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One-third of health care workers leery of getting COVID-19 vaccine, survey shows
Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.
The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.
“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”
For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.
Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.
Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.
Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).
The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).
“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
A focus on rebuilding trust
Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).
“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”
The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).
“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”
Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
Addressing vaccine hesitancy
Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.
In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.
Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”
The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.
A version of this article first appeared on Medscape.com.
Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.
The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.
“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”
For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.
Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.
Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.
Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).
The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).
“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
A focus on rebuilding trust
Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).
“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”
The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).
“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”
Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
Addressing vaccine hesitancy
Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.
In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.
Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”
The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.
A version of this article first appeared on Medscape.com.
Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.
The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.
“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”
For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.
Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.
Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.
Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).
The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).
“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
A focus on rebuilding trust
Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).
“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”
The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).
“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”
Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
Addressing vaccine hesitancy
Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.
In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.
Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”
The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.
A version of this article first appeared on Medscape.com.
The importance of family acceptance for LGBTQ youth
It is well established that LGBTQ individuals experience more health disparities compared with their cisgender, heterosexual counterparts. In general, LGBTQ adolescents and young adults have higher levels of depression, suicide attempts, and substance use than those of their heterosexual peers. However, a key protective factor is family acceptance and support. By encouraging families to modify and change behaviors that are experienced by their LGBTQ children as rejecting and to engage in supportive and affirming behaviors, providers can help families to decrease risk and promote healthy outcomes for LGBTQ youth and young adults.
We all know that a supportive family can make a difference for any child, but this is especially true for LGBTQ youth and is critical during a pandemic when young people are confined with families and separated from peers and supportive adults outside the home. Several research studies show that family support can improve outcomes related to suicide, depression, homelessness, drug use, and HIV in LGBTQ young people. Family acceptance improves health outcomes, while rejection undermines family relationships and worsens both health and other serious outcomes such as homelessness and placement in custodial care. Pediatricians can help their patients by educating parents and caregivers with LGBTQ children about the critical role of family support – both those who see themselves as accepting and those who believe that being gay or transgender is wrong and are struggling with parenting a child who identifies as LGBTQ or who is gender diverse.
The Family Acceptance Project (FAP) at San Francisco State University conducted the first research on LGBTQ youth and families, developed the first evidence-informed family support model, and has published a range of studies and evidence-based resources that demonstrate the harm caused by family rejection, validate the importance of family acceptance, and provide guidance to increase family support. FAP’s research found that parents and caregivers that engage in rejecting behaviors are typically motivated by care and concern and by trying to protect their children from harm. They believe such behaviors will help their LGBTQ children fit in, have a good life, meet cultural and religious expectations, and be respected by others.1 FAP’s research identified and measured more than 50 rejecting behaviors that parents and caregivers use to respond to their LGBTQ children. Some of these commonly expressed rejecting behaviors include ridiculing and making disparaging comments about their child and other LGBTQ people; excluding them from family activities; blaming their child when others mistreat them because they are LGBTQ; blocking access to LGBTQ resources including friends, support groups, and activities; and trying to change their child’s sexual orientation and gender identity.2 LGBTQ youth experience these and other such behaviors as hurtful, harmful, and traumatic and may feel that they need to hide or repress their identity which can affect their self-esteem, increase isolation, depression, and risky behaviors.3 Providers working with families of LGBTQ youth should focus on shared goals, such as reducing risk and having a happy, healthy child. Most parents love their children and fear for their well-being. However, many are uninformed about their child’s gender identity and sexual orientation and don’t know how to nurture and support them.
In FAP’s initial study, LGB young people who reported higher levels of family rejection had substantially higher rates of attempted suicide, depression, illegal drug use, and unprotected sex.4 These rates were even more significant among Latino gay and bisexual men.4 Those who are rejected by family are less likely to want to have a family or to be parents themselves5 and have lower educational and income levels.6
To reduce risk, pediatricians should ask LGBTQ patients about family rejecting behaviors and help parents and caregivers to identify and understand the effect of such behaviors to reduce health risks and conflict that can lead to running away, expulsion, and removal from the home. Even decreasing rejecting behaviors to moderate levels can significantly improve negative outcomes.5
Caitlin Ryan, PhD, and her team also identified and measured more than 50 family accepting behaviors that help protect against risk and promote well-being. They found that young adults who experience high levels of family acceptance during adolescence report significantly higher levels of self-esteem, social support, and general health with much lower levels of depression, suicidality, and substance abuse.7 Family accepting and supportive behaviors include talking with the child about their LGBTQ identity; advocating for their LGBTQ child when others mistreat them; requiring other family members to treat their LGBTQ child with respect; and supporting their child’s gender identity.5 FAP has developed an evidence-informed family support model and multilingual educational resources for families, providers, youth and religious leaders to decrease rejection and increase family support. These are available in print copies and for download at familyproject.sfsu.edu.
In addition, Dr. Ryan and colleagues1,4,8 recommend the following guidance for providers:
- Ask LGBTQ adolescents about family reactions to their sexual orientation, gender identity, and expression, and refer to LGBTQ community support programs and for supportive counseling, as needed.
- Identify LGBTQ community support programs and online resources to educate parents about how to help their children. Parents need culturally relevant peer support to help decrease rejection and increase family support.
- Advise parents that negative reactions to their adolescent’s LGBTQ identity may negatively impact their child’s health and mental health while supportive and affirming reactions promote well-being.
- Advise parents and caregivers to modify and change family rejecting behaviors that increase their child’s risk for suicide, depression, substance abuse ,and risky sexual behaviors.
- Expand anticipatory guidance to include information on the need for support and the link between family rejection and negative health problems.
- Provide guidance on sexual orientation and gender identity as part of normative child development during well-baby and early childhood care.
- Use FAP’s multilingual family education booklets and Healthy Futures poster series in family and patient education and provide these materials in clinical and community settings. FAP’s Healthy Futures posters include a poster guidance, a version on family acceptance, a version on family rejection and a family acceptance version for conservative families and settings. They are available in camera-ready art in four sizes in English and Spanish and are forthcoming in five Asian languages: familyproject.sfsu.edu/poster.
Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.
Resources
• Family Acceptance Project – consultation and training; evidence-based educational materials for families, providers, religious leaders and youth.
• PFLAG – peer support for parents and friends with LGBTQ children in all states and several other countries.
References
1. Ryan C. Generating a revolution in prevention, wellness & care for LGBT children & youth. Temple Political & Civil Rights Law Review. 2014;23(2):331-44.
2. Ryan C. Healthy Futures Poster Series – Family Accepting & Rejecting Behaviors That Impact LGBTQ Children’s Health & Well-Being. In: Family Acceptance Project Marian Wright Edelman Institute SFSU, ed. San Francisco, CA2019.
3. Ryan C. Family Acceptance Project: Culturally grounded framework for supporting LGBTQ children and youth. J Am Acad Child Adolesc Psychiatr. 2019;58(10):S58-9.
4. Ryan C et al. Family rejection as a predictor of negative health outcomes in White and Latino lesbian, gay, and bisexual young adults. Pediatrics. 2009;123(1):346-52.
5. Ryan C. Supportive families, healthy children: Helping families with lesbian, gay, bisexual & transgender children. In: Family Acceptance Project Marian Wright Edelman Institute SFSU, ed. San Francisco, CA2009.
6. Ryan C et al. Parent-initiated sexual orientation change efforts with LGBT adolescents: Implications for young adult mental health and adjustment. J Homosexuality. 2020;67(2):159-73.
7. Ryan C et al. Family acceptance in adolescence and the health of LGBT young adults. J Child Adolesc Psychiatr Nursing. 2010;23(4):205-13. 8. Substance Abuse and Mental Health Services Administration. A Practitioner’s Guide: Helping Families to Support Their LGBT Children. In: Administration SAaMhS, ed. Vol PEP14-LGBTKIDS. Rockville, MD: HHS Publication; 2014.
It is well established that LGBTQ individuals experience more health disparities compared with their cisgender, heterosexual counterparts. In general, LGBTQ adolescents and young adults have higher levels of depression, suicide attempts, and substance use than those of their heterosexual peers. However, a key protective factor is family acceptance and support. By encouraging families to modify and change behaviors that are experienced by their LGBTQ children as rejecting and to engage in supportive and affirming behaviors, providers can help families to decrease risk and promote healthy outcomes for LGBTQ youth and young adults.
We all know that a supportive family can make a difference for any child, but this is especially true for LGBTQ youth and is critical during a pandemic when young people are confined with families and separated from peers and supportive adults outside the home. Several research studies show that family support can improve outcomes related to suicide, depression, homelessness, drug use, and HIV in LGBTQ young people. Family acceptance improves health outcomes, while rejection undermines family relationships and worsens both health and other serious outcomes such as homelessness and placement in custodial care. Pediatricians can help their patients by educating parents and caregivers with LGBTQ children about the critical role of family support – both those who see themselves as accepting and those who believe that being gay or transgender is wrong and are struggling with parenting a child who identifies as LGBTQ or who is gender diverse.
The Family Acceptance Project (FAP) at San Francisco State University conducted the first research on LGBTQ youth and families, developed the first evidence-informed family support model, and has published a range of studies and evidence-based resources that demonstrate the harm caused by family rejection, validate the importance of family acceptance, and provide guidance to increase family support. FAP’s research found that parents and caregivers that engage in rejecting behaviors are typically motivated by care and concern and by trying to protect their children from harm. They believe such behaviors will help their LGBTQ children fit in, have a good life, meet cultural and religious expectations, and be respected by others.1 FAP’s research identified and measured more than 50 rejecting behaviors that parents and caregivers use to respond to their LGBTQ children. Some of these commonly expressed rejecting behaviors include ridiculing and making disparaging comments about their child and other LGBTQ people; excluding them from family activities; blaming their child when others mistreat them because they are LGBTQ; blocking access to LGBTQ resources including friends, support groups, and activities; and trying to change their child’s sexual orientation and gender identity.2 LGBTQ youth experience these and other such behaviors as hurtful, harmful, and traumatic and may feel that they need to hide or repress their identity which can affect their self-esteem, increase isolation, depression, and risky behaviors.3 Providers working with families of LGBTQ youth should focus on shared goals, such as reducing risk and having a happy, healthy child. Most parents love their children and fear for their well-being. However, many are uninformed about their child’s gender identity and sexual orientation and don’t know how to nurture and support them.
In FAP’s initial study, LGB young people who reported higher levels of family rejection had substantially higher rates of attempted suicide, depression, illegal drug use, and unprotected sex.4 These rates were even more significant among Latino gay and bisexual men.4 Those who are rejected by family are less likely to want to have a family or to be parents themselves5 and have lower educational and income levels.6
To reduce risk, pediatricians should ask LGBTQ patients about family rejecting behaviors and help parents and caregivers to identify and understand the effect of such behaviors to reduce health risks and conflict that can lead to running away, expulsion, and removal from the home. Even decreasing rejecting behaviors to moderate levels can significantly improve negative outcomes.5
Caitlin Ryan, PhD, and her team also identified and measured more than 50 family accepting behaviors that help protect against risk and promote well-being. They found that young adults who experience high levels of family acceptance during adolescence report significantly higher levels of self-esteem, social support, and general health with much lower levels of depression, suicidality, and substance abuse.7 Family accepting and supportive behaviors include talking with the child about their LGBTQ identity; advocating for their LGBTQ child when others mistreat them; requiring other family members to treat their LGBTQ child with respect; and supporting their child’s gender identity.5 FAP has developed an evidence-informed family support model and multilingual educational resources for families, providers, youth and religious leaders to decrease rejection and increase family support. These are available in print copies and for download at familyproject.sfsu.edu.
In addition, Dr. Ryan and colleagues1,4,8 recommend the following guidance for providers:
- Ask LGBTQ adolescents about family reactions to their sexual orientation, gender identity, and expression, and refer to LGBTQ community support programs and for supportive counseling, as needed.
- Identify LGBTQ community support programs and online resources to educate parents about how to help their children. Parents need culturally relevant peer support to help decrease rejection and increase family support.
- Advise parents that negative reactions to their adolescent’s LGBTQ identity may negatively impact their child’s health and mental health while supportive and affirming reactions promote well-being.
- Advise parents and caregivers to modify and change family rejecting behaviors that increase their child’s risk for suicide, depression, substance abuse ,and risky sexual behaviors.
- Expand anticipatory guidance to include information on the need for support and the link between family rejection and negative health problems.
- Provide guidance on sexual orientation and gender identity as part of normative child development during well-baby and early childhood care.
- Use FAP’s multilingual family education booklets and Healthy Futures poster series in family and patient education and provide these materials in clinical and community settings. FAP’s Healthy Futures posters include a poster guidance, a version on family acceptance, a version on family rejection and a family acceptance version for conservative families and settings. They are available in camera-ready art in four sizes in English and Spanish and are forthcoming in five Asian languages: familyproject.sfsu.edu/poster.
Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.
Resources
• Family Acceptance Project – consultation and training; evidence-based educational materials for families, providers, religious leaders and youth.
• PFLAG – peer support for parents and friends with LGBTQ children in all states and several other countries.
References
1. Ryan C. Generating a revolution in prevention, wellness & care for LGBT children & youth. Temple Political & Civil Rights Law Review. 2014;23(2):331-44.
2. Ryan C. Healthy Futures Poster Series – Family Accepting & Rejecting Behaviors That Impact LGBTQ Children’s Health & Well-Being. In: Family Acceptance Project Marian Wright Edelman Institute SFSU, ed. San Francisco, CA2019.
3. Ryan C. Family Acceptance Project: Culturally grounded framework for supporting LGBTQ children and youth. J Am Acad Child Adolesc Psychiatr. 2019;58(10):S58-9.
4. Ryan C et al. Family rejection as a predictor of negative health outcomes in White and Latino lesbian, gay, and bisexual young adults. Pediatrics. 2009;123(1):346-52.
5. Ryan C. Supportive families, healthy children: Helping families with lesbian, gay, bisexual & transgender children. In: Family Acceptance Project Marian Wright Edelman Institute SFSU, ed. San Francisco, CA2009.
6. Ryan C et al. Parent-initiated sexual orientation change efforts with LGBT adolescents: Implications for young adult mental health and adjustment. J Homosexuality. 2020;67(2):159-73.
7. Ryan C et al. Family acceptance in adolescence and the health of LGBT young adults. J Child Adolesc Psychiatr Nursing. 2010;23(4):205-13. 8. Substance Abuse and Mental Health Services Administration. A Practitioner’s Guide: Helping Families to Support Their LGBT Children. In: Administration SAaMhS, ed. Vol PEP14-LGBTKIDS. Rockville, MD: HHS Publication; 2014.
It is well established that LGBTQ individuals experience more health disparities compared with their cisgender, heterosexual counterparts. In general, LGBTQ adolescents and young adults have higher levels of depression, suicide attempts, and substance use than those of their heterosexual peers. However, a key protective factor is family acceptance and support. By encouraging families to modify and change behaviors that are experienced by their LGBTQ children as rejecting and to engage in supportive and affirming behaviors, providers can help families to decrease risk and promote healthy outcomes for LGBTQ youth and young adults.
We all know that a supportive family can make a difference for any child, but this is especially true for LGBTQ youth and is critical during a pandemic when young people are confined with families and separated from peers and supportive adults outside the home. Several research studies show that family support can improve outcomes related to suicide, depression, homelessness, drug use, and HIV in LGBTQ young people. Family acceptance improves health outcomes, while rejection undermines family relationships and worsens both health and other serious outcomes such as homelessness and placement in custodial care. Pediatricians can help their patients by educating parents and caregivers with LGBTQ children about the critical role of family support – both those who see themselves as accepting and those who believe that being gay or transgender is wrong and are struggling with parenting a child who identifies as LGBTQ or who is gender diverse.
The Family Acceptance Project (FAP) at San Francisco State University conducted the first research on LGBTQ youth and families, developed the first evidence-informed family support model, and has published a range of studies and evidence-based resources that demonstrate the harm caused by family rejection, validate the importance of family acceptance, and provide guidance to increase family support. FAP’s research found that parents and caregivers that engage in rejecting behaviors are typically motivated by care and concern and by trying to protect their children from harm. They believe such behaviors will help their LGBTQ children fit in, have a good life, meet cultural and religious expectations, and be respected by others.1 FAP’s research identified and measured more than 50 rejecting behaviors that parents and caregivers use to respond to their LGBTQ children. Some of these commonly expressed rejecting behaviors include ridiculing and making disparaging comments about their child and other LGBTQ people; excluding them from family activities; blaming their child when others mistreat them because they are LGBTQ; blocking access to LGBTQ resources including friends, support groups, and activities; and trying to change their child’s sexual orientation and gender identity.2 LGBTQ youth experience these and other such behaviors as hurtful, harmful, and traumatic and may feel that they need to hide or repress their identity which can affect their self-esteem, increase isolation, depression, and risky behaviors.3 Providers working with families of LGBTQ youth should focus on shared goals, such as reducing risk and having a happy, healthy child. Most parents love their children and fear for their well-being. However, many are uninformed about their child’s gender identity and sexual orientation and don’t know how to nurture and support them.
In FAP’s initial study, LGB young people who reported higher levels of family rejection had substantially higher rates of attempted suicide, depression, illegal drug use, and unprotected sex.4 These rates were even more significant among Latino gay and bisexual men.4 Those who are rejected by family are less likely to want to have a family or to be parents themselves5 and have lower educational and income levels.6
To reduce risk, pediatricians should ask LGBTQ patients about family rejecting behaviors and help parents and caregivers to identify and understand the effect of such behaviors to reduce health risks and conflict that can lead to running away, expulsion, and removal from the home. Even decreasing rejecting behaviors to moderate levels can significantly improve negative outcomes.5
Caitlin Ryan, PhD, and her team also identified and measured more than 50 family accepting behaviors that help protect against risk and promote well-being. They found that young adults who experience high levels of family acceptance during adolescence report significantly higher levels of self-esteem, social support, and general health with much lower levels of depression, suicidality, and substance abuse.7 Family accepting and supportive behaviors include talking with the child about their LGBTQ identity; advocating for their LGBTQ child when others mistreat them; requiring other family members to treat their LGBTQ child with respect; and supporting their child’s gender identity.5 FAP has developed an evidence-informed family support model and multilingual educational resources for families, providers, youth and religious leaders to decrease rejection and increase family support. These are available in print copies and for download at familyproject.sfsu.edu.
In addition, Dr. Ryan and colleagues1,4,8 recommend the following guidance for providers:
- Ask LGBTQ adolescents about family reactions to their sexual orientation, gender identity, and expression, and refer to LGBTQ community support programs and for supportive counseling, as needed.
