Alicia Ault

The American Psychiatric Association (APA) is calling on Congress to permanently lift restrictions that have allowed unfettered delivery of telehealth services during the COVID-19 pandemic, which experts say has been a boon to patients and physicians alike.

“We ask Congress to extend the telehealth waiver authority under COVID-19 beyond the emergency and to study its impact while doing so,” said APA President Jeffrey Geller, MD, in a May 27 video briefing with congressional staff and reporters.

The APA is also seeking to make permanent certain waivers granted by the Centers for Medicare & Medicaid Services on April 30, including elimination of geographic restrictions on behavioral health and allowing patients be seen at home, said Dr. Geller.

The APA also is asking for the elimination of the rule that requires clinicians to have an initial face-to-face meeting with patients before they can prescribe controlled substances, Dr. Geller said. The Drug Enforcement Administration waived that requirement, known as the Ryan Haight Act, on March 17 for the duration of the national emergency.

Telemedicine has supporters on both sides of the aisle in Congress, including Rep. Paul Tonko (D-N.Y.) who said at the APA briefing he would fight to make the waivers permanent.

“The expanded use of telehealth has enormous potential during normal times as well, especially in behavioral health,” said Mr. Tonko. “I am pushing fiercely for these current flexibilities to be extended for a reasonable time after the public health emergency so that we can have time to evaluate which should be made permanent,” he said.

Dr. Geller, other clinicians, and advocates in the briefing praised CMS for facilitating telepsychiatry for Medicare. That follows in the footsteps of most private insurers, who have also relaxed requirements into the summer, according to the Medical Group Management Association.
 

Game changer

The Medicare waivers “have dramatically changed the entire scene for someone like myself as a clinician to allow me to see my patients in a much easier way,” said Peter Yellowlees, MBBS, MD, chief wellness officer, University of California Davis Health. Within 2 weeks in March, the health system converted almost all of its regular outpatient visits to telemedicine, he said.

Dr. Yellowlees added government still needs to address, what he called, outdated HIPAA regulations that ban certain technologies.

“It makes no sense that I can talk to someone on an iPhone, but the moment I talk to them on FaceTime, it’s illegal,” said Dr. Yellowlees, a former president of the American Telemedicine Association.

Dr. Geller said that “psychiatric care provided by telehealth is as effective as in-person psychiatric services,” adding that “some patients prefer telepsychiatry because of its convenience and as a means of reducing stigma associated with seeking help for mental health.”

Shabana Khan, MD, a child psychiatrist and director of telepsychiatry at New York University Langone Health, said audio and video conferencing are helping address a shortage and maldistribution of child and adolescent psychiatrists.

Americans’ mental health is suffering during the pandemic. The U.S. Census Bureau recently released data showing that half of those surveyed reported depressed mood and that one-third are reporting anxiety, depression, or both, as reported by the Washington Post.

“At this very time that anxiety, depression, substance use, and other mental health problems are rising, our nation’s already strained mental health system is really being pushed to the brink,” said Jodi Kwarciany, manager for mental health policy for the National Alliance on Mental Illness, during the briefing.

Telemedicine can help “by connecting people to providers at the time and the place and using the technology that works best for them,” she said, adding that NAMI would press policymakers to address barriers to access.

The clinicians on the briefing said they’ve observed that some patients are more comfortable with video or audio interactions than with in-person visits.
 

Increased access to care

Telepsychiatry seems to be convincing some to reconsider therapy, since they can do it at home, said Dr. Yellowlees. The technology is a way of “enlarging the tent for us as a profession and providing more care,” he said.

For instance, he said, he has been able to consult by phone and video with several patients who receive care through the Indian Health Service who had not be able to get into the physical clinic.

Dr. Yellowlees said video sessions also may encourage patients to be more, not less, talkative. “Video is actually counterintuitively a very intimate experience,” he said, in part because of the perceived distance and people’s tendency to be less inhibited on technology platforms.“It’s less embarrassing,” he said. “If you’ve got really dramatic, difficult, traumatic things to talk about, it’s slightly easier to talk to someone who’s slightly further apart from you on video,” said Dr. Yellowlees.

“Individuals who have a significant amount of anxiety may actually feel more comfortable with the distance that this technology affords,” agreed Dr. Khan. She said telemedicine had made sessions more comfortable for some of her patients with autism spectrum disorder.

Dr. Geller said audio and video have been important to his practice during the pandemic. One of his patients never leaves the house and does not use computers. “He spends his time sequestered at home listening to records on his record player,” said Dr. Geller. But he’s been amenable to phone sessions. “What I’ve found with him, and I’ve found with several other patients, is that they actually talk more easily when they’re not face to face,” he said.
 

Far fewer no-shows

Another plus for his New England–based practice during the last few months: patients have not been anxious about missing sessions because of the weather. The clinicians all noted that telepsychiatry seemed to reduce missed visits.

Dr. Yellowlees said that no-show rates had decreased by half at UC Davis. “That means no significant loss of income,” during the pandemic, he said.

“The no-show rate is incredibly low, particularly because when you call the patients and they don’t remember they had an appointment, you have the appointment anyway, most of the time,” said Dr. Geller.

For Dr. Khan, being able to conduct audio and video sessions during the pandemic has meant keeping up continuity of care.

As a result of the pandemic, many college students in New York City had to go home – often to another state. The waivers granted by New York’s Medicaid program and other insurers have allowed Dr. Khan to continue care for these patients.

The NYU clinic also operates day programs in rural areas 5 hours from the city. Dr. Khan recently evaluated a 12-year-old girl with significant anxiety and low mood, both of which had worsened.

“She would not have been able to access care otherwise,” said Dr. Khan. And for rural patients who do not have access to broadband or smartphones, audio visits “have been immensely helpful,” she said.

Dr. Khan, Dr. Geller, and Dr. Yellowlees have disclosed no relevant financial relationships.

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

The American Psychiatric Association (APA) is calling on Congress to permanently lift restrictions that have allowed unfettered delivery of telehealth services during the COVID-19 pandemic, which experts say has been a boon to patients and physicians alike.

“We ask Congress to extend the telehealth waiver authority under COVID-19 beyond the emergency and to study its impact while doing so,” said APA President Jeffrey Geller, MD, in a May 27 video briefing with congressional staff and reporters.

The APA is also seeking to make permanent certain waivers granted by the Centers for Medicare & Medicaid Services on April 30, including elimination of geographic restrictions on behavioral health and allowing patients be seen at home, said Dr. Geller.

The APA also is asking for the elimination of the rule that requires clinicians to have an initial face-to-face meeting with patients before they can prescribe controlled substances, Dr. Geller said. The Drug Enforcement Administration waived that requirement, known as the Ryan Haight Act, on March 17 for the duration of the national emergency.

Telemedicine has supporters on both sides of the aisle in Congress, including Rep. Paul Tonko (D-N.Y.) who said at the APA briefing he would fight to make the waivers permanent.

“The expanded use of telehealth has enormous potential during normal times as well, especially in behavioral health,” said Mr. Tonko. “I am pushing fiercely for these current flexibilities to be extended for a reasonable time after the public health emergency so that we can have time to evaluate which should be made permanent,” he said.

Dr. Geller, other clinicians, and advocates in the briefing praised CMS for facilitating telepsychiatry for Medicare. That follows in the footsteps of most private insurers, who have also relaxed requirements into the summer, according to the Medical Group Management Association.
 

Game changer

The Medicare waivers “have dramatically changed the entire scene for someone like myself as a clinician to allow me to see my patients in a much easier way,” said Peter Yellowlees, MBBS, MD, chief wellness officer, University of California Davis Health. Within 2 weeks in March, the health system converted almost all of its regular outpatient visits to telemedicine, he said.

Dr. Yellowlees added government still needs to address, what he called, outdated HIPAA regulations that ban certain technologies.

“It makes no sense that I can talk to someone on an iPhone, but the moment I talk to them on FaceTime, it’s illegal,” said Dr. Yellowlees, a former president of the American Telemedicine Association.

Dr. Geller said that “psychiatric care provided by telehealth is as effective as in-person psychiatric services,” adding that “some patients prefer telepsychiatry because of its convenience and as a means of reducing stigma associated with seeking help for mental health.”

Shabana Khan, MD, a child psychiatrist and director of telepsychiatry at New York University Langone Health, said audio and video conferencing are helping address a shortage and maldistribution of child and adolescent psychiatrists.

Americans’ mental health is suffering during the pandemic. The U.S. Census Bureau recently released data showing that half of those surveyed reported depressed mood and that one-third are reporting anxiety, depression, or both, as reported by the Washington Post.

“At this very time that anxiety, depression, substance use, and other mental health problems are rising, our nation’s already strained mental health system is really being pushed to the brink,” said Jodi Kwarciany, manager for mental health policy for the National Alliance on Mental Illness, during the briefing.

Telemedicine can help “by connecting people to providers at the time and the place and using the technology that works best for them,” she said, adding that NAMI would press policymakers to address barriers to access.

The clinicians on the briefing said they’ve observed that some patients are more comfortable with video or audio interactions than with in-person visits.
 

Increased access to care

Telepsychiatry seems to be convincing some to reconsider therapy, since they can do it at home, said Dr. Yellowlees. The technology is a way of “enlarging the tent for us as a profession and providing more care,” he said.

For instance, he said, he has been able to consult by phone and video with several patients who receive care through the Indian Health Service who had not be able to get into the physical clinic.

Dr. Yellowlees said video sessions also may encourage patients to be more, not less, talkative. “Video is actually counterintuitively a very intimate experience,” he said, in part because of the perceived distance and people’s tendency to be less inhibited on technology platforms.“It’s less embarrassing,” he said. “If you’ve got really dramatic, difficult, traumatic things to talk about, it’s slightly easier to talk to someone who’s slightly further apart from you on video,” said Dr. Yellowlees.

“Individuals who have a significant amount of anxiety may actually feel more comfortable with the distance that this technology affords,” agreed Dr. Khan. She said telemedicine had made sessions more comfortable for some of her patients with autism spectrum disorder.

Dr. Geller said audio and video have been important to his practice during the pandemic. One of his patients never leaves the house and does not use computers. “He spends his time sequestered at home listening to records on his record player,” said Dr. Geller. But he’s been amenable to phone sessions. “What I’ve found with him, and I’ve found with several other patients, is that they actually talk more easily when they’re not face to face,” he said.
 

Far fewer no-shows

Another plus for his New England–based practice during the last few months: patients have not been anxious about missing sessions because of the weather. The clinicians all noted that telepsychiatry seemed to reduce missed visits.

Dr. Yellowlees said that no-show rates had decreased by half at UC Davis. “That means no significant loss of income,” during the pandemic, he said.

“The no-show rate is incredibly low, particularly because when you call the patients and they don’t remember they had an appointment, you have the appointment anyway, most of the time,” said Dr. Geller.

For Dr. Khan, being able to conduct audio and video sessions during the pandemic has meant keeping up continuity of care.

As a result of the pandemic, many college students in New York City had to go home – often to another state. The waivers granted by New York’s Medicaid program and other insurers have allowed Dr. Khan to continue care for these patients.

The NYU clinic also operates day programs in rural areas 5 hours from the city. Dr. Khan recently evaluated a 12-year-old girl with significant anxiety and low mood, both of which had worsened.

“She would not have been able to access care otherwise,” said Dr. Khan. And for rural patients who do not have access to broadband or smartphones, audio visits “have been immensely helpful,” she said.

Dr. Khan, Dr. Geller, and Dr. Yellowlees have disclosed no relevant financial relationships.

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

The American Psychiatric Association (APA) is calling on Congress to permanently lift restrictions that have allowed unfettered delivery of telehealth services during the COVID-19 pandemic, which experts say has been a boon to patients and physicians alike.

“We ask Congress to extend the telehealth waiver authority under COVID-19 beyond the emergency and to study its impact while doing so,” said APA President Jeffrey Geller, MD, in a May 27 video briefing with congressional staff and reporters.

The APA is also seeking to make permanent certain waivers granted by the Centers for Medicare & Medicaid Services on April 30, including elimination of geographic restrictions on behavioral health and allowing patients be seen at home, said Dr. Geller.

The APA also is asking for the elimination of the rule that requires clinicians to have an initial face-to-face meeting with patients before they can prescribe controlled substances, Dr. Geller said. The Drug Enforcement Administration waived that requirement, known as the Ryan Haight Act, on March 17 for the duration of the national emergency.

Telemedicine has supporters on both sides of the aisle in Congress, including Rep. Paul Tonko (D-N.Y.) who said at the APA briefing he would fight to make the waivers permanent.

“The expanded use of telehealth has enormous potential during normal times as well, especially in behavioral health,” said Mr. Tonko. “I am pushing fiercely for these current flexibilities to be extended for a reasonable time after the public health emergency so that we can have time to evaluate which should be made permanent,” he said.

Dr. Geller, other clinicians, and advocates in the briefing praised CMS for facilitating telepsychiatry for Medicare. That follows in the footsteps of most private insurers, who have also relaxed requirements into the summer, according to the Medical Group Management Association.
 

Game changer

The Medicare waivers “have dramatically changed the entire scene for someone like myself as a clinician to allow me to see my patients in a much easier way,” said Peter Yellowlees, MBBS, MD, chief wellness officer, University of California Davis Health. Within 2 weeks in March, the health system converted almost all of its regular outpatient visits to telemedicine, he said.

Dr. Yellowlees added government still needs to address, what he called, outdated HIPAA regulations that ban certain technologies.

“It makes no sense that I can talk to someone on an iPhone, but the moment I talk to them on FaceTime, it’s illegal,” said Dr. Yellowlees, a former president of the American Telemedicine Association.

Dr. Geller said that “psychiatric care provided by telehealth is as effective as in-person psychiatric services,” adding that “some patients prefer telepsychiatry because of its convenience and as a means of reducing stigma associated with seeking help for mental health.”

Shabana Khan, MD, a child psychiatrist and director of telepsychiatry at New York University Langone Health, said audio and video conferencing are helping address a shortage and maldistribution of child and adolescent psychiatrists.

Americans’ mental health is suffering during the pandemic. The U.S. Census Bureau recently released data showing that half of those surveyed reported depressed mood and that one-third are reporting anxiety, depression, or both, as reported by the Washington Post.

“At this very time that anxiety, depression, substance use, and other mental health problems are rising, our nation’s already strained mental health system is really being pushed to the brink,” said Jodi Kwarciany, manager for mental health policy for the National Alliance on Mental Illness, during the briefing.

Telemedicine can help “by connecting people to providers at the time and the place and using the technology that works best for them,” she said, adding that NAMI would press policymakers to address barriers to access.

The clinicians on the briefing said they’ve observed that some patients are more comfortable with video or audio interactions than with in-person visits.
 

Increased access to care

Telepsychiatry seems to be convincing some to reconsider therapy, since they can do it at home, said Dr. Yellowlees. The technology is a way of “enlarging the tent for us as a profession and providing more care,” he said.

For instance, he said, he has been able to consult by phone and video with several patients who receive care through the Indian Health Service who had not be able to get into the physical clinic.

Dr. Yellowlees said video sessions also may encourage patients to be more, not less, talkative. “Video is actually counterintuitively a very intimate experience,” he said, in part because of the perceived distance and people’s tendency to be less inhibited on technology platforms.“It’s less embarrassing,” he said. “If you’ve got really dramatic, difficult, traumatic things to talk about, it’s slightly easier to talk to someone who’s slightly further apart from you on video,” said Dr. Yellowlees.

“Individuals who have a significant amount of anxiety may actually feel more comfortable with the distance that this technology affords,” agreed Dr. Khan. She said telemedicine had made sessions more comfortable for some of her patients with autism spectrum disorder.

Dr. Geller said audio and video have been important to his practice during the pandemic. One of his patients never leaves the house and does not use computers. “He spends his time sequestered at home listening to records on his record player,” said Dr. Geller. But he’s been amenable to phone sessions. “What I’ve found with him, and I’ve found with several other patients, is that they actually talk more easily when they’re not face to face,” he said.
 

Far fewer no-shows

Another plus for his New England–based practice during the last few months: patients have not been anxious about missing sessions because of the weather. The clinicians all noted that telepsychiatry seemed to reduce missed visits.

Dr. Yellowlees said that no-show rates had decreased by half at UC Davis. “That means no significant loss of income,” during the pandemic, he said.

“The no-show rate is incredibly low, particularly because when you call the patients and they don’t remember they had an appointment, you have the appointment anyway, most of the time,” said Dr. Geller.

For Dr. Khan, being able to conduct audio and video sessions during the pandemic has meant keeping up continuity of care.

As a result of the pandemic, many college students in New York City had to go home – often to another state. The waivers granted by New York’s Medicaid program and other insurers have allowed Dr. Khan to continue care for these patients.

The NYU clinic also operates day programs in rural areas 5 hours from the city. Dr. Khan recently evaluated a 12-year-old girl with significant anxiety and low mood, both of which had worsened.

“She would not have been able to access care otherwise,” said Dr. Khan. And for rural patients who do not have access to broadband or smartphones, audio visits “have been immensely helpful,” she said.

Dr. Khan, Dr. Geller, and Dr. Yellowlees have disclosed no relevant financial relationships.

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

On March 31, soon after the Food and Drug Administration authorized emergency use of antibody-packed plasma from recovered patients with COVID-19, Marisa Leuzzi became the first donor at an American Red Cross center. She hoped it could help her aunt, Renee Bannister, who was failing after 3 weeks on a ventilator at Virtua Hospital in Voorhees, N.J.

It may have worked; 11 days after receiving the plasma, Ms. Bannister was weaned off the ventilator and she is now awake and speaking, said Red Cross spokesperson Stephanie Rendon.

This kind of anecdote is fueling demand for the therapy, which can be provided through an expanded access program led by the Mayo Clinic, backed by the FDA, and the plasma paid for by the U.S. Department of Health & Human Services. But while this program is collecting safety and outcomes data, it’s not a randomized, controlled trial.

Others, however, are pursuing that data. At least a dozen researchers are investigating the potential of plasma – both as a treatment and whether it could act as a stand-in for a vaccine until one is developed.

“One of the things I don’t want this to be is the flavor of the month,” Shmuel Shoham, MD, associate professor of medicine at Johns Hopkins University, said in an interview.

Dr. Shoham, principal investigator for a study evaluating convalescent plasma to prevent the infection in high-risk individuals, said some clinicians, desperate for any treatment, have tried potential therapies such as hydroxychloroquine and remdesivir without evidence of safety or efficacy in COVID-19.

The National Institutes of Health recently said something similar for convalescent plasma, that “there are insufficient clinical data to recommend either for or against” its use for COVID-19.

But plasma has promise, according to a Johns Hopkins School of Medicine’s Bloomberg Distinguished Professor, Arturo Casadevall, MD, PhD, in Baltimore, and Liise-anne Pirofski, MD, a professor at Albert Einstein College of Medicine, New York. They lay out the case for convalescent plasma in an article published online March 13 in the Journal of Clinical Investigation. Passive antibody therapy, they wrote, has been used to stem polio, measles, mumps, and influenza, and more recently has shown some success against SARS-CoV-1 and Middle East respiratory syndrome (MERS).

“The special attraction of this modality of treatment is that, unlike vaccines or newly developed drugs, it could, in principle, be made available very rapidly,” said researchers with the National COVID-19 Convalescent Plasma Project, which includes physicians and scientists from 57 institutions in 46 states. But where principle veers from reality is in availability of the plasma itself, and donors are in short supply.
 

Aiming to prevent infection

So far, the FDA has approved 12 plasma trials – including Dr. Shoham’s – and the NIH’s clinicaltrials.gov lists more than two dozen convalescent plasma studies in the United States and elsewhere.

Most are single-arm trials to determine if one infusion can decrease the need for intubation or help those on a ventilator improve. Two others, one at Johns Hopkins and one at Stanford (Calif.) Hospital are investigating whether convalescent plasma might be used before severe disease sets in.

“A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease,” Dr. Casadevall and Dr. Pirofski wrote.

Stanford’s randomized, double-blind study will evaluate regular versus convalescent plasma in ED patients who are not sick enough to require hospitalization.

The Johns Hopkins trial, which aims to protect against infection in the first place, will begin at Johns Hopkins, Baltimore, and at Hopkins-affiliated hospitals throughout Maryland, Dr. Shoham said. He hopes it will expand nationwide eventually, and said that they expect to enroll the first patients soon.

To start, the prevention study will enroll only 150 patients, each of whom must have had close contact with someone who has COVID-19 within the previous 120 hours and be asymptomatic. The number of subjects is small, compared with the trial size of other potential therapies, and an issue, Shoham said, “that keeps me up at night.” But finding thousands of enrollees for plasma studies is hard, in part because it’s so difficult to recruit donors.

