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What’s best for patients who are dying of anorexia?
SAN FRANCISCO – The patient at a Florida eating disorder clinic said she was eating plenty even though she acknowledged purging once a week. But her vitals told a different story: Her body mass index (BMI) was 12.2, down from 14.8 a couple of years before – a dangerously low value.
While the woman agreed that she needed to gain weight, she refused advice to pursue residential or inpatient treatment. This left her team with a big dilemma: Should they force her into care because she wouldn’t eat? Was that even possible under the law? Did she have the capacity to make decisions about her future? What other alternatives were there?
Determining the best course of action in cases like this is anything but simple, Dr. Cacodcar said. To make matters more complicated, .
“At least in my state of Florida, we know that it can be very, very hard to get patients expert care,” said Dr. Cacodcar. And, she said, it can be even tougher for certain types of patients, such as those that are LGBTQ and those who have severe illness but don’t meet the criteria.
As Dr. Cacodcar noted, the APA released new practice guidelines regarding eating disorders earlier this year, marking their first update since 2006. The guidelines highlight research that suggests nearly 1% – 0.8% – of the U.S. population will develop AN over their lifetimes. Recent studies also suggest that eating disorder numbers rose during the pandemic, with one analysis finding that patients under inpatient care doubled in 2020.
“Mortality rates are high for anorexia nervosa, up to 10 times higher than matched controls,” Dr. Cacodcar said. “It has the highest mortality rate of the psychiatric diseases with the exception of opioid use disorder.”
As for outcomes, she pointed to a 2019 study that surveyed 387 parents who had children with eating disorders, mostly AN. Only 20% made a full recovery. “The farther you get out from the onset of anorexia, the less likely you are to achieve recovery,” Dr. Cacodcar said. “A lot of the control behaviors become very automatic.”
Determining capacity
In some cases of AN, psychiatrists must determine whether they have the capacity to make decisions about treatment, said Gabriel Jerkins, MD, a chief resident of psychiatry at the University of Florida. At issue is “the ability of the individual to comprehend the information being disclosed in regard to their condition, as well as the nature and potential risks and benefits of the proposed treatment alternatives. They include of course, no treatment at all.”
“We know psychiatric conditions can limit one’s ability to appreciate consequence,” he said.
One option is to seek to institutionalize patients with severe AN because they are a danger to themselves. Clinicians opted to not do this in the case of the patient profiled by Dr. Cacodcar, the one with the BMI of 12.2 who didn’t want inpatient or residential care. (A 5-foot-8 person with a BMI of 12.2 would weigh 80 pounds.)
“The main reason we did not hospitalize her is because an appropriate level of care was not going to be readily available,” Dr. Cacodcar said, and her treatment would have been substandard.
Fortunately, the woman did return after a couple of months and accept residential care. No facility in Florida was willing to accept her because of her low BMI, but she did find one in North Carolina, where she stayed for 2 months. She’s doing well, and her BMI is now 21, Dr. Cacodcar said.
The patient’s story shows that involuntary hospitalization “is not necessarily the best course of action,” Dr. Cacodcar said. “It wasn’t necessarily going to be in the patient’s best interest.”
In another case, a 22-year-old woman had severe AN. She had been a gymnast and dancer, Dr. Jerkins said, “and I include that here only because of how commonly we see that kind of demographic information in patients with anorexia nervosa.”
Her BMI was 17.5, and clinicians discussed feeding her through a feeding tube. She still had “no insight that her symptoms were related to an underlying eating disorder,” Dr. Jerkins said, raising questions about her capacity. “Is it sufficient that the patient understand that she’s underweight?”
Ultimately, he said, she received a feeding tube at a time when her BMI had dropped to 16.3. She suffered from an infection but ultimately she improved and has stabilized at a BMI of around 19, he said.
“I do wonder if allowing her to have some control of how to pursue treatment in this case was therapeutic in a way,” he said, especially since matters of control are deeply ingrained in AN.
A former physical trainer, the patient had a BMI of 17.6. The University of Florida’s eating disorder clinic sent her to an out-of-state residential program, but she was discharged when her blood glucose dipped dangerously low as she compulsively exercised. Her BMI dipped to 16.2.
Dr. Schmidt had the patient involuntarily committed upon her return, but she went home after 12 days with no change in her weight. Ultimately, the patient was referred to an eating disorder center in Colorado for medical stabilization where she was given a feeding tube. But her medical situation was so dire that she was discharged to her home, where she went on hospice and died.
“I’m not arguing for or against the term ‘terminal anorexia.’ But this case does make me think about it,” said Dr. Schmidt. She was referring to a controversial term used by some clinicians to refer to patients who face inevitable death from AN. “Unfortunately,” wrote the authors of a recent report proposing a clinical definition, “these patients and their carers often receive minimal support from eating disorders health professionals who are conflicted about terminal care, and who are hampered and limited by the paucity of literature on end-of-life care for those with anorexia nervosa.”
SAN FRANCISCO – The patient at a Florida eating disorder clinic said she was eating plenty even though she acknowledged purging once a week. But her vitals told a different story: Her body mass index (BMI) was 12.2, down from 14.8 a couple of years before – a dangerously low value.
While the woman agreed that she needed to gain weight, she refused advice to pursue residential or inpatient treatment. This left her team with a big dilemma: Should they force her into care because she wouldn’t eat? Was that even possible under the law? Did she have the capacity to make decisions about her future? What other alternatives were there?
Determining the best course of action in cases like this is anything but simple, Dr. Cacodcar said. To make matters more complicated, .
“At least in my state of Florida, we know that it can be very, very hard to get patients expert care,” said Dr. Cacodcar. And, she said, it can be even tougher for certain types of patients, such as those that are LGBTQ and those who have severe illness but don’t meet the criteria.
As Dr. Cacodcar noted, the APA released new practice guidelines regarding eating disorders earlier this year, marking their first update since 2006. The guidelines highlight research that suggests nearly 1% – 0.8% – of the U.S. population will develop AN over their lifetimes. Recent studies also suggest that eating disorder numbers rose during the pandemic, with one analysis finding that patients under inpatient care doubled in 2020.
“Mortality rates are high for anorexia nervosa, up to 10 times higher than matched controls,” Dr. Cacodcar said. “It has the highest mortality rate of the psychiatric diseases with the exception of opioid use disorder.”
As for outcomes, she pointed to a 2019 study that surveyed 387 parents who had children with eating disorders, mostly AN. Only 20% made a full recovery. “The farther you get out from the onset of anorexia, the less likely you are to achieve recovery,” Dr. Cacodcar said. “A lot of the control behaviors become very automatic.”
Determining capacity
In some cases of AN, psychiatrists must determine whether they have the capacity to make decisions about treatment, said Gabriel Jerkins, MD, a chief resident of psychiatry at the University of Florida. At issue is “the ability of the individual to comprehend the information being disclosed in regard to their condition, as well as the nature and potential risks and benefits of the proposed treatment alternatives. They include of course, no treatment at all.”
“We know psychiatric conditions can limit one’s ability to appreciate consequence,” he said.
One option is to seek to institutionalize patients with severe AN because they are a danger to themselves. Clinicians opted to not do this in the case of the patient profiled by Dr. Cacodcar, the one with the BMI of 12.2 who didn’t want inpatient or residential care. (A 5-foot-8 person with a BMI of 12.2 would weigh 80 pounds.)
“The main reason we did not hospitalize her is because an appropriate level of care was not going to be readily available,” Dr. Cacodcar said, and her treatment would have been substandard.
Fortunately, the woman did return after a couple of months and accept residential care. No facility in Florida was willing to accept her because of her low BMI, but she did find one in North Carolina, where she stayed for 2 months. She’s doing well, and her BMI is now 21, Dr. Cacodcar said.
The patient’s story shows that involuntary hospitalization “is not necessarily the best course of action,” Dr. Cacodcar said. “It wasn’t necessarily going to be in the patient’s best interest.”
In another case, a 22-year-old woman had severe AN. She had been a gymnast and dancer, Dr. Jerkins said, “and I include that here only because of how commonly we see that kind of demographic information in patients with anorexia nervosa.”
Her BMI was 17.5, and clinicians discussed feeding her through a feeding tube. She still had “no insight that her symptoms were related to an underlying eating disorder,” Dr. Jerkins said, raising questions about her capacity. “Is it sufficient that the patient understand that she’s underweight?”
Ultimately, he said, she received a feeding tube at a time when her BMI had dropped to 16.3. She suffered from an infection but ultimately she improved and has stabilized at a BMI of around 19, he said.
“I do wonder if allowing her to have some control of how to pursue treatment in this case was therapeutic in a way,” he said, especially since matters of control are deeply ingrained in AN.
A former physical trainer, the patient had a BMI of 17.6. The University of Florida’s eating disorder clinic sent her to an out-of-state residential program, but she was discharged when her blood glucose dipped dangerously low as she compulsively exercised. Her BMI dipped to 16.2.
Dr. Schmidt had the patient involuntarily committed upon her return, but she went home after 12 days with no change in her weight. Ultimately, the patient was referred to an eating disorder center in Colorado for medical stabilization where she was given a feeding tube. But her medical situation was so dire that she was discharged to her home, where she went on hospice and died.
“I’m not arguing for or against the term ‘terminal anorexia.’ But this case does make me think about it,” said Dr. Schmidt. She was referring to a controversial term used by some clinicians to refer to patients who face inevitable death from AN. “Unfortunately,” wrote the authors of a recent report proposing a clinical definition, “these patients and their carers often receive minimal support from eating disorders health professionals who are conflicted about terminal care, and who are hampered and limited by the paucity of literature on end-of-life care for those with anorexia nervosa.”
SAN FRANCISCO – The patient at a Florida eating disorder clinic said she was eating plenty even though she acknowledged purging once a week. But her vitals told a different story: Her body mass index (BMI) was 12.2, down from 14.8 a couple of years before – a dangerously low value.
While the woman agreed that she needed to gain weight, she refused advice to pursue residential or inpatient treatment. This left her team with a big dilemma: Should they force her into care because she wouldn’t eat? Was that even possible under the law? Did she have the capacity to make decisions about her future? What other alternatives were there?
Determining the best course of action in cases like this is anything but simple, Dr. Cacodcar said. To make matters more complicated, .
“At least in my state of Florida, we know that it can be very, very hard to get patients expert care,” said Dr. Cacodcar. And, she said, it can be even tougher for certain types of patients, such as those that are LGBTQ and those who have severe illness but don’t meet the criteria.
As Dr. Cacodcar noted, the APA released new practice guidelines regarding eating disorders earlier this year, marking their first update since 2006. The guidelines highlight research that suggests nearly 1% – 0.8% – of the U.S. population will develop AN over their lifetimes. Recent studies also suggest that eating disorder numbers rose during the pandemic, with one analysis finding that patients under inpatient care doubled in 2020.
“Mortality rates are high for anorexia nervosa, up to 10 times higher than matched controls,” Dr. Cacodcar said. “It has the highest mortality rate of the psychiatric diseases with the exception of opioid use disorder.”
As for outcomes, she pointed to a 2019 study that surveyed 387 parents who had children with eating disorders, mostly AN. Only 20% made a full recovery. “The farther you get out from the onset of anorexia, the less likely you are to achieve recovery,” Dr. Cacodcar said. “A lot of the control behaviors become very automatic.”
Determining capacity
In some cases of AN, psychiatrists must determine whether they have the capacity to make decisions about treatment, said Gabriel Jerkins, MD, a chief resident of psychiatry at the University of Florida. At issue is “the ability of the individual to comprehend the information being disclosed in regard to their condition, as well as the nature and potential risks and benefits of the proposed treatment alternatives. They include of course, no treatment at all.”
“We know psychiatric conditions can limit one’s ability to appreciate consequence,” he said.
One option is to seek to institutionalize patients with severe AN because they are a danger to themselves. Clinicians opted to not do this in the case of the patient profiled by Dr. Cacodcar, the one with the BMI of 12.2 who didn’t want inpatient or residential care. (A 5-foot-8 person with a BMI of 12.2 would weigh 80 pounds.)
“The main reason we did not hospitalize her is because an appropriate level of care was not going to be readily available,” Dr. Cacodcar said, and her treatment would have been substandard.
Fortunately, the woman did return after a couple of months and accept residential care. No facility in Florida was willing to accept her because of her low BMI, but she did find one in North Carolina, where she stayed for 2 months. She’s doing well, and her BMI is now 21, Dr. Cacodcar said.
The patient’s story shows that involuntary hospitalization “is not necessarily the best course of action,” Dr. Cacodcar said. “It wasn’t necessarily going to be in the patient’s best interest.”
In another case, a 22-year-old woman had severe AN. She had been a gymnast and dancer, Dr. Jerkins said, “and I include that here only because of how commonly we see that kind of demographic information in patients with anorexia nervosa.”
Her BMI was 17.5, and clinicians discussed feeding her through a feeding tube. She still had “no insight that her symptoms were related to an underlying eating disorder,” Dr. Jerkins said, raising questions about her capacity. “Is it sufficient that the patient understand that she’s underweight?”
Ultimately, he said, she received a feeding tube at a time when her BMI had dropped to 16.3. She suffered from an infection but ultimately she improved and has stabilized at a BMI of around 19, he said.
“I do wonder if allowing her to have some control of how to pursue treatment in this case was therapeutic in a way,” he said, especially since matters of control are deeply ingrained in AN.
A former physical trainer, the patient had a BMI of 17.6. The University of Florida’s eating disorder clinic sent her to an out-of-state residential program, but she was discharged when her blood glucose dipped dangerously low as she compulsively exercised. Her BMI dipped to 16.2.
Dr. Schmidt had the patient involuntarily committed upon her return, but she went home after 12 days with no change in her weight. Ultimately, the patient was referred to an eating disorder center in Colorado for medical stabilization where she was given a feeding tube. But her medical situation was so dire that she was discharged to her home, where she went on hospice and died.
“I’m not arguing for or against the term ‘terminal anorexia.’ But this case does make me think about it,” said Dr. Schmidt. She was referring to a controversial term used by some clinicians to refer to patients who face inevitable death from AN. “Unfortunately,” wrote the authors of a recent report proposing a clinical definition, “these patients and their carers often receive minimal support from eating disorders health professionals who are conflicted about terminal care, and who are hampered and limited by the paucity of literature on end-of-life care for those with anorexia nervosa.”
AT APA 2023
Alcohol dependence in teens tied to subsequent depression
TOPLINE
Alcohol dependence, but not consumption, at age 18 years increases the risk for depression at age 24 years.
METHODOLOGY
- The study included 3,902 mostly White adolescents, about 58% female, born in England from April 1991 to December 1992, who were part of the Avon Longitudinal Study of Parents and Children (ALSPAC) that examined genetic and environmental determinants of health and development.
- Participants completed the self-report Alcohol Use Disorders Identification Test (AUDIT) between the ages of 16 and 23 years, a period when average alcohol use increases rapidly.
- The primary outcome was probability for depression at age 24 years, using the Clinical Interview Schedule Revised (CIS-R), a self-administered computerized clinical assessment of common mental disorder symptoms during the past week.
- Researchers assessed frequency and quantity of alcohol consumption as well as alcohol dependence.
- Confounders included sex, housing type, maternal education and depressive symptoms, parents’ alcohol use, conduct problems at age 4 years, being bullied, and smoking status.
TAKEAWAYS
- After adjustments, alcohol dependence at age 18 years was associated with depression at age 24 years (unstandardized probit coefficient 0.13; 95% confidence interval, 0.02-0.25; P = .019)
- The relationship appeared to persist for alcohol dependence at each age of the growth curve (17-22 years).
- There was no evidence that frequency or quantity of alcohol consumption at age 18 was significantly associated with depression at age 24, suggesting these factors may not increase the risk for later depression unless there are also features of dependency.
IN PRACTICE
“Our findings suggest that preventing alcohol dependence during adolescence, or treating it early, could reduce the risk of depression,” which could have important public health implications, the researchers write.
STUDY DETAILS
The study was carried out by researchers at the University of Bristol; University College London; Critical Thinking Unit, Public Health Directorate, NHS; University of Nottingham, all in the United Kingdom. It was published online in Lancet Psychiatry
LIMITATIONS
There was substantial attrition in the ALSPAC cohort from birth to age 24 years. The sample was recruited from one U.K. region and most participants were White. Measures of alcohol consumption and dependence excluded some features of abuse. And as this is an observational study, the possibility of residual confounding can’t be excluded.
