Hepatitis C virus transmission peaked in 1950

Focus on testing, not shifting blame
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Hepatitis C virus transmission peaked in 1950

Iatrogenic factors, not high-risk behaviors, were the main cause of the exponential spread of hepatitis C virus infections in North America, according to a phylogenetic study published online in the Lancet Infectious Diseases.

The study shifted the epicenter of spread back by more than 15 years, to about 1950, when medical procedures were expanding after World War II at the same time that clinicians continued to reuse metal and glass syringes, said Dr. Jeffrey Joy of the British Columbia Centre for Excellence in HIV/AIDS, Vancouver, and his associates.

©Jezperklauzen/ThinkStock

Exponential HCV transmission had mostly ended by 1965, negating “the idea that the epidemic among baby boomers and other demographic groups in North America is primarily due to injection drug use, unsafe tattooing, high-risk sex, and travel to high endemic areas during youth,” the researchers added.

The hepatitis C virus evolves rapidly, enabling researchers to characterize its spread based on the genetic divergence of infections. Dr. Joy and his associates studied 45,316 HCV genotype 1a sequences from the National Center for Biotechnology Information GenBank nucleotide database to carry out phylogenetic analyses of five HCV genes – E1, E2, NS2, NS4B, and NS5B (Lancet Infect Dis. 2016 Mar 30. doi: 10.1016/S1473-3099[16]00124-9).

The combined results for all gene regions suggested that the North American HCV epidemic expanded the most between 1940 and 1965, and that transmission rates peaked in 1950, when the oldest baby boomers were only 5 years old. Thus, nosocomial transmission rather than risky behaviors was the likely driver behind most infections, the researchers said.

“Our results could help to reduce stigma related to screening and diagnosis of hepatitis C virus, potentially increasing the numbers of providers offering screening, patients accepting testing, and if positive, presenting for care and treatment,” the authors noted.

The researchers also found that HCV transmission rates plateaued between 1965 and 1989, and dropped in the early 1990s, coinciding with increases in blood product testing and needle exchange programs aimed at preventing HIV infections. Furthermore, HCV infections rose slightly after 2000, mirroring epidemiologic reports of outbreaks among young injection drug users in nonurban areas and among men who have sex with men, the researchers said.

The Canadian Institutes of Health Research, Michael Smith Foundation for Health Research, and BC Centre for Excellence in HIV/AIDS funded the study. The investigators disclosed no competing interests.

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Dr. Jeffrey Joy and colleagues offer evidence that the era of high rates of transmission and rapid expansion of hepatitis C virus infections was from 1940 to 1960, when reuse of glass and metal syringes was common.

The authors conclude that attributing the spread of hepatitis C virus to the medical establishment, rather than youthful behavior long outgrown by most baby boomers, could justify changing the message around screening of baby boomers. Baby boomers came of age when nosocomial transmission could have been rampant. For this additional reason, rather than just individual behavior, all Americans born between 1945 and 1965 should be tested, say the authors.

This change of message, while effective, could backfire. By accepting responsibility for the pre-1960 spread, the medical establishment might increase stigma for patients born after the uptake of disposable syringes and safer clinical practices. Also, screening by birth cohort might already be outlasting its usefulness in some populations. Lowering the cost of hepatitis C virus testing could lead to routine, universal testing becoming the norm, making birth cohort testing obsolete.

Last, the novel method used in this study could be replaced by an even newer, more precise technology; would our message need to change once more?

Here are the facts: Hepatitis C virus is common among Americans born between 1945 and 1965. A current Centers for Disease Control and Prevention fact sheet asserts that most people infected with hepatitis C virus are unaware of their diagnosis, despite aggressive campaigns since 2012 to find cases. Let’s just go ahead and test our baby boomers.

Dr. Anne C. Spaulding and Dr. Lesley S. Miller are at the Rollins School of Public Health, Emory University, Atlanta. They reported receiving grants and other funding from Gilead Sciences and Bristol-Myers Squibb. These comments are from their editorial (Lancet Infect Dis. 2016 Mar 30. doi: 10.1016/S1473-3099[16]30002-0).

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Dr. Jeffrey Joy and colleagues offer evidence that the era of high rates of transmission and rapid expansion of hepatitis C virus infections was from 1940 to 1960, when reuse of glass and metal syringes was common.

The authors conclude that attributing the spread of hepatitis C virus to the medical establishment, rather than youthful behavior long outgrown by most baby boomers, could justify changing the message around screening of baby boomers. Baby boomers came of age when nosocomial transmission could have been rampant. For this additional reason, rather than just individual behavior, all Americans born between 1945 and 1965 should be tested, say the authors.

This change of message, while effective, could backfire. By accepting responsibility for the pre-1960 spread, the medical establishment might increase stigma for patients born after the uptake of disposable syringes and safer clinical practices. Also, screening by birth cohort might already be outlasting its usefulness in some populations. Lowering the cost of hepatitis C virus testing could lead to routine, universal testing becoming the norm, making birth cohort testing obsolete.

Last, the novel method used in this study could be replaced by an even newer, more precise technology; would our message need to change once more?

Here are the facts: Hepatitis C virus is common among Americans born between 1945 and 1965. A current Centers for Disease Control and Prevention fact sheet asserts that most people infected with hepatitis C virus are unaware of their diagnosis, despite aggressive campaigns since 2012 to find cases. Let’s just go ahead and test our baby boomers.

Dr. Anne C. Spaulding and Dr. Lesley S. Miller are at the Rollins School of Public Health, Emory University, Atlanta. They reported receiving grants and other funding from Gilead Sciences and Bristol-Myers Squibb. These comments are from their editorial (Lancet Infect Dis. 2016 Mar 30. doi: 10.1016/S1473-3099[16]30002-0).

Body

Dr. Jeffrey Joy and colleagues offer evidence that the era of high rates of transmission and rapid expansion of hepatitis C virus infections was from 1940 to 1960, when reuse of glass and metal syringes was common.

The authors conclude that attributing the spread of hepatitis C virus to the medical establishment, rather than youthful behavior long outgrown by most baby boomers, could justify changing the message around screening of baby boomers. Baby boomers came of age when nosocomial transmission could have been rampant. For this additional reason, rather than just individual behavior, all Americans born between 1945 and 1965 should be tested, say the authors.

This change of message, while effective, could backfire. By accepting responsibility for the pre-1960 spread, the medical establishment might increase stigma for patients born after the uptake of disposable syringes and safer clinical practices. Also, screening by birth cohort might already be outlasting its usefulness in some populations. Lowering the cost of hepatitis C virus testing could lead to routine, universal testing becoming the norm, making birth cohort testing obsolete.

Last, the novel method used in this study could be replaced by an even newer, more precise technology; would our message need to change once more?

Here are the facts: Hepatitis C virus is common among Americans born between 1945 and 1965. A current Centers for Disease Control and Prevention fact sheet asserts that most people infected with hepatitis C virus are unaware of their diagnosis, despite aggressive campaigns since 2012 to find cases. Let’s just go ahead and test our baby boomers.

Dr. Anne C. Spaulding and Dr. Lesley S. Miller are at the Rollins School of Public Health, Emory University, Atlanta. They reported receiving grants and other funding from Gilead Sciences and Bristol-Myers Squibb. These comments are from their editorial (Lancet Infect Dis. 2016 Mar 30. doi: 10.1016/S1473-3099[16]30002-0).

Title
Focus on testing, not shifting blame
Focus on testing, not shifting blame

Iatrogenic factors, not high-risk behaviors, were the main cause of the exponential spread of hepatitis C virus infections in North America, according to a phylogenetic study published online in the Lancet Infectious Diseases.

The study shifted the epicenter of spread back by more than 15 years, to about 1950, when medical procedures were expanding after World War II at the same time that clinicians continued to reuse metal and glass syringes, said Dr. Jeffrey Joy of the British Columbia Centre for Excellence in HIV/AIDS, Vancouver, and his associates.

©Jezperklauzen/ThinkStock

Exponential HCV transmission had mostly ended by 1965, negating “the idea that the epidemic among baby boomers and other demographic groups in North America is primarily due to injection drug use, unsafe tattooing, high-risk sex, and travel to high endemic areas during youth,” the researchers added.

The hepatitis C virus evolves rapidly, enabling researchers to characterize its spread based on the genetic divergence of infections. Dr. Joy and his associates studied 45,316 HCV genotype 1a sequences from the National Center for Biotechnology Information GenBank nucleotide database to carry out phylogenetic analyses of five HCV genes – E1, E2, NS2, NS4B, and NS5B (Lancet Infect Dis. 2016 Mar 30. doi: 10.1016/S1473-3099[16]00124-9).

The combined results for all gene regions suggested that the North American HCV epidemic expanded the most between 1940 and 1965, and that transmission rates peaked in 1950, when the oldest baby boomers were only 5 years old. Thus, nosocomial transmission rather than risky behaviors was the likely driver behind most infections, the researchers said.

“Our results could help to reduce stigma related to screening and diagnosis of hepatitis C virus, potentially increasing the numbers of providers offering screening, patients accepting testing, and if positive, presenting for care and treatment,” the authors noted.

The researchers also found that HCV transmission rates plateaued between 1965 and 1989, and dropped in the early 1990s, coinciding with increases in blood product testing and needle exchange programs aimed at preventing HIV infections. Furthermore, HCV infections rose slightly after 2000, mirroring epidemiologic reports of outbreaks among young injection drug users in nonurban areas and among men who have sex with men, the researchers said.

The Canadian Institutes of Health Research, Michael Smith Foundation for Health Research, and BC Centre for Excellence in HIV/AIDS funded the study. The investigators disclosed no competing interests.

Iatrogenic factors, not high-risk behaviors, were the main cause of the exponential spread of hepatitis C virus infections in North America, according to a phylogenetic study published online in the Lancet Infectious Diseases.

The study shifted the epicenter of spread back by more than 15 years, to about 1950, when medical procedures were expanding after World War II at the same time that clinicians continued to reuse metal and glass syringes, said Dr. Jeffrey Joy of the British Columbia Centre for Excellence in HIV/AIDS, Vancouver, and his associates.

©Jezperklauzen/ThinkStock

Exponential HCV transmission had mostly ended by 1965, negating “the idea that the epidemic among baby boomers and other demographic groups in North America is primarily due to injection drug use, unsafe tattooing, high-risk sex, and travel to high endemic areas during youth,” the researchers added.

The hepatitis C virus evolves rapidly, enabling researchers to characterize its spread based on the genetic divergence of infections. Dr. Joy and his associates studied 45,316 HCV genotype 1a sequences from the National Center for Biotechnology Information GenBank nucleotide database to carry out phylogenetic analyses of five HCV genes – E1, E2, NS2, NS4B, and NS5B (Lancet Infect Dis. 2016 Mar 30. doi: 10.1016/S1473-3099[16]00124-9).

The combined results for all gene regions suggested that the North American HCV epidemic expanded the most between 1940 and 1965, and that transmission rates peaked in 1950, when the oldest baby boomers were only 5 years old. Thus, nosocomial transmission rather than risky behaviors was the likely driver behind most infections, the researchers said.

“Our results could help to reduce stigma related to screening and diagnosis of hepatitis C virus, potentially increasing the numbers of providers offering screening, patients accepting testing, and if positive, presenting for care and treatment,” the authors noted.

