FDA Approves First Diagnostic Drug for Imaging Tau to Help Detect Alzheimer’s Disease

The Food and Drug Administration (FDA) on Thursday approved the first drug for use in imaging abnormal tau protein, which is thought to be a primary marker of Alzheimer’s disease.

Flortaucipir F18 (Tauvid) is an intravenous radioactive agent for use in positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adults with cognitive impairment. These tangles consist of abnormal tau proteins inside the neurons of the brain. The drug works by binding to sites in the brain where abnormal tau proteins grow.

“This approval will provide health care professionals with a new type of brain scan to use in patients being evaluated for Alzheimer’s disease,” said Charles Ganley, M.D., director of Office of Specialty Medicine in the FDA’s Center for Drug Evaluation and Research, in a press release.

The FDA’s approval was based on two studies involving brain scans that used flortaucipir F18. In the first study, five evaluators evaluated the scans of 156 terminally ill patients and interpreted the scans as positive or negative for NFTs. Sixty-four of the patients died within nine months of their scans. Researchers compared the evaluators’ readings of the deceased patients’ scans with postmortem assessments of the density and distribution of NFTs in the same brains by independent pathologists. The study showed that the five evaluators had a high probability of correctly noting tau pathology in patients who had it and an average-to-high probability of correctly noting no tau pathology in patients who did not have it.

The second study included the same patients as the first study along with 18 patients with terminal illness and 159 patients with cognitive impairment who were being evaluated for Alzheimer’s disease. In this study, five new evaluators reviewed each other’s readings of the scans, and the researchers rated how well the evaluators agreed with one another’s assessments. Perfect agreement was scored as 1, and no agreement was scored as 0. Agreement was 0.87 across all 241 patients.

The most common side effects were headache, pain at the injection site, and increased blood pressure, with all side effects occurring in less than 1.5% of the patients.

Flortaucipir F18 was developed by Avid Radiopharmaceuticals Inc., a subsidiary of Eli Lilly and Co. In a statement, Lilly noted that availability of flortaucipir F18 will be limited initially and will expand in response to demand and coverage by insurers.

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Psychiatric News continues to report news and information relevant to psychiatrists about the COVID-19 pandemic. We will highlight these articles for you as they become available online:

APA’s Ethics Committee Responds to Questions Related to COVID-19

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Relaxed Telehealth Regulations Need to Continue Post Pandemic, Experts Tell Congressional Leaders

During a virtual Congressional briefing on Wednesday, APA President Jeffrey Geller, M.D., M.P.H., and members of APA’s Committee on Telepsychiatry emphasized the need for expanded access to mental health care through telehealth not only during the COVID-19 pandemic, but afterward as well.

The briefing, titled “Collective Crisis: Preparing for America’s Next Wave of Mental Health and Substance Use Disorder Needs With Telehealth,” was hosted by APA and the National Alliance on Mental Illness (NAMI). The panel included Peter Yellowlees, M.B.B.S., M.D., of UC Davis; Shabana Khan, M.D., of NYU Langone Health; and Jodi Kwarciany of NAMI. Yellowlees is the co-editor of Telepsychiatry and Health Technologies from APA Publishing.

Rep. Bill Johnson (R-Ohio) and Rep. Paul Tonko (D-New York) also made remarks during the briefing. Johnson is one of the sponsors of the CONNECT Act (HR 4932), which would expand access to telehealth services for mental health treatment. Tonko recently worked on a bipartisan letter to House and Senate leaders asking them to extend tele-mental health services beyond the COVID-19 emergency.

Geller commended Congress and the Trump administration for taking steps to reduce barriers to telepsychiatry, such as allowing Medicare beneficiaries to receive treatment in their own home and through audio-only appointments when necessary. “The evidence is clear that psychiatric care provided by telehealth is as effective as in-person psychiatric services,” he said. He urged lawmakers to make some of these changes permanent, including the following:

• Remove geographic restrictions on tele-mental health care.
• Allow patients to be receive treatment via telehealth in their homes, as the CONNECT Act does.
• Waive the Ryan Haight Act requirement that stipulates any physician issuing a controlled substance must conduct an initial, in-person medical evaluation.
• Allow audio-only telehealth care when appropriate.

Yellowlees and Khan, both members of APA’s Committee on Telepsychiatry, shared stories about how the loosening of telehealth regulations have helped them reach more patients and continue care for others during the pandemic. Yellowlees described one patient, a physician diagnosed with bipolar disorder, who has been able to avoid hospitalization thanks to being able to meet regularly with Yellowlees through telehealth.

“I hope that it’s very clear to people that the reduction of these regulations has been really very positive,” Yellowlees said. He implored all the participants in the meeting “to do their best to maintain this current situation long term.”

“What we’ve found is that individuals who have a significant amount of anxiety may actually feel more comfortable with the distance that this technology affords them,” Khan said.

Kwarciany noted that the pandemic is causing symptoms related to anxiety, depression, and substance use disorders to rise, but it has also allowed for change and innovation to connect patients with care in a very short time. “It’s really critical that we keep this momentum going, maintain a lot of these existing flexibilities, … and pressure policymakers to address these barriers across locations, populations, and forms of coverage so that everyone can receive the right care at the right time.”

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Experience in COVID-Specific Psychiatric Unit Highlights Challenges Related to Discharging Patients

The journals of APA Publishing are receiving numerous submissions on aspects of the COVID-19 pandemic. To get information about findings to the field faster, Psychiatric News is posting summaries of these submissions soon after acceptance.

