MDedge Pediatrics

When parents of children with autism spectrum disorder (ASD) participating in the largest clinical trial of intranasal oxytocin to date came in for follow-up visits with investigators, they reported marked improvement in the children’s social functioning.

Kids who rarely communicated with their families began to interact more. Those who usually preferred to isolate themselves started joining their parents for meals. It all seemed so promising – until the data came in.

“Those sounded like real improvements to me, and it seemed like they increased over the period of the study,” lead investigator Linmarie Sikich, MD, an associate clinical professor of psychiatry with Duke University School of Medicine and the Duke Center for Autism and Brain Development, Durham, N.C., told this news organization. “Turns out it wasn’t oxytocin that was making that difference.”

Researchers found that after 24 weeks of daily treatment with intranasal oxytocin, there were no significant differences in social functioning between children who received active treatment and those in the placebo group.

The much-anticipated results were published online in The New England Journal of Medicine. To say that they are disappointing, Dr. Sikich said, is an understatement.
 

Increase in off-label use

Most studies in mouse models of ASD and small trials in children produced conflicting results, although there were modest improvements in social functioning associated with the use of intranasal oxytocin. Some clinicians were already prescribing it off label.

On the basis of this research and early feedback from parents of children, Dr. Sikich and colleagues were hopeful.

However, results from a rigorous, 5-year, $11.4 million randomized trial were negative. Yet, parents were convinced their child improved during the study, and there was a significant increase in off-label prescribing of a treatment her research says doesn’t work. What’s next for oxytocin?

Known as the “love hormone,” oxytocin is a neurotransmitter that is primarily synthesized in the hypothalamus. It plays a role in childbirth and lactation and is also involved in the regulation of social functioning and emotions. Research suggests low oxytocin levels are associated with diminished social functioning, regardless of ASD status.

Its potential as an autism therapy for children has been under study for a decade. Some findings link its use to improvements in core deficits associated with ASD, including repetitive behaviors, fixated or restricted interest, and social communication. A study published in 2020 showed that the treatment improved symptoms in high-functioning adults with ASD.

These were mostly small studies and were underpowered to reliably detect an effect of the therapy on social functioning. They often involved only a single dose of oxytocin. Some studies showed improvements, but others did not.

Still, interest in the treatment grew. Physicians began prescribing it for children with ASD, and parents began buying products containing oxytocin on the internet. Researchers feared this off-label use was becoming widespread, despite inconclusive evidence of efficacy.
 

High hopes

With support from a National Institutes of Health grant, Dr. Sikich and her team designed a phase 2, multicenter, randomized, double-blind, placebo-controlled study to determine whether the use of oxytocin in children with ASD works and is safe.

The challenges began before they even enrolled a single child. A number of behavioral assessment tools are used to measure social function in ASD, but there is no consensus on which one is best.

A simple blood test could determine how much oxytocin from the nasal spray was absorbed in the blood, but identifying how much made it to the brain would require fMRI, which is expensive and is challenging to use in this study population. Then there was the acquisition of the drug itself.

The Food and Drug Administration has approved intravenous oxytocin for inducing labor. Intranasal oxytocin is not approved for any indication and isn’t available commercially in the United States. Patients or researchers must secure the drug from a manufacturer in a country where it is approved or order it from a U.S. pharmacy that is capable of compounding IV oxytocin into an intranasal formulation.

The pharmacy in Switzerland Dr. Sikich planned to use couldn’t make enough for the study. Contracting with a compounding pharmacy in the United States was significantly more expensive and time consuming, but it was the researchers’ only option.

“If it hadn’t been something we expected to have a major benefit, I think we would have given up the project at multiple points along the line due to all of these challenges,” said Dr. Sikich.

In August 2014, with all the pieces finally in place, researchers began enrolling children aged 3-17 years. The final cohort included 290 participants with ASD, 146 in the oxytocin group and 144 in the placebo group. Of these, 48% had minimal verbal fluency, and 52% had fluent verbal speech.

Participants received daily synthetic oxytocin or placebo via a nasal spray for 24 weeks. The daily oxytocin dose was 48 IU for the first 7 weeks. After that, the dosage could be titrated to a maximum of 80 IU/d. The mean maximal total daily dose of oxytocin throughout the study was 67.6 ± 16.9 IU.
 

‘It just didn’t work’

Both study groups showed improvement in social withdrawal beginning at 4 weeks and continuing throughout the trial, as determined on the basis of caretakers’ responses on the Aberrant Behavior Checklist Modified Social Withdrawal Subscale, the study’s primary outcome measure.

Sociability and social motivation also improved in both groups, as measured by the Pervasive Developmental Disorders Behavior Inventory and the Social Responsiveness Scale.

But by the end of the trial, the difference between the groups in improvement of social function wasn’t significant (difference, -0.2 points; P = .61) after adjusting for age, verbal fluency, and baseline oxytocin level.

“We were so convinced that it would work,” Dr. Sikich said, “but it just didn’t.”

From observation, parents were also convinced the therapy was working. At the trial’s conclusion, fewer than half of caregivers correctly guessed whether their child was in the treatment group or the placebo group.

A lot of development changes can happen in a child over 6 months. It’s possible the improvements would have occurred regardless of the trial, Dr. Sikich said. Parents’ perceptions could also be a placebo effect. Their child was in a clinical trial of a drug they believed could improve social functioning, so in their mind, it did.

Caregivers received training in how to identify certain behavioral changes, which may have helped them spot an existing positive change they had previously overlooked. Or they may have worked with their child more intently as a result of their participation in the trial.

“People may start doing more things or doing them more intensively or purposefully, consciously or subconsciously, to try to help their child improve the skills or behaviors targeted by the active therapy in the study,” Dr. Sikich said. “These are things that might really help the child move forward which are completely separate from the medication being studied.”

The safety analysis offered more hopeful results. Only one serious adverse event from the treatment was reported: A 17-year-old participant taking a daily dose of 48 IU experienced a sedating effect while driving and had an accident.
 

Too soon to walk away?

Perhaps the most important take-away from the study is that even if it’s safe, intranasal oxytocin as it is currently used doesn’t work and clinicians shouldn’t prescribe it, said Daniel Geschwind, MD, PhD, director of the University of California, Los Angeles (UCLA) Center for Autism Research, who penned a commentary on the study and discussed the findings with this news organization.

“This study shows that using oxytocin the way it’s used in the community right now is not helping anybody, so why put a child through that?” added Dr. Geschwind, who also is a professor of genetics, neurology, and psychiatry at UCLA.

The trial highlights areas that need to be addressed in order to improve research in the field, he said. Establishing a consensus process to measure social functioning and figuring out a better way to access intranasal oxytocin would lead to studies that are more conclusive, comparable, and less expensive. Dr. Sikich agrees.

Despite the findings, Dr. Geschwind and other autism researchers say it’s too soon to walk away from oxytocin altogether, although it may be time to change the approach to autism research.

“We have to take a page from the playbook of modern medicine in other areas and begin to recognize that these syndromes are incredibly heterogeneous,” Dr. Geschwind says. “We can surmise, although we don’t know, that there might be different biological forms of autism that have different pathways involved that are going to respond differently to different medications.”

Calling the researchers’ efforts “heroic,” Karen Parker, PhD, an associate professor and associate chair of psychiatry and behavioral sciences at Stanford (Calif.) University, says efficacy trials such as this one are critical. However, Dr. Parker said in an interview, there are a number of questions that the study didn’t address.

The majority of medication dispensed in a standard intranasal device is sprayed into the back of the throat. Regular blood tests confirmed that oxytocin was getting into participants’ system, but, given how quickly oxytocin degrades in the blood, Dr. Parker said it’s hard to know just how much reached the brain.

It’s also unclear whether the results would have been different had the treatment been paired with behavioral therapy, an approach Dr. Parker suggests might benefit a subset of children with ASD.

A 2017 study from Dr. Parker’s lab found that children with ASD whose use of oxytocin at baseline was low derived greater benefit from synthetic oxytocin, something the new study failed to find. Still, Dr. Parker said, it’s possible oxytocin might increase social motivation and increase a child’s receptiveness to behavioral therapy.

“When you see a negative trial like this, it decreases enthusiasm for the therapy for autism in this context,” Dr. Parker said. “I hope people who are studying these syndromes will continue to explore oxytocin as a therapy.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the Autism Centers of Excellence Program and the Department of Psychiatry and Behavioral Sciences at Duke University. Full disclosures of the authors’ possible conflicts of interest are available online.

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

When parents of children with autism spectrum disorder (ASD) participating in the largest clinical trial of intranasal oxytocin to date came in for follow-up visits with investigators, they reported marked improvement in the children’s social functioning.

Kids who rarely communicated with their families began to interact more. Those who usually preferred to isolate themselves started joining their parents for meals. It all seemed so promising – until the data came in.

“Those sounded like real improvements to me, and it seemed like they increased over the period of the study,” lead investigator Linmarie Sikich, MD, an associate clinical professor of psychiatry with Duke University School of Medicine and the Duke Center for Autism and Brain Development, Durham, N.C., told this news organization. “Turns out it wasn’t oxytocin that was making that difference.”

Researchers found that after 24 weeks of daily treatment with intranasal oxytocin, there were no significant differences in social functioning between children who received active treatment and those in the placebo group.

The much-anticipated results were published online in The New England Journal of Medicine. To say that they are disappointing, Dr. Sikich said, is an understatement.
 

Increase in off-label use

Most studies in mouse models of ASD and small trials in children produced conflicting results, although there were modest improvements in social functioning associated with the use of intranasal oxytocin. Some clinicians were already prescribing it off label.

On the basis of this research and early feedback from parents of children, Dr. Sikich and colleagues were hopeful.

However, results from a rigorous, 5-year, $11.4 million randomized trial were negative. Yet, parents were convinced their child improved during the study, and there was a significant increase in off-label prescribing of a treatment her research says doesn’t work. What’s next for oxytocin?

Known as the “love hormone,” oxytocin is a neurotransmitter that is primarily synthesized in the hypothalamus. It plays a role in childbirth and lactation and is also involved in the regulation of social functioning and emotions. Research suggests low oxytocin levels are associated with diminished social functioning, regardless of ASD status.

Its potential as an autism therapy for children has been under study for a decade. Some findings link its use to improvements in core deficits associated with ASD, including repetitive behaviors, fixated or restricted interest, and social communication. A study published in 2020 showed that the treatment improved symptoms in high-functioning adults with ASD.

These were mostly small studies and were underpowered to reliably detect an effect of the therapy on social functioning. They often involved only a single dose of oxytocin. Some studies showed improvements, but others did not.

Still, interest in the treatment grew. Physicians began prescribing it for children with ASD, and parents began buying products containing oxytocin on the internet. Researchers feared this off-label use was becoming widespread, despite inconclusive evidence of efficacy.
 

High hopes

With support from a National Institutes of Health grant, Dr. Sikich and her team designed a phase 2, multicenter, randomized, double-blind, placebo-controlled study to determine whether the use of oxytocin in children with ASD works and is safe.

The challenges began before they even enrolled a single child. A number of behavioral assessment tools are used to measure social function in ASD, but there is no consensus on which one is best.

A simple blood test could determine how much oxytocin from the nasal spray was absorbed in the blood, but identifying how much made it to the brain would require fMRI, which is expensive and is challenging to use in this study population. Then there was the acquisition of the drug itself.

The Food and Drug Administration has approved intravenous oxytocin for inducing labor. Intranasal oxytocin is not approved for any indication and isn’t available commercially in the United States. Patients or researchers must secure the drug from a manufacturer in a country where it is approved or order it from a U.S. pharmacy that is capable of compounding IV oxytocin into an intranasal formulation.

The pharmacy in Switzerland Dr. Sikich planned to use couldn’t make enough for the study. Contracting with a compounding pharmacy in the United States was significantly more expensive and time consuming, but it was the researchers’ only option.

“If it hadn’t been something we expected to have a major benefit, I think we would have given up the project at multiple points along the line due to all of these challenges,” said Dr. Sikich.

In August 2014, with all the pieces finally in place, researchers began enrolling children aged 3-17 years. The final cohort included 290 participants with ASD, 146 in the oxytocin group and 144 in the placebo group. Of these, 48% had minimal verbal fluency, and 52% had fluent verbal speech.

Participants received daily synthetic oxytocin or placebo via a nasal spray for 24 weeks. The daily oxytocin dose was 48 IU for the first 7 weeks. After that, the dosage could be titrated to a maximum of 80 IU/d. The mean maximal total daily dose of oxytocin throughout the study was 67.6 ± 16.9 IU.
 

‘It just didn’t work’

Both study groups showed improvement in social withdrawal beginning at 4 weeks and continuing throughout the trial, as determined on the basis of caretakers’ responses on the Aberrant Behavior Checklist Modified Social Withdrawal Subscale, the study’s primary outcome measure.

Sociability and social motivation also improved in both groups, as measured by the Pervasive Developmental Disorders Behavior Inventory and the Social Responsiveness Scale.

But by the end of the trial, the difference between the groups in improvement of social function wasn’t significant (difference, -0.2 points; P = .61) after adjusting for age, verbal fluency, and baseline oxytocin level.

“We were so convinced that it would work,” Dr. Sikich said, “but it just didn’t.”

From observation, parents were also convinced the therapy was working. At the trial’s conclusion, fewer than half of caregivers correctly guessed whether their child was in the treatment group or the placebo group.

A lot of development changes can happen in a child over 6 months. It’s possible the improvements would have occurred regardless of the trial, Dr. Sikich said. Parents’ perceptions could also be a placebo effect. Their child was in a clinical trial of a drug they believed could improve social functioning, so in their mind, it did.

Caregivers received training in how to identify certain behavioral changes, which may have helped them spot an existing positive change they had previously overlooked. Or they may have worked with their child more intently as a result of their participation in the trial.

“People may start doing more things or doing them more intensively or purposefully, consciously or subconsciously, to try to help their child improve the skills or behaviors targeted by the active therapy in the study,” Dr. Sikich said. “These are things that might really help the child move forward which are completely separate from the medication being studied.”

The safety analysis offered more hopeful results. Only one serious adverse event from the treatment was reported: A 17-year-old participant taking a daily dose of 48 IU experienced a sedating effect while driving and had an accident.
 

Too soon to walk away?

Perhaps the most important take-away from the study is that even if it’s safe, intranasal oxytocin as it is currently used doesn’t work and clinicians shouldn’t prescribe it, said Daniel Geschwind, MD, PhD, director of the University of California, Los Angeles (UCLA) Center for Autism Research, who penned a commentary on the study and discussed the findings with this news organization.

“This study shows that using oxytocin the way it’s used in the community right now is not helping anybody, so why put a child through that?” added Dr. Geschwind, who also is a professor of genetics, neurology, and psychiatry at UCLA.

The trial highlights areas that need to be addressed in order to improve research in the field, he said. Establishing a consensus process to measure social functioning and figuring out a better way to access intranasal oxytocin would lead to studies that are more conclusive, comparable, and less expensive. Dr. Sikich agrees.

Despite the findings, Dr. Geschwind and other autism researchers say it’s too soon to walk away from oxytocin altogether, although it may be time to change the approach to autism research.

“We have to take a page from the playbook of modern medicine in other areas and begin to recognize that these syndromes are incredibly heterogeneous,” Dr. Geschwind says. “We can surmise, although we don’t know, that there might be different biological forms of autism that have different pathways involved that are going to respond differently to different medications.”

Calling the researchers’ efforts “heroic,” Karen Parker, PhD, an associate professor and associate chair of psychiatry and behavioral sciences at Stanford (Calif.) University, says efficacy trials such as this one are critical. However, Dr. Parker said in an interview, there are a number of questions that the study didn’t address.

The majority of medication dispensed in a standard intranasal device is sprayed into the back of the throat. Regular blood tests confirmed that oxytocin was getting into participants’ system, but, given how quickly oxytocin degrades in the blood, Dr. Parker said it’s hard to know just how much reached the brain.

It’s also unclear whether the results would have been different had the treatment been paired with behavioral therapy, an approach Dr. Parker suggests might benefit a subset of children with ASD.

A 2017 study from Dr. Parker’s lab found that children with ASD whose use of oxytocin at baseline was low derived greater benefit from synthetic oxytocin, something the new study failed to find. Still, Dr. Parker said, it’s possible oxytocin might increase social motivation and increase a child’s receptiveness to behavioral therapy.

“When you see a negative trial like this, it decreases enthusiasm for the therapy for autism in this context,” Dr. Parker said. “I hope people who are studying these syndromes will continue to explore oxytocin as a therapy.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the Autism Centers of Excellence Program and the Department of Psychiatry and Behavioral Sciences at Duke University. Full disclosures of the authors’ possible conflicts of interest are available online.

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

When parents of children with autism spectrum disorder (ASD) participating in the largest clinical trial of intranasal oxytocin to date came in for follow-up visits with investigators, they reported marked improvement in the children’s social functioning.

Kids who rarely communicated with their families began to interact more. Those who usually preferred to isolate themselves started joining their parents for meals. It all seemed so promising – until the data came in.

“Those sounded like real improvements to me, and it seemed like they increased over the period of the study,” lead investigator Linmarie Sikich, MD, an associate clinical professor of psychiatry with Duke University School of Medicine and the Duke Center for Autism and Brain Development, Durham, N.C., told this news organization. “Turns out it wasn’t oxytocin that was making that difference.”

Researchers found that after 24 weeks of daily treatment with intranasal oxytocin, there were no significant differences in social functioning between children who received active treatment and those in the placebo group.

The much-anticipated results were published online in The New England Journal of Medicine. To say that they are disappointing, Dr. Sikich said, is an understatement.
 

Increase in off-label use

Most studies in mouse models of ASD and small trials in children produced conflicting results, although there were modest improvements in social functioning associated with the use of intranasal oxytocin. Some clinicians were already prescribing it off label.

On the basis of this research and early feedback from parents of children, Dr. Sikich and colleagues were hopeful.

However, results from a rigorous, 5-year, $11.4 million randomized trial were negative. Yet, parents were convinced their child improved during the study, and there was a significant increase in off-label prescribing of a treatment her research says doesn’t work. What’s next for oxytocin?

Known as the “love hormone,” oxytocin is a neurotransmitter that is primarily synthesized in the hypothalamus. It plays a role in childbirth and lactation and is also involved in the regulation of social functioning and emotions. Research suggests low oxytocin levels are associated with diminished social functioning, regardless of ASD status.

Its potential as an autism therapy for children has been under study for a decade. Some findings link its use to improvements in core deficits associated with ASD, including repetitive behaviors, fixated or restricted interest, and social communication. A study published in 2020 showed that the treatment improved symptoms in high-functioning adults with ASD.

These were mostly small studies and were underpowered to reliably detect an effect of the therapy on social functioning. They often involved only a single dose of oxytocin. Some studies showed improvements, but others did not.

Still, interest in the treatment grew. Physicians began prescribing it for children with ASD, and parents began buying products containing oxytocin on the internet. Researchers feared this off-label use was becoming widespread, despite inconclusive evidence of efficacy.
 

High hopes

With support from a National Institutes of Health grant, Dr. Sikich and her team designed a phase 2, multicenter, randomized, double-blind, placebo-controlled study to determine whether the use of oxytocin in children with ASD works and is safe.

The challenges began before they even enrolled a single child. A number of behavioral assessment tools are used to measure social function in ASD, but there is no consensus on which one is best.

A simple blood test could determine how much oxytocin from the nasal spray was absorbed in the blood, but identifying how much made it to the brain would require fMRI, which is expensive and is challenging to use in this study population. Then there was the acquisition of the drug itself.

The Food and Drug Administration has approved intravenous oxytocin for inducing labor. Intranasal oxytocin is not approved for any indication and isn’t available commercially in the United States. Patients or researchers must secure the drug from a manufacturer in a country where it is approved or order it from a U.S. pharmacy that is capable of compounding IV oxytocin into an intranasal formulation.

The pharmacy in Switzerland Dr. Sikich planned to use couldn’t make enough for the study. Contracting with a compounding pharmacy in the United States was significantly more expensive and time consuming, but it was the researchers’ only option.

“If it hadn’t been something we expected to have a major benefit, I think we would have given up the project at multiple points along the line due to all of these challenges,” said Dr. Sikich.

In August 2014, with all the pieces finally in place, researchers began enrolling children aged 3-17 years. The final cohort included 290 participants with ASD, 146 in the oxytocin group and 144 in the placebo group. Of these, 48% had minimal verbal fluency, and 52% had fluent verbal speech.

Participants received daily synthetic oxytocin or placebo via a nasal spray for 24 weeks. The daily oxytocin dose was 48 IU for the first 7 weeks. After that, the dosage could be titrated to a maximum of 80 IU/d. The mean maximal total daily dose of oxytocin throughout the study was 67.6 ± 16.9 IU.
 

‘It just didn’t work’

Both study groups showed improvement in social withdrawal beginning at 4 weeks and continuing throughout the trial, as determined on the basis of caretakers’ responses on the Aberrant Behavior Checklist Modified Social Withdrawal Subscale, the study’s primary outcome measure.

Sociability and social motivation also improved in both groups, as measured by the Pervasive Developmental Disorders Behavior Inventory and the Social Responsiveness Scale.

But by the end of the trial, the difference between the groups in improvement of social function wasn’t significant (difference, -0.2 points; P = .61) after adjusting for age, verbal fluency, and baseline oxytocin level.

“We were so convinced that it would work,” Dr. Sikich said, “but it just didn’t.”

From observation, parents were also convinced the therapy was working. At the trial’s conclusion, fewer than half of caregivers correctly guessed whether their child was in the treatment group or the placebo group.

