Federal Practitioner

Annual cases of sexually transmitted infections in the United States jumped for the sixth year in a row in 2019, according to a new Centers for Disease Control and Prevention report that highlights an increase in congenital syphilis and rising rates of syphilis, chlamydia, and gonorrhea in men, especially men who have sex with men (MSM).

The report says nothing about STI rates during the COVID-19 pandemic, when both casual sex and disease screening and surveillance declined significantly, at least in the early months. But epidemiologist Patricia Kissinger, PhD, MPH, from Tulane University School, New Orleans, said in an interview that the findings reflect how “a confluence of factors” drove up rates before the age of COVID. Those factors include online dating, the opioid epidemic, the decline in condom use in the MSM community as HIV became more preventable, and indifference among policy makers and the community at large.

The CDC report, based on data from local health departments, says there were 129,813 cases of syphilis in 2019, up 74% since 2015. Almost 2,000 cases of congenital syphilis were reported, up 279% since 2015, and 128 infants died.

“There’s no reason for us to have congenital syphilis,” said Dr. Kissinger, who noted that the disease can cause birth defects and meningitis in addition to death. “Women should be screened, and it’s relatively easy to treat via penicillin injections.”

Indeed, medical guidelines suggest that pregnant women be routinely tested for syphilis. But that doesn’t always happen because “it falls through the cracks,” Dr. Kissinger said. Or, she added, women might not be tested enough times during their pregnancies: “You have to screen women in the third trimester. You can’t just do it in the first trimester because people do have sex when they’re pregnant.”

Rising congenital syphilis numbers have convinced at least one health system to take action. As of June 1, the University of California, San Diego, will routinely test pregnant women in the emergency department for syphilis in addition to HIV and hepatitis C, Martin Hoenigl, MD, a UCSF infectious disease specialist, said in an interview.

The CDC report also notes 1.8 million cases of chlamydia in 2019, a jump of 19% in 4 years, and a 56% increase in gonorrhea in that time period, to a total of 616,392 cases.

The report says increasing gonorrhea and chlamydia cases in men, especially MSM, could be caused by increased testing/screening, increased transmission, or both. Although women are generally diagnosed with chlamydia more often than men, the report says, numbers among men grew by 32% from 2015 to 2019. And since 2013, rates of gonorrhea among men have risen at a much faster clip than among women.

MSM accounted for most male cases of primary and secondary syphilis in 2019, although the report said the apparent long-term rise in these cases might be slowing.

Many MSM no longer use condoms because they’re using pre-exposure prophylaxis (PrEP) or have undetectable levels of HIV because of treatment, said Jeffrey Klausner, MD, MPH, an STI specialist at the University of Southern California in Los Angeles, said in an interview.

Many MSM might be getting screened much more often for STIs than in the past because frequent screening is required for those on PrEP. However, Dr. Kissinger said some clinics weren’t able to test at times during the pandemic because of a swab shortage. In addition, patients of all types avoided routine medical care during the pandemic, and some medical professionals in the infectious disease field were redirected to COVID care.

Clinical trials have been investigating a possible preventive STI strategy in MSM who don’t wear condoms – prophylaxis, either before or after exposure, with the antibiotic doxycycline. “That’s a very good solution,” Dr. Klausner said, but he believes bigger challenges remain. According to him, the existence of the report itself – which offers statistics from 2 years ago instead of more relevant recent numbers – is evidence of how the federal government isn’t doing enough to fight STIs. “If we’re taking the STD epidemic seriously, there should be timely and regular reporting.” Dr. Klausner said he likes the idea of monthly reports, as well as more funding for prevention.

Instead, he noted, the federal government cut STI prevention funding by 40% in inflation-adjusted dollars from 2002-2003 to 2018-2019, according to the National Coalition of STD Directors. “Burying your head in the sand and hoping the problem goes away is not an effective strategy,” he said.

It’s not clear whether STI rates are on the decline because of pandemic restrictions and stay-at-home orders. Surveys suggest that a dip in casual sex early in pandemic – when much of society shut down – was only temporary, Dr. Klausner said.

Dr. Kissinger disclosed no relevant financial relationships. Dr. Hoenigl reported receiving research funding via his university from Gilead. Dr. Klausner has recently provided consulting services to Danaher, Cepheid, Roche, GlaxoSmithKline, Talis Bio, SpeeDx, and Visby Medical, all manufacturers of diagnostic assays for STIs.

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

Annual cases of sexually transmitted infections in the United States jumped for the sixth year in a row in 2019, according to a new Centers for Disease Control and Prevention report that highlights an increase in congenital syphilis and rising rates of syphilis, chlamydia, and gonorrhea in men, especially men who have sex with men (MSM).

The report says nothing about STI rates during the COVID-19 pandemic, when both casual sex and disease screening and surveillance declined significantly, at least in the early months. But epidemiologist Patricia Kissinger, PhD, MPH, from Tulane University School, New Orleans, said in an interview that the findings reflect how “a confluence of factors” drove up rates before the age of COVID. Those factors include online dating, the opioid epidemic, the decline in condom use in the MSM community as HIV became more preventable, and indifference among policy makers and the community at large.

The CDC report, based on data from local health departments, says there were 129,813 cases of syphilis in 2019, up 74% since 2015. Almost 2,000 cases of congenital syphilis were reported, up 279% since 2015, and 128 infants died.

“There’s no reason for us to have congenital syphilis,” said Dr. Kissinger, who noted that the disease can cause birth defects and meningitis in addition to death. “Women should be screened, and it’s relatively easy to treat via penicillin injections.”

Indeed, medical guidelines suggest that pregnant women be routinely tested for syphilis. But that doesn’t always happen because “it falls through the cracks,” Dr. Kissinger said. Or, she added, women might not be tested enough times during their pregnancies: “You have to screen women in the third trimester. You can’t just do it in the first trimester because people do have sex when they’re pregnant.”

Rising congenital syphilis numbers have convinced at least one health system to take action. As of June 1, the University of California, San Diego, will routinely test pregnant women in the emergency department for syphilis in addition to HIV and hepatitis C, Martin Hoenigl, MD, a UCSF infectious disease specialist, said in an interview.

The CDC report also notes 1.8 million cases of chlamydia in 2019, a jump of 19% in 4 years, and a 56% increase in gonorrhea in that time period, to a total of 616,392 cases.

The report says increasing gonorrhea and chlamydia cases in men, especially MSM, could be caused by increased testing/screening, increased transmission, or both. Although women are generally diagnosed with chlamydia more often than men, the report says, numbers among men grew by 32% from 2015 to 2019. And since 2013, rates of gonorrhea among men have risen at a much faster clip than among women.

MSM accounted for most male cases of primary and secondary syphilis in 2019, although the report said the apparent long-term rise in these cases might be slowing.

Many MSM no longer use condoms because they’re using pre-exposure prophylaxis (PrEP) or have undetectable levels of HIV because of treatment, said Jeffrey Klausner, MD, MPH, an STI specialist at the University of Southern California in Los Angeles, said in an interview.

Many MSM might be getting screened much more often for STIs than in the past because frequent screening is required for those on PrEP. However, Dr. Kissinger said some clinics weren’t able to test at times during the pandemic because of a swab shortage. In addition, patients of all types avoided routine medical care during the pandemic, and some medical professionals in the infectious disease field were redirected to COVID care.

Clinical trials have been investigating a possible preventive STI strategy in MSM who don’t wear condoms – prophylaxis, either before or after exposure, with the antibiotic doxycycline. “That’s a very good solution,” Dr. Klausner said, but he believes bigger challenges remain. According to him, the existence of the report itself – which offers statistics from 2 years ago instead of more relevant recent numbers – is evidence of how the federal government isn’t doing enough to fight STIs. “If we’re taking the STD epidemic seriously, there should be timely and regular reporting.” Dr. Klausner said he likes the idea of monthly reports, as well as more funding for prevention.

Instead, he noted, the federal government cut STI prevention funding by 40% in inflation-adjusted dollars from 2002-2003 to 2018-2019, according to the National Coalition of STD Directors. “Burying your head in the sand and hoping the problem goes away is not an effective strategy,” he said.

It’s not clear whether STI rates are on the decline because of pandemic restrictions and stay-at-home orders. Surveys suggest that a dip in casual sex early in pandemic – when much of society shut down – was only temporary, Dr. Klausner said.

Dr. Kissinger disclosed no relevant financial relationships. Dr. Hoenigl reported receiving research funding via his university from Gilead. Dr. Klausner has recently provided consulting services to Danaher, Cepheid, Roche, GlaxoSmithKline, Talis Bio, SpeeDx, and Visby Medical, all manufacturers of diagnostic assays for STIs.

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

Annual cases of sexually transmitted infections in the United States jumped for the sixth year in a row in 2019, according to a new Centers for Disease Control and Prevention report that highlights an increase in congenital syphilis and rising rates of syphilis, chlamydia, and gonorrhea in men, especially men who have sex with men (MSM).

The report says nothing about STI rates during the COVID-19 pandemic, when both casual sex and disease screening and surveillance declined significantly, at least in the early months. But epidemiologist Patricia Kissinger, PhD, MPH, from Tulane University School, New Orleans, said in an interview that the findings reflect how “a confluence of factors” drove up rates before the age of COVID. Those factors include online dating, the opioid epidemic, the decline in condom use in the MSM community as HIV became more preventable, and indifference among policy makers and the community at large.

The CDC report, based on data from local health departments, says there were 129,813 cases of syphilis in 2019, up 74% since 2015. Almost 2,000 cases of congenital syphilis were reported, up 279% since 2015, and 128 infants died.

“There’s no reason for us to have congenital syphilis,” said Dr. Kissinger, who noted that the disease can cause birth defects and meningitis in addition to death. “Women should be screened, and it’s relatively easy to treat via penicillin injections.”

Indeed, medical guidelines suggest that pregnant women be routinely tested for syphilis. But that doesn’t always happen because “it falls through the cracks,” Dr. Kissinger said. Or, she added, women might not be tested enough times during their pregnancies: “You have to screen women in the third trimester. You can’t just do it in the first trimester because people do have sex when they’re pregnant.”

Rising congenital syphilis numbers have convinced at least one health system to take action. As of June 1, the University of California, San Diego, will routinely test pregnant women in the emergency department for syphilis in addition to HIV and hepatitis C, Martin Hoenigl, MD, a UCSF infectious disease specialist, said in an interview.

The CDC report also notes 1.8 million cases of chlamydia in 2019, a jump of 19% in 4 years, and a 56% increase in gonorrhea in that time period, to a total of 616,392 cases.

The report says increasing gonorrhea and chlamydia cases in men, especially MSM, could be caused by increased testing/screening, increased transmission, or both. Although women are generally diagnosed with chlamydia more often than men, the report says, numbers among men grew by 32% from 2015 to 2019. And since 2013, rates of gonorrhea among men have risen at a much faster clip than among women.

MSM accounted for most male cases of primary and secondary syphilis in 2019, although the report said the apparent long-term rise in these cases might be slowing.

Many MSM no longer use condoms because they’re using pre-exposure prophylaxis (PrEP) or have undetectable levels of HIV because of treatment, said Jeffrey Klausner, MD, MPH, an STI specialist at the University of Southern California in Los Angeles, said in an interview.

Many MSM might be getting screened much more often for STIs than in the past because frequent screening is required for those on PrEP. However, Dr. Kissinger said some clinics weren’t able to test at times during the pandemic because of a swab shortage. In addition, patients of all types avoided routine medical care during the pandemic, and some medical professionals in the infectious disease field were redirected to COVID care.

Clinical trials have been investigating a possible preventive STI strategy in MSM who don’t wear condoms – prophylaxis, either before or after exposure, with the antibiotic doxycycline. “That’s a very good solution,” Dr. Klausner said, but he believes bigger challenges remain. According to him, the existence of the report itself – which offers statistics from 2 years ago instead of more relevant recent numbers – is evidence of how the federal government isn’t doing enough to fight STIs. “If we’re taking the STD epidemic seriously, there should be timely and regular reporting.” Dr. Klausner said he likes the idea of monthly reports, as well as more funding for prevention.

Instead, he noted, the federal government cut STI prevention funding by 40% in inflation-adjusted dollars from 2002-2003 to 2018-2019, according to the National Coalition of STD Directors. “Burying your head in the sand and hoping the problem goes away is not an effective strategy,” he said.

It’s not clear whether STI rates are on the decline because of pandemic restrictions and stay-at-home orders. Surveys suggest that a dip in casual sex early in pandemic – when much of society shut down – was only temporary, Dr. Klausner said.

Dr. Kissinger disclosed no relevant financial relationships. Dr. Hoenigl reported receiving research funding via his university from Gilead. Dr. Klausner has recently provided consulting services to Danaher, Cepheid, Roche, GlaxoSmithKline, Talis Bio, SpeeDx, and Visby Medical, all manufacturers of diagnostic assays for STIs.

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

As some countries brace for yet another possible surge in the COVID-19 pandemic – particularly among young adults who have not yet been vaccinated – clinicians should remain wary of the cardinal symptoms of adult ADHD.

Research from an Israeli study shows that individuals with unmedicated ADHD are 52% more likely to test positive for the virus.^1,2

The symptoms of ADHD, including impulsiveness and inability to follow directions, combined with the tendency to leave adults with ADHD on their own to sort out COVID-19–related protocols – make these individuals susceptible to exposure.

As we know, ADHD is a condition characterized by a pervasive pattern of impulsivity and/or inattention, which greatly reduces organizational capabilities by interfering at the developmental level.³ Other key symptoms include short attention span, hyperactivity, restlessness, difficulty in prioritizing tasks, and an absence of time awareness. Symptom presentation of ADHD is contingent upon the nature of the individual’s overall mental health and etiologic issues that may be traced back to the brain’s development.⁴

Diagnosing ADHD in adults is relatively difficult, because a formal diagnosis generally requires symptoms to show up between the ages of 6 and 12.⁵ Also, clinicians can interview parents and family members to assess whether the classical features of ADHD were present in childhood for those suspected of having the condition.
 

