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Physician sues AMA for defamation over 2022 election controversy
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
Will your smartphone be the next doctor’s office?
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Brain differences suggest therapeutic targets in Takotsubo
A new study has identified differences in the brain present in patients with the cardiac disorder Takotsubo syndrome versus control scans, which may lead to new therapeutic targets.
Takotsubo syndrome is an acute heart failure cardiomyopathy mimicking an acute myocardial infarction in its presentation, but on investigation, no obstructive coronary disease is present. The syndrome, which mainly affects women, typically occurs in the aftermath of intense emotional or physical stress and has become known as “broken heart syndrome.”
The mechanism by which emotional processing in the context of stress leads to significant cardiac injury and acute left ventricular dysfunction is not understood. So, the current study examined both structural and functional effects in the brain in patients with Takotsubo syndrome to shed more light on the issue.
“The abnormalities in the thalamus-amygdala-insula and basal ganglia support the concept of involvement of higher-level function centers in Takotsubo syndrome, and interventions aimed at modulating these may be of benefit,” the authors conclude.
The study was published online in JACC: Heart Failure.
Lead author Hilal Khan, MB BCh, BAO, from the University of Aberdeen (Scotland), explained to this news organization that patients with Takotsubo syndrome have a substantial drop in heart function and show an apical ballooning of the heart.
It is a relatively newly defined condition and was first described in 1990 in Japan, and so named because the heart was thought to resemble the Takotsubo pot used by Japanese fishermen to trap octopus.
Although uncommon, the condition is not rare. Dr. Khan estimates that about 1 in 20 women with suspected MI turn out to have Takotsubo syndrome, with cases increasing in times of global stress such as in the recent pandemic.
While patients tend to recover in a few weeks and the pumping function of the heart usually returns to normal, there are some long-term cardiac complications including a reduction in global longitudinal strain, and patients have similar long-term outcomes as those with MI.
“It is believed that these cardiac changes may be triggered by changes in the brain caused by emotional stress, so we wanted to look at this more closely,” Dr. Khan said.
There have been a couple of studies published previously looking at brain changes in Takotsubo syndrome, but they haven’t reported patients in the acute stage of the condition and they haven’t compared the patients to controls, he noted.
For the current study, the researchers looked at brain scans for 25 acute Takotsubo patients and in 25 controls matched for age, gender, comorbidities, and medications. All the patients and controls were examined using the same MRI scanner in the same hospital.
“This is the largest structural and functional brain study of acute Takotsubo syndrome patients compared with matched control subjects,” Dr. Khan said.
The researchers looked at many different factors including brain volume in different regions, cortical thickness, small-vessel disease, and functional and structural connectivity to try and obtain a complete holistic view of the brain.
Key findings were that patients with Takotsubo syndrome had smaller brain volumes, compared with matched controls, driven by a reduction in brain surface area. In contrast, the insula and thalamus regions were larger.
“A reduction in brain volume could be caused by inflammation; this is often seen in depression,” Dr. Khan commented.
The researchers also found that certain areas of the brain had a reduction in functional connectivity, particularly the thalamus – the central autonomic area of the brain, which regulates the autonomic nervous system – and also the insula region, which is also involved in the autonomic regulation of the heart.
They suggest that there may be a loss of parasympathetic inhibition in Takotsubo syndrome, which would fit the theory that Takotsubo brings with it a surge of catecholamines, which could injure the heart.
Reduced functional connectivity was also seen in parts of the basal ganglia, abnormalities of which have been associated with an increased risk of both arrhythmias, and in the amygdala, similar to patients with a tendency to catastrophize events.
The other observation was that there appeared to be an increase in structural connectivity in certain areas of the brain.
“Structural pathways seem to be increased but functional connectivity was reduced, so while physical pathways are enhanced, they don’t seem to be doing anything,” Dr. Khan said. “We don’t know why this occurs, or if this has happened over time and made the brain and heart more vulnerable in some way.”
One possibility is that ,under a significant emotional stress, the brain may divert function from some areas to others to be able to cope, and that this results in reduced functioning in areas of the brain responsible for regulating the heart, Dr. Khan suggested.
“We believe this study confirms that the brain is involved in Takotsubo syndrome, and we have identified markers in the brain that may be contributing to the condition,” he said.
The researchers are planning to further study these markers and whether it might be possible to modulate these changes with various interventions such as exercise or mindfulness.
“We believe there is some interface between the brain changes and the impact on the heart. We don’t think it is just the release of catecholamines that causes damage to the heart. We think there is something else happening as well,” Dr. Khan commented.
It is also possible that the hearts of patients with Takotsubo syndrome are predisposed in some way and more vulnerable to this condition occurring.
“It will be important to obtain a greater understanding of the triggers and identify people who may be vulnerable,” Dr. Khan noted. “Around 10% of individuals who experience Takotsubo syndrome will have a recurrence, so we need to try and develop preventative strategies to reduce this.”
He suggested that possible preventive or therapeutic approaches may involve interventions such as exercise or mindfulness.
This work was supported by National Health Service Grampian Endowment. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study has identified differences in the brain present in patients with the cardiac disorder Takotsubo syndrome versus control scans, which may lead to new therapeutic targets.
Takotsubo syndrome is an acute heart failure cardiomyopathy mimicking an acute myocardial infarction in its presentation, but on investigation, no obstructive coronary disease is present. The syndrome, which mainly affects women, typically occurs in the aftermath of intense emotional or physical stress and has become known as “broken heart syndrome.”
The mechanism by which emotional processing in the context of stress leads to significant cardiac injury and acute left ventricular dysfunction is not understood. So, the current study examined both structural and functional effects in the brain in patients with Takotsubo syndrome to shed more light on the issue.
“The abnormalities in the thalamus-amygdala-insula and basal ganglia support the concept of involvement of higher-level function centers in Takotsubo syndrome, and interventions aimed at modulating these may be of benefit,” the authors conclude.
The study was published online in JACC: Heart Failure.
Lead author Hilal Khan, MB BCh, BAO, from the University of Aberdeen (Scotland), explained to this news organization that patients with Takotsubo syndrome have a substantial drop in heart function and show an apical ballooning of the heart.
It is a relatively newly defined condition and was first described in 1990 in Japan, and so named because the heart was thought to resemble the Takotsubo pot used by Japanese fishermen to trap octopus.
Although uncommon, the condition is not rare. Dr. Khan estimates that about 1 in 20 women with suspected MI turn out to have Takotsubo syndrome, with cases increasing in times of global stress such as in the recent pandemic.
While patients tend to recover in a few weeks and the pumping function of the heart usually returns to normal, there are some long-term cardiac complications including a reduction in global longitudinal strain, and patients have similar long-term outcomes as those with MI.
“It is believed that these cardiac changes may be triggered by changes in the brain caused by emotional stress, so we wanted to look at this more closely,” Dr. Khan said.
There have been a couple of studies published previously looking at brain changes in Takotsubo syndrome, but they haven’t reported patients in the acute stage of the condition and they haven’t compared the patients to controls, he noted.
For the current study, the researchers looked at brain scans for 25 acute Takotsubo patients and in 25 controls matched for age, gender, comorbidities, and medications. All the patients and controls were examined using the same MRI scanner in the same hospital.
“This is the largest structural and functional brain study of acute Takotsubo syndrome patients compared with matched control subjects,” Dr. Khan said.
The researchers looked at many different factors including brain volume in different regions, cortical thickness, small-vessel disease, and functional and structural connectivity to try and obtain a complete holistic view of the brain.
Key findings were that patients with Takotsubo syndrome had smaller brain volumes, compared with matched controls, driven by a reduction in brain surface area. In contrast, the insula and thalamus regions were larger.
“A reduction in brain volume could be caused by inflammation; this is often seen in depression,” Dr. Khan commented.
The researchers also found that certain areas of the brain had a reduction in functional connectivity, particularly the thalamus – the central autonomic area of the brain, which regulates the autonomic nervous system – and also the insula region, which is also involved in the autonomic regulation of the heart.
They suggest that there may be a loss of parasympathetic inhibition in Takotsubo syndrome, which would fit the theory that Takotsubo brings with it a surge of catecholamines, which could injure the heart.
Reduced functional connectivity was also seen in parts of the basal ganglia, abnormalities of which have been associated with an increased risk of both arrhythmias, and in the amygdala, similar to patients with a tendency to catastrophize events.
The other observation was that there appeared to be an increase in structural connectivity in certain areas of the brain.
“Structural pathways seem to be increased but functional connectivity was reduced, so while physical pathways are enhanced, they don’t seem to be doing anything,” Dr. Khan said. “We don’t know why this occurs, or if this has happened over time and made the brain and heart more vulnerable in some way.”
One possibility is that ,under a significant emotional stress, the brain may divert function from some areas to others to be able to cope, and that this results in reduced functioning in areas of the brain responsible for regulating the heart, Dr. Khan suggested.
“We believe this study confirms that the brain is involved in Takotsubo syndrome, and we have identified markers in the brain that may be contributing to the condition,” he said.
The researchers are planning to further study these markers and whether it might be possible to modulate these changes with various interventions such as exercise or mindfulness.
“We believe there is some interface between the brain changes and the impact on the heart. We don’t think it is just the release of catecholamines that causes damage to the heart. We think there is something else happening as well,” Dr. Khan commented.
It is also possible that the hearts of patients with Takotsubo syndrome are predisposed in some way and more vulnerable to this condition occurring.
“It will be important to obtain a greater understanding of the triggers and identify people who may be vulnerable,” Dr. Khan noted. “Around 10% of individuals who experience Takotsubo syndrome will have a recurrence, so we need to try and develop preventative strategies to reduce this.”
He suggested that possible preventive or therapeutic approaches may involve interventions such as exercise or mindfulness.
This work was supported by National Health Service Grampian Endowment. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study has identified differences in the brain present in patients with the cardiac disorder Takotsubo syndrome versus control scans, which may lead to new therapeutic targets.
Takotsubo syndrome is an acute heart failure cardiomyopathy mimicking an acute myocardial infarction in its presentation, but on investigation, no obstructive coronary disease is present. The syndrome, which mainly affects women, typically occurs in the aftermath of intense emotional or physical stress and has become known as “broken heart syndrome.”
The mechanism by which emotional processing in the context of stress leads to significant cardiac injury and acute left ventricular dysfunction is not understood. So, the current study examined both structural and functional effects in the brain in patients with Takotsubo syndrome to shed more light on the issue.
“The abnormalities in the thalamus-amygdala-insula and basal ganglia support the concept of involvement of higher-level function centers in Takotsubo syndrome, and interventions aimed at modulating these may be of benefit,” the authors conclude.
The study was published online in JACC: Heart Failure.
Lead author Hilal Khan, MB BCh, BAO, from the University of Aberdeen (Scotland), explained to this news organization that patients with Takotsubo syndrome have a substantial drop in heart function and show an apical ballooning of the heart.
It is a relatively newly defined condition and was first described in 1990 in Japan, and so named because the heart was thought to resemble the Takotsubo pot used by Japanese fishermen to trap octopus.
Although uncommon, the condition is not rare. Dr. Khan estimates that about 1 in 20 women with suspected MI turn out to have Takotsubo syndrome, with cases increasing in times of global stress such as in the recent pandemic.
While patients tend to recover in a few weeks and the pumping function of the heart usually returns to normal, there are some long-term cardiac complications including a reduction in global longitudinal strain, and patients have similar long-term outcomes as those with MI.
