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FDA wants annual COVID boosters, just like annual flu shots
The U.S. Food and Drug Administration is suggesting a single annual shot. The formulation would be selected in June targeting the most threatening COVID-19 strains, and then people could get a shot in the fall when people begin spending more time indoors and exposure increases.
Some people, such as those who are older or immunocompromised, may need more than one dose.
A national advisory committee is expected to vote on the proposal at a meeting Jan. 26.
People in the United States have been much less likely to get an updated COVID-19 booster shot, compared with widespread uptake of the primary vaccine series. In its proposal, the FDA indicated it hoped a single annual shot would overcome challenges created by the complexity of the process – both in messaging and administration – attributed to that low booster rate. Nine in 10 people age 12 or older got the primary vaccine series in the United States, but only 15% got the latest booster shot for COVID-19.
About half of children and adults in the U.S. get an annual flu shot, according to Centers for Disease Control and Prevention data.
The FDA also wants to move to a single COVID-19 vaccine formulation that would be used for primary vaccine series and for booster shots.
COVID-19 cases, hospitalizations, and deaths are trending downward, according to the data tracker from the New York Times. Cases are down 28%, with 47,290 tallied daily. Hospitalizations are down 22%, with 37,474 daily. Deaths are down 4%, with an average of 489 per day as of Jan. 22.
A version of this article originally appeared on WebMD.com.
The U.S. Food and Drug Administration is suggesting a single annual shot. The formulation would be selected in June targeting the most threatening COVID-19 strains, and then people could get a shot in the fall when people begin spending more time indoors and exposure increases.
Some people, such as those who are older or immunocompromised, may need more than one dose.
A national advisory committee is expected to vote on the proposal at a meeting Jan. 26.
People in the United States have been much less likely to get an updated COVID-19 booster shot, compared with widespread uptake of the primary vaccine series. In its proposal, the FDA indicated it hoped a single annual shot would overcome challenges created by the complexity of the process – both in messaging and administration – attributed to that low booster rate. Nine in 10 people age 12 or older got the primary vaccine series in the United States, but only 15% got the latest booster shot for COVID-19.
About half of children and adults in the U.S. get an annual flu shot, according to Centers for Disease Control and Prevention data.
The FDA also wants to move to a single COVID-19 vaccine formulation that would be used for primary vaccine series and for booster shots.
COVID-19 cases, hospitalizations, and deaths are trending downward, according to the data tracker from the New York Times. Cases are down 28%, with 47,290 tallied daily. Hospitalizations are down 22%, with 37,474 daily. Deaths are down 4%, with an average of 489 per day as of Jan. 22.
A version of this article originally appeared on WebMD.com.
The U.S. Food and Drug Administration is suggesting a single annual shot. The formulation would be selected in June targeting the most threatening COVID-19 strains, and then people could get a shot in the fall when people begin spending more time indoors and exposure increases.
Some people, such as those who are older or immunocompromised, may need more than one dose.
A national advisory committee is expected to vote on the proposal at a meeting Jan. 26.
People in the United States have been much less likely to get an updated COVID-19 booster shot, compared with widespread uptake of the primary vaccine series. In its proposal, the FDA indicated it hoped a single annual shot would overcome challenges created by the complexity of the process – both in messaging and administration – attributed to that low booster rate. Nine in 10 people age 12 or older got the primary vaccine series in the United States, but only 15% got the latest booster shot for COVID-19.
About half of children and adults in the U.S. get an annual flu shot, according to Centers for Disease Control and Prevention data.
The FDA also wants to move to a single COVID-19 vaccine formulation that would be used for primary vaccine series and for booster shots.
COVID-19 cases, hospitalizations, and deaths are trending downward, according to the data tracker from the New York Times. Cases are down 28%, with 47,290 tallied daily. Hospitalizations are down 22%, with 37,474 daily. Deaths are down 4%, with an average of 489 per day as of Jan. 22.
A version of this article originally appeared on WebMD.com.
Canadian guidance recommends reducing alcohol consumption
“Drinking less is better,” says the guidance, which replaces Canada’s 2011 Low-Risk Drinking Guidelines (LRDGs).
Developed in consultation with an executive committee from federal, provincial, and territorial governments; national organizations; three scientific expert panels; and an internal evidence review working group, the guidance presents the following findings:
- Consuming no drinks per week has benefits, such as better health and better sleep, and it’s the only safe option during pregnancy.
- Consuming one or two standard drinks weekly will likely not have alcohol-related consequences.
- Three to six drinks raise the risk of developing breast, colon, and other cancers.
- Seven or more increase the risk of heart disease or stroke.
- Each additional drink “radically increases” the risk of these health consequences.
“Alcohol is more harmful than was previously thought and is a key component of the health of your patients,” Adam Sherk, PhD, a scientist at the Canadian Institute for Substance Use Research at the University of Victoria (B.C.), and a member of the scientific expert panel that contributed to the guidance, said in an interview. “Display and discuss the new guidance with your patients with the main message that drinking less is better.”
Peter Butt, MD, a clinical associate professor at the University of Saskatchewan, Saskatoon, and cochair of the guidance project, said in an interview: “The World Health Organization has identified over 200 ICD-coded conditions associated with alcohol use. This creates many opportunities to inquire into quantity and frequency of alcohol use, relate it to the patient’s health and well-being, and provide advice on reduction.”
“Canada’s Guidance on Alcohol and Health: Final Report” and a related infographic were published online Jan. 17.
Continuum of risk
The impetus for the new guidance came from the fact that “our 2011 LRDGs were no longer current, and there was emerging evidence that people drinking within those levels were coming to harm,” said Dr. Butt.
That evidence indicates that alcohol causes at least seven types of cancer, mostly of the breast or colon; is a risk factor for most types of heart disease; and is a main cause of liver disease. Evidence also indicates that avoiding drinking to the point of intoxication will reduce people’s risk of perpetrating alcohol-related violence.
Responding to the need to accurately quantify the risk, the guidance defines a “standard” drink as 12 oz of beer, cooler, or cider (5% alcohol); 5 oz of wine (12% alcohol); and 1.5 oz of spirits such as whiskey, vodka, or gin (40% alcohol).
Using different mortality risk thresholds, the project’s experts developed the following continuum of risk:
- Low for individuals who consume two standard drinks or fewer per week
- Moderate for those who consume from three to six standard drinks per week
- Increasingly high for those who consume seven standard drinks or more per week
The guidance makes the following observations:
- Consuming more than two standard drinks per drinking occasion is associated with an increased risk of harms to self and others, including injuries and violence.
- When pregnant or trying to get pregnant, no amount of alcohol is safe.
- When breastfeeding, not drinking is safest.
- Above the upper limit of the moderate risk zone, health risks increase more steeply for females than males.
- Far more injuries, violence, and deaths result from men’s alcohol use, especially for per occasion drinking, than from women’s alcohol use.
- Young people should delay alcohol use for as long as possible.
- Individuals should not start to use alcohol or increase their alcohol use for health benefits.
- Any reduction in alcohol use is beneficial.
Other national guidelines
“Countries that haven’t updated their alcohol use guidelines recently should do so, as the evidence regarding alcohol and health has advanced considerably in the past 10 years,” said Dr. Sherk. He acknowledged that “any time health guidance changes substantially, it’s reasonable to expect a period of readjustment.”
“Some will be resistant,” Dr. Butt agreed. “Some professionals will need more education than others on the health effects of alcohol. Some patients will also be more invested in drinking than others. The harm-reduction, risk-zone approach should assist in the process of engaging patients and helping them reduce over time.
“Just as we benefited from the updates done in the United Kingdom, France, and especially Australia, so also researchers elsewhere will critique our work and our approach and make their own decisions on how best to communicate with their public,” Dr. Butt said. He noted that Canada’s contributions regarding the association between alcohol and violence, as well as their sex/gender approach to the evidence, “may influence the next country’s review.”
Commenting on whether the United States should consider changing its guidance, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York, said in an interview, “A lot of people will be surprised at the recommended limits on alcohol. Most think that they can have one or two glasses of alcohol per day and not have any increased risk to their health. I think the Canadians deserve credit for putting themselves out there.”
Dr. Brennan said there will “certainly be pushback by the drinking lobby, which is very strong both in the U.S. and in Canada.” In fact, the national trade group Beer Canada was recently quoted as stating that it still supports the 2011 guidelines and that the updating process lacked full transparency and expert technical peer review.
Nevertheless, Dr. Brennan said, “it’s overwhelmingly clear that alcohol affects a ton of different parts of our body, so limiting the amount of alcohol we take in is always going to be a good thing. The Canadian graphic is great because it color-codes the risk. I recommend that clinicians put it up in their offices and begin quantifying the units of alcohol that are going into a patient’s body each day.”
A version of this article originally appeared on Medscape.com.
“Drinking less is better,” says the guidance, which replaces Canada’s 2011 Low-Risk Drinking Guidelines (LRDGs).
Developed in consultation with an executive committee from federal, provincial, and territorial governments; national organizations; three scientific expert panels; and an internal evidence review working group, the guidance presents the following findings:
- Consuming no drinks per week has benefits, such as better health and better sleep, and it’s the only safe option during pregnancy.
- Consuming one or two standard drinks weekly will likely not have alcohol-related consequences.
- Three to six drinks raise the risk of developing breast, colon, and other cancers.
- Seven or more increase the risk of heart disease or stroke.
- Each additional drink “radically increases” the risk of these health consequences.
“Alcohol is more harmful than was previously thought and is a key component of the health of your patients,” Adam Sherk, PhD, a scientist at the Canadian Institute for Substance Use Research at the University of Victoria (B.C.), and a member of the scientific expert panel that contributed to the guidance, said in an interview. “Display and discuss the new guidance with your patients with the main message that drinking less is better.”
Peter Butt, MD, a clinical associate professor at the University of Saskatchewan, Saskatoon, and cochair of the guidance project, said in an interview: “The World Health Organization has identified over 200 ICD-coded conditions associated with alcohol use. This creates many opportunities to inquire into quantity and frequency of alcohol use, relate it to the patient’s health and well-being, and provide advice on reduction.”
“Canada’s Guidance on Alcohol and Health: Final Report” and a related infographic were published online Jan. 17.
Continuum of risk
The impetus for the new guidance came from the fact that “our 2011 LRDGs were no longer current, and there was emerging evidence that people drinking within those levels were coming to harm,” said Dr. Butt.
That evidence indicates that alcohol causes at least seven types of cancer, mostly of the breast or colon; is a risk factor for most types of heart disease; and is a main cause of liver disease. Evidence also indicates that avoiding drinking to the point of intoxication will reduce people’s risk of perpetrating alcohol-related violence.
Responding to the need to accurately quantify the risk, the guidance defines a “standard” drink as 12 oz of beer, cooler, or cider (5% alcohol); 5 oz of wine (12% alcohol); and 1.5 oz of spirits such as whiskey, vodka, or gin (40% alcohol).
Using different mortality risk thresholds, the project’s experts developed the following continuum of risk:
- Low for individuals who consume two standard drinks or fewer per week
- Moderate for those who consume from three to six standard drinks per week
- Increasingly high for those who consume seven standard drinks or more per week
The guidance makes the following observations:
- Consuming more than two standard drinks per drinking occasion is associated with an increased risk of harms to self and others, including injuries and violence.
- When pregnant or trying to get pregnant, no amount of alcohol is safe.
- When breastfeeding, not drinking is safest.
- Above the upper limit of the moderate risk zone, health risks increase more steeply for females than males.
- Far more injuries, violence, and deaths result from men’s alcohol use, especially for per occasion drinking, than from women’s alcohol use.
- Young people should delay alcohol use for as long as possible.
- Individuals should not start to use alcohol or increase their alcohol use for health benefits.
- Any reduction in alcohol use is beneficial.
Other national guidelines
“Countries that haven’t updated their alcohol use guidelines recently should do so, as the evidence regarding alcohol and health has advanced considerably in the past 10 years,” said Dr. Sherk. He acknowledged that “any time health guidance changes substantially, it’s reasonable to expect a period of readjustment.”
“Some will be resistant,” Dr. Butt agreed. “Some professionals will need more education than others on the health effects of alcohol. Some patients will also be more invested in drinking than others. The harm-reduction, risk-zone approach should assist in the process of engaging patients and helping them reduce over time.
“Just as we benefited from the updates done in the United Kingdom, France, and especially Australia, so also researchers elsewhere will critique our work and our approach and make their own decisions on how best to communicate with their public,” Dr. Butt said. He noted that Canada’s contributions regarding the association between alcohol and violence, as well as their sex/gender approach to the evidence, “may influence the next country’s review.”
Commenting on whether the United States should consider changing its guidance, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York, said in an interview, “A lot of people will be surprised at the recommended limits on alcohol. Most think that they can have one or two glasses of alcohol per day and not have any increased risk to their health. I think the Canadians deserve credit for putting themselves out there.”
Dr. Brennan said there will “certainly be pushback by the drinking lobby, which is very strong both in the U.S. and in Canada.” In fact, the national trade group Beer Canada was recently quoted as stating that it still supports the 2011 guidelines and that the updating process lacked full transparency and expert technical peer review.
Nevertheless, Dr. Brennan said, “it’s overwhelmingly clear that alcohol affects a ton of different parts of our body, so limiting the amount of alcohol we take in is always going to be a good thing. The Canadian graphic is great because it color-codes the risk. I recommend that clinicians put it up in their offices and begin quantifying the units of alcohol that are going into a patient’s body each day.”
A version of this article originally appeared on Medscape.com.
“Drinking less is better,” says the guidance, which replaces Canada’s 2011 Low-Risk Drinking Guidelines (LRDGs).
Developed in consultation with an executive committee from federal, provincial, and territorial governments; national organizations; three scientific expert panels; and an internal evidence review working group, the guidance presents the following findings:
- Consuming no drinks per week has benefits, such as better health and better sleep, and it’s the only safe option during pregnancy.
- Consuming one or two standard drinks weekly will likely not have alcohol-related consequences.
- Three to six drinks raise the risk of developing breast, colon, and other cancers.
- Seven or more increase the risk of heart disease or stroke.
- Each additional drink “radically increases” the risk of these health consequences.
“Alcohol is more harmful than was previously thought and is a key component of the health of your patients,” Adam Sherk, PhD, a scientist at the Canadian Institute for Substance Use Research at the University of Victoria (B.C.), and a member of the scientific expert panel that contributed to the guidance, said in an interview. “Display and discuss the new guidance with your patients with the main message that drinking less is better.”
Peter Butt, MD, a clinical associate professor at the University of Saskatchewan, Saskatoon, and cochair of the guidance project, said in an interview: “The World Health Organization has identified over 200 ICD-coded conditions associated with alcohol use. This creates many opportunities to inquire into quantity and frequency of alcohol use, relate it to the patient’s health and well-being, and provide advice on reduction.”
“Canada’s Guidance on Alcohol and Health: Final Report” and a related infographic were published online Jan. 17.
Continuum of risk
The impetus for the new guidance came from the fact that “our 2011 LRDGs were no longer current, and there was emerging evidence that people drinking within those levels were coming to harm,” said Dr. Butt.
That evidence indicates that alcohol causes at least seven types of cancer, mostly of the breast or colon; is a risk factor for most types of heart disease; and is a main cause of liver disease. Evidence also indicates that avoiding drinking to the point of intoxication will reduce people’s risk of perpetrating alcohol-related violence.
Responding to the need to accurately quantify the risk, the guidance defines a “standard” drink as 12 oz of beer, cooler, or cider (5% alcohol); 5 oz of wine (12% alcohol); and 1.5 oz of spirits such as whiskey, vodka, or gin (40% alcohol).
Using different mortality risk thresholds, the project’s experts developed the following continuum of risk:
- Low for individuals who consume two standard drinks or fewer per week
- Moderate for those who consume from three to six standard drinks per week
- Increasingly high for those who consume seven standard drinks or more per week
The guidance makes the following observations:
- Consuming more than two standard drinks per drinking occasion is associated with an increased risk of harms to self and others, including injuries and violence.
- When pregnant or trying to get pregnant, no amount of alcohol is safe.
- When breastfeeding, not drinking is safest.
- Above the upper limit of the moderate risk zone, health risks increase more steeply for females than males.
- Far more injuries, violence, and deaths result from men’s alcohol use, especially for per occasion drinking, than from women’s alcohol use.
- Young people should delay alcohol use for as long as possible.
- Individuals should not start to use alcohol or increase their alcohol use for health benefits.
- Any reduction in alcohol use is beneficial.
Other national guidelines
“Countries that haven’t updated their alcohol use guidelines recently should do so, as the evidence regarding alcohol and health has advanced considerably in the past 10 years,” said Dr. Sherk. He acknowledged that “any time health guidance changes substantially, it’s reasonable to expect a period of readjustment.”
“Some will be resistant,” Dr. Butt agreed. “Some professionals will need more education than others on the health effects of alcohol. Some patients will also be more invested in drinking than others. The harm-reduction, risk-zone approach should assist in the process of engaging patients and helping them reduce over time.
“Just as we benefited from the updates done in the United Kingdom, France, and especially Australia, so also researchers elsewhere will critique our work and our approach and make their own decisions on how best to communicate with their public,” Dr. Butt said. He noted that Canada’s contributions regarding the association between alcohol and violence, as well as their sex/gender approach to the evidence, “may influence the next country’s review.”
Commenting on whether the United States should consider changing its guidance, Timothy Brennan, MD, MPH, chief of clinical services for the Addiction Institute of Mount Sinai Health System in New York, said in an interview, “A lot of people will be surprised at the recommended limits on alcohol. Most think that they can have one or two glasses of alcohol per day and not have any increased risk to their health. I think the Canadians deserve credit for putting themselves out there.”
Dr. Brennan said there will “certainly be pushback by the drinking lobby, which is very strong both in the U.S. and in Canada.” In fact, the national trade group Beer Canada was recently quoted as stating that it still supports the 2011 guidelines and that the updating process lacked full transparency and expert technical peer review.
Nevertheless, Dr. Brennan said, “it’s overwhelmingly clear that alcohol affects a ton of different parts of our body, so limiting the amount of alcohol we take in is always going to be a good thing. The Canadian graphic is great because it color-codes the risk. I recommend that clinicians put it up in their offices and begin quantifying the units of alcohol that are going into a patient’s body each day.”
A version of this article originally appeared on Medscape.com.
Concern grows over ‘medical assistance in dying for mental illness’ law
Canada already has the largest number of deaths by MAID of any nation, with 10,064 in 2021, a 32% increase from 2020. With the addition of serious mental illness (SMI) as an eligible category, the country is on track to have the most liberal assisted-death policy in the world.
Concerns about the additional number of patients who could become eligible for MAID, and a lack of evidence-backed standards from disability rights groups, mental health advocates, First Nations leaders, psychiatrists, and other mental health providers, seems to have led the Canadian government to give the proposed law some sober second thought.
“Listening to experts and Canadians, we believe this date needs to be temporarily delayed,” said David Lametti, Canada’s minister of Justice and attorney general of Canada; Jean-Yves Duclos, minister of Health; and Carolyn Bennett, minister of Mental Health and Addictions, in a Dec. 15, 2022, joint statement.