Patients with acute psychiatric needs who are COVID-19 positive can be safely cared for in a COVID-specific psychiatric unit, but determining when they can be discharged can be challenging, wrote Luming Li, M.D., and colleagues at the Yale New Haven Psychiatric Hospital in a Psychiatric Services article in press.

“Emerging evidence suggests that positive test[s] can endure for weeks after a person is no longer infectious,” they wrote. “Although every patient required a COVID+ test … for admission, many patients continue to remain positive or have testing courses with a negative test, positive test, and then inconclusive test, making testing results difficult to interpret.”

The Yale New Haven COVID-specific psychiatric unit was first opened on April 28 after the hospital began to experience an uptick in the number of patients confirmed to have COVID-19 and those suspected of having COVID-19. The adolescent wing of the hospital was converted to a COVID-specific unit after patients in that wing were moved to a unit with young adult patients.

A multidisciplinary leadership team worked to develop a manual to guide the admission criteria for the unit, as well as protocols for infection prevention, use of personal protective equipment, and other issues. To meet criteria for the COVID-specific psychiatric unit, patients needed at least one COVID+ test within the last 14 days and no significant acute medical symptoms. Patients with acute medical concerns continued to be cared for on the general medical unit with psychiatric consultation.

At the time Li and colleagues wrote the paper, 11 patients had been treated in the unit. They noted that since many group living facilities now require two negative tests before patients will be accepted, ongoing positive or variable test results may prove a challenge for discharge. “[P]atients who are acutely stable psychiatrically may need prolonged hospitalizations” due to limited options for discharge, they wrote.

They concluded: “This report helps to outline special considerations for a COVID-specific inpatient psychiatric unit, which can be useful for other behavioral health facilities preparing for infection prevention as states reopen and risk for COVID-19 spread increases.”

The article is in press at Psychiatric Services and can be cited as follows: Li L, Stanley R, Fortunati F: Emerging Need and Early Experiences with a COVID-Specific Psychiatric Unit.

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Psychiatric News continues to report news and information relevant to psychiatrists about the COVID-19 pandemic. We will highlight these articles for you as they become available online:

Psychiatrists Support Those Working to Save COVID-19 Patients

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Potential Risk of Clozapine Toxicity May Occur in Patients With COVID-19

A case report in Schizophrenia Bulletin suggests that patients who are taking clozapine may be at risk of clozapine toxicity if they become infected with COVID-19. Clozapine is considered the best option for patients with treatment-resistant schizophrenia, but patients taking the medication are at heightened risk of a rare but serious condition known as neutropenia, which can increase risk of severe infections.

In the Schizophrenia Bulletin report, Thomas Cranshaw, M.B.B.S., and Thiyyancheri Harikumar, M.B.B.S., of Cumbria, Northumberland, Tyne, and Wear NHS Foundation Trust in England, described a 38-year-old man in an inpatient unit who was taking “325 mg per day of clozapine for organic psychosis” who became infected by COVID-19. The authors noted that after the initial emergence of COVID-19 symptoms (coughing, headache, and reduced oxygen saturation), the patient “was drowsy, with markedly increased hypersalivation and myoclonus.”

A blood test revealed the patient’s clozapine levels to be 0.73 mg/l, norclozapine 0.31 mg/l, which the authors noted was “substantially above the patient’s previous stable baseline of 0.57 mg/l, norclozapine 0.22 mg/l.” They added, “The most likely explanation is precipitation of clozapine toxicity by COVID-19 infection. Mechanisms for increase in plasma clozapine during infection have been shown to involve cytokine release downregulating the metabolism of clozapine in the P450 system through CYP 1A2.”

The patient’s clozapine was stopped, and he recovered from COVID-19; however, he experienced some psychotic symptoms during the temporary clozapine cessation, according to the authors.

“This case demonstrates the importance of full clinical assessment of suspected COVID-19 infection in clozapine-treated patients, including assessment for features of pneumonia, clozapine toxicity, clozapine level, and full blood count. Consideration should be given to dose reduction during infection,” Cranshaw and Harikumar concluded. “The risks posed by clozapine treatment during the COVID-19 pandemic must, however, be balanced against the substantial benefit many patients receive from this medication and the likelihood of mental health deterioration with unplanned treatment cessation.”

The Food and Drug Administration has posted guidance for health care professionals regarding certain Risk Evaluation and Mitigation Strategy (REMS)–required laboratory testing during the COVID-19 public health emergency.

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Kogan’s 2020 Menninger Lecture on Tchaikovsky Now Available Online

This year’s APA Annual Meeting would have featured a special presentation by psychiatrist and award-winning pianist Richard Kogan, M.D., for the William C. Menninger Memorial Convocation Lecture. Though the meeting could not be held due to the COVID-19 pandemic, Kogan made a video of his presentation, “The Mind and Music of Tchaikovsky.”

Kogan is a clinical professor of psychiatry at Weill Cornell Medical College, artistic director of the Weill Cornell Music and Medicine Program, and co-director of the Weill Cornell Human Sexuality Program. He studied piano at the Juilliard School and earned his undergraduate and medical degrees at Harvard.

The 30-minute video is a condensed version of Kogan’s typical crowd-favorite lectures, which combine discussion about the link between musical artistry and mental illness with piano performances by Kogan offering listeners a sense of the composer’s state of mind at the time.