DISCLOSURES
The investigators report no relevant disclosures. The study received support from the UK Medical Research Council and Alcohol Research UK.
A version of this article first appeared on Medscape.com.
TOPLINE
Alcohol dependence, but not consumption, at age 18 years increases the risk for depression at age 24 years.
METHODOLOGY
- The study included 3,902 mostly White adolescents, about 58% female, born in England from April 1991 to December 1992, who were part of the Avon Longitudinal Study of Parents and Children (ALSPAC) that examined genetic and environmental determinants of health and development.
- Participants completed the self-report Alcohol Use Disorders Identification Test (AUDIT) between the ages of 16 and 23 years, a period when average alcohol use increases rapidly.
- The primary outcome was probability for depression at age 24 years, using the Clinical Interview Schedule Revised (CIS-R), a self-administered computerized clinical assessment of common mental disorder symptoms during the past week.
- Researchers assessed frequency and quantity of alcohol consumption as well as alcohol dependence.
- Confounders included sex, housing type, maternal education and depressive symptoms, parents’ alcohol use, conduct problems at age 4 years, being bullied, and smoking status.
TAKEAWAYS
- After adjustments, alcohol dependence at age 18 years was associated with depression at age 24 years (unstandardized probit coefficient 0.13; 95% confidence interval, 0.02-0.25; P = .019)
- The relationship appeared to persist for alcohol dependence at each age of the growth curve (17-22 years).
- There was no evidence that frequency or quantity of alcohol consumption at age 18 was significantly associated with depression at age 24, suggesting these factors may not increase the risk for later depression unless there are also features of dependency.
IN PRACTICE
“Our findings suggest that preventing alcohol dependence during adolescence, or treating it early, could reduce the risk of depression,” which could have important public health implications, the researchers write.
STUDY DETAILS
The study was carried out by researchers at the University of Bristol; University College London; Critical Thinking Unit, Public Health Directorate, NHS; University of Nottingham, all in the United Kingdom. It was published online in Lancet Psychiatry
LIMITATIONS
There was substantial attrition in the ALSPAC cohort from birth to age 24 years. The sample was recruited from one U.K. region and most participants were White. Measures of alcohol consumption and dependence excluded some features of abuse. And as this is an observational study, the possibility of residual confounding can’t be excluded.
DISCLOSURES
The investigators report no relevant disclosures. The study received support from the UK Medical Research Council and Alcohol Research UK.
A version of this article first appeared on Medscape.com.
TOPLINE
Alcohol dependence, but not consumption, at age 18 years increases the risk for depression at age 24 years.
METHODOLOGY
- The study included 3,902 mostly White adolescents, about 58% female, born in England from April 1991 to December 1992, who were part of the Avon Longitudinal Study of Parents and Children (ALSPAC) that examined genetic and environmental determinants of health and development.
- Participants completed the self-report Alcohol Use Disorders Identification Test (AUDIT) between the ages of 16 and 23 years, a period when average alcohol use increases rapidly.
- The primary outcome was probability for depression at age 24 years, using the Clinical Interview Schedule Revised (CIS-R), a self-administered computerized clinical assessment of common mental disorder symptoms during the past week.
- Researchers assessed frequency and quantity of alcohol consumption as well as alcohol dependence.
- Confounders included sex, housing type, maternal education and depressive symptoms, parents’ alcohol use, conduct problems at age 4 years, being bullied, and smoking status.
TAKEAWAYS
- After adjustments, alcohol dependence at age 18 years was associated with depression at age 24 years (unstandardized probit coefficient 0.13; 95% confidence interval, 0.02-0.25; P = .019)
- The relationship appeared to persist for alcohol dependence at each age of the growth curve (17-22 years).
- There was no evidence that frequency or quantity of alcohol consumption at age 18 was significantly associated with depression at age 24, suggesting these factors may not increase the risk for later depression unless there are also features of dependency.
IN PRACTICE
“Our findings suggest that preventing alcohol dependence during adolescence, or treating it early, could reduce the risk of depression,” which could have important public health implications, the researchers write.
STUDY DETAILS
The study was carried out by researchers at the University of Bristol; University College London; Critical Thinking Unit, Public Health Directorate, NHS; University of Nottingham, all in the United Kingdom. It was published online in Lancet Psychiatry
LIMITATIONS
There was substantial attrition in the ALSPAC cohort from birth to age 24 years. The sample was recruited from one U.K. region and most participants were White. Measures of alcohol consumption and dependence excluded some features of abuse. And as this is an observational study, the possibility of residual confounding can’t be excluded.
DISCLOSURES
The investigators report no relevant disclosures. The study received support from the UK Medical Research Council and Alcohol Research UK.
A version of this article first appeared on Medscape.com.
Widespread carboplatin, cisplatin shortages: NCCN survey
The survey, which included responses from 27 NCCN member institutions, revealed that 93% are experiencing a shortage of carboplatin and that 70% have reported a shortage of cisplatin.
“This is an unacceptable situation,” Robert W. Carlson, MD, NCCN’s chief executive offer, said in the statement released by the network.
“We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Carlson said. And while the survey results show patients are still able to get lifesaving care, “it comes at a burden to our overtaxed medical facilities.”
The NCCN called on the federal government, the pharmaceutical industry, providers, and payers to take steps to “help mitigate any impacts” from this cancer drug shortage.
“We need to work together to improve the current situation and prevent it from happening again in the future,” Dr. Carlson stressed.
Carboplatin and cisplatin, which are frequently used together for systemic treatment, are highly effective therapies prescribed to treat many cancer types, including lung, breast, and prostate cancers, as well as leukemias and lymphomas. An estimated 500,000 new patients with cancer receive these agents each year.
The current survey, conducted over the last week of May, found that 100% of responding centers are able to continue to treat patients who need cisplatin without delays.
The same cannot be said for carboplatin: only 64% of centers said they are still able to continue treating all current patients receiving the platinum-based therapy. Among 19 responding centers, 20% reported that they were continuing carboplatin regimens for some but not all patients. And 16% reported treatment delays from having to obtain prior authorization for modified treatment plans, though none reported denials.
“Carboplatin has been in short supply for months but in the last 4 weeks has reached a critical stage,” according to one survey comment. “Without additional inventory many of our sites will be out of drug by early next week.”
In response to the survey question, “Is your center experiencing a shortage of carboplatin,” others made similar comments:
- “Current shipments from established manufacturers have been paused.”
- “The supply of carboplatin available is not meeting our demands.”
- “Without additional supply in early June, we will have to implement several shortage mitigation strategies.”
Survey respondents also addressed whether manufacturers or suppliers have provided any indication of when these drugs will become readily available again. For both drugs, about 60% of respondents said no. And for those who do receive updates, many noted that the “information is tentative and variable.”
Respondents indicated that other cancer agents, including methotrexate (67%) and 5FU (26%), are also in short supply at their centers.
The shortage and the uncertainty as to when it will end are forcing some centers to develop conservation and mitigation strategies.
The NCCN has broadly outlined how the federal government, the pharmaceutical industry, providers, and payers can help with prevention and mitigation. The NCCN has called on the federal government and the pharmaceutical industry to work to secure a steady supply of core anticancer drugs and has asked payers to “put patients first and provide flexible and efficient systems of providing coverage for alternative therapies replacing anti-cancer drugs that are unavailable or in shortage.”
Overall, the survey results “demonstrate the widespread impact of the chemotherapy shortage,” said Alyssa Schatz, MSW, senior director of policy and advocacy for NCCN. “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable, and accessible cancer care for all.”
A version of this article first appeared on Medscape.com.
The survey, which included responses from 27 NCCN member institutions, revealed that 93% are experiencing a shortage of carboplatin and that 70% have reported a shortage of cisplatin.
“This is an unacceptable situation,” Robert W. Carlson, MD, NCCN’s chief executive offer, said in the statement released by the network.
“We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Carlson said. And while the survey results show patients are still able to get lifesaving care, “it comes at a burden to our overtaxed medical facilities.”
The NCCN called on the federal government, the pharmaceutical industry, providers, and payers to take steps to “help mitigate any impacts” from this cancer drug shortage.
“We need to work together to improve the current situation and prevent it from happening again in the future,” Dr. Carlson stressed.
Carboplatin and cisplatin, which are frequently used together for systemic treatment, are highly effective therapies prescribed to treat many cancer types, including lung, breast, and prostate cancers, as well as leukemias and lymphomas. An estimated 500,000 new patients with cancer receive these agents each year.
The current survey, conducted over the last week of May, found that 100% of responding centers are able to continue to treat patients who need cisplatin without delays.
The same cannot be said for carboplatin: only 64% of centers said they are still able to continue treating all current patients receiving the platinum-based therapy. Among 19 responding centers, 20% reported that they were continuing carboplatin regimens for some but not all patients. And 16% reported treatment delays from having to obtain prior authorization for modified treatment plans, though none reported denials.
“Carboplatin has been in short supply for months but in the last 4 weeks has reached a critical stage,” according to one survey comment. “Without additional inventory many of our sites will be out of drug by early next week.”
In response to the survey question, “Is your center experiencing a shortage of carboplatin,” others made similar comments:
- “Current shipments from established manufacturers have been paused.”
- “The supply of carboplatin available is not meeting our demands.”
- “Without additional supply in early June, we will have to implement several shortage mitigation strategies.”
Survey respondents also addressed whether manufacturers or suppliers have provided any indication of when these drugs will become readily available again. For both drugs, about 60% of respondents said no. And for those who do receive updates, many noted that the “information is tentative and variable.”
Respondents indicated that other cancer agents, including methotrexate (67%) and 5FU (26%), are also in short supply at their centers.
The shortage and the uncertainty as to when it will end are forcing some centers to develop conservation and mitigation strategies.
The NCCN has broadly outlined how the federal government, the pharmaceutical industry, providers, and payers can help with prevention and mitigation. The NCCN has called on the federal government and the pharmaceutical industry to work to secure a steady supply of core anticancer drugs and has asked payers to “put patients first and provide flexible and efficient systems of providing coverage for alternative therapies replacing anti-cancer drugs that are unavailable or in shortage.”
Overall, the survey results “demonstrate the widespread impact of the chemotherapy shortage,” said Alyssa Schatz, MSW, senior director of policy and advocacy for NCCN. “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable, and accessible cancer care for all.”
A version of this article first appeared on Medscape.com.
The survey, which included responses from 27 NCCN member institutions, revealed that 93% are experiencing a shortage of carboplatin and that 70% have reported a shortage of cisplatin.
“This is an unacceptable situation,” Robert W. Carlson, MD, NCCN’s chief executive offer, said in the statement released by the network.
“We are hearing from oncologists and pharmacists across the country who have to scramble to find appropriate alternatives for treating their patients with cancer right now,” Dr. Carlson said. And while the survey results show patients are still able to get lifesaving care, “it comes at a burden to our overtaxed medical facilities.”
The NCCN called on the federal government, the pharmaceutical industry, providers, and payers to take steps to “help mitigate any impacts” from this cancer drug shortage.
“We need to work together to improve the current situation and prevent it from happening again in the future,” Dr. Carlson stressed.
Carboplatin and cisplatin, which are frequently used together for systemic treatment, are highly effective therapies prescribed to treat many cancer types, including lung, breast, and prostate cancers, as well as leukemias and lymphomas. An estimated 500,000 new patients with cancer receive these agents each year.
The current survey, conducted over the last week of May, found that 100% of responding centers are able to continue to treat patients who need cisplatin without delays.
The same cannot be said for carboplatin: only 64% of centers said they are still able to continue treating all current patients receiving the platinum-based therapy. Among 19 responding centers, 20% reported that they were continuing carboplatin regimens for some but not all patients. And 16% reported treatment delays from having to obtain prior authorization for modified treatment plans, though none reported denials.
“Carboplatin has been in short supply for months but in the last 4 weeks has reached a critical stage,” according to one survey comment. “Without additional inventory many of our sites will be out of drug by early next week.”
In response to the survey question, “Is your center experiencing a shortage of carboplatin,” others made similar comments:
- “Current shipments from established manufacturers have been paused.”
- “The supply of carboplatin available is not meeting our demands.”
- “Without additional supply in early June, we will have to implement several shortage mitigation strategies.”
Survey respondents also addressed whether manufacturers or suppliers have provided any indication of when these drugs will become readily available again. For both drugs, about 60% of respondents said no. And for those who do receive updates, many noted that the “information is tentative and variable.”
Respondents indicated that other cancer agents, including methotrexate (67%) and 5FU (26%), are also in short supply at their centers.
The shortage and the uncertainty as to when it will end are forcing some centers to develop conservation and mitigation strategies.
The NCCN has broadly outlined how the federal government, the pharmaceutical industry, providers, and payers can help with prevention and mitigation. The NCCN has called on the federal government and the pharmaceutical industry to work to secure a steady supply of core anticancer drugs and has asked payers to “put patients first and provide flexible and efficient systems of providing coverage for alternative therapies replacing anti-cancer drugs that are unavailable or in shortage.”
Overall, the survey results “demonstrate the widespread impact of the chemotherapy shortage,” said Alyssa Schatz, MSW, senior director of policy and advocacy for NCCN. “We hope that by sharing this survey and calling for united action across the oncology community, we can come together to prevent future drug shortages and ensure quality, effective, equitable, and accessible cancer care for all.”
A version of this article first appeared on Medscape.com.
After backlash, publisher to retract article that surveyed parents of children with gender dysphoria, says coauthor
The move is “due to concerns about lack of informed consent,” according to tweets by one of the paper’s authors.
The article, “Rapid Onset Gender Dysphoria: Parent Reports on 1655 Possible Cases,” was published in March in the Archives of Sexual Behavior. It has not been cited in the scientific literature, according to Clarivate’s Web of Science, but Altmetric, which tracks the online attention papers receive, ranks the article in the top 1% of all articles of a similar age.
Rapid Onset Gender Dysphoria (ROGD) is, the article stated, a “controversial theory” that “common cultural beliefs, values, and preoccupations cause some adolescents (especially female adolescents) to attribute their social problems, feelings, and mental health issues to gender dysphoria,” and that “youth with ROGD falsely believe that they are transgender,” in part due to social influences.
Michael Bailey, a psychology professor at Northwestern University in Evanston, Ill., and the paper’s corresponding author, tweeted:
Bailey told Retraction Watch that he would “respond when [he] can” to our request for comment, following “new developments on our end.” Neither Springer Nature nor Kenneth Zucker, editor in chief of Archives of Sexual Behavior, has responded to similar requests.
The paper reported the results of a survey of parents who contacted the website ParentsofROGDKids.com, with which the first author is affiliated. According to the abstract, the authors found:
“Pre-existing mental health issues were common, and youths with these issues were more likely than those without them to have socially and medically transitioned. Parents reported that they had often felt pressured by clinicians to affirm their AYA [adolescent and young adult] child’s new gender and support their transition. According to the parents, AYA children’s mental health deteriorated considerably after social transition.”
Soon after publication, the paper attracted criticism that its method of gathering study participants was biased, and that the authors ignored information that didn’t support the theory of ROGD.
Archives of Sexual Behavior is the official publication of the International Academy of Sex Research, which tweeted on April 19:
The episode prompted a May 5 “Open Letter in Support of Dr. Kenneth Zucker and the Need to Promote Robust Scientific Debate” from the Foundation Against Intolerance and Racism that has now been signed by nearly 2000 people.
On May 10, the following publisher’s note was added to the article:
“readers are alerted that concerns have been raised regarding methodology as described in this article. The publisher is currently investigating this matter and a further response will follow the conclusion of this investigation.
Six days later, the publisher removed the article’s supplementary information “due to a lack of documented consent by study participants.”
The story may feel familiar to readers who recall what happened to another paper in 2018. In that paper, Brown University’s Lisa Littman coined the term ROGD. Following a backlash, Brown took down a press release touting the results, and the paper was eventually republished with corrections.
Bailey has been accused of mistreating transgender research participants, but an investigation by bioethicist Alice Dreger found that of the many accusations, “almost none appear to have been legitimate.”
In a post on UnHerd earlier this month, Bailey responded to the reported concerns about the study lacking approval by an Institutional Review Board (IRB), and that the way the participants were recruited biased the results.
IRB approval was not necessary, Bailey wrote, because Suzanna Diaz, the first author who collected the data, was not affiliated with an institution that required it. “Suzanna Diaz” is a pseudonym for “the mother of a gender dysphoric child she believes has ROGD” who wishes to remain anonymous for the sake of her family, Bailey wrote.