Canada’s Parliament – which approved the expansion – will now have to vote on whether to okay a pause on the legislation.
However, the Canadian Psychiatric Association has not been calling for a delay in the proposed legislation. In a November 2021 statement, the CPA said it “does not take a position on the legality or morality of MAID,” but added that to deny MAID to people with mental illness was discriminatory, and that, as it was the law, it must be followed.
“CPA has not taken a position about MAID,” the association’s president Gary Chaimowitz, MBChB, told this news organization. “We know this is coming and our organization is trying to get its members ready for what will be most likely the ability of people with mental conditions to be able to request MAID,” said Dr. Chaimowitz, who is also head of forensic psychiatry at St. Joseph’s Healthcare and a professor of psychiatry at McMaster University, both in Hamilton, Ont.
Dr. Chaimowitz acknowledges that “a majority of psychiatrists do not want to be involved in anything to do with MAID.”
“The idea, certainly in psychiatry, is to get people well and we’ve been taught that people dying from a major mental disorder is something that we’re trained to prevent,” he added.
A ‘clinical option’
Assisted medical death is especially fraught in psychiatry, said Rebecca Brendel, MD, president of the American Psychiatric Association. She noted a 25-year life expectancy gap between people with SMI and those who do not have such conditions.
“As a profession we have very serious obligations to advance treatment so that a person with serious mental illness can live [a] full, productive, and healthy [life],” Dr. Brendel, associate director of the Center for Bioethics at Harvard Medical School in Boston, said in an interview.
Under the Canadian proposal, psychiatrists would be allowed to suggest MAID as a “clinical option.”
Harold Braswell, PhD, a fellow with The Hastings Center, a bioethics research institute, calls that problematic.
“It’s not neutral to suggest to someone that it would be theoretically reasonable to end their lives,” Dr. Braswell, associate professor at the Albert Gnaegi Center for Health Care Ethics at Saint Louis University, told this news organization.
It also creates a double standard in the treatment of suicidal ideation, in which suicide prevention is absolute for some, but encouraging it as a possibility for others, he added.
“To have that come from an authority figure is something that’s very harsh and, in my opinion, very potentially destructive,” especially for vulnerable groups, like First Nations people, who already have elevated rates of suicide, said Dr. Braswell.
Fierce debate
Since 2016, Canada has allowed MAID for medical conditions and diseases that will not improve and in cases where the evidence shows that medical providers can accurately predict the condition will not improve.
However, in 2019, a Quebec court ruled that the law unconstitutionally barred euthanasia in people who were not terminally ill. In March 2021, Canada’s criminal code was amended to allow MAID for people whose natural death was not “reasonably foreseeable,” but it excluded SMI for a period of 2 years, ending in March 2023.
The 2-year stay was intended to allow for study and to give mental health providers and MAID assessors time to develop standards.
The federal government charged a 12-member expert panel with determining how to safely allow MAID for SMI. In its final report released in May 2022 it recommended that standards be developed.
The panel acknowledged that for many conditions it may be impossible to make predictions about whether an individual might improve. However, it did not mention SMI.
In those cases, when MAID is requested, “establishing incurability and irreversibility on the basis of the evolution and response to past interventions is necessary,” the panel noted, adding that these are the criteria used by psychiatrists assessing euthanasia requests in the Netherlands and Belgium.
But the notion that mental illness can be irremediable has been fiercely debated.
Soon after the expert report was released, the Center for Addiction and Mental Health in Toronto noted on its website that there are currently “no agreed upon standards for psychiatrists or other health care practitioners to use to determine if a person’s mental illness is ‘grievous and irremediable’ for the purposes of MAID.”
Dr. Chaimowitz acknowledged that “there’s no agreed-upon definition of incurability” in mental illness. Some psychiatrists “will argue that there’s always another treatment that can be attempted,” he said, adding that there has been a lack of consensus on irremediability among CPA members.
Protecting vulnerable populations
Matt Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora, said the question of irremediability is crucial. “Most people with mental illness do get better, especially if they’re in treatment,” Dr. Wynia said.
For MAID assessors it may be difficult to know when someone has tried all possible treatments, especially given the wide array of options, including psychedelics, said Dr. Wynia.
Dr. Braswell said there is not enough evidence that mental illness is incurable. With SMI, “there’s a lot more potential for the causes of the individual’s suffering to be ameliorated. By offering MAID, you’re going to kill people who might have been able to get out of this through other nonlethal means.”
Currently, MAID is provided for an irremediable medical condition, “in other words, a condition that will not improve and that we can predict will not improve,” said Karandeep S. Gaind, MD, chief of psychiatry at Toronto’s Humber River Hospital and physician chair of the hospital’s MAID team.
“If that’s the premise, then I think we cannot provide MAID for sole mental illness,” Dr. Gaind said. “Because we can’t honestly make those predictions” with mental illness, he added.
Dr. Gaind does not support MAID for mental illness and believes that it will put the vulnerable – including those living in poverty – at particular risk.
With the proposed expansion, MAID is “now becoming something which is being sought as a way to escape a painful life rather than to avoid a painful death,” said Dr. Gaind, who is also a past president of the CPA.
One member of the federal government’s expert panel – Ellen Cohen, who had a psychiatric condition – wrote in The Globe and Mail that she quit early on when it became apparent that the panel was not seriously considering her own experiences or the possibility that poverty and lack of access to care or social supports could strongly influence a request for MAID.
Social determinants of suffering
People with mental illness often are without homes, have substance use disorders, have been stigmatized and discriminated against, and have poor social supports, said Dr. Wynia. “You worry that it’s all of those things that are making them want to end their lives,” he said.
The Daily Mail ran a story in December 2022 about a 65-year-old Canadian who said he’d applied for MAID solely because of fears that his disability benefits for various chronic health conditions were being cut off and that he didn’t want to live in poverty.
A 51-year-old Ontario woman with multiple chemical sensitivities was granted MAID after she said she could not find housing that could keep her safe, according to an August report by CTV News.
Tarek Rajji, MD, chief of the Adult Neurodevelopment and Geriatric Psychiatry Division at CAMH, said social determinants of health need to be considered in standards created to guide MAID for mental illness.
“We’re very mindful of the fact that the suffering, that is, the grievousness that the person is living with, in the context of mental illness, many times is due to the social determinants of their illness and the social determinants of their suffering,” Dr. Rajji said.
Many are also concerned that it will be difficult to separate out suicidality from sheer hopelessness.
The CPA has advised a group that’s working on developing guidelines for MAID in SMI and is also developing a curriculum for mental health providers, Dr. Chaimowitz said. As part of that, there will be a process to ensure that someone who is actively suicidal is not granted MAID.
“I do not believe that it’s contemplated that MAID is going to accelerate or facilitate suicidal ideation,” he said. Someone who is suicidal will be referred to treatment, said Dr. Chaimowitz.
“People with depression often feel hopeless,” and may refuse treatments that have worked in the past, countered Dr. Gaind. Some of his patients “are absolutely convinced that nothing will help,” he said.
Troublesome cases
The expert panel said in its final report that “it is not possible to provide fixed rules for how many attempts at interventions, how many types of interventions, and over how much time,” are necessary to establish “irreversibility” of mental illness.
Dr. Chaimowitz said MAID will not be offered to anyone “refusing treatment for their condition without any good reason.” They will be “unlikely to meet criteria for incurable,” as they will have needed to avail themselves of the array of treatments available, he said.
That would be similar to rules in Belgium and the Netherlands, which allow euthanasia for psychiatric conditions.
An estimated 100-300 psychiatric patients receive euthanasia each year in those countries, according to a 2021 commentary in Psychiatric Times (Jun 7;38[6]) by Mark S. Komrad, MD, a Towson, Maryland-based psychiatrist.
There are still troublesome cases.
As previously reported by this news organization, many in Belgium were distressed recently at the news that a 23-year-old woman who had survived a terrorist attack, Shanti De Corte, requested and was granted euthanasia.
As the deadline for implementation of MAID grew closer, calls for delay grew louder, especially given the lack of concrete standards for providers.
During the waning months of 2022, Dr. Gaind – who said he was suspended from CPA for “unprofessional interactions” and allegedly misrepresenting CPA’s processes and governance matters – announced the launch of a new organization, the Society of Canadian Psychiatry, in November calling for a delay in MAID of at least 1 year so that evidence-based safeguards could be implemented. The petition has been signed by more than 200 psychiatrists, along with several dozen physicians, MAID assessors, and individuals with mental illness and family members.
The Association of Chairs of Psychiatry in Canada, the Canadian Association for Suicide Prevention, the Council of Canadians with Disabilities, a group of indigenous leaders, and the Ontario Association for ACT and FACT, psychiatrists who provide care to individuals with severe mental illness, among other groups, joined the call for a delay.
In its December announcement, the Canadian federal ministers said a factor in seeking a delay was that standards guiding clinicians would not be delivered until at least February – too close to when applications would be opened.
Upon hearing about the federal government’s intentions, the chair of the expert panel, Mona Gupta, MD, told The Canadian Press that she did not think it was necessary to put off implementation because necessary safeguards were already in place.
Dr. Chaimowitz awaits the standards but is optimistic that for mental illness, “the process will be tightly controlled, closely monitored, and open to scrutiny,” he said.
Dr. Braswell is not convinced. The concern is that adding people with mental illness is “going to overload the capacity of the government to monitor this practice,” he said.
Is the United States next?
Although Canada and the United States share a border, it’s unlikely that U.S. states will allow aid in dying for nonterminal illness, much less for psychiatric conditions any time soon, said Dr. Braswell and others.
Ten states – California, Colorado, Hawaii, Maine, Montana, New Jersey, New Mexico, Oregon, Vermont, and Washington – have laws allowing assistance in dying, but for terminal illness only.
In 2016, the APA adopted the American Medical Association policy on medical euthanasia, stating, “that a psychiatrist should not prescribe or administer any intervention to a nonterminally ill person for the purpose of causing death.”
Dr. Brendel said the field is acutely aware that people with mental illness do suffer, but that more work needs to be done – and is being done – on “distinguishing wishes to hasten death or end one’s life from these historical or traditional notions that any premature death is a suicide.”
There is also increasing discussion within the medical community, not just psychiatry, about a physician’s duty to relieve suffering, said Dr. Wynia. “There’s debate basically about whether we stand for preserving life essentially at all costs and never being involved in the taking of life, or whether we stand for reduction of suffering and being the advocate for the patients that we serve,” he said.
“Those are both legitimate,” said Dr. Wynia, adding, “there are good reasons to want both of those to be true.”
“I suspect that 20 years from now we will still be having conversations about how physicians, how psychiatrists ought to participate in preserving life and in shepherding death,” said Dr. Brendel.
But to Dr. Gaind, the debate is not just esoteric, it’s a soon-to-be reality in Canada. “When we’re providing death to people who aren’t dying, to me that’s like providing what amounts to a wrongful death,” he said.
A version of this article originally appeared on Medscape.com.
Canada already has the largest number of deaths by MAID of any nation, with 10,064 in 2021, a 32% increase from 2020. With the addition of serious mental illness (SMI) as an eligible category, the country is on track to have the most liberal assisted-death policy in the world.
Concerns about the additional number of patients who could become eligible for MAID, and a lack of evidence-backed standards from disability rights groups, mental health advocates, First Nations leaders, psychiatrists, and other mental health providers, seems to have led the Canadian government to give the proposed law some sober second thought.
“Listening to experts and Canadians, we believe this date needs to be temporarily delayed,” said David Lametti, Canada’s minister of Justice and attorney general of Canada; Jean-Yves Duclos, minister of Health; and Carolyn Bennett, minister of Mental Health and Addictions, in a Dec. 15, 2022, joint statement.
Canada’s Parliament – which approved the expansion – will now have to vote on whether to okay a pause on the legislation.
However, the Canadian Psychiatric Association has not been calling for a delay in the proposed legislation. In a November 2021 statement, the CPA said it “does not take a position on the legality or morality of MAID,” but added that to deny MAID to people with mental illness was discriminatory, and that, as it was the law, it must be followed.
“CPA has not taken a position about MAID,” the association’s president Gary Chaimowitz, MBChB, told this news organization. “We know this is coming and our organization is trying to get its members ready for what will be most likely the ability of people with mental conditions to be able to request MAID,” said Dr. Chaimowitz, who is also head of forensic psychiatry at St. Joseph’s Healthcare and a professor of psychiatry at McMaster University, both in Hamilton, Ont.
Dr. Chaimowitz acknowledges that “a majority of psychiatrists do not want to be involved in anything to do with MAID.”
“The idea, certainly in psychiatry, is to get people well and we’ve been taught that people dying from a major mental disorder is something that we’re trained to prevent,” he added.
A ‘clinical option’
Assisted medical death is especially fraught in psychiatry, said Rebecca Brendel, MD, president of the American Psychiatric Association. She noted a 25-year life expectancy gap between people with SMI and those who do not have such conditions.
“As a profession we have very serious obligations to advance treatment so that a person with serious mental illness can live [a] full, productive, and healthy [life],” Dr. Brendel, associate director of the Center for Bioethics at Harvard Medical School in Boston, said in an interview.
Under the Canadian proposal, psychiatrists would be allowed to suggest MAID as a “clinical option.”
Harold Braswell, PhD, a fellow with The Hastings Center, a bioethics research institute, calls that problematic.
“It’s not neutral to suggest to someone that it would be theoretically reasonable to end their lives,” Dr. Braswell, associate professor at the Albert Gnaegi Center for Health Care Ethics at Saint Louis University, told this news organization.
It also creates a double standard in the treatment of suicidal ideation, in which suicide prevention is absolute for some, but encouraging it as a possibility for others, he added.
“To have that come from an authority figure is something that’s very harsh and, in my opinion, very potentially destructive,” especially for vulnerable groups, like First Nations people, who already have elevated rates of suicide, said Dr. Braswell.
Fierce debate
Since 2016, Canada has allowed MAID for medical conditions and diseases that will not improve and in cases where the evidence shows that medical providers can accurately predict the condition will not improve.
However, in 2019, a Quebec court ruled that the law unconstitutionally barred euthanasia in people who were not terminally ill. In March 2021, Canada’s criminal code was amended to allow MAID for people whose natural death was not “reasonably foreseeable,” but it excluded SMI for a period of 2 years, ending in March 2023.
The 2-year stay was intended to allow for study and to give mental health providers and MAID assessors time to develop standards.
The federal government charged a 12-member expert panel with determining how to safely allow MAID for SMI. In its final report released in May 2022 it recommended that standards be developed.
The panel acknowledged that for many conditions it may be impossible to make predictions about whether an individual might improve. However, it did not mention SMI.
In those cases, when MAID is requested, “establishing incurability and irreversibility on the basis of the evolution and response to past interventions is necessary,” the panel noted, adding that these are the criteria used by psychiatrists assessing euthanasia requests in the Netherlands and Belgium.
But the notion that mental illness can be irremediable has been fiercely debated.
Soon after the expert report was released, the Center for Addiction and Mental Health in Toronto noted on its website that there are currently “no agreed upon standards for psychiatrists or other health care practitioners to use to determine if a person’s mental illness is ‘grievous and irremediable’ for the purposes of MAID.”
Dr. Chaimowitz acknowledged that “there’s no agreed-upon definition of incurability” in mental illness. Some psychiatrists “will argue that there’s always another treatment that can be attempted,” he said, adding that there has been a lack of consensus on irremediability among CPA members.
Protecting vulnerable populations
Matt Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora, said the question of irremediability is crucial. “Most people with mental illness do get better, especially if they’re in treatment,” Dr. Wynia said.
For MAID assessors it may be difficult to know when someone has tried all possible treatments, especially given the wide array of options, including psychedelics, said Dr. Wynia.
Dr. Braswell said there is not enough evidence that mental illness is incurable. With SMI, “there’s a lot more potential for the causes of the individual’s suffering to be ameliorated. By offering MAID, you’re going to kill people who might have been able to get out of this through other nonlethal means.”
Currently, MAID is provided for an irremediable medical condition, “in other words, a condition that will not improve and that we can predict will not improve,” said Karandeep S. Gaind, MD, chief of psychiatry at Toronto’s Humber River Hospital and physician chair of the hospital’s MAID team.
“If that’s the premise, then I think we cannot provide MAID for sole mental illness,” Dr. Gaind said. “Because we can’t honestly make those predictions” with mental illness, he added.
Dr. Gaind does not support MAID for mental illness and believes that it will put the vulnerable – including those living in poverty – at particular risk.
With the proposed expansion, MAID is “now becoming something which is being sought as a way to escape a painful life rather than to avoid a painful death,” said Dr. Gaind, who is also a past president of the CPA.
One member of the federal government’s expert panel – Ellen Cohen, who had a psychiatric condition – wrote in The Globe and Mail that she quit early on when it became apparent that the panel was not seriously considering her own experiences or the possibility that poverty and lack of access to care or social supports could strongly influence a request for MAID.
Social determinants of suffering
People with mental illness often are without homes, have substance use disorders, have been stigmatized and discriminated against, and have poor social supports, said Dr. Wynia. “You worry that it’s all of those things that are making them want to end their lives,” he said.
The Daily Mail ran a story in December 2022 about a 65-year-old Canadian who said he’d applied for MAID solely because of fears that his disability benefits for various chronic health conditions were being cut off and that he didn’t want to live in poverty.
A 51-year-old Ontario woman with multiple chemical sensitivities was granted MAID after she said she could not find housing that could keep her safe, according to an August report by CTV News.
Tarek Rajji, MD, chief of the Adult Neurodevelopment and Geriatric Psychiatry Division at CAMH, said social determinants of health need to be considered in standards created to guide MAID for mental illness.
“We’re very mindful of the fact that the suffering, that is, the grievousness that the person is living with, in the context of mental illness, many times is due to the social determinants of their illness and the social determinants of their suffering,” Dr. Rajji said.
Many are also concerned that it will be difficult to separate out suicidality from sheer hopelessness.
The CPA has advised a group that’s working on developing guidelines for MAID in SMI and is also developing a curriculum for mental health providers, Dr. Chaimowitz said. As part of that, there will be a process to ensure that someone who is actively suicidal is not granted MAID.
“I do not believe that it’s contemplated that MAID is going to accelerate or facilitate suicidal ideation,” he said. Someone who is suicidal will be referred to treatment, said Dr. Chaimowitz.
“People with depression often feel hopeless,” and may refuse treatments that have worked in the past, countered Dr. Gaind. Some of his patients “are absolutely convinced that nothing will help,” he said.
Troublesome cases
The expert panel said in its final report that “it is not possible to provide fixed rules for how many attempts at interventions, how many types of interventions, and over how much time,” are necessary to establish “irreversibility” of mental illness.
Dr. Chaimowitz said MAID will not be offered to anyone “refusing treatment for their condition without any good reason.” They will be “unlikely to meet criteria for incurable,” as they will have needed to avail themselves of the array of treatments available, he said.
That would be similar to rules in Belgium and the Netherlands, which allow euthanasia for psychiatric conditions.
An estimated 100-300 psychiatric patients receive euthanasia each year in those countries, according to a 2021 commentary in Psychiatric Times (Jun 7;38[6]) by Mark S. Komrad, MD, a Towson, Maryland-based psychiatrist.
There are still troublesome cases.