“Tchaikovsky’s music is the indelible outgrowth of his mental state,” Kogan told Psychiatric News. “His glorious ballets, for example, reflect an idealized fantasy world where he could escape his real-world despondency.”

In his video, Kogan explores Pyotr Ilyich Tchaikovsky’s despondency as well as his shame over his sexual orientation, and how these feelings led to the creation of some of history’s greatest pieces—from the melodic (and oft-parodied) love theme from Romeo and Juliet to the structurally groundbreaking opening of his first concerto.

“Music has the extraordinary power to lift spirits and soothe anxiety,” Kogan said, noting that Tchaikovsky himself used musical composition as a tool for self-healing (Tchaikovsky once wrote that, “without music, I would go insane.”). Kogan hoped his video might likewise provide some solace from the stresses of COVID-19 that his fellow psychiatrists and others are facing.

For more online content derived from APA’s 2020 Annual Meeting, watch the free virtual APA Spring Highlights Meeting or purchase APA On Demand 2020. Both offer CME credit.

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Five Actions to Promote Well-Being of Health Care Workers During, After COVID-19

Organizations must act to protect the health and well-being of health care workers on the front lines of the COVID-19 pandemic—now and in the future, wrote the leaders of the National Academy of Medicine Action Collaborative on Clinician Well-Being and Resilience in an article in The New England Journal of Medicine.

“Before the virus struck, the U.S. clinical workforce was already experiencing a crisis of burnout. We are now facing a surge of physical and emotional harm that amounts to a parallel pandemic,” wrote Victor J. Dzau, M.D., Darrell Kirch, M.D., and Thomas Nasca, M.D. “Tragically, we are already seeing reports of clinicians dying by suicide amid the pandemic, including the highly publicized death of a prominent emergency medicine physician in Manhattan, the epicenter of the U.S. COVID-19 outbreak.”

The authors identified five actions to protect clinicians’ well-being during and after the crisis:

• Employers should create anonymous reporting mechanisms that allow clinicians to speak openly about stressors they face and to advocate for themselves and their patients without fear of reprisal. “For such systems to be meaningful, leaders must be prepared to respond transparently and proactively to feedback,” the authors wrote.
• Chief wellness officers should be given a powerful voice in decision-making bodies that organizations have assembled to respond to the pandemic.
• Health systems and other employers of clinicians should sustain and supplement existing well-being programs.
• Congress should allocate federal funding to care for clinicians who experience physical and mental health effects due to their COVID-19 service. “We need a national solution that acknowledges the scale of the crisis, and we cannot afford to wait,” the authors wrote.
• Federal funding should also be used to set up a national epidemiologic tracking program to measure clinician well-being during and after the pandemic, preferably led by the Centers for Disease Control and Prevention.

“Just as the country rallied to care for September 11 first responders who suffered long-term health effects, we must take responsibility for the well-being of clinician first responders to COVID-19—now and in the long run,” the authors wrote. “We have a brief window of opportunity to get ahead of two pandemics, the spread of the virus today and the harm to clinician well-being tomorrow. If we fail, we will pay the price for years to come.”

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Are You Getting Access to the Government Funding You Need?

Congress appropriated funds through the CARES Act and the Paycheck Protection Program and Health Care Enhancement Act to provide $175 billion in relief funds to hospitals and other health care professionals on the front lines of the coronavirus response. The Department of Health and Human Services has asked if psychiatrists are having trouble receiving funding from any of these funds. If you are having trouble accessing funds, we would like to know in order to identify ways to help. Please click here to fill out a short survey. Thank you.

How to Identify, Help Older People in Potentially Abusive Situations

The stresses on older people and their caregivers associated with COVID-19—social isolation, financial hardship, difficulties accessing needed care and supplies, and anxiety about infection—may increase the risk of elder abuse, according to a paper in the American Journal of Geriatric Psychiatry.

An estimated 10% of adults 60 years or older experiences abuse annually in the United States, wrote Lena K. Makaroun, M.D., M.S., core investigator with the VA Pittsburgh Center for Health Equity Research and Promotion, and colleagues. This includes physical, sexual, or psychological abuse, as well as financial exploitation or neglect by caregivers.

Increased financial stress and burdens on caregiver time due to COVID-19 may exacerbate abusive behavior, Makaroun and colleagues continued. “With over 20 million people filing for unemployment in the United States from mid-March to mid-April 2020 ... many caregivers are undoubtedly facing new financial strains.” Insolvency and financial dependence on older people (or their financial dependence on caregivers) can increase strife and the risk for abuse, they added.

These are among the steps that clinicians can take to identify and address elder abuse or potential abuse:

Inquire about patient safety and well-being during telehealth visits. “[A]s health care providers doing telephonic or video visits with our older adult patients, we have a unique chance to observe our patients in their home environment. This is a rare window into how they are living, caring for themselves, and being cared for by others,” the authors wrote. If abuse by a caregiver is suspected and the patient appears reluctant to disclose it when the caregiver is present, health care professionals can make unscheduled calls to the older adult, so that the caregiver cannot plan ahead to be present.

Provide support to caregivers. “Caregivers may be more comfortable disclosing sensitive information related to their ability to provide care when speaking from a home environment,” they wrote. “Health care providers can assess caregiver stress, ability to maintain previous levels of caregiving, and ability to access necessary resources and supplies. Providers can then provide brief counseling, problem-solving strategies, and appropriate referrals.”

