Adolescent Medicine

Last night I invested an hour and a half watching the first half of the Super Bowl ... because ... well, just because. As exciting as it might have been to watch, investing another 2 hours on the second half would have kept me up well past my bedtime. As I lay in bed with the thwack-thwack-thud of helmets hitting pads still reverberating in my ears, my thoughts drifted to the ever-shifting landscape of concussion management.

More than 2 decades ago, concussions were just beginning to exit the dark ages when loss of consciousness was the defining symptom or sign that most folks (and here I am including physicians) used to separate the run-of-the-mill stinger or bell-ringer from a “real” concussion.

The new era dawned with the appearance of clinics devoted to concussion management and the development of protocols that limited everything from physical exertion to reading and screen time. Schools were coaxed into subjecting their athletes to preparticipation testing sessions with the hope that creating a baseline cognitive assessment would somehow make the diagnosis and management of concussion feel more scientific. Many of the recommended management strategies were based on the intuitive but flawed notion of “brain rest.” If reading or bright lights aggravate patient’s symptoms, they should be avoided but otherwise resting the brain doesn’t seem to make sense.

Fortunately, there were, and hopefully will continue to be, clinicians willing to question hastily developed management protocols. One recent cohort study from Canada has found that, surprisingly, (to some experts), “early return to school was associated with a lower symptom burden” This association held true for both age groups the researches studied (8-12 years and 13-18 years). The authors conclude that delayed return to school “may be detrimental to recovery.” In this study, early return to school was defined as less than 3 days.

In another study, this one in the journal Pediatrics, the authors found that “the association of early screen time with postconcussion symptoms is not linear.” Their conclusion was that the best approach to clinical management of concussion should include a moderate amount of screen time.

After reading both of these studies I am heartened that we are now hearing voices suggesting a return to concussion management based on careful observation of the individual patient and common sense. A concussed brain is not a torn hamstring or a broken clavicle that under most circumstances will heal in a predictable amount of time. It is prudent to exclude the concussed patient from activities that carry a significant risk of reinjury until the symptoms have subsided. However, postconcussion symptoms are often vague and can be mistaken for or aggravated by a host of other conditions including learning disabilities, anxiety, and depression.

I hope that our experience with the COVID pandemic has taught us that removing children from school and their usual activities can have a serious negative effect on their emotional health and academic achievement. This seems to be particularly true for the young people who were already struggling to adjust to being a student. Getting out of the habit of going to school often intensifies the anxieties of an emotionally or academically challenged student. Each day away from the school atmosphere can compound the symptoms that may or may not have been triggered by the concussion.

The message here is clear that, whether we are talking about concussions or appendectomies or mononucleosis, the sooner we can return the child to something close to their old normal the more successful we will be in a helping them adjust to the new normal.

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].

Last night I invested an hour and a half watching the first half of the Super Bowl ... because ... well, just because. As exciting as it might have been to watch, investing another 2 hours on the second half would have kept me up well past my bedtime. As I lay in bed with the thwack-thwack-thud of helmets hitting pads still reverberating in my ears, my thoughts drifted to the ever-shifting landscape of concussion management.

More than 2 decades ago, concussions were just beginning to exit the dark ages when loss of consciousness was the defining symptom or sign that most folks (and here I am including physicians) used to separate the run-of-the-mill stinger or bell-ringer from a “real” concussion.

The new era dawned with the appearance of clinics devoted to concussion management and the development of protocols that limited everything from physical exertion to reading and screen time. Schools were coaxed into subjecting their athletes to preparticipation testing sessions with the hope that creating a baseline cognitive assessment would somehow make the diagnosis and management of concussion feel more scientific. Many of the recommended management strategies were based on the intuitive but flawed notion of “brain rest.” If reading or bright lights aggravate patient’s symptoms, they should be avoided but otherwise resting the brain doesn’t seem to make sense.

Fortunately, there were, and hopefully will continue to be, clinicians willing to question hastily developed management protocols. One recent cohort study from Canada has found that, surprisingly, (to some experts), “early return to school was associated with a lower symptom burden” This association held true for both age groups the researches studied (8-12 years and 13-18 years). The authors conclude that delayed return to school “may be detrimental to recovery.” In this study, early return to school was defined as less than 3 days.

In another study, this one in the journal Pediatrics, the authors found that “the association of early screen time with postconcussion symptoms is not linear.” Their conclusion was that the best approach to clinical management of concussion should include a moderate amount of screen time.

After reading both of these studies I am heartened that we are now hearing voices suggesting a return to concussion management based on careful observation of the individual patient and common sense. A concussed brain is not a torn hamstring or a broken clavicle that under most circumstances will heal in a predictable amount of time. It is prudent to exclude the concussed patient from activities that carry a significant risk of reinjury until the symptoms have subsided. However, postconcussion symptoms are often vague and can be mistaken for or aggravated by a host of other conditions including learning disabilities, anxiety, and depression.

I hope that our experience with the COVID pandemic has taught us that removing children from school and their usual activities can have a serious negative effect on their emotional health and academic achievement. This seems to be particularly true for the young people who were already struggling to adjust to being a student. Getting out of the habit of going to school often intensifies the anxieties of an emotionally or academically challenged student. Each day away from the school atmosphere can compound the symptoms that may or may not have been triggered by the concussion.

The message here is clear that, whether we are talking about concussions or appendectomies or mononucleosis, the sooner we can return the child to something close to their old normal the more successful we will be in a helping them adjust to the new normal.

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].

Last night I invested an hour and a half watching the first half of the Super Bowl ... because ... well, just because. As exciting as it might have been to watch, investing another 2 hours on the second half would have kept me up well past my bedtime. As I lay in bed with the thwack-thwack-thud of helmets hitting pads still reverberating in my ears, my thoughts drifted to the ever-shifting landscape of concussion management.

More than 2 decades ago, concussions were just beginning to exit the dark ages when loss of consciousness was the defining symptom or sign that most folks (and here I am including physicians) used to separate the run-of-the-mill stinger or bell-ringer from a “real” concussion.

The new era dawned with the appearance of clinics devoted to concussion management and the development of protocols that limited everything from physical exertion to reading and screen time. Schools were coaxed into subjecting their athletes to preparticipation testing sessions with the hope that creating a baseline cognitive assessment would somehow make the diagnosis and management of concussion feel more scientific. Many of the recommended management strategies were based on the intuitive but flawed notion of “brain rest.” If reading or bright lights aggravate patient’s symptoms, they should be avoided but otherwise resting the brain doesn’t seem to make sense.

Fortunately, there were, and hopefully will continue to be, clinicians willing to question hastily developed management protocols. One recent cohort study from Canada has found that, surprisingly, (to some experts), “early return to school was associated with a lower symptom burden” This association held true for both age groups the researches studied (8-12 years and 13-18 years). The authors conclude that delayed return to school “may be detrimental to recovery.” In this study, early return to school was defined as less than 3 days.

In another study, this one in the journal Pediatrics, the authors found that “the association of early screen time with postconcussion symptoms is not linear.” Their conclusion was that the best approach to clinical management of concussion should include a moderate amount of screen time.

After reading both of these studies I am heartened that we are now hearing voices suggesting a return to concussion management based on careful observation of the individual patient and common sense. A concussed brain is not a torn hamstring or a broken clavicle that under most circumstances will heal in a predictable amount of time. It is prudent to exclude the concussed patient from activities that carry a significant risk of reinjury until the symptoms have subsided. However, postconcussion symptoms are often vague and can be mistaken for or aggravated by a host of other conditions including learning disabilities, anxiety, and depression.

I hope that our experience with the COVID pandemic has taught us that removing children from school and their usual activities can have a serious negative effect on their emotional health and academic achievement. This seems to be particularly true for the young people who were already struggling to adjust to being a student. Getting out of the habit of going to school often intensifies the anxieties of an emotionally or academically challenged student. Each day away from the school atmosphere can compound the symptoms that may or may not have been triggered by the concussion.

