An antibody that targets clumps of soluble amyloid-beta before they aggregate into plaques has passed its phase 2 challenge, posting statistically significant results on a combined measure of cognition and function while decreasing amyloid deposition in the brain.

Full data won’t be released until a late-breaker session on July 25 at the Alzheimer’s Association International Conference in Chicago, so it’s still impossible to fully dissect the 18-month, dose exploration study. But according to codevelopers Eisai and Biogen, the significant clinical improvements accrued to the highest dose tested (10 mg/kg intravenously, twice a month) and were evident as early as 6 months. Amyloid cleared in a dose-dependent manner as well.

Although there is no available information on P values or effect sizes, the trial design designated success as at least a 25% reduction in the rate of decline over 1 year, relative to placebo.

In an interview, Lynn Kramer, MD, of Eisai declined to give further details. “I will say, however, that we believe these changes are clinically meaningful,” said Dr. Kramer, chief medical officer of the company’s neurology division.

These results make BAN2401 the first antiamyloid antibody to score significant results in both cognition and amyloid brain imaging a clinical trial, and warrant tempered optimism, according to Keith Fargo, PhD, director of scientific programs for the Alzheimer’s Association.

“We can’t know whether this is a breakthrough until we get past phase 3,” Dr. Fargo said in an interview. “In drug development, you’re never done until you’re done.”

Richard J. Caselli, MD, agreed with the tempered enthusiasm.

“This is very encouraging, but we await the full data and ultimately the phase 3 trial,” said Dr. Caselli, professor of neurology the Mayo Clinic Arizona in Scottsdale and is also associate director and clinical core director of the Arizona Alzheimer’s Disease Center. “I would also say that 25% slowing in disease progression is nice and unprecedented but clinically not exactly earth shattering. If it holds up in phase 3, the cost-benefit will need to be carefully weighed.”

Nevertheless, the publicly available data seem to lay a firm foundation for future studies, he said. “It’s unusual to see this kind of clarity in both clinical and biomarker results in a phase 2. There’s a history of large drug companies taking things from phase 2 to phase 3 on data that have been less clear than this, teasing out results from subgroups or using biomarker but not clinical data to make a decision on moving forward.”

The BAN2401 research team staked this commitment in the 2016 paper describing the study methodology. “They wanted to have clear evidence on both biomarker and clinical efficacy to allow them to make a decision [to move into phase 3],” Dr. Fargo said. “I don’t know if they are or not, but I’d be surprised if they don’t, and I think they would be on solid footing.”

BAN2401 selectively binds to amyloid-beta protofibrils – large AB oligomers that are still soluble – and targets them for clearance. It was originally developed by Swedish biopharma company BioArctic; Eisai acquired the molecule in 2007 and entered the Biogen deal in 2014.

The study randomized 856 patients with mild cognitive impairment or early Alzheimer’s dementia to six treatment arms: BAN2401 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly, and 10 mg/kg biweekly, or placebo. All patients had PET-confirmed amyloid brain pathology, a key baseline requirement; only one other antiamyloid agent (Biogen’s antiamyloid antibody aducanumab) has completed a phase 2 study in a purely amyloid-positive cohort. Before PET imaging, patients with non-Alzheimer’s pathology comprised up to 30% of Alzheimer’s drug studies, which researchers say confounded results and likely contributed to the long string of antiamyloid failures.

The coprimary endpoints were reduction of brain amyloid on PET scan and slowing of progression as measured by the Alzheimer’s Disease Composite Score (ADCOMS), a new tool developed and promoted by Eisai. ADCOMS combines measures from the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog), Clinical Dementia Rating Sum of Boxes (CDR-sb), and the Mini-Mental State Examination (MMSE). In devising ADCOMS, researchers chose individual components of each tool that are most likely to change in very-early-stage disease. The scale was validated retrospectively in 1,160 patients who were included in four datasets. This is the first time it’s been used in an Alzheimer’s study.

The BAN2401 trial employed a Bayesian adaptive randomization, a computer-driven algorithm designed to drive patients to the two most effective doses. Often seen in trials of faster-progressing diseases, like cancer, it is unusual in Alzheimer’s studies, Dr. Fargo said.

“I would say it’s unorthodox, but it doesn’t give me heartburn. It’s an adaptive trial design that’s been considered hard to do in the AD field, because the changes between placebo and treatment groups tend to be very slow. In studies that have a very clear biomarker endpoint, like tumor size for example, that everyone can agree on, you can quickly see which treatment arm is most effective. In general, we haven’t been able to do this in AD because the signal changes so slowly.”

The BAN2401 algorithm assessed outcomes monthly, and reallocated incoming subjects according to the most recent efficacy data. But the 12-month primary endpoint assessment, a widely publicized failure, was “unfortunate,” Dr. Fargo said.

“This study had a built-in 12-month endpoint, at which time the sponsor could declare either futility or early success, and stop it for either one.” If neither was achieved, the study was to continue for 18 months and reassess outcomes. This was the situation Eisai and Biogen encountered in December when they announced that BAN2401 had failed to achieve its clinical and imaging endpoints but that the study would continue as planned. That news generated a large amount of negative press for the companies – which saw stock prices plunge – and contributed to media and consumer confusion about the trial design’s validity, Dr. Fargo said.

The 18-month data released on July 5 also included some information on adverse events. Amyloid-related imaging abnormalities, both edematous and hemorrhagic (ARIA-E and ARIA-H) occurred in an undisclosed number of patients. Dr. Kramer said ARIA occurred in “not more than 10% in any of the treatment arms” and in less than 15% of patients who carried an apolipoprotein E e4 allele. Only a portion of these patients were included in the final analysis, and this may have influenced the results somewhat negatively, Dr. Kramer said. In the first years of the study, before ARIA was understood to be largely subclinical and self-resolving, any patient who developed it was dropped.

“We initially dropped every patient who had ARIA, and this is one of the issues that actually make the observed effect [of BAN2401] probably a little bit conservative. Patients with ARIA are typically responding to amyloid removal, and they could be expected to do better.”

msullivan@mdedge.com

An antibody that targets clumps of soluble amyloid-beta before they aggregate into plaques has passed its phase 2 challenge, posting statistically significant results on a combined measure of cognition and function while decreasing amyloid deposition in the brain.

Full data won’t be released until a late-breaker session on July 25 at the Alzheimer’s Association International Conference in Chicago, so it’s still impossible to fully dissect the 18-month, dose exploration study. But according to codevelopers Eisai and Biogen, the significant clinical improvements accrued to the highest dose tested (10 mg/kg intravenously, twice a month) and were evident as early as 6 months. Amyloid cleared in a dose-dependent manner as well.

Although there is no available information on P values or effect sizes, the trial design designated success as at least a 25% reduction in the rate of decline over 1 year, relative to placebo.

In an interview, Lynn Kramer, MD, of Eisai declined to give further details. “I will say, however, that we believe these changes are clinically meaningful,” said Dr. Kramer, chief medical officer of the company’s neurology division.

These results make BAN2401 the first antiamyloid antibody to score significant results in both cognition and amyloid brain imaging a clinical trial, and warrant tempered optimism, according to Keith Fargo, PhD, director of scientific programs for the Alzheimer’s Association.

“We can’t know whether this is a breakthrough until we get past phase 3,” Dr. Fargo said in an interview. “In drug development, you’re never done until you’re done.”

Richard J. Caselli, MD, agreed with the tempered enthusiasm.

“This is very encouraging, but we await the full data and ultimately the phase 3 trial,” said Dr. Caselli, professor of neurology the Mayo Clinic Arizona in Scottsdale and is also associate director and clinical core director of the Arizona Alzheimer’s Disease Center. “I would also say that 25% slowing in disease progression is nice and unprecedented but clinically not exactly earth shattering. If it holds up in phase 3, the cost-benefit will need to be carefully weighed.”

Nevertheless, the publicly available data seem to lay a firm foundation for future studies, he said. “It’s unusual to see this kind of clarity in both clinical and biomarker results in a phase 2. There’s a history of large drug companies taking things from phase 2 to phase 3 on data that have been less clear than this, teasing out results from subgroups or using biomarker but not clinical data to make a decision on moving forward.”

The BAN2401 research team staked this commitment in the 2016 paper describing the study methodology. “They wanted to have clear evidence on both biomarker and clinical efficacy to allow them to make a decision [to move into phase 3],” Dr. Fargo said. “I don’t know if they are or not, but I’d be surprised if they don’t, and I think they would be on solid footing.”

BAN2401 selectively binds to amyloid-beta protofibrils – large AB oligomers that are still soluble – and targets them for clearance. It was originally developed by Swedish biopharma company BioArctic; Eisai acquired the molecule in 2007 and entered the Biogen deal in 2014.

The study randomized 856 patients with mild cognitive impairment or early Alzheimer’s dementia to six treatment arms: BAN2401 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly, and 10 mg/kg biweekly, or placebo. All patients had PET-confirmed amyloid brain pathology, a key baseline requirement; only one other antiamyloid agent (Biogen’s antiamyloid antibody aducanumab) has completed a phase 2 study in a purely amyloid-positive cohort. Before PET imaging, patients with non-Alzheimer’s pathology comprised up to 30% of Alzheimer’s drug studies, which researchers say confounded results and likely contributed to the long string of antiamyloid failures.