Participants will receive normal plasma (which will act as a placebo) or convalescent plasma.

The primary endpoint is cumulative incidence of COVID-19, defined as symptoms and a polymerase chain reaction–positive test; participants will be tracked for 90 days. Hospitals and health care workers could then decide if they want to use the therapy, he said.

The study will not answer whether participants will continue to have antibodies beyond the 90 days. Convalescent plasma is given as a rapid response to an emergent pathogen – a short-term boost of immunity rather than a long-term therapeutic.
 

What can we learn from expanded access?

Meanwhile, some 2,200 hospitals are participating in the expanded access program being led by the Mayo Clinic nationwide; more than 9,000 patients had received infusions at press time.

One participant is Northwell Health, a 23-hospital system that sprawls across the U.S. COVID epicenter: four of the five boroughs of New York City and Long Island.

Convalescent plasma is an in-demand therapy, said Christina Brennan, MD, vice president of clinical research at Northwell. “We get patients, family members, they say my family member is at X hospital – if it’s not being offered there, can you have them transferred?” she said in an interview.

When Northwell – through the New York Blood Bank – opened up donor registration, 800 people signed up in the first 24 hours, Dr. Brennan said. As of mid-May, 527 patients had received a transfusion.
 

Who’s the best donor and when should donation occur?

The Red Cross, hospitals, and independent blood banks are all soliciting donors, who can sign up at the Red Cross website. The FDA recommends that donors have a history of COVID-19 as confirmed by molecular or antibody testing, be symptom free for 14 days, have a negative follow-up molecular test, and be virus free at the time of collection. The FDA also suggests measuring a donor’s SARS-CoV-2 neutralizing antibody titers, if available, with a recommendation of at least 1:160.

But questions remain, such as whether there is a theoretical risk for antibody-dependent enhancement (ADE) of infection with SARS-CoV-2. “Antibodies to one type of coronavirus could enhance infection to another viral strain,” of coronavirus, Dr. Casadevall wrote. ADE has been observed in both severe acute respiratory syndrome (SARS) and MERS.

The other risk is that donors may still be shedding active virus. While the FDA suggests that donors are unlikely to still be infectious 14 days after infection, that is as of yet unproven. Both COVID-19 diagnostics and antibody tests have high rates of false negatives, which raises the specter that infection could be spread via the plasma donation.

Daniele Focosi, MD, PhD, from Pisa (Italy) University Hospital and colleagues raise that concern in a preprint review on convalescent plasma in COVID-19. “Although the recipient is already infected, theoretically transmission of more infectious particles could worsen clinical conditions,” they wrote, noting that “such a concern can be somewhat reduced by treatment with modern pathogen inactivation techniques.”

No evidence exists that SARS-CoV-2 can be transmitted through blood, but “we don’t know for sure,” Dr. Shoham said in an interview. A reassuring point: Even those with severe infection do not have viral RNA in their blood, he said, adding, “We don’t think there’s going to be viral transmission of this particular virus with transfusion.”

For another highly infectious pathogen, the Ebola virus, the World Health Organization recommended in 2014 that potential plasma donors wait at least 28 days after infection.

It’s also not known how long SARS-CoV-2 antibodies persist in the blood; longer viability could mean a longer donation window. Dr. Focosi noted that a previous Chinese study had shown that SARS-specific antibodies in people infected with the first SARS virus, SARS-CoV-1, persisted for 2 years.

Dr. Casadevall and Dr. Pirofski have disclosed no relevant financial relationships. Shoham has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

On March 31, soon after the Food and Drug Administration authorized emergency use of antibody-packed plasma from recovered patients with COVID-19, Marisa Leuzzi became the first donor at an American Red Cross center. She hoped it could help her aunt, Renee Bannister, who was failing after 3 weeks on a ventilator at Virtua Hospital in Voorhees, N.J.

It may have worked; 11 days after receiving the plasma, Ms. Bannister was weaned off the ventilator and she is now awake and speaking, said Red Cross spokesperson Stephanie Rendon.

This kind of anecdote is fueling demand for the therapy, which can be provided through an expanded access program led by the Mayo Clinic, backed by the FDA, and the plasma paid for by the U.S. Department of Health & Human Services. But while this program is collecting safety and outcomes data, it’s not a randomized, controlled trial.

Others, however, are pursuing that data. At least a dozen researchers are investigating the potential of plasma – both as a treatment and whether it could act as a stand-in for a vaccine until one is developed.

“One of the things I don’t want this to be is the flavor of the month,” Shmuel Shoham, MD, associate professor of medicine at Johns Hopkins University, said in an interview.

Dr. Shoham, principal investigator for a study evaluating convalescent plasma to prevent the infection in high-risk individuals, said some clinicians, desperate for any treatment, have tried potential therapies such as hydroxychloroquine and remdesivir without evidence of safety or efficacy in COVID-19.

The National Institutes of Health recently said something similar for convalescent plasma, that “there are insufficient clinical data to recommend either for or against” its use for COVID-19.

But plasma has promise, according to a Johns Hopkins School of Medicine’s Bloomberg Distinguished Professor, Arturo Casadevall, MD, PhD, in Baltimore, and Liise-anne Pirofski, MD, a professor at Albert Einstein College of Medicine, New York. They lay out the case for convalescent plasma in an article published online March 13 in the Journal of Clinical Investigation. Passive antibody therapy, they wrote, has been used to stem polio, measles, mumps, and influenza, and more recently has shown some success against SARS-CoV-1 and Middle East respiratory syndrome (MERS).

“The special attraction of this modality of treatment is that, unlike vaccines or newly developed drugs, it could, in principle, be made available very rapidly,” said researchers with the National COVID-19 Convalescent Plasma Project, which includes physicians and scientists from 57 institutions in 46 states. But where principle veers from reality is in availability of the plasma itself, and donors are in short supply.
 

Aiming to prevent infection

So far, the FDA has approved 12 plasma trials – including Dr. Shoham’s – and the NIH’s clinicaltrials.gov lists more than two dozen convalescent plasma studies in the United States and elsewhere.

Most are single-arm trials to determine if one infusion can decrease the need for intubation or help those on a ventilator improve. Two others, one at Johns Hopkins and one at Stanford (Calif.) Hospital are investigating whether convalescent plasma might be used before severe disease sets in.

“A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease,” Dr. Casadevall and Dr. Pirofski wrote.

Stanford’s randomized, double-blind study will evaluate regular versus convalescent plasma in ED patients who are not sick enough to require hospitalization.

The Johns Hopkins trial, which aims to protect against infection in the first place, will begin at Johns Hopkins, Baltimore, and at Hopkins-affiliated hospitals throughout Maryland, Dr. Shoham said. He hopes it will expand nationwide eventually, and said that they expect to enroll the first patients soon.

To start, the prevention study will enroll only 150 patients, each of whom must have had close contact with someone who has COVID-19 within the previous 120 hours and be asymptomatic. The number of subjects is small, compared with the trial size of other potential therapies, and an issue, Shoham said, “that keeps me up at night.” But finding thousands of enrollees for plasma studies is hard, in part because it’s so difficult to recruit donors.

Participants will receive normal plasma (which will act as a placebo) or convalescent plasma.

The primary endpoint is cumulative incidence of COVID-19, defined as symptoms and a polymerase chain reaction–positive test; participants will be tracked for 90 days. Hospitals and health care workers could then decide if they want to use the therapy, he said.

The study will not answer whether participants will continue to have antibodies beyond the 90 days. Convalescent plasma is given as a rapid response to an emergent pathogen – a short-term boost of immunity rather than a long-term therapeutic.
 

What can we learn from expanded access?

Meanwhile, some 2,200 hospitals are participating in the expanded access program being led by the Mayo Clinic nationwide; more than 9,000 patients had received infusions at press time.

One participant is Northwell Health, a 23-hospital system that sprawls across the U.S. COVID epicenter: four of the five boroughs of New York City and Long Island.

Convalescent plasma is an in-demand therapy, said Christina Brennan, MD, vice president of clinical research at Northwell. “We get patients, family members, they say my family member is at X hospital – if it’s not being offered there, can you have them transferred?” she said in an interview.

When Northwell – through the New York Blood Bank – opened up donor registration, 800 people signed up in the first 24 hours, Dr. Brennan said. As of mid-May, 527 patients had received a transfusion.
 

Who’s the best donor and when should donation occur?

The Red Cross, hospitals, and independent blood banks are all soliciting donors, who can sign up at the Red Cross website. The FDA recommends that donors have a history of COVID-19 as confirmed by molecular or antibody testing, be symptom free for 14 days, have a negative follow-up molecular test, and be virus free at the time of collection. The FDA also suggests measuring a donor’s SARS-CoV-2 neutralizing antibody titers, if available, with a recommendation of at least 1:160.

But questions remain, such as whether there is a theoretical risk for antibody-dependent enhancement (ADE) of infection with SARS-CoV-2. “Antibodies to one type of coronavirus could enhance infection to another viral strain,” of coronavirus, Dr. Casadevall wrote. ADE has been observed in both severe acute respiratory syndrome (SARS) and MERS.

The other risk is that donors may still be shedding active virus. While the FDA suggests that donors are unlikely to still be infectious 14 days after infection, that is as of yet unproven. Both COVID-19 diagnostics and antibody tests have high rates of false negatives, which raises the specter that infection could be spread via the plasma donation.

Daniele Focosi, MD, PhD, from Pisa (Italy) University Hospital and colleagues raise that concern in a preprint review on convalescent plasma in COVID-19. “Although the recipient is already infected, theoretically transmission of more infectious particles could worsen clinical conditions,” they wrote, noting that “such a concern can be somewhat reduced by treatment with modern pathogen inactivation techniques.”

No evidence exists that SARS-CoV-2 can be transmitted through blood, but “we don’t know for sure,” Dr. Shoham said in an interview. A reassuring point: Even those with severe infection do not have viral RNA in their blood, he said, adding, “We don’t think there’s going to be viral transmission of this particular virus with transfusion.”

For another highly infectious pathogen, the Ebola virus, the World Health Organization recommended in 2014 that potential plasma donors wait at least 28 days after infection.

It’s also not known how long SARS-CoV-2 antibodies persist in the blood; longer viability could mean a longer donation window. Dr. Focosi noted that a previous Chinese study had shown that SARS-specific antibodies in people infected with the first SARS virus, SARS-CoV-1, persisted for 2 years.

Dr. Casadevall and Dr. Pirofski have disclosed no relevant financial relationships. Shoham has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

On March 31, soon after the Food and Drug Administration authorized emergency use of antibody-packed plasma from recovered patients with COVID-19, Marisa Leuzzi became the first donor at an American Red Cross center. She hoped it could help her aunt, Renee Bannister, who was failing after 3 weeks on a ventilator at Virtua Hospital in Voorhees, N.J.

It may have worked; 11 days after receiving the plasma, Ms. Bannister was weaned off the ventilator and she is now awake and speaking, said Red Cross spokesperson Stephanie Rendon.

This kind of anecdote is fueling demand for the therapy, which can be provided through an expanded access program led by the Mayo Clinic, backed by the FDA, and the plasma paid for by the U.S. Department of Health & Human Services. But while this program is collecting safety and outcomes data, it’s not a randomized, controlled trial.

Others, however, are pursuing that data. At least a dozen researchers are investigating the potential of plasma – both as a treatment and whether it could act as a stand-in for a vaccine until one is developed.

“One of the things I don’t want this to be is the flavor of the month,” Shmuel Shoham, MD, associate professor of medicine at Johns Hopkins University, said in an interview.

Dr. Shoham, principal investigator for a study evaluating convalescent plasma to prevent the infection in high-risk individuals, said some clinicians, desperate for any treatment, have tried potential therapies such as hydroxychloroquine and remdesivir without evidence of safety or efficacy in COVID-19.

The National Institutes of Health recently said something similar for convalescent plasma, that “there are insufficient clinical data to recommend either for or against” its use for COVID-19.

But plasma has promise, according to a Johns Hopkins School of Medicine’s Bloomberg Distinguished Professor, Arturo Casadevall, MD, PhD, in Baltimore, and Liise-anne Pirofski, MD, a professor at Albert Einstein College of Medicine, New York. They lay out the case for convalescent plasma in an article published online March 13 in the Journal of Clinical Investigation. Passive antibody therapy, they wrote, has been used to stem polio, measles, mumps, and influenza, and more recently has shown some success against SARS-CoV-1 and Middle East respiratory syndrome (MERS).

“The special attraction of this modality of treatment is that, unlike vaccines or newly developed drugs, it could, in principle, be made available very rapidly,” said researchers with the National COVID-19 Convalescent Plasma Project, which includes physicians and scientists from 57 institutions in 46 states. But where principle veers from reality is in availability of the plasma itself, and donors are in short supply.
 

Aiming to prevent infection

So far, the FDA has approved 12 plasma trials – including Dr. Shoham’s – and the NIH’s clinicaltrials.gov lists more than two dozen convalescent plasma studies in the United States and elsewhere.

Most are single-arm trials to determine if one infusion can decrease the need for intubation or help those on a ventilator improve. Two others, one at Johns Hopkins and one at Stanford (Calif.) Hospital are investigating whether convalescent plasma might be used before severe disease sets in.

“A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease,” Dr. Casadevall and Dr. Pirofski wrote.

Stanford’s randomized, double-blind study will evaluate regular versus convalescent plasma in ED patients who are not sick enough to require hospitalization.

The Johns Hopkins trial, which aims to protect against infection in the first place, will begin at Johns Hopkins, Baltimore, and at Hopkins-affiliated hospitals throughout Maryland, Dr. Shoham said. He hopes it will expand nationwide eventually, and said that they expect to enroll the first patients soon.

To start, the prevention study will enroll only 150 patients, each of whom must have had close contact with someone who has COVID-19 within the previous 120 hours and be asymptomatic. The number of subjects is small, compared with the trial size of other potential therapies, and an issue, Shoham said, “that keeps me up at night.” But finding thousands of enrollees for plasma studies is hard, in part because it’s so difficult to recruit donors.

Participants will receive normal plasma (which will act as a placebo) or convalescent plasma.

The primary endpoint is cumulative incidence of COVID-19, defined as symptoms and a polymerase chain reaction–positive test; participants will be tracked for 90 days. Hospitals and health care workers could then decide if they want to use the therapy, he said.

The study will not answer whether participants will continue to have antibodies beyond the 90 days. Convalescent plasma is given as a rapid response to an emergent pathogen – a short-term boost of immunity rather than a long-term therapeutic.
 

What can we learn from expanded access?

Meanwhile, some 2,200 hospitals are participating in the expanded access program being led by the Mayo Clinic nationwide; more than 9,000 patients had received infusions at press time.

One participant is Northwell Health, a 23-hospital system that sprawls across the U.S. COVID epicenter: four of the five boroughs of New York City and Long Island.

Convalescent plasma is an in-demand therapy, said Christina Brennan, MD, vice president of clinical research at Northwell. “We get patients, family members, they say my family member is at X hospital – if it’s not being offered there, can you have them transferred?” she said in an interview.

When Northwell – through the New York Blood Bank – opened up donor registration, 800 people signed up in the first 24 hours, Dr. Brennan said. As of mid-May, 527 patients had received a transfusion.
 

Who’s the best donor and when should donation occur?

The Red Cross, hospitals, and independent blood banks are all soliciting donors, who can sign up at the Red Cross website. The FDA recommends that donors have a history of COVID-19 as confirmed by molecular or antibody testing, be symptom free for 14 days, have a negative follow-up molecular test, and be virus free at the time of collection. The FDA also suggests measuring a donor’s SARS-CoV-2 neutralizing antibody titers, if available, with a recommendation of at least 1:160.

But questions remain, such as whether there is a theoretical risk for antibody-dependent enhancement (ADE) of infection with SARS-CoV-2. “Antibodies to one type of coronavirus could enhance infection to another viral strain,” of coronavirus, Dr. Casadevall wrote. ADE has been observed in both severe acute respiratory syndrome (SARS) and MERS.

The other risk is that donors may still be shedding active virus. While the FDA suggests that donors are unlikely to still be infectious 14 days after infection, that is as of yet unproven. Both COVID-19 diagnostics and antibody tests have high rates of false negatives, which raises the specter that infection could be spread via the plasma donation.

Daniele Focosi, MD, PhD, from Pisa (Italy) University Hospital and colleagues raise that concern in a preprint review on convalescent plasma in COVID-19. “Although the recipient is already infected, theoretically transmission of more infectious particles could worsen clinical conditions,” they wrote, noting that “such a concern can be somewhat reduced by treatment with modern pathogen inactivation techniques.”

No evidence exists that SARS-CoV-2 can be transmitted through blood, but “we don’t know for sure,” Dr. Shoham said in an interview. A reassuring point: Even those with severe infection do not have viral RNA in their blood, he said, adding, “We don’t think there’s going to be viral transmission of this particular virus with transfusion.”

For another highly infectious pathogen, the Ebola virus, the World Health Organization recommended in 2014 that potential plasma donors wait at least 28 days after infection.

It’s also not known how long SARS-CoV-2 antibodies persist in the blood; longer viability could mean a longer donation window. Dr. Focosi noted that a previous Chinese study had shown that SARS-specific antibodies in people infected with the first SARS virus, SARS-CoV-1, persisted for 2 years.

Dr. Casadevall and Dr. Pirofski have disclosed no relevant financial relationships. Shoham has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A handful of specialties – including family medicine, obstetrics/gynecology, pediatrics, and other primary care specialties – are calling for targeted and urgent relief payments from the federal government, saying that they have been left out of distributions aimed at alleviating the financial fallout associated with the novel coronavirus.

The federal government has already distributed about $150 billion – through direct payments and advances on reimbursement – to clinicians, but, to date, the money has only been given to providers who bill Medicare, and not even all of those individuals have received payments.

“It is critical that frontline physicians who may not participate in Medicare fee-for-service, in whole or in part, including obstetrician/gynecologists, pediatricians, and family physicians, have the resources they need to continue providing essential health care to patients amid the pandemic and in the months to come,” said the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists in a letter to Health & Human Services (Secretary Alex Azar.

In particular, the organizations are concerned that no money has been distributed or earmarked for clinicians who serve Medicaid recipients.

“The organizations that signed that letter are the primary providers of care to the Medicaid population,” Shawn Martin, senior VP for the AAFP, said in an interview. That’s true even for family physicians.

“Typically, in an average family medicine practice, their Medicaid panel size is equal to if not greater than the Medicare panel size,” he said.

On April 23, Mr. Azar said HHS was working on a distribution plan for providers who only take Medicaid, as well as for dentists and skilled nursing facilities. An HHS spokesperson confirmed that the agency still intends to provide money to those groups of providers and that the agency is committed to distributing funds quickly and with transparency.

Mr. Azar had also announced that the government would soon start distributing $20 billion in payments to Medicare providers, on top of the $30 billion that had already been handed out to clinicians on April 10 and 17.

That $50 billion came from the COVID-19–related $100 billion Provider Relief Fund, which was part of the Coronavirus Aid, Relief, and Economic Security Act, signed into law on March 27.

Additionally, the Centers for Medicare & Medicaid Services had distributed some $100 billion to providers who participated in Medicare Part A or B through the Medicare Advance Payment program, which is a deferred loan. The agency brought that program to a halt on April 27.

An additional $75 billion will now be available through the Public Health and Social Services Emergency Fund (PHSSEF) as part of the third congressional COVID relief package, signed into law on April 24.

Mr. Martin said that the AAFP and other physician organizations have been talking with HHS about how to distribute money from that new pool of funds. “There’s been a lot of progress, but there hasn’t been any action,” he said, adding that the purpose of the joint letter to HHS “is to say it’s time for action.”
 

COVID-19 damage

AAFP, AAP, and ACOG noted in the letter the damage that’s being inflicted by COVID-19. They cited data that show a 50% decline in measles, mumps, and rubella shots, a 42% drop in diphtheria and whooping cough vaccinations, and a 73% decline in human papillomavirus shots. The groups also noted a rise in child abuse injuries that are being seen in EDs and the potential for a worsening of the maternal mortality crisis in the United States.

Primary care physicians are also the go-to doctors for upper respiratory infections, noted the groups in the letter.

“Put simply, our physician members need to be able to keep their doors open and continue treating patients,” said the groups.

A study by Harvard University and Phreesia, a health care technology company, found that ambulatory practice visits had declined by at least half since early February, with a 71% drop in visits by 7- to 17-year-olds and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Research conducted by the Physicians Foundation and Merritt Hawkins shows that 21% of 842 physicians who responded to an early April survey said they’d been furloughed or been given a pay cut. That number rose to 30% among doctors who are not treating COVID-19 patients.

Although the majority in the survey (66%) said they planned to keep practicing in the same manner during the pandemic, 32% said they planned to change practices, opt out of patient care roles, close their practices temporarily, or retire. The survey has a margin of error of ±3.5%.
 