A lot of development changes can happen in a child over 6 months. It’s possible the improvements would have occurred regardless of the trial, Dr. Sikich said. Parents’ perceptions could also be a placebo effect. Their child was in a clinical trial of a drug they believed could improve social functioning, so in their mind, it did.

Caregivers received training in how to identify certain behavioral changes, which may have helped them spot an existing positive change they had previously overlooked. Or they may have worked with their child more intently as a result of their participation in the trial.

“People may start doing more things or doing them more intensively or purposefully, consciously or subconsciously, to try to help their child improve the skills or behaviors targeted by the active therapy in the study,” Dr. Sikich said. “These are things that might really help the child move forward which are completely separate from the medication being studied.”

The safety analysis offered more hopeful results. Only one serious adverse event from the treatment was reported: A 17-year-old participant taking a daily dose of 48 IU experienced a sedating effect while driving and had an accident.
 

Too soon to walk away?

Perhaps the most important take-away from the study is that even if it’s safe, intranasal oxytocin as it is currently used doesn’t work and clinicians shouldn’t prescribe it, said Daniel Geschwind, MD, PhD, director of the University of California, Los Angeles (UCLA) Center for Autism Research, who penned a commentary on the study and discussed the findings with this news organization.

“This study shows that using oxytocin the way it’s used in the community right now is not helping anybody, so why put a child through that?” added Dr. Geschwind, who also is a professor of genetics, neurology, and psychiatry at UCLA.

The trial highlights areas that need to be addressed in order to improve research in the field, he said. Establishing a consensus process to measure social functioning and figuring out a better way to access intranasal oxytocin would lead to studies that are more conclusive, comparable, and less expensive. Dr. Sikich agrees.

Despite the findings, Dr. Geschwind and other autism researchers say it’s too soon to walk away from oxytocin altogether, although it may be time to change the approach to autism research.

“We have to take a page from the playbook of modern medicine in other areas and begin to recognize that these syndromes are incredibly heterogeneous,” Dr. Geschwind says. “We can surmise, although we don’t know, that there might be different biological forms of autism that have different pathways involved that are going to respond differently to different medications.”

Calling the researchers’ efforts “heroic,” Karen Parker, PhD, an associate professor and associate chair of psychiatry and behavioral sciences at Stanford (Calif.) University, says efficacy trials such as this one are critical. However, Dr. Parker said in an interview, there are a number of questions that the study didn’t address.

The majority of medication dispensed in a standard intranasal device is sprayed into the back of the throat. Regular blood tests confirmed that oxytocin was getting into participants’ system, but, given how quickly oxytocin degrades in the blood, Dr. Parker said it’s hard to know just how much reached the brain.

It’s also unclear whether the results would have been different had the treatment been paired with behavioral therapy, an approach Dr. Parker suggests might benefit a subset of children with ASD.

A 2017 study from Dr. Parker’s lab found that children with ASD whose use of oxytocin at baseline was low derived greater benefit from synthetic oxytocin, something the new study failed to find. Still, Dr. Parker said, it’s possible oxytocin might increase social motivation and increase a child’s receptiveness to behavioral therapy.

“When you see a negative trial like this, it decreases enthusiasm for the therapy for autism in this context,” Dr. Parker said. “I hope people who are studying these syndromes will continue to explore oxytocin as a therapy.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development through the Autism Centers of Excellence Program and the Department of Psychiatry and Behavioral Sciences at Duke University. Full disclosures of the authors’ possible conflicts of interest are available online.

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

NEW ORLEANS – The increased use of digital screens for school during the COVID-19 pandemic may be causing convergence insufficiency in children, researchers say.

Although the long-term implications for current schoolchildren are not clear, convergence insufficiency sometimes persists for a lifetime, said Kammi Gunton, MD, interim chief of pediatric ophthalmology and strabismus at Wills Eye Hospital, Philadelphia.

“It’s important, if we use digital technology for education, that we are aware that it might contribute to increased eye symptoms in children,” Dr. Gunton told this news organization.

Dr. Gunton’s colleague, Jordan Hamburger, an MD candidate at Sidney Kimmel Medical College, Philadelphia, presented the finding at the American Academy of Ophthalmology 2021 Annual Meeting.

Convergence insufficiency is an impairment of binocularity. Symptoms include headaches while reading, words that seem to move around the page, blurriness, diplopia, and eye fatigue. It can be treated with exercise, prism glasses, or, rarely, surgery.

“We have some kids who improve with either time or maturity, then we have other patients who suffer from it for their entire lives,” Dr. Gunton said.

Previous research has linked the use of digital screens to convergence insufficiency, so when many schools shifted to distance learning for the pandemic, Dr. Gunton and her colleagues wanted to see whether it would have this effect on the students’ eyes.

They surveyed 110 healthy schoolchildren and adolescent students regarding eye symptoms before and after a day of virtual school. The mean age of the participants was 14 years (range, 10-17 years). The participants spent an average of 6.96 hours per day in virtual school. Forty-one percent also attended school in person part time. These students filled out the survey on days when they were in virtual school.

The participants answered questions on the Convergence Insufficiency Symptom Survey (CISS). The survey consists of 15 questions about eye complaints. On each question, the students rated symptoms from 0 to 4, with 4 indicating a severe symptom.

The average sum of the CISS scores rose from 5.17 before school to 9.82 after school, a statistically significant change (P < .001). Sixty-one percent of the participants reported an increase in convergence insufficiency symptoms.

Seventeen percent scored a total of at least 16, which is the threshold score considered suggestive of convergence insufficiency.

The researchers also found that, on average, the more hours each student spent in virtual school, the higher their CISS scores.

This makes sense, because reading requires convergence, Dr. Gunton said. The same problem might occur in traditional school if the students were looking at books all day instead of focusing on objects at various distances in their classrooms, such as the teacher or the whiteboard. “So, in the past, if you read a book, maybe you wouldn’t read for several hours, but now we’re asking children during virtual learning to stay on a device with the camera on,” she said.

Previous research has shown that people blink less when reading or using electronic devices, probably because of their increased concentration. This might explain symptoms such as burning and itching. Fifty-three percent of the students reported an increase in asthenopia symptoms.

The researchers would have liked to have compared the students in virtual school to a matched group of students in traditional school. However, almost all students were enrolled in virtual school when the study was conducted, making such a control difficult.

Although previous research has related virtual learning to myopia, as reported by this news organization, this study did not investigate myopia, and the researchers do not believe that convergence insufficiency causes myopia or vice versa.

Parents can help prevent convergence insufficiency during school by reminding their children to take breaks, Dr. Gunton said. She recommends the 20/20/20 rule: After 20 minutes of work that involves looking at objects nearby, students should take a 20-second break and look at something 20 feet away.

“I also think the take-home message is for parents to ask students if they’re having symptoms,” she said, “and if they hear complaints while kids are on the computers, to have them see an eye doctor and have an evaluation.”

Stephen Lipsky, MD, who wasn’t involved in the study, said he is seeing more cases of eye strain at Children’s Healthcare of Atlanta, where he is a consulting ophthalmologist.

“The study is very valuable in that it shines a light on the fact that these children do have symptoms, such as asthenopia or convergence insufficiency,” he told this news organization. “But I’m optimistic that with a return to more traditional learning, we will return the more traditional incidence of these problems.”

Dr. Gunton and Dr. Lipsky have disclosed no relevant financial relationships.

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

NEW ORLEANS – The increased use of digital screens for school during the COVID-19 pandemic may be causing convergence insufficiency in children, researchers say.

Although the long-term implications for current schoolchildren are not clear, convergence insufficiency sometimes persists for a lifetime, said Kammi Gunton, MD, interim chief of pediatric ophthalmology and strabismus at Wills Eye Hospital, Philadelphia.

“It’s important, if we use digital technology for education, that we are aware that it might contribute to increased eye symptoms in children,” Dr. Gunton told this news organization.

Dr. Gunton’s colleague, Jordan Hamburger, an MD candidate at Sidney Kimmel Medical College, Philadelphia, presented the finding at the American Academy of Ophthalmology 2021 Annual Meeting.

Convergence insufficiency is an impairment of binocularity. Symptoms include headaches while reading, words that seem to move around the page, blurriness, diplopia, and eye fatigue. It can be treated with exercise, prism glasses, or, rarely, surgery.

“We have some kids who improve with either time or maturity, then we have other patients who suffer from it for their entire lives,” Dr. Gunton said.

Previous research has linked the use of digital screens to convergence insufficiency, so when many schools shifted to distance learning for the pandemic, Dr. Gunton and her colleagues wanted to see whether it would have this effect on the students’ eyes.

They surveyed 110 healthy schoolchildren and adolescent students regarding eye symptoms before and after a day of virtual school. The mean age of the participants was 14 years (range, 10-17 years). The participants spent an average of 6.96 hours per day in virtual school. Forty-one percent also attended school in person part time. These students filled out the survey on days when they were in virtual school.

The participants answered questions on the Convergence Insufficiency Symptom Survey (CISS). The survey consists of 15 questions about eye complaints. On each question, the students rated symptoms from 0 to 4, with 4 indicating a severe symptom.

The average sum of the CISS scores rose from 5.17 before school to 9.82 after school, a statistically significant change (P < .001). Sixty-one percent of the participants reported an increase in convergence insufficiency symptoms.

Seventeen percent scored a total of at least 16, which is the threshold score considered suggestive of convergence insufficiency.

The researchers also found that, on average, the more hours each student spent in virtual school, the higher their CISS scores.

This makes sense, because reading requires convergence, Dr. Gunton said. The same problem might occur in traditional school if the students were looking at books all day instead of focusing on objects at various distances in their classrooms, such as the teacher or the whiteboard. “So, in the past, if you read a book, maybe you wouldn’t read for several hours, but now we’re asking children during virtual learning to stay on a device with the camera on,” she said.

Previous research has shown that people blink less when reading or using electronic devices, probably because of their increased concentration. This might explain symptoms such as burning and itching. Fifty-three percent of the students reported an increase in asthenopia symptoms.

The researchers would have liked to have compared the students in virtual school to a matched group of students in traditional school. However, almost all students were enrolled in virtual school when the study was conducted, making such a control difficult.

Although previous research has related virtual learning to myopia, as reported by this news organization, this study did not investigate myopia, and the researchers do not believe that convergence insufficiency causes myopia or vice versa.

Parents can help prevent convergence insufficiency during school by reminding their children to take breaks, Dr. Gunton said. She recommends the 20/20/20 rule: After 20 minutes of work that involves looking at objects nearby, students should take a 20-second break and look at something 20 feet away.

“I also think the take-home message is for parents to ask students if they’re having symptoms,” she said, “and if they hear complaints while kids are on the computers, to have them see an eye doctor and have an evaluation.”

Stephen Lipsky, MD, who wasn’t involved in the study, said he is seeing more cases of eye strain at Children’s Healthcare of Atlanta, where he is a consulting ophthalmologist.

“The study is very valuable in that it shines a light on the fact that these children do have symptoms, such as asthenopia or convergence insufficiency,” he told this news organization. “But I’m optimistic that with a return to more traditional learning, we will return the more traditional incidence of these problems.”

Dr. Gunton and Dr. Lipsky have disclosed no relevant financial relationships.

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

NEW ORLEANS – The increased use of digital screens for school during the COVID-19 pandemic may be causing convergence insufficiency in children, researchers say.

Although the long-term implications for current schoolchildren are not clear, convergence insufficiency sometimes persists for a lifetime, said Kammi Gunton, MD, interim chief of pediatric ophthalmology and strabismus at Wills Eye Hospital, Philadelphia.

“It’s important, if we use digital technology for education, that we are aware that it might contribute to increased eye symptoms in children,” Dr. Gunton told this news organization.

Dr. Gunton’s colleague, Jordan Hamburger, an MD candidate at Sidney Kimmel Medical College, Philadelphia, presented the finding at the American Academy of Ophthalmology 2021 Annual Meeting.

Convergence insufficiency is an impairment of binocularity. Symptoms include headaches while reading, words that seem to move around the page, blurriness, diplopia, and eye fatigue. It can be treated with exercise, prism glasses, or, rarely, surgery.

“We have some kids who improve with either time or maturity, then we have other patients who suffer from it for their entire lives,” Dr. Gunton said.

Previous research has linked the use of digital screens to convergence insufficiency, so when many schools shifted to distance learning for the pandemic, Dr. Gunton and her colleagues wanted to see whether it would have this effect on the students’ eyes.

They surveyed 110 healthy schoolchildren and adolescent students regarding eye symptoms before and after a day of virtual school. The mean age of the participants was 14 years (range, 10-17 years). The participants spent an average of 6.96 hours per day in virtual school. Forty-one percent also attended school in person part time. These students filled out the survey on days when they were in virtual school.

The participants answered questions on the Convergence Insufficiency Symptom Survey (CISS). The survey consists of 15 questions about eye complaints. On each question, the students rated symptoms from 0 to 4, with 4 indicating a severe symptom.

The average sum of the CISS scores rose from 5.17 before school to 9.82 after school, a statistically significant change (P < .001). Sixty-one percent of the participants reported an increase in convergence insufficiency symptoms.

Seventeen percent scored a total of at least 16, which is the threshold score considered suggestive of convergence insufficiency.

The researchers also found that, on average, the more hours each student spent in virtual school, the higher their CISS scores.

This makes sense, because reading requires convergence, Dr. Gunton said. The same problem might occur in traditional school if the students were looking at books all day instead of focusing on objects at various distances in their classrooms, such as the teacher or the whiteboard. “So, in the past, if you read a book, maybe you wouldn’t read for several hours, but now we’re asking children during virtual learning to stay on a device with the camera on,” she said.

Previous research has shown that people blink less when reading or using electronic devices, probably because of their increased concentration. This might explain symptoms such as burning and itching. Fifty-three percent of the students reported an increase in asthenopia symptoms.

The researchers would have liked to have compared the students in virtual school to a matched group of students in traditional school. However, almost all students were enrolled in virtual school when the study was conducted, making such a control difficult.

Although previous research has related virtual learning to myopia, as reported by this news organization, this study did not investigate myopia, and the researchers do not believe that convergence insufficiency causes myopia or vice versa.

Parents can help prevent convergence insufficiency during school by reminding their children to take breaks, Dr. Gunton said. She recommends the 20/20/20 rule: After 20 minutes of work that involves looking at objects nearby, students should take a 20-second break and look at something 20 feet away.

“I also think the take-home message is for parents to ask students if they’re having symptoms,” she said, “and if they hear complaints while kids are on the computers, to have them see an eye doctor and have an evaluation.”

Stephen Lipsky, MD, who wasn’t involved in the study, said he is seeing more cases of eye strain at Children’s Healthcare of Atlanta, where he is a consulting ophthalmologist.

“The study is very valuable in that it shines a light on the fact that these children do have symptoms, such as asthenopia or convergence insufficiency,” he told this news organization. “But I’m optimistic that with a return to more traditional learning, we will return the more traditional incidence of these problems.”

Dr. Gunton and Dr. Lipsky have disclosed no relevant financial relationships.

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

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

Mothers who use cannabis during pregnancy risk disrupting immune gene networks in the placenta and potentially increasing the risk of anxiety and hyperactivity in their children.

These findings emerged from a study led by Yasmin Hurd, PhD, a professor of psychiatry and director of the Addiction Institute at the Icahn School of Medicine at Mount Sinai, New York, and Yoko Nomura, PhD, a professor of behavioral neuroscience at Queen’s College, City University of New York, that was published online in Proceedings of the National Academy of Sciences.

The analysis assessed the effects of gestational maternal cannabis use on psychosocial and physiological measures in young children as well as its potentially immunomodulatory effect on the in utero environment as reflected in the placental transcriptome.

Participants were drawn from a larger cohort in a study launched in 2012; the investigators evaluated offspring aged 3-6 years for hair hormone levels, neurobehavioral traits on the Behavioral Assessment System for Children survey, and heart rate variability (HRV) at rest and during auditory startle.

The cohort consisted of 322 mother-child dyads and children with prenatal exposure to cannabis were compared with those having no exposure. The cohort consisted of 251 non–cannabis-using mothers and 71 cannabis-using mothers, with mean maternal ages in the two groups of 28.46 years and 25.91 years, respectively, The mothers gave birth at Mount Sinai and they and their children were assessed annually at affiliated medical centers in Mount Sinai’s catchment area.

For a subset of children with behavioral assessments, placental specimens collected at birth were processed for RNA sequencing.

Among the findings:

• Maternal cannabis use was associated with reduced maternal and paternal age, more single-mother pregnancies, state anxiety, trait anxiety, depression, cigarette smoking, and African American race.
• Hair hormone analysis revealed increased cortisol levels in the children of cannabis-using mothers, and was associated with greater anxiety, aggression, and hyperactivity.
• Affected children showed a reduction in the high-frequency component of HRV at baseline, reflecting reduced vagal tone.
• In the placenta, there was reduced expression of many genes involved in immune system function. These included genes for type I interferon, neutrophil, and cytokine-signaling pathways.

Several of these genes organized into coexpression networks that correlated with child anxiety and hyperactivity.

The principal active component of cannabis, tetrahydrocannabinol (THC), targets the endocannabinoid system in placental tissue and the developing brain, the authors noted. Exposure during pregnancy is associated with a range of adverse outcomes from fetal growth restriction to low birth weight and preterm birth.

“There are cannabinoid receptors on immune cells, and it is known that cannabinoids can alter immune function, which is important for maintaining maternal tolerance and protecting the fetus,” Dr. Hurd said. “It’s not surprising that something that affects the immune cells can have an impact on the developing fetus.”

“Overall, our findings reveal a relationship between [maternal cannabis use] and immune response gene networks in the placenta as a potential mediator of risk for anxiety-related problems in early childhood,” Dr. Hurd and colleagues wrote, adding that the results have significant implications for defining mental health issues in the children gestated by cannabis-smoking mothers.

Their results align with previous research indicating a greater risk for psychiatric illness in children with prenatal cannabis exposure from maternal use.

“While data are pretty limited in this realm, there are other studies that demonstrate a relationship between early child developmental and behavioral measures and cannabis use during pregnancy,” Camille Hoffman, MD, MSc, a high-risk obstetrics specialist and an associate professor at the University of Colorado at Denver, Aurora, said in an interview. “Our research group found children exposed to cannabis in utero at 10 weeks’ gestation and beyond were less interactive and more withdrawn than children who were not exposed.”

And THC remains in maternal breast milk even 6 weeks after usage stops.

The long-term effects of prenatal cannabis exposure remain to be determined and it is unknown whether the effects of gestational THC might attenuate as a child grows older. “We use early childhood measures in research as a proxy for the later development of diagnosed mental health conditions or behavioral problems,” Dr. Hoffman explained. “We know when we do this that not every child with an abnormal score early will go on to develop an actual condition. Fortunately, or unfortunately, other factors and exposures during childhood can change the trajectory for the better or worse.”

According to Dr. Hurd, child development is a dynamic process and epigenetic events in utero need not be deterministic. “The important thing is to identify children at risk early and to be able to go in and try to improve the environment they’re being raised in – not in terms of impoverishment but in terms of positive nurturing and giving the mother and family support.”

At the prenatal level, what’s the best advice for cannabis-using mothers-to-be? “If a woman doesn’t know she’s pregnant and has been using cannabis, taking extra choline for the remainder of the pregnancy can help buffer the potential negative impact of the cannabis exposure,” Dr. Hoffman said. The Food and Drug Administration and the American Medical Association recommend a dose of 550 mg daily. “The same is true for alcohol, which we know is also very bad for fetal brain development. This is not to say go ahead and use these substances and just take choline. The choline is more to try and salvage damage to the fetal brain that may have already occurred.”

This study was supported by the National Institute of Mental Health and the National Institute on Drug Abuse. The authors declared no competing interests. Dr. Hoffman disclosed no conflicts of interest with respect to her comments.

I was recently asked to see a 16-year-old, unvaccinated (against COVID-19) adolescent with hypothyroidism and obesity (body mass index 37 kg/m²) seen in the pediatric emergency department with tachycardia, O₂ saturation 96%, urinary tract infection, poor appetite, and nausea. Her chest x-ray had low lung volumes but no infiltrates. She was noted to be dehydrated. Testing for COVID-19 was PCR positive.¹

She was observed overnight, tolerated oral rehydration, and was being readied for discharge. Pediatric Infectious Diseases was called about prescribing remdesivir.

Remdesivir was not indicated as its current use is limited to inpatients with oxygen desaturations less than 94%. Infectious Diseases Society of America guidelines do recommend the use of monoclonal antibodies against the SARS-CoV-2 spike protein for prevention of COVID disease progression in high-risk individuals. Specifically, the IDSA guidelines say, “Among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease, bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment.”

The Food and Drug Administration’s Emergency Use Authorization (EUA) allowed use of specific monoclonal antibodies (casirivimab/imdevimab in combination, bamlanivimab/etesevimab in combination, and sotrovimab alone) for individuals 12 years and above with a minimum weight of 40 kg with high-risk conditions, describing the evidence as moderate certainty.²

Several questions have arisen regarding their use. Which children qualify under the EUA? Are the available monoclonal antibodies effective for SARS-CoV-2 variants? What adverse events were observed? Are there implementation hurdles?

Unlike the EUA for prophylactic use, which targeted unvaccinated individuals and those unlikely to have a good antibody response to vaccine, use of monoclonal antibody for prevention of progression does not have such restrictions. Effectiveness may vary by local variant susceptibility and should be considered in the choice of the most appropriate monoclonal antibody therapy. Reductions in hospitalization and progression to critical disease status were reported from phase 3 studies; reductions were also observed in mortality in some, but not all, studies. Enhanced viral clearance on day 7 was observed with few subjects having persistent high viral load.