Early vs. late presentation

Among the preschool population, it has been observed that emerging ADHD symptoms may progress with time or remain relatively constant with respect to the activities that children partake in. In some instances, impulsive behavior, especially compared with other symptoms, might be identified quickly by the attentive parent or caregiver. However, when ADHD appears in adulthood, it is possible that prior ADHD symptoms escaped detection – only to be diagnosed later in life because of varying presentations and the increased organizational demands of adulthood.

Meanwhile, diagnosis in adolescence can bring a different set of challenges to the forefront as teenagers face problems with self-management and responsibilities of daily living. These young people must cope with academic⁶ and social pressures – and a host of new societal expectations.

It is essential to understand how all of those societal factors have affected ADHD and its aspects, especially within the context of COVID-19. The coronavirus has introduced myriad challenges at the global level. Individuals with ADHD exhibit neurodevelopmental and corollary attention deficit issues that make them more susceptible to environmental stressors. Physical distancing practices might aggravate existing behavioral problems.
 

Distance forced by pandemic offers challenges

Despite the widespread adoption of telemedicine during the pandemic, some physicians think that the delivery of optimal care and the ability to adequately address patients’ health-related concerns have been compromised. Certainly, in the case of addressing the needs of patients with ADHD or related learning disorders, in-person examinations and clinical visits are best.

That is also the case for ADHD patients with comorbid sleep disorders. For those patients, it might be prudent to explore lifestyle changes (for example, improvements in sleep hygiene practices) before resorting to the use of pharmacologic agents such as hypnotics and melatonin. Along similar lines, the European ADHD Guideline Group (EAGG) advises the use of pharmacotherapy after the successful completion of a physical exam; patients already adhering to a treatment plan should continue therapy without interruption. Clinicians caring for patients with adult ADHD have faced a dilemma because treatment breaks increase the likelihood of illnesses resulting from the pandemic. Also, the inability to conduct treatment in person because of the pandemic raises concerns about pharmacotherapy.

The pandemic has affected the course of pediatric care and also has presented new challenges for adolescents as they begin to tackle unique problems related to their health concerns. In prepandemic times, teachers played integral roles in the diagnostic process, because they were able to readily identify children and teenagers with mental and physical challenges. In stark contrast, connecting with students online may not allow teachers to identify skill deficits in young patients or in adults with ADHD.

Furthermore, adults with ADHD and medical comorbidities may be at increased risk of disease exposure directly resulting from an inability to address their social and/or emotional well-being adequately. The social distancing and other mitigation measures advised by public health experts ensure safety and protection but also can present numerous hurdles for children, teenagers, adults – and their respective families.

Individuals with adult ADHD and other psychiatric disorders may downplay their psychological distress⁷ [for example, sleep dysfunction, issues concerning activities of daily living], and view it as being the natural product of the COVID-19 environment. As a result of their misconceptions, they may avoid increasing their medication dose to control emergent symptoms of hyperactivity and impulsivity, instead opting to manage stress without aid from health care professionals. The absence of patient-provider interactivity and the integration of telemedicine has introduced unnecessary obstacles with respect to medication management and therapy as well as general access to expert advice. It is of utmost importance for clinicians to identify at-risk patients and reeducate the adult ADHD patient on issues concerning medication intake and psychological wellness.

Individuals with developmental disorders may experience numerous setbacks when trying to navigate their environments. The lack of correct feedback, supervision, and guidance may adversely affect adults with ADHD, contributing toward a lack of self-esteem and social awareness.

Individuals with adult ADHD are more likely than are their younger counterparts to have medical comorbidities, such as cardiovascular disease⁸ and type 2 diabetes,⁹ so it is crucial to prescribe dietary instructions to patients. Sometimes patients with adult ADHD lack support in the form of acceptance by family and peers, so it is critical for the patient to come to terms with his/her condition and seek professional help, incorporating effective strategies wherever needed to maintain day-to-day functioning.

Other possible comorbidities

There can be risk factors associated with isolation of adults who have depression and/or anxiety, poor eating habits, and maladaptive behaviors. Other adverse health-related issues may include substance use disorder.¹⁰ Drug use suppresses developmental growth and may induce ADHD symptom exacerbation. Consistent with Khantzian’s self-medication hypothesis, among individuals with ADHD, including those who lack a formal diagnosis, there is a tendency to gravitate toward illicit substances, in particular, stimulants.¹¹

We also know that adolescents are known to engage in normal risk-taking and social experimentation. Given that, the notion of boundary setting becomes a complicated affair during a pandemic. Adults may no longer be involved in the same types of risk-taking behaviors, but enforced self-isolation coupled with unchecked consumption of various social medial platforms continue to take a toll on personal development. Socialization plays an enormous role in maintaining psychological health, and social media is no substitute for in-person interactions. Such platforms can reduce mental growth opportunities and affect ADHD adults unfavorably.

For instance, it has been reported that women with adult ADHD are more likely to present with negative cognitive biases and symptoms of anxiety as a function of social media use.^12,13 As clinicians, we should recommend introducing activities with the aim of enhancing self-acceptance, mindfulness, and the ability to engage in healthy lifestyles. A holistic framework that focuses on psychological wellness and physical fitness will ensure treatment success. Medication management may prove to be a challenge because of differences in dosing, response schedules, and agreed-upon diagnostic criteria used for young patients, compared with those needed for adults.
 

Treatment strategies

Before the pandemic, researchers were observing an increase globally in the ADHD diagnosis,¹⁴ and clinicians have been exploring the efficacy of select medications, sometimes with limited success.¹⁵ Stimulant medication, combined with behavioral interventions, is supported by evidenced-based medicine and is the treatment of choice for childhood ADHD.

The stimulant remedy considered to be the most efficacious for adult ADHD is methylphenidate or dextroamphetamine.

However, be sure to proceed with caution and prepare a thorough work-up, because there can be cardiovascular risk factors associated with these medications with a pronounced increase in heart rate and blood pressure.

Stimulant medications are known to increase the risk of stroke or myocardial infarction for individuals with preexisting cardiovascular anomalies or structural anomalies. The American Heart Association no longer recommends a baseline EKG before commencing stimulant therapy with the exception of preexisting cardiac risk. Nonstimulant medications such as atomoxetine are available as alternatives.

The process of finding therapies that will reduce symptoms of ADHD takes considerable time, and individuals may fail to notice improvements, at least initially.

Before prescribing any medicine or therapies, it is important to evaluate for factors that are specific to ADHD and rule out the presence of other learning or developmental disorders, to prevent negative consequences.

Health care professionals can introduce nonspecific interventions as a means of tackling complicated cases of adult ADHD, especially those that coincide with underlying medical conditions (for example, cardiovascular disease, seizure disorders, and/or eating disorders). In such cases, stimulant medications may lead to symptom exacerbation, and the health care professional should carry out a systematic evaluation (risks vs. benefits of drug classes), despite the limitations of online appointments over the course of the pandemic.

Moreover, ADHD symptoms can take on a more severe form within the context of preexisting mood and anxiety disorders. Unfortunately, these comorbidities may have a negative prognostic outcome, too, thereby increasing other health-related risk factors. Psychological interventions can be implemented via online assessments because of recent technological advances worldwide, providing a new level of confidence and social engagement. EEG-assisted biofeedback is an example of new technological modalities that may help improve the overall performance and functionality of individuals with adult ADHD.¹⁶ Numerous services and resources are available to patients and their families that can improve mental health and well-being.

Other nonpharmacologic choices also play an instrumental role in bringing harmony and organization into a patient’s life through the use of daily planners, alarms, and to-do lists. In addition, therapists can provide treatment that helps individuals get motivated and reduce their anxiety levels. Behavioral therapies support patient initiatives by increasing their productivity, activity management, and satisfaction. Cognitive-behavioral therapy (CBT), and marriage counseling and family therapy are modalities that may help adults with ADHD change underlying thoughts and perceptions and develop coping skills and self-esteem.

Appropriate to the pandemic situation is another treatment, e-therapy, which includes text-based communication, video calling, and phone calls. It is a low-cost and convenient alternative for people. For some patients, traveling to a particular clinic or counseling center can be difficult, and there is a shortage of counselors worldwide, so it is beneficial to talk with a counselor on a video/phone call or through social media. It is crucial for the ADHD coach to be trained with relevant knowledge to make plans, set goals, and manage a patient’s schedule of activities. For the counselor, sharing tips based on personal experience and making the appropriate suggestions allows adults with ADHD to stay motivated and focus on the task at hand. It should be noted that counselors play an important role in reducing stress levels for those diagnosed with ADHD, allowing patients to lead productive lives and achieve career goals.

Various online support communities can provide patients and their parents with educational resources, to address issues connected to ADHD in a professional manner.¹⁷

The road to treatment success

Any delays in treating adults with ADHD can lead to a frustrating situation in which the entire family will be affected. As stated earlier, numerous support groups are available to adults with ADHD, and some of those groups can offer valuable tips about addressing stress management and the diverse roles that parents and family members may play in patient care.¹⁸ These groups provide a network for people to exchange ideas and recommend strategies. Online support groups may connect patients directly with key opinion leaders and health care providers.

Individuals with ADHD often experience problems with organization and concentration – especially within the context of the pandemic – and receiving guidance from counselors will provide an opportunity to learn valuable coping strategies and manage symptoms, recognizing and mitigating any mood swings associated with anxiety or depression that emerge alongside their ADHD. Psychotherapy is instrumental in patient care, and individuals with adult ADHD should be taught to acknowledge the role of medications (for example, neglect, divert, or self-medicate). A holistic approach to managing ADHD symptoms is necessary for optimal functioning and independence.
 

Dr. Aman is a faculty member in the biology department of City Colleges of Chicago. She is a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF), Montreal; a fellow, medical staff development, from the American Academy of Medical Management; and a Masters Online Teacher, University of Illinois at Chicago. Dr. Aman disclosed no relevant financial relationships. Dr. Islam is a medical adviser for the IMCHF, Montreal, and is based in New York. He is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Islam disclosed no relevant financial relationships. Dr. Karama is a psychiatrist at the Douglas Mental Health University Institute, Montreal. He is an assistant professor at the department of psychiatry, McGill University, also in Montreal. He has no disclosures. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. J Atten Disord. 2020. doi: 10.1177/1087054720943271.

2. ADDitude Magazine. 2020 Jul 23.

3. Management of ADHD in Adults: What the Science Says. 2007 Oct 9. Guilford Press.

4. N Engl J Med. 2013 Nov 14;369(20):1935-44.

5. J Clin Psychiatry. 2002;63 Suppl 12:29-35.

6. J Atten Dis. 2015 Jan 12. doi: 10.1177/1087054144566076.

7. Psychiatry Res. 2020 Oct;292. doi: 10.1016/j.psychres.2020.113345.

8. Case Rep Cardiol. 2016. doi: 10.1155/2016/2343691.

9. Curr Diab Rep. 2019 Jun 27;19(8):46. doi: 10.1007/s11892-019-1174-x.

10. Curr Psychiatry Rep. 2014 Mar;16(3):436. doi: 10.1007/s/11920-013-0436-6.

11. Current Psychiatry. 2014 Dec;13(12):e3-4.

12. BMC Psychiatry. 2020;20(40). doi: 10.1186/s/12888-020-02707-9.

13. Psychol Addict Behav. 2016 Mar;30(2):252–62.

14. ADDitude Magazine. 2017 Apr 6.

15. Harv Mental Health Letter. 2009 Nov.

16. MGM J Med Sci. 2020 Jul 17(3):161-2.

17. J Child Psychol Psychiatry. 2020 Jul 7.

18. Int J Disaster Risk Reduct. 2020 Dec;51. doi: 10.1016/j.ijdrr.2020.101845.

As some countries brace for yet another possible surge in the COVID-19 pandemic – particularly among young adults who have not yet been vaccinated – clinicians should remain wary of the cardinal symptoms of adult ADHD.

Research from an Israeli study shows that individuals with unmedicated ADHD are 52% more likely to test positive for the virus.^1,2

The symptoms of ADHD, including impulsiveness and inability to follow directions, combined with the tendency to leave adults with ADHD on their own to sort out COVID-19–related protocols – make these individuals susceptible to exposure.

As we know, ADHD is a condition characterized by a pervasive pattern of impulsivity and/or inattention, which greatly reduces organizational capabilities by interfering at the developmental level.³ Other key symptoms include short attention span, hyperactivity, restlessness, difficulty in prioritizing tasks, and an absence of time awareness. Symptom presentation of ADHD is contingent upon the nature of the individual’s overall mental health and etiologic issues that may be traced back to the brain’s development.⁴

Diagnosing ADHD in adults is relatively difficult, because a formal diagnosis generally requires symptoms to show up between the ages of 6 and 12.⁵ Also, clinicians can interview parents and family members to assess whether the classical features of ADHD were present in childhood for those suspected of having the condition.
 

Early vs. late presentation

Among the preschool population, it has been observed that emerging ADHD symptoms may progress with time or remain relatively constant with respect to the activities that children partake in. In some instances, impulsive behavior, especially compared with other symptoms, might be identified quickly by the attentive parent or caregiver. However, when ADHD appears in adulthood, it is possible that prior ADHD symptoms escaped detection – only to be diagnosed later in life because of varying presentations and the increased organizational demands of adulthood.

Meanwhile, diagnosis in adolescence can bring a different set of challenges to the forefront as teenagers face problems with self-management and responsibilities of daily living. These young people must cope with academic⁶ and social pressures – and a host of new societal expectations.

It is essential to understand how all of those societal factors have affected ADHD and its aspects, especially within the context of COVID-19. The coronavirus has introduced myriad challenges at the global level. Individuals with ADHD exhibit neurodevelopmental and corollary attention deficit issues that make them more susceptible to environmental stressors. Physical distancing practices might aggravate existing behavioral problems.
 

Distance forced by pandemic offers challenges

Despite the widespread adoption of telemedicine during the pandemic, some physicians think that the delivery of optimal care and the ability to adequately address patients’ health-related concerns have been compromised. Certainly, in the case of addressing the needs of patients with ADHD or related learning disorders, in-person examinations and clinical visits are best.

