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Say my name
Dr. Ben-a-bo?
Nope.
Ben-nabi?
Nope.
Ben-NO-bo?
Also no.
My surname is tricky to pronounce for some people. I sometimes exaggerate to help patients get it right: “Beh-NAAH-bee-oh.” Almost daily someone will reply: “Oh, you’re Italian!” Well, no actually, my friend Enzo who was born in Sicily and lives in Milan, he’s Italian. I’m just a Rhode Islander who knows some Italian words from his grandmother. Most times though, I just answer: ‘Yep, I’m Italian.” It’s faster.
We use names as a shortcut to identify people. In clinic, it can help to find things in common quickly, similar to asking where you’re from. (East Coast patients seem to love that I’m from New England and if they’re Italian and from New York, well then, we’re paisans right from the start.)
However, using names to guess how someone identifies can be risky. In some instances, it could even be seen as microaggressive, particularly if you got it wrong.
Like most of you I’ll bet, I’m pretty good at pronouncing names – we practice thousands of times! Other than accepting a compliment for getting a tricky one right, such as Radivojevic (I think it’s Ra-di-VOI-ye-vich), I hadn’t thought much about names until I heard a great podcast on the topic. I thought I’d share a couple tips.
First, if you’re not particularly good at names or if you struggle with certain types of names, it’s better to ask than to butcher it. Like learning the wrong way to hit a golf ball, you may never be able to do it properly once you’ve done it wrong. (Trust me, I know from both.)
If I’m feeling confident, I’ll give it a try. But if unsure, I ask the patient to pronounce it for me, then I repeat it to confirm I’ve gotten it correct. Then I say it once or twice more during the visit. Lastly, for the knotty tongue-twisting ones, I write it phonetically in their chart.
It is important because mispronouncing names can alienate patients. It might make them feel like we don’t “know” them or that we don’t care about them. and eliminating ethnic disparities in care. Just think how much harder it might be to convince skeptical patients to take their lisinopril if you can’t even get their names right.
Worse perhaps than getting the pronunciation wrong is to turn the name into an issue. Saying: “Oh, that’s hard to pronounce” could be felt as a subtly racist remark – it’s not hard for them to pronounce of course, only for you. Also, guessing a patient’s nationality from the name is risky. Asking “are you Russian?” to someone from Ukraine or “is that Chinese?” to someone from Vietnam can quickly turn a nice office visit down a road named “Awkward.” It can give the impression that they “all look the same” to you, exactly the type of exclusion we’re trying to eliminate in medicine.
Saying a patient’s name perfectly is rewarding and a super-efficient way to connect. It can make salient the truth that you care about the patient and about his or her story, even if the name happens to be Mrs. Xiomara Winyuwongse Khosrowshahi Sundararajan Ngoc. Go ahead, give it a try.
Want more on how properly pronounce names correctly? You might like this episode of NPR’s Life Kit.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
Dr. Ben-a-bo?
Nope.
Ben-nabi?
Nope.
Ben-NO-bo?
Also no.
My surname is tricky to pronounce for some people. I sometimes exaggerate to help patients get it right: “Beh-NAAH-bee-oh.” Almost daily someone will reply: “Oh, you’re Italian!” Well, no actually, my friend Enzo who was born in Sicily and lives in Milan, he’s Italian. I’m just a Rhode Islander who knows some Italian words from his grandmother. Most times though, I just answer: ‘Yep, I’m Italian.” It’s faster.
We use names as a shortcut to identify people. In clinic, it can help to find things in common quickly, similar to asking where you’re from. (East Coast patients seem to love that I’m from New England and if they’re Italian and from New York, well then, we’re paisans right from the start.)
However, using names to guess how someone identifies can be risky. In some instances, it could even be seen as microaggressive, particularly if you got it wrong.
Like most of you I’ll bet, I’m pretty good at pronouncing names – we practice thousands of times! Other than accepting a compliment for getting a tricky one right, such as Radivojevic (I think it’s Ra-di-VOI-ye-vich), I hadn’t thought much about names until I heard a great podcast on the topic. I thought I’d share a couple tips.
First, if you’re not particularly good at names or if you struggle with certain types of names, it’s better to ask than to butcher it. Like learning the wrong way to hit a golf ball, you may never be able to do it properly once you’ve done it wrong. (Trust me, I know from both.)
If I’m feeling confident, I’ll give it a try. But if unsure, I ask the patient to pronounce it for me, then I repeat it to confirm I’ve gotten it correct. Then I say it once or twice more during the visit. Lastly, for the knotty tongue-twisting ones, I write it phonetically in their chart.
It is important because mispronouncing names can alienate patients. It might make them feel like we don’t “know” them or that we don’t care about them. and eliminating ethnic disparities in care. Just think how much harder it might be to convince skeptical patients to take their lisinopril if you can’t even get their names right.
Worse perhaps than getting the pronunciation wrong is to turn the name into an issue. Saying: “Oh, that’s hard to pronounce” could be felt as a subtly racist remark – it’s not hard for them to pronounce of course, only for you. Also, guessing a patient’s nationality from the name is risky. Asking “are you Russian?” to someone from Ukraine or “is that Chinese?” to someone from Vietnam can quickly turn a nice office visit down a road named “Awkward.” It can give the impression that they “all look the same” to you, exactly the type of exclusion we’re trying to eliminate in medicine.
Saying a patient’s name perfectly is rewarding and a super-efficient way to connect. It can make salient the truth that you care about the patient and about his or her story, even if the name happens to be Mrs. Xiomara Winyuwongse Khosrowshahi Sundararajan Ngoc. Go ahead, give it a try.
Want more on how properly pronounce names correctly? You might like this episode of NPR’s Life Kit.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
Dr. Ben-a-bo?
Nope.
Ben-nabi?
Nope.
Ben-NO-bo?
Also no.
My surname is tricky to pronounce for some people. I sometimes exaggerate to help patients get it right: “Beh-NAAH-bee-oh.” Almost daily someone will reply: “Oh, you’re Italian!” Well, no actually, my friend Enzo who was born in Sicily and lives in Milan, he’s Italian. I’m just a Rhode Islander who knows some Italian words from his grandmother. Most times though, I just answer: ‘Yep, I’m Italian.” It’s faster.
We use names as a shortcut to identify people. In clinic, it can help to find things in common quickly, similar to asking where you’re from. (East Coast patients seem to love that I’m from New England and if they’re Italian and from New York, well then, we’re paisans right from the start.)
However, using names to guess how someone identifies can be risky. In some instances, it could even be seen as microaggressive, particularly if you got it wrong.
Like most of you I’ll bet, I’m pretty good at pronouncing names – we practice thousands of times! Other than accepting a compliment for getting a tricky one right, such as Radivojevic (I think it’s Ra-di-VOI-ye-vich), I hadn’t thought much about names until I heard a great podcast on the topic. I thought I’d share a couple tips.
First, if you’re not particularly good at names or if you struggle with certain types of names, it’s better to ask than to butcher it. Like learning the wrong way to hit a golf ball, you may never be able to do it properly once you’ve done it wrong. (Trust me, I know from both.)
If I’m feeling confident, I’ll give it a try. But if unsure, I ask the patient to pronounce it for me, then I repeat it to confirm I’ve gotten it correct. Then I say it once or twice more during the visit. Lastly, for the knotty tongue-twisting ones, I write it phonetically in their chart.
It is important because mispronouncing names can alienate patients. It might make them feel like we don’t “know” them or that we don’t care about them. and eliminating ethnic disparities in care. Just think how much harder it might be to convince skeptical patients to take their lisinopril if you can’t even get their names right.
Worse perhaps than getting the pronunciation wrong is to turn the name into an issue. Saying: “Oh, that’s hard to pronounce” could be felt as a subtly racist remark – it’s not hard for them to pronounce of course, only for you. Also, guessing a patient’s nationality from the name is risky. Asking “are you Russian?” to someone from Ukraine or “is that Chinese?” to someone from Vietnam can quickly turn a nice office visit down a road named “Awkward.” It can give the impression that they “all look the same” to you, exactly the type of exclusion we’re trying to eliminate in medicine.
Saying a patient’s name perfectly is rewarding and a super-efficient way to connect. It can make salient the truth that you care about the patient and about his or her story, even if the name happens to be Mrs. Xiomara Winyuwongse Khosrowshahi Sundararajan Ngoc. Go ahead, give it a try.
Want more on how properly pronounce names correctly? You might like this episode of NPR’s Life Kit.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]
Preventing the psychosocial effects of adult ADHD during the pandemic
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 protective against COVID-19?
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.
“ 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.
“ 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.
“ 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.
Let me tell you about my vaccine
Welcome to our national obsession: Vaccines! You may have noticed – it’s all talk, all the time, with short breaks to discuss what we’re watching on Netflix.
For months, every session with almost every patient includes a commentary on someone they know who has gotten “the shot.” Before our state expanded eligibility to all adults, the discussion might include thoughts about who deserves to go first, who “cut the line,” how they did it, what vaccine is best, and worries about side effects.
And it’s not just my patients: With every friend, with every acquaintance, and even just walking by strangers who are conversing, the topic of discussion is vaccines. The narratives are similar; people want to talk about who has gotten vaccinated, why they qualified, where they went, which one they got, and what side effects they experienced. This is followed by a discussion about what they are now doing that they weren’t doing before being vaccinated, if anything. Some have returned to indoor restaurant dining, others only dine outdoors, still others continue to avoid public settings. There are the fully vaccinated, the partially vaccinated, and those scheduled for the first shot. In the unvaccinated/unregistered group there are the vaccine-hesitants and vaccine-refusers, with their concerns about everything from the safety of the agent to whether the government is using this as a way to insert tracker chips into all of us. There is enthusiasm, trepidation, anxiety, fear, excitement, relief, and absolute joy.
Recently I opened two emails from old friends I have not communicated with in a long time. Both emails began with, “I am fully vaccinated.” And yes, I heard the status of his wife and two children. In the course of one work day, I received distressed text messages from two patients about vaccines – one was anxious about having received the Janssen vaccine that was paused that morning, another was worried about getting a second dose of the Pfizer vaccine later in the week because he was having a symptom that could be indicative of COVID-19. I suggested that his primary care physician might be a better resource for this, but then added that he should probably get tested and delay having the second dose if positive. It seems I did have thoughts about a course of action after all.
Some psychiatrists have wondered how to handle patient questions about their own vaccination status. I have taken the stance that we are physicians, and that patients who may be seeing us – now or in the future – for in-person appointments are entitled to know if we pose a risk to their health, and so I have chosen to answer, without further exploration, when patients ask if I’ve received that coronavirus vaccine. Some psychiatrists feel it is our responsibility to share this information with our patients as a way of modeling safe behavior, and I have had one patient who said she would not be getting vaccinated until I told her that I thought she should.
“Did you get it?” she asked.
“I did,” I responded.
“Okay, if you got it, I will.” She soon discovered that vaccinations were hard to come by and that in her social group, being vaccinated was something of a status symbol. In addition to the worry about contracting a potentially fatal virus, her hesitancy yielded to “vaccine FOMO” or fear of missing out.
Some psychiatrists have felt uneasy with a question that pertains to their personal health, or have used the question as a springboard for exploration. Nicole Leistikow, MD (fully vaccinated, Moderna), is a psychiatrist in private practice in Baltimore. She notes, “Recently, I was discussing vaccination with a patient who wasn’t sure what information to believe or how much to trust the U.S. government. My careful exploration comparing different risks was not very helpful. I mentioned that I was vaccinated and that if he got vaccinated, he could come for a low-risk, in-person appointment after a year of telephone visits. This proved to be a winning argument and he called back later that day to say he had already had his first shot from leftover vaccine at his pharmacy.”
I grew up in a world that did not question vaccines. You got them and they were good things. No one asked which pharmaceutical company manufactured the vaccine. We trusted the system and our physicians. Schools asked for proof of vaccination, and it never occurred to me not to be vaccinated. Life has grown more complicated in the last 30 years, and the groups of people who are opposed to being vaccinated are more diverse. Those opposed to getting a COVID-19 vaccine are not necessarily the same as the broader group of anti-vaxxers that spawned from the fear that childhood vaccines cause autism. For some, it’s a personal issue related to their own health and risk perception, for others it’s a polarized political issue, and for another group there is the question of where their trust lies.