- Identify LGBTQ community support programs and online resources to educate parents about how to help their children. Parents need culturally relevant peer support to help decrease rejection and increase family support.
- Advise parents that negative reactions to their adolescent’s LGBTQ identity may negatively impact their child’s health and mental health while supportive and affirming reactions promote well-being.
- Advise parents and caregivers to modify and change family rejecting behaviors that increase their child’s risk for suicide, depression, substance abuse ,and risky sexual behaviors.
- Expand anticipatory guidance to include information on the need for support and the link between family rejection and negative health problems.
- Provide guidance on sexual orientation and gender identity as part of normative child development during well-baby and early childhood care.
- Use FAP’s multilingual family education booklets and Healthy Futures poster series in family and patient education and provide these materials in clinical and community settings. FAP’s Healthy Futures posters include a poster guidance, a version on family acceptance, a version on family rejection and a family acceptance version for conservative families and settings. They are available in camera-ready art in four sizes in English and Spanish and are forthcoming in five Asian languages: familyproject.sfsu.edu/poster.
Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.
Resources
• Family Acceptance Project – consultation and training; evidence-based educational materials for families, providers, religious leaders and youth.
• PFLAG – peer support for parents and friends with LGBTQ children in all states and several other countries.
References
1. Ryan C. Generating a revolution in prevention, wellness & care for LGBT children & youth. Temple Political & Civil Rights Law Review. 2014;23(2):331-44.
2. Ryan C. Healthy Futures Poster Series – Family Accepting & Rejecting Behaviors That Impact LGBTQ Children’s Health & Well-Being. In: Family Acceptance Project Marian Wright Edelman Institute SFSU, ed. San Francisco, CA2019.
3. Ryan C. Family Acceptance Project: Culturally grounded framework for supporting LGBTQ children and youth. J Am Acad Child Adolesc Psychiatr. 2019;58(10):S58-9.
4. Ryan C et al. Family rejection as a predictor of negative health outcomes in White and Latino lesbian, gay, and bisexual young adults. Pediatrics. 2009;123(1):346-52.
5. Ryan C. Supportive families, healthy children: Helping families with lesbian, gay, bisexual & transgender children. In: Family Acceptance Project Marian Wright Edelman Institute SFSU, ed. San Francisco, CA2009.
6. Ryan C et al. Parent-initiated sexual orientation change efforts with LGBT adolescents: Implications for young adult mental health and adjustment. J Homosexuality. 2020;67(2):159-73.
7. Ryan C et al. Family acceptance in adolescence and the health of LGBT young adults. J Child Adolesc Psychiatr Nursing. 2010;23(4):205-13. 8. Substance Abuse and Mental Health Services Administration. A Practitioner’s Guide: Helping Families to Support Their LGBT Children. In: Administration SAaMhS, ed. Vol PEP14-LGBTKIDS. Rockville, MD: HHS Publication; 2014.
Child ‘Mis’behavior – What’s ‘mis’ing?
“What kind of parent are you? Why don’t you straighten him out!” rants the woman being jostled in the grocery store by your patient. “Easy for you to say,” thinks your patient’s frazzled and now insulted parent.
Blaming the parent for an out-of-control child has historically been a common refrain of neighbors, relatives, and even strangers. But considering child behavior as resulting from both parent and child factors is central to the current transactional model of child development. In this model, mismatch of the parent’s and child’s response patterns is seen as setting them up for chronically rough interactions around parent requests/demands. A parent escalating quickly from a briefly stated request to a tirade may create more tension paired with an anxious child who takes time to act, for example. Once a parent (and ultimately the child) recognize patterns in what leads to conflict, they can become more proactive in predicting and negotiating these situations. Ross Greene, PhD, explains this in his book “The Explosive Child,” calling the method Collaborative Problem Solving (now Collaborative & Proactive Solutions or CPS).
While there are general principles parents can use to modify what they consider “mis”behaviors, these methods often do not account for the “missing” skills of the individual child (and parent) predisposing to those “mis”takes. Thinking of misbehaviors as being because of a kind of “learning disability” in the child rather than willful defiance can help cool off interactions by instead focusing on solving the underlying problem.
What kinds of “gaps in skills” set a child up for defiant or explosive reactions? If you think about what features of children, and parent-child relationships are associated with harmonious interactions this becomes evident. Children over 3 who are patient, easygoing, flexible or adaptable, and good at transitions and problem-solving can delay gratification and tolerate frustration, regulate their emotions, explain their desires, and multitask. They are better at reading the parent’s needs and intent and tend to interpret requests as positive or at least neutral and are more likely to comply with parent requests without a fuss.
What? No kid you know is great at all of these? These skills, at best variable, develop with maturation. Some are part of temperament, considered normal variation in personality. For example, so-called difficult temperament includes low adaptability, high-intensity reactions, low regularity, tendency to withdraw, and negative mood. But in the extreme, weaknesses in these skills are core to or comorbid with diagnosable mental health disorders. Defiance and irritable responses are criteria for oppositional defiant disorder (ODD), and less severe categories called aggressive/oppositional problem or variation. ODD is often found in children diagnosed with ADHD (65%), Tourette’s (15%-65%), depression (70% if severe), bipolar disorder (85%), OCD, anxiety (45%), autism, and language-processing disorders (55%), or trauma. These conditions variably include lower emotion regulation, poorer executive functioning including poor task shifting and impulsivity, obsessiveness, lower expressive and receptive communication skills, and less social awareness that facilitates harmonious problem solving.
The basic components of the CPS approach to addressing parent-child conflict sound intuitive but defining them clearly is important when families are stuck. There are three levels of plans. If the problem is an emergency or nonnegotiable, e.g., child hurting the cat, it may call for Plan A – parent-imposed solutions, sometimes with consequences or rewards. As children mature, Plan A should be used less frequently. If solving the problem is not a top life priority, Plan C – postponing action, may be appropriate. Plan C highlights that behavior change is a long-term project and “picking your fights” is important.
The biggest value of CPS for resolving behavior problems comes from intermediate Plan B. In Plan B the first step of problem solving for parents facing child defiance or upset is to empathically and nonjudgmentally figure out the child’s concern. Questions such as “I’ve noticed that when I remind you that it is trash night you start shouting. What’s up with that?” then patiently asking about the who, what, where, and when of their concern and checking to ensure understanding. Specificity is important as well as noting times when the reaction occurs or not.
Once the child’s concern is clear, e.g., feeling that the demand to take out the trash now interrupts his games during the only time his friends are online, the parents should echo the child’s concern then express their own concern about how the behavior is affecting them and others, potentially including the child; e.g., mother is so upset by the shouting that she can’t sleep, and worry that the child is not learning responsibility, and then checking for child understanding.
Finally, the parent invites brainstorming for a solution that addresses both of their concerns, first asking the child for suggestions, aiming for a strategy that is realistic and specific. Children reluctant to make suggestions may need more time and the parent may be wondering “if there is a way for both of our concerns to be addressed.” Solutions chosen are then tried for several weeks, success tracked, and needed changes negotiated.
For parents, using a collaborative approach to dealing with their child’s behavior takes skills they may not have at the moment, or ever. Especially under the stresses of COVID-19 lockdown, taking a step back from an encounter to consider lack of a skill to turn off the video game promptly when a Zoom meeting starts is challenging. Parents may also genetically share the child’s predisposing ADHD, anxiety, depression, OCD, or weakness in communication or social sensitivity.
Sometimes part of the solution for a conflict is for the parent to reduce expectations. This requires understanding and accepting the child’s cognitive or emotional limitations. Reducing expectations is ideally done before a request rather than by giving in after it, which reinforces protests. For authoritarian adults rigid in their belief that parents are boss, changing expectations can be tough and can feel like losing control or failing as a leader. One benefit of working with a CPS coach (see livesinthebalance.org or ThinkKids.org) is to help parents identify their own limitations.
Predicting the types of demands that tend to create conflict, such as to act immediately or be flexible about options, allows parents to prioritize those requests for calmer moments or when there is more time for discussion. Reviewing a checklist of common gaps in skills and creating a list of expectations and triggers that are difficult for the child helps the family be more proactive in developing solutions. Authors of CPS have validated a checklist of skill deficits, “Thinking Skills Inventory,” to facilitate detection of gaps that is educational plus useful for planning specific solutions.
CPS has been shown in randomized trials with both parent groups and in home counseling to be as effective as Parent Training in reducing oppositional behavior and reducing maternal stress, with effects lasting even longer.
CPS Plan B notably has no reward or punishment components as it assumes the child wants to behave acceptably but can’t; has the “will but not the skill.” When skill deficits are worked around the child is satisfied with complying and pleasing the parents. The idea of a “function” of the misbehavior for the child of gaining attention or reward or avoiding consequences is reinterpreted as serving to communicate the problem the child is having trouble in meeting the parent’s demand. When the parent understands and helps the child solve the problem his/her misbehavior is no longer needed. A benefit of the communication and mutual problem solving used in CPS is on not only improving behavior but empowering parents and children, building parental empathy, and improving child skills.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She has no other relevant disclosures. Dr. Howard’s contribution to this publication is as a paid expert to MDedge News. Email her at [email protected].
Reference
Greene RW et al. A transactional model of oppositional behavior: Underpinnings of the Collaborative Problem Solving approach. J Psychosom Res. 2003;55(1):67-75.
“What kind of parent are you? Why don’t you straighten him out!” rants the woman being jostled in the grocery store by your patient. “Easy for you to say,” thinks your patient’s frazzled and now insulted parent.
Blaming the parent for an out-of-control child has historically been a common refrain of neighbors, relatives, and even strangers. But considering child behavior as resulting from both parent and child factors is central to the current transactional model of child development. In this model, mismatch of the parent’s and child’s response patterns is seen as setting them up for chronically rough interactions around parent requests/demands. A parent escalating quickly from a briefly stated request to a tirade may create more tension paired with an anxious child who takes time to act, for example. Once a parent (and ultimately the child) recognize patterns in what leads to conflict, they can become more proactive in predicting and negotiating these situations. Ross Greene, PhD, explains this in his book “The Explosive Child,” calling the method Collaborative Problem Solving (now Collaborative & Proactive Solutions or CPS).
While there are general principles parents can use to modify what they consider “mis”behaviors, these methods often do not account for the “missing” skills of the individual child (and parent) predisposing to those “mis”takes. Thinking of misbehaviors as being because of a kind of “learning disability” in the child rather than willful defiance can help cool off interactions by instead focusing on solving the underlying problem.
What kinds of “gaps in skills” set a child up for defiant or explosive reactions? If you think about what features of children, and parent-child relationships are associated with harmonious interactions this becomes evident. Children over 3 who are patient, easygoing, flexible or adaptable, and good at transitions and problem-solving can delay gratification and tolerate frustration, regulate their emotions, explain their desires, and multitask. They are better at reading the parent’s needs and intent and tend to interpret requests as positive or at least neutral and are more likely to comply with parent requests without a fuss.
What? No kid you know is great at all of these? These skills, at best variable, develop with maturation. Some are part of temperament, considered normal variation in personality. For example, so-called difficult temperament includes low adaptability, high-intensity reactions, low regularity, tendency to withdraw, and negative mood. But in the extreme, weaknesses in these skills are core to or comorbid with diagnosable mental health disorders. Defiance and irritable responses are criteria for oppositional defiant disorder (ODD), and less severe categories called aggressive/oppositional problem or variation. ODD is often found in children diagnosed with ADHD (65%), Tourette’s (15%-65%), depression (70% if severe), bipolar disorder (85%), OCD, anxiety (45%), autism, and language-processing disorders (55%), or trauma. These conditions variably include lower emotion regulation, poorer executive functioning including poor task shifting and impulsivity, obsessiveness, lower expressive and receptive communication skills, and less social awareness that facilitates harmonious problem solving.
The basic components of the CPS approach to addressing parent-child conflict sound intuitive but defining them clearly is important when families are stuck. There are three levels of plans. If the problem is an emergency or nonnegotiable, e.g., child hurting the cat, it may call for Plan A – parent-imposed solutions, sometimes with consequences or rewards. As children mature, Plan A should be used less frequently. If solving the problem is not a top life priority, Plan C – postponing action, may be appropriate. Plan C highlights that behavior change is a long-term project and “picking your fights” is important.
The biggest value of CPS for resolving behavior problems comes from intermediate Plan B. In Plan B the first step of problem solving for parents facing child defiance or upset is to empathically and nonjudgmentally figure out the child’s concern. Questions such as “I’ve noticed that when I remind you that it is trash night you start shouting. What’s up with that?” then patiently asking about the who, what, where, and when of their concern and checking to ensure understanding. Specificity is important as well as noting times when the reaction occurs or not.
Once the child’s concern is clear, e.g., feeling that the demand to take out the trash now interrupts his games during the only time his friends are online, the parents should echo the child’s concern then express their own concern about how the behavior is affecting them and others, potentially including the child; e.g., mother is so upset by the shouting that she can’t sleep, and worry that the child is not learning responsibility, and then checking for child understanding.
Finally, the parent invites brainstorming for a solution that addresses both of their concerns, first asking the child for suggestions, aiming for a strategy that is realistic and specific. Children reluctant to make suggestions may need more time and the parent may be wondering “if there is a way for both of our concerns to be addressed.” Solutions chosen are then tried for several weeks, success tracked, and needed changes negotiated.
For parents, using a collaborative approach to dealing with their child’s behavior takes skills they may not have at the moment, or ever. Especially under the stresses of COVID-19 lockdown, taking a step back from an encounter to consider lack of a skill to turn off the video game promptly when a Zoom meeting starts is challenging. Parents may also genetically share the child’s predisposing ADHD, anxiety, depression, OCD, or weakness in communication or social sensitivity.
Sometimes part of the solution for a conflict is for the parent to reduce expectations. This requires understanding and accepting the child’s cognitive or emotional limitations. Reducing expectations is ideally done before a request rather than by giving in after it, which reinforces protests. For authoritarian adults rigid in their belief that parents are boss, changing expectations can be tough and can feel like losing control or failing as a leader. One benefit of working with a CPS coach (see livesinthebalance.org or ThinkKids.org) is to help parents identify their own limitations.
Predicting the types of demands that tend to create conflict, such as to act immediately or be flexible about options, allows parents to prioritize those requests for calmer moments or when there is more time for discussion. Reviewing a checklist of common gaps in skills and creating a list of expectations and triggers that are difficult for the child helps the family be more proactive in developing solutions. Authors of CPS have validated a checklist of skill deficits, “Thinking Skills Inventory,” to facilitate detection of gaps that is educational plus useful for planning specific solutions.
CPS has been shown in randomized trials with both parent groups and in home counseling to be as effective as Parent Training in reducing oppositional behavior and reducing maternal stress, with effects lasting even longer.
CPS Plan B notably has no reward or punishment components as it assumes the child wants to behave acceptably but can’t; has the “will but not the skill.” When skill deficits are worked around the child is satisfied with complying and pleasing the parents. The idea of a “function” of the misbehavior for the child of gaining attention or reward or avoiding consequences is reinterpreted as serving to communicate the problem the child is having trouble in meeting the parent’s demand. When the parent understands and helps the child solve the problem his/her misbehavior is no longer needed. A benefit of the communication and mutual problem solving used in CPS is on not only improving behavior but empowering parents and children, building parental empathy, and improving child skills.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She has no other relevant disclosures. Dr. Howard’s contribution to this publication is as a paid expert to MDedge News. Email her at [email protected].
Reference
Greene RW et al. A transactional model of oppositional behavior: Underpinnings of the Collaborative Problem Solving approach. J Psychosom Res. 2003;55(1):67-75.
“What kind of parent are you? Why don’t you straighten him out!” rants the woman being jostled in the grocery store by your patient. “Easy for you to say,” thinks your patient’s frazzled and now insulted parent.
Blaming the parent for an out-of-control child has historically been a common refrain of neighbors, relatives, and even strangers. But considering child behavior as resulting from both parent and child factors is central to the current transactional model of child development. In this model, mismatch of the parent’s and child’s response patterns is seen as setting them up for chronically rough interactions around parent requests/demands. A parent escalating quickly from a briefly stated request to a tirade may create more tension paired with an anxious child who takes time to act, for example. Once a parent (and ultimately the child) recognize patterns in what leads to conflict, they can become more proactive in predicting and negotiating these situations. Ross Greene, PhD, explains this in his book “The Explosive Child,” calling the method Collaborative Problem Solving (now Collaborative & Proactive Solutions or CPS).
While there are general principles parents can use to modify what they consider “mis”behaviors, these methods often do not account for the “missing” skills of the individual child (and parent) predisposing to those “mis”takes. Thinking of misbehaviors as being because of a kind of “learning disability” in the child rather than willful defiance can help cool off interactions by instead focusing on solving the underlying problem.
What kinds of “gaps in skills” set a child up for defiant or explosive reactions? If you think about what features of children, and parent-child relationships are associated with harmonious interactions this becomes evident. Children over 3 who are patient, easygoing, flexible or adaptable, and good at transitions and problem-solving can delay gratification and tolerate frustration, regulate their emotions, explain their desires, and multitask. They are better at reading the parent’s needs and intent and tend to interpret requests as positive or at least neutral and are more likely to comply with parent requests without a fuss.
What? No kid you know is great at all of these? These skills, at best variable, develop with maturation. Some are part of temperament, considered normal variation in personality. For example, so-called difficult temperament includes low adaptability, high-intensity reactions, low regularity, tendency to withdraw, and negative mood. But in the extreme, weaknesses in these skills are core to or comorbid with diagnosable mental health disorders. Defiance and irritable responses are criteria for oppositional defiant disorder (ODD), and less severe categories called aggressive/oppositional problem or variation. ODD is often found in children diagnosed with ADHD (65%), Tourette’s (15%-65%), depression (70% if severe), bipolar disorder (85%), OCD, anxiety (45%), autism, and language-processing disorders (55%), or trauma. These conditions variably include lower emotion regulation, poorer executive functioning including poor task shifting and impulsivity, obsessiveness, lower expressive and receptive communication skills, and less social awareness that facilitates harmonious problem solving.
The basic components of the CPS approach to addressing parent-child conflict sound intuitive but defining them clearly is important when families are stuck. There are three levels of plans. If the problem is an emergency or nonnegotiable, e.g., child hurting the cat, it may call for Plan A – parent-imposed solutions, sometimes with consequences or rewards. As children mature, Plan A should be used less frequently. If solving the problem is not a top life priority, Plan C – postponing action, may be appropriate. Plan C highlights that behavior change is a long-term project and “picking your fights” is important.
