Feature

It’s a story perhaps more appropriate for Halloween than for the festive holiday season, given its scary implications. Four Omicron subvariants of the virus that causes COVID-19 will be the most common strains going from person to person in the winter of 2022-2023, new research predicts.

Not too dire so far, until the researchers’ other findings are considered.

The BQ.1, BQ1.1, XBB, and XBB.1 subvariants are the most resistant to neutralizing antibodies, researcher Qian Wang, PhD, and colleagues wrote in a study published online in the journal Cell. This means people have no or “markedly reduced” protection against infection from these four strains, even if they’ve already had COVID-19 or are vaccinated and boosted multiple times, including with a bivalent vaccine.

On top of that, all available monoclonal antibody treatments are mostly or completely ineffective against these subvariants.

What does that mean for the immediate future? The findings are definitely “worrisome,” said Eric Topol, MD, founder and director of the Scripps Translational Research Institute in La Jolla, Calif.

But evidence from other countries, specifically Singapore and France, show that at least two of these variants turned out not to be as damaging as expected, likely because of high numbers of people vaccinated or who survived previous infections, he said.

Still, there is little to celebrate in the new findings, except that COVID-19 vaccinations and prior infections can still reduce the risk for serious outcomes such as hospitalization and death, the researchers wrote.

In fact, Centers for Disease Control and Prevention data released on Dec. 16 shows that people who have received four shots of the original COVID-19 vaccines as well as the bivalent booster were 57% less likely to visit an urgent care clinic or emergency room, regardless of age. 

It comes at a time when BQ.1 and BQ.1.1 account for about 70% of the circulating variants, data show. In addition, hospitalizations are up 18% over the past 2 weeks and COVID-19 deaths are up 50% nationwide, The New York Times reported.

Globally, in many places, an “immunity wall” that has been built, Dr. Topol said. That may not be the case in the United States.  

“The problem in the United States, making it harder to predict, is that we have a very low rate of recent boosters, in the past 6 months, especially in seniors,” he said. For example, only 36% of Americans aged 65 years and older, the group with highest risk, have received an updated bivalent booster.
 

An evolving virus

The subvariants are successfully replacing BA.5, which reigned as one of the most common Omicron variants over the past year. The latest CDC data show that BA.5 now accounts for only about 10% of the circulating virus. The researchers wrote: “This rapid replacement of virus strains is raising the specter of yet another wave of infections in the coming months.”

BQ.1 and BQ.1.1 evolved directly from BA.5 – adding more and some novel mutations to the SARS-CoV-2 virus. XBB and XBB.1 are the “offspring” of a combination of two other strains, known as BJ.1 and BA.2.75.

The story sounds familiar to the researchers. “The rapid rise of these subvariants and their extensive array of spike mutations are reminiscent of the appearance of the first Omicron variant last year, thus raising concerns that they may further compromise the efficacy of current COVID-19 vaccines and monoclonal antibody therapeutics,” they wrote. “We now report findings that indicate that such concerns are, sadly, justified, especially so for the XBB and XBB.1 subvariants.”

To figure out how effective existing antibodies could be against these newer subvariants, Dr. Wang and colleagues used blood samples from five groups of people. They tested serum from people who had three doses of the original COVID-19 vaccine, four doses of the original vaccine, those who received a bivalent booster, people who experienced a breakthrough infection with the BA.2 Omicron variant, and those who had a breakthrough with a BA.4 or BA.5 variant.

Adding the new subvariants to these serum samples revealed that the existing antibodies in the blood were ineffective at wiping out or neutralizing BQ.1, BQ.1.1, XBB, and XBB.1.

The BQ.1 subvariant was six times more resistant to antibodies than BA.5, its parent strain, and XBB.1 was 63 times more resistant compared with its predecessor, BA.2.

This shift in the ability of vaccines to stop the subvariants “is particularly concerning,” the researchers wrote.
 

Wiping out treatments too

Dr. Wang and colleagues also tested how well a panel of 23 different monoclonal antibody drugs might work against the four subvariants. The therapies all worked well against the original Omicron variant and included some approved for use through the Food and Drug Administration emergency use authorization (EUA) program at the time of the study.

They found that 19 of these 23 monoclonal antibodies lost effectiveness “greatly or completely” against XBB and XBB.1, for example.

This is not the first time that monoclonal antibody therapies have gone from effective to ineffective. Previous variants have come out that no longer responded to treatment with bamlanivimab, etesevimab, imdevimab, casirivimab, tixagevimab, cilgavimab, and sotrovimab. Bebtelovimab now joins this list and is no longer available from Eli Lilly under EUA because of this lack of effectiveness.

The lack of an effective monoclonal antibody treatment “poses a serious problem for millions of immunocompromised individuals who do not respond robustly to COVID-19 vaccines,” the researchers wrote, adding that “the urgent need to develop active monoclonal antibodies for clinical use is obvious.”

A limitation of the study is that the work is done in blood samples. The effectiveness of COVID-19 vaccination against the BQ and XBB subvariants should be evaluated in people in clinical studies, the authors noted.

Also, the current study looked at how well antibodies could neutralize the viral strains, but future research, they added, should look at how well “cellular immunity” or other aspects of the immune system might protect people.

Going forward, the challenge remains to develop vaccines and treatments that offer broad protection as the coronavirus continues to evolve.

In an alarming ending, the researchers wrote: “We have collectively chased after SARS-CoV-2 variants for over 2 years, and yet, the virus continues to evolve and evade.”

A version of this article first appeared on Medscape.com.

It’s a story perhaps more appropriate for Halloween than for the festive holiday season, given its scary implications. Four Omicron subvariants of the virus that causes COVID-19 will be the most common strains going from person to person in the winter of 2022-2023, new research predicts.

Not too dire so far, until the researchers’ other findings are considered.

The BQ.1, BQ1.1, XBB, and XBB.1 subvariants are the most resistant to neutralizing antibodies, researcher Qian Wang, PhD, and colleagues wrote in a study published online in the journal Cell. This means people have no or “markedly reduced” protection against infection from these four strains, even if they’ve already had COVID-19 or are vaccinated and boosted multiple times, including with a bivalent vaccine.

On top of that, all available monoclonal antibody treatments are mostly or completely ineffective against these subvariants.

What does that mean for the immediate future? The findings are definitely “worrisome,” said Eric Topol, MD, founder and director of the Scripps Translational Research Institute in La Jolla, Calif.

But evidence from other countries, specifically Singapore and France, show that at least two of these variants turned out not to be as damaging as expected, likely because of high numbers of people vaccinated or who survived previous infections, he said.

Still, there is little to celebrate in the new findings, except that COVID-19 vaccinations and prior infections can still reduce the risk for serious outcomes such as hospitalization and death, the researchers wrote.

In fact, Centers for Disease Control and Prevention data released on Dec. 16 shows that people who have received four shots of the original COVID-19 vaccines as well as the bivalent booster were 57% less likely to visit an urgent care clinic or emergency room, regardless of age. 

It comes at a time when BQ.1 and BQ.1.1 account for about 70% of the circulating variants, data show. In addition, hospitalizations are up 18% over the past 2 weeks and COVID-19 deaths are up 50% nationwide, The New York Times reported.

Globally, in many places, an “immunity wall” that has been built, Dr. Topol said. That may not be the case in the United States.  

“The problem in the United States, making it harder to predict, is that we have a very low rate of recent boosters, in the past 6 months, especially in seniors,” he said. For example, only 36% of Americans aged 65 years and older, the group with highest risk, have received an updated bivalent booster.
 

An evolving virus

The subvariants are successfully replacing BA.5, which reigned as one of the most common Omicron variants over the past year. The latest CDC data show that BA.5 now accounts for only about 10% of the circulating virus. The researchers wrote: “This rapid replacement of virus strains is raising the specter of yet another wave of infections in the coming months.”

BQ.1 and BQ.1.1 evolved directly from BA.5 – adding more and some novel mutations to the SARS-CoV-2 virus. XBB and XBB.1 are the “offspring” of a combination of two other strains, known as BJ.1 and BA.2.75.

The story sounds familiar to the researchers. “The rapid rise of these subvariants and their extensive array of spike mutations are reminiscent of the appearance of the first Omicron variant last year, thus raising concerns that they may further compromise the efficacy of current COVID-19 vaccines and monoclonal antibody therapeutics,” they wrote. “We now report findings that indicate that such concerns are, sadly, justified, especially so for the XBB and XBB.1 subvariants.”

To figure out how effective existing antibodies could be against these newer subvariants, Dr. Wang and colleagues used blood samples from five groups of people. They tested serum from people who had three doses of the original COVID-19 vaccine, four doses of the original vaccine, those who received a bivalent booster, people who experienced a breakthrough infection with the BA.2 Omicron variant, and those who had a breakthrough with a BA.4 or BA.5 variant.

Adding the new subvariants to these serum samples revealed that the existing antibodies in the blood were ineffective at wiping out or neutralizing BQ.1, BQ.1.1, XBB, and XBB.1.

The BQ.1 subvariant was six times more resistant to antibodies than BA.5, its parent strain, and XBB.1 was 63 times more resistant compared with its predecessor, BA.2.

This shift in the ability of vaccines to stop the subvariants “is particularly concerning,” the researchers wrote.
 

Wiping out treatments too

Dr. Wang and colleagues also tested how well a panel of 23 different monoclonal antibody drugs might work against the four subvariants. The therapies all worked well against the original Omicron variant and included some approved for use through the Food and Drug Administration emergency use authorization (EUA) program at the time of the study.

They found that 19 of these 23 monoclonal antibodies lost effectiveness “greatly or completely” against XBB and XBB.1, for example.

This is not the first time that monoclonal antibody therapies have gone from effective to ineffective. Previous variants have come out that no longer responded to treatment with bamlanivimab, etesevimab, imdevimab, casirivimab, tixagevimab, cilgavimab, and sotrovimab. Bebtelovimab now joins this list and is no longer available from Eli Lilly under EUA because of this lack of effectiveness.

The lack of an effective monoclonal antibody treatment “poses a serious problem for millions of immunocompromised individuals who do not respond robustly to COVID-19 vaccines,” the researchers wrote, adding that “the urgent need to develop active monoclonal antibodies for clinical use is obvious.”

A limitation of the study is that the work is done in blood samples. The effectiveness of COVID-19 vaccination against the BQ and XBB subvariants should be evaluated in people in clinical studies, the authors noted.

Also, the current study looked at how well antibodies could neutralize the viral strains, but future research, they added, should look at how well “cellular immunity” or other aspects of the immune system might protect people.

Going forward, the challenge remains to develop vaccines and treatments that offer broad protection as the coronavirus continues to evolve.

In an alarming ending, the researchers wrote: “We have collectively chased after SARS-CoV-2 variants for over 2 years, and yet, the virus continues to evolve and evade.”

A version of this article first appeared on Medscape.com.

It’s a story perhaps more appropriate for Halloween than for the festive holiday season, given its scary implications. Four Omicron subvariants of the virus that causes COVID-19 will be the most common strains going from person to person in the winter of 2022-2023, new research predicts.

Not too dire so far, until the researchers’ other findings are considered.

The BQ.1, BQ1.1, XBB, and XBB.1 subvariants are the most resistant to neutralizing antibodies, researcher Qian Wang, PhD, and colleagues wrote in a study published online in the journal Cell. This means people have no or “markedly reduced” protection against infection from these four strains, even if they’ve already had COVID-19 or are vaccinated and boosted multiple times, including with a bivalent vaccine.

On top of that, all available monoclonal antibody treatments are mostly or completely ineffective against these subvariants.

What does that mean for the immediate future? The findings are definitely “worrisome,” said Eric Topol, MD, founder and director of the Scripps Translational Research Institute in La Jolla, Calif.

But evidence from other countries, specifically Singapore and France, show that at least two of these variants turned out not to be as damaging as expected, likely because of high numbers of people vaccinated or who survived previous infections, he said.

Still, there is little to celebrate in the new findings, except that COVID-19 vaccinations and prior infections can still reduce the risk for serious outcomes such as hospitalization and death, the researchers wrote.

In fact, Centers for Disease Control and Prevention data released on Dec. 16 shows that people who have received four shots of the original COVID-19 vaccines as well as the bivalent booster were 57% less likely to visit an urgent care clinic or emergency room, regardless of age. 

It comes at a time when BQ.1 and BQ.1.1 account for about 70% of the circulating variants, data show. In addition, hospitalizations are up 18% over the past 2 weeks and COVID-19 deaths are up 50% nationwide, The New York Times reported.

Globally, in many places, an “immunity wall” that has been built, Dr. Topol said. That may not be the case in the United States.  

“The problem in the United States, making it harder to predict, is that we have a very low rate of recent boosters, in the past 6 months, especially in seniors,” he said. For example, only 36% of Americans aged 65 years and older, the group with highest risk, have received an updated bivalent booster.
 

An evolving virus

The subvariants are successfully replacing BA.5, which reigned as one of the most common Omicron variants over the past year. The latest CDC data show that BA.5 now accounts for only about 10% of the circulating virus. The researchers wrote: “This rapid replacement of virus strains is raising the specter of yet another wave of infections in the coming months.”

BQ.1 and BQ.1.1 evolved directly from BA.5 – adding more and some novel mutations to the SARS-CoV-2 virus. XBB and XBB.1 are the “offspring” of a combination of two other strains, known as BJ.1 and BA.2.75.

The story sounds familiar to the researchers. “The rapid rise of these subvariants and their extensive array of spike mutations are reminiscent of the appearance of the first Omicron variant last year, thus raising concerns that they may further compromise the efficacy of current COVID-19 vaccines and monoclonal antibody therapeutics,” they wrote. “We now report findings that indicate that such concerns are, sadly, justified, especially so for the XBB and XBB.1 subvariants.”

To figure out how effective existing antibodies could be against these newer subvariants, Dr. Wang and colleagues used blood samples from five groups of people. They tested serum from people who had three doses of the original COVID-19 vaccine, four doses of the original vaccine, those who received a bivalent booster, people who experienced a breakthrough infection with the BA.2 Omicron variant, and those who had a breakthrough with a BA.4 or BA.5 variant.

Adding the new subvariants to these serum samples revealed that the existing antibodies in the blood were ineffective at wiping out or neutralizing BQ.1, BQ.1.1, XBB, and XBB.1.

The BQ.1 subvariant was six times more resistant to antibodies than BA.5, its parent strain, and XBB.1 was 63 times more resistant compared with its predecessor, BA.2.

This shift in the ability of vaccines to stop the subvariants “is particularly concerning,” the researchers wrote.
 

Wiping out treatments too

Dr. Wang and colleagues also tested how well a panel of 23 different monoclonal antibody drugs might work against the four subvariants. The therapies all worked well against the original Omicron variant and included some approved for use through the Food and Drug Administration emergency use authorization (EUA) program at the time of the study.

They found that 19 of these 23 monoclonal antibodies lost effectiveness “greatly or completely” against XBB and XBB.1, for example.

This is not the first time that monoclonal antibody therapies have gone from effective to ineffective. Previous variants have come out that no longer responded to treatment with bamlanivimab, etesevimab, imdevimab, casirivimab, tixagevimab, cilgavimab, and sotrovimab. Bebtelovimab now joins this list and is no longer available from Eli Lilly under EUA because of this lack of effectiveness.

The lack of an effective monoclonal antibody treatment “poses a serious problem for millions of immunocompromised individuals who do not respond robustly to COVID-19 vaccines,” the researchers wrote, adding that “the urgent need to develop active monoclonal antibodies for clinical use is obvious.”

A limitation of the study is that the work is done in blood samples. The effectiveness of COVID-19 vaccination against the BQ and XBB subvariants should be evaluated in people in clinical studies, the authors noted.

Also, the current study looked at how well antibodies could neutralize the viral strains, but future research, they added, should look at how well “cellular immunity” or other aspects of the immune system might protect people.