That is also the case for ADHD patients with comorbid sleep disorders. For those patients, it might be prudent to explore lifestyle changes (for example, improvements in sleep hygiene practices) before resorting to the use of pharmacologic agents such as hypnotics and melatonin. Along similar lines, the European ADHD Guideline Group (EAGG) advises the use of pharmacotherapy after the successful completion of a physical exam; patients already adhering to a treatment plan should continue therapy without interruption. Clinicians caring for patients with adult ADHD have faced a dilemma because treatment breaks increase the likelihood of illnesses resulting from the pandemic. Also, the inability to conduct treatment in person because of the pandemic raises concerns about pharmacotherapy.

The pandemic has affected the course of pediatric care and also has presented new challenges for adolescents as they begin to tackle unique problems related to their health concerns. In prepandemic times, teachers played integral roles in the diagnostic process, because they were able to readily identify children and teenagers with mental and physical challenges. In stark contrast, connecting with students online may not allow teachers to identify skill deficits in young patients or in adults with ADHD.

Furthermore, adults with ADHD and medical comorbidities may be at increased risk of disease exposure directly resulting from an inability to address their social and/or emotional well-being adequately. The social distancing and other mitigation measures advised by public health experts ensure safety and protection but also can present numerous hurdles for children, teenagers, adults – and their respective families.

Individuals with adult ADHD and other psychiatric disorders may downplay their psychological distress⁷ [for example, sleep dysfunction, issues concerning activities of daily living], and view it as being the natural product of the COVID-19 environment. As a result of their misconceptions, they may avoid increasing their medication dose to control emergent symptoms of hyperactivity and impulsivity, instead opting to manage stress without aid from health care professionals. The absence of patient-provider interactivity and the integration of telemedicine has introduced unnecessary obstacles with respect to medication management and therapy as well as general access to expert advice. It is of utmost importance for clinicians to identify at-risk patients and reeducate the adult ADHD patient on issues concerning medication intake and psychological wellness.

Individuals with developmental disorders may experience numerous setbacks when trying to navigate their environments. The lack of correct feedback, supervision, and guidance may adversely affect adults with ADHD, contributing toward a lack of self-esteem and social awareness.

Individuals with adult ADHD are more likely than are their younger counterparts to have medical comorbidities, such as cardiovascular disease⁸ and type 2 diabetes,⁹ so it is crucial to prescribe dietary instructions to patients. Sometimes patients with adult ADHD lack support in the form of acceptance by family and peers, so it is critical for the patient to come to terms with his/her condition and seek professional help, incorporating effective strategies wherever needed to maintain day-to-day functioning.

Other possible comorbidities

There can be risk factors associated with isolation of adults who have depression and/or anxiety, poor eating habits, and maladaptive behaviors. Other adverse health-related issues may include substance use disorder.¹⁰ Drug use suppresses developmental growth and may induce ADHD symptom exacerbation. Consistent with Khantzian’s self-medication hypothesis, among individuals with ADHD, including those who lack a formal diagnosis, there is a tendency to gravitate toward illicit substances, in particular, stimulants.¹¹

We also know that adolescents are known to engage in normal risk-taking and social experimentation. Given that, the notion of boundary setting becomes a complicated affair during a pandemic. Adults may no longer be involved in the same types of risk-taking behaviors, but enforced self-isolation coupled with unchecked consumption of various social medial platforms continue to take a toll on personal development. Socialization plays an enormous role in maintaining psychological health, and social media is no substitute for in-person interactions. Such platforms can reduce mental growth opportunities and affect ADHD adults unfavorably.

For instance, it has been reported that women with adult ADHD are more likely to present with negative cognitive biases and symptoms of anxiety as a function of social media use.^12,13 As clinicians, we should recommend introducing activities with the aim of enhancing self-acceptance, mindfulness, and the ability to engage in healthy lifestyles. A holistic framework that focuses on psychological wellness and physical fitness will ensure treatment success. Medication management may prove to be a challenge because of differences in dosing, response schedules, and agreed-upon diagnostic criteria used for young patients, compared with those needed for adults.
 

Treatment strategies

Before the pandemic, researchers were observing an increase globally in the ADHD diagnosis,¹⁴ and clinicians have been exploring the efficacy of select medications, sometimes with limited success.¹⁵ Stimulant medication, combined with behavioral interventions, is supported by evidenced-based medicine and is the treatment of choice for childhood ADHD.

The stimulant remedy considered to be the most efficacious for adult ADHD is methylphenidate or dextroamphetamine.

However, be sure to proceed with caution and prepare a thorough work-up, because there can be cardiovascular risk factors associated with these medications with a pronounced increase in heart rate and blood pressure.

Stimulant medications are known to increase the risk of stroke or myocardial infarction for individuals with preexisting cardiovascular anomalies or structural anomalies. The American Heart Association no longer recommends a baseline EKG before commencing stimulant therapy with the exception of preexisting cardiac risk. Nonstimulant medications such as atomoxetine are available as alternatives.

The process of finding therapies that will reduce symptoms of ADHD takes considerable time, and individuals may fail to notice improvements, at least initially.

Before prescribing any medicine or therapies, it is important to evaluate for factors that are specific to ADHD and rule out the presence of other learning or developmental disorders, to prevent negative consequences.

Health care professionals can introduce nonspecific interventions as a means of tackling complicated cases of adult ADHD, especially those that coincide with underlying medical conditions (for example, cardiovascular disease, seizure disorders, and/or eating disorders). In such cases, stimulant medications may lead to symptom exacerbation, and the health care professional should carry out a systematic evaluation (risks vs. benefits of drug classes), despite the limitations of online appointments over the course of the pandemic.

Moreover, ADHD symptoms can take on a more severe form within the context of preexisting mood and anxiety disorders. Unfortunately, these comorbidities may have a negative prognostic outcome, too, thereby increasing other health-related risk factors. Psychological interventions can be implemented via online assessments because of recent technological advances worldwide, providing a new level of confidence and social engagement. EEG-assisted biofeedback is an example of new technological modalities that may help improve the overall performance and functionality of individuals with adult ADHD.¹⁶ Numerous services and resources are available to patients and their families that can improve mental health and well-being.

Other nonpharmacologic choices also play an instrumental role in bringing harmony and organization into a patient’s life through the use of daily planners, alarms, and to-do lists. In addition, therapists can provide treatment that helps individuals get motivated and reduce their anxiety levels. Behavioral therapies support patient initiatives by increasing their productivity, activity management, and satisfaction. Cognitive-behavioral therapy (CBT), and marriage counseling and family therapy are modalities that may help adults with ADHD change underlying thoughts and perceptions and develop coping skills and self-esteem.

Appropriate to the pandemic situation is another treatment, e-therapy, which includes text-based communication, video calling, and phone calls. It is a low-cost and convenient alternative for people. For some patients, traveling to a particular clinic or counseling center can be difficult, and there is a shortage of counselors worldwide, so it is beneficial to talk with a counselor on a video/phone call or through social media. It is crucial for the ADHD coach to be trained with relevant knowledge to make plans, set goals, and manage a patient’s schedule of activities. For the counselor, sharing tips based on personal experience and making the appropriate suggestions allows adults with ADHD to stay motivated and focus on the task at hand. It should be noted that counselors play an important role in reducing stress levels for those diagnosed with ADHD, allowing patients to lead productive lives and achieve career goals.

Various online support communities can provide patients and their parents with educational resources, to address issues connected to ADHD in a professional manner.¹⁷

The road to treatment success

Any delays in treating adults with ADHD can lead to a frustrating situation in which the entire family will be affected. As stated earlier, numerous support groups are available to adults with ADHD, and some of those groups can offer valuable tips about addressing stress management and the diverse roles that parents and family members may play in patient care.¹⁸ These groups provide a network for people to exchange ideas and recommend strategies. Online support groups may connect patients directly with key opinion leaders and health care providers.

Individuals with ADHD often experience problems with organization and concentration – especially within the context of the pandemic – and receiving guidance from counselors will provide an opportunity to learn valuable coping strategies and manage symptoms, recognizing and mitigating any mood swings associated with anxiety or depression that emerge alongside their ADHD. Psychotherapy is instrumental in patient care, and individuals with adult ADHD should be taught to acknowledge the role of medications (for example, neglect, divert, or self-medicate). A holistic approach to managing ADHD symptoms is necessary for optimal functioning and independence.
 

Dr. Aman is a faculty member in the biology department of City Colleges of Chicago. She is a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF), Montreal; a fellow, medical staff development, from the American Academy of Medical Management; and a Masters Online Teacher, University of Illinois at Chicago. Dr. Aman disclosed no relevant financial relationships. Dr. Islam is a medical adviser for the IMCHF, Montreal, and is based in New York. He is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Islam disclosed no relevant financial relationships. Dr. Karama is a psychiatrist at the Douglas Mental Health University Institute, Montreal. He is an assistant professor at the department of psychiatry, McGill University, also in Montreal. He has no disclosures. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. J Atten Disord. 2020. doi: 10.1177/1087054720943271.

2. ADDitude Magazine. 2020 Jul 23.

3. Management of ADHD in Adults: What the Science Says. 2007 Oct 9. Guilford Press.

4. N Engl J Med. 2013 Nov 14;369(20):1935-44.

5. J Clin Psychiatry. 2002;63 Suppl 12:29-35.

6. J Atten Dis. 2015 Jan 12. doi: 10.1177/1087054144566076.

7. Psychiatry Res. 2020 Oct;292. doi: 10.1016/j.psychres.2020.113345.

8. Case Rep Cardiol. 2016. doi: 10.1155/2016/2343691.

9. Curr Diab Rep. 2019 Jun 27;19(8):46. doi: 10.1007/s11892-019-1174-x.

10. Curr Psychiatry Rep. 2014 Mar;16(3):436. doi: 10.1007/s/11920-013-0436-6.

11. Current Psychiatry. 2014 Dec;13(12):e3-4.

12. BMC Psychiatry. 2020;20(40). doi: 10.1186/s/12888-020-02707-9.

13. Psychol Addict Behav. 2016 Mar;30(2):252–62.

14. ADDitude Magazine. 2017 Apr 6.

15. Harv Mental Health Letter. 2009 Nov.

16. MGM J Med Sci. 2020 Jul 17(3):161-2.

17. J Child Psychol Psychiatry. 2020 Jul 7.

18. Int J Disaster Risk Reduct. 2020 Dec;51. doi: 10.1016/j.ijdrr.2020.101845.

As some countries brace for yet another possible surge in the COVID-19 pandemic – particularly among young adults who have not yet been vaccinated – clinicians should remain wary of the cardinal symptoms of adult ADHD.

Research from an Israeli study shows that individuals with unmedicated ADHD are 52% more likely to test positive for the virus.^1,2

The symptoms of ADHD, including impulsiveness and inability to follow directions, combined with the tendency to leave adults with ADHD on their own to sort out COVID-19–related protocols – make these individuals susceptible to exposure.

As we know, ADHD is a condition characterized by a pervasive pattern of impulsivity and/or inattention, which greatly reduces organizational capabilities by interfering at the developmental level.³ Other key symptoms include short attention span, hyperactivity, restlessness, difficulty in prioritizing tasks, and an absence of time awareness. Symptom presentation of ADHD is contingent upon the nature of the individual’s overall mental health and etiologic issues that may be traced back to the brain’s development.⁴

Diagnosing ADHD in adults is relatively difficult, because a formal diagnosis generally requires symptoms to show up between the ages of 6 and 12.⁵ Also, clinicians can interview parents and family members to assess whether the classical features of ADHD were present in childhood for those suspected of having the condition.
 

Early vs. late presentation

Among the preschool population, it has been observed that emerging ADHD symptoms may progress with time or remain relatively constant with respect to the activities that children partake in. In some instances, impulsive behavior, especially compared with other symptoms, might be identified quickly by the attentive parent or caregiver. However, when ADHD appears in adulthood, it is possible that prior ADHD symptoms escaped detection – only to be diagnosed later in life because of varying presentations and the increased organizational demands of adulthood.

Meanwhile, diagnosis in adolescence can bring a different set of challenges to the forefront as teenagers face problems with self-management and responsibilities of daily living. These young people must cope with academic⁶ and social pressures – and a host of new societal expectations.

It is essential to understand how all of those societal factors have affected ADHD and its aspects, especially within the context of COVID-19. The coronavirus has introduced myriad challenges at the global level. Individuals with ADHD exhibit neurodevelopmental and corollary attention deficit issues that make them more susceptible to environmental stressors. Physical distancing practices might aggravate existing behavioral problems.
 

Distance forced by pandemic offers challenges

Despite the widespread adoption of telemedicine during the pandemic, some physicians think that the delivery of optimal care and the ability to adequately address patients’ health-related concerns have been compromised. Certainly, in the case of addressing the needs of patients with ADHD or related learning disorders, in-person examinations and clinical visits are best.

That is also the case for ADHD patients with comorbid sleep disorders. For those patients, it might be prudent to explore lifestyle changes (for example, improvements in sleep hygiene practices) before resorting to the use of pharmacologic agents such as hypnotics and melatonin. Along similar lines, the European ADHD Guideline Group (EAGG) advises the use of pharmacotherapy after the successful completion of a physical exam; patients already adhering to a treatment plan should continue therapy without interruption. Clinicians caring for patients with adult ADHD have faced a dilemma because treatment breaks increase the likelihood of illnesses resulting from the pandemic. Also, the inability to conduct treatment in person because of the pandemic raises concerns about pharmacotherapy.

The pandemic has affected the course of pediatric care and also has presented new challenges for adolescents as they begin to tackle unique problems related to their health concerns. In prepandemic times, teachers played integral roles in the diagnostic process, because they were able to readily identify children and teenagers with mental and physical challenges. In stark contrast, connecting with students online may not allow teachers to identify skill deficits in young patients or in adults with ADHD.

Furthermore, adults with ADHD and medical comorbidities may be at increased risk of disease exposure directly resulting from an inability to address their social and/or emotional well-being adequately. The social distancing and other mitigation measures advised by public health experts ensure safety and protection but also can present numerous hurdles for children, teenagers, adults – and their respective families.