Which children qualify under the EUA? Adolescents 12 years and older and over 40 kg are eligible if a high risk condition is present. High-risk conditions include body mass index at the 85th percentile or higher, immunosuppressive disease, or receipt of immunosuppressive therapies, or baseline (pre-COVID infection) medical-related technological dependence such as tracheostomy or positive pressure ventilation. Additional high-risk conditions are neurodevelopmental disorders, sickle cell disease, congenital or acquired heart disease, asthma, or reactive airway or other chronic respiratory disease that requires daily medication for control, diabetes, chronic kidney disease, or pregnancy.³

Are the available monoclonal antibodies effective for SARS-CoV-2 variants? Of course, this is a critical question and relies on knowledge of the dominant variant in a specific geographic location. The CDC data on which variants are susceptible to which monoclonal therapies were updated as of Oct. 21 online (see Table 1). Local departments of public health often will have current data on the dominant variant in the community. Currently, the dominant variant in the United States is Delta and it is anticipated to be susceptible to the three monoclonal treatments authorized under the EUA based on in vitro neutralizing assays.

Implementation challenges

The first challenge is finding a location to infuse the monoclonal antibodies. Although they can be given subcutaneously, the dose is large and little, if any, time is saved as the recommendation is for observation post administration for 1 hour. The challenge we and other centers may face is that the patients are COVID PCR+ and therefore our usual infusion program, which often is occupied by individuals already compromised and at high risk for severe COVID, is an undesirable location. We are planning to use the emergency department to accommodate such patients currently, but even that solution creates challenges for a busy, urban medical center.

Summary

Anti–SARS-CoV-2 monoclonal antibodies are an important part of the therapeutic approach to minimizing disease severity. Clinicians should review high-risk conditions in adolescents who are PCR+ for SARS-CoV-2 and have mild to moderate symptoms. Medical care systems should implement programs to make monoclonal infusions available for such high-risk adolescents.⁴ Obesity and asthma reactive airways or requiring daily medication for control are the two most common conditions that place adolescents with COVID-19 at risk for progression to hospitalization and severe disease in addition to the more traditional immune-compromising conditions and medical fragility.

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide. U.S. Department of Health and Human Services. 2021 Sep 2.

2. Bhimraj A et al. IDSA Guidelines on the Treatment and Management of Patients with COVID-19. Last updated 2021 Nov 9.

3. Anti-SARS-CoV-2 Monoclonal Antibodies. National Institutes of Health’s COVID 19 Treatment Guidelines. Last updated 2021 Oct 19.

4. Spreading the Word on the Benefits of Monoclonal Antibodies for COVID-19, by Hannah R. Buchdahl. CDC Foundation, 2021 Jul 2.

I was recently asked to see a 16-year-old, unvaccinated (against COVID-19) adolescent with hypothyroidism and obesity (body mass index 37 kg/m²) seen in the pediatric emergency department with tachycardia, O₂ saturation 96%, urinary tract infection, poor appetite, and nausea. Her chest x-ray had low lung volumes but no infiltrates. She was noted to be dehydrated. Testing for COVID-19 was PCR positive.¹

She was observed overnight, tolerated oral rehydration, and was being readied for discharge. Pediatric Infectious Diseases was called about prescribing remdesivir.

Remdesivir was not indicated as its current use is limited to inpatients with oxygen desaturations less than 94%. Infectious Diseases Society of America guidelines do recommend the use of monoclonal antibodies against the SARS-CoV-2 spike protein for prevention of COVID disease progression in high-risk individuals. Specifically, the IDSA guidelines say, “Among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease, bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment.”

The Food and Drug Administration’s Emergency Use Authorization (EUA) allowed use of specific monoclonal antibodies (casirivimab/imdevimab in combination, bamlanivimab/etesevimab in combination, and sotrovimab alone) for individuals 12 years and above with a minimum weight of 40 kg with high-risk conditions, describing the evidence as moderate certainty.²

Several questions have arisen regarding their use. Which children qualify under the EUA? Are the available monoclonal antibodies effective for SARS-CoV-2 variants? What adverse events were observed? Are there implementation hurdles?

Unlike the EUA for prophylactic use, which targeted unvaccinated individuals and those unlikely to have a good antibody response to vaccine, use of monoclonal antibody for prevention of progression does not have such restrictions. Effectiveness may vary by local variant susceptibility and should be considered in the choice of the most appropriate monoclonal antibody therapy. Reductions in hospitalization and progression to critical disease status were reported from phase 3 studies; reductions were also observed in mortality in some, but not all, studies. Enhanced viral clearance on day 7 was observed with few subjects having persistent high viral load.

Which children qualify under the EUA? Adolescents 12 years and older and over 40 kg are eligible if a high risk condition is present. High-risk conditions include body mass index at the 85th percentile or higher, immunosuppressive disease, or receipt of immunosuppressive therapies, or baseline (pre-COVID infection) medical-related technological dependence such as tracheostomy or positive pressure ventilation. Additional high-risk conditions are neurodevelopmental disorders, sickle cell disease, congenital or acquired heart disease, asthma, or reactive airway or other chronic respiratory disease that requires daily medication for control, diabetes, chronic kidney disease, or pregnancy.³

Are the available monoclonal antibodies effective for SARS-CoV-2 variants? Of course, this is a critical question and relies on knowledge of the dominant variant in a specific geographic location. The CDC data on which variants are susceptible to which monoclonal therapies were updated as of Oct. 21 online (see Table 1). Local departments of public health often will have current data on the dominant variant in the community. Currently, the dominant variant in the United States is Delta and it is anticipated to be susceptible to the three monoclonal treatments authorized under the EUA based on in vitro neutralizing assays.

Implementation challenges

The first challenge is finding a location to infuse the monoclonal antibodies. Although they can be given subcutaneously, the dose is large and little, if any, time is saved as the recommendation is for observation post administration for 1 hour. The challenge we and other centers may face is that the patients are COVID PCR+ and therefore our usual infusion program, which often is occupied by individuals already compromised and at high risk for severe COVID, is an undesirable location. We are planning to use the emergency department to accommodate such patients currently, but even that solution creates challenges for a busy, urban medical center.

Summary

Anti–SARS-CoV-2 monoclonal antibodies are an important part of the therapeutic approach to minimizing disease severity. Clinicians should review high-risk conditions in adolescents who are PCR+ for SARS-CoV-2 and have mild to moderate symptoms. Medical care systems should implement programs to make monoclonal infusions available for such high-risk adolescents.⁴ Obesity and asthma reactive airways or requiring daily medication for control are the two most common conditions that place adolescents with COVID-19 at risk for progression to hospitalization and severe disease in addition to the more traditional immune-compromising conditions and medical fragility.

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide. U.S. Department of Health and Human Services. 2021 Sep 2.

2. Bhimraj A et al. IDSA Guidelines on the Treatment and Management of Patients with COVID-19. Last updated 2021 Nov 9.

3. Anti-SARS-CoV-2 Monoclonal Antibodies. National Institutes of Health’s COVID 19 Treatment Guidelines. Last updated 2021 Oct 19.

4. Spreading the Word on the Benefits of Monoclonal Antibodies for COVID-19, by Hannah R. Buchdahl. CDC Foundation, 2021 Jul 2.

I was recently asked to see a 16-year-old, unvaccinated (against COVID-19) adolescent with hypothyroidism and obesity (body mass index 37 kg/m²) seen in the pediatric emergency department with tachycardia, O₂ saturation 96%, urinary tract infection, poor appetite, and nausea. Her chest x-ray had low lung volumes but no infiltrates. She was noted to be dehydrated. Testing for COVID-19 was PCR positive.¹

She was observed overnight, tolerated oral rehydration, and was being readied for discharge. Pediatric Infectious Diseases was called about prescribing remdesivir.

Remdesivir was not indicated as its current use is limited to inpatients with oxygen desaturations less than 94%. Infectious Diseases Society of America guidelines do recommend the use of monoclonal antibodies against the SARS-CoV-2 spike protein for prevention of COVID disease progression in high-risk individuals. Specifically, the IDSA guidelines say, “Among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease, bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment.”

The Food and Drug Administration’s Emergency Use Authorization (EUA) allowed use of specific monoclonal antibodies (casirivimab/imdevimab in combination, bamlanivimab/etesevimab in combination, and sotrovimab alone) for individuals 12 years and above with a minimum weight of 40 kg with high-risk conditions, describing the evidence as moderate certainty.²

Several questions have arisen regarding their use. Which children qualify under the EUA? Are the available monoclonal antibodies effective for SARS-CoV-2 variants? What adverse events were observed? Are there implementation hurdles?

Unlike the EUA for prophylactic use, which targeted unvaccinated individuals and those unlikely to have a good antibody response to vaccine, use of monoclonal antibody for prevention of progression does not have such restrictions. Effectiveness may vary by local variant susceptibility and should be considered in the choice of the most appropriate monoclonal antibody therapy. Reductions in hospitalization and progression to critical disease status were reported from phase 3 studies; reductions were also observed in mortality in some, but not all, studies. Enhanced viral clearance on day 7 was observed with few subjects having persistent high viral load.

Which children qualify under the EUA? Adolescents 12 years and older and over 40 kg are eligible if a high risk condition is present. High-risk conditions include body mass index at the 85th percentile or higher, immunosuppressive disease, or receipt of immunosuppressive therapies, or baseline (pre-COVID infection) medical-related technological dependence such as tracheostomy or positive pressure ventilation. Additional high-risk conditions are neurodevelopmental disorders, sickle cell disease, congenital or acquired heart disease, asthma, or reactive airway or other chronic respiratory disease that requires daily medication for control, diabetes, chronic kidney disease, or pregnancy.³

Are the available monoclonal antibodies effective for SARS-CoV-2 variants? Of course, this is a critical question and relies on knowledge of the dominant variant in a specific geographic location. The CDC data on which variants are susceptible to which monoclonal therapies were updated as of Oct. 21 online (see Table 1). Local departments of public health often will have current data on the dominant variant in the community. Currently, the dominant variant in the United States is Delta and it is anticipated to be susceptible to the three monoclonal treatments authorized under the EUA based on in vitro neutralizing assays.

Implementation challenges

The first challenge is finding a location to infuse the monoclonal antibodies. Although they can be given subcutaneously, the dose is large and little, if any, time is saved as the recommendation is for observation post administration for 1 hour. The challenge we and other centers may face is that the patients are COVID PCR+ and therefore our usual infusion program, which often is occupied by individuals already compromised and at high risk for severe COVID, is an undesirable location. We are planning to use the emergency department to accommodate such patients currently, but even that solution creates challenges for a busy, urban medical center.

Summary

Anti–SARS-CoV-2 monoclonal antibodies are an important part of the therapeutic approach to minimizing disease severity. Clinicians should review high-risk conditions in adolescents who are PCR+ for SARS-CoV-2 and have mild to moderate symptoms. Medical care systems should implement programs to make monoclonal infusions available for such high-risk adolescents.⁴ Obesity and asthma reactive airways or requiring daily medication for control are the two most common conditions that place adolescents with COVID-19 at risk for progression to hospitalization and severe disease in addition to the more traditional immune-compromising conditions and medical fragility.

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide. U.S. Department of Health and Human Services. 2021 Sep 2.

2. Bhimraj A et al. IDSA Guidelines on the Treatment and Management of Patients with COVID-19. Last updated 2021 Nov 9.

3. Anti-SARS-CoV-2 Monoclonal Antibodies. National Institutes of Health’s COVID 19 Treatment Guidelines. Last updated 2021 Oct 19.

4. Spreading the Word on the Benefits of Monoclonal Antibodies for COVID-19, by Hannah R. Buchdahl. CDC Foundation, 2021 Jul 2.

A systematic review of studies of infections found no evidence of airborne transmission of respiratory or enteric pathogens in public washrooms, but some experts disagree with the study’s conclusions. The study was published in Science of the Total Environment.

Sotiris Vardoulakis, PhD, of the Australian National University, Canberra, and colleagues reviewed studies of infections associated with public washrooms.

The researchers used keywords to identify potential articles. After screening study abstracts to ensure that only publicly available washrooms with toilets, sinks, and hand dryers were included, 65 studies remained. The investigators excluded washrooms on public transportation (ships, planes, trains, and buses).

“What most of the studies concluded was that what’s really important is to have good hand hygiene and proper maintenance and ventilation of washrooms,” Dr. Vardoulakis said in an interview. “So if the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”

There has been ongoing debate on whether electric hand dryers or paper towels are better. Some studies focused on hygiene. Others focused on the environmental cost of paper towels. One concern is that air dryers might spread germs further.

One study focused on the idea that the air recirculation from electric dryers may spread infective aerosols. Another study determined that the Airblade filters in some electric dryers clean more than 99% of the bacteria. The first study, published in Mayo Clinic Proceedings by Cunrui Huang, MMed, MSPH, and colleagues, concluded that “drying hands thoroughly with single-use, disposable paper towels is the preferred method of hand drying in terms of hand hygiene.” Many people prefer to use paper towels because they can be used as a barrier when opening the washroom door.

Dr. Vardoulakis dismissed the air-versus-paper debate, saying, “If the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”

Although Dr. Vardoulakis’ review did not find that public washrooms pose a risk for infection, other researchers have shown that some settings do pose problems. For example, toilet plumes are thought to have contributed to the 2003 outbreak of severe acute respiratory syndrome at the Amoy Gardens housing complex in Hong Kong and nearby buildings by aerosolization of fecal waste. Also, norovirus has long been shown to be transmitted by aerosolized particles in vomitus or stool.

Rodney E. Rohde, PhD, professor and chair, clinical lab science program, Texas State University, San Marcos, expressed concern about this systematic review in an interview with this news organization. “I believe one of the major limitations is that studies which involved restrooms on planes, hotels, camping (those camp kids are nasty), and other similar public-access restrooms MUST be included in this type of review. I also believe they excluded restrooms from low-income/rural areas. WHAT? Their ultimate conclusions seem to be in line with the most current understanding about hand hygiene (including drying without devices that create strong air currents, which may create widespread emission of microbes).”

In an interview, Emanuel Goldman, PhD, professor of microbiology, biochemistry, and molecular genetics, New Jersey Medical School, Newark, focused on the COVID-specific aspects of the review. “The chances are less than 1 in 10,000 of getting COVID from a fomite, and that’s very conservative,” he said. “I think it’s a lot lower than that. The virus is fragile. It dies very quickly outside of a human host.” He emphasized, “virtually no infectious virus has been found on fomites over the last 2 years. ... A big mistake in a lot of papers is they confuse viral RNA with the virus. It’s not the same. Viral RNA is the genetic material of the virus, but it also is the ghost of the virus after the virus is dead, and that’s what people are finding. They’re finding the ghost of the virus.”

Because “studies show that the transfer from a surface to fingers is in the neighborhood of 10% efficiency” and one’s fingers also kill the virus, “transmission through your fingers is not easy,” Dr. Goldman said. “You’ve got to really work at it to deliberately infect yourself” with COVID from a fomite.

Dr. Rohde’s conclusion about Dr. Vardoulakis’s review? “So, the question may be, have there been enough studies, in general, of these other areas to include in a review? Otherwise, can we really generalize from this study? I don’t think so.”

Dr. Goldman is not worried about COVID transmission in public bathrooms. His summation: “I think indoor dining is more risky than anything else right now.”

The study was funded by Dyson Technology. Dr. Vardoulakis is a member of the Dyson scientific advisory board.

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

A systematic review of studies of infections found no evidence of airborne transmission of respiratory or enteric pathogens in public washrooms, but some experts disagree with the study’s conclusions. The study was published in Science of the Total Environment.

Sotiris Vardoulakis, PhD, of the Australian National University, Canberra, and colleagues reviewed studies of infections associated with public washrooms.

The researchers used keywords to identify potential articles. After screening study abstracts to ensure that only publicly available washrooms with toilets, sinks, and hand dryers were included, 65 studies remained. The investigators excluded washrooms on public transportation (ships, planes, trains, and buses).

“What most of the studies concluded was that what’s really important is to have good hand hygiene and proper maintenance and ventilation of washrooms,” Dr. Vardoulakis said in an interview. “So if the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”

There has been ongoing debate on whether electric hand dryers or paper towels are better. Some studies focused on hygiene. Others focused on the environmental cost of paper towels. One concern is that air dryers might spread germs further.

One study focused on the idea that the air recirculation from electric dryers may spread infective aerosols. Another study determined that the Airblade filters in some electric dryers clean more than 99% of the bacteria. The first study, published in Mayo Clinic Proceedings by Cunrui Huang, MMed, MSPH, and colleagues, concluded that “drying hands thoroughly with single-use, disposable paper towels is the preferred method of hand drying in terms of hand hygiene.” Many people prefer to use paper towels because they can be used as a barrier when opening the washroom door.

Dr. Vardoulakis dismissed the air-versus-paper debate, saying, “If the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”

Although Dr. Vardoulakis’ review did not find that public washrooms pose a risk for infection, other researchers have shown that some settings do pose problems. For example, toilet plumes are thought to have contributed to the 2003 outbreak of severe acute respiratory syndrome at the Amoy Gardens housing complex in Hong Kong and nearby buildings by aerosolization of fecal waste. Also, norovirus has long been shown to be transmitted by aerosolized particles in vomitus or stool.

Rodney E. Rohde, PhD, professor and chair, clinical lab science program, Texas State University, San Marcos, expressed concern about this systematic review in an interview with this news organization. “I believe one of the major limitations is that studies which involved restrooms on planes, hotels, camping (those camp kids are nasty), and other similar public-access restrooms MUST be included in this type of review. I also believe they excluded restrooms from low-income/rural areas. WHAT? Their ultimate conclusions seem to be in line with the most current understanding about hand hygiene (including drying without devices that create strong air currents, which may create widespread emission of microbes).”

In an interview, Emanuel Goldman, PhD, professor of microbiology, biochemistry, and molecular genetics, New Jersey Medical School, Newark, focused on the COVID-specific aspects of the review. “The chances are less than 1 in 10,000 of getting COVID from a fomite, and that’s very conservative,” he said. “I think it’s a lot lower than that. The virus is fragile. It dies very quickly outside of a human host.” He emphasized, “virtually no infectious virus has been found on fomites over the last 2 years. ... A big mistake in a lot of papers is they confuse viral RNA with the virus. It’s not the same. Viral RNA is the genetic material of the virus, but it also is the ghost of the virus after the virus is dead, and that’s what people are finding. They’re finding the ghost of the virus.”

Because “studies show that the transfer from a surface to fingers is in the neighborhood of 10% efficiency” and one’s fingers also kill the virus, “transmission through your fingers is not easy,” Dr. Goldman said. “You’ve got to really work at it to deliberately infect yourself” with COVID from a fomite.

Dr. Rohde’s conclusion about Dr. Vardoulakis’s review? “So, the question may be, have there been enough studies, in general, of these other areas to include in a review? Otherwise, can we really generalize from this study? I don’t think so.”

Dr. Goldman is not worried about COVID transmission in public bathrooms. His summation: “I think indoor dining is more risky than anything else right now.”

The study was funded by Dyson Technology. Dr. Vardoulakis is a member of the Dyson scientific advisory board.

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

A systematic review of studies of infections found no evidence of airborne transmission of respiratory or enteric pathogens in public washrooms, but some experts disagree with the study’s conclusions. The study was published in Science of the Total Environment.

Sotiris Vardoulakis, PhD, of the Australian National University, Canberra, and colleagues reviewed studies of infections associated with public washrooms.

The researchers used keywords to identify potential articles. After screening study abstracts to ensure that only publicly available washrooms with toilets, sinks, and hand dryers were included, 65 studies remained. The investigators excluded washrooms on public transportation (ships, planes, trains, and buses).

“What most of the studies concluded was that what’s really important is to have good hand hygiene and proper maintenance and ventilation of washrooms,” Dr. Vardoulakis said in an interview. “So if the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”

There has been ongoing debate on whether electric hand dryers or paper towels are better. Some studies focused on hygiene. Others focused on the environmental cost of paper towels. One concern is that air dryers might spread germs further.

One study focused on the idea that the air recirculation from electric dryers may spread infective aerosols. Another study determined that the Airblade filters in some electric dryers clean more than 99% of the bacteria. The first study, published in Mayo Clinic Proceedings by Cunrui Huang, MMed, MSPH, and colleagues, concluded that “drying hands thoroughly with single-use, disposable paper towels is the preferred method of hand drying in terms of hand hygiene.” Many people prefer to use paper towels because they can be used as a barrier when opening the washroom door.

Dr. Vardoulakis dismissed the air-versus-paper debate, saying, “If the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”

Although Dr. Vardoulakis’ review did not find that public washrooms pose a risk for infection, other researchers have shown that some settings do pose problems. For example, toilet plumes are thought to have contributed to the 2003 outbreak of severe acute respiratory syndrome at the Amoy Gardens housing complex in Hong Kong and nearby buildings by aerosolization of fecal waste. Also, norovirus has long been shown to be transmitted by aerosolized particles in vomitus or stool.

Rodney E. Rohde, PhD, professor and chair, clinical lab science program, Texas State University, San Marcos, expressed concern about this systematic review in an interview with this news organization. “I believe one of the major limitations is that studies which involved restrooms on planes, hotels, camping (those camp kids are nasty), and other similar public-access restrooms MUST be included in this type of review. I also believe they excluded restrooms from low-income/rural areas. WHAT? Their ultimate conclusions seem to be in line with the most current understanding about hand hygiene (including drying without devices that create strong air currents, which may create widespread emission of microbes).”