As previously reported by this news organization, many in Belgium were distressed recently at the news that a 23-year-old woman who had survived a terrorist attack, Shanti De Corte, requested and was granted euthanasia.
As the deadline for implementation of MAID grew closer, calls for delay grew louder, especially given the lack of concrete standards for providers.
During the waning months of 2022, Dr. Gaind – who said he was suspended from CPA for “unprofessional interactions” and allegedly misrepresenting CPA’s processes and governance matters – announced the launch of a new organization, the Society of Canadian Psychiatry, in November calling for a delay in MAID of at least 1 year so that evidence-based safeguards could be implemented. The petition has been signed by more than 200 psychiatrists, along with several dozen physicians, MAID assessors, and individuals with mental illness and family members.
The Association of Chairs of Psychiatry in Canada, the Canadian Association for Suicide Prevention, the Council of Canadians with Disabilities, a group of indigenous leaders, and the Ontario Association for ACT and FACT, psychiatrists who provide care to individuals with severe mental illness, among other groups, joined the call for a delay.
In its December announcement, the Canadian federal ministers said a factor in seeking a delay was that standards guiding clinicians would not be delivered until at least February – too close to when applications would be opened.
Upon hearing about the federal government’s intentions, the chair of the expert panel, Mona Gupta, MD, told The Canadian Press that she did not think it was necessary to put off implementation because necessary safeguards were already in place.
Dr. Chaimowitz awaits the standards but is optimistic that for mental illness, “the process will be tightly controlled, closely monitored, and open to scrutiny,” he said.
Dr. Braswell is not convinced. The concern is that adding people with mental illness is “going to overload the capacity of the government to monitor this practice,” he said.
Is the United States next?
Although Canada and the United States share a border, it’s unlikely that U.S. states will allow aid in dying for nonterminal illness, much less for psychiatric conditions any time soon, said Dr. Braswell and others.
Ten states – California, Colorado, Hawaii, Maine, Montana, New Jersey, New Mexico, Oregon, Vermont, and Washington – have laws allowing assistance in dying, but for terminal illness only.
In 2016, the APA adopted the American Medical Association policy on medical euthanasia, stating, “that a psychiatrist should not prescribe or administer any intervention to a nonterminally ill person for the purpose of causing death.”
Dr. Brendel said the field is acutely aware that people with mental illness do suffer, but that more work needs to be done – and is being done – on “distinguishing wishes to hasten death or end one’s life from these historical or traditional notions that any premature death is a suicide.”
There is also increasing discussion within the medical community, not just psychiatry, about a physician’s duty to relieve suffering, said Dr. Wynia. “There’s debate basically about whether we stand for preserving life essentially at all costs and never being involved in the taking of life, or whether we stand for reduction of suffering and being the advocate for the patients that we serve,” he said.
“Those are both legitimate,” said Dr. Wynia, adding, “there are good reasons to want both of those to be true.”
“I suspect that 20 years from now we will still be having conversations about how physicians, how psychiatrists ought to participate in preserving life and in shepherding death,” said Dr. Brendel.
But to Dr. Gaind, the debate is not just esoteric, it’s a soon-to-be reality in Canada. “When we’re providing death to people who aren’t dying, to me that’s like providing what amounts to a wrongful death,” he said.
A version of this article originally appeared on Medscape.com.
Canada already has the largest number of deaths by MAID of any nation, with 10,064 in 2021, a 32% increase from 2020. With the addition of serious mental illness (SMI) as an eligible category, the country is on track to have the most liberal assisted-death policy in the world.
Concerns about the additional number of patients who could become eligible for MAID, and a lack of evidence-backed standards from disability rights groups, mental health advocates, First Nations leaders, psychiatrists, and other mental health providers, seems to have led the Canadian government to give the proposed law some sober second thought.
“Listening to experts and Canadians, we believe this date needs to be temporarily delayed,” said David Lametti, Canada’s minister of Justice and attorney general of Canada; Jean-Yves Duclos, minister of Health; and Carolyn Bennett, minister of Mental Health and Addictions, in a Dec. 15, 2022, joint statement.
Canada’s Parliament – which approved the expansion – will now have to vote on whether to okay a pause on the legislation.
However, the Canadian Psychiatric Association has not been calling for a delay in the proposed legislation. In a November 2021 statement, the CPA said it “does not take a position on the legality or morality of MAID,” but added that to deny MAID to people with mental illness was discriminatory, and that, as it was the law, it must be followed.
“CPA has not taken a position about MAID,” the association’s president Gary Chaimowitz, MBChB, told this news organization. “We know this is coming and our organization is trying to get its members ready for what will be most likely the ability of people with mental conditions to be able to request MAID,” said Dr. Chaimowitz, who is also head of forensic psychiatry at St. Joseph’s Healthcare and a professor of psychiatry at McMaster University, both in Hamilton, Ont.
Dr. Chaimowitz acknowledges that “a majority of psychiatrists do not want to be involved in anything to do with MAID.”
“The idea, certainly in psychiatry, is to get people well and we’ve been taught that people dying from a major mental disorder is something that we’re trained to prevent,” he added.
A ‘clinical option’
Assisted medical death is especially fraught in psychiatry, said Rebecca Brendel, MD, president of the American Psychiatric Association. She noted a 25-year life expectancy gap between people with SMI and those who do not have such conditions.
“As a profession we have very serious obligations to advance treatment so that a person with serious mental illness can live [a] full, productive, and healthy [life],” Dr. Brendel, associate director of the Center for Bioethics at Harvard Medical School in Boston, said in an interview.
Under the Canadian proposal, psychiatrists would be allowed to suggest MAID as a “clinical option.”
Harold Braswell, PhD, a fellow with The Hastings Center, a bioethics research institute, calls that problematic.
“It’s not neutral to suggest to someone that it would be theoretically reasonable to end their lives,” Dr. Braswell, associate professor at the Albert Gnaegi Center for Health Care Ethics at Saint Louis University, told this news organization.
It also creates a double standard in the treatment of suicidal ideation, in which suicide prevention is absolute for some, but encouraging it as a possibility for others, he added.
“To have that come from an authority figure is something that’s very harsh and, in my opinion, very potentially destructive,” especially for vulnerable groups, like First Nations people, who already have elevated rates of suicide, said Dr. Braswell.
Fierce debate
Since 2016, Canada has allowed MAID for medical conditions and diseases that will not improve and in cases where the evidence shows that medical providers can accurately predict the condition will not improve.
However, in 2019, a Quebec court ruled that the law unconstitutionally barred euthanasia in people who were not terminally ill. In March 2021, Canada’s criminal code was amended to allow MAID for people whose natural death was not “reasonably foreseeable,” but it excluded SMI for a period of 2 years, ending in March 2023.
The 2-year stay was intended to allow for study and to give mental health providers and MAID assessors time to develop standards.
The federal government charged a 12-member expert panel with determining how to safely allow MAID for SMI. In its final report released in May 2022 it recommended that standards be developed.
The panel acknowledged that for many conditions it may be impossible to make predictions about whether an individual might improve. However, it did not mention SMI.
In those cases, when MAID is requested, “establishing incurability and irreversibility on the basis of the evolution and response to past interventions is necessary,” the panel noted, adding that these are the criteria used by psychiatrists assessing euthanasia requests in the Netherlands and Belgium.
But the notion that mental illness can be irremediable has been fiercely debated.
Soon after the expert report was released, the Center for Addiction and Mental Health in Toronto noted on its website that there are currently “no agreed upon standards for psychiatrists or other health care practitioners to use to determine if a person’s mental illness is ‘grievous and irremediable’ for the purposes of MAID.”
Dr. Chaimowitz acknowledged that “there’s no agreed-upon definition of incurability” in mental illness. Some psychiatrists “will argue that there’s always another treatment that can be attempted,” he said, adding that there has been a lack of consensus on irremediability among CPA members.
Protecting vulnerable populations
Matt Wynia, MD, MPH, FACP, director of the Center for Bioethics and Humanities at the University of Colorado at Denver, Aurora, said the question of irremediability is crucial. “Most people with mental illness do get better, especially if they’re in treatment,” Dr. Wynia said.
For MAID assessors it may be difficult to know when someone has tried all possible treatments, especially given the wide array of options, including psychedelics, said Dr. Wynia.
Dr. Braswell said there is not enough evidence that mental illness is incurable. With SMI, “there’s a lot more potential for the causes of the individual’s suffering to be ameliorated. By offering MAID, you’re going to kill people who might have been able to get out of this through other nonlethal means.”
Currently, MAID is provided for an irremediable medical condition, “in other words, a condition that will not improve and that we can predict will not improve,” said Karandeep S. Gaind, MD, chief of psychiatry at Toronto’s Humber River Hospital and physician chair of the hospital’s MAID team.
“If that’s the premise, then I think we cannot provide MAID for sole mental illness,” Dr. Gaind said. “Because we can’t honestly make those predictions” with mental illness, he added.
Dr. Gaind does not support MAID for mental illness and believes that it will put the vulnerable – including those living in poverty – at particular risk.
With the proposed expansion, MAID is “now becoming something which is being sought as a way to escape a painful life rather than to avoid a painful death,” said Dr. Gaind, who is also a past president of the CPA.
One member of the federal government’s expert panel – Ellen Cohen, who had a psychiatric condition – wrote in The Globe and Mail that she quit early on when it became apparent that the panel was not seriously considering her own experiences or the possibility that poverty and lack of access to care or social supports could strongly influence a request for MAID.
Social determinants of suffering
People with mental illness often are without homes, have substance use disorders, have been stigmatized and discriminated against, and have poor social supports, said Dr. Wynia. “You worry that it’s all of those things that are making them want to end their lives,” he said.
The Daily Mail ran a story in December 2022 about a 65-year-old Canadian who said he’d applied for MAID solely because of fears that his disability benefits for various chronic health conditions were being cut off and that he didn’t want to live in poverty.
A 51-year-old Ontario woman with multiple chemical sensitivities was granted MAID after she said she could not find housing that could keep her safe, according to an August report by CTV News.
Tarek Rajji, MD, chief of the Adult Neurodevelopment and Geriatric Psychiatry Division at CAMH, said social determinants of health need to be considered in standards created to guide MAID for mental illness.
“We’re very mindful of the fact that the suffering, that is, the grievousness that the person is living with, in the context of mental illness, many times is due to the social determinants of their illness and the social determinants of their suffering,” Dr. Rajji said.
Many are also concerned that it will be difficult to separate out suicidality from sheer hopelessness.
The CPA has advised a group that’s working on developing guidelines for MAID in SMI and is also developing a curriculum for mental health providers, Dr. Chaimowitz said. As part of that, there will be a process to ensure that someone who is actively suicidal is not granted MAID.
“I do not believe that it’s contemplated that MAID is going to accelerate or facilitate suicidal ideation,” he said. Someone who is suicidal will be referred to treatment, said Dr. Chaimowitz.
“People with depression often feel hopeless,” and may refuse treatments that have worked in the past, countered Dr. Gaind. Some of his patients “are absolutely convinced that nothing will help,” he said.
Troublesome cases
The expert panel said in its final report that “it is not possible to provide fixed rules for how many attempts at interventions, how many types of interventions, and over how much time,” are necessary to establish “irreversibility” of mental illness.
Dr. Chaimowitz said MAID will not be offered to anyone “refusing treatment for their condition without any good reason.” They will be “unlikely to meet criteria for incurable,” as they will have needed to avail themselves of the array of treatments available, he said.
That would be similar to rules in Belgium and the Netherlands, which allow euthanasia for psychiatric conditions.
An estimated 100-300 psychiatric patients receive euthanasia each year in those countries, according to a 2021 commentary in Psychiatric Times (Jun 7;38[6]) by Mark S. Komrad, MD, a Towson, Maryland-based psychiatrist.
There are still troublesome cases.
As previously reported by this news organization, many in Belgium were distressed recently at the news that a 23-year-old woman who had survived a terrorist attack, Shanti De Corte, requested and was granted euthanasia.
As the deadline for implementation of MAID grew closer, calls for delay grew louder, especially given the lack of concrete standards for providers.
During the waning months of 2022, Dr. Gaind – who said he was suspended from CPA for “unprofessional interactions” and allegedly misrepresenting CPA’s processes and governance matters – announced the launch of a new organization, the Society of Canadian Psychiatry, in November calling for a delay in MAID of at least 1 year so that evidence-based safeguards could be implemented. The petition has been signed by more than 200 psychiatrists, along with several dozen physicians, MAID assessors, and individuals with mental illness and family members.
The Association of Chairs of Psychiatry in Canada, the Canadian Association for Suicide Prevention, the Council of Canadians with Disabilities, a group of indigenous leaders, and the Ontario Association for ACT and FACT, psychiatrists who provide care to individuals with severe mental illness, among other groups, joined the call for a delay.
In its December announcement, the Canadian federal ministers said a factor in seeking a delay was that standards guiding clinicians would not be delivered until at least February – too close to when applications would be opened.
Upon hearing about the federal government’s intentions, the chair of the expert panel, Mona Gupta, MD, told The Canadian Press that she did not think it was necessary to put off implementation because necessary safeguards were already in place.
Dr. Chaimowitz awaits the standards but is optimistic that for mental illness, “the process will be tightly controlled, closely monitored, and open to scrutiny,” he said.
Dr. Braswell is not convinced. The concern is that adding people with mental illness is “going to overload the capacity of the government to monitor this practice,” he said.
Is the United States next?
Although Canada and the United States share a border, it’s unlikely that U.S. states will allow aid in dying for nonterminal illness, much less for psychiatric conditions any time soon, said Dr. Braswell and others.
Ten states – California, Colorado, Hawaii, Maine, Montana, New Jersey, New Mexico, Oregon, Vermont, and Washington – have laws allowing assistance in dying, but for terminal illness only.
In 2016, the APA adopted the American Medical Association policy on medical euthanasia, stating, “that a psychiatrist should not prescribe or administer any intervention to a nonterminally ill person for the purpose of causing death.”
Dr. Brendel said the field is acutely aware that people with mental illness do suffer, but that more work needs to be done – and is being done – on “distinguishing wishes to hasten death or end one’s life from these historical or traditional notions that any premature death is a suicide.”
There is also increasing discussion within the medical community, not just psychiatry, about a physician’s duty to relieve suffering, said Dr. Wynia. “There’s debate basically about whether we stand for preserving life essentially at all costs and never being involved in the taking of life, or whether we stand for reduction of suffering and being the advocate for the patients that we serve,” he said.
“Those are both legitimate,” said Dr. Wynia, adding, “there are good reasons to want both of those to be true.”
“I suspect that 20 years from now we will still be having conversations about how physicians, how psychiatrists ought to participate in preserving life and in shepherding death,” said Dr. Brendel.
But to Dr. Gaind, the debate is not just esoteric, it’s a soon-to-be reality in Canada. “When we’re providing death to people who aren’t dying, to me that’s like providing what amounts to a wrongful death,” he said.
A version of this article originally appeared on Medscape.com.
Transgender people in rural America struggle to find doctors willing or able to provide care
For Tammy Rainey, finding a health care provider who knows about gender-affirming care has been a challenge in the rural northern Mississippi town where she lives.
As a transgender woman, Ms. Rainey needs the hormone estrogen, which allows her to physically transition by developing more feminine features. But when she asked her doctor for an estrogen prescription, he said he couldn’t provide that type of care.
“He’s generally a good guy and doesn’t act prejudiced. He gets my name and pronouns right,” said Ms. Rainey. “But when I asked him about hormones, he said, ‘I just don’t feel like I know enough about that. I don’t want to get involved in that.’ ”
So Ms. Rainey drives around 170 miles round trip every 6 months to get a supply of estrogen from a clinic in Memphis, Tenn., to take home with her.
The obstacles Ms. Rainey overcomes to access care illustrate a type of medical inequity that transgender people who live in the rural United States often face: A general lack of education about trans-related care among small-town health professionals who might also be reluctant to learn.
“Medical communities across the country are seeing clearly that there is a knowledge gap in the provision of gender-affirming care,” said Morissa Ladinsky, MD, a pediatrician who co-leads the Youth Multidisciplinary Gender Team at the University of Alabama–Birmingham (UAB).
Accurately counting the number of transgender people in rural America is hindered by a lack of U.S. census data and uniform state data. However, the Movement Advancement Project, a nonprofit organization that advocates for LGBTQ+ issues, used 2014-17 Centers for Disease Control and Prevention data from selected ZIP codes in 35 states to estimate that roughly one in six transgender adults in the United States live in a rural area. When that report was released in 2019, there were an estimated 1.4 million transgender people 13 and older nationwide. That number is now at least 1.6 million, according to the Williams Institute, a nonprofit think tank at the UCLA School of Law.
One in three trans people in rural areas experienced discrimination by a health care provider in the year leading up to the 2015 U.S. Transgender Survey Report, according to an analysis by MAP. A third of all trans individuals report having to teach their doctors about their health care needs to receive appropriate care, and 62% worry about being negatively judged by a health care provider because of their sexual orientation or gender identity, according to data collected by the Williams Institute and other organizations.
A lack of local rural providers knowledgeable in trans care can mean long drives to gender-affirming clinics in metropolitan areas. Rural trans people are three times as likely as are all transgender adults to travel 25-49 miles for routine care.
In Colorado, for example, many trans people outside Denver struggle to find proper care. Those who do have a trans-inclusive provider are more likely to receive wellness exams, less likely to delay care due to discrimination, and less likely to attempt suicide, according to results from the Colorado Transgender Health Survey published in 2018.
Much of the lack of care experienced by trans people is linked to insufficient education on LGBTQ+ health in medical schools across the country. In 2014, the Association of American Medical Colleges, which represents 170 accredited medical schools in the United States and Canada, released its first curriculum guidelines on caring for LGBTQ+ patients. As of 2018, 76% of medical schools included LGBTQ health themes in their curriculum, with half providing three or fewer classes on this topic.
Perhaps because of this, almost 77% of students from 10 medical schools in New England felt “not competent” or “somewhat not competent” in treating gender minority patients, according to a 2018 pilot study. Another paper, published last year, found that even clinicians who work in trans-friendly clinics lack knowledge about hormones, gender-affirming surgical options, and how to use appropriate pronouns and trans-inclusive language.
Throughout medical school, trans care was only briefly mentioned in endocrinology class, said Justin Bailey, MD, who received his medical degree from UAB in 2021 and is now a resident there. “I don’t want to say the wrong thing or use the wrong pronouns, so I was hesitant and a little bit tepid in my approach to interviewing and treating this population of patients,” he said.
On top of insufficient medical school education, some practicing doctors don’t take the time to teach themselves about trans people, said Kathie Moehlig, founder of TransFamily Support Services, a nonprofit organization that offers a range of services to transgender people and their families. They are very well intentioned yet uneducated when it comes to transgender care, she said.
Some medical schools, like the one at UAB, have pushed for change. Since 2017, Dr. Ladinsky and her colleagues have worked to include trans people in their standardized patient program, which gives medical students hands-on experience and feedback by interacting with “patients” in simulated clinical environments.
For example, a trans individual acting as a patient will simulate acid reflux by pretending to have pain in their stomach and chest. Then, over the course of the examination, they will reveal that they are transgender.
