dose group outperformed the lower-dose group by just over 1 point on the HAM-D scores, within the noninferiority threshold.

At 6 months, nearly a third of remitters in each group had relapsed with a 10-point or higher increase from their HAM-D taken at the end of their treatment.

The high-dose patients also experienced less impairment to their autobiographical memory (details they told the clinician before receiving ECT) directly after treatment and at 6-month follow-up. The low-dose patients overall recalled about 60% of their autobiographical memory, compared with the high dose group’s 70%. However, Dr. McLoughlin noted that this is normal in the general population, “but it’s probably a bit worse in depressed patients.”

An as yet unpublished meta-analysis Dr. McLoughlin and his colleagues conducted of the six previous trials comparing the efficacy of these two forms of ECT also found no significant difference between the two regarding response or remission, and that higher doses of ECT offered better reorientation times, and better retrograde autobiographical memory, with no differences in global cognition, complex figure tests, or verbal learning.

While cognitive data from the PRIDE phase I and efficacy data from the study’s phase II are forthcoming, according to Dr. Kellner, he agreed with Dr. McLoughlin that overall, bilateral treatments were better, although the unilateral treatments approach the same efficacy levels. Ultimately, however, group data are irrelevant if they fail to jibe with what is happening in front of a clinician treating a patient.

“For an individual patient who doesn’t respond to right unilateral ECT, it’s imperative they be switched over to a different form of ECT,” said Dr. Kellner, since many right unilateral nonresponders will do well with bilateral ECT. “Particularly if patients are urgently ill, one should consider using bilateral ECT from the outset. I still believe that is a true clinical dictum.”

The lineup of international ECT experts drew roughly 200 audience members, the largest such ECT audiences Dr. Kellner and Dr. Sienaert said they’d ever seen.

“The biggest problem is ECT remains stigmatized,” Dr. Kellner said. “It needs to be said at any ECT gathering.”

Dr. Kellner is a consultant to Luitpold Pharmaceuticals. Dr. Sienaert noted he had received travel expenses in the past year from MECTA, and Dr. McLoughlin had no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Despite persistent stigma, electroconvulsive therapy endures as an effective treatment for depression, particularly when applied with a patient-specific approach, according to several study results presented at the annual congress of the European College of Neuropsychopharmacology.

Dr. Charles Kellner, professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, said ECT is well established as effective in elderly populations with depression and is notable for its ability to rapidly curb suicidal ideation, as shown by unpublished data from his PRIDE study (Prolonging Remission in Depressed Elderly, NCT01028508). That study showed an 85% drop in suicidality in patients by the end of their ECT treatment course.

“ECT would be one of the very best treatments in all of medicine” if not for several factors, Dr. Kellner said. ECT cannot prevent relapse in depression unless it is used as maintenance therapy, and varying degrees of negative cognitive impact can come with the procedure, he said. In addition, ECT has been stigmatized by the popular media and others in the profession, and by the antipsychiatry movement, he said.

Despite all this, burgeoning data indicate clinicians have a variety of effective and efficacious ECT methods from which to choose. The overall calculus for which ECT method is best in a specific case “is severity of illness,” Dr. Kellner said in an interview. “It’s usually driven by suicidality and how dysfunctional the patient has become.”

In Dr. Kellner’s PRIDE phase I study, data indicated that 40% of 240 consenting patients with a mean age of 70 years and unipolar depression, given ultrabrief pulse right unilateral ECT three times weekly until remission, and augmented by a low dose of the selective serotonin reuptake inhibitor venlafaxine (up to 225 mg per day after any previous medication washout), were successfully treated for their depression after 1 week.

The response criteria was a 50% or greater reduction from baseline in at least 21 of 24 items on the Hamilton Rating Scale for Depression (HAM-D-24) after 1 week, while remission was defined as scoring 10 or less on the HAM-D-24 at two consecutive follow-up points each week. After two treatments, 8% of responders achieved remission, and nearly 18% remitted after a full week.

Meanwhile, patients who did not complete the study or meet the response and remission criteria still benefited, Dr. Kellner said. “Nonremitters [about 28% of the study] and dropouts [about 10%] get considerably better from whatever ECT they are able to have.”

ECT with a pulse width of less than 0.5 milliseconds is considered ultrabrief pulse ECT. Pulse widths of 0.5 msec or higher are considered standard ECT. Seizures induced by any pulse width are the theorized mechanism of action for reducing depression with ECT, but correlates between higher levels of energy and greater levels of negative cognitive effects are well established in the literature. Presenter Dr. Pascal Sienaert, a psychiatrist and director of the ECT program at the Catholic University of Leuven (Belgium), said that because the “ideal stimulus to depolarize a group of neurons would be 0.1 or 0.2 milliseconds,” ultrabrief pulse ECT should “theoretically” be the most effective with the least cognitive burden.

Whitney McKnight/Frontline Medical News

In the PRIDE study, nearly 85% of participants seized at the lowest stimulus dose during their first treatment when ultralow doses were used to determine each patient’s seizure threshold. Given the age of the cohort, this was a fortunate surprise, Dr. Kellner said, since it allowed subsequent dosing at six times the seizure threshold at low absolute stimulus charges. “This is a very efficient form of ECT for inducing a seizure,” Dr. Kellner said in his presentation.

About 10% of responders in the study experienced more than a 50% drop in their HAM-D scores after one treatment at the ultralow dose, which has created some debate over whether it was a placebo response. Dr. Kellner rejected this theory. “I think ECT is such a powerful biological treatment, it’s very hard to ascribe this to placebo.”

Rates of remission varied greatly in the PRIDE study, ranging from 20% remitting after 4 treatments, to 26% remitting after 10 treatments. “This speaks to the point that you can’t tell a patient how long their treatment will be. Some need fewer treatments; some need prolonged courses.”

But Dr. Sienaert’s own findings cast doubt on the ability of ultrabrief pulse ECT to ensure fewer cognitive burdens than standard ECT.

In a randomized comparison of ultrabrief bifrontal and unilateral ECT for patients with refractory depression, no significant differences were found in response and remission rates. However, the cohort treated with right unilateral ultrabrief pulse ECT required fewer treatments to reach response and remission (J Affect Disord. 2010 Apr;122[1-2]:60-7. doi: 10.1016/j.jad.2009.06.011).

Although all patients had baseline deficits across the cognitive domains, Dr. Sienaert’s study did not find any additional declines in cognition following ECT in either arm. Because the entire study group overall remained cognitively impaired, Dr. Sienaert theorized the sample was either previously cognitively scarred, putting them at risk for depression, or that the inverse was true: their depression left them vulnerable to cognitive deficits.

Taken with the results of a second study by Dr. Sienaert, there doesn’t seem to be any notable cognitive advantage to ultrabrief pulse ECT.

In the second study, a randomized, controlled comparison of right unilateral ultrabrief pulse ECT with right unilateral standard pulse ECT in 116 patients, standard pulse ECT performed significantly better than did ultrabrief pulse ECT, and had similar relapse rates at 3 and 6 months. Most of the patients in the study were women in their early 60s who were taking medication for their depression (J Affect Disord. 2015 Sep 15;184:137-44. doi: 10.1016/j.jad.2015.05.22).

Remission rates in both those who dropped out (58%) of the standard group and those who completed the standard ECT treatments (68.4%) were higher, compared with the ultrabrief intention-to-treat (41.4%) and completion (49%) groups. The standard ECT group also needed, on average, two fewer treatments to reach remission (7 vs. 9). Cognitive burdens in the two therapies were comparable.

However, a recently published meta-analysis of both standard and ultrabrief pulse ECT found that while ultrabrief pulse ECT has lower remission rates than standard ECT, it is associated with having less of a cognitive impact (J Clin Psychiatry. 2015 Jul 21).

Even though, according to Dr. Sienaert, many clinicians have changed their practice, adopting ultrabrief pulse ECT for all patients, he told the audience: “I don’t think it should be the standard of care. There is not one single technique that should be ... the data give us possibilities to tailor treatment to our patients.”

Having a range of treatments also helps to persuade patients who might be put off by near sadistic depictions of “shock therapy” in popular culture such as in the movie “One Flew Over the Cuckoo’s Nest” based on the novel by Ken Kesey and released in 1975. “It’s still responsible for the vast majority of stigma surrounding ECT,” Dr. Kellner said.

In an interview, Dr. Sienaert said having more options means, “You can choose treatments with less cognitive side effects for patients who are either afraid of [experiencing cognitive deficits] or who already have cognitive issues, such as might be in the elderly.”

Data presented by Dr. Declan McLoughlin, a research professor of psychiatry at Trinity College Dublin, considered the question of whether a specific ECT treatment’s efficacy might be outweighed by a lack of effectiveness.

Whitney McKnight/Frontline Medical News

Previous trials have tested whether standard bitemporal ECT has better efficacy than that of high-dose unilateral ECT, but whether a cognitive impact was too great proved unclear.