Connect older patients and their caregivers to resources in the community. Local and regional aging services are offering a host of services to elders and their caregivers. “Encouraging our older patients to forge new bonds being made possible during this pandemic will be more important than ever. We can [help] older patients connect to neighboring families who can help check on their well-being, to volunteers who can pick up needed groceries, and to local organizations that will donate supplies... .”

Makaroun and colleagues added that the crisis is an opportunity for expanding research, especially on caregiver-related risk factors in abuse. “With many people experiencing caregiving stress … caregivers may be more open to participating in research to share their experiences, even uncomfortable ones.”

They concluded, “Attending to mental health needs, addressing increased risks, and connecting older adults to financial and caregiving resources may all help our patients and their loved ones be safer and avoid abusive and violent situations.”

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Exposure to Steroids in the Womb Linked to Long-Term Risk of Mental, Behavioral Disorders

Corticosteroids, when taken by a pregnant woman at high risk of delivering a premature infant, can help accelerate infant lung development and reduce the risk of respiratory distress syndrome, systemic infections, and death. However, such exposure may also come with long-term risks of mental and behavioral disorders in these children, particularly if they are ultimately full term, suggests a study published today in JAMA.

“[C]orticosteroids cross the placenta and the blood-brain barrier and may harm fetal brain development,” wrote Katri Räikkönen, Ph.D., of the University of Helsinki and colleagues. “These findings may help inform decisions about maternal antenatal corticosteroid treatment.”

The researchers conducted a large, population-based study of 670,097 full-term (37 weeks’ gestation) and preterm (less than 37 weeks’ gestation) Finnish children born between 2006 and 2017. Of that group, 2.2% had been exposed to antenatal corticosteroids, and nearly half of the exposed children were born at term. The researchers tracked the children for a median time of 5.8 years, comparing mental and behavioral disorders in the children exposed to corticosteroids versus those not exposed.

Treatment exposure, compared with nonexposure, was significantly associated with higher risk of any mental and behavioral disorder in the entire cohort of children (adjusted hazard ratio, 1.33). In children born full term, this risk was even higher (adjusted hazard ratio, 1.47). The authors noted that while the cumulative incidence rate of any mental and behavioral disorder in preterm-born children was also significantly higher for the treatment-exposed compared with the nonexposed children, the hazard ratio was not significant.

“Although benefits of this therapy outweigh risks in the most vulnerable infants, this may not be true for all infants,” wrote Sara B. DeMauro, M.D., M.S.C.E., of the Children’s Hospital of Philadelphia in an accompanying editorial. “Recommendations to administer this therapy to broader populations of pregnant women may need to be reexamined until sufficient safety data, particularly among more mature infants, are available.”

She added that the study by Räikkönen and colleagues highlights the importance of follow-up of children “at least through school age to ascertain the efficacy and safety of perinatal interventions. … Changes in behavior, executive function, visual-motor integration, learning, attention, and motor coordination, among many other important cognitive and neurologic functions, cannot be assessed reliably in the first few years of life.”

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As chair of APA’s Nominating Committee, Immediate Past President Bruce Schwartz, M.D., is seeking to diversify the elected leadership of APA and invites all members to consider running for one of the open Board of Trustee offices in APA’s 2021 election: president-elect; secretary; early-career psychiatrist trustee-at-large; minority/underrepresented representative trustee; Area 1, 4, and 7 trustees; and resident-fellow member trustee-elect. You may nominate yourself or a colleague—the important point is that you get involved! The deadline is Sunday, September 1.

Access Nomination Requirements and Form

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Researchers Recommend Strategies to Mitigate Risks Due to COVID-19 Economic Impact

The journals of APA Publishing are receiving numerous submissions on aspects of the COVID-19 pandemic. To get information about findings to the field faster, Psychiatric News is posting summaries of these submissions soon after acceptance.

Among the many ways COVID-19 has adversely impacted mental health is via the economic recession caused by this pandemic. Using data gleamed from previous economic crises, a team of specialists has suggested several health policy actions that may mitigate some of the impact of this recession. These recommendations were posted in a Psychiatric Services article in press.

“The immediate need is to expand suicide and domestic violence response systems, to shore up providers facing financial distress in the near term, and to limit state and local budget service cuts when the COVID-19 crisis wanes,” wrote Alison Cuellar, Ph.D., of George Mason University and colleagues. “It is important to extend this support to communities that are hit economically by closures and other policies, independent of the prevalence of COVID-19.”

Cuellar and colleagues recommended several policy solutions to help meet likely demands for behavioral health care:

• Increase investment in suicide prevention. The authors commended Congress for allocating $50 million for suicide prevention programs to the Substance Abuse and Mental Health Services Administration (SAMHSA) as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, but noted more funding is likely needed.
• Extend expansion of telehealth services. The authors lauded the regulatory changes that have expanded telehealth access, but noted such revised regulations will likely be needed “well beyond the initial impacts of the recession.” They also emphasized the importance of parity in reimbursement for telehealth services for mental health and substance use disorders, as well as continued investment in telecommunication programs for health care professionals.
• Ensure health insurance coverage for people who lose coverage through their employer. “Insurance coverage is critical for individuals to access mental health and substance use disorder treatment,” they wrote. The Affordable Care Act—implemented after the last major recession—provides access to insurance through marketplaces and Medicaid expansion, but the authors pointed out that 14 states still had not elected to expand Medicaid, which could increase barriers to behavioral health treatment.
• Develop and support systems that connect patients to social services such as food and housing. Such systems can improve information flow between patients and services.   