In the early years of this program, some students’ bedside manner would change once the patient’s gender identity was revealed, said Elaine Stephens, a trans woman who participates in UAB’s standardized patient program. “Sometimes they would immediately start asking about sexual activity,” Stephens said.
Since UAB launched its program, students’ reactions have improved significantly, she said.
This progress is being replicated by other medical schools, said Ms. Moehlig. “But it’s a slow start, and these are large institutions that take a long time to move forward.”
Advocates also are working outside medical schools to improve care in rural areas. In Colorado, the nonprofit Extension for Community Health Outcomes, or ECHO Colorado, has been offering monthly virtual classes on gender-affirming care to rural providers since 2020. The classes became so popular that the organization created a 4-week boot camp in 2021 for providers to learn about hormone therapy management, proper terminologies, surgical options, and supporting patients’ mental health.
For many years, doctors failed to recognize the need to learn about gender-affirming care, said Caroline Kirsch, DO, director of osteopathic education at the University of Wyoming Family Medicine Residency Program–Casper. In Casper, this led to “a number of patients traveling to Colorado to access care, which is a large burden for them financially,” said Dr. Kirsch, who has participated in the ECHO Colorado program.
“Things that haven’t been as well taught historically in medical school are things that I think many physicians feel anxious about initially,” she said. “The earlier you learn about this type of care in your career, the more likely you are to see its potential and be less anxious about it.”
Educating more providers about trans-related care has become increasingly vital in recent years as gender-affirming clinics nationwide experience a rise in harassment and threats. For instance, Vanderbilt University Medical Center’s Clinic for Transgender Health became the target of far-right hate on social media last year. After growing pressure from Tennessee’s Republican lawmakers, the clinic paused gender-affirmation surgeries on patients younger than 18, potentially leaving many trans individuals without necessary care.
Stephens hopes to see more medical schools include coursework on trans health care. She also wishes for doctors to treat trans people as they would any other patient.
“Just provide quality health care,” she tells the medical students at UAB. “We need health care like everyone else does.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
For Tammy Rainey, finding a health care provider who knows about gender-affirming care has been a challenge in the rural northern Mississippi town where she lives.
As a transgender woman, Ms. Rainey needs the hormone estrogen, which allows her to physically transition by developing more feminine features. But when she asked her doctor for an estrogen prescription, he said he couldn’t provide that type of care.
“He’s generally a good guy and doesn’t act prejudiced. He gets my name and pronouns right,” said Ms. Rainey. “But when I asked him about hormones, he said, ‘I just don’t feel like I know enough about that. I don’t want to get involved in that.’ ”
So Ms. Rainey drives around 170 miles round trip every 6 months to get a supply of estrogen from a clinic in Memphis, Tenn., to take home with her.
The obstacles Ms. Rainey overcomes to access care illustrate a type of medical inequity that transgender people who live in the rural United States often face: A general lack of education about trans-related care among small-town health professionals who might also be reluctant to learn.
“Medical communities across the country are seeing clearly that there is a knowledge gap in the provision of gender-affirming care,” said Morissa Ladinsky, MD, a pediatrician who co-leads the Youth Multidisciplinary Gender Team at the University of Alabama–Birmingham (UAB).
Accurately counting the number of transgender people in rural America is hindered by a lack of U.S. census data and uniform state data. However, the Movement Advancement Project, a nonprofit organization that advocates for LGBTQ+ issues, used 2014-17 Centers for Disease Control and Prevention data from selected ZIP codes in 35 states to estimate that roughly one in six transgender adults in the United States live in a rural area. When that report was released in 2019, there were an estimated 1.4 million transgender people 13 and older nationwide. That number is now at least 1.6 million, according to the Williams Institute, a nonprofit think tank at the UCLA School of Law.
One in three trans people in rural areas experienced discrimination by a health care provider in the year leading up to the 2015 U.S. Transgender Survey Report, according to an analysis by MAP. A third of all trans individuals report having to teach their doctors about their health care needs to receive appropriate care, and 62% worry about being negatively judged by a health care provider because of their sexual orientation or gender identity, according to data collected by the Williams Institute and other organizations.
A lack of local rural providers knowledgeable in trans care can mean long drives to gender-affirming clinics in metropolitan areas. Rural trans people are three times as likely as are all transgender adults to travel 25-49 miles for routine care.
In Colorado, for example, many trans people outside Denver struggle to find proper care. Those who do have a trans-inclusive provider are more likely to receive wellness exams, less likely to delay care due to discrimination, and less likely to attempt suicide, according to results from the Colorado Transgender Health Survey published in 2018.
Much of the lack of care experienced by trans people is linked to insufficient education on LGBTQ+ health in medical schools across the country. In 2014, the Association of American Medical Colleges, which represents 170 accredited medical schools in the United States and Canada, released its first curriculum guidelines on caring for LGBTQ+ patients. As of 2018, 76% of medical schools included LGBTQ health themes in their curriculum, with half providing three or fewer classes on this topic.
Perhaps because of this, almost 77% of students from 10 medical schools in New England felt “not competent” or “somewhat not competent” in treating gender minority patients, according to a 2018 pilot study. Another paper, published last year, found that even clinicians who work in trans-friendly clinics lack knowledge about hormones, gender-affirming surgical options, and how to use appropriate pronouns and trans-inclusive language.
Throughout medical school, trans care was only briefly mentioned in endocrinology class, said Justin Bailey, MD, who received his medical degree from UAB in 2021 and is now a resident there. “I don’t want to say the wrong thing or use the wrong pronouns, so I was hesitant and a little bit tepid in my approach to interviewing and treating this population of patients,” he said.
On top of insufficient medical school education, some practicing doctors don’t take the time to teach themselves about trans people, said Kathie Moehlig, founder of TransFamily Support Services, a nonprofit organization that offers a range of services to transgender people and their families. They are very well intentioned yet uneducated when it comes to transgender care, she said.
Some medical schools, like the one at UAB, have pushed for change. Since 2017, Dr. Ladinsky and her colleagues have worked to include trans people in their standardized patient program, which gives medical students hands-on experience and feedback by interacting with “patients” in simulated clinical environments.
For example, a trans individual acting as a patient will simulate acid reflux by pretending to have pain in their stomach and chest. Then, over the course of the examination, they will reveal that they are transgender.
In the early years of this program, some students’ bedside manner would change once the patient’s gender identity was revealed, said Elaine Stephens, a trans woman who participates in UAB’s standardized patient program. “Sometimes they would immediately start asking about sexual activity,” Stephens said.
Since UAB launched its program, students’ reactions have improved significantly, she said.
This progress is being replicated by other medical schools, said Ms. Moehlig. “But it’s a slow start, and these are large institutions that take a long time to move forward.”
Advocates also are working outside medical schools to improve care in rural areas. In Colorado, the nonprofit Extension for Community Health Outcomes, or ECHO Colorado, has been offering monthly virtual classes on gender-affirming care to rural providers since 2020. The classes became so popular that the organization created a 4-week boot camp in 2021 for providers to learn about hormone therapy management, proper terminologies, surgical options, and supporting patients’ mental health.
For many years, doctors failed to recognize the need to learn about gender-affirming care, said Caroline Kirsch, DO, director of osteopathic education at the University of Wyoming Family Medicine Residency Program–Casper. In Casper, this led to “a number of patients traveling to Colorado to access care, which is a large burden for them financially,” said Dr. Kirsch, who has participated in the ECHO Colorado program.
“Things that haven’t been as well taught historically in medical school are things that I think many physicians feel anxious about initially,” she said. “The earlier you learn about this type of care in your career, the more likely you are to see its potential and be less anxious about it.”
Educating more providers about trans-related care has become increasingly vital in recent years as gender-affirming clinics nationwide experience a rise in harassment and threats. For instance, Vanderbilt University Medical Center’s Clinic for Transgender Health became the target of far-right hate on social media last year. After growing pressure from Tennessee’s Republican lawmakers, the clinic paused gender-affirmation surgeries on patients younger than 18, potentially leaving many trans individuals without necessary care.
Stephens hopes to see more medical schools include coursework on trans health care. She also wishes for doctors to treat trans people as they would any other patient.
“Just provide quality health care,” she tells the medical students at UAB. “We need health care like everyone else does.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
For Tammy Rainey, finding a health care provider who knows about gender-affirming care has been a challenge in the rural northern Mississippi town where she lives.
As a transgender woman, Ms. Rainey needs the hormone estrogen, which allows her to physically transition by developing more feminine features. But when she asked her doctor for an estrogen prescription, he said he couldn’t provide that type of care.
“He’s generally a good guy and doesn’t act prejudiced. He gets my name and pronouns right,” said Ms. Rainey. “But when I asked him about hormones, he said, ‘I just don’t feel like I know enough about that. I don’t want to get involved in that.’ ”
So Ms. Rainey drives around 170 miles round trip every 6 months to get a supply of estrogen from a clinic in Memphis, Tenn., to take home with her.
The obstacles Ms. Rainey overcomes to access care illustrate a type of medical inequity that transgender people who live in the rural United States often face: A general lack of education about trans-related care among small-town health professionals who might also be reluctant to learn.
“Medical communities across the country are seeing clearly that there is a knowledge gap in the provision of gender-affirming care,” said Morissa Ladinsky, MD, a pediatrician who co-leads the Youth Multidisciplinary Gender Team at the University of Alabama–Birmingham (UAB).
Accurately counting the number of transgender people in rural America is hindered by a lack of U.S. census data and uniform state data. However, the Movement Advancement Project, a nonprofit organization that advocates for LGBTQ+ issues, used 2014-17 Centers for Disease Control and Prevention data from selected ZIP codes in 35 states to estimate that roughly one in six transgender adults in the United States live in a rural area. When that report was released in 2019, there were an estimated 1.4 million transgender people 13 and older nationwide. That number is now at least 1.6 million, according to the Williams Institute, a nonprofit think tank at the UCLA School of Law.
One in three trans people in rural areas experienced discrimination by a health care provider in the year leading up to the 2015 U.S. Transgender Survey Report, according to an analysis by MAP. A third of all trans individuals report having to teach their doctors about their health care needs to receive appropriate care, and 62% worry about being negatively judged by a health care provider because of their sexual orientation or gender identity, according to data collected by the Williams Institute and other organizations.
A lack of local rural providers knowledgeable in trans care can mean long drives to gender-affirming clinics in metropolitan areas. Rural trans people are three times as likely as are all transgender adults to travel 25-49 miles for routine care.
In Colorado, for example, many trans people outside Denver struggle to find proper care. Those who do have a trans-inclusive provider are more likely to receive wellness exams, less likely to delay care due to discrimination, and less likely to attempt suicide, according to results from the Colorado Transgender Health Survey published in 2018.
Much of the lack of care experienced by trans people is linked to insufficient education on LGBTQ+ health in medical schools across the country. In 2014, the Association of American Medical Colleges, which represents 170 accredited medical schools in the United States and Canada, released its first curriculum guidelines on caring for LGBTQ+ patients. As of 2018, 76% of medical schools included LGBTQ health themes in their curriculum, with half providing three or fewer classes on this topic.
Perhaps because of this, almost 77% of students from 10 medical schools in New England felt “not competent” or “somewhat not competent” in treating gender minority patients, according to a 2018 pilot study. Another paper, published last year, found that even clinicians who work in trans-friendly clinics lack knowledge about hormones, gender-affirming surgical options, and how to use appropriate pronouns and trans-inclusive language.
Throughout medical school, trans care was only briefly mentioned in endocrinology class, said Justin Bailey, MD, who received his medical degree from UAB in 2021 and is now a resident there. “I don’t want to say the wrong thing or use the wrong pronouns, so I was hesitant and a little bit tepid in my approach to interviewing and treating this population of patients,” he said.
On top of insufficient medical school education, some practicing doctors don’t take the time to teach themselves about trans people, said Kathie Moehlig, founder of TransFamily Support Services, a nonprofit organization that offers a range of services to transgender people and their families. They are very well intentioned yet uneducated when it comes to transgender care, she said.
Some medical schools, like the one at UAB, have pushed for change. Since 2017, Dr. Ladinsky and her colleagues have worked to include trans people in their standardized patient program, which gives medical students hands-on experience and feedback by interacting with “patients” in simulated clinical environments.
For example, a trans individual acting as a patient will simulate acid reflux by pretending to have pain in their stomach and chest. Then, over the course of the examination, they will reveal that they are transgender.
In the early years of this program, some students’ bedside manner would change once the patient’s gender identity was revealed, said Elaine Stephens, a trans woman who participates in UAB’s standardized patient program. “Sometimes they would immediately start asking about sexual activity,” Stephens said.
Since UAB launched its program, students’ reactions have improved significantly, she said.
This progress is being replicated by other medical schools, said Ms. Moehlig. “But it’s a slow start, and these are large institutions that take a long time to move forward.”
Advocates also are working outside medical schools to improve care in rural areas. In Colorado, the nonprofit Extension for Community Health Outcomes, or ECHO Colorado, has been offering monthly virtual classes on gender-affirming care to rural providers since 2020. The classes became so popular that the organization created a 4-week boot camp in 2021 for providers to learn about hormone therapy management, proper terminologies, surgical options, and supporting patients’ mental health.
For many years, doctors failed to recognize the need to learn about gender-affirming care, said Caroline Kirsch, DO, director of osteopathic education at the University of Wyoming Family Medicine Residency Program–Casper. In Casper, this led to “a number of patients traveling to Colorado to access care, which is a large burden for them financially,” said Dr. Kirsch, who has participated in the ECHO Colorado program.
“Things that haven’t been as well taught historically in medical school are things that I think many physicians feel anxious about initially,” she said. “The earlier you learn about this type of care in your career, the more likely you are to see its potential and be less anxious about it.”
Educating more providers about trans-related care has become increasingly vital in recent years as gender-affirming clinics nationwide experience a rise in harassment and threats. For instance, Vanderbilt University Medical Center’s Clinic for Transgender Health became the target of far-right hate on social media last year. After growing pressure from Tennessee’s Republican lawmakers, the clinic paused gender-affirmation surgeries on patients younger than 18, potentially leaving many trans individuals without necessary care.
Stephens hopes to see more medical schools include coursework on trans health care. She also wishes for doctors to treat trans people as they would any other patient.
“Just provide quality health care,” she tells the medical students at UAB. “We need health care like everyone else does.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
How does SARS-CoV-2 affect other respiratory diseases?
In 2020, the rapid spread of the newly identified SARS-CoV-2 coronavirus led various global public health institutions to establish strategies to stop transmission and reduce mortality. Nonpharmacological measures – including social distancing, regular hand washing, and the use of face masks – contributed to reducing the impact of the COVID-19 pandemic on health systems in different regions of the world. However, because of the implementation of these measures, the transmission of other infectious agents also experienced a marked reduction.
Approximately 3 years after the start of the pandemic, , generating phenomena ranging from an immunity gap, which favors the increase in some diseases, to the apparent disappearance of an influenza virus lineage.
Understanding the phenomenon
In mid-2021, doctors and researchers around the world began to share their opinions about the side effect of the strict measures implemented to contain COVID-19.
In May 2021, along with some coresearchers, Emmanuel Grimprel, MD, of the Pediatric Infectious Pathology Group in Créteil, France, wrote for Infectious Disease Now, “The transmission of some pathogens is often similar to that of SARS-CoV-2, essentially large droplets, aerosols, and direct hand contact, often with lower transmissibility. The lack of immune system stimulation due to nonpharmaceutical measures induces an ‘immune debt’ that may have negative consequences when the pandemic is under control.” According to the authors, mathematical models evaluated up to that point were already suggesting that the respiratory syncytial virus (RSV) and influenza A epidemics would be more serious in subsequent years.
In July 2022, a commentary in The Lancet led by Kevin Messacar, MD, of the University of Colorado at Denver, Aurora, grew in relevance and gave prominence to the phenomenon. In the commentary, Dr. Messacar and a group of experts explained how the decrease in exposure to endemic viruses had given rise to an immunity gap.
“The immunity gap phenomenon that has been reported in articles such as The Lancet publication is mainly due to the isolation that took place to prevent SARS-CoV-2 infections. Although this distancing was a good response to combat infections, or at least delay them while coronavirus research advanced, what we are now experiencing is the increase in cases of respiratory diseases caused by other agents such as respiratory syncytial virus and influenza due to lack of exposure,” as explained to this news organization by Erandeni Martínez Jiménez, biomedicine graduate and member of the Medical Virology Laboratory of the Mexican Institute of Social Security, at the Zone No. 5 General Hospital in Metepec-Atlixco, Mexico.
“This phenomenon occurs in all age groups. However, it is more evident in children and babies, since at their age, they have been exposed to fewer pathogens and, when added to isolation, makes this immunity gap more evident. Many immunologists compare this to hygiene theory in which it is explained that a ‘sterile’ environment will cause children to avoid the everyday and common pathogens required to be able to develop an adequate immune system,” added Martínez Jimenez.
“In addition, due to the isolation, the vaccination rate in children decreased, since many parents did not risk their children going out. This causes the immunity gap to grow even further as these children are not protected against common pathogens. While a mother passes antibodies to the child through the uterus via her placenta, the mother will only pass on those antibodies to which she has been exposed and as expected due to the lockdown, exposure to other pathogens has been greatly reduced.”
On the other hand, Andreu Comas, MD, PhD, MHS, of the Center for Research in Health Sciences and Biomedicine of the Autonomous University of San Luis Potosí (Mexico), considered that there are other immunity gaps that are not limited to respiratory infections and that are related to the fall in vaccination coverage. “Children are going to experience several immunity gaps. In the middle of the previous 6-year term, we had a vaccination schedule coverage of around 70% for children. Now that vaccination coverage has fallen to 30%, today we have an immunity gap for measles, rubella, mumps, tetanus, diphtheria, whooping cough, and meningeal tuberculosis. We have a significant growth or risk for other diseases.”
Lineage extinction
Three types of influenza viruses – A, B, and C – cause infections in humans. Although influenza A virus is the main type associated with infections during seasonal periods, as of 2020, influenza B virus was considered the causative agent of about a quarter of annual influenza cases.
During the onset of the COVID-19 pandemic, cocirculation of the two distinct lineages of influenza B viruses, B/Victoria/2/1987 (B/Victoria) and B/Yamagata/16/1988 (B/Yamagata), decreased significantly. According to data from the FluNet tool, which is coordinated by the World Health Organization, since March 2020 the isolation or sequencing of viruses belonging to the Yamagata lineage was not conclusively carried out.
Specialists like John Paget, PhD, from the Netherlands Institute for Health Services Research (Nivel) in Utrecht, have indicated that determining the extinction of the B/Yamagata lineage is critical. There is the possibility of a reintroduction of the lineage, as has occurred in the past with the reemergence of influenza A (H1N1) in 1997, which could represent a risk in subsequent years.
“In the next few years, research related to viruses such as influenza B and the impact on population immunity will be important. Let’s remember that influenza changes every year due to its characteristics, so a lack of exposure will also have an impact on the development of the disease,” said Martínez Jiménez.
Vaccination is essential
According to Dr. Comas, the only way to overcome the immunity gap phenomenon is through vaccination campaigns. “There is no other way to overcome the phenomenon, and how fast it is done will depend on the effort,” he said.