“It is believed that these cardiac changes may be triggered by changes in the brain caused by emotional stress, so we wanted to look at this more closely,” Dr. Khan said.
There have been a couple of studies published previously looking at brain changes in Takotsubo syndrome, but they haven’t reported patients in the acute stage of the condition and they haven’t compared the patients to controls, he noted.
For the current study, the researchers looked at brain scans for 25 acute Takotsubo patients and in 25 controls matched for age, gender, comorbidities, and medications. All the patients and controls were examined using the same MRI scanner in the same hospital.
“This is the largest structural and functional brain study of acute Takotsubo syndrome patients compared with matched control subjects,” Dr. Khan said.
The researchers looked at many different factors including brain volume in different regions, cortical thickness, small-vessel disease, and functional and structural connectivity to try and obtain a complete holistic view of the brain.
Key findings were that patients with Takotsubo syndrome had smaller brain volumes, compared with matched controls, driven by a reduction in brain surface area. In contrast, the insula and thalamus regions were larger.
“A reduction in brain volume could be caused by inflammation; this is often seen in depression,” Dr. Khan commented.
The researchers also found that certain areas of the brain had a reduction in functional connectivity, particularly the thalamus – the central autonomic area of the brain, which regulates the autonomic nervous system – and also the insula region, which is also involved in the autonomic regulation of the heart.
They suggest that there may be a loss of parasympathetic inhibition in Takotsubo syndrome, which would fit the theory that Takotsubo brings with it a surge of catecholamines, which could injure the heart.
Reduced functional connectivity was also seen in parts of the basal ganglia, abnormalities of which have been associated with an increased risk of both arrhythmias, and in the amygdala, similar to patients with a tendency to catastrophize events.
The other observation was that there appeared to be an increase in structural connectivity in certain areas of the brain.
“Structural pathways seem to be increased but functional connectivity was reduced, so while physical pathways are enhanced, they don’t seem to be doing anything,” Dr. Khan said. “We don’t know why this occurs, or if this has happened over time and made the brain and heart more vulnerable in some way.”
One possibility is that ,under a significant emotional stress, the brain may divert function from some areas to others to be able to cope, and that this results in reduced functioning in areas of the brain responsible for regulating the heart, Dr. Khan suggested.
“We believe this study confirms that the brain is involved in Takotsubo syndrome, and we have identified markers in the brain that may be contributing to the condition,” he said.
The researchers are planning to further study these markers and whether it might be possible to modulate these changes with various interventions such as exercise or mindfulness.
“We believe there is some interface between the brain changes and the impact on the heart. We don’t think it is just the release of catecholamines that causes damage to the heart. We think there is something else happening as well,” Dr. Khan commented.
It is also possible that the hearts of patients with Takotsubo syndrome are predisposed in some way and more vulnerable to this condition occurring.
“It will be important to obtain a greater understanding of the triggers and identify people who may be vulnerable,” Dr. Khan noted. “Around 10% of individuals who experience Takotsubo syndrome will have a recurrence, so we need to try and develop preventative strategies to reduce this.”
He suggested that possible preventive or therapeutic approaches may involve interventions such as exercise or mindfulness.
This work was supported by National Health Service Grampian Endowment. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JACC: HEART FAILURE
AGA venture capital fund makes first investment
The American Gastroenterological Association has made the first investment through its new venture capital fund – an initiative that gives gastroenterologists a financial opportunity combined with a chance to help corporations trying to make a difference in the field.
It was established in partnership with Varia Ventures.
The AGA recently announced the fund’s first investment with Carlsbad, Calif.–based Virgo Surgical Video Solutions, which offers endoscopy video recording that uses artificial intelligence for ease of use during procedures, for reviewing video later, and for using video to connect trial investigators with potential candidates.
“While AGA has long guided innovators who share our goal of improving digestive health care, we have doubled down on this commitment by establishing the GI Opportunity Fund,” said Lawrence Kosinski, MD, AGAF, AGA Governing Board Councilor for Development and Growth. “The fund’s first investment – Virgo – exemplifies our pursuit of improved clinical care.”
He said the fund gives physicians a chance to work closely with AGA to invest in difference-making ventures.
“Through our venture fund, gastroenterologists can join AGA to invest in fast-growing, early-stage companies that are transforming care for patients with digestive disease,” Dr. Kosinski said.
Virgo CEO Matthew Z. Schwartz said the company’s product is intended to fill an important need.
“We recognized that it was really difficult for doctors to capture endoscopy procedures video in high-definition at scale,” he said. “Generally, they were just taking still images. And the images were often not of great quality.”
Virgo offers a small device that connects to existing endoscopy equipment, plugging into the back of a video processor, securely compressing and encrypting video and sending it to Virgo’s HIPAA-compliant cloud storage Web portal. Once it’s plugged in, Mr. Schwartz said, it’s “set it and forget it.”
“We try to make it as easy as possible for doctors to record their video – which means we don’t want them to have to do anything different about their normal clinical workflow in order to generate these videos,” Mr. Schwartz said. Physicians don’t even have to press a start or stop button – Virgo’s machine-learning algorithm detects when to start and stop video recording by discerning when the scope is inserted and removed.
“A goal of ours is to change the paradigm for endoscopy to help make sure that every procedure is captured in HD to the cloud,” he said.
The service also includes an “auto-highlight” feature that detects important moments in the procedure video. It automatically marks points in the video when the physician takes a still image and moments when an instrument, such as a snare or forceps, is present in the field of view. This, Mr. Schwartz said, makes it “easy in playback to focus on important aspects of the procedure.”
There is also a clinical trial screening feature, called “auto IBD,” that involves an algorithm that assesses videos to identify patients most likely to be eligible candidates for clinical trials. Mr. Schwartz said that procedures and patients who might go unconsidered – if they are performed at an affiliated community hospital or at an endoscopy center, for instance – can now be brought to the attention of trial investigators, without the need to comb through hundreds or thousands of candidates.
“We believe there are many more patients with these diseases that are eligible for IBD clinical trials than are currently being exposed to research opportunities within large health systems,” he said.
The proceeds from the AGA’s Opportunity Fund will be used, in part, to expand Virgo’s reach, he added. Virgo’s connection with the AGA began with its participation in the AGA Tech Summit Shark Tank competition in 2018.
“For us, the name of the game is getting Virgo in the hands of as many physicians and health systems as possible,” Mr. Schwartz said. “So we’ll be using these proceeds to build up the team and work on global distribution.” The company is also “looking to refine machine-learning algorithms and build out new features and tools.”
Ziad Gellad, MD, MPH, associate professor of medicine in gastroenterology at Duke University, Durham, N.C., was one of the Opportunity Fund’s earliest member investors.
“I was looking for ways to diversify my portfolio and this was an attractive way to get into an area of investment that is not easily accessible, and so I was excited about that,” said Dr. Gellad, who himself is cofounder of a health start-up that develops software for patient navigation and outcomes collection but is not associated with the fund.
“As a start-up cofounder myself, I understand the needs of founders of companies, especially those in the GI space and appreciate the struggles they face,” Dr. Gellad added. “The opportunity to contribute to that was appealing.”
“I also believe that specialty societies like the AGA need to diversify their funding strategy and I think this is a really innovative way to do that,” he said.
The American Gastroenterological Association has made the first investment through its new venture capital fund – an initiative that gives gastroenterologists a financial opportunity combined with a chance to help corporations trying to make a difference in the field.
It was established in partnership with Varia Ventures.
The AGA recently announced the fund’s first investment with Carlsbad, Calif.–based Virgo Surgical Video Solutions, which offers endoscopy video recording that uses artificial intelligence for ease of use during procedures, for reviewing video later, and for using video to connect trial investigators with potential candidates.
“While AGA has long guided innovators who share our goal of improving digestive health care, we have doubled down on this commitment by establishing the GI Opportunity Fund,” said Lawrence Kosinski, MD, AGAF, AGA Governing Board Councilor for Development and Growth. “The fund’s first investment – Virgo – exemplifies our pursuit of improved clinical care.”
He said the fund gives physicians a chance to work closely with AGA to invest in difference-making ventures.
“Through our venture fund, gastroenterologists can join AGA to invest in fast-growing, early-stage companies that are transforming care for patients with digestive disease,” Dr. Kosinski said.
Virgo CEO Matthew Z. Schwartz said the company’s product is intended to fill an important need.
“We recognized that it was really difficult for doctors to capture endoscopy procedures video in high-definition at scale,” he said. “Generally, they were just taking still images. And the images were often not of great quality.”
Virgo offers a small device that connects to existing endoscopy equipment, plugging into the back of a video processor, securely compressing and encrypting video and sending it to Virgo’s HIPAA-compliant cloud storage Web portal. Once it’s plugged in, Mr. Schwartz said, it’s “set it and forget it.”
“We try to make it as easy as possible for doctors to record their video – which means we don’t want them to have to do anything different about their normal clinical workflow in order to generate these videos,” Mr. Schwartz said. Physicians don’t even have to press a start or stop button – Virgo’s machine-learning algorithm detects when to start and stop video recording by discerning when the scope is inserted and removed.
“A goal of ours is to change the paradigm for endoscopy to help make sure that every procedure is captured in HD to the cloud,” he said.
The service also includes an “auto-highlight” feature that detects important moments in the procedure video. It automatically marks points in the video when the physician takes a still image and moments when an instrument, such as a snare or forceps, is present in the field of view. This, Mr. Schwartz said, makes it “easy in playback to focus on important aspects of the procedure.”
There is also a clinical trial screening feature, called “auto IBD,” that involves an algorithm that assesses videos to identify patients most likely to be eligible candidates for clinical trials. Mr. Schwartz said that procedures and patients who might go unconsidered – if they are performed at an affiliated community hospital or at an endoscopy center, for instance – can now be brought to the attention of trial investigators, without the need to comb through hundreds or thousands of candidates.
“We believe there are many more patients with these diseases that are eligible for IBD clinical trials than are currently being exposed to research opportunities within large health systems,” he said.
The proceeds from the AGA’s Opportunity Fund will be used, in part, to expand Virgo’s reach, he added. Virgo’s connection with the AGA began with its participation in the AGA Tech Summit Shark Tank competition in 2018.
“For us, the name of the game is getting Virgo in the hands of as many physicians and health systems as possible,” Mr. Schwartz said. “So we’ll be using these proceeds to build up the team and work on global distribution.” The company is also “looking to refine machine-learning algorithms and build out new features and tools.”
Ziad Gellad, MD, MPH, associate professor of medicine in gastroenterology at Duke University, Durham, N.C., was one of the Opportunity Fund’s earliest member investors.
“I was looking for ways to diversify my portfolio and this was an attractive way to get into an area of investment that is not easily accessible, and so I was excited about that,” said Dr. Gellad, who himself is cofounder of a health start-up that develops software for patient navigation and outcomes collection but is not associated with the fund.
“As a start-up cofounder myself, I understand the needs of founders of companies, especially those in the GI space and appreciate the struggles they face,” Dr. Gellad added. “The opportunity to contribute to that was appealing.”
“I also believe that specialty societies like the AGA need to diversify their funding strategy and I think this is a really innovative way to do that,” he said.
The American Gastroenterological Association has made the first investment through its new venture capital fund – an initiative that gives gastroenterologists a financial opportunity combined with a chance to help corporations trying to make a difference in the field.