Going forward, the challenge remains to develop vaccines and treatments that offer broad protection as the coronavirus continues to evolve.

In an alarming ending, the researchers wrote: “We have collectively chased after SARS-CoV-2 variants for over 2 years, and yet, the virus continues to evolve and evade.”

A version of this article first appeared on Medscape.com.

It’s beginning to look less like an epidemic as seasonal flu activity “appears to be declining in some areas,” according to the Centers for Disease Control and Prevention.

Declines in a few states and territories were enough to lower national activity, as measured by outpatient visits for influenza-like illness, for the second consecutive week. This reduced the weekly number of hospital admissions for the first time in the 2022-2023 season, according to the CDC influenza division’s weekly FluView report.

Flu-related hospital admissions slipped to about 23,500 during the week of Dec. 4-10, after topping 26,000 the week before, based on data reported by 5,000 hospitals from all states and territories.

The weekly hospitalization rate tumbled from 8 per 100,000 people to 4.5 per 100,000, which was still higher than any other December rate from all previous seasons going back to 2009-10, CDC data shows. 

Visits for flu-like illness represented 6.9% of all outpatient visits reported to the CDC during the week of Dec. 4-10. The rate reached 7.5% during the last full week of November before dropping to 7.3%, the CDC said.

There were 28 states or territories with “very high” activity for the latest reporting week, compared with 32 the previous week. Eight states – Colorado, Idaho, Kentucky, Nebraska, New Mexico, Oklahoma, Tennessee, and Washington – and New York City were at the very highest level on the CDC’s 1-13 scale of activity, compared with 14 areas the week before, the agency reported.

So far for the 2022-2023 season, the CDC estimated there have been at least 15 million cases of the flu, 150,000 hospitalizations, and 9,300 deaths. Among those deaths have been 30 reported in children, compared with 44 for the entire 2021-22 season and just 1 for 2020-21.

A version of this article first appeared on WebMD.com.

It’s beginning to look less like an epidemic as seasonal flu activity “appears to be declining in some areas,” according to the Centers for Disease Control and Prevention.

Declines in a few states and territories were enough to lower national activity, as measured by outpatient visits for influenza-like illness, for the second consecutive week. This reduced the weekly number of hospital admissions for the first time in the 2022-2023 season, according to the CDC influenza division’s weekly FluView report.

Flu-related hospital admissions slipped to about 23,500 during the week of Dec. 4-10, after topping 26,000 the week before, based on data reported by 5,000 hospitals from all states and territories.

The weekly hospitalization rate tumbled from 8 per 100,000 people to 4.5 per 100,000, which was still higher than any other December rate from all previous seasons going back to 2009-10, CDC data shows. 

Visits for flu-like illness represented 6.9% of all outpatient visits reported to the CDC during the week of Dec. 4-10. The rate reached 7.5% during the last full week of November before dropping to 7.3%, the CDC said.

There were 28 states or territories with “very high” activity for the latest reporting week, compared with 32 the previous week. Eight states – Colorado, Idaho, Kentucky, Nebraska, New Mexico, Oklahoma, Tennessee, and Washington – and New York City were at the very highest level on the CDC’s 1-13 scale of activity, compared with 14 areas the week before, the agency reported.

So far for the 2022-2023 season, the CDC estimated there have been at least 15 million cases of the flu, 150,000 hospitalizations, and 9,300 deaths. Among those deaths have been 30 reported in children, compared with 44 for the entire 2021-22 season and just 1 for 2020-21.

A version of this article first appeared on WebMD.com.

It’s beginning to look less like an epidemic as seasonal flu activity “appears to be declining in some areas,” according to the Centers for Disease Control and Prevention.

Declines in a few states and territories were enough to lower national activity, as measured by outpatient visits for influenza-like illness, for the second consecutive week. This reduced the weekly number of hospital admissions for the first time in the 2022-2023 season, according to the CDC influenza division’s weekly FluView report.

Flu-related hospital admissions slipped to about 23,500 during the week of Dec. 4-10, after topping 26,000 the week before, based on data reported by 5,000 hospitals from all states and territories.

The weekly hospitalization rate tumbled from 8 per 100,000 people to 4.5 per 100,000, which was still higher than any other December rate from all previous seasons going back to 2009-10, CDC data shows. 

Visits for flu-like illness represented 6.9% of all outpatient visits reported to the CDC during the week of Dec. 4-10. The rate reached 7.5% during the last full week of November before dropping to 7.3%, the CDC said.

There were 28 states or territories with “very high” activity for the latest reporting week, compared with 32 the previous week. Eight states – Colorado, Idaho, Kentucky, Nebraska, New Mexico, Oklahoma, Tennessee, and Washington – and New York City were at the very highest level on the CDC’s 1-13 scale of activity, compared with 14 areas the week before, the agency reported.

So far for the 2022-2023 season, the CDC estimated there have been at least 15 million cases of the flu, 150,000 hospitalizations, and 9,300 deaths. Among those deaths have been 30 reported in children, compared with 44 for the entire 2021-22 season and just 1 for 2020-21.

A version of this article first appeared on WebMD.com.

It’s not unusual for physicians to see other doctors as patients – often they’re colleagues or even friends. That relationship can influence their behavior and how they treat the physician-patient, which may have unintended consequences for both of them.

“When doctors don’t get the proper care, that’s when things go south. Any time physicians lower their standard of care, there is a risk of missing something that could affect their differential diagnosis, ultimate working diagnosis, and treatment plan,” said Michael Myers, MD, professor of clinical psychiatry at State University of New York, Brooklyn, who saw only medical students, physicians, and their family members in his private practice for over 3 decades.

Of the more than 200 physicians who responded to a recent Medscape poll, more than half said they treated physician-patients differently from other patients.

They granted their peers special privileges: They spent more time with them than other patients, gave out their personal contact information, and granted them professional courtesy by waiving or discounting their fees.

Published studies have reported that special treatment of physician-patients, such as giving personal contact information or avoiding uncomfortable testing, can create challenges for the treating physicians who may feel pressure to deviate from the standard of care.

The American Medical Association has recognized the challenges that physicians have when they treat other physicians they know personally or professionally, including a potential loss of objectivity, privacy, or confidentiality.

The AMA recommends that physicians treat physician-patients the same way they would other patients. The guidance states that the treating physician should exercise objective professional judgment and make unbiased treatment recommendations; be sensitive to the potential psychological discomfort of the physician-patient, and respect the physical and informational privacy of physician-patients.

Dr. Myers recalled that one doctor-patient said his primary care physician was his business partner in the practice. They ordered tests for each other and occasionally examined each other, but the patient never felt comfortable asking his partner for a full physical, said Dr. Myers, the author of “Becoming a Doctors’ Doctor: A Memoir.”

“I recommended that he choose a primary care doctor whom he didn’t know so that he could truly be a patient and the doctor could truly be a treating doctor,” said Dr. Myers.

Physician-patients may also be concerned about running into their physicians and being judged, or that they will break confidentiality and tell their spouse or another colleague, said Dr. Myers.

“When your doctor is a complete and total stranger, and especially if you live in a sizable community and your paths never cross, you don’t have that added worry,” he said.
 

Do docs expect special treatment as patients?

Some doctors expect special treatment from other doctors when they’re patients – 14% of physician poll respondents said that was their experience.

Dr. Myers recommends setting boundaries with doctor-patients early on in the relationship. “Some doctors expected me to go over my regular appointment time and when they realized that I started and stopped on time, they got upset. Once, one doctor insisted to my answering service that he had to talk to me although I was at home. When he started talking, I interrupted him and asked if the matter was urgent. He said no, so I offered to fit him in before his next appointment if he felt it couldn’t wait,” said Dr. Myers.

Some doctors also give physician-patients “professional courtesy” when it comes to payment. One in four poll respondents said they waived or discounted their professional fees for a doctor-patient. As most doctors have health insurance, doctors may waive copayments or other out-of-pocket fees, according to the American Academy of Pediatrics.

However, waiving or discounting health insurance fees, especially for government funded insurance, may be illegal under federal anti-fraud and abuse laws and payer contracts as well as state laws, the AAP says. It’s best to check with an attorney.
 

Treating other physicians can be rewarding

“Physicians can be the most rewarding patients because they are allies and partners in the effort to overcome whatever is ailing them,” said one doctor who responded to the Medscape poll.

Over two-thirds of respondents said that doctor-patients participated much more in their care than did other patients – typically, they discussed their care in more depth than did other patients.

Most doctors also felt that it was easier to communicate with their physician-patients than other patients because they understood medicine and were knowledgeable about their conditions.
 

Being judged by your peers can be stressful

How physicians feel about treating physician-patients is complicated. Nearly half of respondents said that it was more stressful than treating other patients.

One respondent said, “If we are honest, treating other physicians as patients is more stressful because we know that our skills are being assessed by someone who is at our level. There is no training for treating physicians, as there is for the Pope’s confessor. And we can be challenging in more ways than one!”

About one-third of poll respondents said they were afraid of disappointing their physician-patients.

“I’m not surprised,” said Dr. Myers, when told of that poll response. “This is why some doctors are reluctant to treat other physicians; they may wonder whether they’re up to speed. I have always thrived on having a high bar set for me – it spurs me on to really stay current with the literature and be humble,” he said.

A version of this article first appeared on Medscape.com.

It’s not unusual for physicians to see other doctors as patients – often they’re colleagues or even friends. That relationship can influence their behavior and how they treat the physician-patient, which may have unintended consequences for both of them.

“When doctors don’t get the proper care, that’s when things go south. Any time physicians lower their standard of care, there is a risk of missing something that could affect their differential diagnosis, ultimate working diagnosis, and treatment plan,” said Michael Myers, MD, professor of clinical psychiatry at State University of New York, Brooklyn, who saw only medical students, physicians, and their family members in his private practice for over 3 decades.

Of the more than 200 physicians who responded to a recent Medscape poll, more than half said they treated physician-patients differently from other patients.

They granted their peers special privileges: They spent more time with them than other patients, gave out their personal contact information, and granted them professional courtesy by waiving or discounting their fees.

Published studies have reported that special treatment of physician-patients, such as giving personal contact information or avoiding uncomfortable testing, can create challenges for the treating physicians who may feel pressure to deviate from the standard of care.

The American Medical Association has recognized the challenges that physicians have when they treat other physicians they know personally or professionally, including a potential loss of objectivity, privacy, or confidentiality.

The AMA recommends that physicians treat physician-patients the same way they would other patients. The guidance states that the treating physician should exercise objective professional judgment and make unbiased treatment recommendations; be sensitive to the potential psychological discomfort of the physician-patient, and respect the physical and informational privacy of physician-patients.

Dr. Myers recalled that one doctor-patient said his primary care physician was his business partner in the practice. They ordered tests for each other and occasionally examined each other, but the patient never felt comfortable asking his partner for a full physical, said Dr. Myers, the author of “Becoming a Doctors’ Doctor: A Memoir.”

“I recommended that he choose a primary care doctor whom he didn’t know so that he could truly be a patient and the doctor could truly be a treating doctor,” said Dr. Myers.

Physician-patients may also be concerned about running into their physicians and being judged, or that they will break confidentiality and tell their spouse or another colleague, said Dr. Myers.

“When your doctor is a complete and total stranger, and especially if you live in a sizable community and your paths never cross, you don’t have that added worry,” he said.
 

Do docs expect special treatment as patients?

Some doctors expect special treatment from other doctors when they’re patients – 14% of physician poll respondents said that was their experience.

Dr. Myers recommends setting boundaries with doctor-patients early on in the relationship. “Some doctors expected me to go over my regular appointment time and when they realized that I started and stopped on time, they got upset. Once, one doctor insisted to my answering service that he had to talk to me although I was at home. When he started talking, I interrupted him and asked if the matter was urgent. He said no, so I offered to fit him in before his next appointment if he felt it couldn’t wait,” said Dr. Myers.

Some doctors also give physician-patients “professional courtesy” when it comes to payment. One in four poll respondents said they waived or discounted their professional fees for a doctor-patient. As most doctors have health insurance, doctors may waive copayments or other out-of-pocket fees, according to the American Academy of Pediatrics.

However, waiving or discounting health insurance fees, especially for government funded insurance, may be illegal under federal anti-fraud and abuse laws and payer contracts as well as state laws, the AAP says. It’s best to check with an attorney.
 

Treating other physicians can be rewarding

“Physicians can be the most rewarding patients because they are allies and partners in the effort to overcome whatever is ailing them,” said one doctor who responded to the Medscape poll.

Over two-thirds of respondents said that doctor-patients participated much more in their care than did other patients – typically, they discussed their care in more depth than did other patients.

Most doctors also felt that it was easier to communicate with their physician-patients than other patients because they understood medicine and were knowledgeable about their conditions.
 

Being judged by your peers can be stressful

How physicians feel about treating physician-patients is complicated. Nearly half of respondents said that it was more stressful than treating other patients.

One respondent said, “If we are honest, treating other physicians as patients is more stressful because we know that our skills are being assessed by someone who is at our level. There is no training for treating physicians, as there is for the Pope’s confessor. And we can be challenging in more ways than one!”

About one-third of poll respondents said they were afraid of disappointing their physician-patients.

“I’m not surprised,” said Dr. Myers, when told of that poll response. “This is why some doctors are reluctant to treat other physicians; they may wonder whether they’re up to speed. I have always thrived on having a high bar set for me – it spurs me on to really stay current with the literature and be humble,” he said.

A version of this article first appeared on Medscape.com.

It’s not unusual for physicians to see other doctors as patients – often they’re colleagues or even friends. That relationship can influence their behavior and how they treat the physician-patient, which may have unintended consequences for both of them.

“When doctors don’t get the proper care, that’s when things go south. Any time physicians lower their standard of care, there is a risk of missing something that could affect their differential diagnosis, ultimate working diagnosis, and treatment plan,” said Michael Myers, MD, professor of clinical psychiatry at State University of New York, Brooklyn, who saw only medical students, physicians, and their family members in his private practice for over 3 decades.

Of the more than 200 physicians who responded to a recent Medscape poll, more than half said they treated physician-patients differently from other patients.

They granted their peers special privileges: They spent more time with them than other patients, gave out their personal contact information, and granted them professional courtesy by waiving or discounting their fees.

Published studies have reported that special treatment of physician-patients, such as giving personal contact information or avoiding uncomfortable testing, can create challenges for the treating physicians who may feel pressure to deviate from the standard of care.

The American Medical Association has recognized the challenges that physicians have when they treat other physicians they know personally or professionally, including a potential loss of objectivity, privacy, or confidentiality.

The AMA recommends that physicians treat physician-patients the same way they would other patients. The guidance states that the treating physician should exercise objective professional judgment and make unbiased treatment recommendations; be sensitive to the potential psychological discomfort of the physician-patient, and respect the physical and informational privacy of physician-patients.

Dr. Myers recalled that one doctor-patient said his primary care physician was his business partner in the practice. They ordered tests for each other and occasionally examined each other, but the patient never felt comfortable asking his partner for a full physical, said Dr. Myers, the author of “Becoming a Doctors’ Doctor: A Memoir.”

“I recommended that he choose a primary care doctor whom he didn’t know so that he could truly be a patient and the doctor could truly be a treating doctor,” said Dr. Myers.

Physician-patients may also be concerned about running into their physicians and being judged, or that they will break confidentiality and tell their spouse or another colleague, said Dr. Myers.

“When your doctor is a complete and total stranger, and especially if you live in a sizable community and your paths never cross, you don’t have that added worry,” he said.
 

Do docs expect special treatment as patients?

Some doctors expect special treatment from other doctors when they’re patients – 14% of physician poll respondents said that was their experience.