Internists seek consideration, too

The American College of Physicians also has urged HHS to give special consideration to its members. The group wrote to Mr. Azar on April 28, recommending that payments from the new $75 billion PHSSEF be prioritized for primary care, as well as for smaller practices, those that provide care in underserved areas, and internal medicine subspecialty practices.

“Internal medicine specialists and other primary care physicians have an essential role in delivering primary, preventive, and comprehensive care not only to patients with symptoms or diagnoses of COVID-19, but also to patients with other underlying medical conditions, including conditions like heart disease and diabetes that put them at greater risk of mortality from COVID-19,” wrote ACP President Jacqueline Fincher, MD, MACP.

ACP said the government could pay physicians on the basis of the amount of additional expenses incurred that were related to COVID-19, such as extra staffing or temporary relocation of their place of residence to prevent exposing family members to the virus. Pay should also be based on the percentage of revenue losses from all payers, including Medicare, Medicaid, and commercial insurers, Dr. Fincher said in the letter.

AAFP, AAP, and ACOG also had a suggestion for distributing payments to non-Medicare providers. “Given that most women’s health, pediatric, and family practices have received less financial relief to date, we recommend that HHS provide these practices with a larger proportion of funds relative to their reported revenue than is provided on average across specialties,” they wrote.

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

A handful of specialties – including family medicine, obstetrics/gynecology, pediatrics, and other primary care specialties – are calling for targeted and urgent relief payments from the federal government, saying that they have been left out of distributions aimed at alleviating the financial fallout associated with the novel coronavirus.

The federal government has already distributed about $150 billion – through direct payments and advances on reimbursement – to clinicians, but, to date, the money has only been given to providers who bill Medicare, and not even all of those individuals have received payments.

“It is critical that frontline physicians who may not participate in Medicare fee-for-service, in whole or in part, including obstetrician/gynecologists, pediatricians, and family physicians, have the resources they need to continue providing essential health care to patients amid the pandemic and in the months to come,” said the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists in a letter to Health & Human Services (Secretary Alex Azar.

In particular, the organizations are concerned that no money has been distributed or earmarked for clinicians who serve Medicaid recipients.

“The organizations that signed that letter are the primary providers of care to the Medicaid population,” Shawn Martin, senior VP for the AAFP, said in an interview. That’s true even for family physicians.

“Typically, in an average family medicine practice, their Medicaid panel size is equal to if not greater than the Medicare panel size,” he said.

On April 23, Mr. Azar said HHS was working on a distribution plan for providers who only take Medicaid, as well as for dentists and skilled nursing facilities. An HHS spokesperson confirmed that the agency still intends to provide money to those groups of providers and that the agency is committed to distributing funds quickly and with transparency.

Mr. Azar had also announced that the government would soon start distributing $20 billion in payments to Medicare providers, on top of the $30 billion that had already been handed out to clinicians on April 10 and 17.

That $50 billion came from the COVID-19–related $100 billion Provider Relief Fund, which was part of the Coronavirus Aid, Relief, and Economic Security Act, signed into law on March 27.

Additionally, the Centers for Medicare & Medicaid Services had distributed some $100 billion to providers who participated in Medicare Part A or B through the Medicare Advance Payment program, which is a deferred loan. The agency brought that program to a halt on April 27.

An additional $75 billion will now be available through the Public Health and Social Services Emergency Fund (PHSSEF) as part of the third congressional COVID relief package, signed into law on April 24.

Mr. Martin said that the AAFP and other physician organizations have been talking with HHS about how to distribute money from that new pool of funds. “There’s been a lot of progress, but there hasn’t been any action,” he said, adding that the purpose of the joint letter to HHS “is to say it’s time for action.”
 

COVID-19 damage

AAFP, AAP, and ACOG noted in the letter the damage that’s being inflicted by COVID-19. They cited data that show a 50% decline in measles, mumps, and rubella shots, a 42% drop in diphtheria and whooping cough vaccinations, and a 73% decline in human papillomavirus shots. The groups also noted a rise in child abuse injuries that are being seen in EDs and the potential for a worsening of the maternal mortality crisis in the United States.

Primary care physicians are also the go-to doctors for upper respiratory infections, noted the groups in the letter.

“Put simply, our physician members need to be able to keep their doors open and continue treating patients,” said the groups.

A study by Harvard University and Phreesia, a health care technology company, found that ambulatory practice visits had declined by at least half since early February, with a 71% drop in visits by 7- to 17-year-olds and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Research conducted by the Physicians Foundation and Merritt Hawkins shows that 21% of 842 physicians who responded to an early April survey said they’d been furloughed or been given a pay cut. That number rose to 30% among doctors who are not treating COVID-19 patients.

Although the majority in the survey (66%) said they planned to keep practicing in the same manner during the pandemic, 32% said they planned to change practices, opt out of patient care roles, close their practices temporarily, or retire. The survey has a margin of error of ±3.5%.
 

Internists seek consideration, too

The American College of Physicians also has urged HHS to give special consideration to its members. The group wrote to Mr. Azar on April 28, recommending that payments from the new $75 billion PHSSEF be prioritized for primary care, as well as for smaller practices, those that provide care in underserved areas, and internal medicine subspecialty practices.

“Internal medicine specialists and other primary care physicians have an essential role in delivering primary, preventive, and comprehensive care not only to patients with symptoms or diagnoses of COVID-19, but also to patients with other underlying medical conditions, including conditions like heart disease and diabetes that put them at greater risk of mortality from COVID-19,” wrote ACP President Jacqueline Fincher, MD, MACP.

ACP said the government could pay physicians on the basis of the amount of additional expenses incurred that were related to COVID-19, such as extra staffing or temporary relocation of their place of residence to prevent exposing family members to the virus. Pay should also be based on the percentage of revenue losses from all payers, including Medicare, Medicaid, and commercial insurers, Dr. Fincher said in the letter.

AAFP, AAP, and ACOG also had a suggestion for distributing payments to non-Medicare providers. “Given that most women’s health, pediatric, and family practices have received less financial relief to date, we recommend that HHS provide these practices with a larger proportion of funds relative to their reported revenue than is provided on average across specialties,” they wrote.

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

A handful of specialties – including family medicine, obstetrics/gynecology, pediatrics, and other primary care specialties – are calling for targeted and urgent relief payments from the federal government, saying that they have been left out of distributions aimed at alleviating the financial fallout associated with the novel coronavirus.

The federal government has already distributed about $150 billion – through direct payments and advances on reimbursement – to clinicians, but, to date, the money has only been given to providers who bill Medicare, and not even all of those individuals have received payments.

“It is critical that frontline physicians who may not participate in Medicare fee-for-service, in whole or in part, including obstetrician/gynecologists, pediatricians, and family physicians, have the resources they need to continue providing essential health care to patients amid the pandemic and in the months to come,” said the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists in a letter to Health & Human Services (Secretary Alex Azar.

In particular, the organizations are concerned that no money has been distributed or earmarked for clinicians who serve Medicaid recipients.

“The organizations that signed that letter are the primary providers of care to the Medicaid population,” Shawn Martin, senior VP for the AAFP, said in an interview. That’s true even for family physicians.

“Typically, in an average family medicine practice, their Medicaid panel size is equal to if not greater than the Medicare panel size,” he said.

On April 23, Mr. Azar said HHS was working on a distribution plan for providers who only take Medicaid, as well as for dentists and skilled nursing facilities. An HHS spokesperson confirmed that the agency still intends to provide money to those groups of providers and that the agency is committed to distributing funds quickly and with transparency.

Mr. Azar had also announced that the government would soon start distributing $20 billion in payments to Medicare providers, on top of the $30 billion that had already been handed out to clinicians on April 10 and 17.

That $50 billion came from the COVID-19–related $100 billion Provider Relief Fund, which was part of the Coronavirus Aid, Relief, and Economic Security Act, signed into law on March 27.

Additionally, the Centers for Medicare & Medicaid Services had distributed some $100 billion to providers who participated in Medicare Part A or B through the Medicare Advance Payment program, which is a deferred loan. The agency brought that program to a halt on April 27.

An additional $75 billion will now be available through the Public Health and Social Services Emergency Fund (PHSSEF) as part of the third congressional COVID relief package, signed into law on April 24.

Mr. Martin said that the AAFP and other physician organizations have been talking with HHS about how to distribute money from that new pool of funds. “There’s been a lot of progress, but there hasn’t been any action,” he said, adding that the purpose of the joint letter to HHS “is to say it’s time for action.”
 

COVID-19 damage

AAFP, AAP, and ACOG noted in the letter the damage that’s being inflicted by COVID-19. They cited data that show a 50% decline in measles, mumps, and rubella shots, a 42% drop in diphtheria and whooping cough vaccinations, and a 73% decline in human papillomavirus shots. The groups also noted a rise in child abuse injuries that are being seen in EDs and the potential for a worsening of the maternal mortality crisis in the United States.

Primary care physicians are also the go-to doctors for upper respiratory infections, noted the groups in the letter.

“Put simply, our physician members need to be able to keep their doors open and continue treating patients,” said the groups.

A study by Harvard University and Phreesia, a health care technology company, found that ambulatory practice visits had declined by at least half since early February, with a 71% drop in visits by 7- to 17-year-olds and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Research conducted by the Physicians Foundation and Merritt Hawkins shows that 21% of 842 physicians who responded to an early April survey said they’d been furloughed or been given a pay cut. That number rose to 30% among doctors who are not treating COVID-19 patients.

Although the majority in the survey (66%) said they planned to keep practicing in the same manner during the pandemic, 32% said they planned to change practices, opt out of patient care roles, close their practices temporarily, or retire. The survey has a margin of error of ±3.5%.
 

Internists seek consideration, too

The American College of Physicians also has urged HHS to give special consideration to its members. The group wrote to Mr. Azar on April 28, recommending that payments from the new $75 billion PHSSEF be prioritized for primary care, as well as for smaller practices, those that provide care in underserved areas, and internal medicine subspecialty practices.

“Internal medicine specialists and other primary care physicians have an essential role in delivering primary, preventive, and comprehensive care not only to patients with symptoms or diagnoses of COVID-19, but also to patients with other underlying medical conditions, including conditions like heart disease and diabetes that put them at greater risk of mortality from COVID-19,” wrote ACP President Jacqueline Fincher, MD, MACP.

ACP said the government could pay physicians on the basis of the amount of additional expenses incurred that were related to COVID-19, such as extra staffing or temporary relocation of their place of residence to prevent exposing family members to the virus. Pay should also be based on the percentage of revenue losses from all payers, including Medicare, Medicaid, and commercial insurers, Dr. Fincher said in the letter.

AAFP, AAP, and ACOG also had a suggestion for distributing payments to non-Medicare providers. “Given that most women’s health, pediatric, and family practices have received less financial relief to date, we recommend that HHS provide these practices with a larger proportion of funds relative to their reported revenue than is provided on average across specialties,” they wrote.

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

There has been a massive decline in outpatient office visits as patients have stayed home – likely deferring needed care – because of COVID-19, new research shows.

The number of visits to ambulatory practices dropped by a whopping 60% in mid-March, and continues to be down by at least 50% since early February, according to new data compiled and analyzed by Harvard University and Phreesia, a health care technology company.

Phreesia – which helps medical practices with patient registration, insurance verification, and payments – has data on 50,000 providers in all 50 states; in a typical year, Phreesia tracks 50 million outpatient visits.

The report was published online April 23 by the Commonwealth Fund.

The company captured data on visits from February 1 through April 16. The decline was greatest in New England and the Mid-Atlantic states, where, at the steepest end of the decline in late March, visits were down 66%.

They have rebounded slightly since then but are still down 64%. Practices in the mountain states had the smallest decline, but visits were down by 45% as of April 16.

Many practices have attempted to reach out to patients through telemedicine. As of April 16, about 30% of all visits tracked by Phreesia were provided via telemedicine – by phone or through video. That’s a monumental increase from mid-February, when zero visits were conducted virtually.

However, the Harvard researchers found that telemedicine visits barely made up for the huge decline in office visits.
 

Decline by specialty

Not surprisingly, declining visits have been steeper in procedure-oriented specialties.

Overall visits – including telemedicine – to ophthalmologists and otolaryngologists had declined by 79% and 75%, respectively, as of the week of April 5. Dermatology saw a 73% decline. Surgery, pulmonology, urology, orthopedics, cardiology, and gastroenterology all experienced declines ranging from 61% to 66%.

Primary care offices, oncology, endocrinology, and obstetrics/gynecology all fared slightly better, with visits down by half. Behavioral health experienced the lowest rate of decline (30%).

School-aged children were skipping care most often. The study showed a 71% drop in visits in 7- to 17-year-olds, and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Nearly two-thirds of Americans over age 65 also stayed away from their doctors. Only half of those aged 18 to 64 reduced their physician visits.

This article first appeared on Medscape.com.

There has been a massive decline in outpatient office visits as patients have stayed home – likely deferring needed care – because of COVID-19, new research shows.

The number of visits to ambulatory practices dropped by a whopping 60% in mid-March, and continues to be down by at least 50% since early February, according to new data compiled and analyzed by Harvard University and Phreesia, a health care technology company.

Phreesia – which helps medical practices with patient registration, insurance verification, and payments – has data on 50,000 providers in all 50 states; in a typical year, Phreesia tracks 50 million outpatient visits.

The report was published online April 23 by the Commonwealth Fund.

The company captured data on visits from February 1 through April 16. The decline was greatest in New England and the Mid-Atlantic states, where, at the steepest end of the decline in late March, visits were down 66%.

They have rebounded slightly since then but are still down 64%. Practices in the mountain states had the smallest decline, but visits were down by 45% as of April 16.

Many practices have attempted to reach out to patients through telemedicine. As of April 16, about 30% of all visits tracked by Phreesia were provided via telemedicine – by phone or through video. That’s a monumental increase from mid-February, when zero visits were conducted virtually.

However, the Harvard researchers found that telemedicine visits barely made up for the huge decline in office visits.
 

Decline by specialty

Not surprisingly, declining visits have been steeper in procedure-oriented specialties.

Overall visits – including telemedicine – to ophthalmologists and otolaryngologists had declined by 79% and 75%, respectively, as of the week of April 5. Dermatology saw a 73% decline. Surgery, pulmonology, urology, orthopedics, cardiology, and gastroenterology all experienced declines ranging from 61% to 66%.

Primary care offices, oncology, endocrinology, and obstetrics/gynecology all fared slightly better, with visits down by half. Behavioral health experienced the lowest rate of decline (30%).

School-aged children were skipping care most often. The study showed a 71% drop in visits in 7- to 17-year-olds, and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Nearly two-thirds of Americans over age 65 also stayed away from their doctors. Only half of those aged 18 to 64 reduced their physician visits.

This article first appeared on Medscape.com.

There has been a massive decline in outpatient office visits as patients have stayed home – likely deferring needed care – because of COVID-19, new research shows.

The number of visits to ambulatory practices dropped by a whopping 60% in mid-March, and continues to be down by at least 50% since early February, according to new data compiled and analyzed by Harvard University and Phreesia, a health care technology company.

Phreesia – which helps medical practices with patient registration, insurance verification, and payments – has data on 50,000 providers in all 50 states; in a typical year, Phreesia tracks 50 million outpatient visits.

The report was published online April 23 by the Commonwealth Fund.

The company captured data on visits from February 1 through April 16. The decline was greatest in New England and the Mid-Atlantic states, where, at the steepest end of the decline in late March, visits were down 66%.

They have rebounded slightly since then but are still down 64%. Practices in the mountain states had the smallest decline, but visits were down by 45% as of April 16.

Many practices have attempted to reach out to patients through telemedicine. As of April 16, about 30% of all visits tracked by Phreesia were provided via telemedicine – by phone or through video. That’s a monumental increase from mid-February, when zero visits were conducted virtually.

However, the Harvard researchers found that telemedicine visits barely made up for the huge decline in office visits.
 

Decline by specialty

Not surprisingly, declining visits have been steeper in procedure-oriented specialties.

Overall visits – including telemedicine – to ophthalmologists and otolaryngologists had declined by 79% and 75%, respectively, as of the week of April 5. Dermatology saw a 73% decline. Surgery, pulmonology, urology, orthopedics, cardiology, and gastroenterology all experienced declines ranging from 61% to 66%.

Primary care offices, oncology, endocrinology, and obstetrics/gynecology all fared slightly better, with visits down by half. Behavioral health experienced the lowest rate of decline (30%).

School-aged children were skipping care most often. The study showed a 71% drop in visits in 7- to 17-year-olds, and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Nearly two-thirds of Americans over age 65 also stayed away from their doctors. Only half of those aged 18 to 64 reduced their physician visits.

This article first appeared on Medscape.com.

The dermatologist had been in practice just a few years when he was approached by a private equity group. This was around 2015, when dermatology was just starting to buzz about investor buyouts. He was curious, so he agreed to meet with the company.

“They approached me with the idea that they could help me grow my practice, help my patients, and cut down overhead,” said the northern Alabama dermatologist, who asked that his name not be used. Over a lavish dinner, the investors lauded the clinician for his business acumen and for having built a great practice so quickly. They made an enticing buyout offer.

Ja_inter/DigitalVision Vectors

Salvation or death sentence?

Depending on whom you ask, the continuing growth of private equity purchases of dermatology practices is either the death – or salvation – of the specialty.

Many dermatologists question whether the financial backers will invest in quality of care, or if they just will hire mid-level providers to churn out procedures to plump up revenues.

Neither the controversy nor the acquisitions show any sign of abating.

The American Academy of Dermatology has hosted debates on the topic at its annual meetings – and was to do so in 2020 until COVID-19 led to the meeting’s cancellation. AAD has not weighed in with any official policy and is not releasing data it may be collecting on the potential impact of private equity ownership. The organization provided a statement from President George J. Hruza, MD, who said, “the AAD supports a member’s right to choose the model that works best for them,” adding that the Academy “expects its members to provide safe and effective patient care, regardless of a dermatologist’s practice setting.” Dr. Hruza sold his Chesterfield, Mo., practice to United Skin Specialists, a private equity–backed company, in 2016, and still works at the same practice.

Some have said the acquisitions need to stop. “Until meaningful data are available on what happens to the quality of care and affordability for patients and payers, dermatologists should stop selling their practices to private equity firms, and legislators should prohibit such transactions,” wrote Joshua M. Sharfstein, MD, and Jamar Slocum, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an editorial in July (JAMA Dermatol. 2019;155[9]:1007-8).

Although he acknowledged that he has not tracked the issue closely and that little data exist on the impact on quality or cost, Dr. Sharfstein has not changed his tune. “I think there are enough warning signs to say we should put the brakes on,” he said in an interview.

“For what reason?” asked Betsy Wernli, MD, president of Forefront Dermatology, an investor-owned group based in Manitowoc, Wis. She said it seems that “on this topic, we abandon our scientific foundations and default to emotion and anecdote,” she said in an interview. “Having capital, and an investor that supports us has allowed us to perform better patient care,” she said. Dermatologist variance across all practices and practice models should be cause for more concern, she added.

Sailesh Konda, MD, has been an outspoken critic. Dr. Konda, medical director and clinical assistant professor in the department of dermatology at the University of Florida, Gainesville, and colleagues detailed the complicated financial machinations of private equity in the Journal of the American Academy of Dermatology. They showed that private investors seemed to hone in on buying outlier practices that performed high numbers of procedures. The paper – first made public in the fall of 2018 – created an uproar, especially among private equity companies. It was initially removed from the website in conjunction with a request from the editor that its conclusions be altered to be less harsh on private equity, according to the New York Times. The paper was eventually published in 2019 (J Am Acad Dermatol. Jul;81[1]:287-296.e8).

Dr. Konda has spoken at various dermatology forums and health care gatherings on private equity. He told the Times that he had given 16 talks to health care groups in 2018, and he was due to speak to a health care investors’ group in 2020. But he would not comment on the record for this story.

Brett Coldiron, MD, a former president of the AAD, also has been critical. He believes investor-owners push for more biopsies, freezing of actinic keratoses, Moh’s surgery, and other well-paying procedures. “I’m convinced that private equity may be the undoing of our specialty,” Dr. Coldiron said in an interview.

In a paper titled, “Private Equity Acquisition of Physician Practices,” published in the Annals of Internal Medicine in January 2019, Lawrence Casalino, MD, PhD, chief of the division of health policy and economics at New York’s Weill Cornell Medicine, and colleagues wrote that “private equity firms focus on specialties with high potential for additional income from elective procedures and ancillary services,” and that “dermatology has been a major focus” (Ann Intern Med. 2019;170[2]:114-5).