The researchers also found that HCV transmission rates plateaued between 1965 and 1989, and dropped in the early 1990s, coinciding with increases in blood product testing and needle exchange programs aimed at preventing HIV infections. Furthermore, HCV infections rose slightly after 2000, mirroring epidemiologic reports of outbreaks among young injection drug users in nonurban areas and among men who have sex with men, the researchers said.

The Canadian Institutes of Health Research, Michael Smith Foundation for Health Research, and BC Centre for Excellence in HIV/AIDS funded the study. The investigators disclosed no competing interests.

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FROM THE LANCET INFECTIOUS DISEASES

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Key clinical point: Iatrogenic factors, rather than high-risk behaviors, were the most likely cause of the exponential spread of hepatitis C virus infections in North America.

Major finding: Transmission of HCV genotype 1a peaked in North America in 1950, when the oldest baby boomers were 5 years old.

Data source: A retrospective phylogenetic study of five HCV genotype 1a genes from 45,316 publicly available sequences.

Disclosures: The Canadian Institutes of Health Research, Michael Smith Foundation for Health Research, and BC Centre for Excellence in HIV/AIDS funded the study. The investigators disclosed no competing interests.

Colombia reports first Zika deaths, all in medically compromised patients

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Colombia reports first Zika deaths, all in medically compromised patients

AMSTERDAM – Five people with confirmed Zika virus infections have died in Colombia, and all had medical comorbidities, including leukemia, diabetes, sickle cell anemia, and hypertension.

All of the deaths occurred last October in northern and central Colombia, Dr. Alfonso Rodriguez-Morales said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Four of the cases were simultaneously published April 7 in the Lancet Infectious Diseases (2016 Apr 7. doi: 10.1016/S1473-3099[16]30006-8). The fifth case occurred in northern Colombia, and was reported in Emerging Infectious Diseases (2016 May. doi: 10.3201/eid2205.151934).

Reports of confirmed Zika-related deaths are rare. Brazil, the only other country to disclose them, has now reported three, said Dr. Rodriguez-Morales of the Universidad Tecnológica de Pereira, Colombia.

©bakhtiar_zein/Thinkstock

“Before the current outbreak in Latin America, Zika virus was not linked to deaths,” he noted. But the eight confirmed Zika-related deaths in South America “call attention to the need for evidence-based guidelines for clinical management of Zika, as well as the possible occurrence of atypical and severe cases, including possibly congenitally related microcephaly.”

Because they all occurred in medically compromised patients, Dr. Rodriguez-Morales also urged clinicians to cast a wary eye on such patients who present with arbovirus-type symptoms, including fever and rash.

From September 2015 to March 2016, Colombia had 58,838 reported cases of Zika. Of those, only 2,361 were lab confirmed. The rest were either diagnosed clinically or were suspected cases, Dr. Rodriguez-Morales said. Although Colombia has a much smaller population than Brazil (49 million vs. 210 million), its Zika case rate is much higher, 120 cases per 100,000 people vs. 34 cases per 100,000 people.

The group of four deaths occurred in central Colombia, and included a 2-year-old girl, a 30-year-old woman, a 61-year-old man, and a 72-year-old woman. All presented with 2-6 days of fever. All were initially suspected to have dengue fever or chikungunya. None tested positive for dengue, but the man was coinfected with chikungunya.

All patients presented with anemia. All but the older man also had severe thrombocytopenia.

The toddler presented with hepatomegaly, mucosal hemorrhage, progressive respiratory collapse, progressive thrombocytopenia, and intravascular coagulation. She died 5 days after symptom onset and was found to have had unrecognized lymphoblastic leukemia.

The 30-year-old woman presented with a severe rash on both arms. She also exhibited coagulation dysfunction, including severe thrombocytopenia and leukopenia that progressed to intracerebral and subarachnoid hemorrhage. She died 12 days after symptom onset. She was determined to have had unrecognized acute myeloid leukemia.

The elderly man had a history of medically controlled hypertension. He experienced mucosal hemorrhage and respiratory distress. He died 7 days after symptom onset. On autopsy, his liver showed necrotic areas, and his spleen indicated a systemic inflammatory response.

The elderly woman had a history of insulin-controlled type 2 diabetes. Her symptoms included gastrointestinal distress, thrombocytopenia, and acute respiratory failure. She died 48 hours after symptom onset; her brain showed edema and ischemic lesions.

The 15-year-old girl in northern Colombia had a 5-year history of sickle cell disease, which, Dr. Rodriguez-Morales pointed out, is a risk factor for arbovirus diseases. However, the patient had never been hospitalized for a vasoocclusive crisis. She presented with a high fever; joint, muscle, and abdominal pain; and jaundice. She was assumed to have dengue virus. Within another day, she had progressed into respiratory failure and was on a ventilator. She died less than 2 days later.

Her autopsy showed hepatic necrosis and severe decrease of splenic lymphoid tissue with splenic sequestration. Systemic inflammation probably triggered a fatal vasoocclusive crisis and splenic sequestration.

Dr. Rodriguez-Morales had no financial disclosures.

[email protected]

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AMSTERDAM – Five people with confirmed Zika virus infections have died in Colombia, and all had medical comorbidities, including leukemia, diabetes, sickle cell anemia, and hypertension.

All of the deaths occurred last October in northern and central Colombia, Dr. Alfonso Rodriguez-Morales said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Four of the cases were simultaneously published April 7 in the Lancet Infectious Diseases (2016 Apr 7. doi: 10.1016/S1473-3099[16]30006-8). The fifth case occurred in northern Colombia, and was reported in Emerging Infectious Diseases (2016 May. doi: 10.3201/eid2205.151934).

Reports of confirmed Zika-related deaths are rare. Brazil, the only other country to disclose them, has now reported three, said Dr. Rodriguez-Morales of the Universidad Tecnológica de Pereira, Colombia.

©bakhtiar_zein/Thinkstock

“Before the current outbreak in Latin America, Zika virus was not linked to deaths,” he noted. But the eight confirmed Zika-related deaths in South America “call attention to the need for evidence-based guidelines for clinical management of Zika, as well as the possible occurrence of atypical and severe cases, including possibly congenitally related microcephaly.”

Because they all occurred in medically compromised patients, Dr. Rodriguez-Morales also urged clinicians to cast a wary eye on such patients who present with arbovirus-type symptoms, including fever and rash.

From September 2015 to March 2016, Colombia had 58,838 reported cases of Zika. Of those, only 2,361 were lab confirmed. The rest were either diagnosed clinically or were suspected cases, Dr. Rodriguez-Morales said. Although Colombia has a much smaller population than Brazil (49 million vs. 210 million), its Zika case rate is much higher, 120 cases per 100,000 people vs. 34 cases per 100,000 people.

The group of four deaths occurred in central Colombia, and included a 2-year-old girl, a 30-year-old woman, a 61-year-old man, and a 72-year-old woman. All presented with 2-6 days of fever. All were initially suspected to have dengue fever or chikungunya. None tested positive for dengue, but the man was coinfected with chikungunya.

All patients presented with anemia. All but the older man also had severe thrombocytopenia.

The toddler presented with hepatomegaly, mucosal hemorrhage, progressive respiratory collapse, progressive thrombocytopenia, and intravascular coagulation. She died 5 days after symptom onset and was found to have had unrecognized lymphoblastic leukemia.

The 30-year-old woman presented with a severe rash on both arms. She also exhibited coagulation dysfunction, including severe thrombocytopenia and leukopenia that progressed to intracerebral and subarachnoid hemorrhage. She died 12 days after symptom onset. She was determined to have had unrecognized acute myeloid leukemia.

The elderly man had a history of medically controlled hypertension. He experienced mucosal hemorrhage and respiratory distress. He died 7 days after symptom onset. On autopsy, his liver showed necrotic areas, and his spleen indicated a systemic inflammatory response.

The elderly woman had a history of insulin-controlled type 2 diabetes. Her symptoms included gastrointestinal distress, thrombocytopenia, and acute respiratory failure. She died 48 hours after symptom onset; her brain showed edema and ischemic lesions.

The 15-year-old girl in northern Colombia had a 5-year history of sickle cell disease, which, Dr. Rodriguez-Morales pointed out, is a risk factor for arbovirus diseases. However, the patient had never been hospitalized for a vasoocclusive crisis. She presented with a high fever; joint, muscle, and abdominal pain; and jaundice. She was assumed to have dengue virus. Within another day, she had progressed into respiratory failure and was on a ventilator. She died less than 2 days later.

Her autopsy showed hepatic necrosis and severe decrease of splenic lymphoid tissue with splenic sequestration. Systemic inflammation probably triggered a fatal vasoocclusive crisis and splenic sequestration.

Dr. Rodriguez-Morales had no financial disclosures.

[email protected]

AMSTERDAM – Five people with confirmed Zika virus infections have died in Colombia, and all had medical comorbidities, including leukemia, diabetes, sickle cell anemia, and hypertension.

All of the deaths occurred last October in northern and central Colombia, Dr. Alfonso Rodriguez-Morales said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.

Four of the cases were simultaneously published April 7 in the Lancet Infectious Diseases (2016 Apr 7. doi: 10.1016/S1473-3099[16]30006-8). The fifth case occurred in northern Colombia, and was reported in Emerging Infectious Diseases (2016 May. doi: 10.3201/eid2205.151934).

Reports of confirmed Zika-related deaths are rare. Brazil, the only other country to disclose them, has now reported three, said Dr. Rodriguez-Morales of the Universidad Tecnológica de Pereira, Colombia.

©bakhtiar_zein/Thinkstock

“Before the current outbreak in Latin America, Zika virus was not linked to deaths,” he noted. But the eight confirmed Zika-related deaths in South America “call attention to the need for evidence-based guidelines for clinical management of Zika, as well as the possible occurrence of atypical and severe cases, including possibly congenitally related microcephaly.”

Because they all occurred in medically compromised patients, Dr. Rodriguez-Morales also urged clinicians to cast a wary eye on such patients who present with arbovirus-type symptoms, including fever and rash.

From September 2015 to March 2016, Colombia had 58,838 reported cases of Zika. Of those, only 2,361 were lab confirmed. The rest were either diagnosed clinically or were suspected cases, Dr. Rodriguez-Morales said. Although Colombia has a much smaller population than Brazil (49 million vs. 210 million), its Zika case rate is much higher, 120 cases per 100,000 people vs. 34 cases per 100,000 people.

The group of four deaths occurred in central Colombia, and included a 2-year-old girl, a 30-year-old woman, a 61-year-old man, and a 72-year-old woman. All presented with 2-6 days of fever. All were initially suspected to have dengue fever or chikungunya. None tested positive for dengue, but the man was coinfected with chikungunya.

All patients presented with anemia. All but the older man also had severe thrombocytopenia.

The toddler presented with hepatomegaly, mucosal hemorrhage, progressive respiratory collapse, progressive thrombocytopenia, and intravascular coagulation. She died 5 days after symptom onset and was found to have had unrecognized lymphoblastic leukemia.

The 30-year-old woman presented with a severe rash on both arms. She also exhibited coagulation dysfunction, including severe thrombocytopenia and leukopenia that progressed to intracerebral and subarachnoid hemorrhage. She died 12 days after symptom onset. She was determined to have had unrecognized acute myeloid leukemia.

The elderly man had a history of medically controlled hypertension. He experienced mucosal hemorrhage and respiratory distress. He died 7 days after symptom onset. On autopsy, his liver showed necrotic areas, and his spleen indicated a systemic inflammatory response.