The paper included the following statement about its ethical approval:
“The first author and creator of the survey is not affiliated with any university or hospital. Thus, she did not seek approval from an IRB. After seeing a presentation of preliminary survey results by the first author, the second author suggested the data to be analyzed and submitted as an academic article (he was not involved in collecting the data). The second author consulted with his university’s IRB, who declined to certify the study because data were already collected. However, they advised that publishing the results was likely ethical provided data were deidentified. Editor’s note: After I reviewed the manuscript, I concluded that its publication is ethically appropriate, consistent with Springer policy.”
In his UnHerd post, Bailey quoted from the journal’s submission guidelines:
“If a study has not been granted ethics committee approval prior to commencing, retrospective ethics approval usually cannot be obtained and it may not be possible to consider the manuscript for peer review. The decision on whether to proceed to peer review in such cases is at the Editor’s discretion.”
“Regarding the methodological limitations of the study, these were addressed forthrightly and thoroughly in our article,” Bailey wrote.
Adam Marcus, a cofounder of Retraction Watch, is an editor at this news organization.
A version of this article first appeared on RetractionWatch.com.
The move is “due to concerns about lack of informed consent,” according to tweets by one of the paper’s authors.
The article, “Rapid Onset Gender Dysphoria: Parent Reports on 1655 Possible Cases,” was published in March in the Archives of Sexual Behavior. It has not been cited in the scientific literature, according to Clarivate’s Web of Science, but Altmetric, which tracks the online attention papers receive, ranks the article in the top 1% of all articles of a similar age.
Rapid Onset Gender Dysphoria (ROGD) is, the article stated, a “controversial theory” that “common cultural beliefs, values, and preoccupations cause some adolescents (especially female adolescents) to attribute their social problems, feelings, and mental health issues to gender dysphoria,” and that “youth with ROGD falsely believe that they are transgender,” in part due to social influences.
Michael Bailey, a psychology professor at Northwestern University in Evanston, Ill., and the paper’s corresponding author, tweeted:
Bailey told Retraction Watch that he would “respond when [he] can” to our request for comment, following “new developments on our end.” Neither Springer Nature nor Kenneth Zucker, editor in chief of Archives of Sexual Behavior, has responded to similar requests.
The paper reported the results of a survey of parents who contacted the website ParentsofROGDKids.com, with which the first author is affiliated. According to the abstract, the authors found:
“Pre-existing mental health issues were common, and youths with these issues were more likely than those without them to have socially and medically transitioned. Parents reported that they had often felt pressured by clinicians to affirm their AYA [adolescent and young adult] child’s new gender and support their transition. According to the parents, AYA children’s mental health deteriorated considerably after social transition.”
Soon after publication, the paper attracted criticism that its method of gathering study participants was biased, and that the authors ignored information that didn’t support the theory of ROGD.
Archives of Sexual Behavior is the official publication of the International Academy of Sex Research, which tweeted on April 19:
The episode prompted a May 5 “Open Letter in Support of Dr. Kenneth Zucker and the Need to Promote Robust Scientific Debate” from the Foundation Against Intolerance and Racism that has now been signed by nearly 2000 people.
On May 10, the following publisher’s note was added to the article:
“readers are alerted that concerns have been raised regarding methodology as described in this article. The publisher is currently investigating this matter and a further response will follow the conclusion of this investigation.
Six days later, the publisher removed the article’s supplementary information “due to a lack of documented consent by study participants.”
The story may feel familiar to readers who recall what happened to another paper in 2018. In that paper, Brown University’s Lisa Littman coined the term ROGD. Following a backlash, Brown took down a press release touting the results, and the paper was eventually republished with corrections.
Bailey has been accused of mistreating transgender research participants, but an investigation by bioethicist Alice Dreger found that of the many accusations, “almost none appear to have been legitimate.”
In a post on UnHerd earlier this month, Bailey responded to the reported concerns about the study lacking approval by an Institutional Review Board (IRB), and that the way the participants were recruited biased the results.
IRB approval was not necessary, Bailey wrote, because Suzanna Diaz, the first author who collected the data, was not affiliated with an institution that required it. “Suzanna Diaz” is a pseudonym for “the mother of a gender dysphoric child she believes has ROGD” who wishes to remain anonymous for the sake of her family, Bailey wrote.
The paper included the following statement about its ethical approval:
“The first author and creator of the survey is not affiliated with any university or hospital. Thus, she did not seek approval from an IRB. After seeing a presentation of preliminary survey results by the first author, the second author suggested the data to be analyzed and submitted as an academic article (he was not involved in collecting the data). The second author consulted with his university’s IRB, who declined to certify the study because data were already collected. However, they advised that publishing the results was likely ethical provided data were deidentified. Editor’s note: After I reviewed the manuscript, I concluded that its publication is ethically appropriate, consistent with Springer policy.”
In his UnHerd post, Bailey quoted from the journal’s submission guidelines:
“If a study has not been granted ethics committee approval prior to commencing, retrospective ethics approval usually cannot be obtained and it may not be possible to consider the manuscript for peer review. The decision on whether to proceed to peer review in such cases is at the Editor’s discretion.”
“Regarding the methodological limitations of the study, these were addressed forthrightly and thoroughly in our article,” Bailey wrote.
Adam Marcus, a cofounder of Retraction Watch, is an editor at this news organization.
A version of this article first appeared on RetractionWatch.com.
The move is “due to concerns about lack of informed consent,” according to tweets by one of the paper’s authors.
The article, “Rapid Onset Gender Dysphoria: Parent Reports on 1655 Possible Cases,” was published in March in the Archives of Sexual Behavior. It has not been cited in the scientific literature, according to Clarivate’s Web of Science, but Altmetric, which tracks the online attention papers receive, ranks the article in the top 1% of all articles of a similar age.
Rapid Onset Gender Dysphoria (ROGD) is, the article stated, a “controversial theory” that “common cultural beliefs, values, and preoccupations cause some adolescents (especially female adolescents) to attribute their social problems, feelings, and mental health issues to gender dysphoria,” and that “youth with ROGD falsely believe that they are transgender,” in part due to social influences.
Michael Bailey, a psychology professor at Northwestern University in Evanston, Ill., and the paper’s corresponding author, tweeted:
Bailey told Retraction Watch that he would “respond when [he] can” to our request for comment, following “new developments on our end.” Neither Springer Nature nor Kenneth Zucker, editor in chief of Archives of Sexual Behavior, has responded to similar requests.
The paper reported the results of a survey of parents who contacted the website ParentsofROGDKids.com, with which the first author is affiliated. According to the abstract, the authors found:
“Pre-existing mental health issues were common, and youths with these issues were more likely than those without them to have socially and medically transitioned. Parents reported that they had often felt pressured by clinicians to affirm their AYA [adolescent and young adult] child’s new gender and support their transition. According to the parents, AYA children’s mental health deteriorated considerably after social transition.”
Soon after publication, the paper attracted criticism that its method of gathering study participants was biased, and that the authors ignored information that didn’t support the theory of ROGD.
Archives of Sexual Behavior is the official publication of the International Academy of Sex Research, which tweeted on April 19:
The episode prompted a May 5 “Open Letter in Support of Dr. Kenneth Zucker and the Need to Promote Robust Scientific Debate” from the Foundation Against Intolerance and Racism that has now been signed by nearly 2000 people.
On May 10, the following publisher’s note was added to the article:
“readers are alerted that concerns have been raised regarding methodology as described in this article. The publisher is currently investigating this matter and a further response will follow the conclusion of this investigation.
Six days later, the publisher removed the article’s supplementary information “due to a lack of documented consent by study participants.”
The story may feel familiar to readers who recall what happened to another paper in 2018. In that paper, Brown University’s Lisa Littman coined the term ROGD. Following a backlash, Brown took down a press release touting the results, and the paper was eventually republished with corrections.
Bailey has been accused of mistreating transgender research participants, but an investigation by bioethicist Alice Dreger found that of the many accusations, “almost none appear to have been legitimate.”
In a post on UnHerd earlier this month, Bailey responded to the reported concerns about the study lacking approval by an Institutional Review Board (IRB), and that the way the participants were recruited biased the results.
IRB approval was not necessary, Bailey wrote, because Suzanna Diaz, the first author who collected the data, was not affiliated with an institution that required it. “Suzanna Diaz” is a pseudonym for “the mother of a gender dysphoric child she believes has ROGD” who wishes to remain anonymous for the sake of her family, Bailey wrote.
The paper included the following statement about its ethical approval:
“The first author and creator of the survey is not affiliated with any university or hospital. Thus, she did not seek approval from an IRB. After seeing a presentation of preliminary survey results by the first author, the second author suggested the data to be analyzed and submitted as an academic article (he was not involved in collecting the data). The second author consulted with his university’s IRB, who declined to certify the study because data were already collected. However, they advised that publishing the results was likely ethical provided data were deidentified. Editor’s note: After I reviewed the manuscript, I concluded that its publication is ethically appropriate, consistent with Springer policy.”
In his UnHerd post, Bailey quoted from the journal’s submission guidelines:
“If a study has not been granted ethics committee approval prior to commencing, retrospective ethics approval usually cannot be obtained and it may not be possible to consider the manuscript for peer review. The decision on whether to proceed to peer review in such cases is at the Editor’s discretion.”
“Regarding the methodological limitations of the study, these were addressed forthrightly and thoroughly in our article,” Bailey wrote.
Adam Marcus, a cofounder of Retraction Watch, is an editor at this news organization.
A version of this article first appeared on RetractionWatch.com.
Wildfire smoke and air quality: How long could health effects last?
People with moderate to severe asthma, chronic obstructive pulmonary disease, and other risk factors are used to checking air quality warnings before heading outside. But this situation is anything but typical.
Even people not normally at risk can have burning eyes, a runny nose, and a hard time breathing. These are among the symptoms to watch for as health effects of wildfire smoke. Special considerations should be made for people with heart disease, lung disease, and other conditions that put them at increased risk. Those affected can also have trouble sleeping, anxiety, and ongoing mental health issues.
The smoke will stick around the next few days, possibly clearing out early next week when the winds change direction, Weather Channel meteorologist Ari Sarsalari predicted June 8. But that doesn’t mean any physical or mental health effects will clear up as quickly.
“We are seeing dramatic increases in air pollution, and we are seeing increases in patients coming to the ED and the hospital. We expect that this will increase in the days ahead,” said Meredith McCormack, MD, MHS, a volunteer medical spokesperson for the American Lung Association.
“The air quality in our area – Baltimore – and other surrounding areas is not healthy for anyone,” said Dr. McCormack, who specializes in pulmonary and critical care medicine at Johns Hopkins University, Baltimore.
How serious are the health warnings?
Residents of California might be more familiar with the hazards of wildfire smoke, but this is a novel experience for many people along the East Coast. Air quality advisories are popping up on cellphones for people living in Boston, New York, and as far south as Northern Virginia. What should the estimated 75 million to 128 million affected Americans do?
We asked experts to weigh in on when it’s safe or not safe to spend time outside, when to seek medical help, and the best ways for people to protect themselves.
“It’s important to stay indoors and close all windows to reduce exposure to smoke from wildfires. It’s also essential to stay away from any windows that may not have a good seal, in order to minimize any potential exposure to smoke,” said Robert Glatter, MD, editor at large for Medscape Emergency Medicine and an emergency medicine doctor at Lenox Hill Hospital/Northwell Health in New York.
Dr. Glatter noted that placing moist towels under doors and sealing leaking windows can help.
Monitor your symptoms, and contact your doctor or go to urgent care, Dr. McCormack advised, if you see any increase in concerning symptoms. These include shortness of breath, coughing, chest tightness, or wheezing. Also make sure you take recommended medications and have enough on hand, she said.
Fine particles, big concerns
The weather is warming in many parts of the country, and that can mean air conditioning. Adding a MERV 13 filter to a central air conditioning system could reduce exposure to wildfire smoke. Using a portable indoor air purifier with a HEPA filter also can help people without central air conditioning. The filter can help remove small particles in the air but must be replaced regularly.
Smoke from wildfires contains multiple toxins, including heavy metals, carcinogens, and fine particulate matter (PM) under 2.5 microns. Dr. Glatter explained that these particles are about 100 times thinner than a human hair. Because of their size, they can embed deeper into the airways in the lungs and trigger chronic inflammation.
“This has also been linked to increased rates of lung cancer and brain tumors,” he said, based on a 2022 study in Canada.
The effects of smoke from wildfires can continue for many years. After the 2014 Hazelwood coal mine fire, emergency department visits for respiratory conditions and cardiovascular complaints remained higher for up to 2-5 years later, Dr. Glatter said. Again, large quantities of fine particulate matter in the smoke, less than 2.5 microns (PM 2.5), was to blame.
Exposure to smoke from wildfires during pregnancy has also been linked to abnormal fetal growth, preterm birth, as well as low birth weight, a January 2023 preprint on MedRxiv suggested.
Time to wear a mask again?
A properly fitted N95 mask will be the best approach to lessen exposure to smoke from wildfires, “but by itself cannot eliminate all of the risk,” Dr. Glatter said. Surgical masks can add minimal protection, and cloth masks will not provide any significant protection against the damaging effects of smoke from wildfires.
KN95 masks tend to be more comfortable to wear than N95s. But leakage often occurs that can make this type of protection less effective, Dr. Glatter said.
“Masks are important if you need to go outdoors,” Dr. McCormack said. Also, if you’re traveling by car, set the air conditioning system to recirculate to filter the air inside the vehicle, she recommended.
What does that number mean?
The federal government monitors air quality nationwide. In case you’re unfamiliar, the U.S. Air Quality Index includes a color-coded scale for ozone levels and particle pollution, the main concern from wildfire smoke. The lowest risk is the Green or satisfactory air quality category, where air pollution poses little or no risk, with an Index number from 0 to 50.
The index gets progressively more serious, from Yellow for moderate risk (51-100) up to a Maroon category, a hazardous range of 300 or higher on the index. When a Maroon advisory is issued, it means an emergency health warning where “everyone is more likely to be affected.”
How do you know if your outside air is polluted? Your local Air Quality Index (AQI) from the EPA can help. It’s a scale of 0 to 500, and the greater the number, the more harmful pollution in the air. It has six levels: good, moderate, unhealthy for sensitive groups, unhealthy, very unhealthy, and hazardous. You can find it at AirNow.gov.
New York is under an air quality alert until midnight Friday with a current “unhealthy” Index report of 200. The city recorded its worst-ever air quality on Wednesday. The New York State Department of Environmental Conservation warns that fine particulate levels – small particles that can enter a person’s lungs – are the biggest concern.
AirNow.gov warns that western New England down to Washington has air quality in the three worst categories – ranging from unhealthy to very unhealthy and hazardous. The ten worst locations on the U.S. Air Quality Index as of 10 a.m. ET on June 8 include the Wilmington, Del., area with an Index of 241, or “very unhealthy.”
Other “very unhealthy” locations have the following Index readings:
- 244: Suburban Washington/Maryland.
- 252: Southern coastal New Jersey.
- 252: Kent County, Del.
- 270: Philadelphia.
- 291: Greater New Castle County, Del.
- 293: Northern Virginia.
- 293: Metropolitan Washington.
These two locations are in the “hazardous” or health emergency warning category:
- 309: Lehigh Valley, Pa.
- 399: Susquehanna Valley, Pa.
To check an air quality advisory in your area, enter your ZIP code at AirNow.gov.
A version of this article first appeared on WebMD.com.
People with moderate to severe asthma, chronic obstructive pulmonary disease, and other risk factors are used to checking air quality warnings before heading outside. But this situation is anything but typical.
Even people not normally at risk can have burning eyes, a runny nose, and a hard time breathing. These are among the symptoms to watch for as health effects of wildfire smoke. Special considerations should be made for people with heart disease, lung disease, and other conditions that put them at increased risk. Those affected can also have trouble sleeping, anxiety, and ongoing mental health issues.
The smoke will stick around the next few days, possibly clearing out early next week when the winds change direction, Weather Channel meteorologist Ari Sarsalari predicted June 8. But that doesn’t mean any physical or mental health effects will clear up as quickly.
“We are seeing dramatic increases in air pollution, and we are seeing increases in patients coming to the ED and the hospital. We expect that this will increase in the days ahead,” said Meredith McCormack, MD, MHS, a volunteer medical spokesperson for the American Lung Association.
“The air quality in our area – Baltimore – and other surrounding areas is not healthy for anyone,” said Dr. McCormack, who specializes in pulmonary and critical care medicine at Johns Hopkins University, Baltimore.
How serious are the health warnings?