Individuals with adult ADHD and other psychiatric disorders may downplay their psychological distress⁷ [for example, sleep dysfunction, issues concerning activities of daily living], and view it as being the natural product of the COVID-19 environment. As a result of their misconceptions, they may avoid increasing their medication dose to control emergent symptoms of hyperactivity and impulsivity, instead opting to manage stress without aid from health care professionals. The absence of patient-provider interactivity and the integration of telemedicine has introduced unnecessary obstacles with respect to medication management and therapy as well as general access to expert advice. It is of utmost importance for clinicians to identify at-risk patients and reeducate the adult ADHD patient on issues concerning medication intake and psychological wellness.

Individuals with developmental disorders may experience numerous setbacks when trying to navigate their environments. The lack of correct feedback, supervision, and guidance may adversely affect adults with ADHD, contributing toward a lack of self-esteem and social awareness.

Individuals with adult ADHD are more likely than are their younger counterparts to have medical comorbidities, such as cardiovascular disease⁸ and type 2 diabetes,⁹ so it is crucial to prescribe dietary instructions to patients. Sometimes patients with adult ADHD lack support in the form of acceptance by family and peers, so it is critical for the patient to come to terms with his/her condition and seek professional help, incorporating effective strategies wherever needed to maintain day-to-day functioning.

Other possible comorbidities

There can be risk factors associated with isolation of adults who have depression and/or anxiety, poor eating habits, and maladaptive behaviors. Other adverse health-related issues may include substance use disorder.¹⁰ Drug use suppresses developmental growth and may induce ADHD symptom exacerbation. Consistent with Khantzian’s self-medication hypothesis, among individuals with ADHD, including those who lack a formal diagnosis, there is a tendency to gravitate toward illicit substances, in particular, stimulants.¹¹

We also know that adolescents are known to engage in normal risk-taking and social experimentation. Given that, the notion of boundary setting becomes a complicated affair during a pandemic. Adults may no longer be involved in the same types of risk-taking behaviors, but enforced self-isolation coupled with unchecked consumption of various social medial platforms continue to take a toll on personal development. Socialization plays an enormous role in maintaining psychological health, and social media is no substitute for in-person interactions. Such platforms can reduce mental growth opportunities and affect ADHD adults unfavorably.

For instance, it has been reported that women with adult ADHD are more likely to present with negative cognitive biases and symptoms of anxiety as a function of social media use.^12,13 As clinicians, we should recommend introducing activities with the aim of enhancing self-acceptance, mindfulness, and the ability to engage in healthy lifestyles. A holistic framework that focuses on psychological wellness and physical fitness will ensure treatment success. Medication management may prove to be a challenge because of differences in dosing, response schedules, and agreed-upon diagnostic criteria used for young patients, compared with those needed for adults.
 

Treatment strategies

Before the pandemic, researchers were observing an increase globally in the ADHD diagnosis,¹⁴ and clinicians have been exploring the efficacy of select medications, sometimes with limited success.¹⁵ Stimulant medication, combined with behavioral interventions, is supported by evidenced-based medicine and is the treatment of choice for childhood ADHD.

The stimulant remedy considered to be the most efficacious for adult ADHD is methylphenidate or dextroamphetamine.

However, be sure to proceed with caution and prepare a thorough work-up, because there can be cardiovascular risk factors associated with these medications with a pronounced increase in heart rate and blood pressure.

Stimulant medications are known to increase the risk of stroke or myocardial infarction for individuals with preexisting cardiovascular anomalies or structural anomalies. The American Heart Association no longer recommends a baseline EKG before commencing stimulant therapy with the exception of preexisting cardiac risk. Nonstimulant medications such as atomoxetine are available as alternatives.

The process of finding therapies that will reduce symptoms of ADHD takes considerable time, and individuals may fail to notice improvements, at least initially.

Before prescribing any medicine or therapies, it is important to evaluate for factors that are specific to ADHD and rule out the presence of other learning or developmental disorders, to prevent negative consequences.

Health care professionals can introduce nonspecific interventions as a means of tackling complicated cases of adult ADHD, especially those that coincide with underlying medical conditions (for example, cardiovascular disease, seizure disorders, and/or eating disorders). In such cases, stimulant medications may lead to symptom exacerbation, and the health care professional should carry out a systematic evaluation (risks vs. benefits of drug classes), despite the limitations of online appointments over the course of the pandemic.

Moreover, ADHD symptoms can take on a more severe form within the context of preexisting mood and anxiety disorders. Unfortunately, these comorbidities may have a negative prognostic outcome, too, thereby increasing other health-related risk factors. Psychological interventions can be implemented via online assessments because of recent technological advances worldwide, providing a new level of confidence and social engagement. EEG-assisted biofeedback is an example of new technological modalities that may help improve the overall performance and functionality of individuals with adult ADHD.¹⁶ Numerous services and resources are available to patients and their families that can improve mental health and well-being.

Other nonpharmacologic choices also play an instrumental role in bringing harmony and organization into a patient’s life through the use of daily planners, alarms, and to-do lists. In addition, therapists can provide treatment that helps individuals get motivated and reduce their anxiety levels. Behavioral therapies support patient initiatives by increasing their productivity, activity management, and satisfaction. Cognitive-behavioral therapy (CBT), and marriage counseling and family therapy are modalities that may help adults with ADHD change underlying thoughts and perceptions and develop coping skills and self-esteem.

Appropriate to the pandemic situation is another treatment, e-therapy, which includes text-based communication, video calling, and phone calls. It is a low-cost and convenient alternative for people. For some patients, traveling to a particular clinic or counseling center can be difficult, and there is a shortage of counselors worldwide, so it is beneficial to talk with a counselor on a video/phone call or through social media. It is crucial for the ADHD coach to be trained with relevant knowledge to make plans, set goals, and manage a patient’s schedule of activities. For the counselor, sharing tips based on personal experience and making the appropriate suggestions allows adults with ADHD to stay motivated and focus on the task at hand. It should be noted that counselors play an important role in reducing stress levels for those diagnosed with ADHD, allowing patients to lead productive lives and achieve career goals.

Various online support communities can provide patients and their parents with educational resources, to address issues connected to ADHD in a professional manner.¹⁷

The road to treatment success

Any delays in treating adults with ADHD can lead to a frustrating situation in which the entire family will be affected. As stated earlier, numerous support groups are available to adults with ADHD, and some of those groups can offer valuable tips about addressing stress management and the diverse roles that parents and family members may play in patient care.¹⁸ These groups provide a network for people to exchange ideas and recommend strategies. Online support groups may connect patients directly with key opinion leaders and health care providers.

Individuals with ADHD often experience problems with organization and concentration – especially within the context of the pandemic – and receiving guidance from counselors will provide an opportunity to learn valuable coping strategies and manage symptoms, recognizing and mitigating any mood swings associated with anxiety or depression that emerge alongside their ADHD. Psychotherapy is instrumental in patient care, and individuals with adult ADHD should be taught to acknowledge the role of medications (for example, neglect, divert, or self-medicate). A holistic approach to managing ADHD symptoms is necessary for optimal functioning and independence.
 

Dr. Aman is a faculty member in the biology department of City Colleges of Chicago. She is a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF), Montreal; a fellow, medical staff development, from the American Academy of Medical Management; and a Masters Online Teacher, University of Illinois at Chicago. Dr. Aman disclosed no relevant financial relationships. Dr. Islam is a medical adviser for the IMCHF, Montreal, and is based in New York. He is a postdoctoral fellow, psychopharmacologist, and a board-certified medical affairs specialist. Dr. Islam disclosed no relevant financial relationships. Dr. Karama is a psychiatrist at the Douglas Mental Health University Institute, Montreal. He is an assistant professor at the department of psychiatry, McGill University, also in Montreal. He has no disclosures. Dr. Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. J Atten Disord. 2020. doi: 10.1177/1087054720943271.

2. ADDitude Magazine. 2020 Jul 23.

3. Management of ADHD in Adults: What the Science Says. 2007 Oct 9. Guilford Press.

4. N Engl J Med. 2013 Nov 14;369(20):1935-44.

5. J Clin Psychiatry. 2002;63 Suppl 12:29-35.

6. J Atten Dis. 2015 Jan 12. doi: 10.1177/1087054144566076.

7. Psychiatry Res. 2020 Oct;292. doi: 10.1016/j.psychres.2020.113345.

8. Case Rep Cardiol. 2016. doi: 10.1155/2016/2343691.

9. Curr Diab Rep. 2019 Jun 27;19(8):46. doi: 10.1007/s11892-019-1174-x.

10. Curr Psychiatry Rep. 2014 Mar;16(3):436. doi: 10.1007/s/11920-013-0436-6.

11. Current Psychiatry. 2014 Dec;13(12):e3-4.

12. BMC Psychiatry. 2020;20(40). doi: 10.1186/s/12888-020-02707-9.

13. Psychol Addict Behav. 2016 Mar;30(2):252–62.

14. ADDitude Magazine. 2017 Apr 6.

15. Harv Mental Health Letter. 2009 Nov.

16. MGM J Med Sci. 2020 Jul 17(3):161-2.

17. J Child Psychol Psychiatry. 2020 Jul 7.

18. Int J Disaster Risk Reduct. 2020 Dec;51. doi: 10.1016/j.ijdrr.2020.101845.

Antipsychotics may protect against SARS-CoV-2 infection or lead to a milder course of illness, new research suggests.

“Counterintuitively,” the investigators noted, vulnerable people with severe mental illness “on antipsychotic treatment showed a lower risk of SARS-CoV-2 infection and a likely better COVID-19 prognosis.”

“These are very interesting findings that reflect a clinical reality where we see few patients with severe COVID-19, despite the presence of various risk factors,” study investigator Manuel Canal-Rivero, PhD, clinical psychologist, Virgen del Rocio University Hospital, Sevilla, Spain, said in a news release.

“The number of COVID-19 patients is lower than expected among this group of people and in cases where a proven infection does occur, the evolution is benign and does not reach a life-threatening clinical situation. These data as a whole seem to point to the protective effect of the medication,” Dr. Canal-Rivero added.

The study was published online as a letter to the editor February 19, 2021, in Schizophrenia Research.
 

A ‘striking’ finding

The researchers assessed the prevalence and prognosis of COVID-19 in 698 patients with serious mental disorders (SMDs) receiving treatment with long-acting injectable antipsychotic medication. The non-SMD population included the catchment area population of 557,576 individuals.

From February to November 2020, 4.1% of the non-SMD population were infected with SARS-CoV-2 versus just 1.3% of the SMD population (9 of 698 patients). All but one patient with SMD had asymptomatic illness (8 of 9, 89%). Accurate information on asymptomatic illness in the non-SMD population was not available.

There were also fewer hospital admissions in the SMD population (0% vs. 8.5%), ICU admissions (0% vs. 0.9%) and deaths because of COVID-19 (0% vs. 1.1%), although the differences were not statistically significant.

In related research, the same investigators found that many of the genes whose expression is altered by SARS-CoV-2 infection are significantly down-regulated by antipsychotic drugs.

“In a striking way, we have shown how antipsychotics reduce the activation of genes involved in many of the inflammatory and immunological pathways associated with the severity of COVID-19 infection,” Benedicto Crespo-Facorro, MD, PhD, University of Sevilla, who led the study, said in the news release.

“Although this finding requires replication, the discovery could be very significant because the treatment of COVID-19 with drugs originally indicated for unrelated clinical situations, that is to say drug repositioning, has been shown to be an interesting source of effective treatments for COVID-19 patients,” he added.
 

Antiviral properties?

In a comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said the findings are “fascinating” and should be explored further.

While the findings on long-acting injectable antipsychotic treatment “seem counterintuitive at first, they are in line with other studies,” said Dr. Ahmad, who heads the inpatient psychiatry unit at Bellevue Hospital Center and is founder of the Integrative Center for Wellness in New York.

“We know that certain antipsychotics can suppress the expression of inflammatory cytokines (thereby theoretically preventing cytokine storm) and antidepressant medications appear to activate key cellular proteins that the SARS-CoV-2 virus uses for replication,” explained Dr. Ahmad, who was not associated with the study.

For example, as reported by this news organization, a preliminary study published in 2020 showed that early treatment with the antidepressant fluvoxamine prevented clinical deterioration in adult outpatients with confirmed COVID-19.

The antipsychotic aripiprazole has also shown potential to treat severe COVID-19 infection.

“Consequently, there appears to be a possible explanation as to why these drugs afford patients with severe mental disorders increased protection against the SARS-CoV-2 virus,” Dr. Ahmad said in an interview.

However, he cautioned, there are several factors at play that could influence the results. Therefore, more research is needed before drawing any firm conclusions.

“Still, the possibility that psychiatric medications may have antiviral properties is a tremendous development and I really hope that additional studies confirm the preliminary findings,” Dr. Ahmad said.

The study had no specific funding. The authors and Dr. Ahmad disclosed no relevant financial relationships.

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

Antipsychotics may protect against SARS-CoV-2 infection or lead to a milder course of illness, new research suggests.

“Counterintuitively,” the investigators noted, vulnerable people with severe mental illness “on antipsychotic treatment showed a lower risk of SARS-CoV-2 infection and a likely better COVID-19 prognosis.”

“These are very interesting findings that reflect a clinical reality where we see few patients with severe COVID-19, despite the presence of various risk factors,” study investigator Manuel Canal-Rivero, PhD, clinical psychologist, Virgen del Rocio University Hospital, Sevilla, Spain, said in a news release.

“The number of COVID-19 patients is lower than expected among this group of people and in cases where a proven infection does occur, the evolution is benign and does not reach a life-threatening clinical situation. These data as a whole seem to point to the protective effect of the medication,” Dr. Canal-Rivero added.

The study was published online as a letter to the editor February 19, 2021, in Schizophrenia Research.
 

A ‘striking’ finding

The researchers assessed the prevalence and prognosis of COVID-19 in 698 patients with serious mental disorders (SMDs) receiving treatment with long-acting injectable antipsychotic medication. The non-SMD population included the catchment area population of 557,576 individuals.