Dr. Myers recommends setting boundaries with doctor-patients early on in the relationship. “Some doctors expected me to go over my regular appointment time and when they realized that I started and stopped on time, they got upset. Once, one doctor insisted to my answering service that he had to talk to me although I was at home. When he started talking, I interrupted him and asked if the matter was urgent. He said no, so I offered to fit him in before his next appointment if he felt it couldn’t wait,” said Dr. Myers.

Some doctors also give physician-patients “professional courtesy” when it comes to payment. One in four poll respondents said they waived or discounted their professional fees for a doctor-patient. As most doctors have health insurance, doctors may waive copayments or other out-of-pocket fees, according to the American Academy of Pediatrics.

However, waiving or discounting health insurance fees, especially for government funded insurance, may be illegal under federal anti-fraud and abuse laws and payer contracts as well as state laws, the AAP says. It’s best to check with an attorney.
 

Treating other physicians can be rewarding

“Physicians can be the most rewarding patients because they are allies and partners in the effort to overcome whatever is ailing them,” said one doctor who responded to the Medscape poll.

Over two-thirds of respondents said that doctor-patients participated much more in their care than did other patients – typically, they discussed their care in more depth than did other patients.

Most doctors also felt that it was easier to communicate with their physician-patients than other patients because they understood medicine and were knowledgeable about their conditions.
 

Being judged by your peers can be stressful

How physicians feel about treating physician-patients is complicated. Nearly half of respondents said that it was more stressful than treating other patients.

One respondent said, “If we are honest, treating other physicians as patients is more stressful because we know that our skills are being assessed by someone who is at our level. There is no training for treating physicians, as there is for the Pope’s confessor. And we can be challenging in more ways than one!”

About one-third of poll respondents said they were afraid of disappointing their physician-patients.

“I’m not surprised,” said Dr. Myers, when told of that poll response. “This is why some doctors are reluctant to treat other physicians; they may wonder whether they’re up to speed. I have always thrived on having a high bar set for me – it spurs me on to really stay current with the literature and be humble,” he said.

A version of this article first appeared on Medscape.com.

At a routine doctor’s visit, a member of the clinic staff takes digital pictures of a patient’s retinas.

Within seconds, an artificial intelligence (AI) algorithm determines if the patient has diabetic retinopathy, a complication of diabetes that can lead to blindness.

If they do, the physician refers the patient to an eye care specialist for further evaluation and treatment.

This scene already is playing out in primary care clinics around the United States and in other countries, and it may become more common.

Health care systems intend to expand their use of AI to screen for diabetic retinopathy in 2023, and companies are developing more algorithms for this purpose.

In May, OSF HealthCare, a network of medical facilities headquartered in Peoria, Ill., piloted an AI system to diagnose diabetic retinopathy, a condition that affects an estimated 4 million Americans. In 2023, the health care system plans to expand the technology to 34 locations.

Meanwhile, the Food and Drug Administration in November approved a new AI system to diagnose diabetic retinopathy, making AEYE-DS from AEYE Health the third such product on the market.

Roomasa Channa, MD, a clinician-scientist with the McPherson Eye Research Institute at the University of Wisconsin–Madison, has studied the use of AI in teenage patients with diabetes. She said she soon plans to use AI screening in federally qualified health centers to screen adults with diabetes.

Dr. Channa welcomed the latest regulatory clearance and said she hopes another Food and Drug Administration–cleared algorithm product will improve accessibility to the technology.

“It is good to see more players in the field: We need this technology to be readily available and affordable,” she said in an interview.
 

A mixed reception

Responses from physicians to this type of AI have been mixed. Some worry, for instance, that the algorithms might be programmed with unrecognized biases that could lead them to less accurately interpret images from certain patient groups. Researchers should be on the lookout out for this possibility, Dr. Channa said.

“We need more real-world studies in different settings,” she said. “We also need to keep collecting data on AI performance post approval,” like investigators do for newly approved drugs.

The first AI system to diagnose diabetic retinopathy, IDx-DR, was approved by the FDA in 2018 and rolled out in retail clinics soon after. A second system, EyeArt, gained clearance by the agency in 2020.

Adding AI algorithms into primary care practice has changed how patients with diabetes can receive a screening. It also has introduced a new way for certain medical conditions to be diagnosed in primary care.

The American Medical Association in 2021 released a new CPT code to allow clinicians to bill government and private insurers for use of these services. CPT code 92229 refers to imaging of the retina to detect disease with an automated analysis and report at the point of care.
 

Meeting a need

Health care clinics in underserved areas often do not have eye care providers onsite to conduct recommended screening exams, so AI could help patients receive screening who otherwise would not get it, Dr. Channa said.

Dr. Channa and colleagues successfully used one AI system, IDx-DR, to screen children at a pediatric diabetes clinic. Over a year, screening rates jumped from 49% to 95%.

This technology “can potentially help us in decreasing disparities in care and focusing our efforts on patients with the most severe diseases,” she said.

OSF HealthCare recently obtained an approximately $1 million grant from drug company Regeneron to expand the use of AI-based screening for diabetic retinopathy, following a successful pilot. Regeneron markets a treatment for diabetic retinopathy.

Without an AI option, recommended eye screening for patients with diabetes often falls through the cracks, according to Mark Meeker, DO, vice president of community medicine at OSF. Primary care physicians may refer patients elsewhere for their annual retinopathy screening exam.

“That often doesn’t get completed because it’s another trip, another appointment, another time away from work,” Dr. Meeker said.

All patients with diabetes should have their eyes screened each year, but between one- to two-thirds of patients nationwide do not, he said.

A member of the clinic staff takes digital pictures of the retina, almost always through undilated pupils.

If the result is normal, the patient is scheduled for another follow-up screening in a year. If early signs of diabetic retinopathy are spotted, patients are referred to an eye care specialist.

After 7 months of the pilot program, OSF had screened about 350 patients. Approximately 20% had diabetic retinopathy, according to OSF.
 

‘A huge impact’

OSF has about 66,000 patients with diabetes. About two-thirds do not receive annual screening, Dr. Meeker estimated. “This can have a huge impact on the quality of life in the coming years for our diabetic patients. It’s pretty profound.”

Eye care specialists typically treat diabetic retinopathy with lasers, surgery, or medication. For primary care clinicians, however, AI screening for retinopathy is an opportunity to emphasize how important it is to manage the disease and what its consequences can be.

AI screening is “another tool for us to use to get patients more engaged in their own care,” Dr. Meeker said. “This is probably the biggest advance in AI affecting our day-to-day interaction with patients that we’ve seen in primary care.”
 

A business opportunity, too?

The IDx-DR platform OSF is using in its clinics is owned by the company Digital Diagnostics. OSF Ventures, an investment arm of OSF HealthCare, has invested in the company, the health care system announced in August.

Other companies have had their products used in practice. In 2019, for example, Eyenuk described how its EyeArt system had been used to screen thousands of patients in Germany and in Italy.

And in 2021, Eyenuk reported that its customer base in the United States had expanded to more than 25 locations. The company credited a Centers for Medicare & Medicaid Services plan to cover CPT code 92229 with supporting this growth.

Zack Dvey-Aharon, PhD, the CEO of AEYE Health, said the company was motivated to enter this space when regulators decided that AI could be used to diagnose a condition — not just as a tool to help doctors arrive at a diagnosis.

With proper training, a person can diagnose diabetic retinopathy relatively easily if the image of the retina is of excellent quality. If image is dark or blurry, however, it’s a different story.

AI has its advantages in this scenario, according to Dr. Dvey-Aharon. “For AI, those darker, more blurry images are actually highly readable with fantastic accuracy.”
 

More to come?

The possibilities of AI in analyzing retinal images are vast.

New research shows that AI may be able to detect Alzheimer’s disease or predict a person’s risk for heart attack and stroke based on snapshots of the retina.

The retina may also shed light on kidney disease, control of blood glucose and blood pressure, hepatobiliary disease, and coronary artery calcium, according to Eric J. Topol, MD, director of Scripps Research Translational Institute in La Jolla, Calif.

Beyond retinas, interpretation of electrocardiograms (ECGs) may be another frontier for AI in primary care. In one trial, an AI-enhanced ECG reading facilitated early diagnosis of low ejection fraction, and some doctors now receive these reports routinely, Dr. Topol wrote.

The potential value of AI in medicine “extends to virtually all forms of medical images that have been assessed to date,” Dr. Topol wrote on his “Ground Truths” Substack.

Although much of the focus has been on what AI can see, researchers also are exploring what AI can do with what it hears. Early research suggests that algorithms may be able to diagnose disease by analyzing patients’ voices.

A version of this article first appeared on Medscape.com.

At a routine doctor’s visit, a member of the clinic staff takes digital pictures of a patient’s retinas.

Within seconds, an artificial intelligence (AI) algorithm determines if the patient has diabetic retinopathy, a complication of diabetes that can lead to blindness.

If they do, the physician refers the patient to an eye care specialist for further evaluation and treatment.

This scene already is playing out in primary care clinics around the United States and in other countries, and it may become more common.

Health care systems intend to expand their use of AI to screen for diabetic retinopathy in 2023, and companies are developing more algorithms for this purpose.

In May, OSF HealthCare, a network of medical facilities headquartered in Peoria, Ill., piloted an AI system to diagnose diabetic retinopathy, a condition that affects an estimated 4 million Americans. In 2023, the health care system plans to expand the technology to 34 locations.

Meanwhile, the Food and Drug Administration in November approved a new AI system to diagnose diabetic retinopathy, making AEYE-DS from AEYE Health the third such product on the market.

Roomasa Channa, MD, a clinician-scientist with the McPherson Eye Research Institute at the University of Wisconsin–Madison, has studied the use of AI in teenage patients with diabetes. She said she soon plans to use AI screening in federally qualified health centers to screen adults with diabetes.

Dr. Channa welcomed the latest regulatory clearance and said she hopes another Food and Drug Administration–cleared algorithm product will improve accessibility to the technology.

“It is good to see more players in the field: We need this technology to be readily available and affordable,” she said in an interview.
 

A mixed reception

Responses from physicians to this type of AI have been mixed. Some worry, for instance, that the algorithms might be programmed with unrecognized biases that could lead them to less accurately interpret images from certain patient groups. Researchers should be on the lookout out for this possibility, Dr. Channa said.

“We need more real-world studies in different settings,” she said. “We also need to keep collecting data on AI performance post approval,” like investigators do for newly approved drugs.

The first AI system to diagnose diabetic retinopathy, IDx-DR, was approved by the FDA in 2018 and rolled out in retail clinics soon after. A second system, EyeArt, gained clearance by the agency in 2020.

Adding AI algorithms into primary care practice has changed how patients with diabetes can receive a screening. It also has introduced a new way for certain medical conditions to be diagnosed in primary care.

The American Medical Association in 2021 released a new CPT code to allow clinicians to bill government and private insurers for use of these services. CPT code 92229 refers to imaging of the retina to detect disease with an automated analysis and report at the point of care.
 

Meeting a need

Health care clinics in underserved areas often do not have eye care providers onsite to conduct recommended screening exams, so AI could help patients receive screening who otherwise would not get it, Dr. Channa said.

Dr. Channa and colleagues successfully used one AI system, IDx-DR, to screen children at a pediatric diabetes clinic. Over a year, screening rates jumped from 49% to 95%.

This technology “can potentially help us in decreasing disparities in care and focusing our efforts on patients with the most severe diseases,” she said.

OSF HealthCare recently obtained an approximately $1 million grant from drug company Regeneron to expand the use of AI-based screening for diabetic retinopathy, following a successful pilot. Regeneron markets a treatment for diabetic retinopathy.

Without an AI option, recommended eye screening for patients with diabetes often falls through the cracks, according to Mark Meeker, DO, vice president of community medicine at OSF. Primary care physicians may refer patients elsewhere for their annual retinopathy screening exam.

“That often doesn’t get completed because it’s another trip, another appointment, another time away from work,” Dr. Meeker said.

All patients with diabetes should have their eyes screened each year, but between one- to two-thirds of patients nationwide do not, he said.

A member of the clinic staff takes digital pictures of the retina, almost always through undilated pupils.

If the result is normal, the patient is scheduled for another follow-up screening in a year. If early signs of diabetic retinopathy are spotted, patients are referred to an eye care specialist.

After 7 months of the pilot program, OSF had screened about 350 patients. Approximately 20% had diabetic retinopathy, according to OSF.
 

‘A huge impact’

OSF has about 66,000 patients with diabetes. About two-thirds do not receive annual screening, Dr. Meeker estimated. “This can have a huge impact on the quality of life in the coming years for our diabetic patients. It’s pretty profound.”

Eye care specialists typically treat diabetic retinopathy with lasers, surgery, or medication. For primary care clinicians, however, AI screening for retinopathy is an opportunity to emphasize how important it is to manage the disease and what its consequences can be.

AI screening is “another tool for us to use to get patients more engaged in their own care,” Dr. Meeker said. “This is probably the biggest advance in AI affecting our day-to-day interaction with patients that we’ve seen in primary care.”
 

A business opportunity, too?

The IDx-DR platform OSF is using in its clinics is owned by the company Digital Diagnostics. OSF Ventures, an investment arm of OSF HealthCare, has invested in the company, the health care system announced in August.

Other companies have had their products used in practice. In 2019, for example, Eyenuk described how its EyeArt system had been used to screen thousands of patients in Germany and in Italy.

And in 2021, Eyenuk reported that its customer base in the United States had expanded to more than 25 locations. The company credited a Centers for Medicare & Medicaid Services plan to cover CPT code 92229 with supporting this growth.

Zack Dvey-Aharon, PhD, the CEO of AEYE Health, said the company was motivated to enter this space when regulators decided that AI could be used to diagnose a condition — not just as a tool to help doctors arrive at a diagnosis.

With proper training, a person can diagnose diabetic retinopathy relatively easily if the image of the retina is of excellent quality. If image is dark or blurry, however, it’s a different story.

AI has its advantages in this scenario, according to Dr. Dvey-Aharon. “For AI, those darker, more blurry images are actually highly readable with fantastic accuracy.”
 

More to come?

The possibilities of AI in analyzing retinal images are vast.

New research shows that AI may be able to detect Alzheimer’s disease or predict a person’s risk for heart attack and stroke based on snapshots of the retina.

The retina may also shed light on kidney disease, control of blood glucose and blood pressure, hepatobiliary disease, and coronary artery calcium, according to Eric J. Topol, MD, director of Scripps Research Translational Institute in La Jolla, Calif.

Beyond retinas, interpretation of electrocardiograms (ECGs) may be another frontier for AI in primary care. In one trial, an AI-enhanced ECG reading facilitated early diagnosis of low ejection fraction, and some doctors now receive these reports routinely, Dr. Topol wrote.

The potential value of AI in medicine “extends to virtually all forms of medical images that have been assessed to date,” Dr. Topol wrote on his “Ground Truths” Substack.

Although much of the focus has been on what AI can see, researchers also are exploring what AI can do with what it hears. Early research suggests that algorithms may be able to diagnose disease by analyzing patients’ voices.

A version of this article first appeared on Medscape.com.

At a routine doctor’s visit, a member of the clinic staff takes digital pictures of a patient’s retinas.

Within seconds, an artificial intelligence (AI) algorithm determines if the patient has diabetic retinopathy, a complication of diabetes that can lead to blindness.

If they do, the physician refers the patient to an eye care specialist for further evaluation and treatment.

This scene already is playing out in primary care clinics around the United States and in other countries, and it may become more common.

Health care systems intend to expand their use of AI to screen for diabetic retinopathy in 2023, and companies are developing more algorithms for this purpose.

In May, OSF HealthCare, a network of medical facilities headquartered in Peoria, Ill., piloted an AI system to diagnose diabetic retinopathy, a condition that affects an estimated 4 million Americans. In 2023, the health care system plans to expand the technology to 34 locations.

Meanwhile, the Food and Drug Administration in November approved a new AI system to diagnose diabetic retinopathy, making AEYE-DS from AEYE Health the third such product on the market.