“In the case of COVID-19, it is not planned to vaccinate children under 5 years of age, and if we do not vaccinate children under 5 years of age, that gap will exist. In addition, this winter season will be important to know whether we are already endemic or not. It will be the key point, and it will determine if we will have a peak or not in the summer.
“In the case of the rest of the diseases, we need to correct what has been deficient in different governments, and we are going to have the resurgence of other infectious diseases that had already been forgotten. We have the example of poliomyelitis, the increase in meningeal tuberculosis, and we will have an increase in whooping cough and pertussislike syndrome. In this sense, we are going back to the point where Mexico and the world were around the ‘60s and ‘70s, and we have to be very alert to detect, isolate, and revaccinate.”
Finally, Dr. Comas called for continuing precautionary measures before the arrival of the sixth wave. “At a national level, the sixth wave of COVID-19 has already begun, and an increase in cases is expected in January. Regarding vaccines, if you are over 18 years of age and have not had any vaccine dose, you can get Abdala, however, there are no studies on this vaccine as a booster, and it is not authorized by the Mexican government for this purpose. Therefore, it is necessary to continue with measures such as the use of face masks in crowded places or with poor ventilation, and in the event of having symptoms, avoid going out and encourage ventilation at work and schools. If we do this, at least in the case of diseases that are transmitted by the respiratory route, the impact will be minimal.”
Martínez Jiménez and Dr. Comas have disclosed no relevant financial relationships.
This article was translated from the Medscape Spanish Edition.
A version of this article first appeared on Medscape.com.
In 2020, the rapid spread of the newly identified SARS-CoV-2 coronavirus led various global public health institutions to establish strategies to stop transmission and reduce mortality. Nonpharmacological measures – including social distancing, regular hand washing, and the use of face masks – contributed to reducing the impact of the COVID-19 pandemic on health systems in different regions of the world. However, because of the implementation of these measures, the transmission of other infectious agents also experienced a marked reduction.
Approximately 3 years after the start of the pandemic, , generating phenomena ranging from an immunity gap, which favors the increase in some diseases, to the apparent disappearance of an influenza virus lineage.
Understanding the phenomenon
In mid-2021, doctors and researchers around the world began to share their opinions about the side effect of the strict measures implemented to contain COVID-19.
In May 2021, along with some coresearchers, Emmanuel Grimprel, MD, of the Pediatric Infectious Pathology Group in Créteil, France, wrote for Infectious Disease Now, “The transmission of some pathogens is often similar to that of SARS-CoV-2, essentially large droplets, aerosols, and direct hand contact, often with lower transmissibility. The lack of immune system stimulation due to nonpharmaceutical measures induces an ‘immune debt’ that may have negative consequences when the pandemic is under control.” According to the authors, mathematical models evaluated up to that point were already suggesting that the respiratory syncytial virus (RSV) and influenza A epidemics would be more serious in subsequent years.
In July 2022, a commentary in The Lancet led by Kevin Messacar, MD, of the University of Colorado at Denver, Aurora, grew in relevance and gave prominence to the phenomenon. In the commentary, Dr. Messacar and a group of experts explained how the decrease in exposure to endemic viruses had given rise to an immunity gap.
“The immunity gap phenomenon that has been reported in articles such as The Lancet publication is mainly due to the isolation that took place to prevent SARS-CoV-2 infections. Although this distancing was a good response to combat infections, or at least delay them while coronavirus research advanced, what we are now experiencing is the increase in cases of respiratory diseases caused by other agents such as respiratory syncytial virus and influenza due to lack of exposure,” as explained to this news organization by Erandeni Martínez Jiménez, biomedicine graduate and member of the Medical Virology Laboratory of the Mexican Institute of Social Security, at the Zone No. 5 General Hospital in Metepec-Atlixco, Mexico.
“This phenomenon occurs in all age groups. However, it is more evident in children and babies, since at their age, they have been exposed to fewer pathogens and, when added to isolation, makes this immunity gap more evident. Many immunologists compare this to hygiene theory in which it is explained that a ‘sterile’ environment will cause children to avoid the everyday and common pathogens required to be able to develop an adequate immune system,” added Martínez Jimenez.
“In addition, due to the isolation, the vaccination rate in children decreased, since many parents did not risk their children going out. This causes the immunity gap to grow even further as these children are not protected against common pathogens. While a mother passes antibodies to the child through the uterus via her placenta, the mother will only pass on those antibodies to which she has been exposed and as expected due to the lockdown, exposure to other pathogens has been greatly reduced.”
On the other hand, Andreu Comas, MD, PhD, MHS, of the Center for Research in Health Sciences and Biomedicine of the Autonomous University of San Luis Potosí (Mexico), considered that there are other immunity gaps that are not limited to respiratory infections and that are related to the fall in vaccination coverage. “Children are going to experience several immunity gaps. In the middle of the previous 6-year term, we had a vaccination schedule coverage of around 70% for children. Now that vaccination coverage has fallen to 30%, today we have an immunity gap for measles, rubella, mumps, tetanus, diphtheria, whooping cough, and meningeal tuberculosis. We have a significant growth or risk for other diseases.”
Lineage extinction
Three types of influenza viruses – A, B, and C – cause infections in humans. Although influenza A virus is the main type associated with infections during seasonal periods, as of 2020, influenza B virus was considered the causative agent of about a quarter of annual influenza cases.
During the onset of the COVID-19 pandemic, cocirculation of the two distinct lineages of influenza B viruses, B/Victoria/2/1987 (B/Victoria) and B/Yamagata/16/1988 (B/Yamagata), decreased significantly. According to data from the FluNet tool, which is coordinated by the World Health Organization, since March 2020 the isolation or sequencing of viruses belonging to the Yamagata lineage was not conclusively carried out.
Specialists like John Paget, PhD, from the Netherlands Institute for Health Services Research (Nivel) in Utrecht, have indicated that determining the extinction of the B/Yamagata lineage is critical. There is the possibility of a reintroduction of the lineage, as has occurred in the past with the reemergence of influenza A (H1N1) in 1997, which could represent a risk in subsequent years.
“In the next few years, research related to viruses such as influenza B and the impact on population immunity will be important. Let’s remember that influenza changes every year due to its characteristics, so a lack of exposure will also have an impact on the development of the disease,” said Martínez Jiménez.
Vaccination is essential
According to Dr. Comas, the only way to overcome the immunity gap phenomenon is through vaccination campaigns. “There is no other way to overcome the phenomenon, and how fast it is done will depend on the effort,” he said.
“In the case of COVID-19, it is not planned to vaccinate children under 5 years of age, and if we do not vaccinate children under 5 years of age, that gap will exist. In addition, this winter season will be important to know whether we are already endemic or not. It will be the key point, and it will determine if we will have a peak or not in the summer.
“In the case of the rest of the diseases, we need to correct what has been deficient in different governments, and we are going to have the resurgence of other infectious diseases that had already been forgotten. We have the example of poliomyelitis, the increase in meningeal tuberculosis, and we will have an increase in whooping cough and pertussislike syndrome. In this sense, we are going back to the point where Mexico and the world were around the ‘60s and ‘70s, and we have to be very alert to detect, isolate, and revaccinate.”
Finally, Dr. Comas called for continuing precautionary measures before the arrival of the sixth wave. “At a national level, the sixth wave of COVID-19 has already begun, and an increase in cases is expected in January. Regarding vaccines, if you are over 18 years of age and have not had any vaccine dose, you can get Abdala, however, there are no studies on this vaccine as a booster, and it is not authorized by the Mexican government for this purpose. Therefore, it is necessary to continue with measures such as the use of face masks in crowded places or with poor ventilation, and in the event of having symptoms, avoid going out and encourage ventilation at work and schools. If we do this, at least in the case of diseases that are transmitted by the respiratory route, the impact will be minimal.”
Martínez Jiménez and Dr. Comas have disclosed no relevant financial relationships.
This article was translated from the Medscape Spanish Edition.
A version of this article first appeared on Medscape.com.
In 2020, the rapid spread of the newly identified SARS-CoV-2 coronavirus led various global public health institutions to establish strategies to stop transmission and reduce mortality. Nonpharmacological measures – including social distancing, regular hand washing, and the use of face masks – contributed to reducing the impact of the COVID-19 pandemic on health systems in different regions of the world. However, because of the implementation of these measures, the transmission of other infectious agents also experienced a marked reduction.
Approximately 3 years after the start of the pandemic, , generating phenomena ranging from an immunity gap, which favors the increase in some diseases, to the apparent disappearance of an influenza virus lineage.
Understanding the phenomenon
In mid-2021, doctors and researchers around the world began to share their opinions about the side effect of the strict measures implemented to contain COVID-19.
In May 2021, along with some coresearchers, Emmanuel Grimprel, MD, of the Pediatric Infectious Pathology Group in Créteil, France, wrote for Infectious Disease Now, “The transmission of some pathogens is often similar to that of SARS-CoV-2, essentially large droplets, aerosols, and direct hand contact, often with lower transmissibility. The lack of immune system stimulation due to nonpharmaceutical measures induces an ‘immune debt’ that may have negative consequences when the pandemic is under control.” According to the authors, mathematical models evaluated up to that point were already suggesting that the respiratory syncytial virus (RSV) and influenza A epidemics would be more serious in subsequent years.
In July 2022, a commentary in The Lancet led by Kevin Messacar, MD, of the University of Colorado at Denver, Aurora, grew in relevance and gave prominence to the phenomenon. In the commentary, Dr. Messacar and a group of experts explained how the decrease in exposure to endemic viruses had given rise to an immunity gap.
“The immunity gap phenomenon that has been reported in articles such as The Lancet publication is mainly due to the isolation that took place to prevent SARS-CoV-2 infections. Although this distancing was a good response to combat infections, or at least delay them while coronavirus research advanced, what we are now experiencing is the increase in cases of respiratory diseases caused by other agents such as respiratory syncytial virus and influenza due to lack of exposure,” as explained to this news organization by Erandeni Martínez Jiménez, biomedicine graduate and member of the Medical Virology Laboratory of the Mexican Institute of Social Security, at the Zone No. 5 General Hospital in Metepec-Atlixco, Mexico.
“This phenomenon occurs in all age groups. However, it is more evident in children and babies, since at their age, they have been exposed to fewer pathogens and, when added to isolation, makes this immunity gap more evident. Many immunologists compare this to hygiene theory in which it is explained that a ‘sterile’ environment will cause children to avoid the everyday and common pathogens required to be able to develop an adequate immune system,” added Martínez Jimenez.
“In addition, due to the isolation, the vaccination rate in children decreased, since many parents did not risk their children going out. This causes the immunity gap to grow even further as these children are not protected against common pathogens. While a mother passes antibodies to the child through the uterus via her placenta, the mother will only pass on those antibodies to which she has been exposed and as expected due to the lockdown, exposure to other pathogens has been greatly reduced.”
On the other hand, Andreu Comas, MD, PhD, MHS, of the Center for Research in Health Sciences and Biomedicine of the Autonomous University of San Luis Potosí (Mexico), considered that there are other immunity gaps that are not limited to respiratory infections and that are related to the fall in vaccination coverage. “Children are going to experience several immunity gaps. In the middle of the previous 6-year term, we had a vaccination schedule coverage of around 70% for children. Now that vaccination coverage has fallen to 30%, today we have an immunity gap for measles, rubella, mumps, tetanus, diphtheria, whooping cough, and meningeal tuberculosis. We have a significant growth or risk for other diseases.”
Lineage extinction
Three types of influenza viruses – A, B, and C – cause infections in humans. Although influenza A virus is the main type associated with infections during seasonal periods, as of 2020, influenza B virus was considered the causative agent of about a quarter of annual influenza cases.
During the onset of the COVID-19 pandemic, cocirculation of the two distinct lineages of influenza B viruses, B/Victoria/2/1987 (B/Victoria) and B/Yamagata/16/1988 (B/Yamagata), decreased significantly. According to data from the FluNet tool, which is coordinated by the World Health Organization, since March 2020 the isolation or sequencing of viruses belonging to the Yamagata lineage was not conclusively carried out.
Specialists like John Paget, PhD, from the Netherlands Institute for Health Services Research (Nivel) in Utrecht, have indicated that determining the extinction of the B/Yamagata lineage is critical. There is the possibility of a reintroduction of the lineage, as has occurred in the past with the reemergence of influenza A (H1N1) in 1997, which could represent a risk in subsequent years.
“In the next few years, research related to viruses such as influenza B and the impact on population immunity will be important. Let’s remember that influenza changes every year due to its characteristics, so a lack of exposure will also have an impact on the development of the disease,” said Martínez Jiménez.
Vaccination is essential
According to Dr. Comas, the only way to overcome the immunity gap phenomenon is through vaccination campaigns. “There is no other way to overcome the phenomenon, and how fast it is done will depend on the effort,” he said.
“In the case of COVID-19, it is not planned to vaccinate children under 5 years of age, and if we do not vaccinate children under 5 years of age, that gap will exist. In addition, this winter season will be important to know whether we are already endemic or not. It will be the key point, and it will determine if we will have a peak or not in the summer.
“In the case of the rest of the diseases, we need to correct what has been deficient in different governments, and we are going to have the resurgence of other infectious diseases that had already been forgotten. We have the example of poliomyelitis, the increase in meningeal tuberculosis, and we will have an increase in whooping cough and pertussislike syndrome. In this sense, we are going back to the point where Mexico and the world were around the ‘60s and ‘70s, and we have to be very alert to detect, isolate, and revaccinate.”
Finally, Dr. Comas called for continuing precautionary measures before the arrival of the sixth wave. “At a national level, the sixth wave of COVID-19 has already begun, and an increase in cases is expected in January. Regarding vaccines, if you are over 18 years of age and have not had any vaccine dose, you can get Abdala, however, there are no studies on this vaccine as a booster, and it is not authorized by the Mexican government for this purpose. Therefore, it is necessary to continue with measures such as the use of face masks in crowded places or with poor ventilation, and in the event of having symptoms, avoid going out and encourage ventilation at work and schools. If we do this, at least in the case of diseases that are transmitted by the respiratory route, the impact will be minimal.”
Martínez Jiménez and Dr. Comas have disclosed no relevant financial relationships.
This article was translated from the Medscape Spanish Edition.
A version of this article first appeared on Medscape.com.
Mastocytosis: Rare, underdiagnosed, potentially fatal
Nationwide, approximately 1,000 adults are diagnosed with systemic mastocytosis annually. This rare disease is a myeloid neoplasm with a highly variable phenotypic expression, in which abnormal mast cells proliferate and infiltrate organs and tissues. It swings widely from a nonadvanced form, composed of indolent or smoldering disease, to advanced disease that progresses to leukemia in 6% of cases.
More than 80% of systemic mastocytosis is driven by the KIT D816V mutation. Along with a host of other rare KIT mutations, KIT D816V activates KIT-receptor tyrosine kinase to trigger mast cell proliferation.
Dr. Gotlib could not be contacted for an interview. However, there are many good reasons to identify patients with systemic mastocytosis, according to Attilio Orazi, MD, professor and chair of the department of pathology at Texas Tech University, El Paso. The chief reason is that the patient may be in grave peril.
“The degree of heterogeneity is amazing. ... There’s very indolent [disease], which is really not a big deal. And then you have a disease in which you’re dead in 3 months,” Dr. Orazi said. “So you run the gamut between an indolent, no-problem cutaneous disease to a very nasty systemic, aggressive leukemia-like neoplasm.”
Since 2001, the diagnosis of mastocytosis has been guided by the World Health Organization Classification of Tumours, or “Blue Book.” In 2022, Dr. Orazi along with 137 other senior experts, most of whom were involved in past editions of the Blue Book, published their own version: The International Consensus Classification of Myeloid Neoplasms and Acute Leukemias (the ICC 2022).
In September 2021, this group of specialists held a virtual/in-person advisory committee meeting at the University of Chicago to create the document. One factor in their decision to go it alone, Dr. Orazi said, was that WHO decided to proceed with the fifth edition of the Blue Book using its own internal editorial group without convening an advisory committee, despite repeated requests to do so.
ICC 2022 divides advanced systemic mastocytosis into three subtypes: aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL). Median survival is 3.5 years for patients with ASM, 2 years for those with SM-AHN and as low as 2 months for MCL.
The second key reason to increase awareness of mastocytosis among physicians, said Dr. Orazi, is that patients falling through the net are likely to be ambulatory, and their presentation can be “a little confusing.”
Patients with indolent disease are relatively straightforward to recognize, explained Dr. Orazi. Similarly, very sick patients with SM-AHN or MCL are easily recognized by hem-oncs.
“But if you see a patient in an ambulatory setting, in your clinic or whatever, and you’re suspicious, then you need to decide [how] you’re going to investigate that patient further,” he said, Dr. Orazi noted the next step is not always obvious, especially for primary-practice or internal medicine physicians likely to be unfamiliar with such a rare disease.
A practice survey published in 2022 by other researchers backed up Dr. Orazi’s remarks. The study found that community/solo-practice physicians were less likely to have tested systemic mastocytosis patients for KIT816V mutation than academic/specialty physicians (58% vs. 80%; P = .004; n = 111). Clinicians treating these patients estimated that it took an average of 8.5 months for a “typical” patient to receive the diagnosis from the time of symptom onset.
The research was headed by Ruben Mesa, MD, director of University of Texas Health, San Antonio, and funded by Blueprint Medicines, the manufacturer of avapritinib (Ayvakit), a new drug for the disease.
Dr. Orazi urged clinicians to have a high degree of suspicion for mastocytosis in a patient who walks into the clinic with any combination of the following: urticarial-type skin manifestations, especially if persistent into adulthood; history of undue reaction to an insect sting; a big spleen in a patient with a history of cutaneous flushing or rash; chronic diarrhea, especially if a biopsy has shown “too many mast cells” in the lamina propria of the small bowel; and positivity for KIT816V mutation.
Dr. Orazi stressed that the majority of patients will have indolent disease, but for the few patients for whom immediate treatment is essential, “the distinction between indolent and aggressive [disease] is really very, very important.”
Patients with advanced systemic mastocytosis can now be effectively treated, following the arrival of midostaurin (Rydapt, Tauritmo) and avapritinib.
Midostaurin, a multikinase/KIT inhibitor, was approved by the Food and Drug Administration in 2017 for the treatment of advanced systemic mastocytosis (ASM, SM-AHN, and MCL). Avapritinib, a selective kinase inhibitor of KIT816V and platelet-derived growth factor receptor alpha as well as multiple KIT exon 11, 11/17 and 17 mutants, gained the same indication in June 2021.
As with all rare diseases, it is challenging to obtain accurate numbers on how many patients are affected by systemic mastocytosis. The first population-based study of the disorder, presented at the 2018 annual meeting of the American Society of Hematology, used the Surveillance, Epidemiology, and End Results database from 2000 to 2014 to estimate incidence at 0.046 per 10,000, which translates to 1,050 new adult cases per year. The study data have never been published in full.
How many of these cases are advanced disease? There are no U.S. data but extrapolating from a Danish registry study that found 82% of systemic mastocytosis cases to be indolent disease, the incidence of advanced systemic mastocytosis in the United States could be as low as 200 adults a year.