The message here is clear that, whether we are talking about concussions or appendectomies or mononucleosis, the sooner we can return the child to something close to their old normal the more successful we will be in a helping them adjust to the new normal.

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].

More than 1 in 5 children worldwide are at risk of developing an eating disorder such as bulimia, anorexia, or binge eating, a new analysis suggests.

The study was published in the journal JAMA Pediatrics. Researchers analyzed data for 63,181 adolescents 6-18 years old from 16 countries to look for what is called “disordered eating.” None of the children included in the study had diagnosed physical or mental disorders, and data were not included from the COVID-19 time period.

The researchers examined results from a widely used standardized eating disorder questionnaire called the Sick, Control, One, Fat, Food (SCOFF). When someone answers yes to two or more of the questions, the person is considered to have disordered eating, which “denotes a suspicion of an existing eating disorder,” the researchers write. The five questions are:

• Do you make yourself sick because you feel uncomfortably full?
• Do you worry you have lost control over how much you eat?
• Have you recently lost more than 14 pounds in a 3-month period?
• Do you believe yourself to be fat when others say you are too thin?
• Would you say that food dominates your life?

Overall, 22% of children replied yes to two or more of the questions. The proportion of children with disordered eating is likely even higher, the researchers explain, because children may hide symptoms “due to feelings of shame or stigmatization.”

The findings are a dramatic shift from the estimation that 2.7% of people ages 13-18 have an eating disorder during their adolescent years.

In this latest study, disordered eating was more common among girls, older children, and those with a higher body mass index, or BMI, which is a combined measure of height and weight.

The analysis showed that 30% of girls had disordered eating, compared with 17% of boys. When looking at responses by age, the proportion of kids with disordered eating increased by 20 percentage points between the ages of 10 and 18.

The findings regarding children who already have a high BMI confirms previous research that many of those children are already following disordered eating behaviors while trying to lose weight, the authors write.

“Although most adolescents who develop an eating disorder do not report prior excess weight problems, some adolescents could misinterpret what eating healthy consists of and engage in unhealthy behaviors (for instance, skipping meals to generate a caloric deficit), which could then lead to development of an eating disorder,” the researchers explain.

The study points to the need for parents, caregivers, and health care professionals to be on the lookout for disordered eating symptoms in children because they are linked to the risk of developing a clinical eating disorder. The symptoms to watch for include behaviors such as weight loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics, the researchers write.

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

More than 1 in 5 children worldwide are at risk of developing an eating disorder such as bulimia, anorexia, or binge eating, a new analysis suggests.

The study was published in the journal JAMA Pediatrics. Researchers analyzed data for 63,181 adolescents 6-18 years old from 16 countries to look for what is called “disordered eating.” None of the children included in the study had diagnosed physical or mental disorders, and data were not included from the COVID-19 time period.

The researchers examined results from a widely used standardized eating disorder questionnaire called the Sick, Control, One, Fat, Food (SCOFF). When someone answers yes to two or more of the questions, the person is considered to have disordered eating, which “denotes a suspicion of an existing eating disorder,” the researchers write. The five questions are:

• Do you make yourself sick because you feel uncomfortably full?
• Do you worry you have lost control over how much you eat?
• Have you recently lost more than 14 pounds in a 3-month period?
• Do you believe yourself to be fat when others say you are too thin?
• Would you say that food dominates your life?

Overall, 22% of children replied yes to two or more of the questions. The proportion of children with disordered eating is likely even higher, the researchers explain, because children may hide symptoms “due to feelings of shame or stigmatization.”

The findings are a dramatic shift from the estimation that 2.7% of people ages 13-18 have an eating disorder during their adolescent years.

In this latest study, disordered eating was more common among girls, older children, and those with a higher body mass index, or BMI, which is a combined measure of height and weight.

The analysis showed that 30% of girls had disordered eating, compared with 17% of boys. When looking at responses by age, the proportion of kids with disordered eating increased by 20 percentage points between the ages of 10 and 18.

The findings regarding children who already have a high BMI confirms previous research that many of those children are already following disordered eating behaviors while trying to lose weight, the authors write.

“Although most adolescents who develop an eating disorder do not report prior excess weight problems, some adolescents could misinterpret what eating healthy consists of and engage in unhealthy behaviors (for instance, skipping meals to generate a caloric deficit), which could then lead to development of an eating disorder,” the researchers explain.

The study points to the need for parents, caregivers, and health care professionals to be on the lookout for disordered eating symptoms in children because they are linked to the risk of developing a clinical eating disorder. The symptoms to watch for include behaviors such as weight loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics, the researchers write.

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

More than 1 in 5 children worldwide are at risk of developing an eating disorder such as bulimia, anorexia, or binge eating, a new analysis suggests.

The study was published in the journal JAMA Pediatrics. Researchers analyzed data for 63,181 adolescents 6-18 years old from 16 countries to look for what is called “disordered eating.” None of the children included in the study had diagnosed physical or mental disorders, and data were not included from the COVID-19 time period.

The researchers examined results from a widely used standardized eating disorder questionnaire called the Sick, Control, One, Fat, Food (SCOFF). When someone answers yes to two or more of the questions, the person is considered to have disordered eating, which “denotes a suspicion of an existing eating disorder,” the researchers write. The five questions are:

• Do you make yourself sick because you feel uncomfortably full?
• Do you worry you have lost control over how much you eat?
• Have you recently lost more than 14 pounds in a 3-month period?
• Do you believe yourself to be fat when others say you are too thin?
• Would you say that food dominates your life?

Overall, 22% of children replied yes to two or more of the questions. The proportion of children with disordered eating is likely even higher, the researchers explain, because children may hide symptoms “due to feelings of shame or stigmatization.”

The findings are a dramatic shift from the estimation that 2.7% of people ages 13-18 have an eating disorder during their adolescent years.

In this latest study, disordered eating was more common among girls, older children, and those with a higher body mass index, or BMI, which is a combined measure of height and weight.

The analysis showed that 30% of girls had disordered eating, compared with 17% of boys. When looking at responses by age, the proportion of kids with disordered eating increased by 20 percentage points between the ages of 10 and 18.

The findings regarding children who already have a high BMI confirms previous research that many of those children are already following disordered eating behaviors while trying to lose weight, the authors write.

“Although most adolescents who develop an eating disorder do not report prior excess weight problems, some adolescents could misinterpret what eating healthy consists of and engage in unhealthy behaviors (for instance, skipping meals to generate a caloric deficit), which could then lead to development of an eating disorder,” the researchers explain.

The study points to the need for parents, caregivers, and health care professionals to be on the lookout for disordered eating symptoms in children because they are linked to the risk of developing a clinical eating disorder. The symptoms to watch for include behaviors such as weight loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics, the researchers write.

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

Youth with type 1 diabetes who use real-time continuous glucose monitoring (rtCGM) and an insulin pump spend more time in target glucose range than do those using intermittently scanned CGM (isCGM) and/or multiple daily insulin injections, new data show.

In the multinational cohort study of more than 4,500 people younger than age 21 with type 1 diabetes, those using rtCGM and pumps also spent less time above and below glucose targets and had fewer severe adverse events – either severe hypoglycemia or diabetic ketoacidosis (DKA) – compared with injections and isCGM.

Daria Nipot/Getty Images

The findings were published online in JAMA Network Open by Klemen Dovc, MD, PhD, assistant professor in the department of pediatric endocrinology, diabetes, and metabolic diseases, University Children’s Hospital, Ljubljana, Slovenia, and colleagues.

“These results underscore the synergistic effect of advanced diabetes technologies that should be more readily available to youths with type 1 diabetes for further improvement of diabetes-related clinical outcomes,” the authors wrote.

Moreover, Dr. Dovc told this news organization: “Clinicians should be aware that there may be differences in effectiveness between different types of devices, and that choosing the right device for each individual may be important for achieving optimal outcomes.”
 