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APA Speaks Out for International Medical Graduates During COVID-19

Yesterday APA joined five other physician groups in calling on the Trump administration and Congress to ensure that international medical graduates (IMGs) practicing in the United States and those seeking to begin residency training this summer are able to meet the nation’s health care workforce needs during the COVID-19 pandemic.

The six organizations, which together represent more than 600,000 physicians and medical students, also include the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the American Osteopathic Association. In a joint statement, they urged the administration and Congress to support the IMG workforce in the following three ways:

• Expedite processing of H-1B visas for IMGs.
• Prioritize change of status applications for those on O-1, J-1, and H-1B visas.
• Grant an automatic one-year extension of H-4 visas for spouses and dependent children of IMGs.

“Further delays in visa processing will unnecessarily compromise the nation’s COVID-19 response, needlessly endanger vulnerable patient populations, and place even greater pressure on those serving heroically in this effort. It is imperative that IMGs be allowed to continue their important work on the front lines of the COVID-19 pandemic without fear of the loss of their immigration status or that of their families,” the organizations stated. 

Last month APA joined 10 other psychiatric and emergency medicine organizations in a letter to Kenneth Cuccinelli, J.D., the acting director of the U.S. Citizenship and Immigration Services, urging the federal government to extend visas and expedite their approval for IMGs. The letter requested that the federal government take the following steps:

• Temporarily extend visas automatically for one year.
• Resume premium processing, which was put on hold March 20 and which guarantees expedited processing of an applicant’s visa within 15 days.
• Expedite approvals of extensions and changes of status for non-U.S. citizen IMGs practicing, or otherwise lawfully present, in the United States.

“As the COVID-19 pandemic progresses, we will see an increased need for mental health care in a system that already has a shortage of psychiatrists,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. “We must preserve our psychiatry workforce as well as the physician workforce in all specialties, and that includes ensuring that our IMGs can continue to work and remain in their communities with their families.”

APA supports the Healthcare Workforce Resilience Act (HR 6788/S 3599). This legislation would allow IMGs and their families to stay in the U.S. so that IMGs can continue to provide care to patients. It would recapture up to 15,000 unused employment-based visas for international physicians, provide IMGs currently in the U.S. with status assistance, and facilitate IMGs coming to the U.S. APA is calling upon APA members to join the Association in its support of the bills by writing to their members of Congress.

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Psychiatric News continues to report news and information relevant to psychiatrists about the COVID-19 pandemic. We will highlight these articles for you as they become available online:

Pandemic Creates Challenges, New Opportunities for Treating Patients With Substance Use Disorder

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As Pandemic Highlights Health Disparities, Opportunities to Create Change Emerge

While available data on racial disparities in COVID-19 incidence and mortality are limited, preliminary evidence suggests that minority communities in the United States are disproportionately affected by the virus. The scientific, public health, and clinical communities must work to address these inequities, an effort that may lay the groundwork to reduce health disparities overall, wrote three officials with the National Institute on Minority Health and Health Disparities (NIMHD) in an article published in JAMA.

“The pandemic presents a window of opportunity for achieving greater equity in the health care of all vulnerable populations,” wrote Monica Webb Hooper, Ph.D., Anna María Nápoles, Ph.D., M.P.H., and Eliseo J. Pérez-Stable, M.D.

Rigorous research must be conducted to identify the roots of inequities that might predispose individuals to more severe reactions to COVID-19, as well as community, policy, health care system, and society-level determinants.

As the pandemic progresses and more data emerge, the authors said there will likely be evidence of health disparities due to a number of factors, such as lack of health insurance, poorer quality care, inequitable distribution of testing and hospital resources, food and housing insecurity, and work-related exposures.

“There is an obligation to address these predictable consequences with evidence-based interventions,” the authors wrote. “Public policies have the power to enhance health and also exacerbate health disparities.”

More studies are needed to investigate the following areas:

• The influence of state and local mitigation policies on differences in health services utilization and health outcomes.
• The role of community-level protective factors and interventions in mitigating the outbreak’s adverse consequences.
• The influence of COVID-19–related racism and other types of discrimination.
• The role of social determinants of health in influencing preventive health behaviors.

“These efforts will help pave the way for therapeutic and vaccine trials that must be inclusive of diverse participants at high risk,” the authors concluded. “These studies are also needed to guide the science of community-engaged intervention development, implementation, and evaluation and lay the foundation for a systemwide goal of decreasing health disparities beyond the detrimental effects of COVID-19.”

In a conversation with National Institutes of Health (NIH) Director Francis Collins, M.D., Ph.D., posted today on the NIH Director’s Blog, Pérez-Stable discussed NIMHD’s work to support research investigating the causes of health disparities and interventions that might help. “[A]s we use the power of science to understand and contain the COVID-19 pandemic, I’d like to re-emphasize the importance of considering race, ethnicity, socioeconomic status, the built environment, the social environment, and systems. Much of the time these factors may only play secondary roles, but, as in all science related to humans, I think they have to be considered. This experience should be a lesson for us to learn more about that.”

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Black Community Especially Vulnerable to COVID-19

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Psychotic Symptoms Found to Be Associated With Suicide Attempts in Patients With First-Episode MDD

Just under 10% of patients having a first episode of major depressive disorder (MDD) also experience psychotic symptoms, according to a report in Depression and Anxiety. Moreover, there was a strong correlation between psychotic symptoms and anxiety and suicide attempts.