Residents of California might be more familiar with the hazards of wildfire smoke, but this is a novel experience for many people along the East Coast. Air quality advisories are popping up on cellphones for people living in Boston, New York, and as far south as Northern Virginia. What should the estimated 75 million to 128 million affected Americans do?
We asked experts to weigh in on when it’s safe or not safe to spend time outside, when to seek medical help, and the best ways for people to protect themselves.
“It’s important to stay indoors and close all windows to reduce exposure to smoke from wildfires. It’s also essential to stay away from any windows that may not have a good seal, in order to minimize any potential exposure to smoke,” said Robert Glatter, MD, editor at large for Medscape Emergency Medicine and an emergency medicine doctor at Lenox Hill Hospital/Northwell Health in New York.
Dr. Glatter noted that placing moist towels under doors and sealing leaking windows can help.
Monitor your symptoms, and contact your doctor or go to urgent care, Dr. McCormack advised, if you see any increase in concerning symptoms. These include shortness of breath, coughing, chest tightness, or wheezing. Also make sure you take recommended medications and have enough on hand, she said.
Fine particles, big concerns
The weather is warming in many parts of the country, and that can mean air conditioning. Adding a MERV 13 filter to a central air conditioning system could reduce exposure to wildfire smoke. Using a portable indoor air purifier with a HEPA filter also can help people without central air conditioning. The filter can help remove small particles in the air but must be replaced regularly.
Smoke from wildfires contains multiple toxins, including heavy metals, carcinogens, and fine particulate matter (PM) under 2.5 microns. Dr. Glatter explained that these particles are about 100 times thinner than a human hair. Because of their size, they can embed deeper into the airways in the lungs and trigger chronic inflammation.
“This has also been linked to increased rates of lung cancer and brain tumors,” he said, based on a 2022 study in Canada.
The effects of smoke from wildfires can continue for many years. After the 2014 Hazelwood coal mine fire, emergency department visits for respiratory conditions and cardiovascular complaints remained higher for up to 2-5 years later, Dr. Glatter said. Again, large quantities of fine particulate matter in the smoke, less than 2.5 microns (PM 2.5), was to blame.
Exposure to smoke from wildfires during pregnancy has also been linked to abnormal fetal growth, preterm birth, as well as low birth weight, a January 2023 preprint on MedRxiv suggested.
Time to wear a mask again?
A properly fitted N95 mask will be the best approach to lessen exposure to smoke from wildfires, “but by itself cannot eliminate all of the risk,” Dr. Glatter said. Surgical masks can add minimal protection, and cloth masks will not provide any significant protection against the damaging effects of smoke from wildfires.
KN95 masks tend to be more comfortable to wear than N95s. But leakage often occurs that can make this type of protection less effective, Dr. Glatter said.
“Masks are important if you need to go outdoors,” Dr. McCormack said. Also, if you’re traveling by car, set the air conditioning system to recirculate to filter the air inside the vehicle, she recommended.
What does that number mean?
The federal government monitors air quality nationwide. In case you’re unfamiliar, the U.S. Air Quality Index includes a color-coded scale for ozone levels and particle pollution, the main concern from wildfire smoke. The lowest risk is the Green or satisfactory air quality category, where air pollution poses little or no risk, with an Index number from 0 to 50.
The index gets progressively more serious, from Yellow for moderate risk (51-100) up to a Maroon category, a hazardous range of 300 or higher on the index. When a Maroon advisory is issued, it means an emergency health warning where “everyone is more likely to be affected.”
How do you know if your outside air is polluted? Your local Air Quality Index (AQI) from the EPA can help. It’s a scale of 0 to 500, and the greater the number, the more harmful pollution in the air. It has six levels: good, moderate, unhealthy for sensitive groups, unhealthy, very unhealthy, and hazardous. You can find it at AirNow.gov.
New York is under an air quality alert until midnight Friday with a current “unhealthy” Index report of 200. The city recorded its worst-ever air quality on Wednesday. The New York State Department of Environmental Conservation warns that fine particulate levels – small particles that can enter a person’s lungs – are the biggest concern.
AirNow.gov warns that western New England down to Washington has air quality in the three worst categories – ranging from unhealthy to very unhealthy and hazardous. The ten worst locations on the U.S. Air Quality Index as of 10 a.m. ET on June 8 include the Wilmington, Del., area with an Index of 241, or “very unhealthy.”
Other “very unhealthy” locations have the following Index readings:
- 244: Suburban Washington/Maryland.
- 252: Southern coastal New Jersey.
- 252: Kent County, Del.
- 270: Philadelphia.
- 291: Greater New Castle County, Del.
- 293: Northern Virginia.
- 293: Metropolitan Washington.
These two locations are in the “hazardous” or health emergency warning category:
- 309: Lehigh Valley, Pa.
- 399: Susquehanna Valley, Pa.
To check an air quality advisory in your area, enter your ZIP code at AirNow.gov.
A version of this article first appeared on WebMD.com.
People with moderate to severe asthma, chronic obstructive pulmonary disease, and other risk factors are used to checking air quality warnings before heading outside. But this situation is anything but typical.
Even people not normally at risk can have burning eyes, a runny nose, and a hard time breathing. These are among the symptoms to watch for as health effects of wildfire smoke. Special considerations should be made for people with heart disease, lung disease, and other conditions that put them at increased risk. Those affected can also have trouble sleeping, anxiety, and ongoing mental health issues.
The smoke will stick around the next few days, possibly clearing out early next week when the winds change direction, Weather Channel meteorologist Ari Sarsalari predicted June 8. But that doesn’t mean any physical or mental health effects will clear up as quickly.
“We are seeing dramatic increases in air pollution, and we are seeing increases in patients coming to the ED and the hospital. We expect that this will increase in the days ahead,” said Meredith McCormack, MD, MHS, a volunteer medical spokesperson for the American Lung Association.
“The air quality in our area – Baltimore – and other surrounding areas is not healthy for anyone,” said Dr. McCormack, who specializes in pulmonary and critical care medicine at Johns Hopkins University, Baltimore.
How serious are the health warnings?
Residents of California might be more familiar with the hazards of wildfire smoke, but this is a novel experience for many people along the East Coast. Air quality advisories are popping up on cellphones for people living in Boston, New York, and as far south as Northern Virginia. What should the estimated 75 million to 128 million affected Americans do?
We asked experts to weigh in on when it’s safe or not safe to spend time outside, when to seek medical help, and the best ways for people to protect themselves.
“It’s important to stay indoors and close all windows to reduce exposure to smoke from wildfires. It’s also essential to stay away from any windows that may not have a good seal, in order to minimize any potential exposure to smoke,” said Robert Glatter, MD, editor at large for Medscape Emergency Medicine and an emergency medicine doctor at Lenox Hill Hospital/Northwell Health in New York.
Dr. Glatter noted that placing moist towels under doors and sealing leaking windows can help.
Monitor your symptoms, and contact your doctor or go to urgent care, Dr. McCormack advised, if you see any increase in concerning symptoms. These include shortness of breath, coughing, chest tightness, or wheezing. Also make sure you take recommended medications and have enough on hand, she said.
Fine particles, big concerns
The weather is warming in many parts of the country, and that can mean air conditioning. Adding a MERV 13 filter to a central air conditioning system could reduce exposure to wildfire smoke. Using a portable indoor air purifier with a HEPA filter also can help people without central air conditioning. The filter can help remove small particles in the air but must be replaced regularly.
Smoke from wildfires contains multiple toxins, including heavy metals, carcinogens, and fine particulate matter (PM) under 2.5 microns. Dr. Glatter explained that these particles are about 100 times thinner than a human hair. Because of their size, they can embed deeper into the airways in the lungs and trigger chronic inflammation.
“This has also been linked to increased rates of lung cancer and brain tumors,” he said, based on a 2022 study in Canada.
The effects of smoke from wildfires can continue for many years. After the 2014 Hazelwood coal mine fire, emergency department visits for respiratory conditions and cardiovascular complaints remained higher for up to 2-5 years later, Dr. Glatter said. Again, large quantities of fine particulate matter in the smoke, less than 2.5 microns (PM 2.5), was to blame.
Exposure to smoke from wildfires during pregnancy has also been linked to abnormal fetal growth, preterm birth, as well as low birth weight, a January 2023 preprint on MedRxiv suggested.
Time to wear a mask again?
A properly fitted N95 mask will be the best approach to lessen exposure to smoke from wildfires, “but by itself cannot eliminate all of the risk,” Dr. Glatter said. Surgical masks can add minimal protection, and cloth masks will not provide any significant protection against the damaging effects of smoke from wildfires.
KN95 masks tend to be more comfortable to wear than N95s. But leakage often occurs that can make this type of protection less effective, Dr. Glatter said.
“Masks are important if you need to go outdoors,” Dr. McCormack said. Also, if you’re traveling by car, set the air conditioning system to recirculate to filter the air inside the vehicle, she recommended.
What does that number mean?
The federal government monitors air quality nationwide. In case you’re unfamiliar, the U.S. Air Quality Index includes a color-coded scale for ozone levels and particle pollution, the main concern from wildfire smoke. The lowest risk is the Green or satisfactory air quality category, where air pollution poses little or no risk, with an Index number from 0 to 50.
The index gets progressively more serious, from Yellow for moderate risk (51-100) up to a Maroon category, a hazardous range of 300 or higher on the index. When a Maroon advisory is issued, it means an emergency health warning where “everyone is more likely to be affected.”
How do you know if your outside air is polluted? Your local Air Quality Index (AQI) from the EPA can help. It’s a scale of 0 to 500, and the greater the number, the more harmful pollution in the air. It has six levels: good, moderate, unhealthy for sensitive groups, unhealthy, very unhealthy, and hazardous. You can find it at AirNow.gov.
New York is under an air quality alert until midnight Friday with a current “unhealthy” Index report of 200. The city recorded its worst-ever air quality on Wednesday. The New York State Department of Environmental Conservation warns that fine particulate levels – small particles that can enter a person’s lungs – are the biggest concern.
AirNow.gov warns that western New England down to Washington has air quality in the three worst categories – ranging from unhealthy to very unhealthy and hazardous. The ten worst locations on the U.S. Air Quality Index as of 10 a.m. ET on June 8 include the Wilmington, Del., area with an Index of 241, or “very unhealthy.”
Other “very unhealthy” locations have the following Index readings:
- 244: Suburban Washington/Maryland.
- 252: Southern coastal New Jersey.
- 252: Kent County, Del.
- 270: Philadelphia.
- 291: Greater New Castle County, Del.
- 293: Northern Virginia.
- 293: Metropolitan Washington.
These two locations are in the “hazardous” or health emergency warning category:
- 309: Lehigh Valley, Pa.
- 399: Susquehanna Valley, Pa.
To check an air quality advisory in your area, enter your ZIP code at AirNow.gov.
A version of this article first appeared on WebMD.com.
Halting active inflammation key in treating PIH
CHICAGO –
Dr. Desai, clinical assistant professor in the department of dermatology at the University of Texas Southwestern Medical Center, Dallas, spoke at the Pigmentary Disorders Exchange Symposium, provided by MedscapeLive!
Like all dermatologists, he said at the meeting, he sees lots of acne cases. However, PIH is often the presenting reason for the visit in his practice, which focuses predominantly on skin of color.
“Most of my patients come in not even worried about the acne,” he said. “They come in wanting me to fix the dark spots.”
Inflammation persists
Dermatologists, Dr. Desai said, should educate patients with active PIH resulting from acne or other diseases that even though the condition has been labeled post- inflammatory hyperpigmentation, the inflammation continues to be a problem.
He said, while patients may think PIH is “just scars,” the inflammation is still active and the condition needs to be treated from a skin-lightening perspective but, more importantly, with a focus on halting the inflammation. “If you were to biopsy the areas of hyperpigmentation, you would find a high density of active inflammatory behaviors still present in the skin,” he said.
When treating patients, it’s critical to first treat the underlying skin condition aggressively, he said. “Things like topical retinoids and azelaic acid mechanistically actually make a lot more sense for PIH than even hydroquinone, in some cases, because these therapies are actually anti-inflammatory for many of the diseases we treat.”
Dr. Desai noted that, in patients with darker skin tones, even diseases like seborrheic dermatitis and plaque psoriasis can result in PIH, while in patients with lighter skin tones, the same diseases may leave some residual postinflammatory erythema.
“I think it’s very important, particularly when you’re treating a darker skin–toned patient, to arrest the erythema early on to prevent that further worsening of hyperpigmentation,” he said.
Biopsies important
In cases of PIH, determining the best treatment requires finding out where the pigment is and how deep it is, Dr. Desai said.
He noted dermatologists are often worried about doing biopsies, particularly in patients with darker skin, because of the risk of scarring and keloid formation for those more prone to keloids. The preference is also for a therapeutic effect without using invasive procedures.
“But particularly with PIH, in patients who have been therapeutically challenging, I don’t hesitate to do very small biopsies – 2- and 3-mm punch biopsies – particularly if they are from the head and neck area.”
He suggests doing biopsies on part of the ear, lower jaw line, or the neck area, as these areas tend to heal nicely. “You don’t have to be so concerned about the scarring if you counsel appropriately,” he said.
The biopsy can be valuable in determining whether a very expensive treatment will reach the intended target.
Topical retinoids play an important role as anti-inflammatories for PIH, Dr. Desai said.
He gave an example of a patient with Fitzpatrick skin type IV or V with chronic acne and extensive PIH. “Are you going to effectively tell that patient to apply 4% hydroquinone triple-combination compound across 30 different areas of PIH on their face? The answer is that’s really not very efficient or effective.”
That’s why therapies, such as retinoids, that target the pathogenesis of PIH, particularly the inflammatory component, are important, he added.
Psychological burden
PIH comes with significant stigma and loss of quality of life loss that can last many years.
During another presentation at the meeting, Susan C. Taylor, MD, professor and vice chair of diversity, equity and inclusion in the department of dermatology, at the University of Pennsylvania, Philadelphia, pointed out that in a 2016 study of 324 patients in seven Asian countries, acne-related PIH lasted longer than 1 year in 65.2% of patients and 5 years or longer in 22.3%, significantly affecting their quality of life.
Dr. Desai added that, in a paper recently published in the British Journal of Dermatology, on the impact of postacne hyperpigmentation in patients, the authors pointed out that the reported prevalence of PIH in patients with acne ranges between 45.5% and 87.2%, depending on skin phototype, and that in most cases, PIH takes more than a year to fade.
“Studies have demonstrated that patients with acne and resulting scarring often face stigmatization, leading to quality of life impairment, social withdrawal and body image disorders, which can further contribute to higher risk for depression and social anxiety,” the paper’s authors wrote.
Dr. Desai reported no financial disclosures relevant to his talk.
CHICAGO –
Dr. Desai, clinical assistant professor in the department of dermatology at the University of Texas Southwestern Medical Center, Dallas, spoke at the Pigmentary Disorders Exchange Symposium, provided by MedscapeLive!
Like all dermatologists, he said at the meeting, he sees lots of acne cases. However, PIH is often the presenting reason for the visit in his practice, which focuses predominantly on skin of color.
“Most of my patients come in not even worried about the acne,” he said. “They come in wanting me to fix the dark spots.”
Inflammation persists
Dermatologists, Dr. Desai said, should educate patients with active PIH resulting from acne or other diseases that even though the condition has been labeled post- inflammatory hyperpigmentation, the inflammation continues to be a problem.
He said, while patients may think PIH is “just scars,” the inflammation is still active and the condition needs to be treated from a skin-lightening perspective but, more importantly, with a focus on halting the inflammation. “If you were to biopsy the areas of hyperpigmentation, you would find a high density of active inflammatory behaviors still present in the skin,” he said.
When treating patients, it’s critical to first treat the underlying skin condition aggressively, he said. “Things like topical retinoids and azelaic acid mechanistically actually make a lot more sense for PIH than even hydroquinone, in some cases, because these therapies are actually anti-inflammatory for many of the diseases we treat.”
Dr. Desai noted that, in patients with darker skin tones, even diseases like seborrheic dermatitis and plaque psoriasis can result in PIH, while in patients with lighter skin tones, the same diseases may leave some residual postinflammatory erythema.
“I think it’s very important, particularly when you’re treating a darker skin–toned patient, to arrest the erythema early on to prevent that further worsening of hyperpigmentation,” he said.
Biopsies important
In cases of PIH, determining the best treatment requires finding out where the pigment is and how deep it is, Dr. Desai said.