And in a viewpoint published in JAMA in February 2019, first-year medical student Suhas Gondi and Zirui Song, MD, PhD, both of Harvard Medical School, Boston, concluded that investor-owned practices could drive up overall health spending in part because they extract better reimbursement from insurers (JAMA. 2019;321[11]:1047-8).

Access could also become an issue if the companies drive smaller independent practices out of business, they wrote.

On the other hand, they said, “these investments may also benefit patients and bring more efficiency to a system burdened with waste.” The authors called for more research and “thoughtful regulation” to enhance the potential positives while mitigating the negatives.

So far, the acquisitions have largely escaped the notice of regulators or lawmakers. Congress has made noises about targeting specialty practices owned by private equity as a means of taming surprise medical bills, but that legislation has been stymied.

Dr. Coldiron is convinced that private investors will eventually be tripped up by state laws that prohibit the corporate practice of medicine.

Leslie Baumann, MD, who sold her Miami practice in October 2019 to the investor-owned Skin and Cancer Associates, said critics are too cynical. “What if these private equity firms are going to actually make our specialty better?” she asked in an interview.

What makes dermatology attractive?

Private equity has been acquiring specialty practices since at least 2009, with an acceleration over the last 5 years. Dermatology has been a frequent target, in part because so many dermatologists were in independent or small group private practices, making them ripe for takeover.

A 2015 report on the specialty by Cegedim, a company that provides information technology support to health care, found that the majority of practices had fewer than five physicians and that 57% of the practices were independent.

But more dermatologists are choosing employment. In a 2018 Medscape survey, 57% of dermatologists reported they were employed, while 49% were self-employed.

During 2013-2016, investors bought 35 dermatology practices – comprising 334 physicians, according to one study published in February (JAMA. 2020;323[7]:663-5). Investors bought 69 anesthesiology practices, 43 emergency medicine practices, and 39 family medicine practices during the same period.

Harvard’s Mr. Gondi and Dr. Song estimated that dermatology practices accounted for 15% of investor purchases in 2015 and 2016, even though dermatologists make up just 1% of U.S. clinicians.

In another paper published in JAMA Dermatology, Sally Tan, MD, and colleagues at Brigham and Women’s Hospital, Boston, and Harvard medical and business schools, estimated that, in 2019, at least 184 practices, comprising 381 clinics, were owned by 17 private equity groups and that the acquisitions had been accelerating: from 5 in 2012 to 59 in 2017 to 34 in the first 5 months of 2018 (JAMA Dermatol. 2019;155[9]:1013-21).

“It’s a very attractive area for investors because they know that the future is bright for dermatology,” said Reuven Porges, MD, CEO of Ft. Lauderdale-based Skin and Cancer Associates, which is owned by a private investor. Because dermatology involves providing many ancillary services and cash-only cosmetic services, “it has tremendous potential to continue to be successful in the future regardless of what health care changes are coming,” Dr. Porges said in an interview.

Investors also see promise in dermatology in the United States because “there’s a huge supply demand mismatch,” said Vance Vanier, MD, a cofounding managing partner at Chicago Pacific Founders, the private equity owner of Pinnacle Dermatology, which has 52 locations in Illinois, Indiana, Michigan, Minnesota, and Tennessee.

Theoretically, when investors handle billing, insurance negotiations, and health information technology, it gives clinicians more time to practice, Dr. Vanier said in an interview.

“Once that doctor is freed up to not do administrative tasks and focus on patient care, then, if they want to, they can see more patients and be more responsive to their needs,” he said.

Dr. Vanier said investor acquisitions are here to stay. “This is a trend that could go on for another 50 years before any saturation point is hit,” he said. “It’s a $2 trillion market. It’s hard to wrap your head around how enormous health care services is,” he said.

Dermatology acquisitions will be driven by the continuing imbalance of physician supply and patient demand; the financial pressure on newly graduating physicians who have big debt loads; the requirements for investment in health information technology to report quality metrics; and an aging population, Dr. Vanier said.

In a JAMA Dermatology viewpoint, Jack Resneck Jr., MD, professor of dermatology, University of California, San Francisco, listed many of the same factors – plus a skin cancer epidemic – as fueling dermatology acquisitions (JAMA Dermatol. 2018;154[1]:13-4).

Medical practices – not just dermatology practices – also offer a pure financial play. “Acquisitions of smaller practices provide a major arbitrage opportunity,” Dr. Casalino and colleagues said in the January 2019 Annals of Internal Medicine paper. In a merger of smaller practices into larger, the smaller practice’s valuation immediately becomes that of the bigger one, they wrote.
 

Could the bottom fall out?

Creating giant groups through consolidation is a main aim for private equity.

Skin and Cancer Associates, founded in 1971, was a large entity, with 25 practices. But for a long time, its leaders had wanted to become a regional or a national player, said Dr. Porges. Those leaders asked Dr. Porges – who helped take his former radiology practice through a private equity purchase – to help them attract investors. In March 2018, Susquehanna Private Capital signed on as a “partner” with Skin and Cancer Associates.

It has since almost doubled in size, with 40 locations and 60 dermatologists, all in Florida, Dr. Porges said. “The only limiting factor for growing it as fast as we want, is really money,” he said.

Consolidation is just an initial step. Most investors have a finite timeline for cashing out. “The ultimate goal is often to realize a profitable secondary sale in three to seven years to another PE investor (or even a publicly traded entity),” Dr. Resneck wrote in the 2018 JAMA Dermatology paper.

Not all private equity companies are the same, said Dr. Wernli, of Forefront. Dermatologists can investigate a company’s “hold period” – how long they keep an investment before trading – and the strength of its capitalization before deciding to sell, she said.

Since 2016, Forefront has been owned by the Ontario Municipal Employee Retirement System (OMERS), a pension fund for the province’s public workers. OMERS bought Forefront from Varsity Healthcare Partners, which had owned the dermatology group for just 2 years.

Dr. Wernli said OMERS is a good, solid investor. “They have unlimited resources to invest so they don’t have to quickly flip a company to satisfy an investment in another company,” she said.

Some investor-backed dermatology practices have gone belly up. In 2012, WestWind Investors bought DermOne, based in Toms River, N.J. But by early 2018, the business had fallen apart, and some practices – in North Carolina, New Jersey, Texas, and Virginia – just shut their doors.

Long Island City, N.Y.–based Schweiger Dermatology Group, backed by private equity, snapped up nine of the New Jersey DermOne practices in March 2018.

Another private equity–backed company, U.S. Dermatology Partners, defaulted on a $377 million loan in January 2020. As reported by Bloomberg, the company had $340 million in revenue in 2018. U.S. Dermatology’s owners are reportedly working out a recapitalization or debt-for-equity swap with the lenders.

Dr. Wernli said that financial problems aren’t unique to investor-owned practices and that doctors could still be out of a job if a private practice goes under.

“A private practice can also default on their loans that they’ve used to fund their own personal practice, leaving employed physicians in the same situation,” she said.

Patients are likely to be in the dark, however, until the doors close.

Pressure on practices

Private equity is changing the shape of practice for both those who work for investor-owned businesses and those still out on their own.

The Alabama dermatologist, for instance, said it has made it harder for him to recruit new doctors, who are offered big signing bonuses and a steady income by the investor-owned practices. “They’re skewing the numbers,” he said, adding that residents are now expecting a big payment and benefits.

Dr. Baumann said that when she was on her own, she had trouble finding and recruiting good dermatologists. But it has become easier since she’d sold to Skin and Cancer Associates, she said, noting that Dr. Porges recently found a qualified candidate for her to interview a week after she put in a request.

Another dermatologist in a Midwestern metropolitan practice – who did not want his name used – said that when it came time for him to increase his equity stake, his older partner, who was near retirement and had explored selling to private equity – wanted four-and-a-half times the price that had been discussed when he joined the practice.

The younger partner believes the private equity offers inflated the practice’s valuation in his partner’s mind. He ended up leaving the practice.

Many dermatologists have been led to believe that their practices are worth more than they might be, according to Dr. Coldiron. “I think a lot of these doctors that sell out are deluded. They think that they’re getting a lot of money and they’re not,” he said.

Typically, investors may offer three or four times earnings before interest, taxes, depreciation and amortization (EBITDA). The money paid out is taxed at the capital gains rate, which provides some savings. “But you have to pay that all back, because when they sign you up, you become an employee,” Dr. Coldiron said.

Doctors often agree to work for 5 years, but during that period, their base salary is decreased while the buyout cash is meted out to them, he added. A chunk of the buyout usually is also given as equity, but that equity is worthless unless the investor sells to another entity.

Pinnacle Dermatology doesn’t want doctors to retire immediately upon an acquisition, said Dr. Vanier of Chicago Pacific Founders. “We want to find physician partners who want to keep working,” he said. “We strongly believe if you don’t have strong physician leadership, experienced physician leadership, that your odds of success go down.”

Chicago Pacific also believes physicians should have an ownership interest, he said. It allows them to share in the eventual financial rewards – whether that’s 5 or 20 years later, said Dr. Vanier.

Dr. Coldiron sees other pressures that skew practice styles and can harm patient care. Clinicians in investor-owned practices are often urged to refer all dermatopathology to labs owned by the practice and often, a Moh’s surgeon is employed to service all the practices – sometimes even being flown in from elsewhere, he claimed.

That takes away the clinician’s autonomy in terms of referring where he or she feels appropriate and also could harm pathologists and Moh’s surgeons that depend on those referral streams, he added.

In their paper, Mr. Gondi and Dr. Song wrote that this practice is concerning because “keeping referrals within the practice may render referral patterns less responsive to patient needs or preference.”
 

Procedure factories?

Many critics say investor-backed practices are goosing revenues by hiring more mid-level providers – such as nurse practitioners and physician assistants – and getting them to perform more procedures.

Midlevel practitioners do more biopsies than dermatologists do to get a diagnosis, according to Dr. Coldiron.

A 2018 JAMA Dermatology study appears to back that up. Physician assistants needed to conduct 3.9 biopsies to diagnose one skin cancer, compared to 3.3 for dermatologists. For a single melanoma, the number needed to biopsy was 39.4 for PAs and 25.4 for dermatologists (JAMA Dermatol. 2018;154[5]:569-73).

Skin biopsies have almost doubled in the last decade, said Dr. Coldiron. “The skin cancer epidemic would account for only half of that,” he said.

“The ultimate loser is the patient – because the patient doesn’t get the highest quality care and the patient has unnecessary things done to him or her,” he said. But, he said, he could not directly tie the biopsy increase to the rise of private equity.

Forefront tracks the number of biopsies per patient done by every dermatologist in its network – to make sure that no one is outside the norms set by the Centers for Medicare and Medicaid Services, said Dr. Wernli. And she said biopsies declined after the group was bought by private equity.

Dr. Baumann said the average number of biopsies per patient at Skin and Cancer Associates in 2019 was 0.20 – less than the 0.30 average reported by Medicare that same year.

The rising use of mid-level providers existed long before private equity came on the scene, said Dr. Wernli. “There’s not enough board-certified dermatologists to satisfy need,” she said, noting that, in addition, many clinicians won’t serve rural areas. “If we don’t move and extend ourselves, there will be someone who fills our shoes,” she said, adding that Forefront has 1 mid-level for every 1.5 to 2 dermatologists.

Skin and Cancer Associates has 55 doctors and 29 physician assistants, said Dr. Baumann, adding that she had not been pressured to add any mid-level providers to her practice.
 

Excitement about sale shot down

Dr. Wernli and Dr. Baumann both have been happy with their decision to ally with private equity. For Dr. Baumann, however, her move was tinged by online attacks that reflected the strong opinions on the topic.

She began looking into selling her practice when one of her businesses – Skin Type Solutions – began taking off. Both her clinical practice and research business were thriving. She had two children at home and was having a hard time keeping up with the administrative end of her businesses.

None of her partners nor any groups in Miami showed interest in purchasing the practice, so she began researching private equity. She spoke with seven companies before settling on Skin and Cancer Associates. They had “a long track record of successfully running practices,” said Dr. Baumann, adding that “the doctors who work there are happy, and I respect the quality of the physicians and the organization.”

When she closed the deal in October 2019, she agreed to stay on for 5 years and signed a noncompete clause that she deems “very reasonable.” Among the perks she cites: being able to consult via telemedicine with an expert on pigmented lesions; quick and easy referrals to a Moh’s surgeon; being able to train residents; and having paid personal time off.

It’s less responsibility and the same or better job satisfaction, she said.

But when she shared the news on a private Facebook group for board-certified dermatologists, she was vilified. Of some 195 comments, about half were “mean,” said Dr. Baumann.

“I was shocked about how strongly everybody feels,” she said. Those commenting accused her of doing it for the money or said that her move was contributing to the ruination of dermatology.

“I just defended myself,” she said. “For me, it was my time.”

Dr. Coldiron and Dr. Baumann are members of the Dermatology News editorial advisory board.

The dermatologist had been in practice just a few years when he was approached by a private equity group. This was around 2015, when dermatology was just starting to buzz about investor buyouts. He was curious, so he agreed to meet with the company.

“They approached me with the idea that they could help me grow my practice, help my patients, and cut down overhead,” said the northern Alabama dermatologist, who asked that his name not be used. Over a lavish dinner, the investors lauded the clinician for his business acumen and for having built a great practice so quickly. They made an enticing buyout offer.

Ja_inter/DigitalVision Vectors

Salvation or death sentence?

Depending on whom you ask, the continuing growth of private equity purchases of dermatology practices is either the death – or salvation – of the specialty.

Many dermatologists question whether the financial backers will invest in quality of care, or if they just will hire mid-level providers to churn out procedures to plump up revenues.

Neither the controversy nor the acquisitions show any sign of abating.

The American Academy of Dermatology has hosted debates on the topic at its annual meetings – and was to do so in 2020 until COVID-19 led to the meeting’s cancellation. AAD has not weighed in with any official policy and is not releasing data it may be collecting on the potential impact of private equity ownership. The organization provided a statement from President George J. Hruza, MD, who said, “the AAD supports a member’s right to choose the model that works best for them,” adding that the Academy “expects its members to provide safe and effective patient care, regardless of a dermatologist’s practice setting.” Dr. Hruza sold his Chesterfield, Mo., practice to United Skin Specialists, a private equity–backed company, in 2016, and still works at the same practice.

Some have said the acquisitions need to stop. “Until meaningful data are available on what happens to the quality of care and affordability for patients and payers, dermatologists should stop selling their practices to private equity firms, and legislators should prohibit such transactions,” wrote Joshua M. Sharfstein, MD, and Jamar Slocum, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an editorial in July (JAMA Dermatol. 2019;155[9]:1007-8).

Although he acknowledged that he has not tracked the issue closely and that little data exist on the impact on quality or cost, Dr. Sharfstein has not changed his tune. “I think there are enough warning signs to say we should put the brakes on,” he said in an interview.

“For what reason?” asked Betsy Wernli, MD, president of Forefront Dermatology, an investor-owned group based in Manitowoc, Wis. She said it seems that “on this topic, we abandon our scientific foundations and default to emotion and anecdote,” she said in an interview. “Having capital, and an investor that supports us has allowed us to perform better patient care,” she said. Dermatologist variance across all practices and practice models should be cause for more concern, she added.

Sailesh Konda, MD, has been an outspoken critic. Dr. Konda, medical director and clinical assistant professor in the department of dermatology at the University of Florida, Gainesville, and colleagues detailed the complicated financial machinations of private equity in the Journal of the American Academy of Dermatology. They showed that private investors seemed to hone in on buying outlier practices that performed high numbers of procedures. The paper – first made public in the fall of 2018 – created an uproar, especially among private equity companies. It was initially removed from the website in conjunction with a request from the editor that its conclusions be altered to be less harsh on private equity, according to the New York Times. The paper was eventually published in 2019 (J Am Acad Dermatol. Jul;81[1]:287-296.e8).

Dr. Konda has spoken at various dermatology forums and health care gatherings on private equity. He told the Times that he had given 16 talks to health care groups in 2018, and he was due to speak to a health care investors’ group in 2020. But he would not comment on the record for this story.

Brett Coldiron, MD, a former president of the AAD, also has been critical. He believes investor-owners push for more biopsies, freezing of actinic keratoses, Moh’s surgery, and other well-paying procedures. “I’m convinced that private equity may be the undoing of our specialty,” Dr. Coldiron said in an interview.

In a paper titled, “Private Equity Acquisition of Physician Practices,” published in the Annals of Internal Medicine in January 2019, Lawrence Casalino, MD, PhD, chief of the division of health policy and economics at New York’s Weill Cornell Medicine, and colleagues wrote that “private equity firms focus on specialties with high potential for additional income from elective procedures and ancillary services,” and that “dermatology has been a major focus” (Ann Intern Med. 2019;170[2]:114-5).

And in a viewpoint published in JAMA in February 2019, first-year medical student Suhas Gondi and Zirui Song, MD, PhD, both of Harvard Medical School, Boston, concluded that investor-owned practices could drive up overall health spending in part because they extract better reimbursement from insurers (JAMA. 2019;321[11]:1047-8).

Access could also become an issue if the companies drive smaller independent practices out of business, they wrote.

On the other hand, they said, “these investments may also benefit patients and bring more efficiency to a system burdened with waste.” The authors called for more research and “thoughtful regulation” to enhance the potential positives while mitigating the negatives.

So far, the acquisitions have largely escaped the notice of regulators or lawmakers. Congress has made noises about targeting specialty practices owned by private equity as a means of taming surprise medical bills, but that legislation has been stymied.

Dr. Coldiron is convinced that private investors will eventually be tripped up by state laws that prohibit the corporate practice of medicine.

Leslie Baumann, MD, who sold her Miami practice in October 2019 to the investor-owned Skin and Cancer Associates, said critics are too cynical. “What if these private equity firms are going to actually make our specialty better?” she asked in an interview.

What makes dermatology attractive?

Private equity has been acquiring specialty practices since at least 2009, with an acceleration over the last 5 years. Dermatology has been a frequent target, in part because so many dermatologists were in independent or small group private practices, making them ripe for takeover.

A 2015 report on the specialty by Cegedim, a company that provides information technology support to health care, found that the majority of practices had fewer than five physicians and that 57% of the practices were independent.

But more dermatologists are choosing employment. In a 2018 Medscape survey, 57% of dermatologists reported they were employed, while 49% were self-employed.

During 2013-2016, investors bought 35 dermatology practices – comprising 334 physicians, according to one study published in February (JAMA. 2020;323[7]:663-5). Investors bought 69 anesthesiology practices, 43 emergency medicine practices, and 39 family medicine practices during the same period.

Harvard’s Mr. Gondi and Dr. Song estimated that dermatology practices accounted for 15% of investor purchases in 2015 and 2016, even though dermatologists make up just 1% of U.S. clinicians.

In another paper published in JAMA Dermatology, Sally Tan, MD, and colleagues at Brigham and Women’s Hospital, Boston, and Harvard medical and business schools, estimated that, in 2019, at least 184 practices, comprising 381 clinics, were owned by 17 private equity groups and that the acquisitions had been accelerating: from 5 in 2012 to 59 in 2017 to 34 in the first 5 months of 2018 (JAMA Dermatol. 2019;155[9]:1013-21).

“It’s a very attractive area for investors because they know that the future is bright for dermatology,” said Reuven Porges, MD, CEO of Ft. Lauderdale-based Skin and Cancer Associates, which is owned by a private investor. Because dermatology involves providing many ancillary services and cash-only cosmetic services, “it has tremendous potential to continue to be successful in the future regardless of what health care changes are coming,” Dr. Porges said in an interview.

Investors also see promise in dermatology in the United States because “there’s a huge supply demand mismatch,” said Vance Vanier, MD, a cofounding managing partner at Chicago Pacific Founders, the private equity owner of Pinnacle Dermatology, which has 52 locations in Illinois, Indiana, Michigan, Minnesota, and Tennessee.

Theoretically, when investors handle billing, insurance negotiations, and health information technology, it gives clinicians more time to practice, Dr. Vanier said in an interview.

“Once that doctor is freed up to not do administrative tasks and focus on patient care, then, if they want to, they can see more patients and be more responsive to their needs,” he said.

Dr. Vanier said investor acquisitions are here to stay. “This is a trend that could go on for another 50 years before any saturation point is hit,” he said. “It’s a $2 trillion market. It’s hard to wrap your head around how enormous health care services is,” he said.

Dermatology acquisitions will be driven by the continuing imbalance of physician supply and patient demand; the financial pressure on newly graduating physicians who have big debt loads; the requirements for investment in health information technology to report quality metrics; and an aging population, Dr. Vanier said.

In a JAMA Dermatology viewpoint, Jack Resneck Jr., MD, professor of dermatology, University of California, San Francisco, listed many of the same factors – plus a skin cancer epidemic – as fueling dermatology acquisitions (JAMA Dermatol. 2018;154[1]:13-4).