“[W]e found a close association between suicide and psychotic MDD, suggesting that the risk of suicide in psychotic MDD patients should be regularly assessed in clinical practice to better identify suicide risk and prevent suicide from the very beginning of illness course,” wrote Xuerong Luo, M.D., of the Department of Psychiatry at Second Xiangya Hospital in Hunan, China, and colleagues.

The research team enrolled 573 outpatients aged 16 to 45 at a psychiatric clinic in a general hospital. Patients were diagnosed as having MDD if they had a score of 24 or greater on the 17‐item Hamilton Rating Scale for Depression. Patients were defined as having severe anxiety symptoms if they had a score of 29 or higher on the 14‐item Hamilton Anxiety Rating Scale. Patients with a total positive subscale score of 15 or greater on the Positive and Negative Symptom Scale were defined as having psychotic symptoms.

The researchers interviewed all participants using the Structured Clinical Interview for DSM-IV (SCID) at the start of the study and again three to six months later. The patients were also asked if they had ever attempted suicide, and those who responded yes were asked to provide further details.

The researchers found that 56 of the 573 patients (9.8%) had psychotic symptoms. Moreover, the rate of severe anxiety was significantly higher among patients with psychotic symptoms than those without psychotic symptoms (67.9% vs. 6.0%).

The frequency of attempted suicide was 50% for the patients with psychotic symptoms compared with 16.6% for the patients without psychotic symptoms.

“The strong association between psychotic MDD and anxiety or suicide attempts demonstrates the importance of reducing anxiety,” the researchers wrote.

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Psychiatric News continues to report news and information relevant to psychiatrists about the COVID-19 pandemic. We will highlight these articles for you as they become available online:

Do Not Forget Delirium During the COVID-19 Scramble

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Psychiatrists Urge Field to Plan Now for Post–COVID-19 Psychiatry

The lifting of federal and state regulatory barriers to telemedicine in response to COVID-19 has led to an unprecedented revolution in telehealth. Psychiatrists, patients, and health systems have shown in recent months that they can quickly adapt to telepsychiatry, but numerous questions remain: “What happens next?” and “What happens when the COVID-19 pandemic ends?” Such questions are the subject of an article appearing in JAMA Psychiatry by psychiatrists Jay H. Shore, M.D., M.P.H., and Christopher D. Schneck, M.D., of the University of Colorado School of Medicine and Matthew C. Mishkind, Ph.D., of the Steven A. Cohen Military Family Clinic at the University of Colorado.

“When the pandemic eventually ends, psychiatry and telepsychiatry will be transformed. What the psychiatric care environment will look like is currently unpredictable,” they wrote. “The longer the pandemic and associated quarantines continue, the more likely current changes become solidified and routinized into the practice of psychiatry. Less certain are what changes will remain in effect when the pandemic is controlled, as well as what changes that will occur if the pandemic becomes episodic, resulting in a series of sporadic and regional quarantines. Will the current regulatory and structural changes stay in place, or will they also change in a parallel, sporadic, and episodic manner?”

Now is the time for psychiatric organizations and clinicians to plan for these different scenarios, they wrote, including “how, when, and to what extent they would transition back to more in-person care” and what the financial implications of such changes may be. “It is not clear how the current billing environment will affect the long-term resources and sustainability of psychiatric organizations and clinicians. To the extent that information is available, financial forecasting and planning with assumptions of both current and traditional billing environments is warranted.”

This time also presents an opportunity for the field to learn more about the interactions with patients that can and should take place in person versus those that can be done through telepsychiatry or other technologies, they continued. “How much virtual care is too much? Is there a virtual saturation point, at which the benefits of a virtual relationship decrease or patients request more in-person interactions? What data need to be captured now to better understand this and identify current lessons learned?”

They concluded, “The regulatory and system changes wrought by the COVID-19 crisis present the opportunity for the field to gather lessons learned to strategically shape the post–COVID-19 world of psychiatry and telepsychiatry. This work could usher in a golden era for technology in psychiatry in which we are able to harmonize the benefits of telepsychiatry and virtual care while maintaining the core of our treatment: that of human connectedness.”

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We’re All Telepsychiatrists Now

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Psychiatrists Report Mostly Positive Transition to Telemedicine During Pandemic

The journals of APA Publishing are receiving numerous submissions on aspects of the COVID-19 pandemic. To get information about findings to the field faster, Psychiatric News is posting summaries of these submissions soon after acceptance.

Despite some challenges, 20 psychiatrists who completed interviews from March 31 to April 9 said that the transition to seeing patients via telemedicine due to COVID-19 has generally been a positive experience. The findings appear in an article in press at Psychiatric Services.

“The majority argued that given the unprecedented circumstances, the transition to telemedicine went more smoothly than they had expected, and they were pleasantly surprised that they could meet patients’ needs via telemedicine,” wrote Lori Uscher-Pines, Ph.D., of the RAND Corporation and colleagues.

The researchers interviewed 20 outpatient psychiatrists transitioning to telemedicine due to the COVID-19 pandemic. The researchers recruited psychiatrists for the study from a panel of 730,000 physicians who are part of an online network; psychiatrists were sent an eight-item screener survey to assess eligibility for participation. The psychiatrists were practicing in states especially hard-hit by the pandemic, including New York, California, Washington, New Jersey, and Louisiana. During 30-minute phone calls, the researchers covered topics such as practice setting, patient population, and barriers encountered during the transition to telemedicine.

While most of the psychiatrists had only limited telemedicine experience with their patients prior to the outbreak of COVID-19, by March most had transitioned to fully virtual practices through which they offered video visits and/or phone visits.