He noted dermatologists are often worried about doing biopsies, particularly in patients with darker skin, because of the risk of scarring and keloid formation for those more prone to keloids. The preference is also for a therapeutic effect without using invasive procedures.
“But particularly with PIH, in patients who have been therapeutically challenging, I don’t hesitate to do very small biopsies – 2- and 3-mm punch biopsies – particularly if they are from the head and neck area.”
He suggests doing biopsies on part of the ear, lower jaw line, or the neck area, as these areas tend to heal nicely. “You don’t have to be so concerned about the scarring if you counsel appropriately,” he said.
The biopsy can be valuable in determining whether a very expensive treatment will reach the intended target.
Topical retinoids play an important role as anti-inflammatories for PIH, Dr. Desai said.
He gave an example of a patient with Fitzpatrick skin type IV or V with chronic acne and extensive PIH. “Are you going to effectively tell that patient to apply 4% hydroquinone triple-combination compound across 30 different areas of PIH on their face? The answer is that’s really not very efficient or effective.”
That’s why therapies, such as retinoids, that target the pathogenesis of PIH, particularly the inflammatory component, are important, he added.
Psychological burden
PIH comes with significant stigma and loss of quality of life loss that can last many years.
During another presentation at the meeting, Susan C. Taylor, MD, professor and vice chair of diversity, equity and inclusion in the department of dermatology, at the University of Pennsylvania, Philadelphia, pointed out that in a 2016 study of 324 patients in seven Asian countries, acne-related PIH lasted longer than 1 year in 65.2% of patients and 5 years or longer in 22.3%, significantly affecting their quality of life.
Dr. Desai added that, in a paper recently published in the British Journal of Dermatology, on the impact of postacne hyperpigmentation in patients, the authors pointed out that the reported prevalence of PIH in patients with acne ranges between 45.5% and 87.2%, depending on skin phototype, and that in most cases, PIH takes more than a year to fade.
“Studies have demonstrated that patients with acne and resulting scarring often face stigmatization, leading to quality of life impairment, social withdrawal and body image disorders, which can further contribute to higher risk for depression and social anxiety,” the paper’s authors wrote.
Dr. Desai reported no financial disclosures relevant to his talk.
CHICAGO –
Dr. Desai, clinical assistant professor in the department of dermatology at the University of Texas Southwestern Medical Center, Dallas, spoke at the Pigmentary Disorders Exchange Symposium, provided by MedscapeLive!
Like all dermatologists, he said at the meeting, he sees lots of acne cases. However, PIH is often the presenting reason for the visit in his practice, which focuses predominantly on skin of color.
“Most of my patients come in not even worried about the acne,” he said. “They come in wanting me to fix the dark spots.”
Inflammation persists
Dermatologists, Dr. Desai said, should educate patients with active PIH resulting from acne or other diseases that even though the condition has been labeled post- inflammatory hyperpigmentation, the inflammation continues to be a problem.
He said, while patients may think PIH is “just scars,” the inflammation is still active and the condition needs to be treated from a skin-lightening perspective but, more importantly, with a focus on halting the inflammation. “If you were to biopsy the areas of hyperpigmentation, you would find a high density of active inflammatory behaviors still present in the skin,” he said.
When treating patients, it’s critical to first treat the underlying skin condition aggressively, he said. “Things like topical retinoids and azelaic acid mechanistically actually make a lot more sense for PIH than even hydroquinone, in some cases, because these therapies are actually anti-inflammatory for many of the diseases we treat.”
Dr. Desai noted that, in patients with darker skin tones, even diseases like seborrheic dermatitis and plaque psoriasis can result in PIH, while in patients with lighter skin tones, the same diseases may leave some residual postinflammatory erythema.
“I think it’s very important, particularly when you’re treating a darker skin–toned patient, to arrest the erythema early on to prevent that further worsening of hyperpigmentation,” he said.
Biopsies important
In cases of PIH, determining the best treatment requires finding out where the pigment is and how deep it is, Dr. Desai said.
He noted dermatologists are often worried about doing biopsies, particularly in patients with darker skin, because of the risk of scarring and keloid formation for those more prone to keloids. The preference is also for a therapeutic effect without using invasive procedures.
“But particularly with PIH, in patients who have been therapeutically challenging, I don’t hesitate to do very small biopsies – 2- and 3-mm punch biopsies – particularly if they are from the head and neck area.”
He suggests doing biopsies on part of the ear, lower jaw line, or the neck area, as these areas tend to heal nicely. “You don’t have to be so concerned about the scarring if you counsel appropriately,” he said.
The biopsy can be valuable in determining whether a very expensive treatment will reach the intended target.
Topical retinoids play an important role as anti-inflammatories for PIH, Dr. Desai said.
He gave an example of a patient with Fitzpatrick skin type IV or V with chronic acne and extensive PIH. “Are you going to effectively tell that patient to apply 4% hydroquinone triple-combination compound across 30 different areas of PIH on their face? The answer is that’s really not very efficient or effective.”
That’s why therapies, such as retinoids, that target the pathogenesis of PIH, particularly the inflammatory component, are important, he added.
Psychological burden
PIH comes with significant stigma and loss of quality of life loss that can last many years.
During another presentation at the meeting, Susan C. Taylor, MD, professor and vice chair of diversity, equity and inclusion in the department of dermatology, at the University of Pennsylvania, Philadelphia, pointed out that in a 2016 study of 324 patients in seven Asian countries, acne-related PIH lasted longer than 1 year in 65.2% of patients and 5 years or longer in 22.3%, significantly affecting their quality of life.
Dr. Desai added that, in a paper recently published in the British Journal of Dermatology, on the impact of postacne hyperpigmentation in patients, the authors pointed out that the reported prevalence of PIH in patients with acne ranges between 45.5% and 87.2%, depending on skin phototype, and that in most cases, PIH takes more than a year to fade.
“Studies have demonstrated that patients with acne and resulting scarring often face stigmatization, leading to quality of life impairment, social withdrawal and body image disorders, which can further contribute to higher risk for depression and social anxiety,” the paper’s authors wrote.
Dr. Desai reported no financial disclosures relevant to his talk.
AT THE MEDSCAPELIVE! PIGMENTARY DISORDERS SYMPOSIUM
MS relapse rates similar between anti-CD20 mAbs and switching to fumarates
DENVER – according to a retrospective study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. Those who switched did, however, experience a lower rate of inpatient infection-related health care visits per year than those who continued anti-CD20 mAbs.
“As MS is a chronic disease requiring long-term treatment, switching between disease-modifying therapies [DMTs] is a common clinical strategy to optimize individual patient outcomes,” lead author Aliza Ben-Zacharia, PhD, DNP, RN, an assistant professor at the Phillips School of Nursing at Mount Sinai and Hunter College, both in New York, and colleagues reported. They noted that anti-CD20 mAbs are considered high-efficacy DMTs while fumarates are considered moderate-efficacy DMTs.
The researchers used data from the Komodo Health Sentinel Claims Database to track and compare 108 patients who were clinically stable on anti-CD20 mAbs and then switched to fumarates with 540 patients who remained on anti-CD20 mAbs for a follow-up period of approximately 1 year.
The study included adults with a diagnosis of MS between January 2015 and August 2022, and only those with a gap of no more than 9 months between anti-CD20 mAbs and fumarates were included as switchers. The researchers also required that switchers had not had any relapses in the previous year on anti-CD20 mAbs before switching, and had to have been on fumarates for at least 3 months after switching.
Women made up 70% of both groups, and both had an average age of 49 years. The racial/ethnic demographics were similar in both groups, and the average MS severity score was 5.5 in the switching group and 5.6 in the staying group. Most patients had been taking or remained on ocrelizumab (93.5%) with a smaller proportion on rituximab (5.6%). Just over a third of those who switched therapy took diroximel fumarate while 64% took dimethyl fumarate.
The researchers noted that patients who stayed on anti-CD20 mAbs had “slightly higher use of other mAbs prior to anti-CD20 mAbs.” Further, “a higher proportion of patients were DMT naive prior to anti-CD20 mAb initiation, compared with those in the switchers group.”
Patients who switched had been on anti-CD20 mAbs an average 730 days before switching to fumarates, and the average time between their last anti-CD20 mAbs dose and starting fumarates was 274 days. Average exposure to fumarates was 341 days.
The 10.2% of patients who relapsed during follow-up after switching to fumarates was not significantly statistically different than the 6.7% of patients who relapsed while remaining on anti-CD20 mAbs (P = .17). A relapse was considered “an MS-related inpatient claim with a primary diagnosis of MS or an outpatient MS-related diagnosis and a prescription claim for an intravenous steroid, adrenocorticotropic hormone, total plasma exchange, or a high-dose oral corticosteroid 7 days or sooner after the outpatient visit,” the researchers explained. The researchers could not track mild relapses that didn’t involve a health care interaction.
There was also no significant difference in overall average health care encounters between those who switched (7.85 encounters) and those who stayed (8.08; P = .57). Further, average health care costs were statistically similar between those who switched ($22,512) and those who stayed ($20,634; P = 0.59).
The likelihood of having more than one infection-related health care encounter was greater for those who remained on anti-CD20 mAbs, but the difference was not statistically significant. The annual rate of infection-related health care encounters was also not statistically different for outpatient and ED visits, but those who switched did have a statistically lower rate of annual infection-related inpatient visits (P = .03).
Among those who switched, 2.8% were hospitalized for infections, compared with 6.5% who stayed on anti-CD20 mAbs. Urinary tract infections, sepsis, and Escherichia coli were the most common infections among those who switched to fumarates, compared with COVID-19, sepsis, and pneumonia, among those who stayed on anti-CD20 mAbs.
The research was sponsored by and funded by Biogen. Six of the authors are Biogen employees who hold stock options in the company. The other three authors reported combined consulting fees from Biogen, EMD Serono, Greenwich Biosciences, TG Therapeutics, Bristol-Myers Squibb, Horizon, and Novartis; research funding from Genentech and Novartis; and stock options in Pfizer.
DENVER – according to a retrospective study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. Those who switched did, however, experience a lower rate of inpatient infection-related health care visits per year than those who continued anti-CD20 mAbs.
“As MS is a chronic disease requiring long-term treatment, switching between disease-modifying therapies [DMTs] is a common clinical strategy to optimize individual patient outcomes,” lead author Aliza Ben-Zacharia, PhD, DNP, RN, an assistant professor at the Phillips School of Nursing at Mount Sinai and Hunter College, both in New York, and colleagues reported. They noted that anti-CD20 mAbs are considered high-efficacy DMTs while fumarates are considered moderate-efficacy DMTs.
The researchers used data from the Komodo Health Sentinel Claims Database to track and compare 108 patients who were clinically stable on anti-CD20 mAbs and then switched to fumarates with 540 patients who remained on anti-CD20 mAbs for a follow-up period of approximately 1 year.
The study included adults with a diagnosis of MS between January 2015 and August 2022, and only those with a gap of no more than 9 months between anti-CD20 mAbs and fumarates were included as switchers. The researchers also required that switchers had not had any relapses in the previous year on anti-CD20 mAbs before switching, and had to have been on fumarates for at least 3 months after switching.
Women made up 70% of both groups, and both had an average age of 49 years. The racial/ethnic demographics were similar in both groups, and the average MS severity score was 5.5 in the switching group and 5.6 in the staying group. Most patients had been taking or remained on ocrelizumab (93.5%) with a smaller proportion on rituximab (5.6%). Just over a third of those who switched therapy took diroximel fumarate while 64% took dimethyl fumarate.
The researchers noted that patients who stayed on anti-CD20 mAbs had “slightly higher use of other mAbs prior to anti-CD20 mAbs.” Further, “a higher proportion of patients were DMT naive prior to anti-CD20 mAb initiation, compared with those in the switchers group.”
Patients who switched had been on anti-CD20 mAbs an average 730 days before switching to fumarates, and the average time between their last anti-CD20 mAbs dose and starting fumarates was 274 days. Average exposure to fumarates was 341 days.
The 10.2% of patients who relapsed during follow-up after switching to fumarates was not significantly statistically different than the 6.7% of patients who relapsed while remaining on anti-CD20 mAbs (P = .17). A relapse was considered “an MS-related inpatient claim with a primary diagnosis of MS or an outpatient MS-related diagnosis and a prescription claim for an intravenous steroid, adrenocorticotropic hormone, total plasma exchange, or a high-dose oral corticosteroid 7 days or sooner after the outpatient visit,” the researchers explained. The researchers could not track mild relapses that didn’t involve a health care interaction.
There was also no significant difference in overall average health care encounters between those who switched (7.85 encounters) and those who stayed (8.08; P = .57). Further, average health care costs were statistically similar between those who switched ($22,512) and those who stayed ($20,634; P = 0.59).
The likelihood of having more than one infection-related health care encounter was greater for those who remained on anti-CD20 mAbs, but the difference was not statistically significant. The annual rate of infection-related health care encounters was also not statistically different for outpatient and ED visits, but those who switched did have a statistically lower rate of annual infection-related inpatient visits (P = .03).
Among those who switched, 2.8% were hospitalized for infections, compared with 6.5% who stayed on anti-CD20 mAbs. Urinary tract infections, sepsis, and Escherichia coli were the most common infections among those who switched to fumarates, compared with COVID-19, sepsis, and pneumonia, among those who stayed on anti-CD20 mAbs.
The research was sponsored by and funded by Biogen. Six of the authors are Biogen employees who hold stock options in the company. The other three authors reported combined consulting fees from Biogen, EMD Serono, Greenwich Biosciences, TG Therapeutics, Bristol-Myers Squibb, Horizon, and Novartis; research funding from Genentech and Novartis; and stock options in Pfizer.
DENVER – according to a retrospective study presented at the annual meeting of the Consortium of Multiple Sclerosis Centers. Those who switched did, however, experience a lower rate of inpatient infection-related health care visits per year than those who continued anti-CD20 mAbs.
“As MS is a chronic disease requiring long-term treatment, switching between disease-modifying therapies [DMTs] is a common clinical strategy to optimize individual patient outcomes,” lead author Aliza Ben-Zacharia, PhD, DNP, RN, an assistant professor at the Phillips School of Nursing at Mount Sinai and Hunter College, both in New York, and colleagues reported. They noted that anti-CD20 mAbs are considered high-efficacy DMTs while fumarates are considered moderate-efficacy DMTs.
The researchers used data from the Komodo Health Sentinel Claims Database to track and compare 108 patients who were clinically stable on anti-CD20 mAbs and then switched to fumarates with 540 patients who remained on anti-CD20 mAbs for a follow-up period of approximately 1 year.
The study included adults with a diagnosis of MS between January 2015 and August 2022, and only those with a gap of no more than 9 months between anti-CD20 mAbs and fumarates were included as switchers. The researchers also required that switchers had not had any relapses in the previous year on anti-CD20 mAbs before switching, and had to have been on fumarates for at least 3 months after switching.
Women made up 70% of both groups, and both had an average age of 49 years. The racial/ethnic demographics were similar in both groups, and the average MS severity score was 5.5 in the switching group and 5.6 in the staying group. Most patients had been taking or remained on ocrelizumab (93.5%) with a smaller proportion on rituximab (5.6%). Just over a third of those who switched therapy took diroximel fumarate while 64% took dimethyl fumarate.
The researchers noted that patients who stayed on anti-CD20 mAbs had “slightly higher use of other mAbs prior to anti-CD20 mAbs.” Further, “a higher proportion of patients were DMT naive prior to anti-CD20 mAb initiation, compared with those in the switchers group.”
Patients who switched had been on anti-CD20 mAbs an average 730 days before switching to fumarates, and the average time between their last anti-CD20 mAbs dose and starting fumarates was 274 days. Average exposure to fumarates was 341 days.
The 10.2% of patients who relapsed during follow-up after switching to fumarates was not significantly statistically different than the 6.7% of patients who relapsed while remaining on anti-CD20 mAbs (P = .17). A relapse was considered “an MS-related inpatient claim with a primary diagnosis of MS or an outpatient MS-related diagnosis and a prescription claim for an intravenous steroid, adrenocorticotropic hormone, total plasma exchange, or a high-dose oral corticosteroid 7 days or sooner after the outpatient visit,” the researchers explained. The researchers could not track mild relapses that didn’t involve a health care interaction.
There was also no significant difference in overall average health care encounters between those who switched (7.85 encounters) and those who stayed (8.08; P = .57). Further, average health care costs were statistically similar between those who switched ($22,512) and those who stayed ($20,634; P = 0.59).