Medical practices – not just dermatology practices – also offer a pure financial play. “Acquisitions of smaller practices provide a major arbitrage opportunity,” Dr. Casalino and colleagues said in the January 2019 Annals of Internal Medicine paper. In a merger of smaller practices into larger, the smaller practice’s valuation immediately becomes that of the bigger one, they wrote.
 

Could the bottom fall out?

Creating giant groups through consolidation is a main aim for private equity.

Skin and Cancer Associates, founded in 1971, was a large entity, with 25 practices. But for a long time, its leaders had wanted to become a regional or a national player, said Dr. Porges. Those leaders asked Dr. Porges – who helped take his former radiology practice through a private equity purchase – to help them attract investors. In March 2018, Susquehanna Private Capital signed on as a “partner” with Skin and Cancer Associates.

It has since almost doubled in size, with 40 locations and 60 dermatologists, all in Florida, Dr. Porges said. “The only limiting factor for growing it as fast as we want, is really money,” he said.

Consolidation is just an initial step. Most investors have a finite timeline for cashing out. “The ultimate goal is often to realize a profitable secondary sale in three to seven years to another PE investor (or even a publicly traded entity),” Dr. Resneck wrote in the 2018 JAMA Dermatology paper.

Not all private equity companies are the same, said Dr. Wernli, of Forefront. Dermatologists can investigate a company’s “hold period” – how long they keep an investment before trading – and the strength of its capitalization before deciding to sell, she said.

Since 2016, Forefront has been owned by the Ontario Municipal Employee Retirement System (OMERS), a pension fund for the province’s public workers. OMERS bought Forefront from Varsity Healthcare Partners, which had owned the dermatology group for just 2 years.

Dr. Wernli said OMERS is a good, solid investor. “They have unlimited resources to invest so they don’t have to quickly flip a company to satisfy an investment in another company,” she said.

Some investor-backed dermatology practices have gone belly up. In 2012, WestWind Investors bought DermOne, based in Toms River, N.J. But by early 2018, the business had fallen apart, and some practices – in North Carolina, New Jersey, Texas, and Virginia – just shut their doors.

Long Island City, N.Y.–based Schweiger Dermatology Group, backed by private equity, snapped up nine of the New Jersey DermOne practices in March 2018.

Another private equity–backed company, U.S. Dermatology Partners, defaulted on a $377 million loan in January 2020. As reported by Bloomberg, the company had $340 million in revenue in 2018. U.S. Dermatology’s owners are reportedly working out a recapitalization or debt-for-equity swap with the lenders.

Dr. Wernli said that financial problems aren’t unique to investor-owned practices and that doctors could still be out of a job if a private practice goes under.

“A private practice can also default on their loans that they’ve used to fund their own personal practice, leaving employed physicians in the same situation,” she said.

Patients are likely to be in the dark, however, until the doors close.

Pressure on practices

Private equity is changing the shape of practice for both those who work for investor-owned businesses and those still out on their own.

The Alabama dermatologist, for instance, said it has made it harder for him to recruit new doctors, who are offered big signing bonuses and a steady income by the investor-owned practices. “They’re skewing the numbers,” he said, adding that residents are now expecting a big payment and benefits.

Dr. Baumann said that when she was on her own, she had trouble finding and recruiting good dermatologists. But it has become easier since she’d sold to Skin and Cancer Associates, she said, noting that Dr. Porges recently found a qualified candidate for her to interview a week after she put in a request.

Another dermatologist in a Midwestern metropolitan practice – who did not want his name used – said that when it came time for him to increase his equity stake, his older partner, who was near retirement and had explored selling to private equity – wanted four-and-a-half times the price that had been discussed when he joined the practice.

The younger partner believes the private equity offers inflated the practice’s valuation in his partner’s mind. He ended up leaving the practice.

Many dermatologists have been led to believe that their practices are worth more than they might be, according to Dr. Coldiron. “I think a lot of these doctors that sell out are deluded. They think that they’re getting a lot of money and they’re not,” he said.

Typically, investors may offer three or four times earnings before interest, taxes, depreciation and amortization (EBITDA). The money paid out is taxed at the capital gains rate, which provides some savings. “But you have to pay that all back, because when they sign you up, you become an employee,” Dr. Coldiron said.

Doctors often agree to work for 5 years, but during that period, their base salary is decreased while the buyout cash is meted out to them, he added. A chunk of the buyout usually is also given as equity, but that equity is worthless unless the investor sells to another entity.

Pinnacle Dermatology doesn’t want doctors to retire immediately upon an acquisition, said Dr. Vanier of Chicago Pacific Founders. “We want to find physician partners who want to keep working,” he said. “We strongly believe if you don’t have strong physician leadership, experienced physician leadership, that your odds of success go down.”

Chicago Pacific also believes physicians should have an ownership interest, he said. It allows them to share in the eventual financial rewards – whether that’s 5 or 20 years later, said Dr. Vanier.

Dr. Coldiron sees other pressures that skew practice styles and can harm patient care. Clinicians in investor-owned practices are often urged to refer all dermatopathology to labs owned by the practice and often, a Moh’s surgeon is employed to service all the practices – sometimes even being flown in from elsewhere, he claimed.

That takes away the clinician’s autonomy in terms of referring where he or she feels appropriate and also could harm pathologists and Moh’s surgeons that depend on those referral streams, he added.

In their paper, Mr. Gondi and Dr. Song wrote that this practice is concerning because “keeping referrals within the practice may render referral patterns less responsive to patient needs or preference.”
 

Procedure factories?

Many critics say investor-backed practices are goosing revenues by hiring more mid-level providers – such as nurse practitioners and physician assistants – and getting them to perform more procedures.

Midlevel practitioners do more biopsies than dermatologists do to get a diagnosis, according to Dr. Coldiron.

A 2018 JAMA Dermatology study appears to back that up. Physician assistants needed to conduct 3.9 biopsies to diagnose one skin cancer, compared to 3.3 for dermatologists. For a single melanoma, the number needed to biopsy was 39.4 for PAs and 25.4 for dermatologists (JAMA Dermatol. 2018;154[5]:569-73).

Skin biopsies have almost doubled in the last decade, said Dr. Coldiron. “The skin cancer epidemic would account for only half of that,” he said.

“The ultimate loser is the patient – because the patient doesn’t get the highest quality care and the patient has unnecessary things done to him or her,” he said. But, he said, he could not directly tie the biopsy increase to the rise of private equity.

Forefront tracks the number of biopsies per patient done by every dermatologist in its network – to make sure that no one is outside the norms set by the Centers for Medicare and Medicaid Services, said Dr. Wernli. And she said biopsies declined after the group was bought by private equity.

Dr. Baumann said the average number of biopsies per patient at Skin and Cancer Associates in 2019 was 0.20 – less than the 0.30 average reported by Medicare that same year.

The rising use of mid-level providers existed long before private equity came on the scene, said Dr. Wernli. “There’s not enough board-certified dermatologists to satisfy need,” she said, noting that, in addition, many clinicians won’t serve rural areas. “If we don’t move and extend ourselves, there will be someone who fills our shoes,” she said, adding that Forefront has 1 mid-level for every 1.5 to 2 dermatologists.

Skin and Cancer Associates has 55 doctors and 29 physician assistants, said Dr. Baumann, adding that she had not been pressured to add any mid-level providers to her practice.
 

Excitement about sale shot down

Dr. Wernli and Dr. Baumann both have been happy with their decision to ally with private equity. For Dr. Baumann, however, her move was tinged by online attacks that reflected the strong opinions on the topic.

She began looking into selling her practice when one of her businesses – Skin Type Solutions – began taking off. Both her clinical practice and research business were thriving. She had two children at home and was having a hard time keeping up with the administrative end of her businesses.

None of her partners nor any groups in Miami showed interest in purchasing the practice, so she began researching private equity. She spoke with seven companies before settling on Skin and Cancer Associates. They had “a long track record of successfully running practices,” said Dr. Baumann, adding that “the doctors who work there are happy, and I respect the quality of the physicians and the organization.”

When she closed the deal in October 2019, she agreed to stay on for 5 years and signed a noncompete clause that she deems “very reasonable.” Among the perks she cites: being able to consult via telemedicine with an expert on pigmented lesions; quick and easy referrals to a Moh’s surgeon; being able to train residents; and having paid personal time off.

It’s less responsibility and the same or better job satisfaction, she said.

But when she shared the news on a private Facebook group for board-certified dermatologists, she was vilified. Of some 195 comments, about half were “mean,” said Dr. Baumann.

“I was shocked about how strongly everybody feels,” she said. Those commenting accused her of doing it for the money or said that her move was contributing to the ruination of dermatology.

“I just defended myself,” she said. “For me, it was my time.”

Dr. Coldiron and Dr. Baumann are members of the Dermatology News editorial advisory board.

The dermatologist had been in practice just a few years when he was approached by a private equity group. This was around 2015, when dermatology was just starting to buzz about investor buyouts. He was curious, so he agreed to meet with the company.

“They approached me with the idea that they could help me grow my practice, help my patients, and cut down overhead,” said the northern Alabama dermatologist, who asked that his name not be used. Over a lavish dinner, the investors lauded the clinician for his business acumen and for having built a great practice so quickly. They made an enticing buyout offer.

Ja_inter/DigitalVision Vectors

Salvation or death sentence?

Depending on whom you ask, the continuing growth of private equity purchases of dermatology practices is either the death – or salvation – of the specialty.

Many dermatologists question whether the financial backers will invest in quality of care, or if they just will hire mid-level providers to churn out procedures to plump up revenues.

Neither the controversy nor the acquisitions show any sign of abating.

The American Academy of Dermatology has hosted debates on the topic at its annual meetings – and was to do so in 2020 until COVID-19 led to the meeting’s cancellation. AAD has not weighed in with any official policy and is not releasing data it may be collecting on the potential impact of private equity ownership. The organization provided a statement from President George J. Hruza, MD, who said, “the AAD supports a member’s right to choose the model that works best for them,” adding that the Academy “expects its members to provide safe and effective patient care, regardless of a dermatologist’s practice setting.” Dr. Hruza sold his Chesterfield, Mo., practice to United Skin Specialists, a private equity–backed company, in 2016, and still works at the same practice.

Some have said the acquisitions need to stop. “Until meaningful data are available on what happens to the quality of care and affordability for patients and payers, dermatologists should stop selling their practices to private equity firms, and legislators should prohibit such transactions,” wrote Joshua M. Sharfstein, MD, and Jamar Slocum, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an editorial in July (JAMA Dermatol. 2019;155[9]:1007-8).

Although he acknowledged that he has not tracked the issue closely and that little data exist on the impact on quality or cost, Dr. Sharfstein has not changed his tune. “I think there are enough warning signs to say we should put the brakes on,” he said in an interview.

“For what reason?” asked Betsy Wernli, MD, president of Forefront Dermatology, an investor-owned group based in Manitowoc, Wis. She said it seems that “on this topic, we abandon our scientific foundations and default to emotion and anecdote,” she said in an interview. “Having capital, and an investor that supports us has allowed us to perform better patient care,” she said. Dermatologist variance across all practices and practice models should be cause for more concern, she added.

Sailesh Konda, MD, has been an outspoken critic. Dr. Konda, medical director and clinical assistant professor in the department of dermatology at the University of Florida, Gainesville, and colleagues detailed the complicated financial machinations of private equity in the Journal of the American Academy of Dermatology. They showed that private investors seemed to hone in on buying outlier practices that performed high numbers of procedures. The paper – first made public in the fall of 2018 – created an uproar, especially among private equity companies. It was initially removed from the website in conjunction with a request from the editor that its conclusions be altered to be less harsh on private equity, according to the New York Times. The paper was eventually published in 2019 (J Am Acad Dermatol. Jul;81[1]:287-296.e8).

Dr. Konda has spoken at various dermatology forums and health care gatherings on private equity. He told the Times that he had given 16 talks to health care groups in 2018, and he was due to speak to a health care investors’ group in 2020. But he would not comment on the record for this story.

Brett Coldiron, MD, a former president of the AAD, also has been critical. He believes investor-owners push for more biopsies, freezing of actinic keratoses, Moh’s surgery, and other well-paying procedures. “I’m convinced that private equity may be the undoing of our specialty,” Dr. Coldiron said in an interview.

In a paper titled, “Private Equity Acquisition of Physician Practices,” published in the Annals of Internal Medicine in January 2019, Lawrence Casalino, MD, PhD, chief of the division of health policy and economics at New York’s Weill Cornell Medicine, and colleagues wrote that “private equity firms focus on specialties with high potential for additional income from elective procedures and ancillary services,” and that “dermatology has been a major focus” (Ann Intern Med. 2019;170[2]:114-5).

And in a viewpoint published in JAMA in February 2019, first-year medical student Suhas Gondi and Zirui Song, MD, PhD, both of Harvard Medical School, Boston, concluded that investor-owned practices could drive up overall health spending in part because they extract better reimbursement from insurers (JAMA. 2019;321[11]:1047-8).

Access could also become an issue if the companies drive smaller independent practices out of business, they wrote.

On the other hand, they said, “these investments may also benefit patients and bring more efficiency to a system burdened with waste.” The authors called for more research and “thoughtful regulation” to enhance the potential positives while mitigating the negatives.

So far, the acquisitions have largely escaped the notice of regulators or lawmakers. Congress has made noises about targeting specialty practices owned by private equity as a means of taming surprise medical bills, but that legislation has been stymied.

Dr. Coldiron is convinced that private investors will eventually be tripped up by state laws that prohibit the corporate practice of medicine.

Leslie Baumann, MD, who sold her Miami practice in October 2019 to the investor-owned Skin and Cancer Associates, said critics are too cynical. “What if these private equity firms are going to actually make our specialty better?” she asked in an interview.

What makes dermatology attractive?

Private equity has been acquiring specialty practices since at least 2009, with an acceleration over the last 5 years. Dermatology has been a frequent target, in part because so many dermatologists were in independent or small group private practices, making them ripe for takeover.

A 2015 report on the specialty by Cegedim, a company that provides information technology support to health care, found that the majority of practices had fewer than five physicians and that 57% of the practices were independent.

But more dermatologists are choosing employment. In a 2018 Medscape survey, 57% of dermatologists reported they were employed, while 49% were self-employed.

During 2013-2016, investors bought 35 dermatology practices – comprising 334 physicians, according to one study published in February (JAMA. 2020;323[7]:663-5). Investors bought 69 anesthesiology practices, 43 emergency medicine practices, and 39 family medicine practices during the same period.

Harvard’s Mr. Gondi and Dr. Song estimated that dermatology practices accounted for 15% of investor purchases in 2015 and 2016, even though dermatologists make up just 1% of U.S. clinicians.

In another paper published in JAMA Dermatology, Sally Tan, MD, and colleagues at Brigham and Women’s Hospital, Boston, and Harvard medical and business schools, estimated that, in 2019, at least 184 practices, comprising 381 clinics, were owned by 17 private equity groups and that the acquisitions had been accelerating: from 5 in 2012 to 59 in 2017 to 34 in the first 5 months of 2018 (JAMA Dermatol. 2019;155[9]:1013-21).

“It’s a very attractive area for investors because they know that the future is bright for dermatology,” said Reuven Porges, MD, CEO of Ft. Lauderdale-based Skin and Cancer Associates, which is owned by a private investor. Because dermatology involves providing many ancillary services and cash-only cosmetic services, “it has tremendous potential to continue to be successful in the future regardless of what health care changes are coming,” Dr. Porges said in an interview.

Investors also see promise in dermatology in the United States because “there’s a huge supply demand mismatch,” said Vance Vanier, MD, a cofounding managing partner at Chicago Pacific Founders, the private equity owner of Pinnacle Dermatology, which has 52 locations in Illinois, Indiana, Michigan, Minnesota, and Tennessee.

Theoretically, when investors handle billing, insurance negotiations, and health information technology, it gives clinicians more time to practice, Dr. Vanier said in an interview.

“Once that doctor is freed up to not do administrative tasks and focus on patient care, then, if they want to, they can see more patients and be more responsive to their needs,” he said.

Dr. Vanier said investor acquisitions are here to stay. “This is a trend that could go on for another 50 years before any saturation point is hit,” he said. “It’s a $2 trillion market. It’s hard to wrap your head around how enormous health care services is,” he said.

Dermatology acquisitions will be driven by the continuing imbalance of physician supply and patient demand; the financial pressure on newly graduating physicians who have big debt loads; the requirements for investment in health information technology to report quality metrics; and an aging population, Dr. Vanier said.

In a JAMA Dermatology viewpoint, Jack Resneck Jr., MD, professor of dermatology, University of California, San Francisco, listed many of the same factors – plus a skin cancer epidemic – as fueling dermatology acquisitions (JAMA Dermatol. 2018;154[1]:13-4).

Medical practices – not just dermatology practices – also offer a pure financial play. “Acquisitions of smaller practices provide a major arbitrage opportunity,” Dr. Casalino and colleagues said in the January 2019 Annals of Internal Medicine paper. In a merger of smaller practices into larger, the smaller practice’s valuation immediately becomes that of the bigger one, they wrote.
 

Could the bottom fall out?

Creating giant groups through consolidation is a main aim for private equity.

Skin and Cancer Associates, founded in 1971, was a large entity, with 25 practices. But for a long time, its leaders had wanted to become a regional or a national player, said Dr. Porges. Those leaders asked Dr. Porges – who helped take his former radiology practice through a private equity purchase – to help them attract investors. In March 2018, Susquehanna Private Capital signed on as a “partner” with Skin and Cancer Associates.

It has since almost doubled in size, with 40 locations and 60 dermatologists, all in Florida, Dr. Porges said. “The only limiting factor for growing it as fast as we want, is really money,” he said.

Consolidation is just an initial step. Most investors have a finite timeline for cashing out. “The ultimate goal is often to realize a profitable secondary sale in three to seven years to another PE investor (or even a publicly traded entity),” Dr. Resneck wrote in the 2018 JAMA Dermatology paper.

Not all private equity companies are the same, said Dr. Wernli, of Forefront. Dermatologists can investigate a company’s “hold period” – how long they keep an investment before trading – and the strength of its capitalization before deciding to sell, she said.

Since 2016, Forefront has been owned by the Ontario Municipal Employee Retirement System (OMERS), a pension fund for the province’s public workers. OMERS bought Forefront from Varsity Healthcare Partners, which had owned the dermatology group for just 2 years.

Dr. Wernli said OMERS is a good, solid investor. “They have unlimited resources to invest so they don’t have to quickly flip a company to satisfy an investment in another company,” she said.

Some investor-backed dermatology practices have gone belly up. In 2012, WestWind Investors bought DermOne, based in Toms River, N.J. But by early 2018, the business had fallen apart, and some practices – in North Carolina, New Jersey, Texas, and Virginia – just shut their doors.

Long Island City, N.Y.–based Schweiger Dermatology Group, backed by private equity, snapped up nine of the New Jersey DermOne practices in March 2018.

Another private equity–backed company, U.S. Dermatology Partners, defaulted on a $377 million loan in January 2020. As reported by Bloomberg, the company had $340 million in revenue in 2018. U.S. Dermatology’s owners are reportedly working out a recapitalization or debt-for-equity swap with the lenders.

Dr. Wernli said that financial problems aren’t unique to investor-owned practices and that doctors could still be out of a job if a private practice goes under.

“A private practice can also default on their loans that they’ve used to fund their own personal practice, leaving employed physicians in the same situation,” she said.

Patients are likely to be in the dark, however, until the doors close.

Pressure on practices

Private equity is changing the shape of practice for both those who work for investor-owned businesses and those still out on their own.

The Alabama dermatologist, for instance, said it has made it harder for him to recruit new doctors, who are offered big signing bonuses and a steady income by the investor-owned practices. “They’re skewing the numbers,” he said, adding that residents are now expecting a big payment and benefits.

Dr. Baumann said that when she was on her own, she had trouble finding and recruiting good dermatologists. But it has become easier since she’d sold to Skin and Cancer Associates, she said, noting that Dr. Porges recently found a qualified candidate for her to interview a week after she put in a request.

Another dermatologist in a Midwestern metropolitan practice – who did not want his name used – said that when it came time for him to increase his equity stake, his older partner, who was near retirement and had explored selling to private equity – wanted four-and-a-half times the price that had been discussed when he joined the practice.

The younger partner believes the private equity offers inflated the practice’s valuation in his partner’s mind. He ended up leaving the practice.

Many dermatologists have been led to believe that their practices are worth more than they might be, according to Dr. Coldiron. “I think a lot of these doctors that sell out are deluded. They think that they’re getting a lot of money and they’re not,” he said.

Typically, investors may offer three or four times earnings before interest, taxes, depreciation and amortization (EBITDA). The money paid out is taxed at the capital gains rate, which provides some savings. “But you have to pay that all back, because when they sign you up, you become an employee,” Dr. Coldiron said.