The biggest value of CPS for resolving behavior problems comes from intermediate Plan B. In Plan B the first step of problem solving for parents facing child defiance or upset is to empathically and nonjudgmentally figure out the child’s concern. Questions such as “I’ve noticed that when I remind you that it is trash night you start shouting. What’s up with that?” then patiently asking about the who, what, where, and when of their concern and checking to ensure understanding. Specificity is important as well as noting times when the reaction occurs or not.
Once the child’s concern is clear, e.g., feeling that the demand to take out the trash now interrupts his games during the only time his friends are online, the parents should echo the child’s concern then express their own concern about how the behavior is affecting them and others, potentially including the child; e.g., mother is so upset by the shouting that she can’t sleep, and worry that the child is not learning responsibility, and then checking for child understanding.
Finally, the parent invites brainstorming for a solution that addresses both of their concerns, first asking the child for suggestions, aiming for a strategy that is realistic and specific. Children reluctant to make suggestions may need more time and the parent may be wondering “if there is a way for both of our concerns to be addressed.” Solutions chosen are then tried for several weeks, success tracked, and needed changes negotiated.
For parents, using a collaborative approach to dealing with their child’s behavior takes skills they may not have at the moment, or ever. Especially under the stresses of COVID-19 lockdown, taking a step back from an encounter to consider lack of a skill to turn off the video game promptly when a Zoom meeting starts is challenging. Parents may also genetically share the child’s predisposing ADHD, anxiety, depression, OCD, or weakness in communication or social sensitivity.
Sometimes part of the solution for a conflict is for the parent to reduce expectations. This requires understanding and accepting the child’s cognitive or emotional limitations. Reducing expectations is ideally done before a request rather than by giving in after it, which reinforces protests. For authoritarian adults rigid in their belief that parents are boss, changing expectations can be tough and can feel like losing control or failing as a leader. One benefit of working with a CPS coach (see livesinthebalance.org or ThinkKids.org) is to help parents identify their own limitations.
Predicting the types of demands that tend to create conflict, such as to act immediately or be flexible about options, allows parents to prioritize those requests for calmer moments or when there is more time for discussion. Reviewing a checklist of common gaps in skills and creating a list of expectations and triggers that are difficult for the child helps the family be more proactive in developing solutions. Authors of CPS have validated a checklist of skill deficits, “Thinking Skills Inventory,” to facilitate detection of gaps that is educational plus useful for planning specific solutions.
CPS has been shown in randomized trials with both parent groups and in home counseling to be as effective as Parent Training in reducing oppositional behavior and reducing maternal stress, with effects lasting even longer.
CPS Plan B notably has no reward or punishment components as it assumes the child wants to behave acceptably but can’t; has the “will but not the skill.” When skill deficits are worked around the child is satisfied with complying and pleasing the parents. The idea of a “function” of the misbehavior for the child of gaining attention or reward or avoiding consequences is reinterpreted as serving to communicate the problem the child is having trouble in meeting the parent’s demand. When the parent understands and helps the child solve the problem his/her misbehavior is no longer needed. A benefit of the communication and mutual problem solving used in CPS is on not only improving behavior but empowering parents and children, building parental empathy, and improving child skills.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS. She has no other relevant disclosures. Dr. Howard’s contribution to this publication is as a paid expert to MDedge News. Email her at [email protected].
Reference
Greene RW et al. A transactional model of oppositional behavior: Underpinnings of the Collaborative Problem Solving approach. J Psychosom Res. 2003;55(1):67-75.
COVID-19: Helping patients overcome what might feel like an existential crisis
Way back in the spring of last year, I wrote about a pandemic of posttraumatic stress disorder that would descend upon us because of COVID-19. At the time, we were told that, by summer – June or July 2020 – all the steps we needed to take to stay ahead of the virus, including remaining socially distant, and yes, even wearing masks, would be over. Life would get back to normal.
Little did we know that a national plan for our safety, including making sure that we had enough masks and PPE, would not be forthcoming, and that so many thousands of Americans would perish, leaving millions of distraught families and friends.
So many people are suffering. Mothers, for example, are struggling to balance remote schooling with additional child care and domestic work. More than 2 million women left the U.S. workforce last year between February 2020 and October 2020, according to a report by the National Women’s Law Center. Even before COVID-19, loneliness among young adults was considered a domestic epidemic – and the social isolation forced by the pandemic has worsened those trends, research shows. These trends are creating so much more anxiety, depression, despair, and yes, even PTSD. As mental health professionals, we have a lot of work to do in educating people about coping skills and in providing treatments when appropriate.
Experiences take on new meaning
One day a friend and professional colleague called me, and he sounded quite distraught. He had not been able to reach his primary care physician and thought that, as a physician, I might have some insights about his symptoms. He began telling me that something really strange was happening whenever he walked around outside with his mask on. He couldn’t breathe with it on, he told me. In addition, his eyes teared up, his nose started running, and his eyeglasses fogged up so much that he couldn’t see where he was going. He was really anxious, nervous, and felt a great sense of despair – and disorientation. He did not fully understand what was happening and didn’t know whether those disorienting symptoms were mask-related or whether he was incubating some yet undiagnosed illness.
I addressed his concerns in the moment by assuring him that I, too, had been experiencing similar challenges with fogged-up glasses and a runny nose; many people were experiencing some of the same things. I explained that even I had called an allergist to find out whether I might be allergic to some component in the mask and whether he had seen those symptoms in his practice.
Albeit, those issues tied to masks are relatively minor, compared with the enormous psychological toll this pandemic has taken on some people. But it’s clear that different people suffer different effects in light of the marked changes in life and lifestyles caused by the pandemic.
‘It’s something else’
Two people I know, both professionals, recently told me that in their social lives they constantly feel tired and anxious, and that their concentration has diminished. They worry more about their futures, they told me separately. (They don’t know each other.) They reported going through daily life “like being on automatic.” Both said they were far too irritable and reported feeling that social isolation had dulled their thinking.
They said they were not depressed; “it’s something else.” I reassured them both that this would pass with time and suggested that they work at not socially isolating – to the extent that they can – during the pandemic. I also encouraged them to get vaccinated and to talk with a professional if their malaise was altering their level of functioning.
So far, more than 475,000 people in the United States have died of COVID-19, and thousands continue to suffer. People are saying goodbye to loved ones on iPads, and watching news stories about hospitals at overcapacity and refrigeration units storing bodies. Meanwhile, health care workers, many of whom are putting their lives and those of their families at risk, are reporting increased levels of burnout – and moral injury.
Value of relaxation techniques
We know that the latest mitigation measures advised by the Centers for Disease Control and Prevention must continue during the COVID-19 vaccination process. The new CDC guidelines on the value of double masking make sense and should be followed. However, even as we learn more about the virus and how to stop its spread, we must recognize that social distancing is not the same as social isolation. We must continue to do what we can to maintain social relationships and keep open the lines of communication, including the use of virtual tools. I am pleased to see the growth of telemedicine during the pandemic. When applicable, telemedicine allows greater medical and mental health care without the stress of travel and the risk of exposure to more people than necessary.
, whether it’s hypnosis, mindfulness, transcendental meditation, or deep breathing exercises. For the more advanced therapies, guided imagery can help patients develop a sense of calm and equanimity.
For those who are not skilled in relaxation techniques, YouTube offers some excellent programs that teach relaxation and mindfulness. Another thing I do is talk regularly with people I know and sometimes with people I know I’ll disagree with – just to keep my brain active. I also try to learn new things in my spare time to establish new brain pathways and stay mentally active.
The pain and grief tied to the pandemic are unlike anything we’ve ever experienced. Our training as psychiatrists, psychologists, and other mental health care professionals makes us all uniquely suited to assist patients as they process these traumatic times. We must step forward and do so.
Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (Kettlehole Publishing, 2019). He has no conflicts of interest.
Way back in the spring of last year, I wrote about a pandemic of posttraumatic stress disorder that would descend upon us because of COVID-19. At the time, we were told that, by summer – June or July 2020 – all the steps we needed to take to stay ahead of the virus, including remaining socially distant, and yes, even wearing masks, would be over. Life would get back to normal.
Little did we know that a national plan for our safety, including making sure that we had enough masks and PPE, would not be forthcoming, and that so many thousands of Americans would perish, leaving millions of distraught families and friends.
So many people are suffering. Mothers, for example, are struggling to balance remote schooling with additional child care and domestic work. More than 2 million women left the U.S. workforce last year between February 2020 and October 2020, according to a report by the National Women’s Law Center. Even before COVID-19, loneliness among young adults was considered a domestic epidemic – and the social isolation forced by the pandemic has worsened those trends, research shows. These trends are creating so much more anxiety, depression, despair, and yes, even PTSD. As mental health professionals, we have a lot of work to do in educating people about coping skills and in providing treatments when appropriate.
Experiences take on new meaning
One day a friend and professional colleague called me, and he sounded quite distraught. He had not been able to reach his primary care physician and thought that, as a physician, I might have some insights about his symptoms. He began telling me that something really strange was happening whenever he walked around outside with his mask on. He couldn’t breathe with it on, he told me. In addition, his eyes teared up, his nose started running, and his eyeglasses fogged up so much that he couldn’t see where he was going. He was really anxious, nervous, and felt a great sense of despair – and disorientation. He did not fully understand what was happening and didn’t know whether those disorienting symptoms were mask-related or whether he was incubating some yet undiagnosed illness.
I addressed his concerns in the moment by assuring him that I, too, had been experiencing similar challenges with fogged-up glasses and a runny nose; many people were experiencing some of the same things. I explained that even I had called an allergist to find out whether I might be allergic to some component in the mask and whether he had seen those symptoms in his practice.
Albeit, those issues tied to masks are relatively minor, compared with the enormous psychological toll this pandemic has taken on some people. But it’s clear that different people suffer different effects in light of the marked changes in life and lifestyles caused by the pandemic.
‘It’s something else’
Two people I know, both professionals, recently told me that in their social lives they constantly feel tired and anxious, and that their concentration has diminished. They worry more about their futures, they told me separately. (They don’t know each other.) They reported going through daily life “like being on automatic.” Both said they were far too irritable and reported feeling that social isolation had dulled their thinking.
They said they were not depressed; “it’s something else.” I reassured them both that this would pass with time and suggested that they work at not socially isolating – to the extent that they can – during the pandemic. I also encouraged them to get vaccinated and to talk with a professional if their malaise was altering their level of functioning.
So far, more than 475,000 people in the United States have died of COVID-19, and thousands continue to suffer. People are saying goodbye to loved ones on iPads, and watching news stories about hospitals at overcapacity and refrigeration units storing bodies. Meanwhile, health care workers, many of whom are putting their lives and those of their families at risk, are reporting increased levels of burnout – and moral injury.
Value of relaxation techniques
We know that the latest mitigation measures advised by the Centers for Disease Control and Prevention must continue during the COVID-19 vaccination process. The new CDC guidelines on the value of double masking make sense and should be followed. However, even as we learn more about the virus and how to stop its spread, we must recognize that social distancing is not the same as social isolation. We must continue to do what we can to maintain social relationships and keep open the lines of communication, including the use of virtual tools. I am pleased to see the growth of telemedicine during the pandemic. When applicable, telemedicine allows greater medical and mental health care without the stress of travel and the risk of exposure to more people than necessary.
, whether it’s hypnosis, mindfulness, transcendental meditation, or deep breathing exercises. For the more advanced therapies, guided imagery can help patients develop a sense of calm and equanimity.
For those who are not skilled in relaxation techniques, YouTube offers some excellent programs that teach relaxation and mindfulness. Another thing I do is talk regularly with people I know and sometimes with people I know I’ll disagree with – just to keep my brain active. I also try to learn new things in my spare time to establish new brain pathways and stay mentally active.
The pain and grief tied to the pandemic are unlike anything we’ve ever experienced. Our training as psychiatrists, psychologists, and other mental health care professionals makes us all uniquely suited to assist patients as they process these traumatic times. We must step forward and do so.
Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (Kettlehole Publishing, 2019). He has no conflicts of interest.
Way back in the spring of last year, I wrote about a pandemic of posttraumatic stress disorder that would descend upon us because of COVID-19. At the time, we were told that, by summer – June or July 2020 – all the steps we needed to take to stay ahead of the virus, including remaining socially distant, and yes, even wearing masks, would be over. Life would get back to normal.
Little did we know that a national plan for our safety, including making sure that we had enough masks and PPE, would not be forthcoming, and that so many thousands of Americans would perish, leaving millions of distraught families and friends.
So many people are suffering. Mothers, for example, are struggling to balance remote schooling with additional child care and domestic work. More than 2 million women left the U.S. workforce last year between February 2020 and October 2020, according to a report by the National Women’s Law Center. Even before COVID-19, loneliness among young adults was considered a domestic epidemic – and the social isolation forced by the pandemic has worsened those trends, research shows. These trends are creating so much more anxiety, depression, despair, and yes, even PTSD. As mental health professionals, we have a lot of work to do in educating people about coping skills and in providing treatments when appropriate.
Experiences take on new meaning
One day a friend and professional colleague called me, and he sounded quite distraught. He had not been able to reach his primary care physician and thought that, as a physician, I might have some insights about his symptoms. He began telling me that something really strange was happening whenever he walked around outside with his mask on. He couldn’t breathe with it on, he told me. In addition, his eyes teared up, his nose started running, and his eyeglasses fogged up so much that he couldn’t see where he was going. He was really anxious, nervous, and felt a great sense of despair – and disorientation. He did not fully understand what was happening and didn’t know whether those disorienting symptoms were mask-related or whether he was incubating some yet undiagnosed illness.
I addressed his concerns in the moment by assuring him that I, too, had been experiencing similar challenges with fogged-up glasses and a runny nose; many people were experiencing some of the same things. I explained that even I had called an allergist to find out whether I might be allergic to some component in the mask and whether he had seen those symptoms in his practice.
Albeit, those issues tied to masks are relatively minor, compared with the enormous psychological toll this pandemic has taken on some people. But it’s clear that different people suffer different effects in light of the marked changes in life and lifestyles caused by the pandemic.
‘It’s something else’
Two people I know, both professionals, recently told me that in their social lives they constantly feel tired and anxious, and that their concentration has diminished. They worry more about their futures, they told me separately. (They don’t know each other.) They reported going through daily life “like being on automatic.” Both said they were far too irritable and reported feeling that social isolation had dulled their thinking.
They said they were not depressed; “it’s something else.” I reassured them both that this would pass with time and suggested that they work at not socially isolating – to the extent that they can – during the pandemic. I also encouraged them to get vaccinated and to talk with a professional if their malaise was altering their level of functioning.
So far, more than 475,000 people in the United States have died of COVID-19, and thousands continue to suffer. People are saying goodbye to loved ones on iPads, and watching news stories about hospitals at overcapacity and refrigeration units storing bodies. Meanwhile, health care workers, many of whom are putting their lives and those of their families at risk, are reporting increased levels of burnout – and moral injury.
Value of relaxation techniques
We know that the latest mitigation measures advised by the Centers for Disease Control and Prevention must continue during the COVID-19 vaccination process. The new CDC guidelines on the value of double masking make sense and should be followed. However, even as we learn more about the virus and how to stop its spread, we must recognize that social distancing is not the same as social isolation. We must continue to do what we can to maintain social relationships and keep open the lines of communication, including the use of virtual tools. I am pleased to see the growth of telemedicine during the pandemic. When applicable, telemedicine allows greater medical and mental health care without the stress of travel and the risk of exposure to more people than necessary.
, whether it’s hypnosis, mindfulness, transcendental meditation, or deep breathing exercises. For the more advanced therapies, guided imagery can help patients develop a sense of calm and equanimity.
For those who are not skilled in relaxation techniques, YouTube offers some excellent programs that teach relaxation and mindfulness. Another thing I do is talk regularly with people I know and sometimes with people I know I’ll disagree with – just to keep my brain active. I also try to learn new things in my spare time to establish new brain pathways and stay mentally active.
The pain and grief tied to the pandemic are unlike anything we’ve ever experienced. Our training as psychiatrists, psychologists, and other mental health care professionals makes us all uniquely suited to assist patients as they process these traumatic times. We must step forward and do so.
Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (Kettlehole Publishing, 2019). He has no conflicts of interest.
Antidepressants may scupper efficacy of MDMA for PTSD
Pooled data from four phase 2 trials reveal that patients with recent SSRI exposure were significantly more likely to continue to meet PTSD diagnostic criteria after methylenedioxymethamphetamine (MDMA)-assisted psychotherapy than their peers who had not recently taken SSRIs.
Although preliminary, the findings have implications for clinical practice if MDMA-assisted psychotherapy is approved by the Food and Drug Administration, Allison Feduccia, PhD, study coauthor and founder of the education platform Psychedelic.Support, said in an interview.
“As psychedelic medicines become available, it’s going to be important that we try to understand what factors impact the response rate and if there are ways that we can improve the treatment outcomes. Allowing for a longer period for tapering completely off SSRIs before initiating MDMA sessions might increase the effectiveness of MDMA,” Dr. Feduccia said.
The study was published online Nov. 20, 2020, in Psychopharmacology (doi: 10.1007/s00213-020-05710-w).
Reduced response
The primary mechanism of action of MDMA involves the same reuptake transporters that are targeted by antidepressant medications commonly prescribed for PTSD. These medications include SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), NRIs, and norepinephrine-dopamine reuptake inhibitors (NDRIs).
Prior research shows that, when MDMA is coadministered with a reuptake inhibitor, subjective and psychological effects of the therapy are attenuated.
The researchers sought to determine whether or not recent tapering off of an antidepressant that targets the same primary binding sites as MDMA would affect treatment response. They analyzed data on 50 adults who underwent two sessions of MDMA-assisted psychotherapy in phase 2 clinical trials.
For 16 of these patients, SSRI therapy was tapered off prior to the MDMA sessions. For 34 patients, SSRI therapy was not tapered off, because the patients had not been taking the medication at the time of initial study screening (nontaper group).
The taper protocols specified that medications be tapered gradually over a period of weeks to minimize withdrawal symptoms and for them to be discontinued at least five half-lives of each drug prior to MDMA administration.
Demographics, baseline PTSD, and depression severity were similar between the taper and the nontaper groups. Participants in the studies had chronic PTSD (symptoms lasting >6 months). Severity scores on the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) were at least 50.
After MDMA-assisted psychotherapy, the nontaper group had significantly lower (better) CAPS-IV total scores, compared with the taper group (mean, 45.7 vs. 70.3; P = .009).
About two-thirds (63.6%) of the nontaper group no longer met PTSD criteria after MDMA-assisted therapy, compared with only 25% of those in the taper group.
The nontaper group also had lower depression symptom severity scores on the Beck Depression Inventory–II, compared with the taper group (mean, 12.7 vs. 22.6; P = .010).