In an interview, Emanuel Goldman, PhD, professor of microbiology, biochemistry, and molecular genetics, New Jersey Medical School, Newark, focused on the COVID-specific aspects of the review. “The chances are less than 1 in 10,000 of getting COVID from a fomite, and that’s very conservative,” he said. “I think it’s a lot lower than that. The virus is fragile. It dies very quickly outside of a human host.” He emphasized, “virtually no infectious virus has been found on fomites over the last 2 years. ... A big mistake in a lot of papers is they confuse viral RNA with the virus. It’s not the same. Viral RNA is the genetic material of the virus, but it also is the ghost of the virus after the virus is dead, and that’s what people are finding. They’re finding the ghost of the virus.”

Because “studies show that the transfer from a surface to fingers is in the neighborhood of 10% efficiency” and one’s fingers also kill the virus, “transmission through your fingers is not easy,” Dr. Goldman said. “You’ve got to really work at it to deliberately infect yourself” with COVID from a fomite.

Dr. Rohde’s conclusion about Dr. Vardoulakis’s review? “So, the question may be, have there been enough studies, in general, of these other areas to include in a review? Otherwise, can we really generalize from this study? I don’t think so.”

Dr. Goldman is not worried about COVID transmission in public bathrooms. His summation: “I think indoor dining is more risky than anything else right now.”

The study was funded by Dyson Technology. Dr. Vardoulakis is a member of the Dyson scientific advisory board.

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

How much did you get per tooth from the Tooth Fairy? How much do your children or grandchildren receive each time they lose a baby tooth? In my family the Tooth Fairy seems to be more than keeping with inflation. Has she ever been caught in the act of swapping cash for enamel in your home? Has she every slipped up one night but managed to resurrect her credibility the following night by doubling the reward? And, by the way, what does the Tooth Fairy do with all those teeth, and who’s funding her nocturnal switcheroos?

A recent study from the Center for Genomic Medicine at the Massachusetts General Hospital in Boston may provide an answer to at least one of those questions. It turns out some researchers have been collecting baby teeth in hopes of assessing prenatal and perinatal stress in infants.

Not surprisingly, teeth are like trees, preserving a history of the environment in their growth rings. The Boston researchers hypothesized that the thickness of one particular growth line referred to as the neonatal line (NNL) might reflect prenatal and immediate postnatal environmental stress. Using data and naturally shed teeth collected in an English longitudinal study, the authors discovered that the teeth of children whose mothers had a long history of severe depression or other psychiatric problems and children of mothers who at 32 weeks’ gestation experienced anxiety and/or depression were more likely to have thicker NNLs. On the other hand, the teeth of children whose mothers had received “significant social support” in the immediate postnatal period exhibited thinner NNLs.

Based on anecdotal observations, I think most of us already suspected that the children whose mothers had significant psychiatric illness began life with a challenge, but it is nice to know that we may now have a tool to document one small bit of evidence of the structural damage that occurred during this period of stress. Of course, the prior owners of these baby teeth won’t benefit from the findings in this study; however, the evidence that social support during the critical perinatal period can ameliorate the damage might stimulate more robust prenatal programs for mother and infants at risk in the future.

It will be interesting to see if this investigative tool becomes more widely used to determine the degree to which a variety of potential perinatal stressors are manifesting themselves in structural change in newborns. For example, collecting baby teeth from neonatal ICU graduates may answer some questions about how certain environmental conditions such as sound, vibration, bright light, and temperature may result in long-term damage to the infants. Most of us suspect that skin-to-skin contact with mother and kangaroo care are beneficial. A study that includes a survey of NNLs might go a long way toward supporting our suspicions.

I can even imagine that a deep retrospective study of NNLs in baby teeth collected over the last 100 years might demonstrate the effect of phenomena such as wars, natural disasters, forced migration, and pandemics, to name a few.

It may be time to put out a nationwide call to all Tooth Fairies both active and retired to dig deep in their top bureau drawers. Those little bits of long-forgotten enamel may hold the answers to a plethora of unanswered questions about those critical months surrounding the birth of a child.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

How much did you get per tooth from the Tooth Fairy? How much do your children or grandchildren receive each time they lose a baby tooth? In my family the Tooth Fairy seems to be more than keeping with inflation. Has she ever been caught in the act of swapping cash for enamel in your home? Has she every slipped up one night but managed to resurrect her credibility the following night by doubling the reward? And, by the way, what does the Tooth Fairy do with all those teeth, and who’s funding her nocturnal switcheroos?

A recent study from the Center for Genomic Medicine at the Massachusetts General Hospital in Boston may provide an answer to at least one of those questions. It turns out some researchers have been collecting baby teeth in hopes of assessing prenatal and perinatal stress in infants.

Not surprisingly, teeth are like trees, preserving a history of the environment in their growth rings. The Boston researchers hypothesized that the thickness of one particular growth line referred to as the neonatal line (NNL) might reflect prenatal and immediate postnatal environmental stress. Using data and naturally shed teeth collected in an English longitudinal study, the authors discovered that the teeth of children whose mothers had a long history of severe depression or other psychiatric problems and children of mothers who at 32 weeks’ gestation experienced anxiety and/or depression were more likely to have thicker NNLs. On the other hand, the teeth of children whose mothers had received “significant social support” in the immediate postnatal period exhibited thinner NNLs.

Based on anecdotal observations, I think most of us already suspected that the children whose mothers had significant psychiatric illness began life with a challenge, but it is nice to know that we may now have a tool to document one small bit of evidence of the structural damage that occurred during this period of stress. Of course, the prior owners of these baby teeth won’t benefit from the findings in this study; however, the evidence that social support during the critical perinatal period can ameliorate the damage might stimulate more robust prenatal programs for mother and infants at risk in the future.

It will be interesting to see if this investigative tool becomes more widely used to determine the degree to which a variety of potential perinatal stressors are manifesting themselves in structural change in newborns. For example, collecting baby teeth from neonatal ICU graduates may answer some questions about how certain environmental conditions such as sound, vibration, bright light, and temperature may result in long-term damage to the infants. Most of us suspect that skin-to-skin contact with mother and kangaroo care are beneficial. A study that includes a survey of NNLs might go a long way toward supporting our suspicions.

I can even imagine that a deep retrospective study of NNLs in baby teeth collected over the last 100 years might demonstrate the effect of phenomena such as wars, natural disasters, forced migration, and pandemics, to name a few.

It may be time to put out a nationwide call to all Tooth Fairies both active and retired to dig deep in their top bureau drawers. Those little bits of long-forgotten enamel may hold the answers to a plethora of unanswered questions about those critical months surrounding the birth of a child.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

How much did you get per tooth from the Tooth Fairy? How much do your children or grandchildren receive each time they lose a baby tooth? In my family the Tooth Fairy seems to be more than keeping with inflation. Has she ever been caught in the act of swapping cash for enamel in your home? Has she every slipped up one night but managed to resurrect her credibility the following night by doubling the reward? And, by the way, what does the Tooth Fairy do with all those teeth, and who’s funding her nocturnal switcheroos?

A recent study from the Center for Genomic Medicine at the Massachusetts General Hospital in Boston may provide an answer to at least one of those questions. It turns out some researchers have been collecting baby teeth in hopes of assessing prenatal and perinatal stress in infants.

Not surprisingly, teeth are like trees, preserving a history of the environment in their growth rings. The Boston researchers hypothesized that the thickness of one particular growth line referred to as the neonatal line (NNL) might reflect prenatal and immediate postnatal environmental stress. Using data and naturally shed teeth collected in an English longitudinal study, the authors discovered that the teeth of children whose mothers had a long history of severe depression or other psychiatric problems and children of mothers who at 32 weeks’ gestation experienced anxiety and/or depression were more likely to have thicker NNLs. On the other hand, the teeth of children whose mothers had received “significant social support” in the immediate postnatal period exhibited thinner NNLs.

Based on anecdotal observations, I think most of us already suspected that the children whose mothers had significant psychiatric illness began life with a challenge, but it is nice to know that we may now have a tool to document one small bit of evidence of the structural damage that occurred during this period of stress. Of course, the prior owners of these baby teeth won’t benefit from the findings in this study; however, the evidence that social support during the critical perinatal period can ameliorate the damage might stimulate more robust prenatal programs for mother and infants at risk in the future.

It will be interesting to see if this investigative tool becomes more widely used to determine the degree to which a variety of potential perinatal stressors are manifesting themselves in structural change in newborns. For example, collecting baby teeth from neonatal ICU graduates may answer some questions about how certain environmental conditions such as sound, vibration, bright light, and temperature may result in long-term damage to the infants. Most of us suspect that skin-to-skin contact with mother and kangaroo care are beneficial. A study that includes a survey of NNLs might go a long way toward supporting our suspicions.

I can even imagine that a deep retrospective study of NNLs in baby teeth collected over the last 100 years might demonstrate the effect of phenomena such as wars, natural disasters, forced migration, and pandemics, to name a few.

It may be time to put out a nationwide call to all Tooth Fairies both active and retired to dig deep in their top bureau drawers. Those little bits of long-forgotten enamel may hold the answers to a plethora of unanswered questions about those critical months surrounding the birth of a child.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Deer, COVID, how?

Usually humans cannot get close enough to a deer to really be face-to-face, so it’s easy to question how on Earth deer are contracting COVID-19. Well, stranger things have happened, and honestly, we’ve just stopped questioning most of them.

petemeade/PxHere

Exhibit A comes to us from a Penn State University study: Eighty percent of deer sampled in Iowa in December 2020 and January 2021 – as part of the state’s chronic wasting disease surveillance program – were found to be positive for COVID-19.

A statement from the university said that “white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans.” The investigators also suggested that deer probably caught the virus from humans and then transmitted it to other deer.

If you or someone you know is a hunter or a white-tailed deer, it’s best to proceed with caution. There’s no evidence that COVID-19 has jumped from deer to humans, but hunters should wear masks and gloves while working with deer, worrying not just about the deer’s face, but also … you know, the gastrointestinal parts, Robert Salata, MD, of University Hospitals Cleveland Medical Center, told Syracuse.com. It also shouldn’t be too risky to eat venison, he said, just make sure the meat is cooked thoroughly.

The more you know!
 

The neurological super powers of grandma are real

What is it about grandmothers that makes them seem almost magical at times? They somehow always know how you feel. And they can almost always tell when something is wrong. They also seem to be the biggest ally a child will have against his or her parents.

Mark Edward Atkinson/Tracey Lee

So what makes these super matriarchs? The answer is in the brain.

Apparently there’s a function in the brains of grandmothers geared toward “emotional empathy.” James Rilling, PhD, of Emory University, lead author of a recent study focused on looking at the brain function of grandmothers, suggested that they’re neurologically tapped into feeling how their grandchildren feel: “If their grandchild is smiling, they’re feeling the child’s joy. And if their grandchild is crying, they’re feeling the child’s pain and distress.”

And then there’s the cute factor. Never underestimate a child’s ability to manipulate his or her grandmother’s brain.

So how do the researchers know this? Functional MRI showed more brain activity in the parts of the brain that deal with emotional empathy and movement in the participating grandmas when shown pictures of their grandchildren. Images of their own adult children lit up areas more associated with cognitive empathy. So less emotional and more mental/logical understanding.

Kids, don’t tell Mom about the secret midnight snacks with grandma. She wouldn’t get it.

Then there’s the grandmother hypothesis, which suggests that women tend to live longer to provide some kind of evolutionary benefit to their children and grandchildren. Evidence also exists that children with positive engagement from their grandmothers tend to have better social and academic outcomes, behavior, and physical health.

A lot of credit on how children turn out, of course, goes to parents, but more can be said about grandmas. Don’t let the age and freshly baked cookies fool you. They have neurologic superpowers within.
 

Brain cleanup on aisle 5

You’ve got your local grocery store down. You know the ins and outs; you know where everything is. Last week you did your trip in record time. This week, however, you have to stop at a different store. Same chain, but a different location. You stroll in, confidently walk toward the first aisle for your fruits and veggies, and ... it’s all ice cream. Oops.

Max Pixel

There’s a lot we don’t understand about the brain, including how it remembers familiar environments to avoid confusion. Or why it fails to do so, as with our grocery store example. However, thanks to a study from the University of Arizona, we may have an answer.

For the experiment, a group of participants watched a video tour of three virtual cities. Those cities were very similar, being laid out in basically identical fashion. Stores could be found in the same places, but the identity of those stores varied. Some stores were in all three cities, some were in two, and some were unique. Participants were asked to memorize the layouts, and those who got things more than 80% correct ran through the test again, only this time their brain activity was monitored through MRI.

In general, brain activity was similar for the participants; after all, they were recalling similar environments. However, when asked about stores that appeared in multiple cities, brain activity varied dramatically. This indicated to the researchers that the brain was recalling shared stores as if they were more dissimilar than two completely disparate and unique stores, a concept often known to brain scientists as “repulsion.” It also indicates that the memories regarding shared environments are stored in the prefrontal cortex, not the hippocampus, which typically handles memory.

The researchers plan to apply this information to questions about diseases such as Alzheimer’s, so the next time you get turned around in a weirdly unfamiliar grocery store, just think: “It’s okay, I’m helping to solve a terrible brain disease.”
 

The real endgame: Friction is the winner

Spoiler alert! If you haven’t seen “Avengers: Infinity War” yet, we’re about to ruin it for you.

Georgia Tech

For those still with us, here’s the spoiler: Thanos would not have been able to snap his fingers while wearing the Infinity Gauntlet.

Saad Bhamla, PhD, of Georgia Tech University’s school of chemical and biomolecular engineering, had been studying powerful and ultrafast motions in living organisms along with several colleagues before the movie came out in 2018, and when they saw the finger-snapping scene it got them wondering.

Being scientists of course, they had no choice. They got out their high-speed imaging equipment, automated image processing software, and dynamic force sensors and analyzed finger snaps, paying close attention to friction by covering fingers with “different materials, including metallic thimbles to simulate the effects of trying to snap while wearing a metallic gauntlet, much like Thanos,” according to a statement on Eurekalert.

With finger snaps, it’s all about the rotational velocity. The angular acceleration involved is the fastest ever measured in a human, with a professional baseball pitcher’s throwing arm a distant second.

Dr. Bhamla’s reaction to their work explains why scientists are the ones doing science. “When I first saw the data, I jumped out of my chair,” he said in the written statement.

Rotational velocities dropped dramatically when the friction-reducing thimbles were used, so there was no snap. Which means that billions and billions of fictional lives could have been saved if the filmmakers had just talked to the right scientist.

That scientist, clearly, is Dr. Bhamla, who said that “this is the only scientific project in my lab in which we could snap our fingers and get data.”

Deer, COVID, how?

Usually humans cannot get close enough to a deer to really be face-to-face, so it’s easy to question how on Earth deer are contracting COVID-19. Well, stranger things have happened, and honestly, we’ve just stopped questioning most of them.

petemeade/PxHere

Exhibit A comes to us from a Penn State University study: Eighty percent of deer sampled in Iowa in December 2020 and January 2021 – as part of the state’s chronic wasting disease surveillance program – were found to be positive for COVID-19.

A statement from the university said that “white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans.” The investigators also suggested that deer probably caught the virus from humans and then transmitted it to other deer.

If you or someone you know is a hunter or a white-tailed deer, it’s best to proceed with caution. There’s no evidence that COVID-19 has jumped from deer to humans, but hunters should wear masks and gloves while working with deer, worrying not just about the deer’s face, but also … you know, the gastrointestinal parts, Robert Salata, MD, of University Hospitals Cleveland Medical Center, told Syracuse.com. It also shouldn’t be too risky to eat venison, he said, just make sure the meat is cooked thoroughly.

The more you know!
 

The neurological super powers of grandma are real

What is it about grandmothers that makes them seem almost magical at times? They somehow always know how you feel. And they can almost always tell when something is wrong. They also seem to be the biggest ally a child will have against his or her parents.

Mark Edward Atkinson/Tracey Lee

So what makes these super matriarchs? The answer is in the brain.

Apparently there’s a function in the brains of grandmothers geared toward “emotional empathy.” James Rilling, PhD, of Emory University, lead author of a recent study focused on looking at the brain function of grandmothers, suggested that they’re neurologically tapped into feeling how their grandchildren feel: “If their grandchild is smiling, they’re feeling the child’s joy. And if their grandchild is crying, they’re feeling the child’s pain and distress.”

And then there’s the cute factor. Never underestimate a child’s ability to manipulate his or her grandmother’s brain.

So how do the researchers know this? Functional MRI showed more brain activity in the parts of the brain that deal with emotional empathy and movement in the participating grandmas when shown pictures of their grandchildren. Images of their own adult children lit up areas more associated with cognitive empathy. So less emotional and more mental/logical understanding.

Kids, don’t tell Mom about the secret midnight snacks with grandma. She wouldn’t get it.

Then there’s the grandmother hypothesis, which suggests that women tend to live longer to provide some kind of evolutionary benefit to their children and grandchildren. Evidence also exists that children with positive engagement from their grandmothers tend to have better social and academic outcomes, behavior, and physical health.

A lot of credit on how children turn out, of course, goes to parents, but more can be said about grandmas. Don’t let the age and freshly baked cookies fool you. They have neurologic superpowers within.
 

Brain cleanup on aisle 5

You’ve got your local grocery store down. You know the ins and outs; you know where everything is. Last week you did your trip in record time. This week, however, you have to stop at a different store. Same chain, but a different location. You stroll in, confidently walk toward the first aisle for your fruits and veggies, and ... it’s all ice cream. Oops.

Max Pixel

There’s a lot we don’t understand about the brain, including how it remembers familiar environments to avoid confusion. Or why it fails to do so, as with our grocery store example. However, thanks to a study from the University of Arizona, we may have an answer.

For the experiment, a group of participants watched a video tour of three virtual cities. Those cities were very similar, being laid out in basically identical fashion. Stores could be found in the same places, but the identity of those stores varied. Some stores were in all three cities, some were in two, and some were unique. Participants were asked to memorize the layouts, and those who got things more than 80% correct ran through the test again, only this time their brain activity was monitored through MRI.

In general, brain activity was similar for the participants; after all, they were recalling similar environments. However, when asked about stores that appeared in multiple cities, brain activity varied dramatically. This indicated to the researchers that the brain was recalling shared stores as if they were more dissimilar than two completely disparate and unique stores, a concept often known to brain scientists as “repulsion.” It also indicates that the memories regarding shared environments are stored in the prefrontal cortex, not the hippocampus, which typically handles memory.

The researchers plan to apply this information to questions about diseases such as Alzheimer’s, so the next time you get turned around in a weirdly unfamiliar grocery store, just think: “It’s okay, I’m helping to solve a terrible brain disease.”
 

The real endgame: Friction is the winner

Spoiler alert! If you haven’t seen “Avengers: Infinity War” yet, we’re about to ruin it for you.

Georgia Tech

For those still with us, here’s the spoiler: Thanos would not have been able to snap his fingers while wearing the Infinity Gauntlet.

Saad Bhamla, PhD, of Georgia Tech University’s school of chemical and biomolecular engineering, had been studying powerful and ultrafast motions in living organisms along with several colleagues before the movie came out in 2018, and when they saw the finger-snapping scene it got them wondering.

Being scientists of course, they had no choice. They got out their high-speed imaging equipment, automated image processing software, and dynamic force sensors and analyzed finger snaps, paying close attention to friction by covering fingers with “different materials, including metallic thimbles to simulate the effects of trying to snap while wearing a metallic gauntlet, much like Thanos,” according to a statement on Eurekalert.

With finger snaps, it’s all about the rotational velocity. The angular acceleration involved is the fastest ever measured in a human, with a professional baseball pitcher’s throwing arm a distant second.

Dr. Bhamla’s reaction to their work explains why scientists are the ones doing science. “When I first saw the data, I jumped out of my chair,” he said in the written statement.

Rotational velocities dropped dramatically when the friction-reducing thimbles were used, so there was no snap. Which means that billions and billions of fictional lives could have been saved if the filmmakers had just talked to the right scientist.

That scientist, clearly, is Dr. Bhamla, who said that “this is the only scientific project in my lab in which we could snap our fingers and get data.”

Deer, COVID, how?

Usually humans cannot get close enough to a deer to really be face-to-face, so it’s easy to question how on Earth deer are contracting COVID-19. Well, stranger things have happened, and honestly, we’ve just stopped questioning most of them.

petemeade/PxHere

Exhibit A comes to us from a Penn State University study: Eighty percent of deer sampled in Iowa in December 2020 and January 2021 – as part of the state’s chronic wasting disease surveillance program – were found to be positive for COVID-19.

A statement from the university said that “white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans.” The investigators also suggested that deer probably caught the virus from humans and then transmitted it to other deer.

If you or someone you know is a hunter or a white-tailed deer, it’s best to proceed with caution. There’s no evidence that COVID-19 has jumped from deer to humans, but hunters should wear masks and gloves while working with deer, worrying not just about the deer’s face, but also … you know, the gastrointestinal parts, Robert Salata, MD, of University Hospitals Cleveland Medical Center, told Syracuse.com. It also shouldn’t be too risky to eat venison, he said, just make sure the meat is cooked thoroughly.

The more you know!
 

The neurological super powers of grandma are real

What is it about grandmothers that makes them seem almost magical at times? They somehow always know how you feel. And they can almost always tell when something is wrong. They also seem to be the biggest ally a child will have against his or her parents.

Mark Edward Atkinson/Tracey Lee

So what makes these super matriarchs? The answer is in the brain.

Apparently there’s a function in the brains of grandmothers geared toward “emotional empathy.” James Rilling, PhD, of Emory University, lead author of a recent study focused on looking at the brain function of grandmothers, suggested that they’re neurologically tapped into feeling how their grandchildren feel: “If their grandchild is smiling, they’re feeling the child’s joy. And if their grandchild is crying, they’re feeling the child’s pain and distress.”