What lies ahead in our postvaccine world? This will be our next national conversation, and just as we negotiated our own levels of comfort with regard to working and socializing during the pandemic, I imagine the postvaccine world will have the same adjustment. There already are cases of COVID-19 in those who have been fully vaccinated, as well as the rare hospitalizations and deaths – we simply cannot expect a vaccine that did so well in controlled studies of tens of thousands of study subjects to do as well when given to tens of millions of uncontrolled citizens. One of the first deaths in a fully vaccinated person in late March was an older psychologist, and it remains unclear how effective the vaccine is for immunocompromised patients. Some people will play it very safe, eschewing all activities that entail risk, while others will choose to adhere to either their own intuition about what is safe, or to the recommendations of Anthony S. Fauci, MD, and the Centers for Disease Control and Prevention.
I’ll end with a final thought from the Twitter feed of Ashish K. Jha, MD, dean of the School of Public Health at Brown University, Providence, R.I. Dr. Jha tweeted, “Once you get fully vaccinated, it absolutely changes what you can do safely.” It seems our national conversation is not slated to change anytime soon.
Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
Welcome to our national obsession: Vaccines! You may have noticed – it’s all talk, all the time, with short breaks to discuss what we’re watching on Netflix.
For months, every session with almost every patient includes a commentary on someone they know who has gotten “the shot.” Before our state expanded eligibility to all adults, the discussion might include thoughts about who deserves to go first, who “cut the line,” how they did it, what vaccine is best, and worries about side effects.
And it’s not just my patients: With every friend, with every acquaintance, and even just walking by strangers who are conversing, the topic of discussion is vaccines. The narratives are similar; people want to talk about who has gotten vaccinated, why they qualified, where they went, which one they got, and what side effects they experienced. This is followed by a discussion about what they are now doing that they weren’t doing before being vaccinated, if anything. Some have returned to indoor restaurant dining, others only dine outdoors, still others continue to avoid public settings. There are the fully vaccinated, the partially vaccinated, and those scheduled for the first shot. In the unvaccinated/unregistered group there are the vaccine-hesitants and vaccine-refusers, with their concerns about everything from the safety of the agent to whether the government is using this as a way to insert tracker chips into all of us. There is enthusiasm, trepidation, anxiety, fear, excitement, relief, and absolute joy.
Recently I opened two emails from old friends I have not communicated with in a long time. Both emails began with, “I am fully vaccinated.” And yes, I heard the status of his wife and two children. In the course of one work day, I received distressed text messages from two patients about vaccines – one was anxious about having received the Janssen vaccine that was paused that morning, another was worried about getting a second dose of the Pfizer vaccine later in the week because he was having a symptom that could be indicative of COVID-19. I suggested that his primary care physician might be a better resource for this, but then added that he should probably get tested and delay having the second dose if positive. It seems I did have thoughts about a course of action after all.
Some psychiatrists have wondered how to handle patient questions about their own vaccination status. I have taken the stance that we are physicians, and that patients who may be seeing us – now or in the future – for in-person appointments are entitled to know if we pose a risk to their health, and so I have chosen to answer, without further exploration, when patients ask if I’ve received that coronavirus vaccine. Some psychiatrists feel it is our responsibility to share this information with our patients as a way of modeling safe behavior, and I have had one patient who said she would not be getting vaccinated until I told her that I thought she should.
“Did you get it?” she asked.
“I did,” I responded.
“Okay, if you got it, I will.” She soon discovered that vaccinations were hard to come by and that in her social group, being vaccinated was something of a status symbol. In addition to the worry about contracting a potentially fatal virus, her hesitancy yielded to “vaccine FOMO” or fear of missing out.
Some psychiatrists have felt uneasy with a question that pertains to their personal health, or have used the question as a springboard for exploration. Nicole Leistikow, MD (fully vaccinated, Moderna), is a psychiatrist in private practice in Baltimore. She notes, “Recently, I was discussing vaccination with a patient who wasn’t sure what information to believe or how much to trust the U.S. government. My careful exploration comparing different risks was not very helpful. I mentioned that I was vaccinated and that if he got vaccinated, he could come for a low-risk, in-person appointment after a year of telephone visits. This proved to be a winning argument and he called back later that day to say he had already had his first shot from leftover vaccine at his pharmacy.”
I grew up in a world that did not question vaccines. You got them and they were good things. No one asked which pharmaceutical company manufactured the vaccine. We trusted the system and our physicians. Schools asked for proof of vaccination, and it never occurred to me not to be vaccinated. Life has grown more complicated in the last 30 years, and the groups of people who are opposed to being vaccinated are more diverse. Those opposed to getting a COVID-19 vaccine are not necessarily the same as the broader group of anti-vaxxers that spawned from the fear that childhood vaccines cause autism. For some, it’s a personal issue related to their own health and risk perception, for others it’s a polarized political issue, and for another group there is the question of where their trust lies.
What lies ahead in our postvaccine world? This will be our next national conversation, and just as we negotiated our own levels of comfort with regard to working and socializing during the pandemic, I imagine the postvaccine world will have the same adjustment. There already are cases of COVID-19 in those who have been fully vaccinated, as well as the rare hospitalizations and deaths – we simply cannot expect a vaccine that did so well in controlled studies of tens of thousands of study subjects to do as well when given to tens of millions of uncontrolled citizens. One of the first deaths in a fully vaccinated person in late March was an older psychologist, and it remains unclear how effective the vaccine is for immunocompromised patients. Some people will play it very safe, eschewing all activities that entail risk, while others will choose to adhere to either their own intuition about what is safe, or to the recommendations of Anthony S. Fauci, MD, and the Centers for Disease Control and Prevention.
I’ll end with a final thought from the Twitter feed of Ashish K. Jha, MD, dean of the School of Public Health at Brown University, Providence, R.I. Dr. Jha tweeted, “Once you get fully vaccinated, it absolutely changes what you can do safely.” It seems our national conversation is not slated to change anytime soon.
Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
Welcome to our national obsession: Vaccines! You may have noticed – it’s all talk, all the time, with short breaks to discuss what we’re watching on Netflix.
For months, every session with almost every patient includes a commentary on someone they know who has gotten “the shot.” Before our state expanded eligibility to all adults, the discussion might include thoughts about who deserves to go first, who “cut the line,” how they did it, what vaccine is best, and worries about side effects.
And it’s not just my patients: With every friend, with every acquaintance, and even just walking by strangers who are conversing, the topic of discussion is vaccines. The narratives are similar; people want to talk about who has gotten vaccinated, why they qualified, where they went, which one they got, and what side effects they experienced. This is followed by a discussion about what they are now doing that they weren’t doing before being vaccinated, if anything. Some have returned to indoor restaurant dining, others only dine outdoors, still others continue to avoid public settings. There are the fully vaccinated, the partially vaccinated, and those scheduled for the first shot. In the unvaccinated/unregistered group there are the vaccine-hesitants and vaccine-refusers, with their concerns about everything from the safety of the agent to whether the government is using this as a way to insert tracker chips into all of us. There is enthusiasm, trepidation, anxiety, fear, excitement, relief, and absolute joy.
Recently I opened two emails from old friends I have not communicated with in a long time. Both emails began with, “I am fully vaccinated.” And yes, I heard the status of his wife and two children. In the course of one work day, I received distressed text messages from two patients about vaccines – one was anxious about having received the Janssen vaccine that was paused that morning, another was worried about getting a second dose of the Pfizer vaccine later in the week because he was having a symptom that could be indicative of COVID-19. I suggested that his primary care physician might be a better resource for this, but then added that he should probably get tested and delay having the second dose if positive. It seems I did have thoughts about a course of action after all.
Some psychiatrists have wondered how to handle patient questions about their own vaccination status. I have taken the stance that we are physicians, and that patients who may be seeing us – now or in the future – for in-person appointments are entitled to know if we pose a risk to their health, and so I have chosen to answer, without further exploration, when patients ask if I’ve received that coronavirus vaccine. Some psychiatrists feel it is our responsibility to share this information with our patients as a way of modeling safe behavior, and I have had one patient who said she would not be getting vaccinated until I told her that I thought she should.
“Did you get it?” she asked.
“I did,” I responded.
“Okay, if you got it, I will.” She soon discovered that vaccinations were hard to come by and that in her social group, being vaccinated was something of a status symbol. In addition to the worry about contracting a potentially fatal virus, her hesitancy yielded to “vaccine FOMO” or fear of missing out.
Some psychiatrists have felt uneasy with a question that pertains to their personal health, or have used the question as a springboard for exploration. Nicole Leistikow, MD (fully vaccinated, Moderna), is a psychiatrist in private practice in Baltimore. She notes, “Recently, I was discussing vaccination with a patient who wasn’t sure what information to believe or how much to trust the U.S. government. My careful exploration comparing different risks was not very helpful. I mentioned that I was vaccinated and that if he got vaccinated, he could come for a low-risk, in-person appointment after a year of telephone visits. This proved to be a winning argument and he called back later that day to say he had already had his first shot from leftover vaccine at his pharmacy.”
I grew up in a world that did not question vaccines. You got them and they were good things. No one asked which pharmaceutical company manufactured the vaccine. We trusted the system and our physicians. Schools asked for proof of vaccination, and it never occurred to me not to be vaccinated. Life has grown more complicated in the last 30 years, and the groups of people who are opposed to being vaccinated are more diverse. Those opposed to getting a COVID-19 vaccine are not necessarily the same as the broader group of anti-vaxxers that spawned from the fear that childhood vaccines cause autism. For some, it’s a personal issue related to their own health and risk perception, for others it’s a polarized political issue, and for another group there is the question of where their trust lies.
What lies ahead in our postvaccine world? This will be our next national conversation, and just as we negotiated our own levels of comfort with regard to working and socializing during the pandemic, I imagine the postvaccine world will have the same adjustment. There already are cases of COVID-19 in those who have been fully vaccinated, as well as the rare hospitalizations and deaths – we simply cannot expect a vaccine that did so well in controlled studies of tens of thousands of study subjects to do as well when given to tens of millions of uncontrolled citizens. One of the first deaths in a fully vaccinated person in late March was an older psychologist, and it remains unclear how effective the vaccine is for immunocompromised patients. Some people will play it very safe, eschewing all activities that entail risk, while others will choose to adhere to either their own intuition about what is safe, or to the recommendations of Anthony S. Fauci, MD, and the Centers for Disease Control and Prevention.
I’ll end with a final thought from the Twitter feed of Ashish K. Jha, MD, dean of the School of Public Health at Brown University, Providence, R.I. Dr. Jha tweeted, “Once you get fully vaccinated, it absolutely changes what you can do safely.” It seems our national conversation is not slated to change anytime soon.
Dr. Miller is a coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
COVID vaccine ‘side effect’ or functional neurologic disorder?
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.
A version of this article first appeared on Medscape.com.
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.
A version of this article first appeared on Medscape.com.
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.
A version of this article first appeared on Medscape.com.
Adolescent substance use and the COVID-19 pandemic
During the past year, adolescents, families, educators, and health care providers have had to press forward through myriad challenges and stressors with flexibility and adaptability. With appropriate concern, we ask ourselves how children and youth are coping emotionally with the unprecedented changes of the past year.
Adolescent substance use represents an important area of concern. What has happened during the pandemic? Has youth substance use increased or decreased? Has access to substances increased or decreased, has monitoring and support for at-risk youth increased or decreased?
The answers to these questions are mixed. If anything, the pandemic has highlighted the heterogeneity of adolescent substance use. Now is a key time for assessment, support, and conversation with teens and families.
Monitoring the Future (MTF), a nationally representative annual survey, has provided a broad perspective on trends of adolescent substance use for decades.1 The MTF data is usually collected from February to May and was cut short in 2020 because of school closures associated with the pandemic. The sample size, though still nationally representative, was about a quarter of the typical volume. Some of the data are encouraging, including a flattening out of previous years’ stark increase in vaping of both nicotine and cannabis products (though overall numbers remain alarmingly high). Other data are more concerning including a continued increase in misuse of cough medicine, amphetamines, and inhalants among the youngest cohort surveyed (eighth graders). However, these data were largely representative of prepandemic circumstances.
The COVID-19 pandemic has significantly affected risk and protective factors for teen drug and alcohol use. Most notably, it has had a widely observed negative impact on adolescent mental health, across multiple disease categories.2 In addition, the cancellation of in-person academic and extracurricular activities such as arts and athletics markedly increased unstructured time, a known associated factor for higher-risk activities including substance use. This has also led to decreased contact with many supportive adults such as teachers and coaches. On the other hand, some adolescents now have more time with supportive parents and caregivers, more meals together, and more supervision, all of which are associated with decreased likelihood of substance use disorders.