The likelihood of having more than one infection-related health care encounter was greater for those who remained on anti-CD20 mAbs, but the difference was not statistically significant. The annual rate of infection-related health care encounters was also not statistically different for outpatient and ED visits, but those who switched did have a statistically lower rate of annual infection-related inpatient visits (P = .03).
Among those who switched, 2.8% were hospitalized for infections, compared with 6.5% who stayed on anti-CD20 mAbs. Urinary tract infections, sepsis, and Escherichia coli were the most common infections among those who switched to fumarates, compared with COVID-19, sepsis, and pneumonia, among those who stayed on anti-CD20 mAbs.
The research was sponsored by and funded by Biogen. Six of the authors are Biogen employees who hold stock options in the company. The other three authors reported combined consulting fees from Biogen, EMD Serono, Greenwich Biosciences, TG Therapeutics, Bristol-Myers Squibb, Horizon, and Novartis; research funding from Genentech and Novartis; and stock options in Pfizer.
AT CMSC 2023
High Lp(a) tied to higher coronary plaque volume, progression
MANNHEIM, GERMANY – , an observational imaging study shows.
This could explain the greater risk for major adverse cardiovascular events seen in patients with high Lp(a) levels, suggests the research, presented during the annual European Atherosclerosis Society Congress.
The team performed follow-up coronary CT angiography (CCTA) on almost 275 patients who had undergone imaging approximately 10 years earlier, finding that almost one-third had high Lp(a) levels.
At baseline, per cent plaque volumes were 1.8 times greater in high Lp(a) patients versus those with low levels of the protein. After 10 years, plaque volumes were 3.3 times larger in patients with high Lp(a) levels.
Over this period, the rate of increase of plaque volume was 1.9 times greater in patients with high Lp(a) levels.
Study presenter Nick S. Nurmohamed, MD, PhD candidate, department of vascular medicine, Amsterdam University Medical Centers, also showed that high Lp(a) levels were associated with a 2.1-fold increase in rates of MACE.
He said in an interview that this finding could be related to Lp(a) increasing inflammatory signaling in the plaque, “making it more prone to rupture, and we saw that on the CCTA scans,” where high Lp(a) levels were associated with the presence of more high-risk plaques.
He added that in the absence of drugs that target Lp(a) levels directly, the results underline the need to focus on other means of lipid-lowering, as well as “creating awareness that Lp(a) is associated with plaque formation.”
Dr. Nurmohamed said that “for the moment, we have to treat patients with high Lp(a) with other risk-lowering therapies, such as low-density lipoprotein [LDL] cholesterol–lowering drugs, and the management of other risk factors.”
However, he noted that “there are a couple of Lp(a)-lowering medications in trials,” with results expected in the next 2-3 years.
“Then we will have the means to treat those patients, and with CCTA we can identify the patients with the biggest risk,” Dr. Nurmohamed added.
Plaque burden
Philippe Moulin, MD, PhD, head of endocrinology and professor of human nutrition at Faculté Lyon Est, Claude Bernard Lyon (France) 1 University, said that the association between Lp(a) and plaque burden has been seen previously in the literature in a very similar study but with only 1-year follow-up.
Similarly, registry data have suggested that Lp(a) is associated with worsening plaque progression over time.
“Here, with 10-year follow-up, [the study] is much more interesting,” due to its greater statistical power, he said in an interview. It is also “well-documented” and uses an “appropriate” methodology.
But Dr. Moulin underlined that the number of patients with high Lp(a) levels included in the study is relatively small.
Consequently, the researchers were not able to look at the level and rate of progression of atherosclerosis between different quartiles of Lp(a), “so you have no dose-response analysis.”
It also does not “establish causality,” as it remains an observational study, despite being longitudinal, “well done, and so on.”
Dr. Moulin added that the study nevertheless adds “one more stone” to the construct of the idea of high risk around high Lp(a) levels, and “prepares the ground” for the availability of two drugs to decrease Lp(a) levels, expected in 2026 and 2027.
These are expected to substantially reduce Lp(a) levels and achieve a reduction in cardiovascular risk of around 20%-40%, “which would be interesting,” especially as “we have patients who have Lp(a) levels four times above the upper normal value.”
Crucially, they may already have normal LDL cholesterol levels, meaning that, for some patients, “there is clearly a need for such treatment, as long as it is proven that it will decrease cardiovascular risk.”
For the moment, however, the strategy for managing patients with high Lp(a) remains to increase the dose of statin and to have more stringent targets, although Dr. Moulin pointed out that, “when you give statins, you raise slightly Lp(a) levels.”
Dr. Nurmohamed said in an interview that “we know from largely genetic and observational studies that Lp(a) is causally associated with atherosclerotic cardiovascular disease.”
What is less clear is the exact underlying mechanism, he said, noting that there have been several imaging studies in high and low Lp(a) patients that have yielded conflicting results in terms of the relationship with plaque burden.
To investigate the impact of Lp(a) levels on long-term coronary plaque progression, the team invited patients who had taken part in a previous CCTA study to undergo repeat CCTA, regardless of their underlying symptoms.
In all, 299 patients underwent follow-up imaging a median of 10.2 years after their original scan. Plaque volumes were quantified and adjusted for vessel volumes, and the patients were classified as having high (≥ 70 nmol/L) or low (< 70 nmol/L) Lp(a) levels.
After excluding patients who had undergone coronary artery bypass grafting, the team analyzed 274 patients with a mean age at baseline of 57 years. Of these, 159 (58%) were men. High Lp(a) levels were identified in 87 (32%) patients.
The team found that at baseline, patients with high Lp(a) levels had significantly larger percent atheroma volumes than those with low levels, at 3.92% versus 2.17%, or an absolute difference of 1.75% (P = .013).
The difference between the two groups was even greater at the follow-up, when percent atheroma volumes reached 8.75% in patients with high Lp(a) levels versus 3.90% for those with low levels, or an absolute difference of 4.85% (P = .005).
Similar findings were seen when looking separately at percentage of noncalcified and calcified plaque volumes as well as when analyzing for the presence of low-density plaques.
Multivariate analysis taking into account clinical risk factors, statin use, and CT tube voltage found that high Lp(a) levels were associated with a greater percent atheroma volume at baseline, at an odds ratio versus low Lp(a) of 1.83 (95% confidence interval, 0.12-3.54; P = .037).
High Lp(a) levels were also linked to a larger percent atheroma volume on follow-up imaging, at an odds ratio of 3.25 (95% CI, 0.80-5.71; P = .010), and a significantly greater change in atheroma volume from baseline to follow-up imaging, at an odds ratio of 1.86 (95% CI, 0.59-3.14; P = .005)
Finally, the team showed that, after adjusting for clinical risk factors, high baseline Lp(a) levels were associated with an increased risk of MACE during the follow-up period, at a hazard ratio versus low Lp(a) levels of 2.10 (95% CI, 1.01-4.29, P = .048).
No funding was declared. Dr. Nurmohamed is cofounder of Lipid Tools. Other authors declare relationships with Amgen, Novartis, Esperion, Sanofi-Regeneron, Ackee, Cleerly, GW Heart and Vascular Institute, Siemens Healthineers, and HeartFlow.
A version of this article first appeared on Medscape.com.
MANNHEIM, GERMANY – , an observational imaging study shows.
This could explain the greater risk for major adverse cardiovascular events seen in patients with high Lp(a) levels, suggests the research, presented during the annual European Atherosclerosis Society Congress.
The team performed follow-up coronary CT angiography (CCTA) on almost 275 patients who had undergone imaging approximately 10 years earlier, finding that almost one-third had high Lp(a) levels.
At baseline, per cent plaque volumes were 1.8 times greater in high Lp(a) patients versus those with low levels of the protein. After 10 years, plaque volumes were 3.3 times larger in patients with high Lp(a) levels.
Over this period, the rate of increase of plaque volume was 1.9 times greater in patients with high Lp(a) levels.
Study presenter Nick S. Nurmohamed, MD, PhD candidate, department of vascular medicine, Amsterdam University Medical Centers, also showed that high Lp(a) levels were associated with a 2.1-fold increase in rates of MACE.
He said in an interview that this finding could be related to Lp(a) increasing inflammatory signaling in the plaque, “making it more prone to rupture, and we saw that on the CCTA scans,” where high Lp(a) levels were associated with the presence of more high-risk plaques.
He added that in the absence of drugs that target Lp(a) levels directly, the results underline the need to focus on other means of lipid-lowering, as well as “creating awareness that Lp(a) is associated with plaque formation.”
Dr. Nurmohamed said that “for the moment, we have to treat patients with high Lp(a) with other risk-lowering therapies, such as low-density lipoprotein [LDL] cholesterol–lowering drugs, and the management of other risk factors.”
However, he noted that “there are a couple of Lp(a)-lowering medications in trials,” with results expected in the next 2-3 years.
“Then we will have the means to treat those patients, and with CCTA we can identify the patients with the biggest risk,” Dr. Nurmohamed added.
Plaque burden
Philippe Moulin, MD, PhD, head of endocrinology and professor of human nutrition at Faculté Lyon Est, Claude Bernard Lyon (France) 1 University, said that the association between Lp(a) and plaque burden has been seen previously in the literature in a very similar study but with only 1-year follow-up.
Similarly, registry data have suggested that Lp(a) is associated with worsening plaque progression over time.
“Here, with 10-year follow-up, [the study] is much more interesting,” due to its greater statistical power, he said in an interview. It is also “well-documented” and uses an “appropriate” methodology.
But Dr. Moulin underlined that the number of patients with high Lp(a) levels included in the study is relatively small.
Consequently, the researchers were not able to look at the level and rate of progression of atherosclerosis between different quartiles of Lp(a), “so you have no dose-response analysis.”
It also does not “establish causality,” as it remains an observational study, despite being longitudinal, “well done, and so on.”
Dr. Moulin added that the study nevertheless adds “one more stone” to the construct of the idea of high risk around high Lp(a) levels, and “prepares the ground” for the availability of two drugs to decrease Lp(a) levels, expected in 2026 and 2027.
These are expected to substantially reduce Lp(a) levels and achieve a reduction in cardiovascular risk of around 20%-40%, “which would be interesting,” especially as “we have patients who have Lp(a) levels four times above the upper normal value.”
Crucially, they may already have normal LDL cholesterol levels, meaning that, for some patients, “there is clearly a need for such treatment, as long as it is proven that it will decrease cardiovascular risk.”
For the moment, however, the strategy for managing patients with high Lp(a) remains to increase the dose of statin and to have more stringent targets, although Dr. Moulin pointed out that, “when you give statins, you raise slightly Lp(a) levels.”
Dr. Nurmohamed said in an interview that “we know from largely genetic and observational studies that Lp(a) is causally associated with atherosclerotic cardiovascular disease.”
What is less clear is the exact underlying mechanism, he said, noting that there have been several imaging studies in high and low Lp(a) patients that have yielded conflicting results in terms of the relationship with plaque burden.
To investigate the impact of Lp(a) levels on long-term coronary plaque progression, the team invited patients who had taken part in a previous CCTA study to undergo repeat CCTA, regardless of their underlying symptoms.
In all, 299 patients underwent follow-up imaging a median of 10.2 years after their original scan. Plaque volumes were quantified and adjusted for vessel volumes, and the patients were classified as having high (≥ 70 nmol/L) or low (< 70 nmol/L) Lp(a) levels.
After excluding patients who had undergone coronary artery bypass grafting, the team analyzed 274 patients with a mean age at baseline of 57 years. Of these, 159 (58%) were men. High Lp(a) levels were identified in 87 (32%) patients.
The team found that at baseline, patients with high Lp(a) levels had significantly larger percent atheroma volumes than those with low levels, at 3.92% versus 2.17%, or an absolute difference of 1.75% (P = .013).
The difference between the two groups was even greater at the follow-up, when percent atheroma volumes reached 8.75% in patients with high Lp(a) levels versus 3.90% for those with low levels, or an absolute difference of 4.85% (P = .005).
Similar findings were seen when looking separately at percentage of noncalcified and calcified plaque volumes as well as when analyzing for the presence of low-density plaques.
Multivariate analysis taking into account clinical risk factors, statin use, and CT tube voltage found that high Lp(a) levels were associated with a greater percent atheroma volume at baseline, at an odds ratio versus low Lp(a) of 1.83 (95% confidence interval, 0.12-3.54; P = .037).
High Lp(a) levels were also linked to a larger percent atheroma volume on follow-up imaging, at an odds ratio of 3.25 (95% CI, 0.80-5.71; P = .010), and a significantly greater change in atheroma volume from baseline to follow-up imaging, at an odds ratio of 1.86 (95% CI, 0.59-3.14; P = .005)
Finally, the team showed that, after adjusting for clinical risk factors, high baseline Lp(a) levels were associated with an increased risk of MACE during the follow-up period, at a hazard ratio versus low Lp(a) levels of 2.10 (95% CI, 1.01-4.29, P = .048).
No funding was declared. Dr. Nurmohamed is cofounder of Lipid Tools. Other authors declare relationships with Amgen, Novartis, Esperion, Sanofi-Regeneron, Ackee, Cleerly, GW Heart and Vascular Institute, Siemens Healthineers, and HeartFlow.
A version of this article first appeared on Medscape.com.
MANNHEIM, GERMANY – , an observational imaging study shows.
This could explain the greater risk for major adverse cardiovascular events seen in patients with high Lp(a) levels, suggests the research, presented during the annual European Atherosclerosis Society Congress.
The team performed follow-up coronary CT angiography (CCTA) on almost 275 patients who had undergone imaging approximately 10 years earlier, finding that almost one-third had high Lp(a) levels.
At baseline, per cent plaque volumes were 1.8 times greater in high Lp(a) patients versus those with low levels of the protein. After 10 years, plaque volumes were 3.3 times larger in patients with high Lp(a) levels.
Over this period, the rate of increase of plaque volume was 1.9 times greater in patients with high Lp(a) levels.
Study presenter Nick S. Nurmohamed, MD, PhD candidate, department of vascular medicine, Amsterdam University Medical Centers, also showed that high Lp(a) levels were associated with a 2.1-fold increase in rates of MACE.
He said in an interview that this finding could be related to Lp(a) increasing inflammatory signaling in the plaque, “making it more prone to rupture, and we saw that on the CCTA scans,” where high Lp(a) levels were associated with the presence of more high-risk plaques.
He added that in the absence of drugs that target Lp(a) levels directly, the results underline the need to focus on other means of lipid-lowering, as well as “creating awareness that Lp(a) is associated with plaque formation.”
Dr. Nurmohamed said that “for the moment, we have to treat patients with high Lp(a) with other risk-lowering therapies, such as low-density lipoprotein [LDL] cholesterol–lowering drugs, and the management of other risk factors.”
However, he noted that “there are a couple of Lp(a)-lowering medications in trials,” with results expected in the next 2-3 years.
“Then we will have the means to treat those patients, and with CCTA we can identify the patients with the biggest risk,” Dr. Nurmohamed added.
Plaque burden
Philippe Moulin, MD, PhD, head of endocrinology and professor of human nutrition at Faculté Lyon Est, Claude Bernard Lyon (France) 1 University, said that the association between Lp(a) and plaque burden has been seen previously in the literature in a very similar study but with only 1-year follow-up.
Similarly, registry data have suggested that Lp(a) is associated with worsening plaque progression over time.
“Here, with 10-year follow-up, [the study] is much more interesting,” due to its greater statistical power, he said in an interview. It is also “well-documented” and uses an “appropriate” methodology.
But Dr. Moulin underlined that the number of patients with high Lp(a) levels included in the study is relatively small.
Consequently, the researchers were not able to look at the level and rate of progression of atherosclerosis between different quartiles of Lp(a), “so you have no dose-response analysis.”
It also does not “establish causality,” as it remains an observational study, despite being longitudinal, “well done, and so on.”
Dr. Moulin added that the study nevertheless adds “one more stone” to the construct of the idea of high risk around high Lp(a) levels, and “prepares the ground” for the availability of two drugs to decrease Lp(a) levels, expected in 2026 and 2027.
These are expected to substantially reduce Lp(a) levels and achieve a reduction in cardiovascular risk of around 20%-40%, “which would be interesting,” especially as “we have patients who have Lp(a) levels four times above the upper normal value.”
Crucially, they may already have normal LDL cholesterol levels, meaning that, for some patients, “there is clearly a need for such treatment, as long as it is proven that it will decrease cardiovascular risk.”
For the moment, however, the strategy for managing patients with high Lp(a) remains to increase the dose of statin and to have more stringent targets, although Dr. Moulin pointed out that, “when you give statins, you raise slightly Lp(a) levels.”