It was established in partnership with Varia Ventures.
The AGA recently announced the fund’s first investment with Carlsbad, Calif.–based Virgo Surgical Video Solutions, which offers endoscopy video recording that uses artificial intelligence for ease of use during procedures, for reviewing video later, and for using video to connect trial investigators with potential candidates.
“While AGA has long guided innovators who share our goal of improving digestive health care, we have doubled down on this commitment by establishing the GI Opportunity Fund,” said Lawrence Kosinski, MD, AGAF, AGA Governing Board Councilor for Development and Growth. “The fund’s first investment – Virgo – exemplifies our pursuit of improved clinical care.”
He said the fund gives physicians a chance to work closely with AGA to invest in difference-making ventures.
“Through our venture fund, gastroenterologists can join AGA to invest in fast-growing, early-stage companies that are transforming care for patients with digestive disease,” Dr. Kosinski said.
Virgo CEO Matthew Z. Schwartz said the company’s product is intended to fill an important need.
“We recognized that it was really difficult for doctors to capture endoscopy procedures video in high-definition at scale,” he said. “Generally, they were just taking still images. And the images were often not of great quality.”
Virgo offers a small device that connects to existing endoscopy equipment, plugging into the back of a video processor, securely compressing and encrypting video and sending it to Virgo’s HIPAA-compliant cloud storage Web portal. Once it’s plugged in, Mr. Schwartz said, it’s “set it and forget it.”
“We try to make it as easy as possible for doctors to record their video – which means we don’t want them to have to do anything different about their normal clinical workflow in order to generate these videos,” Mr. Schwartz said. Physicians don’t even have to press a start or stop button – Virgo’s machine-learning algorithm detects when to start and stop video recording by discerning when the scope is inserted and removed.
“A goal of ours is to change the paradigm for endoscopy to help make sure that every procedure is captured in HD to the cloud,” he said.
The service also includes an “auto-highlight” feature that detects important moments in the procedure video. It automatically marks points in the video when the physician takes a still image and moments when an instrument, such as a snare or forceps, is present in the field of view. This, Mr. Schwartz said, makes it “easy in playback to focus on important aspects of the procedure.”
There is also a clinical trial screening feature, called “auto IBD,” that involves an algorithm that assesses videos to identify patients most likely to be eligible candidates for clinical trials. Mr. Schwartz said that procedures and patients who might go unconsidered – if they are performed at an affiliated community hospital or at an endoscopy center, for instance – can now be brought to the attention of trial investigators, without the need to comb through hundreds or thousands of candidates.
“We believe there are many more patients with these diseases that are eligible for IBD clinical trials than are currently being exposed to research opportunities within large health systems,” he said.
The proceeds from the AGA’s Opportunity Fund will be used, in part, to expand Virgo’s reach, he added. Virgo’s connection with the AGA began with its participation in the AGA Tech Summit Shark Tank competition in 2018.
“For us, the name of the game is getting Virgo in the hands of as many physicians and health systems as possible,” Mr. Schwartz said. “So we’ll be using these proceeds to build up the team and work on global distribution.” The company is also “looking to refine machine-learning algorithms and build out new features and tools.”
Ziad Gellad, MD, MPH, associate professor of medicine in gastroenterology at Duke University, Durham, N.C., was one of the Opportunity Fund’s earliest member investors.
“I was looking for ways to diversify my portfolio and this was an attractive way to get into an area of investment that is not easily accessible, and so I was excited about that,” said Dr. Gellad, who himself is cofounder of a health start-up that develops software for patient navigation and outcomes collection but is not associated with the fund.
“As a start-up cofounder myself, I understand the needs of founders of companies, especially those in the GI space and appreciate the struggles they face,” Dr. Gellad added. “The opportunity to contribute to that was appealing.”
“I also believe that specialty societies like the AGA need to diversify their funding strategy and I think this is a really innovative way to do that,” he said.
More support for MDMA-assisted psychotherapy for PTSD
The MAPP2 study is the second randomized, double-blind, placebo-controlled study to demonstrate the safety and efficacy of MDMA-assisted therapy for PTSD.
The investigators confirm results of the MAPP1 study, which were published in Nature Medicine. Patients who received MDMA-assisted psychotherapy in MAPP1 demonstrated greater improvement in PTSD symptoms, mood, and empathy, compared with participants who received psychotherapy with placebo.
The design of the MAPP2 study was similar to that of MAPP1, and its results were similar, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), which sponsored MAPP1 and MAPP2, said in a news release.
No specific results from MAPP2 were provided at this time. The full data from MAPP2 are expected to be published in a peer-reviewed journal later this year, and a new drug application to the U.S. Food and Drug Administration will follow.
The FDA granted breakthrough therapy designation to MDMA as an adjunct to psychotherapy for adults with PTSD in 2017.
MAPS was founded in 1986 to fund and facilitate research into the potential of psychedelic-assisted therapies; to educate the public about psychedelics for medical, social, and spiritual use; and to advocate for drug policy reform.
“When I first articulated a plan to legitimize a psychedelic-assisted therapy through FDA approval, many people said it was impossible,” Rick Doblin, PhD, founder and executive director of MAPS, said in the news release.
“Thirty-seven years later, we are on the precipice of bringing a novel therapy to the millions of Americans living with PTSD who haven’t found relief through current treatments,” said Dr. Doblin.
“The impossible became possible through the bravery of clinical trial participants, the compassion of mental health practitioners, and the generosity of thousands of donors. Today, we can imagine that MDMA-assisted therapy for PTSD may soon be available and accessible to all who could benefit,” Dr. Doblin added.
According to MAPS, phase 2 trials are being planned or conducted regarding the efficacy of MDMA-assisted therapies for substance use disorder and eating disorders, as well as couples therapy and group therapy among veterans.
Currently, no psychedelic-assisted therapy has been approved by the FDA or other regulatory authorities.
A version of this article first appeared on Medscape.com.
The MAPP2 study is the second randomized, double-blind, placebo-controlled study to demonstrate the safety and efficacy of MDMA-assisted therapy for PTSD.
The investigators confirm results of the MAPP1 study, which were published in Nature Medicine. Patients who received MDMA-assisted psychotherapy in MAPP1 demonstrated greater improvement in PTSD symptoms, mood, and empathy, compared with participants who received psychotherapy with placebo.
The design of the MAPP2 study was similar to that of MAPP1, and its results were similar, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), which sponsored MAPP1 and MAPP2, said in a news release.
No specific results from MAPP2 were provided at this time. The full data from MAPP2 are expected to be published in a peer-reviewed journal later this year, and a new drug application to the U.S. Food and Drug Administration will follow.
The FDA granted breakthrough therapy designation to MDMA as an adjunct to psychotherapy for adults with PTSD in 2017.
MAPS was founded in 1986 to fund and facilitate research into the potential of psychedelic-assisted therapies; to educate the public about psychedelics for medical, social, and spiritual use; and to advocate for drug policy reform.
“When I first articulated a plan to legitimize a psychedelic-assisted therapy through FDA approval, many people said it was impossible,” Rick Doblin, PhD, founder and executive director of MAPS, said in the news release.
“Thirty-seven years later, we are on the precipice of bringing a novel therapy to the millions of Americans living with PTSD who haven’t found relief through current treatments,” said Dr. Doblin.
“The impossible became possible through the bravery of clinical trial participants, the compassion of mental health practitioners, and the generosity of thousands of donors. Today, we can imagine that MDMA-assisted therapy for PTSD may soon be available and accessible to all who could benefit,” Dr. Doblin added.
According to MAPS, phase 2 trials are being planned or conducted regarding the efficacy of MDMA-assisted therapies for substance use disorder and eating disorders, as well as couples therapy and group therapy among veterans.
Currently, no psychedelic-assisted therapy has been approved by the FDA or other regulatory authorities.
A version of this article first appeared on Medscape.com.
The MAPP2 study is the second randomized, double-blind, placebo-controlled study to demonstrate the safety and efficacy of MDMA-assisted therapy for PTSD.
The investigators confirm results of the MAPP1 study, which were published in Nature Medicine. Patients who received MDMA-assisted psychotherapy in MAPP1 demonstrated greater improvement in PTSD symptoms, mood, and empathy, compared with participants who received psychotherapy with placebo.
The design of the MAPP2 study was similar to that of MAPP1, and its results were similar, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), which sponsored MAPP1 and MAPP2, said in a news release.
No specific results from MAPP2 were provided at this time. The full data from MAPP2 are expected to be published in a peer-reviewed journal later this year, and a new drug application to the U.S. Food and Drug Administration will follow.
The FDA granted breakthrough therapy designation to MDMA as an adjunct to psychotherapy for adults with PTSD in 2017.
MAPS was founded in 1986 to fund and facilitate research into the potential of psychedelic-assisted therapies; to educate the public about psychedelics for medical, social, and spiritual use; and to advocate for drug policy reform.
“When I first articulated a plan to legitimize a psychedelic-assisted therapy through FDA approval, many people said it was impossible,” Rick Doblin, PhD, founder and executive director of MAPS, said in the news release.
“Thirty-seven years later, we are on the precipice of bringing a novel therapy to the millions of Americans living with PTSD who haven’t found relief through current treatments,” said Dr. Doblin.
“The impossible became possible through the bravery of clinical trial participants, the compassion of mental health practitioners, and the generosity of thousands of donors. Today, we can imagine that MDMA-assisted therapy for PTSD may soon be available and accessible to all who could benefit,” Dr. Doblin added.
According to MAPS, phase 2 trials are being planned or conducted regarding the efficacy of MDMA-assisted therapies for substance use disorder and eating disorders, as well as couples therapy and group therapy among veterans.
Currently, no psychedelic-assisted therapy has been approved by the FDA or other regulatory authorities.
A version of this article first appeared on Medscape.com.
Cervical cancer in women 65+ often deadly: so why not screen?
Approximately one-fifth of cervical cancer cases are diagnosed in women aged 65 years or older, and most of the cases are late-stage disease associated with poor survival rates. The new finding calls into question yet again the many national screening guidelines that advise physicians to halt cervical screening at age 65.
The findings emerged from an analysis of the California Cancer Registry for 2009-2018. The authors, from the University of California, Davis, who manage the registry on behalf of the state, found that 17% of women diagnosed with a first primary cancer were aged 65 years or older.
Up to 71% of these older women had late-stage disease vs. 34%-to 59% of women aged 21-64.
The team also found that older patients, even those with early disease, had much poorer survival after they were diagnosed with cervical cancer than their younger counterparts. For example, patients aged between 65 and 69 with stage I cervical cancer had a 5-year relative survival – that is, survival adjusted for noncancer causes of death – of 82%. By contrast, 94% of women aged 20-39 survived for at least 5 years.
The study was published on January 9 in Cancer Epidemiology, Biomarkers & Prevention.
These new data echo similar findings from other recent cervical cancer studies out of California, Massachusetts, Ohio, and nationally. Those studies show that, in comparison with younger patients, rates of late-stage disease are higher and survival is poorer among women aged 65 and older.
Even so, a coauthor of the present study, Frances Maguire, PhD, who is an epidemiologist at the University of California, Davis, said she and her colleagues were surprised by what they found.
