Whitney McKnight

SCOTTSDALE, ARIZ. – Failing to see depression as a chronic condition that needs to be managed has hampered the ability of psychiatry to help patients with the mood disorder, according to the principal investigator of a recently published prospective study on the most refractory of depression cases.

“The majority of research [in our field] has been on how we manage acute episodes of depression. But, these are chronic, often lifelong conditions. We need to pay attention to that and come up with solutions,” said Scott T. Aaronson, MD, program chair of this year’s annual meeting of the American College of Psychiatrists, in an interview.

courtesy of Dr. Aaronson

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – Failing to see depression as a chronic condition that needs to be managed has hampered the ability of psychiatry to help patients with the mood disorder, according to the principal investigator of a recently published prospective study on the most refractory of depression cases.

“The majority of research [in our field] has been on how we manage acute episodes of depression. But, these are chronic, often lifelong conditions. We need to pay attention to that and come up with solutions,” said Scott T. Aaronson, MD, program chair of this year’s annual meeting of the American College of Psychiatrists, in an interview.

courtesy of Dr. Aaronson

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – Failing to see depression as a chronic condition that needs to be managed has hampered the ability of psychiatry to help patients with the mood disorder, according to the principal investigator of a recently published prospective study on the most refractory of depression cases.

“The majority of research [in our field] has been on how we manage acute episodes of depression. But, these are chronic, often lifelong conditions. We need to pay attention to that and come up with solutions,” said Scott T. Aaronson, MD, program chair of this year’s annual meeting of the American College of Psychiatrists, in an interview.

courtesy of Dr. Aaronson

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

How pain management is evaluated in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is changing, thanks in part to the advocacy efforts of the Society of Hospital Medicine’s public policy committee.

Based on input from SHM and other organizations, the Centers for Medicare & Medicaid Services decided that the way the survey was worded concerning pain management could be leading to unintended consequences, particularly in light of the opioid epidemic.

In a video interview recorded during HM17, John Biebelhausen, MD, MBA, discussed how SHM worked with the CMS to help “improve the HCAHPS survey to make a better patient satisfaction tool for our assessments and also eliminate some of the competing pressures the physician might face.”

Dr. Biebelhausen is a hospitalist and physician lead for quality reporting at Virginia Mason Hospital in Seattle. He had no relevant disclosures.hospitalist and Physician Lead for Quality Reporting.

How pain management is evaluated in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is changing, thanks in part to the advocacy efforts of the Society of Hospital Medicine’s public policy committee.

Based on input from SHM and other organizations, the Centers for Medicare & Medicaid Services decided that the way the survey was worded concerning pain management could be leading to unintended consequences, particularly in light of the opioid epidemic.

In a video interview recorded during HM17, John Biebelhausen, MD, MBA, discussed how SHM worked with the CMS to help “improve the HCAHPS survey to make a better patient satisfaction tool for our assessments and also eliminate some of the competing pressures the physician might face.”

Dr. Biebelhausen is a hospitalist and physician lead for quality reporting at Virginia Mason Hospital in Seattle. He had no relevant disclosures.hospitalist and Physician Lead for Quality Reporting.

How pain management is evaluated in the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is changing, thanks in part to the advocacy efforts of the Society of Hospital Medicine’s public policy committee.

Based on input from SHM and other organizations, the Centers for Medicare & Medicaid Services decided that the way the survey was worded concerning pain management could be leading to unintended consequences, particularly in light of the opioid epidemic.

In a video interview recorded during HM17, John Biebelhausen, MD, MBA, discussed how SHM worked with the CMS to help “improve the HCAHPS survey to make a better patient satisfaction tool for our assessments and also eliminate some of the competing pressures the physician might face.”

Dr. Biebelhausen is a hospitalist and physician lead for quality reporting at Virginia Mason Hospital in Seattle. He had no relevant disclosures.hospitalist and Physician Lead for Quality Reporting.

What are some of the most common interruptions physicians face, and what simple solutions exist to help minimize the breaks in workflow?

Physicians are interrupted, on average, 15 times an hour, according to Roberta Himebaugh, a senior vice president at TeamHealth in Pleasanton, Calif., but as she explains in this video recorded at HM17, there are some simple, low-tech – and other – solutions that health systems can use to help hospitalists streamline workflow.

Vidyard Video

What are some of the most common interruptions physicians face, and what simple solutions exist to help minimize the breaks in workflow?

Physicians are interrupted, on average, 15 times an hour, according to Roberta Himebaugh, a senior vice president at TeamHealth in Pleasanton, Calif., but as she explains in this video recorded at HM17, there are some simple, low-tech – and other – solutions that health systems can use to help hospitalists streamline workflow.

Vidyard Video

What are some of the most common interruptions physicians face, and what simple solutions exist to help minimize the breaks in workflow?

Physicians are interrupted, on average, 15 times an hour, according to Roberta Himebaugh, a senior vice president at TeamHealth in Pleasanton, Calif., but as she explains in this video recorded at HM17, there are some simple, low-tech – and other – solutions that health systems can use to help hospitalists streamline workflow.

Vidyard Video

Value-based care’s ascendancy equals increased opportunities for hospitalists who know how to wield informatics, speak the language of systems improvement, and have an ability to function as a commodity within a health system, according to the dean of hospital medicine.

“If I were a betting man, I’d say there is no way value-based care can happen without hospitalists,” Robert Wachter, MD, MHM, said during a leadership summit at this year’s annual meeting of the Society of Hospital Medicine. Dr. Wachter is the New York Times bestselling author of “The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age.” He also is a professor and chair of the department of medicine at the University of California, San Francisco.

Darnell Scott

Value-based care’s ascendancy equals increased opportunities for hospitalists who know how to wield informatics, speak the language of systems improvement, and have an ability to function as a commodity within a health system, according to the dean of hospital medicine.

“If I were a betting man, I’d say there is no way value-based care can happen without hospitalists,” Robert Wachter, MD, MHM, said during a leadership summit at this year’s annual meeting of the Society of Hospital Medicine. Dr. Wachter is the New York Times bestselling author of “The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age.” He also is a professor and chair of the department of medicine at the University of California, San Francisco.

Darnell Scott

Value-based care’s ascendancy equals increased opportunities for hospitalists who know how to wield informatics, speak the language of systems improvement, and have an ability to function as a commodity within a health system, according to the dean of hospital medicine.

“If I were a betting man, I’d say there is no way value-based care can happen without hospitalists,” Robert Wachter, MD, MHM, said during a leadership summit at this year’s annual meeting of the Society of Hospital Medicine. Dr. Wachter is the New York Times bestselling author of “The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age.” He also is a professor and chair of the department of medicine at the University of California, San Francisco.

Darnell Scott

BOSTON – A group of aspiring innovators appeared before a panel of experts at the 2017 AGA Tech Summit Shark Tank event to make the case for how their novel device or technology could help advance the field of gastroenterology.

“The conversation that occurs here is really the start of other conversations we hope will continue out of this room and into the future to help everyone move their device or concept forward,” Michael L. Kochman, MD, AGAF, chair of the AGA Center for GI Innovation and Technology (CGIT), which sponsors the summit, told the assembled audience of potential investors, regulatory officials, and other innovators. Dr. Kochman also served as one of the “sharks” who sought to ask fundamental questions and identify potential gaps in each business plan in an ultimate attempt to make the product better and market ready. He was joined by V. Raman Muthusamy, MD, CGIT’s incoming chair, and director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, where he is also clinical professor of medicine in the division of digestive diseases. The panel also included Jeffrey M. Marks, MD, director of surgical endoscopy at University Hospitals Cleveland Medical Center, and Dennis McWilliams, president and chief commercial officer of Apollo Endosurgery, Inc.

Analyzing RNA biomarkers in stool samples

First to face the sharks was Erica Barnell, an MD/PhD candidate at the Washington University School of Medicine in St. Louis and the chief science officer of Geneoscopy, LLC. She and her collaborators have created a series of patent-pending methods to isolate and preserve neoplasia-associated RNA biomarkers in stool samples. The technology is expected to improve screening for colorectal cancer, which is the second leading cause of cancer-related deaths in the United States, with more than 50,000 deaths annually. The high mortality rate of colorectal cancer is due, in part, to flaws in existing methodologies to screen for the disease and because of a high rate of patient noncompliance with screening guidelines, according to Ms. Barnell.

Reducing risk of repetitive motion injuries

Prosper Abitbol, MD, a gastroenterologist in private practice in Boca Raton, Fla., seeks to limit the potential for harm to the clinician who performs hundreds – or more – of colorectal screening procedures annually. The EndoFeed™ device Dr. Abitbol and his team brought to the Shark Tank panel practically eliminates the need for repetitive, coordinated wrist and thumb movements when performing a colonoscopy.