Real-time CGM + insulin pump = highest time in range

The researchers explained that two modalities of CGM are broadly available: rtCGM, which continuously displays glucose concentration in the interstitial fluid (usually at intervals of 1-5 minutes) on a dedicated receiver or other portable device, such as a smartphone, and provides various adjustable alarms, and isCGM, which displays data on demand when the transmitter is scanned using either a dedicated reader or smartphone-based application.

rtCGMs include devices from Dexcom and Medtronic. The isCGM, or “flash,” generally refers to the Abbott FreeStyle Libre.

The study included individuals younger than 21 years from 34 centers in 21 countries in the SWEET registry, a worldwide network of diabetes care centers for youth, between Jan. 1, 2016, and Dec. 31, 2021.

The researchers didn’t report which particular devices were used in the trial, rather they just divided patients into four groups: 850 used isCGM with a pump, 1,231 used isCGM with multiple daily injections, 2,252 used rtCGM with a pump, and 886 used rtCGM with insulin injections.

After adjustments for sex, age, diabetes duration, and body mass index standard deviation score, rtCGM plus insulin pump was the most likely group to achieve the recommended greater than 70% time in target glycemic range (70-180 mg/dL), with 36.2% achieving it, followed by rtCGM plus injections, at 20.9%, and isCGM plus injections, at 12.5%. Those using isCGM with an insulin pump were the least likely to achieve time in range, at just 11.3%.

Similar trends were seen for the recommended goal of less than 4% of time spent below range (< 70 mg/dL) and less than 25% of time spent above range (> 180 mg/dL). Those using rtCGM with a pump had the highest proportions achieving both of those goals, 73.1% and 32.5%, respectively.  

The use of rtCGM, with or without a pump, was associated with lower rates of severe hypoglycemia (2.5% and 2.0%, respectively) than isCGM with or without a pump (5.5% and 5.2%, respectively).

Similarly, the proportion experiencing at least one DKA episode varied from 1.4% for rtCGM plus insulin pump and 0.7% for rtCGM plus injections to 3.0% for isCGM plus pump and 1.5% isCGM plus injections.


 

Study looked at older technology but results still reflect benefit

Among the rtCGM plus insulin pump group were 264 participants (5% of the total study population) recorded in the database as using automated insulin delivery (AID) systems, also known as the artificial pancreas, although this is likely an undercount as the presence of communication between the two devices was not automatically recorded, Dr. Dovc explained.

Those individuals recorded as using AIDs had a higher unadjusted time in range compared with non-AID users (66.3% vs. 59.0%) and lower time above range (30.1% vs. 37.0%) but didn’t differ in time below range (2.9% vs. 3.0%).

Dr. Dovc told this news organization: “While automated systems are becoming more common, there are still many individuals who do not have access to glucose-responsive devices.” Reasons include lack of reimbursement, or decisions not to use them, he said.

But, he added, “Despite the low reported numbers of AID users, results achieved in the pump with real-time CGM [group] are admirable and approaching recommended consensus targets with a clinically meaningful difference towards all other treatment modalities. As our findings may not be directly applicable to all participants using automated systems, they may still provide useful insights into the factors that influence glycemic control.”

Similarly, the intermittently scanned CGMs used by most in the study, and particularly in the earlier period, didn’t have low- or high-glucose alarms as do later versions. And an even more recent version also doesn’t require scanning either, so is essentially also “real-time.”

Dr. Dovc noted, “in the first half of our observational period only first generation of intermittently-scanned CGM was generally available, and we can speculate that only a small proportion started to use second generation towards the end of our observational period. The exact number of second-generation users was not available in this analysis.”

He acknowledged that because the study was observational and not randomized, patient choice of device could have influenced the outcomes.

“For example, participants who choose to use a more expensive device may have more resources or support available to them, which could influence their ability to manage their diabetes effectively. Additionally, individuals who choose to use a particular device may be more motivated or engaged in their diabetes care, which could also impact their outcomes. It would be important for future studies to explore the impact of device selection on device effectiveness and to control for this potential confounding factor in the analysis.”

This study was supported by the international Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference (SWEET) corporate members, including Abbott Laboratories, Boehringer Ingelheim, Dexcom, Insulet, Eli Lilly, Medtronic, Sanofi, and the Slovenian National Research Agency. Dr. Dovc disclosed ties with Abbott Laboratories, Medtronic, Novo Nordisk, Eli Lilly, and Pfizer. He served as a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes.   

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

Youth with type 1 diabetes who use real-time continuous glucose monitoring (rtCGM) and an insulin pump spend more time in target glucose range than do those using intermittently scanned CGM (isCGM) and/or multiple daily insulin injections, new data show.

In the multinational cohort study of more than 4,500 people younger than age 21 with type 1 diabetes, those using rtCGM and pumps also spent less time above and below glucose targets and had fewer severe adverse events – either severe hypoglycemia or diabetic ketoacidosis (DKA) – compared with injections and isCGM.

Daria Nipot/Getty Images

The findings were published online in JAMA Network Open by Klemen Dovc, MD, PhD, assistant professor in the department of pediatric endocrinology, diabetes, and metabolic diseases, University Children’s Hospital, Ljubljana, Slovenia, and colleagues.

“These results underscore the synergistic effect of advanced diabetes technologies that should be more readily available to youths with type 1 diabetes for further improvement of diabetes-related clinical outcomes,” the authors wrote.

Moreover, Dr. Dovc told this news organization: “Clinicians should be aware that there may be differences in effectiveness between different types of devices, and that choosing the right device for each individual may be important for achieving optimal outcomes.”
 

Real-time CGM + insulin pump = highest time in range

The researchers explained that two modalities of CGM are broadly available: rtCGM, which continuously displays glucose concentration in the interstitial fluid (usually at intervals of 1-5 minutes) on a dedicated receiver or other portable device, such as a smartphone, and provides various adjustable alarms, and isCGM, which displays data on demand when the transmitter is scanned using either a dedicated reader or smartphone-based application.

rtCGMs include devices from Dexcom and Medtronic. The isCGM, or “flash,” generally refers to the Abbott FreeStyle Libre.

The study included individuals younger than 21 years from 34 centers in 21 countries in the SWEET registry, a worldwide network of diabetes care centers for youth, between Jan. 1, 2016, and Dec. 31, 2021.

The researchers didn’t report which particular devices were used in the trial, rather they just divided patients into four groups: 850 used isCGM with a pump, 1,231 used isCGM with multiple daily injections, 2,252 used rtCGM with a pump, and 886 used rtCGM with insulin injections.

After adjustments for sex, age, diabetes duration, and body mass index standard deviation score, rtCGM plus insulin pump was the most likely group to achieve the recommended greater than 70% time in target glycemic range (70-180 mg/dL), with 36.2% achieving it, followed by rtCGM plus injections, at 20.9%, and isCGM plus injections, at 12.5%. Those using isCGM with an insulin pump were the least likely to achieve time in range, at just 11.3%.

Similar trends were seen for the recommended goal of less than 4% of time spent below range (< 70 mg/dL) and less than 25% of time spent above range (> 180 mg/dL). Those using rtCGM with a pump had the highest proportions achieving both of those goals, 73.1% and 32.5%, respectively.  

The use of rtCGM, with or without a pump, was associated with lower rates of severe hypoglycemia (2.5% and 2.0%, respectively) than isCGM with or without a pump (5.5% and 5.2%, respectively).

Similarly, the proportion experiencing at least one DKA episode varied from 1.4% for rtCGM plus insulin pump and 0.7% for rtCGM plus injections to 3.0% for isCGM plus pump and 1.5% isCGM plus injections.


 

Study looked at older technology but results still reflect benefit

Among the rtCGM plus insulin pump group were 264 participants (5% of the total study population) recorded in the database as using automated insulin delivery (AID) systems, also known as the artificial pancreas, although this is likely an undercount as the presence of communication between the two devices was not automatically recorded, Dr. Dovc explained.