“There are a lot of women in this older-age category who are being diagnosed, and they’re being diagnosed later stage and their survival is worse,” Dr. Maguire said. “That was surprising to all of us,” given that the current recommendations are to stop screening once women reach the age of 65, and yet this age group is “doing quite poorly.”
The American Cancer Society, the U.S. Preventive Services Task Force, and the American College of Obstetricians and Gynecologists all recommend that cervical screening stop at aged 65 for patients with “adequate prior screening.”
Adequate screening is defined as having three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative cotests within the prior 10 years, with the most recent screening within 5 years and having no precancerous lesions in the past 25 years.
However, as many as 23% of women aged 60-64 report that their last Pap test was administered more than 5 years ago, according to a recent study by Alex Francoeur, MD, and colleagues at the University of California, Los Angeles.
When asked to comment on the new article, Dr. Francoeur said, “There is literature that increasing comorbidities and visits to the doctor [with age] decrease the likelihood of getting a Pap test, which is concerning, as these may be the highest-risk women.”
Said study author Dr. Maguire, “It could be that [the guidelines] are perfectly fine if women were properly screened before they hit 65, so that’s one of our big questions. Perhaps this group are not properly screened before age 65, and then they hit 65, they don’t screen, and this is the result we’re seeing.”
The situation is compounded by the lack of continuity in care at this crucial juncture, said Alexander Olawaiye, MD, a professor in the division of gynecologic oncology at the University of Pittsburgh, who was also approached for comment.
At age 65, many women retire, move across the country, or access new health care providers through Medicare, which kicks in at age 65, so the woman’s new physician doesn’t have access to her screening history, he commented.
This means that a physician needs to rely on the patient’s memory.
This is unrealistic, said Dr. Olawaiye: “Let’s forget about the 65-year-old women for now. Let’s talk about young women with sharp minds. Half of these young adults cannot even remember correctly their last monthly period. And these are the people you want to recollect accurately [at age 65] the number of tests they’ve had over 10 years and the results of those tests? Are you kidding me?” said Dr. Olawaiye. “Is that the kind of verification that you rely on?”
Dr. Olawaiye has consistently advocated for scrapping the 65+ screening moratorium in past and current versions of the cervical screening guidelines. He is puzzled by the national unwillingness to do so and rejects the economic argument, pointing out that a handful of extra tests is a lot cheaper than caring for a patient with advanced cervical cancer.
“Most American women will die around 84-85 years of age,” Dr. Olawaiye commented. “So between 65 and 85, you will need five screens, maybe four. What are you saving by not doing that?”
Dr. Maguire, Dr. Francoeur, and Dr. Olawaiye have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Approximately one-fifth of cervical cancer cases are diagnosed in women aged 65 years or older, and most of the cases are late-stage disease associated with poor survival rates. The new finding calls into question yet again the many national screening guidelines that advise physicians to halt cervical screening at age 65.
The findings emerged from an analysis of the California Cancer Registry for 2009-2018. The authors, from the University of California, Davis, who manage the registry on behalf of the state, found that 17% of women diagnosed with a first primary cancer were aged 65 years or older.
Up to 71% of these older women had late-stage disease vs. 34%-to 59% of women aged 21-64.
The team also found that older patients, even those with early disease, had much poorer survival after they were diagnosed with cervical cancer than their younger counterparts. For example, patients aged between 65 and 69 with stage I cervical cancer had a 5-year relative survival – that is, survival adjusted for noncancer causes of death – of 82%. By contrast, 94% of women aged 20-39 survived for at least 5 years.
The study was published on January 9 in Cancer Epidemiology, Biomarkers & Prevention.
These new data echo similar findings from other recent cervical cancer studies out of California, Massachusetts, Ohio, and nationally. Those studies show that, in comparison with younger patients, rates of late-stage disease are higher and survival is poorer among women aged 65 and older.
Even so, a coauthor of the present study, Frances Maguire, PhD, who is an epidemiologist at the University of California, Davis, said she and her colleagues were surprised by what they found.
“There are a lot of women in this older-age category who are being diagnosed, and they’re being diagnosed later stage and their survival is worse,” Dr. Maguire said. “That was surprising to all of us,” given that the current recommendations are to stop screening once women reach the age of 65, and yet this age group is “doing quite poorly.”
The American Cancer Society, the U.S. Preventive Services Task Force, and the American College of Obstetricians and Gynecologists all recommend that cervical screening stop at aged 65 for patients with “adequate prior screening.”
Adequate screening is defined as having three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative cotests within the prior 10 years, with the most recent screening within 5 years and having no precancerous lesions in the past 25 years.
However, as many as 23% of women aged 60-64 report that their last Pap test was administered more than 5 years ago, according to a recent study by Alex Francoeur, MD, and colleagues at the University of California, Los Angeles.
When asked to comment on the new article, Dr. Francoeur said, “There is literature that increasing comorbidities and visits to the doctor [with age] decrease the likelihood of getting a Pap test, which is concerning, as these may be the highest-risk women.”
Said study author Dr. Maguire, “It could be that [the guidelines] are perfectly fine if women were properly screened before they hit 65, so that’s one of our big questions. Perhaps this group are not properly screened before age 65, and then they hit 65, they don’t screen, and this is the result we’re seeing.”
The situation is compounded by the lack of continuity in care at this crucial juncture, said Alexander Olawaiye, MD, a professor in the division of gynecologic oncology at the University of Pittsburgh, who was also approached for comment.
At age 65, many women retire, move across the country, or access new health care providers through Medicare, which kicks in at age 65, so the woman’s new physician doesn’t have access to her screening history, he commented.
This means that a physician needs to rely on the patient’s memory.
This is unrealistic, said Dr. Olawaiye: “Let’s forget about the 65-year-old women for now. Let’s talk about young women with sharp minds. Half of these young adults cannot even remember correctly their last monthly period. And these are the people you want to recollect accurately [at age 65] the number of tests they’ve had over 10 years and the results of those tests? Are you kidding me?” said Dr. Olawaiye. “Is that the kind of verification that you rely on?”
Dr. Olawaiye has consistently advocated for scrapping the 65+ screening moratorium in past and current versions of the cervical screening guidelines. He is puzzled by the national unwillingness to do so and rejects the economic argument, pointing out that a handful of extra tests is a lot cheaper than caring for a patient with advanced cervical cancer.
“Most American women will die around 84-85 years of age,” Dr. Olawaiye commented. “So between 65 and 85, you will need five screens, maybe four. What are you saving by not doing that?”
Dr. Maguire, Dr. Francoeur, and Dr. Olawaiye have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Approximately one-fifth of cervical cancer cases are diagnosed in women aged 65 years or older, and most of the cases are late-stage disease associated with poor survival rates. The new finding calls into question yet again the many national screening guidelines that advise physicians to halt cervical screening at age 65.
The findings emerged from an analysis of the California Cancer Registry for 2009-2018. The authors, from the University of California, Davis, who manage the registry on behalf of the state, found that 17% of women diagnosed with a first primary cancer were aged 65 years or older.
Up to 71% of these older women had late-stage disease vs. 34%-to 59% of women aged 21-64.
The team also found that older patients, even those with early disease, had much poorer survival after they were diagnosed with cervical cancer than their younger counterparts. For example, patients aged between 65 and 69 with stage I cervical cancer had a 5-year relative survival – that is, survival adjusted for noncancer causes of death – of 82%. By contrast, 94% of women aged 20-39 survived for at least 5 years.
The study was published on January 9 in Cancer Epidemiology, Biomarkers & Prevention.
These new data echo similar findings from other recent cervical cancer studies out of California, Massachusetts, Ohio, and nationally. Those studies show that, in comparison with younger patients, rates of late-stage disease are higher and survival is poorer among women aged 65 and older.
Even so, a coauthor of the present study, Frances Maguire, PhD, who is an epidemiologist at the University of California, Davis, said she and her colleagues were surprised by what they found.
“There are a lot of women in this older-age category who are being diagnosed, and they’re being diagnosed later stage and their survival is worse,” Dr. Maguire said. “That was surprising to all of us,” given that the current recommendations are to stop screening once women reach the age of 65, and yet this age group is “doing quite poorly.”
The American Cancer Society, the U.S. Preventive Services Task Force, and the American College of Obstetricians and Gynecologists all recommend that cervical screening stop at aged 65 for patients with “adequate prior screening.”
Adequate screening is defined as having three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative cotests within the prior 10 years, with the most recent screening within 5 years and having no precancerous lesions in the past 25 years.
However, as many as 23% of women aged 60-64 report that their last Pap test was administered more than 5 years ago, according to a recent study by Alex Francoeur, MD, and colleagues at the University of California, Los Angeles.
When asked to comment on the new article, Dr. Francoeur said, “There is literature that increasing comorbidities and visits to the doctor [with age] decrease the likelihood of getting a Pap test, which is concerning, as these may be the highest-risk women.”
Said study author Dr. Maguire, “It could be that [the guidelines] are perfectly fine if women were properly screened before they hit 65, so that’s one of our big questions. Perhaps this group are not properly screened before age 65, and then they hit 65, they don’t screen, and this is the result we’re seeing.”
The situation is compounded by the lack of continuity in care at this crucial juncture, said Alexander Olawaiye, MD, a professor in the division of gynecologic oncology at the University of Pittsburgh, who was also approached for comment.
At age 65, many women retire, move across the country, or access new health care providers through Medicare, which kicks in at age 65, so the woman’s new physician doesn’t have access to her screening history, he commented.
This means that a physician needs to rely on the patient’s memory.
This is unrealistic, said Dr. Olawaiye: “Let’s forget about the 65-year-old women for now. Let’s talk about young women with sharp minds. Half of these young adults cannot even remember correctly their last monthly period. And these are the people you want to recollect accurately [at age 65] the number of tests they’ve had over 10 years and the results of those tests? Are you kidding me?” said Dr. Olawaiye. “Is that the kind of verification that you rely on?”
Dr. Olawaiye has consistently advocated for scrapping the 65+ screening moratorium in past and current versions of the cervical screening guidelines. He is puzzled by the national unwillingness to do so and rejects the economic argument, pointing out that a handful of extra tests is a lot cheaper than caring for a patient with advanced cervical cancer.
“Most American women will die around 84-85 years of age,” Dr. Olawaiye commented. “So between 65 and 85, you will need five screens, maybe four. What are you saving by not doing that?”
Dr. Maguire, Dr. Francoeur, and Dr. Olawaiye have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION
Nitrite food additives may increase risk of type 2 diabetes
Consuming a large amount of nitrites from food additives versus none was associated with a greater risk of developing type 2 diabetes in the NutriNet-Santé study in France, researchers report.
However, a few experts who were not involved with this research question the strength of the findings because of study limitations.
The study involved more than 100,000 adults with a mean age of 43, and 79% were women.
Individuals with the highest intakes of nitrites from food additives (top third) had a 53% higher risk of developing type 2 diabetes during a median follow-up of 7 years compared with those with the lowest intake of this food additive after controlling for intake of sugars, red and processed meats, heme iron, salt, and saturated fatty acids. Consumption of nitrates from food additives was not associated with risk of type 2 diabetes.
“Our findings suggest a direct association between additives-originated nitrites and [type 2 diabetes] risk and corroborate previously suggested associations between total dietary nitrites and [type 2 diabetes],” the researchers report in an article published online in PLoS Medicine.