The EndoFeed™ drive mechanism moves the instruments through the channel of the endoscope’s insertion tube, making it easy to complete the necessary insertion and extraction motions in biopsies without injury from repetitive motion.

Dr. Abitbol and his team also presented the EndoReVu™, which he said increases polyp detection during screening through the use of a mirror that is inserted through the instrument channel of the scope, and then provides reflective images with existing endoscope optics. The mirror is flexible to ensure there is no damage to surrounding tissue. Both devices presented by Dr. Abitbol are single use and disposable.

He concluded his presentation to the panel by saying, “I spend most of my day in the endoscopy suite every day, and I know what I need to do a better job ... I see [what] the reactions of other doctors and nurses are to this product, and I have no doubt these two products will play a major role in the endoscopy suite.”

However, while Dr. Abitbol was commended for considering the problem of operator fatigue in colonoscopies – something at least one audience member said was too often overlooked – the panel unanimously agreed that for Dr. Abitbol to move his products forward he would need to conduct some rigorous studies to show conclusive data that they improve levels of fatigue.

Identifying, classifying small polyps during a procedure

A vexing problem for clinicians is what to do after detecting a colonic polyp, since the majority of those found are not precancerous. Now, Rizkullah “Ray” Dogum, an MS/MBA candidate, and his colleagues are seeking to market a technology that reads the information gathered by elastic scattering spectroscopy to determine whether a sample is dysplastic, essentially creating the first in vivo definitive polyp classification method.

“Using elastic scattering spectroscopy technology, polyps with negligible malignant potential are detected and classified during the procedure, circumventing the routine track to pathology labs,” Mr. Dogum explained in an interview, noting that this adds up to hundreds of millions of dollars savings per year. An important fact, he said, since as our population ages it requires more screening. “As much as $1 billion could be saved annually if diminutive polyps could simply be diagnosed, resected, and discarded in lieu of histopathological processing,” Mr. Dogum said.

Currently being tested in several clinical trials that so far are yielding what Mr. Dogum says are “promising” results, especially when compared with chromoendoscopy and narrow-band imaging, the patented technology uses a white light that is transmitted through fiber optic cables that are integrated into both the snare and forceps tools; the back-reflection is detected by a computer, making polyp classification possible.

An advantage in practice for using the technology is that it does not require any significant alteration in the current standard practice for colonoscopy and does not disrupt the standard flow of work, meaning there is less training required, according to Mr. Dogum.

An audience member who identified himself as a regulator with the FDA told Mr. Dogum that over the years the agency has “struggled” with how to classify imaging technologies, because they are tools, but do not actually change practice, noting that whether to resect and discard is a clinical decision made at the physician’s discretion, not one determined by a device. He expressed his skepticism that the product would qualify as a Class II device but did suggest that it might qualify as a low-risk, de novo product, something that Mr. Dogum said in an interview following the presentation that he and his collaborators would be interested in pursuing.
 

Preventing endoscopic retrograde infections

Mining Big Data for algorithms that can detect endoscopic infection clusters is what Susan Hutfless, PhD, an epidemiologist and assistant professor in the division of gastroenterology and hepatology at Johns Hopkins University in Baltimore, told the shark panel she and her collaborators want to do using Medicare and Medicaid claims.

“Using Medicare and Medicaid billing data, our technology identifies endoscopic errors in a succinct and quantitative way,” Dr. Hutfless said in an interview. She explained that this benefits device manufacturers, health care facilities, and insurers. Included on the as-yet unnamed software program’s dashboard are a range of metrics that allows continuous monitoring of care, risk factors, and sources of infection, all to prevent serious outbreaks and the proliferation of illness.

Dr. Hutfless and her team came upon the idea after a string of deadly endoscope-related infectious outbreaks were linked to closed-channel duodenoscopes.

“We think that our technology helps move the field forward, because it provides a solution to contain endoscopically transmitted infections without re-engineering the endoscope,” Dr. Hutfless said. “For instance, there was an outbreak despite the use of a redesigned scope. Our technology is able to identify gaps in the care pathway that include the endoscope itself as well as the possible human factors that may be playing a role.”

Another plus, she told the panel, is that the product would not require FDA approval.

Despite data Dr. Hutfless said she and her collaborators will be presenting later this year at the annual Digestive Disease Week(R) that show a tight correlation between relevant claims data and data collected by the FDA during the infection outbreaks, the panel concluded that the stronger marketing potential for this product would be as a monitoring system, not a predictive one, used in combination with an engineering solution.
 

Simplifying LED incorporation in scopes

LED is only the fourth lighting technology ever invented, according to Thomas V. Root, president and CEO of Acera Inc. In an interview, Mr. Root said that while LEDs are “overtaking all major lighting markets,” medical device manufacturers have been slow to catch on.

“Acera moves the industry ahead with its elliptical optic that significantly improves the collection efficiency and distribution of the LED light. This optic, provided in a modular assembly, simplifies incorporation of LEDs in the practice of scope design and manufacture,” he said.

By eliminating the light guide tether, the use of LED increases mobility and the potential for low-cost or even single-use devices, Mr. Root said. “The result is that engineers are liberated to reimagine how endoscopes are designed.”

Because half of fires that occur in the endoscopy setting come from malfunctioning light sources, one of the sharks suggested that since the Acera product does not use the infrared wavelengths in its light, and its electrical cord remains cool to the touch while in use, Mr. Root and his colleagues should highlight that as a unique safety feature in their marketing materials.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

BOSTON – A group of aspiring innovators appeared before a panel of experts at the 2017 AGA Tech Summit Shark Tank event to make the case for how their novel device or technology could help advance the field of gastroenterology.

“The conversation that occurs here is really the start of other conversations we hope will continue out of this room and into the future to help everyone move their device or concept forward,” Michael L. Kochman, MD, AGAF, chair of the AGA Center for GI Innovation and Technology (CGIT), which sponsors the summit, told the assembled audience of potential investors, regulatory officials, and other innovators. Dr. Kochman also served as one of the “sharks” who sought to ask fundamental questions and identify potential gaps in each business plan in an ultimate attempt to make the product better and market ready. He was joined by V. Raman Muthusamy, MD, CGIT’s incoming chair, and director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, where he is also clinical professor of medicine in the division of digestive diseases. The panel also included Jeffrey M. Marks, MD, director of surgical endoscopy at University Hospitals Cleveland Medical Center, and Dennis McWilliams, president and chief commercial officer of Apollo Endosurgery, Inc.

Analyzing RNA biomarkers in stool samples

First to face the sharks was Erica Barnell, an MD/PhD candidate at the Washington University School of Medicine in St. Louis and the chief science officer of Geneoscopy, LLC. She and her collaborators have created a series of patent-pending methods to isolate and preserve neoplasia-associated RNA biomarkers in stool samples. The technology is expected to improve screening for colorectal cancer, which is the second leading cause of cancer-related deaths in the United States, with more than 50,000 deaths annually. The high mortality rate of colorectal cancer is due, in part, to flaws in existing methodologies to screen for the disease and because of a high rate of patient noncompliance with screening guidelines, according to Ms. Barnell.

Reducing risk of repetitive motion injuries

Prosper Abitbol, MD, a gastroenterologist in private practice in Boca Raton, Fla., seeks to limit the potential for harm to the clinician who performs hundreds – or more – of colorectal screening procedures annually. The EndoFeed™ device Dr. Abitbol and his team brought to the Shark Tank panel practically eliminates the need for repetitive, coordinated wrist and thumb movements when performing a colonoscopy.

The EndoFeed™ drive mechanism moves the instruments through the channel of the endoscope’s insertion tube, making it easy to complete the necessary insertion and extraction motions in biopsies without injury from repetitive motion.

Dr. Abitbol and his team also presented the EndoReVu™, which he said increases polyp detection during screening through the use of a mirror that is inserted through the instrument channel of the scope, and then provides reflective images with existing endoscope optics. The mirror is flexible to ensure there is no damage to surrounding tissue. Both devices presented by Dr. Abitbol are single use and disposable.

He concluded his presentation to the panel by saying, “I spend most of my day in the endoscopy suite every day, and I know what I need to do a better job ... I see [what] the reactions of other doctors and nurses are to this product, and I have no doubt these two products will play a major role in the endoscopy suite.”

However, while Dr. Abitbol was commended for considering the problem of operator fatigue in colonoscopies – something at least one audience member said was too often overlooked – the panel unanimously agreed that for Dr. Abitbol to move his products forward he would need to conduct some rigorous studies to show conclusive data that they improve levels of fatigue.