Doctors often agree to work for 5 years, but during that period, their base salary is decreased while the buyout cash is meted out to them, he added. A chunk of the buyout usually is also given as equity, but that equity is worthless unless the investor sells to another entity.

Pinnacle Dermatology doesn’t want doctors to retire immediately upon an acquisition, said Dr. Vanier of Chicago Pacific Founders. “We want to find physician partners who want to keep working,” he said. “We strongly believe if you don’t have strong physician leadership, experienced physician leadership, that your odds of success go down.”

Chicago Pacific also believes physicians should have an ownership interest, he said. It allows them to share in the eventual financial rewards – whether that’s 5 or 20 years later, said Dr. Vanier.

Dr. Coldiron sees other pressures that skew practice styles and can harm patient care. Clinicians in investor-owned practices are often urged to refer all dermatopathology to labs owned by the practice and often, a Moh’s surgeon is employed to service all the practices – sometimes even being flown in from elsewhere, he claimed.

That takes away the clinician’s autonomy in terms of referring where he or she feels appropriate and also could harm pathologists and Moh’s surgeons that depend on those referral streams, he added.

In their paper, Mr. Gondi and Dr. Song wrote that this practice is concerning because “keeping referrals within the practice may render referral patterns less responsive to patient needs or preference.”
 

Procedure factories?

Many critics say investor-backed practices are goosing revenues by hiring more mid-level providers – such as nurse practitioners and physician assistants – and getting them to perform more procedures.

Midlevel practitioners do more biopsies than dermatologists do to get a diagnosis, according to Dr. Coldiron.

A 2018 JAMA Dermatology study appears to back that up. Physician assistants needed to conduct 3.9 biopsies to diagnose one skin cancer, compared to 3.3 for dermatologists. For a single melanoma, the number needed to biopsy was 39.4 for PAs and 25.4 for dermatologists (JAMA Dermatol. 2018;154[5]:569-73).

Skin biopsies have almost doubled in the last decade, said Dr. Coldiron. “The skin cancer epidemic would account for only half of that,” he said.

“The ultimate loser is the patient – because the patient doesn’t get the highest quality care and the patient has unnecessary things done to him or her,” he said. But, he said, he could not directly tie the biopsy increase to the rise of private equity.

Forefront tracks the number of biopsies per patient done by every dermatologist in its network – to make sure that no one is outside the norms set by the Centers for Medicare and Medicaid Services, said Dr. Wernli. And she said biopsies declined after the group was bought by private equity.

Dr. Baumann said the average number of biopsies per patient at Skin and Cancer Associates in 2019 was 0.20 – less than the 0.30 average reported by Medicare that same year.

The rising use of mid-level providers existed long before private equity came on the scene, said Dr. Wernli. “There’s not enough board-certified dermatologists to satisfy need,” she said, noting that, in addition, many clinicians won’t serve rural areas. “If we don’t move and extend ourselves, there will be someone who fills our shoes,” she said, adding that Forefront has 1 mid-level for every 1.5 to 2 dermatologists.

Skin and Cancer Associates has 55 doctors and 29 physician assistants, said Dr. Baumann, adding that she had not been pressured to add any mid-level providers to her practice.
 

Excitement about sale shot down

Dr. Wernli and Dr. Baumann both have been happy with their decision to ally with private equity. For Dr. Baumann, however, her move was tinged by online attacks that reflected the strong opinions on the topic.

She began looking into selling her practice when one of her businesses – Skin Type Solutions – began taking off. Both her clinical practice and research business were thriving. She had two children at home and was having a hard time keeping up with the administrative end of her businesses.

None of her partners nor any groups in Miami showed interest in purchasing the practice, so she began researching private equity. She spoke with seven companies before settling on Skin and Cancer Associates. They had “a long track record of successfully running practices,” said Dr. Baumann, adding that “the doctors who work there are happy, and I respect the quality of the physicians and the organization.”

When she closed the deal in October 2019, she agreed to stay on for 5 years and signed a noncompete clause that she deems “very reasonable.” Among the perks she cites: being able to consult via telemedicine with an expert on pigmented lesions; quick and easy referrals to a Moh’s surgeon; being able to train residents; and having paid personal time off.

It’s less responsibility and the same or better job satisfaction, she said.

But when she shared the news on a private Facebook group for board-certified dermatologists, she was vilified. Of some 195 comments, about half were “mean,” said Dr. Baumann.

“I was shocked about how strongly everybody feels,” she said. Those commenting accused her of doing it for the money or said that her move was contributing to the ruination of dermatology.

“I just defended myself,” she said. “For me, it was my time.”

Dr. Coldiron and Dr. Baumann are members of the Dermatology News editorial advisory board.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

Although conflicting, the available data indicate that SARS-CoV-2 could continue to spread in warmer spring and summer months in the US, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS).

Current data suggest that the novel coronavirus may be transmitted less efficiently in higher temperatures and humidity, but the studies are not conclusive because of poor data quality, confounding factors, and the relatively short existence of the pandemic, which makes it difficult to determine its true course, writes David A. Relman, MD, a member of the NAS’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, in a rapid expert consultation letter to the White House Office of Science and Technology Policy on April 7.

A number of factors could influence whether SARS-CoV-2 follows the same seasonal pattern as the influenza virus and other seasonal coronaviruses, which wane during warmer months, writes Relman, a professor of microbiology and immunology at Stanford University in California.

But he pointed out that previous coronavirus strains that have caused serious illness – SARS-CoV and MERS-CoV – “have not demonstrated any evidence of seasonality following their emergence.”

Relman cites an example from the current outbreak: “Given that countries currently in ‘summer’ climates, such as Australia and Iran, are experiencing rapid virus spread, a decrease in cases with increases in humidity and temperature elsewhere should not be assumed…Additional studies as the pandemic unfolds could shed more light on the effects of climate on transmission,” he writes.

And even if SARS-CoV-2 turns out to be less infectious in warmer months, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” writes Relman.

Conflicting Data

Relman cites a handful of studies indicating that, on the one hand, SARS-CoV-2 has declined with increasing humidity and temperatures, but that conversely, infectivity has increased in warmer, more humid climates.

A recent study in China, published on the repository and international journal site SSRN, found that while increased temperatures and humidity decreased the infectivity, “the average R0 (R naught) was still close to 2 at maximum temperatures and humidity in their data set, suggesting that the virus will still spread exponentially at higher temperatures and humidity,” said Relman.

Several other studies found higher growth rates in temperate regions. One study, still in preprint on MedRxiv, looked at 310 geographic regions across 116 countries, and shows an inverse relationship between temperature and humidity and the incidence of COVID-19.

All the available studies so far have significant limitations, including limitation in time and location, confounding factors having to do with geography, access to and the quality of public health and health care systems, human behavior, and the availability of testing, said Relman.

However, he said, “it is useful to note that pandemic influenza strains have not exhibited the typical seasonal pattern of endemic/epidemic strains,” and, regardless of whether they started in a warmer or a cooler month, “all had a peak second wave approximately six months after the emergence in the human population.”

Worrisome Persistence on Masks

Seasonality can also be potentially gauged in the laboratory. Most of the studies on environmental persistence of SARS-CoV-2 have been conducted using virus grown in tissue culture. But that, too, is an imperfect method.

Virus disseminated into the environment from naturally infected humans likely has different survival properties than virus grown in culture, said Relman.

In addition, many labs cannot, or fail to, control and vary relative humidity, the committee letter noted. The aerosol studies so far have used humidity levels of 50% to 65%, which is more favorable to decay, while respiratory fluid is more likely to protect against infectivity, and the 20%-to-40% wintertime indoor humidity in temperate regions is more favorable for virus survival.

Even with these caveats, the committee cited worrisome studies on SARS-CoV-2 survival.

In a study published April 2 online in The Lancet, Hong Kong researchers reported significant reductions in virus in culture starting with temperatures at 37°C (98.6°F) or above.

On surfaces at a room temperature of 22°C (71.6°F) with a relative humidity of 65%, there was no infectious virus on printing paper or tissue papers after just 3 hours. It took 4 days for an infectious level to break down on glass and money, and 7 days for stainless steel and plastic. But after 7 days, investigators found 0.1% of the original inoculum on the outside of a surgical mask.

“The persistence of infectious virus on PPE is concerning,” writes Relman, noting that more studies are needed to guide healthcare workers, especially on what might be used to disinfect personal protective equipment “when they cannot be discarded after single use.”

Chad Roy, PhD, a researcher from Tulane University National Primate Research Center in New Orleans, Louisiana, told Relman by phone that in experiments where the virus was suspended as an aerosol at a temperature of 23°C (73.4° F) and about 50% humidity, SARS-CoV-2 had a longer half-life than the influenza virus, SARS-CoV-1, monkeypox virus, and Mycobacterium tuberculosis.

“This result is also concerning, but quite preliminary,” writes Relman.

This article first appeared on Medscape.com.

Although conflicting, the available data indicate that SARS-CoV-2 could continue to spread in warmer spring and summer months in the US, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS).

Current data suggest that the novel coronavirus may be transmitted less efficiently in higher temperatures and humidity, but the studies are not conclusive because of poor data quality, confounding factors, and the relatively short existence of the pandemic, which makes it difficult to determine its true course, writes David A. Relman, MD, a member of the NAS’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, in a rapid expert consultation letter to the White House Office of Science and Technology Policy on April 7.

A number of factors could influence whether SARS-CoV-2 follows the same seasonal pattern as the influenza virus and other seasonal coronaviruses, which wane during warmer months, writes Relman, a professor of microbiology and immunology at Stanford University in California.

But he pointed out that previous coronavirus strains that have caused serious illness – SARS-CoV and MERS-CoV – “have not demonstrated any evidence of seasonality following their emergence.”

Relman cites an example from the current outbreak: “Given that countries currently in ‘summer’ climates, such as Australia and Iran, are experiencing rapid virus spread, a decrease in cases with increases in humidity and temperature elsewhere should not be assumed…Additional studies as the pandemic unfolds could shed more light on the effects of climate on transmission,” he writes.

And even if SARS-CoV-2 turns out to be less infectious in warmer months, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” writes Relman.

Conflicting Data

Relman cites a handful of studies indicating that, on the one hand, SARS-CoV-2 has declined with increasing humidity and temperatures, but that conversely, infectivity has increased in warmer, more humid climates.

A recent study in China, published on the repository and international journal site SSRN, found that while increased temperatures and humidity decreased the infectivity, “the average R0 (R naught) was still close to 2 at maximum temperatures and humidity in their data set, suggesting that the virus will still spread exponentially at higher temperatures and humidity,” said Relman.

Several other studies found higher growth rates in temperate regions. One study, still in preprint on MedRxiv, looked at 310 geographic regions across 116 countries, and shows an inverse relationship between temperature and humidity and the incidence of COVID-19.

All the available studies so far have significant limitations, including limitation in time and location, confounding factors having to do with geography, access to and the quality of public health and health care systems, human behavior, and the availability of testing, said Relman.

However, he said, “it is useful to note that pandemic influenza strains have not exhibited the typical seasonal pattern of endemic/epidemic strains,” and, regardless of whether they started in a warmer or a cooler month, “all had a peak second wave approximately six months after the emergence in the human population.”

Worrisome Persistence on Masks

Seasonality can also be potentially gauged in the laboratory. Most of the studies on environmental persistence of SARS-CoV-2 have been conducted using virus grown in tissue culture. But that, too, is an imperfect method.

Virus disseminated into the environment from naturally infected humans likely has different survival properties than virus grown in culture, said Relman.

In addition, many labs cannot, or fail to, control and vary relative humidity, the committee letter noted. The aerosol studies so far have used humidity levels of 50% to 65%, which is more favorable to decay, while respiratory fluid is more likely to protect against infectivity, and the 20%-to-40% wintertime indoor humidity in temperate regions is more favorable for virus survival.

Even with these caveats, the committee cited worrisome studies on SARS-CoV-2 survival.

In a study published April 2 online in The Lancet, Hong Kong researchers reported significant reductions in virus in culture starting with temperatures at 37°C (98.6°F) or above.

On surfaces at a room temperature of 22°C (71.6°F) with a relative humidity of 65%, there was no infectious virus on printing paper or tissue papers after just 3 hours. It took 4 days for an infectious level to break down on glass and money, and 7 days for stainless steel and plastic. But after 7 days, investigators found 0.1% of the original inoculum on the outside of a surgical mask.

“The persistence of infectious virus on PPE is concerning,” writes Relman, noting that more studies are needed to guide healthcare workers, especially on what might be used to disinfect personal protective equipment “when they cannot be discarded after single use.”

Chad Roy, PhD, a researcher from Tulane University National Primate Research Center in New Orleans, Louisiana, told Relman by phone that in experiments where the virus was suspended as an aerosol at a temperature of 23°C (73.4° F) and about 50% humidity, SARS-CoV-2 had a longer half-life than the influenza virus, SARS-CoV-1, monkeypox virus, and Mycobacterium tuberculosis.

“This result is also concerning, but quite preliminary,” writes Relman.

This article first appeared on Medscape.com.

Although conflicting, the available data indicate that SARS-CoV-2 could continue to spread in warmer spring and summer months in the US, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS).

Current data suggest that the novel coronavirus may be transmitted less efficiently in higher temperatures and humidity, but the studies are not conclusive because of poor data quality, confounding factors, and the relatively short existence of the pandemic, which makes it difficult to determine its true course, writes David A. Relman, MD, a member of the NAS’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, in a rapid expert consultation letter to the White House Office of Science and Technology Policy on April 7.

A number of factors could influence whether SARS-CoV-2 follows the same seasonal pattern as the influenza virus and other seasonal coronaviruses, which wane during warmer months, writes Relman, a professor of microbiology and immunology at Stanford University in California.

But he pointed out that previous coronavirus strains that have caused serious illness – SARS-CoV and MERS-CoV – “have not demonstrated any evidence of seasonality following their emergence.”

Relman cites an example from the current outbreak: “Given that countries currently in ‘summer’ climates, such as Australia and Iran, are experiencing rapid virus spread, a decrease in cases with increases in humidity and temperature elsewhere should not be assumed…Additional studies as the pandemic unfolds could shed more light on the effects of climate on transmission,” he writes.

And even if SARS-CoV-2 turns out to be less infectious in warmer months, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” writes Relman.

Conflicting Data

Relman cites a handful of studies indicating that, on the one hand, SARS-CoV-2 has declined with increasing humidity and temperatures, but that conversely, infectivity has increased in warmer, more humid climates.

A recent study in China, published on the repository and international journal site SSRN, found that while increased temperatures and humidity decreased the infectivity, “the average R0 (R naught) was still close to 2 at maximum temperatures and humidity in their data set, suggesting that the virus will still spread exponentially at higher temperatures and humidity,” said Relman.

Several other studies found higher growth rates in temperate regions. One study, still in preprint on MedRxiv, looked at 310 geographic regions across 116 countries, and shows an inverse relationship between temperature and humidity and the incidence of COVID-19.

All the available studies so far have significant limitations, including limitation in time and location, confounding factors having to do with geography, access to and the quality of public health and health care systems, human behavior, and the availability of testing, said Relman.

However, he said, “it is useful to note that pandemic influenza strains have not exhibited the typical seasonal pattern of endemic/epidemic strains,” and, regardless of whether they started in a warmer or a cooler month, “all had a peak second wave approximately six months after the emergence in the human population.”

Worrisome Persistence on Masks

Seasonality can also be potentially gauged in the laboratory. Most of the studies on environmental persistence of SARS-CoV-2 have been conducted using virus grown in tissue culture. But that, too, is an imperfect method.

Virus disseminated into the environment from naturally infected humans likely has different survival properties than virus grown in culture, said Relman.

In addition, many labs cannot, or fail to, control and vary relative humidity, the committee letter noted. The aerosol studies so far have used humidity levels of 50% to 65%, which is more favorable to decay, while respiratory fluid is more likely to protect against infectivity, and the 20%-to-40% wintertime indoor humidity in temperate regions is more favorable for virus survival.

Even with these caveats, the committee cited worrisome studies on SARS-CoV-2 survival.

In a study published April 2 online in The Lancet, Hong Kong researchers reported significant reductions in virus in culture starting with temperatures at 37°C (98.6°F) or above.

On surfaces at a room temperature of 22°C (71.6°F) with a relative humidity of 65%, there was no infectious virus on printing paper or tissue papers after just 3 hours. It took 4 days for an infectious level to break down on glass and money, and 7 days for stainless steel and plastic. But after 7 days, investigators found 0.1% of the original inoculum on the outside of a surgical mask.

“The persistence of infectious virus on PPE is concerning,” writes Relman, noting that more studies are needed to guide healthcare workers, especially on what might be used to disinfect personal protective equipment “when they cannot be discarded after single use.”

Chad Roy, PhD, a researcher from Tulane University National Primate Research Center in New Orleans, Louisiana, told Relman by phone that in experiments where the virus was suspended as an aerosol at a temperature of 23°C (73.4° F) and about 50% humidity, SARS-CoV-2 had a longer half-life than the influenza virus, SARS-CoV-1, monkeypox virus, and Mycobacterium tuberculosis.

“This result is also concerning, but quite preliminary,” writes Relman.

This article first appeared on Medscape.com.

Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

“These things are being proposed based on a lot of misinformation,” said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers “are not looking at the scientific evidence that supports current clinical practice guidelines,” Rosenthal, who treats transgender children, told Medscape Medical News.

And “People just aren’t really understanding the harm that regulating this kind of medicine would do,” stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom’s only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1,500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called “rapid-onset gender dysphoria” in born females who say they wish to become males and some clinicians have said this represents a “social” phenomenon.

But guidelines from US clinical organizations – including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) – all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More data needed but evidence to intervene is compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data “even if it’s rudimentary, are convincing that there is a biological component to gender identity.”

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it’s still not known what causes gender identity – whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process – said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, “The data for interventions for transgender people ... is compelling,” he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

“Those data are modest at this point and we need better data, but they do all move in the same direction,” he asserted.

Meanwhile, a large group of around 1,800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

“We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare,” the parents write.

“These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children,” they continue.

“They should not be made by politicians who think they know better than medical professionals,” they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts “to block access to these recognized interventions,” it said in a statement.

Proponents of laws speak of harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri’s proposed legislation labels surgical or hormonal treatment for a child under age 18 “abuse or neglect”; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2,000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it “supports physicians’ ability to provide the best evidence-based treatment to their patients,” and that “these decisions should be made by the family and physician, and not dictated by policymakers.”

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

“The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment,” wrote Turban.

“State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them,” he added.
 

Few states seem to have approached clinicians for feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they’ve received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it “supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children.”

“However, we do not support state bills that are not victim-led or used for political gain,” they added.
 

Existing knowledge imperfect but treatment indicated for some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California–based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers “a public health emergency.”

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society’s 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that “the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy.”

Laidlaw told Medscape Medical News at the time that “If we’re talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, ‘This is still the right course for me,’ then I don’t have any objection.”

But considering the use of cross-sex hormones in children and adolescents is “quite a different story,” he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw’s letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

“We agree that research to validate the safety and efficacy of all forms of treatment is desirable,” they wrote, noting some of that research is underway.

“However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is.”
 

Research to validate safety and efficacy of transgender TX underway

Rosenthal’s center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

“We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms,” he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

“We don’t push anybody down any path,” he said. “The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals,” said Rosenthal.

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

“Everything we do in medicine has a theoretical risk of harm,” noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

“Puberty blockers are exactly the epitome of ‘do no harm’ in this case,” argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn’t mean there aren’t still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, “How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not,” he said.

“So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones,” he explained.
 

State proposals will have chilling effect on gender-questioning kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

“They’re already in a hard position,” Brady said of her patients.

“They’re coming here to seek something for a life that they’ve already not wanted to live and then we have people who are trying to put a real big block on that – I see that obviously affecting their mental health,” she observed.

“I can’t imagine how their lives would be without this care,” Brady said.

With the bills being out there, “two things can happen – one is, it can be very depressing and limiting, but it can also embolden people,” Rosenthal told Medscape Medical News.

“The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH),” he explained.

“These people are going to do everything they can, whether it’s to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research,” said Rosenthal.

Safer believes it’s ill-considered to try to legislate any aspect of medicine.

“The pitfalls of trying to legislate these things are myriad,” he said.

“Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be,” he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

“These things are being proposed based on a lot of misinformation,” said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers “are not looking at the scientific evidence that supports current clinical practice guidelines,” Rosenthal, who treats transgender children, told Medscape Medical News.

And “People just aren’t really understanding the harm that regulating this kind of medicine would do,” stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom’s only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1,500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called “rapid-onset gender dysphoria” in born females who say they wish to become males and some clinicians have said this represents a “social” phenomenon.