The elderly woman had a history of insulin-controlled type 2 diabetes. Her symptoms included gastrointestinal distress, thrombocytopenia, and acute respiratory failure. She died 48 hours after symptom onset; her brain showed edema and ischemic lesions.

The 15-year-old girl in northern Colombia had a 5-year history of sickle cell disease, which, Dr. Rodriguez-Morales pointed out, is a risk factor for arbovirus diseases. However, the patient had never been hospitalized for a vasoocclusive crisis. She presented with a high fever; joint, muscle, and abdominal pain; and jaundice. She was assumed to have dengue virus. Within another day, she had progressed into respiratory failure and was on a ventilator. She died less than 2 days later.

Her autopsy showed hepatic necrosis and severe decrease of splenic lymphoid tissue with splenic sequestration. Systemic inflammation probably triggered a fatal vasoocclusive crisis and splenic sequestration.

Dr. Rodriguez-Morales had no financial disclosures.

[email protected]

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Policy Experts Urge Hospitalists to Get Involved, Share Knowledge

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SAN DIEGO — Think beyond your four walls, speakers told hospitalists at HM16. When it comes to public health and public policy, with your experience and knowledge, your input is simply too valuable not to share, they said.

During several sessions at the SHM annual meeting, hospitalists were urged to understand that they could influence the world of healthcare beyond their own patients and their own centers.

“You have more power than you realize,” U.S. Surgeon General Vivek Murthy, MD, MBA, told hospitalists in his opening address. As a hospitalist at Brigham and Women’s Hospital in Boston, Dr. Murthy created the nonprofit organization Doctors for America, which promotes affordable, high-quality healthcare for all Americans.

A member of Congress, he said, once told him that a call from a doctor is listed as “a notable event” and 10 calls from doctors in a day is “a full-blown crisis.” “I’m often struck by how infrequently elected leaders hear from doctors,” Dr. Murthy added. “I’m also struck by how many good ideas I hear from doctors.”

Dr. Murthy suggested that as the HM movement grows, hospitalists should ask themselves questions around issues of leadership, change, and public health.

“Can hospitalists leverage their leadership in the hospital to not only improve systems but also create a culture that supports healing in health?” Dr. Murthy asked. “Can hospitalists be as powerful a force for change outside the hospital as they are inside the hospital, recognizing that critical drivers of illness like nutrition, safety, and physical activity are most often grounded in the community rather than the clinic? As people who often mentor trainees and younger physicians, can we inspire the next generation of physicians with a broader vision of medicine, one where physicians’ sacred duty is to safeguard the health of their community by treating illness but also by preventing it?”

Achieving such goals might be a tall order. When asked about how influential they feel in the world of public health, some hospitalists said they feel they can have some impact in their daily work but, beyond the hospital, not so much.

“I don’t feel very empowered,” said Janna Gelderman-Moffett, DO, a locum tenens physician in Boulder City, Colo. She added, though, that she is “frustrated with how medicine is portrayed.”

Robert Wachter, MD, MHM, chief of the division of hospital medicine at the University of California, San Francisco Medical Center, who coined the term “hospitalist” 20 years ago, told hospitalists at HM16 that it’s “crucial” for them to take on new roles. But he also waved a caution flag: too much and you may go too far afield.

“We have to be careful about scope creep,” Dr. Wachter said. “And as much as I enjoyed the Surgeon General’s comments, I think we’ve got to be thoughtful about taking on [too much responsibility]. I have people in my group who do a lot of work, for example, in population health. That’s part of their job, but I’m not sure that’s our job, to fix the world of prevention outside of the hospital and SNF. If we begin becoming something for everybody, I think we’ll lose the special focus that made us successful.”

Ron Greeno, MD, FCCP, MHM, chief strategy officer for IPC Healthcare in North Hollywood, Calif., chair of SHM’s Public Policy Committee, and an SHM board member, said the society and hospitalists are “specially suited” to give input to help shape the details of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which replaced the repealed Sustainable Growth Rate (SGR) formula.

With MACRA, SGR’s threat of broader Medicare payment cuts is eliminated, but it increases the scope of quality measurement, including resource use and clinical-improvement practices. It also uses incentives to push providers toward risk-based models.

 

 

With many of MACRA’s specifics now left to the rule-making process, it’s still largely “a creature devoid of form,” Dr. Greeno said. Hospitalists and SHM can make a difference largely because of their roles within systems, he said. “We are trying to actually make things better,” he added. “We’re always looking for a better way to do things.”

Joining SHM’s Grassroots Network, which can involve something as simple as sending a pre-written letter to Washington, D.C.–based legislators, can be a big help. “You know what?” Dr. Greeno said. “This stuff actually has an impact.”

Tresa McNeal, MD, a hospitalist at Baylor Scott & White Health, a not-for-profit healthcare system serving Texas communities, said she was motivated by the speakers’ remarks.

“It’s really good to know that we have people representing us from SHM to [not only] help us learn about these issues but also represent us,” Dr. McNeal said. “I think it makes me want to be part of the grassroots initiative, just realizing that there’s power in numbers.” TH


Thomas R. Collins is a freelance writer in South Florida.

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SAN DIEGO — Think beyond your four walls, speakers told hospitalists at HM16. When it comes to public health and public policy, with your experience and knowledge, your input is simply too valuable not to share, they said.

During several sessions at the SHM annual meeting, hospitalists were urged to understand that they could influence the world of healthcare beyond their own patients and their own centers.

“You have more power than you realize,” U.S. Surgeon General Vivek Murthy, MD, MBA, told hospitalists in his opening address. As a hospitalist at Brigham and Women’s Hospital in Boston, Dr. Murthy created the nonprofit organization Doctors for America, which promotes affordable, high-quality healthcare for all Americans.

A member of Congress, he said, once told him that a call from a doctor is listed as “a notable event” and 10 calls from doctors in a day is “a full-blown crisis.” “I’m often struck by how infrequently elected leaders hear from doctors,” Dr. Murthy added. “I’m also struck by how many good ideas I hear from doctors.”

Dr. Murthy suggested that as the HM movement grows, hospitalists should ask themselves questions around issues of leadership, change, and public health.

“Can hospitalists leverage their leadership in the hospital to not only improve systems but also create a culture that supports healing in health?” Dr. Murthy asked. “Can hospitalists be as powerful a force for change outside the hospital as they are inside the hospital, recognizing that critical drivers of illness like nutrition, safety, and physical activity are most often grounded in the community rather than the clinic? As people who often mentor trainees and younger physicians, can we inspire the next generation of physicians with a broader vision of medicine, one where physicians’ sacred duty is to safeguard the health of their community by treating illness but also by preventing it?”

Achieving such goals might be a tall order. When asked about how influential they feel in the world of public health, some hospitalists said they feel they can have some impact in their daily work but, beyond the hospital, not so much.

“I don’t feel very empowered,” said Janna Gelderman-Moffett, DO, a locum tenens physician in Boulder City, Colo. She added, though, that she is “frustrated with how medicine is portrayed.”

Robert Wachter, MD, MHM, chief of the division of hospital medicine at the University of California, San Francisco Medical Center, who coined the term “hospitalist” 20 years ago, told hospitalists at HM16 that it’s “crucial” for them to take on new roles. But he also waved a caution flag: too much and you may go too far afield.

“We have to be careful about scope creep,” Dr. Wachter said. “And as much as I enjoyed the Surgeon General’s comments, I think we’ve got to be thoughtful about taking on [too much responsibility]. I have people in my group who do a lot of work, for example, in population health. That’s part of their job, but I’m not sure that’s our job, to fix the world of prevention outside of the hospital and SNF. If we begin becoming something for everybody, I think we’ll lose the special focus that made us successful.”

Ron Greeno, MD, FCCP, MHM, chief strategy officer for IPC Healthcare in North Hollywood, Calif., chair of SHM’s Public Policy Committee, and an SHM board member, said the society and hospitalists are “specially suited” to give input to help shape the details of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which replaced the repealed Sustainable Growth Rate (SGR) formula.

With MACRA, SGR’s threat of broader Medicare payment cuts is eliminated, but it increases the scope of quality measurement, including resource use and clinical-improvement practices. It also uses incentives to push providers toward risk-based models.

 

 

With many of MACRA’s specifics now left to the rule-making process, it’s still largely “a creature devoid of form,” Dr. Greeno said. Hospitalists and SHM can make a difference largely because of their roles within systems, he said. “We are trying to actually make things better,” he added. “We’re always looking for a better way to do things.”

Joining SHM’s Grassroots Network, which can involve something as simple as sending a pre-written letter to Washington, D.C.–based legislators, can be a big help. “You know what?” Dr. Greeno said. “This stuff actually has an impact.”

Tresa McNeal, MD, a hospitalist at Baylor Scott & White Health, a not-for-profit healthcare system serving Texas communities, said she was motivated by the speakers’ remarks.

“It’s really good to know that we have people representing us from SHM to [not only] help us learn about these issues but also represent us,” Dr. McNeal said. “I think it makes me want to be part of the grassroots initiative, just realizing that there’s power in numbers.” TH


Thomas R. Collins is a freelance writer in South Florida.

SAN DIEGO — Think beyond your four walls, speakers told hospitalists at HM16. When it comes to public health and public policy, with your experience and knowledge, your input is simply too valuable not to share, they said.

During several sessions at the SHM annual meeting, hospitalists were urged to understand that they could influence the world of healthcare beyond their own patients and their own centers.

“You have more power than you realize,” U.S. Surgeon General Vivek Murthy, MD, MBA, told hospitalists in his opening address. As a hospitalist at Brigham and Women’s Hospital in Boston, Dr. Murthy created the nonprofit organization Doctors for America, which promotes affordable, high-quality healthcare for all Americans.

A member of Congress, he said, once told him that a call from a doctor is listed as “a notable event” and 10 calls from doctors in a day is “a full-blown crisis.” “I’m often struck by how infrequently elected leaders hear from doctors,” Dr. Murthy added. “I’m also struck by how many good ideas I hear from doctors.”

Dr. Murthy suggested that as the HM movement grows, hospitalists should ask themselves questions around issues of leadership, change, and public health.

“Can hospitalists leverage their leadership in the hospital to not only improve systems but also create a culture that supports healing in health?” Dr. Murthy asked. “Can hospitalists be as powerful a force for change outside the hospital as they are inside the hospital, recognizing that critical drivers of illness like nutrition, safety, and physical activity are most often grounded in the community rather than the clinic? As people who often mentor trainees and younger physicians, can we inspire the next generation of physicians with a broader vision of medicine, one where physicians’ sacred duty is to safeguard the health of their community by treating illness but also by preventing it?”

Achieving such goals might be a tall order. When asked about how influential they feel in the world of public health, some hospitalists said they feel they can have some impact in their daily work but, beyond the hospital, not so much.

“I don’t feel very empowered,” said Janna Gelderman-Moffett, DO, a locum tenens physician in Boulder City, Colo. She added, though, that she is “frustrated with how medicine is portrayed.”

Robert Wachter, MD, MHM, chief of the division of hospital medicine at the University of California, San Francisco Medical Center, who coined the term “hospitalist” 20 years ago, told hospitalists at HM16 that it’s “crucial” for them to take on new roles. But he also waved a caution flag: too much and you may go too far afield.

“We have to be careful about scope creep,” Dr. Wachter said. “And as much as I enjoyed the Surgeon General’s comments, I think we’ve got to be thoughtful about taking on [too much responsibility]. I have people in my group who do a lot of work, for example, in population health. That’s part of their job, but I’m not sure that’s our job, to fix the world of prevention outside of the hospital and SNF. If we begin becoming something for everybody, I think we’ll lose the special focus that made us successful.”