Identifying, classifying small polyps during a procedure

A vexing problem for clinicians is what to do after detecting a colonic polyp, since the majority of those found are not precancerous. Now, Rizkullah “Ray” Dogum, an MS/MBA candidate, and his colleagues are seeking to market a technology that reads the information gathered by elastic scattering spectroscopy to determine whether a sample is dysplastic, essentially creating the first in vivo definitive polyp classification method.

“Using elastic scattering spectroscopy technology, polyps with negligible malignant potential are detected and classified during the procedure, circumventing the routine track to pathology labs,” Mr. Dogum explained in an interview, noting that this adds up to hundreds of millions of dollars savings per year. An important fact, he said, since as our population ages it requires more screening. “As much as $1 billion could be saved annually if diminutive polyps could simply be diagnosed, resected, and discarded in lieu of histopathological processing,” Mr. Dogum said.

Currently being tested in several clinical trials that so far are yielding what Mr. Dogum says are “promising” results, especially when compared with chromoendoscopy and narrow-band imaging, the patented technology uses a white light that is transmitted through fiber optic cables that are integrated into both the snare and forceps tools; the back-reflection is detected by a computer, making polyp classification possible.

An advantage in practice for using the technology is that it does not require any significant alteration in the current standard practice for colonoscopy and does not disrupt the standard flow of work, meaning there is less training required, according to Mr. Dogum.

An audience member who identified himself as a regulator with the FDA told Mr. Dogum that over the years the agency has “struggled” with how to classify imaging technologies, because they are tools, but do not actually change practice, noting that whether to resect and discard is a clinical decision made at the physician’s discretion, not one determined by a device. He expressed his skepticism that the product would qualify as a Class II device but did suggest that it might qualify as a low-risk, de novo product, something that Mr. Dogum said in an interview following the presentation that he and his collaborators would be interested in pursuing.
 

Preventing endoscopic retrograde infections

Mining Big Data for algorithms that can detect endoscopic infection clusters is what Susan Hutfless, PhD, an epidemiologist and assistant professor in the division of gastroenterology and hepatology at Johns Hopkins University in Baltimore, told the shark panel she and her collaborators want to do using Medicare and Medicaid claims.

“Using Medicare and Medicaid billing data, our technology identifies endoscopic errors in a succinct and quantitative way,” Dr. Hutfless said in an interview. She explained that this benefits device manufacturers, health care facilities, and insurers. Included on the as-yet unnamed software program’s dashboard are a range of metrics that allows continuous monitoring of care, risk factors, and sources of infection, all to prevent serious outbreaks and the proliferation of illness.

Dr. Hutfless and her team came upon the idea after a string of deadly endoscope-related infectious outbreaks were linked to closed-channel duodenoscopes.

“We think that our technology helps move the field forward, because it provides a solution to contain endoscopically transmitted infections without re-engineering the endoscope,” Dr. Hutfless said. “For instance, there was an outbreak despite the use of a redesigned scope. Our technology is able to identify gaps in the care pathway that include the endoscope itself as well as the possible human factors that may be playing a role.”

Another plus, she told the panel, is that the product would not require FDA approval.

Despite data Dr. Hutfless said she and her collaborators will be presenting later this year at the annual Digestive Disease Week(R) that show a tight correlation between relevant claims data and data collected by the FDA during the infection outbreaks, the panel concluded that the stronger marketing potential for this product would be as a monitoring system, not a predictive one, used in combination with an engineering solution.
 

Simplifying LED incorporation in scopes

LED is only the fourth lighting technology ever invented, according to Thomas V. Root, president and CEO of Acera Inc. In an interview, Mr. Root said that while LEDs are “overtaking all major lighting markets,” medical device manufacturers have been slow to catch on.

“Acera moves the industry ahead with its elliptical optic that significantly improves the collection efficiency and distribution of the LED light. This optic, provided in a modular assembly, simplifies incorporation of LEDs in the practice of scope design and manufacture,” he said.

By eliminating the light guide tether, the use of LED increases mobility and the potential for low-cost or even single-use devices, Mr. Root said. “The result is that engineers are liberated to reimagine how endoscopes are designed.”

Because half of fires that occur in the endoscopy setting come from malfunctioning light sources, one of the sharks suggested that since the Acera product does not use the infrared wavelengths in its light, and its electrical cord remains cool to the touch while in use, Mr. Root and his colleagues should highlight that as a unique safety feature in their marketing materials.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

BOSTON – A group of aspiring innovators appeared before a panel of experts at the 2017 AGA Tech Summit Shark Tank event to make the case for how their novel device or technology could help advance the field of gastroenterology.

“The conversation that occurs here is really the start of other conversations we hope will continue out of this room and into the future to help everyone move their device or concept forward,” Michael L. Kochman, MD, AGAF, chair of the AGA Center for GI Innovation and Technology (CGIT), which sponsors the summit, told the assembled audience of potential investors, regulatory officials, and other innovators. Dr. Kochman also served as one of the “sharks” who sought to ask fundamental questions and identify potential gaps in each business plan in an ultimate attempt to make the product better and market ready. He was joined by V. Raman Muthusamy, MD, CGIT’s incoming chair, and director of interventional endoscopy and general GI endoscopy at the University of California, Los Angeles, where he is also clinical professor of medicine in the division of digestive diseases. The panel also included Jeffrey M. Marks, MD, director of surgical endoscopy at University Hospitals Cleveland Medical Center, and Dennis McWilliams, president and chief commercial officer of Apollo Endosurgery, Inc.

Analyzing RNA biomarkers in stool samples

First to face the sharks was Erica Barnell, an MD/PhD candidate at the Washington University School of Medicine in St. Louis and the chief science officer of Geneoscopy, LLC. She and her collaborators have created a series of patent-pending methods to isolate and preserve neoplasia-associated RNA biomarkers in stool samples. The technology is expected to improve screening for colorectal cancer, which is the second leading cause of cancer-related deaths in the United States, with more than 50,000 deaths annually. The high mortality rate of colorectal cancer is due, in part, to flaws in existing methodologies to screen for the disease and because of a high rate of patient noncompliance with screening guidelines, according to Ms. Barnell.

Reducing risk of repetitive motion injuries

Prosper Abitbol, MD, a gastroenterologist in private practice in Boca Raton, Fla., seeks to limit the potential for harm to the clinician who performs hundreds – or more – of colorectal screening procedures annually. The EndoFeed™ device Dr. Abitbol and his team brought to the Shark Tank panel practically eliminates the need for repetitive, coordinated wrist and thumb movements when performing a colonoscopy.

The EndoFeed™ drive mechanism moves the instruments through the channel of the endoscope’s insertion tube, making it easy to complete the necessary insertion and extraction motions in biopsies without injury from repetitive motion.

Dr. Abitbol and his team also presented the EndoReVu™, which he said increases polyp detection during screening through the use of a mirror that is inserted through the instrument channel of the scope, and then provides reflective images with existing endoscope optics. The mirror is flexible to ensure there is no damage to surrounding tissue. Both devices presented by Dr. Abitbol are single use and disposable.

He concluded his presentation to the panel by saying, “I spend most of my day in the endoscopy suite every day, and I know what I need to do a better job ... I see [what] the reactions of other doctors and nurses are to this product, and I have no doubt these two products will play a major role in the endoscopy suite.”

However, while Dr. Abitbol was commended for considering the problem of operator fatigue in colonoscopies – something at least one audience member said was too often overlooked – the panel unanimously agreed that for Dr. Abitbol to move his products forward he would need to conduct some rigorous studies to show conclusive data that they improve levels of fatigue.

Identifying, classifying small polyps during a procedure

A vexing problem for clinicians is what to do after detecting a colonic polyp, since the majority of those found are not precancerous. Now, Rizkullah “Ray” Dogum, an MS/MBA candidate, and his colleagues are seeking to market a technology that reads the information gathered by elastic scattering spectroscopy to determine whether a sample is dysplastic, essentially creating the first in vivo definitive polyp classification method.

“Using elastic scattering spectroscopy technology, polyps with negligible malignant potential are detected and classified during the procedure, circumventing the routine track to pathology labs,” Mr. Dogum explained in an interview, noting that this adds up to hundreds of millions of dollars savings per year. An important fact, he said, since as our population ages it requires more screening. “As much as $1 billion could be saved annually if diminutive polyps could simply be diagnosed, resected, and discarded in lieu of histopathological processing,” Mr. Dogum said.

Currently being tested in several clinical trials that so far are yielding what Mr. Dogum says are “promising” results, especially when compared with chromoendoscopy and narrow-band imaging, the patented technology uses a white light that is transmitted through fiber optic cables that are integrated into both the snare and forceps tools; the back-reflection is detected by a computer, making polyp classification possible.

An advantage in practice for using the technology is that it does not require any significant alteration in the current standard practice for colonoscopy and does not disrupt the standard flow of work, meaning there is less training required, according to Mr. Dogum.