This information, in turn, suggests that identifying more patients with advanced disease would not only benefit those patients but would also benefit clinical trial investigators who are seeking the proverbial needle in the haystack.
Nationwide, five clinical trials are recruiting individuals with advanced systemic mastocytosis, collectively looking for 352 patients in the United States. Two of the studies focus on mast-cell activation (NCT0544944) and cutaneous mastocytoses (NCT04846348). Two trials in a range of hematological malignancies are testing bispecific antibodies flotetuzumab and MGD024 (both from Macrogenics; NCT04681105, NCT05362773).
Apex, a phase 2 study of tyrosine-kinase inhibitor bezuclastinib (a Cogent hopeful), is specifically focusing on advanced disease. Dr. Gotlib and coinvestigators are aiming for 140 participants.
As a pathologist, Dr. Orazi said he find mastocytosis fascinating because he believes he has “a truly useful role,” contrasting with some other hematological diseases in which the molecular profile rules.
“Pathology plays a major role here,” he explained, “because you have to correlate what you see at the microscope with the full clinical picture, selected laboratory tests such as CBC and serum tryptase, and molecular results. You often need integration through a pathologist to put all the pieces together.
“It’s easier to treat once you know exactly what disease you’re dealing with and whether it is an aggressive or indolent subtype,” Dr. Orazi concluded.
Dr. Orazi disclosed no conflicts of interest. Dr. Gotlib has disclosed ties with Blueprint Medicines, Deciphera, Incyte, and Kartos Therapeutics, and has led committees for Blueprint Medicine’s EXPLORER and PATHFINDER studies, Deciphera’s Study Steering Committee for ripretinib in AdvSM, and the Central Response Review Committee for the phase 2 study of bezuclastinib in AdvSM.
Nationwide, approximately 1,000 adults are diagnosed with systemic mastocytosis annually. This rare disease is a myeloid neoplasm with a highly variable phenotypic expression, in which abnormal mast cells proliferate and infiltrate organs and tissues. It swings widely from a nonadvanced form, composed of indolent or smoldering disease, to advanced disease that progresses to leukemia in 6% of cases.
More than 80% of systemic mastocytosis is driven by the KIT D816V mutation. Along with a host of other rare KIT mutations, KIT D816V activates KIT-receptor tyrosine kinase to trigger mast cell proliferation.
Dr. Gotlib could not be contacted for an interview. However, there are many good reasons to identify patients with systemic mastocytosis, according to Attilio Orazi, MD, professor and chair of the department of pathology at Texas Tech University, El Paso. The chief reason is that the patient may be in grave peril.
“The degree of heterogeneity is amazing. ... There’s very indolent [disease], which is really not a big deal. And then you have a disease in which you’re dead in 3 months,” Dr. Orazi said. “So you run the gamut between an indolent, no-problem cutaneous disease to a very nasty systemic, aggressive leukemia-like neoplasm.”
Since 2001, the diagnosis of mastocytosis has been guided by the World Health Organization Classification of Tumours, or “Blue Book.” In 2022, Dr. Orazi along with 137 other senior experts, most of whom were involved in past editions of the Blue Book, published their own version: The International Consensus Classification of Myeloid Neoplasms and Acute Leukemias (the ICC 2022).
In September 2021, this group of specialists held a virtual/in-person advisory committee meeting at the University of Chicago to create the document. One factor in their decision to go it alone, Dr. Orazi said, was that WHO decided to proceed with the fifth edition of the Blue Book using its own internal editorial group without convening an advisory committee, despite repeated requests to do so.
ICC 2022 divides advanced systemic mastocytosis into three subtypes: aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL). Median survival is 3.5 years for patients with ASM, 2 years for those with SM-AHN and as low as 2 months for MCL.
The second key reason to increase awareness of mastocytosis among physicians, said Dr. Orazi, is that patients falling through the net are likely to be ambulatory, and their presentation can be “a little confusing.”
Patients with indolent disease are relatively straightforward to recognize, explained Dr. Orazi. Similarly, very sick patients with SM-AHN or MCL are easily recognized by hem-oncs.
“But if you see a patient in an ambulatory setting, in your clinic or whatever, and you’re suspicious, then you need to decide [how] you’re going to investigate that patient further,” he said, Dr. Orazi noted the next step is not always obvious, especially for primary-practice or internal medicine physicians likely to be unfamiliar with such a rare disease.
A practice survey published in 2022 by other researchers backed up Dr. Orazi’s remarks. The study found that community/solo-practice physicians were less likely to have tested systemic mastocytosis patients for KIT816V mutation than academic/specialty physicians (58% vs. 80%; P = .004; n = 111). Clinicians treating these patients estimated that it took an average of 8.5 months for a “typical” patient to receive the diagnosis from the time of symptom onset.
The research was headed by Ruben Mesa, MD, director of University of Texas Health, San Antonio, and funded by Blueprint Medicines, the manufacturer of avapritinib (Ayvakit), a new drug for the disease.
Dr. Orazi urged clinicians to have a high degree of suspicion for mastocytosis in a patient who walks into the clinic with any combination of the following: urticarial-type skin manifestations, especially if persistent into adulthood; history of undue reaction to an insect sting; a big spleen in a patient with a history of cutaneous flushing or rash; chronic diarrhea, especially if a biopsy has shown “too many mast cells” in the lamina propria of the small bowel; and positivity for KIT816V mutation.
Dr. Orazi stressed that the majority of patients will have indolent disease, but for the few patients for whom immediate treatment is essential, “the distinction between indolent and aggressive [disease] is really very, very important.”
Patients with advanced systemic mastocytosis can now be effectively treated, following the arrival of midostaurin (Rydapt, Tauritmo) and avapritinib.
Midostaurin, a multikinase/KIT inhibitor, was approved by the Food and Drug Administration in 2017 for the treatment of advanced systemic mastocytosis (ASM, SM-AHN, and MCL). Avapritinib, a selective kinase inhibitor of KIT816V and platelet-derived growth factor receptor alpha as well as multiple KIT exon 11, 11/17 and 17 mutants, gained the same indication in June 2021.
As with all rare diseases, it is challenging to obtain accurate numbers on how many patients are affected by systemic mastocytosis. The first population-based study of the disorder, presented at the 2018 annual meeting of the American Society of Hematology, used the Surveillance, Epidemiology, and End Results database from 2000 to 2014 to estimate incidence at 0.046 per 10,000, which translates to 1,050 new adult cases per year. The study data have never been published in full.
How many of these cases are advanced disease? There are no U.S. data but extrapolating from a Danish registry study that found 82% of systemic mastocytosis cases to be indolent disease, the incidence of advanced systemic mastocytosis in the United States could be as low as 200 adults a year.
This information, in turn, suggests that identifying more patients with advanced disease would not only benefit those patients but would also benefit clinical trial investigators who are seeking the proverbial needle in the haystack.
Nationwide, five clinical trials are recruiting individuals with advanced systemic mastocytosis, collectively looking for 352 patients in the United States. Two of the studies focus on mast-cell activation (NCT0544944) and cutaneous mastocytoses (NCT04846348). Two trials in a range of hematological malignancies are testing bispecific antibodies flotetuzumab and MGD024 (both from Macrogenics; NCT04681105, NCT05362773).
Apex, a phase 2 study of tyrosine-kinase inhibitor bezuclastinib (a Cogent hopeful), is specifically focusing on advanced disease. Dr. Gotlib and coinvestigators are aiming for 140 participants.
As a pathologist, Dr. Orazi said he find mastocytosis fascinating because he believes he has “a truly useful role,” contrasting with some other hematological diseases in which the molecular profile rules.
“Pathology plays a major role here,” he explained, “because you have to correlate what you see at the microscope with the full clinical picture, selected laboratory tests such as CBC and serum tryptase, and molecular results. You often need integration through a pathologist to put all the pieces together.
“It’s easier to treat once you know exactly what disease you’re dealing with and whether it is an aggressive or indolent subtype,” Dr. Orazi concluded.
Dr. Orazi disclosed no conflicts of interest. Dr. Gotlib has disclosed ties with Blueprint Medicines, Deciphera, Incyte, and Kartos Therapeutics, and has led committees for Blueprint Medicine’s EXPLORER and PATHFINDER studies, Deciphera’s Study Steering Committee for ripretinib in AdvSM, and the Central Response Review Committee for the phase 2 study of bezuclastinib in AdvSM.
Nationwide, approximately 1,000 adults are diagnosed with systemic mastocytosis annually. This rare disease is a myeloid neoplasm with a highly variable phenotypic expression, in which abnormal mast cells proliferate and infiltrate organs and tissues. It swings widely from a nonadvanced form, composed of indolent or smoldering disease, to advanced disease that progresses to leukemia in 6% of cases.
More than 80% of systemic mastocytosis is driven by the KIT D816V mutation. Along with a host of other rare KIT mutations, KIT D816V activates KIT-receptor tyrosine kinase to trigger mast cell proliferation.
Dr. Gotlib could not be contacted for an interview. However, there are many good reasons to identify patients with systemic mastocytosis, according to Attilio Orazi, MD, professor and chair of the department of pathology at Texas Tech University, El Paso. The chief reason is that the patient may be in grave peril.
“The degree of heterogeneity is amazing. ... There’s very indolent [disease], which is really not a big deal. And then you have a disease in which you’re dead in 3 months,” Dr. Orazi said. “So you run the gamut between an indolent, no-problem cutaneous disease to a very nasty systemic, aggressive leukemia-like neoplasm.”
Since 2001, the diagnosis of mastocytosis has been guided by the World Health Organization Classification of Tumours, or “Blue Book.” In 2022, Dr. Orazi along with 137 other senior experts, most of whom were involved in past editions of the Blue Book, published their own version: The International Consensus Classification of Myeloid Neoplasms and Acute Leukemias (the ICC 2022).
In September 2021, this group of specialists held a virtual/in-person advisory committee meeting at the University of Chicago to create the document. One factor in their decision to go it alone, Dr. Orazi said, was that WHO decided to proceed with the fifth edition of the Blue Book using its own internal editorial group without convening an advisory committee, despite repeated requests to do so.
ICC 2022 divides advanced systemic mastocytosis into three subtypes: aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL). Median survival is 3.5 years for patients with ASM, 2 years for those with SM-AHN and as low as 2 months for MCL.
The second key reason to increase awareness of mastocytosis among physicians, said Dr. Orazi, is that patients falling through the net are likely to be ambulatory, and their presentation can be “a little confusing.”
Patients with indolent disease are relatively straightforward to recognize, explained Dr. Orazi. Similarly, very sick patients with SM-AHN or MCL are easily recognized by hem-oncs.
“But if you see a patient in an ambulatory setting, in your clinic or whatever, and you’re suspicious, then you need to decide [how] you’re going to investigate that patient further,” he said, Dr. Orazi noted the next step is not always obvious, especially for primary-practice or internal medicine physicians likely to be unfamiliar with such a rare disease.
A practice survey published in 2022 by other researchers backed up Dr. Orazi’s remarks. The study found that community/solo-practice physicians were less likely to have tested systemic mastocytosis patients for KIT816V mutation than academic/specialty physicians (58% vs. 80%; P = .004; n = 111). Clinicians treating these patients estimated that it took an average of 8.5 months for a “typical” patient to receive the diagnosis from the time of symptom onset.
The research was headed by Ruben Mesa, MD, director of University of Texas Health, San Antonio, and funded by Blueprint Medicines, the manufacturer of avapritinib (Ayvakit), a new drug for the disease.
Dr. Orazi urged clinicians to have a high degree of suspicion for mastocytosis in a patient who walks into the clinic with any combination of the following: urticarial-type skin manifestations, especially if persistent into adulthood; history of undue reaction to an insect sting; a big spleen in a patient with a history of cutaneous flushing or rash; chronic diarrhea, especially if a biopsy has shown “too many mast cells” in the lamina propria of the small bowel; and positivity for KIT816V mutation.
Dr. Orazi stressed that the majority of patients will have indolent disease, but for the few patients for whom immediate treatment is essential, “the distinction between indolent and aggressive [disease] is really very, very important.”
Patients with advanced systemic mastocytosis can now be effectively treated, following the arrival of midostaurin (Rydapt, Tauritmo) and avapritinib.
Midostaurin, a multikinase/KIT inhibitor, was approved by the Food and Drug Administration in 2017 for the treatment of advanced systemic mastocytosis (ASM, SM-AHN, and MCL). Avapritinib, a selective kinase inhibitor of KIT816V and platelet-derived growth factor receptor alpha as well as multiple KIT exon 11, 11/17 and 17 mutants, gained the same indication in June 2021.
As with all rare diseases, it is challenging to obtain accurate numbers on how many patients are affected by systemic mastocytosis. The first population-based study of the disorder, presented at the 2018 annual meeting of the American Society of Hematology, used the Surveillance, Epidemiology, and End Results database from 2000 to 2014 to estimate incidence at 0.046 per 10,000, which translates to 1,050 new adult cases per year. The study data have never been published in full.
How many of these cases are advanced disease? There are no U.S. data but extrapolating from a Danish registry study that found 82% of systemic mastocytosis cases to be indolent disease, the incidence of advanced systemic mastocytosis in the United States could be as low as 200 adults a year.
This information, in turn, suggests that identifying more patients with advanced disease would not only benefit those patients but would also benefit clinical trial investigators who are seeking the proverbial needle in the haystack.
Nationwide, five clinical trials are recruiting individuals with advanced systemic mastocytosis, collectively looking for 352 patients in the United States. Two of the studies focus on mast-cell activation (NCT0544944) and cutaneous mastocytoses (NCT04846348). Two trials in a range of hematological malignancies are testing bispecific antibodies flotetuzumab and MGD024 (both from Macrogenics; NCT04681105, NCT05362773).
Apex, a phase 2 study of tyrosine-kinase inhibitor bezuclastinib (a Cogent hopeful), is specifically focusing on advanced disease. Dr. Gotlib and coinvestigators are aiming for 140 participants.
As a pathologist, Dr. Orazi said he find mastocytosis fascinating because he believes he has “a truly useful role,” contrasting with some other hematological diseases in which the molecular profile rules.
“Pathology plays a major role here,” he explained, “because you have to correlate what you see at the microscope with the full clinical picture, selected laboratory tests such as CBC and serum tryptase, and molecular results. You often need integration through a pathologist to put all the pieces together.
“It’s easier to treat once you know exactly what disease you’re dealing with and whether it is an aggressive or indolent subtype,” Dr. Orazi concluded.
Dr. Orazi disclosed no conflicts of interest. Dr. Gotlib has disclosed ties with Blueprint Medicines, Deciphera, Incyte, and Kartos Therapeutics, and has led committees for Blueprint Medicine’s EXPLORER and PATHFINDER studies, Deciphera’s Study Steering Committee for ripretinib in AdvSM, and the Central Response Review Committee for the phase 2 study of bezuclastinib in AdvSM.
Guidelines recommend CBT alone for mild acute depression, more options for more severe cases
The guidelines also state that patients with mild depression should start with CBT alone, and if a patient with moderate to severe depression prefers, they can use a combination of both CBT and an SGA.
These nuanced recommendations contrast sharply with the 2016 ACP guidelines for depression, which lumped all stages and severity levels together, and came with just one recommendation: Clinicians should choose between CBT and an SGA.
More data have come to light over the years, requiring the present update, reported lead author Amir Qaseem, MD, PhD, vice president of Clinical Policy and the Center for Evidence Reviews at the ACP, and adjunct faculty at Thomas Jefferson University, Philadelphia, and colleagues.
In addition to the focus on acute depression, Dr. Qaseem and colleagues highlighted the new guidelines' “consideration of patient values and preferences, and costs,” as well as responses to therapy.
Recommendations were derived from a network meta-analysis that included studies evaluating nonpharmacologic and pharmacologic therapies, the authors wrote in Annals of Internal Medicine. They compared effectiveness across a range of SGAs, “including selective serotonin reuptake inhibitors; serotonin-norepinephrine reuptake inhibitors; and others such as bupropion, mirtazapine, nefazodone, trazodone, vilazodone, and vortioxetine.”
This analysis yielded three pieces of clinical advice.
First, patients in the acute phase of mild depression should receive CBT alone as their initial treatment.
Dr. Qaseem and colleagues noted that many depression studies for pharmacologic therapies excluded these patients in favor of those with moderate to severe depression, leaving an evidence gap.
“Furthermore, the Clinical Guidelines Committee had concerns about adverse effects of SGAs in these patients and suggests that the use of SGAs as initial treatment of these patients should be based on additional considerations, such as limited access to or cost of CBT, history of moderate or severe major depressive disorder, or patient preferences,” they added.
The committee’s next recommendation, based on moderate-certainty evidence, suggested that CBT alone or an SGA alone should be considered for patients in the acute phase of moderate to severe depression. This call for monotherapy is balanced by a conditional recommendation based on low-certainty evidence that the same group may benefit from initial combination therapy with both CBT and an SGA.
“The informed decision on the options of monotherapy with CBT versus SGAs, or combination therapy, should be personalized and based on discussion of potential treatment benefits, harms, adverse effect profiles, cost, feasibility, patients’ specific symptoms (such as insomnia, hypersomnia, or fluctuation in appetite), comorbidities, concomitant medication use, and patient preferences,” the guidelines state.
The third and final recommendation offers an algorithm for patients who do not respond to initial therapy with an SGA. Multiple pathways are provided: Switch to CBT or augment with CBT; or switch to a different SGA or augment with a second pharmacologic therapy, such as mirtazapine, bupropion, or buspirone.
“These second-line treatment strategies show similar efficacy when compared with each other,” the guidelines committee noted.
Again, the guidelines suggest that second-line choices should be personalized based on the various factors previously discussed.
A timely update
“The new guideline is very different from the last guideline,” said Ryan Mire, MD, president of the ACP and practicing internal medicine physician in Nashville, Tenn. in a written comment. “ACP decided to update the depression guidelines with a focus on acute depression because approximately 70% of patients with major depressive disorder do not achieve remission and remain in the acute phase after the initial pharmacologic treatment attempt. In addition, there is new evidence on second-line treatments since the 2016 ACP guideline was published.”
Neil S. Skolnik, MD, of Thomas Jefferson University, Philadelphia, agreed that the guidelines offer a necessary and fresh perspective on caring for patients with depression.
“These guidelines are a helpful update, assuring us that we are using the latest, evidence-based therapies, and [they] are written in a practical, easy-to-implement manner,” Dr. Skolnik said in a written comment.
“First, the guidelines reaffirm that CBT is an effective first-line option, with or without the concurrent use of an SGA,” Dr. Skolnik said, noting that CBT alone may reduce likelihood of recurrence, compared with an SGA alone. “Many patients do not like the idea of medication, or the potential side effects of medications, and CBT is an evidenced-based approach that can be very helpful for patients.”
Dr. Skolnik also applauded the guidelines authors for offering a clear path forward for patients who do not have full remission after treatment – a common clinical scenario.
He went on to offer some more detailed steps forward.
“If someone chooses to be treated with an SGA alone and has not had much response at all to an initial SGA, usually a selective serotonin reuptake inhibitor, I’ll usually switch to a different SSRI or serotonin and norepinephrine reuptake inhibitor (SNRI) and/or add CBT,” Dr. Skolnik said. “If they have had a partial response, I’ll often encourage CBT and consider the addition of augmentation with an additional medication as discussed in the guidelines.”