The coprimary endpoints were reduction of brain amyloid on PET scan and slowing of progression as measured by the Alzheimer’s Disease Composite Score (ADCOMS), a new tool developed and promoted by Eisai. ADCOMS combines measures from the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog), Clinical Dementia Rating Sum of Boxes (CDR-sb), and the Mini-Mental State Examination (MMSE). In devising ADCOMS, researchers chose individual components of each tool that are most likely to change in very-early-stage disease. The scale was validated retrospectively in 1,160 patients who were included in four datasets. This is the first time it’s been used in an Alzheimer’s study.

The BAN2401 trial employed a Bayesian adaptive randomization, a computer-driven algorithm designed to drive patients to the two most effective doses. Often seen in trials of faster-progressing diseases, like cancer, it is unusual in Alzheimer’s studies, Dr. Fargo said.

“I would say it’s unorthodox, but it doesn’t give me heartburn. It’s an adaptive trial design that’s been considered hard to do in the AD field, because the changes between placebo and treatment groups tend to be very slow. In studies that have a very clear biomarker endpoint, like tumor size for example, that everyone can agree on, you can quickly see which treatment arm is most effective. In general, we haven’t been able to do this in AD because the signal changes so slowly.”

The BAN2401 algorithm assessed outcomes monthly, and reallocated incoming subjects according to the most recent efficacy data. But the 12-month primary endpoint assessment, a widely publicized failure, was “unfortunate,” Dr. Fargo said.

“This study had a built-in 12-month endpoint, at which time the sponsor could declare either futility or early success, and stop it for either one.” If neither was achieved, the study was to continue for 18 months and reassess outcomes. This was the situation Eisai and Biogen encountered in December when they announced that BAN2401 had failed to achieve its clinical and imaging endpoints but that the study would continue as planned. That news generated a large amount of negative press for the companies – which saw stock prices plunge – and contributed to media and consumer confusion about the trial design’s validity, Dr. Fargo said.

The 18-month data released on July 5 also included some information on adverse events. Amyloid-related imaging abnormalities, both edematous and hemorrhagic (ARIA-E and ARIA-H) occurred in an undisclosed number of patients. Dr. Kramer said ARIA occurred in “not more than 10% in any of the treatment arms” and in less than 15% of patients who carried an apolipoprotein E e4 allele. Only a portion of these patients were included in the final analysis, and this may have influenced the results somewhat negatively, Dr. Kramer said. In the first years of the study, before ARIA was understood to be largely subclinical and self-resolving, any patient who developed it was dropped.

“We initially dropped every patient who had ARIA, and this is one of the issues that actually make the observed effect [of BAN2401] probably a little bit conservative. Patients with ARIA are typically responding to amyloid removal, and they could be expected to do better.”

msullivan@mdedge.com

An antibody that targets clumps of soluble amyloid-beta before they aggregate into plaques has passed its phase 2 challenge, posting statistically significant results on a combined measure of cognition and function while decreasing amyloid deposition in the brain.

Full data won’t be released until a late-breaker session on July 25 at the Alzheimer’s Association International Conference in Chicago, so it’s still impossible to fully dissect the 18-month, dose exploration study. But according to codevelopers Eisai and Biogen, the significant clinical improvements accrued to the highest dose tested (10 mg/kg intravenously, twice a month) and were evident as early as 6 months. Amyloid cleared in a dose-dependent manner as well.

Although there is no available information on P values or effect sizes, the trial design designated success as at least a 25% reduction in the rate of decline over 1 year, relative to placebo.

In an interview, Lynn Kramer, MD, of Eisai declined to give further details. “I will say, however, that we believe these changes are clinically meaningful,” said Dr. Kramer, chief medical officer of the company’s neurology division.

These results make BAN2401 the first antiamyloid antibody to score significant results in both cognition and amyloid brain imaging a clinical trial, and warrant tempered optimism, according to Keith Fargo, PhD, director of scientific programs for the Alzheimer’s Association.

“We can’t know whether this is a breakthrough until we get past phase 3,” Dr. Fargo said in an interview. “In drug development, you’re never done until you’re done.”

Richard J. Caselli, MD, agreed with the tempered enthusiasm.

“This is very encouraging, but we await the full data and ultimately the phase 3 trial,” said Dr. Caselli, professor of neurology the Mayo Clinic Arizona in Scottsdale and is also associate director and clinical core director of the Arizona Alzheimer’s Disease Center. “I would also say that 25% slowing in disease progression is nice and unprecedented but clinically not exactly earth shattering. If it holds up in phase 3, the cost-benefit will need to be carefully weighed.”

Nevertheless, the publicly available data seem to lay a firm foundation for future studies, he said. “It’s unusual to see this kind of clarity in both clinical and biomarker results in a phase 2. There’s a history of large drug companies taking things from phase 2 to phase 3 on data that have been less clear than this, teasing out results from subgroups or using biomarker but not clinical data to make a decision on moving forward.”

The BAN2401 research team staked this commitment in the 2016 paper describing the study methodology. “They wanted to have clear evidence on both biomarker and clinical efficacy to allow them to make a decision [to move into phase 3],” Dr. Fargo said. “I don’t know if they are or not, but I’d be surprised if they don’t, and I think they would be on solid footing.”

BAN2401 selectively binds to amyloid-beta protofibrils – large AB oligomers that are still soluble – and targets them for clearance. It was originally developed by Swedish biopharma company BioArctic; Eisai acquired the molecule in 2007 and entered the Biogen deal in 2014.

The study randomized 856 patients with mild cognitive impairment or early Alzheimer’s dementia to six treatment arms: BAN2401 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly, and 10 mg/kg biweekly, or placebo. All patients had PET-confirmed amyloid brain pathology, a key baseline requirement; only one other antiamyloid agent (Biogen’s antiamyloid antibody aducanumab) has completed a phase 2 study in a purely amyloid-positive cohort. Before PET imaging, patients with non-Alzheimer’s pathology comprised up to 30% of Alzheimer’s drug studies, which researchers say confounded results and likely contributed to the long string of antiamyloid failures.

The coprimary endpoints were reduction of brain amyloid on PET scan and slowing of progression as measured by the Alzheimer’s Disease Composite Score (ADCOMS), a new tool developed and promoted by Eisai. ADCOMS combines measures from the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-Cog), Clinical Dementia Rating Sum of Boxes (CDR-sb), and the Mini-Mental State Examination (MMSE). In devising ADCOMS, researchers chose individual components of each tool that are most likely to change in very-early-stage disease. The scale was validated retrospectively in 1,160 patients who were included in four datasets. This is the first time it’s been used in an Alzheimer’s study.

The BAN2401 trial employed a Bayesian adaptive randomization, a computer-driven algorithm designed to drive patients to the two most effective doses. Often seen in trials of faster-progressing diseases, like cancer, it is unusual in Alzheimer’s studies, Dr. Fargo said.

“I would say it’s unorthodox, but it doesn’t give me heartburn. It’s an adaptive trial design that’s been considered hard to do in the AD field, because the changes between placebo and treatment groups tend to be very slow. In studies that have a very clear biomarker endpoint, like tumor size for example, that everyone can agree on, you can quickly see which treatment arm is most effective. In general, we haven’t been able to do this in AD because the signal changes so slowly.”

The BAN2401 algorithm assessed outcomes monthly, and reallocated incoming subjects according to the most recent efficacy data. But the 12-month primary endpoint assessment, a widely publicized failure, was “unfortunate,” Dr. Fargo said.

“This study had a built-in 12-month endpoint, at which time the sponsor could declare either futility or early success, and stop it for either one.” If neither was achieved, the study was to continue for 18 months and reassess outcomes. This was the situation Eisai and Biogen encountered in December when they announced that BAN2401 had failed to achieve its clinical and imaging endpoints but that the study would continue as planned. That news generated a large amount of negative press for the companies – which saw stock prices plunge – and contributed to media and consumer confusion about the trial design’s validity, Dr. Fargo said.

The 18-month data released on July 5 also included some information on adverse events. Amyloid-related imaging abnormalities, both edematous and hemorrhagic (ARIA-E and ARIA-H) occurred in an undisclosed number of patients. Dr. Kramer said ARIA occurred in “not more than 10% in any of the treatment arms” and in less than 15% of patients who carried an apolipoprotein E e4 allele. Only a portion of these patients were included in the final analysis, and this may have influenced the results somewhat negatively, Dr. Kramer said. In the first years of the study, before ARIA was understood to be largely subclinical and self-resolving, any patient who developed it was dropped.

“We initially dropped every patient who had ARIA, and this is one of the issues that actually make the observed effect [of BAN2401] probably a little bit conservative. Patients with ARIA are typically responding to amyloid removal, and they could be expected to do better.”

msullivan@mdedge.com

On Friday, June 29, at 5:42 a.m., I stood with my family on a Florida shore overlooking Kennedy Space Center. We had gathered with about a hundred other people to watch a rocket launch and were overwhelmed with excitement as the coastline erupted in fire, and the spacecraft lifted off toward the heavens. Standing there watching the spectacle, I couldn’t help but be caught up in the irony of the moment. Here we were, at the place where NASA sent the first Americans into space – on the very shores where the Apollo astronauts set off for the moon to plant our nation’s flag in the lunar dust in July of 1969. Yet now, almost 50 years later, this launch was profoundly different. The rocket wasn’t built by NASA, and the intention of its builders wasn’t exploration. This was a Falcon 9, built by SpaceX, a for-profit company founded by an enterprising billionaire. Most surprisingly, this relatively routine launch was intended to accomplish something that NASA – the United States’ own space agency – currently can’t do on its own: Launch rockets.