But guidelines from US clinical organizations – including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) – all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More data needed but evidence to intervene is compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data “even if it’s rudimentary, are convincing that there is a biological component to gender identity.”

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it’s still not known what causes gender identity – whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process – said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, “The data for interventions for transgender people ... is compelling,” he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

“Those data are modest at this point and we need better data, but they do all move in the same direction,” he asserted.

Meanwhile, a large group of around 1,800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

“We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare,” the parents write.

“These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children,” they continue.

“They should not be made by politicians who think they know better than medical professionals,” they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts “to block access to these recognized interventions,” it said in a statement.

Proponents of laws speak of harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri’s proposed legislation labels surgical or hormonal treatment for a child under age 18 “abuse or neglect”; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2,000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it “supports physicians’ ability to provide the best evidence-based treatment to their patients,” and that “these decisions should be made by the family and physician, and not dictated by policymakers.”

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

“The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment,” wrote Turban.

“State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them,” he added.
 

Few states seem to have approached clinicians for feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they’ve received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it “supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children.”

“However, we do not support state bills that are not victim-led or used for political gain,” they added.
 

Existing knowledge imperfect but treatment indicated for some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California–based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers “a public health emergency.”

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society’s 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that “the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy.”

Laidlaw told Medscape Medical News at the time that “If we’re talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, ‘This is still the right course for me,’ then I don’t have any objection.”

But considering the use of cross-sex hormones in children and adolescents is “quite a different story,” he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw’s letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

“We agree that research to validate the safety and efficacy of all forms of treatment is desirable,” they wrote, noting some of that research is underway.

“However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is.”
 

Research to validate safety and efficacy of transgender TX underway

Rosenthal’s center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

“We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms,” he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

“We don’t push anybody down any path,” he said. “The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals,” said Rosenthal.

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

“Everything we do in medicine has a theoretical risk of harm,” noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

“Puberty blockers are exactly the epitome of ‘do no harm’ in this case,” argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn’t mean there aren’t still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, “How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not,” he said.

“So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones,” he explained.
 

State proposals will have chilling effect on gender-questioning kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

“They’re already in a hard position,” Brady said of her patients.

“They’re coming here to seek something for a life that they’ve already not wanted to live and then we have people who are trying to put a real big block on that – I see that obviously affecting their mental health,” she observed.

“I can’t imagine how their lives would be without this care,” Brady said.

With the bills being out there, “two things can happen – one is, it can be very depressing and limiting, but it can also embolden people,” Rosenthal told Medscape Medical News.

“The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH),” he explained.

“These people are going to do everything they can, whether it’s to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research,” said Rosenthal.

Safer believes it’s ill-considered to try to legislate any aspect of medicine.

“The pitfalls of trying to legislate these things are myriad,” he said.

“Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be,” he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Many US endocrinologists are crying foul as a growing number of state lawmakers are attempting to enact legislation that would prohibit, and in some cases criminalize, medical treatment for minors with gender dysphoria.

As of press time, 13 states had introduced such bills, and legislators in two additional states said they were drafting bills. So far, one — in South Dakota — was defeated in a Senate committee, and another, in Florida, was essentially tabled without being enacted.

They all have a common goal of preventing minors from receiving puberty blockers, cross-sex hormones, or gender-affirmation surgery.

“These things are being proposed based on a lot of misinformation,” said Stephen Rosenthal, MD, professor of pediatrics at the University of California, San Francisco (UCSF), and a past president of the Pediatric Endocrine Society.

Lawmakers “are not looking at the scientific evidence that supports current clinical practice guidelines,” Rosenthal, who treats transgender children, told Medscape Medical News.

And “People just aren’t really understanding the harm that regulating this kind of medicine would do,” stressed Cassandra Brady, MD, assistant professor of pediatric endocrinology at Vanderbilt University School of Medicine, Memphis, Tennessee.

The bills come at a time when gender identity clinics for minors around the world have seen a significant uptick in cases. And, as widely reported by Medscape Medical News, some clinicians have begun to question whether treatment decisions are outpacing science.

Queries about use of puberty blockers and cross-sex hormones have embroiled the United Kingdom’s only publicly funded Gender Identity Development Service (GIDS) in controversy, for example, with five clinicians resigning last year over concerns about overuse of the treatments.

And earlier this month, the UK National Health Service (NHS) announced an independent review of services including the use of puberty blockers and cross-sex hormones in youth with gender dysphoria.

Meanwhile, the topic has ignited debate in Sweden, where a report from the Board of Health and Welfare confirmed a 1,500% rise between 2008 and 2018 in gender dysphoria diagnoses among 13- to 17-year-olds born as girls, as detailed by The Guardian.

Indeed, there is some indication of a so-called “rapid-onset gender dysphoria” in born females who say they wish to become males and some clinicians have said this represents a “social” phenomenon.

But guidelines from US clinical organizations – including the American Academy of Pediatrics issued in 2018, the Endocrine Society as reported by Medscape Medical News in 2017, and the US Professional Association for Transgender Health (USPATH) – all support the use of medical treatment in adolescents with gender dysphoria who have received mental health evaluations from appropriately trained professionals.

More data needed but evidence to intervene is compelling

Joshua Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York City, says the data “even if it’s rudimentary, are convincing that there is a biological component to gender identity.”

Attempts to manipulate gender identity in people who are born intersex, for example, have uniformly failed, he noted.

Yet it’s still not known what causes gender identity – whether it might be a result of a cluster of genes or a bundle in the brain, or some other biological process – said Safer, who treats transgender adults, but not children, and is also a coauthor of the aforementioned Endocrine Society Clinical Practice Guideline on Endocrine Treatment of Gender Dysphoric/Gender Incongruent Persons.

This is an area for future research, he noted.

Nevertheless, “The data for interventions for transgender people ... is compelling,” he added, noting evidence for improved mental health morbidity among those gender-questioning people who have medical interventions.

“Those data are modest at this point and we need better data, but they do all move in the same direction,” he asserted.

Meanwhile, a large group of around 1,800 parents of transgender and nonbinary children have called on legislators to withdraw the proposals in an open letter organized by the Human Rights Campaign.

“We know better than anyone what our children need in order to thrive: access to best practice, evidence-based gender-affirming healthcare,” the parents write.

“These healthcare decisions must be made on a case-by-case basis, in careful consultation with a medical team, and with the goal of reducing the physical and emotional distress experienced by many transgender children,” they continue.

“They should not be made by politicians who think they know better than medical professionals,” they add.

The American Academy of Child and Adolescent Psychiatry has also condemned state efforts “to block access to these recognized interventions,” it said in a statement.

Proponents of laws speak of harms

Most of the state proposals portray medical interventions as harmful to minors.

Missouri’s proposed legislation labels surgical or hormonal treatment for a child under age 18 “abuse or neglect”; a physician or anyone who assists or provides for the child would be charged with a felony.

One of the first bills was introduced in South Dakota in January. House bill 1057 would have charged clinicians providing gender-affirming care in anyone under age 16 with a misdemeanor punishable by up to a year in prison and a $2,000 fine.

The bill was defeated in the Senate after the South Dakota State Medical Association and several other physicians, families, and adolescents testified against the proposal, according to the Argus Leader.

The Endocrine Society applauded the failure and noted in a statement that it “supports physicians’ ability to provide the best evidence-based treatment to their patients,” and that “these decisions should be made by the family and physician, and not dictated by policymakers.”

Jack Turban, MD, a resident physician in child and adolescent psychiatry at Massachusetts General Hospital, Boston, who conducted a pivotal study of some 26,000 transgender adults showing that early administration of puberty blockers led to lower odds of lifetime suicidal ideation, also expressed dismay over the bills in an opinion piece for the New York Times.

“The potential benefits of providing gender-affirmative care typically outweigh the minor risks associated with treatment,” wrote Turban.

“State legislators need to educate themselves about these young people and their medical care before introducing legislation that will hurt them,” he added.
 

Few states seem to have approached clinicians for feedback

In Tennessee, lawmakers have approached some clinicians at Vanderbilt and have appreciated the feedback they’ve received so far, said Brady.

But that may be an exception. It seems that few medical organizations have been consulted in the crafting of bills in the other states: Colorado, Florida, Idaho, Illinois, Kentucky, Mississippi, Missouri, New Hampshire, Oklahoma, South Carolina, South Dakota, and West Virginia. Lawmakers in Ohio and Utah also are drafting proposals.

Physicians could be charged with a felony in Florida, Idaho, Kentucky, Missouri, and reportedly, in the Ohio proposal under development.

The bills have been introduced at the behest of some conservative groups that doubt the existence of gender dysphoria or who have questions about treatment: the Eagle Forum, the Alliance Defending Freedom, and the Kelsey Coalition.

In a recent tweet clarifying its position on state efforts, the Kelsey Coalition said it “supports all bills that protect children, even those that may provide criminal penalties, because we believe these medical interventions should never be performed on children.”

“However, we do not support state bills that are not victim-led or used for political gain,” they added.
 

Existing knowledge imperfect but treatment indicated for some

The bills have also garnered support from some endocrinologists who have raised concerns about puberty blockers and other medical treatments for gender dysphoria.

One is Michael K. Laidlaw, MD, a Rocklin, California–based endocrinologist who has not treated transgender people but frequently writes about the subject, most recently calling the use of puberty blockers “a public health emergency.”

Laidlaw joined several other clinicians who do not treat transgender people in testifying in favor of the South Dakota bill.

Last year, as previously reported by Medscape Medical News, Laidlaw, along with others, criticized the Endocrine Society’s 2017 Clinical Practice Guideline on Treating Dysphoric/Gender-Incongruent Persons in a letter to the Journal of Clinical Endocrinology & Metabolism.

They stated that there is no lab, imaging, or other objective test to diagnose someone as transgender and that “the consequences of this gender-affirmative therapy are not trivial and include potential sterility, sexual dysfunction, thromboembolic and cardiovascular disease, and malignancy.”

Laidlaw told Medscape Medical News at the time that “If we’re talking about [transgender] adults [who have gone through puberty of their biological sex] and who can make a decision, if they have been truly notified of the risks and benefits [of cross-sex hormones] and have also had psychological evaluation, and they decide, ‘This is still the right course for me,’ then I don’t have any objection.”

But considering the use of cross-sex hormones in children and adolescents is “quite a different story,” he contended.

In May 2019, Rosenthal, Safer and colleagues responded to Laidlaw’s letter in the same journal, stating that for the right person, puberty blockers and cross-sex hormones are appropriate, and that medications can improve mental health outcomes.

“We agree that research to validate the safety and efficacy of all forms of treatment is desirable,” they wrote, noting some of that research is underway.

“However, we believe physicians would fall short in their duty of care if they withheld hormonal treatment of gender dysphoria/incongruence in pubertal youth, when indicated, given the existing state of knowledge, imperfect though it is.”
 

Research to validate safety and efficacy of transgender TX underway

Rosenthal’s center at UCSF is one of four in the United States that has been carrying out a National Institutes of Health-funded long-term observational study of the impact of early medical intervention on transgender adolescents.

It will take time to get those results, but in the meantime, clinicians should act on what is known now, said Rosenthal.

“We already have very compelling data to suggest that the benefits [of treatment] outweigh the potential harms,” he said.

Rosenthal told Medscape Medical News that Laidlaw has advanced the notion that clinicians who prescribe puberty blockers are forcing those individuals into a transgender outcome.

“We don’t push anybody down any path,” he said. “The guidelines make these treatments available in a very specific subset of people who are evaluated by skilled mental health professionals,” said Rosenthal.

Both he and Safer acknowledge that puberty blockers do have the potential for some harm. For instance, a frank discussion needs to happen about the likely lack of future fertility, said Rosenthal.

“Everything we do in medicine has a theoretical risk of harm,” noted Safer.

However, he said, to deny a puberty blocker to an individual approaching puberty who is distraught about growing breasts — but then to possibly have to surgically remove them later — is in itself doing harm.

“Puberty blockers are exactly the epitome of ‘do no harm’ in this case,” argued Safer.

The medications are reversible, he said, adding that they also give an individual and the family time to think through whether the adolescent is transgender, and, if yes, what they want to do in terms of taking cross-sex hormones in the future or getting other interventions.

Safer acknowledged that this doesn’t mean there aren’t still some concerns, however.

For instance, once puberty blockers — which have the potential to interfere with bone development — are started, “How much harm are you willing to risk? Maybe a couple of years is okay, but maybe 6 years is not,” he said.

“So, we do discuss how quickly...you have to get to your next decision point, whether it be to actually introduce hormones or not to introduce hormones,” he explained.
 

State proposals will have chilling effect on gender-questioning kids

Clinicians say that even if the proposals do not become law, just the fact of their existence could have a chilling effect on gender-questioning children, their families, and doctors considering whether to provide treatment.

“They’re already in a hard position,” Brady said of her patients.

“They’re coming here to seek something for a life that they’ve already not wanted to live and then we have people who are trying to put a real big block on that – I see that obviously affecting their mental health,” she observed.

“I can’t imagine how their lives would be without this care,” Brady said.

With the bills being out there, “two things can happen – one is, it can be very depressing and limiting, but it can also embolden people,” Rosenthal told Medscape Medical News.

“The people behind these things are the same people that have tried to stop our research at the National Institutes of Health (NIH),” he explained.

“These people are going to do everything they can, whether it’s to go state by state to try and exhaust us, or go to the NIH and try to get them to pull the plug on our research,” said Rosenthal.

Safer believes it’s ill-considered to try to legislate any aspect of medicine.

“The pitfalls of trying to legislate these things are myriad,” he said.

“Across all of medicine, interventions are very customized. Can you imagine a state legislature trying to legislate the optimal approach in medicines that can and cannot be given to people with diabetes? How crazy that would be,” he noted.

Rosenthal has served on an advisory panel for Endo Pharmaceuticals and is a grantee of the NIH. Safer has also served on an advisory panel for Endo Pharmaceuticals. Brady has reported no relevant financial relationships.

This article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

President Donald J. Trump took on multiple health care issues in his State of the Union address, imploring Congress to avoid the “socialism” of Medicare-for-all, to pass legislation banning late-term abortions, and to protect insurance coverage for preexisting conditions while joining together to reduce rising drug prices.

Mr. Trump said his administration has already been “taking on the big pharmaceutical companies,” claiming that, in 2019, “for the first time in 51 years, the cost of prescription drugs actually went down.”

That statement was called “misleading” by the New York Times because such efforts have excluded some high-cost drugs, and prices had risen by the end of the year, the publication noted in a fact-check of the president’s speech.

A survey issued in December 2019 found that the United States pays the highest prices in the world for pharmaceuticals, as reported by Medscape Medical News.

But the president did throw down a gauntlet for Congress. “Working together, the Congress can reduce drug prices substantially from current levels,” he said, stating that he had been “speaking to Sen. Chuck Grassley of Iowa and others in the Congress in order to get something on drug pricing done, and done properly.

“Get a bill to my desk, and I will sign it into law without delay,” Mr. Trump said.

A group of House Democrats then stood up in the chamber and loudly chanted, “HR3, HR3,” referring to the Lower Drug Costs Now Act, which the House passed in December 2019.

The bill would give the Department of Health & Human Services the power to negotiate directly with drug companies on up to 250 drugs per year, in particular, the highest-costing and most-utilized drugs.

The Senate has not taken up the legislation, but Sen. Grassley (R) and Sen. Ron Wyden (D-Ore.) introduced a similar bill, the Prescription Drug Pricing Reduction Act. It has been approved by the Senate Finance Committee but has not been moved to the Senate floor.

“I appreciate President Trump recognizing the work we’re doing to lower prescription drug prices,” Sen. Grassley said in a statement after the State of the Union. “Iowans and Americans across the country are demanding reforms that lower sky-high drug costs. A recent poll showed 70% of Americans want Congress to make lowering drug prices its top priority.”

Rep. Greg Walden (R-Ore.), the ranking Republican on the House Energy and Commerce Committee, said he believed Trump was committed to lowering drug costs. “I’ve never seen a president lean in further than President Donald Trump on lowering health care costs,” said Rep. Walden in a statement after the speech.

Trump touted his price transparency rule, which he said would go into effect next January, as a key way to cut health care costs.

Preexisting conditions

The president said that since he’d taken office, insurance had become more affordable and that the quality of health care had improved. He also said that he was making what he called an “iron-clad pledge” to American families.

“We will always protect patients with preexisting conditions – that is a guarantee,” Mr. Trump said.

In a press conference before the speech, Speaker of the House Nancy Pelosi (D-Calif.) took issue with that pledge. “The president swears that he supports protections for people with preexisting conditions, but right now, he is fighting in federal court to eliminate these lifesaving protections and every last protection and benefit of the Affordable Care Act,” she said.

During the speech, Rep. G. K. Butterfield (D-N.C.) tweeted “#FactCheck: Claiming to protect Americans with preexisting conditions, Trump and his administration have repeatedly sought to undermine protections offered by the ACA through executive orders and the courts. He is seeking to strike down the law and its protections entirely.”

Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, pointed out in a tweet that insurance plans that Trump touted as “affordable alternatives” are in fact missing those protections.

“Ironically, the cheaper health insurance plans that President Trump has expanded are short-term plans that don’t cover preexisting conditions,” Mr. Levitt said.

Socialist takeover

Mr. Trump condemned the Medicare-for-all proposals that have been introduced in Congress and that are being backed in whole or in part by all of the Democratic candidates for president.

“As we work to improve Americans’ health care, there are those who want to take away your health care, take away your doctor, and abolish private insurance entirely,” said Mr. Trump.

He said that 132 members of Congress “have endorsed legislation to impose a socialist takeover of our health care system, wiping out the private health insurance plans of 180 million Americans.”

Added Mr. Trump: “We will never let socialism destroy American health care!”

Medicare-for-all has waxed and waned in popularity among voters, with generally more Democrats than Republicans favoring a single-payer system, with or without a public option.

Preliminary exit polls in Iowa that were conducted during Monday’s caucus found that 57% of Iowa Democratic caucus-goers supported a single-payer plan; 38% opposed such a plan, according to the Washington Post.
 

Opioids, the coronavirus, and abortion

In some of his final remarks on health care, Mr. Trump cited progress in the opioid crisis, noting that, in 2019, drug overdose deaths declined for the first time in 30 years.

He said that his administration was coordinating with the Chinese government regarding the coronavirus outbreak and noted the launch of initiatives to improve care for people with kidney disease, Alzheimer’s, and mental health problems.

Mr. Trump repeated his 2019 State of the Union claim that the government would help end AIDS in America by the end of the decade.

The president also announced that he was asking Congress for “an additional $50 million” to fund neonatal research. He followed that up with a plea about abortion.

“I am calling upon the members of Congress here tonight to pass legislation finally banning the late-term abortion of babies,” he said.

Insulin costs?

In the days before the speech, some news outlets had reported that Mr. Trump and the HHS were working on a plan to lower insulin prices for Medicare beneficiaries, and there were suggestions it would come up in the speech.

At least 13 members of Congress invited people advocating for lower insulin costs as their guests for the State of the Union, Stat reported. Rep. Pelosi invited twins from San Francisco with type 1 diabetes as her guests.

But Mr. Trump never mentioned insulin in his speech.

This article first appeared on Medscape.com.

Academic cancer centers around the United States continue to get caught up in an ever-evolving investigation into researchers – American and Chinese – who did not disclose payments from or the work they did for Chinese institutions while simultaneously accepting taxpayer money through U.S. government grants.

The U.S. Federal Bureau of Investigation has been ferreting out researchers it says have acted illegally.

On Jan. 28, the agency arrested Charles Lieber, a chemist from Harvard University, Cambridge, Mass., and also unveiled charges against Zheng Zaosong, a cancer researcher who is in the United States on a Harvard-sponsored visa.

The FBI said Mr. Zheng, who worked at the Harvard-affiliated Beth Israel Deaconess Medical Center, Boston, tried to smuggle 21 vials of biological material and research to China. Mr. Zheng was arrested in December at Boston’s Logan Airport. He admitted he planned to conduct and publish research in China using the stolen samples, said the FBI.

“All of the individuals charged today were either directly or indirectly working for the Chinese government, at our country’s expense,” said the agent in charge of the FBI’s Boston office, Joseph R. Bonavolonta.

Sen. Charles Grassley (R-IA), who has been pushing for more government action against foreign theft of U.S. research, said in a statement, “I’m glad the FBI appears to be taking foreign threats to taxpayer-funded research seriously, but I fear that this case is only the tip of the iceberg.”

The FBI said it is investigating China-related cases in all 50 states.

Ross McKinney, MD, the chief scientific officer at the Association of American Medical Colleges (AAMC), said he is aware of some 200 investigations, not all of which are cancer related, at 70-75 institutions.