The highly variable reasons for substance use affect highly variable pandemic-related changes in use. Understanding the impetus for use is a good place to start conversation and can help providers assess risk of escalation during the pandemic. Some teens primarily use for social enhancement while others use as a means of coping with stress or to mask or escape negative emotions. Still others continue use because of physiological dependence, craving, and other symptoms consistent with use disorders.
Highlighting the heterogeneity of this issue, one study assessing use early in the pandemic showed a decrease in the percentage of teens who use substances but an increase in frequency of use for those who are using.3 Though expected, an increase in frequency of use by oneself as compared with peers was also notable. Using substances alone is associated with more severe use disorders, carries greater risk of overdose, and can increase shame and secrecy, further fueling use disorders.
The pandemic has thus represented a protective pause for some experimental or socially motivated substance-using teens who have experienced a period of abstinence even if not fully by choice. For others, it has represented an acute amplification of risk factors and use has accelerated. This latter group includes those whose use represents an effort to cope with depression, anxiety, and loneliness or for whom isolation at home represents less monitoring, increased access, and greater exposure to substances.
Over the past year, in the treatment of adolescents struggling with substance use, many clinicians have observed a sifting effect during these unprecedented social changes. Many youth, who no longer have access to substances, have found they can “take it or leave it”. Other youth have been observed engaging in additional risk or going to greater lengths to access substances and continue their use. For both groups and everyone in between, this is an important time for screening, clinical assessment, and support.
While anticipating further research and data regarding broad substance use trends, including MTF data from 2021, recognizing that the impact of the COVID-19 pandemic is individual, with marked differences from adolescent to adolescent, will help us continue to act now to assess this important area of adolescent health. The first step for primary care providers is unchanged: to routinely screen for and discuss substance use in clinical settings.
Two brief, validated, easily accessible screening tools are available for primary care settings. They can both be self-administered and take less than 2 minutes to complete. Screening, Brief Intervention and Referral to Treatment and the Brief Screener for Tobacco, Alcohol and other Drugs can both be used for youth aged 12-17 years.4,5 Both screens are available online at drugabuse.gov.6
Routine screening will normalize conversations about substance use and healthy choices, provide opportunities for positive reinforcement, identify adolescents at risk, increase comfort and competence in providing brief intervention, and expedite referrals for additional support and treatment.
A false assumption that a particular adolescent isn’t using substances creates a missed opportunity to offer guidance and treatment. An oft-overlooked opportunity is that of providing positive reinforcement for an adolescent who isn’t using any substances or experimenting at all. Positive reinforcement is a strong component of reinforcing health maintenance.
Parent guidance and family assessment will also be critical tools. Parents and caregivers play a primary role in substance use treatment for teens and have a contributory impact on risk through both genes and environment. Of note, research suggests a moderate overall increase in adult substance use during the pandemic, particularly substances that are widely available such as alcohol. Adolescents may thus have greater access and exposure to substance use. A remarkably high percentage, 42%, of substance-using teens surveyed early in the pandemic indicated that they were using substances with their parents.3 Parents, who have equally been challenged by the pandemic, may need guidance in balancing compassion and support for struggling youth, while setting appropriate limits and maintaining expectations of healthy activities.
Unprecedented change and uncertainty provide an opportunity to reassess risks and openly discuss substance use with youth and families. Even with much on our minds during the COVID-19 pandemic, we can maintain focus on this significant risk to adolescent health and wellness. Our efforts now, from screening to treatment for adolescent substance use should be reinforced rather than delayed.
Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington.
References
1. Monitoringthefuture.org
2. Jones EAK et al. Int J Environ Res Public Health, 2021;18(5):2470.
3. Dumas TM et al. J Adolesc Health, 2020;67(3):354-61.
4. Levy S et al. JAMA Pediatr. 2014;168(9):822-8.
5. Kelly SM et al. Pediatrics. 2014;133(5):819-26.
6. National Institute on Drug Abuse. Adolescent Substance Use Screening Tools. 2016 Apr 27. https://www.drugabuse.gov/nidamed-medical-health-professionals/screening-tools-prevention/screening-tools-adolescent-substance-use/adolescent-substance-use-screening-tools
During the past year, adolescents, families, educators, and health care providers have had to press forward through myriad challenges and stressors with flexibility and adaptability. With appropriate concern, we ask ourselves how children and youth are coping emotionally with the unprecedented changes of the past year.
Adolescent substance use represents an important area of concern. What has happened during the pandemic? Has youth substance use increased or decreased? Has access to substances increased or decreased, has monitoring and support for at-risk youth increased or decreased?
The answers to these questions are mixed. If anything, the pandemic has highlighted the heterogeneity of adolescent substance use. Now is a key time for assessment, support, and conversation with teens and families.
Monitoring the Future (MTF), a nationally representative annual survey, has provided a broad perspective on trends of adolescent substance use for decades.1 The MTF data is usually collected from February to May and was cut short in 2020 because of school closures associated with the pandemic. The sample size, though still nationally representative, was about a quarter of the typical volume. Some of the data are encouraging, including a flattening out of previous years’ stark increase in vaping of both nicotine and cannabis products (though overall numbers remain alarmingly high). Other data are more concerning including a continued increase in misuse of cough medicine, amphetamines, and inhalants among the youngest cohort surveyed (eighth graders). However, these data were largely representative of prepandemic circumstances.
The COVID-19 pandemic has significantly affected risk and protective factors for teen drug and alcohol use. Most notably, it has had a widely observed negative impact on adolescent mental health, across multiple disease categories.2 In addition, the cancellation of in-person academic and extracurricular activities such as arts and athletics markedly increased unstructured time, a known associated factor for higher-risk activities including substance use. This has also led to decreased contact with many supportive adults such as teachers and coaches. On the other hand, some adolescents now have more time with supportive parents and caregivers, more meals together, and more supervision, all of which are associated with decreased likelihood of substance use disorders.
The highly variable reasons for substance use affect highly variable pandemic-related changes in use. Understanding the impetus for use is a good place to start conversation and can help providers assess risk of escalation during the pandemic. Some teens primarily use for social enhancement while others use as a means of coping with stress or to mask or escape negative emotions. Still others continue use because of physiological dependence, craving, and other symptoms consistent with use disorders.
Highlighting the heterogeneity of this issue, one study assessing use early in the pandemic showed a decrease in the percentage of teens who use substances but an increase in frequency of use for those who are using.3 Though expected, an increase in frequency of use by oneself as compared with peers was also notable. Using substances alone is associated with more severe use disorders, carries greater risk of overdose, and can increase shame and secrecy, further fueling use disorders.
The pandemic has thus represented a protective pause for some experimental or socially motivated substance-using teens who have experienced a period of abstinence even if not fully by choice. For others, it has represented an acute amplification of risk factors and use has accelerated. This latter group includes those whose use represents an effort to cope with depression, anxiety, and loneliness or for whom isolation at home represents less monitoring, increased access, and greater exposure to substances.
Over the past year, in the treatment of adolescents struggling with substance use, many clinicians have observed a sifting effect during these unprecedented social changes. Many youth, who no longer have access to substances, have found they can “take it or leave it”. Other youth have been observed engaging in additional risk or going to greater lengths to access substances and continue their use. For both groups and everyone in between, this is an important time for screening, clinical assessment, and support.
While anticipating further research and data regarding broad substance use trends, including MTF data from 2021, recognizing that the impact of the COVID-19 pandemic is individual, with marked differences from adolescent to adolescent, will help us continue to act now to assess this important area of adolescent health. The first step for primary care providers is unchanged: to routinely screen for and discuss substance use in clinical settings.
Two brief, validated, easily accessible screening tools are available for primary care settings. They can both be self-administered and take less than 2 minutes to complete. Screening, Brief Intervention and Referral to Treatment and the Brief Screener for Tobacco, Alcohol and other Drugs can both be used for youth aged 12-17 years.4,5 Both screens are available online at drugabuse.gov.6
Routine screening will normalize conversations about substance use and healthy choices, provide opportunities for positive reinforcement, identify adolescents at risk, increase comfort and competence in providing brief intervention, and expedite referrals for additional support and treatment.
A false assumption that a particular adolescent isn’t using substances creates a missed opportunity to offer guidance and treatment. An oft-overlooked opportunity is that of providing positive reinforcement for an adolescent who isn’t using any substances or experimenting at all. Positive reinforcement is a strong component of reinforcing health maintenance.
Parent guidance and family assessment will also be critical tools. Parents and caregivers play a primary role in substance use treatment for teens and have a contributory impact on risk through both genes and environment. Of note, research suggests a moderate overall increase in adult substance use during the pandemic, particularly substances that are widely available such as alcohol. Adolescents may thus have greater access and exposure to substance use. A remarkably high percentage, 42%, of substance-using teens surveyed early in the pandemic indicated that they were using substances with their parents.3 Parents, who have equally been challenged by the pandemic, may need guidance in balancing compassion and support for struggling youth, while setting appropriate limits and maintaining expectations of healthy activities.
Unprecedented change and uncertainty provide an opportunity to reassess risks and openly discuss substance use with youth and families. Even with much on our minds during the COVID-19 pandemic, we can maintain focus on this significant risk to adolescent health and wellness. Our efforts now, from screening to treatment for adolescent substance use should be reinforced rather than delayed.
Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington.
References
1. Monitoringthefuture.org
2. Jones EAK et al. Int J Environ Res Public Health, 2021;18(5):2470.
3. Dumas TM et al. J Adolesc Health, 2020;67(3):354-61.
4. Levy S et al. JAMA Pediatr. 2014;168(9):822-8.
5. Kelly SM et al. Pediatrics. 2014;133(5):819-26.
6. National Institute on Drug Abuse. Adolescent Substance Use Screening Tools. 2016 Apr 27. https://www.drugabuse.gov/nidamed-medical-health-professionals/screening-tools-prevention/screening-tools-adolescent-substance-use/adolescent-substance-use-screening-tools
During the past year, adolescents, families, educators, and health care providers have had to press forward through myriad challenges and stressors with flexibility and adaptability. With appropriate concern, we ask ourselves how children and youth are coping emotionally with the unprecedented changes of the past year.
Adolescent substance use represents an important area of concern. What has happened during the pandemic? Has youth substance use increased or decreased? Has access to substances increased or decreased, has monitoring and support for at-risk youth increased or decreased?
The answers to these questions are mixed. If anything, the pandemic has highlighted the heterogeneity of adolescent substance use. Now is a key time for assessment, support, and conversation with teens and families.
Monitoring the Future (MTF), a nationally representative annual survey, has provided a broad perspective on trends of adolescent substance use for decades.1 The MTF data is usually collected from February to May and was cut short in 2020 because of school closures associated with the pandemic. The sample size, though still nationally representative, was about a quarter of the typical volume. Some of the data are encouraging, including a flattening out of previous years’ stark increase in vaping of both nicotine and cannabis products (though overall numbers remain alarmingly high). Other data are more concerning including a continued increase in misuse of cough medicine, amphetamines, and inhalants among the youngest cohort surveyed (eighth graders). However, these data were largely representative of prepandemic circumstances.
The COVID-19 pandemic has significantly affected risk and protective factors for teen drug and alcohol use. Most notably, it has had a widely observed negative impact on adolescent mental health, across multiple disease categories.2 In addition, the cancellation of in-person academic and extracurricular activities such as arts and athletics markedly increased unstructured time, a known associated factor for higher-risk activities including substance use. This has also led to decreased contact with many supportive adults such as teachers and coaches. On the other hand, some adolescents now have more time with supportive parents and caregivers, more meals together, and more supervision, all of which are associated with decreased likelihood of substance use disorders.
The highly variable reasons for substance use affect highly variable pandemic-related changes in use. Understanding the impetus for use is a good place to start conversation and can help providers assess risk of escalation during the pandemic. Some teens primarily use for social enhancement while others use as a means of coping with stress or to mask or escape negative emotions. Still others continue use because of physiological dependence, craving, and other symptoms consistent with use disorders.
Highlighting the heterogeneity of this issue, one study assessing use early in the pandemic showed a decrease in the percentage of teens who use substances but an increase in frequency of use for those who are using.3 Though expected, an increase in frequency of use by oneself as compared with peers was also notable. Using substances alone is associated with more severe use disorders, carries greater risk of overdose, and can increase shame and secrecy, further fueling use disorders.
The pandemic has thus represented a protective pause for some experimental or socially motivated substance-using teens who have experienced a period of abstinence even if not fully by choice. For others, it has represented an acute amplification of risk factors and use has accelerated. This latter group includes those whose use represents an effort to cope with depression, anxiety, and loneliness or for whom isolation at home represents less monitoring, increased access, and greater exposure to substances.