Since retiring the Space Shuttle in 2011, the United States has had to rely on others – including even Roscosmos (the Russian space agency) – to ferry passengers, satellites, and cargo into space. Seeing this opportunity in a multibillion-dollar industry, private enterprise has risen to the challenge, innovating more quickly and at a lower cost than “the establishment” has ever been capable of. As a result, space travel has been disrupted by corporations competing in a new “space race.” Instead of national pride or scientific dominance, this race has been fueled by profit and is quite similar to one being run in another industry: health care.

Just 1 day prior to watching the launch – on June 28 – we learned that Amazon had purchased PillPack, a prescription drug home delivery service. The stock market responded to the news, and the establishment (in this case CVS, Walgreen’s, and WalMart, among others) collectively lost $17.5 billion in one day. This isn’t the first time Amazon has disrupted the health care world; in January of this year, they, along with Berkshire Hathaway and JPMorgan Chase, announced a health care partnership to cut costs and improve care delivery for their employees. This move also sent shivers through the market, as health insurers and providers such as Aetna and United Health lost big on expectations that Amazon et al. wouldn’t stop with their own employees. Those of us watching this play out from the sidelines realized we were witnessing a revolution that would mean the end of health care delivery as we know it – and that’s not necessarily a bad thing, especially in the world of Electronic Health Records.

As you’ve probably noticed, it is quite rare to find physicians nowadays who love computers. Once an exciting novelty in health care, PCs have become a burdensome necessity and providers often feel enslaved to the EHRs that run on them. There are numerous reasons for this, but one primary cause is that the hundreds of disparate EHRs currently available sprouted out of health care – a centuries-old and very provincial industry – prior to the development of technical and regulatory standards to govern them. As they’ve grown larger and larger from their primitive underpinnings, these EHRs have become more cumbersome to navigate, and vendors have simply “bolted-on” additional features without significant changes to their near-obsolete software architecture.

It’s worth noting that a few EHR companies purport to be true innovators in platform usability, such as industry giant, Epic. According to CEO Judy Faulkner, Epic pours 50% of their revenue back into research and development (though, as Epic is a privately held company, this number can’t be verified). If accurate, Epic is truly an exception, as most electronic record companies spend about 10%-30% on improving their products – far less than they spend on recruiting new customers. Regardless, the outcome is this: Physician expectations for user interface and user experience have far outpaced the current state of the art of EHRs, and this has left a gap that new players outside the health care establishment are apt to fill.

Like Amazon, other software giants have made significant investments in health care over the past several years. According to their website, Apple has been working with hospitals, scientists, and developers to “help health care providers streamline their work, deliver better care, and conduct medical research.” Similarly, Google claims to be “making a number of big bets in health care and life sciences,” by leveraging their artificial intelligence technology to assist in clinical diagnosis and scientific discovery. In spite of a few false starts in the past, these companies are poised to do more than simply disrupt health care. As experts in user interface and design, they could truly change the way physicians interact with health care technology, and it seems like it’s no longer a question of if, but when we’ll see that happen.

The effort of SpaceX and others to change the way we launch rockets tells a story that transcends space travel – It’s a story of how new thinking, more efficient processes, and better design can disrupt the establishment. It’s worth pointing out that NASA hasn’t given up – they are continuing to develop the Space Launch System, which, when completed, will be the most powerful rocket in the world and be capable of carrying astronauts into deep space. In the meantime, however, NASA is embracing the efforts of private industry to help pave a better way forward and make space travel safer and more accessible for everyone. We are hopeful that EHR vendors and other establishment health care institutions are taking note, adapting to meet the needs of the current generation of physicians and patients, and innovating a better way to launch health care into the future.


 

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

On Friday, June 29, at 5:42 a.m., I stood with my family on a Florida shore overlooking Kennedy Space Center. We had gathered with about a hundred other people to watch a rocket launch and were overwhelmed with excitement as the coastline erupted in fire, and the spacecraft lifted off toward the heavens. Standing there watching the spectacle, I couldn’t help but be caught up in the irony of the moment. Here we were, at the place where NASA sent the first Americans into space – on the very shores where the Apollo astronauts set off for the moon to plant our nation’s flag in the lunar dust in July of 1969. Yet now, almost 50 years later, this launch was profoundly different. The rocket wasn’t built by NASA, and the intention of its builders wasn’t exploration. This was a Falcon 9, built by SpaceX, a for-profit company founded by an enterprising billionaire. Most surprisingly, this relatively routine launch was intended to accomplish something that NASA – the United States’ own space agency – currently can’t do on its own: Launch rockets.

Since retiring the Space Shuttle in 2011, the United States has had to rely on others – including even Roscosmos (the Russian space agency) – to ferry passengers, satellites, and cargo into space. Seeing this opportunity in a multibillion-dollar industry, private enterprise has risen to the challenge, innovating more quickly and at a lower cost than “the establishment” has ever been capable of. As a result, space travel has been disrupted by corporations competing in a new “space race.” Instead of national pride or scientific dominance, this race has been fueled by profit and is quite similar to one being run in another industry: health care.

Just 1 day prior to watching the launch – on June 28 – we learned that Amazon had purchased PillPack, a prescription drug home delivery service. The stock market responded to the news, and the establishment (in this case CVS, Walgreen’s, and WalMart, among others) collectively lost $17.5 billion in one day. This isn’t the first time Amazon has disrupted the health care world; in January of this year, they, along with Berkshire Hathaway and JPMorgan Chase, announced a health care partnership to cut costs and improve care delivery for their employees. This move also sent shivers through the market, as health insurers and providers such as Aetna and United Health lost big on expectations that Amazon et al. wouldn’t stop with their own employees. Those of us watching this play out from the sidelines realized we were witnessing a revolution that would mean the end of health care delivery as we know it – and that’s not necessarily a bad thing, especially in the world of Electronic Health Records.

As you’ve probably noticed, it is quite rare to find physicians nowadays who love computers. Once an exciting novelty in health care, PCs have become a burdensome necessity and providers often feel enslaved to the EHRs that run on them. There are numerous reasons for this, but one primary cause is that the hundreds of disparate EHRs currently available sprouted out of health care – a centuries-old and very provincial industry – prior to the development of technical and regulatory standards to govern them. As they’ve grown larger and larger from their primitive underpinnings, these EHRs have become more cumbersome to navigate, and vendors have simply “bolted-on” additional features without significant changes to their near-obsolete software architecture.

It’s worth noting that a few EHR companies purport to be true innovators in platform usability, such as industry giant, Epic. According to CEO Judy Faulkner, Epic pours 50% of their revenue back into research and development (though, as Epic is a privately held company, this number can’t be verified). If accurate, Epic is truly an exception, as most electronic record companies spend about 10%-30% on improving their products – far less than they spend on recruiting new customers. Regardless, the outcome is this: Physician expectations for user interface and user experience have far outpaced the current state of the art of EHRs, and this has left a gap that new players outside the health care establishment are apt to fill.

Like Amazon, other software giants have made significant investments in health care over the past several years. According to their website, Apple has been working with hospitals, scientists, and developers to “help health care providers streamline their work, deliver better care, and conduct medical research.” Similarly, Google claims to be “making a number of big bets in health care and life sciences,” by leveraging their artificial intelligence technology to assist in clinical diagnosis and scientific discovery. In spite of a few false starts in the past, these companies are poised to do more than simply disrupt health care. As experts in user interface and design, they could truly change the way physicians interact with health care technology, and it seems like it’s no longer a question of if, but when we’ll see that happen.

The effort of SpaceX and others to change the way we launch rockets tells a story that transcends space travel – It’s a story of how new thinking, more efficient processes, and better design can disrupt the establishment. It’s worth pointing out that NASA hasn’t given up – they are continuing to develop the Space Launch System, which, when completed, will be the most powerful rocket in the world and be capable of carrying astronauts into deep space. In the meantime, however, NASA is embracing the efforts of private industry to help pave a better way forward and make space travel safer and more accessible for everyone. We are hopeful that EHR vendors and other establishment health care institutions are taking note, adapting to meet the needs of the current generation of physicians and patients, and innovating a better way to launch health care into the future.


 

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

On Friday, June 29, at 5:42 a.m., I stood with my family on a Florida shore overlooking Kennedy Space Center. We had gathered with about a hundred other people to watch a rocket launch and were overwhelmed with excitement as the coastline erupted in fire, and the spacecraft lifted off toward the heavens. Standing there watching the spectacle, I couldn’t help but be caught up in the irony of the moment. Here we were, at the place where NASA sent the first Americans into space – on the very shores where the Apollo astronauts set off for the moon to plant our nation’s flag in the lunar dust in July of 1969. Yet now, almost 50 years later, this launch was profoundly different. The rocket wasn’t built by NASA, and the intention of its builders wasn’t exploration. This was a Falcon 9, built by SpaceX, a for-profit company founded by an enterprising billionaire. Most surprisingly, this relatively routine launch was intended to accomplish something that NASA – the United States’ own space agency – currently can’t do on its own: Launch rockets.