Valuable despite the gaps
Other experts expressed mixed impressions of the update, noting both highs and lows.
“Although [this guideline] has some gaps, it is more valuable in several ways than other widely consulted practice guidelines for depression,” wrote Miriam Shuchman, MD and Elia Abi-Jaoude, MSc, MD, PhD, of the University of Toronto, in an accompanying editorial.
Specifically, they praised the publication’s focus on shared decision-making in the treatment planning process.
“This effort to respond to patient preferences is crucial and may even increase the chance that patients will improve with treatment,” they wrote.
They also applauded the ACP’s efforts to recuse any committee members who may have had conflicts of interest “that could affect their judgment about treatments for depression.”
After highlighting these attributes, Dr. Shuchman and Dr. Abi-Jaoude noted that the guidelines still contain “significant gaps.”
Foremost, they pointed out the guidelines' emphasis on CBT to the exclusion of other nonpharmacologic options.
“The guideline does patients a disservice by leaving out several nonmedication treatment options that clinicians can offer as first- or second-line therapies,” they wrote.
This oversight may increase risk that patients simply hop from one SGA to another, which is a common, and often ineffective, strategy, according to Dr. Shuchman and Dr. Abi-Jaoude.
“Patients often go from one drug to the next in the hopes of landing on one that ‘works,’ ” the editorialists wrote. “This narrow clinical approach of pursuing medication-based treatments ignores the ways difficulties in a person’s work or relationships may contribute to their struggles with depression. At a time when the COVID-19 pandemic has underscored the importance of the social context of mental health, clinicians may need to consider other forms of support and tailor prescribing to what is most relevant and accessible for a particular patient.”
Dr. Shuchman and Dr. Abi-Jaoude went on to suggest several nonpharmacologic options beyond CBT, including interpersonal therapy, psychodynamic therapy, problem solving, behavioral activation, and guided self-help.
The other key gap they pointed out relates to withdrawal.
Although the guideline does advise physicians to taper antidepressants to reduce risk of withdrawal, the editorialists suggested that this recommendation lacked sufficient emphasis, as it can be a particularly difficult period in the treatment process.
“Tapering of an antidepressant may need to be done over months or years, not weeks, and a patient may need to visit a compounding pharmacy to obtain doses of a second-generation antidepressant not marketed by drug manufacturers so that prescriptions can be tapered even more slowly,” they suggested.
Financial costs remain unclear
Beyond the above medical considerations, one other piece of the depression puzzle remains unsolved: cost.
In a simultaneously published rapid review, Andreea Dobrescu, MD, PhD, of Cochrane Austria, and colleagues evaluated the relative cost-effectiveness of first- and second-step treatment strategies.
For most comparisons, evidence was insufficient to reach a conclusion, although they suggested that CBT may be more cost effective at the 5-year mark.
“For most pharmacologic and nonpharmacologic interventions for major depressive disorder, evidence was missing or was insufficient to draw conclusions about the cost-effectiveness of first- or second-step treatments for MDD,” Dr. Dobrescu and colleagues wrote. “The strongest evidence (albeit still low certainty of evidence) was for the cost-effectiveness of CBT compared with SGA as a first-step treatment over a 5-year time horizon from the societal and health care sector perspectives. However, this evidence should also be interpreted cautiously considering it is based on a single study.”
When asked about the financial findings, Dr. Mire agreed that more data are needed, especially because CBT and SGA costs range widely. He suggested that cost, for each patient, should be considered in the personalized approach now highlighted by the new guidelines.
The guidelines and the Cochrane cost-effectiveness study were supported by the ACP. The guidelines' authors and other individuals quoted in this article reported no conflicts of interest.
The guidelines also state that patients with mild depression should start with CBT alone, and if a patient with moderate to severe depression prefers, they can use a combination of both CBT and an SGA.
These nuanced recommendations contrast sharply with the 2016 ACP guidelines for depression, which lumped all stages and severity levels together, and came with just one recommendation: Clinicians should choose between CBT and an SGA.
More data have come to light over the years, requiring the present update, reported lead author Amir Qaseem, MD, PhD, vice president of Clinical Policy and the Center for Evidence Reviews at the ACP, and adjunct faculty at Thomas Jefferson University, Philadelphia, and colleagues.
In addition to the focus on acute depression, Dr. Qaseem and colleagues highlighted the new guidelines' “consideration of patient values and preferences, and costs,” as well as responses to therapy.
Recommendations were derived from a network meta-analysis that included studies evaluating nonpharmacologic and pharmacologic therapies, the authors wrote in Annals of Internal Medicine. They compared effectiveness across a range of SGAs, “including selective serotonin reuptake inhibitors; serotonin-norepinephrine reuptake inhibitors; and others such as bupropion, mirtazapine, nefazodone, trazodone, vilazodone, and vortioxetine.”
This analysis yielded three pieces of clinical advice.
First, patients in the acute phase of mild depression should receive CBT alone as their initial treatment.
Dr. Qaseem and colleagues noted that many depression studies for pharmacologic therapies excluded these patients in favor of those with moderate to severe depression, leaving an evidence gap.
“Furthermore, the Clinical Guidelines Committee had concerns about adverse effects of SGAs in these patients and suggests that the use of SGAs as initial treatment of these patients should be based on additional considerations, such as limited access to or cost of CBT, history of moderate or severe major depressive disorder, or patient preferences,” they added.
The committee’s next recommendation, based on moderate-certainty evidence, suggested that CBT alone or an SGA alone should be considered for patients in the acute phase of moderate to severe depression. This call for monotherapy is balanced by a conditional recommendation based on low-certainty evidence that the same group may benefit from initial combination therapy with both CBT and an SGA.
“The informed decision on the options of monotherapy with CBT versus SGAs, or combination therapy, should be personalized and based on discussion of potential treatment benefits, harms, adverse effect profiles, cost, feasibility, patients’ specific symptoms (such as insomnia, hypersomnia, or fluctuation in appetite), comorbidities, concomitant medication use, and patient preferences,” the guidelines state.
The third and final recommendation offers an algorithm for patients who do not respond to initial therapy with an SGA. Multiple pathways are provided: Switch to CBT or augment with CBT; or switch to a different SGA or augment with a second pharmacologic therapy, such as mirtazapine, bupropion, or buspirone.
“These second-line treatment strategies show similar efficacy when compared with each other,” the guidelines committee noted.
Again, the guidelines suggest that second-line choices should be personalized based on the various factors previously discussed.
A timely update
“The new guideline is very different from the last guideline,” said Ryan Mire, MD, president of the ACP and practicing internal medicine physician in Nashville, Tenn. in a written comment. “ACP decided to update the depression guidelines with a focus on acute depression because approximately 70% of patients with major depressive disorder do not achieve remission and remain in the acute phase after the initial pharmacologic treatment attempt. In addition, there is new evidence on second-line treatments since the 2016 ACP guideline was published.”
Neil S. Skolnik, MD, of Thomas Jefferson University, Philadelphia, agreed that the guidelines offer a necessary and fresh perspective on caring for patients with depression.
“These guidelines are a helpful update, assuring us that we are using the latest, evidence-based therapies, and [they] are written in a practical, easy-to-implement manner,” Dr. Skolnik said in a written comment.
“First, the guidelines reaffirm that CBT is an effective first-line option, with or without the concurrent use of an SGA,” Dr. Skolnik said, noting that CBT alone may reduce likelihood of recurrence, compared with an SGA alone. “Many patients do not like the idea of medication, or the potential side effects of medications, and CBT is an evidenced-based approach that can be very helpful for patients.”
Dr. Skolnik also applauded the guidelines authors for offering a clear path forward for patients who do not have full remission after treatment – a common clinical scenario.
He went on to offer some more detailed steps forward.
“If someone chooses to be treated with an SGA alone and has not had much response at all to an initial SGA, usually a selective serotonin reuptake inhibitor, I’ll usually switch to a different SSRI or serotonin and norepinephrine reuptake inhibitor (SNRI) and/or add CBT,” Dr. Skolnik said. “If they have had a partial response, I’ll often encourage CBT and consider the addition of augmentation with an additional medication as discussed in the guidelines.”
Valuable despite the gaps
Other experts expressed mixed impressions of the update, noting both highs and lows.
“Although [this guideline] has some gaps, it is more valuable in several ways than other widely consulted practice guidelines for depression,” wrote Miriam Shuchman, MD and Elia Abi-Jaoude, MSc, MD, PhD, of the University of Toronto, in an accompanying editorial.
Specifically, they praised the publication’s focus on shared decision-making in the treatment planning process.
“This effort to respond to patient preferences is crucial and may even increase the chance that patients will improve with treatment,” they wrote.
They also applauded the ACP’s efforts to recuse any committee members who may have had conflicts of interest “that could affect their judgment about treatments for depression.”
After highlighting these attributes, Dr. Shuchman and Dr. Abi-Jaoude noted that the guidelines still contain “significant gaps.”
Foremost, they pointed out the guidelines' emphasis on CBT to the exclusion of other nonpharmacologic options.
“The guideline does patients a disservice by leaving out several nonmedication treatment options that clinicians can offer as first- or second-line therapies,” they wrote.
This oversight may increase risk that patients simply hop from one SGA to another, which is a common, and often ineffective, strategy, according to Dr. Shuchman and Dr. Abi-Jaoude.
“Patients often go from one drug to the next in the hopes of landing on one that ‘works,’ ” the editorialists wrote. “This narrow clinical approach of pursuing medication-based treatments ignores the ways difficulties in a person’s work or relationships may contribute to their struggles with depression. At a time when the COVID-19 pandemic has underscored the importance of the social context of mental health, clinicians may need to consider other forms of support and tailor prescribing to what is most relevant and accessible for a particular patient.”
Dr. Shuchman and Dr. Abi-Jaoude went on to suggest several nonpharmacologic options beyond CBT, including interpersonal therapy, psychodynamic therapy, problem solving, behavioral activation, and guided self-help.
The other key gap they pointed out relates to withdrawal.
Although the guideline does advise physicians to taper antidepressants to reduce risk of withdrawal, the editorialists suggested that this recommendation lacked sufficient emphasis, as it can be a particularly difficult period in the treatment process.
“Tapering of an antidepressant may need to be done over months or years, not weeks, and a patient may need to visit a compounding pharmacy to obtain doses of a second-generation antidepressant not marketed by drug manufacturers so that prescriptions can be tapered even more slowly,” they suggested.
Financial costs remain unclear
Beyond the above medical considerations, one other piece of the depression puzzle remains unsolved: cost.
In a simultaneously published rapid review, Andreea Dobrescu, MD, PhD, of Cochrane Austria, and colleagues evaluated the relative cost-effectiveness of first- and second-step treatment strategies.
For most comparisons, evidence was insufficient to reach a conclusion, although they suggested that CBT may be more cost effective at the 5-year mark.
“For most pharmacologic and nonpharmacologic interventions for major depressive disorder, evidence was missing or was insufficient to draw conclusions about the cost-effectiveness of first- or second-step treatments for MDD,” Dr. Dobrescu and colleagues wrote. “The strongest evidence (albeit still low certainty of evidence) was for the cost-effectiveness of CBT compared with SGA as a first-step treatment over a 5-year time horizon from the societal and health care sector perspectives. However, this evidence should also be interpreted cautiously considering it is based on a single study.”
When asked about the financial findings, Dr. Mire agreed that more data are needed, especially because CBT and SGA costs range widely. He suggested that cost, for each patient, should be considered in the personalized approach now highlighted by the new guidelines.
The guidelines and the Cochrane cost-effectiveness study were supported by the ACP. The guidelines' authors and other individuals quoted in this article reported no conflicts of interest.
The guidelines also state that patients with mild depression should start with CBT alone, and if a patient with moderate to severe depression prefers, they can use a combination of both CBT and an SGA.
These nuanced recommendations contrast sharply with the 2016 ACP guidelines for depression, which lumped all stages and severity levels together, and came with just one recommendation: Clinicians should choose between CBT and an SGA.
More data have come to light over the years, requiring the present update, reported lead author Amir Qaseem, MD, PhD, vice president of Clinical Policy and the Center for Evidence Reviews at the ACP, and adjunct faculty at Thomas Jefferson University, Philadelphia, and colleagues.
In addition to the focus on acute depression, Dr. Qaseem and colleagues highlighted the new guidelines' “consideration of patient values and preferences, and costs,” as well as responses to therapy.
Recommendations were derived from a network meta-analysis that included studies evaluating nonpharmacologic and pharmacologic therapies, the authors wrote in Annals of Internal Medicine. They compared effectiveness across a range of SGAs, “including selective serotonin reuptake inhibitors; serotonin-norepinephrine reuptake inhibitors; and others such as bupropion, mirtazapine, nefazodone, trazodone, vilazodone, and vortioxetine.”
This analysis yielded three pieces of clinical advice.
First, patients in the acute phase of mild depression should receive CBT alone as their initial treatment.
Dr. Qaseem and colleagues noted that many depression studies for pharmacologic therapies excluded these patients in favor of those with moderate to severe depression, leaving an evidence gap.
“Furthermore, the Clinical Guidelines Committee had concerns about adverse effects of SGAs in these patients and suggests that the use of SGAs as initial treatment of these patients should be based on additional considerations, such as limited access to or cost of CBT, history of moderate or severe major depressive disorder, or patient preferences,” they added.
The committee’s next recommendation, based on moderate-certainty evidence, suggested that CBT alone or an SGA alone should be considered for patients in the acute phase of moderate to severe depression. This call for monotherapy is balanced by a conditional recommendation based on low-certainty evidence that the same group may benefit from initial combination therapy with both CBT and an SGA.
“The informed decision on the options of monotherapy with CBT versus SGAs, or combination therapy, should be personalized and based on discussion of potential treatment benefits, harms, adverse effect profiles, cost, feasibility, patients’ specific symptoms (such as insomnia, hypersomnia, or fluctuation in appetite), comorbidities, concomitant medication use, and patient preferences,” the guidelines state.
The third and final recommendation offers an algorithm for patients who do not respond to initial therapy with an SGA. Multiple pathways are provided: Switch to CBT or augment with CBT; or switch to a different SGA or augment with a second pharmacologic therapy, such as mirtazapine, bupropion, or buspirone.
“These second-line treatment strategies show similar efficacy when compared with each other,” the guidelines committee noted.
Again, the guidelines suggest that second-line choices should be personalized based on the various factors previously discussed.
A timely update
“The new guideline is very different from the last guideline,” said Ryan Mire, MD, president of the ACP and practicing internal medicine physician in Nashville, Tenn. in a written comment. “ACP decided to update the depression guidelines with a focus on acute depression because approximately 70% of patients with major depressive disorder do not achieve remission and remain in the acute phase after the initial pharmacologic treatment attempt. In addition, there is new evidence on second-line treatments since the 2016 ACP guideline was published.”
Neil S. Skolnik, MD, of Thomas Jefferson University, Philadelphia, agreed that the guidelines offer a necessary and fresh perspective on caring for patients with depression.
“These guidelines are a helpful update, assuring us that we are using the latest, evidence-based therapies, and [they] are written in a practical, easy-to-implement manner,” Dr. Skolnik said in a written comment.
“First, the guidelines reaffirm that CBT is an effective first-line option, with or without the concurrent use of an SGA,” Dr. Skolnik said, noting that CBT alone may reduce likelihood of recurrence, compared with an SGA alone. “Many patients do not like the idea of medication, or the potential side effects of medications, and CBT is an evidenced-based approach that can be very helpful for patients.”
Dr. Skolnik also applauded the guidelines authors for offering a clear path forward for patients who do not have full remission after treatment – a common clinical scenario.
He went on to offer some more detailed steps forward.
“If someone chooses to be treated with an SGA alone and has not had much response at all to an initial SGA, usually a selective serotonin reuptake inhibitor, I’ll usually switch to a different SSRI or serotonin and norepinephrine reuptake inhibitor (SNRI) and/or add CBT,” Dr. Skolnik said. “If they have had a partial response, I’ll often encourage CBT and consider the addition of augmentation with an additional medication as discussed in the guidelines.”
Valuable despite the gaps
Other experts expressed mixed impressions of the update, noting both highs and lows.
“Although [this guideline] has some gaps, it is more valuable in several ways than other widely consulted practice guidelines for depression,” wrote Miriam Shuchman, MD and Elia Abi-Jaoude, MSc, MD, PhD, of the University of Toronto, in an accompanying editorial.
Specifically, they praised the publication’s focus on shared decision-making in the treatment planning process.
“This effort to respond to patient preferences is crucial and may even increase the chance that patients will improve with treatment,” they wrote.
They also applauded the ACP’s efforts to recuse any committee members who may have had conflicts of interest “that could affect their judgment about treatments for depression.”
After highlighting these attributes, Dr. Shuchman and Dr. Abi-Jaoude noted that the guidelines still contain “significant gaps.”
Foremost, they pointed out the guidelines' emphasis on CBT to the exclusion of other nonpharmacologic options.
“The guideline does patients a disservice by leaving out several nonmedication treatment options that clinicians can offer as first- or second-line therapies,” they wrote.
This oversight may increase risk that patients simply hop from one SGA to another, which is a common, and often ineffective, strategy, according to Dr. Shuchman and Dr. Abi-Jaoude.
“Patients often go from one drug to the next in the hopes of landing on one that ‘works,’ ” the editorialists wrote. “This narrow clinical approach of pursuing medication-based treatments ignores the ways difficulties in a person’s work or relationships may contribute to their struggles with depression. At a time when the COVID-19 pandemic has underscored the importance of the social context of mental health, clinicians may need to consider other forms of support and tailor prescribing to what is most relevant and accessible for a particular patient.”
Dr. Shuchman and Dr. Abi-Jaoude went on to suggest several nonpharmacologic options beyond CBT, including interpersonal therapy, psychodynamic therapy, problem solving, behavioral activation, and guided self-help.
The other key gap they pointed out relates to withdrawal.
Although the guideline does advise physicians to taper antidepressants to reduce risk of withdrawal, the editorialists suggested that this recommendation lacked sufficient emphasis, as it can be a particularly difficult period in the treatment process.
“Tapering of an antidepressant may need to be done over months or years, not weeks, and a patient may need to visit a compounding pharmacy to obtain doses of a second-generation antidepressant not marketed by drug manufacturers so that prescriptions can be tapered even more slowly,” they suggested.
Financial costs remain unclear
Beyond the above medical considerations, one other piece of the depression puzzle remains unsolved: cost.
In a simultaneously published rapid review, Andreea Dobrescu, MD, PhD, of Cochrane Austria, and colleagues evaluated the relative cost-effectiveness of first- and second-step treatment strategies.
For most comparisons, evidence was insufficient to reach a conclusion, although they suggested that CBT may be more cost effective at the 5-year mark.
“For most pharmacologic and nonpharmacologic interventions for major depressive disorder, evidence was missing or was insufficient to draw conclusions about the cost-effectiveness of first- or second-step treatments for MDD,” Dr. Dobrescu and colleagues wrote. “The strongest evidence (albeit still low certainty of evidence) was for the cost-effectiveness of CBT compared with SGA as a first-step treatment over a 5-year time horizon from the societal and health care sector perspectives. However, this evidence should also be interpreted cautiously considering it is based on a single study.”