And then there’s the cute factor. Never underestimate a child’s ability to manipulate his or her grandmother’s brain.

So how do the researchers know this? Functional MRI showed more brain activity in the parts of the brain that deal with emotional empathy and movement in the participating grandmas when shown pictures of their grandchildren. Images of their own adult children lit up areas more associated with cognitive empathy. So less emotional and more mental/logical understanding.

Kids, don’t tell Mom about the secret midnight snacks with grandma. She wouldn’t get it.

Then there’s the grandmother hypothesis, which suggests that women tend to live longer to provide some kind of evolutionary benefit to their children and grandchildren. Evidence also exists that children with positive engagement from their grandmothers tend to have better social and academic outcomes, behavior, and physical health.

A lot of credit on how children turn out, of course, goes to parents, but more can be said about grandmas. Don’t let the age and freshly baked cookies fool you. They have neurologic superpowers within.
 

Brain cleanup on aisle 5

You’ve got your local grocery store down. You know the ins and outs; you know where everything is. Last week you did your trip in record time. This week, however, you have to stop at a different store. Same chain, but a different location. You stroll in, confidently walk toward the first aisle for your fruits and veggies, and ... it’s all ice cream. Oops.

Max Pixel

There’s a lot we don’t understand about the brain, including how it remembers familiar environments to avoid confusion. Or why it fails to do so, as with our grocery store example. However, thanks to a study from the University of Arizona, we may have an answer.

For the experiment, a group of participants watched a video tour of three virtual cities. Those cities were very similar, being laid out in basically identical fashion. Stores could be found in the same places, but the identity of those stores varied. Some stores were in all three cities, some were in two, and some were unique. Participants were asked to memorize the layouts, and those who got things more than 80% correct ran through the test again, only this time their brain activity was monitored through MRI.

In general, brain activity was similar for the participants; after all, they were recalling similar environments. However, when asked about stores that appeared in multiple cities, brain activity varied dramatically. This indicated to the researchers that the brain was recalling shared stores as if they were more dissimilar than two completely disparate and unique stores, a concept often known to brain scientists as “repulsion.” It also indicates that the memories regarding shared environments are stored in the prefrontal cortex, not the hippocampus, which typically handles memory.

The researchers plan to apply this information to questions about diseases such as Alzheimer’s, so the next time you get turned around in a weirdly unfamiliar grocery store, just think: “It’s okay, I’m helping to solve a terrible brain disease.”
 

The real endgame: Friction is the winner

Spoiler alert! If you haven’t seen “Avengers: Infinity War” yet, we’re about to ruin it for you.

Georgia Tech

For those still with us, here’s the spoiler: Thanos would not have been able to snap his fingers while wearing the Infinity Gauntlet.

Saad Bhamla, PhD, of Georgia Tech University’s school of chemical and biomolecular engineering, had been studying powerful and ultrafast motions in living organisms along with several colleagues before the movie came out in 2018, and when they saw the finger-snapping scene it got them wondering.

Being scientists of course, they had no choice. They got out their high-speed imaging equipment, automated image processing software, and dynamic force sensors and analyzed finger snaps, paying close attention to friction by covering fingers with “different materials, including metallic thimbles to simulate the effects of trying to snap while wearing a metallic gauntlet, much like Thanos,” according to a statement on Eurekalert.

With finger snaps, it’s all about the rotational velocity. The angular acceleration involved is the fastest ever measured in a human, with a professional baseball pitcher’s throwing arm a distant second.

Dr. Bhamla’s reaction to their work explains why scientists are the ones doing science. “When I first saw the data, I jumped out of my chair,” he said in the written statement.

Rotational velocities dropped dramatically when the friction-reducing thimbles were used, so there was no snap. Which means that billions and billions of fictional lives could have been saved if the filmmakers had just talked to the right scientist.

That scientist, clearly, is Dr. Bhamla, who said that “this is the only scientific project in my lab in which we could snap our fingers and get data.”

A series of sharp knocks on his driver’s side window startled Jason Burt awake.

It was the middle of the night on a Saturday in 2016. Burt was sleeping in his pickup truck in the parking lot of St. Jude Children’s Research Hospital in downtown Memphis, Tenn., where his 5-year-old daughter was being treated for brain cancer. He’d driven more than 500 miles from his home in Central Texas to visit her.

A St. Jude security guard peered into the truck and asked Burt what he was doing. Burt explained that his daughter and her mother, his ex-girlfriend, were staying in the hospital’s free patient housing. But St. Jude provides housing for only one parent. Burt, a school bus driver making $20,000 a year, told the guard he couldn’t afford a hotel. The guard let the exhausted father go back to sleep.

St. Jude would do no more to find him a place to stay.

“They were aware of the situation,” Burt said. “I didn’t push anything. I was just grateful she was getting treated and I was doing what I needed to do.”

St. Jude is the largest and most highly regarded health care charity in the country. Each year, the Memphis hospital’s fundraisers send out hundreds of millions of letters, many with heart-wrenching photographs of children left bald from battling cancer. Celebrities like Jennifer Aniston and Sofia Vergara sing the hospital’s praises in televised advertisements. This year, St. Jude’s fundraising reached outer space. The SpaceX Inspiration4 mission in September included a former St. Jude patient as a crew member.

Last year, St. Jude raised a record $2 billion. U.S. News & World Report ranked it the country’s 10th-best children’s cancer hospital, and St. Jude raised roughly as much as the nine hospitals ahead of it put together. It currently has $5.2 billion in reserves, a sum large enough to run the institution at current levels for the next four and a half years without a single additional donation.

St. Jude makes a unique promise as part of its fundraising: “Families never receive a bill from St. Jude for treatment, travel, housing or food – because all a family should worry about is helping their child live.”

But for many families, treatment at St. Jude does not relieve all the financial burdens they incur in getting care for their children, including housing, travel, and food costs that fall outside the hospital’s strict limits, a ProPublica investigation has found.

While families may not receive a bill from St. Jude, the hospital doesn’t cover what’s usually the biggest source of financial stress associated with childhood cancer: The loss of income as parents quit or take leave from jobs to be with their child during treatment. For many families, the consequence is missed payments for cars, utilities, and cellphones. Others face eviction or foreclosure because they can’t keep up with rent and mortgage payments.

Parents at St. Jude have exhausted savings and retirement accounts, borrowed from family and friends, or asked other charities for aid. ProPublica identified more than 100 St. Jude families seeking financial help through the online fundraiser GoFundMe, with half of the campaigns started in the past two years. We counted scores of other events like concerts and yard sales organized to help St. Jude families in need.

One family relied on a mixed martial arts fighter to help raise money for expenses like car repairs and cellphone bills, items that St. Jude would not cover. Another spent $10,000, originally saved to purchase a home, on costs related to treatment at St. Jude.

Only about half of the $7.3 billion St. Jude has received in contributions in the past five fiscal years went to the hospital’s research and caring for patients, according to its financial filings with the Internal Revenue Service. About 30% covered the cost of its fundraising operations, and the remaining 20%, or $1 of every $5 donated, increased its reserve fund.

Further, ProPublica found, a substantial portion of the cost for treatment is paid not by St. Jude but by families’ private insurance or by Medicaid, the government insurance program for low-income families. About 90% of patients are insured, bringing in more than $100 million in reimbursements for treatment a year. If a family shows up at St. Jude without insurance, a company hired by the charity helps them find it. St. Jude does cover copays and deductibles, an unusual benefit.

St. Jude spends about $500 million a year on patient services – a figure that includes all medical care and other assistance. Very little of what St. Jude raises from the public goes to pay for food, travel, and housing for families, the investigation found. Last year, it was 2% of the money raised, or nearly $40 million.

In written responses to ProPublica, lawyers for St. Jude and its fundraising arm, the American Lebanese Syrian Associated Charities, or ALSAC, emphasized that countless families have benefited from the charity provided since the hospital opened its doors in 1962.

“ProPublica should be celebrating St. Jude and ALSAC for their commitment to finding cures, saving children’s lives, and optimizing patient outcomes,” one of their letters said.

It is unquestioned that St. Jude has helped thousands of children and their families over the decades. Patients have offered scores of testimonials about the hospital’s generosity and care.

“This often comes as a huge relief to families who often expect to sell all their belongings just so their children can get the medical care and treatment they need to save their lives,” the hospital’s lawyers wrote. “St. Jude and ALSAC understand that this arrangement cannot cover all financial obligations of all families, nor can St. Jude or ALSAC shield families from all the financial and emotional effects” of a child’s illness.

St. Jude said it discloses the limits of its aid to families on its website and in material provided to those whose children are admitted to the hospital. That includes the rule Burt ran into, that the hospital covers the travel and housing costs of only one caregiver and one patient. For many families, the daily food budget is capped at $50. In some cases, hotel stays en route are provided only if families travel more than 500 miles to get to St. Jude.

St. Jude said its assistance is “based on guidelines to ensure fairness and responsible use of donor funds” and on remaining compliant with a federal anti-kickback statute that makes it a criminal offense to offer something of value to induce a medical referral. St. Jude declined to explain how the law affects the amount or type of financial assistance it provides to families.

“St. Jude has never promised anyone – neither patients nor the public in general – that it can solve all financial problems,” the letter said.

When parents need additional financial help, St. Jude’s social workers often send them to smaller charities or in some cases suggest that they apply for government aid.

They refer many to the Andrew McDonough B+ Foundation, which gives more than $2.5 million a year in grants to thousands of families of pediatric cancer patients at hospitals across the country to help cover rent, utilities, and other urgent expenses.

Joe McDonough, the foundation’s founder and president, said St. Jude families have the same money problems as families of patients at other children’s hospitals, even though he said St. Jude’s marketing creates the public perception that it alleviates these burdens.

“People say to me, ‘Why are you helping St. Jude families?’ ” McDonough said. “Well, what happens when a family lives in Augusta, Georgia, and they’re being treated at St. Jude? They still have to pay the rent on their apartment back in Augusta, Georgia. They still have to make their car payment. And it’s not my position to say whether St. Jude should be paying for all those expenses or not. I’m just explaining that it’s not a totally free ride.”

The help St. Jude provides to families may soon be increasing.

After ProPublica provided St. Jude with the findings of its reporting, the hospital informed families of a dramatic expansion in the assistance it will give to parents and other relatives during their kids’ treatment in Memphis.

Among the most significant changes are increasing travel benefits to two parents instead of one and covering regular trips to Memphis for siblings and other loved ones. St. Jude’s letter to parents said the changes take effect Nov. 15.

That would’ve made a big difference for Burt.

Burt’s daughter, whom ProPublica is not identifying at her mother’s request, was originally diagnosed with cancer in early 2015, when doctors discovered a tumor pressing against her brain stem. She had successful emergency surgery to remove the mass at Dell Children’s Medical Center in Austin, Texas. Medicaid and Dell Children’s covered the bill, but the family was still faced with the cost of her ongoing treatment.

“At that point I’m thinking: ‘What am I going to do? I guess I’m selling my house, whatever it takes,’” Burt recalled. “Honestly, that was probably a big deciding factor for St. Jude.”

St. Jude accepted Burt’s daughter into a clinical trial, and the family moved to the hospital’s patient housing in Memphis for several months. Both parents stopped working for a time, and people in their hometown raised cash to pay their bills.

Her cancer relapsed the following year with several new, inoperable brain tumors. Burt and his daughter’s mom broke up during that round of treatment, and financial problems piled up.

Burt said his credit score dropped so low that utility companies refused to set up service unless he first paid a deposit. One of the family’s cars was repossessed, he said. Burt’s 2005 Chevrolet Colorado pickup has 300,000 miles on it, many of them logged on trips from Texas to Memphis. When Burt’s daughter was at St. Jude for treatment or exams, he’d work all week, then visit on many weekends where he would spend Saturday night sleeping in the hospital parking lot.

He asked hospital officials if he could sleep in St. Jude’s housing, but they turned him down, he said.

Burt said he was happy with the care St. Jude provided. His daughter’s health is stable, he said, and brain scans taken during her September exam confirmed her two remaining tumors haven’t grown. But he’s still trying to recover financially.

“It’s five years now,” Burt said, “and I’m not completely caught up yet.”
 

A fundraising giant

St. Jude began with a fledgling entertainer praying for a career break.

When Danny Thomas, a comic and actor best known for the TV sitcom “Make Room for Daddy,” was struggling to earn a living in the late 1930s, the devout Roman Catholic went to church and asked for help from the patron saint of desperate cases, St. Jude Thaddeus. If he made it big, Thomas promised to build “a shrine where the poor and the helpless and the hopeless may come for comfort and aid,” according to a history published by ALSAC.

Within five years, Thomas became a star and worked to fulfill his promise by building a children’s hospital named after St. Jude and a fundraising organization to support it. Thomas, whose parents were Lebanese immigrants, recruited others who shared his Middle Eastern roots to help.

He used his fame to raise the hospital’s profile, appearing in ads for St. Jude and hosting fundraising events starring the likes of Elvis Presley and Sammy Davis Jr. Thomas’ daughter Marlo, herself a TV star, succeeded him in championing St. Jude.

Today, St. Jude is a specialty treatment and research center with about 5,700 employees and 73 beds. Other top children’s hospitals have more staff and beds, and they also treat more conditions.

Though St. Jude raises money across the world, most of its patients come from Tennessee and surrounding states. Patients from elsewhere are usually enrolled in clinical trials.

ALSAC, which handles St. Jude’s fundraising and investments, has 2,188 employees in Memphis and in 36 regional offices across the country. More than 400 of the fundraising arm’s employees are paid over $100,000, according to IRS filings. The charity takes in so much money each year that it regularly steers hundreds of millions of dollars in donations to reserve accounts, the filings show.

Overall, St. Jude’s reserve has grown by 58% over the past five fiscal years, during which it has added $1.9 billion to its investment accounts and shifted its portfolio toward financial products designed to generate bigger returns than stocks, bonds, and mutual funds traditionally deliver. The charity stowed more than a third of the new surplus, $688 million, in riskier private equity investments.

IRS rules do not limit the size of a nonprofit’s reserves, and experts on charitable finance differ on best practices.

St. Jude meets Better Business Bureau guidelines, which call for charities to maintain reserves of less than three times total expenses, but other experts expressed alarm that the hospital had accumulated such a large sum of money.

The size of the St. Jude reserve is “staggering,” said Laura Otten, the director of LaSalle University’s master program in nonprofit leadership. She said a typical reserve for a nonprofit the size of St. Jude is one to two years of expenses. Donors generally want to know their dollars are being put to work, she said.

The hospital said it needs a large reserve because its unique operating model relies on donations to fund annual operating costs. “[W]e are highly donor-dependent and subject to the economic driven vagaries of charitable giving,” the hospital said in a written response to ProPublica questions.

But the hospital’s reserve is already more than large enough to buffer against recessions and potential drops in donations, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. “They should be spending the money as aggressively as they raise it, but they seem to be hoarding,” Bai said.

The hospital said it is also raising billions to fund the construction of new housing and research space, although its plans do not currently include spending any of the reserve on new facilities.

St. Jude’s reserves have ballooned at a time when researchers, oncologists, advocates, and families complain about a dearth of funding for pediatric cancer studies nationally.

Dozens of other children’s hospitals across the country have research divisions devoted to pediatric cancer and enroll their patients in clinical trials for new drugs and procedures. They pay for research staff and studies in part with donations from their local communities, often competing directly against St. Jude. ALSAC has regional offices in several U.S. cities with elite pediatric cancer centers of their own, including Atlanta, Chicago, Denver, and Seattle.

Coury Shadyac, an ALSAC vice president and daughter of the organization’s CEO, Richard Shadyac Jr., oversees a team of 45 fundraisers along the West Coast “raising $300 million annually” for St. Jude, according to her LinkedIn profile. That’s $100 million more in donations than either Children’s Hospital Los Angeles or Seattle Children’s Hospital, two of the nation’s leading pediatric cancer institutions, received in fiscal year 2019, IRS disclosures show. But it’s only a small part of St. Jude’s fundraising haul.

ALSAC’s ubiquitous fundraising has led to concerns that it undercuts other hospitals’ campaigns. Some doctors interviewed by ProPublica said they have encouraged donors to give their money to hospitals closer to home.

David Clark, a pediatrician and former longtime chairperson of pediatrics at Albany Medical Center in New York, said St. Jude raises tens of thousands of dollars in his region that does little to benefit the children with cancer in his area since almost all are treated locally. ALSAC has a fundraising office located a few miles from Albany Medical.

“They think of every way they can to make money and the least amount of ways to spend it,” Clark said. “They deceive people into supporting something that is totally dishonest.”

Nearly all St. Jude solicitations feature the hospital’s patients – the children usually smiling and bald from treatment – along with the familiar promise that it never sends families a bill.

It’s a message that ALSAC has tested and researched to maximize donations. Donors appreciate the promise to never bill families, said Mary Kate Tolan, an ALSAC executive, in a podcast last year. She added that no parent should have to take out a second mortgage or lose their job because their child is being treated at St. Jude.

Alternative messaging to the no-bills promise did not “perform as well,” said Tolan, who develops emerging technologies for ALSAC. Tolan did not return requests for comment.
 

“Borrowing and begging”

Catherine Rainey thought she would be free of financial worry when her 2-year-old daughter Harlee was admitted to St. Jude last year.

“The first thing my dad said was: ‘Catherine, you have nothing to worry about. They raise billions of dollars. Anytime you have a problem, you tell them and they will take care of it,’ ” she said.

But like many families, the Raineys discovered that St. Jude’s charity came with limits on payments for expenses such as travel that could be bewildering.

Harlee ended up at St. Jude after first going to nearby Niswonger Children’s Hospital in Johnson City, Tenn., in October 2020. The doctors there discovered a cancerous mass attached to her right kidney. The hospital is a St. Jude affiliate, and the doctors recommended the toddler be treated in Memphis.

Rainey, a single mother of two young girls, had to leave her job as a nurse for months to be with Harlee at St. Jude. The loss of income quickly created problems. “My family, we don’t come from money,” she said. “We are not doctors and billionaires. We make it. That is it.”

St. Jude did provide food and housing on campus. But the hospital said it couldn’t help with the items that were causing Rainey to worry, including car payments, insurance, and cellphone bills.

Rainey’s boss set up a GoFundMe account to help make up some of her lost income. A small local charity, Kari’s Heart Foundation, also helped out by paying about $3,000 worth of phone bills and car payments, staving off repossession.

“It was just a bunch of borrowing and begging,” Rainey said of her experience while her daughter was treated in Memphis. “They acted like it was coming out of their own pocket.”

Harlee has checkups at St. Jude every three months that last about four days. The costs of travel to and from St. Jude put an additional strain on Rainey and Harlee. St. Jude is an eight-hour ride, without stops, from Rainey’s home in Appalachia, Va., a town of 1,432 people near the Kentucky border.

Rainey said her daughter generally can make it about two-thirds of the way, with frequent stops, before she has had enough. “When she is done, she is really done,” Rainey said. “She will scream, cry, and kick.”

In July, in advance of an August trip to Memphis, Rainey called the patient services department at St. Jude to see whether they could help pay for a hotel to break up the travel day — an expense Rainey said she could not afford.

To qualify for a hotel reimbursement, Rainey said, St. Jude told her she had to live more than 500 miles from Memphis. The ride from her home to the hospital is 530 miles (a measurement ProPublica confirmed with mapping tools). However, Rainey said, St. Jude told her it measured the trip from city limit to city limit and came up with a distance of 491 miles. Even using that metric, the distance is still more than 500 miles, ProPublica found.

When she challenged the hospital’s stance, Rainey said she was berated by a patient services representative.

“I was feeling pissed off, and I was crying,” Rainey said of the interaction. “You give up your whole life for your child, and they tell you don’t worry about anything, we will cover this and then they tell you to just push through the drive.”

Rainey did what she could to make the trip go smoothly: She configured a small table to extend across her daughter’s car seat, so Harlee could play with the coloring books, markers, and Play-Doh bought for the ride. She packed snacks and a cooler full of drinks. Since Harlee was still potty training, she brought extra towels and clothes for accidents. The final step was handing Harlee her Baby Yoda doll once she settled into her car seat. Rainey had sewed a port in the doll’s chest to mirror the one Harlee has in hers.

About three hours from Memphis, Harlee was crying inconsolably. Rainey pulled off the interstate and stopped at the first hotel she could find. She later learned it had been described in online reviews as “awful,” a “nightmare,” “disgusting,” and “horrible.”

“I didn’t know the area,” she said. “The hotel was garbage. It just made it worse.”

The drive home also required a hotel stop, but this time Rainey was able to find one that was cleaner. A $100 donation from a local charity helped to offset the cost.

Among the changes St. Jude is making is to reimburse families like Rainey’s, who live more than 400 miles from the hospital, for an overnight stay at a hotel when making the trip to Memphis.

Rainey said she was called by a St. Jude representative after ProPublica asked about her situation and was told the hospital would pay for her past hotel stays when traveling back and forth to St. Jude. The representative, Rainey said, also told her the hospital discovered the way it had been measuring mileage was inaccurate.

“I am not the only one,” Rainey said. “There are others. They should reimburse all the families.”

The anxiety of unpaid bills piling up, combined with caring for a child undergoing chemotherapy or radiation, takes a severe toll on parents and guardians, said Christopher Hope, a UPS driver who started a Memphis-based foundation after meeting St. Jude parents who were in financial crisis.

Hope’s small charity spent $12,000 last year to help families. Parents in St. Jude social media groups often refer families in need to it. The charity has helped families cover mortgage and car payments.

“I never knew anything about this until hearing about it from families,” Hope said. “All we hear is about kids and treatment, not the other side of it.”
 