Since retiring the Space Shuttle in 2011, the United States has had to rely on others – including even Roscosmos (the Russian space agency) – to ferry passengers, satellites, and cargo into space. Seeing this opportunity in a multibillion-dollar industry, private enterprise has risen to the challenge, innovating more quickly and at a lower cost than “the establishment” has ever been capable of. As a result, space travel has been disrupted by corporations competing in a new “space race.” Instead of national pride or scientific dominance, this race has been fueled by profit and is quite similar to one being run in another industry: health care.

Just 1 day prior to watching the launch – on June 28 – we learned that Amazon had purchased PillPack, a prescription drug home delivery service. The stock market responded to the news, and the establishment (in this case CVS, Walgreen’s, and WalMart, among others) collectively lost $17.5 billion in one day. This isn’t the first time Amazon has disrupted the health care world; in January of this year, they, along with Berkshire Hathaway and JPMorgan Chase, announced a health care partnership to cut costs and improve care delivery for their employees. This move also sent shivers through the market, as health insurers and providers such as Aetna and United Health lost big on expectations that Amazon et al. wouldn’t stop with their own employees. Those of us watching this play out from the sidelines realized we were witnessing a revolution that would mean the end of health care delivery as we know it – and that’s not necessarily a bad thing, especially in the world of Electronic Health Records.

As you’ve probably noticed, it is quite rare to find physicians nowadays who love computers. Once an exciting novelty in health care, PCs have become a burdensome necessity and providers often feel enslaved to the EHRs that run on them. There are numerous reasons for this, but one primary cause is that the hundreds of disparate EHRs currently available sprouted out of health care – a centuries-old and very provincial industry – prior to the development of technical and regulatory standards to govern them. As they’ve grown larger and larger from their primitive underpinnings, these EHRs have become more cumbersome to navigate, and vendors have simply “bolted-on” additional features without significant changes to their near-obsolete software architecture.

It’s worth noting that a few EHR companies purport to be true innovators in platform usability, such as industry giant, Epic. According to CEO Judy Faulkner, Epic pours 50% of their revenue back into research and development (though, as Epic is a privately held company, this number can’t be verified). If accurate, Epic is truly an exception, as most electronic record companies spend about 10%-30% on improving their products – far less than they spend on recruiting new customers. Regardless, the outcome is this: Physician expectations for user interface and user experience have far outpaced the current state of the art of EHRs, and this has left a gap that new players outside the health care establishment are apt to fill.

Like Amazon, other software giants have made significant investments in health care over the past several years. According to their website, Apple has been working with hospitals, scientists, and developers to “help health care providers streamline their work, deliver better care, and conduct medical research.” Similarly, Google claims to be “making a number of big bets in health care and life sciences,” by leveraging their artificial intelligence technology to assist in clinical diagnosis and scientific discovery. In spite of a few false starts in the past, these companies are poised to do more than simply disrupt health care. As experts in user interface and design, they could truly change the way physicians interact with health care technology, and it seems like it’s no longer a question of if, but when we’ll see that happen.

The effort of SpaceX and others to change the way we launch rockets tells a story that transcends space travel – It’s a story of how new thinking, more efficient processes, and better design can disrupt the establishment. It’s worth pointing out that NASA hasn’t given up – they are continuing to develop the Space Launch System, which, when completed, will be the most powerful rocket in the world and be capable of carrying astronauts into deep space. In the meantime, however, NASA is embracing the efforts of private industry to help pave a better way forward and make space travel safer and more accessible for everyone. We are hopeful that EHR vendors and other establishment health care institutions are taking note, adapting to meet the needs of the current generation of physicians and patients, and innovating a better way to launch health care into the future.


 

Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on twitter (@doctornotte). Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.

Previous rulings by President Trump’s Supreme Court nominee could provide insight into the fate of the Affordable Care Act should Judge Brett M. Kavanaugh be confirmed.

In 2011, Judge Kavanaugh wrote a dissenting opinion on Seven-Sky v. Holder, noting that the ACA’s individual mandate was in fact a tax and that the court could not hear questions about the law’s constitutionality because the tax had not been levied.

That dissenting opinion could become germane in the currently debated Texas v. Azar, which looks destined to reach the high court.

In Texas v. Azar, the Department of Justice has refused to defend the ACA and is siding with Texas and 19 other states. Texas and 19 other states in the case contend that the penalty for not carrying health insurance under the individual mandate is a tax; however, since the penalty was reduced to zero by the Tax Cuts and Jobs Act of 2017, the plaintiffs argue that the individual mandate is unconstitutional. They further contend that the ACA provisions of guaranteed issue and community rating are inseverable and should be eliminated as well.

If confirmed, Judge Kavanaugh’s views that the penalty for the individual mandate is in fact a tax could shift the Supreme Court’s majority view, further putting the law in jeopardy.

Judge Kavanaugh currently serves on the U.S. Court of Appeals for the District of Columbia Circuit, he was appointed by President George W. Bush and has held the position since May 30, 2006. He previously served as White House staff secretary for nearly 3 years.

As an attorney, he had a lead role in drafting the Starr Report, which recommended impeachment of President Bill Clinton.

Judge Kavanaugh will face a contentious confirmation process. In addition to health care, abortion rights will be front and center to the debate as moderate Republican senators who are proponents of abortion rights may not support his nomination. The GOP currently holds a slim 51-49 majority in the Senate, but with the medical absence of Sen. John McCain (R-Ariz.), the majority party may only have 50 members present to vote, meaning only one GOP vote against Judge Kavanaugh could deny his confirmation.

Judge Kavanaugh does not have a stated position on Roe v. Wade; however, his dissenting opinion in Garza v. Hargan questioned whether the government should be involved in provisioning abortions for undocumented immigrant minors.

That opinion is a reason Physicians for Reproductive Health have come out against Judge Kavanaugh’s nomination.

“The Trump administration has already enacted numerous policies restricting access to vital reproductive health services, including contraception, abortion, and maternity care, and will continue to chip away at health care access,” Willie Parker, MD, board chair of Physicians for Reproductive Health, said in a statement. “This nominee will harm not only abortion rights, but will imperil other fundamental rights as well.”

Senate Majority Leader Mitch McConnell said in a statement that Judge Kavanaugh “understands that, in the United States of America, judges are not unelected super-legislators whom we select for their personal views or policy preferences. A judge’s duty is to interpret the plain meaning of our laws and our Constitution according to how they are written. Judges need to be unbiased. They need to treat all parties fairly. They need to approach every case with open ears and an open mind. Judges’ decisions must turn on the facts of each case and be based on the texts that it is their job to interpret. By all accounts, Judge Kavanaugh is precisely that sort of judge.”

gtwachtman@mededge.com

Previous rulings by President Trump’s Supreme Court nominee could provide insight into the fate of the Affordable Care Act should Judge Brett M. Kavanaugh be confirmed.

In 2011, Judge Kavanaugh wrote a dissenting opinion on Seven-Sky v. Holder, noting that the ACA’s individual mandate was in fact a tax and that the court could not hear questions about the law’s constitutionality because the tax had not been levied.

That dissenting opinion could become germane in the currently debated Texas v. Azar, which looks destined to reach the high court.

In Texas v. Azar, the Department of Justice has refused to defend the ACA and is siding with Texas and 19 other states. Texas and 19 other states in the case contend that the penalty for not carrying health insurance under the individual mandate is a tax; however, since the penalty was reduced to zero by the Tax Cuts and Jobs Act of 2017, the plaintiffs argue that the individual mandate is unconstitutional. They further contend that the ACA provisions of guaranteed issue and community rating are inseverable and should be eliminated as well.

If confirmed, Judge Kavanaugh’s views that the penalty for the individual mandate is in fact a tax could shift the Supreme Court’s majority view, further putting the law in jeopardy.

Judge Kavanaugh currently serves on the U.S. Court of Appeals for the District of Columbia Circuit, he was appointed by President George W. Bush and has held the position since May 30, 2006. He previously served as White House staff secretary for nearly 3 years.

As an attorney, he had a lead role in drafting the Starr Report, which recommended impeachment of President Bill Clinton.

Judge Kavanaugh will face a contentious confirmation process. In addition to health care, abortion rights will be front and center to the debate as moderate Republican senators who are proponents of abortion rights may not support his nomination. The GOP currently holds a slim 51-49 majority in the Senate, but with the medical absence of Sen. John McCain (R-Ariz.), the majority party may only have 50 members present to vote, meaning only one GOP vote against Judge Kavanaugh could deny his confirmation.

Judge Kavanaugh does not have a stated position on Roe v. Wade; however, his dissenting opinion in Garza v. Hargan questioned whether the government should be involved in provisioning abortions for undocumented immigrant minors.

That opinion is a reason Physicians for Reproductive Health have come out against Judge Kavanaugh’s nomination.

“The Trump administration has already enacted numerous policies restricting access to vital reproductive health services, including contraception, abortion, and maternity care, and will continue to chip away at health care access,” Willie Parker, MD, board chair of Physicians for Reproductive Health, said in a statement. “This nominee will harm not only abortion rights, but will imperil other fundamental rights as well.”