Dr. Nurmohamed said in an interview that “we know from largely genetic and observational studies that Lp(a) is causally associated with atherosclerotic cardiovascular disease.”
What is less clear is the exact underlying mechanism, he said, noting that there have been several imaging studies in high and low Lp(a) patients that have yielded conflicting results in terms of the relationship with plaque burden.
To investigate the impact of Lp(a) levels on long-term coronary plaque progression, the team invited patients who had taken part in a previous CCTA study to undergo repeat CCTA, regardless of their underlying symptoms.
In all, 299 patients underwent follow-up imaging a median of 10.2 years after their original scan. Plaque volumes were quantified and adjusted for vessel volumes, and the patients were classified as having high (≥ 70 nmol/L) or low (< 70 nmol/L) Lp(a) levels.
After excluding patients who had undergone coronary artery bypass grafting, the team analyzed 274 patients with a mean age at baseline of 57 years. Of these, 159 (58%) were men. High Lp(a) levels were identified in 87 (32%) patients.
The team found that at baseline, patients with high Lp(a) levels had significantly larger percent atheroma volumes than those with low levels, at 3.92% versus 2.17%, or an absolute difference of 1.75% (P = .013).
The difference between the two groups was even greater at the follow-up, when percent atheroma volumes reached 8.75% in patients with high Lp(a) levels versus 3.90% for those with low levels, or an absolute difference of 4.85% (P = .005).
Similar findings were seen when looking separately at percentage of noncalcified and calcified plaque volumes as well as when analyzing for the presence of low-density plaques.
Multivariate analysis taking into account clinical risk factors, statin use, and CT tube voltage found that high Lp(a) levels were associated with a greater percent atheroma volume at baseline, at an odds ratio versus low Lp(a) of 1.83 (95% confidence interval, 0.12-3.54; P = .037).
High Lp(a) levels were also linked to a larger percent atheroma volume on follow-up imaging, at an odds ratio of 3.25 (95% CI, 0.80-5.71; P = .010), and a significantly greater change in atheroma volume from baseline to follow-up imaging, at an odds ratio of 1.86 (95% CI, 0.59-3.14; P = .005)
Finally, the team showed that, after adjusting for clinical risk factors, high baseline Lp(a) levels were associated with an increased risk of MACE during the follow-up period, at a hazard ratio versus low Lp(a) levels of 2.10 (95% CI, 1.01-4.29, P = .048).
No funding was declared. Dr. Nurmohamed is cofounder of Lipid Tools. Other authors declare relationships with Amgen, Novartis, Esperion, Sanofi-Regeneron, Ackee, Cleerly, GW Heart and Vascular Institute, Siemens Healthineers, and HeartFlow.
A version of this article first appeared on Medscape.com.
AT EAS 2023
Cognitive decline risk in adult childhood cancer survivors
Among more than 2,300 adult survivors of childhood cancer and their siblings, who served as controls, new-onset memory impairment emerged more often in survivors decades later.
The increased risk was associated with the cancer treatment that was provided as well as modifiable health behaviors and chronic health conditions.
Even 35 years after being diagnosed, cancer survivors who never received chemotherapies or radiation therapies known to damage the brain reported far greater memory impairment than did their siblings, first author Nicholas Phillips, MD, told this news organization.
What the findings suggest is that “we need to educate oncologists and primary care providers on the risks our survivors face long after completion of therapy,” said Dr. Phillips, of the epidemiology and cancer control department at St. Jude Children’s Research Hospital, Memphis, Tenn.
The study was published online in JAMA Network Open.
Cancer survivors face an elevated risk for severe neurocognitive effects that can emerge 5-10 years following their diagnosis and treatment. However, it’s unclear whether new-onset neurocognitive problems can still develop a decade or more following diagnosis.
Over a long-term follow-up, Dr. Phillips and colleagues explored this question in 2,375 adult survivors of childhood cancer from the Childhood Cancer Survivor Study and 232 of their siblings.
Among the cancer cohort, 1,316 patients were survivors of acute lymphoblastic leukemia (ALL), 488 were survivors of central nervous system (CNS) tumors, and 571 had survived Hodgkin lymphoma.
The researchers determined the prevalence of new-onset neurocognitive impairment between baseline (23 years after diagnosis) and follow-up (35 years after diagnosis). New-onset neurocognitive impairment – present at follow-up but not at baseline – was defined as having a score in the worst 10% of the sibling cohort.
A higher proportion of survivors had new-onset memory impairment at follow-up compared with siblings. Specifically, about 8% of siblings had new-onset memory trouble, compared with 14% of ALL survivors treated with chemotherapy only, 26% of ALL survivors treated with cranial radiation, 35% of CNS tumor survivors, and 17% of Hodgkin lymphoma survivors.
New-onset memory impairment was associated with cranial radiation among CNS tumor survivors (relative risk [RR], 1.97) and alkylator chemotherapy at or above 8,000 mg/m2 among survivors of ALL who were treated without cranial radiation (RR, 2.80). The authors also found that smoking, low educational attainment, and low physical activity were associated with an elevated risk for new-onset memory impairment.
Dr. Phillips noted that current guidelines emphasize the importance of short-term monitoring of a survivor’s neurocognitive status on the basis of that person’s chemotherapy and radiation exposures.
However, “our study suggests that all survivors, regardless of their therapy, should be screened regularly for new-onset neurocognitive problems. And this screening should be done regularly for decades after diagnosis,” he said in an interview.
Dr. Phillips also noted the importance of communicating lifestyle modifications, such as not smoking and maintaining an active lifestyle.
“We need to start early and use the power of repetition when communicating with our survivors and their families,” Dr. Phillips said. “When our families and survivors hear the word ‘exercise,’ they think of gym memberships, lifting weights, and running on treadmills. But what we really want our survivors to do is stay active.”
What this means is engaging for about 2.5 hours a week in a range of activities, such as ballet, basketball, volleyball, bicycling, or swimming.
“And if our kids want to quit after 3 months, let them know that this is okay. They just need to replace that activity with another activity,” said Dr. Phillips. “We want them to find a fun hobby that they will enjoy that will keep them active.”
The study was supported by the National Cancer Institute. Dr. Phillips has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among more than 2,300 adult survivors of childhood cancer and their siblings, who served as controls, new-onset memory impairment emerged more often in survivors decades later.
The increased risk was associated with the cancer treatment that was provided as well as modifiable health behaviors and chronic health conditions.
Even 35 years after being diagnosed, cancer survivors who never received chemotherapies or radiation therapies known to damage the brain reported far greater memory impairment than did their siblings, first author Nicholas Phillips, MD, told this news organization.
What the findings suggest is that “we need to educate oncologists and primary care providers on the risks our survivors face long after completion of therapy,” said Dr. Phillips, of the epidemiology and cancer control department at St. Jude Children’s Research Hospital, Memphis, Tenn.
The study was published online in JAMA Network Open.
Cancer survivors face an elevated risk for severe neurocognitive effects that can emerge 5-10 years following their diagnosis and treatment. However, it’s unclear whether new-onset neurocognitive problems can still develop a decade or more following diagnosis.
Over a long-term follow-up, Dr. Phillips and colleagues explored this question in 2,375 adult survivors of childhood cancer from the Childhood Cancer Survivor Study and 232 of their siblings.
Among the cancer cohort, 1,316 patients were survivors of acute lymphoblastic leukemia (ALL), 488 were survivors of central nervous system (CNS) tumors, and 571 had survived Hodgkin lymphoma.
The researchers determined the prevalence of new-onset neurocognitive impairment between baseline (23 years after diagnosis) and follow-up (35 years after diagnosis). New-onset neurocognitive impairment – present at follow-up but not at baseline – was defined as having a score in the worst 10% of the sibling cohort.
A higher proportion of survivors had new-onset memory impairment at follow-up compared with siblings. Specifically, about 8% of siblings had new-onset memory trouble, compared with 14% of ALL survivors treated with chemotherapy only, 26% of ALL survivors treated with cranial radiation, 35% of CNS tumor survivors, and 17% of Hodgkin lymphoma survivors.
New-onset memory impairment was associated with cranial radiation among CNS tumor survivors (relative risk [RR], 1.97) and alkylator chemotherapy at or above 8,000 mg/m2 among survivors of ALL who were treated without cranial radiation (RR, 2.80). The authors also found that smoking, low educational attainment, and low physical activity were associated with an elevated risk for new-onset memory impairment.
Dr. Phillips noted that current guidelines emphasize the importance of short-term monitoring of a survivor’s neurocognitive status on the basis of that person’s chemotherapy and radiation exposures.
However, “our study suggests that all survivors, regardless of their therapy, should be screened regularly for new-onset neurocognitive problems. And this screening should be done regularly for decades after diagnosis,” he said in an interview.
Dr. Phillips also noted the importance of communicating lifestyle modifications, such as not smoking and maintaining an active lifestyle.
“We need to start early and use the power of repetition when communicating with our survivors and their families,” Dr. Phillips said. “When our families and survivors hear the word ‘exercise,’ they think of gym memberships, lifting weights, and running on treadmills. But what we really want our survivors to do is stay active.”
What this means is engaging for about 2.5 hours a week in a range of activities, such as ballet, basketball, volleyball, bicycling, or swimming.
“And if our kids want to quit after 3 months, let them know that this is okay. They just need to replace that activity with another activity,” said Dr. Phillips. “We want them to find a fun hobby that they will enjoy that will keep them active.”
The study was supported by the National Cancer Institute. Dr. Phillips has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among more than 2,300 adult survivors of childhood cancer and their siblings, who served as controls, new-onset memory impairment emerged more often in survivors decades later.
The increased risk was associated with the cancer treatment that was provided as well as modifiable health behaviors and chronic health conditions.
Even 35 years after being diagnosed, cancer survivors who never received chemotherapies or radiation therapies known to damage the brain reported far greater memory impairment than did their siblings, first author Nicholas Phillips, MD, told this news organization.
What the findings suggest is that “we need to educate oncologists and primary care providers on the risks our survivors face long after completion of therapy,” said Dr. Phillips, of the epidemiology and cancer control department at St. Jude Children’s Research Hospital, Memphis, Tenn.
The study was published online in JAMA Network Open.
Cancer survivors face an elevated risk for severe neurocognitive effects that can emerge 5-10 years following their diagnosis and treatment. However, it’s unclear whether new-onset neurocognitive problems can still develop a decade or more following diagnosis.
Over a long-term follow-up, Dr. Phillips and colleagues explored this question in 2,375 adult survivors of childhood cancer from the Childhood Cancer Survivor Study and 232 of their siblings.
Among the cancer cohort, 1,316 patients were survivors of acute lymphoblastic leukemia (ALL), 488 were survivors of central nervous system (CNS) tumors, and 571 had survived Hodgkin lymphoma.
The researchers determined the prevalence of new-onset neurocognitive impairment between baseline (23 years after diagnosis) and follow-up (35 years after diagnosis). New-onset neurocognitive impairment – present at follow-up but not at baseline – was defined as having a score in the worst 10% of the sibling cohort.
A higher proportion of survivors had new-onset memory impairment at follow-up compared with siblings. Specifically, about 8% of siblings had new-onset memory trouble, compared with 14% of ALL survivors treated with chemotherapy only, 26% of ALL survivors treated with cranial radiation, 35% of CNS tumor survivors, and 17% of Hodgkin lymphoma survivors.
New-onset memory impairment was associated with cranial radiation among CNS tumor survivors (relative risk [RR], 1.97) and alkylator chemotherapy at or above 8,000 mg/m2 among survivors of ALL who were treated without cranial radiation (RR, 2.80). The authors also found that smoking, low educational attainment, and low physical activity were associated with an elevated risk for new-onset memory impairment.
Dr. Phillips noted that current guidelines emphasize the importance of short-term monitoring of a survivor’s neurocognitive status on the basis of that person’s chemotherapy and radiation exposures.
However, “our study suggests that all survivors, regardless of their therapy, should be screened regularly for new-onset neurocognitive problems. And this screening should be done regularly for decades after diagnosis,” he said in an interview.
Dr. Phillips also noted the importance of communicating lifestyle modifications, such as not smoking and maintaining an active lifestyle.
“We need to start early and use the power of repetition when communicating with our survivors and their families,” Dr. Phillips said. “When our families and survivors hear the word ‘exercise,’ they think of gym memberships, lifting weights, and running on treadmills. But what we really want our survivors to do is stay active.”
What this means is engaging for about 2.5 hours a week in a range of activities, such as ballet, basketball, volleyball, bicycling, or swimming.
“And if our kids want to quit after 3 months, let them know that this is okay. They just need to replace that activity with another activity,” said Dr. Phillips. “We want them to find a fun hobby that they will enjoy that will keep them active.”
The study was supported by the National Cancer Institute. Dr. Phillips has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Is ChatGPT a friend or foe of medical publishing?
. These tools should not be listed as authors, and researchers must denote how AI-assisted technologies were used, the committee said.
These new guidelines are the latest effort for medical journals to define policies for using these large-scale language models (LLMs) in scientific publication. While these AI-assisted tools can help with tasks such as writing, analyzing data, catching mistakes, and much more, they are also prone to errors, noted Casey Greene, PhD, a professor of biomedical informatics at the University of Colorado at Denver, Aurora. It is also not totally clear how information is stored and processed in these kinds of tools, and who has access to that information, he noted.
At the same time, experts argue that these AI tools could have a positive impact on the field by limiting some of the linguistic disparities in scientific publishing as well as alleviating the burden of some monotonous or mechanical tasks that come along with manuscript writing.
What experts can agree on, though, is that the use of AI tools is here to stay. “This is going to become a common tool,” Dr. Greene said. “I don’t think there’s a way out of that at this point.”
A change in medical publishing
OpenAI released ChatGPT in November 2022. In its own words, ChatGPT is “a deep learning model that has been trained on a massive amount of text data to understand and generate humanlike text.” Enter a question or a prompt, and it will respond. For example, when asked how the AI tool can be used in scientific publishing, ChatGPT responded:
“ChatGPT can aid scientific publishing by generating ideas, clarifying concepts, conducting preliminary literature reviews, providing proofreading and editing suggestions, and assisting with outlining and organizing scientific papers. However, it should be used as a supportive tool alongside domain expertise and validation from trusted scientific sources.”
Just a few months after ChatGPT became available, researchers began using this tool in their own work. One individual, Som Biswas, MD, a radiologist at the University of Tennessee Health Science Center in Memphis, reportedly used ChatGPT to author 16 scientific articles in just 4 months, according to the Daily Beast. Five of these articles have been published in four different journals. Dr. Biswas declined to be interviewed for this article.
There were also reports of papers with ChatGPT as one of the listed authors, which sparked backlash. In response, JAMA, Nature, and Science all published editorials in January outlining their policies for using ChatGPT and other large language models in the scientific authoring process. Editors from the journals of the American College of Cardiology and the American College of Rheumatology also updated their policies to reflect the influence of AI authoring tools.
The consensus is that AI has no place on the author byline.
“We think that’s not appropriate, because coauthorship means that you are taking responsibility for the analysis and the generation of data that are included in a manuscript. A machine that is dictated by AI can’t take responsibility,” said Daniel Solomon, MD, MPH, a rheumatologist at Brigham and Women’s Hospital, Boston, and the editor in chief of the ACR journal Arthritis & Rheumatology.
Issues with AI
One of the big concerns around using AI in writing is that it can generate text that seems plausible but is untrue or not supported by data. For example, Dr. Greene and colleague Milton Pividori, PhD, also of the University of Colorado, were writing a journal article about new software they developed that uses a large language model to revise scientific manuscripts.
“We used the same software to revise that article and at one point, it added a line that noted that the large language model had been fine-tuned on a data set of manuscripts from within the same field. This makes a lot of sense, and is absolutely something you could do, but was not something that we did,” Dr. Greene said. “Without a really careful review of the content, it becomes possible to invent things that were not actually done.”
In another case, ChatGPT falsely stated that a prominent law professor had been accused of sexual assault, citing a Washington Post article that did not exist.
“We live in a society where we are extremely concerned about fake news,” Dr. Pividori added, “and [these kinds of errors] could certainly exacerbate that in the scientific community, which is very concerning because science informs public policy.”
Another issue is the lack of transparency around how large language models like ChatGPT process and store data used to make queries.
“We have no idea how they are recording all the prompts and things that we input into ChatGPT and their systems,” Dr. Pividori said.