“It’s a very ubiquitous problem,” Dr. McKinney said in an interview.

He also pointed out that some 6,000 National Institutes of Health–funded principal investigators are of Asian background. “So that 200 is a pretty small proportion,” said Dr. McKinney.

The NIH warned some 10,000 institutions in August 2018 that it had uncovered Chinese manipulation of peer review and a lack of disclosure of work for Chinese institutions. It urged the institutions to report irregularities.

For universities, “the trouble is sorting out who is the violator from who is not,” said Dr. McKinney. He noted that they are not set up to investigate whether someone has a laboratory in China.

“The fact that the Chinese government exploited the fact that universities are typically fairly trusting is extremely disappointing,” he said.
 

Moffitt story still unfolding

The most serious allegations have been leveled against six former employees of the Moffitt Cancer Center and Research Institute in Tampa, Florida.

In December 2019, Moffitt announced that the six – including President and CEO Alan List, MD, and the center director, Thomas Sellers, PhD – had left Moffitt as a result of “violations of conflict of interest rules through their work in China.”

New details have emerged, thanks to a new investigative report from a committee of the Florida House of Representatives.

The report said that Sheng Wei, a naturalized U.S. citizen who had worked at Moffitt since 2008 – when Moffitt began its affiliation with the Tianjin Medical University Cancer Institute and Hospital – was instrumental in recruiting top executives into the Thousand Talents program, which Wei had joined in 2010, according to the report. These executives included Dr. List, Dr. Sellers, and also Daniel Sullivan, head of Moffitt’s clinical science program, and cancer biologist Pearlie Epling-Burnette, it noted.

Begun in 2008, China’s Thousand Talents Plan gave salaries, funding, laboratory space, and other incentives to researchers who promised to bring U.S.-gained knowledge and research to China.

All information about this program has been removed from the Internet, but the program may still be active, Dr. McKinney commented.

According to the report, Dr. List pledged to work for the Tianjin cancer center 9 months a year for $71,000 annually. He was appointed head of the hematology department ($85,300 a year) in 2016. He opened a bank account in China to receive that salary and other Thousand Talents payments, the report found. The report notes that the exact amount Dr. List was paid is still not known.

Initially, Dr. Sellers, who was the principal investigator for Moffitt’s National Cancer Institute core grant, said he had not been involved in the Thousand Talents program. He later admitted that he had pledged to work in China 2 months a year for the program and that he’d opened a Chinese bank account and had deposited at least $35,000 into the account, the report notes.

The others pledged to work for the Thousand Talents program and also opened bank accounts in China and received money in those accounts.

Another Moffitt employee, Howard McLeod, MD, had worked for Thousand Talents before he joined Moffitt but did not disclose his China work. Dr. McLeod also supervised and had a close relationship with another researcher, Yijing (Bob) He, MD, who was employed by Moffitt but who lived in China, unbeknownst to Moffitt. “Dr. He appears to have functioned as an agent of Dr. McLeod in China,” said the report.

The report concluded that “none of the Moffitt faculty who were Talents program participants properly or timely disclosed their Talents program involvement to Moffitt, and none disclosed the full extent of their Talents program activities prior to Moffitt’s internal investigation.”

No charges have been filed against any of the former Moffitt employees.

However, the Cancer Letter has reported that Dr. Sellers is claiming he was not involved in the program and that he is preparing to sue Moffitt.

AAMC’s Dr. McKinney notes that it is illegal for researchers to take U.S. government grant money and pledge a certain amount of time but not deliver on that commitment because they are working for someone else – in this case, China. They also lied about not having any other research support, which is also illegal, he said.

The researchers received Chinese money and deposited it in Chinese accounts, which was never reported to the U.S. Internal Revenue Service.

“One of the hallmarks of the Chinese recruitment program was that people were instructed to not tell their normal U.S. host institution and not tell any U.S. government agency about their relationship with China,” Dr. McKinney said. “It was creating a culture where dishonesty in this situation was norm,” he added.

The lack of honesty brings up bigger questions for the field, he said. “Once you start lying about one thing, do you lie about your science, too?”
 

Lack of oversight?

Dr. McKinney said the NIH, as well as universities and hospitals, had a long and trusting relationship with China and should not be blamed for falling prey to the Chinese government’s concerted effort to steal intellectual property.

But some government watchdog groups have chided the NIH for lax oversight. In February 2019, the federal Health & Human Services’ Office of Inspector General found that “NIH has not assessed the risks to national security when permitting data access to foreign [principal investigators].”

Federal investigators have said that Thousand Talents has been one of the biggest threats.

The U.S. Senate Permanent Subcommittee on Investigations reported in November 2019 that “the federal government’s grant-making agencies did little to prevent this from happening, nor did the FBI and other federal agencies develop a coordinated response to mitigate the threat.”

The NIH invests $31 billion a year in medical research through 50,000 competitive grants to more than 300,000 researchers, according to that report. Even after uncovering grant fraud and peer-review manipulation that benefited China, “significant gaps in NIH’s grant integrity process remain,” the report states. Site visits by the NIH’s Division of Grants Compliance and Oversight dropped from 28 in 2012 to just 3 in 2018, the report noted.
 

Widening dragnet

In April 2019, Science reported that the NIH identified five researchers at MD Anderson Cancer Center in Houston who had failed to disclose their ties to Chinese enterprises and who had failed to keep peer review confidential.

Two resigned before they could be fired, one was fired, another eventually left the institution, and the fifth was found to have not willfully engaged in subterfuge.

Just a month later, Emory University in Atlanta announced that it had fired a husband and wife research team. The neuroscientists were known for their studies of Huntington disease. Both were U.S. citizens and had worked at Emory for more than 2 decades, according to the Science report.

The Moffitt situation led to the Florida legislature’s investigation, and also prompted some soul searching. The Tampa Bay Times reported that U.S. Senator Rick Scott (R-FL) asked state universities to provide information on what they are doing to stop foreign influence. The University of Florida then acknowledged that four faculty members resigned or were terminated because of ties to a foreign recruitment program.
 

This article first appeared on Medscape.com.

Academic cancer centers around the United States continue to get caught up in an ever-evolving investigation into researchers – American and Chinese – who did not disclose payments from or the work they did for Chinese institutions while simultaneously accepting taxpayer money through U.S. government grants.

The U.S. Federal Bureau of Investigation has been ferreting out researchers it says have acted illegally.

On Jan. 28, the agency arrested Charles Lieber, a chemist from Harvard University, Cambridge, Mass., and also unveiled charges against Zheng Zaosong, a cancer researcher who is in the United States on a Harvard-sponsored visa.

The FBI said Mr. Zheng, who worked at the Harvard-affiliated Beth Israel Deaconess Medical Center, Boston, tried to smuggle 21 vials of biological material and research to China. Mr. Zheng was arrested in December at Boston’s Logan Airport. He admitted he planned to conduct and publish research in China using the stolen samples, said the FBI.

“All of the individuals charged today were either directly or indirectly working for the Chinese government, at our country’s expense,” said the agent in charge of the FBI’s Boston office, Joseph R. Bonavolonta.

Sen. Charles Grassley (R-IA), who has been pushing for more government action against foreign theft of U.S. research, said in a statement, “I’m glad the FBI appears to be taking foreign threats to taxpayer-funded research seriously, but I fear that this case is only the tip of the iceberg.”

The FBI said it is investigating China-related cases in all 50 states.

Ross McKinney, MD, the chief scientific officer at the Association of American Medical Colleges (AAMC), said he is aware of some 200 investigations, not all of which are cancer related, at 70-75 institutions.

“It’s a very ubiquitous problem,” Dr. McKinney said in an interview.

He also pointed out that some 6,000 National Institutes of Health–funded principal investigators are of Asian background. “So that 200 is a pretty small proportion,” said Dr. McKinney.

The NIH warned some 10,000 institutions in August 2018 that it had uncovered Chinese manipulation of peer review and a lack of disclosure of work for Chinese institutions. It urged the institutions to report irregularities.

For universities, “the trouble is sorting out who is the violator from who is not,” said Dr. McKinney. He noted that they are not set up to investigate whether someone has a laboratory in China.

“The fact that the Chinese government exploited the fact that universities are typically fairly trusting is extremely disappointing,” he said.
 

Moffitt story still unfolding

The most serious allegations have been leveled against six former employees of the Moffitt Cancer Center and Research Institute in Tampa, Florida.

In December 2019, Moffitt announced that the six – including President and CEO Alan List, MD, and the center director, Thomas Sellers, PhD – had left Moffitt as a result of “violations of conflict of interest rules through their work in China.”

New details have emerged, thanks to a new investigative report from a committee of the Florida House of Representatives.

The report said that Sheng Wei, a naturalized U.S. citizen who had worked at Moffitt since 2008 – when Moffitt began its affiliation with the Tianjin Medical University Cancer Institute and Hospital – was instrumental in recruiting top executives into the Thousand Talents program, which Wei had joined in 2010, according to the report. These executives included Dr. List, Dr. Sellers, and also Daniel Sullivan, head of Moffitt’s clinical science program, and cancer biologist Pearlie Epling-Burnette, it noted.

Begun in 2008, China’s Thousand Talents Plan gave salaries, funding, laboratory space, and other incentives to researchers who promised to bring U.S.-gained knowledge and research to China.

All information about this program has been removed from the Internet, but the program may still be active, Dr. McKinney commented.

According to the report, Dr. List pledged to work for the Tianjin cancer center 9 months a year for $71,000 annually. He was appointed head of the hematology department ($85,300 a year) in 2016. He opened a bank account in China to receive that salary and other Thousand Talents payments, the report found. The report notes that the exact amount Dr. List was paid is still not known.

Initially, Dr. Sellers, who was the principal investigator for Moffitt’s National Cancer Institute core grant, said he had not been involved in the Thousand Talents program. He later admitted that he had pledged to work in China 2 months a year for the program and that he’d opened a Chinese bank account and had deposited at least $35,000 into the account, the report notes.

The others pledged to work for the Thousand Talents program and also opened bank accounts in China and received money in those accounts.

Another Moffitt employee, Howard McLeod, MD, had worked for Thousand Talents before he joined Moffitt but did not disclose his China work. Dr. McLeod also supervised and had a close relationship with another researcher, Yijing (Bob) He, MD, who was employed by Moffitt but who lived in China, unbeknownst to Moffitt. “Dr. He appears to have functioned as an agent of Dr. McLeod in China,” said the report.

The report concluded that “none of the Moffitt faculty who were Talents program participants properly or timely disclosed their Talents program involvement to Moffitt, and none disclosed the full extent of their Talents program activities prior to Moffitt’s internal investigation.”

No charges have been filed against any of the former Moffitt employees.

However, the Cancer Letter has reported that Dr. Sellers is claiming he was not involved in the program and that he is preparing to sue Moffitt.

AAMC’s Dr. McKinney notes that it is illegal for researchers to take U.S. government grant money and pledge a certain amount of time but not deliver on that commitment because they are working for someone else – in this case, China. They also lied about not having any other research support, which is also illegal, he said.

The researchers received Chinese money and deposited it in Chinese accounts, which was never reported to the U.S. Internal Revenue Service.

“One of the hallmarks of the Chinese recruitment program was that people were instructed to not tell their normal U.S. host institution and not tell any U.S. government agency about their relationship with China,” Dr. McKinney said. “It was creating a culture where dishonesty in this situation was norm,” he added.

The lack of honesty brings up bigger questions for the field, he said. “Once you start lying about one thing, do you lie about your science, too?”
 

Lack of oversight?

Dr. McKinney said the NIH, as well as universities and hospitals, had a long and trusting relationship with China and should not be blamed for falling prey to the Chinese government’s concerted effort to steal intellectual property.

But some government watchdog groups have chided the NIH for lax oversight. In February 2019, the federal Health & Human Services’ Office of Inspector General found that “NIH has not assessed the risks to national security when permitting data access to foreign [principal investigators].”

Federal investigators have said that Thousand Talents has been one of the biggest threats.

The U.S. Senate Permanent Subcommittee on Investigations reported in November 2019 that “the federal government’s grant-making agencies did little to prevent this from happening, nor did the FBI and other federal agencies develop a coordinated response to mitigate the threat.”

The NIH invests $31 billion a year in medical research through 50,000 competitive grants to more than 300,000 researchers, according to that report. Even after uncovering grant fraud and peer-review manipulation that benefited China, “significant gaps in NIH’s grant integrity process remain,” the report states. Site visits by the NIH’s Division of Grants Compliance and Oversight dropped from 28 in 2012 to just 3 in 2018, the report noted.
 

Widening dragnet

In April 2019, Science reported that the NIH identified five researchers at MD Anderson Cancer Center in Houston who had failed to disclose their ties to Chinese enterprises and who had failed to keep peer review confidential.

Two resigned before they could be fired, one was fired, another eventually left the institution, and the fifth was found to have not willfully engaged in subterfuge.

Just a month later, Emory University in Atlanta announced that it had fired a husband and wife research team. The neuroscientists were known for their studies of Huntington disease. Both were U.S. citizens and had worked at Emory for more than 2 decades, according to the Science report.

The Moffitt situation led to the Florida legislature’s investigation, and also prompted some soul searching. The Tampa Bay Times reported that U.S. Senator Rick Scott (R-FL) asked state universities to provide information on what they are doing to stop foreign influence. The University of Florida then acknowledged that four faculty members resigned or were terminated because of ties to a foreign recruitment program.
 

This article first appeared on Medscape.com.

Academic cancer centers around the United States continue to get caught up in an ever-evolving investigation into researchers – American and Chinese – who did not disclose payments from or the work they did for Chinese institutions while simultaneously accepting taxpayer money through U.S. government grants.

The U.S. Federal Bureau of Investigation has been ferreting out researchers it says have acted illegally.

On Jan. 28, the agency arrested Charles Lieber, a chemist from Harvard University, Cambridge, Mass., and also unveiled charges against Zheng Zaosong, a cancer researcher who is in the United States on a Harvard-sponsored visa.

The FBI said Mr. Zheng, who worked at the Harvard-affiliated Beth Israel Deaconess Medical Center, Boston, tried to smuggle 21 vials of biological material and research to China. Mr. Zheng was arrested in December at Boston’s Logan Airport. He admitted he planned to conduct and publish research in China using the stolen samples, said the FBI.

“All of the individuals charged today were either directly or indirectly working for the Chinese government, at our country’s expense,” said the agent in charge of the FBI’s Boston office, Joseph R. Bonavolonta.

Sen. Charles Grassley (R-IA), who has been pushing for more government action against foreign theft of U.S. research, said in a statement, “I’m glad the FBI appears to be taking foreign threats to taxpayer-funded research seriously, but I fear that this case is only the tip of the iceberg.”

The FBI said it is investigating China-related cases in all 50 states.

Ross McKinney, MD, the chief scientific officer at the Association of American Medical Colleges (AAMC), said he is aware of some 200 investigations, not all of which are cancer related, at 70-75 institutions.

“It’s a very ubiquitous problem,” Dr. McKinney said in an interview.

He also pointed out that some 6,000 National Institutes of Health–funded principal investigators are of Asian background. “So that 200 is a pretty small proportion,” said Dr. McKinney.

The NIH warned some 10,000 institutions in August 2018 that it had uncovered Chinese manipulation of peer review and a lack of disclosure of work for Chinese institutions. It urged the institutions to report irregularities.

For universities, “the trouble is sorting out who is the violator from who is not,” said Dr. McKinney. He noted that they are not set up to investigate whether someone has a laboratory in China.

“The fact that the Chinese government exploited the fact that universities are typically fairly trusting is extremely disappointing,” he said.
 

Moffitt story still unfolding

The most serious allegations have been leveled against six former employees of the Moffitt Cancer Center and Research Institute in Tampa, Florida.

In December 2019, Moffitt announced that the six – including President and CEO Alan List, MD, and the center director, Thomas Sellers, PhD – had left Moffitt as a result of “violations of conflict of interest rules through their work in China.”

New details have emerged, thanks to a new investigative report from a committee of the Florida House of Representatives.

The report said that Sheng Wei, a naturalized U.S. citizen who had worked at Moffitt since 2008 – when Moffitt began its affiliation with the Tianjin Medical University Cancer Institute and Hospital – was instrumental in recruiting top executives into the Thousand Talents program, which Wei had joined in 2010, according to the report. These executives included Dr. List, Dr. Sellers, and also Daniel Sullivan, head of Moffitt’s clinical science program, and cancer biologist Pearlie Epling-Burnette, it noted.

Begun in 2008, China’s Thousand Talents Plan gave salaries, funding, laboratory space, and other incentives to researchers who promised to bring U.S.-gained knowledge and research to China.

All information about this program has been removed from the Internet, but the program may still be active, Dr. McKinney commented.

According to the report, Dr. List pledged to work for the Tianjin cancer center 9 months a year for $71,000 annually. He was appointed head of the hematology department ($85,300 a year) in 2016. He opened a bank account in China to receive that salary and other Thousand Talents payments, the report found. The report notes that the exact amount Dr. List was paid is still not known.

Initially, Dr. Sellers, who was the principal investigator for Moffitt’s National Cancer Institute core grant, said he had not been involved in the Thousand Talents program. He later admitted that he had pledged to work in China 2 months a year for the program and that he’d opened a Chinese bank account and had deposited at least $35,000 into the account, the report notes.

The others pledged to work for the Thousand Talents program and also opened bank accounts in China and received money in those accounts.

Another Moffitt employee, Howard McLeod, MD, had worked for Thousand Talents before he joined Moffitt but did not disclose his China work. Dr. McLeod also supervised and had a close relationship with another researcher, Yijing (Bob) He, MD, who was employed by Moffitt but who lived in China, unbeknownst to Moffitt. “Dr. He appears to have functioned as an agent of Dr. McLeod in China,” said the report.

The report concluded that “none of the Moffitt faculty who were Talents program participants properly or timely disclosed their Talents program involvement to Moffitt, and none disclosed the full extent of their Talents program activities prior to Moffitt’s internal investigation.”

No charges have been filed against any of the former Moffitt employees.

However, the Cancer Letter has reported that Dr. Sellers is claiming he was not involved in the program and that he is preparing to sue Moffitt.

AAMC’s Dr. McKinney notes that it is illegal for researchers to take U.S. government grant money and pledge a certain amount of time but not deliver on that commitment because they are working for someone else – in this case, China. They also lied about not having any other research support, which is also illegal, he said.

The researchers received Chinese money and deposited it in Chinese accounts, which was never reported to the U.S. Internal Revenue Service.

“One of the hallmarks of the Chinese recruitment program was that people were instructed to not tell their normal U.S. host institution and not tell any U.S. government agency about their relationship with China,” Dr. McKinney said. “It was creating a culture where dishonesty in this situation was norm,” he added.

The lack of honesty brings up bigger questions for the field, he said. “Once you start lying about one thing, do you lie about your science, too?”
 

Lack of oversight?

Dr. McKinney said the NIH, as well as universities and hospitals, had a long and trusting relationship with China and should not be blamed for falling prey to the Chinese government’s concerted effort to steal intellectual property.

But some government watchdog groups have chided the NIH for lax oversight. In February 2019, the federal Health & Human Services’ Office of Inspector General found that “NIH has not assessed the risks to national security when permitting data access to foreign [principal investigators].”

Federal investigators have said that Thousand Talents has been one of the biggest threats.

The U.S. Senate Permanent Subcommittee on Investigations reported in November 2019 that “the federal government’s grant-making agencies did little to prevent this from happening, nor did the FBI and other federal agencies develop a coordinated response to mitigate the threat.”

The NIH invests $31 billion a year in medical research through 50,000 competitive grants to more than 300,000 researchers, according to that report. Even after uncovering grant fraud and peer-review manipulation that benefited China, “significant gaps in NIH’s grant integrity process remain,” the report states. Site visits by the NIH’s Division of Grants Compliance and Oversight dropped from 28 in 2012 to just 3 in 2018, the report noted.
 

Widening dragnet

In April 2019, Science reported that the NIH identified five researchers at MD Anderson Cancer Center in Houston who had failed to disclose their ties to Chinese enterprises and who had failed to keep peer review confidential.

Two resigned before they could be fired, one was fired, another eventually left the institution, and the fifth was found to have not willfully engaged in subterfuge.

Just a month later, Emory University in Atlanta announced that it had fired a husband and wife research team. The neuroscientists were known for their studies of Huntington disease. Both were U.S. citizens and had worked at Emory for more than 2 decades, according to the Science report.

The Moffitt situation led to the Florida legislature’s investigation, and also prompted some soul searching. The Tampa Bay Times reported that U.S. Senator Rick Scott (R-FL) asked state universities to provide information on what they are doing to stop foreign influence. The University of Florida then acknowledged that four faculty members resigned or were terminated because of ties to a foreign recruitment program.
 

This article first appeared on Medscape.com.