Senate Majority Leader Mitch McConnell said in a statement that Judge Kavanaugh “understands that, in the United States of America, judges are not unelected super-legislators whom we select for their personal views or policy preferences. A judge’s duty is to interpret the plain meaning of our laws and our Constitution according to how they are written. Judges need to be unbiased. They need to treat all parties fairly. They need to approach every case with open ears and an open mind. Judges’ decisions must turn on the facts of each case and be based on the texts that it is their job to interpret. By all accounts, Judge Kavanaugh is precisely that sort of judge.”

gtwachtman@mededge.com

Previous rulings by President Trump’s Supreme Court nominee could provide insight into the fate of the Affordable Care Act should Judge Brett M. Kavanaugh be confirmed.

In 2011, Judge Kavanaugh wrote a dissenting opinion on Seven-Sky v. Holder, noting that the ACA’s individual mandate was in fact a tax and that the court could not hear questions about the law’s constitutionality because the tax had not been levied.

That dissenting opinion could become germane in the currently debated Texas v. Azar, which looks destined to reach the high court.

In Texas v. Azar, the Department of Justice has refused to defend the ACA and is siding with Texas and 19 other states. Texas and 19 other states in the case contend that the penalty for not carrying health insurance under the individual mandate is a tax; however, since the penalty was reduced to zero by the Tax Cuts and Jobs Act of 2017, the plaintiffs argue that the individual mandate is unconstitutional. They further contend that the ACA provisions of guaranteed issue and community rating are inseverable and should be eliminated as well.

If confirmed, Judge Kavanaugh’s views that the penalty for the individual mandate is in fact a tax could shift the Supreme Court’s majority view, further putting the law in jeopardy.

Judge Kavanaugh currently serves on the U.S. Court of Appeals for the District of Columbia Circuit, he was appointed by President George W. Bush and has held the position since May 30, 2006. He previously served as White House staff secretary for nearly 3 years.

As an attorney, he had a lead role in drafting the Starr Report, which recommended impeachment of President Bill Clinton.

Judge Kavanaugh will face a contentious confirmation process. In addition to health care, abortion rights will be front and center to the debate as moderate Republican senators who are proponents of abortion rights may not support his nomination. The GOP currently holds a slim 51-49 majority in the Senate, but with the medical absence of Sen. John McCain (R-Ariz.), the majority party may only have 50 members present to vote, meaning only one GOP vote against Judge Kavanaugh could deny his confirmation.

Judge Kavanaugh does not have a stated position on Roe v. Wade; however, his dissenting opinion in Garza v. Hargan questioned whether the government should be involved in provisioning abortions for undocumented immigrant minors.

That opinion is a reason Physicians for Reproductive Health have come out against Judge Kavanaugh’s nomination.

“The Trump administration has already enacted numerous policies restricting access to vital reproductive health services, including contraception, abortion, and maternity care, and will continue to chip away at health care access,” Willie Parker, MD, board chair of Physicians for Reproductive Health, said in a statement. “This nominee will harm not only abortion rights, but will imperil other fundamental rights as well.”

Senate Majority Leader Mitch McConnell said in a statement that Judge Kavanaugh “understands that, in the United States of America, judges are not unelected super-legislators whom we select for their personal views or policy preferences. A judge’s duty is to interpret the plain meaning of our laws and our Constitution according to how they are written. Judges need to be unbiased. They need to treat all parties fairly. They need to approach every case with open ears and an open mind. Judges’ decisions must turn on the facts of each case and be based on the texts that it is their job to interpret. By all accounts, Judge Kavanaugh is precisely that sort of judge.”

gtwachtman@mededge.com

In a large, nationally representative retrospective cohort study, migraine admission with aura was independently associated with transient ischemic attack (TIA) readmission, and status migrainosus was independently associated with subarachnoid hemorrhage. The Nationwide Readmissions Database was designed to analyze readmissions for all payers and uninsured, with data on more than 14 million US admissions in 2013. Researchers identified index migraine admissions with and without aura or status migrainosus, and readmissions for cerebrovascular events. Cox proportional hazards regression was performed for each outcome with aura and status migrainosus as main predictors, adjusting for age and vascular risk factors. They found:

• Out of 12,448 index admissions for migraine, 9972 (80.1%) were women, mean age was 45.5 ± 14.8 years, aura was present in 3038 (24.41%), and status migrainosus in 1798 (14.44%).
• The 30‐day readmission rate (per 100,000 index admissions) was 154 for ischemic stroke, 86 for TIA, 42 for subarachnoid hemorrhage, and 17 for intracranial hemorrhage.
• In unadjusted models, aura was significantly associated with TIA (hazard ratio 2.43), but not acute ischemic stroke (1.26), intracranial hemorrhage (1.86), or subarachnoid hemorrhage (1.85).

Velickovic Osotjic L, Liang JW, Sheikh HU, Dhamoon MS. Impact of aura and status migrainosus on readmissions for vascular events after migraine admission. [Published online ahead of print June 22, 2018]. Headache. doi:10.1111/head.13347.

In a large, nationally representative retrospective cohort study, migraine admission with aura was independently associated with transient ischemic attack (TIA) readmission, and status migrainosus was independently associated with subarachnoid hemorrhage. The Nationwide Readmissions Database was designed to analyze readmissions for all payers and uninsured, with data on more than 14 million US admissions in 2013. Researchers identified index migraine admissions with and without aura or status migrainosus, and readmissions for cerebrovascular events. Cox proportional hazards regression was performed for each outcome with aura and status migrainosus as main predictors, adjusting for age and vascular risk factors. They found:

• Out of 12,448 index admissions for migraine, 9972 (80.1%) were women, mean age was 45.5 ± 14.8 years, aura was present in 3038 (24.41%), and status migrainosus in 1798 (14.44%).
• The 30‐day readmission rate (per 100,000 index admissions) was 154 for ischemic stroke, 86 for TIA, 42 for subarachnoid hemorrhage, and 17 for intracranial hemorrhage.
• In unadjusted models, aura was significantly associated with TIA (hazard ratio 2.43), but not acute ischemic stroke (1.26), intracranial hemorrhage (1.86), or subarachnoid hemorrhage (1.85).

Velickovic Osotjic L, Liang JW, Sheikh HU, Dhamoon MS. Impact of aura and status migrainosus on readmissions for vascular events after migraine admission. [Published online ahead of print June 22, 2018]. Headache. doi:10.1111/head.13347.

In a large, nationally representative retrospective cohort study, migraine admission with aura was independently associated with transient ischemic attack (TIA) readmission, and status migrainosus was independently associated with subarachnoid hemorrhage. The Nationwide Readmissions Database was designed to analyze readmissions for all payers and uninsured, with data on more than 14 million US admissions in 2013. Researchers identified index migraine admissions with and without aura or status migrainosus, and readmissions for cerebrovascular events. Cox proportional hazards regression was performed for each outcome with aura and status migrainosus as main predictors, adjusting for age and vascular risk factors. They found:

• Out of 12,448 index admissions for migraine, 9972 (80.1%) were women, mean age was 45.5 ± 14.8 years, aura was present in 3038 (24.41%), and status migrainosus in 1798 (14.44%).
• The 30‐day readmission rate (per 100,000 index admissions) was 154 for ischemic stroke, 86 for TIA, 42 for subarachnoid hemorrhage, and 17 for intracranial hemorrhage.
• In unadjusted models, aura was significantly associated with TIA (hazard ratio 2.43), but not acute ischemic stroke (1.26), intracranial hemorrhage (1.86), or subarachnoid hemorrhage (1.85).

Velickovic Osotjic L, Liang JW, Sheikh HU, Dhamoon MS. Impact of aura and status migrainosus on readmissions for vascular events after migraine admission. [Published online ahead of print June 22, 2018]. Headache. doi:10.1111/head.13347.

Headache smartphone applications (apps) shared information with third parties, posing privacy risks partly because there are few legal protections against the sale or disclosure of data from medical apps to third parties. This is according to a recent study that sought to assess whether there are privacy issues surrounding apps and the potential privacy implications of how the app companies (and other third parties) might use that information. Researchers conducted a systematic search of the most popular “headache” and “migraine” apps and developed a database of the types of data the apps requested for input by the user, and whether the apps had clear privacy policies. They also examined the content of the privacy policies and found:

• Twenty-nine apps were examined (14 diary apps, 15 relaxation apps).
• Of the diary applications, 79% (11/14) had visible privacy policies.
• Of the diary apps with privacy policies, all (11/11) stated whether or not the app collects and stores information remotely.
• A total of 55% (6/11) stated that some user data were used to serve targeted advertisements.
• A total of 11/15 (73%) of the relaxation apps had privacy policies.

Minen MT, Stieglitz EJ, Sciortino R, Torous J. Privacy issues in smartphone applications: An analysis of headache/migraine applications. [Published online ahead of print July 4, 2018]. Headache. doi:10.1111/head.13341.

Headache smartphone applications (apps) shared information with third parties, posing privacy risks partly because there are few legal protections against the sale or disclosure of data from medical apps to third parties. This is according to a recent study that sought to assess whether there are privacy issues surrounding apps and the potential privacy implications of how the app companies (and other third parties) might use that information. Researchers conducted a systematic search of the most popular “headache” and “migraine” apps and developed a database of the types of data the apps requested for input by the user, and whether the apps had clear privacy policies. They also examined the content of the privacy policies and found:

• Twenty-nine apps were examined (14 diary apps, 15 relaxation apps).
• Of the diary applications, 79% (11/14) had visible privacy policies.
• Of the diary apps with privacy policies, all (11/11) stated whether or not the app collects and stores information remotely.
• A total of 55% (6/11) stated that some user data were used to serve targeted advertisements.
• A total of 11/15 (73%) of the relaxation apps had privacy policies.