Over the past year, in the treatment of adolescents struggling with substance use, many clinicians have observed a sifting effect during these unprecedented social changes. Many youth, who no longer have access to substances, have found they can “take it or leave it”. Other youth have been observed engaging in additional risk or going to greater lengths to access substances and continue their use. For both groups and everyone in between, this is an important time for screening, clinical assessment, and support.
While anticipating further research and data regarding broad substance use trends, including MTF data from 2021, recognizing that the impact of the COVID-19 pandemic is individual, with marked differences from adolescent to adolescent, will help us continue to act now to assess this important area of adolescent health. The first step for primary care providers is unchanged: to routinely screen for and discuss substance use in clinical settings.
Two brief, validated, easily accessible screening tools are available for primary care settings. They can both be self-administered and take less than 2 minutes to complete. Screening, Brief Intervention and Referral to Treatment and the Brief Screener for Tobacco, Alcohol and other Drugs can both be used for youth aged 12-17 years.4,5 Both screens are available online at drugabuse.gov.6
Routine screening will normalize conversations about substance use and healthy choices, provide opportunities for positive reinforcement, identify adolescents at risk, increase comfort and competence in providing brief intervention, and expedite referrals for additional support and treatment.
A false assumption that a particular adolescent isn’t using substances creates a missed opportunity to offer guidance and treatment. An oft-overlooked opportunity is that of providing positive reinforcement for an adolescent who isn’t using any substances or experimenting at all. Positive reinforcement is a strong component of reinforcing health maintenance.
Parent guidance and family assessment will also be critical tools. Parents and caregivers play a primary role in substance use treatment for teens and have a contributory impact on risk through both genes and environment. Of note, research suggests a moderate overall increase in adult substance use during the pandemic, particularly substances that are widely available such as alcohol. Adolescents may thus have greater access and exposure to substance use. A remarkably high percentage, 42%, of substance-using teens surveyed early in the pandemic indicated that they were using substances with their parents.3 Parents, who have equally been challenged by the pandemic, may need guidance in balancing compassion and support for struggling youth, while setting appropriate limits and maintaining expectations of healthy activities.
Unprecedented change and uncertainty provide an opportunity to reassess risks and openly discuss substance use with youth and families. Even with much on our minds during the COVID-19 pandemic, we can maintain focus on this significant risk to adolescent health and wellness. Our efforts now, from screening to treatment for adolescent substance use should be reinforced rather than delayed.
Dr. Jackson is assistant professor of psychiatry at the University of Vermont, Burlington.
References
1. Monitoringthefuture.org
2. Jones EAK et al. Int J Environ Res Public Health, 2021;18(5):2470.
3. Dumas TM et al. J Adolesc Health, 2020;67(3):354-61.
4. Levy S et al. JAMA Pediatr. 2014;168(9):822-8.
5. Kelly SM et al. Pediatrics. 2014;133(5):819-26.
6. National Institute on Drug Abuse. Adolescent Substance Use Screening Tools. 2016 Apr 27. https://www.drugabuse.gov/nidamed-medical-health-professionals/screening-tools-prevention/screening-tools-adolescent-substance-use/adolescent-substance-use-screening-tools
CDC panel: Pause of J&J COVID-19 vaccine to remain for now
The Advisory Committee on Immunization Practices decided there was not adequate information to change again recommend use of the Johnson & Johnson vaccine.
The committee’s decision comes the day after the CDC and Food and Drug Administration recommended that J&J injections be paused after reports of rare, but serious types of blood clots in six patients among the 6.8 million people who had received the J&J vaccine in the United States.
A member of the committee, Beth Bell, MD, said: “I do not want to be sending a message that there is some huge concern here on a different order of magnitude than any other vaccine safety signals that we evaluate. And I don’t want to send a message that there is something fundamentally wrong with the vaccine because that also I don’t agree with.”
At the end of the 4-hour meeting, ACIP members decided to call a meeting in 1 or 2 weeks and evaluate more safety data, specifically reports of people who have received the J&J vaccine in the past 2 weeks.
Some, however, pointed out that delaying a decision could have substantial consequences as well in terms of unused vaccine doses and public confidence.
Committee member Camiile Kotton, MD, described the pause as “devastating.”
“Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,” she said. “I agree in general that we don’t have enough data to make a decision at this time but we were planning on using this vaccine in the state of Massachusetts for people who were homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population often with many comorbidities and at high risk for disease but haven’t been able to get vaccinated otherwise.”
Pausing the one-and-done vaccine that doesn’t have the significant refrigeration requirements of the others “is a significant loss,” she said.
What is known, not known
Sara Oliver, MD, who leads the COVID-19 Vaccines ACIP Work Group, summarized what is known and unknown about the blood clots.
Among the six cases of cerebral venous sinus thrombosis reported to the Vaccine Adverse Event Reporting System after the J&J shot, all were women aged 18-48 years and all developed the clots 6-13 days after receiving the vaccine.
No cases of these clots have been reported from either the Pfizer or Moderna shots, she noted.
In the United States, the two mRNA vaccine alternatives – the Moderna and Pfizer vaccines – are available “and based on current projections supply of both vaccines are expected to be relatively stable in the near future,” she said.
She said 14 million doses of Pfizer and Moderna are expected each week in the United States and J&J vaccines makes up less than 5% of vaccines administered in the country.
Approximately 13 million J&J doses are available to order or are already at administration sites, she said.
But much more is unknown, she said.
“There may be more cases identified in the coming days to weeks,” Dr. Oliver said, referring back to the average time from vaccination to symptom onset.
Scott Ratzan, MD, editor-in-chief of the Journal of Health Communication: International Perspectives and executive director of Business Partners to CONVINCE (BP2C), a global network of employers that promotes COVID-19 vaccination among employees, suppliers, and customers, applauded ACIP’s delay on making a decision.
Dr. Ratzan, who watched the deliberations online, said in an interview the decision “shows an admirable abundance of caution in the distribution of COVID-19 vaccines.”
“Unfortunately,” he said, “the pause also worsens the existing and pervasive vaccine hesitancy issue.
“We need a rational strategy regarding who should or should not get the J&J/Janssen vaccine since these rare adverse events appear to affect a particular group of people, females aged 18-48. It is essential that we build vaccine confidence and retain the option of using this vaccine for people who are not in this risk group.”
He pointed out there are safety red flags with the Pfizer and Moderna COVID-19 vaccines.
“We should feel reassured about the process of ensuring vaccine safety as the FDA and CDC have quickly addressed risk and shared the data transparently of the J&J vaccine and taken appropriate action,” he said.
ACIP’s executive secretary, Amanda Cohn, MD, said the date for the next meeting would be set by April 16.
A version of this article first appeared on WebMD.com.
The Advisory Committee on Immunization Practices decided there was not adequate information to change again recommend use of the Johnson & Johnson vaccine.
The committee’s decision comes the day after the CDC and Food and Drug Administration recommended that J&J injections be paused after reports of rare, but serious types of blood clots in six patients among the 6.8 million people who had received the J&J vaccine in the United States.
A member of the committee, Beth Bell, MD, said: “I do not want to be sending a message that there is some huge concern here on a different order of magnitude than any other vaccine safety signals that we evaluate. And I don’t want to send a message that there is something fundamentally wrong with the vaccine because that also I don’t agree with.”
At the end of the 4-hour meeting, ACIP members decided to call a meeting in 1 or 2 weeks and evaluate more safety data, specifically reports of people who have received the J&J vaccine in the past 2 weeks.
Some, however, pointed out that delaying a decision could have substantial consequences as well in terms of unused vaccine doses and public confidence.
Committee member Camiile Kotton, MD, described the pause as “devastating.”
“Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,” she said. “I agree in general that we don’t have enough data to make a decision at this time but we were planning on using this vaccine in the state of Massachusetts for people who were homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population often with many comorbidities and at high risk for disease but haven’t been able to get vaccinated otherwise.”
Pausing the one-and-done vaccine that doesn’t have the significant refrigeration requirements of the others “is a significant loss,” she said.
What is known, not known
Sara Oliver, MD, who leads the COVID-19 Vaccines ACIP Work Group, summarized what is known and unknown about the blood clots.
Among the six cases of cerebral venous sinus thrombosis reported to the Vaccine Adverse Event Reporting System after the J&J shot, all were women aged 18-48 years and all developed the clots 6-13 days after receiving the vaccine.
No cases of these clots have been reported from either the Pfizer or Moderna shots, she noted.
In the United States, the two mRNA vaccine alternatives – the Moderna and Pfizer vaccines – are available “and based on current projections supply of both vaccines are expected to be relatively stable in the near future,” she said.
She said 14 million doses of Pfizer and Moderna are expected each week in the United States and J&J vaccines makes up less than 5% of vaccines administered in the country.
Approximately 13 million J&J doses are available to order or are already at administration sites, she said.
But much more is unknown, she said.
“There may be more cases identified in the coming days to weeks,” Dr. Oliver said, referring back to the average time from vaccination to symptom onset.
Scott Ratzan, MD, editor-in-chief of the Journal of Health Communication: International Perspectives and executive director of Business Partners to CONVINCE (BP2C), a global network of employers that promotes COVID-19 vaccination among employees, suppliers, and customers, applauded ACIP’s delay on making a decision.
Dr. Ratzan, who watched the deliberations online, said in an interview the decision “shows an admirable abundance of caution in the distribution of COVID-19 vaccines.”
“Unfortunately,” he said, “the pause also worsens the existing and pervasive vaccine hesitancy issue.
“We need a rational strategy regarding who should or should not get the J&J/Janssen vaccine since these rare adverse events appear to affect a particular group of people, females aged 18-48. It is essential that we build vaccine confidence and retain the option of using this vaccine for people who are not in this risk group.”
He pointed out there are safety red flags with the Pfizer and Moderna COVID-19 vaccines.
“We should feel reassured about the process of ensuring vaccine safety as the FDA and CDC have quickly addressed risk and shared the data transparently of the J&J vaccine and taken appropriate action,” he said.
ACIP’s executive secretary, Amanda Cohn, MD, said the date for the next meeting would be set by April 16.
A version of this article first appeared on WebMD.com.
The Advisory Committee on Immunization Practices decided there was not adequate information to change again recommend use of the Johnson & Johnson vaccine.
The committee’s decision comes the day after the CDC and Food and Drug Administration recommended that J&J injections be paused after reports of rare, but serious types of blood clots in six patients among the 6.8 million people who had received the J&J vaccine in the United States.
A member of the committee, Beth Bell, MD, said: “I do not want to be sending a message that there is some huge concern here on a different order of magnitude than any other vaccine safety signals that we evaluate. And I don’t want to send a message that there is something fundamentally wrong with the vaccine because that also I don’t agree with.”
At the end of the 4-hour meeting, ACIP members decided to call a meeting in 1 or 2 weeks and evaluate more safety data, specifically reports of people who have received the J&J vaccine in the past 2 weeks.
Some, however, pointed out that delaying a decision could have substantial consequences as well in terms of unused vaccine doses and public confidence.
Committee member Camiile Kotton, MD, described the pause as “devastating.”
“Putting this vaccine on pause for those of us that are frontline health care workers has really been devastating,” she said. “I agree in general that we don’t have enough data to make a decision at this time but we were planning on using this vaccine in the state of Massachusetts for people who were homebound and otherwise not able to get a vaccine. We were planning on using it for our vulnerable inpatient population often with many comorbidities and at high risk for disease but haven’t been able to get vaccinated otherwise.”
Pausing the one-and-done vaccine that doesn’t have the significant refrigeration requirements of the others “is a significant loss,” she said.
What is known, not known
Sara Oliver, MD, who leads the COVID-19 Vaccines ACIP Work Group, summarized what is known and unknown about the blood clots.
Among the six cases of cerebral venous sinus thrombosis reported to the Vaccine Adverse Event Reporting System after the J&J shot, all were women aged 18-48 years and all developed the clots 6-13 days after receiving the vaccine.
No cases of these clots have been reported from either the Pfizer or Moderna shots, she noted.
In the United States, the two mRNA vaccine alternatives – the Moderna and Pfizer vaccines – are available “and based on current projections supply of both vaccines are expected to be relatively stable in the near future,” she said.
She said 14 million doses of Pfizer and Moderna are expected each week in the United States and J&J vaccines makes up less than 5% of vaccines administered in the country.
Approximately 13 million J&J doses are available to order or are already at administration sites, she said.
But much more is unknown, she said.
“There may be more cases identified in the coming days to weeks,” Dr. Oliver said, referring back to the average time from vaccination to symptom onset.