In a currently unpublished study, Dr. McLoughlin and his associates showed that both forms of treatment were efficacious and effective. The upshot was that high-dose ECT was not inferior and offered some cognitive advantages, “Particularly if cognitive side effects are an issue to begin with,” he said.

The study randomly assigned 138 patients with severe depression, two-thirds of whom were women primarily in their late 50s, to receive standard bitemporal ECT at 1.5 times the patient’s established seizure threshold twice weekly, or high-dose right unilateral ECT at 6.0 times the patient’s seizure threshold twice weekly. Patients received up to 12 sessions depending upon the treatment recommended by the individual clinician. All participants, except for the clinicians administering the treatments, were blinded. Patients were rated for their response and remission rates after every second ECT treatment and were followed for 12 months after their last treatment.

Nearly 51% of patients in the low-dose group met the primary clinical outcome with a 60% or greater change from baseline on their HAM-D-24, scoring 16 or less. Just under 61% of patients met the response criteria in the high-dose group.

Forty-two percent of patients in the low-dose group met remission criteria of at least a 60% decrease in their baseline HAM-D with a score of 10 or less on two consecutive rating sessions, while just over 46% did in the high-dose group.

“Over time, the unilateral group did slightly better, including at 6 months’ follow-up,” Dr. McLoughlin said.

The higher dose group outperformed the lower-dose group by just over 1 point on the HAM-D scores, within the noninferiority threshold.

At 6 months, nearly a third of remitters in each group had relapsed with a 10-point or higher increase from their HAM-D taken at the end of their treatment.

The high-dose patients also experienced less impairment to their autobiographical memory (details they told the clinician before receiving ECT) directly after treatment and at 6-month follow-up. The low-dose patients overall recalled about 60% of their autobiographical memory, compared with the high dose group’s 70%. However, Dr. McLoughlin noted that this is normal in the general population, “but it’s probably a bit worse in depressed patients.”

An as yet unpublished meta-analysis Dr. McLoughlin and his colleagues conducted of the six previous trials comparing the efficacy of these two forms of ECT also found no significant difference between the two regarding response or remission, and that higher doses of ECT offered better reorientation times, and better retrograde autobiographical memory, with no differences in global cognition, complex figure tests, or verbal learning.

While cognitive data from the PRIDE phase I and efficacy data from the study’s phase II are forthcoming, according to Dr. Kellner, he agreed with Dr. McLoughlin that overall, bilateral treatments were better, although the unilateral treatments approach the same efficacy levels. Ultimately, however, group data are irrelevant if they fail to jibe with what is happening in front of a clinician treating a patient.

“For an individual patient who doesn’t respond to right unilateral ECT, it’s imperative they be switched over to a different form of ECT,” said Dr. Kellner, since many right unilateral nonresponders will do well with bilateral ECT. “Particularly if patients are urgently ill, one should consider using bilateral ECT from the outset. I still believe that is a true clinical dictum.”

The lineup of international ECT experts drew roughly 200 audience members, the largest such ECT audiences Dr. Kellner and Dr. Sienaert said they’d ever seen.

“The biggest problem is ECT remains stigmatized,” Dr. Kellner said. “It needs to be said at any ECT gathering.”

Dr. Kellner is a consultant to Luitpold Pharmaceuticals. Dr. Sienaert noted he had received travel expenses in the past year from MECTA, and Dr. McLoughlin had no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

AMSTERDAM – Despite persistent stigma, electroconvulsive therapy endures as an effective treatment for depression, particularly when applied with a patient-specific approach, according to several study results presented at the annual congress of the European College of Neuropsychopharmacology.

Dr. Charles Kellner, professor of psychiatry at the Icahn School of Medicine at Mount Sinai, New York, said ECT is well established as effective in elderly populations with depression and is notable for its ability to rapidly curb suicidal ideation, as shown by unpublished data from his PRIDE study (Prolonging Remission in Depressed Elderly, NCT01028508). That study showed an 85% drop in suicidality in patients by the end of their ECT treatment course.

“ECT would be one of the very best treatments in all of medicine” if not for several factors, Dr. Kellner said. ECT cannot prevent relapse in depression unless it is used as maintenance therapy, and varying degrees of negative cognitive impact can come with the procedure, he said. In addition, ECT has been stigmatized by the popular media and others in the profession, and by the antipsychiatry movement, he said.

Despite all this, burgeoning data indicate clinicians have a variety of effective and efficacious ECT methods from which to choose. The overall calculus for which ECT method is best in a specific case “is severity of illness,” Dr. Kellner said in an interview. “It’s usually driven by suicidality and how dysfunctional the patient has become.”

In Dr. Kellner’s PRIDE phase I study, data indicated that 40% of 240 consenting patients with a mean age of 70 years and unipolar depression, given ultrabrief pulse right unilateral ECT three times weekly until remission, and augmented by a low dose of the selective serotonin reuptake inhibitor venlafaxine (up to 225 mg per day after any previous medication washout), were successfully treated for their depression after 1 week.

The response criteria was a 50% or greater reduction from baseline in at least 21 of 24 items on the Hamilton Rating Scale for Depression (HAM-D-24) after 1 week, while remission was defined as scoring 10 or less on the HAM-D-24 at two consecutive follow-up points each week. After two treatments, 8% of responders achieved remission, and nearly 18% remitted after a full week.

Meanwhile, patients who did not complete the study or meet the response and remission criteria still benefited, Dr. Kellner said. “Nonremitters [about 28% of the study] and dropouts [about 10%] get considerably better from whatever ECT they are able to have.”

ECT with a pulse width of less than 0.5 milliseconds is considered ultrabrief pulse ECT. Pulse widths of 0.5 msec or higher are considered standard ECT. Seizures induced by any pulse width are the theorized mechanism of action for reducing depression with ECT, but correlates between higher levels of energy and greater levels of negative cognitive effects are well established in the literature. Presenter Dr. Pascal Sienaert, a psychiatrist and director of the ECT program at the Catholic University of Leuven (Belgium), said that because the “ideal stimulus to depolarize a group of neurons would be 0.1 or 0.2 milliseconds,” ultrabrief pulse ECT should “theoretically” be the most effective with the least cognitive burden.

Whitney McKnight/Frontline Medical News

In the PRIDE study, nearly 85% of participants seized at the lowest stimulus dose during their first treatment when ultralow doses were used to determine each patient’s seizure threshold. Given the age of the cohort, this was a fortunate surprise, Dr. Kellner said, since it allowed subsequent dosing at six times the seizure threshold at low absolute stimulus charges. “This is a very efficient form of ECT for inducing a seizure,” Dr. Kellner said in his presentation.

About 10% of responders in the study experienced more than a 50% drop in their HAM-D scores after one treatment at the ultralow dose, which has created some debate over whether it was a placebo response. Dr. Kellner rejected this theory. “I think ECT is such a powerful biological treatment, it’s very hard to ascribe this to placebo.”

Rates of remission varied greatly in the PRIDE study, ranging from 20% remitting after 4 treatments, to 26% remitting after 10 treatments. “This speaks to the point that you can’t tell a patient how long their treatment will be. Some need fewer treatments; some need prolonged courses.”

But Dr. Sienaert’s own findings cast doubt on the ability of ultrabrief pulse ECT to ensure fewer cognitive burdens than standard ECT.

In a randomized comparison of ultrabrief bifrontal and unilateral ECT for patients with refractory depression, no significant differences were found in response and remission rates. However, the cohort treated with right unilateral ultrabrief pulse ECT required fewer treatments to reach response and remission (J Affect Disord. 2010 Apr;122[1-2]:60-7. doi: 10.1016/j.jad.2009.06.011).

Although all patients had baseline deficits across the cognitive domains, Dr. Sienaert’s study did not find any additional declines in cognition following ECT in either arm. Because the entire study group overall remained cognitively impaired, Dr. Sienaert theorized the sample was either previously cognitively scarred, putting them at risk for depression, or that the inverse was true: their depression left them vulnerable to cognitive deficits.

Taken with the results of a second study by Dr. Sienaert, there doesn’t seem to be any notable cognitive advantage to ultrabrief pulse ECT.

In the second study, a randomized, controlled comparison of right unilateral ultrabrief pulse ECT with right unilateral standard pulse ECT in 116 patients, standard pulse ECT performed significantly better than did ultrabrief pulse ECT, and had similar relapse rates at 3 and 6 months. Most of the patients in the study were women in their early 60s who were taking medication for their depression (J Affect Disord. 2015 Sep 15;184:137-44. doi: 10.1016/j.jad.2015.05.22).

Remission rates in both those who dropped out (58%) of the standard group and those who completed the standard ECT treatments (68.4%) were higher, compared with the ultrabrief intention-to-treat (41.4%) and completion (49%) groups. The standard ECT group also needed, on average, two fewer treatments to reach remission (7 vs. 9). Cognitive burdens in the two therapies were comparable.

However, a recently published meta-analysis of both standard and ultrabrief pulse ECT found that while ultrabrief pulse ECT has lower remission rates than standard ECT, it is associated with having less of a cognitive impact (J Clin Psychiatry. 2015 Jul 21).