Roomasa Channa, MD, a clinician-scientist with the McPherson Eye Research Institute at the University of Wisconsin–Madison, has studied the use of AI in teenage patients with diabetes. She said she soon plans to use AI screening in federally qualified health centers to screen adults with diabetes.

Dr. Channa welcomed the latest regulatory clearance and said she hopes another Food and Drug Administration–cleared algorithm product will improve accessibility to the technology.

“It is good to see more players in the field: We need this technology to be readily available and affordable,” she said in an interview.
 

A mixed reception

Responses from physicians to this type of AI have been mixed. Some worry, for instance, that the algorithms might be programmed with unrecognized biases that could lead them to less accurately interpret images from certain patient groups. Researchers should be on the lookout out for this possibility, Dr. Channa said.

“We need more real-world studies in different settings,” she said. “We also need to keep collecting data on AI performance post approval,” like investigators do for newly approved drugs.

The first AI system to diagnose diabetic retinopathy, IDx-DR, was approved by the FDA in 2018 and rolled out in retail clinics soon after. A second system, EyeArt, gained clearance by the agency in 2020.

Adding AI algorithms into primary care practice has changed how patients with diabetes can receive a screening. It also has introduced a new way for certain medical conditions to be diagnosed in primary care.

The American Medical Association in 2021 released a new CPT code to allow clinicians to bill government and private insurers for use of these services. CPT code 92229 refers to imaging of the retina to detect disease with an automated analysis and report at the point of care.
 

Meeting a need

Health care clinics in underserved areas often do not have eye care providers onsite to conduct recommended screening exams, so AI could help patients receive screening who otherwise would not get it, Dr. Channa said.

Dr. Channa and colleagues successfully used one AI system, IDx-DR, to screen children at a pediatric diabetes clinic. Over a year, screening rates jumped from 49% to 95%.

This technology “can potentially help us in decreasing disparities in care and focusing our efforts on patients with the most severe diseases,” she said.

OSF HealthCare recently obtained an approximately $1 million grant from drug company Regeneron to expand the use of AI-based screening for diabetic retinopathy, following a successful pilot. Regeneron markets a treatment for diabetic retinopathy.

Without an AI option, recommended eye screening for patients with diabetes often falls through the cracks, according to Mark Meeker, DO, vice president of community medicine at OSF. Primary care physicians may refer patients elsewhere for their annual retinopathy screening exam.

“That often doesn’t get completed because it’s another trip, another appointment, another time away from work,” Dr. Meeker said.

All patients with diabetes should have their eyes screened each year, but between one- to two-thirds of patients nationwide do not, he said.

A member of the clinic staff takes digital pictures of the retina, almost always through undilated pupils.

If the result is normal, the patient is scheduled for another follow-up screening in a year. If early signs of diabetic retinopathy are spotted, patients are referred to an eye care specialist.

After 7 months of the pilot program, OSF had screened about 350 patients. Approximately 20% had diabetic retinopathy, according to OSF.
 

‘A huge impact’

OSF has about 66,000 patients with diabetes. About two-thirds do not receive annual screening, Dr. Meeker estimated. “This can have a huge impact on the quality of life in the coming years for our diabetic patients. It’s pretty profound.”

Eye care specialists typically treat diabetic retinopathy with lasers, surgery, or medication. For primary care clinicians, however, AI screening for retinopathy is an opportunity to emphasize how important it is to manage the disease and what its consequences can be.

AI screening is “another tool for us to use to get patients more engaged in their own care,” Dr. Meeker said. “This is probably the biggest advance in AI affecting our day-to-day interaction with patients that we’ve seen in primary care.”
 

A business opportunity, too?

The IDx-DR platform OSF is using in its clinics is owned by the company Digital Diagnostics. OSF Ventures, an investment arm of OSF HealthCare, has invested in the company, the health care system announced in August.

Other companies have had their products used in practice. In 2019, for example, Eyenuk described how its EyeArt system had been used to screen thousands of patients in Germany and in Italy.

And in 2021, Eyenuk reported that its customer base in the United States had expanded to more than 25 locations. The company credited a Centers for Medicare & Medicaid Services plan to cover CPT code 92229 with supporting this growth.

Zack Dvey-Aharon, PhD, the CEO of AEYE Health, said the company was motivated to enter this space when regulators decided that AI could be used to diagnose a condition — not just as a tool to help doctors arrive at a diagnosis.

With proper training, a person can diagnose diabetic retinopathy relatively easily if the image of the retina is of excellent quality. If image is dark or blurry, however, it’s a different story.

AI has its advantages in this scenario, according to Dr. Dvey-Aharon. “For AI, those darker, more blurry images are actually highly readable with fantastic accuracy.”
 

More to come?

The possibilities of AI in analyzing retinal images are vast.

New research shows that AI may be able to detect Alzheimer’s disease or predict a person’s risk for heart attack and stroke based on snapshots of the retina.

The retina may also shed light on kidney disease, control of blood glucose and blood pressure, hepatobiliary disease, and coronary artery calcium, according to Eric J. Topol, MD, director of Scripps Research Translational Institute in La Jolla, Calif.

Beyond retinas, interpretation of electrocardiograms (ECGs) may be another frontier for AI in primary care. In one trial, an AI-enhanced ECG reading facilitated early diagnosis of low ejection fraction, and some doctors now receive these reports routinely, Dr. Topol wrote.

The potential value of AI in medicine “extends to virtually all forms of medical images that have been assessed to date,” Dr. Topol wrote on his “Ground Truths” Substack.

Although much of the focus has been on what AI can see, researchers also are exploring what AI can do with what it hears. Early research suggests that algorithms may be able to diagnose disease by analyzing patients’ voices.

A version of this article first appeared on Medscape.com.

Just 56% of infectious disease fellowship programs filled their 2023 slots, according to new data released by the National Resident Matching Program. Infectious disease (ID) fellowships had seen a jump in applications in the previous 2 years, but these new numbers may suggest a backward slide in a specialty that for many years has struggled to recruit residents.

This latest match rate in ID fellowships is lower than those of the previous 5 years. There are unfilled positions across the country, including in health care hot spots. In Boston, all three slots at Boston Medical Center ID fellowship program are currently empty.

“For our program, going unfilled is a pretty rare event,” said Daniel Bourque, MD, an assistant professor of infectious disease at Boston University and director of the program. “For a program in the city of Boston that’s at a large tertiary care center, that definitely was a big surprise.”

Many other ID fellowships have joined BMC in posting about their vacancies on social media, looking for residents who may not have matched in other fellowships and for physicians who initially decided not to pursue additional training but are now reconsidering.

“If you are interested in a career in this exciting field, in the amazing city of Seattle, with incredible and friendly colleagues, please contact us,” the University of Washington’s ID fellowship program tweeted. Tulane University, Creighton University, the University of Connecticut, Washington University in St. Louis, and the University of Colorado also advertised their unfilled positions.

Other ID doctors commiserated with the disappointing match year. “I made a new riddle after yesterday’s match results: In the hospital, everyone needs me. Yet, no one wants to be me. What am I? An ID doctor,” tweeted Nathan Nolan, MD, MPH, an infectious disease specialist at the Veterans Health Administration in St. Louis.
 

Infectious disease positions continue to grow

One contributor to this downturn could be the growing number of infectious disease programs offered, whereas the number of applicants has generally remained stable. In 2018, there were 394 slots at 151 infectious disease fellowship programs offered. For the 2023 match year, there were 441 slots at 175 programs.

At the same time, there has not been a notable rise in applicants. From match years 2018 to 2020, about 320 applicants applied for ID fellowship positions each year. There was a rise in in interest in first 2 years of the pandemic, with 404 and 387 applicants in the 2021 and 2022 match years, respectively. The most recent round suggests a return to prepandemic numbers, with 330 residents applying to ID programs.

“I think it’s fair to question whether, as a field, we should be increasing training programs and spots at this point, and if it’s better to focus on ways to increase interest and demand,” said Daniel Diekema, MD, an ID physician at Maine Medical Center in Portland. “Otherwise, we’re just going to look worse and worse every year,” he added, and the work that goes into creating these training opportunities will not have a return on investment.
 

More training, less pay

The fellowship recruitment issues combined with an already short supply of infectious disease specialists can be traced back to comparatively worse pay compared with other subspecialties, experts say. Infectious disease was the fifth lowest paid specialty in the 2022 Medscape Physician Compensation Report – ranking above only primary care specialties and diabetes and endocrinology.

Pursuing this subspeciality in medicine may not translate to higher pay, Dr. Diekema noted. For example, a physician who completes an internal medicine residency and then a 2- to 3-year infectious disease fellowship can make less than a physician who pursues hospital medicine directly after completing the same residency.

“You’re in a situation where you’re doing additional training to reduce your income earning potential, and that’s a very hard sales pitch to make,” he said. It’s become more difficult as student loan debts continue to increase, he added.

Because infectious disease is a cognitive specialty and does not perform procedures, it is at a disadvantage in a typical fee-for-service pay model. ID physicians also advise on hospital policies for testing and personal protective equipment, which is not always compensated, said Wendy Armstrong, MD, a professor of infectious diseases at Emory University, Atlanta.
 

A reflection of pandemic burnout?

Experts also wonder if the past 2 years of the pandemic and the notable burnout in ID and other in-demand specialties may have dissuaded applicants from pursuing the ID career path.

“This residency class is the class that started their training in June or July of 2020 and represent that residency class that has trained throughout the pandemic,” Dr. Bourque said. “Does [this low match rate] reflect a negative outlook on the field of ID because of COVID? Is it a reflection of trainee burnout in the setting of the pandemic?”

Dr. Diekema wonders if increased public scrutiny and politicization of the field may have discouraged residents. “The vilification of public health and [of] infectious disease experts like Dr. Fauci by significant portions of our society can be demoralizing,” he said. “People might say, ‘Why would I want to put myself through that?’ ”

But Dr. Armstrong doubts this is the case. “I’ve never had a resident tell me that was on their radar screen,” she said, noting that while there had been recent improvements in applicants, lower match numbers for ID fellowships have been a long-standing issue.
 

Rethinking reimbursement

Experts agree that pay issues need to be addressed to make ID a more attractive specialty. Moving away from traditional payment plans to value-based models using quality measurements specific to infectious disease could be one way to quantify the value of ID specialists in care systems.

The Infectious Diseases Society of America recently met with the panel that sets compensation rates for Medicare to discuss ways to increase compensation for ID, said IDSA president Carlos del Rio, MD. He is also a professor of medicine at Emory University.

ID specialists need to be able to put a dollar value to their policy work that’s not related to patient reimbursement, Dr. del Rio said. IDSA’s ongoing compensation initiative advocates for value-based care and provides salary negotiation tools for ID specialists, he added.

“Salaries shouldn’t simply be defined by what reimbursement is, and that’s true for other specialties,” such as hospital medicine and palliative care at many institutions, Dr. Armstrong said. “Infectious disease needs to be held at the same level of respect and value.”

But despite issues within the specialties, ID physicians remain passionate about their field.

“It is the most fascinating specialty I can ever imagine,” Dr. Armstrong said. Dr. Bourque agreed, noting the dynamic nature of specialty, with the emergence of new diseases like COVID-19 and reemergence of diseases like mpox (formerly called monkeypox), Zika, Ebola, and chikungunya in the past decade.

“There’s nothing about the field of infectious diseases that, in my mind, isn’t fascinating or rewarding enough to bring people in,” added Dr. Diekema. “The factors that are keeping people out are primarily economic factors and aspects of our health care system that need attention.”

A version of this article first appeared on Medscape.com.

Just 56% of infectious disease fellowship programs filled their 2023 slots, according to new data released by the National Resident Matching Program. Infectious disease (ID) fellowships had seen a jump in applications in the previous 2 years, but these new numbers may suggest a backward slide in a specialty that for many years has struggled to recruit residents.

This latest match rate in ID fellowships is lower than those of the previous 5 years. There are unfilled positions across the country, including in health care hot spots. In Boston, all three slots at Boston Medical Center ID fellowship program are currently empty.

“For our program, going unfilled is a pretty rare event,” said Daniel Bourque, MD, an assistant professor of infectious disease at Boston University and director of the program. “For a program in the city of Boston that’s at a large tertiary care center, that definitely was a big surprise.”

Many other ID fellowships have joined BMC in posting about their vacancies on social media, looking for residents who may not have matched in other fellowships and for physicians who initially decided not to pursue additional training but are now reconsidering.

“If you are interested in a career in this exciting field, in the amazing city of Seattle, with incredible and friendly colleagues, please contact us,” the University of Washington’s ID fellowship program tweeted. Tulane University, Creighton University, the University of Connecticut, Washington University in St. Louis, and the University of Colorado also advertised their unfilled positions.

Other ID doctors commiserated with the disappointing match year. “I made a new riddle after yesterday’s match results: In the hospital, everyone needs me. Yet, no one wants to be me. What am I? An ID doctor,” tweeted Nathan Nolan, MD, MPH, an infectious disease specialist at the Veterans Health Administration in St. Louis.
 

Infectious disease positions continue to grow

One contributor to this downturn could be the growing number of infectious disease programs offered, whereas the number of applicants has generally remained stable. In 2018, there were 394 slots at 151 infectious disease fellowship programs offered. For the 2023 match year, there were 441 slots at 175 programs.

At the same time, there has not been a notable rise in applicants. From match years 2018 to 2020, about 320 applicants applied for ID fellowship positions each year. There was a rise in in interest in first 2 years of the pandemic, with 404 and 387 applicants in the 2021 and 2022 match years, respectively. The most recent round suggests a return to prepandemic numbers, with 330 residents applying to ID programs.

“I think it’s fair to question whether, as a field, we should be increasing training programs and spots at this point, and if it’s better to focus on ways to increase interest and demand,” said Daniel Diekema, MD, an ID physician at Maine Medical Center in Portland. “Otherwise, we’re just going to look worse and worse every year,” he added, and the work that goes into creating these training opportunities will not have a return on investment.
 

More training, less pay

The fellowship recruitment issues combined with an already short supply of infectious disease specialists can be traced back to comparatively worse pay compared with other subspecialties, experts say. Infectious disease was the fifth lowest paid specialty in the 2022 Medscape Physician Compensation Report – ranking above only primary care specialties and diabetes and endocrinology.

Pursuing this subspeciality in medicine may not translate to higher pay, Dr. Diekema noted. For example, a physician who completes an internal medicine residency and then a 2- to 3-year infectious disease fellowship can make less than a physician who pursues hospital medicine directly after completing the same residency.

“You’re in a situation where you’re doing additional training to reduce your income earning potential, and that’s a very hard sales pitch to make,” he said. It’s become more difficult as student loan debts continue to increase, he added.

Because infectious disease is a cognitive specialty and does not perform procedures, it is at a disadvantage in a typical fee-for-service pay model. ID physicians also advise on hospital policies for testing and personal protective equipment, which is not always compensated, said Wendy Armstrong, MD, a professor of infectious diseases at Emory University, Atlanta.
 

A reflection of pandemic burnout?

Experts also wonder if the past 2 years of the pandemic and the notable burnout in ID and other in-demand specialties may have dissuaded applicants from pursuing the ID career path.

“This residency class is the class that started their training in June or July of 2020 and represent that residency class that has trained throughout the pandemic,” Dr. Bourque said. “Does [this low match rate] reflect a negative outlook on the field of ID because of COVID? Is it a reflection of trainee burnout in the setting of the pandemic?”

Dr. Diekema wonders if increased public scrutiny and politicization of the field may have discouraged residents. “The vilification of public health and [of] infectious disease experts like Dr. Fauci by significant portions of our society can be demoralizing,” he said. “People might say, ‘Why would I want to put myself through that?’ ”

But Dr. Armstrong doubts this is the case. “I’ve never had a resident tell me that was on their radar screen,” she said, noting that while there had been recent improvements in applicants, lower match numbers for ID fellowships have been a long-standing issue.
 