Those individuals recorded as using AIDs had a higher unadjusted time in range compared with non-AID users (66.3% vs. 59.0%) and lower time above range (30.1% vs. 37.0%) but didn’t differ in time below range (2.9% vs. 3.0%).

Dr. Dovc told this news organization: “While automated systems are becoming more common, there are still many individuals who do not have access to glucose-responsive devices.” Reasons include lack of reimbursement, or decisions not to use them, he said.

But, he added, “Despite the low reported numbers of AID users, results achieved in the pump with real-time CGM [group] are admirable and approaching recommended consensus targets with a clinically meaningful difference towards all other treatment modalities. As our findings may not be directly applicable to all participants using automated systems, they may still provide useful insights into the factors that influence glycemic control.”

Similarly, the intermittently scanned CGMs used by most in the study, and particularly in the earlier period, didn’t have low- or high-glucose alarms as do later versions. And an even more recent version also doesn’t require scanning either, so is essentially also “real-time.”

Dr. Dovc noted, “in the first half of our observational period only first generation of intermittently-scanned CGM was generally available, and we can speculate that only a small proportion started to use second generation towards the end of our observational period. The exact number of second-generation users was not available in this analysis.”

He acknowledged that because the study was observational and not randomized, patient choice of device could have influenced the outcomes.

“For example, participants who choose to use a more expensive device may have more resources or support available to them, which could influence their ability to manage their diabetes effectively. Additionally, individuals who choose to use a particular device may be more motivated or engaged in their diabetes care, which could also impact their outcomes. It would be important for future studies to explore the impact of device selection on device effectiveness and to control for this potential confounding factor in the analysis.”

This study was supported by the international Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference (SWEET) corporate members, including Abbott Laboratories, Boehringer Ingelheim, Dexcom, Insulet, Eli Lilly, Medtronic, Sanofi, and the Slovenian National Research Agency. Dr. Dovc disclosed ties with Abbott Laboratories, Medtronic, Novo Nordisk, Eli Lilly, and Pfizer. He served as a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes.   

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

Youth with type 1 diabetes who use real-time continuous glucose monitoring (rtCGM) and an insulin pump spend more time in target glucose range than do those using intermittently scanned CGM (isCGM) and/or multiple daily insulin injections, new data show.

In the multinational cohort study of more than 4,500 people younger than age 21 with type 1 diabetes, those using rtCGM and pumps also spent less time above and below glucose targets and had fewer severe adverse events – either severe hypoglycemia or diabetic ketoacidosis (DKA) – compared with injections and isCGM.

Daria Nipot/Getty Images

The findings were published online in JAMA Network Open by Klemen Dovc, MD, PhD, assistant professor in the department of pediatric endocrinology, diabetes, and metabolic diseases, University Children’s Hospital, Ljubljana, Slovenia, and colleagues.

“These results underscore the synergistic effect of advanced diabetes technologies that should be more readily available to youths with type 1 diabetes for further improvement of diabetes-related clinical outcomes,” the authors wrote.

Moreover, Dr. Dovc told this news organization: “Clinicians should be aware that there may be differences in effectiveness between different types of devices, and that choosing the right device for each individual may be important for achieving optimal outcomes.”
 

Real-time CGM + insulin pump = highest time in range

The researchers explained that two modalities of CGM are broadly available: rtCGM, which continuously displays glucose concentration in the interstitial fluid (usually at intervals of 1-5 minutes) on a dedicated receiver or other portable device, such as a smartphone, and provides various adjustable alarms, and isCGM, which displays data on demand when the transmitter is scanned using either a dedicated reader or smartphone-based application.

rtCGMs include devices from Dexcom and Medtronic. The isCGM, or “flash,” generally refers to the Abbott FreeStyle Libre.

The study included individuals younger than 21 years from 34 centers in 21 countries in the SWEET registry, a worldwide network of diabetes care centers for youth, between Jan. 1, 2016, and Dec. 31, 2021.

The researchers didn’t report which particular devices were used in the trial, rather they just divided patients into four groups: 850 used isCGM with a pump, 1,231 used isCGM with multiple daily injections, 2,252 used rtCGM with a pump, and 886 used rtCGM with insulin injections.

After adjustments for sex, age, diabetes duration, and body mass index standard deviation score, rtCGM plus insulin pump was the most likely group to achieve the recommended greater than 70% time in target glycemic range (70-180 mg/dL), with 36.2% achieving it, followed by rtCGM plus injections, at 20.9%, and isCGM plus injections, at 12.5%. Those using isCGM with an insulin pump were the least likely to achieve time in range, at just 11.3%.

Similar trends were seen for the recommended goal of less than 4% of time spent below range (< 70 mg/dL) and less than 25% of time spent above range (> 180 mg/dL). Those using rtCGM with a pump had the highest proportions achieving both of those goals, 73.1% and 32.5%, respectively.  

The use of rtCGM, with or without a pump, was associated with lower rates of severe hypoglycemia (2.5% and 2.0%, respectively) than isCGM with or without a pump (5.5% and 5.2%, respectively).

Similarly, the proportion experiencing at least one DKA episode varied from 1.4% for rtCGM plus insulin pump and 0.7% for rtCGM plus injections to 3.0% for isCGM plus pump and 1.5% isCGM plus injections.


 

Study looked at older technology but results still reflect benefit

Among the rtCGM plus insulin pump group were 264 participants (5% of the total study population) recorded in the database as using automated insulin delivery (AID) systems, also known as the artificial pancreas, although this is likely an undercount as the presence of communication between the two devices was not automatically recorded, Dr. Dovc explained.

Those individuals recorded as using AIDs had a higher unadjusted time in range compared with non-AID users (66.3% vs. 59.0%) and lower time above range (30.1% vs. 37.0%) but didn’t differ in time below range (2.9% vs. 3.0%).

Dr. Dovc told this news organization: “While automated systems are becoming more common, there are still many individuals who do not have access to glucose-responsive devices.” Reasons include lack of reimbursement, or decisions not to use them, he said.

But, he added, “Despite the low reported numbers of AID users, results achieved in the pump with real-time CGM [group] are admirable and approaching recommended consensus targets with a clinically meaningful difference towards all other treatment modalities. As our findings may not be directly applicable to all participants using automated systems, they may still provide useful insights into the factors that influence glycemic control.”

Similarly, the intermittently scanned CGMs used by most in the study, and particularly in the earlier period, didn’t have low- or high-glucose alarms as do later versions. And an even more recent version also doesn’t require scanning either, so is essentially also “real-time.”

Dr. Dovc noted, “in the first half of our observational period only first generation of intermittently-scanned CGM was generally available, and we can speculate that only a small proportion started to use second generation towards the end of our observational period. The exact number of second-generation users was not available in this analysis.”

He acknowledged that because the study was observational and not randomized, patient choice of device could have influenced the outcomes.

“For example, participants who choose to use a more expensive device may have more resources or support available to them, which could influence their ability to manage their diabetes effectively. Additionally, individuals who choose to use a particular device may be more motivated or engaged in their diabetes care, which could also impact their outcomes. It would be important for future studies to explore the impact of device selection on device effectiveness and to control for this potential confounding factor in the analysis.”

This study was supported by the international Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference (SWEET) corporate members, including Abbott Laboratories, Boehringer Ingelheim, Dexcom, Insulet, Eli Lilly, Medtronic, Sanofi, and the Slovenian National Research Agency. Dr. Dovc disclosed ties with Abbott Laboratories, Medtronic, Novo Nordisk, Eli Lilly, and Pfizer. He served as a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes.   

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

HONOLULU – In the clinical experience of John S. Barbieri, MD, MBA, cheilitis occurs in nearly all patients taking any dose of isotretinoin.

“If they don’t have dry lips, you have to wonder if they’re even absorbing isotretinoin,” Dr. Barbieri, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “Everyone is going to get dry lips.”