“Another really interesting” observation, said Dr. Feduccia, is that the expected increases in systolic and diastolic blood pressure following MDMA administration were reduced in the taper group, compared with the nontaper group.
“This suggests that MDMA didn’t have the same physiological response in individuals who tapered SSRIs. This should be followed up,” she said.
The investigators offerred several potential mechanisms for the negative effect of recent SSRI use on MDMA-assisted psychotherapy for PTSD.
These include the down-regulation of binding sites (serotonin, dopamine, and/or norepinephrine) related to SSRI use, reduced MDMA treatment-relevant increases in blood pressure in patients with recent SSRI use, and the possibility that withdrawal symptoms from SSRIs may reduce the effectiveness of MDMA psychotherapy.
Important clinical implications
In a comment, Steven R. Thorp, PhD, professor at Alliant International University, San Diego, said the findings are “very interesting” and likely “not well known.”
“There has been great interest in MDMA-assisted psychotherapy in recent years, and if this finding is replicated, it will have important implications for that research,” Dr. Thorp said.
“Although psychotherapy is often preferred by clients with PTSD, compared to medications, and typically shows efficacy that is as strong or stronger (and longer lasting) than medications, many individuals with PTSD are provided with medication only,” Dr. Thorp noted.
“This study suggests that, in addition to the other potential disadvantages of medications (e.g., cost, side effects, potential for addiction), those who take SSRIs, SNRIs, NRIs, and NDRIs for PTSD may also benefit less from MDMA-assisted psychotherapy,” Dr. Thorp added.
The four phase 2 studies used in the analysis were sponsored by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization. Dr. Feduccia received salary support for full-time employment with MAPS Public Benefit Corporation. Dr. Thorp disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pooled data from four phase 2 trials reveal that patients with recent SSRI exposure were significantly more likely to continue to meet PTSD diagnostic criteria after methylenedioxymethamphetamine (MDMA)-assisted psychotherapy than their peers who had not recently taken SSRIs.
Although preliminary, the findings have implications for clinical practice if MDMA-assisted psychotherapy is approved by the Food and Drug Administration, Allison Feduccia, PhD, study coauthor and founder of the education platform Psychedelic.Support, said in an interview.
“As psychedelic medicines become available, it’s going to be important that we try to understand what factors impact the response rate and if there are ways that we can improve the treatment outcomes. Allowing for a longer period for tapering completely off SSRIs before initiating MDMA sessions might increase the effectiveness of MDMA,” Dr. Feduccia said.
The study was published online Nov. 20, 2020, in Psychopharmacology (doi: 10.1007/s00213-020-05710-w).
Reduced response
The primary mechanism of action of MDMA involves the same reuptake transporters that are targeted by antidepressant medications commonly prescribed for PTSD. These medications include SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), NRIs, and norepinephrine-dopamine reuptake inhibitors (NDRIs).
Prior research shows that, when MDMA is coadministered with a reuptake inhibitor, subjective and psychological effects of the therapy are attenuated.
The researchers sought to determine whether or not recent tapering off of an antidepressant that targets the same primary binding sites as MDMA would affect treatment response. They analyzed data on 50 adults who underwent two sessions of MDMA-assisted psychotherapy in phase 2 clinical trials.
For 16 of these patients, SSRI therapy was tapered off prior to the MDMA sessions. For 34 patients, SSRI therapy was not tapered off, because the patients had not been taking the medication at the time of initial study screening (nontaper group).
The taper protocols specified that medications be tapered gradually over a period of weeks to minimize withdrawal symptoms and for them to be discontinued at least five half-lives of each drug prior to MDMA administration.
Demographics, baseline PTSD, and depression severity were similar between the taper and the nontaper groups. Participants in the studies had chronic PTSD (symptoms lasting >6 months). Severity scores on the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) were at least 50.
After MDMA-assisted psychotherapy, the nontaper group had significantly lower (better) CAPS-IV total scores, compared with the taper group (mean, 45.7 vs. 70.3; P = .009).
About two-thirds (63.6%) of the nontaper group no longer met PTSD criteria after MDMA-assisted therapy, compared with only 25% of those in the taper group.
The nontaper group also had lower depression symptom severity scores on the Beck Depression Inventory–II, compared with the taper group (mean, 12.7 vs. 22.6; P = .010).
“Another really interesting” observation, said Dr. Feduccia, is that the expected increases in systolic and diastolic blood pressure following MDMA administration were reduced in the taper group, compared with the nontaper group.
“This suggests that MDMA didn’t have the same physiological response in individuals who tapered SSRIs. This should be followed up,” she said.
The investigators offerred several potential mechanisms for the negative effect of recent SSRI use on MDMA-assisted psychotherapy for PTSD.
These include the down-regulation of binding sites (serotonin, dopamine, and/or norepinephrine) related to SSRI use, reduced MDMA treatment-relevant increases in blood pressure in patients with recent SSRI use, and the possibility that withdrawal symptoms from SSRIs may reduce the effectiveness of MDMA psychotherapy.
Important clinical implications
In a comment, Steven R. Thorp, PhD, professor at Alliant International University, San Diego, said the findings are “very interesting” and likely “not well known.”
“There has been great interest in MDMA-assisted psychotherapy in recent years, and if this finding is replicated, it will have important implications for that research,” Dr. Thorp said.
“Although psychotherapy is often preferred by clients with PTSD, compared to medications, and typically shows efficacy that is as strong or stronger (and longer lasting) than medications, many individuals with PTSD are provided with medication only,” Dr. Thorp noted.
“This study suggests that, in addition to the other potential disadvantages of medications (e.g., cost, side effects, potential for addiction), those who take SSRIs, SNRIs, NRIs, and NDRIs for PTSD may also benefit less from MDMA-assisted psychotherapy,” Dr. Thorp added.
The four phase 2 studies used in the analysis were sponsored by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization. Dr. Feduccia received salary support for full-time employment with MAPS Public Benefit Corporation. Dr. Thorp disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pooled data from four phase 2 trials reveal that patients with recent SSRI exposure were significantly more likely to continue to meet PTSD diagnostic criteria after methylenedioxymethamphetamine (MDMA)-assisted psychotherapy than their peers who had not recently taken SSRIs.
Although preliminary, the findings have implications for clinical practice if MDMA-assisted psychotherapy is approved by the Food and Drug Administration, Allison Feduccia, PhD, study coauthor and founder of the education platform Psychedelic.Support, said in an interview.
“As psychedelic medicines become available, it’s going to be important that we try to understand what factors impact the response rate and if there are ways that we can improve the treatment outcomes. Allowing for a longer period for tapering completely off SSRIs before initiating MDMA sessions might increase the effectiveness of MDMA,” Dr. Feduccia said.
The study was published online Nov. 20, 2020, in Psychopharmacology (doi: 10.1007/s00213-020-05710-w).
Reduced response
The primary mechanism of action of MDMA involves the same reuptake transporters that are targeted by antidepressant medications commonly prescribed for PTSD. These medications include SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), NRIs, and norepinephrine-dopamine reuptake inhibitors (NDRIs).
Prior research shows that, when MDMA is coadministered with a reuptake inhibitor, subjective and psychological effects of the therapy are attenuated.
The researchers sought to determine whether or not recent tapering off of an antidepressant that targets the same primary binding sites as MDMA would affect treatment response. They analyzed data on 50 adults who underwent two sessions of MDMA-assisted psychotherapy in phase 2 clinical trials.
For 16 of these patients, SSRI therapy was tapered off prior to the MDMA sessions. For 34 patients, SSRI therapy was not tapered off, because the patients had not been taking the medication at the time of initial study screening (nontaper group).
The taper protocols specified that medications be tapered gradually over a period of weeks to minimize withdrawal symptoms and for them to be discontinued at least five half-lives of each drug prior to MDMA administration.
Demographics, baseline PTSD, and depression severity were similar between the taper and the nontaper groups. Participants in the studies had chronic PTSD (symptoms lasting >6 months). Severity scores on the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) were at least 50.
After MDMA-assisted psychotherapy, the nontaper group had significantly lower (better) CAPS-IV total scores, compared with the taper group (mean, 45.7 vs. 70.3; P = .009).
About two-thirds (63.6%) of the nontaper group no longer met PTSD criteria after MDMA-assisted therapy, compared with only 25% of those in the taper group.
The nontaper group also had lower depression symptom severity scores on the Beck Depression Inventory–II, compared with the taper group (mean, 12.7 vs. 22.6; P = .010).
“Another really interesting” observation, said Dr. Feduccia, is that the expected increases in systolic and diastolic blood pressure following MDMA administration were reduced in the taper group, compared with the nontaper group.
“This suggests that MDMA didn’t have the same physiological response in individuals who tapered SSRIs. This should be followed up,” she said.
The investigators offerred several potential mechanisms for the negative effect of recent SSRI use on MDMA-assisted psychotherapy for PTSD.
These include the down-regulation of binding sites (serotonin, dopamine, and/or norepinephrine) related to SSRI use, reduced MDMA treatment-relevant increases in blood pressure in patients with recent SSRI use, and the possibility that withdrawal symptoms from SSRIs may reduce the effectiveness of MDMA psychotherapy.
Important clinical implications
In a comment, Steven R. Thorp, PhD, professor at Alliant International University, San Diego, said the findings are “very interesting” and likely “not well known.”
“There has been great interest in MDMA-assisted psychotherapy in recent years, and if this finding is replicated, it will have important implications for that research,” Dr. Thorp said.
“Although psychotherapy is often preferred by clients with PTSD, compared to medications, and typically shows efficacy that is as strong or stronger (and longer lasting) than medications, many individuals with PTSD are provided with medication only,” Dr. Thorp noted.
“This study suggests that, in addition to the other potential disadvantages of medications (e.g., cost, side effects, potential for addiction), those who take SSRIs, SNRIs, NRIs, and NDRIs for PTSD may also benefit less from MDMA-assisted psychotherapy,” Dr. Thorp added.
The four phase 2 studies used in the analysis were sponsored by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization. Dr. Feduccia received salary support for full-time employment with MAPS Public Benefit Corporation. Dr. Thorp disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Clozapine still underused in refractory schizophrenia
With the exception of clozapine, the selection of an antipsychotic medication for acute treatment is driven by side effects.
That’s a key pearl of wisdom that Stephen R. Marder, MD, shared during a discussion of key criteria for choosing an antipsychotic for patients with schizophrenia.
“It’s a decision that can have huge consequences, both to an individual’s mental health and their physical health,” Dr. Marder said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “If a patient did well and liked a prior antipsychotic, that’s usually evidence that they’ll respond again. That’s been shown numerous times. Aside from that, the largest consideration is usually adverse effects.”
In a multiple-treatments meta-analysis that compared the efficacy and tolerability of 15 antipsychotic drugs in schizophrenia, researchers found that an overall positive change in symptoms occurred with clozapine, compared with any other drug.
“Clozapine is not just the most effective antipsychotic for patients who are treatment resistant; it’s also the most effective antipsychotic in general populations,” said Dr. Marder, the Daniel X. Freedman Professor of Psychiatry at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles. “The next most effective antipsychotic is amisulpride, which is not available in the U.S., although there’s a company that’s developing a formulation of amisulpride. After that, the 95% confidence intervals overlap, and the differences are probably related not to their true effectiveness but to other circumstances.”
For example, he continued, risperidone and olanzapine were developed in the 1990s. They were always compared with haloperidol and they tended to work a little bit better. “The drugs developed later on in clinical trials tended to be used in patients who were more treatment resistant,” he said. “Aside from clozapine, the differences in effectiveness are relatively small. But the differences in side effects are large.”
The meta-analysis found that haloperidol stood out as the antipsychotic most likely to cause extrapyramidal side effects. Olanzapine and clozapine stood out as causing the most weight gain, while ziprasidone and lurasidone were less likely to cause weight gain. In addition, risperidone, paliperidone, and haloperidol tended to cause the greatest elevation of prolactin levels, while aripiprazole was found to reduce prolactin levels.
“This becomes an important issue, particularly in young people when one is worried about galactorrhea in women or gynecomastia in men, which sometimes happens with risperidone or haloperidol, and to a lesser extent, sexual dysfunction,” said Dr. Marder, who is also director of the VISN 22 Mental Illness Research, Education, and Clinical Center for the Department of Veterans Affairs. “Sedation is a major consideration for clozapine and chlorpromazine, but less for other antipsychotics.”
When do you know if you’ve selected the right medication for your patient? According to a meta-analysis of 42 studies involving 7,450 patients, improvement tends to occur within the first 2 weeks of treatment. “Which means Dr. Marder said. “This has been consequential because it provides guidance for clinicians to make decisions.”
Symptoms that are likely to improve in the first couple of days include agitation and psychomotor excitement. Improvement in psychotic symptoms typically occurs in the following order: those with thought disorder symptoms tend to develop more organized thinking, those with hallucinations tend to experience a decrease the intensity and frequency of their episodes, and those with well-ingrained delusions “tend to experience fewer misinterpretations,” Dr. Marder said. “They may feel less suspicious and they may talk less about delusions.”
Dr. Marder makes it a point to evaluate the antipsychotic response of patients in 2-3 weeks. “If it’s a partial response, continue a bit longer,” he advised. “It it’s no response, switch. And, of course, if the drug isn’t tolerated well, switch.”
He advised against thinking that patients can easily be categorized as being strong responders or nonresponders. Instead, he favors viewing responsiveness to an antipsychotic along a continuum. “Ten to fifteen percent of patients will fail to remit even at first exposure to an antipsychotic medication, but it’s more common that patients will be partial responders,” Dr. Marder said. “One will have to determine whether that response is adequate or not. There’s also the idea that patients sometimes respond vigorously to an antipsychotic early on. For example, first-episode patients tend to respond very well, and they respond at substantially lower doses. But I set a high criteria that we really want patients on an antipsychotic to respond well, to being in a remission that they can live with, not just to be partially remitted.”
In an analysis of response rates, 244 patients with first-episode schizophrenia moved through two antipsychotic trials, followed by a trial with clozapine. For the first two trials, treatment consisted of risperidone followed by olanzapine, or vice versa. About 75% of patients on either drug showed an initial response. “Among those who did not respond in the first trial but were switched to either drug, the response rate was very low, averaging about 16%,” Dr. Marder said. “In other words, if somebody responds poorly to risperidone, they’re not likely to respond to olanzapine, or vice versa. I think this is true among nearly all of the antipsychotic drugs that are available. Patients tend to have sort of an idiosyncratic ability to respond to a nonclozapine antipsychotic. They may respond to one better than the other, but oftentimes they won’t respond well.” When patients in the trial were switched to clozapine, 75% showed an adequate response.
Based on the study findings and on his own clinical practice, Dr. Marder recommends trying one or two antipsychotics before prescribing clozapine. “If they haven’t responded in a couple of weeks, it’s probably good to change them to another antipsychotic,” he said. “If the patient is responding poorly they should go on to clozapine, which I think is very underutilized.”
In late 2019, the Food and Drug Administration approved lumateperone, a presynaptic D2 partial agonist and a postsynaptic D2 antagonist, for the treatment of schizophrenia in adults. “Its dopamine blockage doesn’t lead to increased dopamine, so it seems to work differently than other antipsychotics,” Dr. Marder said. “It’s effective at lower D2 affinity, which is similar to drugs like clozapine, and it has greater 5 HT2A:D2 antagonism.” It appears to have a relatively benign safety profile, including minimal weight gain, minimal metabolic adverse effects, and minimal extrapyramidal effects. “However, I think the jury’s out,” he added. “There is very little information about head-to-head comparisons between lumateperone and other antipsychotics.”
The new kid on the block is the Alkermes agent AKLS 3831, a combination drug of olanzapine-samidorphan, for the treatment of adults with schizophrenia and adults with bipolar I disorder. In December 2020, the FDA accepted the company’s New Drug Application and set the Prescription Drug User Fee Act target action date of June 1, 2021. Results from a phase 2 trial demonstrated mitigation of olanzapine-induced weight gain with the opioid antagonist samidorphan. “This is not a weight-loss drug,” Dr. Marder said. “It’s just a formulation that causes less weight gain. For patients who do well on olanzapine, putting them on this combination may be helpful in preventing weight gain.”
Dr. Marder disclosed that he has served as a consultant for AbbVie, Allergan, Boehringer Ingelheim, Forum, Genentech, Lundbeck, Neurocrine, Otsuka, Roche, Sunovion, Takeda, Targacept, and Teva. He has also received research support from Boehringer Ingelheim, Neurocrine, and Takeda, and is a section editor for UpToDate.
With the exception of clozapine, the selection of an antipsychotic medication for acute treatment is driven by side effects.
That’s a key pearl of wisdom that Stephen R. Marder, MD, shared during a discussion of key criteria for choosing an antipsychotic for patients with schizophrenia.
“It’s a decision that can have huge consequences, both to an individual’s mental health and their physical health,” Dr. Marder said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “If a patient did well and liked a prior antipsychotic, that’s usually evidence that they’ll respond again. That’s been shown numerous times. Aside from that, the largest consideration is usually adverse effects.”
In a multiple-treatments meta-analysis that compared the efficacy and tolerability of 15 antipsychotic drugs in schizophrenia, researchers found that an overall positive change in symptoms occurred with clozapine, compared with any other drug.
“Clozapine is not just the most effective antipsychotic for patients who are treatment resistant; it’s also the most effective antipsychotic in general populations,” said Dr. Marder, the Daniel X. Freedman Professor of Psychiatry at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles. “The next most effective antipsychotic is amisulpride, which is not available in the U.S., although there’s a company that’s developing a formulation of amisulpride. After that, the 95% confidence intervals overlap, and the differences are probably related not to their true effectiveness but to other circumstances.”
For example, he continued, risperidone and olanzapine were developed in the 1990s. They were always compared with haloperidol and they tended to work a little bit better. “The drugs developed later on in clinical trials tended to be used in patients who were more treatment resistant,” he said. “Aside from clozapine, the differences in effectiveness are relatively small. But the differences in side effects are large.”
The meta-analysis found that haloperidol stood out as the antipsychotic most likely to cause extrapyramidal side effects. Olanzapine and clozapine stood out as causing the most weight gain, while ziprasidone and lurasidone were less likely to cause weight gain. In addition, risperidone, paliperidone, and haloperidol tended to cause the greatest elevation of prolactin levels, while aripiprazole was found to reduce prolactin levels.
“This becomes an important issue, particularly in young people when one is worried about galactorrhea in women or gynecomastia in men, which sometimes happens with risperidone or haloperidol, and to a lesser extent, sexual dysfunction,” said Dr. Marder, who is also director of the VISN 22 Mental Illness Research, Education, and Clinical Center for the Department of Veterans Affairs. “Sedation is a major consideration for clozapine and chlorpromazine, but less for other antipsychotics.”