From February to November 2020, 4.1% of the non-SMD population were infected with SARS-CoV-2 versus just 1.3% of the SMD population (9 of 698 patients). All but one patient with SMD had asymptomatic illness (8 of 9, 89%). Accurate information on asymptomatic illness in the non-SMD population was not available.

There were also fewer hospital admissions in the SMD population (0% vs. 8.5%), ICU admissions (0% vs. 0.9%) and deaths because of COVID-19 (0% vs. 1.1%), although the differences were not statistically significant.

In related research, the same investigators found that many of the genes whose expression is altered by SARS-CoV-2 infection are significantly down-regulated by antipsychotic drugs.

“In a striking way, we have shown how antipsychotics reduce the activation of genes involved in many of the inflammatory and immunological pathways associated with the severity of COVID-19 infection,” Benedicto Crespo-Facorro, MD, PhD, University of Sevilla, who led the study, said in the news release.

“Although this finding requires replication, the discovery could be very significant because the treatment of COVID-19 with drugs originally indicated for unrelated clinical situations, that is to say drug repositioning, has been shown to be an interesting source of effective treatments for COVID-19 patients,” he added.
 

Antiviral properties?

In a comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said the findings are “fascinating” and should be explored further.

While the findings on long-acting injectable antipsychotic treatment “seem counterintuitive at first, they are in line with other studies,” said Dr. Ahmad, who heads the inpatient psychiatry unit at Bellevue Hospital Center and is founder of the Integrative Center for Wellness in New York.

“We know that certain antipsychotics can suppress the expression of inflammatory cytokines (thereby theoretically preventing cytokine storm) and antidepressant medications appear to activate key cellular proteins that the SARS-CoV-2 virus uses for replication,” explained Dr. Ahmad, who was not associated with the study.

For example, as reported by this news organization, a preliminary study published in 2020 showed that early treatment with the antidepressant fluvoxamine prevented clinical deterioration in adult outpatients with confirmed COVID-19.

The antipsychotic aripiprazole has also shown potential to treat severe COVID-19 infection.

“Consequently, there appears to be a possible explanation as to why these drugs afford patients with severe mental disorders increased protection against the SARS-CoV-2 virus,” Dr. Ahmad said in an interview.

However, he cautioned, there are several factors at play that could influence the results. Therefore, more research is needed before drawing any firm conclusions.

“Still, the possibility that psychiatric medications may have antiviral properties is a tremendous development and I really hope that additional studies confirm the preliminary findings,” Dr. Ahmad said.

The study had no specific funding. The authors and Dr. Ahmad disclosed no relevant financial relationships.

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

Antipsychotics may protect against SARS-CoV-2 infection or lead to a milder course of illness, new research suggests.

“Counterintuitively,” the investigators noted, vulnerable people with severe mental illness “on antipsychotic treatment showed a lower risk of SARS-CoV-2 infection and a likely better COVID-19 prognosis.”

“These are very interesting findings that reflect a clinical reality where we see few patients with severe COVID-19, despite the presence of various risk factors,” study investigator Manuel Canal-Rivero, PhD, clinical psychologist, Virgen del Rocio University Hospital, Sevilla, Spain, said in a news release.

“The number of COVID-19 patients is lower than expected among this group of people and in cases where a proven infection does occur, the evolution is benign and does not reach a life-threatening clinical situation. These data as a whole seem to point to the protective effect of the medication,” Dr. Canal-Rivero added.

The study was published online as a letter to the editor February 19, 2021, in Schizophrenia Research.
 

A ‘striking’ finding

The researchers assessed the prevalence and prognosis of COVID-19 in 698 patients with serious mental disorders (SMDs) receiving treatment with long-acting injectable antipsychotic medication. The non-SMD population included the catchment area population of 557,576 individuals.

From February to November 2020, 4.1% of the non-SMD population were infected with SARS-CoV-2 versus just 1.3% of the SMD population (9 of 698 patients). All but one patient with SMD had asymptomatic illness (8 of 9, 89%). Accurate information on asymptomatic illness in the non-SMD population was not available.

There were also fewer hospital admissions in the SMD population (0% vs. 8.5%), ICU admissions (0% vs. 0.9%) and deaths because of COVID-19 (0% vs. 1.1%), although the differences were not statistically significant.

In related research, the same investigators found that many of the genes whose expression is altered by SARS-CoV-2 infection are significantly down-regulated by antipsychotic drugs.

“In a striking way, we have shown how antipsychotics reduce the activation of genes involved in many of the inflammatory and immunological pathways associated with the severity of COVID-19 infection,” Benedicto Crespo-Facorro, MD, PhD, University of Sevilla, who led the study, said in the news release.

“Although this finding requires replication, the discovery could be very significant because the treatment of COVID-19 with drugs originally indicated for unrelated clinical situations, that is to say drug repositioning, has been shown to be an interesting source of effective treatments for COVID-19 patients,” he added.
 

Antiviral properties?

In a comment, Samoon Ahmad, MD, professor, department of psychiatry, New York University, said the findings are “fascinating” and should be explored further.

While the findings on long-acting injectable antipsychotic treatment “seem counterintuitive at first, they are in line with other studies,” said Dr. Ahmad, who heads the inpatient psychiatry unit at Bellevue Hospital Center and is founder of the Integrative Center for Wellness in New York.

“We know that certain antipsychotics can suppress the expression of inflammatory cytokines (thereby theoretically preventing cytokine storm) and antidepressant medications appear to activate key cellular proteins that the SARS-CoV-2 virus uses for replication,” explained Dr. Ahmad, who was not associated with the study.

For example, as reported by this news organization, a preliminary study published in 2020 showed that early treatment with the antidepressant fluvoxamine prevented clinical deterioration in adult outpatients with confirmed COVID-19.

The antipsychotic aripiprazole has also shown potential to treat severe COVID-19 infection.

“Consequently, there appears to be a possible explanation as to why these drugs afford patients with severe mental disorders increased protection against the SARS-CoV-2 virus,” Dr. Ahmad said in an interview.

However, he cautioned, there are several factors at play that could influence the results. Therefore, more research is needed before drawing any firm conclusions.

“Still, the possibility that psychiatric medications may have antiviral properties is a tremendous development and I really hope that additional studies confirm the preliminary findings,” Dr. Ahmad said.

The study had no specific funding. The authors and Dr. Ahmad disclosed no relevant financial relationships.

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

The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.

HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.

Medical organizations and reproductive health specialists lauded the move.

“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”

“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”

HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.

HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.

The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.

The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.

The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.

The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”

Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.

March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.

“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.

The Title X program does not pay for abortions, however.

The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”

The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”

The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.

The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.

Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.

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

The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.

HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.

Medical organizations and reproductive health specialists lauded the move.

“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”

“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”

HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.

HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.

The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.

The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.

The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.

The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”

Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.

March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.

“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.

The Title X program does not pay for abortions, however.

The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”

The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”

The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.

The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.

Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.

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

The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.

HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.

Medical organizations and reproductive health specialists lauded the move.

“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”

“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”

HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.

HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.

The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.

The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.

The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.

The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”

Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.

March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.

“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.

The Title X program does not pay for abortions, however.

The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”

The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”

The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.

The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.

Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.

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

An investigational polymerase chain reaction (PCR) test that detects the presence of a viral gene in Lyme disease–causing bacteria can distinguish between early and late infection, according to the results of a study that the authors described as “systematic and comprehensive.”

“The current way of diagnosing Lyme disease is struggling to reflect the ‘true’ incidence of Lyme disease,” study investigator Jinyu Shan, PhD, said in an interview. Although there are tests for Lyme disease approved by the Food and Drug Administration, they are based on the development of antibodies in the blood, and the problem is that antibodies might not develop until several weeks after an infection.

Diagnosis therefore still relies heavily on the clinician’s experience. There are often telltale signs – such as a “bullseye” skin rash or having been to an area known to be infested with ticks that carry Lyme disease – but this might not always be the case.

For the new test, “we’re not targeting bacteria. We’re targeting bacteriophages,” said Dr. Shan, a research fellow in the department of genetics and genome biology at the University of Leicester (England).

Fortunately, there’s high correlation between the presence of the terL gene and the presence of Borrelia burgdorferi, the spirochete that causes Lyme disease. “If you find the bacteriophages, the bacteria are there,” said Dr. Shan.

“Importantly, there are 10 times more bacteriophages, compared with the bacteria, so you have a lot more targets,” he added.

In an evaluation of a total of 312 samples (156 whole blood and 156 serum samples), significantly fewer copies of the terL gene were found in samples from people with early Lyme disease than in those with late Lyme disease, whereas the fewest copies of terL were seen in healthy volunteers.

Most pathogenic bacteria carry viral DNA either as multiple complete or partial prophages, Dr. Shan explained. Knowing the prophage sequences means that quantitative PCR primers and probes can be designed and used to detect the presence of the associated bacteria.

Although the novel test still needs evaluation in a clinical trial, it could represent a “step-change” in the detection of Lyme disease, Dr. Shan and associates suggested in their report published in Frontiers in Microbiology.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

Early treatment is key to the prevention of longer-term consequences of Lyme disease. Clinicians familiar with the treatment of Lyme disease might choose to initiate antibiotic treatment without a positive lab test. However, the lack of a test that can pick out people with Lyme disease in the first few weeks of infection means that many people are not diagnosed or treated early enough.

The new phage-based PCR test Dr. Shan and associates have developed could change all that. With only 0.3 mL of blood being needed, it can potentially be developed as a simple point-of-care test, but that’s a long way off.

At this stage, the research is very much a “proof of concept,” Dr. Shan said. One of the things he plans to try to work out next is whether the test can distinguish between active and dormant disease, which is a “big question” in the diagnosis of Lyme disease.

“Bacteriophages can only be sustained by actively growing bacteria,” explained Dr. Shan, so there is a chance that if they are present in a substantive amount the disease is active, and if they are not – or are in very low numbers – then the disease is dormant. The cutoff value, however, “is not trivial to establish, but we are working toward it,” added Dr. Shan.

Over the past 2 years, Dr. Shan and associates have been working with the Belgian-based diagnostics company, R.E.D Laboratories, to see how the test will fare in a real-world environment. This relationship is providing useful information to add to their bid to perform a clinical trial for which they are now seeking additional sponsorship.

“The lack of an early and effective diagnosis of Lyme disease remains a major cause of misdiagnosis and long-term patient suffering,” commented Rosie Milsom, charity manager for Caudwell LymeCo Charity in the United Kingdom.

It could be a game changer if the test passes the necessary clinical trial testing and validation stages, noted Ms. Milsom, who was not involved in the research.

“Not only would the test help to establish the level or length of infection,” she said, “but it could also act as a way to test after treatment to see if the infection levels are decreasing.” If levels are still high, “you would know more treatment is needed.

The research is being funded by the charity Phelix Research and Development with support from the University of Leicester and the Dutch-based Lyme Fund, Lymefonds. Dr. Shan is named as coinventor of the phage-targeting PCR test, alongside Martha R.J. Clokie, professor of microbiology at the University of Leicester and the senior author of the study. Dr. Shan is chief scientific officer for Phelix Research and Development. Ms. Clokie and other coauthors hold key positions within the medical research charity.

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

An investigational polymerase chain reaction (PCR) test that detects the presence of a viral gene in Lyme disease–causing bacteria can distinguish between early and late infection, according to the results of a study that the authors described as “systematic and comprehensive.”

“The current way of diagnosing Lyme disease is struggling to reflect the ‘true’ incidence of Lyme disease,” study investigator Jinyu Shan, PhD, said in an interview. Although there are tests for Lyme disease approved by the Food and Drug Administration, they are based on the development of antibodies in the blood, and the problem is that antibodies might not develop until several weeks after an infection.

Diagnosis therefore still relies heavily on the clinician’s experience. There are often telltale signs – such as a “bullseye” skin rash or having been to an area known to be infested with ticks that carry Lyme disease – but this might not always be the case.

For the new test, “we’re not targeting bacteria. We’re targeting bacteriophages,” said Dr. Shan, a research fellow in the department of genetics and genome biology at the University of Leicester (England).

Fortunately, there’s high correlation between the presence of the terL gene and the presence of Borrelia burgdorferi, the spirochete that causes Lyme disease. “If you find the bacteriophages, the bacteria are there,” said Dr. Shan.

“Importantly, there are 10 times more bacteriophages, compared with the bacteria, so you have a lot more targets,” he added.

In an evaluation of a total of 312 samples (156 whole blood and 156 serum samples), significantly fewer copies of the terL gene were found in samples from people with early Lyme disease than in those with late Lyme disease, whereas the fewest copies of terL were seen in healthy volunteers.

Most pathogenic bacteria carry viral DNA either as multiple complete or partial prophages, Dr. Shan explained. Knowing the prophage sequences means that quantitative PCR primers and probes can be designed and used to detect the presence of the associated bacteria.

Although the novel test still needs evaluation in a clinical trial, it could represent a “step-change” in the detection of Lyme disease, Dr. Shan and associates suggested in their report published in Frontiers in Microbiology.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

Early treatment is key to the prevention of longer-term consequences of Lyme disease. Clinicians familiar with the treatment of Lyme disease might choose to initiate antibiotic treatment without a positive lab test. However, the lack of a test that can pick out people with Lyme disease in the first few weeks of infection means that many people are not diagnosed or treated early enough.

The new phage-based PCR test Dr. Shan and associates have developed could change all that. With only 0.3 mL of blood being needed, it can potentially be developed as a simple point-of-care test, but that’s a long way off.

At this stage, the research is very much a “proof of concept,” Dr. Shan said. One of the things he plans to try to work out next is whether the test can distinguish between active and dormant disease, which is a “big question” in the diagnosis of Lyme disease.

“Bacteriophages can only be sustained by actively growing bacteria,” explained Dr. Shan, so there is a chance that if they are present in a substantive amount the disease is active, and if they are not – or are in very low numbers – then the disease is dormant. The cutoff value, however, “is not trivial to establish, but we are working toward it,” added Dr. Shan.

Over the past 2 years, Dr. Shan and associates have been working with the Belgian-based diagnostics company, R.E.D Laboratories, to see how the test will fare in a real-world environment. This relationship is providing useful information to add to their bid to perform a clinical trial for which they are now seeking additional sponsorship.