However, “as this is the first large-scale study finding these associations, these results need to be replicated in other large-scale cohorts,” senior author Mathilde Touvier, PhD, head of the Nutritional Epidemiology Research Team (EREN-CRESS), INSERM, INRAE, Sorbonne Paris Nord University, and lead author Bernard Srour, PhD, PharmD, a scientist at the same institution, said in a joint email to this news organization.
Short-term intervention studies to determine insulin resistance could also be tested, they add.
In the meantime, “this study adds further evidence to the existing strong link between nitrites and colorectal cancer risk, and supports the importance of further regulation of nitrites as food additives and nitrogen fertilizers,” they say.
According to Dr. Touvier and Dr. Srour, the takeaway message for clinicians is the finding that nitrites from food additives are associated with type 2 diabetes, “support existing guidelines recommending [limiting] the consumption of processed meats to prevent chronic diseases. However, the consumption of vegetables should be encouraged as they contain several beneficial compounds and contribute to chronic disease prevention.”
Some experts are skeptical
But three experts who were not involved with the research were skeptical about the conclusions, in comments made to the U.K. Science Media Centre.
“The fundamental weakness of this study is how the food additive intake was assessed,” said Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics, King’s College London. “Estimates of intake were based on recalls of dietary intake on two separate occasions at the beginning of the study with no further estimates in the follow-up period of over 7 years,” he noted.
Other limitations include the relatively young age of the cohort and relatively low incidence of new cases of type 2 diabetes (about 1% of the study population over 7 years).
Moreover, the level of nitrite food additive ingestion is much lower than the acceptable daily intake. The findings would need to be replicated with appropriate adjustment for differences in body weight.
Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading, England, said that “the study does not support the claim in the press release and paper that food additives are responsible for the increased risk.”
He pointed out that “nitrite from additives contributes only about 4%-6% of total nitrite intake in the population, and it is not clear why this should have a stronger impact on risk than nitrite from other sources,” such as nitrate found in food and water.
Duane Mellor, PhD, registered dietitian and senior lecturer, Aston University, Birmingham, England, said: “It could be questioned how accurate estimating intakes of individual additives like sodium nitrite, which was less than 1 mg per day from a record of just 2 days food intake per year, as it assumes people ate the same the other 363 days of the year.”
Moreover, “it is perhaps worth noting that the use of nitrites as an additive is often as sodium nitrite, which is used to cure meats like bacon, which if someone is seeking to reduce their risk of type 2 diabetes would be something people would be encouraged to eat less of [anyway].”
“The best way to reduce your risk of developing type 2 diabetes,” he said, “is to be physically active, maintain a healthy weight for you, and eat a varied diet based on vegetables, pulses, nuts, seeds, and fruit along with wholegrain and moderate intakes of dairy foods and meat (especially processed meats).”
Study details
Nitrites and nitrates are used as food additives to prevent bacterial growth, mainly in processed meats, and they are also found in foods (mainly green leafy vegetables) and water (nitrates from the use of nitrogen fertilizer can enter the water supply).
The researchers analyzed data from 104,168 participants in NutriNet-Santé who had no diabetes at baseline and who completed 24-hour dietary intake records. They investigated the association between exposure to nitrites and nitrates (in food and water or in additives) and incident type 2 diabetes.
Most nitrites came from food (95.3%), and less often from food additives (4.7%) and water (< 0.01%). The nitrites in foods were mainly from vegetables (60%) and seasonings (23%).
Most nitrates also came from food (93%), followed by water (6.9%) and food additives (0.1%). The nitrates in foods were mainly from vegetables (41%), processed meat (19%), and meat (17%).
During a median follow-up of 7.3 years, there were 969 incident cases of type 2 diabetes.
Compared with individuals in the lowest third of nitrites from food and water, those in the highest tertile had a 27% higher risk of incident type 2 diabetes, after adjusting for multiple variables (hazard ratio, 1.27; P = .009).
The risk of type 2 diabetes associated with the highest intake of nitrites from additives was as previously described, 53% higher, than that for those with the lowest intake.
There was no evidence of an association between nitrates and risk of type 2 diabetes.
The researchers acknowledge that study limitations include potential errors in assessment of nitrate and nitrate exposure, potential selection bias (participants in the web-based study may have had healthier behaviors than the general population), and potential unaccounted confounders (because it was an observational study).
A version of this article first appeared on Medscape.com.
Consuming a large amount of nitrites from food additives versus none was associated with a greater risk of developing type 2 diabetes in the NutriNet-Santé study in France, researchers report.
However, a few experts who were not involved with this research question the strength of the findings because of study limitations.
The study involved more than 100,000 adults with a mean age of 43, and 79% were women.
Individuals with the highest intakes of nitrites from food additives (top third) had a 53% higher risk of developing type 2 diabetes during a median follow-up of 7 years compared with those with the lowest intake of this food additive after controlling for intake of sugars, red and processed meats, heme iron, salt, and saturated fatty acids. Consumption of nitrates from food additives was not associated with risk of type 2 diabetes.
“Our findings suggest a direct association between additives-originated nitrites and [type 2 diabetes] risk and corroborate previously suggested associations between total dietary nitrites and [type 2 diabetes],” the researchers report in an article published online in PLoS Medicine.
However, “as this is the first large-scale study finding these associations, these results need to be replicated in other large-scale cohorts,” senior author Mathilde Touvier, PhD, head of the Nutritional Epidemiology Research Team (EREN-CRESS), INSERM, INRAE, Sorbonne Paris Nord University, and lead author Bernard Srour, PhD, PharmD, a scientist at the same institution, said in a joint email to this news organization.
Short-term intervention studies to determine insulin resistance could also be tested, they add.
In the meantime, “this study adds further evidence to the existing strong link between nitrites and colorectal cancer risk, and supports the importance of further regulation of nitrites as food additives and nitrogen fertilizers,” they say.
According to Dr. Touvier and Dr. Srour, the takeaway message for clinicians is the finding that nitrites from food additives are associated with type 2 diabetes, “support existing guidelines recommending [limiting] the consumption of processed meats to prevent chronic diseases. However, the consumption of vegetables should be encouraged as they contain several beneficial compounds and contribute to chronic disease prevention.”
Some experts are skeptical
But three experts who were not involved with the research were skeptical about the conclusions, in comments made to the U.K. Science Media Centre.
“The fundamental weakness of this study is how the food additive intake was assessed,” said Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics, King’s College London. “Estimates of intake were based on recalls of dietary intake on two separate occasions at the beginning of the study with no further estimates in the follow-up period of over 7 years,” he noted.
Other limitations include the relatively young age of the cohort and relatively low incidence of new cases of type 2 diabetes (about 1% of the study population over 7 years).
Moreover, the level of nitrite food additive ingestion is much lower than the acceptable daily intake. The findings would need to be replicated with appropriate adjustment for differences in body weight.
Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading, England, said that “the study does not support the claim in the press release and paper that food additives are responsible for the increased risk.”
He pointed out that “nitrite from additives contributes only about 4%-6% of total nitrite intake in the population, and it is not clear why this should have a stronger impact on risk than nitrite from other sources,” such as nitrate found in food and water.
Duane Mellor, PhD, registered dietitian and senior lecturer, Aston University, Birmingham, England, said: “It could be questioned how accurate estimating intakes of individual additives like sodium nitrite, which was less than 1 mg per day from a record of just 2 days food intake per year, as it assumes people ate the same the other 363 days of the year.”
Moreover, “it is perhaps worth noting that the use of nitrites as an additive is often as sodium nitrite, which is used to cure meats like bacon, which if someone is seeking to reduce their risk of type 2 diabetes would be something people would be encouraged to eat less of [anyway].”
“The best way to reduce your risk of developing type 2 diabetes,” he said, “is to be physically active, maintain a healthy weight for you, and eat a varied diet based on vegetables, pulses, nuts, seeds, and fruit along with wholegrain and moderate intakes of dairy foods and meat (especially processed meats).”
Study details
Nitrites and nitrates are used as food additives to prevent bacterial growth, mainly in processed meats, and they are also found in foods (mainly green leafy vegetables) and water (nitrates from the use of nitrogen fertilizer can enter the water supply).
The researchers analyzed data from 104,168 participants in NutriNet-Santé who had no diabetes at baseline and who completed 24-hour dietary intake records. They investigated the association between exposure to nitrites and nitrates (in food and water or in additives) and incident type 2 diabetes.
Most nitrites came from food (95.3%), and less often from food additives (4.7%) and water (< 0.01%). The nitrites in foods were mainly from vegetables (60%) and seasonings (23%).
Most nitrates also came from food (93%), followed by water (6.9%) and food additives (0.1%). The nitrates in foods were mainly from vegetables (41%), processed meat (19%), and meat (17%).
During a median follow-up of 7.3 years, there were 969 incident cases of type 2 diabetes.
Compared with individuals in the lowest third of nitrites from food and water, those in the highest tertile had a 27% higher risk of incident type 2 diabetes, after adjusting for multiple variables (hazard ratio, 1.27; P = .009).
The risk of type 2 diabetes associated with the highest intake of nitrites from additives was as previously described, 53% higher, than that for those with the lowest intake.
There was no evidence of an association between nitrates and risk of type 2 diabetes.
The researchers acknowledge that study limitations include potential errors in assessment of nitrate and nitrate exposure, potential selection bias (participants in the web-based study may have had healthier behaviors than the general population), and potential unaccounted confounders (because it was an observational study).
A version of this article first appeared on Medscape.com.
Consuming a large amount of nitrites from food additives versus none was associated with a greater risk of developing type 2 diabetes in the NutriNet-Santé study in France, researchers report.
However, a few experts who were not involved with this research question the strength of the findings because of study limitations.
The study involved more than 100,000 adults with a mean age of 43, and 79% were women.
Individuals with the highest intakes of nitrites from food additives (top third) had a 53% higher risk of developing type 2 diabetes during a median follow-up of 7 years compared with those with the lowest intake of this food additive after controlling for intake of sugars, red and processed meats, heme iron, salt, and saturated fatty acids. Consumption of nitrates from food additives was not associated with risk of type 2 diabetes.
“Our findings suggest a direct association between additives-originated nitrites and [type 2 diabetes] risk and corroborate previously suggested associations between total dietary nitrites and [type 2 diabetes],” the researchers report in an article published online in PLoS Medicine.
However, “as this is the first large-scale study finding these associations, these results need to be replicated in other large-scale cohorts,” senior author Mathilde Touvier, PhD, head of the Nutritional Epidemiology Research Team (EREN-CRESS), INSERM, INRAE, Sorbonne Paris Nord University, and lead author Bernard Srour, PhD, PharmD, a scientist at the same institution, said in a joint email to this news organization.
Short-term intervention studies to determine insulin resistance could also be tested, they add.
In the meantime, “this study adds further evidence to the existing strong link between nitrites and colorectal cancer risk, and supports the importance of further regulation of nitrites as food additives and nitrogen fertilizers,” they say.
According to Dr. Touvier and Dr. Srour, the takeaway message for clinicians is the finding that nitrites from food additives are associated with type 2 diabetes, “support existing guidelines recommending [limiting] the consumption of processed meats to prevent chronic diseases. However, the consumption of vegetables should be encouraged as they contain several beneficial compounds and contribute to chronic disease prevention.”
Some experts are skeptical
But three experts who were not involved with the research were skeptical about the conclusions, in comments made to the U.K. Science Media Centre.