When do you know if you’ve selected the right medication for your patient? According to a meta-analysis of 42 studies involving 7,450 patients, improvement tends to occur within the first 2 weeks of treatment. “Which means Dr. Marder said. “This has been consequential because it provides guidance for clinicians to make decisions.”
Symptoms that are likely to improve in the first couple of days include agitation and psychomotor excitement. Improvement in psychotic symptoms typically occurs in the following order: those with thought disorder symptoms tend to develop more organized thinking, those with hallucinations tend to experience a decrease the intensity and frequency of their episodes, and those with well-ingrained delusions “tend to experience fewer misinterpretations,” Dr. Marder said. “They may feel less suspicious and they may talk less about delusions.”
Dr. Marder makes it a point to evaluate the antipsychotic response of patients in 2-3 weeks. “If it’s a partial response, continue a bit longer,” he advised. “It it’s no response, switch. And, of course, if the drug isn’t tolerated well, switch.”
He advised against thinking that patients can easily be categorized as being strong responders or nonresponders. Instead, he favors viewing responsiveness to an antipsychotic along a continuum. “Ten to fifteen percent of patients will fail to remit even at first exposure to an antipsychotic medication, but it’s more common that patients will be partial responders,” Dr. Marder said. “One will have to determine whether that response is adequate or not. There’s also the idea that patients sometimes respond vigorously to an antipsychotic early on. For example, first-episode patients tend to respond very well, and they respond at substantially lower doses. But I set a high criteria that we really want patients on an antipsychotic to respond well, to being in a remission that they can live with, not just to be partially remitted.”
In an analysis of response rates, 244 patients with first-episode schizophrenia moved through two antipsychotic trials, followed by a trial with clozapine. For the first two trials, treatment consisted of risperidone followed by olanzapine, or vice versa. About 75% of patients on either drug showed an initial response. “Among those who did not respond in the first trial but were switched to either drug, the response rate was very low, averaging about 16%,” Dr. Marder said. “In other words, if somebody responds poorly to risperidone, they’re not likely to respond to olanzapine, or vice versa. I think this is true among nearly all of the antipsychotic drugs that are available. Patients tend to have sort of an idiosyncratic ability to respond to a nonclozapine antipsychotic. They may respond to one better than the other, but oftentimes they won’t respond well.” When patients in the trial were switched to clozapine, 75% showed an adequate response.
Based on the study findings and on his own clinical practice, Dr. Marder recommends trying one or two antipsychotics before prescribing clozapine. “If they haven’t responded in a couple of weeks, it’s probably good to change them to another antipsychotic,” he said. “If the patient is responding poorly they should go on to clozapine, which I think is very underutilized.”
In late 2019, the Food and Drug Administration approved lumateperone, a presynaptic D2 partial agonist and a postsynaptic D2 antagonist, for the treatment of schizophrenia in adults. “Its dopamine blockage doesn’t lead to increased dopamine, so it seems to work differently than other antipsychotics,” Dr. Marder said. “It’s effective at lower D2 affinity, which is similar to drugs like clozapine, and it has greater 5 HT2A:D2 antagonism.” It appears to have a relatively benign safety profile, including minimal weight gain, minimal metabolic adverse effects, and minimal extrapyramidal effects. “However, I think the jury’s out,” he added. “There is very little information about head-to-head comparisons between lumateperone and other antipsychotics.”
The new kid on the block is the Alkermes agent AKLS 3831, a combination drug of olanzapine-samidorphan, for the treatment of adults with schizophrenia and adults with bipolar I disorder. In December 2020, the FDA accepted the company’s New Drug Application and set the Prescription Drug User Fee Act target action date of June 1, 2021. Results from a phase 2 trial demonstrated mitigation of olanzapine-induced weight gain with the opioid antagonist samidorphan. “This is not a weight-loss drug,” Dr. Marder said. “It’s just a formulation that causes less weight gain. For patients who do well on olanzapine, putting them on this combination may be helpful in preventing weight gain.”
Dr. Marder disclosed that he has served as a consultant for AbbVie, Allergan, Boehringer Ingelheim, Forum, Genentech, Lundbeck, Neurocrine, Otsuka, Roche, Sunovion, Takeda, Targacept, and Teva. He has also received research support from Boehringer Ingelheim, Neurocrine, and Takeda, and is a section editor for UpToDate.
With the exception of clozapine, the selection of an antipsychotic medication for acute treatment is driven by side effects.
That’s a key pearl of wisdom that Stephen R. Marder, MD, shared during a discussion of key criteria for choosing an antipsychotic for patients with schizophrenia.
“It’s a decision that can have huge consequences, both to an individual’s mental health and their physical health,” Dr. Marder said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “If a patient did well and liked a prior antipsychotic, that’s usually evidence that they’ll respond again. That’s been shown numerous times. Aside from that, the largest consideration is usually adverse effects.”
In a multiple-treatments meta-analysis that compared the efficacy and tolerability of 15 antipsychotic drugs in schizophrenia, researchers found that an overall positive change in symptoms occurred with clozapine, compared with any other drug.
“Clozapine is not just the most effective antipsychotic for patients who are treatment resistant; it’s also the most effective antipsychotic in general populations,” said Dr. Marder, the Daniel X. Freedman Professor of Psychiatry at the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles. “The next most effective antipsychotic is amisulpride, which is not available in the U.S., although there’s a company that’s developing a formulation of amisulpride. After that, the 95% confidence intervals overlap, and the differences are probably related not to their true effectiveness but to other circumstances.”
For example, he continued, risperidone and olanzapine were developed in the 1990s. They were always compared with haloperidol and they tended to work a little bit better. “The drugs developed later on in clinical trials tended to be used in patients who were more treatment resistant,” he said. “Aside from clozapine, the differences in effectiveness are relatively small. But the differences in side effects are large.”
The meta-analysis found that haloperidol stood out as the antipsychotic most likely to cause extrapyramidal side effects. Olanzapine and clozapine stood out as causing the most weight gain, while ziprasidone and lurasidone were less likely to cause weight gain. In addition, risperidone, paliperidone, and haloperidol tended to cause the greatest elevation of prolactin levels, while aripiprazole was found to reduce prolactin levels.
“This becomes an important issue, particularly in young people when one is worried about galactorrhea in women or gynecomastia in men, which sometimes happens with risperidone or haloperidol, and to a lesser extent, sexual dysfunction,” said Dr. Marder, who is also director of the VISN 22 Mental Illness Research, Education, and Clinical Center for the Department of Veterans Affairs. “Sedation is a major consideration for clozapine and chlorpromazine, but less for other antipsychotics.”
When do you know if you’ve selected the right medication for your patient? According to a meta-analysis of 42 studies involving 7,450 patients, improvement tends to occur within the first 2 weeks of treatment. “Which means Dr. Marder said. “This has been consequential because it provides guidance for clinicians to make decisions.”
Symptoms that are likely to improve in the first couple of days include agitation and psychomotor excitement. Improvement in psychotic symptoms typically occurs in the following order: those with thought disorder symptoms tend to develop more organized thinking, those with hallucinations tend to experience a decrease the intensity and frequency of their episodes, and those with well-ingrained delusions “tend to experience fewer misinterpretations,” Dr. Marder said. “They may feel less suspicious and they may talk less about delusions.”
Dr. Marder makes it a point to evaluate the antipsychotic response of patients in 2-3 weeks. “If it’s a partial response, continue a bit longer,” he advised. “It it’s no response, switch. And, of course, if the drug isn’t tolerated well, switch.”
He advised against thinking that patients can easily be categorized as being strong responders or nonresponders. Instead, he favors viewing responsiveness to an antipsychotic along a continuum. “Ten to fifteen percent of patients will fail to remit even at first exposure to an antipsychotic medication, but it’s more common that patients will be partial responders,” Dr. Marder said. “One will have to determine whether that response is adequate or not. There’s also the idea that patients sometimes respond vigorously to an antipsychotic early on. For example, first-episode patients tend to respond very well, and they respond at substantially lower doses. But I set a high criteria that we really want patients on an antipsychotic to respond well, to being in a remission that they can live with, not just to be partially remitted.”
In an analysis of response rates, 244 patients with first-episode schizophrenia moved through two antipsychotic trials, followed by a trial with clozapine. For the first two trials, treatment consisted of risperidone followed by olanzapine, or vice versa. About 75% of patients on either drug showed an initial response. “Among those who did not respond in the first trial but were switched to either drug, the response rate was very low, averaging about 16%,” Dr. Marder said. “In other words, if somebody responds poorly to risperidone, they’re not likely to respond to olanzapine, or vice versa. I think this is true among nearly all of the antipsychotic drugs that are available. Patients tend to have sort of an idiosyncratic ability to respond to a nonclozapine antipsychotic. They may respond to one better than the other, but oftentimes they won’t respond well.” When patients in the trial were switched to clozapine, 75% showed an adequate response.
Based on the study findings and on his own clinical practice, Dr. Marder recommends trying one or two antipsychotics before prescribing clozapine. “If they haven’t responded in a couple of weeks, it’s probably good to change them to another antipsychotic,” he said. “If the patient is responding poorly they should go on to clozapine, which I think is very underutilized.”
In late 2019, the Food and Drug Administration approved lumateperone, a presynaptic D2 partial agonist and a postsynaptic D2 antagonist, for the treatment of schizophrenia in adults. “Its dopamine blockage doesn’t lead to increased dopamine, so it seems to work differently than other antipsychotics,” Dr. Marder said. “It’s effective at lower D2 affinity, which is similar to drugs like clozapine, and it has greater 5 HT2A:D2 antagonism.” It appears to have a relatively benign safety profile, including minimal weight gain, minimal metabolic adverse effects, and minimal extrapyramidal effects. “However, I think the jury’s out,” he added. “There is very little information about head-to-head comparisons between lumateperone and other antipsychotics.”
The new kid on the block is the Alkermes agent AKLS 3831, a combination drug of olanzapine-samidorphan, for the treatment of adults with schizophrenia and adults with bipolar I disorder. In December 2020, the FDA accepted the company’s New Drug Application and set the Prescription Drug User Fee Act target action date of June 1, 2021. Results from a phase 2 trial demonstrated mitigation of olanzapine-induced weight gain with the opioid antagonist samidorphan. “This is not a weight-loss drug,” Dr. Marder said. “It’s just a formulation that causes less weight gain. For patients who do well on olanzapine, putting them on this combination may be helpful in preventing weight gain.”
Dr. Marder disclosed that he has served as a consultant for AbbVie, Allergan, Boehringer Ingelheim, Forum, Genentech, Lundbeck, Neurocrine, Otsuka, Roche, Sunovion, Takeda, Targacept, and Teva. He has also received research support from Boehringer Ingelheim, Neurocrine, and Takeda, and is a section editor for UpToDate.
FROM NPA 2021
PPE protected critical care staff from COVID-19 transmission
, a new study has found.
“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.
She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.
The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.
“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”
The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.
The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.
“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”
All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.
Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).
Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.
“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”
Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.
The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.
“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”
There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.
These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.
In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.
“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”
Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”
, a new study has found.
“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.
She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.
The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.
“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”
The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.
The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.
“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”
All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.
Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).
Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.
“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”
Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.
The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.
“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”
There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.
These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.
In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.
“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”
Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”
, a new study has found.
“Other staff, other areas of the hospital, and the wider community are more likely sources of infection,” said lead author Kate El Bouzidi, MRCP, South London Specialist Virology Centre, King’s College Hospital NHS Foundation Trust, London.
She noted that 60% of critical care staff were symptomatic during the first wave of the coronavirus pandemic and 20% were antibody positive, with 10% asymptomatic. “Staff acquisition peaked 3 weeks before the peak of COVID-19 ICU admission, and personal protective equipment (PPE) was effective at preventing transmission from patients.” Working in other areas of the hospital was associated with higher seroprevalence, Dr. El Bouzidi noted.
The findings were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
The novel coronavirus was spreading around the world, and when it reached northern Italy, medical authorities began to think in terms of how it might overwhelm the health care system in the United Kingdom, explained Dr. El Bouzidi.
“There was a lot of interest at this time about health care workers who were particularly vulnerable and also about the allocation of resources and rationing of care, particularly in intensive care,” she said. “And this only intensified when our prime minister was admitted to intensive care. About this time, antibody testing also became available.”
The goal of their study was to determine the SARS-CoV-2 seroprevalence in critical care staff, as well as look at the correlation between antibody status, prior swab testing, and COVID-19 symptoms.
The survey was conducted at Kings College Hospital in London, which is a tertiary-care teaching center. The critical care department is one of the largest in the United Kingdom. The authors estimate that more than 800 people worked in the critical care units, and between March and April 2020, more than 2,000 patients with COVID-19 were admitted, of whom 180 required care in the ICU.
“There was good PPE available in the ICU units right from the start,” she said, “and staff testing was available.”
All staff working in the critical care department participated in the study, which required serum samples and completion of a questionnaire. The samples were tested via six different assays to measure receptor-binding domain, nucleoprotein, and tri-spike, with one antibody result determined for each sample.
Of the 625 staff members, 384 (61.4%) had previously reported experiencing symptoms and 124 (19.8%) had sent a swab for testing. COVID-19 infection had been confirmed in 37 of those health care workers (29.8%).
Overall, 21% were positive for SARS-CoV-2 antibodies, of whom 9.9% had been asymptomatic.
“We were surprised to find that 61% of staff reported symptoms they felt could be consistent with COVID-19,” she said, noting that fatigue, headache, and cough were the most common symptoms reported. “Seroprevalence was reported in 31% of symptomatic staff and in 5% of those without symptoms.”
Seroprevalence differed by role in a critical care unit, although it did not significantly differ by factors such as age, sex, ethnicity, or underlying conditions. Consultants, who are senior physicians, were twice as likely to test positive, compared with junior doctors. The reason for this finding is not clear, but it may lie in the nature of their work responsibilities, such as performing more aerosol-generating procedures in the ICU or in other departments.
The investigators looked at the timing of infections and found that they preceded peak of patient admissions by 3 weeks, with peak onset of staff symptoms in early March. At this time, Dr. El Bouzidi noted, there were very few patients with COVID-19 in the hospital, and good PPE was available throughout this time period.
“Staff were unlikely to be infected by ICU patients, and therefore PPE was largely effective,” she said. “Other sources of infection were more likely to be the cause, such as interactions with other staff, meetings, or contact in break rooms. Routine mask-wearing throughout the hospital was only encouraged as of June 15.”
There were several limitations to the study, such as the cross-sectional design, reliance on response/recall, the fact that antibody tests are unlikely to detect all previous infections, and no genomic data were available to confirm infections. Even though the study had limitations, Dr. El Bouzidi concluded that ICU staff are unlikely to contract COVID-19 from patients but that other staff, other areas of the hospital, and the wider community are more likely sources of infection.
These findings, she added, demonstrate that PPE was effective at preventing transmission from patients and that protective measures need to be maintained when staff is away from the bedside.
In commenting on the study, Greg S. Martin, MD, professor of medicine in the division of pulmonary, allergy, critical care and sleep medicine, Emory University, Atlanta, noted that, even though the study was conducted almost a year ago, the results are still relevant with regard to the effectiveness of PPE.
“There was a huge amount of uncertainty about PPE – what was most effective, could we reuse it, how to sterilize it, what about surfaces, and so on,” he said. “Even for people who work in ICU and who are familiar with the environment and familiar with the patients, there was 1,000 times more uncertainty about everything they were doing.”
Dr. Martin believes that the situation has improved. “It’s not that we take COVID more lightly, but I think the staff is more comfortable dealing with it,” he said. “They now know what they need to do on an hourly and daily basis to stay safe. The PPE had become second nature to them now, with all the other precautions.”
FROM CCC50
Inpatient psychiatrist? Maybe I’ll be a vaccinator instead
Now that completion of residency is fast approaching, I am asked regularly what I plan to do when I become a Real Doctor on July 1. It feels like it wasn’t so long ago I was trying to decide if I should even go to medical school, then later, if I should go into psychiatry, family medicine, or emergency medicine. And here I am at another decision point, another of the regular, 4-year milestones in my journey to full physicianhood.
A surprising thing happened to me during my psychiatry training: I fell in love with acute care. Instead of outpatient care, I preferred the longer hours with patients who insist they are Jesus Christ, believe deeply they are being actively pursued by the FBI, and sometimes eat their own feces. I was in awe of the remarkable capacity of the human brain to convince a graduate-school educated man with bipolar disorder that it is acceptable to call in bomb threats to a hospital. To lead a patient on a conservatorship to believe that I am not a doctor but, instead, a seamstress or leave socks full of feces as presents for Santa Claus (lots of feces in inpatient psychiatry). To believe their spouses are not humans or hear voices telling them they should jump off a bridge, sustaining near-lethal injuries. I was hooked.
Psychiatry as a field is not for those requiring instant gratification. Other than Ativan challenges and the remarkably quick response some patients have to ECT, outcomes of our treatments are usually modest, and they take time. We often delude ourselves into thinking that bumping a patient’s fluoxetine from 10 mg to 20 mg will be The Thing that changes a patient’s life. We address our own sense of helplessness as much as that of our patients, who are desperate for something, for someone, to do something that will alter the course of their lives.
Of course, what I can offer my patients usually falls short of their lofty expectations of my prowess. I offer them compassion, validation, empathy. I offer them medications for which we usually have meager data and meager results. I cannot find them shelter but for a few nights, perhaps a week. I rarely, in settings in which primary diagnoses of substance use and personality disorders are forbidden by insurance companies, can help them with their addiction to methamphetamine. I cannot cure their maladaptive characterological pathology stemming from childhood attachment trauma. To address my own sense of failure as a healer, I resort to the bottom of Maslow’s hierarchy of needs, providing their choice of juice box, more blankets. I slow-roll their discharges overnight so that they can stay in the ER hallway instead of spending the night outside in the rare Southern California rain.
In my 3rd year of residency, we were thrown into a pandemic. I felt both terrified of getting COVID-19 in the hospital and inadequate as a physician. I did not want to be intubating patients, but even more, I dreaded the potential “psychiatry-friendly” assignment of calling the family members of those who had perished from the disease. Rumors circulated that certain versions of surge planning had the inpatient psychiatry unit transitioned to a COVID unit and psychiatry residents “redeployed” to cover medicine floors. Fortunately, we did not have to (or have not yet had to) endure this apocalyptic episode of worst-case scenario. I remained a psychiatrist-in-training, seeing occasional COVID patients but with full personal protective equipment and the ability to maintain some physical distance to complete my examinations. Coming home to my apartment building in scrubs, now acceptable attire on inpatient units – it always should have been since, as we have established, our units are filled with feces – I early on felt like a leper. Later on, I was treated with dignity and respect, like a hero.