Scott Ratzan, MD, editor-in-chief of the Journal of Health Communication: International Perspectives and executive director of Business Partners to CONVINCE (BP2C), a global network of employers that promotes COVID-19 vaccination among employees, suppliers, and customers, applauded ACIP’s delay on making a decision.
Dr. Ratzan, who watched the deliberations online, said in an interview the decision “shows an admirable abundance of caution in the distribution of COVID-19 vaccines.”
“Unfortunately,” he said, “the pause also worsens the existing and pervasive vaccine hesitancy issue.
“We need a rational strategy regarding who should or should not get the J&J/Janssen vaccine since these rare adverse events appear to affect a particular group of people, females aged 18-48. It is essential that we build vaccine confidence and retain the option of using this vaccine for people who are not in this risk group.”
He pointed out there are safety red flags with the Pfizer and Moderna COVID-19 vaccines.
“We should feel reassured about the process of ensuring vaccine safety as the FDA and CDC have quickly addressed risk and shared the data transparently of the J&J vaccine and taken appropriate action,” he said.
ACIP’s executive secretary, Amanda Cohn, MD, said the date for the next meeting would be set by April 16.
A version of this article first appeared on WebMD.com.
How some COVID-19 vaccines could cause rare blood clots
on April 14, 2021, after the CDC and Food and Drug Administration recommended that states hold off on using it pending a detailed review of six cases of the same kind of rare but serious event – a blood clot in the vessels that drain blood from the brain combined with a large drop in platelets, which increases the risk for bleeding.
This combination can lead to severe strokes that can lead to brain damage or death. Among the six cases reported, which came to light over the past 3 weeks, one person died, according to the CDC. All six were women and ranged in age from 18 to 48 years.
According to a report from the Vaccine Adverse Event Reporting System (VAERS), which is maintained by the Department of Health & Human Services, the woman who died was 45. She developed a gradually worsening headache about a week after receiving the Johnson & Johnson vaccine.
On March 17, the day she came to the hospital, she was dry heaving. Her headache had suddenly gotten much worse, and the left side of her body was weak, which are signs of a stroke. A CT scan revealed both bleeding in her brain and a clot in her cortical vein. She died the following day.
In addition to VAERS, which accepts reports from anyone, the CDC and FDA are monitoring at least eight other safety systems maintained by hospitals, research centers, long-term care facilities, and insurance companies for signs of trouble with the vaccines. VAERS data is searchable and open to the public. Most of these systems are not publicly available to protect patient privacy. It’s unclear which systems detected the six cases cited by federal regulators.
“These are very serious and potentially fatal problems occurring in a healthy young adult. It’s serious and we need to get to the bottom of it,” said Ed Belongia, MD, director of the Center for Clinical Epidemiology and Population Health at the Marshfield (Wis.) Clinic Research Institute. Dr. Belongia leads a research team that helps the CDC monitor vaccine safety and effectiveness.
“Safety is always the highest priority, and I think what we’ve seen here in the past 24 hours is our vaccine safety monitoring system is working,” he said.
Others agree. “I think what CDC and FDA have detected is a rare, but likely real adverse event associated with this vaccine,” said Paul Offit, MD, director of vaccine education at Children’s Hospital of Philadelphia.
Although much is still unknown about these events, they follow a similar pattern of blood clots reported with the AstraZeneca vaccine in Europe. That vaccine is now sold under the brand name Vaxzevria.
This has experts questioning whether all vaccines of this type may cause these rare clots.
“I think it’s likely a class effect,” said Dr. Offit, who was a member of the FDA advisory committee that reviewed clinical trial data on the J&J vaccine before it was authorized for use.
Adenovirus vaccines scrutinized
Both the Johnson & Johnson and Vaxzevria vaccines use an adenovirus to ferry genetic instructions for making the coronaviruses spike protein into our cells.
Adenoviruses are common, relatively simple viruses that normally cause mild cold or flu symptoms. The ones used in the vaccine are disabled so they can’t make us sick. They’re more like Trojan horses.
Once inside our cells, they release the DNA instructions they carry to make the spike protein of the new coronavirus. Those cells then crank out copies of the spike protein, which then get displayed on the outer surface of the cell membrane where they are recognized by the immune system.
The immune system then makes antibodies and other defenses against the spike so that, when the real coronavirus comes along, our bodies are ready to fight the infection.
There’s no question the vaccine works. In clinical trials, the Johnson & Johnson vaccine was 66% percent effective at preventing against moderate to severe COVID-19 infection, and none of the patients who got COVID-19 after vaccination had to be admitted to the hospital or died.
The idea behind using adenoviruses in vaccines isn’t a new one. In a kind of fight-fire-with-fire approach, the idea is to use a virus, which is good at infecting us, to fight a different kind of virus.
Researchers have been working on the concept for about 10 years, but the COVID-19 vaccines that use this technology are some of the first adenovirus-vector vaccines deployed in humans.
Only one other adenovirus vaccine, for Ebola, has been approved for use in humans. It was approved in Europe last year. Before the Johnson & Johnson vaccine, no other adenovirus vector has been available for use in humans in the United States.
There are six adenovirus-vector vaccines for COVID-19. In addition to AstraZeneca and Johnson & Johnson, there’s the Russian-developed vaccine Sputnik V, along with CanSino from China, and the Covishield vaccine in India.
Adenovirus vaccines are more stable than the mRNA vaccines. That makes them easier to store and transport.
But they have a significant downside, too. Because adenoviruses infect humans out in the world, we already make antibodies against them. So there’s always a danger that our immune systems might recognize and react to the vaccine, rendering it ineffective. For that reason, scientists try to carefully select the adenovirus vectors, or carriers, they use.
The two vaccines under investigation for blood clots are slightly different. The Johnson & Johnson vaccine uses the vector AD26, because most of the population lacks preexisting immunity to it. Vaxzevria uses an adenovirus that infects chimpanzees, called ChAdOx1.
Vaxzevria has been widely used in Europe but has not yet been authorized in the United States.
On April 7, the European Medicines Agency, Europe’s counterpart to the FDA, ruled that unusual blood clots with low blood platelets should be listed as rare side effects on the Vaxzevria vaccine.
The decision came after reviewing 62 cases of cerebral venous sinus thrombosis (CVST) linked to the vaccine and 25 cases of another rare type of clot, called a splanchnic vein thrombosis. Splanchnic veins drain blood from the major organs in the digestive system, including the stomach, liver, and intestines; 18 of those events were fatal.
The reports were culled from reporting in Europe and the United Kingdom, where around 25 million people have received the Vaxzevria vaccine, making these clots exceptionally rare, but serious.
So far, six cases of CVST have been reported in the United States, after more than 7 million doses of the Johnson & Johnson vaccines have been administered.
A key question for U.S. regulators will be the background rate for these types of rare combinations of clots and deplenished platelets. The background rate is the number of events that would be expected to occur naturally in a population of unvaccinated people. On a press call on April 13, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, was asked about the frequency of this dangerous combination. He said the combination of low platelets and clots was so rare that it was hard to pinpoint, but might be somewhere between 2 and 14 cases per million people over the course of a year.
The first Johnson & Johnson doses were given in early March. That means the six cases came to light within the first few weeks of use of the vaccine in the United States, a very short amount of time.
“These were six cases per million people for 2 weeks, which is the same thing as 25 million per year, so it’s clearly above the background rate,” Dr. Offit said.
Studies suggest possible mechanism
On April 9, the New England Journal of Medicine published a detailed evaluation of the 11 patients in Germany and Austria who developed the rare clots after their Vaxzevria vaccines.
The study detected rare antibodies to a signaling protein called platelet factor 4, which helps to coordinate clot formation.
These same type of antibodies form in some people given the blood thinning drug heparin. In those reactions, which are also exceptionally rare, the same type of syndrome develops, leading to large, devastating clots that consume circulating platelets.
It’s not yet clear whether people who develop reactions to the vaccines already have some platelet factor 4 antibodies before they are vaccinated, or whether the vaccines somehow spur the body to make these antibodies, which then launch a kind of autoimmune attack.
The researchers on the paper gave the syndrome a name, vaccine-induced thrombotic thrombocytopenia (VITT).
It’s also not clear why more cases seem to be in women than in men. Andrew Eisenberger, MD, an associate professor of hematology and oncology at Columbia University, New York, said the most common causes of cerebral venous sinus thrombosis have to do with conditions that raise estrogen levels, like pregnancy and hormonal contraception.
“Estrogen naturally leads to changes in several clotting proteins in the blood that may predispose to abnormal blood clotting in a few different sites in the body,” he said. “The clotting changes we are encountering with some of COVID-19 vaccines are likely to be synergistic with the effects of estrogen on the blood.”
No matter the cause, the CDC on April 13 alerted doctors to keep a high index of suspicion for VITT in patients who have received the Johnson & Johnson vaccination within the last 2 weeks. In those patients, the usual course of treatment with blood thinning drugs like heparin may be harmful.
Symptoms to watch for include severe headache or backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin, or easy bruising.
Grappling with evidence
The CDC’s Advisory Committee on Immunization Practices will meet today in an emergency session to review the cases and see if any changes are needed to use of the J&J vaccine in the United States.
Last week, for example, the United Kingdom restricted the use of the AstraZeneca vaccine in people aged younger than 30 years, saying the risks and benefits of vaccination are “more finely balanced” for this age group.
With cases of COVID-19 rising again in the United States, and the Johnson & Johnson vaccine currently the most convenient form of protection against the virus, the committee will have to weigh the risks of that infection against the risk of rare clots caused by vaccination.
They will also likely have to rule out whether any of the cases had COVID. At least one study has reported CVST clots in three patients with confirmed COVID infections. In Europe, COVID infection did not seem to play a role in the formation of the clots with low platelets.
Hilda Bastian, PhD, a clinical trials expert who cofounded the Cochrane Collaboration, said it won’t be an easy task. Much will depend on how certain the committee members feel they know about all the events linked to the vaccine.
“That’s the really, really hard issue from my point of view for them right this moment. Have we missed any? Or how many are we likely to have missed?” asked Dr. Bastian, who lives in Australia.
“In a country that size with that fragmented [of] a health care system, how sure can you be that you know them all? That’s going to be a really difficult situation for them to grapple with, the quality of information that they’ve got,” she said.
A version of this article first appeared on Medscape.com.
on April 14, 2021, after the CDC and Food and Drug Administration recommended that states hold off on using it pending a detailed review of six cases of the same kind of rare but serious event – a blood clot in the vessels that drain blood from the brain combined with a large drop in platelets, which increases the risk for bleeding.
This combination can lead to severe strokes that can lead to brain damage or death. Among the six cases reported, which came to light over the past 3 weeks, one person died, according to the CDC. All six were women and ranged in age from 18 to 48 years.
According to a report from the Vaccine Adverse Event Reporting System (VAERS), which is maintained by the Department of Health & Human Services, the woman who died was 45. She developed a gradually worsening headache about a week after receiving the Johnson & Johnson vaccine.
On March 17, the day she came to the hospital, she was dry heaving. Her headache had suddenly gotten much worse, and the left side of her body was weak, which are signs of a stroke. A CT scan revealed both bleeding in her brain and a clot in her cortical vein. She died the following day.
In addition to VAERS, which accepts reports from anyone, the CDC and FDA are monitoring at least eight other safety systems maintained by hospitals, research centers, long-term care facilities, and insurance companies for signs of trouble with the vaccines. VAERS data is searchable and open to the public. Most of these systems are not publicly available to protect patient privacy. It’s unclear which systems detected the six cases cited by federal regulators.
“These are very serious and potentially fatal problems occurring in a healthy young adult. It’s serious and we need to get to the bottom of it,” said Ed Belongia, MD, director of the Center for Clinical Epidemiology and Population Health at the Marshfield (Wis.) Clinic Research Institute. Dr. Belongia leads a research team that helps the CDC monitor vaccine safety and effectiveness.
“Safety is always the highest priority, and I think what we’ve seen here in the past 24 hours is our vaccine safety monitoring system is working,” he said.
Others agree. “I think what CDC and FDA have detected is a rare, but likely real adverse event associated with this vaccine,” said Paul Offit, MD, director of vaccine education at Children’s Hospital of Philadelphia.
Although much is still unknown about these events, they follow a similar pattern of blood clots reported with the AstraZeneca vaccine in Europe. That vaccine is now sold under the brand name Vaxzevria.
This has experts questioning whether all vaccines of this type may cause these rare clots.