OpenAI recently addressed some privacy concerns by allowing users to turn off their chat history with the AI chatbot, so conversations cannot be used to train or improve the company’s models. But Dr. Greene noted that the terms of service “still remain pretty nebulous.”
Dr. Solomon is also concerned with researchers using these AI tools in authoring without knowing how they work. “The thing we are really concerned about is that fact that [LLMs] are a bit of a black box – people don’t really understand the methodologies,” he said.
A positive tool?
But despite these concerns, many think that these types of AI-assisted tools could have a positive impact on medical publishing, particularly for researchers for whom English is not their first language, noted Catherine Gao, MD, a pulmonary and critical care instructor at Northwestern University, Chicago. She recently led research comparing scientific abstracts written by ChatGPT and real abstracts and discovered that reviewers found it “surprisingly difficult” to differentiate the two.
“The majority of research is published in English,” she said in an email. “Responsible use of LLMs can potentially reduce the burden of writing for busy scientists and improve equity for those who are not native English speakers.”
Dr. Pividori agreed, adding that as a non-native English speaker, he spends much more time working on the structure and grammar of sentences when authoring a manuscript, compared with people who speak English as a first language. He noted that these tools can also be used to automate some of the more monotonous tasks that come along with writing manuscripts and allow researchers to focus on the more creative aspects.
In the future, “I want to focus more on the things that only a human can do and let these tools do all the rest of it,” he said.
New rules
But despite how individual researchers feel about LLMs, they agree that these AI tools are here to stay.
“I think that we should anticipate that they will become part of the medical research establishment over time, when we figure out how to use them appropriately,” Dr. Solomon said.
While the debate of how to best use AI in medical publications will continue, journal editors agree that all authors of a manuscript are solely responsible for content in articles that used AI-assisted technology.
“Authors should carefully review and edit the result because AI can generate authoritative-sounding output that can be incorrect, incomplete, or biased,” the ICMJE guidelines state. “Authors should be able to assert that there is no plagiarism in their paper, including in text and images produced by the AI.” This includes appropriate attribution of all cited materials.
The committee also recommends that authors write in both the cover letter and submitted work how AI was used in the manuscript writing process. Recently updated guidelines from the World Association of Medical Editors recommend that all prompts used to generate new text or analytical work should be provided in submitted work. Dr. Greene also noted that if authors used an AI tool to revise their work, they can include a version of the manuscript untouched by LLMs.
It is similar to a preprint, he said, but rather than publishing a version of a paper prior to peer review, someone is showing a version of a manuscript before it was reviewed and revised by AI. “This type of practice could be a path that lets us benefit from these models,” he said, “without having the drawbacks that many are concerned about.”
Dr. Solomon has financial relationships with AbbVie, Amgen, Janssen, CorEvitas, and Moderna. Both Dr. Greene and Dr. Pividori are inventors in the U.S. Provisional Patent Application No. 63/486,706 that the University of Colorado has filed for the “Publishing Infrastructure For AI-Assisted Academic Authoring” invention with the U.S. Patent and Trademark Office. Dr. Greene and Dr. Pividori also received a grant from the Alfred P. Sloan Foundation to improve their AI-based manuscript revision tool. Dr. Gao reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
. These tools should not be listed as authors, and researchers must denote how AI-assisted technologies were used, the committee said.
These new guidelines are the latest effort for medical journals to define policies for using these large-scale language models (LLMs) in scientific publication. While these AI-assisted tools can help with tasks such as writing, analyzing data, catching mistakes, and much more, they are also prone to errors, noted Casey Greene, PhD, a professor of biomedical informatics at the University of Colorado at Denver, Aurora. It is also not totally clear how information is stored and processed in these kinds of tools, and who has access to that information, he noted.
At the same time, experts argue that these AI tools could have a positive impact on the field by limiting some of the linguistic disparities in scientific publishing as well as alleviating the burden of some monotonous or mechanical tasks that come along with manuscript writing.
What experts can agree on, though, is that the use of AI tools is here to stay. “This is going to become a common tool,” Dr. Greene said. “I don’t think there’s a way out of that at this point.”
A change in medical publishing
OpenAI released ChatGPT in November 2022. In its own words, ChatGPT is “a deep learning model that has been trained on a massive amount of text data to understand and generate humanlike text.” Enter a question or a prompt, and it will respond. For example, when asked how the AI tool can be used in scientific publishing, ChatGPT responded:
“ChatGPT can aid scientific publishing by generating ideas, clarifying concepts, conducting preliminary literature reviews, providing proofreading and editing suggestions, and assisting with outlining and organizing scientific papers. However, it should be used as a supportive tool alongside domain expertise and validation from trusted scientific sources.”
Just a few months after ChatGPT became available, researchers began using this tool in their own work. One individual, Som Biswas, MD, a radiologist at the University of Tennessee Health Science Center in Memphis, reportedly used ChatGPT to author 16 scientific articles in just 4 months, according to the Daily Beast. Five of these articles have been published in four different journals. Dr. Biswas declined to be interviewed for this article.
There were also reports of papers with ChatGPT as one of the listed authors, which sparked backlash. In response, JAMA, Nature, and Science all published editorials in January outlining their policies for using ChatGPT and other large language models in the scientific authoring process. Editors from the journals of the American College of Cardiology and the American College of Rheumatology also updated their policies to reflect the influence of AI authoring tools.
The consensus is that AI has no place on the author byline.
“We think that’s not appropriate, because coauthorship means that you are taking responsibility for the analysis and the generation of data that are included in a manuscript. A machine that is dictated by AI can’t take responsibility,” said Daniel Solomon, MD, MPH, a rheumatologist at Brigham and Women’s Hospital, Boston, and the editor in chief of the ACR journal Arthritis & Rheumatology.
Issues with AI
One of the big concerns around using AI in writing is that it can generate text that seems plausible but is untrue or not supported by data. For example, Dr. Greene and colleague Milton Pividori, PhD, also of the University of Colorado, were writing a journal article about new software they developed that uses a large language model to revise scientific manuscripts.
“We used the same software to revise that article and at one point, it added a line that noted that the large language model had been fine-tuned on a data set of manuscripts from within the same field. This makes a lot of sense, and is absolutely something you could do, but was not something that we did,” Dr. Greene said. “Without a really careful review of the content, it becomes possible to invent things that were not actually done.”
In another case, ChatGPT falsely stated that a prominent law professor had been accused of sexual assault, citing a Washington Post article that did not exist.
“We live in a society where we are extremely concerned about fake news,” Dr. Pividori added, “and [these kinds of errors] could certainly exacerbate that in the scientific community, which is very concerning because science informs public policy.”
Another issue is the lack of transparency around how large language models like ChatGPT process and store data used to make queries.
“We have no idea how they are recording all the prompts and things that we input into ChatGPT and their systems,” Dr. Pividori said.
OpenAI recently addressed some privacy concerns by allowing users to turn off their chat history with the AI chatbot, so conversations cannot be used to train or improve the company’s models. But Dr. Greene noted that the terms of service “still remain pretty nebulous.”
Dr. Solomon is also concerned with researchers using these AI tools in authoring without knowing how they work. “The thing we are really concerned about is that fact that [LLMs] are a bit of a black box – people don’t really understand the methodologies,” he said.
A positive tool?
But despite these concerns, many think that these types of AI-assisted tools could have a positive impact on medical publishing, particularly for researchers for whom English is not their first language, noted Catherine Gao, MD, a pulmonary and critical care instructor at Northwestern University, Chicago. She recently led research comparing scientific abstracts written by ChatGPT and real abstracts and discovered that reviewers found it “surprisingly difficult” to differentiate the two.
“The majority of research is published in English,” she said in an email. “Responsible use of LLMs can potentially reduce the burden of writing for busy scientists and improve equity for those who are not native English speakers.”
Dr. Pividori agreed, adding that as a non-native English speaker, he spends much more time working on the structure and grammar of sentences when authoring a manuscript, compared with people who speak English as a first language. He noted that these tools can also be used to automate some of the more monotonous tasks that come along with writing manuscripts and allow researchers to focus on the more creative aspects.
In the future, “I want to focus more on the things that only a human can do and let these tools do all the rest of it,” he said.
New rules
But despite how individual researchers feel about LLMs, they agree that these AI tools are here to stay.
“I think that we should anticipate that they will become part of the medical research establishment over time, when we figure out how to use them appropriately,” Dr. Solomon said.
While the debate of how to best use AI in medical publications will continue, journal editors agree that all authors of a manuscript are solely responsible for content in articles that used AI-assisted technology.
“Authors should carefully review and edit the result because AI can generate authoritative-sounding output that can be incorrect, incomplete, or biased,” the ICMJE guidelines state. “Authors should be able to assert that there is no plagiarism in their paper, including in text and images produced by the AI.” This includes appropriate attribution of all cited materials.
The committee also recommends that authors write in both the cover letter and submitted work how AI was used in the manuscript writing process. Recently updated guidelines from the World Association of Medical Editors recommend that all prompts used to generate new text or analytical work should be provided in submitted work. Dr. Greene also noted that if authors used an AI tool to revise their work, they can include a version of the manuscript untouched by LLMs.
It is similar to a preprint, he said, but rather than publishing a version of a paper prior to peer review, someone is showing a version of a manuscript before it was reviewed and revised by AI. “This type of practice could be a path that lets us benefit from these models,” he said, “without having the drawbacks that many are concerned about.”
Dr. Solomon has financial relationships with AbbVie, Amgen, Janssen, CorEvitas, and Moderna. Both Dr. Greene and Dr. Pividori are inventors in the U.S. Provisional Patent Application No. 63/486,706 that the University of Colorado has filed for the “Publishing Infrastructure For AI-Assisted Academic Authoring” invention with the U.S. Patent and Trademark Office. Dr. Greene and Dr. Pividori also received a grant from the Alfred P. Sloan Foundation to improve their AI-based manuscript revision tool. Dr. Gao reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
. These tools should not be listed as authors, and researchers must denote how AI-assisted technologies were used, the committee said.
These new guidelines are the latest effort for medical journals to define policies for using these large-scale language models (LLMs) in scientific publication. While these AI-assisted tools can help with tasks such as writing, analyzing data, catching mistakes, and much more, they are also prone to errors, noted Casey Greene, PhD, a professor of biomedical informatics at the University of Colorado at Denver, Aurora. It is also not totally clear how information is stored and processed in these kinds of tools, and who has access to that information, he noted.
At the same time, experts argue that these AI tools could have a positive impact on the field by limiting some of the linguistic disparities in scientific publishing as well as alleviating the burden of some monotonous or mechanical tasks that come along with manuscript writing.
What experts can agree on, though, is that the use of AI tools is here to stay. “This is going to become a common tool,” Dr. Greene said. “I don’t think there’s a way out of that at this point.”
A change in medical publishing
OpenAI released ChatGPT in November 2022. In its own words, ChatGPT is “a deep learning model that has been trained on a massive amount of text data to understand and generate humanlike text.” Enter a question or a prompt, and it will respond. For example, when asked how the AI tool can be used in scientific publishing, ChatGPT responded:
“ChatGPT can aid scientific publishing by generating ideas, clarifying concepts, conducting preliminary literature reviews, providing proofreading and editing suggestions, and assisting with outlining and organizing scientific papers. However, it should be used as a supportive tool alongside domain expertise and validation from trusted scientific sources.”
Just a few months after ChatGPT became available, researchers began using this tool in their own work. One individual, Som Biswas, MD, a radiologist at the University of Tennessee Health Science Center in Memphis, reportedly used ChatGPT to author 16 scientific articles in just 4 months, according to the Daily Beast. Five of these articles have been published in four different journals. Dr. Biswas declined to be interviewed for this article.
There were also reports of papers with ChatGPT as one of the listed authors, which sparked backlash. In response, JAMA, Nature, and Science all published editorials in January outlining their policies for using ChatGPT and other large language models in the scientific authoring process. Editors from the journals of the American College of Cardiology and the American College of Rheumatology also updated their policies to reflect the influence of AI authoring tools.
The consensus is that AI has no place on the author byline.
“We think that’s not appropriate, because coauthorship means that you are taking responsibility for the analysis and the generation of data that are included in a manuscript. A machine that is dictated by AI can’t take responsibility,” said Daniel Solomon, MD, MPH, a rheumatologist at Brigham and Women’s Hospital, Boston, and the editor in chief of the ACR journal Arthritis & Rheumatology.
Issues with AI
One of the big concerns around using AI in writing is that it can generate text that seems plausible but is untrue or not supported by data. For example, Dr. Greene and colleague Milton Pividori, PhD, also of the University of Colorado, were writing a journal article about new software they developed that uses a large language model to revise scientific manuscripts.
“We used the same software to revise that article and at one point, it added a line that noted that the large language model had been fine-tuned on a data set of manuscripts from within the same field. This makes a lot of sense, and is absolutely something you could do, but was not something that we did,” Dr. Greene said. “Without a really careful review of the content, it becomes possible to invent things that were not actually done.”
In another case, ChatGPT falsely stated that a prominent law professor had been accused of sexual assault, citing a Washington Post article that did not exist.
“We live in a society where we are extremely concerned about fake news,” Dr. Pividori added, “and [these kinds of errors] could certainly exacerbate that in the scientific community, which is very concerning because science informs public policy.”
Another issue is the lack of transparency around how large language models like ChatGPT process and store data used to make queries.
“We have no idea how they are recording all the prompts and things that we input into ChatGPT and their systems,” Dr. Pividori said.
OpenAI recently addressed some privacy concerns by allowing users to turn off their chat history with the AI chatbot, so conversations cannot be used to train or improve the company’s models. But Dr. Greene noted that the terms of service “still remain pretty nebulous.”
Dr. Solomon is also concerned with researchers using these AI tools in authoring without knowing how they work. “The thing we are really concerned about is that fact that [LLMs] are a bit of a black box – people don’t really understand the methodologies,” he said.
A positive tool?
But despite these concerns, many think that these types of AI-assisted tools could have a positive impact on medical publishing, particularly for researchers for whom English is not their first language, noted Catherine Gao, MD, a pulmonary and critical care instructor at Northwestern University, Chicago. She recently led research comparing scientific abstracts written by ChatGPT and real abstracts and discovered that reviewers found it “surprisingly difficult” to differentiate the two.
“The majority of research is published in English,” she said in an email. “Responsible use of LLMs can potentially reduce the burden of writing for busy scientists and improve equity for those who are not native English speakers.”
Dr. Pividori agreed, adding that as a non-native English speaker, he spends much more time working on the structure and grammar of sentences when authoring a manuscript, compared with people who speak English as a first language. He noted that these tools can also be used to automate some of the more monotonous tasks that come along with writing manuscripts and allow researchers to focus on the more creative aspects.
In the future, “I want to focus more on the things that only a human can do and let these tools do all the rest of it,” he said.
New rules
But despite how individual researchers feel about LLMs, they agree that these AI tools are here to stay.
“I think that we should anticipate that they will become part of the medical research establishment over time, when we figure out how to use them appropriately,” Dr. Solomon said.
While the debate of how to best use AI in medical publications will continue, journal editors agree that all authors of a manuscript are solely responsible for content in articles that used AI-assisted technology.
“Authors should carefully review and edit the result because AI can generate authoritative-sounding output that can be incorrect, incomplete, or biased,” the ICMJE guidelines state. “Authors should be able to assert that there is no plagiarism in their paper, including in text and images produced by the AI.” This includes appropriate attribution of all cited materials.
The committee also recommends that authors write in both the cover letter and submitted work how AI was used in the manuscript writing process. Recently updated guidelines from the World Association of Medical Editors recommend that all prompts used to generate new text or analytical work should be provided in submitted work. Dr. Greene also noted that if authors used an AI tool to revise their work, they can include a version of the manuscript untouched by LLMs.
It is similar to a preprint, he said, but rather than publishing a version of a paper prior to peer review, someone is showing a version of a manuscript before it was reviewed and revised by AI. “This type of practice could be a path that lets us benefit from these models,” he said, “without having the drawbacks that many are concerned about.”
Dr. Solomon has financial relationships with AbbVie, Amgen, Janssen, CorEvitas, and Moderna. Both Dr. Greene and Dr. Pividori are inventors in the U.S. Provisional Patent Application No. 63/486,706 that the University of Colorado has filed for the “Publishing Infrastructure For AI-Assisted Academic Authoring” invention with the U.S. Patent and Trademark Office. Dr. Greene and Dr. Pividori also received a grant from the Alfred P. Sloan Foundation to improve their AI-based manuscript revision tool. Dr. Gao reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.