Even though, according to Dr. Sienaert, many clinicians have changed their practice, adopting ultrabrief pulse ECT for all patients, he told the audience: “I don’t think it should be the standard of care. There is not one single technique that should be ... the data give us possibilities to tailor treatment to our patients.”

Having a range of treatments also helps to persuade patients who might be put off by near sadistic depictions of “shock therapy” in popular culture such as in the movie “One Flew Over the Cuckoo’s Nest” based on the novel by Ken Kesey and released in 1975. “It’s still responsible for the vast majority of stigma surrounding ECT,” Dr. Kellner said.

In an interview, Dr. Sienaert said having more options means, “You can choose treatments with less cognitive side effects for patients who are either afraid of [experiencing cognitive deficits] or who already have cognitive issues, such as might be in the elderly.”

Data presented by Dr. Declan McLoughlin, a research professor of psychiatry at Trinity College Dublin, considered the question of whether a specific ECT treatment’s efficacy might be outweighed by a lack of effectiveness.

Whitney McKnight/Frontline Medical News

Previous trials have tested whether standard bitemporal ECT has better efficacy than that of high-dose unilateral ECT, but whether a cognitive impact was too great proved unclear.

In a currently unpublished study, Dr. McLoughlin and his associates showed that both forms of treatment were efficacious and effective. The upshot was that high-dose ECT was not inferior and offered some cognitive advantages, “Particularly if cognitive side effects are an issue to begin with,” he said.

The study randomly assigned 138 patients with severe depression, two-thirds of whom were women primarily in their late 50s, to receive standard bitemporal ECT at 1.5 times the patient’s established seizure threshold twice weekly, or high-dose right unilateral ECT at 6.0 times the patient’s seizure threshold twice weekly. Patients received up to 12 sessions depending upon the treatment recommended by the individual clinician. All participants, except for the clinicians administering the treatments, were blinded. Patients were rated for their response and remission rates after every second ECT treatment and were followed for 12 months after their last treatment.

Nearly 51% of patients in the low-dose group met the primary clinical outcome with a 60% or greater change from baseline on their HAM-D-24, scoring 16 or less. Just under 61% of patients met the response criteria in the high-dose group.

Forty-two percent of patients in the low-dose group met remission criteria of at least a 60% decrease in their baseline HAM-D with a score of 10 or less on two consecutive rating sessions, while just over 46% did in the high-dose group.

“Over time, the unilateral group did slightly better, including at 6 months’ follow-up,” Dr. McLoughlin said.

The higher dose group outperformed the lower-dose group by just over 1 point on the HAM-D scores, within the noninferiority threshold.

At 6 months, nearly a third of remitters in each group had relapsed with a 10-point or higher increase from their HAM-D taken at the end of their treatment.

The high-dose patients also experienced less impairment to their autobiographical memory (details they told the clinician before receiving ECT) directly after treatment and at 6-month follow-up. The low-dose patients overall recalled about 60% of their autobiographical memory, compared with the high dose group’s 70%. However, Dr. McLoughlin noted that this is normal in the general population, “but it’s probably a bit worse in depressed patients.”

An as yet unpublished meta-analysis Dr. McLoughlin and his colleagues conducted of the six previous trials comparing the efficacy of these two forms of ECT also found no significant difference between the two regarding response or remission, and that higher doses of ECT offered better reorientation times, and better retrograde autobiographical memory, with no differences in global cognition, complex figure tests, or verbal learning.

While cognitive data from the PRIDE phase I and efficacy data from the study’s phase II are forthcoming, according to Dr. Kellner, he agreed with Dr. McLoughlin that overall, bilateral treatments were better, although the unilateral treatments approach the same efficacy levels. Ultimately, however, group data are irrelevant if they fail to jibe with what is happening in front of a clinician treating a patient.

“For an individual patient who doesn’t respond to right unilateral ECT, it’s imperative they be switched over to a different form of ECT,” said Dr. Kellner, since many right unilateral nonresponders will do well with bilateral ECT. “Particularly if patients are urgently ill, one should consider using bilateral ECT from the outset. I still believe that is a true clinical dictum.”

The lineup of international ECT experts drew roughly 200 audience members, the largest such ECT audiences Dr. Kellner and Dr. Sienaert said they’d ever seen.

“The biggest problem is ECT remains stigmatized,” Dr. Kellner said. “It needs to be said at any ECT gathering.”

Dr. Kellner is a consultant to Luitpold Pharmaceuticals. Dr. Sienaert noted he had received travel expenses in the past year from MECTA, and Dr. McLoughlin had no relevant disclosures.

[email protected]

On Twitter @whitneymcknight

The 2nd U.S. Circuit Court of Appeals has ruled that health insurance claims administrators who exercise “total control” over health plans may be sued for violating mental health parity law under the Employee Retirement Income Security Act of 1974.

The decision, made Aug. 20, states that the New York State Psychiatric Association (NYSPA) is authorized to sue third-party administrators of Employee Retirement Income Security Act (ERISA)-regulated health plans on behalf of its members and their patients for violations of the mental health parity law.

©Kuzma/iStockphoto.com

This is the first time a federal appeals court has ruled on enforcement of the Mental Health Parity and Addiction Equity Act of 2008, Meiram Bendat, Ph.D., a California attorney and licensed psychotherapist who argued on behalf of the plaintiffs in the case, said in an interview. “There’s no free pass around complying with parity. This [decision] puts teeth into the law.”

In 2013, the NYSPA filed a class-action suit on behalf of its members and their patients against UnitedHealthGroup for not covering mental health–related claims, citing as examples different algorithms; preauthorization; and concurrent review procedures than for medical claims, often resulting in denial of coverage. The federal district court of New York agreed that the plaintiffs had plausibly alleged violations of the parity act; it nonetheless dismissed the case, finding that NYSPA did not have associational standing in this instance and noting that the association itself was not harmed. United also argued that employers should be the defendants, not the third-party claims administrators, since employers were the official plan administrators.

The appellate court’s decision to overturn that ruling further clarifies who can sue and be sued in cases of mental health parity violations that might occur under ERISA-regulated plans. The discrete lines puts pressure on claims administrators to make transparent the bases for their claims review said Dr. Bendat.*

In a statement, NYSPA’s executive director and general counsel, Seth P. Stein, said: “The decision … is particularly important because it removes a technicality that plan administrators might raise to avoid being responsible when they make determinations that run afoul of federal parity laws.”

Because ERISA regulates only about 50% of commercial plans in the United States, Dr. Bendat said remedies for mental health parity law violations that might occur in the administration of plans purchased through exchanges created by the Affordable Care Act have yet to be tested, although he thought the recent ruling might strengthen any legal theories plaintiffs in those situations might employ.

Former U.S. Rep. Patrick J. Kennedy (D-R.I.) called the ruling a "major turning point for mental health parity in the United States."

"This is exactly what was intended when the law was passed," the mental health advocate and former congressman said in a statement. "Today's ruling is a clear victory for patients and their families."

[email protected]

On Twitter @whitneymcknight

This article has been updated after publication.

The 2nd U.S. Circuit Court of Appeals has ruled that health insurance claims administrators who exercise “total control” over health plans may be sued for violating mental health parity law under the Employee Retirement Income Security Act of 1974.

The decision, made Aug. 20, states that the New York State Psychiatric Association (NYSPA) is authorized to sue third-party administrators of Employee Retirement Income Security Act (ERISA)-regulated health plans on behalf of its members and their patients for violations of the mental health parity law.

©Kuzma/iStockphoto.com

This is the first time a federal appeals court has ruled on enforcement of the Mental Health Parity and Addiction Equity Act of 2008, Meiram Bendat, Ph.D., a California attorney and licensed psychotherapist who argued on behalf of the plaintiffs in the case, said in an interview. “There’s no free pass around complying with parity. This [decision] puts teeth into the law.”

In 2013, the NYSPA filed a class-action suit on behalf of its members and their patients against UnitedHealthGroup for not covering mental health–related claims, citing as examples different algorithms; preauthorization; and concurrent review procedures than for medical claims, often resulting in denial of coverage. The federal district court of New York agreed that the plaintiffs had plausibly alleged violations of the parity act; it nonetheless dismissed the case, finding that NYSPA did not have associational standing in this instance and noting that the association itself was not harmed. United also argued that employers should be the defendants, not the third-party claims administrators, since employers were the official plan administrators.

The appellate court’s decision to overturn that ruling further clarifies who can sue and be sued in cases of mental health parity violations that might occur under ERISA-regulated plans. The discrete lines puts pressure on claims administrators to make transparent the bases for their claims review said Dr. Bendat.*

In a statement, NYSPA’s executive director and general counsel, Seth P. Stein, said: “The decision … is particularly important because it removes a technicality that plan administrators might raise to avoid being responsible when they make determinations that run afoul of federal parity laws.”

Because ERISA regulates only about 50% of commercial plans in the United States, Dr. Bendat said remedies for mental health parity law violations that might occur in the administration of plans purchased through exchanges created by the Affordable Care Act have yet to be tested, although he thought the recent ruling might strengthen any legal theories plaintiffs in those situations might employ.