“The lack of an early and effective diagnosis of Lyme disease remains a major cause of misdiagnosis and long-term patient suffering,” commented Rosie Milsom, charity manager for Caudwell LymeCo Charity in the United Kingdom.

It could be a game changer if the test passes the necessary clinical trial testing and validation stages, noted Ms. Milsom, who was not involved in the research.

“Not only would the test help to establish the level or length of infection,” she said, “but it could also act as a way to test after treatment to see if the infection levels are decreasing.” If levels are still high, “you would know more treatment is needed.

The research is being funded by the charity Phelix Research and Development with support from the University of Leicester and the Dutch-based Lyme Fund, Lymefonds. Dr. Shan is named as coinventor of the phage-targeting PCR test, alongside Martha R.J. Clokie, professor of microbiology at the University of Leicester and the senior author of the study. Dr. Shan is chief scientific officer for Phelix Research and Development. Ms. Clokie and other coauthors hold key positions within the medical research charity.

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

An investigational polymerase chain reaction (PCR) test that detects the presence of a viral gene in Lyme disease–causing bacteria can distinguish between early and late infection, according to the results of a study that the authors described as “systematic and comprehensive.”

“The current way of diagnosing Lyme disease is struggling to reflect the ‘true’ incidence of Lyme disease,” study investigator Jinyu Shan, PhD, said in an interview. Although there are tests for Lyme disease approved by the Food and Drug Administration, they are based on the development of antibodies in the blood, and the problem is that antibodies might not develop until several weeks after an infection.

Diagnosis therefore still relies heavily on the clinician’s experience. There are often telltale signs – such as a “bullseye” skin rash or having been to an area known to be infested with ticks that carry Lyme disease – but this might not always be the case.

For the new test, “we’re not targeting bacteria. We’re targeting bacteriophages,” said Dr. Shan, a research fellow in the department of genetics and genome biology at the University of Leicester (England).

Fortunately, there’s high correlation between the presence of the terL gene and the presence of Borrelia burgdorferi, the spirochete that causes Lyme disease. “If you find the bacteriophages, the bacteria are there,” said Dr. Shan.

“Importantly, there are 10 times more bacteriophages, compared with the bacteria, so you have a lot more targets,” he added.

In an evaluation of a total of 312 samples (156 whole blood and 156 serum samples), significantly fewer copies of the terL gene were found in samples from people with early Lyme disease than in those with late Lyme disease, whereas the fewest copies of terL were seen in healthy volunteers.

Most pathogenic bacteria carry viral DNA either as multiple complete or partial prophages, Dr. Shan explained. Knowing the prophage sequences means that quantitative PCR primers and probes can be designed and used to detect the presence of the associated bacteria.

Although the novel test still needs evaluation in a clinical trial, it could represent a “step-change” in the detection of Lyme disease, Dr. Shan and associates suggested in their report published in Frontiers in Microbiology.

CDC/ Dr. Amanda Loftis, Dr. William Nicholson, Dr. Will Reeves, Dr. Chris Paddock

Early treatment is key to the prevention of longer-term consequences of Lyme disease. Clinicians familiar with the treatment of Lyme disease might choose to initiate antibiotic treatment without a positive lab test. However, the lack of a test that can pick out people with Lyme disease in the first few weeks of infection means that many people are not diagnosed or treated early enough.

The new phage-based PCR test Dr. Shan and associates have developed could change all that. With only 0.3 mL of blood being needed, it can potentially be developed as a simple point-of-care test, but that’s a long way off.

At this stage, the research is very much a “proof of concept,” Dr. Shan said. One of the things he plans to try to work out next is whether the test can distinguish between active and dormant disease, which is a “big question” in the diagnosis of Lyme disease.

“Bacteriophages can only be sustained by actively growing bacteria,” explained Dr. Shan, so there is a chance that if they are present in a substantive amount the disease is active, and if they are not – or are in very low numbers – then the disease is dormant. The cutoff value, however, “is not trivial to establish, but we are working toward it,” added Dr. Shan.

Over the past 2 years, Dr. Shan and associates have been working with the Belgian-based diagnostics company, R.E.D Laboratories, to see how the test will fare in a real-world environment. This relationship is providing useful information to add to their bid to perform a clinical trial for which they are now seeking additional sponsorship.

“The lack of an early and effective diagnosis of Lyme disease remains a major cause of misdiagnosis and long-term patient suffering,” commented Rosie Milsom, charity manager for Caudwell LymeCo Charity in the United Kingdom.

It could be a game changer if the test passes the necessary clinical trial testing and validation stages, noted Ms. Milsom, who was not involved in the research.

“Not only would the test help to establish the level or length of infection,” she said, “but it could also act as a way to test after treatment to see if the infection levels are decreasing.” If levels are still high, “you would know more treatment is needed.

The research is being funded by the charity Phelix Research and Development with support from the University of Leicester and the Dutch-based Lyme Fund, Lymefonds. Dr. Shan is named as coinventor of the phage-targeting PCR test, alongside Martha R.J. Clokie, professor of microbiology at the University of Leicester and the senior author of the study. Dr. Shan is chief scientific officer for Phelix Research and Development. Ms. Clokie and other coauthors hold key positions within the medical research charity.

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

Research suggests certain gut bacteria can reduce the efficacy of radiotherapy against cancers, but targeting those bacteria with vancomycin can reverse this effect.

Andrea Facciabene, PhD, of the University of Pennsylvania, Philadelphia, and colleagues conducted a preclinical study in which vancomycin enhanced the efficacy of radiotherapy against melanoma and lung cancer. Now, researchers are conducting a clinical trial to determine if vancomycin can have the same effect in patients with non–small cell lung cancer.

Dr. Facciabene reviewed this research at the AACR Virtual Special Conference: Radiation Science and Medicine.

According to Dr. Facciabene, “gut microbiota” includes the more than 1,000 different strains of bacteria living in human intestines. He indicated that the average human has 10 times more bacteria than cells in the body and 150 times more genes in the gut microbiome than in the human genome.

In healthy individuals, the gut microbiota play a key role in intestinal function and digestive processes, modulation of hormones and vitamin secretion, energy extraction from food, and development and maintenance of a balanced immune system.

“Dysbiosis” is the term applied to a change in the composition, diversity, or metabolites of the microbiome from a healthy pattern to one associated with disease. Antibiotic therapy is a classic cause of dysbiosis, and dysbiosis has been implicated in a variety of inflammatory diseases.

The mechanisms by which the gut microbiome could influence systemic immunity is not known but is relevant to cancer therapy response. Augmenting the frequency and durability of response to immune-targeted treatments – potentially by manipulating the influence of gut microbiota on the immune system – could be highly impactful.
 

Gut microbiota and radiation-induced cell death

Immunogenic cell death – a process by which tumors die and release their intracellular molecular contents – is one of the mechanisms by which radiotherapy kills cancer cells.

Tumor cells succumbing to immunogenic cell death stimulate antigen presenting cells, such as dendritic cells, that engulf tumor antigens and cross-present them to CD8+ cytotoxic T lymphocytes. This process culminates in the generation of a specific immune response capable of killing the malignant cells in the irradiated area, but it also impacts distant nonirradiated tumors – an abscopal effect.

Dr. Facciabene and colleagues hypothesized that alterations of the gut microbiota could have an impact on the effect of radiotherapy. To investigate this, they studied mouse models of melanoma.

The team allowed B16-OVA tumors to grow for 9-12 days, then delivered a single dose of radiotherapy (21 Gy) to one – but not all – tumors. Simultaneously with the delivery of radiotherapy, the investigators started some animals on oral vancomycin. The team chose vancomycin because its effects are localized and impact the gut microbiota directly, without any known systemic effects.

Results showed that vancomycin significantly augmented the impact of radiotherapy in the irradiated area and was associated with regression of remote tumors.

The effects of the combination treatment on tumor volume were significantly greater than the effects of either treatment alone. Since manipulation of the gut microbiome potentiated radiotherapy effects both locally and distantly, the investigators concluded that immunogenic cell death may be involved in both the local and abscopal effects of radiotherapy.

When the experiment was repeated with a lung tumor model, similar findings were observed.
 

Involvement of cytotoxic T cells and interferon-gamma

Dr. Facciabene and colleagues found that the irradiated and unirradiated B16 OVA melanoma tumors treated with the radiotherapy-vancomycin combination were infiltrated by CD3+ and CD8+ T cells.

The investigators selectively depleted CD8+ T cells by pretreating the mice with an anti-CD8 monoclonal antibody. Depletion of CD8+ cells prior to administering radiotherapy plus vancomycin abrogated the antitumor effects of the combination treatment, demonstrating that the CD8+ T cells were required.

To characterize the antigen specificity of the tumor-infiltrating CD8+ T cells, Dr. Facciabene and colleagues used OVA MHC class 1 tetramer. Tumors from mice treated with vancomycin alone, radiotherapy alone, or the combination were dissected. Individual dendritic cells were assayed for OVA tetramer by flow cytometry.

The investigators found that tumors from mice treated with radiotherapy plus vancomycin had a significantly higher number of OVA-specific CD8+ T cells, in comparison with untreated tumors or tumors treated with either vancomycin alone or radiotherapy alone. Since antibody that impaired recognition of MHC class I peptides by T cells ablated the effect, it was clear that antigen recognition was vital.

Interferon-gamma (IFN-gamma) is known to play a critical role in both differentiation and effector functions of CD8+ cytolytic T cells in the antitumor immune response. To determine whether IFN-gamma is involved in the antitumor effects of the radiotherapy-vancomycin combination, the investigators measured intratumoral expression of IFN-gamma in the tumors 5 days after radiotherapy.

IFN-gamma messenger RNA expression levels were significantly elevated in the combination treatment group when compared with either treatment alone. In B16-OVA melanoma–challenged knockout mice, the enhancement of the radiotherapy effects by vancomycin was ablated.

The investigators concluded that vancomycin remodels the tumor microenvironment and increases the functionality of tumor-infiltrating, tumor-specific, CD8+ T cells. Furthermore, IFN-gamma is required to augment the radiotherapy-induced immune effect against the tumor.
 

Potential biochemical mediators of immune effects

The gut microbiota aid host digestion and generate a large repertoire of metabolites after defermentation of fiber. Short-chain fatty acids (SCFAs) constitute the major products of bacterial fermentation.

Acetic acid, propionic acid, and butyric acid represent 95% of total SCFAs present in the intestine. SCFAs are known to directly modulate cytokine production and dendritic cell function.

In their study, Dr. Facciabene and colleagues focused on butyric acid. Using mass spectroscopy, they demonstrated that vancomycin treatment reduces butyrate concentrations in tumor and tumor-draining lymph nodes by eradicating the major families of SCFA-producing Clostridia species.

To test whether supplementing butyrate could influence the synergy of the radiotherapy-vancomycin combination in vivo, the investigators added sodium butyrate to the mice’s drinking water when starting vancomycin treatment. The team then challenged the mice with B16-OVA tumors and treated them with radiotherapy.

In agreement with the group’s prior findings, vancomycin enhanced the tumor-inhibitory effects of radiotherapy, but dietary butyrate inhibited the benefit. The investigators found a significant decrease in the population of B16-OVA–presenting dendritic cells in the lymph nodes of mice receiving the supplemental butyrate.

Dr. Facciabene said these findings were supported by a recent publication. The authors observed that butyrate inhibited type I IFN expression in dendritic cells and radiotherapy-induced, tumor-specific cytotoxic T-cell immune responses without directly protecting tumor cells from the cytotoxic effects of radiotherapy.
 

Wide-ranging implications

Overall, Dr. Facciabene’s research has shown that:

• Vancomycin significantly enhances the tumor inhibitory effect of targeted radiation, including abscopal effects.
• The synergistic effects are dependent upon IFN-gamma and CD8+ cells.
• Depletion of some gut microbiome species increases antigen presentation by dendritic cells. This is mediated by SCFAs produced by certain bacterial families.
• There are promising new strategies to improve responses to radiotherapy, including targeting gut microbiota.

A clinical trial (NCT03546829) of vancomycin plus stereotactic body radiation in patients with locally advanced non–small cell lung cancer has been launched to investigate these findings further. Early data analysis has shown a significant impact of vancomycin on several species of gut microbiota, according to Dr. Facciabene.

Revolutionary results from immune-targeted therapy in the recent past have highlighted the important role the immune system can play in fighting cancer. Still, up to one-third of cancer patients fail to respond to overtly immune-targeted therapy.

The ability to inhibit cancer cells from evading immune surveillance by using new adjuvants – including those acting on non-traditional targets like gut microbiota – could herald the next major advances in cancer therapy. During his presentation, Dr. Facciabene gave participants an enticing hint of what could be coming for cancer patients in the years ahead.

Dr. Facciabene reported having no relevant disclosures.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

Research suggests certain gut bacteria can reduce the efficacy of radiotherapy against cancers, but targeting those bacteria with vancomycin can reverse this effect.

Andrea Facciabene, PhD, of the University of Pennsylvania, Philadelphia, and colleagues conducted a preclinical study in which vancomycin enhanced the efficacy of radiotherapy against melanoma and lung cancer. Now, researchers are conducting a clinical trial to determine if vancomycin can have the same effect in patients with non–small cell lung cancer.

Dr. Facciabene reviewed this research at the AACR Virtual Special Conference: Radiation Science and Medicine.

According to Dr. Facciabene, “gut microbiota” includes the more than 1,000 different strains of bacteria living in human intestines. He indicated that the average human has 10 times more bacteria than cells in the body and 150 times more genes in the gut microbiome than in the human genome.

In healthy individuals, the gut microbiota play a key role in intestinal function and digestive processes, modulation of hormones and vitamin secretion, energy extraction from food, and development and maintenance of a balanced immune system.

“Dysbiosis” is the term applied to a change in the composition, diversity, or metabolites of the microbiome from a healthy pattern to one associated with disease. Antibiotic therapy is a classic cause of dysbiosis, and dysbiosis has been implicated in a variety of inflammatory diseases.