An audience member who identified himself as a regulator with the FDA told Mr. Dogum that over the years the agency has “struggled” with how to classify imaging technologies, because they are tools, but do not actually change practice, noting that whether to resect and discard is a clinical decision made at the physician’s discretion, not one determined by a device. He expressed his skepticism that the product would qualify as a Class II device but did suggest that it might qualify as a low-risk, de novo product, something that Mr. Dogum said in an interview following the presentation that he and his collaborators would be interested in pursuing.
 

Preventing endoscopic retrograde infections

Mining Big Data for algorithms that can detect endoscopic infection clusters is what Susan Hutfless, PhD, an epidemiologist and assistant professor in the division of gastroenterology and hepatology at Johns Hopkins University in Baltimore, told the shark panel she and her collaborators want to do using Medicare and Medicaid claims.

“Using Medicare and Medicaid billing data, our technology identifies endoscopic errors in a succinct and quantitative way,” Dr. Hutfless said in an interview. She explained that this benefits device manufacturers, health care facilities, and insurers. Included on the as-yet unnamed software program’s dashboard are a range of metrics that allows continuous monitoring of care, risk factors, and sources of infection, all to prevent serious outbreaks and the proliferation of illness.

Dr. Hutfless and her team came upon the idea after a string of deadly endoscope-related infectious outbreaks were linked to closed-channel duodenoscopes.

“We think that our technology helps move the field forward, because it provides a solution to contain endoscopically transmitted infections without re-engineering the endoscope,” Dr. Hutfless said. “For instance, there was an outbreak despite the use of a redesigned scope. Our technology is able to identify gaps in the care pathway that include the endoscope itself as well as the possible human factors that may be playing a role.”

Another plus, she told the panel, is that the product would not require FDA approval.

Despite data Dr. Hutfless said she and her collaborators will be presenting later this year at the annual Digestive Disease Week(R) that show a tight correlation between relevant claims data and data collected by the FDA during the infection outbreaks, the panel concluded that the stronger marketing potential for this product would be as a monitoring system, not a predictive one, used in combination with an engineering solution.
 

Simplifying LED incorporation in scopes

LED is only the fourth lighting technology ever invented, according to Thomas V. Root, president and CEO of Acera Inc. In an interview, Mr. Root said that while LEDs are “overtaking all major lighting markets,” medical device manufacturers have been slow to catch on.

“Acera moves the industry ahead with its elliptical optic that significantly improves the collection efficiency and distribution of the LED light. This optic, provided in a modular assembly, simplifies incorporation of LEDs in the practice of scope design and manufacture,” he said.

By eliminating the light guide tether, the use of LED increases mobility and the potential for low-cost or even single-use devices, Mr. Root said. “The result is that engineers are liberated to reimagine how endoscopes are designed.”

Because half of fires that occur in the endoscopy setting come from malfunctioning light sources, one of the sharks suggested that since the Acera product does not use the infrared wavelengths in its light, and its electrical cord remains cool to the touch while in use, Mr. Root and his colleagues should highlight that as a unique safety feature in their marketing materials.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

The White House pick for the newly created post of mental health czar has raised some hackles on Capitol Hill.

President Donald Trump recently announced that Elinore “Ellie” F. McCance-Katz, MD, PhD, a psychiatrist whose career has focused on substance abuse and addiction, was his nominee to serve as nation’s first assistant secretary for mental health and substance use. In 2013, Dr. McCance-Katz served as the Substance Abuse and Mental Health Services Administration’s first chief medical officer. She resigned after 2 years.

The choice does not sit well with Rep. Tim Murphy (R-Pa.), whose landmark legislation, Helping Families in Mental Health Crisis – ultimately passed as part of the bipartisan 21st Century Cures Act – created the cabinet-level post to help end what many have seen as SAMHSA’s poor performance in meeting the nation’s mental health needs.

“I am stunned the president put forth a nominee who served in a key post at SAMHSA under the previous administration when the agency was actively opposing the transformative changes in H.R. 3717, the original version of my Helping Families in Mental Health Crisis Act,” Rep. Murphy said in a statement. “After an intensive investigation bringing to light the many leadership failures across the federal government, but particularly at SAMHSA, I drafted strong legislation to fix the broken mental health system. One of the most critical reforms was restructuring the agency, focusing on evidence-based models of care and establishing an assistant secretary within [the Department of Health & Human Services] to put an end to what the Government Accountability Office termed a lack of leadership.”

Key provisions of the legislation include clearer HIPAA language, expanded access to inpatient psychiatric hospital beds, and a stronger and more streamlined federal commitment to evidence-based practices in mental and behavioral health care delivery.

The American Psychiatric Association, however, endorsed the nomination and called for swift confirmation by the Senate. “We look forward to working with her to improve the quality of care of mental health and substance use disorders,” APA CEO and Medical Director Saul Levin, MD, said in a statement.

Currently, Dr. McCance-Katz is the chief medical officer for Rhode Island’s department of behavioral health care, developmental disabilities, and hospitals. Dr. McCance-Katz, widely regarded as an expert in medication-assisted treatment for substance use disorders, among other addiction-related specialties, also is a former California department of alcohol and drug programs state medical director.

Since leaving her previous post at SAMHSA, Dr. McCance-Katz has been an outspoken critic of the agency she is now being tapped to run. She once editorialized against what she called its poor performance in addressing the needs of people with serious mental illness and its “hostility toward psychiatric medicine.”

Rep. Murphy’s own reported preference for the role was Michael Welner, MD, a forensic psychiatrist upon whom the congressman – himself a clinical psychologist – relied on in part to help craft his mental health legislation. According to mental health blogger Pete Early – who often writes about his son’s struggles with bipolar disorder – the announcement is a surprise to many who expected Dr. Welner to be the pick. On his blog, Mr. Early wrote that Senate sources had told him that Dr. Welner, who publicly supports President Trump, “had a lock on the job.”

Several other names were floated for the position, according to Mr. Early, including John Wernert, MD, who served as head of Indiana’s mental health policy under then-governor, Vice President Mike Pence, and Miami-Dade County, Fla., Judge Steve Leifman, known for his interest in diverting those with serious mental illness from the criminal justice system and into treatment. However, the judge did not have an advanced medical degree, as stipulated by the law, a provision pushed by Rep. Murphy to safeguard against what he said was SAMHSA’s antipsychiatry stance.

In an APA blog post, APA President Maria A. Oquendo, MD, PhD, said Dr. McCance-Katz would “bring a wealth of knowledge in the prevention, treatment, and recovery of substance use disorders” that challenge the United States. “APA strongly supports her appointment.”

Dr. McCance-Katz’s nomination will go before the Senate’s Committee on Health, Education, Labor, and Pensions, which is chaired by Sen. Lamar Alexander (R-Tenn.). His office said the senator “looks forward to learning more about how Dr. McCance-Katz would use her experience in medicine and government to implement the new mental health law passed last Congress to help the one in five adults in this country suffering from a mental illness receive the treatment they need.”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

The White House pick for the newly created post of mental health czar has raised some hackles on Capitol Hill.

President Donald Trump recently announced that Elinore “Ellie” F. McCance-Katz, MD, PhD, a psychiatrist whose career has focused on substance abuse and addiction, was his nominee to serve as nation’s first assistant secretary for mental health and substance use. In 2013, Dr. McCance-Katz served as the Substance Abuse and Mental Health Services Administration’s first chief medical officer. She resigned after 2 years.

The choice does not sit well with Rep. Tim Murphy (R-Pa.), whose landmark legislation, Helping Families in Mental Health Crisis – ultimately passed as part of the bipartisan 21st Century Cures Act – created the cabinet-level post to help end what many have seen as SAMHSA’s poor performance in meeting the nation’s mental health needs.

“I am stunned the president put forth a nominee who served in a key post at SAMHSA under the previous administration when the agency was actively opposing the transformative changes in H.R. 3717, the original version of my Helping Families in Mental Health Crisis Act,” Rep. Murphy said in a statement. “After an intensive investigation bringing to light the many leadership failures across the federal government, but particularly at SAMHSA, I drafted strong legislation to fix the broken mental health system. One of the most critical reforms was restructuring the agency, focusing on evidence-based models of care and establishing an assistant secretary within [the Department of Health & Human Services] to put an end to what the Government Accountability Office termed a lack of leadership.”

Key provisions of the legislation include clearer HIPAA language, expanded access to inpatient psychiatric hospital beds, and a stronger and more streamlined federal commitment to evidence-based practices in mental and behavioral health care delivery.

The American Psychiatric Association, however, endorsed the nomination and called for swift confirmation by the Senate. “We look forward to working with her to improve the quality of care of mental health and substance use disorders,” APA CEO and Medical Director Saul Levin, MD, said in a statement.