“The fundamental weakness of this study is how the food additive intake was assessed,” said Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics, King’s College London. “Estimates of intake were based on recalls of dietary intake on two separate occasions at the beginning of the study with no further estimates in the follow-up period of over 7 years,” he noted.
Other limitations include the relatively young age of the cohort and relatively low incidence of new cases of type 2 diabetes (about 1% of the study population over 7 years).
Moreover, the level of nitrite food additive ingestion is much lower than the acceptable daily intake. The findings would need to be replicated with appropriate adjustment for differences in body weight.
Gunter Kuhnle, PhD, professor of nutrition and food science, University of Reading, England, said that “the study does not support the claim in the press release and paper that food additives are responsible for the increased risk.”
He pointed out that “nitrite from additives contributes only about 4%-6% of total nitrite intake in the population, and it is not clear why this should have a stronger impact on risk than nitrite from other sources,” such as nitrate found in food and water.
Duane Mellor, PhD, registered dietitian and senior lecturer, Aston University, Birmingham, England, said: “It could be questioned how accurate estimating intakes of individual additives like sodium nitrite, which was less than 1 mg per day from a record of just 2 days food intake per year, as it assumes people ate the same the other 363 days of the year.”
Moreover, “it is perhaps worth noting that the use of nitrites as an additive is often as sodium nitrite, which is used to cure meats like bacon, which if someone is seeking to reduce their risk of type 2 diabetes would be something people would be encouraged to eat less of [anyway].”
“The best way to reduce your risk of developing type 2 diabetes,” he said, “is to be physically active, maintain a healthy weight for you, and eat a varied diet based on vegetables, pulses, nuts, seeds, and fruit along with wholegrain and moderate intakes of dairy foods and meat (especially processed meats).”
Study details
Nitrites and nitrates are used as food additives to prevent bacterial growth, mainly in processed meats, and they are also found in foods (mainly green leafy vegetables) and water (nitrates from the use of nitrogen fertilizer can enter the water supply).
The researchers analyzed data from 104,168 participants in NutriNet-Santé who had no diabetes at baseline and who completed 24-hour dietary intake records. They investigated the association between exposure to nitrites and nitrates (in food and water or in additives) and incident type 2 diabetes.
Most nitrites came from food (95.3%), and less often from food additives (4.7%) and water (< 0.01%). The nitrites in foods were mainly from vegetables (60%) and seasonings (23%).
Most nitrates also came from food (93%), followed by water (6.9%) and food additives (0.1%). The nitrates in foods were mainly from vegetables (41%), processed meat (19%), and meat (17%).
During a median follow-up of 7.3 years, there were 969 incident cases of type 2 diabetes.
Compared with individuals in the lowest third of nitrites from food and water, those in the highest tertile had a 27% higher risk of incident type 2 diabetes, after adjusting for multiple variables (hazard ratio, 1.27; P = .009).
The risk of type 2 diabetes associated with the highest intake of nitrites from additives was as previously described, 53% higher, than that for those with the lowest intake.
There was no evidence of an association between nitrates and risk of type 2 diabetes.
The researchers acknowledge that study limitations include potential errors in assessment of nitrate and nitrate exposure, potential selection bias (participants in the web-based study may have had healthier behaviors than the general population), and potential unaccounted confounders (because it was an observational study).
A version of this article first appeared on Medscape.com.
FROM PLOS MEDICINE
FAST score appears accurate for diagnosis of fibrotic NASH
The FAST score had an overall sensitivity of 89% and an overall specificity of 89% with a defined rule-out cutoff of .35 or lower and rule-in cutoff of .67 or higher, respectively, Federico Ravaioli, MD, PhD, a gastroenterologist at the University of Modena & Reggio Emilia in Italy, and colleagues, wrote in Gut.
“These results could be used in clinical screening studies to efficiently identify patients at risk of progressive NASH, who should be referred for a conclusive liver biopsy, and who might benefit from treatment with emerging pharmacotherapies,” the authors wrote.
The research team analyzed 12 observational studies with 5,835 participants with biopsy-confirmed nonalcoholic fatty liver disease (NAFLD) between February 2020 and April 2022. They included articles that reported data for the calculation of sensitivity and specificity of the FAST score for identifying adult patients with fibrotic NASH based on a defined rule-out cutoff of .35 or lower and rule-in cutoff of .67 or higher. Fibrotic NASH was defined as patients with NASH plus a NAFLD activity score of 4 or greater and fibrosis stage 2 or higher.
The pooled prevalence of fibrotic NASH was 28%. The mean age of participants ranged from 40 to 60, and the proportion of men ranged from 23% to 91%. The mean body mass index ranged from 23 kg/m2 to 41 kg/m2, with a prevalence of obesity ranging from 23% to 100% and preexisting type 2 diabetes ranging from 18% to 60%. Nine studies included patients with biopsy-proven NAFLD from tertiary care liver centers, and three studies included patients from bariatric clinics or bariatric surgery centers with available liver biopsy data.
Fibrotic NASH was ruled out in 2,723 patients (45.5%) by a FAST score of .35 or lower and ruled in 1,287 patients (21.5%) by a FAST score of .67 or higher. In addition, 1,979 patients (33%) had a FAST score in the so-called “grey” intermediate zone.
Overall, the FAST score pooled sensitivity was 89%, and the pooled specificity was 89%. By the rule-out cutoff of .35, the sensitivity was 89% and the specificity was 56%. By the rule-in cutoff of .67, the sensitivity was 46% and the specificity was 89%.
At an expected prevalence of fibrotic NASH of 30%, the negative predictive value of the .35 cutoff was 92%, and the positive predictive value of the .67 cutoff was 65%. Across the included studies, the negative predictive value ranged from 77% to 98%, and the positive predictive value ranged from 32% to 87%.
For the rule-in cutoff of .67, at a pretest probability of 10%, 20%, 26.3%, and 30%, there was an increasing likelihood of detecting fibrotic NASH by FAST score at 32%, 52%, 60%, and 65%, respectively. For the rule-out cutoff of .35, at the same pretest probability levels, the likelihood of someone not having fibrotic NASH and not being detected by FAST score was 2%, 5%, 7%, and 8%, respectively.
In subgroup analyses, the sensitivity of the rule-out cutoff was significantly affected by the study design. In addition, age and BMI above the median both affected pooled sensitivity but not pooled specificity. On the other hand, the rule-in cutoff was significantly affected by study design, BMI above the median, and presence of preexisting type 2 diabetes above the median.
“Today, we stand on the cusp of a revolutionary time to treat NASH. This is due in part to the fact that many exciting, novel precision metabolic treatments are in the pipeline to combat this disease,” said Brian DeBosch, MD, PhD, associate professor of cell biology and physiology at the Washington University in St. Louis, who was not involved with this study.
“A major barrier in clinical NASH management is a rapid, noninvasive, and precise means by which to clinically stage such patients,” Dr. DeBosch said. “We now approach as closely as ever the sensitivity and specificity required to stratify the highest-risk patients, identify candidates for advanced therapy, and meaningfully reduce biopsies through using noninvasive testing.”
Dr. DeBosch noted the importance of pretest probability and specific subpopulations when deciding whether to use the FAST score. For instance, he said, a tertiary academic liver transplant center will see a different patient population than in a primary care setting. Also, in this study, the presence or absence of diabetes and a BMI above 30 significantly altered sensitivity and specificity.
“One important remaining question stemming from these data is whether FAST can also be used as a surrogate measure to follow disease regression over time following intervention,” Dr. DeBosch said. “Even if FAST is not useful in that way, defining individuals who most need to undergo biopsy and/or those who need to undergo treatment remain important uses for this test.”
The study authors did not declare a specific funding source or report any competing interests. DeBosch reported no relevant disclosures.
The FAST score had an overall sensitivity of 89% and an overall specificity of 89% with a defined rule-out cutoff of .35 or lower and rule-in cutoff of .67 or higher, respectively, Federico Ravaioli, MD, PhD, a gastroenterologist at the University of Modena & Reggio Emilia in Italy, and colleagues, wrote in Gut.
“These results could be used in clinical screening studies to efficiently identify patients at risk of progressive NASH, who should be referred for a conclusive liver biopsy, and who might benefit from treatment with emerging pharmacotherapies,” the authors wrote.
The research team analyzed 12 observational studies with 5,835 participants with biopsy-confirmed nonalcoholic fatty liver disease (NAFLD) between February 2020 and April 2022. They included articles that reported data for the calculation of sensitivity and specificity of the FAST score for identifying adult patients with fibrotic NASH based on a defined rule-out cutoff of .35 or lower and rule-in cutoff of .67 or higher. Fibrotic NASH was defined as patients with NASH plus a NAFLD activity score of 4 or greater and fibrosis stage 2 or higher.
The pooled prevalence of fibrotic NASH was 28%. The mean age of participants ranged from 40 to 60, and the proportion of men ranged from 23% to 91%. The mean body mass index ranged from 23 kg/m2 to 41 kg/m2, with a prevalence of obesity ranging from 23% to 100% and preexisting type 2 diabetes ranging from 18% to 60%. Nine studies included patients with biopsy-proven NAFLD from tertiary care liver centers, and three studies included patients from bariatric clinics or bariatric surgery centers with available liver biopsy data.
Fibrotic NASH was ruled out in 2,723 patients (45.5%) by a FAST score of .35 or lower and ruled in 1,287 patients (21.5%) by a FAST score of .67 or higher. In addition, 1,979 patients (33%) had a FAST score in the so-called “grey” intermediate zone.
Overall, the FAST score pooled sensitivity was 89%, and the pooled specificity was 89%. By the rule-out cutoff of .35, the sensitivity was 89% and the specificity was 56%. By the rule-in cutoff of .67, the sensitivity was 46% and the specificity was 89%.
At an expected prevalence of fibrotic NASH of 30%, the negative predictive value of the .35 cutoff was 92%, and the positive predictive value of the .67 cutoff was 65%. Across the included studies, the negative predictive value ranged from 77% to 98%, and the positive predictive value ranged from 32% to 87%.
For the rule-in cutoff of .67, at a pretest probability of 10%, 20%, 26.3%, and 30%, there was an increasing likelihood of detecting fibrotic NASH by FAST score at 32%, 52%, 60%, and 65%, respectively. For the rule-out cutoff of .35, at the same pretest probability levels, the likelihood of someone not having fibrotic NASH and not being detected by FAST score was 2%, 5%, 7%, and 8%, respectively.
In subgroup analyses, the sensitivity of the rule-out cutoff was significantly affected by the study design. In addition, age and BMI above the median both affected pooled sensitivity but not pooled specificity. On the other hand, the rule-in cutoff was significantly affected by study design, BMI above the median, and presence of preexisting type 2 diabetes above the median.
“Today, we stand on the cusp of a revolutionary time to treat NASH. This is due in part to the fact that many exciting, novel precision metabolic treatments are in the pipeline to combat this disease,” said Brian DeBosch, MD, PhD, associate professor of cell biology and physiology at the Washington University in St. Louis, who was not involved with this study.
“A major barrier in clinical NASH management is a rapid, noninvasive, and precise means by which to clinically stage such patients,” Dr. DeBosch said. “We now approach as closely as ever the sensitivity and specificity required to stratify the highest-risk patients, identify candidates for advanced therapy, and meaningfully reduce biopsies through using noninvasive testing.”