My position as a non–frontline-physician was personally challenging. I wanted to help, felt like I should and could help. I am a helper-in-recovery who has spent years learning to achieve a balance of service and loyalty to others and my own desires. The initial guilt I felt at feeling appreciated during the nightly celebration of health care workers downtown ultimately dissipated. I was no hero, nor did I claim to be one. I made peace with my pandemic hobbies of sourdough bread-baking, Moscow mule-making, jigsaw-puzzling, and, briefly, running (before a calcaneal stress fracture reminded me that I am not built for land exercise). I went to work; I came home. My cat was happy.
Then, in rapid succession, vaccines were approved and distributed. My hospital had partnered with the county to administer them at a new superstation, and they were in desperate need of licensed humans to be vaccinators. They cared not that I had given very few (n = 3) injections and only during medical school. I watched the YouTube videos on the Z-track technique for IMs, learned about needle gauges, and went off to the baseball stadium.
I loved this new gig, disproportionately. The 8+ hours flew by, 100 vaccines given to occupants of cars who had eagerly waited hours for the privilege of being vaccinated by an almost-psychiatrist. It was not the technical expertise of sticking a needle into someone’s arm that gave me a dopamine rush, nor the microstress of preparing the syringes with a flimsy needle and a slight caffeine-induced tremor while trying to flick air bubbles out of the syringe without dropping the precious vaccine vial. It was not the travel nurse asking me why anyone – especially an overworked resident – would volunteer to do this for free, while she and others were making “stupid amounts of money” to do the same job.
What drove me to keep volunteering for no pay, only Cheez-Its available as sustenance, minimal gratitude from my employer, long hours on my feet doing a task that was rote and at which I probably would never completely excel? On my second shift, I realized why I found it so gratifying to be a vaccinator: There was a perfect 1:1 correspondence in what patients wanted at that moment and in what I had to offer them. They did not want me to fix their lives, secure them housing, or go back in time and remove them from abusive homes so they could grow up to be more functional, happier adults. They merely wanted a shot. They were profusely grateful, hopeful that this was the Beginning of the End. Nobody spat on me; nobody called me obscene names. Nobody was upset with me for involuntarily holding them against their will. My services were welcome, appreciated. I had lovely, superficial conversations with dozens of people. I felt connected to strangers in a way that has been sorely lacking since March 2020. Understandably mistaken for a nurse throughout the day, I felt more like a bona fide physician than I had in over a year.
I know the adrenaline rush will fade, that volunteer-vaccinating in my free time will eventually become less exciting to me. I know I won’t be able to convince my colleagues indefinitely that volunteering together is a great, institution-sanctioned bonding opportunity. I know the initial enthusiasm over vaccine distribution will fade as the pandemic continues to transform our everyday lives and threaten the health of millions, the economy, and the sanctity of normal human interactions. The gratitude and hopefulness may well be replaced with frustration over waiting hours in a car to get an injection from a psychiatrist, with fear that this promised panacea may not restore normalcy anytime soon. But right now, 11 months into a pandemic that has left our profession exhausted and jaded, the coprophilia and catatonia have temporarily lost their allure. So, I’m adding “vaccinator” to my list of pandemic hobbies.
Dr. Stone is a chief resident in psychiatry at the University of California, San Diego. Before deciding to become a physician, she obtained a master’s degree in public health and worked in health policy research studying empathy and patient-doctor interactions. She has a passion for public psychiatry and acute care, and she dabbles in physician wellness, medical education, and the interface of psychiatry and primary care. Dr. Stone has no disclosures.
Now that completion of residency is fast approaching, I am asked regularly what I plan to do when I become a Real Doctor on July 1. It feels like it wasn’t so long ago I was trying to decide if I should even go to medical school, then later, if I should go into psychiatry, family medicine, or emergency medicine. And here I am at another decision point, another of the regular, 4-year milestones in my journey to full physicianhood.
A surprising thing happened to me during my psychiatry training: I fell in love with acute care. Instead of outpatient care, I preferred the longer hours with patients who insist they are Jesus Christ, believe deeply they are being actively pursued by the FBI, and sometimes eat their own feces. I was in awe of the remarkable capacity of the human brain to convince a graduate-school educated man with bipolar disorder that it is acceptable to call in bomb threats to a hospital. To lead a patient on a conservatorship to believe that I am not a doctor but, instead, a seamstress or leave socks full of feces as presents for Santa Claus (lots of feces in inpatient psychiatry). To believe their spouses are not humans or hear voices telling them they should jump off a bridge, sustaining near-lethal injuries. I was hooked.
Psychiatry as a field is not for those requiring instant gratification. Other than Ativan challenges and the remarkably quick response some patients have to ECT, outcomes of our treatments are usually modest, and they take time. We often delude ourselves into thinking that bumping a patient’s fluoxetine from 10 mg to 20 mg will be The Thing that changes a patient’s life. We address our own sense of helplessness as much as that of our patients, who are desperate for something, for someone, to do something that will alter the course of their lives.
Of course, what I can offer my patients usually falls short of their lofty expectations of my prowess. I offer them compassion, validation, empathy. I offer them medications for which we usually have meager data and meager results. I cannot find them shelter but for a few nights, perhaps a week. I rarely, in settings in which primary diagnoses of substance use and personality disorders are forbidden by insurance companies, can help them with their addiction to methamphetamine. I cannot cure their maladaptive characterological pathology stemming from childhood attachment trauma. To address my own sense of failure as a healer, I resort to the bottom of Maslow’s hierarchy of needs, providing their choice of juice box, more blankets. I slow-roll their discharges overnight so that they can stay in the ER hallway instead of spending the night outside in the rare Southern California rain.
In my 3rd year of residency, we were thrown into a pandemic. I felt both terrified of getting COVID-19 in the hospital and inadequate as a physician. I did not want to be intubating patients, but even more, I dreaded the potential “psychiatry-friendly” assignment of calling the family members of those who had perished from the disease. Rumors circulated that certain versions of surge planning had the inpatient psychiatry unit transitioned to a COVID unit and psychiatry residents “redeployed” to cover medicine floors. Fortunately, we did not have to (or have not yet had to) endure this apocalyptic episode of worst-case scenario. I remained a psychiatrist-in-training, seeing occasional COVID patients but with full personal protective equipment and the ability to maintain some physical distance to complete my examinations. Coming home to my apartment building in scrubs, now acceptable attire on inpatient units – it always should have been since, as we have established, our units are filled with feces – I early on felt like a leper. Later on, I was treated with dignity and respect, like a hero.
My position as a non–frontline-physician was personally challenging. I wanted to help, felt like I should and could help. I am a helper-in-recovery who has spent years learning to achieve a balance of service and loyalty to others and my own desires. The initial guilt I felt at feeling appreciated during the nightly celebration of health care workers downtown ultimately dissipated. I was no hero, nor did I claim to be one. I made peace with my pandemic hobbies of sourdough bread-baking, Moscow mule-making, jigsaw-puzzling, and, briefly, running (before a calcaneal stress fracture reminded me that I am not built for land exercise). I went to work; I came home. My cat was happy.
Then, in rapid succession, vaccines were approved and distributed. My hospital had partnered with the county to administer them at a new superstation, and they were in desperate need of licensed humans to be vaccinators. They cared not that I had given very few (n = 3) injections and only during medical school. I watched the YouTube videos on the Z-track technique for IMs, learned about needle gauges, and went off to the baseball stadium.
I loved this new gig, disproportionately. The 8+ hours flew by, 100 vaccines given to occupants of cars who had eagerly waited hours for the privilege of being vaccinated by an almost-psychiatrist. It was not the technical expertise of sticking a needle into someone’s arm that gave me a dopamine rush, nor the microstress of preparing the syringes with a flimsy needle and a slight caffeine-induced tremor while trying to flick air bubbles out of the syringe without dropping the precious vaccine vial. It was not the travel nurse asking me why anyone – especially an overworked resident – would volunteer to do this for free, while she and others were making “stupid amounts of money” to do the same job.
What drove me to keep volunteering for no pay, only Cheez-Its available as sustenance, minimal gratitude from my employer, long hours on my feet doing a task that was rote and at which I probably would never completely excel? On my second shift, I realized why I found it so gratifying to be a vaccinator: There was a perfect 1:1 correspondence in what patients wanted at that moment and in what I had to offer them. They did not want me to fix their lives, secure them housing, or go back in time and remove them from abusive homes so they could grow up to be more functional, happier adults. They merely wanted a shot. They were profusely grateful, hopeful that this was the Beginning of the End. Nobody spat on me; nobody called me obscene names. Nobody was upset with me for involuntarily holding them against their will. My services were welcome, appreciated. I had lovely, superficial conversations with dozens of people. I felt connected to strangers in a way that has been sorely lacking since March 2020. Understandably mistaken for a nurse throughout the day, I felt more like a bona fide physician than I had in over a year.
I know the adrenaline rush will fade, that volunteer-vaccinating in my free time will eventually become less exciting to me. I know I won’t be able to convince my colleagues indefinitely that volunteering together is a great, institution-sanctioned bonding opportunity. I know the initial enthusiasm over vaccine distribution will fade as the pandemic continues to transform our everyday lives and threaten the health of millions, the economy, and the sanctity of normal human interactions. The gratitude and hopefulness may well be replaced with frustration over waiting hours in a car to get an injection from a psychiatrist, with fear that this promised panacea may not restore normalcy anytime soon. But right now, 11 months into a pandemic that has left our profession exhausted and jaded, the coprophilia and catatonia have temporarily lost their allure. So, I’m adding “vaccinator” to my list of pandemic hobbies.
Dr. Stone is a chief resident in psychiatry at the University of California, San Diego. Before deciding to become a physician, she obtained a master’s degree in public health and worked in health policy research studying empathy and patient-doctor interactions. She has a passion for public psychiatry and acute care, and she dabbles in physician wellness, medical education, and the interface of psychiatry and primary care. Dr. Stone has no disclosures.
Now that completion of residency is fast approaching, I am asked regularly what I plan to do when I become a Real Doctor on July 1. It feels like it wasn’t so long ago I was trying to decide if I should even go to medical school, then later, if I should go into psychiatry, family medicine, or emergency medicine. And here I am at another decision point, another of the regular, 4-year milestones in my journey to full physicianhood.
A surprising thing happened to me during my psychiatry training: I fell in love with acute care. Instead of outpatient care, I preferred the longer hours with patients who insist they are Jesus Christ, believe deeply they are being actively pursued by the FBI, and sometimes eat their own feces. I was in awe of the remarkable capacity of the human brain to convince a graduate-school educated man with bipolar disorder that it is acceptable to call in bomb threats to a hospital. To lead a patient on a conservatorship to believe that I am not a doctor but, instead, a seamstress or leave socks full of feces as presents for Santa Claus (lots of feces in inpatient psychiatry). To believe their spouses are not humans or hear voices telling them they should jump off a bridge, sustaining near-lethal injuries. I was hooked.
Psychiatry as a field is not for those requiring instant gratification. Other than Ativan challenges and the remarkably quick response some patients have to ECT, outcomes of our treatments are usually modest, and they take time. We often delude ourselves into thinking that bumping a patient’s fluoxetine from 10 mg to 20 mg will be The Thing that changes a patient’s life. We address our own sense of helplessness as much as that of our patients, who are desperate for something, for someone, to do something that will alter the course of their lives.
Of course, what I can offer my patients usually falls short of their lofty expectations of my prowess. I offer them compassion, validation, empathy. I offer them medications for which we usually have meager data and meager results. I cannot find them shelter but for a few nights, perhaps a week. I rarely, in settings in which primary diagnoses of substance use and personality disorders are forbidden by insurance companies, can help them with their addiction to methamphetamine. I cannot cure their maladaptive characterological pathology stemming from childhood attachment trauma. To address my own sense of failure as a healer, I resort to the bottom of Maslow’s hierarchy of needs, providing their choice of juice box, more blankets. I slow-roll their discharges overnight so that they can stay in the ER hallway instead of spending the night outside in the rare Southern California rain.
In my 3rd year of residency, we were thrown into a pandemic. I felt both terrified of getting COVID-19 in the hospital and inadequate as a physician. I did not want to be intubating patients, but even more, I dreaded the potential “psychiatry-friendly” assignment of calling the family members of those who had perished from the disease. Rumors circulated that certain versions of surge planning had the inpatient psychiatry unit transitioned to a COVID unit and psychiatry residents “redeployed” to cover medicine floors. Fortunately, we did not have to (or have not yet had to) endure this apocalyptic episode of worst-case scenario. I remained a psychiatrist-in-training, seeing occasional COVID patients but with full personal protective equipment and the ability to maintain some physical distance to complete my examinations. Coming home to my apartment building in scrubs, now acceptable attire on inpatient units – it always should have been since, as we have established, our units are filled with feces – I early on felt like a leper. Later on, I was treated with dignity and respect, like a hero.
My position as a non–frontline-physician was personally challenging. I wanted to help, felt like I should and could help. I am a helper-in-recovery who has spent years learning to achieve a balance of service and loyalty to others and my own desires. The initial guilt I felt at feeling appreciated during the nightly celebration of health care workers downtown ultimately dissipated. I was no hero, nor did I claim to be one. I made peace with my pandemic hobbies of sourdough bread-baking, Moscow mule-making, jigsaw-puzzling, and, briefly, running (before a calcaneal stress fracture reminded me that I am not built for land exercise). I went to work; I came home. My cat was happy.
Then, in rapid succession, vaccines were approved and distributed. My hospital had partnered with the county to administer them at a new superstation, and they were in desperate need of licensed humans to be vaccinators. They cared not that I had given very few (n = 3) injections and only during medical school. I watched the YouTube videos on the Z-track technique for IMs, learned about needle gauges, and went off to the baseball stadium.
I loved this new gig, disproportionately. The 8+ hours flew by, 100 vaccines given to occupants of cars who had eagerly waited hours for the privilege of being vaccinated by an almost-psychiatrist. It was not the technical expertise of sticking a needle into someone’s arm that gave me a dopamine rush, nor the microstress of preparing the syringes with a flimsy needle and a slight caffeine-induced tremor while trying to flick air bubbles out of the syringe without dropping the precious vaccine vial. It was not the travel nurse asking me why anyone – especially an overworked resident – would volunteer to do this for free, while she and others were making “stupid amounts of money” to do the same job.
What drove me to keep volunteering for no pay, only Cheez-Its available as sustenance, minimal gratitude from my employer, long hours on my feet doing a task that was rote and at which I probably would never completely excel? On my second shift, I realized why I found it so gratifying to be a vaccinator: There was a perfect 1:1 correspondence in what patients wanted at that moment and in what I had to offer them. They did not want me to fix their lives, secure them housing, or go back in time and remove them from abusive homes so they could grow up to be more functional, happier adults. They merely wanted a shot. They were profusely grateful, hopeful that this was the Beginning of the End. Nobody spat on me; nobody called me obscene names. Nobody was upset with me for involuntarily holding them against their will. My services were welcome, appreciated. I had lovely, superficial conversations with dozens of people. I felt connected to strangers in a way that has been sorely lacking since March 2020. Understandably mistaken for a nurse throughout the day, I felt more like a bona fide physician than I had in over a year.
I know the adrenaline rush will fade, that volunteer-vaccinating in my free time will eventually become less exciting to me. I know I won’t be able to convince my colleagues indefinitely that volunteering together is a great, institution-sanctioned bonding opportunity. I know the initial enthusiasm over vaccine distribution will fade as the pandemic continues to transform our everyday lives and threaten the health of millions, the economy, and the sanctity of normal human interactions. The gratitude and hopefulness may well be replaced with frustration over waiting hours in a car to get an injection from a psychiatrist, with fear that this promised panacea may not restore normalcy anytime soon. But right now, 11 months into a pandemic that has left our profession exhausted and jaded, the coprophilia and catatonia have temporarily lost their allure. So, I’m adding “vaccinator” to my list of pandemic hobbies.
Dr. Stone is a chief resident in psychiatry at the University of California, San Diego. Before deciding to become a physician, she obtained a master’s degree in public health and worked in health policy research studying empathy and patient-doctor interactions. She has a passion for public psychiatry and acute care, and she dabbles in physician wellness, medical education, and the interface of psychiatry and primary care. Dr. Stone has no disclosures.
Psychiatrist recounts haunting ordeal with an anonymous stalker
Looking back on his experience of being stalked by a former patient for nearly 1 year, William J. Newman, MD, regrets not reaching out to colleagues about the patient boundary violations earlier than he did.
“My mindset was: ‘Maybe I did something wrong that created this,’ ” Dr. Newman, professor and interim chair of psychiatry at Saint Louis University, said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “That’s a common theme among victims of stalking, being kind of embarrassed and not wanting to share it with other people.”
Dr. Newman’s ordeal began in August 2014, when the first of several threatening emails messages were sent to his account at the University of California, Davis, where he held a faculty post and worked on the teaching service at the Sacramento Mental Health Treatment Center, a county hospital that serves mainly uninsured or underinsured populations. The messages always contained a nonspecific email recipient name and the first wasn’t terribly worrisome, Dr. Newman said. It basically read (profanities excluded): “What is wrong with you? Leave me alone. All I want is some privacy.”
About 3 months later, he received another message in a similar writing pattern, but the name of the sender was “god devil,” which raised a red flag to him. “Once you start to get religious concepts, people are compelled to commit acts when they believe they’re doing so beyond the laws of the land and are doing so for a religious purpose,” said Dr. Newman, who is immediate past president of the American Academy of Psychiatry and the Law.
The content of the message contained the first name of a coworker and phrasing inferring suicide, which gave Dr. Newman a hint that it was someone he had cared for at the mental health treatment center, “but as anybody who has worked on a busy inpatient service can tell you, you encounter several suicidal patients, and this didn’t really narrow it down,” he said. “This told me the person had presented after a suicide attempt. In some ways, that made me a little more concerned, because because they don’t really worry about the consequences of being shot by law enforcement or dying in an attack.”
Dr. Newman contacted the university’s information technology team, which was able to trace all messages to an IP address from a computer located at a downtown branch of the public library, which had surveillance video. Armed with this information, he contacted the Sacramento Police Department to see if they would help. He had “what I can only describe as an unsatisfying and somewhat condescending conversation with an officer, who said: ‘Sir, we can’t just go around asking people questions without knowing they did something wrong. There’s nothing we’re going to do.’ ”
Between November 2014 and May 2015, Dr. Newman continued to receive periodic messages from the individual of varied length and intensity.