Currently, Dr. McCance-Katz is the chief medical officer for Rhode Island’s department of behavioral health care, developmental disabilities, and hospitals. Dr. McCance-Katz, widely regarded as an expert in medication-assisted treatment for substance use disorders, among other addiction-related specialties, also is a former California department of alcohol and drug programs state medical director.

Since leaving her previous post at SAMHSA, Dr. McCance-Katz has been an outspoken critic of the agency she is now being tapped to run. She once editorialized against what she called its poor performance in addressing the needs of people with serious mental illness and its “hostility toward psychiatric medicine.”

Rep. Murphy’s own reported preference for the role was Michael Welner, MD, a forensic psychiatrist upon whom the congressman – himself a clinical psychologist – relied on in part to help craft his mental health legislation. According to mental health blogger Pete Early – who often writes about his son’s struggles with bipolar disorder – the announcement is a surprise to many who expected Dr. Welner to be the pick. On his blog, Mr. Early wrote that Senate sources had told him that Dr. Welner, who publicly supports President Trump, “had a lock on the job.”

Several other names were floated for the position, according to Mr. Early, including John Wernert, MD, who served as head of Indiana’s mental health policy under then-governor, Vice President Mike Pence, and Miami-Dade County, Fla., Judge Steve Leifman, known for his interest in diverting those with serious mental illness from the criminal justice system and into treatment. However, the judge did not have an advanced medical degree, as stipulated by the law, a provision pushed by Rep. Murphy to safeguard against what he said was SAMHSA’s antipsychiatry stance.

In an APA blog post, APA President Maria A. Oquendo, MD, PhD, said Dr. McCance-Katz would “bring a wealth of knowledge in the prevention, treatment, and recovery of substance use disorders” that challenge the United States. “APA strongly supports her appointment.”

Dr. McCance-Katz’s nomination will go before the Senate’s Committee on Health, Education, Labor, and Pensions, which is chaired by Sen. Lamar Alexander (R-Tenn.). His office said the senator “looks forward to learning more about how Dr. McCance-Katz would use her experience in medicine and government to implement the new mental health law passed last Congress to help the one in five adults in this country suffering from a mental illness receive the treatment they need.”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

The White House pick for the newly created post of mental health czar has raised some hackles on Capitol Hill.

President Donald Trump recently announced that Elinore “Ellie” F. McCance-Katz, MD, PhD, a psychiatrist whose career has focused on substance abuse and addiction, was his nominee to serve as nation’s first assistant secretary for mental health and substance use. In 2013, Dr. McCance-Katz served as the Substance Abuse and Mental Health Services Administration’s first chief medical officer. She resigned after 2 years.

The choice does not sit well with Rep. Tim Murphy (R-Pa.), whose landmark legislation, Helping Families in Mental Health Crisis – ultimately passed as part of the bipartisan 21st Century Cures Act – created the cabinet-level post to help end what many have seen as SAMHSA’s poor performance in meeting the nation’s mental health needs.

“I am stunned the president put forth a nominee who served in a key post at SAMHSA under the previous administration when the agency was actively opposing the transformative changes in H.R. 3717, the original version of my Helping Families in Mental Health Crisis Act,” Rep. Murphy said in a statement. “After an intensive investigation bringing to light the many leadership failures across the federal government, but particularly at SAMHSA, I drafted strong legislation to fix the broken mental health system. One of the most critical reforms was restructuring the agency, focusing on evidence-based models of care and establishing an assistant secretary within [the Department of Health & Human Services] to put an end to what the Government Accountability Office termed a lack of leadership.”

Key provisions of the legislation include clearer HIPAA language, expanded access to inpatient psychiatric hospital beds, and a stronger and more streamlined federal commitment to evidence-based practices in mental and behavioral health care delivery.

The American Psychiatric Association, however, endorsed the nomination and called for swift confirmation by the Senate. “We look forward to working with her to improve the quality of care of mental health and substance use disorders,” APA CEO and Medical Director Saul Levin, MD, said in a statement.

Currently, Dr. McCance-Katz is the chief medical officer for Rhode Island’s department of behavioral health care, developmental disabilities, and hospitals. Dr. McCance-Katz, widely regarded as an expert in medication-assisted treatment for substance use disorders, among other addiction-related specialties, also is a former California department of alcohol and drug programs state medical director.

Since leaving her previous post at SAMHSA, Dr. McCance-Katz has been an outspoken critic of the agency she is now being tapped to run. She once editorialized against what she called its poor performance in addressing the needs of people with serious mental illness and its “hostility toward psychiatric medicine.”

Rep. Murphy’s own reported preference for the role was Michael Welner, MD, a forensic psychiatrist upon whom the congressman – himself a clinical psychologist – relied on in part to help craft his mental health legislation. According to mental health blogger Pete Early – who often writes about his son’s struggles with bipolar disorder – the announcement is a surprise to many who expected Dr. Welner to be the pick. On his blog, Mr. Early wrote that Senate sources had told him that Dr. Welner, who publicly supports President Trump, “had a lock on the job.”

Several other names were floated for the position, according to Mr. Early, including John Wernert, MD, who served as head of Indiana’s mental health policy under then-governor, Vice President Mike Pence, and Miami-Dade County, Fla., Judge Steve Leifman, known for his interest in diverting those with serious mental illness from the criminal justice system and into treatment. However, the judge did not have an advanced medical degree, as stipulated by the law, a provision pushed by Rep. Murphy to safeguard against what he said was SAMHSA’s antipsychiatry stance.

In an APA blog post, APA President Maria A. Oquendo, MD, PhD, said Dr. McCance-Katz would “bring a wealth of knowledge in the prevention, treatment, and recovery of substance use disorders” that challenge the United States. “APA strongly supports her appointment.”

Dr. McCance-Katz’s nomination will go before the Senate’s Committee on Health, Education, Labor, and Pensions, which is chaired by Sen. Lamar Alexander (R-Tenn.). His office said the senator “looks forward to learning more about how Dr. McCance-Katz would use her experience in medicine and government to implement the new mental health law passed last Congress to help the one in five adults in this country suffering from a mental illness receive the treatment they need.”

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

BOSTON – Fundamental questions remain over how best to use personalized medicine to predict and treat a variety of GI cancers, according to a panel of expert speakers at the 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“There are no rules presently, but we’re hoping to define some of the problems,” Abigail T. Berman, MD, MSCE, associate clinical director of the Penn Center for Precision Medicine in Philadelphia and associate professor of radiation oncology, told the audience. “To know how we’re going to pay for it, we need to define it.”

Emerging technologies: Worth the cost?

Among the growing number of novel predictive tools for clinical use is the liquid biopsy. Mechanical engineer Shannon Stott, PhD, assistant professor of medicine at Harvard Medical School, Boston, described how she applies her knowledge of microfluidics, optics, tissue engineering, and cryopreservation to clinical medicine and cell biology. She is the coinventor of the Herringbone Circulating Tumor Cell Chip, a liquid biopsy device that captures cancer cells circulating in the bloodstream of localized and metastatic cancer patients. By observing the biology of these extremely rare cells, she and her collaborators are helping identify novel pathways for metastasis.

Cost will drive innovation

Because precision medicine is high tech, it’s commonly assumed that it will prove too expensive to benefit the health of a population. Seen from a prevention perspective, however, that assumption is not necessarily true. Still, skepticism about the cost of precision medicine remains, Dr. Berman, citing an in-submission article she coauthored that compared standard to targeted therapy, said that for every $1,000 spent on targeted therapy, patients lived an average of 0.129 months vs. about 0.126 per $1,000 spent on standard therapies.

“Maybe we’re not saving payers money, but the field is not necessarily spending more and the patients are living longer,” she said. “This might be difficult to think about in front of the patient, but on the societal level, as reimbursements are decreasing, these are value-based therapies.”

Perhaps the biggest hurdle to establishing how to incorporate precision medicine into practice is data collection. Payers are starting to request multiple data streams to determine when a test or procedure is medically necessary or investigational. Other questions are what should be done when a test or procedure does not fit current evidentiary standards and at what point should it become exploratory. “The bottom line is that there is no consensus as to what payers should routinely reimburse,” she said.

In terms of managing the cost of targeted therapies, current debate seems to focus on a few potential solutions, according to Dr. Berman. One example is to develop a special entity that will pay for precision medicines up front, then the patient pays back the amount over time, with interest. Another possible solution is to spread the cost over large pools of individuals, rather than over large employee pools, similar to the way catastrophic insurance is currently structured. An additional critical approach is to conduct research using novel clinical trial designs, such as “basket” trials, where different tumors with the same mutation are given a similar targeted therapy. And yet another important approach is to standardize testing as much as possible to cut the cost of deviations in screening and treatment pathways.