Minen MT, Stieglitz EJ, Sciortino R, Torous J. Privacy issues in smartphone applications: An analysis of headache/migraine applications. [Published online ahead of print July 4, 2018]. Headache. doi:10.1111/head.13341.

Headache smartphone applications (apps) shared information with third parties, posing privacy risks partly because there are few legal protections against the sale or disclosure of data from medical apps to third parties. This is according to a recent study that sought to assess whether there are privacy issues surrounding apps and the potential privacy implications of how the app companies (and other third parties) might use that information. Researchers conducted a systematic search of the most popular “headache” and “migraine” apps and developed a database of the types of data the apps requested for input by the user, and whether the apps had clear privacy policies. They also examined the content of the privacy policies and found:

• Twenty-nine apps were examined (14 diary apps, 15 relaxation apps).
• Of the diary applications, 79% (11/14) had visible privacy policies.
• Of the diary apps with privacy policies, all (11/11) stated whether or not the app collects and stores information remotely.
• A total of 55% (6/11) stated that some user data were used to serve targeted advertisements.
• A total of 11/15 (73%) of the relaxation apps had privacy policies.

Minen MT, Stieglitz EJ, Sciortino R, Torous J. Privacy issues in smartphone applications: An analysis of headache/migraine applications. [Published online ahead of print July 4, 2018]. Headache. doi:10.1111/head.13341.

Patients with migraine undergoing surgery are at increased risk of 30-day hospital readmission due to pain, a recent study found. This hospital registry study examined 150,710 patients, aged 18 years or older, who underwent surgery with general anesthesia and mechanical ventilation between 2007 and 2015 at a tertiary care center and 2 affiliated community hospitals in Massachusetts. Researchers found:

• Migraine was associated with an increased risk of 30-day pain-related readmission after surgery (adjusted odds ratio [OR] 1.42).
• The association was stronger for migraine with aura (compared to migraine without aura: adjusted OR 1.69; compared to no migraine: adjusted OR 2.20).
• The predicted adjusted risk of pain-related 30-day readmissions was 9.1 in 1000 surgical patients with migraine with aura and 5.4 in 1,000 patients with migraine without aura, compared to 4.2 in 1000 patients with no migraine.
• Furthermore, migraine was associated with an increased risk of postsurgical 30-day readmission due to a priori defined migraine-related pain (headache or abdominal pain) (adjusted OR 1.55).

Platzbecker K, Zhang MB, Kurth T, et al. The association between migraine and hospital readmission due to pain after surgery: A hospital registry study. [Published online ahead of print July 8, 2018]. Cephalalgia. doi:10.1177/0333102418786457.

Patients with migraine undergoing surgery are at increased risk of 30-day hospital readmission due to pain, a recent study found. This hospital registry study examined 150,710 patients, aged 18 years or older, who underwent surgery with general anesthesia and mechanical ventilation between 2007 and 2015 at a tertiary care center and 2 affiliated community hospitals in Massachusetts. Researchers found:

• Migraine was associated with an increased risk of 30-day pain-related readmission after surgery (adjusted odds ratio [OR] 1.42).
• The association was stronger for migraine with aura (compared to migraine without aura: adjusted OR 1.69; compared to no migraine: adjusted OR 2.20).
• The predicted adjusted risk of pain-related 30-day readmissions was 9.1 in 1000 surgical patients with migraine with aura and 5.4 in 1,000 patients with migraine without aura, compared to 4.2 in 1000 patients with no migraine.
• Furthermore, migraine was associated with an increased risk of postsurgical 30-day readmission due to a priori defined migraine-related pain (headache or abdominal pain) (adjusted OR 1.55).

Platzbecker K, Zhang MB, Kurth T, et al. The association between migraine and hospital readmission due to pain after surgery: A hospital registry study. [Published online ahead of print July 8, 2018]. Cephalalgia. doi:10.1177/0333102418786457.

Patients with migraine undergoing surgery are at increased risk of 30-day hospital readmission due to pain, a recent study found. This hospital registry study examined 150,710 patients, aged 18 years or older, who underwent surgery with general anesthesia and mechanical ventilation between 2007 and 2015 at a tertiary care center and 2 affiliated community hospitals in Massachusetts. Researchers found:

• Migraine was associated with an increased risk of 30-day pain-related readmission after surgery (adjusted odds ratio [OR] 1.42).
• The association was stronger for migraine with aura (compared to migraine without aura: adjusted OR 1.69; compared to no migraine: adjusted OR 2.20).
• The predicted adjusted risk of pain-related 30-day readmissions was 9.1 in 1000 surgical patients with migraine with aura and 5.4 in 1,000 patients with migraine without aura, compared to 4.2 in 1000 patients with no migraine.
• Furthermore, migraine was associated with an increased risk of postsurgical 30-day readmission due to a priori defined migraine-related pain (headache or abdominal pain) (adjusted OR 1.55).

Platzbecker K, Zhang MB, Kurth T, et al. The association between migraine and hospital readmission due to pain after surgery: A hospital registry study. [Published online ahead of print July 8, 2018]. Cephalalgia. doi:10.1177/0333102418786457.

AMSTERDAM – Greater increases in bone strength were achieved with denosumab (Prolia) than with risedronate in patients receiving glucocorticoid treatment in a phase 3 trial, suggesting it may prove to be an effective means of preventing osteoporosis in this at-risk population of patients.

At 2 years, the percentage change in bone mineral density (BMD) from baseline with denosumab compared to risedronate in patients initiating steroid treatment was significantly higher (all P values less than .001) at the lumbar spine (6% vs. 2%), total hip (3% vs. 0%), and the femoral neck (1.5% vs. –1%). Similar results were seen in patients who were continuing steroid treatment when they entered the randomized, multicenter, double blind trial.

These data build on the 1-year data that have just been published (Lancet Diabetes Endocrinol. 2018;6[6]:445-54), Willem F. Lems, MD, the presenting study investigator, said at the European Congress of Rheumatology.

“Denosumab continued to increased BMD significantly more then risedronate through 24 months,” said Dr. Lems of VU University Medical Center, Amsterdam. He added that “the treatment differences at all skeletal sites were larger at 24 months than as 12 months.”

The Food and Drug Administration approved an additional indication in May of 2018 for denosumab to treat glucocorticoid-induced osteoporosis in adults at high risk of fracture. The biologic, a monoclonal antibody that targets the RANK ligand, was already approved to treat postmenopausal women with osteoporosis at high fracture risk, to increase bone mass in men with osteoporosis at high fracture risk, and to increase bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer and in men receiving androgen deprivation therapy for nonmetastatic prostate cancer.

Secondary osteoporosis is a well known downside of glucocorticoid treatment, and despite there being approved therapies, many patients do not receive such treatment, Dr. Lems noted.

“This 24-month study assessed the safety and efficacy of denosumab versus risedronate in glucocorticoid-treated individuals, in whom guidelines advocate treatment,” Dr. Lems said.

Sara Freeman/MDedge News

SOURCE: Saag KG et al. Ann Rheum Dis. 2018;77(Suppl 2):218. Abstract OP0345.

AMSTERDAM – Greater increases in bone strength were achieved with denosumab (Prolia) than with risedronate in patients receiving glucocorticoid treatment in a phase 3 trial, suggesting it may prove to be an effective means of preventing osteoporosis in this at-risk population of patients.

At 2 years, the percentage change in bone mineral density (BMD) from baseline with denosumab compared to risedronate in patients initiating steroid treatment was significantly higher (all P values less than .001) at the lumbar spine (6% vs. 2%), total hip (3% vs. 0%), and the femoral neck (1.5% vs. –1%). Similar results were seen in patients who were continuing steroid treatment when they entered the randomized, multicenter, double blind trial.

These data build on the 1-year data that have just been published (Lancet Diabetes Endocrinol. 2018;6[6]:445-54), Willem F. Lems, MD, the presenting study investigator, said at the European Congress of Rheumatology.

“Denosumab continued to increased BMD significantly more then risedronate through 24 months,” said Dr. Lems of VU University Medical Center, Amsterdam. He added that “the treatment differences at all skeletal sites were larger at 24 months than as 12 months.”

The Food and Drug Administration approved an additional indication in May of 2018 for denosumab to treat glucocorticoid-induced osteoporosis in adults at high risk of fracture. The biologic, a monoclonal antibody that targets the RANK ligand, was already approved to treat postmenopausal women with osteoporosis at high fracture risk, to increase bone mass in men with osteoporosis at high fracture risk, and to increase bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer and in men receiving androgen deprivation therapy for nonmetastatic prostate cancer.

Secondary osteoporosis is a well known downside of glucocorticoid treatment, and despite there being approved therapies, many patients do not receive such treatment, Dr. Lems noted.

“This 24-month study assessed the safety and efficacy of denosumab versus risedronate in glucocorticoid-treated individuals, in whom guidelines advocate treatment,” Dr. Lems said.

Sara Freeman/MDedge News

SOURCE: Saag KG et al. Ann Rheum Dis. 2018;77(Suppl 2):218. Abstract OP0345.

AMSTERDAM – Greater increases in bone strength were achieved with denosumab (Prolia) than with risedronate in patients receiving glucocorticoid treatment in a phase 3 trial, suggesting it may prove to be an effective means of preventing osteoporosis in this at-risk population of patients.