“I think it’s likely a class effect,” said Dr. Offit, who was a member of the FDA advisory committee that reviewed clinical trial data on the J&J vaccine before it was authorized for use.
Adenovirus vaccines scrutinized
Both the Johnson & Johnson and Vaxzevria vaccines use an adenovirus to ferry genetic instructions for making the coronaviruses spike protein into our cells.
Adenoviruses are common, relatively simple viruses that normally cause mild cold or flu symptoms. The ones used in the vaccine are disabled so they can’t make us sick. They’re more like Trojan horses.
Once inside our cells, they release the DNA instructions they carry to make the spike protein of the new coronavirus. Those cells then crank out copies of the spike protein, which then get displayed on the outer surface of the cell membrane where they are recognized by the immune system.
The immune system then makes antibodies and other defenses against the spike so that, when the real coronavirus comes along, our bodies are ready to fight the infection.
There’s no question the vaccine works. In clinical trials, the Johnson & Johnson vaccine was 66% percent effective at preventing against moderate to severe COVID-19 infection, and none of the patients who got COVID-19 after vaccination had to be admitted to the hospital or died.
The idea behind using adenoviruses in vaccines isn’t a new one. In a kind of fight-fire-with-fire approach, the idea is to use a virus, which is good at infecting us, to fight a different kind of virus.
Researchers have been working on the concept for about 10 years, but the COVID-19 vaccines that use this technology are some of the first adenovirus-vector vaccines deployed in humans.
Only one other adenovirus vaccine, for Ebola, has been approved for use in humans. It was approved in Europe last year. Before the Johnson & Johnson vaccine, no other adenovirus vector has been available for use in humans in the United States.
There are six adenovirus-vector vaccines for COVID-19. In addition to AstraZeneca and Johnson & Johnson, there’s the Russian-developed vaccine Sputnik V, along with CanSino from China, and the Covishield vaccine in India.
Adenovirus vaccines are more stable than the mRNA vaccines. That makes them easier to store and transport.
But they have a significant downside, too. Because adenoviruses infect humans out in the world, we already make antibodies against them. So there’s always a danger that our immune systems might recognize and react to the vaccine, rendering it ineffective. For that reason, scientists try to carefully select the adenovirus vectors, or carriers, they use.
The two vaccines under investigation for blood clots are slightly different. The Johnson & Johnson vaccine uses the vector AD26, because most of the population lacks preexisting immunity to it. Vaxzevria uses an adenovirus that infects chimpanzees, called ChAdOx1.
Vaxzevria has been widely used in Europe but has not yet been authorized in the United States.
On April 7, the European Medicines Agency, Europe’s counterpart to the FDA, ruled that unusual blood clots with low blood platelets should be listed as rare side effects on the Vaxzevria vaccine.
The decision came after reviewing 62 cases of cerebral venous sinus thrombosis (CVST) linked to the vaccine and 25 cases of another rare type of clot, called a splanchnic vein thrombosis. Splanchnic veins drain blood from the major organs in the digestive system, including the stomach, liver, and intestines; 18 of those events were fatal.
The reports were culled from reporting in Europe and the United Kingdom, where around 25 million people have received the Vaxzevria vaccine, making these clots exceptionally rare, but serious.
So far, six cases of CVST have been reported in the United States, after more than 7 million doses of the Johnson & Johnson vaccines have been administered.
A key question for U.S. regulators will be the background rate for these types of rare combinations of clots and deplenished platelets. The background rate is the number of events that would be expected to occur naturally in a population of unvaccinated people. On a press call on April 13, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, was asked about the frequency of this dangerous combination. He said the combination of low platelets and clots was so rare that it was hard to pinpoint, but might be somewhere between 2 and 14 cases per million people over the course of a year.
The first Johnson & Johnson doses were given in early March. That means the six cases came to light within the first few weeks of use of the vaccine in the United States, a very short amount of time.
“These were six cases per million people for 2 weeks, which is the same thing as 25 million per year, so it’s clearly above the background rate,” Dr. Offit said.
Studies suggest possible mechanism
On April 9, the New England Journal of Medicine published a detailed evaluation of the 11 patients in Germany and Austria who developed the rare clots after their Vaxzevria vaccines.
The study detected rare antibodies to a signaling protein called platelet factor 4, which helps to coordinate clot formation.
These same type of antibodies form in some people given the blood thinning drug heparin. In those reactions, which are also exceptionally rare, the same type of syndrome develops, leading to large, devastating clots that consume circulating platelets.
It’s not yet clear whether people who develop reactions to the vaccines already have some platelet factor 4 antibodies before they are vaccinated, or whether the vaccines somehow spur the body to make these antibodies, which then launch a kind of autoimmune attack.
The researchers on the paper gave the syndrome a name, vaccine-induced thrombotic thrombocytopenia (VITT).
It’s also not clear why more cases seem to be in women than in men. Andrew Eisenberger, MD, an associate professor of hematology and oncology at Columbia University, New York, said the most common causes of cerebral venous sinus thrombosis have to do with conditions that raise estrogen levels, like pregnancy and hormonal contraception.
“Estrogen naturally leads to changes in several clotting proteins in the blood that may predispose to abnormal blood clotting in a few different sites in the body,” he said. “The clotting changes we are encountering with some of COVID-19 vaccines are likely to be synergistic with the effects of estrogen on the blood.”
No matter the cause, the CDC on April 13 alerted doctors to keep a high index of suspicion for VITT in patients who have received the Johnson & Johnson vaccination within the last 2 weeks. In those patients, the usual course of treatment with blood thinning drugs like heparin may be harmful.
Symptoms to watch for include severe headache or backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin, or easy bruising.
Grappling with evidence
The CDC’s Advisory Committee on Immunization Practices will meet today in an emergency session to review the cases and see if any changes are needed to use of the J&J vaccine in the United States.
Last week, for example, the United Kingdom restricted the use of the AstraZeneca vaccine in people aged younger than 30 years, saying the risks and benefits of vaccination are “more finely balanced” for this age group.
With cases of COVID-19 rising again in the United States, and the Johnson & Johnson vaccine currently the most convenient form of protection against the virus, the committee will have to weigh the risks of that infection against the risk of rare clots caused by vaccination.
They will also likely have to rule out whether any of the cases had COVID. At least one study has reported CVST clots in three patients with confirmed COVID infections. In Europe, COVID infection did not seem to play a role in the formation of the clots with low platelets.
Hilda Bastian, PhD, a clinical trials expert who cofounded the Cochrane Collaboration, said it won’t be an easy task. Much will depend on how certain the committee members feel they know about all the events linked to the vaccine.
“That’s the really, really hard issue from my point of view for them right this moment. Have we missed any? Or how many are we likely to have missed?” asked Dr. Bastian, who lives in Australia.
“In a country that size with that fragmented [of] a health care system, how sure can you be that you know them all? That’s going to be a really difficult situation for them to grapple with, the quality of information that they’ve got,” she said.
A version of this article first appeared on Medscape.com.
on April 14, 2021, after the CDC and Food and Drug Administration recommended that states hold off on using it pending a detailed review of six cases of the same kind of rare but serious event – a blood clot in the vessels that drain blood from the brain combined with a large drop in platelets, which increases the risk for bleeding.
This combination can lead to severe strokes that can lead to brain damage or death. Among the six cases reported, which came to light over the past 3 weeks, one person died, according to the CDC. All six were women and ranged in age from 18 to 48 years.
According to a report from the Vaccine Adverse Event Reporting System (VAERS), which is maintained by the Department of Health & Human Services, the woman who died was 45. She developed a gradually worsening headache about a week after receiving the Johnson & Johnson vaccine.
On March 17, the day she came to the hospital, she was dry heaving. Her headache had suddenly gotten much worse, and the left side of her body was weak, which are signs of a stroke. A CT scan revealed both bleeding in her brain and a clot in her cortical vein. She died the following day.
In addition to VAERS, which accepts reports from anyone, the CDC and FDA are monitoring at least eight other safety systems maintained by hospitals, research centers, long-term care facilities, and insurance companies for signs of trouble with the vaccines. VAERS data is searchable and open to the public. Most of these systems are not publicly available to protect patient privacy. It’s unclear which systems detected the six cases cited by federal regulators.
“These are very serious and potentially fatal problems occurring in a healthy young adult. It’s serious and we need to get to the bottom of it,” said Ed Belongia, MD, director of the Center for Clinical Epidemiology and Population Health at the Marshfield (Wis.) Clinic Research Institute. Dr. Belongia leads a research team that helps the CDC monitor vaccine safety and effectiveness.
“Safety is always the highest priority, and I think what we’ve seen here in the past 24 hours is our vaccine safety monitoring system is working,” he said.
Others agree. “I think what CDC and FDA have detected is a rare, but likely real adverse event associated with this vaccine,” said Paul Offit, MD, director of vaccine education at Children’s Hospital of Philadelphia.
Although much is still unknown about these events, they follow a similar pattern of blood clots reported with the AstraZeneca vaccine in Europe. That vaccine is now sold under the brand name Vaxzevria.
This has experts questioning whether all vaccines of this type may cause these rare clots.
“I think it’s likely a class effect,” said Dr. Offit, who was a member of the FDA advisory committee that reviewed clinical trial data on the J&J vaccine before it was authorized for use.
Adenovirus vaccines scrutinized
Both the Johnson & Johnson and Vaxzevria vaccines use an adenovirus to ferry genetic instructions for making the coronaviruses spike protein into our cells.
Adenoviruses are common, relatively simple viruses that normally cause mild cold or flu symptoms. The ones used in the vaccine are disabled so they can’t make us sick. They’re more like Trojan horses.
Once inside our cells, they release the DNA instructions they carry to make the spike protein of the new coronavirus. Those cells then crank out copies of the spike protein, which then get displayed on the outer surface of the cell membrane where they are recognized by the immune system.
The immune system then makes antibodies and other defenses against the spike so that, when the real coronavirus comes along, our bodies are ready to fight the infection.
There’s no question the vaccine works. In clinical trials, the Johnson & Johnson vaccine was 66% percent effective at preventing against moderate to severe COVID-19 infection, and none of the patients who got COVID-19 after vaccination had to be admitted to the hospital or died.
The idea behind using adenoviruses in vaccines isn’t a new one. In a kind of fight-fire-with-fire approach, the idea is to use a virus, which is good at infecting us, to fight a different kind of virus.
Researchers have been working on the concept for about 10 years, but the COVID-19 vaccines that use this technology are some of the first adenovirus-vector vaccines deployed in humans.
Only one other adenovirus vaccine, for Ebola, has been approved for use in humans. It was approved in Europe last year. Before the Johnson & Johnson vaccine, no other adenovirus vector has been available for use in humans in the United States.
There are six adenovirus-vector vaccines for COVID-19. In addition to AstraZeneca and Johnson & Johnson, there’s the Russian-developed vaccine Sputnik V, along with CanSino from China, and the Covishield vaccine in India.
Adenovirus vaccines are more stable than the mRNA vaccines. That makes them easier to store and transport.
But they have a significant downside, too. Because adenoviruses infect humans out in the world, we already make antibodies against them. So there’s always a danger that our immune systems might recognize and react to the vaccine, rendering it ineffective. For that reason, scientists try to carefully select the adenovirus vectors, or carriers, they use.
The two vaccines under investigation for blood clots are slightly different. The Johnson & Johnson vaccine uses the vector AD26, because most of the population lacks preexisting immunity to it. Vaxzevria uses an adenovirus that infects chimpanzees, called ChAdOx1.
Vaxzevria has been widely used in Europe but has not yet been authorized in the United States.
On April 7, the European Medicines Agency, Europe’s counterpart to the FDA, ruled that unusual blood clots with low blood platelets should be listed as rare side effects on the Vaxzevria vaccine.
The decision came after reviewing 62 cases of cerebral venous sinus thrombosis (CVST) linked to the vaccine and 25 cases of another rare type of clot, called a splanchnic vein thrombosis. Splanchnic veins drain blood from the major organs in the digestive system, including the stomach, liver, and intestines; 18 of those events were fatal.
The reports were culled from reporting in Europe and the United Kingdom, where around 25 million people have received the Vaxzevria vaccine, making these clots exceptionally rare, but serious.
So far, six cases of CVST have been reported in the United States, after more than 7 million doses of the Johnson & Johnson vaccines have been administered.
A key question for U.S. regulators will be the background rate for these types of rare combinations of clots and deplenished platelets. The background rate is the number of events that would be expected to occur naturally in a population of unvaccinated people. On a press call on April 13, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, was asked about the frequency of this dangerous combination. He said the combination of low platelets and clots was so rare that it was hard to pinpoint, but might be somewhere between 2 and 14 cases per million people over the course of a year.