Rethinking reimbursement

Experts agree that pay issues need to be addressed to make ID a more attractive specialty. Moving away from traditional payment plans to value-based models using quality measurements specific to infectious disease could be one way to quantify the value of ID specialists in care systems.

The Infectious Diseases Society of America recently met with the panel that sets compensation rates for Medicare to discuss ways to increase compensation for ID, said IDSA president Carlos del Rio, MD. He is also a professor of medicine at Emory University.

ID specialists need to be able to put a dollar value to their policy work that’s not related to patient reimbursement, Dr. del Rio said. IDSA’s ongoing compensation initiative advocates for value-based care and provides salary negotiation tools for ID specialists, he added.

“Salaries shouldn’t simply be defined by what reimbursement is, and that’s true for other specialties,” such as hospital medicine and palliative care at many institutions, Dr. Armstrong said. “Infectious disease needs to be held at the same level of respect and value.”

But despite issues within the specialties, ID physicians remain passionate about their field.

“It is the most fascinating specialty I can ever imagine,” Dr. Armstrong said. Dr. Bourque agreed, noting the dynamic nature of specialty, with the emergence of new diseases like COVID-19 and reemergence of diseases like mpox (formerly called monkeypox), Zika, Ebola, and chikungunya in the past decade.

“There’s nothing about the field of infectious diseases that, in my mind, isn’t fascinating or rewarding enough to bring people in,” added Dr. Diekema. “The factors that are keeping people out are primarily economic factors and aspects of our health care system that need attention.”

A version of this article first appeared on Medscape.com.

Just 56% of infectious disease fellowship programs filled their 2023 slots, according to new data released by the National Resident Matching Program. Infectious disease (ID) fellowships had seen a jump in applications in the previous 2 years, but these new numbers may suggest a backward slide in a specialty that for many years has struggled to recruit residents.

This latest match rate in ID fellowships is lower than those of the previous 5 years. There are unfilled positions across the country, including in health care hot spots. In Boston, all three slots at Boston Medical Center ID fellowship program are currently empty.

“For our program, going unfilled is a pretty rare event,” said Daniel Bourque, MD, an assistant professor of infectious disease at Boston University and director of the program. “For a program in the city of Boston that’s at a large tertiary care center, that definitely was a big surprise.”

Many other ID fellowships have joined BMC in posting about their vacancies on social media, looking for residents who may not have matched in other fellowships and for physicians who initially decided not to pursue additional training but are now reconsidering.

“If you are interested in a career in this exciting field, in the amazing city of Seattle, with incredible and friendly colleagues, please contact us,” the University of Washington’s ID fellowship program tweeted. Tulane University, Creighton University, the University of Connecticut, Washington University in St. Louis, and the University of Colorado also advertised their unfilled positions.

Other ID doctors commiserated with the disappointing match year. “I made a new riddle after yesterday’s match results: In the hospital, everyone needs me. Yet, no one wants to be me. What am I? An ID doctor,” tweeted Nathan Nolan, MD, MPH, an infectious disease specialist at the Veterans Health Administration in St. Louis.
 

Infectious disease positions continue to grow

One contributor to this downturn could be the growing number of infectious disease programs offered, whereas the number of applicants has generally remained stable. In 2018, there were 394 slots at 151 infectious disease fellowship programs offered. For the 2023 match year, there were 441 slots at 175 programs.

At the same time, there has not been a notable rise in applicants. From match years 2018 to 2020, about 320 applicants applied for ID fellowship positions each year. There was a rise in in interest in first 2 years of the pandemic, with 404 and 387 applicants in the 2021 and 2022 match years, respectively. The most recent round suggests a return to prepandemic numbers, with 330 residents applying to ID programs.

“I think it’s fair to question whether, as a field, we should be increasing training programs and spots at this point, and if it’s better to focus on ways to increase interest and demand,” said Daniel Diekema, MD, an ID physician at Maine Medical Center in Portland. “Otherwise, we’re just going to look worse and worse every year,” he added, and the work that goes into creating these training opportunities will not have a return on investment.
 

More training, less pay

The fellowship recruitment issues combined with an already short supply of infectious disease specialists can be traced back to comparatively worse pay compared with other subspecialties, experts say. Infectious disease was the fifth lowest paid specialty in the 2022 Medscape Physician Compensation Report – ranking above only primary care specialties and diabetes and endocrinology.

Pursuing this subspeciality in medicine may not translate to higher pay, Dr. Diekema noted. For example, a physician who completes an internal medicine residency and then a 2- to 3-year infectious disease fellowship can make less than a physician who pursues hospital medicine directly after completing the same residency.

“You’re in a situation where you’re doing additional training to reduce your income earning potential, and that’s a very hard sales pitch to make,” he said. It’s become more difficult as student loan debts continue to increase, he added.

Because infectious disease is a cognitive specialty and does not perform procedures, it is at a disadvantage in a typical fee-for-service pay model. ID physicians also advise on hospital policies for testing and personal protective equipment, which is not always compensated, said Wendy Armstrong, MD, a professor of infectious diseases at Emory University, Atlanta.
 

A reflection of pandemic burnout?

Experts also wonder if the past 2 years of the pandemic and the notable burnout in ID and other in-demand specialties may have dissuaded applicants from pursuing the ID career path.

“This residency class is the class that started their training in June or July of 2020 and represent that residency class that has trained throughout the pandemic,” Dr. Bourque said. “Does [this low match rate] reflect a negative outlook on the field of ID because of COVID? Is it a reflection of trainee burnout in the setting of the pandemic?”

Dr. Diekema wonders if increased public scrutiny and politicization of the field may have discouraged residents. “The vilification of public health and [of] infectious disease experts like Dr. Fauci by significant portions of our society can be demoralizing,” he said. “People might say, ‘Why would I want to put myself through that?’ ”

But Dr. Armstrong doubts this is the case. “I’ve never had a resident tell me that was on their radar screen,” she said, noting that while there had been recent improvements in applicants, lower match numbers for ID fellowships have been a long-standing issue.
 

Rethinking reimbursement

Experts agree that pay issues need to be addressed to make ID a more attractive specialty. Moving away from traditional payment plans to value-based models using quality measurements specific to infectious disease could be one way to quantify the value of ID specialists in care systems.

The Infectious Diseases Society of America recently met with the panel that sets compensation rates for Medicare to discuss ways to increase compensation for ID, said IDSA president Carlos del Rio, MD. He is also a professor of medicine at Emory University.

ID specialists need to be able to put a dollar value to their policy work that’s not related to patient reimbursement, Dr. del Rio said. IDSA’s ongoing compensation initiative advocates for value-based care and provides salary negotiation tools for ID specialists, he added.

“Salaries shouldn’t simply be defined by what reimbursement is, and that’s true for other specialties,” such as hospital medicine and palliative care at many institutions, Dr. Armstrong said. “Infectious disease needs to be held at the same level of respect and value.”

But despite issues within the specialties, ID physicians remain passionate about their field.

“It is the most fascinating specialty I can ever imagine,” Dr. Armstrong said. Dr. Bourque agreed, noting the dynamic nature of specialty, with the emergence of new diseases like COVID-19 and reemergence of diseases like mpox (formerly called monkeypox), Zika, Ebola, and chikungunya in the past decade.

“There’s nothing about the field of infectious diseases that, in my mind, isn’t fascinating or rewarding enough to bring people in,” added Dr. Diekema. “The factors that are keeping people out are primarily economic factors and aspects of our health care system that need attention.”

A version of this article first appeared on Medscape.com.

The financial burden of contemporary care for hepatocellular carcinoma (HCC) is high for Medicare beneficiaries, a new analysis shows.

In the first year after a diagnosis of HCC, median Medicare payments exceed $65,000 and out-of-pocket costs top $10,000.

Even after adjustment for the presence of cirrhosis and its related costs, patients with HCC still have Medicare payments exceeding $50,000 and out-of-pocket costs topping $7000.

Amit Singal, MD, of UT Southwestern Medical Center in Dallas, and colleagues reported their findings in Clinical Gastroenterology and Hepatology.
 

Common and costly

HCC, the most common type of primary liver cancer, is a leading cause of death in patients with cirrhosis and is projected to become the third leading cause of cancer-related death in the United States by 2040, the researchers wrote.

The treatment landscape for HCC has changed over the past decade, with expanded surgical options, introduction of radiation-based therapies, and approval of immunotherapies – all of which are costly.

Yet the magnitude of financial burden of HCC therapy has been understudied, the researchers noted.

To investigate, Dr. Singal and colleagues evaluated Surveillance, Epidemiology, and End Results (SEER)–Medicare data for 4,525 adults with traditional Medicare coverage who were diagnosed with HCC between 2011 and 2015 and a propensity-matched cohort of 4,525 adults with cirrhosis but no HCC as a comparator group to tease out HCC-specific costs beyond those related to cirrhosis. Patients in Medicare managed care were excluded because their cost information is not available in the database.

In the first year after a diagnosis of HCC, the median total Medicare payments were $66,338 (interquartile range [IQR], $30,931-$158,740) and patient liabilities (a proxy for out-of-pocket costs) were $10,008 (IQR, $5,427-$19,669).

First-year costs were higher for patients with HCC than matched patients without HCC; the former group incurred median incremental Medicare payments of $50,110 (IQR, $14,242-$136,239) and patient liabilities of $7,166 (IQR, $2,401-$16,099), the investigators found.

Patients with early-stage HCC had lower incremental patient liabilities (median, $4,195 vs. $8,238) and Medicare payments (median, $28,207 vs. $59,509) than did their peers with larger tumor burden.
 

NAFLD notably tied to higher costs

Factors associated with higher HCC-related costs were nonalcoholic fatty liver disease (NAFLD) etiology, higher comorbidities, presence of ascites and hepatic encephalopathy, and larger tumor burden.

The researchers said that the link between NAFLD and higher costs is notable, given that NAFLD is an increasingly common underlying cause of HCC.

The link between larger tumor burden and higher costs underscores “another benefit of HCC surveillance and early detection,” they added.

“By separating the financial liabilities borne by patients and Medicare, we provide a clearer outlook of how cancer-related costs are distributed between patients and public payers,” Dr. Singal and colleagues said.

“Our findings will inform policy interventions and will help formulate better financial supports targeting the most vulnerable HCC patients,” they concluded.

The study had no commercial funding. Dr. Singal has been on advisory boards and served as a consultant for Wako Diagnostics, Glycotest, Exact Sciences, Roche, Genentech, Bayer, Eisai, BMS, Exelixis, AstraZeneca, and TARGET RWE.

A version of this article first appeared on Medscape.com.

The financial burden of contemporary care for hepatocellular carcinoma (HCC) is high for Medicare beneficiaries, a new analysis shows.

In the first year after a diagnosis of HCC, median Medicare payments exceed $65,000 and out-of-pocket costs top $10,000.

Even after adjustment for the presence of cirrhosis and its related costs, patients with HCC still have Medicare payments exceeding $50,000 and out-of-pocket costs topping $7000.

Amit Singal, MD, of UT Southwestern Medical Center in Dallas, and colleagues reported their findings in Clinical Gastroenterology and Hepatology.
 

Common and costly

HCC, the most common type of primary liver cancer, is a leading cause of death in patients with cirrhosis and is projected to become the third leading cause of cancer-related death in the United States by 2040, the researchers wrote.

The treatment landscape for HCC has changed over the past decade, with expanded surgical options, introduction of radiation-based therapies, and approval of immunotherapies – all of which are costly.

Yet the magnitude of financial burden of HCC therapy has been understudied, the researchers noted.

To investigate, Dr. Singal and colleagues evaluated Surveillance, Epidemiology, and End Results (SEER)–Medicare data for 4,525 adults with traditional Medicare coverage who were diagnosed with HCC between 2011 and 2015 and a propensity-matched cohort of 4,525 adults with cirrhosis but no HCC as a comparator group to tease out HCC-specific costs beyond those related to cirrhosis. Patients in Medicare managed care were excluded because their cost information is not available in the database.

In the first year after a diagnosis of HCC, the median total Medicare payments were $66,338 (interquartile range [IQR], $30,931-$158,740) and patient liabilities (a proxy for out-of-pocket costs) were $10,008 (IQR, $5,427-$19,669).

First-year costs were higher for patients with HCC than matched patients without HCC; the former group incurred median incremental Medicare payments of $50,110 (IQR, $14,242-$136,239) and patient liabilities of $7,166 (IQR, $2,401-$16,099), the investigators found.

Patients with early-stage HCC had lower incremental patient liabilities (median, $4,195 vs. $8,238) and Medicare payments (median, $28,207 vs. $59,509) than did their peers with larger tumor burden.
 

NAFLD notably tied to higher costs

Factors associated with higher HCC-related costs were nonalcoholic fatty liver disease (NAFLD) etiology, higher comorbidities, presence of ascites and hepatic encephalopathy, and larger tumor burden.

The researchers said that the link between NAFLD and higher costs is notable, given that NAFLD is an increasingly common underlying cause of HCC.

The link between larger tumor burden and higher costs underscores “another benefit of HCC surveillance and early detection,” they added.

“By separating the financial liabilities borne by patients and Medicare, we provide a clearer outlook of how cancer-related costs are distributed between patients and public payers,” Dr. Singal and colleagues said.

“Our findings will inform policy interventions and will help formulate better financial supports targeting the most vulnerable HCC patients,” they concluded.

The study had no commercial funding. Dr. Singal has been on advisory boards and served as a consultant for Wako Diagnostics, Glycotest, Exact Sciences, Roche, Genentech, Bayer, Eisai, BMS, Exelixis, AstraZeneca, and TARGET RWE.

A version of this article first appeared on Medscape.com.

The financial burden of contemporary care for hepatocellular carcinoma (HCC) is high for Medicare beneficiaries, a new analysis shows.

In the first year after a diagnosis of HCC, median Medicare payments exceed $65,000 and out-of-pocket costs top $10,000.

Even after adjustment for the presence of cirrhosis and its related costs, patients with HCC still have Medicare payments exceeding $50,000 and out-of-pocket costs topping $7000.

Amit Singal, MD, of UT Southwestern Medical Center in Dallas, and colleagues reported their findings in Clinical Gastroenterology and Hepatology.
 

Common and costly

HCC, the most common type of primary liver cancer, is a leading cause of death in patients with cirrhosis and is projected to become the third leading cause of cancer-related death in the United States by 2040, the researchers wrote.

The treatment landscape for HCC has changed over the past decade, with expanded surgical options, introduction of radiation-based therapies, and approval of immunotherapies – all of which are costly.

Yet the magnitude of financial burden of HCC therapy has been understudied, the researchers noted.

To investigate, Dr. Singal and colleagues evaluated Surveillance, Epidemiology, and End Results (SEER)–Medicare data for 4,525 adults with traditional Medicare coverage who were diagnosed with HCC between 2011 and 2015 and a propensity-matched cohort of 4,525 adults with cirrhosis but no HCC as a comparator group to tease out HCC-specific costs beyond those related to cirrhosis. Patients in Medicare managed care were excluded because their cost information is not available in the database.

In the first year after a diagnosis of HCC, the median total Medicare payments were $66,338 (interquartile range [IQR], $30,931-$158,740) and patient liabilities (a proxy for out-of-pocket costs) were $10,008 (IQR, $5,427-$19,669).

First-year costs were higher for patients with HCC than matched patients without HCC; the former group incurred median incremental Medicare payments of $50,110 (IQR, $14,242-$136,239) and patient liabilities of $7,166 (IQR, $2,401-$16,099), the investigators found.

Patients with early-stage HCC had lower incremental patient liabilities (median, $4,195 vs. $8,238) and Medicare payments (median, $28,207 vs. $59,509) than did their peers with larger tumor burden.
 