Ron Greeno, MD, FCCP, MHM, chief strategy officer for IPC Healthcare in North Hollywood, Calif., chair of SHM’s Public Policy Committee, and an SHM board member, said the society and hospitalists are “specially suited” to give input to help shape the details of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which replaced the repealed Sustainable Growth Rate (SGR) formula.

With MACRA, SGR’s threat of broader Medicare payment cuts is eliminated, but it increases the scope of quality measurement, including resource use and clinical-improvement practices. It also uses incentives to push providers toward risk-based models.

 

 

With many of MACRA’s specifics now left to the rule-making process, it’s still largely “a creature devoid of form,” Dr. Greeno said. Hospitalists and SHM can make a difference largely because of their roles within systems, he said. “We are trying to actually make things better,” he added. “We’re always looking for a better way to do things.”

Joining SHM’s Grassroots Network, which can involve something as simple as sending a pre-written letter to Washington, D.C.–based legislators, can be a big help. “You know what?” Dr. Greeno said. “This stuff actually has an impact.”

Tresa McNeal, MD, a hospitalist at Baylor Scott & White Health, a not-for-profit healthcare system serving Texas communities, said she was motivated by the speakers’ remarks.

“It’s really good to know that we have people representing us from SHM to [not only] help us learn about these issues but also represent us,” Dr. McNeal said. “I think it makes me want to be part of the grassroots initiative, just realizing that there’s power in numbers.” TH


Thomas R. Collins is a freelance writer in South Florida.

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Society of Hospital Medicine Awards 3 Master in Hospital Medicine Designation

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SAN DIEGO—Add three more names to the short list of individuals who’ve reached the peak of the specialty. The Master in Hospital Medicine (MHM) designation, introduced in 2010, honors “highly accomplished individuals” who have made major contributions to HM. Twenty-one people have now attained the designation.

Dr. Howell

Because Eric Howell, MD, MHM, is an introvert by personality and an engineer by training, he knows full well perfection doesn’t exist. But he tries, as evidenced by a résumé that includes being a past SHM president, current SHM board member, perennial faculty member at the society’s annual meeting, and award-winning professor.

“You’re constantly trying to achieve mastery, but no one ever really reaches it,” says Dr. Howell, director of the collaborative inpatient medicine service (CIMS) at Johns Hopkins Bayview Medical Center in Baltimore and chief of its Division of Hospital Medicine. “It’s just good to know that at least I’m viewed by others as being worthy … at least I’m on the right track.

“It’s hard as you become more experienced to find ways to assess your performance, and so getting an award like a Masters is incredibly rewarding because it verifies that your colleagues feel like your work to improve is valid and [has] paid off.”

Budnitz

Tina Budnitz, MPH, MHM, doesn’t see her MHM honorarium as hers alone. Sure, the designation is a nod to accomplishments made over 14 years in multiple leadership roles, including as SHM’s chief strategy and development officer. She helped the nascent specialty craft the “Core Competencies in Hospital Medicine,” design the leadership academies, and launch the now well-established Project BOOST. She developed SHM’s mentored implementation program and the SHM strategic communications plan to help guide the society into 2020.

“As the first non-physician to get this award, I am humbled and honored,” she says. “But what’s most important is the statement being made by SHM that hospital medicine will be propelled forward through the contributions of many professionals including, but not only, physicians. That’s such an important message that I want people to hear.”

Budnitz says SHM is not just a group of individuals.

“The entire team is needed to improve healthcare,” she says.

Dr. Maynard

Gregory Maynard, MD, MSc, MHM, has been a clinician, educator, and quality improvement (QI) pioneer. He helped build and lead mentored-implementation programs to improve transitions of care, upgrade glycemic controls, and prevent venous thromboembolism (VTE).

And now, as chief quality officer at the University of California Davis Medical Center in Sacramento, he is a master.

So why does he still feel like the student and not the teacher?

“What I probably feel best about in hospital medicine is the collaborative approach to mentored implementation, these coaching models to educate broad groups,” he says. “When I’ve had an opportunity to try to work with other hospitalists and mentor them in terms of how to survive as a hospital medicine program or how to attack a problem in quality, be it VTE or something else … they end up teaching me a lot and mentoring me in return.” TH


Richard Quinn is a freelance writer in New Jersey.

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SAN DIEGO—Add three more names to the short list of individuals who’ve reached the peak of the specialty. The Master in Hospital Medicine (MHM) designation, introduced in 2010, honors “highly accomplished individuals” who have made major contributions to HM. Twenty-one people have now attained the designation.

Dr. Howell

Because Eric Howell, MD, MHM, is an introvert by personality and an engineer by training, he knows full well perfection doesn’t exist. But he tries, as evidenced by a résumé that includes being a past SHM president, current SHM board member, perennial faculty member at the society’s annual meeting, and award-winning professor.

“You’re constantly trying to achieve mastery, but no one ever really reaches it,” says Dr. Howell, director of the collaborative inpatient medicine service (CIMS) at Johns Hopkins Bayview Medical Center in Baltimore and chief of its Division of Hospital Medicine. “It’s just good to know that at least I’m viewed by others as being worthy … at least I’m on the right track.

“It’s hard as you become more experienced to find ways to assess your performance, and so getting an award like a Masters is incredibly rewarding because it verifies that your colleagues feel like your work to improve is valid and [has] paid off.”

Budnitz

Tina Budnitz, MPH, MHM, doesn’t see her MHM honorarium as hers alone. Sure, the designation is a nod to accomplishments made over 14 years in multiple leadership roles, including as SHM’s chief strategy and development officer. She helped the nascent specialty craft the “Core Competencies in Hospital Medicine,” design the leadership academies, and launch the now well-established Project BOOST. She developed SHM’s mentored implementation program and the SHM strategic communications plan to help guide the society into 2020.

“As the first non-physician to get this award, I am humbled and honored,” she says. “But what’s most important is the statement being made by SHM that hospital medicine will be propelled forward through the contributions of many professionals including, but not only, physicians. That’s such an important message that I want people to hear.”

Budnitz says SHM is not just a group of individuals.

“The entire team is needed to improve healthcare,” she says.

Dr. Maynard

Gregory Maynard, MD, MSc, MHM, has been a clinician, educator, and quality improvement (QI) pioneer. He helped build and lead mentored-implementation programs to improve transitions of care, upgrade glycemic controls, and prevent venous thromboembolism (VTE).

And now, as chief quality officer at the University of California Davis Medical Center in Sacramento, he is a master.

So why does he still feel like the student and not the teacher?

“What I probably feel best about in hospital medicine is the collaborative approach to mentored implementation, these coaching models to educate broad groups,” he says. “When I’ve had an opportunity to try to work with other hospitalists and mentor them in terms of how to survive as a hospital medicine program or how to attack a problem in quality, be it VTE or something else … they end up teaching me a lot and mentoring me in return.” TH


Richard Quinn is a freelance writer in New Jersey.

SAN DIEGO—Add three more names to the short list of individuals who’ve reached the peak of the specialty. The Master in Hospital Medicine (MHM) designation, introduced in 2010, honors “highly accomplished individuals” who have made major contributions to HM. Twenty-one people have now attained the designation.

Dr. Howell

Because Eric Howell, MD, MHM, is an introvert by personality and an engineer by training, he knows full well perfection doesn’t exist. But he tries, as evidenced by a résumé that includes being a past SHM president, current SHM board member, perennial faculty member at the society’s annual meeting, and award-winning professor.

“You’re constantly trying to achieve mastery, but no one ever really reaches it,” says Dr. Howell, director of the collaborative inpatient medicine service (CIMS) at Johns Hopkins Bayview Medical Center in Baltimore and chief of its Division of Hospital Medicine. “It’s just good to know that at least I’m viewed by others as being worthy … at least I’m on the right track.

“It’s hard as you become more experienced to find ways to assess your performance, and so getting an award like a Masters is incredibly rewarding because it verifies that your colleagues feel like your work to improve is valid and [has] paid off.”

Budnitz

Tina Budnitz, MPH, MHM, doesn’t see her MHM honorarium as hers alone. Sure, the designation is a nod to accomplishments made over 14 years in multiple leadership roles, including as SHM’s chief strategy and development officer. She helped the nascent specialty craft the “Core Competencies in Hospital Medicine,” design the leadership academies, and launch the now well-established Project BOOST. She developed SHM’s mentored implementation program and the SHM strategic communications plan to help guide the society into 2020.

“As the first non-physician to get this award, I am humbled and honored,” she says. “But what’s most important is the statement being made by SHM that hospital medicine will be propelled forward through the contributions of many professionals including, but not only, physicians. That’s such an important message that I want people to hear.”

Budnitz says SHM is not just a group of individuals.

“The entire team is needed to improve healthcare,” she says.

Dr. Maynard

Gregory Maynard, MD, MSc, MHM, has been a clinician, educator, and quality improvement (QI) pioneer. He helped build and lead mentored-implementation programs to improve transitions of care, upgrade glycemic controls, and prevent venous thromboembolism (VTE).

And now, as chief quality officer at the University of California Davis Medical Center in Sacramento, he is a master.

So why does he still feel like the student and not the teacher?

“What I probably feel best about in hospital medicine is the collaborative approach to mentored implementation, these coaching models to educate broad groups,” he says. “When I’ve had an opportunity to try to work with other hospitalists and mentor them in terms of how to survive as a hospital medicine program or how to attack a problem in quality, be it VTE or something else … they end up teaching me a lot and mentoring me in return.” TH


Richard Quinn is a freelance writer in New Jersey.

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Work ‘paves the way’ for platelet manufacture

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Megakaryocytes

in the bone marrow

Researchers in the UK have developed a new method of producing megakaryocytes from human pluripotent stem cells (hPSCs).

The team said their method generated large quantities of functional megakaryocytes that produced functional platelets.

They believe this work brings us one step closer to manufacturing platelets for transfusion.

The research was published in Nature Communications.

“Making megakaryocytes and platelets from stem cells for transfusion has been a long-standing challenge because of the sheer numbers we need to produce to make a single unit for transfusion,” said study author Cedric Ghevaert, MD, PhD, of the University of Cambridge and NHS Blood and Transplant in Cambridge, UK.

“We have found a way to ‘rewire’ the stem cells to make them become megakaryocytes a lot faster and more efficiently. It is a major step forward towards our goal to one day make blood cells in the laboratory to transfuse to patients.”

Dr Ghevaert and his colleagues employed a “forward programming” strategy in which 3 transcription factors—GATA1, FLI1, and TAL1—were used drive the differentiation of hPSCs into megakaryocytes.

The team said the forward-programmed megakaryocytes matured into platelet-producing cells that could be cryopreserved, maintained, and amplified in vitro for more than 90 days. The average yield was 200,000 megakaryocytes per hPSC.

The researchers generated platelets from the forward-programmed megakaryocytes via culture. And tests suggested these platelets were functionally similar to donor-derived platelets.

“The success of this research team in producing megakaryocytes in the laboratory has paved the way for the ultimate goal—manufacturing platelets for transfusion,” said Edwin Massey, MBChB, associate medical director for diagnostic and therapeutic services at NHS Blood and Transplant, who was not involved in this research.