“Some messages were more disorganized and difficult to follow, while others were very intense and pointed about my imminent death,” he recalled. “I started to ignore these messages as much as possible, tried to put my head in the sand and move forward.”
However, one phrase contained in a message read “you won’t even recognize me,” which gave Dr. Newman pause. “It highlighted the idea that because I don’t know who this is, they could walk up to me on the sidewalk, and I would have no idea, which in its own right is somewhat terrorizing.”
At this point, he contacted the police again, telling them he was fearful for his imminent safety. He also met with his department chair and administrators, who helped Dr. Newman develop a plan to enter and exit the hospital at different times. Then, in May 2015, the stalker sent Dr. Newman another email message threatening not only his life, but the lives of his colleagues at the hospital.
“This was viewed as a terroristic threat, because [it inferred that] other people were going to be shot other than just me,” he said.
After this, Dr. Newman’s administrators contacted the police about the threat, who identified the individual through video surveillance footage at the public library and began to search for him. It was a patient who had been on testosterone and previously had sent similar messages to another mental health provider in town and wound up showing up at that person’s office with a loaded firearm.
“At that point, the police were called to the scene, picked the individual up, and took him to a local emergency room where he was placed on an involuntary 5150 psychiatric hold,” he said. “It was frustrating to me that this was very much minimized and kind of put to the side.”
Once he learned the stalker’s name, Dr. Newman had no recollection of the individual. “The patient had presented after a carbon monoxide overdose, had been sent to a local emergency room and came to my service,” he said. “It was a very nonconfrontational hospitalization, nothing out of the ordinary.”
At this point, the stalker was still at large, so Dr. Newman wrote farewell notes to his wife, children, and loved ones, “just in case,” he said. “I had those tucked away. That wasn’t an overly pleasant experience.” He also lived away from his family outside of Sacramento while police searched for his stalker.
In late May 2015, police located and arrested the individual, and Dr. Newman began a series of conversations with the District Attorney’s office. “They told me there were seven terroristic threat charges that had been levied. They said they were taking this very seriously and [that the case] would be going to trial.” About 1 year later, after Dr. Newman’s move to Missouri, the District Attorney indicated that there would be a court trial and that Dr. Newman would be asked to serve as a fact witness. “I gave them all the information I had, talked to investigators, and the process was moving along for about a year to the point that they had an anticipated trial date,” he said. About 1 year later, he received an automated phone message which stated that the individual had been released from jail. He called the District Attorney to ask what happened.
“He said the judge didn’t really want to deal with this [case] anymore, and accepted a plea with time served and released him,” Dr. Newman said. “That was the outcome of the situation.”
According to a 1997 study of 100 stalking victims, 94% made major lifestyle changes after their ordeal, 82% modified usual activities, 73% increased security measures, 70% curtailed social outings, 53% decreased/stopped work or school, and 39% relocated. “You do change a lot of what you do and how you do it in your life when you’ve had this experience, especially when it’s been a chronic experience for months or years,” said Dr. Newman, who is also medical director of adult psychiatric inpatient services for Saint Louis University. “To this day I get antsy any time I think about the story or prepare to talk about it. It remains uncomfortable even 6 years later, even without an ongoing direct threat at this point.”
The physiological impact of chronic stalking also takes its toll. The body releases adrenaline and cortisol as part of the fight or flight response, while chronic stress “is when you feel an increased stress response and have adrenaline and cortisol elevated for an extended period of time,” he said. “There are negative impacts in terms of increased inflammation in the body and in the brain. I have spoken to several professionals who have been stalked by former patients. Commonly, they have been diagnosed in the period after that with an autoimmune illness or a cancer. Less than a year after my stalking situation ended, I was diagnosed with a metastatic cancer and had to start chemotherapy. I would not at all be surprised that those things are highly related to one another.”
When patient boundary violations start to become problematic or worrisome, Dr. Newman advised reaching out to colleagues and law enforcement for help. “Don’t let it go on insidiously for an extended period of time,” he said. “I think that was the biggest lesson I learned.”
He reported having no financial disclosures.
Looking back on his experience of being stalked by a former patient for nearly 1 year, William J. Newman, MD, regrets not reaching out to colleagues about the patient boundary violations earlier than he did.
“My mindset was: ‘Maybe I did something wrong that created this,’ ” Dr. Newman, professor and interim chair of psychiatry at Saint Louis University, said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “That’s a common theme among victims of stalking, being kind of embarrassed and not wanting to share it with other people.”
Dr. Newman’s ordeal began in August 2014, when the first of several threatening emails messages were sent to his account at the University of California, Davis, where he held a faculty post and worked on the teaching service at the Sacramento Mental Health Treatment Center, a county hospital that serves mainly uninsured or underinsured populations. The messages always contained a nonspecific email recipient name and the first wasn’t terribly worrisome, Dr. Newman said. It basically read (profanities excluded): “What is wrong with you? Leave me alone. All I want is some privacy.”
About 3 months later, he received another message in a similar writing pattern, but the name of the sender was “god devil,” which raised a red flag to him. “Once you start to get religious concepts, people are compelled to commit acts when they believe they’re doing so beyond the laws of the land and are doing so for a religious purpose,” said Dr. Newman, who is immediate past president of the American Academy of Psychiatry and the Law.
The content of the message contained the first name of a coworker and phrasing inferring suicide, which gave Dr. Newman a hint that it was someone he had cared for at the mental health treatment center, “but as anybody who has worked on a busy inpatient service can tell you, you encounter several suicidal patients, and this didn’t really narrow it down,” he said. “This told me the person had presented after a suicide attempt. In some ways, that made me a little more concerned, because because they don’t really worry about the consequences of being shot by law enforcement or dying in an attack.”
Dr. Newman contacted the university’s information technology team, which was able to trace all messages to an IP address from a computer located at a downtown branch of the public library, which had surveillance video. Armed with this information, he contacted the Sacramento Police Department to see if they would help. He had “what I can only describe as an unsatisfying and somewhat condescending conversation with an officer, who said: ‘Sir, we can’t just go around asking people questions without knowing they did something wrong. There’s nothing we’re going to do.’ ”
Between November 2014 and May 2015, Dr. Newman continued to receive periodic messages from the individual of varied length and intensity.
“Some messages were more disorganized and difficult to follow, while others were very intense and pointed about my imminent death,” he recalled. “I started to ignore these messages as much as possible, tried to put my head in the sand and move forward.”
However, one phrase contained in a message read “you won’t even recognize me,” which gave Dr. Newman pause. “It highlighted the idea that because I don’t know who this is, they could walk up to me on the sidewalk, and I would have no idea, which in its own right is somewhat terrorizing.”
At this point, he contacted the police again, telling them he was fearful for his imminent safety. He also met with his department chair and administrators, who helped Dr. Newman develop a plan to enter and exit the hospital at different times. Then, in May 2015, the stalker sent Dr. Newman another email message threatening not only his life, but the lives of his colleagues at the hospital.
“This was viewed as a terroristic threat, because [it inferred that] other people were going to be shot other than just me,” he said.
After this, Dr. Newman’s administrators contacted the police about the threat, who identified the individual through video surveillance footage at the public library and began to search for him. It was a patient who had been on testosterone and previously had sent similar messages to another mental health provider in town and wound up showing up at that person’s office with a loaded firearm.
“At that point, the police were called to the scene, picked the individual up, and took him to a local emergency room where he was placed on an involuntary 5150 psychiatric hold,” he said. “It was frustrating to me that this was very much minimized and kind of put to the side.”
Once he learned the stalker’s name, Dr. Newman had no recollection of the individual. “The patient had presented after a carbon monoxide overdose, had been sent to a local emergency room and came to my service,” he said. “It was a very nonconfrontational hospitalization, nothing out of the ordinary.”
At this point, the stalker was still at large, so Dr. Newman wrote farewell notes to his wife, children, and loved ones, “just in case,” he said. “I had those tucked away. That wasn’t an overly pleasant experience.” He also lived away from his family outside of Sacramento while police searched for his stalker.
In late May 2015, police located and arrested the individual, and Dr. Newman began a series of conversations with the District Attorney’s office. “They told me there were seven terroristic threat charges that had been levied. They said they were taking this very seriously and [that the case] would be going to trial.” About 1 year later, after Dr. Newman’s move to Missouri, the District Attorney indicated that there would be a court trial and that Dr. Newman would be asked to serve as a fact witness. “I gave them all the information I had, talked to investigators, and the process was moving along for about a year to the point that they had an anticipated trial date,” he said. About 1 year later, he received an automated phone message which stated that the individual had been released from jail. He called the District Attorney to ask what happened.
“He said the judge didn’t really want to deal with this [case] anymore, and accepted a plea with time served and released him,” Dr. Newman said. “That was the outcome of the situation.”
According to a 1997 study of 100 stalking victims, 94% made major lifestyle changes after their ordeal, 82% modified usual activities, 73% increased security measures, 70% curtailed social outings, 53% decreased/stopped work or school, and 39% relocated. “You do change a lot of what you do and how you do it in your life when you’ve had this experience, especially when it’s been a chronic experience for months or years,” said Dr. Newman, who is also medical director of adult psychiatric inpatient services for Saint Louis University. “To this day I get antsy any time I think about the story or prepare to talk about it. It remains uncomfortable even 6 years later, even without an ongoing direct threat at this point.”
The physiological impact of chronic stalking also takes its toll. The body releases adrenaline and cortisol as part of the fight or flight response, while chronic stress “is when you feel an increased stress response and have adrenaline and cortisol elevated for an extended period of time,” he said. “There are negative impacts in terms of increased inflammation in the body and in the brain. I have spoken to several professionals who have been stalked by former patients. Commonly, they have been diagnosed in the period after that with an autoimmune illness or a cancer. Less than a year after my stalking situation ended, I was diagnosed with a metastatic cancer and had to start chemotherapy. I would not at all be surprised that those things are highly related to one another.”
When patient boundary violations start to become problematic or worrisome, Dr. Newman advised reaching out to colleagues and law enforcement for help. “Don’t let it go on insidiously for an extended period of time,” he said. “I think that was the biggest lesson I learned.”
He reported having no financial disclosures.
Looking back on his experience of being stalked by a former patient for nearly 1 year, William J. Newman, MD, regrets not reaching out to colleagues about the patient boundary violations earlier than he did.
“My mindset was: ‘Maybe I did something wrong that created this,’ ” Dr. Newman, professor and interim chair of psychiatry at Saint Louis University, said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “That’s a common theme among victims of stalking, being kind of embarrassed and not wanting to share it with other people.”
Dr. Newman’s ordeal began in August 2014, when the first of several threatening emails messages were sent to his account at the University of California, Davis, where he held a faculty post and worked on the teaching service at the Sacramento Mental Health Treatment Center, a county hospital that serves mainly uninsured or underinsured populations. The messages always contained a nonspecific email recipient name and the first wasn’t terribly worrisome, Dr. Newman said. It basically read (profanities excluded): “What is wrong with you? Leave me alone. All I want is some privacy.”
About 3 months later, he received another message in a similar writing pattern, but the name of the sender was “god devil,” which raised a red flag to him. “Once you start to get religious concepts, people are compelled to commit acts when they believe they’re doing so beyond the laws of the land and are doing so for a religious purpose,” said Dr. Newman, who is immediate past president of the American Academy of Psychiatry and the Law.
The content of the message contained the first name of a coworker and phrasing inferring suicide, which gave Dr. Newman a hint that it was someone he had cared for at the mental health treatment center, “but as anybody who has worked on a busy inpatient service can tell you, you encounter several suicidal patients, and this didn’t really narrow it down,” he said. “This told me the person had presented after a suicide attempt. In some ways, that made me a little more concerned, because because they don’t really worry about the consequences of being shot by law enforcement or dying in an attack.”
Dr. Newman contacted the university’s information technology team, which was able to trace all messages to an IP address from a computer located at a downtown branch of the public library, which had surveillance video. Armed with this information, he contacted the Sacramento Police Department to see if they would help. He had “what I can only describe as an unsatisfying and somewhat condescending conversation with an officer, who said: ‘Sir, we can’t just go around asking people questions without knowing they did something wrong. There’s nothing we’re going to do.’ ”
Between November 2014 and May 2015, Dr. Newman continued to receive periodic messages from the individual of varied length and intensity.
“Some messages were more disorganized and difficult to follow, while others were very intense and pointed about my imminent death,” he recalled. “I started to ignore these messages as much as possible, tried to put my head in the sand and move forward.”
However, one phrase contained in a message read “you won’t even recognize me,” which gave Dr. Newman pause. “It highlighted the idea that because I don’t know who this is, they could walk up to me on the sidewalk, and I would have no idea, which in its own right is somewhat terrorizing.”
At this point, he contacted the police again, telling them he was fearful for his imminent safety. He also met with his department chair and administrators, who helped Dr. Newman develop a plan to enter and exit the hospital at different times. Then, in May 2015, the stalker sent Dr. Newman another email message threatening not only his life, but the lives of his colleagues at the hospital.
“This was viewed as a terroristic threat, because [it inferred that] other people were going to be shot other than just me,” he said.
After this, Dr. Newman’s administrators contacted the police about the threat, who identified the individual through video surveillance footage at the public library and began to search for him. It was a patient who had been on testosterone and previously had sent similar messages to another mental health provider in town and wound up showing up at that person’s office with a loaded firearm.
“At that point, the police were called to the scene, picked the individual up, and took him to a local emergency room where he was placed on an involuntary 5150 psychiatric hold,” he said. “It was frustrating to me that this was very much minimized and kind of put to the side.”
Once he learned the stalker’s name, Dr. Newman had no recollection of the individual. “The patient had presented after a carbon monoxide overdose, had been sent to a local emergency room and came to my service,” he said. “It was a very nonconfrontational hospitalization, nothing out of the ordinary.”
At this point, the stalker was still at large, so Dr. Newman wrote farewell notes to his wife, children, and loved ones, “just in case,” he said. “I had those tucked away. That wasn’t an overly pleasant experience.” He also lived away from his family outside of Sacramento while police searched for his stalker.
In late May 2015, police located and arrested the individual, and Dr. Newman began a series of conversations with the District Attorney’s office. “They told me there were seven terroristic threat charges that had been levied. They said they were taking this very seriously and [that the case] would be going to trial.” About 1 year later, after Dr. Newman’s move to Missouri, the District Attorney indicated that there would be a court trial and that Dr. Newman would be asked to serve as a fact witness. “I gave them all the information I had, talked to investigators, and the process was moving along for about a year to the point that they had an anticipated trial date,” he said. About 1 year later, he received an automated phone message which stated that the individual had been released from jail. He called the District Attorney to ask what happened.
“He said the judge didn’t really want to deal with this [case] anymore, and accepted a plea with time served and released him,” Dr. Newman said. “That was the outcome of the situation.”
According to a 1997 study of 100 stalking victims, 94% made major lifestyle changes after their ordeal, 82% modified usual activities, 73% increased security measures, 70% curtailed social outings, 53% decreased/stopped work or school, and 39% relocated. “You do change a lot of what you do and how you do it in your life when you’ve had this experience, especially when it’s been a chronic experience for months or years,” said Dr. Newman, who is also medical director of adult psychiatric inpatient services for Saint Louis University. “To this day I get antsy any time I think about the story or prepare to talk about it. It remains uncomfortable even 6 years later, even without an ongoing direct threat at this point.”
The physiological impact of chronic stalking also takes its toll. The body releases adrenaline and cortisol as part of the fight or flight response, while chronic stress “is when you feel an increased stress response and have adrenaline and cortisol elevated for an extended period of time,” he said. “There are negative impacts in terms of increased inflammation in the body and in the brain. I have spoken to several professionals who have been stalked by former patients. Commonly, they have been diagnosed in the period after that with an autoimmune illness or a cancer. Less than a year after my stalking situation ended, I was diagnosed with a metastatic cancer and had to start chemotherapy. I would not at all be surprised that those things are highly related to one another.”
When patient boundary violations start to become problematic or worrisome, Dr. Newman advised reaching out to colleagues and law enforcement for help. “Don’t let it go on insidiously for an extended period of time,” he said. “I think that was the biggest lesson I learned.”
He reported having no financial disclosures.
FROM NPA 2021
ColCORONA: More questions than answers for colchicine in COVID-19
Science by press release and preprint has cooled clinician enthusiasm for the use of colchicine in nonhospitalized patients with COVID-19, despite a pressing need for early treatments.
As previously reported by this news organization, a Jan. 22 press release announced that the massive ColCORONA study missed its primary endpoint of hospitalization or death among 4,488 newly diagnosed patients at increased risk for hospitalization.
But it also touted that use of the anti-inflammatory drug significantly reduced the primary endpoint in 4,159 of those patients with polymerase chain reaction–confirmed COVID and led to reductions of 25%, 50%, and 44%, respectively, for hospitalizations, ventilations, and death.
Lead investigator Jean-Claude Tardif, MD, director of the Montreal Heart Institute Research Centre, deemed the findings a “medical breakthrough.”
When the preprint released a few days later, however, newly revealed confidence intervals showed colchicine did not meaningfully reduce the need for mechanical ventilation (odds ratio, 0.50; 95% confidence interval, 0.23-1.07) or death alone (OR, 0.56; 95% CI, 0.19-1.66).
Further, the significant benefit on the primary outcome came at the cost of a fivefold increase in pulmonary embolism (11 vs. 2; P = .01), which was not mentioned in the press release.
“Whether this represents a real phenomenon or simply the play of chance is not known,” Dr. Tardif and colleagues noted later in the preprint.
“I read the preprint on colchicine and I have so many questions,” Aaron E. Glatt, MD, spokesperson for the Infectious Diseases Society of America and chief of infectious diseases, Mount Sinai South Nassau, Hewlett, N.Y., said in an interview. “I’ve been burned too many times with COVID and prefer to see better data.
“People sometimes say if you wait for perfect data, people are going to die,” he said. “Yeah, but we have no idea if people are going to die from getting this drug more than not getting it. That’s what concerns me. How many pulmonary emboli are going to be fatal versus the slight benefit that the study showed?”
The pushback to the non–peer-reviewed data on social media and via emails was so strong that Dr. Tardif posted a nearly 2,000-word letter responding to the many questions at play.
Chief among them was why the trial, originally planned for 6,000 patients, was stopped early by the investigators without consultation with the data safety monitoring board (DSMB).
The explanation in the letter that logistical issues like running the study call center, budget constraints, and a perceived need to quickly communicate the results left some calling foul that the study wasn’t allowed to finish and come to a more definitive conclusion.