“It’s not free”

In addition to charities like Hope’s, St. Jude families have repeatedly turned to fundraising sites and networks of their relatives, friends, and neighbors to help cover basic expenses while unable to work during their children’s treatment. Parents’ requests on fundraising sites are sometimes desperate pleas.

In January 2017, one father in North Carolina said he’d had to abandon a business venture to take time for his son to receive care at St. Jude. His income had plummeted. He asked friends to give as little as $10 to “at least make it possible to survive.”

This year, a mother in Memphis whose 1-year-old son receives care at St. Jude for sickle cell disorder ran out of medical leave and couldn’t work her shifts at a clothing distribution center. After the child had a flare-up in July requiring several days of treatment at the hospital, she said she returned home to find her power shut off. Sitting in a dark apartment, unable to pay her utility bills, she set up a GoFundMe campaign. She received less than $20 through the site; her relatives eventually pooled $350 to get her electricity restored.

Even parents with stable jobs and private health insurance often take on debt and need outside help.

When Taylr and Treg Murphy’s 17-year-old son Peyton was diagnosed with cancer and needed monthslong treatment at St. Jude in 2017, the entire family – mom, dad, sister, and brother – went with him, traveling from their home in Lafayette, La., to Memphis. Treg took a leave from his job at an oil mining company and Taylr, who works at her mother’s bakery, did the same.

“We knew that it was going to be a collective team effort,” Treg said. “Without even a discussion, we figured that if Peyton’s got to go for the surgery, we’re all going.”

Peyton had an enormous tumor that had grown out of his right femur and was crowding his knee. Rounds of chemotherapy appeared to have killed osteosarcoma cells elsewhere in his body. But he needed to undergo a procedure called limb-sparing surgery that would require weeks of recovery time at the hospital.

The hospital agreed to allow all five family members to stay for free at St. Jude if they bunked together in a single room. It assigned them a spot in Tri Delta Place, its hotel-like short-term patient residence on the campus. Tri Delta is set up for visits of up to seven days, according to the hospital’s guide for volunteers, but the Murphys were there for almost 50.

Taylr said the unit at Tri Delta had no oven or stove and St. Jude provided no grocery money, instead allotting them a $50-per-day credit at the hospital cafeteria, Kay Kafe – not enough to feed the family of five. As the weeks wore on, the Murphys split grilled cheese sandwiches and paid for food out of pocket.

After ProPublica asked about the hospital’s food allowances, St. Jude said it would increase them as part of the changes scheduled to go into effect this month. The hospital switched from a $50-a-day cap per family to providing $25 a day to each family member. For a family of four, that would double the food benefit. A weekly stipend given to families in long-term housing was increased to $150 from $125.

For the Murphys, it was the loss of their work income, more than out-of-pocket expenses, that put them into a financial hole as Peyton’s treatment went on. Treg’s employer couldn’t pay him during his long absences.

Fearful of being evicted or having their car repossessed, Taylr said she asked a St. Jude social worker for assistance. The social worker helped her apply for grants from other charities. Taylr said the B+ Foundation paid their rent one month, which ensured they’d have a home to return to.

In the years since his initial treatment, Peyton has gone back to St. Jude repeatedly for exams and surgeries to remove malignant growths in his lungs. Taylr and Treg have missed more work to bring Peyton to Memphis, costing them thousands of dollars more in income.

By the start of this year, Taylr and Treg said they were about $20,000 in debt and panicking. Dustin Poirier, a former UFC champion from their hometown, heard from a friend about Peyton and the family’s financial trouble. He donated $10,000 to them from his personal charity and in May hosted a local fundraiser that collected enough to pay off their credit cards.

St. Jude families sometimes commiserate about money problems with each other, Taylr said, but few are aware of the extent of the hospital’s unspent resources. The Murphys said they didn’t know St. Jude has more than $5 billion in reserve or that it continues to raise hundreds of millions of dollars in surplus donations each year.

“That’s just insane,” Taylr said. “That just blows my mind. When we first started getting treated, people would be like, ‘Oh, St. Jude covers everything, that’s awesome.’ That’s not how it works. People don’t understand that. I truly didn’t understand before I got into St. Jude.”

Taylr and Treg said the doctors at St. Jude are “amazing” and they’re grateful for their son’s care. But they bristled at the assumption that it was covered by the hospital’s charity. The family’s insurance paid a substantial part of the bills.

“It’s not free,” Taylr said. “My husband works very hard for the insurance we have – and they are billed.” The Murphys pay $12,000 in health insurance premiums each year.

Their struggle continues. Peyton’s cancer has relapsed, and he’s making regular trips with his mom or dad back to St. Jude for chemotherapy. The family is again applying for help from other charities.
 

Wiped out savings

The costs associated with care at St. Jude caused at least one family to stop going to Memphis altogether.

Last winter, Kelly Edwards was excitedly searching through Tulsa real estate listings after years of diligently saving $10,000 for a down payment on a house. She craved a permanent home for herself and the two young brothers she had taken in five years earlier at the behest of a family friend. She hoped to adopt the boys, now 13 and 9, who call her mom.

In February, the older boy, DJ, was lethargic and uninterested in his schoolwork. After several doctor visits, he was diagnosed with acute lymphoblastic leukemia at a Tulsa hospital. The cancer, referred to as ALL, is the most common type among children, with survival rates that exceed 90%. A day after his diagnosis, DJ and Edwards were driving six hours to Memphis for treatment at St. Jude, which is affiliated with the Oklahoma hospital.

The pair stayed for free at an independently operated Ronald McDonald House near St. Jude, and a weekly stipend from the hospital helped to pay for meals – aid that Edwards said was a blessing. DJ had health insurance through the Oklahoma Medicaid program.

But as with the Murphys, lost income soon put Edwards’ family into financial jeopardy. She works as a supervisor for a company that delivers packages for Amazon. After she used up two weeks of paid time off, she stopped getting paychecks. The bills, however, kept coming: rent, car payments, utilities. To that was added the $250 a week she paid a friend to stay with DJ’s younger brother and her two dogs in Tulsa.

Within four months, her house savings were wiped out. Edwards said she told her St. Jude social worker about her financial woes but got no additional help.

One of Edwards’ adult daughters started a GoFundMe campaign to help, bringing in just over $3,000. Edwards said she appreciated the aid but believes donations were kept low by the widespread perception that St. Jude families don’t have financial problems.

“Everyone hears that everything is taken care of by St. Jude,” she said. “That is not true, but everyone has that mentality.” She said someone she knew asked her “what is that money going for if St. Jude’s is paying for everything?”

DJ was scheduled to go back to St. Jude for three weeks of treatment in August, but Edwards decided she simply couldn’t afford it. “I don’t have the money to go back and forth,” she said. She worked with DJ’s local doctors and found that the hospital near her home in Tulsa could provide the same treatment he was scheduled to get in Tennessee.

The local treatment allowed her to continue working some shifts and to be at home with both of her boys. DJ is also happier when he is home, Edwards said.

Edwards and the boys are now living in a small house her brother owns just outside Tulsa. Late on a recent weekday afternoon, DJ slowly shuffled into the living room, exhausted from a day of chemotherapy treatment.

He is in the midst of a 20-week regimen where he receives the cancer-killing drugs every other day, just one phase of a nearly three-year treatment plan. He wore an orange knit hat, T-shirt, and shorts. He rubbed his eyes before asking a visitor, “How is your day going?” He smiled at the positive response. When he heard the family was eating steak for dinner, he eagerly jumped up to start helping in the kitchen. After they moved in, Edwards hung family portraits on the walls to make it feel homier. She doesn’t expect they will be moving again any time soon.

The dream of buying a home of their own is gone.

Former ProPublica reporter Marshall Allen contributed reporting. Kirsten Berg contributed research.

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

A series of sharp knocks on his driver’s side window startled Jason Burt awake.

It was the middle of the night on a Saturday in 2016. Burt was sleeping in his pickup truck in the parking lot of St. Jude Children’s Research Hospital in downtown Memphis, Tenn., where his 5-year-old daughter was being treated for brain cancer. He’d driven more than 500 miles from his home in Central Texas to visit her.

A St. Jude security guard peered into the truck and asked Burt what he was doing. Burt explained that his daughter and her mother, his ex-girlfriend, were staying in the hospital’s free patient housing. But St. Jude provides housing for only one parent. Burt, a school bus driver making $20,000 a year, told the guard he couldn’t afford a hotel. The guard let the exhausted father go back to sleep.

St. Jude would do no more to find him a place to stay.

“They were aware of the situation,” Burt said. “I didn’t push anything. I was just grateful she was getting treated and I was doing what I needed to do.”

St. Jude is the largest and most highly regarded health care charity in the country. Each year, the Memphis hospital’s fundraisers send out hundreds of millions of letters, many with heart-wrenching photographs of children left bald from battling cancer. Celebrities like Jennifer Aniston and Sofia Vergara sing the hospital’s praises in televised advertisements. This year, St. Jude’s fundraising reached outer space. The SpaceX Inspiration4 mission in September included a former St. Jude patient as a crew member.

Last year, St. Jude raised a record $2 billion. U.S. News & World Report ranked it the country’s 10th-best children’s cancer hospital, and St. Jude raised roughly as much as the nine hospitals ahead of it put together. It currently has $5.2 billion in reserves, a sum large enough to run the institution at current levels for the next four and a half years without a single additional donation.

St. Jude makes a unique promise as part of its fundraising: “Families never receive a bill from St. Jude for treatment, travel, housing or food – because all a family should worry about is helping their child live.”

But for many families, treatment at St. Jude does not relieve all the financial burdens they incur in getting care for their children, including housing, travel, and food costs that fall outside the hospital’s strict limits, a ProPublica investigation has found.

While families may not receive a bill from St. Jude, the hospital doesn’t cover what’s usually the biggest source of financial stress associated with childhood cancer: The loss of income as parents quit or take leave from jobs to be with their child during treatment. For many families, the consequence is missed payments for cars, utilities, and cellphones. Others face eviction or foreclosure because they can’t keep up with rent and mortgage payments.

Parents at St. Jude have exhausted savings and retirement accounts, borrowed from family and friends, or asked other charities for aid. ProPublica identified more than 100 St. Jude families seeking financial help through the online fundraiser GoFundMe, with half of the campaigns started in the past two years. We counted scores of other events like concerts and yard sales organized to help St. Jude families in need.

One family relied on a mixed martial arts fighter to help raise money for expenses like car repairs and cellphone bills, items that St. Jude would not cover. Another spent $10,000, originally saved to purchase a home, on costs related to treatment at St. Jude.

Only about half of the $7.3 billion St. Jude has received in contributions in the past five fiscal years went to the hospital’s research and caring for patients, according to its financial filings with the Internal Revenue Service. About 30% covered the cost of its fundraising operations, and the remaining 20%, or $1 of every $5 donated, increased its reserve fund.

Further, ProPublica found, a substantial portion of the cost for treatment is paid not by St. Jude but by families’ private insurance or by Medicaid, the government insurance program for low-income families. About 90% of patients are insured, bringing in more than $100 million in reimbursements for treatment a year. If a family shows up at St. Jude without insurance, a company hired by the charity helps them find it. St. Jude does cover copays and deductibles, an unusual benefit.

St. Jude spends about $500 million a year on patient services – a figure that includes all medical care and other assistance. Very little of what St. Jude raises from the public goes to pay for food, travel, and housing for families, the investigation found. Last year, it was 2% of the money raised, or nearly $40 million.

In written responses to ProPublica, lawyers for St. Jude and its fundraising arm, the American Lebanese Syrian Associated Charities, or ALSAC, emphasized that countless families have benefited from the charity provided since the hospital opened its doors in 1962.

“ProPublica should be celebrating St. Jude and ALSAC for their commitment to finding cures, saving children’s lives, and optimizing patient outcomes,” one of their letters said.

It is unquestioned that St. Jude has helped thousands of children and their families over the decades. Patients have offered scores of testimonials about the hospital’s generosity and care.

“This often comes as a huge relief to families who often expect to sell all their belongings just so their children can get the medical care and treatment they need to save their lives,” the hospital’s lawyers wrote. “St. Jude and ALSAC understand that this arrangement cannot cover all financial obligations of all families, nor can St. Jude or ALSAC shield families from all the financial and emotional effects” of a child’s illness.

St. Jude said it discloses the limits of its aid to families on its website and in material provided to those whose children are admitted to the hospital. That includes the rule Burt ran into, that the hospital covers the travel and housing costs of only one caregiver and one patient. For many families, the daily food budget is capped at $50. In some cases, hotel stays en route are provided only if families travel more than 500 miles to get to St. Jude.

St. Jude said its assistance is “based on guidelines to ensure fairness and responsible use of donor funds” and on remaining compliant with a federal anti-kickback statute that makes it a criminal offense to offer something of value to induce a medical referral. St. Jude declined to explain how the law affects the amount or type of financial assistance it provides to families.

“St. Jude has never promised anyone – neither patients nor the public in general – that it can solve all financial problems,” the letter said.

When parents need additional financial help, St. Jude’s social workers often send them to smaller charities or in some cases suggest that they apply for government aid.

They refer many to the Andrew McDonough B+ Foundation, which gives more than $2.5 million a year in grants to thousands of families of pediatric cancer patients at hospitals across the country to help cover rent, utilities, and other urgent expenses.

Joe McDonough, the foundation’s founder and president, said St. Jude families have the same money problems as families of patients at other children’s hospitals, even though he said St. Jude’s marketing creates the public perception that it alleviates these burdens.

“People say to me, ‘Why are you helping St. Jude families?’ ” McDonough said. “Well, what happens when a family lives in Augusta, Georgia, and they’re being treated at St. Jude? They still have to pay the rent on their apartment back in Augusta, Georgia. They still have to make their car payment. And it’s not my position to say whether St. Jude should be paying for all those expenses or not. I’m just explaining that it’s not a totally free ride.”

The help St. Jude provides to families may soon be increasing.

After ProPublica provided St. Jude with the findings of its reporting, the hospital informed families of a dramatic expansion in the assistance it will give to parents and other relatives during their kids’ treatment in Memphis.

Among the most significant changes are increasing travel benefits to two parents instead of one and covering regular trips to Memphis for siblings and other loved ones. St. Jude’s letter to parents said the changes take effect Nov. 15.

That would’ve made a big difference for Burt.

Burt’s daughter, whom ProPublica is not identifying at her mother’s request, was originally diagnosed with cancer in early 2015, when doctors discovered a tumor pressing against her brain stem. She had successful emergency surgery to remove the mass at Dell Children’s Medical Center in Austin, Texas. Medicaid and Dell Children’s covered the bill, but the family was still faced with the cost of her ongoing treatment.

“At that point I’m thinking: ‘What am I going to do? I guess I’m selling my house, whatever it takes,’” Burt recalled. “Honestly, that was probably a big deciding factor for St. Jude.”

St. Jude accepted Burt’s daughter into a clinical trial, and the family moved to the hospital’s patient housing in Memphis for several months. Both parents stopped working for a time, and people in their hometown raised cash to pay their bills.

Her cancer relapsed the following year with several new, inoperable brain tumors. Burt and his daughter’s mom broke up during that round of treatment, and financial problems piled up.

Burt said his credit score dropped so low that utility companies refused to set up service unless he first paid a deposit. One of the family’s cars was repossessed, he said. Burt’s 2005 Chevrolet Colorado pickup has 300,000 miles on it, many of them logged on trips from Texas to Memphis. When Burt’s daughter was at St. Jude for treatment or exams, he’d work all week, then visit on many weekends where he would spend Saturday night sleeping in the hospital parking lot.

He asked hospital officials if he could sleep in St. Jude’s housing, but they turned him down, he said.

Burt said he was happy with the care St. Jude provided. His daughter’s health is stable, he said, and brain scans taken during her September exam confirmed her two remaining tumors haven’t grown. But he’s still trying to recover financially.

“It’s five years now,” Burt said, “and I’m not completely caught up yet.”
 

A fundraising giant

St. Jude began with a fledgling entertainer praying for a career break.

When Danny Thomas, a comic and actor best known for the TV sitcom “Make Room for Daddy,” was struggling to earn a living in the late 1930s, the devout Roman Catholic went to church and asked for help from the patron saint of desperate cases, St. Jude Thaddeus. If he made it big, Thomas promised to build “a shrine where the poor and the helpless and the hopeless may come for comfort and aid,” according to a history published by ALSAC.

Within five years, Thomas became a star and worked to fulfill his promise by building a children’s hospital named after St. Jude and a fundraising organization to support it. Thomas, whose parents were Lebanese immigrants, recruited others who shared his Middle Eastern roots to help.

He used his fame to raise the hospital’s profile, appearing in ads for St. Jude and hosting fundraising events starring the likes of Elvis Presley and Sammy Davis Jr. Thomas’ daughter Marlo, herself a TV star, succeeded him in championing St. Jude.

Today, St. Jude is a specialty treatment and research center with about 5,700 employees and 73 beds. Other top children’s hospitals have more staff and beds, and they also treat more conditions.

Though St. Jude raises money across the world, most of its patients come from Tennessee and surrounding states. Patients from elsewhere are usually enrolled in clinical trials.

ALSAC, which handles St. Jude’s fundraising and investments, has 2,188 employees in Memphis and in 36 regional offices across the country. More than 400 of the fundraising arm’s employees are paid over $100,000, according to IRS filings. The charity takes in so much money each year that it regularly steers hundreds of millions of dollars in donations to reserve accounts, the filings show.

Overall, St. Jude’s reserve has grown by 58% over the past five fiscal years, during which it has added $1.9 billion to its investment accounts and shifted its portfolio toward financial products designed to generate bigger returns than stocks, bonds, and mutual funds traditionally deliver. The charity stowed more than a third of the new surplus, $688 million, in riskier private equity investments.

IRS rules do not limit the size of a nonprofit’s reserves, and experts on charitable finance differ on best practices.

St. Jude meets Better Business Bureau guidelines, which call for charities to maintain reserves of less than three times total expenses, but other experts expressed alarm that the hospital had accumulated such a large sum of money.

The size of the St. Jude reserve is “staggering,” said Laura Otten, the director of LaSalle University’s master program in nonprofit leadership. She said a typical reserve for a nonprofit the size of St. Jude is one to two years of expenses. Donors generally want to know their dollars are being put to work, she said.

The hospital said it needs a large reserve because its unique operating model relies on donations to fund annual operating costs. “[W]e are highly donor-dependent and subject to the economic driven vagaries of charitable giving,” the hospital said in a written response to ProPublica questions.

But the hospital’s reserve is already more than large enough to buffer against recessions and potential drops in donations, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. “They should be spending the money as aggressively as they raise it, but they seem to be hoarding,” Bai said.

The hospital said it is also raising billions to fund the construction of new housing and research space, although its plans do not currently include spending any of the reserve on new facilities.

St. Jude’s reserves have ballooned at a time when researchers, oncologists, advocates, and families complain about a dearth of funding for pediatric cancer studies nationally.

Dozens of other children’s hospitals across the country have research divisions devoted to pediatric cancer and enroll their patients in clinical trials for new drugs and procedures. They pay for research staff and studies in part with donations from their local communities, often competing directly against St. Jude. ALSAC has regional offices in several U.S. cities with elite pediatric cancer centers of their own, including Atlanta, Chicago, Denver, and Seattle.

Coury Shadyac, an ALSAC vice president and daughter of the organization’s CEO, Richard Shadyac Jr., oversees a team of 45 fundraisers along the West Coast “raising $300 million annually” for St. Jude, according to her LinkedIn profile. That’s $100 million more in donations than either Children’s Hospital Los Angeles or Seattle Children’s Hospital, two of the nation’s leading pediatric cancer institutions, received in fiscal year 2019, IRS disclosures show. But it’s only a small part of St. Jude’s fundraising haul.

ALSAC’s ubiquitous fundraising has led to concerns that it undercuts other hospitals’ campaigns. Some doctors interviewed by ProPublica said they have encouraged donors to give their money to hospitals closer to home.

David Clark, a pediatrician and former longtime chairperson of pediatrics at Albany Medical Center in New York, said St. Jude raises tens of thousands of dollars in his region that does little to benefit the children with cancer in his area since almost all are treated locally. ALSAC has a fundraising office located a few miles from Albany Medical.

“They think of every way they can to make money and the least amount of ways to spend it,” Clark said. “They deceive people into supporting something that is totally dishonest.”

Nearly all St. Jude solicitations feature the hospital’s patients – the children usually smiling and bald from treatment – along with the familiar promise that it never sends families a bill.

It’s a message that ALSAC has tested and researched to maximize donations. Donors appreciate the promise to never bill families, said Mary Kate Tolan, an ALSAC executive, in a podcast last year. She added that no parent should have to take out a second mortgage or lose their job because their child is being treated at St. Jude.

Alternative messaging to the no-bills promise did not “perform as well,” said Tolan, who develops emerging technologies for ALSAC. Tolan did not return requests for comment.
 

“Borrowing and begging”

Catherine Rainey thought she would be free of financial worry when her 2-year-old daughter Harlee was admitted to St. Jude last year.

“The first thing my dad said was: ‘Catherine, you have nothing to worry about. They raise billions of dollars. Anytime you have a problem, you tell them and they will take care of it,’ ” she said.

But like many families, the Raineys discovered that St. Jude’s charity came with limits on payments for expenses such as travel that could be bewildering.

Harlee ended up at St. Jude after first going to nearby Niswonger Children’s Hospital in Johnson City, Tenn., in October 2020. The doctors there discovered a cancerous mass attached to her right kidney. The hospital is a St. Jude affiliate, and the doctors recommended the toddler be treated in Memphis.

Rainey, a single mother of two young girls, had to leave her job as a nurse for months to be with Harlee at St. Jude. The loss of income quickly created problems. “My family, we don’t come from money,” she said. “We are not doctors and billionaires. We make it. That is it.”