According to a retrospective review of 1,743 patients started on isotretinoin, other common mucocutaneous side effects include eczema, nose bleeds, and eye problems. Emerging research suggests that there may be a role for oral omega-3 in decreasing such side effects of the drug. In a case control study, 118 patients were randomized to isotretinoin alone or isotretinoin plus 1 g/day of oral omega-3 for 16 weeks. At week 16, the rate of dry lips was 26% in the isoretinoin only group compared with 14% in the combination group; similar trends were seen with dry nose (11% vs. 0 %, respectively) and dry skin (11% vs. 2%).

“Omega-3 is a simple thing that we can think about recommending for patients,” Dr. Barbieri said. “It’s very safe, inexpensive, and it may help us manage these common sides effect we run into.”

Another potential side effect of isotretinoin that he characterized as underappreciated is chronic dry eye and other ocular changes. One retrospective cohort study of 14,682 adolescents and young adults in Israel found that use of the drug resulted in reduced tear production and reduced tear quality. In another study, a review and meta-analysis of 21 publications involving 1,105 eyes of 842 patients, isotretinoin use was associated with increased conjunctival fluorescein staining, decreased corneal thickness, and worse patient-reported ocular surface disease index scores.

“These changes may be mediated by meibomian gland dysfunction and atrophy,” Dr. Barbieri said. “Fortunately, many of these tear film changes appear to resolve after treatment. Those changes in corneal thickness do seem to get better. That’s reassuring.”

In a study of 54 patients treated with isotretinoin, tear production and quality returned to baseline within 6 months of treatment completion. “But some changes in the meibomian gland may be persistent,” Dr. Barbieri said. “At 6 and 12 months after the end of treatment, you can still see changes in the meibomian glands of patients who were treated with a standard course of 120 to 150 mg/kg isotretinoin,” he said, referring to the results of a study of 88 patients .

One study investigated the effects of omega-3 fatty acids and punctal plugs on tear film and ocular surface parameters in 90 patients receiving systemic isotretinoin therapy. They were divided into three groups: Those who received a soft preloaded silicone plug that was inserted in the inferior punctum of both eyes and received oral omega-3 fatty acid capsules twice daily for a total dose of 1,040 mg/day for 6 months; those who received a soft preloaded silicone plug and oral placebo, and those who received isotretinoin alone. At 6 months’ follow-up, those who were treated with omega-3 combined with the preloaded silicone plug had better meibomian gland function than did those who received isotretinoin alone or isotretinoin with the preloaded silicone plug.

Dr. Barbieri also noted that antihistamines may play a role in enhancing the effect of isotretinoin. In one study, 20 patients were treated with isotretinoin 0.4 mg/kg per day and 20 patients were also treated with an antihistamine, desloratadine 5 mg/day for 12 weeks. At week 12, patients in the group treated with isotretinoin and the antihistamine showed a more statistically significant decrease in acne lesion counts, compared with the isotretinoin-only group (reductions of 44.8% vs. 17.8%, respectively, in noninflammatory lesions; 55.8% vs. 22.9% in inflammatory lesions, and 45.6% vs. 18.7% in total lesions (P < .05 for all associations).

A subsequent larger study yielded similar findings. There were also lower rates of initial flaring and higher rates of patient satisfaction in the antihistamine groups in both studies.

In an interview at the meeting, Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, described Dr. Barbieri as “a leader in taking a comprehensive view on what the history and latest information is on isotretinoin. His fresh approach is something everyone should consider and figure out what they can use in their practice.”

Dr. Barbieri disclosed that he receives consulting fees from Dexcel for work unrelated to his presentation. Dr. Eichenfield disclosed that he has been an investigator and/or consultant for Almirall, Cassiopea, Dermata, Galderma, and Ortho Dermatologics. Medscape and this news organization are owned by the same parent company.

HONOLULU – In the clinical experience of John S. Barbieri, MD, MBA, cheilitis occurs in nearly all patients taking any dose of isotretinoin.

“If they don’t have dry lips, you have to wonder if they’re even absorbing isotretinoin,” Dr. Barbieri, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “Everyone is going to get dry lips.”

According to a retrospective review of 1,743 patients started on isotretinoin, other common mucocutaneous side effects include eczema, nose bleeds, and eye problems. Emerging research suggests that there may be a role for oral omega-3 in decreasing such side effects of the drug. In a case control study, 118 patients were randomized to isotretinoin alone or isotretinoin plus 1 g/day of oral omega-3 for 16 weeks. At week 16, the rate of dry lips was 26% in the isoretinoin only group compared with 14% in the combination group; similar trends were seen with dry nose (11% vs. 0 %, respectively) and dry skin (11% vs. 2%).

“Omega-3 is a simple thing that we can think about recommending for patients,” Dr. Barbieri said. “It’s very safe, inexpensive, and it may help us manage these common sides effect we run into.”

Another potential side effect of isotretinoin that he characterized as underappreciated is chronic dry eye and other ocular changes. One retrospective cohort study of 14,682 adolescents and young adults in Israel found that use of the drug resulted in reduced tear production and reduced tear quality. In another study, a review and meta-analysis of 21 publications involving 1,105 eyes of 842 patients, isotretinoin use was associated with increased conjunctival fluorescein staining, decreased corneal thickness, and worse patient-reported ocular surface disease index scores.

“These changes may be mediated by meibomian gland dysfunction and atrophy,” Dr. Barbieri said. “Fortunately, many of these tear film changes appear to resolve after treatment. Those changes in corneal thickness do seem to get better. That’s reassuring.”

In a study of 54 patients treated with isotretinoin, tear production and quality returned to baseline within 6 months of treatment completion. “But some changes in the meibomian gland may be persistent,” Dr. Barbieri said. “At 6 and 12 months after the end of treatment, you can still see changes in the meibomian glands of patients who were treated with a standard course of 120 to 150 mg/kg isotretinoin,” he said, referring to the results of a study of 88 patients .

One study investigated the effects of omega-3 fatty acids and punctal plugs on tear film and ocular surface parameters in 90 patients receiving systemic isotretinoin therapy. They were divided into three groups: Those who received a soft preloaded silicone plug that was inserted in the inferior punctum of both eyes and received oral omega-3 fatty acid capsules twice daily for a total dose of 1,040 mg/day for 6 months; those who received a soft preloaded silicone plug and oral placebo, and those who received isotretinoin alone. At 6 months’ follow-up, those who were treated with omega-3 combined with the preloaded silicone plug had better meibomian gland function than did those who received isotretinoin alone or isotretinoin with the preloaded silicone plug.

Dr. Barbieri also noted that antihistamines may play a role in enhancing the effect of isotretinoin. In one study, 20 patients were treated with isotretinoin 0.4 mg/kg per day and 20 patients were also treated with an antihistamine, desloratadine 5 mg/day for 12 weeks. At week 12, patients in the group treated with isotretinoin and the antihistamine showed a more statistically significant decrease in acne lesion counts, compared with the isotretinoin-only group (reductions of 44.8% vs. 17.8%, respectively, in noninflammatory lesions; 55.8% vs. 22.9% in inflammatory lesions, and 45.6% vs. 18.7% in total lesions (P < .05 for all associations).

A subsequent larger study yielded similar findings. There were also lower rates of initial flaring and higher rates of patient satisfaction in the antihistamine groups in both studies.

In an interview at the meeting, Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, described Dr. Barbieri as “a leader in taking a comprehensive view on what the history and latest information is on isotretinoin. His fresh approach is something everyone should consider and figure out what they can use in their practice.”

Dr. Barbieri disclosed that he receives consulting fees from Dexcel for work unrelated to his presentation. Dr. Eichenfield disclosed that he has been an investigator and/or consultant for Almirall, Cassiopea, Dermata, Galderma, and Ortho Dermatologics. Medscape and this news organization are owned by the same parent company.

HONOLULU – In the clinical experience of John S. Barbieri, MD, MBA, cheilitis occurs in nearly all patients taking any dose of isotretinoin.

“If they don’t have dry lips, you have to wonder if they’re even absorbing isotretinoin,” Dr. Barbieri, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “Everyone is going to get dry lips.”