At 2 years, the percentage change in bone mineral density (BMD) from baseline with denosumab compared to risedronate in patients initiating steroid treatment was significantly higher (all P values less than .001) at the lumbar spine (6% vs. 2%), total hip (3% vs. 0%), and the femoral neck (1.5% vs. –1%). Similar results were seen in patients who were continuing steroid treatment when they entered the randomized, multicenter, double blind trial.

These data build on the 1-year data that have just been published (Lancet Diabetes Endocrinol. 2018;6[6]:445-54), Willem F. Lems, MD, the presenting study investigator, said at the European Congress of Rheumatology.

“Denosumab continued to increased BMD significantly more then risedronate through 24 months,” said Dr. Lems of VU University Medical Center, Amsterdam. He added that “the treatment differences at all skeletal sites were larger at 24 months than as 12 months.”

The Food and Drug Administration approved an additional indication in May of 2018 for denosumab to treat glucocorticoid-induced osteoporosis in adults at high risk of fracture. The biologic, a monoclonal antibody that targets the RANK ligand, was already approved to treat postmenopausal women with osteoporosis at high fracture risk, to increase bone mass in men with osteoporosis at high fracture risk, and to increase bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer and in men receiving androgen deprivation therapy for nonmetastatic prostate cancer.

Secondary osteoporosis is a well known downside of glucocorticoid treatment, and despite there being approved therapies, many patients do not receive such treatment, Dr. Lems noted.

“This 24-month study assessed the safety and efficacy of denosumab versus risedronate in glucocorticoid-treated individuals, in whom guidelines advocate treatment,” Dr. Lems said.

Sara Freeman/MDedge News

SOURCE: Saag KG et al. Ann Rheum Dis. 2018;77(Suppl 2):218. Abstract OP0345.

The Department of Defense has received emergency use authorization from the Food and Drug Administration to use pathogen-reduced, leukocyte-depleted, freeze-dried plasma for the emergency treatment of hemorrhage and coagulopathy in combat situations.

Hemorrhage and coagulopathy are the leading causes of preventable deaths among combat trauma casualties. While plasma contains proteins that help clot blood and thus can treat these conditions, it isn’t feasible to keep it on hand for combat emergencies in the field because of logistical and operational requirements, such as refrigeration or thawing periods. This freeze-dried plasma product, on the other hand, can be easily reconstituted in situations in which refrigeration isn’t possible.

The FDA authorization allows for the use of a French-made, powdered, freeze-dried product. This emergency use authorization came about in part because of a joint program established between the FDA and the Department of Defense in January 2018.

“Earlier this year, we reaffirmed our commitment to the Department of Defense and to the dedicated men and women protecting our country, by expediting the development and availability of safe and effective, priority medical products that are essential to the health of our military service members,” said FDA commissioner Scott Gottlieb, MD. “This is especially true when it comes to products used to treat injuries in a potential battlefield setting.”

More information about this emergency use authorization can be found in the FDA’s full press announcement.

cpalmer@mdedge.com

The Department of Defense has received emergency use authorization from the Food and Drug Administration to use pathogen-reduced, leukocyte-depleted, freeze-dried plasma for the emergency treatment of hemorrhage and coagulopathy in combat situations.

Hemorrhage and coagulopathy are the leading causes of preventable deaths among combat trauma casualties. While plasma contains proteins that help clot blood and thus can treat these conditions, it isn’t feasible to keep it on hand for combat emergencies in the field because of logistical and operational requirements, such as refrigeration or thawing periods. This freeze-dried plasma product, on the other hand, can be easily reconstituted in situations in which refrigeration isn’t possible.

The FDA authorization allows for the use of a French-made, powdered, freeze-dried product. This emergency use authorization came about in part because of a joint program established between the FDA and the Department of Defense in January 2018.

“Earlier this year, we reaffirmed our commitment to the Department of Defense and to the dedicated men and women protecting our country, by expediting the development and availability of safe and effective, priority medical products that are essential to the health of our military service members,” said FDA commissioner Scott Gottlieb, MD. “This is especially true when it comes to products used to treat injuries in a potential battlefield setting.”

More information about this emergency use authorization can be found in the FDA’s full press announcement.

cpalmer@mdedge.com

The Department of Defense has received emergency use authorization from the Food and Drug Administration to use pathogen-reduced, leukocyte-depleted, freeze-dried plasma for the emergency treatment of hemorrhage and coagulopathy in combat situations.

Hemorrhage and coagulopathy are the leading causes of preventable deaths among combat trauma casualties. While plasma contains proteins that help clot blood and thus can treat these conditions, it isn’t feasible to keep it on hand for combat emergencies in the field because of logistical and operational requirements, such as refrigeration or thawing periods. This freeze-dried plasma product, on the other hand, can be easily reconstituted in situations in which refrigeration isn’t possible.

The FDA authorization allows for the use of a French-made, powdered, freeze-dried product. This emergency use authorization came about in part because of a joint program established between the FDA and the Department of Defense in January 2018.

“Earlier this year, we reaffirmed our commitment to the Department of Defense and to the dedicated men and women protecting our country, by expediting the development and availability of safe and effective, priority medical products that are essential to the health of our military service members,” said FDA commissioner Scott Gottlieb, MD. “This is especially true when it comes to products used to treat injuries in a potential battlefield setting.”

More information about this emergency use authorization can be found in the FDA’s full press announcement.

cpalmer@mdedge.com

Transcutaneous electrical nerve stimulation (TENS) was effective at treating chronic vulvar pain at the vestibule in combination with vaginal diazepam and with placebo in a randomized, double-blind, placebo-controlled trial.

In the TENS/diazepam and TENS/placebo groups, participants reported significant improvements from baseline in pain and sexual functioning by questionnaire and visual analog scale. They also improved in measurements of pelvic floor muscle tone and vestibular nerve fiber current perception threshold.

The study had two groups of 21 women each, all aged 18 years or older and diagnosed (by physical exam) with moderate or severe pelvic floor hypertonic dysfunction. The diazepam was a tablet inserted vaginally daily before bed.

The TENS therapy was also self-administered (after six or seven supervised trial sessions), a recommended three times per week. The device is a 20-mm diameter plastic vaginal probe with gold metallic transversal rings as electrodes, inserted 20 mm, with 30 minutes of electrical stimulation increased slowly until sensation “reached a level described as the maximum tolerable without experiencing pain.” Vulvar pain was assessed on a on a 10-cm visual analog scale and dyspareunia on the Marinoff dyspareunia scale.

At the primary endpoint, the mean change from baseline to 60 days, the diazepam combination improved from 7.5 on the visual scale to 4.7, while the placebo combination improved from 7.2 to 4.3 (P not significant between the groups). Marinoff dyspareunia scores, however, improved from 2.5 to 1.6 and from 2.0 to 1.3, respectively (P less than .01).

Though “very few statistically significant differences in outcomes between the two groups were observed ... our results indicate that diazepam is able to positively change the functions of the pelvic floor muscle often highlighted” in women with vestibulodynia, reported Filippo Murina, MD, of the University of Milan and his coauthors. This conclusion followed from the Marinoff scores and from vaginal surface electromyography. In the latter measure, the diazepam group showed a significantly greater ability to relax the pelvic floor muscle after contraction (3.8 vs. 2.4 microvolts; P = .01), compared with the placebo group.

“We also observed that TENS itself is essential in reducing vulvar pain and the action of diazepam is useful but not decisive. ... It is possible that vaginal diazepam alone is insufficient to resolve the symptoms related to pelvic floor muscle dysfunction, while vaginal diazepam and TENS together provide a synergistic benefit in vestibulodynia patients,” wrote Dr. Murina and his coauthors.

This study was supported by the Associazione Italiana Vulvodinia. The authors declared no conflicts of interest.

dwatson@mdedge.com

SOURCE: Murina F et al. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;228:148-53.

Transcutaneous electrical nerve stimulation (TENS) was effective at treating chronic vulvar pain at the vestibule in combination with vaginal diazepam and with placebo in a randomized, double-blind, placebo-controlled trial.

In the TENS/diazepam and TENS/placebo groups, participants reported significant improvements from baseline in pain and sexual functioning by questionnaire and visual analog scale. They also improved in measurements of pelvic floor muscle tone and vestibular nerve fiber current perception threshold.

The study had two groups of 21 women each, all aged 18 years or older and diagnosed (by physical exam) with moderate or severe pelvic floor hypertonic dysfunction. The diazepam was a tablet inserted vaginally daily before bed.

The TENS therapy was also self-administered (after six or seven supervised trial sessions), a recommended three times per week. The device is a 20-mm diameter plastic vaginal probe with gold metallic transversal rings as electrodes, inserted 20 mm, with 30 minutes of electrical stimulation increased slowly until sensation “reached a level described as the maximum tolerable without experiencing pain.” Vulvar pain was assessed on a on a 10-cm visual analog scale and dyspareunia on the Marinoff dyspareunia scale.

At the primary endpoint, the mean change from baseline to 60 days, the diazepam combination improved from 7.5 on the visual scale to 4.7, while the placebo combination improved from 7.2 to 4.3 (P not significant between the groups). Marinoff dyspareunia scores, however, improved from 2.5 to 1.6 and from 2.0 to 1.3, respectively (P less than .01).