Former U.S. Rep. Patrick J. Kennedy (D-R.I.) called the ruling a "major turning point for mental health parity in the United States."

"This is exactly what was intended when the law was passed," the mental health advocate and former congressman said in a statement. "Today's ruling is a clear victory for patients and their families."

[email protected]

On Twitter @whitneymcknight

This article has been updated after publication.

The 2nd U.S. Circuit Court of Appeals has ruled that health insurance claims administrators who exercise “total control” over health plans may be sued for violating mental health parity law under the Employee Retirement Income Security Act of 1974.

The decision, made Aug. 20, states that the New York State Psychiatric Association (NYSPA) is authorized to sue third-party administrators of Employee Retirement Income Security Act (ERISA)-regulated health plans on behalf of its members and their patients for violations of the mental health parity law.

©Kuzma/iStockphoto.com

This is the first time a federal appeals court has ruled on enforcement of the Mental Health Parity and Addiction Equity Act of 2008, Meiram Bendat, Ph.D., a California attorney and licensed psychotherapist who argued on behalf of the plaintiffs in the case, said in an interview. “There’s no free pass around complying with parity. This [decision] puts teeth into the law.”

In 2013, the NYSPA filed a class-action suit on behalf of its members and their patients against UnitedHealthGroup for not covering mental health–related claims, citing as examples different algorithms; preauthorization; and concurrent review procedures than for medical claims, often resulting in denial of coverage. The federal district court of New York agreed that the plaintiffs had plausibly alleged violations of the parity act; it nonetheless dismissed the case, finding that NYSPA did not have associational standing in this instance and noting that the association itself was not harmed. United also argued that employers should be the defendants, not the third-party claims administrators, since employers were the official plan administrators.

The appellate court’s decision to overturn that ruling further clarifies who can sue and be sued in cases of mental health parity violations that might occur under ERISA-regulated plans. The discrete lines puts pressure on claims administrators to make transparent the bases for their claims review said Dr. Bendat.*

In a statement, NYSPA’s executive director and general counsel, Seth P. Stein, said: “The decision … is particularly important because it removes a technicality that plan administrators might raise to avoid being responsible when they make determinations that run afoul of federal parity laws.”

Because ERISA regulates only about 50% of commercial plans in the United States, Dr. Bendat said remedies for mental health parity law violations that might occur in the administration of plans purchased through exchanges created by the Affordable Care Act have yet to be tested, although he thought the recent ruling might strengthen any legal theories plaintiffs in those situations might employ.

Former U.S. Rep. Patrick J. Kennedy (D-R.I.) called the ruling a "major turning point for mental health parity in the United States."

"This is exactly what was intended when the law was passed," the mental health advocate and former congressman said in a statement. "Today's ruling is a clear victory for patients and their families."

[email protected]

On Twitter @whitneymcknight

This article has been updated after publication.

WASHINGTON – The Obama administration announced Aug. 17 that it will spend an additional $13.4 million fighting opioid and heroin abuse, emphasizing treatment over law enforcement.

The increased emphasis will center on geographic areas where heroin and opioid abuse are rampant, specifically Appalachia; New England; Philadelphia/Camden, N.J.; metropolitan New York City, particularly northern New Jersey; and the Washington/Baltimore metro region. Public safety officers and first responders will be trained in how to administer naloxone and provide other medical attention for those in the midst of a heroin or opioid overdose.

©PaulPaladin/thinkstockphotos.com

The 15 states in the targeted areas will share and leverage data to determine regional patterns of heroin and prescription painkiller-related overdose. These data are expected to delineate where the narcotics – especially those laced with other, more dangerous drugs – are being produced and distributed so that heroin response teams can disrupt the production and distribution of illegal drugs, but respond pre-emptively by expanding resources to communities hardest hit.

In a statement, Michael Botticelli, director of the White House Office of National Drug Control Policy, said the administration’s emphasis on “the national drug challenge as both a public health and public safety issue” is based on viewing drug addiction as “a chronic disease of the brain that can be successfully prevented and treated, and from which one can recover.”

The initiative also will provide additional funding for similar efforts to address opioid abuse and methamphetamine abuse in the Southwest and along the United States/Mexico border.

“This program demonstrates the importance of linking health to criminal justice in collaboration rather than seeing better, new drug policy as a choice between health and law enforcement,” Dr. Robert L. DuPont, former director of the National Institute on Drug Abuse (NIDA), and president of the Institute for Behavior and Health, said in an interview.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – The Obama administration announced Aug. 17 that it will spend an additional $13.4 million fighting opioid and heroin abuse, emphasizing treatment over law enforcement.

The increased emphasis will center on geographic areas where heroin and opioid abuse are rampant, specifically Appalachia; New England; Philadelphia/Camden, N.J.; metropolitan New York City, particularly northern New Jersey; and the Washington/Baltimore metro region. Public safety officers and first responders will be trained in how to administer naloxone and provide other medical attention for those in the midst of a heroin or opioid overdose.

©PaulPaladin/thinkstockphotos.com

The 15 states in the targeted areas will share and leverage data to determine regional patterns of heroin and prescription painkiller-related overdose. These data are expected to delineate where the narcotics – especially those laced with other, more dangerous drugs – are being produced and distributed so that heroin response teams can disrupt the production and distribution of illegal drugs, but respond pre-emptively by expanding resources to communities hardest hit.

In a statement, Michael Botticelli, director of the White House Office of National Drug Control Policy, said the administration’s emphasis on “the national drug challenge as both a public health and public safety issue” is based on viewing drug addiction as “a chronic disease of the brain that can be successfully prevented and treated, and from which one can recover.”

The initiative also will provide additional funding for similar efforts to address opioid abuse and methamphetamine abuse in the Southwest and along the United States/Mexico border.

“This program demonstrates the importance of linking health to criminal justice in collaboration rather than seeing better, new drug policy as a choice between health and law enforcement,” Dr. Robert L. DuPont, former director of the National Institute on Drug Abuse (NIDA), and president of the Institute for Behavior and Health, said in an interview.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – The Obama administration announced Aug. 17 that it will spend an additional $13.4 million fighting opioid and heroin abuse, emphasizing treatment over law enforcement.

The increased emphasis will center on geographic areas where heroin and opioid abuse are rampant, specifically Appalachia; New England; Philadelphia/Camden, N.J.; metropolitan New York City, particularly northern New Jersey; and the Washington/Baltimore metro region. Public safety officers and first responders will be trained in how to administer naloxone and provide other medical attention for those in the midst of a heroin or opioid overdose.

©PaulPaladin/thinkstockphotos.com

The 15 states in the targeted areas will share and leverage data to determine regional patterns of heroin and prescription painkiller-related overdose. These data are expected to delineate where the narcotics – especially those laced with other, more dangerous drugs – are being produced and distributed so that heroin response teams can disrupt the production and distribution of illegal drugs, but respond pre-emptively by expanding resources to communities hardest hit.

In a statement, Michael Botticelli, director of the White House Office of National Drug Control Policy, said the administration’s emphasis on “the national drug challenge as both a public health and public safety issue” is based on viewing drug addiction as “a chronic disease of the brain that can be successfully prevented and treated, and from which one can recover.”

The initiative also will provide additional funding for similar efforts to address opioid abuse and methamphetamine abuse in the Southwest and along the United States/Mexico border.

“This program demonstrates the importance of linking health to criminal justice in collaboration rather than seeing better, new drug policy as a choice between health and law enforcement,” Dr. Robert L. DuPont, former director of the National Institute on Drug Abuse (NIDA), and president of the Institute for Behavior and Health, said in an interview.

[email protected]

On Twitter @whitneymcknight

ROCKVILLE, MD. – Pamela S. Hyde has announced she is stepping down as administrator of the federal Substance Abuse and Mental Health Services Administration, effective Aug. 22.

In a blogpost dated Aug. 4, Ms. Hyde stated that “personal issues call me home to New Mexico.”

An internal memo from U.S. Department of Health & Human Services Secretary Sylvia Burwell praised Ms. Hyde for her “remarkable” commitment, calling her a “steadfast leader who has “worked to integrate behavioral health into all of HHS’ coverage, prevention, treatment, and human services programs.”

Ms. Hyde will be replaced at the Substance Abuse and Mental Health Services Administration (SAMHSA) in the interim by Principal Deputy Administrator Kana Enomoto.

The announcement comes amid a time when, driven in part by the alarming incarceration rates of those with serious mental illnesses such as schizophrenia, mental illness is a nascent concern, with no less than six major proposed legislative actions being debated currently in Congress.

Since the beginning of Ms. Hyde’s tenure in November 2009, SAMHSA has come under increasing fire from some in the mental health field including the Dr. E. Fuller Torrey, a psychiatrist who has complained in the National Review and elsewhere that the agency focuses more on mental wellness than mental illness.