According to a retrospective review of 1,743 patients started on isotretinoin, other common mucocutaneous side effects include eczema, nose bleeds, and eye problems. Emerging research suggests that there may be a role for oral omega-3 in decreasing such side effects of the drug. In a case control study, 118 patients were randomized to isotretinoin alone or isotretinoin plus 1 g/day of oral omega-3 for 16 weeks. At week 16, the rate of dry lips was 26% in the isoretinoin only group compared with 14% in the combination group; similar trends were seen with dry nose (11% vs. 0 %, respectively) and dry skin (11% vs. 2%).

“Omega-3 is a simple thing that we can think about recommending for patients,” Dr. Barbieri said. “It’s very safe, inexpensive, and it may help us manage these common sides effect we run into.”

Another potential side effect of isotretinoin that he characterized as underappreciated is chronic dry eye and other ocular changes. One retrospective cohort study of 14,682 adolescents and young adults in Israel found that use of the drug resulted in reduced tear production and reduced tear quality. In another study, a review and meta-analysis of 21 publications involving 1,105 eyes of 842 patients, isotretinoin use was associated with increased conjunctival fluorescein staining, decreased corneal thickness, and worse patient-reported ocular surface disease index scores.

“These changes may be mediated by meibomian gland dysfunction and atrophy,” Dr. Barbieri said. “Fortunately, many of these tear film changes appear to resolve after treatment. Those changes in corneal thickness do seem to get better. That’s reassuring.”

In a study of 54 patients treated with isotretinoin, tear production and quality returned to baseline within 6 months of treatment completion. “But some changes in the meibomian gland may be persistent,” Dr. Barbieri said. “At 6 and 12 months after the end of treatment, you can still see changes in the meibomian glands of patients who were treated with a standard course of 120 to 150 mg/kg isotretinoin,” he said, referring to the results of a study of 88 patients .

One study investigated the effects of omega-3 fatty acids and punctal plugs on tear film and ocular surface parameters in 90 patients receiving systemic isotretinoin therapy. They were divided into three groups: Those who received a soft preloaded silicone plug that was inserted in the inferior punctum of both eyes and received oral omega-3 fatty acid capsules twice daily for a total dose of 1,040 mg/day for 6 months; those who received a soft preloaded silicone plug and oral placebo, and those who received isotretinoin alone. At 6 months’ follow-up, those who were treated with omega-3 combined with the preloaded silicone plug had better meibomian gland function than did those who received isotretinoin alone or isotretinoin with the preloaded silicone plug.

Dr. Barbieri also noted that antihistamines may play a role in enhancing the effect of isotretinoin. In one study, 20 patients were treated with isotretinoin 0.4 mg/kg per day and 20 patients were also treated with an antihistamine, desloratadine 5 mg/day for 12 weeks. At week 12, patients in the group treated with isotretinoin and the antihistamine showed a more statistically significant decrease in acne lesion counts, compared with the isotretinoin-only group (reductions of 44.8% vs. 17.8%, respectively, in noninflammatory lesions; 55.8% vs. 22.9% in inflammatory lesions, and 45.6% vs. 18.7% in total lesions (P < .05 for all associations).

A subsequent larger study yielded similar findings. There were also lower rates of initial flaring and higher rates of patient satisfaction in the antihistamine groups in both studies.

In an interview at the meeting, Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, described Dr. Barbieri as “a leader in taking a comprehensive view on what the history and latest information is on isotretinoin. His fresh approach is something everyone should consider and figure out what they can use in their practice.”

Dr. Barbieri disclosed that he receives consulting fees from Dexcel for work unrelated to his presentation. Dr. Eichenfield disclosed that he has been an investigator and/or consultant for Almirall, Cassiopea, Dermata, Galderma, and Ortho Dermatologics. Medscape and this news organization are owned by the same parent company.

Teenage girls are experiencing record high levels of sexual violence, and nearly three in five girls report feeling persistently sad or hopeless, according to a new report by the Centers for Disease Control and Prevention.
 

Nearly 70% of teens who identified as lesbian, bisexual, gay, or questioning (LGBQ+) report experiencing feelings of persistent sadness and hopeless, and nearly one in four (22%) LGBQ+ had attempted suicide in 2021, according to the report.

“High school should be a time for trailblazing, not trauma. These data show our kids need far more support to cope, hope, and thrive,” said Debra Houry, MD, MPH, the CDC’s acting principal deputy director, in a press release about the findings.

The new analysis looked at data from 2011 to 2021 from the CDC’s Youth Risk and Behavior Survey (YRBS), a semiannual analysis of the health behaviors of students in grades 9-12. The 2021 survey is the first YRBS conducted since the COVID-19 pandemic began and included 17,232 respondents.

Although the researchers saw signs of improvement in risky sexual behaviors and substance abuse, as well as fewer experiences of bullying, the analysis found youth mental health worsened over the past 10 years. This trend was particularly troubling for teenage girls: 57% said they felt persistently sad or hopeless in 2021, a 60% increase from a decade ago. By comparison, 29% of teenage boys reported feeling persistently sad or hopeless, compared with 21% in 2011.

Nearly one-third of girls (30%) reported seriously considering suicide, up from 19% in 2011. In teenage boys, serious thoughts of suicide increased from 13% to 14% from 2011 to 2021. The percentage of teenage girls who had attempted suicide in 2021 was 13%, nearly twice that of teenage boys (7%).

More than half of students with a same-sex partner (58%) reported seriously considering suicide, and 45% of LGBQ+ teens reported the same thoughts. One third of students with a same-sex partner reported attempting suicide in the past year.

The report did not have trend data on LGBQ+ students because of changes in survey methods. The 2021 survey did not have a question accessing gender identity, but this will be incorporated into future surveys, according to the researchers.

Hispanic and multiracial students were more likely to experience persistent feelings of sadness or hopelessness, compared with their peers, with 46% and 49%, respectively, reporting these feelings. From 2011-2021, the percentage of students reporting feelings of hopelessness increased in each racial and ethnic group. The percentage of Black, Hispanic, and White teens who seriously considered suicide also increased over the decade. (A different report released by the CDC on Feb. 10 found that the rate of suicide among Blacks in the United States aged 10-24 jumped 36.6% between 2018 and 2021, the largest increase for any racial or ethnic group.)

The survey also found an alarming spike in sexual violence toward teenage girls. Nearly one in five females (18%) experienced sexual violence in the past year, a 20% increase from 2017. More than 1 in 10 teen girls (14%) said they had been forced to have sex, according to the researchers.

Rates of sexual violence was even higher in LGBQ+ teens. Nearly two in five teens with a partner of the same sex (39%) experienced sexual violence, and 37% reported being sexually assaulted. More than one in five LGBQ+ teens (22%) had experienced sexual violence, and 20% said they had been forced to have sex, the report found.

Among racial and ethnic groups, American Indian and Alaskan Native and multiracial students were more likely to experience sexual violence. The percentage of White students reporting sexual violence increased from 2017 to 2021, but that trend was not observed in other racial and ethnic groups.

Delaney Ruston, MD, an internal medicine specialist in Seattle and creator of “Screenagers,” a 2016 documentary about how technology affects youth, said excessive exposure to social media can compound feelings of depression in teens – particularly, but not only, girls. “They can scroll and consume media for hours, and rather than do activities and have interactions that would help heal from depression symptoms, they stay stuck,” Ruston said in an interview. “As a primary care physician working with teens, this is an extremely common problem I see in my clinic.”

One approach that can help, Dr. Ruston added, is behavioral activation. “This is a strategy where you get them, usually with the support of other people, to do small activities that help to reset brain reward pathways so they start to experience doses of well-being and hope that eventually reverses the depression. Being stuck on screens prevents these healing actions from happening.”

The report also emphasized the importance of school-based services to support students and combat these troubling trends in worsening mental health. “Schools are the gateway to needed services for many young people,” the report stated. “Schools can provide health, behavioral, and mental health services directly or establish referral systems to connect to community sources of care.”