Though “very few statistically significant differences in outcomes between the two groups were observed ... our results indicate that diazepam is able to positively change the functions of the pelvic floor muscle often highlighted” in women with vestibulodynia, reported Filippo Murina, MD, of the University of Milan and his coauthors. This conclusion followed from the Marinoff scores and from vaginal surface electromyography. In the latter measure, the diazepam group showed a significantly greater ability to relax the pelvic floor muscle after contraction (3.8 vs. 2.4 microvolts; P = .01), compared with the placebo group.

“We also observed that TENS itself is essential in reducing vulvar pain and the action of diazepam is useful but not decisive. ... It is possible that vaginal diazepam alone is insufficient to resolve the symptoms related to pelvic floor muscle dysfunction, while vaginal diazepam and TENS together provide a synergistic benefit in vestibulodynia patients,” wrote Dr. Murina and his coauthors.

This study was supported by the Associazione Italiana Vulvodinia. The authors declared no conflicts of interest.

dwatson@mdedge.com

SOURCE: Murina F et al. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;228:148-53.

Transcutaneous electrical nerve stimulation (TENS) was effective at treating chronic vulvar pain at the vestibule in combination with vaginal diazepam and with placebo in a randomized, double-blind, placebo-controlled trial.

In the TENS/diazepam and TENS/placebo groups, participants reported significant improvements from baseline in pain and sexual functioning by questionnaire and visual analog scale. They also improved in measurements of pelvic floor muscle tone and vestibular nerve fiber current perception threshold.

The study had two groups of 21 women each, all aged 18 years or older and diagnosed (by physical exam) with moderate or severe pelvic floor hypertonic dysfunction. The diazepam was a tablet inserted vaginally daily before bed.

The TENS therapy was also self-administered (after six or seven supervised trial sessions), a recommended three times per week. The device is a 20-mm diameter plastic vaginal probe with gold metallic transversal rings as electrodes, inserted 20 mm, with 30 minutes of electrical stimulation increased slowly until sensation “reached a level described as the maximum tolerable without experiencing pain.” Vulvar pain was assessed on a on a 10-cm visual analog scale and dyspareunia on the Marinoff dyspareunia scale.

At the primary endpoint, the mean change from baseline to 60 days, the diazepam combination improved from 7.5 on the visual scale to 4.7, while the placebo combination improved from 7.2 to 4.3 (P not significant between the groups). Marinoff dyspareunia scores, however, improved from 2.5 to 1.6 and from 2.0 to 1.3, respectively (P less than .01).

Though “very few statistically significant differences in outcomes between the two groups were observed ... our results indicate that diazepam is able to positively change the functions of the pelvic floor muscle often highlighted” in women with vestibulodynia, reported Filippo Murina, MD, of the University of Milan and his coauthors. This conclusion followed from the Marinoff scores and from vaginal surface electromyography. In the latter measure, the diazepam group showed a significantly greater ability to relax the pelvic floor muscle after contraction (3.8 vs. 2.4 microvolts; P = .01), compared with the placebo group.

“We also observed that TENS itself is essential in reducing vulvar pain and the action of diazepam is useful but not decisive. ... It is possible that vaginal diazepam alone is insufficient to resolve the symptoms related to pelvic floor muscle dysfunction, while vaginal diazepam and TENS together provide a synergistic benefit in vestibulodynia patients,” wrote Dr. Murina and his coauthors.

This study was supported by the Associazione Italiana Vulvodinia. The authors declared no conflicts of interest.

dwatson@mdedge.com

SOURCE: Murina F et al. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;228:148-53.

After a successful and invigorating 2018 AGA Tech Summit, we can confidently say that innovation continues to be alive and well in the GI space. As you’ll see in the pages of this comprehensive AGA Tech Summit report, there is no shortage of novel ideas or potentially disruptive technologies poised to improve how we care for our patients.

What’s most special about the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology, is the camaraderie and shared commitment to innovation from physicians, innovators, industry, regulators, and investors. By coming together for this important dialogue, we can continue to move the pendulum forward and work toward new innovations that ultimately will improve patient outcomes. As the chair and vice chair of the center, we’re committed to continuing the conversations from the AGA Tech Summit year-round to help bring promising new technologies to our practices.

In this report, you’ll find summaries of select AGA Tech Summit presentations and key takeaways that will help you as a practicing gastroenterologist. Our recap of the annual AGA Tech Summit Shark Tank will give you insight into five new technologies making a splash in GI – flip to page 9 to see which device won this year’s Shark Tank. We also discuss physician barriers to incorporating new technologies, with tips for overcoming these challenges. You’ll also find articles on areas ripe for innovation in GI, including digital health, tissue resection techniques, and obesity treatment. Finally, for our physician innovators, we have advice and guidance throughout on how to take your idea from concept to product.

We’re looking ahead to the 2019 AGA Tech Summit, taking place April 10-12 at the Mark Hopkins Intercontinental in San Francisco, CA. This will be our 10th annual meeting of stakeholders in GI innovation – it’s amazing to reflect on all we’ve accomplished in the last 10 years. If you read this report with great interest, we hope you’ll join us for this unique and lively dialogue on advancing innovation in GI.

If you’d like to connect with us about innovation in GI – send us an email at cgit@gastro.org or visit www.gastro.org/CGIT.

Sincerely,

V. Raman Muthusamy, MD, AGAF, FACG, FASGE
Chair, AGA Center for GI Innovation and Technology

Sri Komanduri, MD, AGAF
Vice Chair, AGA Center for GI Innovation and Technology

After a successful and invigorating 2018 AGA Tech Summit, we can confidently say that innovation continues to be alive and well in the GI space. As you’ll see in the pages of this comprehensive AGA Tech Summit report, there is no shortage of novel ideas or potentially disruptive technologies poised to improve how we care for our patients.

What’s most special about the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology, is the camaraderie and shared commitment to innovation from physicians, innovators, industry, regulators, and investors. By coming together for this important dialogue, we can continue to move the pendulum forward and work toward new innovations that ultimately will improve patient outcomes. As the chair and vice chair of the center, we’re committed to continuing the conversations from the AGA Tech Summit year-round to help bring promising new technologies to our practices.

In this report, you’ll find summaries of select AGA Tech Summit presentations and key takeaways that will help you as a practicing gastroenterologist. Our recap of the annual AGA Tech Summit Shark Tank will give you insight into five new technologies making a splash in GI – flip to page 9 to see which device won this year’s Shark Tank. We also discuss physician barriers to incorporating new technologies, with tips for overcoming these challenges. You’ll also find articles on areas ripe for innovation in GI, including digital health, tissue resection techniques, and obesity treatment. Finally, for our physician innovators, we have advice and guidance throughout on how to take your idea from concept to product.

We’re looking ahead to the 2019 AGA Tech Summit, taking place April 10-12 at the Mark Hopkins Intercontinental in San Francisco, CA. This will be our 10th annual meeting of stakeholders in GI innovation – it’s amazing to reflect on all we’ve accomplished in the last 10 years. If you read this report with great interest, we hope you’ll join us for this unique and lively dialogue on advancing innovation in GI.

If you’d like to connect with us about innovation in GI – send us an email at cgit@gastro.org or visit www.gastro.org/CGIT.

Sincerely,

V. Raman Muthusamy, MD, AGAF, FACG, FASGE
Chair, AGA Center for GI Innovation and Technology

Sri Komanduri, MD, AGAF
Vice Chair, AGA Center for GI Innovation and Technology

After a successful and invigorating 2018 AGA Tech Summit, we can confidently say that innovation continues to be alive and well in the GI space. As you’ll see in the pages of this comprehensive AGA Tech Summit report, there is no shortage of novel ideas or potentially disruptive technologies poised to improve how we care for our patients.

What’s most special about the AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology, is the camaraderie and shared commitment to innovation from physicians, innovators, industry, regulators, and investors. By coming together for this important dialogue, we can continue to move the pendulum forward and work toward new innovations that ultimately will improve patient outcomes. As the chair and vice chair of the center, we’re committed to continuing the conversations from the AGA Tech Summit year-round to help bring promising new technologies to our practices.

In this report, you’ll find summaries of select AGA Tech Summit presentations and key takeaways that will help you as a practicing gastroenterologist. Our recap of the annual AGA Tech Summit Shark Tank will give you insight into five new technologies making a splash in GI – flip to page 9 to see which device won this year’s Shark Tank. We also discuss physician barriers to incorporating new technologies, with tips for overcoming these challenges. You’ll also find articles on areas ripe for innovation in GI, including digital health, tissue resection techniques, and obesity treatment. Finally, for our physician innovators, we have advice and guidance throughout on how to take your idea from concept to product.

We’re looking ahead to the 2019 AGA Tech Summit, taking place April 10-12 at the Mark Hopkins Intercontinental in San Francisco, CA. This will be our 10th annual meeting of stakeholders in GI innovation – it’s amazing to reflect on all we’ve accomplished in the last 10 years. If you read this report with great interest, we hope you’ll join us for this unique and lively dialogue on advancing innovation in GI.

If you’d like to connect with us about innovation in GI – send us an email at cgit@gastro.org or visit www.gastro.org/CGIT.

Sincerely,

V. Raman Muthusamy, MD, AGAF, FACG, FASGE
Chair, AGA Center for GI Innovation and Technology

Sri Komanduri, MD, AGAF
Vice Chair, AGA Center for GI Innovation and Technology