Rep. Tim Murphy (R-Penn.), a clinical psychologist, also has publicly criticized SAMHSA for what he has characterized as SAMHSA’s lack of an evidence-based approach to dealing with mental health issues. In an interview earlier this year, Rep. Murphy accused SAMHSA of being “antipsychiatry” and operating from a “feel-good space.” Rep. Murphy, who has introduced legislation that would restructure the agency, said in that interview that his bill “drives the science on serious mental illness, because right now there is no science at SAMSHA.”

His bill also would require that the top leadership be held by a person with either a medical degree or an advanced degree in clinical psychology. Ms. Hyde is a lawyer by training. Ms. Enomoto holds a master’s degree in clinical psychology.

Asked whether the timing of Ms. Hyde’s resignation was related to the heightened level of criticism she has faced, a SAMHSA spokesperson reiterated that Ms. Hyde’s decision was “for personal reasons.”

[email protected]

On Twitter @whitneymcknight

ROCKVILLE, MD. – Pamela S. Hyde has announced she is stepping down as administrator of the federal Substance Abuse and Mental Health Services Administration, effective Aug. 22.

In a blogpost dated Aug. 4, Ms. Hyde stated that “personal issues call me home to New Mexico.”

An internal memo from U.S. Department of Health & Human Services Secretary Sylvia Burwell praised Ms. Hyde for her “remarkable” commitment, calling her a “steadfast leader who has “worked to integrate behavioral health into all of HHS’ coverage, prevention, treatment, and human services programs.”

Ms. Hyde will be replaced at the Substance Abuse and Mental Health Services Administration (SAMHSA) in the interim by Principal Deputy Administrator Kana Enomoto.

The announcement comes amid a time when, driven in part by the alarming incarceration rates of those with serious mental illnesses such as schizophrenia, mental illness is a nascent concern, with no less than six major proposed legislative actions being debated currently in Congress.

Since the beginning of Ms. Hyde’s tenure in November 2009, SAMHSA has come under increasing fire from some in the mental health field including the Dr. E. Fuller Torrey, a psychiatrist who has complained in the National Review and elsewhere that the agency focuses more on mental wellness than mental illness.

Rep. Tim Murphy (R-Penn.), a clinical psychologist, also has publicly criticized SAMHSA for what he has characterized as SAMHSA’s lack of an evidence-based approach to dealing with mental health issues. In an interview earlier this year, Rep. Murphy accused SAMHSA of being “antipsychiatry” and operating from a “feel-good space.” Rep. Murphy, who has introduced legislation that would restructure the agency, said in that interview that his bill “drives the science on serious mental illness, because right now there is no science at SAMSHA.”

His bill also would require that the top leadership be held by a person with either a medical degree or an advanced degree in clinical psychology. Ms. Hyde is a lawyer by training. Ms. Enomoto holds a master’s degree in clinical psychology.

Asked whether the timing of Ms. Hyde’s resignation was related to the heightened level of criticism she has faced, a SAMHSA spokesperson reiterated that Ms. Hyde’s decision was “for personal reasons.”

[email protected]

On Twitter @whitneymcknight

ROCKVILLE, MD. – Pamela S. Hyde has announced she is stepping down as administrator of the federal Substance Abuse and Mental Health Services Administration, effective Aug. 22.

In a blogpost dated Aug. 4, Ms. Hyde stated that “personal issues call me home to New Mexico.”

An internal memo from U.S. Department of Health & Human Services Secretary Sylvia Burwell praised Ms. Hyde for her “remarkable” commitment, calling her a “steadfast leader who has “worked to integrate behavioral health into all of HHS’ coverage, prevention, treatment, and human services programs.”

Ms. Hyde will be replaced at the Substance Abuse and Mental Health Services Administration (SAMHSA) in the interim by Principal Deputy Administrator Kana Enomoto.

The announcement comes amid a time when, driven in part by the alarming incarceration rates of those with serious mental illnesses such as schizophrenia, mental illness is a nascent concern, with no less than six major proposed legislative actions being debated currently in Congress.

Since the beginning of Ms. Hyde’s tenure in November 2009, SAMHSA has come under increasing fire from some in the mental health field including the Dr. E. Fuller Torrey, a psychiatrist who has complained in the National Review and elsewhere that the agency focuses more on mental wellness than mental illness.

Rep. Tim Murphy (R-Penn.), a clinical psychologist, also has publicly criticized SAMHSA for what he has characterized as SAMHSA’s lack of an evidence-based approach to dealing with mental health issues. In an interview earlier this year, Rep. Murphy accused SAMHSA of being “antipsychiatry” and operating from a “feel-good space.” Rep. Murphy, who has introduced legislation that would restructure the agency, said in that interview that his bill “drives the science on serious mental illness, because right now there is no science at SAMSHA.”

His bill also would require that the top leadership be held by a person with either a medical degree or an advanced degree in clinical psychology. Ms. Hyde is a lawyer by training. Ms. Enomoto holds a master’s degree in clinical psychology.

Asked whether the timing of Ms. Hyde’s resignation was related to the heightened level of criticism she has faced, a SAMHSA spokesperson reiterated that Ms. Hyde’s decision was “for personal reasons.”

[email protected]

On Twitter @whitneymcknight

The pivotal moment in Dr. David Jaspan’s decision to create an LGBT-friendly practice was when a first-year resident physician told him a lesbian woman had presented with advanced-stage cervical cancer to their Philadelphia-based community ob.gyn. clinic.

“She had health insurance. She lived within walking distance of the clinic,” recalled Dr. Jaspan, chairman of the Einstein Medical Center in Philadelphia.

Courtesy Einstein Medical Center

The patient had been avoiding preventive care, including routine Pap smears, because she feared being judged for her sexuality, he said. “She had access to care, but was afraid to use it. That’s ridiculous. We had to do something.”

In a 2010 survey of nearly 5,000 LGBT (lesbian, gay, bisexual, transgender) individuals nationwide conducted by the LGBT advocacy group Lambda Legal, more than half of the nearly 400 transgender individuals, and nearly 10% of the entire gay, lesbian, and bisexual population surveyed said they believed they would be refused care if they sought it.

An analysis of the literature published in the last 5 years, conducted by Dr. Gloria Bachmann, professor and interim chair of obstetrics and gynecology at the Robert Wood Johnson Medical School in Newark, N.J., and her colleagues, showed that in the ob.gyn. setting, 2% of transgender respondents in one survey reported being physically attacked in a patient waiting area, while nearly 20% of respondents reported being denied care altogether.

Aside from these real or perceived fears of harm or denial, another barrier to care for the LGBT community appears to be a lack of education in the medical training establishment.

A survey published earlier this year in the American Journal of Public Health, and conducted by researchers from the University of California at Los Angeles, showed that of the half of all 138 U.S. academic medical faculty practices currently accredited by the Liaison Committee on Medical Education that responded to the survey, only 10% have standard procedures for connecting patients to LGBT-competent physicians.

The medical community at large seems to be more proactive about inclusion. In 2014, the Human Rights Campaign Foundation designated more than 400 community health care facilities across the country as leaders in LGBT health care equality, more than double the number they designated in 2013.

“I think that things are better than they used to be,” said Dr. Rachel Levine, Pennsylvania’s first transgender physician general.

Dr. Levine was appointed to her post earlier this year by Gov. Tom Wolf (D). “I can’t see someone being refused care because they are LGBT.” Besides, she added, “it’s not ethical.”

While not everyone will practice LGBT medicine, Dr. Levine said, “all medical personnel should have training in, and at least be aware of, the broad outlines of LGBT health issues.” She pointed to a growing number of organizations, such as the Institute of Medicine and the American Medical Association, that also offer guidelines for treating the LGBT population.

Achieving culturally competent care

For Dr. Jaspan, the will and desire to provide care was strong, even though he wasn’t entirely sure how to go about it. “I wondered, What if a man walked into our clinic? But it was clear to me, it doesn’t matter. What matters is that he chose to access care.”

Delivering what is largely referred to by LGBT health experts as “culturally competent care” comes down to two factors: gender neutrality and honesty, according to Dr. Bachmann.

“Unconscious biases find their way into personal and professional interactions, but defining all clinical encounters as gender equal works to eliminate that bias in clinical-patient interactions,” she said.

Gender neutrality helps to establish trust with a transgender patient and makes it easier to get a full history, including details about the surgical and management strategies for the patient’s transition, the difficulties the patient might be having, and how to get the assistance that patient might need, Dr. Bachmann said.

That leads to the second essential element of culturally competent care: honesty.

“[Physicians] don’t have to know everything,” Dr. Bachmann said. “Opening the lines of communication is probably the most important, and acknowledging that you might not have the most in-depth knowledge to meet the [LGBT patient’s] needs, but you do want to take the best care of them, and that you might need their assistance for that.”

Clear communication also helps maintain accurate electronic health records, particularly in the case of transgender patients, said Dr. Levine, who before assuming her role as Pennsylvania’s top physician, was the vice chair for clinical affairs for the department of pediatrics and chief of the division of adolescent medicine and eating disorders at the Penn State Hershey Children’s Hospital at the Penn State Hershey Medical Center.