“Young people are experiencing a level of distress that calls on us to act with urgency and compassion,” Kathleen Ethier, PhD, director of the CDC’s division of adolescent and school health, added in a statement. “With the right programs and services in place, schools have the unique ability to help our youth flourish.”

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

Teenage girls are experiencing record high levels of sexual violence, and nearly three in five girls report feeling persistently sad or hopeless, according to a new report by the Centers for Disease Control and Prevention.
 

Nearly 70% of teens who identified as lesbian, bisexual, gay, or questioning (LGBQ+) report experiencing feelings of persistent sadness and hopeless, and nearly one in four (22%) LGBQ+ had attempted suicide in 2021, according to the report.

“High school should be a time for trailblazing, not trauma. These data show our kids need far more support to cope, hope, and thrive,” said Debra Houry, MD, MPH, the CDC’s acting principal deputy director, in a press release about the findings.

The new analysis looked at data from 2011 to 2021 from the CDC’s Youth Risk and Behavior Survey (YRBS), a semiannual analysis of the health behaviors of students in grades 9-12. The 2021 survey is the first YRBS conducted since the COVID-19 pandemic began and included 17,232 respondents.

Although the researchers saw signs of improvement in risky sexual behaviors and substance abuse, as well as fewer experiences of bullying, the analysis found youth mental health worsened over the past 10 years. This trend was particularly troubling for teenage girls: 57% said they felt persistently sad or hopeless in 2021, a 60% increase from a decade ago. By comparison, 29% of teenage boys reported feeling persistently sad or hopeless, compared with 21% in 2011.

Nearly one-third of girls (30%) reported seriously considering suicide, up from 19% in 2011. In teenage boys, serious thoughts of suicide increased from 13% to 14% from 2011 to 2021. The percentage of teenage girls who had attempted suicide in 2021 was 13%, nearly twice that of teenage boys (7%).

More than half of students with a same-sex partner (58%) reported seriously considering suicide, and 45% of LGBQ+ teens reported the same thoughts. One third of students with a same-sex partner reported attempting suicide in the past year.

The report did not have trend data on LGBQ+ students because of changes in survey methods. The 2021 survey did not have a question accessing gender identity, but this will be incorporated into future surveys, according to the researchers.

Hispanic and multiracial students were more likely to experience persistent feelings of sadness or hopelessness, compared with their peers, with 46% and 49%, respectively, reporting these feelings. From 2011-2021, the percentage of students reporting feelings of hopelessness increased in each racial and ethnic group. The percentage of Black, Hispanic, and White teens who seriously considered suicide also increased over the decade. (A different report released by the CDC on Feb. 10 found that the rate of suicide among Blacks in the United States aged 10-24 jumped 36.6% between 2018 and 2021, the largest increase for any racial or ethnic group.)

The survey also found an alarming spike in sexual violence toward teenage girls. Nearly one in five females (18%) experienced sexual violence in the past year, a 20% increase from 2017. More than 1 in 10 teen girls (14%) said they had been forced to have sex, according to the researchers.

Rates of sexual violence was even higher in LGBQ+ teens. Nearly two in five teens with a partner of the same sex (39%) experienced sexual violence, and 37% reported being sexually assaulted. More than one in five LGBQ+ teens (22%) had experienced sexual violence, and 20% said they had been forced to have sex, the report found.

Among racial and ethnic groups, American Indian and Alaskan Native and multiracial students were more likely to experience sexual violence. The percentage of White students reporting sexual violence increased from 2017 to 2021, but that trend was not observed in other racial and ethnic groups.

Delaney Ruston, MD, an internal medicine specialist in Seattle and creator of “Screenagers,” a 2016 documentary about how technology affects youth, said excessive exposure to social media can compound feelings of depression in teens – particularly, but not only, girls. “They can scroll and consume media for hours, and rather than do activities and have interactions that would help heal from depression symptoms, they stay stuck,” Ruston said in an interview. “As a primary care physician working with teens, this is an extremely common problem I see in my clinic.”

One approach that can help, Dr. Ruston added, is behavioral activation. “This is a strategy where you get them, usually with the support of other people, to do small activities that help to reset brain reward pathways so they start to experience doses of well-being and hope that eventually reverses the depression. Being stuck on screens prevents these healing actions from happening.”

The report also emphasized the importance of school-based services to support students and combat these troubling trends in worsening mental health. “Schools are the gateway to needed services for many young people,” the report stated. “Schools can provide health, behavioral, and mental health services directly or establish referral systems to connect to community sources of care.”

“Young people are experiencing a level of distress that calls on us to act with urgency and compassion,” Kathleen Ethier, PhD, director of the CDC’s division of adolescent and school health, added in a statement. “With the right programs and services in place, schools have the unique ability to help our youth flourish.”

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

Teenage girls are experiencing record high levels of sexual violence, and nearly three in five girls report feeling persistently sad or hopeless, according to a new report by the Centers for Disease Control and Prevention.
 

Nearly 70% of teens who identified as lesbian, bisexual, gay, or questioning (LGBQ+) report experiencing feelings of persistent sadness and hopeless, and nearly one in four (22%) LGBQ+ had attempted suicide in 2021, according to the report.

“High school should be a time for trailblazing, not trauma. These data show our kids need far more support to cope, hope, and thrive,” said Debra Houry, MD, MPH, the CDC’s acting principal deputy director, in a press release about the findings.

The new analysis looked at data from 2011 to 2021 from the CDC’s Youth Risk and Behavior Survey (YRBS), a semiannual analysis of the health behaviors of students in grades 9-12. The 2021 survey is the first YRBS conducted since the COVID-19 pandemic began and included 17,232 respondents.

Although the researchers saw signs of improvement in risky sexual behaviors and substance abuse, as well as fewer experiences of bullying, the analysis found youth mental health worsened over the past 10 years. This trend was particularly troubling for teenage girls: 57% said they felt persistently sad or hopeless in 2021, a 60% increase from a decade ago. By comparison, 29% of teenage boys reported feeling persistently sad or hopeless, compared with 21% in 2011.

Nearly one-third of girls (30%) reported seriously considering suicide, up from 19% in 2011. In teenage boys, serious thoughts of suicide increased from 13% to 14% from 2011 to 2021. The percentage of teenage girls who had attempted suicide in 2021 was 13%, nearly twice that of teenage boys (7%).

More than half of students with a same-sex partner (58%) reported seriously considering suicide, and 45% of LGBQ+ teens reported the same thoughts. One third of students with a same-sex partner reported attempting suicide in the past year.

The report did not have trend data on LGBQ+ students because of changes in survey methods. The 2021 survey did not have a question accessing gender identity, but this will be incorporated into future surveys, according to the researchers.

Hispanic and multiracial students were more likely to experience persistent feelings of sadness or hopelessness, compared with their peers, with 46% and 49%, respectively, reporting these feelings. From 2011-2021, the percentage of students reporting feelings of hopelessness increased in each racial and ethnic group. The percentage of Black, Hispanic, and White teens who seriously considered suicide also increased over the decade. (A different report released by the CDC on Feb. 10 found that the rate of suicide among Blacks in the United States aged 10-24 jumped 36.6% between 2018 and 2021, the largest increase for any racial or ethnic group.)

The survey also found an alarming spike in sexual violence toward teenage girls. Nearly one in five females (18%) experienced sexual violence in the past year, a 20% increase from 2017. More than 1 in 10 teen girls (14%) said they had been forced to have sex, according to the researchers.

Rates of sexual violence was even higher in LGBQ+ teens. Nearly two in five teens with a partner of the same sex (39%) experienced sexual violence, and 37% reported being sexually assaulted. More than one in five LGBQ+ teens (22%) had experienced sexual violence, and 20% said they had been forced to have sex, the report found.

Among racial and ethnic groups, American Indian and Alaskan Native and multiracial students were more likely to experience sexual violence. The percentage of White students reporting sexual violence increased from 2017 to 2021, but that trend was not observed in other racial and ethnic groups.