The mechanisms by which the gut microbiome could influence systemic immunity is not known but is relevant to cancer therapy response. Augmenting the frequency and durability of response to immune-targeted treatments – potentially by manipulating the influence of gut microbiota on the immune system – could be highly impactful.
 

Gut microbiota and radiation-induced cell death

Immunogenic cell death – a process by which tumors die and release their intracellular molecular contents – is one of the mechanisms by which radiotherapy kills cancer cells.

Tumor cells succumbing to immunogenic cell death stimulate antigen presenting cells, such as dendritic cells, that engulf tumor antigens and cross-present them to CD8+ cytotoxic T lymphocytes. This process culminates in the generation of a specific immune response capable of killing the malignant cells in the irradiated area, but it also impacts distant nonirradiated tumors – an abscopal effect.

Dr. Facciabene and colleagues hypothesized that alterations of the gut microbiota could have an impact on the effect of radiotherapy. To investigate this, they studied mouse models of melanoma.

The team allowed B16-OVA tumors to grow for 9-12 days, then delivered a single dose of radiotherapy (21 Gy) to one – but not all – tumors. Simultaneously with the delivery of radiotherapy, the investigators started some animals on oral vancomycin. The team chose vancomycin because its effects are localized and impact the gut microbiota directly, without any known systemic effects.

Results showed that vancomycin significantly augmented the impact of radiotherapy in the irradiated area and was associated with regression of remote tumors.

The effects of the combination treatment on tumor volume were significantly greater than the effects of either treatment alone. Since manipulation of the gut microbiome potentiated radiotherapy effects both locally and distantly, the investigators concluded that immunogenic cell death may be involved in both the local and abscopal effects of radiotherapy.

When the experiment was repeated with a lung tumor model, similar findings were observed.
 

Involvement of cytotoxic T cells and interferon-gamma

Dr. Facciabene and colleagues found that the irradiated and unirradiated B16 OVA melanoma tumors treated with the radiotherapy-vancomycin combination were infiltrated by CD3+ and CD8+ T cells.

The investigators selectively depleted CD8+ T cells by pretreating the mice with an anti-CD8 monoclonal antibody. Depletion of CD8+ cells prior to administering radiotherapy plus vancomycin abrogated the antitumor effects of the combination treatment, demonstrating that the CD8+ T cells were required.

To characterize the antigen specificity of the tumor-infiltrating CD8+ T cells, Dr. Facciabene and colleagues used OVA MHC class 1 tetramer. Tumors from mice treated with vancomycin alone, radiotherapy alone, or the combination were dissected. Individual dendritic cells were assayed for OVA tetramer by flow cytometry.

The investigators found that tumors from mice treated with radiotherapy plus vancomycin had a significantly higher number of OVA-specific CD8+ T cells, in comparison with untreated tumors or tumors treated with either vancomycin alone or radiotherapy alone. Since antibody that impaired recognition of MHC class I peptides by T cells ablated the effect, it was clear that antigen recognition was vital.

Interferon-gamma (IFN-gamma) is known to play a critical role in both differentiation and effector functions of CD8+ cytolytic T cells in the antitumor immune response. To determine whether IFN-gamma is involved in the antitumor effects of the radiotherapy-vancomycin combination, the investigators measured intratumoral expression of IFN-gamma in the tumors 5 days after radiotherapy.

IFN-gamma messenger RNA expression levels were significantly elevated in the combination treatment group when compared with either treatment alone. In B16-OVA melanoma–challenged knockout mice, the enhancement of the radiotherapy effects by vancomycin was ablated.

The investigators concluded that vancomycin remodels the tumor microenvironment and increases the functionality of tumor-infiltrating, tumor-specific, CD8+ T cells. Furthermore, IFN-gamma is required to augment the radiotherapy-induced immune effect against the tumor.
 

Potential biochemical mediators of immune effects

The gut microbiota aid host digestion and generate a large repertoire of metabolites after defermentation of fiber. Short-chain fatty acids (SCFAs) constitute the major products of bacterial fermentation.

Acetic acid, propionic acid, and butyric acid represent 95% of total SCFAs present in the intestine. SCFAs are known to directly modulate cytokine production and dendritic cell function.

In their study, Dr. Facciabene and colleagues focused on butyric acid. Using mass spectroscopy, they demonstrated that vancomycin treatment reduces butyrate concentrations in tumor and tumor-draining lymph nodes by eradicating the major families of SCFA-producing Clostridia species.

To test whether supplementing butyrate could influence the synergy of the radiotherapy-vancomycin combination in vivo, the investigators added sodium butyrate to the mice’s drinking water when starting vancomycin treatment. The team then challenged the mice with B16-OVA tumors and treated them with radiotherapy.

In agreement with the group’s prior findings, vancomycin enhanced the tumor-inhibitory effects of radiotherapy, but dietary butyrate inhibited the benefit. The investigators found a significant decrease in the population of B16-OVA–presenting dendritic cells in the lymph nodes of mice receiving the supplemental butyrate.

Dr. Facciabene said these findings were supported by a recent publication. The authors observed that butyrate inhibited type I IFN expression in dendritic cells and radiotherapy-induced, tumor-specific cytotoxic T-cell immune responses without directly protecting tumor cells from the cytotoxic effects of radiotherapy.
 

Wide-ranging implications

Overall, Dr. Facciabene’s research has shown that:

• Vancomycin significantly enhances the tumor inhibitory effect of targeted radiation, including abscopal effects.
• The synergistic effects are dependent upon IFN-gamma and CD8+ cells.
• Depletion of some gut microbiome species increases antigen presentation by dendritic cells. This is mediated by SCFAs produced by certain bacterial families.
• There are promising new strategies to improve responses to radiotherapy, including targeting gut microbiota.

A clinical trial (NCT03546829) of vancomycin plus stereotactic body radiation in patients with locally advanced non–small cell lung cancer has been launched to investigate these findings further. Early data analysis has shown a significant impact of vancomycin on several species of gut microbiota, according to Dr. Facciabene.

Revolutionary results from immune-targeted therapy in the recent past have highlighted the important role the immune system can play in fighting cancer. Still, up to one-third of cancer patients fail to respond to overtly immune-targeted therapy.

The ability to inhibit cancer cells from evading immune surveillance by using new adjuvants – including those acting on non-traditional targets like gut microbiota – could herald the next major advances in cancer therapy. During his presentation, Dr. Facciabene gave participants an enticing hint of what could be coming for cancer patients in the years ahead.

Dr. Facciabene reported having no relevant disclosures.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

Research suggests certain gut bacteria can reduce the efficacy of radiotherapy against cancers, but targeting those bacteria with vancomycin can reverse this effect.

Andrea Facciabene, PhD, of the University of Pennsylvania, Philadelphia, and colleagues conducted a preclinical study in which vancomycin enhanced the efficacy of radiotherapy against melanoma and lung cancer. Now, researchers are conducting a clinical trial to determine if vancomycin can have the same effect in patients with non–small cell lung cancer.

Dr. Facciabene reviewed this research at the AACR Virtual Special Conference: Radiation Science and Medicine.

According to Dr. Facciabene, “gut microbiota” includes the more than 1,000 different strains of bacteria living in human intestines. He indicated that the average human has 10 times more bacteria than cells in the body and 150 times more genes in the gut microbiome than in the human genome.

In healthy individuals, the gut microbiota play a key role in intestinal function and digestive processes, modulation of hormones and vitamin secretion, energy extraction from food, and development and maintenance of a balanced immune system.

“Dysbiosis” is the term applied to a change in the composition, diversity, or metabolites of the microbiome from a healthy pattern to one associated with disease. Antibiotic therapy is a classic cause of dysbiosis, and dysbiosis has been implicated in a variety of inflammatory diseases.

The mechanisms by which the gut microbiome could influence systemic immunity is not known but is relevant to cancer therapy response. Augmenting the frequency and durability of response to immune-targeted treatments – potentially by manipulating the influence of gut microbiota on the immune system – could be highly impactful.
 

Gut microbiota and radiation-induced cell death

Immunogenic cell death – a process by which tumors die and release their intracellular molecular contents – is one of the mechanisms by which radiotherapy kills cancer cells.

Tumor cells succumbing to immunogenic cell death stimulate antigen presenting cells, such as dendritic cells, that engulf tumor antigens and cross-present them to CD8+ cytotoxic T lymphocytes. This process culminates in the generation of a specific immune response capable of killing the malignant cells in the irradiated area, but it also impacts distant nonirradiated tumors – an abscopal effect.

Dr. Facciabene and colleagues hypothesized that alterations of the gut microbiota could have an impact on the effect of radiotherapy. To investigate this, they studied mouse models of melanoma.

The team allowed B16-OVA tumors to grow for 9-12 days, then delivered a single dose of radiotherapy (21 Gy) to one – but not all – tumors. Simultaneously with the delivery of radiotherapy, the investigators started some animals on oral vancomycin. The team chose vancomycin because its effects are localized and impact the gut microbiota directly, without any known systemic effects.

Results showed that vancomycin significantly augmented the impact of radiotherapy in the irradiated area and was associated with regression of remote tumors.

The effects of the combination treatment on tumor volume were significantly greater than the effects of either treatment alone. Since manipulation of the gut microbiome potentiated radiotherapy effects both locally and distantly, the investigators concluded that immunogenic cell death may be involved in both the local and abscopal effects of radiotherapy.

When the experiment was repeated with a lung tumor model, similar findings were observed.
 

Involvement of cytotoxic T cells and interferon-gamma

Dr. Facciabene and colleagues found that the irradiated and unirradiated B16 OVA melanoma tumors treated with the radiotherapy-vancomycin combination were infiltrated by CD3+ and CD8+ T cells.

The investigators selectively depleted CD8+ T cells by pretreating the mice with an anti-CD8 monoclonal antibody. Depletion of CD8+ cells prior to administering radiotherapy plus vancomycin abrogated the antitumor effects of the combination treatment, demonstrating that the CD8+ T cells were required.

To characterize the antigen specificity of the tumor-infiltrating CD8+ T cells, Dr. Facciabene and colleagues used OVA MHC class 1 tetramer. Tumors from mice treated with vancomycin alone, radiotherapy alone, or the combination were dissected. Individual dendritic cells were assayed for OVA tetramer by flow cytometry.

The investigators found that tumors from mice treated with radiotherapy plus vancomycin had a significantly higher number of OVA-specific CD8+ T cells, in comparison with untreated tumors or tumors treated with either vancomycin alone or radiotherapy alone. Since antibody that impaired recognition of MHC class I peptides by T cells ablated the effect, it was clear that antigen recognition was vital.

Interferon-gamma (IFN-gamma) is known to play a critical role in both differentiation and effector functions of CD8+ cytolytic T cells in the antitumor immune response. To determine whether IFN-gamma is involved in the antitumor effects of the radiotherapy-vancomycin combination, the investigators measured intratumoral expression of IFN-gamma in the tumors 5 days after radiotherapy.

IFN-gamma messenger RNA expression levels were significantly elevated in the combination treatment group when compared with either treatment alone. In B16-OVA melanoma–challenged knockout mice, the enhancement of the radiotherapy effects by vancomycin was ablated.

The investigators concluded that vancomycin remodels the tumor microenvironment and increases the functionality of tumor-infiltrating, tumor-specific, CD8+ T cells. Furthermore, IFN-gamma is required to augment the radiotherapy-induced immune effect against the tumor.
 

Potential biochemical mediators of immune effects

The gut microbiota aid host digestion and generate a large repertoire of metabolites after defermentation of fiber. Short-chain fatty acids (SCFAs) constitute the major products of bacterial fermentation.

Acetic acid, propionic acid, and butyric acid represent 95% of total SCFAs present in the intestine. SCFAs are known to directly modulate cytokine production and dendritic cell function.

In their study, Dr. Facciabene and colleagues focused on butyric acid. Using mass spectroscopy, they demonstrated that vancomycin treatment reduces butyrate concentrations in tumor and tumor-draining lymph nodes by eradicating the major families of SCFA-producing Clostridia species.

To test whether supplementing butyrate could influence the synergy of the radiotherapy-vancomycin combination in vivo, the investigators added sodium butyrate to the mice’s drinking water when starting vancomycin treatment. The team then challenged the mice with B16-OVA tumors and treated them with radiotherapy.

In agreement with the group’s prior findings, vancomycin enhanced the tumor-inhibitory effects of radiotherapy, but dietary butyrate inhibited the benefit. The investigators found a significant decrease in the population of B16-OVA–presenting dendritic cells in the lymph nodes of mice receiving the supplemental butyrate.

Dr. Facciabene said these findings were supported by a recent publication. The authors observed that butyrate inhibited type I IFN expression in dendritic cells and radiotherapy-induced, tumor-specific cytotoxic T-cell immune responses without directly protecting tumor cells from the cytotoxic effects of radiotherapy.
 

Wide-ranging implications

Overall, Dr. Facciabene’s research has shown that:

• Vancomycin significantly enhances the tumor inhibitory effect of targeted radiation, including abscopal effects.
• The synergistic effects are dependent upon IFN-gamma and CD8+ cells.
• Depletion of some gut microbiome species increases antigen presentation by dendritic cells. This is mediated by SCFAs produced by certain bacterial families.
• There are promising new strategies to improve responses to radiotherapy, including targeting gut microbiota.

A clinical trial (NCT03546829) of vancomycin plus stereotactic body radiation in patients with locally advanced non–small cell lung cancer has been launched to investigate these findings further. Early data analysis has shown a significant impact of vancomycin on several species of gut microbiota, according to Dr. Facciabene.

Revolutionary results from immune-targeted therapy in the recent past have highlighted the important role the immune system can play in fighting cancer. Still, up to one-third of cancer patients fail to respond to overtly immune-targeted therapy.

The ability to inhibit cancer cells from evading immune surveillance by using new adjuvants – including those acting on non-traditional targets like gut microbiota – could herald the next major advances in cancer therapy. During his presentation, Dr. Facciabene gave participants an enticing hint of what could be coming for cancer patients in the years ahead.