“In the privacy of the examination room, ask the patient what name they would like to be called, what pronoun they would like you to use, and in the context of the visit, you use those,” Dr. Levine said.

But because both HIPPA and insurers require a person’s legal name and gender, it is important their EHRs reflect that information, while the dictation makes the patient’s preferences clear.

‘A very important lesson’

But sometimes, as Dr. Jaspan discovered, a notation is simply not enough.

Once Dr. Jaspan’s clinic officially announced it was LGBT friendly, the first patient from that community to enroll was a bearded transgender man who’d had his breasts removed, but still had a uterus and ovaries and so was in need of a pelvic ultrasound.

Dr. Jaspan wrote the script for the radiologist, but Dr. Michele Style, the resident who had first urged him to reach out to the LGBT community, pointed out the peril of not thinking through how the patient would be received at the radiology clinic. She told him that unless they gave fair warning, the radiology tech would call out the patient’s legal name, which would indicate a woman would respond, but instead, it would be a man who would reply.

“Rather than have the tech say, ‘Oh sorry, I have the wrong person,’ and create embarrassment for the patient, we needed a different plan,” he said.

Instead, Dr. Jaspan’s office contacted the radiology staff before the appointment, and they were “overwhelmingly happy to help,” he said. The patient was greeted by a staff member of the radiology clinic who was also part of the LGBT community and was escorted to the exam room without being called by name.

“It was a very important lesson,” Dr. Jaspan said.

Rainbow power

When word got out about plans to open the Pride Clinic at Einstein Medical Center in Philadelphia, Dr. Jaspan started receiving calls from people across the country offering to collaborate, or to give financial assistance.

“It was unbelievable,” Dr. Jaspan said. One important ally was the LGBT brown bag lunch group who met regularly at Einstein and whose members were happy to serve as a focus group for the project. “They also trained our staff on how to answer the phones so LGBT people would immediately feel at ease,” he said.

Courtesy Dr. David Jaspan

But what surprised Dr. Jaspan the most was the power of the rainbow. Although he expected the clinic would need some type of overhaul, the focus group assured him that simply by displaying a sticker of a rainbow – long the international symbol of the LGBT community – at the clinic’s entrance, as well as placing rainbow flags on the reception desk and the door of every examination room, LGBT individuals would know they were welcome.

“I thought it was so phenomenal there was that much power in a symbol,” Dr. Jaspan said. “I just couldn’t believe that would make that much difference, but it does.”

From start to finish, including applying for the designation as an LGBT health equality leader by the Human Rights Campaign Foundation and training his staff in how to take information from patients using language that makes no assumptions about their sexual identity or preferences, the process of officially opening his doors to Philadelphia’s LGBT community took a year. “But I was aggressive with it,” Dr. Jaspan added.

Since opening, the clinic has enrolled about 10 LGBT patients on its patient panel, all of whom have access to a network of physicians, including cardiologists, pediatricians, endocrinologists, psychiatrists, and the gynecologic oncologists who now care for the lesbian patient who first presented with advanced-stage cervical cancer.

“I learn something new every day, every single day,” said Dr. Jaspan. “Just because we’ve opened doesn’t mean we’re doing it right, but a [college-aged LGBT patient] we saw the other day said she’d spread the word because she thought we had done everything right.”

Checklist for transgender patient exams

The main barriers to getting basic health care in the lesbian, gay, bisexual, and transgender community are “anticipated, perceived, and actual insensitivity, or rejection,” said Walter O. Bockting, Ph.D., codirector of the LGBT Health Initiative and professor of medical psychology at the New York State Psychiatric Institute and the Columbia University School of Nursing.

Courtesy Columbia University

Underlying that, he said, is the lack of training in LGBT health concerns for health care professionals, given this cohort’s “marginalization.”

Dr. Bockting shared his advice for providing the best possible primary care for transgender patients.

Mental health

Screen for depression and anxiety, create a network of mental health professionals with expertise in transgender-related concerns, and help patients with resilience-building strategies, Dr. Bockting advised.

Transgender women have a higher relative risk for depression and anxiety, he said. This is often a result of “social stigma attached to their nonconformity,” and rejection of their claimed sexual identity by family members, especially if they are a parent. Additionally, “simply having to deal with being transgender, the process of finding a comfortable gender role and expression, and parts of the coming out process may be stressful, contributing to feelings of vulnerability, and symptoms of depression and anxiety.”

Preventive care

Continue to perform pelvic exams and Pap smears in transgender men with a cervix and uterus, screen transgender men for uterine and breast cancers, and screen transgender women for prostate cancers, Dr. Bockting advised.

In addition to the medical interventions necessary to affirm gender identities, one’s sex at birth, and one’s sexual orientation, taking a complete medical history that includes what surgeries the patient has had to date, and what the subsequent management strategies have been, is essential to knowing which preventive care is most appropriate for the individual patient, he said.

“What being transgender means, and is, varies from person to person,” Dr. Bockting said. “Developing an understanding of what it means for a particular patient is key.”

Educate yourself

Own your limitations, but also seek to learn by enlisting colleagues with more expertise, Dr. Bockting advised.

If you have been treating anatomical women your entire career, being called upon to treat a transgender woman with prostate concerns can be daunting, he said. But understanding your limitations is good, according to Dr. Bockting, though even better is to “do your homework, and talk to colleagues and other experts about how to provide the best possible care.”

“It’s okay to admit you do not know it all,” he said. “That is often referred to as having ‘cultural humility.’ ”

Resources for providing LGBT care

For more information about creating an LGBT-friendly clinic, the following organizations can offer tips, support, and expertise:

Fenway Health

This is one of the nation’s oldest LGBT-focused clinics, and the largest U.S. LGBT health research center, with locations throughout Boston.

617-927-6400

Lyon-Martin Health Services

Initially opened in 1979 to serve San Francisco’s lesbian community, it now offers care and resources to the entire LGBT community.

415-565-7667

The Mazzoni Center

Also opened in 1979 to serve the LGBT community, it is one of the first AIDS-service organizations in the United States.

215-563-0652

World Professional Association for Transgender Health

Formerly the Harry Benjamin International Gender Dysphoria Association, in Minneapolis, WPATH promotes evidence-based care, education, research, advocacy, public policy, and respect in transgender health.

Human Rights Campaign

This LGBT advocacy group based in Washington, D.C., issues an annual report on leaders in LGBT health care delivery, and offers resources to help meet their criteria.

[email protected]

On Twitter @whitneymcknight

The pivotal moment in Dr. David Jaspan’s decision to create an LGBT-friendly practice was when a first-year resident physician told him a lesbian woman had presented with advanced-stage cervical cancer to their Philadelphia-based community ob.gyn. clinic.

“She had health insurance. She lived within walking distance of the clinic,” recalled Dr. Jaspan, chairman of the Einstein Medical Center in Philadelphia.

Courtesy Einstein Medical Center

The patient had been avoiding preventive care, including routine Pap smears, because she feared being judged for her sexuality, he said. “She had access to care, but was afraid to use it. That’s ridiculous. We had to do something.”

In a 2010 survey of nearly 5,000 LGBT (lesbian, gay, bisexual, transgender) individuals nationwide conducted by the LGBT advocacy group Lambda Legal, more than half of the nearly 400 transgender individuals, and nearly 10% of the entire gay, lesbian, and bisexual population surveyed said they believed they would be refused care if they sought it.

An analysis of the literature published in the last 5 years, conducted by Dr. Gloria Bachmann, professor and interim chair of obstetrics and gynecology at the Robert Wood Johnson Medical School in Newark, N.J., and her colleagues, showed that in the ob.gyn. setting, 2% of transgender respondents in one survey reported being physically attacked in a patient waiting area, while nearly 20% of respondents reported being denied care altogether.

Aside from these real or perceived fears of harm or denial, another barrier to care for the LGBT community appears to be a lack of education in the medical training establishment.

A survey published earlier this year in the American Journal of Public Health, and conducted by researchers from the University of California at Los Angeles, showed that of the half of all 138 U.S. academic medical faculty practices currently accredited by the Liaison Committee on Medical Education that responded to the survey, only 10% have standard procedures for connecting patients to LGBT-competent physicians.

The medical community at large seems to be more proactive about inclusion. In 2014, the Human Rights Campaign Foundation designated more than 400 community health care facilities across the country as leaders in LGBT health care equality, more than double the number they designated in 2013.

“I think that things are better than they used to be,” said Dr. Rachel Levine, Pennsylvania’s first transgender physician general.

Dr. Levine was appointed to her post earlier this year by Gov. Tom Wolf (D). “I can’t see someone being refused care because they are LGBT.” Besides, she added, “it’s not ethical.”

While not everyone will practice LGBT medicine, Dr. Levine said, “all medical personnel should have training in, and at least be aware of, the broad outlines of LGBT health issues.” She pointed to a growing number of organizations, such as the Institute of Medicine and the American Medical Association, that also offer guidelines for treating the LGBT population.

Achieving culturally competent care

For Dr. Jaspan, the will and desire to provide care was strong, even though he wasn’t entirely sure how to go about it. “I wondered, What if a man walked into our clinic? But it was clear to me, it doesn’t matter. What matters is that he chose to access care.”