Regardless of the solution, Dr. Berman said that at the heart of precision medicine should be ensuring that every patient is being treated in the most effective and value-based way.

–Heidi Splete contributed to this article.

BOSTON – Fundamental questions remain over how best to use personalized medicine to predict and treat a variety of GI cancers, according to a panel of expert speakers at the 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“There are no rules presently, but we’re hoping to define some of the problems,” Abigail T. Berman, MD, MSCE, associate clinical director of the Penn Center for Precision Medicine in Philadelphia and associate professor of radiation oncology, told the audience. “To know how we’re going to pay for it, we need to define it.”

Emerging technologies: Worth the cost?

Among the growing number of novel predictive tools for clinical use is the liquid biopsy. Mechanical engineer Shannon Stott, PhD, assistant professor of medicine at Harvard Medical School, Boston, described how she applies her knowledge of microfluidics, optics, tissue engineering, and cryopreservation to clinical medicine and cell biology. She is the coinventor of the Herringbone Circulating Tumor Cell Chip, a liquid biopsy device that captures cancer cells circulating in the bloodstream of localized and metastatic cancer patients. By observing the biology of these extremely rare cells, she and her collaborators are helping identify novel pathways for metastasis.

Cost will drive innovation

Because precision medicine is high tech, it’s commonly assumed that it will prove too expensive to benefit the health of a population. Seen from a prevention perspective, however, that assumption is not necessarily true. Still, skepticism about the cost of precision medicine remains, Dr. Berman, citing an in-submission article she coauthored that compared standard to targeted therapy, said that for every $1,000 spent on targeted therapy, patients lived an average of 0.129 months vs. about 0.126 per $1,000 spent on standard therapies.

“Maybe we’re not saving payers money, but the field is not necessarily spending more and the patients are living longer,” she said. “This might be difficult to think about in front of the patient, but on the societal level, as reimbursements are decreasing, these are value-based therapies.”

Perhaps the biggest hurdle to establishing how to incorporate precision medicine into practice is data collection. Payers are starting to request multiple data streams to determine when a test or procedure is medically necessary or investigational. Other questions are what should be done when a test or procedure does not fit current evidentiary standards and at what point should it become exploratory. “The bottom line is that there is no consensus as to what payers should routinely reimburse,” she said.

In terms of managing the cost of targeted therapies, current debate seems to focus on a few potential solutions, according to Dr. Berman. One example is to develop a special entity that will pay for precision medicines up front, then the patient pays back the amount over time, with interest. Another possible solution is to spread the cost over large pools of individuals, rather than over large employee pools, similar to the way catastrophic insurance is currently structured. An additional critical approach is to conduct research using novel clinical trial designs, such as “basket” trials, where different tumors with the same mutation are given a similar targeted therapy. And yet another important approach is to standardize testing as much as possible to cut the cost of deviations in screening and treatment pathways.

Regardless of the solution, Dr. Berman said that at the heart of precision medicine should be ensuring that every patient is being treated in the most effective and value-based way.

–Heidi Splete contributed to this article.

BOSTON – Fundamental questions remain over how best to use personalized medicine to predict and treat a variety of GI cancers, according to a panel of expert speakers at the 2017 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“There are no rules presently, but we’re hoping to define some of the problems,” Abigail T. Berman, MD, MSCE, associate clinical director of the Penn Center for Precision Medicine in Philadelphia and associate professor of radiation oncology, told the audience. “To know how we’re going to pay for it, we need to define it.”

Emerging technologies: Worth the cost?

Among the growing number of novel predictive tools for clinical use is the liquid biopsy. Mechanical engineer Shannon Stott, PhD, assistant professor of medicine at Harvard Medical School, Boston, described how she applies her knowledge of microfluidics, optics, tissue engineering, and cryopreservation to clinical medicine and cell biology. She is the coinventor of the Herringbone Circulating Tumor Cell Chip, a liquid biopsy device that captures cancer cells circulating in the bloodstream of localized and metastatic cancer patients. By observing the biology of these extremely rare cells, she and her collaborators are helping identify novel pathways for metastasis.

Cost will drive innovation

Because precision medicine is high tech, it’s commonly assumed that it will prove too expensive to benefit the health of a population. Seen from a prevention perspective, however, that assumption is not necessarily true. Still, skepticism about the cost of precision medicine remains, Dr. Berman, citing an in-submission article she coauthored that compared standard to targeted therapy, said that for every $1,000 spent on targeted therapy, patients lived an average of 0.129 months vs. about 0.126 per $1,000 spent on standard therapies.

“Maybe we’re not saving payers money, but the field is not necessarily spending more and the patients are living longer,” she said. “This might be difficult to think about in front of the patient, but on the societal level, as reimbursements are decreasing, these are value-based therapies.”

Perhaps the biggest hurdle to establishing how to incorporate precision medicine into practice is data collection. Payers are starting to request multiple data streams to determine when a test or procedure is medically necessary or investigational. Other questions are what should be done when a test or procedure does not fit current evidentiary standards and at what point should it become exploratory. “The bottom line is that there is no consensus as to what payers should routinely reimburse,” she said.

In terms of managing the cost of targeted therapies, current debate seems to focus on a few potential solutions, according to Dr. Berman. One example is to develop a special entity that will pay for precision medicines up front, then the patient pays back the amount over time, with interest. Another possible solution is to spread the cost over large pools of individuals, rather than over large employee pools, similar to the way catastrophic insurance is currently structured. An additional critical approach is to conduct research using novel clinical trial designs, such as “basket” trials, where different tumors with the same mutation are given a similar targeted therapy. And yet another important approach is to standardize testing as much as possible to cut the cost of deviations in screening and treatment pathways.

Regardless of the solution, Dr. Berman said that at the heart of precision medicine should be ensuring that every patient is being treated in the most effective and value-based way.

–Heidi Splete contributed to this article.

BOSTON – Gastroenterology is becoming a game of risk: It’s either learn to leverage risk through the creation of advanced alternative payment methods (APM) under Medicare’s new Quality Payment Program or risk losing money through the commoditization of the field, according to an expert.

“Our culture right now is one where we get paid for making widgets,” said Lawrence Kosinski, MD, a practice councilor on the American Gastroenterological Association Governing Board and former chairman of its Practice Management and Economics Committee. He made his remarks in an interview in advance of his presentation at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “The more colonoscopies we do, the more money we make. The more we can charge for those colonoscopies and get collected, the better things are for us.”

Eli Zimmerman/Frontline Medical News

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

BOSTON – Gastroenterology is becoming a game of risk: It’s either learn to leverage risk through the creation of advanced alternative payment methods (APM) under Medicare’s new Quality Payment Program or risk losing money through the commoditization of the field, according to an expert.

“Our culture right now is one where we get paid for making widgets,” said Lawrence Kosinski, MD, a practice councilor on the American Gastroenterological Association Governing Board and former chairman of its Practice Management and Economics Committee. He made his remarks in an interview in advance of his presentation at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “The more colonoscopies we do, the more money we make. The more we can charge for those colonoscopies and get collected, the better things are for us.”

Eli Zimmerman/Frontline Medical News

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

BOSTON – Gastroenterology is becoming a game of risk: It’s either learn to leverage risk through the creation of advanced alternative payment methods (APM) under Medicare’s new Quality Payment Program or risk losing money through the commoditization of the field, according to an expert.

“Our culture right now is one where we get paid for making widgets,” said Lawrence Kosinski, MD, a practice councilor on the American Gastroenterological Association Governing Board and former chairman of its Practice Management and Economics Committee. He made his remarks in an interview in advance of his presentation at the 2017 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “The more colonoscopies we do, the more money we make. The more we can charge for those colonoscopies and get collected, the better things are for us.”

Eli Zimmerman/Frontline Medical News

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

The Food and Drug Administration is restricting the use of two opiates – codeine and tramadol – in children, and also warns they are potentially dangerous to infants of breastfeeding women.

Codeine is approved to treat pain and cough; tramadol is approved to treat pain.

“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Douglas Throckmorton, MD, the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, said in a statement.

In the current safety statement, the FDA said it will require additional labeling changes, including contraindications for use of codeine or tramadol in all children younger than 12 years of age and a new contraindication for tramadol in children younger than 18 years being treated for pain after tonsillectomy and/or adenoidectomy, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.

Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults, the agency noted.

The agency cited particular concerns over those who are “ultra-rapid metabolizers” of substrates of the cytochrome P450 isoenzyme 2D6 (CYP2D6) genotype. These people more quickly convert codeine into potentially dangerously high levels of morphine, which can lead to fatal respiratory depression.