There were positive and negative impacts to working with patients via telemedicine, the psychiatrists reported. Negative impacts included their reduced ability to observe nonverbal cues of patients to support diagnosis and treatment and hear patients clearly; additionally, patients may not have had privacy and had to deal with more distractions in the home. Positive impacts included increased ease and access for some patients and the ability to see patients’ home environment. Most participants reported that patients had been responding positively to the switch, as well.

The psychiatrists expressed a strong preference to return to in-person care after the pandemic ends. “Reasons include the ritual of going to an office, the fact that the office is a private and safe space, and for some, the perceived inferior quality of physician-patient interactions via telemedicine,” the authors wrote.

The psychiatrists shared lessons they had learned during the rapid transition to telemedicine, including the following:

• Start each visit by asking patients whether they are concerned about their privacy, and if they do not have privacy, reschedule the session. One psychiatrist reported that some patients have done visits from a car outside the home.
• Reassure patients by conducting video visits from the same spot in your home or office.
• Identify patients “at risk” of having difficulty with video visits and explore if there is someone in their environment who can help them.
• Choose a platform that will ensure patients cannot see your personal phone number.

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Behavioral Health Organizations Struggle Financially During Pandemic

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More Data Needed to Address Negative Impact of COVID-19 on Racial Minorities

The COVID-19 pandemic has shone a spotlight on racial disparities in health care. Demographic data collected by the states indicate that people who belong to racial minorities are disproportionately affected by the COVID-19 virus. However, to gain a complete understanding of how vulnerability is distributed, it is vital to consider the data in the context of socioeconomic status and other factors that may affect risk, according to an article in the New England Journal of Medicine.

“Disparity figures without explanatory context can perpetuate harmful myths and misunderstandings that actually undermine the goal of eliminating health inequities,” wrote Merlin Chowkwanyun, Ph.D., M.P.H., of Columbia University and Adolph L. Reed Jr., Ph.D., of the University of Pennsylvania. “Such clarifying perspective is required not just for COVID-19 but also for future epidemics.”

Chowkwanyun and Reed highlighted four potential pitfalls of considering data on racial disparities without context:

• First, it can foster biologic explanations for racial health disparities. “Such explanations posit that congenital qualities unique to specific racial minorities predispose them to higher rates of a particular disease,” they wrote.
• Second, it can promote explanations grounded in racial stereotypes of behavior. The authors cited examples of this phenomenon wherein black, Chinese, Japanese, and Mexican Americans at the turn of the 20th century were depicted as having poor hygiene and engaging in vices that made them more susceptible to contracting disease.
• Third, placing too much of a focus on location when interpreting the data can reinforce “territorial stigmatization,” wherein neighborhoods that lack resources are regarded as composed of people who are poor, members of racial minorities, and/or from other countries. “In the case of COVID-19, place-based stigma might be further amplified by association with sickness and could in turn lead to blaming of local residents’ allegedly deviant behavior, repressive forms of surveillance, calls for demolition, or simply neglect by a society that wishes to distance itself from such areas,” the authors wrote.
• Fourth, taken together, these potential pitfalls may feed the perception that certain social problems are mainly “racial” and matter only to people in minority groups, a perception that has been used in the past to justify neglect and funding cuts.

The authors wrote that data on socioeconomic status should be collected or otherwise accounted for along with racial data.

“Complementary SES [socioeconomic status] information will clarify how racial and class forces are intertwined—and when they are not—in the case of COVID-19,” they wrote. “By highlighting connections between racial disparities and upstream forces such as economic inequality, which carry widespread societal consequences, we can also guard against future cynical—and dangerous—political attempts to frame COVID-19 as largely a problem of minorities.”

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COVID-19 and People With SMI: New Notes From the Field

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Sleep Difficulties in Infants Linked to Later Development of Autism

Sleep difficulties are more prevalent in 6- to 12-month-olds who later develop autism spectrum disorder (ASD) compared with those who do not, reports a study published today in AJP in Advance. The study also found that these early sleep problems were associated with subsequent altered development in the brain’s hippocampus.

“The hippocampus is critical for learning and memory, and changes in the size of the hippocampus have been associated with poor sleep in adults and older children,” stated lead author Kate MacDuffie, Ph.D., of the University of Washington Autism Center in a press release. “However, this is the first study we are aware of to find an association in infants as young as 6 months of age.”

MacDuffie and colleagues assessed 432 infants (305 of whom were at-risk of developing ASD due to family history; for example, having an older sibling with the disorder) across three time points: 6, 12, and 24 months. MRI scans and behavioral assessments (including sleep) were conducted at each time point, while the 24-month visit also included a diagnostic assessment for ASD. Based on the 24-month results, the infants were divided into three groups: at-risk infants who developed ASD (n=71), at-risk infants who did not develop ASD (n=234), and low-risk infants who did not develop ASD (n=127).

They found that the infants who developed ASD were much more likely to have difficulty falling asleep (or falling back asleep) at 6 to 12 months of age compared with the other two groups. The children with ASD also had larger hippocampal volumes at 24 months compared with those of the other groups. There were no significant differences in other brain regions examined.

“Our findings provide initial evidence that sleep difficulties in the first year of life may precede ASD diagnosis and are associated with altered neurodevelopmental trajectories in high-risk siblings who go on to develop ASD,” MacDuffie and colleagues wrote. “We expect future work to reveal the implications of these results for understanding neurodevelopment in ASD and for developing early, targeted interventions for sleep difficulties in infants at high risk for ASD.”