Delivering what is largely referred to by LGBT health experts as “culturally competent care” comes down to two factors: gender neutrality and honesty, according to Dr. Bachmann.

“Unconscious biases find their way into personal and professional interactions, but defining all clinical encounters as gender equal works to eliminate that bias in clinical-patient interactions,” she said.

Gender neutrality helps to establish trust with a transgender patient and makes it easier to get a full history, including details about the surgical and management strategies for the patient’s transition, the difficulties the patient might be having, and how to get the assistance that patient might need, Dr. Bachmann said.

That leads to the second essential element of culturally competent care: honesty.

“[Physicians] don’t have to know everything,” Dr. Bachmann said. “Opening the lines of communication is probably the most important, and acknowledging that you might not have the most in-depth knowledge to meet the [LGBT patient’s] needs, but you do want to take the best care of them, and that you might need their assistance for that.”

Clear communication also helps maintain accurate electronic health records, particularly in the case of transgender patients, said Dr. Levine, who before assuming her role as Pennsylvania’s top physician, was the vice chair for clinical affairs for the department of pediatrics and chief of the division of adolescent medicine and eating disorders at the Penn State Hershey Children’s Hospital at the Penn State Hershey Medical Center.

“In the privacy of the examination room, ask the patient what name they would like to be called, what pronoun they would like you to use, and in the context of the visit, you use those,” Dr. Levine said.

But because both HIPPA and insurers require a person’s legal name and gender, it is important their EHRs reflect that information, while the dictation makes the patient’s preferences clear.

‘A very important lesson’

But sometimes, as Dr. Jaspan discovered, a notation is simply not enough.

Once Dr. Jaspan’s clinic officially announced it was LGBT friendly, the first patient from that community to enroll was a bearded transgender man who’d had his breasts removed, but still had a uterus and ovaries and so was in need of a pelvic ultrasound.

Dr. Jaspan wrote the script for the radiologist, but Dr. Michele Style, the resident who had first urged him to reach out to the LGBT community, pointed out the peril of not thinking through how the patient would be received at the radiology clinic. She told him that unless they gave fair warning, the radiology tech would call out the patient’s legal name, which would indicate a woman would respond, but instead, it would be a man who would reply.

“Rather than have the tech say, ‘Oh sorry, I have the wrong person,’ and create embarrassment for the patient, we needed a different plan,” he said.

Instead, Dr. Jaspan’s office contacted the radiology staff before the appointment, and they were “overwhelmingly happy to help,” he said. The patient was greeted by a staff member of the radiology clinic who was also part of the LGBT community and was escorted to the exam room without being called by name.

“It was a very important lesson,” Dr. Jaspan said.

Rainbow power

When word got out about plans to open the Pride Clinic at Einstein Medical Center in Philadelphia, Dr. Jaspan started receiving calls from people across the country offering to collaborate, or to give financial assistance.

“It was unbelievable,” Dr. Jaspan said. One important ally was the LGBT brown bag lunch group who met regularly at Einstein and whose members were happy to serve as a focus group for the project. “They also trained our staff on how to answer the phones so LGBT people would immediately feel at ease,” he said.

Courtesy Dr. David Jaspan

But what surprised Dr. Jaspan the most was the power of the rainbow. Although he expected the clinic would need some type of overhaul, the focus group assured him that simply by displaying a sticker of a rainbow – long the international symbol of the LGBT community – at the clinic’s entrance, as well as placing rainbow flags on the reception desk and the door of every examination room, LGBT individuals would know they were welcome.

“I thought it was so phenomenal there was that much power in a symbol,” Dr. Jaspan said. “I just couldn’t believe that would make that much difference, but it does.”

From start to finish, including applying for the designation as an LGBT health equality leader by the Human Rights Campaign Foundation and training his staff in how to take information from patients using language that makes no assumptions about their sexual identity or preferences, the process of officially opening his doors to Philadelphia’s LGBT community took a year. “But I was aggressive with it,” Dr. Jaspan added.

Since opening, the clinic has enrolled about 10 LGBT patients on its patient panel, all of whom have access to a network of physicians, including cardiologists, pediatricians, endocrinologists, psychiatrists, and the gynecologic oncologists who now care for the lesbian patient who first presented with advanced-stage cervical cancer.

“I learn something new every day, every single day,” said Dr. Jaspan. “Just because we’ve opened doesn’t mean we’re doing it right, but a [college-aged LGBT patient] we saw the other day said she’d spread the word because she thought we had done everything right.”

Checklist for transgender patient exams

The main barriers to getting basic health care in the lesbian, gay, bisexual, and transgender community are “anticipated, perceived, and actual insensitivity, or rejection,” said Walter O. Bockting, Ph.D., codirector of the LGBT Health Initiative and professor of medical psychology at the New York State Psychiatric Institute and the Columbia University School of Nursing.

Courtesy Columbia University

Underlying that, he said, is the lack of training in LGBT health concerns for health care professionals, given this cohort’s “marginalization.”

Dr. Bockting shared his advice for providing the best possible primary care for transgender patients.

Mental health

Screen for depression and anxiety, create a network of mental health professionals with expertise in transgender-related concerns, and help patients with resilience-building strategies, Dr. Bockting advised.

Transgender women have a higher relative risk for depression and anxiety, he said. This is often a result of “social stigma attached to their nonconformity,” and rejection of their claimed sexual identity by family members, especially if they are a parent. Additionally, “simply having to deal with being transgender, the process of finding a comfortable gender role and expression, and parts of the coming out process may be stressful, contributing to feelings of vulnerability, and symptoms of depression and anxiety.”

Preventive care

Continue to perform pelvic exams and Pap smears in transgender men with a cervix and uterus, screen transgender men for uterine and breast cancers, and screen transgender women for prostate cancers, Dr. Bockting advised.

In addition to the medical interventions necessary to affirm gender identities, one’s sex at birth, and one’s sexual orientation, taking a complete medical history that includes what surgeries the patient has had to date, and what the subsequent management strategies have been, is essential to knowing which preventive care is most appropriate for the individual patient, he said.

“What being transgender means, and is, varies from person to person,” Dr. Bockting said. “Developing an understanding of what it means for a particular patient is key.”

Educate yourself

Own your limitations, but also seek to learn by enlisting colleagues with more expertise, Dr. Bockting advised.

If you have been treating anatomical women your entire career, being called upon to treat a transgender woman with prostate concerns can be daunting, he said. But understanding your limitations is good, according to Dr. Bockting, though even better is to “do your homework, and talk to colleagues and other experts about how to provide the best possible care.”

“It’s okay to admit you do not know it all,” he said. “That is often referred to as having ‘cultural humility.’ ”

Resources for providing LGBT care

For more information about creating an LGBT-friendly clinic, the following organizations can offer tips, support, and expertise:

Fenway Health

This is one of the nation’s oldest LGBT-focused clinics, and the largest U.S. LGBT health research center, with locations throughout Boston.

617-927-6400

Lyon-Martin Health Services

Initially opened in 1979 to serve San Francisco’s lesbian community, it now offers care and resources to the entire LGBT community.

415-565-7667

The Mazzoni Center

Also opened in 1979 to serve the LGBT community, it is one of the first AIDS-service organizations in the United States.

215-563-0652

World Professional Association for Transgender Health

Formerly the Harry Benjamin International Gender Dysphoria Association, in Minneapolis, WPATH promotes evidence-based care, education, research, advocacy, public policy, and respect in transgender health.

Human Rights Campaign

This LGBT advocacy group based in Washington, D.C., issues an annual report on leaders in LGBT health care delivery, and offers resources to help meet their criteria.

[email protected]

On Twitter @whitneymcknight

The pivotal moment in Dr. David Jaspan’s decision to create an LGBT-friendly practice was when a first-year resident physician told him a lesbian woman had presented with advanced-stage cervical cancer to their Philadelphia-based community ob.gyn. clinic.

“She had health insurance. She lived within walking distance of the clinic,” recalled Dr. Jaspan, chairman of the Einstein Medical Center in Philadelphia.

Courtesy Einstein Medical Center

The patient had been avoiding preventive care, including routine Pap smears, because she feared being judged for her sexuality, he said. “She had access to care, but was afraid to use it. That’s ridiculous. We had to do something.”

In a 2010 survey of nearly 5,000 LGBT (lesbian, gay, bisexual, transgender) individuals nationwide conducted by the LGBT advocacy group Lambda Legal, more than half of the nearly 400 transgender individuals, and nearly 10% of the entire gay, lesbian, and bisexual population surveyed said they believed they would be refused care if they sought it.

An analysis of the literature published in the last 5 years, conducted by Dr. Gloria Bachmann, professor and interim chair of obstetrics and gynecology at the Robert Wood Johnson Medical School in Newark, N.J., and her colleagues, showed that in the ob.gyn. setting, 2% of transgender respondents in one survey reported being physically attacked in a patient waiting area, while nearly 20% of respondents reported being denied care altogether.