NAFLD notably tied to higher costs

Factors associated with higher HCC-related costs were nonalcoholic fatty liver disease (NAFLD) etiology, higher comorbidities, presence of ascites and hepatic encephalopathy, and larger tumor burden.

The researchers said that the link between NAFLD and higher costs is notable, given that NAFLD is an increasingly common underlying cause of HCC.

The link between larger tumor burden and higher costs underscores “another benefit of HCC surveillance and early detection,” they added.

“By separating the financial liabilities borne by patients and Medicare, we provide a clearer outlook of how cancer-related costs are distributed between patients and public payers,” Dr. Singal and colleagues said.

“Our findings will inform policy interventions and will help formulate better financial supports targeting the most vulnerable HCC patients,” they concluded.

The study had no commercial funding. Dr. Singal has been on advisory boards and served as a consultant for Wako Diagnostics, Glycotest, Exact Sciences, Roche, Genentech, Bayer, Eisai, BMS, Exelixis, AstraZeneca, and TARGET RWE.

A version of this article first appeared on Medscape.com.

A former associate professor at Purdue University faked data in two published papers and hundreds of images in 16 grant applications, according to a U.S. government research watchdog. 

Alice C. Chang, PhD, whose publications and grants listed her name as Chun-Ju Chang, received nearly $700,000 in funding from the National Institutes of Health through grant applications that the U.S. Office of Research Integrity said contained fake data. She will be banned from receiving federal grants for a decade – a more severe sanction than ORI has typically imposed in recent years.

In its findings, ORI said Dr. Chang, who was an associate professor of basic medical sciences at Purdue’s College of Veterinary Medicine, West Lafayette, Ind., “knowingly, intentionally, or recklessly falsified and/or fabricated data from the same mouse models or cell lines by reusing the data, with or without manipulation, to represent unrelated experiments from different mouse models or cell lines with different treatments in three hundred eighty-four (384) figure panels in sixteen (16) grant applications.”

Two of the grant applications were funded. Dr. Chang received $688,196 from the National Cancer Institute, a division of NIH, from 2018 to 2019 for “Targeting metformin-directed stem cell fate in triple negative breast cancer.” The other grant ORI says was submitted in 2014 and funded, “Targeting cell polarity machinery to exhaust breast cancer stem cell pool,” does not show up in NIH RePorter. The rest of the grants were not approved. 

We found a Chun-Ju Chang who is dean of the College of Life Sciences at China Medical University in Taiwan and has published papers with a group that Chun-Ju Chang at Purdue also published with. She did not immediately respond to our request for comment. 

ORI’s finding also stated Dr. Chang faked data in two papers supported by government funding by reusing figures reporting gene expression in mice and cells after drug treatments, relabeling them to say they showed the results of different experiments. According to the agency, she has agreed to request corrections for the papers: 

“Leptin–STAT3–G9a Signaling Promotes Obesity-Mediated Breast Cancer Progression,” published in May 2015 in Cancer Research and cited 83 times, according to Clarivate’s Web of Science. 

“Retinoic acid directs breast cancer cell state changes through regulation of TET2-PKC-zeta pathway,” published in February 2017 in Oncogene and cited 26 times. 

Between the two papers and 15 of the grant applications, ORI said that Dr. Chang reused gene expression data, sometimes with manipulation, in 119 figure panels. She reused other types of data and images in hundreds of figures across multiple grant applications, ORI found. 

As well as correcting the two papers, Dr. Chang agreed to a 10-year ban from all federal contracting, including grant funding. She also agreed not to serve in any advisory or consulting role with the U.S. Public Health Service, which includes the NIH, for that time period.

A version of this article first appeared on Retraction Watch.

A former associate professor at Purdue University faked data in two published papers and hundreds of images in 16 grant applications, according to a U.S. government research watchdog. 

Alice C. Chang, PhD, whose publications and grants listed her name as Chun-Ju Chang, received nearly $700,000 in funding from the National Institutes of Health through grant applications that the U.S. Office of Research Integrity said contained fake data. She will be banned from receiving federal grants for a decade – a more severe sanction than ORI has typically imposed in recent years.

In its findings, ORI said Dr. Chang, who was an associate professor of basic medical sciences at Purdue’s College of Veterinary Medicine, West Lafayette, Ind., “knowingly, intentionally, or recklessly falsified and/or fabricated data from the same mouse models or cell lines by reusing the data, with or without manipulation, to represent unrelated experiments from different mouse models or cell lines with different treatments in three hundred eighty-four (384) figure panels in sixteen (16) grant applications.”

Two of the grant applications were funded. Dr. Chang received $688,196 from the National Cancer Institute, a division of NIH, from 2018 to 2019 for “Targeting metformin-directed stem cell fate in triple negative breast cancer.” The other grant ORI says was submitted in 2014 and funded, “Targeting cell polarity machinery to exhaust breast cancer stem cell pool,” does not show up in NIH RePorter. The rest of the grants were not approved. 

We found a Chun-Ju Chang who is dean of the College of Life Sciences at China Medical University in Taiwan and has published papers with a group that Chun-Ju Chang at Purdue also published with. She did not immediately respond to our request for comment. 

ORI’s finding also stated Dr. Chang faked data in two papers supported by government funding by reusing figures reporting gene expression in mice and cells after drug treatments, relabeling them to say they showed the results of different experiments. According to the agency, she has agreed to request corrections for the papers: 

“Leptin–STAT3–G9a Signaling Promotes Obesity-Mediated Breast Cancer Progression,” published in May 2015 in Cancer Research and cited 83 times, according to Clarivate’s Web of Science. 

“Retinoic acid directs breast cancer cell state changes through regulation of TET2-PKC-zeta pathway,” published in February 2017 in Oncogene and cited 26 times. 

Between the two papers and 15 of the grant applications, ORI said that Dr. Chang reused gene expression data, sometimes with manipulation, in 119 figure panels. She reused other types of data and images in hundreds of figures across multiple grant applications, ORI found. 

As well as correcting the two papers, Dr. Chang agreed to a 10-year ban from all federal contracting, including grant funding. She also agreed not to serve in any advisory or consulting role with the U.S. Public Health Service, which includes the NIH, for that time period.

A version of this article first appeared on Retraction Watch.

A former associate professor at Purdue University faked data in two published papers and hundreds of images in 16 grant applications, according to a U.S. government research watchdog. 

Alice C. Chang, PhD, whose publications and grants listed her name as Chun-Ju Chang, received nearly $700,000 in funding from the National Institutes of Health through grant applications that the U.S. Office of Research Integrity said contained fake data. She will be banned from receiving federal grants for a decade – a more severe sanction than ORI has typically imposed in recent years.

In its findings, ORI said Dr. Chang, who was an associate professor of basic medical sciences at Purdue’s College of Veterinary Medicine, West Lafayette, Ind., “knowingly, intentionally, or recklessly falsified and/or fabricated data from the same mouse models or cell lines by reusing the data, with or without manipulation, to represent unrelated experiments from different mouse models or cell lines with different treatments in three hundred eighty-four (384) figure panels in sixteen (16) grant applications.”

Two of the grant applications were funded. Dr. Chang received $688,196 from the National Cancer Institute, a division of NIH, from 2018 to 2019 for “Targeting metformin-directed stem cell fate in triple negative breast cancer.” The other grant ORI says was submitted in 2014 and funded, “Targeting cell polarity machinery to exhaust breast cancer stem cell pool,” does not show up in NIH RePorter. The rest of the grants were not approved. 

We found a Chun-Ju Chang who is dean of the College of Life Sciences at China Medical University in Taiwan and has published papers with a group that Chun-Ju Chang at Purdue also published with. She did not immediately respond to our request for comment. 

ORI’s finding also stated Dr. Chang faked data in two papers supported by government funding by reusing figures reporting gene expression in mice and cells after drug treatments, relabeling them to say they showed the results of different experiments. According to the agency, she has agreed to request corrections for the papers: 

“Leptin–STAT3–G9a Signaling Promotes Obesity-Mediated Breast Cancer Progression,” published in May 2015 in Cancer Research and cited 83 times, according to Clarivate’s Web of Science. 

“Retinoic acid directs breast cancer cell state changes through regulation of TET2-PKC-zeta pathway,” published in February 2017 in Oncogene and cited 26 times. 

Between the two papers and 15 of the grant applications, ORI said that Dr. Chang reused gene expression data, sometimes with manipulation, in 119 figure panels. She reused other types of data and images in hundreds of figures across multiple grant applications, ORI found. 

As well as correcting the two papers, Dr. Chang agreed to a 10-year ban from all federal contracting, including grant funding. She also agreed not to serve in any advisory or consulting role with the U.S. Public Health Service, which includes the NIH, for that time period.

A version of this article first appeared on Retraction Watch.

Maybe the cow was late for its appointment

It’s been a long day running the front desk at your doctor’s office. People calling in prescriptions, a million appointments, you’ve been running yourself ragged keeping things together. Finally, it’s almost closing time. The last patient of the day has just checked out and you turn back to the waiting room, expecting to see it blessedly empty.

Instead, a 650-pound cow is staring at you.

“I’m sorry, sir or madam, we’re about to close.”

Moo.
 

tilo/Thinkstock

We can see that decision in your eyes

The cliché that eyes are the windows to the soul doesn’t tell the whole story about how telling eyes really are. It’s all about how they move. In a recent study, researchers determined that a type of eye movement known as a saccade reveals your choice before you even decide.

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Saccades involve the eyes jumping from one fixation point to another, senior author Alaa Ahmed of the University of Colorado, Boulder, explained in a statement from the university. Saccade vigor was the key in how aligned the type of decisions were made by the 22 study participants.

In the study, subjects walked on a treadmill at varied inclines for a period of time. Then they sat in front of a monitor and a high-speed camera that tracked their eye movements as the monitor presented them with a series of exercise options. The participants had only 4 seconds to choose between them.

After they made their choices, participants went back on the treadmill to perform the exercises they had chosen. The researchers found that participants’ eyes jumped between the options slowly then faster to the option they eventually picked. The more impulsive decision-makers also tended to move their eyes even more rapidly before slowing down after a decision was made, making it pretty conclusive that the eyes were revealing their choices.

The way your eyes shift gives you away without saying a thing. Might be wise, then, to wear sunglasses to your next poker tournament.
 

Let them eat soap

Okay, we admit it: LOTME spends a lot of time in the bathroom. Today, though, we’re interested in the sinks. Specifically, the P-traps under the sinks. You know, the curvy bit that keeps sewer gas from wafting back into the room?

PxHere

Well, researchers from the University of Reading (England) recently found some fungi while examining a bunch of sinks on the university’s Whiteknights campus. “It isn’t a big surprise to find fungi in a warm, wet environment. But sinks and P-traps have thus far been overlooked as potential reservoirs of these microorganisms,” they said in a written statement.

Samples collected from 289 P-traps contained “a very similar community of yeasts and molds, showing that sinks in use in public environments share a role as reservoirs of fungal organisms,” they noted.

The fungi living in the traps survived conditions with high temperatures, low pH, and little in the way of nutrients. So what were they eating? Some varieties, they said, “use detergents, found in soap, as a source of carbon-rich food.” We’ll repeat that last part: They used the soap as food.

WARNING: Rant Ahead.

There are a lot of cleaning products for sale that say they will make your home safe by killing 99.9% of germs and bacteria. Not fungi, exactly, but we’re still talking microorganisms. Molds, bacteria, and viruses are all stuff that can infect humans and make them sick.

So you kill 99.9% of them. Great, but that leaves 0.1% that you just made angry. And what do they do next? They learn to eat soap. Then University of Reading investigators find out that all the extra hand washing going on during the COVID-19 pandemic was “clogging up sinks with nasty disease-causing bacteria.”

These are microorganisms we’re talking about people. They’ve been at this for a billion years! Rats can’t beat them, cockroaches won’t stop them – Earth’s ultimate survivors are powerless against the invisible horde.

We’re doomed.

Maybe the cow was late for its appointment

It’s been a long day running the front desk at your doctor’s office. People calling in prescriptions, a million appointments, you’ve been running yourself ragged keeping things together. Finally, it’s almost closing time. The last patient of the day has just checked out and you turn back to the waiting room, expecting to see it blessedly empty.

Instead, a 650-pound cow is staring at you.

“I’m sorry, sir or madam, we’re about to close.”

Moo.
 

tilo/Thinkstock

We can see that decision in your eyes

The cliché that eyes are the windows to the soul doesn’t tell the whole story about how telling eyes really are. It’s all about how they move. In a recent study, researchers determined that a type of eye movement known as a saccade reveals your choice before you even decide.

pxfuel

Saccades involve the eyes jumping from one fixation point to another, senior author Alaa Ahmed of the University of Colorado, Boulder, explained in a statement from the university. Saccade vigor was the key in how aligned the type of decisions were made by the 22 study participants.

In the study, subjects walked on a treadmill at varied inclines for a period of time. Then they sat in front of a monitor and a high-speed camera that tracked their eye movements as the monitor presented them with a series of exercise options. The participants had only 4 seconds to choose between them.

After they made their choices, participants went back on the treadmill to perform the exercises they had chosen. The researchers found that participants’ eyes jumped between the options slowly then faster to the option they eventually picked. The more impulsive decision-makers also tended to move their eyes even more rapidly before slowing down after a decision was made, making it pretty conclusive that the eyes were revealing their choices.

The way your eyes shift gives you away without saying a thing. Might be wise, then, to wear sunglasses to your next poker tournament.
 

Let them eat soap

Okay, we admit it: LOTME spends a lot of time in the bathroom. Today, though, we’re interested in the sinks. Specifically, the P-traps under the sinks. You know, the curvy bit that keeps sewer gas from wafting back into the room?

PxHere

Well, researchers from the University of Reading (England) recently found some fungi while examining a bunch of sinks on the university’s Whiteknights campus. “It isn’t a big surprise to find fungi in a warm, wet environment. But sinks and P-traps have thus far been overlooked as potential reservoirs of these microorganisms,” they said in a written statement.

Samples collected from 289 P-traps contained “a very similar community of yeasts and molds, showing that sinks in use in public environments share a role as reservoirs of fungal organisms,” they noted.

The fungi living in the traps survived conditions with high temperatures, low pH, and little in the way of nutrients. So what were they eating? Some varieties, they said, “use detergents, found in soap, as a source of carbon-rich food.” We’ll repeat that last part: They used the soap as food.

WARNING: Rant Ahead.

There are a lot of cleaning products for sale that say they will make your home safe by killing 99.9% of germs and bacteria. Not fungi, exactly, but we’re still talking microorganisms. Molds, bacteria, and viruses are all stuff that can infect humans and make them sick.

So you kill 99.9% of them. Great, but that leaves 0.1% that you just made angry. And what do they do next? They learn to eat soap. Then University of Reading investigators find out that all the extra hand washing going on during the COVID-19 pandemic was “clogging up sinks with nasty disease-causing bacteria.”

These are microorganisms we’re talking about people. They’ve been at this for a billion years! Rats can’t beat them, cockroaches won’t stop them – Earth’s ultimate survivors are powerless against the invisible horde.

We’re doomed.

Maybe the cow was late for its appointment

It’s been a long day running the front desk at your doctor’s office. People calling in prescriptions, a million appointments, you’ve been running yourself ragged keeping things together. Finally, it’s almost closing time. The last patient of the day has just checked out and you turn back to the waiting room, expecting to see it blessedly empty.

Instead, a 650-pound cow is staring at you.

“I’m sorry, sir or madam, we’re about to close.”

Moo.
 

tilo/Thinkstock

We can see that decision in your eyes

The cliché that eyes are the windows to the soul doesn’t tell the whole story about how telling eyes really are. It’s all about how they move. In a recent study, researchers determined that a type of eye movement known as a saccade reveals your choice before you even decide.

pxfuel

Saccades involve the eyes jumping from one fixation point to another, senior author Alaa Ahmed of the University of Colorado, Boulder, explained in a statement from the university. Saccade vigor was the key in how aligned the type of decisions were made by the 22 study participants.