The first Johnson & Johnson doses were given in early March. That means the six cases came to light within the first few weeks of use of the vaccine in the United States, a very short amount of time.
“These were six cases per million people for 2 weeks, which is the same thing as 25 million per year, so it’s clearly above the background rate,” Dr. Offit said.
Studies suggest possible mechanism
On April 9, the New England Journal of Medicine published a detailed evaluation of the 11 patients in Germany and Austria who developed the rare clots after their Vaxzevria vaccines.
The study detected rare antibodies to a signaling protein called platelet factor 4, which helps to coordinate clot formation.
These same type of antibodies form in some people given the blood thinning drug heparin. In those reactions, which are also exceptionally rare, the same type of syndrome develops, leading to large, devastating clots that consume circulating platelets.
It’s not yet clear whether people who develop reactions to the vaccines already have some platelet factor 4 antibodies before they are vaccinated, or whether the vaccines somehow spur the body to make these antibodies, which then launch a kind of autoimmune attack.
The researchers on the paper gave the syndrome a name, vaccine-induced thrombotic thrombocytopenia (VITT).
It’s also not clear why more cases seem to be in women than in men. Andrew Eisenberger, MD, an associate professor of hematology and oncology at Columbia University, New York, said the most common causes of cerebral venous sinus thrombosis have to do with conditions that raise estrogen levels, like pregnancy and hormonal contraception.
“Estrogen naturally leads to changes in several clotting proteins in the blood that may predispose to abnormal blood clotting in a few different sites in the body,” he said. “The clotting changes we are encountering with some of COVID-19 vaccines are likely to be synergistic with the effects of estrogen on the blood.”
No matter the cause, the CDC on April 13 alerted doctors to keep a high index of suspicion for VITT in patients who have received the Johnson & Johnson vaccination within the last 2 weeks. In those patients, the usual course of treatment with blood thinning drugs like heparin may be harmful.
Symptoms to watch for include severe headache or backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, tiny red spots on the skin, or easy bruising.
Grappling with evidence
The CDC’s Advisory Committee on Immunization Practices will meet today in an emergency session to review the cases and see if any changes are needed to use of the J&J vaccine in the United States.
Last week, for example, the United Kingdom restricted the use of the AstraZeneca vaccine in people aged younger than 30 years, saying the risks and benefits of vaccination are “more finely balanced” for this age group.
With cases of COVID-19 rising again in the United States, and the Johnson & Johnson vaccine currently the most convenient form of protection against the virus, the committee will have to weigh the risks of that infection against the risk of rare clots caused by vaccination.
They will also likely have to rule out whether any of the cases had COVID. At least one study has reported CVST clots in three patients with confirmed COVID infections. In Europe, COVID infection did not seem to play a role in the formation of the clots with low platelets.
Hilda Bastian, PhD, a clinical trials expert who cofounded the Cochrane Collaboration, said it won’t be an easy task. Much will depend on how certain the committee members feel they know about all the events linked to the vaccine.
“That’s the really, really hard issue from my point of view for them right this moment. Have we missed any? Or how many are we likely to have missed?” asked Dr. Bastian, who lives in Australia.
“In a country that size with that fragmented [of] a health care system, how sure can you be that you know them all? That’s going to be a really difficult situation for them to grapple with, the quality of information that they’ve got,” she said.
A version of this article first appeared on Medscape.com.
Adjunctive MDMA safe, effective for severe PTSD
Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder, including those with the dissociative subtype, new research suggests.
MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.
MDMA was “extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment,” study coinvestigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress.
Growing interest
, particularly because failure rates with most available evidence-based treatments have been relatively high.
As previously reported by this news organization, in 2017, the U.S. Food and Drug Administration approved the trial design of Dr. van der Kolk’s and colleagues’ MAPP1 study after granting MDMA breakthrough designation.
The MAPP1 investigators assessed 90 patients with PTSD (mean age, 41 years; 77% White; 66% women) from 50 sites. For the majority of patients (84%), trauma history was developmental. “In other words, trauma [occurred] very early in life, usually at the hands of their own caregivers,” Dr. van der Kolk noted.
In addition, 18% of the patients were veterans, and 12% had combat exposure. The average duration of PTSD before enrollment was 18 years. All patients underwent screening and three preparatory psychotherapy sessions at enrollment.
Participants were randomly assigned to receive MDMA 80 mg or 120 mg (n = 46) or placebo (n = 44) followed by three integrative psychotherapy sessions lasting a total of 8 hours. A supplemental dose of 40 or 60 mg of MDMA could be administered from 1.5 to 2 hours after the first dose.
The patients stayed in the laboratory on the evening of the treatment session and attended a debriefing the next morning. The session was repeated a month later and again a month after that. In between, patients had telephone contact with the raters, who were blinded to the treatment received.
Follow-up assessments were conducted 2 months after the third treatment session and again at 12 months. The primary outcome measure was change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) score from baseline.
‘Dramatic improvement’
Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, “but MDMA had a dramatically significant improvement, with an effect size of over 0.9,” Dr. van der Kolk said.
The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.
Patients also reported having heightened openness, “and clearly the issue of empathy for themselves and others was a very large part of the process,” said Dr. van der Kolk.
“But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect,” he noted. In other words, “the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant.”
Dr. van der Kolk added that the dissociative subtype of PTSD was first described in the DSM-5 and that patients are “notoriously unresponsive to most unconventional treatments.”
In the current study, 13 patients met the criteria for the subtype, and investigators found they “did better than people with classical PTSD,” Dr. van der Kolk said. He added that this is a “very, very important finding.”
Carefully controlled
Overall, 82% of patients reported a significant improvement by the end of the study; 56% reported that they no longer had PTSD.
In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group.
Eleven patients (12%) experienced relapse by 12 months; in nine of the cases, this was due to the presence of additional stressors.
There were “very few adverse side effects” during the study, Dr. van der Kolk noted. In addition, “there were really no serious mental side effects,” despite the patients’ “opening up so much very painful material,” he added.
The most common adverse events among the MDMA group were muscle tightness (63%), decreased appetite (52%), nausea (30%), hyperhidrosis (20%), and feeling cold (20%). These effects were “quite small [and] the sort of side effects you would expect in response to an amphetamine substance like MDMA,” said Dr. van der Kolk.
“An important reason why we think the side effect profile is so good is because the study was extremely carefully done, very carefully controlled,” he added. “There was a great deal of support, [and] we paid an enormous amount of attention to creating a very safe context in which this drug was being used.”
However, he expressed concern that “as people see the very good results, they may skimp a little bit on the creation of the context and not have as careful a psychotherapy protocol as we had here.”
‘On the right track’
Commenting on the findings for this news organization, David Nutt, MD, PhD, Edmond J. Safra Professor of Neuropsychopharmacology, Imperial College London, said the results are proof that the investigators’ “earlier smaller trials of MDMA were on the right track.”
“This larger and multicenter trial shows that MDMA therapy can be broadened into newer research groups, which augurs well for the much larger rollout that will be required once it gets a license,” said Dr. Nutt, who was not involved with the research.
He added, “the prior evidence of the safety of MDMA has [now] been confirmed.”
The study represents an “important step in the path to the clinical use of MDMA for PTSD,” Dr. Nutt said.
The study was sponsored by the Multidisciplinary Association for Psychedelic Studies. The investigators and Dr. Nutt have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder, including those with the dissociative subtype, new research suggests.
MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.
MDMA was “extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment,” study coinvestigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress.
Growing interest
, particularly because failure rates with most available evidence-based treatments have been relatively high.
As previously reported by this news organization, in 2017, the U.S. Food and Drug Administration approved the trial design of Dr. van der Kolk’s and colleagues’ MAPP1 study after granting MDMA breakthrough designation.
The MAPP1 investigators assessed 90 patients with PTSD (mean age, 41 years; 77% White; 66% women) from 50 sites. For the majority of patients (84%), trauma history was developmental. “In other words, trauma [occurred] very early in life, usually at the hands of their own caregivers,” Dr. van der Kolk noted.
In addition, 18% of the patients were veterans, and 12% had combat exposure. The average duration of PTSD before enrollment was 18 years. All patients underwent screening and three preparatory psychotherapy sessions at enrollment.
Participants were randomly assigned to receive MDMA 80 mg or 120 mg (n = 46) or placebo (n = 44) followed by three integrative psychotherapy sessions lasting a total of 8 hours. A supplemental dose of 40 or 60 mg of MDMA could be administered from 1.5 to 2 hours after the first dose.
The patients stayed in the laboratory on the evening of the treatment session and attended a debriefing the next morning. The session was repeated a month later and again a month after that. In between, patients had telephone contact with the raters, who were blinded to the treatment received.
Follow-up assessments were conducted 2 months after the third treatment session and again at 12 months. The primary outcome measure was change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) score from baseline.
‘Dramatic improvement’
Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, “but MDMA had a dramatically significant improvement, with an effect size of over 0.9,” Dr. van der Kolk said.
The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.
Patients also reported having heightened openness, “and clearly the issue of empathy for themselves and others was a very large part of the process,” said Dr. van der Kolk.
“But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect,” he noted. In other words, “the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant.”
Dr. van der Kolk added that the dissociative subtype of PTSD was first described in the DSM-5 and that patients are “notoriously unresponsive to most unconventional treatments.”
In the current study, 13 patients met the criteria for the subtype, and investigators found they “did better than people with classical PTSD,” Dr. van der Kolk said. He added that this is a “very, very important finding.”
Carefully controlled
Overall, 82% of patients reported a significant improvement by the end of the study; 56% reported that they no longer had PTSD.
In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group.
Eleven patients (12%) experienced relapse by 12 months; in nine of the cases, this was due to the presence of additional stressors.
There were “very few adverse side effects” during the study, Dr. van der Kolk noted. In addition, “there were really no serious mental side effects,” despite the patients’ “opening up so much very painful material,” he added.
The most common adverse events among the MDMA group were muscle tightness (63%), decreased appetite (52%), nausea (30%), hyperhidrosis (20%), and feeling cold (20%). These effects were “quite small [and] the sort of side effects you would expect in response to an amphetamine substance like MDMA,” said Dr. van der Kolk.
“An important reason why we think the side effect profile is so good is because the study was extremely carefully done, very carefully controlled,” he added. “There was a great deal of support, [and] we paid an enormous amount of attention to creating a very safe context in which this drug was being used.”
However, he expressed concern that “as people see the very good results, they may skimp a little bit on the creation of the context and not have as careful a psychotherapy protocol as we had here.”
‘On the right track’
Commenting on the findings for this news organization, David Nutt, MD, PhD, Edmond J. Safra Professor of Neuropsychopharmacology, Imperial College London, said the results are proof that the investigators’ “earlier smaller trials of MDMA were on the right track.”
“This larger and multicenter trial shows that MDMA therapy can be broadened into newer research groups, which augurs well for the much larger rollout that will be required once it gets a license,” said Dr. Nutt, who was not involved with the research.
He added, “the prior evidence of the safety of MDMA has [now] been confirmed.”
The study represents an “important step in the path to the clinical use of MDMA for PTSD,” Dr. Nutt said.
The study was sponsored by the Multidisciplinary Association for Psychedelic Studies. The investigators and Dr. Nutt have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder, including those with the dissociative subtype, new research suggests.
MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.
MDMA was “extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment,” study coinvestigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress.
Growing interest
, particularly because failure rates with most available evidence-based treatments have been relatively high.
As previously reported by this news organization, in 2017, the U.S. Food and Drug Administration approved the trial design of Dr. van der Kolk’s and colleagues’ MAPP1 study after granting MDMA breakthrough designation.
The MAPP1 investigators assessed 90 patients with PTSD (mean age, 41 years; 77% White; 66% women) from 50 sites. For the majority of patients (84%), trauma history was developmental. “In other words, trauma [occurred] very early in life, usually at the hands of their own caregivers,” Dr. van der Kolk noted.
In addition, 18% of the patients were veterans, and 12% had combat exposure. The average duration of PTSD before enrollment was 18 years. All patients underwent screening and three preparatory psychotherapy sessions at enrollment.
Participants were randomly assigned to receive MDMA 80 mg or 120 mg (n = 46) or placebo (n = 44) followed by three integrative psychotherapy sessions lasting a total of 8 hours. A supplemental dose of 40 or 60 mg of MDMA could be administered from 1.5 to 2 hours after the first dose.