St. Jude did provide food and housing on campus. But the hospital said it couldn’t help with the items that were causing Rainey to worry, including car payments, insurance, and cellphone bills.

Rainey’s boss set up a GoFundMe account to help make up some of her lost income. A small local charity, Kari’s Heart Foundation, also helped out by paying about $3,000 worth of phone bills and car payments, staving off repossession.

“It was just a bunch of borrowing and begging,” Rainey said of her experience while her daughter was treated in Memphis. “They acted like it was coming out of their own pocket.”

Harlee has checkups at St. Jude every three months that last about four days. The costs of travel to and from St. Jude put an additional strain on Rainey and Harlee. St. Jude is an eight-hour ride, without stops, from Rainey’s home in Appalachia, Va., a town of 1,432 people near the Kentucky border.

Rainey said her daughter generally can make it about two-thirds of the way, with frequent stops, before she has had enough. “When she is done, she is really done,” Rainey said. “She will scream, cry, and kick.”

In July, in advance of an August trip to Memphis, Rainey called the patient services department at St. Jude to see whether they could help pay for a hotel to break up the travel day — an expense Rainey said she could not afford.

To qualify for a hotel reimbursement, Rainey said, St. Jude told her she had to live more than 500 miles from Memphis. The ride from her home to the hospital is 530 miles (a measurement ProPublica confirmed with mapping tools). However, Rainey said, St. Jude told her it measured the trip from city limit to city limit and came up with a distance of 491 miles. Even using that metric, the distance is still more than 500 miles, ProPublica found.

When she challenged the hospital’s stance, Rainey said she was berated by a patient services representative.

“I was feeling pissed off, and I was crying,” Rainey said of the interaction. “You give up your whole life for your child, and they tell you don’t worry about anything, we will cover this and then they tell you to just push through the drive.”

Rainey did what she could to make the trip go smoothly: She configured a small table to extend across her daughter’s car seat, so Harlee could play with the coloring books, markers, and Play-Doh bought for the ride. She packed snacks and a cooler full of drinks. Since Harlee was still potty training, she brought extra towels and clothes for accidents. The final step was handing Harlee her Baby Yoda doll once she settled into her car seat. Rainey had sewed a port in the doll’s chest to mirror the one Harlee has in hers.

About three hours from Memphis, Harlee was crying inconsolably. Rainey pulled off the interstate and stopped at the first hotel she could find. She later learned it had been described in online reviews as “awful,” a “nightmare,” “disgusting,” and “horrible.”

“I didn’t know the area,” she said. “The hotel was garbage. It just made it worse.”

The drive home also required a hotel stop, but this time Rainey was able to find one that was cleaner. A $100 donation from a local charity helped to offset the cost.

Among the changes St. Jude is making is to reimburse families like Rainey’s, who live more than 400 miles from the hospital, for an overnight stay at a hotel when making the trip to Memphis.

Rainey said she was called by a St. Jude representative after ProPublica asked about her situation and was told the hospital would pay for her past hotel stays when traveling back and forth to St. Jude. The representative, Rainey said, also told her the hospital discovered the way it had been measuring mileage was inaccurate.

“I am not the only one,” Rainey said. “There are others. They should reimburse all the families.”

The anxiety of unpaid bills piling up, combined with caring for a child undergoing chemotherapy or radiation, takes a severe toll on parents and guardians, said Christopher Hope, a UPS driver who started a Memphis-based foundation after meeting St. Jude parents who were in financial crisis.

Hope’s small charity spent $12,000 last year to help families. Parents in St. Jude social media groups often refer families in need to it. The charity has helped families cover mortgage and car payments.

“I never knew anything about this until hearing about it from families,” Hope said. “All we hear is about kids and treatment, not the other side of it.”
 

“It’s not free”

In addition to charities like Hope’s, St. Jude families have repeatedly turned to fundraising sites and networks of their relatives, friends, and neighbors to help cover basic expenses while unable to work during their children’s treatment. Parents’ requests on fundraising sites are sometimes desperate pleas.

In January 2017, one father in North Carolina said he’d had to abandon a business venture to take time for his son to receive care at St. Jude. His income had plummeted. He asked friends to give as little as $10 to “at least make it possible to survive.”

This year, a mother in Memphis whose 1-year-old son receives care at St. Jude for sickle cell disorder ran out of medical leave and couldn’t work her shifts at a clothing distribution center. After the child had a flare-up in July requiring several days of treatment at the hospital, she said she returned home to find her power shut off. Sitting in a dark apartment, unable to pay her utility bills, she set up a GoFundMe campaign. She received less than $20 through the site; her relatives eventually pooled $350 to get her electricity restored.

Even parents with stable jobs and private health insurance often take on debt and need outside help.

When Taylr and Treg Murphy’s 17-year-old son Peyton was diagnosed with cancer and needed monthslong treatment at St. Jude in 2017, the entire family – mom, dad, sister, and brother – went with him, traveling from their home in Lafayette, La., to Memphis. Treg took a leave from his job at an oil mining company and Taylr, who works at her mother’s bakery, did the same.

“We knew that it was going to be a collective team effort,” Treg said. “Without even a discussion, we figured that if Peyton’s got to go for the surgery, we’re all going.”

Peyton had an enormous tumor that had grown out of his right femur and was crowding his knee. Rounds of chemotherapy appeared to have killed osteosarcoma cells elsewhere in his body. But he needed to undergo a procedure called limb-sparing surgery that would require weeks of recovery time at the hospital.

The hospital agreed to allow all five family members to stay for free at St. Jude if they bunked together in a single room. It assigned them a spot in Tri Delta Place, its hotel-like short-term patient residence on the campus. Tri Delta is set up for visits of up to seven days, according to the hospital’s guide for volunteers, but the Murphys were there for almost 50.

Taylr said the unit at Tri Delta had no oven or stove and St. Jude provided no grocery money, instead allotting them a $50-per-day credit at the hospital cafeteria, Kay Kafe – not enough to feed the family of five. As the weeks wore on, the Murphys split grilled cheese sandwiches and paid for food out of pocket.

After ProPublica asked about the hospital’s food allowances, St. Jude said it would increase them as part of the changes scheduled to go into effect this month. The hospital switched from a $50-a-day cap per family to providing $25 a day to each family member. For a family of four, that would double the food benefit. A weekly stipend given to families in long-term housing was increased to $150 from $125.

For the Murphys, it was the loss of their work income, more than out-of-pocket expenses, that put them into a financial hole as Peyton’s treatment went on. Treg’s employer couldn’t pay him during his long absences.

Fearful of being evicted or having their car repossessed, Taylr said she asked a St. Jude social worker for assistance. The social worker helped her apply for grants from other charities. Taylr said the B+ Foundation paid their rent one month, which ensured they’d have a home to return to.

In the years since his initial treatment, Peyton has gone back to St. Jude repeatedly for exams and surgeries to remove malignant growths in his lungs. Taylr and Treg have missed more work to bring Peyton to Memphis, costing them thousands of dollars more in income.

By the start of this year, Taylr and Treg said they were about $20,000 in debt and panicking. Dustin Poirier, a former UFC champion from their hometown, heard from a friend about Peyton and the family’s financial trouble. He donated $10,000 to them from his personal charity and in May hosted a local fundraiser that collected enough to pay off their credit cards.

St. Jude families sometimes commiserate about money problems with each other, Taylr said, but few are aware of the extent of the hospital’s unspent resources. The Murphys said they didn’t know St. Jude has more than $5 billion in reserve or that it continues to raise hundreds of millions of dollars in surplus donations each year.

“That’s just insane,” Taylr said. “That just blows my mind. When we first started getting treated, people would be like, ‘Oh, St. Jude covers everything, that’s awesome.’ That’s not how it works. People don’t understand that. I truly didn’t understand before I got into St. Jude.”

Taylr and Treg said the doctors at St. Jude are “amazing” and they’re grateful for their son’s care. But they bristled at the assumption that it was covered by the hospital’s charity. The family’s insurance paid a substantial part of the bills.

“It’s not free,” Taylr said. “My husband works very hard for the insurance we have – and they are billed.” The Murphys pay $12,000 in health insurance premiums each year.

Their struggle continues. Peyton’s cancer has relapsed, and he’s making regular trips with his mom or dad back to St. Jude for chemotherapy. The family is again applying for help from other charities.
 

Wiped out savings

The costs associated with care at St. Jude caused at least one family to stop going to Memphis altogether.

Last winter, Kelly Edwards was excitedly searching through Tulsa real estate listings after years of diligently saving $10,000 for a down payment on a house. She craved a permanent home for herself and the two young brothers she had taken in five years earlier at the behest of a family friend. She hoped to adopt the boys, now 13 and 9, who call her mom.

In February, the older boy, DJ, was lethargic and uninterested in his schoolwork. After several doctor visits, he was diagnosed with acute lymphoblastic leukemia at a Tulsa hospital. The cancer, referred to as ALL, is the most common type among children, with survival rates that exceed 90%. A day after his diagnosis, DJ and Edwards were driving six hours to Memphis for treatment at St. Jude, which is affiliated with the Oklahoma hospital.

The pair stayed for free at an independently operated Ronald McDonald House near St. Jude, and a weekly stipend from the hospital helped to pay for meals – aid that Edwards said was a blessing. DJ had health insurance through the Oklahoma Medicaid program.

But as with the Murphys, lost income soon put Edwards’ family into financial jeopardy. She works as a supervisor for a company that delivers packages for Amazon. After she used up two weeks of paid time off, she stopped getting paychecks. The bills, however, kept coming: rent, car payments, utilities. To that was added the $250 a week she paid a friend to stay with DJ’s younger brother and her two dogs in Tulsa.

Within four months, her house savings were wiped out. Edwards said she told her St. Jude social worker about her financial woes but got no additional help.

One of Edwards’ adult daughters started a GoFundMe campaign to help, bringing in just over $3,000. Edwards said she appreciated the aid but believes donations were kept low by the widespread perception that St. Jude families don’t have financial problems.

“Everyone hears that everything is taken care of by St. Jude,” she said. “That is not true, but everyone has that mentality.” She said someone she knew asked her “what is that money going for if St. Jude’s is paying for everything?”

DJ was scheduled to go back to St. Jude for three weeks of treatment in August, but Edwards decided she simply couldn’t afford it. “I don’t have the money to go back and forth,” she said. She worked with DJ’s local doctors and found that the hospital near her home in Tulsa could provide the same treatment he was scheduled to get in Tennessee.

The local treatment allowed her to continue working some shifts and to be at home with both of her boys. DJ is also happier when he is home, Edwards said.

Edwards and the boys are now living in a small house her brother owns just outside Tulsa. Late on a recent weekday afternoon, DJ slowly shuffled into the living room, exhausted from a day of chemotherapy treatment.

He is in the midst of a 20-week regimen where he receives the cancer-killing drugs every other day, just one phase of a nearly three-year treatment plan. He wore an orange knit hat, T-shirt, and shorts. He rubbed his eyes before asking a visitor, “How is your day going?” He smiled at the positive response. When he heard the family was eating steak for dinner, he eagerly jumped up to start helping in the kitchen. After they moved in, Edwards hung family portraits on the walls to make it feel homier. She doesn’t expect they will be moving again any time soon.

The dream of buying a home of their own is gone.

Former ProPublica reporter Marshall Allen contributed reporting. Kirsten Berg contributed research.

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

A series of sharp knocks on his driver’s side window startled Jason Burt awake.

It was the middle of the night on a Saturday in 2016. Burt was sleeping in his pickup truck in the parking lot of St. Jude Children’s Research Hospital in downtown Memphis, Tenn., where his 5-year-old daughter was being treated for brain cancer. He’d driven more than 500 miles from his home in Central Texas to visit her.

A St. Jude security guard peered into the truck and asked Burt what he was doing. Burt explained that his daughter and her mother, his ex-girlfriend, were staying in the hospital’s free patient housing. But St. Jude provides housing for only one parent. Burt, a school bus driver making $20,000 a year, told the guard he couldn’t afford a hotel. The guard let the exhausted father go back to sleep.

St. Jude would do no more to find him a place to stay.

“They were aware of the situation,” Burt said. “I didn’t push anything. I was just grateful she was getting treated and I was doing what I needed to do.”

St. Jude is the largest and most highly regarded health care charity in the country. Each year, the Memphis hospital’s fundraisers send out hundreds of millions of letters, many with heart-wrenching photographs of children left bald from battling cancer. Celebrities like Jennifer Aniston and Sofia Vergara sing the hospital’s praises in televised advertisements. This year, St. Jude’s fundraising reached outer space. The SpaceX Inspiration4 mission in September included a former St. Jude patient as a crew member.

Last year, St. Jude raised a record $2 billion. U.S. News & World Report ranked it the country’s 10th-best children’s cancer hospital, and St. Jude raised roughly as much as the nine hospitals ahead of it put together. It currently has $5.2 billion in reserves, a sum large enough to run the institution at current levels for the next four and a half years without a single additional donation.

St. Jude makes a unique promise as part of its fundraising: “Families never receive a bill from St. Jude for treatment, travel, housing or food – because all a family should worry about is helping their child live.”

But for many families, treatment at St. Jude does not relieve all the financial burdens they incur in getting care for their children, including housing, travel, and food costs that fall outside the hospital’s strict limits, a ProPublica investigation has found.

While families may not receive a bill from St. Jude, the hospital doesn’t cover what’s usually the biggest source of financial stress associated with childhood cancer: The loss of income as parents quit or take leave from jobs to be with their child during treatment. For many families, the consequence is missed payments for cars, utilities, and cellphones. Others face eviction or foreclosure because they can’t keep up with rent and mortgage payments.

Parents at St. Jude have exhausted savings and retirement accounts, borrowed from family and friends, or asked other charities for aid. ProPublica identified more than 100 St. Jude families seeking financial help through the online fundraiser GoFundMe, with half of the campaigns started in the past two years. We counted scores of other events like concerts and yard sales organized to help St. Jude families in need.

One family relied on a mixed martial arts fighter to help raise money for expenses like car repairs and cellphone bills, items that St. Jude would not cover. Another spent $10,000, originally saved to purchase a home, on costs related to treatment at St. Jude.

Only about half of the $7.3 billion St. Jude has received in contributions in the past five fiscal years went to the hospital’s research and caring for patients, according to its financial filings with the Internal Revenue Service. About 30% covered the cost of its fundraising operations, and the remaining 20%, or $1 of every $5 donated, increased its reserve fund.

Further, ProPublica found, a substantial portion of the cost for treatment is paid not by St. Jude but by families’ private insurance or by Medicaid, the government insurance program for low-income families. About 90% of patients are insured, bringing in more than $100 million in reimbursements for treatment a year. If a family shows up at St. Jude without insurance, a company hired by the charity helps them find it. St. Jude does cover copays and deductibles, an unusual benefit.

St. Jude spends about $500 million a year on patient services – a figure that includes all medical care and other assistance. Very little of what St. Jude raises from the public goes to pay for food, travel, and housing for families, the investigation found. Last year, it was 2% of the money raised, or nearly $40 million.

In written responses to ProPublica, lawyers for St. Jude and its fundraising arm, the American Lebanese Syrian Associated Charities, or ALSAC, emphasized that countless families have benefited from the charity provided since the hospital opened its doors in 1962.

“ProPublica should be celebrating St. Jude and ALSAC for their commitment to finding cures, saving children’s lives, and optimizing patient outcomes,” one of their letters said.

It is unquestioned that St. Jude has helped thousands of children and their families over the decades. Patients have offered scores of testimonials about the hospital’s generosity and care.

“This often comes as a huge relief to families who often expect to sell all their belongings just so their children can get the medical care and treatment they need to save their lives,” the hospital’s lawyers wrote. “St. Jude and ALSAC understand that this arrangement cannot cover all financial obligations of all families, nor can St. Jude or ALSAC shield families from all the financial and emotional effects” of a child’s illness.

St. Jude said it discloses the limits of its aid to families on its website and in material provided to those whose children are admitted to the hospital. That includes the rule Burt ran into, that the hospital covers the travel and housing costs of only one caregiver and one patient. For many families, the daily food budget is capped at $50. In some cases, hotel stays en route are provided only if families travel more than 500 miles to get to St. Jude.

St. Jude said its assistance is “based on guidelines to ensure fairness and responsible use of donor funds” and on remaining compliant with a federal anti-kickback statute that makes it a criminal offense to offer something of value to induce a medical referral. St. Jude declined to explain how the law affects the amount or type of financial assistance it provides to families.

“St. Jude has never promised anyone – neither patients nor the public in general – that it can solve all financial problems,” the letter said.

When parents need additional financial help, St. Jude’s social workers often send them to smaller charities or in some cases suggest that they apply for government aid.

They refer many to the Andrew McDonough B+ Foundation, which gives more than $2.5 million a year in grants to thousands of families of pediatric cancer patients at hospitals across the country to help cover rent, utilities, and other urgent expenses.

Joe McDonough, the foundation’s founder and president, said St. Jude families have the same money problems as families of patients at other children’s hospitals, even though he said St. Jude’s marketing creates the public perception that it alleviates these burdens.

“People say to me, ‘Why are you helping St. Jude families?’ ” McDonough said. “Well, what happens when a family lives in Augusta, Georgia, and they’re being treated at St. Jude? They still have to pay the rent on their apartment back in Augusta, Georgia. They still have to make their car payment. And it’s not my position to say whether St. Jude should be paying for all those expenses or not. I’m just explaining that it’s not a totally free ride.”

The help St. Jude provides to families may soon be increasing.

After ProPublica provided St. Jude with the findings of its reporting, the hospital informed families of a dramatic expansion in the assistance it will give to parents and other relatives during their kids’ treatment in Memphis.

Among the most significant changes are increasing travel benefits to two parents instead of one and covering regular trips to Memphis for siblings and other loved ones. St. Jude’s letter to parents said the changes take effect Nov. 15.

That would’ve made a big difference for Burt.

Burt’s daughter, whom ProPublica is not identifying at her mother’s request, was originally diagnosed with cancer in early 2015, when doctors discovered a tumor pressing against her brain stem. She had successful emergency surgery to remove the mass at Dell Children’s Medical Center in Austin, Texas. Medicaid and Dell Children’s covered the bill, but the family was still faced with the cost of her ongoing treatment.

“At that point I’m thinking: ‘What am I going to do? I guess I’m selling my house, whatever it takes,’” Burt recalled. “Honestly, that was probably a big deciding factor for St. Jude.”

St. Jude accepted Burt’s daughter into a clinical trial, and the family moved to the hospital’s patient housing in Memphis for several months. Both parents stopped working for a time, and people in their hometown raised cash to pay their bills.

Her cancer relapsed the following year with several new, inoperable brain tumors. Burt and his daughter’s mom broke up during that round of treatment, and financial problems piled up.

Burt said his credit score dropped so low that utility companies refused to set up service unless he first paid a deposit. One of the family’s cars was repossessed, he said. Burt’s 2005 Chevrolet Colorado pickup has 300,000 miles on it, many of them logged on trips from Texas to Memphis. When Burt’s daughter was at St. Jude for treatment or exams, he’d work all week, then visit on many weekends where he would spend Saturday night sleeping in the hospital parking lot.

He asked hospital officials if he could sleep in St. Jude’s housing, but they turned him down, he said.

Burt said he was happy with the care St. Jude provided. His daughter’s health is stable, he said, and brain scans taken during her September exam confirmed her two remaining tumors haven’t grown. But he’s still trying to recover financially.

“It’s five years now,” Burt said, “and I’m not completely caught up yet.”
 

A fundraising giant

St. Jude began with a fledgling entertainer praying for a career break.

When Danny Thomas, a comic and actor best known for the TV sitcom “Make Room for Daddy,” was struggling to earn a living in the late 1930s, the devout Roman Catholic went to church and asked for help from the patron saint of desperate cases, St. Jude Thaddeus. If he made it big, Thomas promised to build “a shrine where the poor and the helpless and the hopeless may come for comfort and aid,” according to a history published by ALSAC.

Within five years, Thomas became a star and worked to fulfill his promise by building a children’s hospital named after St. Jude and a fundraising organization to support it. Thomas, whose parents were Lebanese immigrants, recruited others who shared his Middle Eastern roots to help.

He used his fame to raise the hospital’s profile, appearing in ads for St. Jude and hosting fundraising events starring the likes of Elvis Presley and Sammy Davis Jr. Thomas’ daughter Marlo, herself a TV star, succeeded him in championing St. Jude.

Today, St. Jude is a specialty treatment and research center with about 5,700 employees and 73 beds. Other top children’s hospitals have more staff and beds, and they also treat more conditions.

Though St. Jude raises money across the world, most of its patients come from Tennessee and surrounding states. Patients from elsewhere are usually enrolled in clinical trials.

ALSAC, which handles St. Jude’s fundraising and investments, has 2,188 employees in Memphis and in 36 regional offices across the country. More than 400 of the fundraising arm’s employees are paid over $100,000, according to IRS filings. The charity takes in so much money each year that it regularly steers hundreds of millions of dollars in donations to reserve accounts, the filings show.

Overall, St. Jude’s reserve has grown by 58% over the past five fiscal years, during which it has added $1.9 billion to its investment accounts and shifted its portfolio toward financial products designed to generate bigger returns than stocks, bonds, and mutual funds traditionally deliver. The charity stowed more than a third of the new surplus, $688 million, in riskier private equity investments.

IRS rules do not limit the size of a nonprofit’s reserves, and experts on charitable finance differ on best practices.

St. Jude meets Better Business Bureau guidelines, which call for charities to maintain reserves of less than three times total expenses, but other experts expressed alarm that the hospital had accumulated such a large sum of money.