In the study, subjects walked on a treadmill at varied inclines for a period of time. Then they sat in front of a monitor and a high-speed camera that tracked their eye movements as the monitor presented them with a series of exercise options. The participants had only 4 seconds to choose between them.

After they made their choices, participants went back on the treadmill to perform the exercises they had chosen. The researchers found that participants’ eyes jumped between the options slowly then faster to the option they eventually picked. The more impulsive decision-makers also tended to move their eyes even more rapidly before slowing down after a decision was made, making it pretty conclusive that the eyes were revealing their choices.

The way your eyes shift gives you away without saying a thing. Might be wise, then, to wear sunglasses to your next poker tournament.
 

Let them eat soap

Okay, we admit it: LOTME spends a lot of time in the bathroom. Today, though, we’re interested in the sinks. Specifically, the P-traps under the sinks. You know, the curvy bit that keeps sewer gas from wafting back into the room?

PxHere

Well, researchers from the University of Reading (England) recently found some fungi while examining a bunch of sinks on the university’s Whiteknights campus. “It isn’t a big surprise to find fungi in a warm, wet environment. But sinks and P-traps have thus far been overlooked as potential reservoirs of these microorganisms,” they said in a written statement.

Samples collected from 289 P-traps contained “a very similar community of yeasts and molds, showing that sinks in use in public environments share a role as reservoirs of fungal organisms,” they noted.

The fungi living in the traps survived conditions with high temperatures, low pH, and little in the way of nutrients. So what were they eating? Some varieties, they said, “use detergents, found in soap, as a source of carbon-rich food.” We’ll repeat that last part: They used the soap as food.

WARNING: Rant Ahead.

There are a lot of cleaning products for sale that say they will make your home safe by killing 99.9% of germs and bacteria. Not fungi, exactly, but we’re still talking microorganisms. Molds, bacteria, and viruses are all stuff that can infect humans and make them sick.

So you kill 99.9% of them. Great, but that leaves 0.1% that you just made angry. And what do they do next? They learn to eat soap. Then University of Reading investigators find out that all the extra hand washing going on during the COVID-19 pandemic was “clogging up sinks with nasty disease-causing bacteria.”

These are microorganisms we’re talking about people. They’ve been at this for a billion years! Rats can’t beat them, cockroaches won’t stop them – Earth’s ultimate survivors are powerless against the invisible horde.

We’re doomed.

Transcranial photobiomodulation (tPBM), a noninvasive laser light therapy, can improve short-term memory in young adults when applied to the right prefrontal cortex (PFC) of the brain, new research suggests.

Investigators compared the effect of 1,064 nm of tPBM delivered over a 12-minute session to the right PFC vs. three other treatment arms: delivery of the same intervention to the left PFC, delivery of the intervention at a lower frequency, and a sham intervention.

All participants were shown a series of items prior to the intervention and  asked to recall them after the intervention. Those who received tPBM 1,064 nm to the right PFC showed a superior performance of up to 25% in the memory tasks compared with the other groups.

Patients with attention-related conditions, such as attention deficit hyperactivity disorder, “could benefit from this type of treatment, which is safe, simple, and noninvasive, with no side effects,” coinvestigator Dongwei Li, a visiting PhD student at the Centre for Human Brain Health, University of Birmingham, England, said in a news release.

The findings were published online in Science Advances.
 

Differing wavelengths

The researchers note that “in the past decades,” noninvasive brain stimulation technology using transcranial application of direct or alternating electrical or magnetic fields “has been proven to be useful” in the improvement of working memory (WM).

When applied to the right PFC, tPBM has been shown to improve accuracy and speed of reaction time in WM tasks and improvements in “high-order cognitive functions,” such as sustained attention, emotion, and executive functions.

The investigators wanted to assess the impact of tPBM applied to different parts of the brain and at different wavelengths. They conducted four double-blind, sham-controlled experiments encompassing 90 neurotypical college students (mean age, 22 years). Each student participated in only one of the four experiments.

All completed two different tPBM sessions, separated by a week, in which sham and active tPBM were compared. Two different types of change-detection memory tasks were given: one requiring participants to remember the orientation of a series of items before and after the intervention and one other requiring them to remember the color of the items (experiments 1 and 2).

A series of follow-up experiments focused on comparing different wavelengths (1,064 nm vs. 852 nm) and different stimulation sites (right vs. left PFC; experiments 3 and 4).

EEG recordings were obtained during the intervention and the memory tasks.

Each experiment consisted of one active tPBM session and one sham tPBM session, with sessions consisting of 12 minutes of laser light (or sham) intervention. These sessions were conducted on the first and the seventh day; then, on the eighth day, participants were asked to report (or guess) which session was the active tPBM session.
 

Stimulating astrocytes

Results showed that, compared with sham tPBM, there was an improvement in WM capacity and scores by the 1,064 nm intervention in the orientation as well as the color task.

Participants who received the targeted treatment were able to remember between four and five test objects, whereas those with the treatment variations were only able to remember between three and four objects.

“These results support the hypothesis that 1,064 nm tPBM on the right PFC enhances WM capacity,” the investigators wrote.

They also found improvements in WM in participants receiving tPBM vs. sham regardless of whether their performance in the WM task was at a low or high level. This finding held true in both the orientation and the color tasks.

“Therefore, participants with good and poor WM capacity improved after 1,064 nm tPBM,” the researchers noted.

In addition, participants were unable to guess or report whether they had received sham or active tPBM.

EEG monitoring showed changes in brain activity that predicted the improvements in memory performance. In particular, 1,064 tPBM applied to the right PFC increased occipitoparietal contralateral delay activity (CDA), with CDA mediating the WM improvement.

This is “consistent with previous research that CDA is indicative of the number of maintained objects in visual working memory,” the investigators wrote.

Pearson correlation analyses showed that the differences in CDA set-size effects between active and sham session “correlated positively” with the behavioral differences between these sessions. For the orientation task, the r was 0.446 (P < .04); and for the color task, the r was .563 (P < .02).

No similar improvements were found with the 852 nm tPBM.

“We need further research to understand exactly why the tPBM is having this positive effect,” coinvestigator Ole Jensen, PhD, professor in translational neuroscience and codirector of the Centre for Human Brain Health, said in the release.

“It’s possible that the light is stimulating the astrocytes – the powerplants – in the nerve cells within the PFC, and this has a positive effect on the cells’ efficiency,” he noted.

Dr. Jensen added that his team “will also be investigating how long the effects might last. Clearly, if these experiments are to lead to a clinical intervention, we will need to see long-lasting benefits.”
 

Beneficial cognitive, emotional effects

Commenting for this news organization, Francisco Gonzalez-Lima, PhD, professor in the department of psychology, University of Texas at Austin, called the study “well done.”

Dr. Gonzalez-Lima was one of the first researchers to demonstrate that 1,064 nm transcranial infrared laser stimulation “produces beneficial cognitive and emotional effects in humans, including improving visual working memory,” he said.

The current study “reported an additional brain effect linked to the improved visual working memory that consists of an EEG-derived response, which is a new finding,” noted Dr. Gonzales-Lima, who was not involved with the new research.

He added that the same laser method “has been found by the Gonzalez-Lima lab to be effective at improving cognition in older adults and depressed and bipolar patients.”

The study was supported by the National Natural Science Foundation of China, the Ministry of Science and Technology of the People’s Republic of China, and the National Defence Basic Scientific Research Program of China. The investigators and Dr. Gonzalez-Lima report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Transcranial photobiomodulation (tPBM), a noninvasive laser light therapy, can improve short-term memory in young adults when applied to the right prefrontal cortex (PFC) of the brain, new research suggests.

Investigators compared the effect of 1,064 nm of tPBM delivered over a 12-minute session to the right PFC vs. three other treatment arms: delivery of the same intervention to the left PFC, delivery of the intervention at a lower frequency, and a sham intervention.

All participants were shown a series of items prior to the intervention and  asked to recall them after the intervention. Those who received tPBM 1,064 nm to the right PFC showed a superior performance of up to 25% in the memory tasks compared with the other groups.

Patients with attention-related conditions, such as attention deficit hyperactivity disorder, “could benefit from this type of treatment, which is safe, simple, and noninvasive, with no side effects,” coinvestigator Dongwei Li, a visiting PhD student at the Centre for Human Brain Health, University of Birmingham, England, said in a news release.

The findings were published online in Science Advances.
 

Differing wavelengths

The researchers note that “in the past decades,” noninvasive brain stimulation technology using transcranial application of direct or alternating electrical or magnetic fields “has been proven to be useful” in the improvement of working memory (WM).

When applied to the right PFC, tPBM has been shown to improve accuracy and speed of reaction time in WM tasks and improvements in “high-order cognitive functions,” such as sustained attention, emotion, and executive functions.

The investigators wanted to assess the impact of tPBM applied to different parts of the brain and at different wavelengths. They conducted four double-blind, sham-controlled experiments encompassing 90 neurotypical college students (mean age, 22 years). Each student participated in only one of the four experiments.

All completed two different tPBM sessions, separated by a week, in which sham and active tPBM were compared. Two different types of change-detection memory tasks were given: one requiring participants to remember the orientation of a series of items before and after the intervention and one other requiring them to remember the color of the items (experiments 1 and 2).

A series of follow-up experiments focused on comparing different wavelengths (1,064 nm vs. 852 nm) and different stimulation sites (right vs. left PFC; experiments 3 and 4).

EEG recordings were obtained during the intervention and the memory tasks.

Each experiment consisted of one active tPBM session and one sham tPBM session, with sessions consisting of 12 minutes of laser light (or sham) intervention. These sessions were conducted on the first and the seventh day; then, on the eighth day, participants were asked to report (or guess) which session was the active tPBM session.
 

Stimulating astrocytes

Results showed that, compared with sham tPBM, there was an improvement in WM capacity and scores by the 1,064 nm intervention in the orientation as well as the color task.

Participants who received the targeted treatment were able to remember between four and five test objects, whereas those with the treatment variations were only able to remember between three and four objects.

“These results support the hypothesis that 1,064 nm tPBM on the right PFC enhances WM capacity,” the investigators wrote.

They also found improvements in WM in participants receiving tPBM vs. sham regardless of whether their performance in the WM task was at a low or high level. This finding held true in both the orientation and the color tasks.

“Therefore, participants with good and poor WM capacity improved after 1,064 nm tPBM,” the researchers noted.

In addition, participants were unable to guess or report whether they had received sham or active tPBM.

EEG monitoring showed changes in brain activity that predicted the improvements in memory performance. In particular, 1,064 tPBM applied to the right PFC increased occipitoparietal contralateral delay activity (CDA), with CDA mediating the WM improvement.

This is “consistent with previous research that CDA is indicative of the number of maintained objects in visual working memory,” the investigators wrote.

Pearson correlation analyses showed that the differences in CDA set-size effects between active and sham session “correlated positively” with the behavioral differences between these sessions. For the orientation task, the r was 0.446 (P < .04); and for the color task, the r was .563 (P < .02).

No similar improvements were found with the 852 nm tPBM.

“We need further research to understand exactly why the tPBM is having this positive effect,” coinvestigator Ole Jensen, PhD, professor in translational neuroscience and codirector of the Centre for Human Brain Health, said in the release.

“It’s possible that the light is stimulating the astrocytes – the powerplants – in the nerve cells within the PFC, and this has a positive effect on the cells’ efficiency,” he noted.

Dr. Jensen added that his team “will also be investigating how long the effects might last. Clearly, if these experiments are to lead to a clinical intervention, we will need to see long-lasting benefits.”
 

Beneficial cognitive, emotional effects

Commenting for this news organization, Francisco Gonzalez-Lima, PhD, professor in the department of psychology, University of Texas at Austin, called the study “well done.”

Dr. Gonzalez-Lima was one of the first researchers to demonstrate that 1,064 nm transcranial infrared laser stimulation “produces beneficial cognitive and emotional effects in humans, including improving visual working memory,” he said.

The current study “reported an additional brain effect linked to the improved visual working memory that consists of an EEG-derived response, which is a new finding,” noted Dr. Gonzales-Lima, who was not involved with the new research.

He added that the same laser method “has been found by the Gonzalez-Lima lab to be effective at improving cognition in older adults and depressed and bipolar patients.”

The study was supported by the National Natural Science Foundation of China, the Ministry of Science and Technology of the People’s Republic of China, and the National Defence Basic Scientific Research Program of China. The investigators and Dr. Gonzalez-Lima report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Transcranial photobiomodulation (tPBM), a noninvasive laser light therapy, can improve short-term memory in young adults when applied to the right prefrontal cortex (PFC) of the brain, new research suggests.

Investigators compared the effect of 1,064 nm of tPBM delivered over a 12-minute session to the right PFC vs. three other treatment arms: delivery of the same intervention to the left PFC, delivery of the intervention at a lower frequency, and a sham intervention.

All participants were shown a series of items prior to the intervention and  asked to recall them after the intervention. Those who received tPBM 1,064 nm to the right PFC showed a superior performance of up to 25% in the memory tasks compared with the other groups.

Patients with attention-related conditions, such as attention deficit hyperactivity disorder, “could benefit from this type of treatment, which is safe, simple, and noninvasive, with no side effects,” coinvestigator Dongwei Li, a visiting PhD student at the Centre for Human Brain Health, University of Birmingham, England, said in a news release.

The findings were published online in Science Advances.
 

Differing wavelengths

The researchers note that “in the past decades,” noninvasive brain stimulation technology using transcranial application of direct or alternating electrical or magnetic fields “has been proven to be useful” in the improvement of working memory (WM).

When applied to the right PFC, tPBM has been shown to improve accuracy and speed of reaction time in WM tasks and improvements in “high-order cognitive functions,” such as sustained attention, emotion, and executive functions.

The investigators wanted to assess the impact of tPBM applied to different parts of the brain and at different wavelengths. They conducted four double-blind, sham-controlled experiments encompassing 90 neurotypical college students (mean age, 22 years). Each student participated in only one of the four experiments.

All completed two different tPBM sessions, separated by a week, in which sham and active tPBM were compared. Two different types of change-detection memory tasks were given: one requiring participants to remember the orientation of a series of items before and after the intervention and one other requiring them to remember the color of the items (experiments 1 and 2).

A series of follow-up experiments focused on comparing different wavelengths (1,064 nm vs. 852 nm) and different stimulation sites (right vs. left PFC; experiments 3 and 4).

EEG recordings were obtained during the intervention and the memory tasks.

Each experiment consisted of one active tPBM session and one sham tPBM session, with sessions consisting of 12 minutes of laser light (or sham) intervention. These sessions were conducted on the first and the seventh day; then, on the eighth day, participants were asked to report (or guess) which session was the active tPBM session.
 

Stimulating astrocytes

Results showed that, compared with sham tPBM, there was an improvement in WM capacity and scores by the 1,064 nm intervention in the orientation as well as the color task.

Participants who received the targeted treatment were able to remember between four and five test objects, whereas those with the treatment variations were only able to remember between three and four objects.

“These results support the hypothesis that 1,064 nm tPBM on the right PFC enhances WM capacity,” the investigators wrote.

They also found improvements in WM in participants receiving tPBM vs. sham regardless of whether their performance in the WM task was at a low or high level. This finding held true in both the orientation and the color tasks.

“Therefore, participants with good and poor WM capacity improved after 1,064 nm tPBM,” the researchers noted.

In addition, participants were unable to guess or report whether they had received sham or active tPBM.

EEG monitoring showed changes in brain activity that predicted the improvements in memory performance. In particular, 1,064 tPBM applied to the right PFC increased occipitoparietal contralateral delay activity (CDA), with CDA mediating the WM improvement.

This is “consistent with previous research that CDA is indicative of the number of maintained objects in visual working memory,” the investigators wrote.