The patients stayed in the laboratory on the evening of the treatment session and attended a debriefing the next morning. The session was repeated a month later and again a month after that. In between, patients had telephone contact with the raters, who were blinded to the treatment received.
Follow-up assessments were conducted 2 months after the third treatment session and again at 12 months. The primary outcome measure was change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) score from baseline.
‘Dramatic improvement’
Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, “but MDMA had a dramatically significant improvement, with an effect size of over 0.9,” Dr. van der Kolk said.
The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.
Patients also reported having heightened openness, “and clearly the issue of empathy for themselves and others was a very large part of the process,” said Dr. van der Kolk.
“But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect,” he noted. In other words, “the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant.”
Dr. van der Kolk added that the dissociative subtype of PTSD was first described in the DSM-5 and that patients are “notoriously unresponsive to most unconventional treatments.”
In the current study, 13 patients met the criteria for the subtype, and investigators found they “did better than people with classical PTSD,” Dr. van der Kolk said. He added that this is a “very, very important finding.”
Carefully controlled
Overall, 82% of patients reported a significant improvement by the end of the study; 56% reported that they no longer had PTSD.
In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group.
Eleven patients (12%) experienced relapse by 12 months; in nine of the cases, this was due to the presence of additional stressors.
There were “very few adverse side effects” during the study, Dr. van der Kolk noted. In addition, “there were really no serious mental side effects,” despite the patients’ “opening up so much very painful material,” he added.
The most common adverse events among the MDMA group were muscle tightness (63%), decreased appetite (52%), nausea (30%), hyperhidrosis (20%), and feeling cold (20%). These effects were “quite small [and] the sort of side effects you would expect in response to an amphetamine substance like MDMA,” said Dr. van der Kolk.
“An important reason why we think the side effect profile is so good is because the study was extremely carefully done, very carefully controlled,” he added. “There was a great deal of support, [and] we paid an enormous amount of attention to creating a very safe context in which this drug was being used.”
However, he expressed concern that “as people see the very good results, they may skimp a little bit on the creation of the context and not have as careful a psychotherapy protocol as we had here.”
‘On the right track’
Commenting on the findings for this news organization, David Nutt, MD, PhD, Edmond J. Safra Professor of Neuropsychopharmacology, Imperial College London, said the results are proof that the investigators’ “earlier smaller trials of MDMA were on the right track.”
“This larger and multicenter trial shows that MDMA therapy can be broadened into newer research groups, which augurs well for the much larger rollout that will be required once it gets a license,” said Dr. Nutt, who was not involved with the research.
He added, “the prior evidence of the safety of MDMA has [now] been confirmed.”
The study represents an “important step in the path to the clinical use of MDMA for PTSD,” Dr. Nutt said.
The study was sponsored by the Multidisciplinary Association for Psychedelic Studies. The investigators and Dr. Nutt have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
How to counsel worried patients about the J&J vaccine news
On April 13, the Centers for Disease Control and Prevention and the Food and Drug Administration issued a joint statement recommending a pause in Johnson & Johnson vaccine administration, pending review of six reported U.S. cases of a rare and severe type of blood clot occurring after receiving the Johnson & Johnson vaccine. To date, more than 6.8 million doses of that vaccine have been given in the United States, so at this point the rate of detected cases of this problem is less than one in a million.
The six cases occurred in women aged 18-48 years, and symptoms occurred 6-13 days after vaccination. In these cases, cerebral venous sinus thrombosis was seen in addition to thrombocytopenia.
Physicians may receive calls from concerned patients who have received a COVID vaccine. However, more than 95% of the vaccine administrations in the United States to date have been the Pfizer and Moderna messenger RNA vaccines. No association between these vaccines and blood clots has been detected. Also, these six cases occurred within 2 weeks of Johnson & Johnson vaccination, so even among those receiving the Johnson & Johnson vaccine, those who are more than 3 weeks out from their vaccination have no need for concern regarding this rare complication.
Physicians should counsel those who have received the Johnson & Johnson vaccine less than 3 weeks ago to watch for easy bruising, gum bleeding, nose bleeds, leg or arm pain or swelling, severe headache or abdominal pain, shortness of breath, or chest pain. If they notice one or more of those symptoms, they should seek medical attention.
The Centers for Disease Control and Prevention will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to review the six U.S. cases of the Johnson & Johnson vaccine and determine their significance.
Several cases of unusual thromboses and thrombocytopenia have been detected after the Oxford AstraZeneca vaccine, which uses the same adenovirus vector technology as the Johnson & Johnson vaccine, but which is not authorized for use in the United States. The Oxford AstraZeneca vaccine uses a recombinant deficient chimpanzee adenovirus to deliver the message to cells to produce antibody against the SARS-CoV-2 spike protein. The Johnson & Johnson vaccine uses a recombinant deficient human adenovirus to deliver this same message.
Two recent reports in the New England Journal of Medicine have reported on thrombosis and thrombocytopenia after the Oxford AstraZeneca vaccine in Europe. Both of these reports identified high levels of IgG antibodies to platelet factor 4–polyanion complexes, similar to the mechanism of heparin-induced thrombocytopenia. The term vaccine-induced immune thrombocytopenia was proposed for this phenomenon. Treatment of this condition involves administration of intravenous immunoglobulin and nonheparin anticoagulants. Recent updates from the World Health Organization report that 169 cases of cerebral venous sinus thrombosis and 53 of splanchnic venous thrombosis occurred after 34 million doses of the Oxford AstraZeneca vaccine was administered in the European Union and United Kingdom.
While this pause in Johnson & Johnson vaccination is disappointing news amid increased cases in parts of the country, the Johnson & Johnson vaccines make up less than 5% of the U.S. vaccine doses administered to date. According to the CDC, more than 122 million Americans have received at least one dose and more than 75 million are fully vaccinated.
Dr. Patterson has received an honorarium from Pfizer for an antifungal symposium and is a subinvestigator for the Novavax vaccine. Her spouse served as a consultant for SCYNEXIS, as a speaker for Gilead Sciences and Basilea, and has received a research grant from the National Institutes of Health for the ACTT remdesivir trial.
A version of this article first appeared on Medscape.com.
On April 13, the Centers for Disease Control and Prevention and the Food and Drug Administration issued a joint statement recommending a pause in Johnson & Johnson vaccine administration, pending review of six reported U.S. cases of a rare and severe type of blood clot occurring after receiving the Johnson & Johnson vaccine. To date, more than 6.8 million doses of that vaccine have been given in the United States, so at this point the rate of detected cases of this problem is less than one in a million.
The six cases occurred in women aged 18-48 years, and symptoms occurred 6-13 days after vaccination. In these cases, cerebral venous sinus thrombosis was seen in addition to thrombocytopenia.
Physicians may receive calls from concerned patients who have received a COVID vaccine. However, more than 95% of the vaccine administrations in the United States to date have been the Pfizer and Moderna messenger RNA vaccines. No association between these vaccines and blood clots has been detected. Also, these six cases occurred within 2 weeks of Johnson & Johnson vaccination, so even among those receiving the Johnson & Johnson vaccine, those who are more than 3 weeks out from their vaccination have no need for concern regarding this rare complication.
Physicians should counsel those who have received the Johnson & Johnson vaccine less than 3 weeks ago to watch for easy bruising, gum bleeding, nose bleeds, leg or arm pain or swelling, severe headache or abdominal pain, shortness of breath, or chest pain. If they notice one or more of those symptoms, they should seek medical attention.
The Centers for Disease Control and Prevention will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to review the six U.S. cases of the Johnson & Johnson vaccine and determine their significance.
Several cases of unusual thromboses and thrombocytopenia have been detected after the Oxford AstraZeneca vaccine, which uses the same adenovirus vector technology as the Johnson & Johnson vaccine, but which is not authorized for use in the United States. The Oxford AstraZeneca vaccine uses a recombinant deficient chimpanzee adenovirus to deliver the message to cells to produce antibody against the SARS-CoV-2 spike protein. The Johnson & Johnson vaccine uses a recombinant deficient human adenovirus to deliver this same message.
Two recent reports in the New England Journal of Medicine have reported on thrombosis and thrombocytopenia after the Oxford AstraZeneca vaccine in Europe. Both of these reports identified high levels of IgG antibodies to platelet factor 4–polyanion complexes, similar to the mechanism of heparin-induced thrombocytopenia. The term vaccine-induced immune thrombocytopenia was proposed for this phenomenon. Treatment of this condition involves administration of intravenous immunoglobulin and nonheparin anticoagulants. Recent updates from the World Health Organization report that 169 cases of cerebral venous sinus thrombosis and 53 of splanchnic venous thrombosis occurred after 34 million doses of the Oxford AstraZeneca vaccine was administered in the European Union and United Kingdom.
While this pause in Johnson & Johnson vaccination is disappointing news amid increased cases in parts of the country, the Johnson & Johnson vaccines make up less than 5% of the U.S. vaccine doses administered to date. According to the CDC, more than 122 million Americans have received at least one dose and more than 75 million are fully vaccinated.
Dr. Patterson has received an honorarium from Pfizer for an antifungal symposium and is a subinvestigator for the Novavax vaccine. Her spouse served as a consultant for SCYNEXIS, as a speaker for Gilead Sciences and Basilea, and has received a research grant from the National Institutes of Health for the ACTT remdesivir trial.
A version of this article first appeared on Medscape.com.
On April 13, the Centers for Disease Control and Prevention and the Food and Drug Administration issued a joint statement recommending a pause in Johnson & Johnson vaccine administration, pending review of six reported U.S. cases of a rare and severe type of blood clot occurring after receiving the Johnson & Johnson vaccine. To date, more than 6.8 million doses of that vaccine have been given in the United States, so at this point the rate of detected cases of this problem is less than one in a million.
The six cases occurred in women aged 18-48 years, and symptoms occurred 6-13 days after vaccination. In these cases, cerebral venous sinus thrombosis was seen in addition to thrombocytopenia.
Physicians may receive calls from concerned patients who have received a COVID vaccine. However, more than 95% of the vaccine administrations in the United States to date have been the Pfizer and Moderna messenger RNA vaccines. No association between these vaccines and blood clots has been detected. Also, these six cases occurred within 2 weeks of Johnson & Johnson vaccination, so even among those receiving the Johnson & Johnson vaccine, those who are more than 3 weeks out from their vaccination have no need for concern regarding this rare complication.
Physicians should counsel those who have received the Johnson & Johnson vaccine less than 3 weeks ago to watch for easy bruising, gum bleeding, nose bleeds, leg or arm pain or swelling, severe headache or abdominal pain, shortness of breath, or chest pain. If they notice one or more of those symptoms, they should seek medical attention.
The Centers for Disease Control and Prevention will convene a meeting of the Advisory Committee on Immunization Practices on April 14 to review the six U.S. cases of the Johnson & Johnson vaccine and determine their significance.
Several cases of unusual thromboses and thrombocytopenia have been detected after the Oxford AstraZeneca vaccine, which uses the same adenovirus vector technology as the Johnson & Johnson vaccine, but which is not authorized for use in the United States. The Oxford AstraZeneca vaccine uses a recombinant deficient chimpanzee adenovirus to deliver the message to cells to produce antibody against the SARS-CoV-2 spike protein. The Johnson & Johnson vaccine uses a recombinant deficient human adenovirus to deliver this same message.
Two recent reports in the New England Journal of Medicine have reported on thrombosis and thrombocytopenia after the Oxford AstraZeneca vaccine in Europe. Both of these reports identified high levels of IgG antibodies to platelet factor 4–polyanion complexes, similar to the mechanism of heparin-induced thrombocytopenia. The term vaccine-induced immune thrombocytopenia was proposed for this phenomenon. Treatment of this condition involves administration of intravenous immunoglobulin and nonheparin anticoagulants. Recent updates from the World Health Organization report that 169 cases of cerebral venous sinus thrombosis and 53 of splanchnic venous thrombosis occurred after 34 million doses of the Oxford AstraZeneca vaccine was administered in the European Union and United Kingdom.
While this pause in Johnson & Johnson vaccination is disappointing news amid increased cases in parts of the country, the Johnson & Johnson vaccines make up less than 5% of the U.S. vaccine doses administered to date. According to the CDC, more than 122 million Americans have received at least one dose and more than 75 million are fully vaccinated.
Dr. Patterson has received an honorarium from Pfizer for an antifungal symposium and is a subinvestigator for the Novavax vaccine. Her spouse served as a consultant for SCYNEXIS, as a speaker for Gilead Sciences and Basilea, and has received a research grant from the National Institutes of Health for the ACTT remdesivir trial.
A version of this article first appeared on Medscape.com.