When asked about the financial findings, Dr. Mire agreed that more data are needed, especially because CBT and SGA costs range widely. He suggested that cost, for each patient, should be considered in the personalized approach now highlighted by the new guidelines.
The guidelines and the Cochrane cost-effectiveness study were supported by the ACP. The guidelines' authors and other individuals quoted in this article reported no conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
3D-printed tumor models could advance new cancer therapies
Scientists have made big strides in the fight against cancer. A person’s risk of dying of cancer in the U.S. fell by 27% in the past 2 decades, thanks in large part to researchers who continue to uncover the complex details of how cancer works and to make advances in treatment.
Now the by enabling scientists to develop 3D tumor models that better represent samples from patients.
The impact could be “huge,” says Y. Shrike Zhang, PhD, an assistant professor of medicine at Harvard Medical School and associate bioengineer at Brigham and Women’s Hospital, both in Boston, who studies 3D bioprinting. “It is not the only technology that may allow modeling of tumors in vitro, but it certainly is one of the most capable.”
Why does that matter? Because the 2D cell cultures that scientists often use now may not capture all the complexities of how cancer grows, spreads, and responds to treatment. It’s one reason why so few potential new cancer drugs – 3.4%, according to one estimate – can pass all clinical trials. Results may not carry over from the culture dish to the patient.
Researchers say these 3D-printed blood vessels may treat certain dangerous health problems that affect your veins, arteries, or capillaries.
A 3D-bioprinted model, on the other hand, may be better at copying a tumor’s “microenvironment” – all the parts (cells, molecules, blood vessels) that surround a tumor.
“The tumor microenvironment plays an integral role in defining how cancer progresses,” says Madhuri Dey, a PhD candidate and researcher at Penn State University. “In vitro 3D models are an attempt at reconstituting a [cancer] microenvironment, which sheds light on how tumors respond to chemo or immunotherapeutic treatments when they are present in a native-like microenvironment.”
Ms. Dey is the lead author of a study funded by the National Science Foundation in which breast cancer tumors were 3D-bioprinted and successfully treated. Unlike some previous 3D models of cancer cells, this model did a better job of imitating that microenvironment, she explains.
So far, “3D bioprinting of cancer models has been limited to bioprinting of individual cancer cells laden in hydrogels,” she says. But she and her colleagues developed a technique called aspiration-assisted bioprinting that lets them control where blood vessels are located relative to the tumor. “This model lays the foundation for studying these nuances of cancer,” Ms. Dey says.
“This is a quite cool work,” Dr. Zhang says of the Penn State study (which he was not involved in). “Vascularization is always a key component in [a] majority of the tumor types.” A model that incorporates blood vessels provides a “critical niche” to help tumor models reach their full potential in cancer research.
A 3D printer for your body
Chances are you’ve heard of 3D printing and may even own (or know someone who owns) a 3D printer. The concept is like regular printing, but instead of spewing ink onto paper, a 3D printer releases layers of plastic or other materials, hundreds or thousands of times, to build an object from the ground up.
Three-dimensional bioprinting works much the same way, except those layers are made of living cells to create biological structures like skin, vessels, organs, or bone.
Bioprinting has been around since 1988. So far, it’s mainly used in research settings, such as in the field of regenerative medicine. Research is underway for ear reconstruction, nerve regeneration, and skin regeneration. The technology was also recently used to create eye tissue to help researchers study eye diseases.
The technology’s potential for use in cancer research has yet to be fully realized, Ms. Dey says. But that may be changing.
“The use of 3D-bioprinted tumor models is getting close to translations in cancer research,” says Dr. Zhang. “They are being increasingly adopted by the research field, and [the technology] has started to be explored by the pharma industry for use towards cancer drug development.”
Because bioprinting can be automated, it could allow researchers to create high-quality, complex tumor models at scale, Dr. Zhang says.
Such 3D models also have the potential to replace or reduce the use of animals in tumor drug testing, Ms. Dey notes. They “are expected to provide a more accurate drug response, compared [with] animal models, as animal physiology does not match humans’.”
The FDA Modernization Act 2.0, a new U.S. law eliminating the requirement that drugs be tested in animals before humans, has “further paved the way for such technologies in the drug development pipeline,” Dr. Zhang says.
What if we could build a custom tumor model for each patient?
Possible uses for bioprinting go beyond the lab, Ms. Dey says. Imagine if we could customize 3D tumor models based on biopsies from individual patients. Doctors could test many treatments on these patient-specific models, letting them more accurately predict how each patient would respond to different therapies. This would help doctors decide which course of treatment is best.
In Ms. Dey’s study, the 3D model was treated with chemotherapy and with immunotherapy, and it responded to both. This highlights the potential for such 3D models to reveal the body’s immune response and be used to screen therapies, she says. “We hope is that in the future, this technique can be adapted in the hospital, which would speed up the course of cancer treatment.”
To that end, she and her colleagues are now working with real breast cancer tumors removed from patients, re-creating them in the lab in 3D to use for chemo and immunotherapy screening.
A version of this article first appeared on WebMD.com.
Scientists have made big strides in the fight against cancer. A person’s risk of dying of cancer in the U.S. fell by 27% in the past 2 decades, thanks in large part to researchers who continue to uncover the complex details of how cancer works and to make advances in treatment.
Now the by enabling scientists to develop 3D tumor models that better represent samples from patients.
The impact could be “huge,” says Y. Shrike Zhang, PhD, an assistant professor of medicine at Harvard Medical School and associate bioengineer at Brigham and Women’s Hospital, both in Boston, who studies 3D bioprinting. “It is not the only technology that may allow modeling of tumors in vitro, but it certainly is one of the most capable.”
Why does that matter? Because the 2D cell cultures that scientists often use now may not capture all the complexities of how cancer grows, spreads, and responds to treatment. It’s one reason why so few potential new cancer drugs – 3.4%, according to one estimate – can pass all clinical trials. Results may not carry over from the culture dish to the patient.
Researchers say these 3D-printed blood vessels may treat certain dangerous health problems that affect your veins, arteries, or capillaries.
A 3D-bioprinted model, on the other hand, may be better at copying a tumor’s “microenvironment” – all the parts (cells, molecules, blood vessels) that surround a tumor.
“The tumor microenvironment plays an integral role in defining how cancer progresses,” says Madhuri Dey, a PhD candidate and researcher at Penn State University. “In vitro 3D models are an attempt at reconstituting a [cancer] microenvironment, which sheds light on how tumors respond to chemo or immunotherapeutic treatments when they are present in a native-like microenvironment.”
Ms. Dey is the lead author of a study funded by the National Science Foundation in which breast cancer tumors were 3D-bioprinted and successfully treated. Unlike some previous 3D models of cancer cells, this model did a better job of imitating that microenvironment, she explains.
So far, “3D bioprinting of cancer models has been limited to bioprinting of individual cancer cells laden in hydrogels,” she says. But she and her colleagues developed a technique called aspiration-assisted bioprinting that lets them control where blood vessels are located relative to the tumor. “This model lays the foundation for studying these nuances of cancer,” Ms. Dey says.
“This is a quite cool work,” Dr. Zhang says of the Penn State study (which he was not involved in). “Vascularization is always a key component in [a] majority of the tumor types.” A model that incorporates blood vessels provides a “critical niche” to help tumor models reach their full potential in cancer research.
A 3D printer for your body
Chances are you’ve heard of 3D printing and may even own (or know someone who owns) a 3D printer. The concept is like regular printing, but instead of spewing ink onto paper, a 3D printer releases layers of plastic or other materials, hundreds or thousands of times, to build an object from the ground up.
Three-dimensional bioprinting works much the same way, except those layers are made of living cells to create biological structures like skin, vessels, organs, or bone.
Bioprinting has been around since 1988. So far, it’s mainly used in research settings, such as in the field of regenerative medicine. Research is underway for ear reconstruction, nerve regeneration, and skin regeneration. The technology was also recently used to create eye tissue to help researchers study eye diseases.
The technology’s potential for use in cancer research has yet to be fully realized, Ms. Dey says. But that may be changing.
“The use of 3D-bioprinted tumor models is getting close to translations in cancer research,” says Dr. Zhang. “They are being increasingly adopted by the research field, and [the technology] has started to be explored by the pharma industry for use towards cancer drug development.”
Because bioprinting can be automated, it could allow researchers to create high-quality, complex tumor models at scale, Dr. Zhang says.
Such 3D models also have the potential to replace or reduce the use of animals in tumor drug testing, Ms. Dey notes. They “are expected to provide a more accurate drug response, compared [with] animal models, as animal physiology does not match humans’.”
The FDA Modernization Act 2.0, a new U.S. law eliminating the requirement that drugs be tested in animals before humans, has “further paved the way for such technologies in the drug development pipeline,” Dr. Zhang says.
What if we could build a custom tumor model for each patient?
Possible uses for bioprinting go beyond the lab, Ms. Dey says. Imagine if we could customize 3D tumor models based on biopsies from individual patients. Doctors could test many treatments on these patient-specific models, letting them more accurately predict how each patient would respond to different therapies. This would help doctors decide which course of treatment is best.
In Ms. Dey’s study, the 3D model was treated with chemotherapy and with immunotherapy, and it responded to both. This highlights the potential for such 3D models to reveal the body’s immune response and be used to screen therapies, she says. “We hope is that in the future, this technique can be adapted in the hospital, which would speed up the course of cancer treatment.”
To that end, she and her colleagues are now working with real breast cancer tumors removed from patients, re-creating them in the lab in 3D to use for chemo and immunotherapy screening.
A version of this article first appeared on WebMD.com.
Scientists have made big strides in the fight against cancer. A person’s risk of dying of cancer in the U.S. fell by 27% in the past 2 decades, thanks in large part to researchers who continue to uncover the complex details of how cancer works and to make advances in treatment.
Now the by enabling scientists to develop 3D tumor models that better represent samples from patients.
The impact could be “huge,” says Y. Shrike Zhang, PhD, an assistant professor of medicine at Harvard Medical School and associate bioengineer at Brigham and Women’s Hospital, both in Boston, who studies 3D bioprinting. “It is not the only technology that may allow modeling of tumors in vitro, but it certainly is one of the most capable.”
Why does that matter? Because the 2D cell cultures that scientists often use now may not capture all the complexities of how cancer grows, spreads, and responds to treatment. It’s one reason why so few potential new cancer drugs – 3.4%, according to one estimate – can pass all clinical trials. Results may not carry over from the culture dish to the patient.
Researchers say these 3D-printed blood vessels may treat certain dangerous health problems that affect your veins, arteries, or capillaries.
A 3D-bioprinted model, on the other hand, may be better at copying a tumor’s “microenvironment” – all the parts (cells, molecules, blood vessels) that surround a tumor.
“The tumor microenvironment plays an integral role in defining how cancer progresses,” says Madhuri Dey, a PhD candidate and researcher at Penn State University. “In vitro 3D models are an attempt at reconstituting a [cancer] microenvironment, which sheds light on how tumors respond to chemo or immunotherapeutic treatments when they are present in a native-like microenvironment.”
Ms. Dey is the lead author of a study funded by the National Science Foundation in which breast cancer tumors were 3D-bioprinted and successfully treated. Unlike some previous 3D models of cancer cells, this model did a better job of imitating that microenvironment, she explains.
So far, “3D bioprinting of cancer models has been limited to bioprinting of individual cancer cells laden in hydrogels,” she says. But she and her colleagues developed a technique called aspiration-assisted bioprinting that lets them control where blood vessels are located relative to the tumor. “This model lays the foundation for studying these nuances of cancer,” Ms. Dey says.
“This is a quite cool work,” Dr. Zhang says of the Penn State study (which he was not involved in). “Vascularization is always a key component in [a] majority of the tumor types.” A model that incorporates blood vessels provides a “critical niche” to help tumor models reach their full potential in cancer research.
A 3D printer for your body
Chances are you’ve heard of 3D printing and may even own (or know someone who owns) a 3D printer. The concept is like regular printing, but instead of spewing ink onto paper, a 3D printer releases layers of plastic or other materials, hundreds or thousands of times, to build an object from the ground up.
Three-dimensional bioprinting works much the same way, except those layers are made of living cells to create biological structures like skin, vessels, organs, or bone.
Bioprinting has been around since 1988. So far, it’s mainly used in research settings, such as in the field of regenerative medicine. Research is underway for ear reconstruction, nerve regeneration, and skin regeneration. The technology was also recently used to create eye tissue to help researchers study eye diseases.
The technology’s potential for use in cancer research has yet to be fully realized, Ms. Dey says. But that may be changing.
“The use of 3D-bioprinted tumor models is getting close to translations in cancer research,” says Dr. Zhang. “They are being increasingly adopted by the research field, and [the technology] has started to be explored by the pharma industry for use towards cancer drug development.”
Because bioprinting can be automated, it could allow researchers to create high-quality, complex tumor models at scale, Dr. Zhang says.
Such 3D models also have the potential to replace or reduce the use of animals in tumor drug testing, Ms. Dey notes. They “are expected to provide a more accurate drug response, compared [with] animal models, as animal physiology does not match humans’.”
The FDA Modernization Act 2.0, a new U.S. law eliminating the requirement that drugs be tested in animals before humans, has “further paved the way for such technologies in the drug development pipeline,” Dr. Zhang says.
What if we could build a custom tumor model for each patient?
Possible uses for bioprinting go beyond the lab, Ms. Dey says. Imagine if we could customize 3D tumor models based on biopsies from individual patients. Doctors could test many treatments on these patient-specific models, letting them more accurately predict how each patient would respond to different therapies. This would help doctors decide which course of treatment is best.
In Ms. Dey’s study, the 3D model was treated with chemotherapy and with immunotherapy, and it responded to both. This highlights the potential for such 3D models to reveal the body’s immune response and be used to screen therapies, she says. “We hope is that in the future, this technique can be adapted in the hospital, which would speed up the course of cancer treatment.”
To that end, she and her colleagues are now working with real breast cancer tumors removed from patients, re-creating them in the lab in 3D to use for chemo and immunotherapy screening.
A version of this article first appeared on WebMD.com.
Doctors’ happiness has not rebounded as pandemic drags on
Physicians reported similar levels of unhappiness in 2022 too.
Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*
“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.
“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”
Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.
Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.
While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.
“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.
Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.
Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.
Physicians’ personal life suffers
Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.
“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.
That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.
More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.
When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.
“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
Prioritize your well-being
Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”
Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.
A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.
Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”
She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”
A version of this article originally appeared on Medscape.com.
Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.
Physicians reported similar levels of unhappiness in 2022 too.
Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*
“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.
“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”
Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.
Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.
While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.
“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.
Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.
Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.
Physicians’ personal life suffers
Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.
“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.
That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.
More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.
When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.
“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
Prioritize your well-being
Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”
Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.
A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.
Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”
She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”
A version of this article originally appeared on Medscape.com.
Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.
Physicians reported similar levels of unhappiness in 2022 too.
Fewer than half of physicians said they were currently somewhat or very happy at work, compared with 75% of physicians who said they were somewhat or very happy at work in a previous survey conducted before the pandemic, the new Medscape Physician Lifestyle & Happiness Report 2023 shows.*
“I am not surprised that we’re less happy now,” said Amaryllis Sánchez, MD, a board-certified family medicine physician and a certified physician coach.
“I speak to physicians around the country and I hear that their workplaces are understaffed, they’re overworked and they don’t feel safe. Although we’re in a different phase of the pandemic, doctors feel that the ground beneath them is still shaky,” said Dr. Sánchez, the author of “Recapturing Joy in Medicine.”
Most doctors are seeing more patients than they can handle and are expected to do that consistently. “When you no longer have the capacity to give of yourself, that becomes a nearly impossible task,” said Dr. Sánchez.
Also, physicians in understaffed workplaces often must take on additional work such as administrative or nursing duties, said Katie Cole, DO, a board-certified psychiatrist and a physician coach.
While health systems are aware that physicians need time to rest and recharge, staffing shortages prevent doctors from taking time off because they can’t find coverage, said Dr. Cole.
“While we know that it’s important for physicians to take vacations, more than one-third of doctors still take 2 weeks or less of vacation annually,” said Dr. Cole.
Physicians also tend to have less compassion for themselves and sacrifice self-care compared to other health care workers. “When a patient dies, nurses get together, debrief, and hug each other, whereas doctors have another patient to see. The culture of medicine doesn’t support self-compassion for physicians,” said Dr. Cole.
Physicians also felt less safe at work during the pandemic because of to shortages of personal protective equipment, said Dr. Sánchez. They have also witnessed or experienced an increase in abusive behavior, violence and threats of violence.
Physicians’ personal life suffers
Doctors maintain their mental health primarily by spending time with family members and friends, according to 2022’s Medscape Physician Lifestyle & Happiness Report. Yet half of doctors reported in a survey by the Physicians Foundation that they withdrew from family, friends or coworkers in 2022, said Dr. Sánchez.
“When you exceed your mental, emotional, and physical capacity at work, you have no reserve left for your personal life,” said Dr. Cole.
That may explain why only 58% of doctors reported feeling somewhat or very happy outside of work, compared with 84% who felt that way before the pandemic.
More women doctors said they deal with stronger feelings of conflict in trying to balance parenting responsibilities with a highly demanding job. Nearly one in two women physician-parents reported feeling very conflicted at work, compared with about one in four male physician-parents.
When physicians go home, they may be emotionally drained and tired mentally from making a lot of decisions at work, said Dr. Cole.
“As a woman, if you have children and a husband and you’re responsible for dinner, picking up the kids at daycare or helping them with homework, and making all these decisions when you get home, it’s overwhelming,” said Dr. Cole.
Prioritize your well-being
Doctors need to prioritize their own well-being, said Dr. Sánchez. “That’s not being selfish, that’s doing what’s necessary to stay well and be able to take care of patients. If doctors don’t take care of themselves, no one else will.”
Dr. Sánchez recommended that doctors regularly interact with relatives, friends, trusted colleagues, or clergy to help maintain their well-being, rather than waiting until a crisis to reach out.
A good coach, mentor, or counselor can help physicians gain enough self-awareness to handle their emotions and gain more clarity about what changes need to be made, she said.
Dr. Cole suggested that doctors figure out what makes them happy and fulfilled at work and try to spend more time on that activity. “Knowing what makes you happy and your strengths are foundational for creating a life you love.”
She urged doctors to “start thinking now about what you love about medicine and what is going right at home, and what areas you want to change. Then, start advocating for your needs.”
A version of this article originally appeared on Medscape.com.
Correction, 1/26/23: An earlier version of this article misstated the findings of the survey.
A patient named ‘Settle’ decides to sue instead
On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.
Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.
Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.
Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.
Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.
His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.
Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.
Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.
Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”
His suit seeks not only compensatory damages and other relief but also punitive damages.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article originally appeared on Medscape.com.
On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.
Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.
Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.
Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.
Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.
His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.
Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.
Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.
Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”
His suit seeks not only compensatory damages and other relief but also punitive damages.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article originally appeared on Medscape.com.
On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.
Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.
Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.
Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.
Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.
His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.
Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.
Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.
Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”
His suit seeks not only compensatory damages and other relief but also punitive damages.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article originally appeared on Medscape.com.