“It will, however, be many years before a process for the large-scale production of platelets is developed. Donated platelets will still be needed by patients for the foreseeable future, either as part of a blood donation or by dedicated platelet donation using a machine collection process.”

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Megakaryocytes

in the bone marrow

Researchers in the UK have developed a new method of producing megakaryocytes from human pluripotent stem cells (hPSCs).

The team said their method generated large quantities of functional megakaryocytes that produced functional platelets.

They believe this work brings us one step closer to manufacturing platelets for transfusion.

The research was published in Nature Communications.

“Making megakaryocytes and platelets from stem cells for transfusion has been a long-standing challenge because of the sheer numbers we need to produce to make a single unit for transfusion,” said study author Cedric Ghevaert, MD, PhD, of the University of Cambridge and NHS Blood and Transplant in Cambridge, UK.

“We have found a way to ‘rewire’ the stem cells to make them become megakaryocytes a lot faster and more efficiently. It is a major step forward towards our goal to one day make blood cells in the laboratory to transfuse to patients.”

Dr Ghevaert and his colleagues employed a “forward programming” strategy in which 3 transcription factors—GATA1, FLI1, and TAL1—were used drive the differentiation of hPSCs into megakaryocytes.

The team said the forward-programmed megakaryocytes matured into platelet-producing cells that could be cryopreserved, maintained, and amplified in vitro for more than 90 days. The average yield was 200,000 megakaryocytes per hPSC.

The researchers generated platelets from the forward-programmed megakaryocytes via culture. And tests suggested these platelets were functionally similar to donor-derived platelets.

“The success of this research team in producing megakaryocytes in the laboratory has paved the way for the ultimate goal—manufacturing platelets for transfusion,” said Edwin Massey, MBChB, associate medical director for diagnostic and therapeutic services at NHS Blood and Transplant, who was not involved in this research.

“It will, however, be many years before a process for the large-scale production of platelets is developed. Donated platelets will still be needed by patients for the foreseeable future, either as part of a blood donation or by dedicated platelet donation using a machine collection process.”

Megakaryocytes

in the bone marrow

Researchers in the UK have developed a new method of producing megakaryocytes from human pluripotent stem cells (hPSCs).

The team said their method generated large quantities of functional megakaryocytes that produced functional platelets.

They believe this work brings us one step closer to manufacturing platelets for transfusion.

The research was published in Nature Communications.

“Making megakaryocytes and platelets from stem cells for transfusion has been a long-standing challenge because of the sheer numbers we need to produce to make a single unit for transfusion,” said study author Cedric Ghevaert, MD, PhD, of the University of Cambridge and NHS Blood and Transplant in Cambridge, UK.

“We have found a way to ‘rewire’ the stem cells to make them become megakaryocytes a lot faster and more efficiently. It is a major step forward towards our goal to one day make blood cells in the laboratory to transfuse to patients.”

Dr Ghevaert and his colleagues employed a “forward programming” strategy in which 3 transcription factors—GATA1, FLI1, and TAL1—were used drive the differentiation of hPSCs into megakaryocytes.

The team said the forward-programmed megakaryocytes matured into platelet-producing cells that could be cryopreserved, maintained, and amplified in vitro for more than 90 days. The average yield was 200,000 megakaryocytes per hPSC.

The researchers generated platelets from the forward-programmed megakaryocytes via culture. And tests suggested these platelets were functionally similar to donor-derived platelets.

“The success of this research team in producing megakaryocytes in the laboratory has paved the way for the ultimate goal—manufacturing platelets for transfusion,” said Edwin Massey, MBChB, associate medical director for diagnostic and therapeutic services at NHS Blood and Transplant, who was not involved in this research.

“It will, however, be many years before a process for the large-scale production of platelets is developed. Donated platelets will still be needed by patients for the foreseeable future, either as part of a blood donation or by dedicated platelet donation using a machine collection process.”

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Postvaccination anaphylaxis still possible with certain vaccines

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New findings confirm that although it is rare, postvaccination anaphylaxis can still occur with certain vaccines.

Dr. Michael M. McNeil of the Centers for Disease Control and Prevention, Atlanta, and his associates identified 17,606,500 vaccination visits from Jan. 1, 2009, through Dec. 31, 2011, at which 25,173,965 vaccine doses were administered. The researchers identified 76 cases of chart-confirmed anaphylaxis; 33 anaphylaxis cases were associated with vaccination, and 43 were attributed to other causes.

©luiscar/Thinkstockphotos

Inactivated trivalent influenza vaccine (TIV) was the major contributor to vaccine-triggered anaphylaxis cases in the population, although the rate (1.35 cases per 1 million vaccine doses of TIV given alone) was similar to the rate for all vaccines. The postvaccination anaphylaxis case rate not involving TIV was 1.32 per million vaccine doses.

The study factored in race, age, gender, symptoms, and history of the patients. There were no deaths, and only 1 patient (3%) was hospitalized. A total of 28 of the 33 vaccine-triggered anaphylaxis cases involved patients with a history of atopy.

“Although anaphylaxis after immunization is rare, its immediate onset (usually within minutes) and life-threatening nature require that all personnel and facilities providing vaccinations have procedures in place for anaphylaxis management,” the investigators noted. “Additional provider education concerning current recommendations for treatment and follow-up appears to be warranted.”

Find the full story in the Journal of Allergy and Clinical Immunology (2016 Mar;137[3]:868-78).

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New findings confirm that although it is rare, postvaccination anaphylaxis can still occur with certain vaccines.

Dr. Michael M. McNeil of the Centers for Disease Control and Prevention, Atlanta, and his associates identified 17,606,500 vaccination visits from Jan. 1, 2009, through Dec. 31, 2011, at which 25,173,965 vaccine doses were administered. The researchers identified 76 cases of chart-confirmed anaphylaxis; 33 anaphylaxis cases were associated with vaccination, and 43 were attributed to other causes.

©luiscar/Thinkstockphotos

Inactivated trivalent influenza vaccine (TIV) was the major contributor to vaccine-triggered anaphylaxis cases in the population, although the rate (1.35 cases per 1 million vaccine doses of TIV given alone) was similar to the rate for all vaccines. The postvaccination anaphylaxis case rate not involving TIV was 1.32 per million vaccine doses.

The study factored in race, age, gender, symptoms, and history of the patients. There were no deaths, and only 1 patient (3%) was hospitalized. A total of 28 of the 33 vaccine-triggered anaphylaxis cases involved patients with a history of atopy.

“Although anaphylaxis after immunization is rare, its immediate onset (usually within minutes) and life-threatening nature require that all personnel and facilities providing vaccinations have procedures in place for anaphylaxis management,” the investigators noted. “Additional provider education concerning current recommendations for treatment and follow-up appears to be warranted.”

Find the full story in the Journal of Allergy and Clinical Immunology (2016 Mar;137[3]:868-78).

New findings confirm that although it is rare, postvaccination anaphylaxis can still occur with certain vaccines.

Dr. Michael M. McNeil of the Centers for Disease Control and Prevention, Atlanta, and his associates identified 17,606,500 vaccination visits from Jan. 1, 2009, through Dec. 31, 2011, at which 25,173,965 vaccine doses were administered. The researchers identified 76 cases of chart-confirmed anaphylaxis; 33 anaphylaxis cases were associated with vaccination, and 43 were attributed to other causes.

©luiscar/Thinkstockphotos

Inactivated trivalent influenza vaccine (TIV) was the major contributor to vaccine-triggered anaphylaxis cases in the population, although the rate (1.35 cases per 1 million vaccine doses of TIV given alone) was similar to the rate for all vaccines. The postvaccination anaphylaxis case rate not involving TIV was 1.32 per million vaccine doses.

The study factored in race, age, gender, symptoms, and history of the patients. There were no deaths, and only 1 patient (3%) was hospitalized. A total of 28 of the 33 vaccine-triggered anaphylaxis cases involved patients with a history of atopy.

“Although anaphylaxis after immunization is rare, its immediate onset (usually within minutes) and life-threatening nature require that all personnel and facilities providing vaccinations have procedures in place for anaphylaxis management,” the investigators noted. “Additional provider education concerning current recommendations for treatment and follow-up appears to be warranted.”

Find the full story in the Journal of Allergy and Clinical Immunology (2016 Mar;137[3]:868-78).

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FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

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Osteoarthritis hip pain follows four distinct paths

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AMSTERDAM – There are four distinct patterns of pain in patients with early presumed hip osteoarthritis, and several factors could help identify patients most likely to experience more severe pain, according to analysis from a Dutch study.

The majority of the 545 patients included in the analysis from the Cohort Hip and Knee (CHECK) study experienced a low or a mild constant hip pain over a 5-year follow-up period (231 patients, 42.4%). Around one-quarter had moderate hip pain with moderate pain progression (132 patients, 24.2%), about one in six (88 patients, 16.1%) had moderate hip pain with moderate pain regression, and the remainder (94 patients, 17.2%) had constant, severe hip pain.

©iStock/Thinkstock

Factors associated with these pain trajectories included the level of education achieved, ability to cope with pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale, and pain experienced from internal rotation of the hip.

The findings were reported at the World Congress on Osteoarthritis sponsored by the Osteoarthritis Research Society International. They were also published online in Osteoarthritis and Cartilage (2106 Feb 5. doi: 10.1016/j.joca.2015.11.023).

Although prior studies examined progression predictors in hip OA, none looked specifically at how pain changes over time, noted study author Dr. Alex Bastick of Erasmus University Medical Center, Rotterdam, the Netherlands. Thus, the current aim was to define the trajectory of hip pain among individuals with early symptoms of hip OA, and identify any baseline factors that might help clinicians predict which pain trajectory patients may follow.

The CHECK study is a 10-year nationwide cohort study of 1,002 participants in the Netherlands with assumed early symptomatic OA of the knee, hip, or both. For the current analysis, Dr. Bastick and his associates considered only those patients with hip pain or stiffness who had completed 5 years of follow-up. At baseline, the mean age of the total population was 55.7 years, and 81% of participants were female. About one-quarter (26%) of participants had a clinical OA diagnosis according to American College of Rheumatology criteria.

Baseline radiographic severity was not associated with the various pain trajectories identified, Dr. Bastick observed, but patients who had achieved a lower level of education were roughly three times more likely to experience severe pain than mild or low constant pain. Patients experiencing severe pain were more likely to use pain transformation as a coping strategy, have higher activity limitation scores, and experience painful internal hip rotation.

Because around 60% of patients follow the mild or moderately progressing pain trajectories, conservative treatment in the early stages of hip OA appears appropriate, Dr. Bastick and his associates suggested. Their findings highlight the importance of a physical examination, and that reassessment of clinical symptoms should perhaps be undertaken in the first year of follow-up.

“Future research should be aimed at measuring symptomatic progression of hip OA with even more frequent symptom assessment,” the researchers proposed.

Reumafonds, the Dutch Arthritis Foundation, funded the study. Dr. Bastick did not have financial disclosures.

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AMSTERDAM – There are four distinct patterns of pain in patients with early presumed hip osteoarthritis, and several factors could help identify patients most likely to experience more severe pain, according to analysis from a Dutch study.

The majority of the 545 patients included in the analysis from the Cohort Hip and Knee (CHECK) study experienced a low or a mild constant hip pain over a 5-year follow-up period (231 patients, 42.4%). Around one-quarter had moderate hip pain with moderate pain progression (132 patients, 24.2%), about one in six (88 patients, 16.1%) had moderate hip pain with moderate pain regression, and the remainder (94 patients, 17.2%) had constant, severe hip pain.

