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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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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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.

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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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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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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.

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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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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.

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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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