Dr. DeBosch noted the importance of pretest probability and specific subpopulations when deciding whether to use the FAST score. For instance, he said, a tertiary academic liver transplant center will see a different patient population than in a primary care setting. Also, in this study, the presence or absence of diabetes and a BMI above 30 significantly altered sensitivity and specificity.
“One important remaining question stemming from these data is whether FAST can also be used as a surrogate measure to follow disease regression over time following intervention,” Dr. DeBosch said. “Even if FAST is not useful in that way, defining individuals who most need to undergo biopsy and/or those who need to undergo treatment remain important uses for this test.”
The study authors did not declare a specific funding source or report any competing interests. DeBosch reported no relevant disclosures.
The FAST score had an overall sensitivity of 89% and an overall specificity of 89% with a defined rule-out cutoff of .35 or lower and rule-in cutoff of .67 or higher, respectively, Federico Ravaioli, MD, PhD, a gastroenterologist at the University of Modena & Reggio Emilia in Italy, and colleagues, wrote in Gut.
“These results could be used in clinical screening studies to efficiently identify patients at risk of progressive NASH, who should be referred for a conclusive liver biopsy, and who might benefit from treatment with emerging pharmacotherapies,” the authors wrote.
The research team analyzed 12 observational studies with 5,835 participants with biopsy-confirmed nonalcoholic fatty liver disease (NAFLD) between February 2020 and April 2022. They included articles that reported data for the calculation of sensitivity and specificity of the FAST score for identifying adult patients with fibrotic NASH based on a defined rule-out cutoff of .35 or lower and rule-in cutoff of .67 or higher. Fibrotic NASH was defined as patients with NASH plus a NAFLD activity score of 4 or greater and fibrosis stage 2 or higher.
The pooled prevalence of fibrotic NASH was 28%. The mean age of participants ranged from 40 to 60, and the proportion of men ranged from 23% to 91%. The mean body mass index ranged from 23 kg/m2 to 41 kg/m2, with a prevalence of obesity ranging from 23% to 100% and preexisting type 2 diabetes ranging from 18% to 60%. Nine studies included patients with biopsy-proven NAFLD from tertiary care liver centers, and three studies included patients from bariatric clinics or bariatric surgery centers with available liver biopsy data.
Fibrotic NASH was ruled out in 2,723 patients (45.5%) by a FAST score of .35 or lower and ruled in 1,287 patients (21.5%) by a FAST score of .67 or higher. In addition, 1,979 patients (33%) had a FAST score in the so-called “grey” intermediate zone.
Overall, the FAST score pooled sensitivity was 89%, and the pooled specificity was 89%. By the rule-out cutoff of .35, the sensitivity was 89% and the specificity was 56%. By the rule-in cutoff of .67, the sensitivity was 46% and the specificity was 89%.
At an expected prevalence of fibrotic NASH of 30%, the negative predictive value of the .35 cutoff was 92%, and the positive predictive value of the .67 cutoff was 65%. Across the included studies, the negative predictive value ranged from 77% to 98%, and the positive predictive value ranged from 32% to 87%.
For the rule-in cutoff of .67, at a pretest probability of 10%, 20%, 26.3%, and 30%, there was an increasing likelihood of detecting fibrotic NASH by FAST score at 32%, 52%, 60%, and 65%, respectively. For the rule-out cutoff of .35, at the same pretest probability levels, the likelihood of someone not having fibrotic NASH and not being detected by FAST score was 2%, 5%, 7%, and 8%, respectively.
In subgroup analyses, the sensitivity of the rule-out cutoff was significantly affected by the study design. In addition, age and BMI above the median both affected pooled sensitivity but not pooled specificity. On the other hand, the rule-in cutoff was significantly affected by study design, BMI above the median, and presence of preexisting type 2 diabetes above the median.
“Today, we stand on the cusp of a revolutionary time to treat NASH. This is due in part to the fact that many exciting, novel precision metabolic treatments are in the pipeline to combat this disease,” said Brian DeBosch, MD, PhD, associate professor of cell biology and physiology at the Washington University in St. Louis, who was not involved with this study.
“A major barrier in clinical NASH management is a rapid, noninvasive, and precise means by which to clinically stage such patients,” Dr. DeBosch said. “We now approach as closely as ever the sensitivity and specificity required to stratify the highest-risk patients, identify candidates for advanced therapy, and meaningfully reduce biopsies through using noninvasive testing.”
Dr. DeBosch noted the importance of pretest probability and specific subpopulations when deciding whether to use the FAST score. For instance, he said, a tertiary academic liver transplant center will see a different patient population than in a primary care setting. Also, in this study, the presence or absence of diabetes and a BMI above 30 significantly altered sensitivity and specificity.
“One important remaining question stemming from these data is whether FAST can also be used as a surrogate measure to follow disease regression over time following intervention,” Dr. DeBosch said. “Even if FAST is not useful in that way, defining individuals who most need to undergo biopsy and/or those who need to undergo treatment remain important uses for this test.”
The study authors did not declare a specific funding source or report any competing interests. DeBosch reported no relevant disclosures.
FROM GUT
Novel antipsychotic ‘encouraging’ for resistant schizophrenia
The topline results from an exploratory study, which were released by the developer Newron Pharmaceuticals, are “very encouraging,” Stephen R. Marder, MD, professor of psychiatry and biobehavioral sciences at the University of California, Los Angeles, said in a company news release.
“The magnitude of the improvements experienced by these TRS patients, not responding to their current antipsychotic, on evenamide was substantial, improved over time, and was likely to be clinically meaningful,” Dr. Marder said.
First 100 patients
The topline results are based on the first 100 patients enrolled in study 014 and randomly assigned to receive evenamide at 7.5 mg, 15 mg, or 30 mg twice daily, as well as patients in the extension arm (study 015) that have completed 30 weeks.
Key findings released by the company included statistically significant improvement over baseline at 30 weeks (P < .001) in Positive and Negative Syndrome Scale (PANSS) scores, with continued improvement over that seen at 6 weeks.
The proportion of patients with clinically meaningful PANSS improvement at 30 weeks more than doubled from 16.5% at 6 weeks.
In addition, results showed statistically significant improvement (P < .001) at week 30 compared with baseline in illness severity as measured by the Clinical Global Impression of Severity (CGI-S), with continued improvement over that seen at 6 weeks.
The proportion of patients whose illness improved by at least one level of severity was 60% at week 6 and increased approximately by an additional 20% at week 30.
The proportion of patients judged to have clinically meaningful improvement, defined as at least “much improved,” on the Clinical Global Impression of Change (CGI-C) was 27% at week 6 – and increased a further 10% at week 30.
Evenamide was also well tolerated, with few adverse effects reported, and 85 of 100 patients remained on treatment at 30 weeks.
New options ‘desperately needed’
Newron plans to present the full results from study 014 at the European Congress of Psychiatry, scheduled for March 25-28 in Paris.
The extension study 015 is ongoing and will provide results on evenamide treatment for up to 1 year by the second quarter of 2023.
The company reported it expects to launch a randomized, placebo-controlled study (study 003) of the drug in TRS this year.
If the current results are confirmed in the randomized controlled trial, “evenamide would be the first medication that could be added to an antipsychotic to improve symptoms in treatment-refractory schizophrenia,” Dr. Marder said.
New therapeutic options for TRS, which occurs in about one-third of patients, are “desperately needed,” Ravi Anand, MD, chief medical officer at Newron, said in the release.
The reported data, comparing the effect of evenamide at 6 weeks vs. 6 months, “suggest that not only was there sustained improvement in the key measures, but the proportion of patients achieving clinically meaningful improvement increased over time,” Dr. Anand added.
A version of this article first appeared on Medscape.com.
The topline results from an exploratory study, which were released by the developer Newron Pharmaceuticals, are “very encouraging,” Stephen R. Marder, MD, professor of psychiatry and biobehavioral sciences at the University of California, Los Angeles, said in a company news release.
“The magnitude of the improvements experienced by these TRS patients, not responding to their current antipsychotic, on evenamide was substantial, improved over time, and was likely to be clinically meaningful,” Dr. Marder said.
First 100 patients
The topline results are based on the first 100 patients enrolled in study 014 and randomly assigned to receive evenamide at 7.5 mg, 15 mg, or 30 mg twice daily, as well as patients in the extension arm (study 015) that have completed 30 weeks.
Key findings released by the company included statistically significant improvement over baseline at 30 weeks (P < .001) in Positive and Negative Syndrome Scale (PANSS) scores, with continued improvement over that seen at 6 weeks.
The proportion of patients with clinically meaningful PANSS improvement at 30 weeks more than doubled from 16.5% at 6 weeks.
In addition, results showed statistically significant improvement (P < .001) at week 30 compared with baseline in illness severity as measured by the Clinical Global Impression of Severity (CGI-S), with continued improvement over that seen at 6 weeks.
The proportion of patients whose illness improved by at least one level of severity was 60% at week 6 and increased approximately by an additional 20% at week 30.
The proportion of patients judged to have clinically meaningful improvement, defined as at least “much improved,” on the Clinical Global Impression of Change (CGI-C) was 27% at week 6 – and increased a further 10% at week 30.
Evenamide was also well tolerated, with few adverse effects reported, and 85 of 100 patients remained on treatment at 30 weeks.
New options ‘desperately needed’
Newron plans to present the full results from study 014 at the European Congress of Psychiatry, scheduled for March 25-28 in Paris.
The extension study 015 is ongoing and will provide results on evenamide treatment for up to 1 year by the second quarter of 2023.
The company reported it expects to launch a randomized, placebo-controlled study (study 003) of the drug in TRS this year.
If the current results are confirmed in the randomized controlled trial, “evenamide would be the first medication that could be added to an antipsychotic to improve symptoms in treatment-refractory schizophrenia,” Dr. Marder said.
New therapeutic options for TRS, which occurs in about one-third of patients, are “desperately needed,” Ravi Anand, MD, chief medical officer at Newron, said in the release.
The reported data, comparing the effect of evenamide at 6 weeks vs. 6 months, “suggest that not only was there sustained improvement in the key measures, but the proportion of patients achieving clinically meaningful improvement increased over time,” Dr. Anand added.
A version of this article first appeared on Medscape.com.
The topline results from an exploratory study, which were released by the developer Newron Pharmaceuticals, are “very encouraging,” Stephen R. Marder, MD, professor of psychiatry and biobehavioral sciences at the University of California, Los Angeles, said in a company news release.
“The magnitude of the improvements experienced by these TRS patients, not responding to their current antipsychotic, on evenamide was substantial, improved over time, and was likely to be clinically meaningful,” Dr. Marder said.
First 100 patients
The topline results are based on the first 100 patients enrolled in study 014 and randomly assigned to receive evenamide at 7.5 mg, 15 mg, or 30 mg twice daily, as well as patients in the extension arm (study 015) that have completed 30 weeks.
Key findings released by the company included statistically significant improvement over baseline at 30 weeks (P < .001) in Positive and Negative Syndrome Scale (PANSS) scores, with continued improvement over that seen at 6 weeks.
The proportion of patients with clinically meaningful PANSS improvement at 30 weeks more than doubled from 16.5% at 6 weeks.
In addition, results showed statistically significant improvement (P < .001) at week 30 compared with baseline in illness severity as measured by the Clinical Global Impression of Severity (CGI-S), with continued improvement over that seen at 6 weeks.