Dr. Facciabene reported having no relevant disclosures.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

New Supplement to Federal Practitioner: Advances in Neurology

Read more about:

• Lumbar Fusion With PEEK Rods Use for Patients With Degenerative Disease
• Systemic Literature Review of the Use of Virtual Reality for Rehabilitation in Parkinson Disease
• COVID-19 Vaccine in Veterans With Multiple Sclerosis: Protect the Vulnerable

Click here to read the supplement or click on the image

New Supplement to Federal Practitioner: Advances in Neurology

Read more about:

• Lumbar Fusion With PEEK Rods Use for Patients With Degenerative Disease
• Systemic Literature Review of the Use of Virtual Reality for Rehabilitation in Parkinson Disease
• COVID-19 Vaccine in Veterans With Multiple Sclerosis: Protect the Vulnerable

Click here to read the supplement or click on the image

New Supplement to Federal Practitioner: Advances in Neurology

Read more about:

• Lumbar Fusion With PEEK Rods Use for Patients With Degenerative Disease
• Systemic Literature Review of the Use of Virtual Reality for Rehabilitation in Parkinson Disease
• COVID-19 Vaccine in Veterans With Multiple Sclerosis: Protect the Vulnerable

Click here to read the supplement or click on the image

Black patients diagnosed by dermatologists with cutaneous sarcoidosis were significantly more likely to have unrecognized systemic organ involvement than were non-Black patients, according to a retrospective chart review of patients seen at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Black patients were also significantly more likely to have two or more organs involved and have higher rates of cardiac involvement, the latter of which is associated with worse prognosis. “Our data suggest there may be substantial variations in organ involvement between racial groups of patients presenting with cutaneous sarcoidosis,” said medical student Kylee Kus, a medical student at Oakland University, Auburn Hills, Mich., who presented the findings with Bina Kassamali, a medical student at Harvard University, Boston, at the annual Skin of Color Society scientific symposium.

Sotonye Imadojemu, MD, MBE; Avery LeChance, MD, MPH; and Ruth Anne Vleugels, MD, MPH, MBA; of Brigham and Women’s Hospital, are cosenior authors of the abstract.

The researchers identified 111 patients who were diagnosed with cutaneous sarcoidosis over a 20-year period (January 2000–December 2019), 50 of whom presented without established extracutaneous disease. They examined the charts of these 50 patients for whether subsequent work-up revealed systemic disease.

Of the 50 patients, 9 were Black. Seven of these nine patients (77.8%), were found to have systemic involvement, compared with 14 of 41 (46.3%) non-Black patients – a 31.5% higher probability (P < .05). One-third of the nine Black patients were found to have disease in one organ, and 44.4% in two or more organs. In non-Black patients, these rates were 12.2% and 34.1%, respectively.

Cardiovascular involvement was not found in any of the non-Black patients who had extracutaneous disease, but was found in 29% of the Black patients with extracutaneous disease, a statistically significant difference.

Black patients are known to be at higher risk for sarcoidosis than non-Black patients, and because “there is an association between cardiac sarcoid involvement and poor prognosis largely due to manifestations such as heart block, arrhythmias, and heart failure ... the study helps demonstrate how this organ involvement can disproportionately affect the Black population,” Ms. Kassamali said in an interview after the meeting.

A separate, recently published analysis of data from the same patient population examined the work-ups that patients received after a dermatologist’s diagnosis of sarcoidosis and found that patients with no previous systemic work-up were subsequently assessed for cardiac involvement in only 58.3% of cases. Assessment for pulmonary and ocular disease was completed more than 90% of the time.

“Crucial testing for cardiac involvement fell short,” Dr. Imadojemu, of the department of dermatology, Brigham and Women’s Hospital, and coinvestigators wrote in the research letter.

“Because the cutaneous manifestations of sarcoidosis often present at disease onset, dermatologists may be the first physicians to diagnose a patient with sarcoidosis,” they wrote. “As such, dermatologists are often responsible for initiating the appropriate evaluation of patients with sarcoidosis.”

Pulmonary involvement occurs in nearly all cases of sarcoidosis, while ocular and cardiac disease develop in approximately 25% and 10% of patients, respectively. Cardiac sarcoidosis is usually asymptomatic and accounts for 13%-25% of sarcoidosis-related deaths in the United States, they wrote.

An electrocardiogram is the appropriate initial screening tool and “is warranted in all patients with sarcoidosis,” they advised.

Black patients diagnosed by dermatologists with cutaneous sarcoidosis were significantly more likely to have unrecognized systemic organ involvement than were non-Black patients, according to a retrospective chart review of patients seen at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Black patients were also significantly more likely to have two or more organs involved and have higher rates of cardiac involvement, the latter of which is associated with worse prognosis. “Our data suggest there may be substantial variations in organ involvement between racial groups of patients presenting with cutaneous sarcoidosis,” said medical student Kylee Kus, a medical student at Oakland University, Auburn Hills, Mich., who presented the findings with Bina Kassamali, a medical student at Harvard University, Boston, at the annual Skin of Color Society scientific symposium.

Sotonye Imadojemu, MD, MBE; Avery LeChance, MD, MPH; and Ruth Anne Vleugels, MD, MPH, MBA; of Brigham and Women’s Hospital, are cosenior authors of the abstract.

The researchers identified 111 patients who were diagnosed with cutaneous sarcoidosis over a 20-year period (January 2000–December 2019), 50 of whom presented without established extracutaneous disease. They examined the charts of these 50 patients for whether subsequent work-up revealed systemic disease.

Of the 50 patients, 9 were Black. Seven of these nine patients (77.8%), were found to have systemic involvement, compared with 14 of 41 (46.3%) non-Black patients – a 31.5% higher probability (P < .05). One-third of the nine Black patients were found to have disease in one organ, and 44.4% in two or more organs. In non-Black patients, these rates were 12.2% and 34.1%, respectively.

Cardiovascular involvement was not found in any of the non-Black patients who had extracutaneous disease, but was found in 29% of the Black patients with extracutaneous disease, a statistically significant difference.

Black patients are known to be at higher risk for sarcoidosis than non-Black patients, and because “there is an association between cardiac sarcoid involvement and poor prognosis largely due to manifestations such as heart block, arrhythmias, and heart failure ... the study helps demonstrate how this organ involvement can disproportionately affect the Black population,” Ms. Kassamali said in an interview after the meeting.

A separate, recently published analysis of data from the same patient population examined the work-ups that patients received after a dermatologist’s diagnosis of sarcoidosis and found that patients with no previous systemic work-up were subsequently assessed for cardiac involvement in only 58.3% of cases. Assessment for pulmonary and ocular disease was completed more than 90% of the time.

“Crucial testing for cardiac involvement fell short,” Dr. Imadojemu, of the department of dermatology, Brigham and Women’s Hospital, and coinvestigators wrote in the research letter.

“Because the cutaneous manifestations of sarcoidosis often present at disease onset, dermatologists may be the first physicians to diagnose a patient with sarcoidosis,” they wrote. “As such, dermatologists are often responsible for initiating the appropriate evaluation of patients with sarcoidosis.”

Pulmonary involvement occurs in nearly all cases of sarcoidosis, while ocular and cardiac disease develop in approximately 25% and 10% of patients, respectively. Cardiac sarcoidosis is usually asymptomatic and accounts for 13%-25% of sarcoidosis-related deaths in the United States, they wrote.

An electrocardiogram is the appropriate initial screening tool and “is warranted in all patients with sarcoidosis,” they advised.

Black patients diagnosed by dermatologists with cutaneous sarcoidosis were significantly more likely to have unrecognized systemic organ involvement than were non-Black patients, according to a retrospective chart review of patients seen at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston.

Black patients were also significantly more likely to have two or more organs involved and have higher rates of cardiac involvement, the latter of which is associated with worse prognosis. “Our data suggest there may be substantial variations in organ involvement between racial groups of patients presenting with cutaneous sarcoidosis,” said medical student Kylee Kus, a medical student at Oakland University, Auburn Hills, Mich., who presented the findings with Bina Kassamali, a medical student at Harvard University, Boston, at the annual Skin of Color Society scientific symposium.

Sotonye Imadojemu, MD, MBE; Avery LeChance, MD, MPH; and Ruth Anne Vleugels, MD, MPH, MBA; of Brigham and Women’s Hospital, are cosenior authors of the abstract.

The researchers identified 111 patients who were diagnosed with cutaneous sarcoidosis over a 20-year period (January 2000–December 2019), 50 of whom presented without established extracutaneous disease. They examined the charts of these 50 patients for whether subsequent work-up revealed systemic disease.

Of the 50 patients, 9 were Black. Seven of these nine patients (77.8%), were found to have systemic involvement, compared with 14 of 41 (46.3%) non-Black patients – a 31.5% higher probability (P < .05). One-third of the nine Black patients were found to have disease in one organ, and 44.4% in two or more organs. In non-Black patients, these rates were 12.2% and 34.1%, respectively.

Cardiovascular involvement was not found in any of the non-Black patients who had extracutaneous disease, but was found in 29% of the Black patients with extracutaneous disease, a statistically significant difference.

Black patients are known to be at higher risk for sarcoidosis than non-Black patients, and because “there is an association between cardiac sarcoid involvement and poor prognosis largely due to manifestations such as heart block, arrhythmias, and heart failure ... the study helps demonstrate how this organ involvement can disproportionately affect the Black population,” Ms. Kassamali said in an interview after the meeting.

A separate, recently published analysis of data from the same patient population examined the work-ups that patients received after a dermatologist’s diagnosis of sarcoidosis and found that patients with no previous systemic work-up were subsequently assessed for cardiac involvement in only 58.3% of cases. Assessment for pulmonary and ocular disease was completed more than 90% of the time.

“Crucial testing for cardiac involvement fell short,” Dr. Imadojemu, of the department of dermatology, Brigham and Women’s Hospital, and coinvestigators wrote in the research letter.

“Because the cutaneous manifestations of sarcoidosis often present at disease onset, dermatologists may be the first physicians to diagnose a patient with sarcoidosis,” they wrote. “As such, dermatologists are often responsible for initiating the appropriate evaluation of patients with sarcoidosis.”

Pulmonary involvement occurs in nearly all cases of sarcoidosis, while ocular and cardiac disease develop in approximately 25% and 10% of patients, respectively. Cardiac sarcoidosis is usually asymptomatic and accounts for 13%-25% of sarcoidosis-related deaths in the United States, they wrote.

An electrocardiogram is the appropriate initial screening tool and “is warranted in all patients with sarcoidosis,” they advised.

The development of unusual movements after COVID-19 vaccination may be a result of functional neurologic disorder rather than being a direct adverse effect of the vaccine, it has been suggested.

Writing in an article published online in JAMA Neurology on April 9, 2021, two neurologists and a psychiatrist report the recent circulation of videos on social media about major neurologic adverse events, including continuous movements of the trunk and limbs or walking difficulties after administration of the COVID-19 vaccine. Some of these videos have been viewed millions of times by the public, they noted.

While these videos may be unsubstantiated, and it is not definitively known if the COVID-19 vaccine was administered in these cases, it was reported in the news that at least one patient was told by their physician that the diagnosis was conversion disorder, also known as functional neurological disorder (FND), the authors noted.

In addition, the Functional Neurological Disorder Society released a statement in January 2021 pointing out that the conditions described in these videos are seemingly consistent with FND, they added.

“We thought it would be useful to explain more about what functional neurological disorder is, as many people are not familiar with it,” lead author David Kim, MD, said in an interview. “We wanted to provide some contextual information about the condition, as these reports may not necessarily mean the vaccine is unsafe.”

Dr. Kim, who is part of the division of cognitive behavioral neurology at Massachusetts General Hospital, Boston, explained that, in FND, physical symptoms can be brought about after events such as head injury, surgery, vaccination, other medical procedures, or life events such as loss of employment.

“Many different factors can bring these symptoms on, and while there are definitely cases associated with stressful events, it is not necessarily stress induced,” he said. “However, the event itself does not cause the condition, rather it is the reaction of the patient to the event.”

FND is now viewed as a true brain-based disorder, Dr. Kim noted. “While in the past it has been described as psychosomatic, we are now moving away from that terminology, toward the idea of a neurological disorder that affects function. It is a neuropsychiatric disorder on the borderline between neurology and psychiatry.”

The authors believed that some of these cases of unusual movements reported after COVID vaccination are likely to be FND.

“In these cases, it is not the substance in the vaccine that is causing the condition, but the common side effects that can occur after vaccination such as aches and chills bring the attention of the patient to their bodily functions and this reaction can become maladaptive, triggering FND,” Dr. Kim said.

“We believe that health care professionals should be more aware of FND at the current time. They need to know that the general public are aware that some people are experiencing movement disorders after COVID vaccination, and that this conversation is happening on social media,” he commented. “If they see patients with these symptoms, they could consider FND to be one possibility.”

The authors emphasized that, because they have not seen the individual patients, they cannot comment on any specific cases.

“But as some of these videos circulating can be consistent with the condition being FND, and especially with news reports indicating that at least one patient was given that diagnosis, we wanted to raise awareness of this condition among health professionals,” Dr. Kim added.  

He explained that, in the past, FND has been a diagnosis of exclusion but now it is diagnosed with a clinical history and physical examination, looking for appropriate rule-in signs. Ancillary testing such as neuroimaging, electrophysiological studies, and blood tests are often used to rule out other conditions.

“Neurologists have a lot of training in this condition, as it is the second most common reason for a patient to visit a neurologist after headache,” Dr. Kim noted.

It is managed with education, counseling, physical rehabilitation and cognitive behavioral therapy. “A key part of the therapeutic process is working with the patient to explain the diagnosis. If they understand the condition, they do better. Patients can learn distraction techniques to allow more fluid movements,” he reported.

“As neurologists, and health care professionals more broadly, we must explain transparently and nonjudgmentally the nature of FND, including that these symptoms are real but not the direct result of toxic vaccine effects,” the authors wrote.

“Transparency and effective communication are needed in our society more than ever, and a condition as prevalent and potentially debilitating as FND can no longer remain marginalized and in the shadows. Effective communication will help educate the public and reduce fears so that patients can make informed decisions for themselves on receiving the vaccine to reduce the risk of COVID-19,” they concluded.