Supporting the restrictions and warning were data on 64 cases of respiratory depression that occurred worldwide between 1969 and 2015, when a codeine-based medicine was used in children younger than 18 years. Twenty-four of these children died.

The most frequently cited medicines in the cases were acetaminophen with codeine and promethazine with codeine with or without phenylephrine, either given to soothe postoperative pain, general pain, sore or strep throat pain, or cough and cold.

Ten of the 64 cases implicated the CYP2D6 genotype. Seven of the patients were “ultrarapid metabolizers,” five of whom died.

Data cited on tramadol included nine worldwide cases of tramadol-related respiratory depression occurring between 1969 and 2016, resulting in the deaths of three children, all under the age of 6 years, and all of whom were taking the drug for postoperative pain or fever.

All but one case of respiratory depression occurred within the first 24 hours of taking the drug. One of the patients was genotyped for CYP2D6, and found to have three functional alleles consistent with ultrarapid metabolism.

Mothers who are ultrarapid metabolizers of codeine can have high levels of morphine in their breast milk that are dangerous to their breastfed infants, whereas there is less of a threat posed by women with normal codeine metabolism because the amount of codeine secreted into the breast milk is low and dose dependent.

The FDA stated that data reveal numerous reports of respiratory depression and at least one death in infants of breastfeeding mothers taking these medicines, particularly mothers with the CYP2D6 genotype. Although there are FDA-cleared tests for ultrarapid metabolism, they are not commonly used.

The agency stated that breastfeeding women taking any opioid pain medicine, including codeine or tramadol should contact their health care provider if they notice the infant is sleeping more than 4 hours at a time, or if the infant is having difficulty breastfeeding or seems limp.

Clinicians are urged to report side effects that occur while using codeine or tramadol to the FDA’s MedWatch Adverse Event Reporting program.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

The Food and Drug Administration is restricting the use of two opiates – codeine and tramadol – in children, and also warns they are potentially dangerous to infants of breastfeeding women.

Codeine is approved to treat pain and cough; tramadol is approved to treat pain.

“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Douglas Throckmorton, MD, the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, said in a statement.

In the current safety statement, the FDA said it will require additional labeling changes, including contraindications for use of codeine or tramadol in all children younger than 12 years of age and a new contraindication for tramadol in children younger than 18 years being treated for pain after tonsillectomy and/or adenoidectomy, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.

Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults, the agency noted.

The agency cited particular concerns over those who are “ultra-rapid metabolizers” of substrates of the cytochrome P450 isoenzyme 2D6 (CYP2D6) genotype. These people more quickly convert codeine into potentially dangerously high levels of morphine, which can lead to fatal respiratory depression.

Supporting the restrictions and warning were data on 64 cases of respiratory depression that occurred worldwide between 1969 and 2015, when a codeine-based medicine was used in children younger than 18 years. Twenty-four of these children died.

The most frequently cited medicines in the cases were acetaminophen with codeine and promethazine with codeine with or without phenylephrine, either given to soothe postoperative pain, general pain, sore or strep throat pain, or cough and cold.

Ten of the 64 cases implicated the CYP2D6 genotype. Seven of the patients were “ultrarapid metabolizers,” five of whom died.

Data cited on tramadol included nine worldwide cases of tramadol-related respiratory depression occurring between 1969 and 2016, resulting in the deaths of three children, all under the age of 6 years, and all of whom were taking the drug for postoperative pain or fever.

All but one case of respiratory depression occurred within the first 24 hours of taking the drug. One of the patients was genotyped for CYP2D6, and found to have three functional alleles consistent with ultrarapid metabolism.

Mothers who are ultrarapid metabolizers of codeine can have high levels of morphine in their breast milk that are dangerous to their breastfed infants, whereas there is less of a threat posed by women with normal codeine metabolism because the amount of codeine secreted into the breast milk is low and dose dependent.

The FDA stated that data reveal numerous reports of respiratory depression and at least one death in infants of breastfeeding mothers taking these medicines, particularly mothers with the CYP2D6 genotype. Although there are FDA-cleared tests for ultrarapid metabolism, they are not commonly used.

The agency stated that breastfeeding women taking any opioid pain medicine, including codeine or tramadol should contact their health care provider if they notice the infant is sleeping more than 4 hours at a time, or if the infant is having difficulty breastfeeding or seems limp.

Clinicians are urged to report side effects that occur while using codeine or tramadol to the FDA’s MedWatch Adverse Event Reporting program.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

The Food and Drug Administration is restricting the use of two opiates – codeine and tramadol – in children, and also warns they are potentially dangerous to infants of breastfeeding women.

Codeine is approved to treat pain and cough; tramadol is approved to treat pain.

“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Douglas Throckmorton, MD, the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, said in a statement.

In the current safety statement, the FDA said it will require additional labeling changes, including contraindications for use of codeine or tramadol in all children younger than 12 years of age and a new contraindication for tramadol in children younger than 18 years being treated for pain after tonsillectomy and/or adenoidectomy, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.

Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults, the agency noted.

The agency cited particular concerns over those who are “ultra-rapid metabolizers” of substrates of the cytochrome P450 isoenzyme 2D6 (CYP2D6) genotype. These people more quickly convert codeine into potentially dangerously high levels of morphine, which can lead to fatal respiratory depression.

Supporting the restrictions and warning were data on 64 cases of respiratory depression that occurred worldwide between 1969 and 2015, when a codeine-based medicine was used in children younger than 18 years. Twenty-four of these children died.

The most frequently cited medicines in the cases were acetaminophen with codeine and promethazine with codeine with or without phenylephrine, either given to soothe postoperative pain, general pain, sore or strep throat pain, or cough and cold.

Ten of the 64 cases implicated the CYP2D6 genotype. Seven of the patients were “ultrarapid metabolizers,” five of whom died.

Data cited on tramadol included nine worldwide cases of tramadol-related respiratory depression occurring between 1969 and 2016, resulting in the deaths of three children, all under the age of 6 years, and all of whom were taking the drug for postoperative pain or fever.

All but one case of respiratory depression occurred within the first 24 hours of taking the drug. One of the patients was genotyped for CYP2D6, and found to have three functional alleles consistent with ultrarapid metabolism.

Mothers who are ultrarapid metabolizers of codeine can have high levels of morphine in their breast milk that are dangerous to their breastfed infants, whereas there is less of a threat posed by women with normal codeine metabolism because the amount of codeine secreted into the breast milk is low and dose dependent.

The FDA stated that data reveal numerous reports of respiratory depression and at least one death in infants of breastfeeding mothers taking these medicines, particularly mothers with the CYP2D6 genotype. Although there are FDA-cleared tests for ultrarapid metabolism, they are not commonly used.

The agency stated that breastfeeding women taking any opioid pain medicine, including codeine or tramadol should contact their health care provider if they notice the infant is sleeping more than 4 hours at a time, or if the infant is having difficulty breastfeeding or seems limp.

Clinicians are urged to report side effects that occur while using codeine or tramadol to the FDA’s MedWatch Adverse Event Reporting program.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – The treatment of preadolescents who present with gender questions is often complicated by the absence of evidence-based data on who is most likely to remain gender dysphoric into adulthood and who is not, an expert said at the annual meeting of the American College of Psychiatrists.

“There are some [clinicians] who believe they can predict who will persist and who will not. But they have not published, to my satisfaction, a way to show anyone else how to tell the difference,” said Jack Drescher, MD, a member of the World Health Organization’s (WHO’s) Working Group on the Classification of Sexual Disorders and Sexual Health and clinical professor of psychiatry and behavioral sciences at New York Medical College, Valhalla.

Whitney McKnight/Frontline Medical News

Gender-related glossary of terms

"There are so many moving parts to our understanding of gender," said Jack Drescher, MD, during a plenary session at the annual meeting of the American College of Psychiatrists. For that reason, "language is very important" when addressing children who might have questions about their gender identity, he said.

To help establish as much clarity as possible when discussing gender in the clinical setting, Dr. Drescher offered the following glossary of terms. These are not listed alphabetically but in a stepwise fashion aimed at leading to a clearer understanding of successive terms.
 
Sex: The biological attributes of being male or female. This includes sex chromosomes, gonads, sex hormones, and nonambiguous internal and external genitalia.
 
Gender: The public - and typically the legal - recognition of one's lived role as a boy, girl, man, woman or of other biological factors in combination with psychosocial factors that are seen as contributing to identity development.
 
Sexual orientation: A person's erotic response tendency or sexual attractions, either directed toward individuals of the same sex (homosexual), the other sex (heterosexual), or both sexes (bisexual).  
 
Gender identity: Often an independent variable from sexual orientation, this refers to how an individual identifies as either male, female, or, in some cases, some other category.
 