©iStock/Thinkstock

Factors associated with these pain trajectories included the level of education achieved, ability to cope with pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale, and pain experienced from internal rotation of the hip.

The findings were reported at the World Congress on Osteoarthritis sponsored by the Osteoarthritis Research Society International. They were also published online in Osteoarthritis and Cartilage (2106 Feb 5. doi: 10.1016/j.joca.2015.11.023).

Although prior studies examined progression predictors in hip OA, none looked specifically at how pain changes over time, noted study author Dr. Alex Bastick of Erasmus University Medical Center, Rotterdam, the Netherlands. Thus, the current aim was to define the trajectory of hip pain among individuals with early symptoms of hip OA, and identify any baseline factors that might help clinicians predict which pain trajectory patients may follow.

The CHECK study is a 10-year nationwide cohort study of 1,002 participants in the Netherlands with assumed early symptomatic OA of the knee, hip, or both. For the current analysis, Dr. Bastick and his associates considered only those patients with hip pain or stiffness who had completed 5 years of follow-up. At baseline, the mean age of the total population was 55.7 years, and 81% of participants were female. About one-quarter (26%) of participants had a clinical OA diagnosis according to American College of Rheumatology criteria.

Baseline radiographic severity was not associated with the various pain trajectories identified, Dr. Bastick observed, but patients who had achieved a lower level of education were roughly three times more likely to experience severe pain than mild or low constant pain. Patients experiencing severe pain were more likely to use pain transformation as a coping strategy, have higher activity limitation scores, and experience painful internal hip rotation.

Because around 60% of patients follow the mild or moderately progressing pain trajectories, conservative treatment in the early stages of hip OA appears appropriate, Dr. Bastick and his associates suggested. Their findings highlight the importance of a physical examination, and that reassessment of clinical symptoms should perhaps be undertaken in the first year of follow-up.

“Future research should be aimed at measuring symptomatic progression of hip OA with even more frequent symptom assessment,” the researchers proposed.

Reumafonds, the Dutch Arthritis Foundation, funded the study. Dr. Bastick did not have financial disclosures.

AMSTERDAM – There are four distinct patterns of pain in patients with early presumed hip osteoarthritis, and several factors could help identify patients most likely to experience more severe pain, according to analysis from a Dutch study.

The majority of the 545 patients included in the analysis from the Cohort Hip and Knee (CHECK) study experienced a low or a mild constant hip pain over a 5-year follow-up period (231 patients, 42.4%). Around one-quarter had moderate hip pain with moderate pain progression (132 patients, 24.2%), about one in six (88 patients, 16.1%) had moderate hip pain with moderate pain regression, and the remainder (94 patients, 17.2%) had constant, severe hip pain.

©iStock/Thinkstock

Factors associated with these pain trajectories included the level of education achieved, ability to cope with pain, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function subscale, and pain experienced from internal rotation of the hip.

The findings were reported at the World Congress on Osteoarthritis sponsored by the Osteoarthritis Research Society International. They were also published online in Osteoarthritis and Cartilage (2106 Feb 5. doi: 10.1016/j.joca.2015.11.023).

Although prior studies examined progression predictors in hip OA, none looked specifically at how pain changes over time, noted study author Dr. Alex Bastick of Erasmus University Medical Center, Rotterdam, the Netherlands. Thus, the current aim was to define the trajectory of hip pain among individuals with early symptoms of hip OA, and identify any baseline factors that might help clinicians predict which pain trajectory patients may follow.

The CHECK study is a 10-year nationwide cohort study of 1,002 participants in the Netherlands with assumed early symptomatic OA of the knee, hip, or both. For the current analysis, Dr. Bastick and his associates considered only those patients with hip pain or stiffness who had completed 5 years of follow-up. At baseline, the mean age of the total population was 55.7 years, and 81% of participants were female. About one-quarter (26%) of participants had a clinical OA diagnosis according to American College of Rheumatology criteria.

Baseline radiographic severity was not associated with the various pain trajectories identified, Dr. Bastick observed, but patients who had achieved a lower level of education were roughly three times more likely to experience severe pain than mild or low constant pain. Patients experiencing severe pain were more likely to use pain transformation as a coping strategy, have higher activity limitation scores, and experience painful internal hip rotation.

Because around 60% of patients follow the mild or moderately progressing pain trajectories, conservative treatment in the early stages of hip OA appears appropriate, Dr. Bastick and his associates suggested. Their findings highlight the importance of a physical examination, and that reassessment of clinical symptoms should perhaps be undertaken in the first year of follow-up.

“Future research should be aimed at measuring symptomatic progression of hip OA with even more frequent symptom assessment,” the researchers proposed.

Reumafonds, the Dutch Arthritis Foundation, funded the study. Dr. Bastick did not have financial disclosures.

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Key clinical point: Understanding how osteoarthritis hip pain changes over time may help manage those who experience severe pain.

Major finding: Four hip pain trajectories were identified: low, mild constant pain (42.4%, n = 231); moderate, with moderate pain progression (24.2%, n = 132); moderate, with moderate pain regression (16.1%, n = 88); and constant severe pain (17.2%, n = 94).

Data source: The Cohort Hip and Knee (CHECK) study, a Dutch, prospective, nationwide study of 1,002 participants with assumed early symptomatic osteoarthritis of the knee, hip, or both.

Disclosures: Reumafonds, the Dutch Arthritis Foundation, funded the study. Dr. Bastick did not have financial disclosures.

Stem cells show heart failure benefits in phase II trial

Results merit phase III trial follow-up
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CHICAGO – After rattling around in early-stage clinical studies for more than a decade, stem cell therapy for heart failure may have finally gained the efficacy evidence to send it to the next level: large-scale, phase III trials.

Patients with ischemic cardiomyopathy and severe heart failure showed a statistically significant 37% relative reduction in their combined rate of death and cardiovascular hospitalization during 1 year of follow-up after autologous stem cell injections to their left ventricular myocardium in a multicenter, fully blinded control, phase II trial with 109 North American patients.

Mitchel L. Zoler/Frontline Medical News
Dr. Timothy D. Henry

The treatment used a technique in commercial development by Vericel that selectively expands ex vivo bone marrow cells taken from the heart failure patient. Clinicians inject 0.4 mL aliquots of the expanded cells – enriched for mesenchymal stem cells and M2 macrophages – via a transcatheter approach into the left ventricular myocardium using 12-17 injections per patient. The bone marrow preparation during ex vivo expansion is called ixmyelocel-T.

This treatment now needs testing in more patients, Dr. Timothy D. Henry said at the annual meeting of the American College of Cardiology. “We need a new generation of cell trials in larger studies with completely double-blind, placebo controls using a more uniform preparation of cells,” said Dr. Henry.

“To the best of our knowledge, ixCELL-DCM is the largest randomized, double-blind clinical trial to date for cell therapy use in congestive heart failure,” said Dr. Henry and his associates in their report. The concept of stem cell therapy to replace damaged myocardium “has been very attractive, but most clinical trials to date have been small and unblinded, and used unselected bone marrow cells,” explained Dr. Henry, director of cardiology at the Cedars-Sinai Heart Institute in Los Angeles.

The ixCELL-DCM study ran at 31 sites in the United States and Canada. About 90% of patients had New York Heart Association class III disease, the average left ventricular ejection fraction was about 25%, patients on average would cover about 310 m during a 6-minute walk test, and the average serum level of NT-ProBNP was about 1,900 pg/L. Patients in the control arm all underwent the same bone marrow retrieval and transcatheter injection into the left ventricle, but the injections only contained carrier material without active cells.

The primary endpoint of death or a cardiovascular event, primarily hospitalization, occurred at a rate of 110 events per 100 patient years during 1-year follow-up of 51 patients in the sham-treatment group. In the active-treatment arm, the endpoint occurred at a rate of 70 events per 100 patient years among 58 patients. The difference was primarily driven by a 3% death rate with cell therapy, compared with a 14% rate in the controls, and a 38% hospitalization rate, compared with a 47% rate among controls.

The study results appeared online concurrent with Dr. Henry’s report (Lancet. 2016 Apr 5. doi: 10.1016/S0140-6736[16]30137-4).

The results showed no significant differences between the active and sham groups for changes in left ventricular size, ejection fraction, and 6-minute walk distance.

“This trial was designed to look at events. It is not a cause for concern that we did not see effects on heart function,” Dr. Henry said. The current results were also generally consistent with results from two earlier, controlled, phase II studies with a total of 61 patients (Circ Res. 2014 Sep 26;115[8]:730-7).

In the safety analysis, done in 114 patients, the rates of all adverse events and major adverse cardiovascular events were similar in the two arms. The rate of serious adverse events was significantly reduced in the patients treated with expanded bone marrow cells, compared with the controls.

The high rate of death and hospitalization of patients with severe heart failure “is a very large, unmet need, so it’s a natural to go to a larger trial,” Dr. Henry said. “The cell preparation was very safe and easy to do.”

Another pressing research issue is to try to understand the mechanism by which the cell treatment improves clinical outcomes, with improved heart function or improved exercise capacity apparently excluded as mechanisms.

The trial was sponsored by Vericel, the company developing the ex vivo protocol for selective marrow cell expansion. Dr. Henry has been a consultant to or received honoraria from Abbott Vascular, Baxter, Capricor, Cytori, Eli Lilly, and the Medicines Company, and he has received research grants from Aastrom, Baxter International, Mesoblast, and Vericel.

[email protected]

On Twitter @mitchelzoler

References

Body

The results reported by Dr. Henry come from one of the first trials of stem cell or bone marrow treatment of failing hearts that used clinical outcomes as the primary endpoint. In contrast, prior studies focused on changes in functional characteristics of patients, such as 6-minute walk distance or left ventricular ejection fraction or size. What makes Dr. Henry’s study distinctive is that it showed benefit for a clinical outcome: the rate of death or cardiovascular hospitalization.

Another distinct difference, compared with the vast majority of earlier trials, was the way the bone marrow was handled prior to placement in a heart. The bone marrow cells underwent a 12-day period of ex vivo treatment designed to expand the content of certain mesenchymal stem cells and macrophages.

The current study was also larger than most prior reported studies, with 114 randomized patients available for the safety analysis and 109 for the efficacy analysis. But by no means was this a large study; in fact, it is relatively small. Although it produced a statistically significant result for the primary endpoint, the efficacy needs expanded testing in larger numbers.

It’s currently unclear how the expanded bone marrow cell injections improve clinical status and lead to reduced deaths and hospitalization. The results show essentially no impact from the treatment on ejection fraction or 6-minute walk distance, raising the question of what alternative mechanisms link this treatment to improved clinical outcomes.

Until now, it has not been possible to move beyond early-stage trial designs for cell therapy of failing hearts. Now, for the first time, we have study results that suggest a phase III trial is indicated.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Dr. John A. Jarcho is a deputy editor of the New England Journal of Medicine and a cardiologist at Brigham and Women’s Hospital, both in Boston. He had no disclosures. He made these comments as a discussant of Dr. Henry’s report and in an interview.

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The results reported by Dr. Henry come from one of the first trials of stem cell or bone marrow treatment of failing hearts that used clinical outcomes as the primary endpoint. In contrast, prior studies focused on changes in functional characteristics of patients, such as 6-minute walk distance or left ventricular ejection fraction or size. What makes Dr. Henry’s study distinctive is that it showed benefit for a clinical outcome: the rate of death or cardiovascular hospitalization.