“I can be a little bit sympathetic to their cause but at the same time the DSMB should have said no,” said David Boulware, MD, MPH, who led a recent hydroxychloroquine trial in COVID-19. “The problem is we’re sort of left in limbo, where some people kind of believe it and some say it’s not really a thing. So it’s not really moving the needle, as far as guidelines go.”
Indeed, a Twitter poll by cardiologist James Januzzi Jr., MD, captured the uncertainty, with 28% of respondents saying the trial was “neutral,” 58% saying “maybe but meh,” and 14% saying “colchicine for all.”
Another poll cheekily asked whether ColCORONA was the Gamestop/Reddit equivalent of COVID.
“The press release really didn’t help things because it very much oversold the effect. That, I think, poisoned the well,” said Dr. Boulware, professor of medicine in infectious diseases at the University of Minnesota, Minneapolis.
“The question I’m left with is not whether colchicine works, but who does it work in,” he said. “That’s really the fundamental question because it does seem that there are probably high-risk groups in their trial and others where they benefit, whereas other groups don’t benefit. In the subgroup analysis, there was absolutely no beneficial effect in women.”
According to the authors, the number needed to treat to prevent one death or hospitalization was 71 overall, but 29 for patients with diabetes, 31 for those aged 70 years and older, 53 for patients with respiratory disease, and 25 for those with coronary disease or heart failure.
Men are at higher risk overall for poor outcomes. But “the authors didn’t present a multivariable analysis, so it is unclear if another factor, such as a differential prevalence of smoking or cardiovascular risk factors, contributed to the differential benefit,” Rachel Bender Ignacio, MD, MPH, infectious disease specialist, University of Washington, Seattle, said in an interview.
Importantly, in this pragmatic study, duration and severity of symptoms were not reported, observed Dr. Bender Ignacio, who is also a STOP-COVID-2 investigator. “We don’t yet have data as to whether colchicine shortens duration or severity of symptoms or prevents long COVID, so we need more data on that.”
The overall risk for serious adverse events was lower in the colchicine group, but the difference in pulmonary embolism (PE) was striking, she said. This could be caused by a real biologic effect, or it’s possible that persons with shortness of breath and hypoxia, without evident viral pneumonia on chest x-ray after a positive COVID-19 test, were more likely to receive a CT-PE study.
The press release also failed to include information, later noted in the preprint, that the MHI has submitted two patents related to colchicine: “Methods of treating a coronavirus infection using colchicine” and “Early administration of low-dose colchicine after myocardial infarction.”
Reached for clarification, MHI communications adviser Camille Turbide said in an interview that the first patent “simply refers to the novel concept of preventing complications of COVID-19, such as admission to the hospital, with colchicine as tested in the ColCORONA study.”
The second patent, she said, refers to the “novel concept that administering colchicine early after a major adverse cardiovascular event is better than waiting several days,” as supported by the COLCOT study, which Dr. Tardif also led.
The patents are being reviewed by authorities and “Dr. Tardif has waived his rights in these patents and does not stand to benefit financially at all if colchicine becomes used as a treatment for COVID-19,” Ms. Turbide said.
Dr. Tardif did not respond to interview requests for this story. Dr. Glatt said conflicts of interest must be assessed and are “something that is of great concern in any scientific study.”
Cardiologist Steve Nissen, MD, of the Cleveland Clinic said in an interview that, “despite the negative results, the study does suggest that colchicine might have a benefit and should be studied in future trials. These findings are not sufficient evidence to suggest use of the drug in patients infected with COVID-19.”
He noted that adverse effects like diarrhea were expected but that the excess PE was unexpected and needs greater clarification.
“Stopping the trial for administrative reasons is puzzling and undermined the ability of the trial to give a reliable answer,” Dr. Nissen said. “This is a reasonable pilot study that should be viewed as hypothesis generating but inconclusive.”
Several sources said a new trial is unlikely, particularly given the cost and 28 trials already evaluating colchicine. Among these are RECOVERY and COLCOVID, testing whether colchicine can reduce the duration of hospitalization or death in hospitalized patients with COVID-19.
Because there are so many trials ongoing right now, including for antivirals and other immunomodulators, it’s important that, if colchicine comes to routine clinical use, it provides access to treatment for those not able or willing to access clinical trials, rather than impeding clinical trial enrollment, Dr. Bender Ignacio suggested.
“We have already learned the lesson in the pandemic that early adoption of potentially promising therapies can negatively impact our ability to study and develop other promising treatments,” she said.
The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the National Heart, Lung, and Blood Institute of the National Institutes of Health; Montreal philanthropist Sophie Desmarais, and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators. Dr. Glatt reported no conflicts of interest. Dr. Boulware reported receiving $18 in food and beverages from Gilead Sciences in 2018.
A version of this article first appeared on Medscape.com.
Science by press release and preprint has cooled clinician enthusiasm for the use of colchicine in nonhospitalized patients with COVID-19, despite a pressing need for early treatments.
As previously reported by this news organization, a Jan. 22 press release announced that the massive ColCORONA study missed its primary endpoint of hospitalization or death among 4,488 newly diagnosed patients at increased risk for hospitalization.
But it also touted that use of the anti-inflammatory drug significantly reduced the primary endpoint in 4,159 of those patients with polymerase chain reaction–confirmed COVID and led to reductions of 25%, 50%, and 44%, respectively, for hospitalizations, ventilations, and death.
Lead investigator Jean-Claude Tardif, MD, director of the Montreal Heart Institute Research Centre, deemed the findings a “medical breakthrough.”
When the preprint released a few days later, however, newly revealed confidence intervals showed colchicine did not meaningfully reduce the need for mechanical ventilation (odds ratio, 0.50; 95% confidence interval, 0.23-1.07) or death alone (OR, 0.56; 95% CI, 0.19-1.66).
Further, the significant benefit on the primary outcome came at the cost of a fivefold increase in pulmonary embolism (11 vs. 2; P = .01), which was not mentioned in the press release.
“Whether this represents a real phenomenon or simply the play of chance is not known,” Dr. Tardif and colleagues noted later in the preprint.
“I read the preprint on colchicine and I have so many questions,” Aaron E. Glatt, MD, spokesperson for the Infectious Diseases Society of America and chief of infectious diseases, Mount Sinai South Nassau, Hewlett, N.Y., said in an interview. “I’ve been burned too many times with COVID and prefer to see better data.
“People sometimes say if you wait for perfect data, people are going to die,” he said. “Yeah, but we have no idea if people are going to die from getting this drug more than not getting it. That’s what concerns me. How many pulmonary emboli are going to be fatal versus the slight benefit that the study showed?”
The pushback to the non–peer-reviewed data on social media and via emails was so strong that Dr. Tardif posted a nearly 2,000-word letter responding to the many questions at play.
Chief among them was why the trial, originally planned for 6,000 patients, was stopped early by the investigators without consultation with the data safety monitoring board (DSMB).
The explanation in the letter that logistical issues like running the study call center, budget constraints, and a perceived need to quickly communicate the results left some calling foul that the study wasn’t allowed to finish and come to a more definitive conclusion.
“I can be a little bit sympathetic to their cause but at the same time the DSMB should have said no,” said David Boulware, MD, MPH, who led a recent hydroxychloroquine trial in COVID-19. “The problem is we’re sort of left in limbo, where some people kind of believe it and some say it’s not really a thing. So it’s not really moving the needle, as far as guidelines go.”
Indeed, a Twitter poll by cardiologist James Januzzi Jr., MD, captured the uncertainty, with 28% of respondents saying the trial was “neutral,” 58% saying “maybe but meh,” and 14% saying “colchicine for all.”
Another poll cheekily asked whether ColCORONA was the Gamestop/Reddit equivalent of COVID.
“The press release really didn’t help things because it very much oversold the effect. That, I think, poisoned the well,” said Dr. Boulware, professor of medicine in infectious diseases at the University of Minnesota, Minneapolis.
“The question I’m left with is not whether colchicine works, but who does it work in,” he said. “That’s really the fundamental question because it does seem that there are probably high-risk groups in their trial and others where they benefit, whereas other groups don’t benefit. In the subgroup analysis, there was absolutely no beneficial effect in women.”
According to the authors, the number needed to treat to prevent one death or hospitalization was 71 overall, but 29 for patients with diabetes, 31 for those aged 70 years and older, 53 for patients with respiratory disease, and 25 for those with coronary disease or heart failure.
Men are at higher risk overall for poor outcomes. But “the authors didn’t present a multivariable analysis, so it is unclear if another factor, such as a differential prevalence of smoking or cardiovascular risk factors, contributed to the differential benefit,” Rachel Bender Ignacio, MD, MPH, infectious disease specialist, University of Washington, Seattle, said in an interview.
Importantly, in this pragmatic study, duration and severity of symptoms were not reported, observed Dr. Bender Ignacio, who is also a STOP-COVID-2 investigator. “We don’t yet have data as to whether colchicine shortens duration or severity of symptoms or prevents long COVID, so we need more data on that.”
The overall risk for serious adverse events was lower in the colchicine group, but the difference in pulmonary embolism (PE) was striking, she said. This could be caused by a real biologic effect, or it’s possible that persons with shortness of breath and hypoxia, without evident viral pneumonia on chest x-ray after a positive COVID-19 test, were more likely to receive a CT-PE study.
The press release also failed to include information, later noted in the preprint, that the MHI has submitted two patents related to colchicine: “Methods of treating a coronavirus infection using colchicine” and “Early administration of low-dose colchicine after myocardial infarction.”
Reached for clarification, MHI communications adviser Camille Turbide said in an interview that the first patent “simply refers to the novel concept of preventing complications of COVID-19, such as admission to the hospital, with colchicine as tested in the ColCORONA study.”
The second patent, she said, refers to the “novel concept that administering colchicine early after a major adverse cardiovascular event is better than waiting several days,” as supported by the COLCOT study, which Dr. Tardif also led.
The patents are being reviewed by authorities and “Dr. Tardif has waived his rights in these patents and does not stand to benefit financially at all if colchicine becomes used as a treatment for COVID-19,” Ms. Turbide said.
Dr. Tardif did not respond to interview requests for this story. Dr. Glatt said conflicts of interest must be assessed and are “something that is of great concern in any scientific study.”
Cardiologist Steve Nissen, MD, of the Cleveland Clinic said in an interview that, “despite the negative results, the study does suggest that colchicine might have a benefit and should be studied in future trials. These findings are not sufficient evidence to suggest use of the drug in patients infected with COVID-19.”
He noted that adverse effects like diarrhea were expected but that the excess PE was unexpected and needs greater clarification.
“Stopping the trial for administrative reasons is puzzling and undermined the ability of the trial to give a reliable answer,” Dr. Nissen said. “This is a reasonable pilot study that should be viewed as hypothesis generating but inconclusive.”
Several sources said a new trial is unlikely, particularly given the cost and 28 trials already evaluating colchicine. Among these are RECOVERY and COLCOVID, testing whether colchicine can reduce the duration of hospitalization or death in hospitalized patients with COVID-19.
Because there are so many trials ongoing right now, including for antivirals and other immunomodulators, it’s important that, if colchicine comes to routine clinical use, it provides access to treatment for those not able or willing to access clinical trials, rather than impeding clinical trial enrollment, Dr. Bender Ignacio suggested.
“We have already learned the lesson in the pandemic that early adoption of potentially promising therapies can negatively impact our ability to study and develop other promising treatments,” she said.
The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the National Heart, Lung, and Blood Institute of the National Institutes of Health; Montreal philanthropist Sophie Desmarais, and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators. Dr. Glatt reported no conflicts of interest. Dr. Boulware reported receiving $18 in food and beverages from Gilead Sciences in 2018.
A version of this article first appeared on Medscape.com.
Science by press release and preprint has cooled clinician enthusiasm for the use of colchicine in nonhospitalized patients with COVID-19, despite a pressing need for early treatments.
As previously reported by this news organization, a Jan. 22 press release announced that the massive ColCORONA study missed its primary endpoint of hospitalization or death among 4,488 newly diagnosed patients at increased risk for hospitalization.
But it also touted that use of the anti-inflammatory drug significantly reduced the primary endpoint in 4,159 of those patients with polymerase chain reaction–confirmed COVID and led to reductions of 25%, 50%, and 44%, respectively, for hospitalizations, ventilations, and death.
Lead investigator Jean-Claude Tardif, MD, director of the Montreal Heart Institute Research Centre, deemed the findings a “medical breakthrough.”
When the preprint released a few days later, however, newly revealed confidence intervals showed colchicine did not meaningfully reduce the need for mechanical ventilation (odds ratio, 0.50; 95% confidence interval, 0.23-1.07) or death alone (OR, 0.56; 95% CI, 0.19-1.66).
Further, the significant benefit on the primary outcome came at the cost of a fivefold increase in pulmonary embolism (11 vs. 2; P = .01), which was not mentioned in the press release.
“Whether this represents a real phenomenon or simply the play of chance is not known,” Dr. Tardif and colleagues noted later in the preprint.
“I read the preprint on colchicine and I have so many questions,” Aaron E. Glatt, MD, spokesperson for the Infectious Diseases Society of America and chief of infectious diseases, Mount Sinai South Nassau, Hewlett, N.Y., said in an interview. “I’ve been burned too many times with COVID and prefer to see better data.
“People sometimes say if you wait for perfect data, people are going to die,” he said. “Yeah, but we have no idea if people are going to die from getting this drug more than not getting it. That’s what concerns me. How many pulmonary emboli are going to be fatal versus the slight benefit that the study showed?”
The pushback to the non–peer-reviewed data on social media and via emails was so strong that Dr. Tardif posted a nearly 2,000-word letter responding to the many questions at play.
Chief among them was why the trial, originally planned for 6,000 patients, was stopped early by the investigators without consultation with the data safety monitoring board (DSMB).
The explanation in the letter that logistical issues like running the study call center, budget constraints, and a perceived need to quickly communicate the results left some calling foul that the study wasn’t allowed to finish and come to a more definitive conclusion.
“I can be a little bit sympathetic to their cause but at the same time the DSMB should have said no,” said David Boulware, MD, MPH, who led a recent hydroxychloroquine trial in COVID-19. “The problem is we’re sort of left in limbo, where some people kind of believe it and some say it’s not really a thing. So it’s not really moving the needle, as far as guidelines go.”
Indeed, a Twitter poll by cardiologist James Januzzi Jr., MD, captured the uncertainty, with 28% of respondents saying the trial was “neutral,” 58% saying “maybe but meh,” and 14% saying “colchicine for all.”
Another poll cheekily asked whether ColCORONA was the Gamestop/Reddit equivalent of COVID.
“The press release really didn’t help things because it very much oversold the effect. That, I think, poisoned the well,” said Dr. Boulware, professor of medicine in infectious diseases at the University of Minnesota, Minneapolis.
“The question I’m left with is not whether colchicine works, but who does it work in,” he said. “That’s really the fundamental question because it does seem that there are probably high-risk groups in their trial and others where they benefit, whereas other groups don’t benefit. In the subgroup analysis, there was absolutely no beneficial effect in women.”
According to the authors, the number needed to treat to prevent one death or hospitalization was 71 overall, but 29 for patients with diabetes, 31 for those aged 70 years and older, 53 for patients with respiratory disease, and 25 for those with coronary disease or heart failure.
Men are at higher risk overall for poor outcomes. But “the authors didn’t present a multivariable analysis, so it is unclear if another factor, such as a differential prevalence of smoking or cardiovascular risk factors, contributed to the differential benefit,” Rachel Bender Ignacio, MD, MPH, infectious disease specialist, University of Washington, Seattle, said in an interview.
Importantly, in this pragmatic study, duration and severity of symptoms were not reported, observed Dr. Bender Ignacio, who is also a STOP-COVID-2 investigator. “We don’t yet have data as to whether colchicine shortens duration or severity of symptoms or prevents long COVID, so we need more data on that.”
The overall risk for serious adverse events was lower in the colchicine group, but the difference in pulmonary embolism (PE) was striking, she said. This could be caused by a real biologic effect, or it’s possible that persons with shortness of breath and hypoxia, without evident viral pneumonia on chest x-ray after a positive COVID-19 test, were more likely to receive a CT-PE study.
The press release also failed to include information, later noted in the preprint, that the MHI has submitted two patents related to colchicine: “Methods of treating a coronavirus infection using colchicine” and “Early administration of low-dose colchicine after myocardial infarction.”
Reached for clarification, MHI communications adviser Camille Turbide said in an interview that the first patent “simply refers to the novel concept of preventing complications of COVID-19, such as admission to the hospital, with colchicine as tested in the ColCORONA study.”
The second patent, she said, refers to the “novel concept that administering colchicine early after a major adverse cardiovascular event is better than waiting several days,” as supported by the COLCOT study, which Dr. Tardif also led.
The patents are being reviewed by authorities and “Dr. Tardif has waived his rights in these patents and does not stand to benefit financially at all if colchicine becomes used as a treatment for COVID-19,” Ms. Turbide said.
Dr. Tardif did not respond to interview requests for this story. Dr. Glatt said conflicts of interest must be assessed and are “something that is of great concern in any scientific study.”
Cardiologist Steve Nissen, MD, of the Cleveland Clinic said in an interview that, “despite the negative results, the study does suggest that colchicine might have a benefit and should be studied in future trials. These findings are not sufficient evidence to suggest use of the drug in patients infected with COVID-19.”
He noted that adverse effects like diarrhea were expected but that the excess PE was unexpected and needs greater clarification.
“Stopping the trial for administrative reasons is puzzling and undermined the ability of the trial to give a reliable answer,” Dr. Nissen said. “This is a reasonable pilot study that should be viewed as hypothesis generating but inconclusive.”
Several sources said a new trial is unlikely, particularly given the cost and 28 trials already evaluating colchicine. Among these are RECOVERY and COLCOVID, testing whether colchicine can reduce the duration of hospitalization or death in hospitalized patients with COVID-19.
Because there are so many trials ongoing right now, including for antivirals and other immunomodulators, it’s important that, if colchicine comes to routine clinical use, it provides access to treatment for those not able or willing to access clinical trials, rather than impeding clinical trial enrollment, Dr. Bender Ignacio suggested.
“We have already learned the lesson in the pandemic that early adoption of potentially promising therapies can negatively impact our ability to study and develop other promising treatments,” she said.
The trial was coordinated by the Montreal Heart Institute and funded by the government of Quebec; the National Heart, Lung, and Blood Institute of the National Institutes of Health; Montreal philanthropist Sophie Desmarais, and the COVID-19 Therapeutics Accelerator launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. CGI, Dacima, and Pharmascience of Montreal were also collaborators. Dr. Glatt reported no conflicts of interest. Dr. Boulware reported receiving $18 in food and beverages from Gilead Sciences in 2018.
A version of this article first appeared on Medscape.com.