The size of the St. Jude reserve is “staggering,” said Laura Otten, the director of LaSalle University’s master program in nonprofit leadership. She said a typical reserve for a nonprofit the size of St. Jude is one to two years of expenses. Donors generally want to know their dollars are being put to work, she said.

The hospital said it needs a large reserve because its unique operating model relies on donations to fund annual operating costs. “[W]e are highly donor-dependent and subject to the economic driven vagaries of charitable giving,” the hospital said in a written response to ProPublica questions.

But the hospital’s reserve is already more than large enough to buffer against recessions and potential drops in donations, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. “They should be spending the money as aggressively as they raise it, but they seem to be hoarding,” Bai said.

The hospital said it is also raising billions to fund the construction of new housing and research space, although its plans do not currently include spending any of the reserve on new facilities.

St. Jude’s reserves have ballooned at a time when researchers, oncologists, advocates, and families complain about a dearth of funding for pediatric cancer studies nationally.

Dozens of other children’s hospitals across the country have research divisions devoted to pediatric cancer and enroll their patients in clinical trials for new drugs and procedures. They pay for research staff and studies in part with donations from their local communities, often competing directly against St. Jude. ALSAC has regional offices in several U.S. cities with elite pediatric cancer centers of their own, including Atlanta, Chicago, Denver, and Seattle.

Coury Shadyac, an ALSAC vice president and daughter of the organization’s CEO, Richard Shadyac Jr., oversees a team of 45 fundraisers along the West Coast “raising $300 million annually” for St. Jude, according to her LinkedIn profile. That’s $100 million more in donations than either Children’s Hospital Los Angeles or Seattle Children’s Hospital, two of the nation’s leading pediatric cancer institutions, received in fiscal year 2019, IRS disclosures show. But it’s only a small part of St. Jude’s fundraising haul.

ALSAC’s ubiquitous fundraising has led to concerns that it undercuts other hospitals’ campaigns. Some doctors interviewed by ProPublica said they have encouraged donors to give their money to hospitals closer to home.

David Clark, a pediatrician and former longtime chairperson of pediatrics at Albany Medical Center in New York, said St. Jude raises tens of thousands of dollars in his region that does little to benefit the children with cancer in his area since almost all are treated locally. ALSAC has a fundraising office located a few miles from Albany Medical.

“They think of every way they can to make money and the least amount of ways to spend it,” Clark said. “They deceive people into supporting something that is totally dishonest.”

Nearly all St. Jude solicitations feature the hospital’s patients – the children usually smiling and bald from treatment – along with the familiar promise that it never sends families a bill.

It’s a message that ALSAC has tested and researched to maximize donations. Donors appreciate the promise to never bill families, said Mary Kate Tolan, an ALSAC executive, in a podcast last year. She added that no parent should have to take out a second mortgage or lose their job because their child is being treated at St. Jude.

Alternative messaging to the no-bills promise did not “perform as well,” said Tolan, who develops emerging technologies for ALSAC. Tolan did not return requests for comment.
 

“Borrowing and begging”

Catherine Rainey thought she would be free of financial worry when her 2-year-old daughter Harlee was admitted to St. Jude last year.

“The first thing my dad said was: ‘Catherine, you have nothing to worry about. They raise billions of dollars. Anytime you have a problem, you tell them and they will take care of it,’ ” she said.

But like many families, the Raineys discovered that St. Jude’s charity came with limits on payments for expenses such as travel that could be bewildering.

Harlee ended up at St. Jude after first going to nearby Niswonger Children’s Hospital in Johnson City, Tenn., in October 2020. The doctors there discovered a cancerous mass attached to her right kidney. The hospital is a St. Jude affiliate, and the doctors recommended the toddler be treated in Memphis.

Rainey, a single mother of two young girls, had to leave her job as a nurse for months to be with Harlee at St. Jude. The loss of income quickly created problems. “My family, we don’t come from money,” she said. “We are not doctors and billionaires. We make it. That is it.”

St. Jude did provide food and housing on campus. But the hospital said it couldn’t help with the items that were causing Rainey to worry, including car payments, insurance, and cellphone bills.

Rainey’s boss set up a GoFundMe account to help make up some of her lost income. A small local charity, Kari’s Heart Foundation, also helped out by paying about $3,000 worth of phone bills and car payments, staving off repossession.

“It was just a bunch of borrowing and begging,” Rainey said of her experience while her daughter was treated in Memphis. “They acted like it was coming out of their own pocket.”

Harlee has checkups at St. Jude every three months that last about four days. The costs of travel to and from St. Jude put an additional strain on Rainey and Harlee. St. Jude is an eight-hour ride, without stops, from Rainey’s home in Appalachia, Va., a town of 1,432 people near the Kentucky border.

Rainey said her daughter generally can make it about two-thirds of the way, with frequent stops, before she has had enough. “When she is done, she is really done,” Rainey said. “She will scream, cry, and kick.”

In July, in advance of an August trip to Memphis, Rainey called the patient services department at St. Jude to see whether they could help pay for a hotel to break up the travel day — an expense Rainey said she could not afford.

To qualify for a hotel reimbursement, Rainey said, St. Jude told her she had to live more than 500 miles from Memphis. The ride from her home to the hospital is 530 miles (a measurement ProPublica confirmed with mapping tools). However, Rainey said, St. Jude told her it measured the trip from city limit to city limit and came up with a distance of 491 miles. Even using that metric, the distance is still more than 500 miles, ProPublica found.

When she challenged the hospital’s stance, Rainey said she was berated by a patient services representative.

“I was feeling pissed off, and I was crying,” Rainey said of the interaction. “You give up your whole life for your child, and they tell you don’t worry about anything, we will cover this and then they tell you to just push through the drive.”

Rainey did what she could to make the trip go smoothly: She configured a small table to extend across her daughter’s car seat, so Harlee could play with the coloring books, markers, and Play-Doh bought for the ride. She packed snacks and a cooler full of drinks. Since Harlee was still potty training, she brought extra towels and clothes for accidents. The final step was handing Harlee her Baby Yoda doll once she settled into her car seat. Rainey had sewed a port in the doll’s chest to mirror the one Harlee has in hers.

About three hours from Memphis, Harlee was crying inconsolably. Rainey pulled off the interstate and stopped at the first hotel she could find. She later learned it had been described in online reviews as “awful,” a “nightmare,” “disgusting,” and “horrible.”

“I didn’t know the area,” she said. “The hotel was garbage. It just made it worse.”

The drive home also required a hotel stop, but this time Rainey was able to find one that was cleaner. A $100 donation from a local charity helped to offset the cost.

Among the changes St. Jude is making is to reimburse families like Rainey’s, who live more than 400 miles from the hospital, for an overnight stay at a hotel when making the trip to Memphis.

Rainey said she was called by a St. Jude representative after ProPublica asked about her situation and was told the hospital would pay for her past hotel stays when traveling back and forth to St. Jude. The representative, Rainey said, also told her the hospital discovered the way it had been measuring mileage was inaccurate.

“I am not the only one,” Rainey said. “There are others. They should reimburse all the families.”

The anxiety of unpaid bills piling up, combined with caring for a child undergoing chemotherapy or radiation, takes a severe toll on parents and guardians, said Christopher Hope, a UPS driver who started a Memphis-based foundation after meeting St. Jude parents who were in financial crisis.

Hope’s small charity spent $12,000 last year to help families. Parents in St. Jude social media groups often refer families in need to it. The charity has helped families cover mortgage and car payments.

“I never knew anything about this until hearing about it from families,” Hope said. “All we hear is about kids and treatment, not the other side of it.”
 

“It’s not free”

In addition to charities like Hope’s, St. Jude families have repeatedly turned to fundraising sites and networks of their relatives, friends, and neighbors to help cover basic expenses while unable to work during their children’s treatment. Parents’ requests on fundraising sites are sometimes desperate pleas.

In January 2017, one father in North Carolina said he’d had to abandon a business venture to take time for his son to receive care at St. Jude. His income had plummeted. He asked friends to give as little as $10 to “at least make it possible to survive.”

This year, a mother in Memphis whose 1-year-old son receives care at St. Jude for sickle cell disorder ran out of medical leave and couldn’t work her shifts at a clothing distribution center. After the child had a flare-up in July requiring several days of treatment at the hospital, she said she returned home to find her power shut off. Sitting in a dark apartment, unable to pay her utility bills, she set up a GoFundMe campaign. She received less than $20 through the site; her relatives eventually pooled $350 to get her electricity restored.

Even parents with stable jobs and private health insurance often take on debt and need outside help.

When Taylr and Treg Murphy’s 17-year-old son Peyton was diagnosed with cancer and needed monthslong treatment at St. Jude in 2017, the entire family – mom, dad, sister, and brother – went with him, traveling from their home in Lafayette, La., to Memphis. Treg took a leave from his job at an oil mining company and Taylr, who works at her mother’s bakery, did the same.

“We knew that it was going to be a collective team effort,” Treg said. “Without even a discussion, we figured that if Peyton’s got to go for the surgery, we’re all going.”

Peyton had an enormous tumor that had grown out of his right femur and was crowding his knee. Rounds of chemotherapy appeared to have killed osteosarcoma cells elsewhere in his body. But he needed to undergo a procedure called limb-sparing surgery that would require weeks of recovery time at the hospital.

The hospital agreed to allow all five family members to stay for free at St. Jude if they bunked together in a single room. It assigned them a spot in Tri Delta Place, its hotel-like short-term patient residence on the campus. Tri Delta is set up for visits of up to seven days, according to the hospital’s guide for volunteers, but the Murphys were there for almost 50.

Taylr said the unit at Tri Delta had no oven or stove and St. Jude provided no grocery money, instead allotting them a $50-per-day credit at the hospital cafeteria, Kay Kafe – not enough to feed the family of five. As the weeks wore on, the Murphys split grilled cheese sandwiches and paid for food out of pocket.

After ProPublica asked about the hospital’s food allowances, St. Jude said it would increase them as part of the changes scheduled to go into effect this month. The hospital switched from a $50-a-day cap per family to providing $25 a day to each family member. For a family of four, that would double the food benefit. A weekly stipend given to families in long-term housing was increased to $150 from $125.

For the Murphys, it was the loss of their work income, more than out-of-pocket expenses, that put them into a financial hole as Peyton’s treatment went on. Treg’s employer couldn’t pay him during his long absences.

Fearful of being evicted or having their car repossessed, Taylr said she asked a St. Jude social worker for assistance. The social worker helped her apply for grants from other charities. Taylr said the B+ Foundation paid their rent one month, which ensured they’d have a home to return to.

In the years since his initial treatment, Peyton has gone back to St. Jude repeatedly for exams and surgeries to remove malignant growths in his lungs. Taylr and Treg have missed more work to bring Peyton to Memphis, costing them thousands of dollars more in income.

By the start of this year, Taylr and Treg said they were about $20,000 in debt and panicking. Dustin Poirier, a former UFC champion from their hometown, heard from a friend about Peyton and the family’s financial trouble. He donated $10,000 to them from his personal charity and in May hosted a local fundraiser that collected enough to pay off their credit cards.

St. Jude families sometimes commiserate about money problems with each other, Taylr said, but few are aware of the extent of the hospital’s unspent resources. The Murphys said they didn’t know St. Jude has more than $5 billion in reserve or that it continues to raise hundreds of millions of dollars in surplus donations each year.

“That’s just insane,” Taylr said. “That just blows my mind. When we first started getting treated, people would be like, ‘Oh, St. Jude covers everything, that’s awesome.’ That’s not how it works. People don’t understand that. I truly didn’t understand before I got into St. Jude.”

Taylr and Treg said the doctors at St. Jude are “amazing” and they’re grateful for their son’s care. But they bristled at the assumption that it was covered by the hospital’s charity. The family’s insurance paid a substantial part of the bills.

“It’s not free,” Taylr said. “My husband works very hard for the insurance we have – and they are billed.” The Murphys pay $12,000 in health insurance premiums each year.

Their struggle continues. Peyton’s cancer has relapsed, and he’s making regular trips with his mom or dad back to St. Jude for chemotherapy. The family is again applying for help from other charities.
 

Wiped out savings

The costs associated with care at St. Jude caused at least one family to stop going to Memphis altogether.

Last winter, Kelly Edwards was excitedly searching through Tulsa real estate listings after years of diligently saving $10,000 for a down payment on a house. She craved a permanent home for herself and the two young brothers she had taken in five years earlier at the behest of a family friend. She hoped to adopt the boys, now 13 and 9, who call her mom.

In February, the older boy, DJ, was lethargic and uninterested in his schoolwork. After several doctor visits, he was diagnosed with acute lymphoblastic leukemia at a Tulsa hospital. The cancer, referred to as ALL, is the most common type among children, with survival rates that exceed 90%. A day after his diagnosis, DJ and Edwards were driving six hours to Memphis for treatment at St. Jude, which is affiliated with the Oklahoma hospital.

The pair stayed for free at an independently operated Ronald McDonald House near St. Jude, and a weekly stipend from the hospital helped to pay for meals – aid that Edwards said was a blessing. DJ had health insurance through the Oklahoma Medicaid program.

But as with the Murphys, lost income soon put Edwards’ family into financial jeopardy. She works as a supervisor for a company that delivers packages for Amazon. After she used up two weeks of paid time off, she stopped getting paychecks. The bills, however, kept coming: rent, car payments, utilities. To that was added the $250 a week she paid a friend to stay with DJ’s younger brother and her two dogs in Tulsa.

Within four months, her house savings were wiped out. Edwards said she told her St. Jude social worker about her financial woes but got no additional help.

One of Edwards’ adult daughters started a GoFundMe campaign to help, bringing in just over $3,000. Edwards said she appreciated the aid but believes donations were kept low by the widespread perception that St. Jude families don’t have financial problems.

“Everyone hears that everything is taken care of by St. Jude,” she said. “That is not true, but everyone has that mentality.” She said someone she knew asked her “what is that money going for if St. Jude’s is paying for everything?”

DJ was scheduled to go back to St. Jude for three weeks of treatment in August, but Edwards decided she simply couldn’t afford it. “I don’t have the money to go back and forth,” she said. She worked with DJ’s local doctors and found that the hospital near her home in Tulsa could provide the same treatment he was scheduled to get in Tennessee.

The local treatment allowed her to continue working some shifts and to be at home with both of her boys. DJ is also happier when he is home, Edwards said.

Edwards and the boys are now living in a small house her brother owns just outside Tulsa. Late on a recent weekday afternoon, DJ slowly shuffled into the living room, exhausted from a day of chemotherapy treatment.

He is in the midst of a 20-week regimen where he receives the cancer-killing drugs every other day, just one phase of a nearly three-year treatment plan. He wore an orange knit hat, T-shirt, and shorts. He rubbed his eyes before asking a visitor, “How is your day going?” He smiled at the positive response. When he heard the family was eating steak for dinner, he eagerly jumped up to start helping in the kitchen. After they moved in, Edwards hung family portraits on the walls to make it feel homier. She doesn’t expect they will be moving again any time soon.

The dream of buying a home of their own is gone.

Former ProPublica reporter Marshall Allen contributed reporting. Kirsten Berg contributed research.

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

In this issue of JFP, the Clinical Inquiry seeks to answer the question: What are effective injection treatments for lateral epicondylitis? Answering this question proved to be a daunting task for the authors. The difficulty lies in answering this question: effective compared to what?

What they discovered is that no type of injection therapy has been proven to be better than a saline injection.

The injections evaluated in their comprehensive review—corticosteroids, botulinum toxin, hyaluronic acid, platelet-rich plasma, prolotherapy, and autologous blood—have been compared in randomized trials to each other, usual treatment, no treatment, nonmedication treatments, noninjection treatments, surgeries, braces, and physical therapy.¹ But which comparison is the best one to determine true effectiveness beyond a placebo effect?

There are 2 choices for an ideal comparison group. One choice compares the active intervention to an adequate placebo, the other compares it to another treatment that has previously been proven effective. Ideally, the other treatment would be a “gold standard”—that is, the best treatment currently available. Unfortunately, for treatment of lateral epicondylitis, no gold standard has been established.

So, what is an “adequate placebo” for injection therapy? This is a very difficult question. The placebo should probably include putting a needle into the treatment site and injecting a nonactive substance, such as saline solution. This is the comparison group Vukelic et al chose for their review. But even saline could theoretically be therapeutic.

Another fair comparison for the treatment of lateral epicondylitis would be an injection near, but not at, the lateral epicondyle. Yet another comparison—dry needling without any medication to the lateral epicondyle vs dry needling of an adjacent location—would also be a fair comparison to help understand the effect of needling alone. Unfortunately, these comparisons have not been explored in randomized controlled trials. Although several studies have evaluated dry needling for lateral epicondylitis,^2-4 none have used a fair comparison.

Some studies¹ evaluating treatments for lateral epicondylitis used comparisons to agents that are ineffective or of uncertain effectiveness. Comparing 1 agent to another ineffective or potentially harmful agent obscures our knowledge. Evidence-based medicine must be built on a reliable foundation.

Vukelic and colleagues did an admirable job of selecting studies with an appropriate comparison group—that is, saline injection, the best comparator that has been studied. What they discovered is that no type of injection therapy has been proven to be better than a saline injection.

So, if your patient is not satisfied with conservative therapy for epicondylitis and wants an injection, salt water seems as good as anything.

In this issue of JFP, the Clinical Inquiry seeks to answer the question: What are effective injection treatments for lateral epicondylitis? Answering this question proved to be a daunting task for the authors. The difficulty lies in answering this question: effective compared to what?

What they discovered is that no type of injection therapy has been proven to be better than a saline injection.

The injections evaluated in their comprehensive review—corticosteroids, botulinum toxin, hyaluronic acid, platelet-rich plasma, prolotherapy, and autologous blood—have been compared in randomized trials to each other, usual treatment, no treatment, nonmedication treatments, noninjection treatments, surgeries, braces, and physical therapy.¹ But which comparison is the best one to determine true effectiveness beyond a placebo effect?

There are 2 choices for an ideal comparison group. One choice compares the active intervention to an adequate placebo, the other compares it to another treatment that has previously been proven effective. Ideally, the other treatment would be a “gold standard”—that is, the best treatment currently available. Unfortunately, for treatment of lateral epicondylitis, no gold standard has been established.

So, what is an “adequate placebo” for injection therapy? This is a very difficult question. The placebo should probably include putting a needle into the treatment site and injecting a nonactive substance, such as saline solution. This is the comparison group Vukelic et al chose for their review. But even saline could theoretically be therapeutic.

Another fair comparison for the treatment of lateral epicondylitis would be an injection near, but not at, the lateral epicondyle. Yet another comparison—dry needling without any medication to the lateral epicondyle vs dry needling of an adjacent location—would also be a fair comparison to help understand the effect of needling alone. Unfortunately, these comparisons have not been explored in randomized controlled trials. Although several studies have evaluated dry needling for lateral epicondylitis,^2-4 none have used a fair comparison.

Some studies¹ evaluating treatments for lateral epicondylitis used comparisons to agents that are ineffective or of uncertain effectiveness. Comparing 1 agent to another ineffective or potentially harmful agent obscures our knowledge. Evidence-based medicine must be built on a reliable foundation.

Vukelic and colleagues did an admirable job of selecting studies with an appropriate comparison group—that is, saline injection, the best comparator that has been studied. What they discovered is that no type of injection therapy has been proven to be better than a saline injection.

So, if your patient is not satisfied with conservative therapy for epicondylitis and wants an injection, salt water seems as good as anything.

In this issue of JFP, the Clinical Inquiry seeks to answer the question: What are effective injection treatments for lateral epicondylitis? Answering this question proved to be a daunting task for the authors. The difficulty lies in answering this question: effective compared to what?

What they discovered is that no type of injection therapy has been proven to be better than a saline injection.

The injections evaluated in their comprehensive review—corticosteroids, botulinum toxin, hyaluronic acid, platelet-rich plasma, prolotherapy, and autologous blood—have been compared in randomized trials to each other, usual treatment, no treatment, nonmedication treatments, noninjection treatments, surgeries, braces, and physical therapy.¹ But which comparison is the best one to determine true effectiveness beyond a placebo effect?

There are 2 choices for an ideal comparison group. One choice compares the active intervention to an adequate placebo, the other compares it to another treatment that has previously been proven effective. Ideally, the other treatment would be a “gold standard”—that is, the best treatment currently available. Unfortunately, for treatment of lateral epicondylitis, no gold standard has been established.

So, what is an “adequate placebo” for injection therapy? This is a very difficult question. The placebo should probably include putting a needle into the treatment site and injecting a nonactive substance, such as saline solution. This is the comparison group Vukelic et al chose for their review. But even saline could theoretically be therapeutic.

Another fair comparison for the treatment of lateral epicondylitis would be an injection near, but not at, the lateral epicondyle. Yet another comparison—dry needling without any medication to the lateral epicondyle vs dry needling of an adjacent location—would also be a fair comparison to help understand the effect of needling alone. Unfortunately, these comparisons have not been explored in randomized controlled trials. Although several studies have evaluated dry needling for lateral epicondylitis,^2-4 none have used a fair comparison.

Some studies¹ evaluating treatments for lateral epicondylitis used comparisons to agents that are ineffective or of uncertain effectiveness. Comparing 1 agent to another ineffective or potentially harmful agent obscures our knowledge. Evidence-based medicine must be built on a reliable foundation.

Vukelic and colleagues did an admirable job of selecting studies with an appropriate comparison group—that is, saline injection, the best comparator that has been studied. What they discovered is that no type of injection therapy has been proven to be better than a saline injection.

So, if your patient is not satisfied with conservative therapy for epicondylitis and wants an injection, salt water seems as good as anything.