Another distinct difference, compared with the vast majority of earlier trials, was the way the bone marrow was handled prior to placement in a heart. The bone marrow cells underwent a 12-day period of ex vivo treatment designed to expand the content of certain mesenchymal stem cells and macrophages.

The current study was also larger than most prior reported studies, with 114 randomized patients available for the safety analysis and 109 for the efficacy analysis. But by no means was this a large study; in fact, it is relatively small. Although it produced a statistically significant result for the primary endpoint, the efficacy needs expanded testing in larger numbers.

It’s currently unclear how the expanded bone marrow cell injections improve clinical status and lead to reduced deaths and hospitalization. The results show essentially no impact from the treatment on ejection fraction or 6-minute walk distance, raising the question of what alternative mechanisms link this treatment to improved clinical outcomes.

Until now, it has not been possible to move beyond early-stage trial designs for cell therapy of failing hearts. Now, for the first time, we have study results that suggest a phase III trial is indicated.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Dr. John A. Jarcho is a deputy editor of the New England Journal of Medicine and a cardiologist at Brigham and Women’s Hospital, both in Boston. He had no disclosures. He made these comments as a discussant of Dr. Henry’s report and in an interview.

Body

The results reported by Dr. Henry come from one of the first trials of stem cell or bone marrow treatment of failing hearts that used clinical outcomes as the primary endpoint. In contrast, prior studies focused on changes in functional characteristics of patients, such as 6-minute walk distance or left ventricular ejection fraction or size. What makes Dr. Henry’s study distinctive is that it showed benefit for a clinical outcome: the rate of death or cardiovascular hospitalization.

Another distinct difference, compared with the vast majority of earlier trials, was the way the bone marrow was handled prior to placement in a heart. The bone marrow cells underwent a 12-day period of ex vivo treatment designed to expand the content of certain mesenchymal stem cells and macrophages.

The current study was also larger than most prior reported studies, with 114 randomized patients available for the safety analysis and 109 for the efficacy analysis. But by no means was this a large study; in fact, it is relatively small. Although it produced a statistically significant result for the primary endpoint, the efficacy needs expanded testing in larger numbers.

It’s currently unclear how the expanded bone marrow cell injections improve clinical status and lead to reduced deaths and hospitalization. The results show essentially no impact from the treatment on ejection fraction or 6-minute walk distance, raising the question of what alternative mechanisms link this treatment to improved clinical outcomes.

Until now, it has not been possible to move beyond early-stage trial designs for cell therapy of failing hearts. Now, for the first time, we have study results that suggest a phase III trial is indicated.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

Dr. John A. Jarcho is a deputy editor of the New England Journal of Medicine and a cardiologist at Brigham and Women’s Hospital, both in Boston. He had no disclosures. He made these comments as a discussant of Dr. Henry’s report and in an interview.

Title
Results merit phase III trial follow-up
Results merit phase III trial follow-up

CHICAGO – After rattling around in early-stage clinical studies for more than a decade, stem cell therapy for heart failure may have finally gained the efficacy evidence to send it to the next level: large-scale, phase III trials.

Patients with ischemic cardiomyopathy and severe heart failure showed a statistically significant 37% relative reduction in their combined rate of death and cardiovascular hospitalization during 1 year of follow-up after autologous stem cell injections to their left ventricular myocardium in a multicenter, fully blinded control, phase II trial with 109 North American patients.

Mitchel L. Zoler/Frontline Medical News
Dr. Timothy D. Henry

The treatment used a technique in commercial development by Vericel that selectively expands ex vivo bone marrow cells taken from the heart failure patient. Clinicians inject 0.4 mL aliquots of the expanded cells – enriched for mesenchymal stem cells and M2 macrophages – via a transcatheter approach into the left ventricular myocardium using 12-17 injections per patient. The bone marrow preparation during ex vivo expansion is called ixmyelocel-T.

This treatment now needs testing in more patients, Dr. Timothy D. Henry said at the annual meeting of the American College of Cardiology. “We need a new generation of cell trials in larger studies with completely double-blind, placebo controls using a more uniform preparation of cells,” said Dr. Henry.

“To the best of our knowledge, ixCELL-DCM is the largest randomized, double-blind clinical trial to date for cell therapy use in congestive heart failure,” said Dr. Henry and his associates in their report. The concept of stem cell therapy to replace damaged myocardium “has been very attractive, but most clinical trials to date have been small and unblinded, and used unselected bone marrow cells,” explained Dr. Henry, director of cardiology at the Cedars-Sinai Heart Institute in Los Angeles.

The ixCELL-DCM study ran at 31 sites in the United States and Canada. About 90% of patients had New York Heart Association class III disease, the average left ventricular ejection fraction was about 25%, patients on average would cover about 310 m during a 6-minute walk test, and the average serum level of NT-ProBNP was about 1,900 pg/L. Patients in the control arm all underwent the same bone marrow retrieval and transcatheter injection into the left ventricle, but the injections only contained carrier material without active cells.

The primary endpoint of death or a cardiovascular event, primarily hospitalization, occurred at a rate of 110 events per 100 patient years during 1-year follow-up of 51 patients in the sham-treatment group. In the active-treatment arm, the endpoint occurred at a rate of 70 events per 100 patient years among 58 patients. The difference was primarily driven by a 3% death rate with cell therapy, compared with a 14% rate in the controls, and a 38% hospitalization rate, compared with a 47% rate among controls.

The study results appeared online concurrent with Dr. Henry’s report (Lancet. 2016 Apr 5. doi: 10.1016/S0140-6736[16]30137-4).

The results showed no significant differences between the active and sham groups for changes in left ventricular size, ejection fraction, and 6-minute walk distance.

“This trial was designed to look at events. It is not a cause for concern that we did not see effects on heart function,” Dr. Henry said. The current results were also generally consistent with results from two earlier, controlled, phase II studies with a total of 61 patients (Circ Res. 2014 Sep 26;115[8]:730-7).

In the safety analysis, done in 114 patients, the rates of all adverse events and major adverse cardiovascular events were similar in the two arms. The rate of serious adverse events was significantly reduced in the patients treated with expanded bone marrow cells, compared with the controls.

The high rate of death and hospitalization of patients with severe heart failure “is a very large, unmet need, so it’s a natural to go to a larger trial,” Dr. Henry said. “The cell preparation was very safe and easy to do.”

Another pressing research issue is to try to understand the mechanism by which the cell treatment improves clinical outcomes, with improved heart function or improved exercise capacity apparently excluded as mechanisms.

The trial was sponsored by Vericel, the company developing the ex vivo protocol for selective marrow cell expansion. Dr. Henry has been a consultant to or received honoraria from Abbott Vascular, Baxter, Capricor, Cytori, Eli Lilly, and the Medicines Company, and he has received research grants from Aastrom, Baxter International, Mesoblast, and Vericel.

[email protected]

On Twitter @mitchelzoler

CHICAGO – After rattling around in early-stage clinical studies for more than a decade, stem cell therapy for heart failure may have finally gained the efficacy evidence to send it to the next level: large-scale, phase III trials.

Patients with ischemic cardiomyopathy and severe heart failure showed a statistically significant 37% relative reduction in their combined rate of death and cardiovascular hospitalization during 1 year of follow-up after autologous stem cell injections to their left ventricular myocardium in a multicenter, fully blinded control, phase II trial with 109 North American patients.

Mitchel L. Zoler/Frontline Medical News
Dr. Timothy D. Henry

The treatment used a technique in commercial development by Vericel that selectively expands ex vivo bone marrow cells taken from the heart failure patient. Clinicians inject 0.4 mL aliquots of the expanded cells – enriched for mesenchymal stem cells and M2 macrophages – via a transcatheter approach into the left ventricular myocardium using 12-17 injections per patient. The bone marrow preparation during ex vivo expansion is called ixmyelocel-T.

This treatment now needs testing in more patients, Dr. Timothy D. Henry said at the annual meeting of the American College of Cardiology. “We need a new generation of cell trials in larger studies with completely double-blind, placebo controls using a more uniform preparation of cells,” said Dr. Henry.

“To the best of our knowledge, ixCELL-DCM is the largest randomized, double-blind clinical trial to date for cell therapy use in congestive heart failure,” said Dr. Henry and his associates in their report. The concept of stem cell therapy to replace damaged myocardium “has been very attractive, but most clinical trials to date have been small and unblinded, and used unselected bone marrow cells,” explained Dr. Henry, director of cardiology at the Cedars-Sinai Heart Institute in Los Angeles.

The ixCELL-DCM study ran at 31 sites in the United States and Canada. About 90% of patients had New York Heart Association class III disease, the average left ventricular ejection fraction was about 25%, patients on average would cover about 310 m during a 6-minute walk test, and the average serum level of NT-ProBNP was about 1,900 pg/L. Patients in the control arm all underwent the same bone marrow retrieval and transcatheter injection into the left ventricle, but the injections only contained carrier material without active cells.

The primary endpoint of death or a cardiovascular event, primarily hospitalization, occurred at a rate of 110 events per 100 patient years during 1-year follow-up of 51 patients in the sham-treatment group. In the active-treatment arm, the endpoint occurred at a rate of 70 events per 100 patient years among 58 patients. The difference was primarily driven by a 3% death rate with cell therapy, compared with a 14% rate in the controls, and a 38% hospitalization rate, compared with a 47% rate among controls.

The study results appeared online concurrent with Dr. Henry’s report (Lancet. 2016 Apr 5. doi: 10.1016/S0140-6736[16]30137-4).

The results showed no significant differences between the active and sham groups for changes in left ventricular size, ejection fraction, and 6-minute walk distance.

“This trial was designed to look at events. It is not a cause for concern that we did not see effects on heart function,” Dr. Henry said. The current results were also generally consistent with results from two earlier, controlled, phase II studies with a total of 61 patients (Circ Res. 2014 Sep 26;115[8]:730-7).

In the safety analysis, done in 114 patients, the rates of all adverse events and major adverse cardiovascular events were similar in the two arms. The rate of serious adverse events was significantly reduced in the patients treated with expanded bone marrow cells, compared with the controls.

The high rate of death and hospitalization of patients with severe heart failure “is a very large, unmet need, so it’s a natural to go to a larger trial,” Dr. Henry said. “The cell preparation was very safe and easy to do.”

Another pressing research issue is to try to understand the mechanism by which the cell treatment improves clinical outcomes, with improved heart function or improved exercise capacity apparently excluded as mechanisms.

The trial was sponsored by Vericel, the company developing the ex vivo protocol for selective marrow cell expansion. Dr. Henry has been a consultant to or received honoraria from Abbott Vascular, Baxter, Capricor, Cytori, Eli Lilly, and the Medicines Company, and he has received research grants from Aastrom, Baxter International, Mesoblast, and Vericel.

[email protected]

On Twitter @mitchelzoler

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Key clinical point: Severe, ischemic heart failure patients had a significant cut in death and cardiovascular hospitalizations 1 year after endovascular myocardial injection with selectively expanded autologous bone marrow cells in a fully blinded, placebo-controlled phase II study.

Major finding: Cell-treated patients had a 37% drop in death and cardiovascular hospitalization relative to controls in 1-year follow-up.

Data source: A multicenter, fully blinded study with 109 patients for the per protocol efficacy analysis, and 114 patients for the safety analysis.