Gender assignment: The natal presentation as either male or female. The historical terms are "biological male" or "biological female"; also occasionally known as "birth assigned male" or "birth assigned female."
 
Gender atypical: The somatic features or behaviors not statistically typical in individuals with the same assigned gender in a given society or era.
 
Gender nonconforming: Typically used as an alternative descriptive term for "gender atypical".
 
Gender dysphoria: The conflict between a person's assigned gender and that person's gender identity and expression; replaced "gender identity disorder" in the DSM-5.
 
Gender variant: Often used by those who are concerned the term "gender dysphoria" will unnecessarily pathologize a child.
 
Gender expression: How an individual demonstrates gender to others, including by way of dress, behavior, and appearance. Increasingly, the term is used in antidiscrimination documents.
 
Desister: Prepubescent children who present with gender dysphoria but who do not become transgender adults.  
 
Persister: This refers to children who present with gender dysphoria and progress to a transgender adulthood.
 
Gender reassignment: An official - and often legal - change of gender by way of cross-sex endocrine therapy and/or gender reassignment surgery.
 
Transsexual: An individual who modifies the body via endocrine and/or surgical means to conform with gender identity either partially or completely.  
 
Transwoman: A person, such as Caitlyn Jenner, who transitions from a male sex assignment to become female.  
 
Transman:  A person who transitions from a female sex assignment to become male.
 
Transgender: The "T" in the acronym LGBT; the popular - not scientific - inclusive term for those whose gender identity, gender expression, or behavior does not conform to that which is typically associated with the natal sex assignment.
 
Cisgender: From the Latin for "on the same side"; used in the transgender community to describe those whose gender identities align with their natal assignment.
 
Gender beliefs: Used to refer to the implicit, typically binary, cultural views on the "essential" qualities of men and women.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – The treatment of preadolescents who present with gender questions is often complicated by the absence of evidence-based data on who is most likely to remain gender dysphoric into adulthood and who is not, an expert said at the annual meeting of the American College of Psychiatrists.

“There are some [clinicians] who believe they can predict who will persist and who will not. But they have not published, to my satisfaction, a way to show anyone else how to tell the difference,” said Jack Drescher, MD, a member of the World Health Organization’s (WHO’s) Working Group on the Classification of Sexual Disorders and Sexual Health and clinical professor of psychiatry and behavioral sciences at New York Medical College, Valhalla.

Whitney McKnight/Frontline Medical News

Gender-related glossary of terms

"There are so many moving parts to our understanding of gender," said Jack Drescher, MD, during a plenary session at the annual meeting of the American College of Psychiatrists. For that reason, "language is very important" when addressing children who might have questions about their gender identity, he said.

To help establish as much clarity as possible when discussing gender in the clinical setting, Dr. Drescher offered the following glossary of terms. These are not listed alphabetically but in a stepwise fashion aimed at leading to a clearer understanding of successive terms.
 
Sex: The biological attributes of being male or female. This includes sex chromosomes, gonads, sex hormones, and nonambiguous internal and external genitalia.
 
Gender: The public - and typically the legal - recognition of one's lived role as a boy, girl, man, woman or of other biological factors in combination with psychosocial factors that are seen as contributing to identity development.
 
Sexual orientation: A person's erotic response tendency or sexual attractions, either directed toward individuals of the same sex (homosexual), the other sex (heterosexual), or both sexes (bisexual).  
 
Gender identity: Often an independent variable from sexual orientation, this refers to how an individual identifies as either male, female, or, in some cases, some other category.
 
Gender assignment: The natal presentation as either male or female. The historical terms are "biological male" or "biological female"; also occasionally known as "birth assigned male" or "birth assigned female."
 
Gender atypical: The somatic features or behaviors not statistically typical in individuals with the same assigned gender in a given society or era.
 
Gender nonconforming: Typically used as an alternative descriptive term for "gender atypical".
 
Gender dysphoria: The conflict between a person's assigned gender and that person's gender identity and expression; replaced "gender identity disorder" in the DSM-5.
 
Gender variant: Often used by those who are concerned the term "gender dysphoria" will unnecessarily pathologize a child.
 
Gender expression: How an individual demonstrates gender to others, including by way of dress, behavior, and appearance. Increasingly, the term is used in antidiscrimination documents.
 
Desister: Prepubescent children who present with gender dysphoria but who do not become transgender adults.  
 
Persister: This refers to children who present with gender dysphoria and progress to a transgender adulthood.
 
Gender reassignment: An official - and often legal - change of gender by way of cross-sex endocrine therapy and/or gender reassignment surgery.
 
Transsexual: An individual who modifies the body via endocrine and/or surgical means to conform with gender identity either partially or completely.  
 
Transwoman: A person, such as Caitlyn Jenner, who transitions from a male sex assignment to become female.  
 
Transman:  A person who transitions from a female sex assignment to become male.
 
Transgender: The "T" in the acronym LGBT; the popular - not scientific - inclusive term for those whose gender identity, gender expression, or behavior does not conform to that which is typically associated with the natal sex assignment.
 
Cisgender: From the Latin for "on the same side"; used in the transgender community to describe those whose gender identities align with their natal assignment.
 
Gender beliefs: Used to refer to the implicit, typically binary, cultural views on the "essential" qualities of men and women.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – The treatment of preadolescents who present with gender questions is often complicated by the absence of evidence-based data on who is most likely to remain gender dysphoric into adulthood and who is not, an expert said at the annual meeting of the American College of Psychiatrists.

“There are some [clinicians] who believe they can predict who will persist and who will not. But they have not published, to my satisfaction, a way to show anyone else how to tell the difference,” said Jack Drescher, MD, a member of the World Health Organization’s (WHO’s) Working Group on the Classification of Sexual Disorders and Sexual Health and clinical professor of psychiatry and behavioral sciences at New York Medical College, Valhalla.

Whitney McKnight/Frontline Medical News

Gender-related glossary of terms

"There are so many moving parts to our understanding of gender," said Jack Drescher, MD, during a plenary session at the annual meeting of the American College of Psychiatrists. For that reason, "language is very important" when addressing children who might have questions about their gender identity, he said.

To help establish as much clarity as possible when discussing gender in the clinical setting, Dr. Drescher offered the following glossary of terms. These are not listed alphabetically but in a stepwise fashion aimed at leading to a clearer understanding of successive terms.
 
Sex: The biological attributes of being male or female. This includes sex chromosomes, gonads, sex hormones, and nonambiguous internal and external genitalia.
 
Gender: The public - and typically the legal - recognition of one's lived role as a boy, girl, man, woman or of other biological factors in combination with psychosocial factors that are seen as contributing to identity development.
 
Sexual orientation: A person's erotic response tendency or sexual attractions, either directed toward individuals of the same sex (homosexual), the other sex (heterosexual), or both sexes (bisexual).  
 
Gender identity: Often an independent variable from sexual orientation, this refers to how an individual identifies as either male, female, or, in some cases, some other category.
 
Gender assignment: The natal presentation as either male or female. The historical terms are "biological male" or "biological female"; also occasionally known as "birth assigned male" or "birth assigned female."
 
Gender atypical: The somatic features or behaviors not statistically typical in individuals with the same assigned gender in a given society or era.
 
Gender nonconforming: Typically used as an alternative descriptive term for "gender atypical".
 
Gender dysphoria: The conflict between a person's assigned gender and that person's gender identity and expression; replaced "gender identity disorder" in the DSM-5.
 
Gender variant: Often used by those who are concerned the term "gender dysphoria" will unnecessarily pathologize a child.
 
Gender expression: How an individual demonstrates gender to others, including by way of dress, behavior, and appearance. Increasingly, the term is used in antidiscrimination documents.
 
Desister: Prepubescent children who present with gender dysphoria but who do not become transgender adults.  
 
Persister: This refers to children who present with gender dysphoria and progress to a transgender adulthood.
 
Gender reassignment: An official - and often legal - change of gender by way of cross-sex endocrine therapy and/or gender reassignment surgery.
 
Transsexual: An individual who modifies the body via endocrine and/or surgical means to conform with gender identity either partially or completely.  
 
Transwoman: A person, such as Caitlyn Jenner, who transitions from a male sex assignment to become female.  
 
Transman:  A person who transitions from a female sex assignment to become male.
 
Transgender: The "T" in the acronym LGBT; the popular - not scientific - inclusive term for those whose gender identity, gender expression, or behavior does not conform to that which is typically associated with the natal sex assignment.
 
Cisgender: From the Latin for "on the same side"; used in the transgender community to describe those whose gender identities align with their natal assignment.
 
Gender beliefs: Used to refer to the implicit, typically binary, cultural views on the "essential" qualities of men and women.

wmcknight@frontlinemedcom.com

On Twitter @whitneymcknight