Pearson correlation analyses showed that the differences in CDA set-size effects between active and sham session “correlated positively” with the behavioral differences between these sessions. For the orientation task, the r was 0.446 (P < .04); and for the color task, the r was .563 (P < .02).

No similar improvements were found with the 852 nm tPBM.

“We need further research to understand exactly why the tPBM is having this positive effect,” coinvestigator Ole Jensen, PhD, professor in translational neuroscience and codirector of the Centre for Human Brain Health, said in the release.

“It’s possible that the light is stimulating the astrocytes – the powerplants – in the nerve cells within the PFC, and this has a positive effect on the cells’ efficiency,” he noted.

Dr. Jensen added that his team “will also be investigating how long the effects might last. Clearly, if these experiments are to lead to a clinical intervention, we will need to see long-lasting benefits.”
 

Beneficial cognitive, emotional effects

Commenting for this news organization, Francisco Gonzalez-Lima, PhD, professor in the department of psychology, University of Texas at Austin, called the study “well done.”

Dr. Gonzalez-Lima was one of the first researchers to demonstrate that 1,064 nm transcranial infrared laser stimulation “produces beneficial cognitive and emotional effects in humans, including improving visual working memory,” he said.

The current study “reported an additional brain effect linked to the improved visual working memory that consists of an EEG-derived response, which is a new finding,” noted Dr. Gonzales-Lima, who was not involved with the new research.

He added that the same laser method “has been found by the Gonzalez-Lima lab to be effective at improving cognition in older adults and depressed and bipolar patients.”

The study was supported by the National Natural Science Foundation of China, the Ministry of Science and Technology of the People’s Republic of China, and the National Defence Basic Scientific Research Program of China. The investigators and Dr. Gonzalez-Lima report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.

Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon be ending, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.

“Are you kidding me that this is happening?” she thought.

But she also wanted to keep learning and growing in her remaining years, to devote them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.

“The last 2 years have kind of been this dance with Lady Death,” she said.

They have also been a dance with Lady Justice.

In March 2021, Ms. Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.

Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Ms. Baldeschwiler is seeking.

Psilocybin is illegal in the United States, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the Food and Drug Administration but have passed phase 1 clinical trials.

This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.

The push to expand access to psilocybin is picking up steam in the United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.

It is also gaining momentum outside the United States. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.

“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
 

Reverberations of Right to Try

The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.

After conventional therapies failed, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.

She died in 2001 at age 21.

Ms. Burroughs’ father, Frank Burroughs, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.

Still, the case sparked a Right to Try movement.

“Right to Try laws swept the U.S. in a firestorm,” Ms. Tucker said.

Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.

The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. Baldeschwiler could benefit.

“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”

He applied for the right to cultivate psilocybin mushrooms, but the fungus doesn’t meet Right to Try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.

Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.

The response, she said, was predictable.

“The DEA’s knee always jerks in the direction of no access,” Ms. Tucker said. “So it said ‘no access.’ “

The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
 

Suing the DEA

Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.

They decided to sue.

Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.

The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.

In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.

In late June, the DEA provided its final answer: No access.

In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”

In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”

The government’s response is due in January 2023.

Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.

The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”

Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.

Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.

In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.

And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
 

The fight north of the border

In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.

After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.

Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.

In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.

“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”

TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.

But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.

Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”

As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.

“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”

Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.

In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.
 

An uncertain future

Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.

When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.

Although in clinical trials psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds.

That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.

In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.

“Oftentimes, we hear only the positive anecdotes,” Dr. Yaden said. “We don’t hear ... neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”

A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”

But Ms. Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.

A version of this article first appeared on Medscape.com.

In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.

Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon be ending, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.

“Are you kidding me that this is happening?” she thought.

But she also wanted to keep learning and growing in her remaining years, to devote them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.

“The last 2 years have kind of been this dance with Lady Death,” she said.

They have also been a dance with Lady Justice.

In March 2021, Ms. Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.

Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Ms. Baldeschwiler is seeking.

Psilocybin is illegal in the United States, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the Food and Drug Administration but have passed phase 1 clinical trials.

This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.

The push to expand access to psilocybin is picking up steam in the United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.

It is also gaining momentum outside the United States. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.

“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
 

Reverberations of Right to Try

The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.

After conventional therapies failed, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.

She died in 2001 at age 21.

Ms. Burroughs’ father, Frank Burroughs, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.

Still, the case sparked a Right to Try movement.

“Right to Try laws swept the U.S. in a firestorm,” Ms. Tucker said.

Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.

The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. Baldeschwiler could benefit.

“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”

He applied for the right to cultivate psilocybin mushrooms, but the fungus doesn’t meet Right to Try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.

Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.

The response, she said, was predictable.

“The DEA’s knee always jerks in the direction of no access,” Ms. Tucker said. “So it said ‘no access.’ “

The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
 

Suing the DEA

Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.

They decided to sue.

Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.

The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.

In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.

In late June, the DEA provided its final answer: No access.

In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”

In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”

The government’s response is due in January 2023.

Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.

The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”

Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.

Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.

In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.

And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
 

The fight north of the border

In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.

After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.

Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.

In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.

“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”

TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.

But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.

Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”

As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.

“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”

Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.

In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.
 

An uncertain future

Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.

When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.

Although in clinical trials psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds.

That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.

In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.

“Oftentimes, we hear only the positive anecdotes,” Dr. Yaden said. “We don’t hear ... neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”

A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”

But Ms. Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.

A version of this article first appeared on Medscape.com.

In March 2020, when the world was struck by the news of the COVID-19 pandemic, Erinn Baldeschwiler received her own gut punch. She was diagnosed with stage IV metastatic breast cancer and was given about 2 years to live.

Then 48, the mother of two teenagers had just started a new chapter in her life. She’d gotten divorced, moved to a new home, and left a small business she had spent 18 years cultivating. The prospect that her life story might soon be ending, that she wouldn’t see her children grow up, was a twist of fate almost too devastating to bear.

“Are you kidding me that this is happening?” she thought.

But she also wanted to keep learning and growing in her remaining years, to devote them to creating meaningful memories, contemplating her mortality, and trying to find inner peace.

“The last 2 years have kind of been this dance with Lady Death,” she said.

They have also been a dance with Lady Justice.

In March 2021, Ms. Baldeschwiler, along with Michal Bloom, who also has terminal cancer, and their palliative care physician, Sunil Aggarwal, MD, PhD, decided to sue the Drug Enforcement Administration (DEA) for the right to access psilocybin, the psychoactive ingredient in “magic” mushrooms.

Psilocybin-assisted therapy has been shown to help terminally ill people overcome their fear, anxiety, and despair about death and to experience the kind of peace Ms. Baldeschwiler is seeking.

Psilocybin is illegal in the United States, but the plaintiffs argue they should be able to take the substance through the Right to Try Act. The 2018 federal law says that people with life-threatening conditions who have exhausted all approved treatment options can access drugs that have not yet been approved by the Food and Drug Administration but have passed phase 1 clinical trials.

This case marks the first time patients have fought to use a Schedule I drug under the Right to Try Act.

The push to expand access to psilocybin is picking up steam in the United States. In 2023, facilitated use of psilocybin will become legal in Oregon and Colorado. Recent proposals from the Biden administration and members of Congress could make psilocybin more widely accessible in the next few years.

It is also gaining momentum outside the United States. In Canada, patients are suing the government to help patients obtain psilocybin-assisted therapy for medical purposes.

“I think what we have here is a confluence of events that are driving toward the mandatory opening of a path to access psilocybin for therapeutic use sooner rather than later,” said Kathryn Tucker, lead counsel in the case against the DEA.
 

Reverberations of Right to Try

The story of Right to Try began with Abigail Burroughs, who was diagnosed with head and neck cancer at age 19.

After conventional therapies failed, Ms. Burroughs’ oncologist recommended cetuximab, a drug targeting EGFR that was experimental at the time. Because the drug was available only through colon cancer trials, she was denied access.

She died in 2001 at age 21.

Ms. Burroughs’ father, Frank Burroughs, formed an organization that in 2003 sued the FDA to provide terminally ill patients access to unapproved drugs. In 2005, they lost, and subsequent attempts to appeal the decision failed.

Still, the case sparked a Right to Try movement.

“Right to Try laws swept the U.S. in a firestorm,” Ms. Tucker said.

Along with the federal law, which passed in 2018, 41 states have enacted Right to Try laws.

The movement intrigued Dr. Aggarwal, codirector of the Advanced Integrative Medical Science (AIMS) Institute in Seattle. Dr. Aggarwal had been treating patients with cannabis, and after taking psilocybin himself and finding it therapeutic, he thought Ms. Baldeschwiler could benefit.

“I always knew that the powerful medicines within Schedule I had a significant role to play in healing,” he said. “That was baked into my decision to become a doctor, to research, and to innovate.”

He applied for the right to cultivate psilocybin mushrooms, but the fungus doesn’t meet Right to Try requirements. He then found a manufacturer willing to supply synthesized psilocybin, but because it’s a Schedule I drug, the manufacturer needed an okay from the DEA.

Dr. Aggarwal joined forces with Ms. Tucker, who has spent 35 years protecting the rights of terminally ill patients. In January 2021, Ms. Tucker contacted the DEA about allowing dying patients, including Ms. Baldeschwiler and Mr. Bloom, to access psilocybin-assisted therapy.

The response, she said, was predictable.

“The DEA’s knee always jerks in the direction of no access,” Ms. Tucker said. “So it said ‘no access.’ “

The reason: In a letter dated February 2021, the DEA said it “has no authority to waive” any requirements of the Controlled Substances Act under Right to Try laws.
 

Suing the DEA

Dr. Aggarwal and Ms. Tucker did not accept the DEA’s “no access” answer.

They decided to sue.

Dr. Aggarwal and Ms. Tucker took the matter to the Ninth Circuit Court in March 2021. In January 2022, the court dismissed the case after the DEA claimed its initial denial was not final.

The following month, the plaintiffs petitioned the DEA to deliver a concrete answer.

In May, while waiting for a response, demonstrators gathered at the DEA’s headquarters to call for legal access to psilocybin. One of the protesters was Ms. Baldeschwiler, who choked back tears as she told the crowd she was likely missing her last Mother’s Day with her children to attend the event. She was arrested, along with 16 other people.

In late June, the DEA provided its final answer: No access.

In a letter addressed to Ms. Tucker, Thomas W. Prevoznik, the DEA’s deputy assistant administrator, said it “finds no basis” to reconsider its initial denial in February 2021 “because the legal and factual considerations remain unchanged.”

In an appeal, Ms. Tucker wrote: “In denying Petitioners’ requested accommodation in the Final Agency Action, DEA hides behind a smokescreen, neglecting its duty to implement the federal [Right to Try Act] and violating the state [Right to Try law].”

The government’s response is due in January 2023.

Ms. Tucker and her legal team also petitioned the DEA on behalf of Dr. Aggarwal to reschedule psilocybin from Schedule I to Schedule II.

The DEA defines Schedule I substances as “drugs with no currently accepted medical use and a high potential for abuse.” But the FDA has designated psilocybin as a breakthrough therapy for depression, which, Ms. Tucker noted, “reflects that there is a currently accepted medical use.”

Nevertheless, in September, the DEA denied Ms. Tucker’s petition to reschedule psilocybin, and her team is now petitioning the Ninth Circuit Court for a review of that decision.

Despite the setbacks, actions from the Biden administration and members of Congress could help improve access.

In July, Senators Cory Booker and Rand Paul introduced the Right to Try Clarification Act to clarify that the federal law includes Schedule I substances. If passed, Ms. Tucker said, it would negate the DEA’s “no access” argument.

And earlier this year, the Biden administration announced plans to establish a federal task force to address the “myriad of complex issues” associated with the anticipated FDA approval of psilocybin to treat depression. The task force will explore “the potential of psychedelic-assisted therapies” to tackle the mental health crisis as well as any “risks to public health” that “may require harm reduction, risk mitigation, and safety monitoring.”
 

The fight north of the border

In 2016, Canadian resident Thomas Hartle, then 48, awoke from surgery for a bowel obstruction to learn he had stage IV colon cancer.

After another surgery, his doctors believed the tumors were gone. But in 2019, the cancer came back, along with extreme anxiety and distress over his impending death and how his two special-needs children would cope.

Mr. Hartle wanted to try magic mushroom–assisted psychotherapy. The Saskatoon resident sought help from TheraPsil, a Canadian nonprofit organization that advocates for therapeutic psilocybin. They applied for access under Section 56, which allows health officials to exempt patients from certain provisions of drug law.

In 2020, Hartle became the first Canadian to legally obtain psilocybin-assisted therapy.

“It has been nothing short of life changing for me,” Mr. Hartle said at a palliative care conference in Saskatoon this past June. “I am now no longer actively dying. I feel like I am genuinely actively living.”

TheraPsil has obtained Section 56 exemptions for around 60 patients to access psilocybin-assisted therapy as well as 19 health care professionals who are training to become psilocybin-assisted therapists.

But then an election ushered in new health ministers, and in early 2022, the exemptions evaporated. Thousands of patients and health care practitioners on TheraPsil’s waiting list were left in limbo.

Health Canada told CBC News that the rule change came about because “while psilocybin has shown promise in clinical trials for the treatment of some indications, further research is still needed to determine its safety and efficacy.”

As an alternative, TheraPsil began applying for access under Canada’s Special Access Program, which is similar to Right to Try laws in the United States. But Canada’s program doesn’t apply to therapists in training, and the petition process is so slow that many patients die before requests can be approved.

“People like to pretend that the Special Access Program is not political, but it is very political,” said TheraPsil’s CEO, Spencer Hawkswell. “It means a patient and a doctor are asking a politician for access to their medicine, which is absolutely unacceptable.”

Now, TheraPsil is helping patients take the Canadian government to court. In July, Mr. Hartle and seven others with conditions ranging from cancer to chronic pain filed a lawsuit against Canada’s health ministry that challenges the limited legal pathways to the use of psilocybin. The lawsuit argues that patients have a “constitutional right to access psilocybin for medicinal purposes,” and it advocates for access to regulated psilocybin products from licensed dealers, much like Canada’s medical marijuana program already does.

In the filing, TheraPsil said that as of February 2022, it has a wait-list of more than 800 patients who are requesting help in obtaining psilocybin-assisted psychotherapy.
 

An uncertain future

Despite the groundswell of support, many unknowns remain about the safety of expanding access to psilocybin-assisted therapy.

When Oregon and Colorado launch their psilocybin programs in 2023, the licensed centers will provide testing grounds for the safety and efficacy of broader access to psilocybin for people with depression or terminal cancer as well as those looking to grow spiritually.

Although in clinical trials psilocybin has been found to ease symptoms of depression and end-of-life demoralization for people with life-threatening conditions, it has not been adequately tested in people with a range of mental health problems, traumas, and racial backgrounds.

That uncertainty has given some people pause. In recent months, some researchers and journalists have pushed back against the frenzy over the promise of psychedelics.

In September, David Yaden, PhD, a psychedelics researcher at Johns Hopkins, spoke at the Interdisciplinary Conference on Psychedelic Research in the Netherlands. He encouraged people to pay more attention to potential adverse effects of psychedelics, which could include anything from headaches to lingering dysphoria.

“Oftentimes, we hear only the positive anecdotes,” Dr. Yaden said. “We don’t hear ... neutral or negative ones. So, I think all of those anecdotes need to be part of the picture.”

A recent piece in Wired noted that mentioning the potential harms of psychedelics amid its renaissance has been “taboo,” but the authors cautioned that as clinical trials involving psychedelics grow larger and the drugs become commercialized, “more negative outcomes are likely to transpire.”

But Ms. Baldeschwiler remains steadfast in her pursuit. While it’s important to approach broader access to psychedelics with caution, “end-of-life patients don’t have time to wait,” she said.

A version of this article first appeared on Medscape.com.