Disclosures: The trial was sponsored by Vericel, the company developing the ex vivo protocol for selective marrow cell expansion. Dr. Henry has been a consultant to or received honoraria from Abbott Vascular, Baxter, Capricor, Cytori, Eli Lilly, and the Medicines Company, and he has received research grants from Aastrom, Baxter International, Mesoblast, and Vericel.

Addiction – how are we being played?

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Addiction – how are we being played?

Sometimes, you come across an article that makes you cringe. After this initial reaction – and if we are up for the challenge – we realize that this information can help us grow by pushing our clinical approach in new directions.

This is the experience I had with an article by Dr. Daniel Bouland and colleagues that explored the ways in which people struggling with addiction obtain prescription medications (J Addict Med. 2015 Jul-Aug;9[4]:281-5).

Dr. Jon O. Ebbert

In this semiquantitative qualitative study, investigators interviewed 36 patients in a residential addiction treatment program who obtained prescriptions from clinicians in support of an addiction. Types of medications obtained by respondents were opioids (97.2%), sedative hypnotics (47.4%), and amphetamines (5.5%).

Patients reported obtaining prescriptions from clinicians because it was perceived to be “legal” – even though 75% of them faked symptoms, several falsified MRI images of an injury, and some used old or forged prescriptions. One patient paid a physician outright for the medication.

Eight percent of patients physically harmed themselves to obtain prescriptions by doing things such as cutting themselves to put blood in the urine, hitting their head against the wall to the point of unconsciousness, and undergoing unnecessary surgery.

Primary care clinicians and pain specialists were viewed as the easiest sources of medication. Most patients used “mom and pop” pharmacies, visited multiple pharmacies, and paid in cash. Importantly, 67% of patients said that an intervention could have changed their behaviors.

I think I knew this, but it challenged me to see it in writing. I appreciated the honesty of these individuals and was struck by the fact that almost two-thirds suggested that an intervention could have transformed them.

But how to start this conversation?

The last time I expressed concern about a patient’s allergy to any pain medication – except oxycodone and the potentially toxic doses of ibuprofen and acetaminophen that didn’t “touch it” – I was the recipient of seething rage and hostility.

Addiction treatment is hard, diagnosing addiction in daily primary care practice is harder, and holding up a mirror to a patient’s prescription drug habits requires protective body armor. That’s why not many of us do it.

So, now that we have guidelines for chronic opioids, we need best practices for acute visits presenting with x-rays of broken animal bones labeled with their name handwritten on duct tape.

Are we up for urine drug screens for every controlled substance prescription on nonestablished patients every time? Probably not, but we have to start somewhere.

At least it might start a conversation when we can say: “We do this for all of our patients, we are not singling you out. Is there anything you would like to talk about before we complete this test?”

Most importantly, once we make a diagnosis of prescription drug abuse, we need resources to which to refer them and health insurance to help cover the cost for this care.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

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Sometimes, you come across an article that makes you cringe. After this initial reaction – and if we are up for the challenge – we realize that this information can help us grow by pushing our clinical approach in new directions.

This is the experience I had with an article by Dr. Daniel Bouland and colleagues that explored the ways in which people struggling with addiction obtain prescription medications (J Addict Med. 2015 Jul-Aug;9[4]:281-5).

Dr. Jon O. Ebbert

In this semiquantitative qualitative study, investigators interviewed 36 patients in a residential addiction treatment program who obtained prescriptions from clinicians in support of an addiction. Types of medications obtained by respondents were opioids (97.2%), sedative hypnotics (47.4%), and amphetamines (5.5%).

Patients reported obtaining prescriptions from clinicians because it was perceived to be “legal” – even though 75% of them faked symptoms, several falsified MRI images of an injury, and some used old or forged prescriptions. One patient paid a physician outright for the medication.

Eight percent of patients physically harmed themselves to obtain prescriptions by doing things such as cutting themselves to put blood in the urine, hitting their head against the wall to the point of unconsciousness, and undergoing unnecessary surgery.

Primary care clinicians and pain specialists were viewed as the easiest sources of medication. Most patients used “mom and pop” pharmacies, visited multiple pharmacies, and paid in cash. Importantly, 67% of patients said that an intervention could have changed their behaviors.

I think I knew this, but it challenged me to see it in writing. I appreciated the honesty of these individuals and was struck by the fact that almost two-thirds suggested that an intervention could have transformed them.

But how to start this conversation?

The last time I expressed concern about a patient’s allergy to any pain medication – except oxycodone and the potentially toxic doses of ibuprofen and acetaminophen that didn’t “touch it” – I was the recipient of seething rage and hostility.

Addiction treatment is hard, diagnosing addiction in daily primary care practice is harder, and holding up a mirror to a patient’s prescription drug habits requires protective body armor. That’s why not many of us do it.

So, now that we have guidelines for chronic opioids, we need best practices for acute visits presenting with x-rays of broken animal bones labeled with their name handwritten on duct tape.

Are we up for urine drug screens for every controlled substance prescription on nonestablished patients every time? Probably not, but we have to start somewhere.

At least it might start a conversation when we can say: “We do this for all of our patients, we are not singling you out. Is there anything you would like to talk about before we complete this test?”

Most importantly, once we make a diagnosis of prescription drug abuse, we need resources to which to refer them and health insurance to help cover the cost for this care.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

Sometimes, you come across an article that makes you cringe. After this initial reaction – and if we are up for the challenge – we realize that this information can help us grow by pushing our clinical approach in new directions.

This is the experience I had with an article by Dr. Daniel Bouland and colleagues that explored the ways in which people struggling with addiction obtain prescription medications (J Addict Med. 2015 Jul-Aug;9[4]:281-5).

Dr. Jon O. Ebbert

In this semiquantitative qualitative study, investigators interviewed 36 patients in a residential addiction treatment program who obtained prescriptions from clinicians in support of an addiction. Types of medications obtained by respondents were opioids (97.2%), sedative hypnotics (47.4%), and amphetamines (5.5%).

Patients reported obtaining prescriptions from clinicians because it was perceived to be “legal” – even though 75% of them faked symptoms, several falsified MRI images of an injury, and some used old or forged prescriptions. One patient paid a physician outright for the medication.

Eight percent of patients physically harmed themselves to obtain prescriptions by doing things such as cutting themselves to put blood in the urine, hitting their head against the wall to the point of unconsciousness, and undergoing unnecessary surgery.

Primary care clinicians and pain specialists were viewed as the easiest sources of medication. Most patients used “mom and pop” pharmacies, visited multiple pharmacies, and paid in cash. Importantly, 67% of patients said that an intervention could have changed their behaviors.

I think I knew this, but it challenged me to see it in writing. I appreciated the honesty of these individuals and was struck by the fact that almost two-thirds suggested that an intervention could have transformed them.

But how to start this conversation?

The last time I expressed concern about a patient’s allergy to any pain medication – except oxycodone and the potentially toxic doses of ibuprofen and acetaminophen that didn’t “touch it” – I was the recipient of seething rage and hostility.

Addiction treatment is hard, diagnosing addiction in daily primary care practice is harder, and holding up a mirror to a patient’s prescription drug habits requires protective body armor. That’s why not many of us do it.

So, now that we have guidelines for chronic opioids, we need best practices for acute visits presenting with x-rays of broken animal bones labeled with their name handwritten on duct tape.

Are we up for urine drug screens for every controlled substance prescription on nonestablished patients every time? Probably not, but we have to start somewhere.

At least it might start a conversation when we can say: “We do this for all of our patients, we are not singling you out. Is there anything you would like to talk about before we complete this test?”

Most importantly, once we make a diagnosis of prescription drug abuse, we need resources to which to refer them and health insurance to help cover the cost for this care.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition nor should they be used as a substitute for medical advice from a qualified, board-certified practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article.

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U.S. flu activity continues to drop, but still widespread

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A third straight week of reduced influenza-like illness (ILI) left the U.S. with no states at the highest level of ILI activity for the first time since early February, according to the Centers for Disease Control and Prevention.

The states with the highest activity for the week ending April 2, 2016, were New Jersey and New Mexico, and both were at level 8 on the CDC’s 1-10 scale, putting them on the low end of the “high” range. States in the “moderate” range were Georgia and North Carolina at level 7 and Alabama, Alaska, Arkansas, Missouri, and Virginia at level 6, according to a report from the CDC’s Influenza-like Illness Surveillance Network (ILINet).

The proportion of outpatient visits for ILI was 2.4% for the week, down from 2.9% the week before but still above the national baseline of 2.1%, the CDC said. The CDC also reported a cumulative rate of 24.4 laboratory-confirmed influenza-associated hospitalizations per 100,000 population for the 2015-16 flu season.

There were seven flu-related pediatric deaths reported – all of them occurring during earlier weeks. So far, 40 flu-related pediatric deaths have been reported during the 2015-2016 season, with California having the highest number (9). The CDC said 7.4% of all deaths reported through the 122 Cities Mortality Reporting System were due to pneumonia and influenza. This percentage was above the epidemic threshold of 7.1% for week 13 of the flu season.

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A third straight week of reduced influenza-like illness (ILI) left the U.S. with no states at the highest level of ILI activity for the first time since early February, according to the Centers for Disease Control and Prevention.

The states with the highest activity for the week ending April 2, 2016, were New Jersey and New Mexico, and both were at level 8 on the CDC’s 1-10 scale, putting them on the low end of the “high” range. States in the “moderate” range were Georgia and North Carolina at level 7 and Alabama, Alaska, Arkansas, Missouri, and Virginia at level 6, according to a report from the CDC’s Influenza-like Illness Surveillance Network (ILINet).

The proportion of outpatient visits for ILI was 2.4% for the week, down from 2.9% the week before but still above the national baseline of 2.1%, the CDC said. The CDC also reported a cumulative rate of 24.4 laboratory-confirmed influenza-associated hospitalizations per 100,000 population for the 2015-16 flu season.

There were seven flu-related pediatric deaths reported – all of them occurring during earlier weeks. So far, 40 flu-related pediatric deaths have been reported during the 2015-2016 season, with California having the highest number (9). The CDC said 7.4% of all deaths reported through the 122 Cities Mortality Reporting System were due to pneumonia and influenza. This percentage was above the epidemic threshold of 7.1% for week 13 of the flu season.

[email protected]

A third straight week of reduced influenza-like illness (ILI) left the U.S. with no states at the highest level of ILI activity for the first time since early February, according to the Centers for Disease Control and Prevention.

The states with the highest activity for the week ending April 2, 2016, were New Jersey and New Mexico, and both were at level 8 on the CDC’s 1-10 scale, putting them on the low end of the “high” range. States in the “moderate” range were Georgia and North Carolina at level 7 and Alabama, Alaska, Arkansas, Missouri, and Virginia at level 6, according to a report from the CDC’s Influenza-like Illness Surveillance Network (ILINet).

The proportion of outpatient visits for ILI was 2.4% for the week, down from 2.9% the week before but still above the national baseline of 2.1%, the CDC said. The CDC also reported a cumulative rate of 24.4 laboratory-confirmed influenza-associated hospitalizations per 100,000 population for the 2015-16 flu season.

There were seven flu-related pediatric deaths reported – all of them occurring during earlier weeks. So far, 40 flu-related pediatric deaths have been reported during the 2015-2016 season, with California having the highest number (9). The CDC said 7.4% of all deaths reported through the 122 Cities Mortality Reporting System were due to pneumonia and influenza. This percentage was above the epidemic threshold of 7.1% for week 13 of the flu season.

[email protected]

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