Aside from these real or perceived fears of harm or denial, another barrier to care for the LGBT community appears to be a lack of education in the medical training establishment.

A survey published earlier this year in the American Journal of Public Health, and conducted by researchers from the University of California at Los Angeles, showed that of the half of all 138 U.S. academic medical faculty practices currently accredited by the Liaison Committee on Medical Education that responded to the survey, only 10% have standard procedures for connecting patients to LGBT-competent physicians.

The medical community at large seems to be more proactive about inclusion. In 2014, the Human Rights Campaign Foundation designated more than 400 community health care facilities across the country as leaders in LGBT health care equality, more than double the number they designated in 2013.

“I think that things are better than they used to be,” said Dr. Rachel Levine, Pennsylvania’s first transgender physician general.

Dr. Levine was appointed to her post earlier this year by Gov. Tom Wolf (D). “I can’t see someone being refused care because they are LGBT.” Besides, she added, “it’s not ethical.”

While not everyone will practice LGBT medicine, Dr. Levine said, “all medical personnel should have training in, and at least be aware of, the broad outlines of LGBT health issues.” She pointed to a growing number of organizations, such as the Institute of Medicine and the American Medical Association, that also offer guidelines for treating the LGBT population.

Achieving culturally competent care

For Dr. Jaspan, the will and desire to provide care was strong, even though he wasn’t entirely sure how to go about it. “I wondered, What if a man walked into our clinic? But it was clear to me, it doesn’t matter. What matters is that he chose to access care.”

Delivering what is largely referred to by LGBT health experts as “culturally competent care” comes down to two factors: gender neutrality and honesty, according to Dr. Bachmann.

“Unconscious biases find their way into personal and professional interactions, but defining all clinical encounters as gender equal works to eliminate that bias in clinical-patient interactions,” she said.

Gender neutrality helps to establish trust with a transgender patient and makes it easier to get a full history, including details about the surgical and management strategies for the patient’s transition, the difficulties the patient might be having, and how to get the assistance that patient might need, Dr. Bachmann said.

That leads to the second essential element of culturally competent care: honesty.

“[Physicians] don’t have to know everything,” Dr. Bachmann said. “Opening the lines of communication is probably the most important, and acknowledging that you might not have the most in-depth knowledge to meet the [LGBT patient’s] needs, but you do want to take the best care of them, and that you might need their assistance for that.”

Clear communication also helps maintain accurate electronic health records, particularly in the case of transgender patients, said Dr. Levine, who before assuming her role as Pennsylvania’s top physician, was the vice chair for clinical affairs for the department of pediatrics and chief of the division of adolescent medicine and eating disorders at the Penn State Hershey Children’s Hospital at the Penn State Hershey Medical Center.

“In the privacy of the examination room, ask the patient what name they would like to be called, what pronoun they would like you to use, and in the context of the visit, you use those,” Dr. Levine said.

But because both HIPPA and insurers require a person’s legal name and gender, it is important their EHRs reflect that information, while the dictation makes the patient’s preferences clear.

‘A very important lesson’

But sometimes, as Dr. Jaspan discovered, a notation is simply not enough.

Once Dr. Jaspan’s clinic officially announced it was LGBT friendly, the first patient from that community to enroll was a bearded transgender man who’d had his breasts removed, but still had a uterus and ovaries and so was in need of a pelvic ultrasound.

Dr. Jaspan wrote the script for the radiologist, but Dr. Michele Style, the resident who had first urged him to reach out to the LGBT community, pointed out the peril of not thinking through how the patient would be received at the radiology clinic. She told him that unless they gave fair warning, the radiology tech would call out the patient’s legal name, which would indicate a woman would respond, but instead, it would be a man who would reply.

“Rather than have the tech say, ‘Oh sorry, I have the wrong person,’ and create embarrassment for the patient, we needed a different plan,” he said.

Instead, Dr. Jaspan’s office contacted the radiology staff before the appointment, and they were “overwhelmingly happy to help,” he said. The patient was greeted by a staff member of the radiology clinic who was also part of the LGBT community and was escorted to the exam room without being called by name.

“It was a very important lesson,” Dr. Jaspan said.

Rainbow power

When word got out about plans to open the Pride Clinic at Einstein Medical Center in Philadelphia, Dr. Jaspan started receiving calls from people across the country offering to collaborate, or to give financial assistance.

“It was unbelievable,” Dr. Jaspan said. One important ally was the LGBT brown bag lunch group who met regularly at Einstein and whose members were happy to serve as a focus group for the project. “They also trained our staff on how to answer the phones so LGBT people would immediately feel at ease,” he said.

Courtesy Dr. David Jaspan

But what surprised Dr. Jaspan the most was the power of the rainbow. Although he expected the clinic would need some type of overhaul, the focus group assured him that simply by displaying a sticker of a rainbow – long the international symbol of the LGBT community – at the clinic’s entrance, as well as placing rainbow flags on the reception desk and the door of every examination room, LGBT individuals would know they were welcome.

“I thought it was so phenomenal there was that much power in a symbol,” Dr. Jaspan said. “I just couldn’t believe that would make that much difference, but it does.”

From start to finish, including applying for the designation as an LGBT health equality leader by the Human Rights Campaign Foundation and training his staff in how to take information from patients using language that makes no assumptions about their sexual identity or preferences, the process of officially opening his doors to Philadelphia’s LGBT community took a year. “But I was aggressive with it,” Dr. Jaspan added.

Since opening, the clinic has enrolled about 10 LGBT patients on its patient panel, all of whom have access to a network of physicians, including cardiologists, pediatricians, endocrinologists, psychiatrists, and the gynecologic oncologists who now care for the lesbian patient who first presented with advanced-stage cervical cancer.

“I learn something new every day, every single day,” said Dr. Jaspan. “Just because we’ve opened doesn’t mean we’re doing it right, but a [college-aged LGBT patient] we saw the other day said she’d spread the word because she thought we had done everything right.”

Checklist for transgender patient exams

The main barriers to getting basic health care in the lesbian, gay, bisexual, and transgender community are “anticipated, perceived, and actual insensitivity, or rejection,” said Walter O. Bockting, Ph.D., codirector of the LGBT Health Initiative and professor of medical psychology at the New York State Psychiatric Institute and the Columbia University School of Nursing.

Courtesy Columbia University

Underlying that, he said, is the lack of training in LGBT health concerns for health care professionals, given this cohort’s “marginalization.”

Dr. Bockting shared his advice for providing the best possible primary care for transgender patients.

Mental health

Screen for depression and anxiety, create a network of mental health professionals with expertise in transgender-related concerns, and help patients with resilience-building strategies, Dr. Bockting advised.

Transgender women have a higher relative risk for depression and anxiety, he said. This is often a result of “social stigma attached to their nonconformity,” and rejection of their claimed sexual identity by family members, especially if they are a parent. Additionally, “simply having to deal with being transgender, the process of finding a comfortable gender role and expression, and parts of the coming out process may be stressful, contributing to feelings of vulnerability, and symptoms of depression and anxiety.”

Preventive care

Continue to perform pelvic exams and Pap smears in transgender men with a cervix and uterus, screen transgender men for uterine and breast cancers, and screen transgender women for prostate cancers, Dr. Bockting advised.

In addition to the medical interventions necessary to affirm gender identities, one’s sex at birth, and one’s sexual orientation, taking a complete medical history that includes what surgeries the patient has had to date, and what the subsequent management strategies have been, is essential to knowing which preventive care is most appropriate for the individual patient, he said.

“What being transgender means, and is, varies from person to person,” Dr. Bockting said. “Developing an understanding of what it means for a particular patient is key.”

Educate yourself

Own your limitations, but also seek to learn by enlisting colleagues with more expertise, Dr. Bockting advised.

If you have been treating anatomical women your entire career, being called upon to treat a transgender woman with prostate concerns can be daunting, he said. But understanding your limitations is good, according to Dr. Bockting, though even better is to “do your homework, and talk to colleagues and other experts about how to provide the best possible care.”

“It’s okay to admit you do not know it all,” he said. “That is often referred to as having ‘cultural humility.’ ”

Resources for providing LGBT care

For more information about creating an LGBT-friendly clinic, the following organizations can offer tips, support, and expertise:

Fenway Health

This is one of the nation’s oldest LGBT-focused clinics, and the largest U.S. LGBT health research center, with locations throughout Boston.

617-927-6400

Lyon-Martin Health Services

Initially opened in 1979 to serve San Francisco’s lesbian community, it now offers care and resources to the entire LGBT community.

415-565-7667

The Mazzoni Center

Also opened in 1979 to serve the LGBT community, it is one of the first AIDS-service organizations in the United States.

215-563-0652

World Professional Association for Transgender Health

Formerly the Harry Benjamin International Gender Dysphoria Association, in Minneapolis, WPATH promotes evidence-based care, education, research, advocacy, public policy, and respect in transgender health.

Human Rights Campaign

This LGBT advocacy group based in Washington, D.C., issues an annual report on leaders in LGBT health care delivery, and offers resources to help meet their criteria.

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