The proportion of patients whose illness improved by at least one level of severity was 60% at week 6 and increased approximately by an additional 20% at week 30.
The proportion of patients judged to have clinically meaningful improvement, defined as at least “much improved,” on the Clinical Global Impression of Change (CGI-C) was 27% at week 6 – and increased a further 10% at week 30.
Evenamide was also well tolerated, with few adverse effects reported, and 85 of 100 patients remained on treatment at 30 weeks.
New options ‘desperately needed’
Newron plans to present the full results from study 014 at the European Congress of Psychiatry, scheduled for March 25-28 in Paris.
The extension study 015 is ongoing and will provide results on evenamide treatment for up to 1 year by the second quarter of 2023.
The company reported it expects to launch a randomized, placebo-controlled study (study 003) of the drug in TRS this year.
If the current results are confirmed in the randomized controlled trial, “evenamide would be the first medication that could be added to an antipsychotic to improve symptoms in treatment-refractory schizophrenia,” Dr. Marder said.
New therapeutic options for TRS, which occurs in about one-third of patients, are “desperately needed,” Ravi Anand, MD, chief medical officer at Newron, said in the release.
The reported data, comparing the effect of evenamide at 6 weeks vs. 6 months, “suggest that not only was there sustained improvement in the key measures, but the proportion of patients achieving clinically meaningful improvement increased over time,” Dr. Anand added.
A version of this article first appeared on Medscape.com.
Post-birth hospitalizations dropped with Medicaid expansion
Women living in states that expanded Medicaid over the past decade were nearly 20% less likely to be hospitalized within 2 months of giving birth, according to a first-of-its-kind study published in Health Affairs.
Researchers analyzed patient records from eight states – four that expanded Medicaid insurance to include a broader swath of residents following the implementation of the Affordable Care Act, and four states that did not.
Hospitalizations in the 60 days after a woman gave birth fell by 17% in states that expanded Medicaid. The analysis also revealed an 8% drop in hospitalizations between 61 days and 6 months post partum.
“This is a very meaningful decline in hospitalization rates,” said Laura Wherry, PhD, a professor of economics and public service at New York University and a co-author of the study.
Women in states that chose not to expand Medicaid experienced a 7% increase in postpartum hospitalizations during that same time frame, the researchers report.
Many states raised income eligibility thresholds to 138% of the federal poverty level in 2014 with the implementation of the Affordable Care Act, which resulted in more coverage for low-income expectant mothers. To date, a dozen states have not implemented Medicaid expansion.
Dr. Wherry and her colleague wanted to take a closer look at outcomes for pregnant women during the postpartum period, both before and after states chose to expand Medicaid.
“A lot of prior work looking at the Medicaid program examined huge expansions to cover pregnant women during pregnancy, but often other periods of a woman’s life have been overlooked,” Dr. Wherry said. “What we were interested in is how that changed with the Affordable Care Act. You no longer needed to be pregnant to qualify.”
The researchers analyzed hospital discharge data between 2010 and 2017 before and after expansion in Iowa, Maryland, New Mexico, and Washington, which expanded coverage under Medicaid, and Florida, Georgia, Mississippi, and Utah, which did not do so.
Prior to 2014, fewer than 2% of births resulted in a postpartum hospitalization during the 60-day period in Medicaid expansion states. But in states that expanded Medicaid, hospitalizations decreased by 0.289 percentage points (P = .052), or 17% during the 60-day post-birth period.
Approximately 75% of the decline was attributed to diagnoses related to complications in pregnancy, childbirth, and the postpartum period.
Dr. Wherry said a variety of factors possibly drove down hospitalizations for new mothers who were able to obtain Medicaid coverage, including access to robust prenatal care, preconception counseling, and improved management of postpartum conditions outside the hospital.
The study provides a strategy for tackling the rising rate of maternal mortality in the United States, an increase largely attributed to postpartum deaths, said Lindsay Admon, MD, an ob.gyn. at the University of Michigan Medical School in Ann Arbor.
“This is one of the first studies showing or suggesting that Medicaid expansion not only led to improvements in Medicaid insurance but health outcomes as well,” said Dr. Admon, who is also researching maternal health and expanded Medicaid coverage.
Federal law has long required states to provide coverage for pregnant women up to 60 days post partum.
The 2021 American Rescue Act allowed states to extend coverage for pregnant women beyond the federal requirement to a year. More than half of states have chosen to do so. Since the study indicates that Medicaid expansion improves outcomes for these enrollees, Dr. Wherry and Dr. Admon said they hope state officials will consider the new findings during discussions to utilize the Rescue Act Coverage for pregnant women.
Dr. Wherry received support for the study from the Robert Wood Johnson Foundation Policies for Action Program and grant funding from the National Institute on Aging and the National Institute of Child Health and Human Development. Another author received grants from the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development.
A version of this article first appeared on Medscape.com.
Women living in states that expanded Medicaid over the past decade were nearly 20% less likely to be hospitalized within 2 months of giving birth, according to a first-of-its-kind study published in Health Affairs.
Researchers analyzed patient records from eight states – four that expanded Medicaid insurance to include a broader swath of residents following the implementation of the Affordable Care Act, and four states that did not.
Hospitalizations in the 60 days after a woman gave birth fell by 17% in states that expanded Medicaid. The analysis also revealed an 8% drop in hospitalizations between 61 days and 6 months post partum.
“This is a very meaningful decline in hospitalization rates,” said Laura Wherry, PhD, a professor of economics and public service at New York University and a co-author of the study.
Women in states that chose not to expand Medicaid experienced a 7% increase in postpartum hospitalizations during that same time frame, the researchers report.
Many states raised income eligibility thresholds to 138% of the federal poverty level in 2014 with the implementation of the Affordable Care Act, which resulted in more coverage for low-income expectant mothers. To date, a dozen states have not implemented Medicaid expansion.
Dr. Wherry and her colleague wanted to take a closer look at outcomes for pregnant women during the postpartum period, both before and after states chose to expand Medicaid.
“A lot of prior work looking at the Medicaid program examined huge expansions to cover pregnant women during pregnancy, but often other periods of a woman’s life have been overlooked,” Dr. Wherry said. “What we were interested in is how that changed with the Affordable Care Act. You no longer needed to be pregnant to qualify.”
The researchers analyzed hospital discharge data between 2010 and 2017 before and after expansion in Iowa, Maryland, New Mexico, and Washington, which expanded coverage under Medicaid, and Florida, Georgia, Mississippi, and Utah, which did not do so.
Prior to 2014, fewer than 2% of births resulted in a postpartum hospitalization during the 60-day period in Medicaid expansion states. But in states that expanded Medicaid, hospitalizations decreased by 0.289 percentage points (P = .052), or 17% during the 60-day post-birth period.
Approximately 75% of the decline was attributed to diagnoses related to complications in pregnancy, childbirth, and the postpartum period.
Dr. Wherry said a variety of factors possibly drove down hospitalizations for new mothers who were able to obtain Medicaid coverage, including access to robust prenatal care, preconception counseling, and improved management of postpartum conditions outside the hospital.
The study provides a strategy for tackling the rising rate of maternal mortality in the United States, an increase largely attributed to postpartum deaths, said Lindsay Admon, MD, an ob.gyn. at the University of Michigan Medical School in Ann Arbor.
“This is one of the first studies showing or suggesting that Medicaid expansion not only led to improvements in Medicaid insurance but health outcomes as well,” said Dr. Admon, who is also researching maternal health and expanded Medicaid coverage.
Federal law has long required states to provide coverage for pregnant women up to 60 days post partum.
The 2021 American Rescue Act allowed states to extend coverage for pregnant women beyond the federal requirement to a year. More than half of states have chosen to do so. Since the study indicates that Medicaid expansion improves outcomes for these enrollees, Dr. Wherry and Dr. Admon said they hope state officials will consider the new findings during discussions to utilize the Rescue Act Coverage for pregnant women.
Dr. Wherry received support for the study from the Robert Wood Johnson Foundation Policies for Action Program and grant funding from the National Institute on Aging and the National Institute of Child Health and Human Development. Another author received grants from the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development.
A version of this article first appeared on Medscape.com.
Women living in states that expanded Medicaid over the past decade were nearly 20% less likely to be hospitalized within 2 months of giving birth, according to a first-of-its-kind study published in Health Affairs.
Researchers analyzed patient records from eight states – four that expanded Medicaid insurance to include a broader swath of residents following the implementation of the Affordable Care Act, and four states that did not.
Hospitalizations in the 60 days after a woman gave birth fell by 17% in states that expanded Medicaid. The analysis also revealed an 8% drop in hospitalizations between 61 days and 6 months post partum.
“This is a very meaningful decline in hospitalization rates,” said Laura Wherry, PhD, a professor of economics and public service at New York University and a co-author of the study.
Women in states that chose not to expand Medicaid experienced a 7% increase in postpartum hospitalizations during that same time frame, the researchers report.
Many states raised income eligibility thresholds to 138% of the federal poverty level in 2014 with the implementation of the Affordable Care Act, which resulted in more coverage for low-income expectant mothers. To date, a dozen states have not implemented Medicaid expansion.
Dr. Wherry and her colleague wanted to take a closer look at outcomes for pregnant women during the postpartum period, both before and after states chose to expand Medicaid.
“A lot of prior work looking at the Medicaid program examined huge expansions to cover pregnant women during pregnancy, but often other periods of a woman’s life have been overlooked,” Dr. Wherry said. “What we were interested in is how that changed with the Affordable Care Act. You no longer needed to be pregnant to qualify.”
The researchers analyzed hospital discharge data between 2010 and 2017 before and after expansion in Iowa, Maryland, New Mexico, and Washington, which expanded coverage under Medicaid, and Florida, Georgia, Mississippi, and Utah, which did not do so.
Prior to 2014, fewer than 2% of births resulted in a postpartum hospitalization during the 60-day period in Medicaid expansion states. But in states that expanded Medicaid, hospitalizations decreased by 0.289 percentage points (P = .052), or 17% during the 60-day post-birth period.
Approximately 75% of the decline was attributed to diagnoses related to complications in pregnancy, childbirth, and the postpartum period.
Dr. Wherry said a variety of factors possibly drove down hospitalizations for new mothers who were able to obtain Medicaid coverage, including access to robust prenatal care, preconception counseling, and improved management of postpartum conditions outside the hospital.
The study provides a strategy for tackling the rising rate of maternal mortality in the United States, an increase largely attributed to postpartum deaths, said Lindsay Admon, MD, an ob.gyn. at the University of Michigan Medical School in Ann Arbor.
“This is one of the first studies showing or suggesting that Medicaid expansion not only led to improvements in Medicaid insurance but health outcomes as well,” said Dr. Admon, who is also researching maternal health and expanded Medicaid coverage.
Federal law has long required states to provide coverage for pregnant women up to 60 days post partum.
The 2021 American Rescue Act allowed states to extend coverage for pregnant women beyond the federal requirement to a year. More than half of states have chosen to do so. Since the study indicates that Medicaid expansion improves outcomes for these enrollees, Dr. Wherry and Dr. Admon said they hope state officials will consider the new findings during discussions to utilize the Rescue Act Coverage for pregnant women.
Dr. Wherry received support for the study from the Robert Wood Johnson Foundation Policies for Action Program and grant funding from the National Institute on Aging and the National Institute of Child Health and Human Development. Another author received grants from the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development.
A version of this article first appeared on Medscape.com.