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Speakers Share Insights on Inpatient Psychiatric Care During COVID-19 Pandemic

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Policy Changes in Response to Pandemic Have Transformed MH Care

The journals of APA Publishing are receiving numerous submissions on aspects of the COVID-19 pandemic. To get information about findings to the field faster, Psychiatric News is posting summaries of these submissions soon after journal submissions are accepted.

Responding to the COVID-19 pandemic has required rapid and far-reaching changes in health care delivery, including changes in services for patients with mental and substance use disorders. These changes were enabled by a surge of policies made at the local, state, and federal levels, policies that the authors of an article in press in Psychiatric Services say should be evaluated for use in a post-pandemic world.

“Seldom in recent history have so many policies evolved so quickly as in this period of COVID-19 crisis response. These circumstances raise a critically important question: What evidence for new policies and approaches have been born from the COVID-19 crisis that should—or should not—be sustained in the future?” wrote Matthew L. Goldman, M.D., M.S., of the University of California, San Francisco, and colleagues. “As we continue to move through the unique challenges presented by this global pandemic, we can and should be opportunistic when it serves the public interest and the well-being of people with mental illness.”

The authors highlighted pandemic-related changes in mental health policy in several areas: legislation, regulation, financing, accountability, and workforce development.

Legislation. The Families First Coronavirus Response Act provides paid sick leave for people affected by COVID-19. The Coronavirus Aid, Relief, and Economic Security (CARES) Act is a $2 trillion stimulus package that includes appropriations for the Substance Abuse and Mental Health Services Administration, the Department of Health and Human Services, the Federal Communications Commission, and others to use to create programs or disseminate to various stakeholders affected by the pandemic.

Regulation. The majority of the regulations issued in response to the pandemic aim to reduce requirements for face-to-face contact between patients and health care professionals. These regulations include an exception regarding the maximum take-home methadone doses for patients with opioid use disorder enrolled in an Opioid Treatment Program and an easing of Medicare telehealth rules.

Financing. The Centers for Medicare and Medicaid Services (CMS) has made several changes that help professionals and organizations that provide mental health services remain afloat. These changes include reimbursements for telehealth services that are equivalent to that of in-person appointments and a blanket waiver that allows more flexibility in Medicare and Medicaid reimbursements, reduces prior authorizations, and affords easier transfer of patients between facilities.

Accountability. CMS has delayed quality reporting requirements for programs such as the Merit-based Incentive Payment System. While accountability mechanisms are essential, the pandemic crisis justifies the relaxation of burdensome reporting requirements.

Workforce Development. Several measures address issues concerning credentialing, licensure, scope of practice, training and technical assistance, and incentives such as loan repayment programs. For example, many states have temporarily waived state licensing and renewal requirements, CMS has temporarily exempted requirements for physician supervision of nurse practitioners and physician assistants, and the Drug Enforcement Agency waived the requirement to register in new states to prescribe controlled substances.

“[These] major areas of mental health policy … encompass a large range of stakeholders, each of whom [has] unique perspectives and incentives,” the authors wrote. “Engaging a diverse coalition of partners can help ensure the success of a policy regardless of the lever involved.”

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Telehealth to Flatten the Curve: A Plea From Psychiatry Trainees

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Lessons Learned From Italy: COVID-19 and Mental Health Services

Mental health services in Italy, as in the United States, have undergone significant changes because of the COVID-19 pandemic. In an article in JAMA Psychiatry, leaders from the Departments of Mental Health and Addiction in Lombardy describe several lessons learned during the COVID-19 crisis and unknowns about the long-term mental health of the population.

Italy has a National Mental Health System divided into 134 Departments of Mental Health and Addiction, 27 of which are in Lombardy. While mental health care in Italy is available to all, changes to hospital psychiatric wards, day facilities, outpatient clinics, and home visits due to COVID-19 led to disruptions in care and considerable stress among people with mental illness, wrote Giovanni de Girolamo, M.D., of the IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, and colleagues. To be prepared for future crises, the authors recommended that mental health leaders take the following actions:

Expand e-health technologies: While some Departments of Mental Health and Addiction in Italy were able to rapidly implement e-mental health services in response to COVID-19, others were not, according to the authors. Such services are particularly critical for assisting people supporting patients living alone at home, those suddenly exposed to marked isolation, those living in households with high levels of conflict, and those who have children with attention-deficit/hyperactivity disorder or intellectual disabilities, they wrote.

Strengthen ability to offer the public psychosocial support following disasters: “[I]n Italy, very few if any [Departments of Mental Health and Addiction] are equipped in terms of skills, knowledge, and training to intervene in natural or other disasters,” the authors continued. “While a shortage of information can be detrimental, we have faced an information overload about the epidemic, and the consequences of this must be evaluated, even in terms of secondary traumatization and increase in posttraumatic stress disorder and stress reactions.” Departments of Mental Health and Addiction should be prepared to inform the public about risk, disseminate information about psychological interventions following disaster, and support distressed health care workers and those experiencing bereavement.

Develop plans for rapid reorganizations of inpatient and residential facilities in the event of emergencies: “Patients in these centers may be particularly distressed at the sudden introduction of restrictive measures,” the authors wrote. “Being able to measure [individuals’] stress levels and psychosocial adjustment is essential to both plan for the necessary psychosocial support during the recovery phase and prepare ourselves should this happen again.”

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