Delaney Ruston, MD, an internal medicine specialist in Seattle and creator of “Screenagers,” a 2016 documentary about how technology affects youth, said excessive exposure to social media can compound feelings of depression in teens – particularly, but not only, girls. “They can scroll and consume media for hours, and rather than do activities and have interactions that would help heal from depression symptoms, they stay stuck,” Ruston said in an interview. “As a primary care physician working with teens, this is an extremely common problem I see in my clinic.”

One approach that can help, Dr. Ruston added, is behavioral activation. “This is a strategy where you get them, usually with the support of other people, to do small activities that help to reset brain reward pathways so they start to experience doses of well-being and hope that eventually reverses the depression. Being stuck on screens prevents these healing actions from happening.”

The report also emphasized the importance of school-based services to support students and combat these troubling trends in worsening mental health. “Schools are the gateway to needed services for many young people,” the report stated. “Schools can provide health, behavioral, and mental health services directly or establish referral systems to connect to community sources of care.”

“Young people are experiencing a level of distress that calls on us to act with urgency and compassion,” Kathleen Ethier, PhD, director of the CDC’s division of adolescent and school health, added in a statement. “With the right programs and services in place, schools have the unique ability to help our youth flourish.”

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

The rising national suicide rate is being driven by increases among younger people and among people of color, according to a new report. 

Significant increases in suicide occurred among Native American, Black and Hispanic people, with a startling rise among young Black people. Meanwhile, the rate of suicide among older people declined between 2018 and 2021, the Centers for Disease Control and Prevention has reported.

In 2021, 48,183 people died by suicide in the United States, which equates to a suicide rate of 14.1 per 100,000 people. That level equals the 2018 suicide rate, which had seen a peak that was followed by declines associated with the pandemic.

Experts said rebounding suicide rates are common following times of crisis, such as the COVID-19 pandemic. Suicide declines have also occurred during times of war and natural disaster, when psychological resilience tends to increase and people work together to overcome shared adversity.

“That will wane, and then you will see rebounding in suicide rates. That is, in fact, what we feared would happen. And it has happened, at least in 2021,” Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, told the New York Times.

The new CDC report found that the largest increase was among Black people aged 10-24 years, who experienced a 36.6% increase in suicide rate between 2018 and 2021. While Black people experience mental illness at the same rates as that of the general population, historically they have disproportionately limited access to mental health care, according to the American Psychiatric Association.

CDC report authors noted that some of the biggest increases in suicide rates occurred among groups most affected by the pandemic. 

From 2018 to 2021, the suicide rate for people aged 25-44 increased among Native Americans by 33.7% and among Black people by 22.9%. Suicide increased among multiracial people by 20.6% and among Hispanic or Latinx people by 19.4%. Among White people of all ages, the suicide rate declined or remained steady.

“As the nation continues to respond to the short- and long-term impacts of the COVID-19 pandemic, remaining vigilant in prevention efforts is critical, especially among disproportionately affected populations where longer-term impacts might compound preexisting inequities in suicide risk,” the CDC researchers wrote.

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

The rising national suicide rate is being driven by increases among younger people and among people of color, according to a new report. 

Significant increases in suicide occurred among Native American, Black and Hispanic people, with a startling rise among young Black people. Meanwhile, the rate of suicide among older people declined between 2018 and 2021, the Centers for Disease Control and Prevention has reported.

In 2021, 48,183 people died by suicide in the United States, which equates to a suicide rate of 14.1 per 100,000 people. That level equals the 2018 suicide rate, which had seen a peak that was followed by declines associated with the pandemic.

Experts said rebounding suicide rates are common following times of crisis, such as the COVID-19 pandemic. Suicide declines have also occurred during times of war and natural disaster, when psychological resilience tends to increase and people work together to overcome shared adversity.

“That will wane, and then you will see rebounding in suicide rates. That is, in fact, what we feared would happen. And it has happened, at least in 2021,” Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, told the New York Times.

The new CDC report found that the largest increase was among Black people aged 10-24 years, who experienced a 36.6% increase in suicide rate between 2018 and 2021. While Black people experience mental illness at the same rates as that of the general population, historically they have disproportionately limited access to mental health care, according to the American Psychiatric Association.

CDC report authors noted that some of the biggest increases in suicide rates occurred among groups most affected by the pandemic. 

From 2018 to 2021, the suicide rate for people aged 25-44 increased among Native Americans by 33.7% and among Black people by 22.9%. Suicide increased among multiracial people by 20.6% and among Hispanic or Latinx people by 19.4%. Among White people of all ages, the suicide rate declined or remained steady.

“As the nation continues to respond to the short- and long-term impacts of the COVID-19 pandemic, remaining vigilant in prevention efforts is critical, especially among disproportionately affected populations where longer-term impacts might compound preexisting inequities in suicide risk,” the CDC researchers wrote.

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

The rising national suicide rate is being driven by increases among younger people and among people of color, according to a new report. 

Significant increases in suicide occurred among Native American, Black and Hispanic people, with a startling rise among young Black people. Meanwhile, the rate of suicide among older people declined between 2018 and 2021, the Centers for Disease Control and Prevention has reported.

In 2021, 48,183 people died by suicide in the United States, which equates to a suicide rate of 14.1 per 100,000 people. That level equals the 2018 suicide rate, which had seen a peak that was followed by declines associated with the pandemic.

Experts said rebounding suicide rates are common following times of crisis, such as the COVID-19 pandemic. Suicide declines have also occurred during times of war and natural disaster, when psychological resilience tends to increase and people work together to overcome shared adversity.

“That will wane, and then you will see rebounding in suicide rates. That is, in fact, what we feared would happen. And it has happened, at least in 2021,” Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, told the New York Times.

The new CDC report found that the largest increase was among Black people aged 10-24 years, who experienced a 36.6% increase in suicide rate between 2018 and 2021. While Black people experience mental illness at the same rates as that of the general population, historically they have disproportionately limited access to mental health care, according to the American Psychiatric Association.

CDC report authors noted that some of the biggest increases in suicide rates occurred among groups most affected by the pandemic. 

From 2018 to 2021, the suicide rate for people aged 25-44 increased among Native Americans by 33.7% and among Black people by 22.9%. Suicide increased among multiracial people by 20.6% and among Hispanic or Latinx people by 19.4%. Among White people of all ages, the suicide rate declined or remained steady.

“As the nation continues to respond to the short- and long-term impacts of the COVID-19 pandemic, remaining vigilant in prevention efforts is critical, especially among disproportionately affected populations where longer-term impacts might compound preexisting inequities in suicide risk,” the CDC researchers wrote.

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

In May 2021, a nurse at UnitedHealthcare called a colleague to share some welcome news about a problem the two had been grappling with for weeks.

United provided the health insurance plan for students at Penn State University. It was a large and potentially lucrative account: lots of young, healthy students paying premiums in, not too many huge medical reimbursements going out.

But one student was costing United a lot of money. Christopher McNaughton suffered from a crippling case of ulcerative colitis – an ailment that caused him to develop severe arthritis, debilitating diarrhea, numbing fatigue, and life-threatening blood clots. His medical bills were running nearly $2 million a year.

United had flagged Mr. McNaughton’s case as a “high dollar account,” and the company was reviewing whether it needed to keep paying for the expensive cocktail of drugs crafted by a Mayo Clinic specialist that had brought Mr. McNaughton’s disease under control after he’d been through years of misery.

On the 2021 phone call, which was recorded by the company, nurse Victoria Kavanaugh told her colleague that a doctor contracted by United to review the case had concluded that Mr. McNaughton’s treatment was “not medically necessary.” Her colleague, Dave Opperman, reacted to the news with a long laugh.

“I knew that was coming,” said Mr. Opperman, who heads up a United subsidiary that brokered the health insurance contract between United and Penn State. “I did too,” Ms. Kavanaugh replied.

Mr. Opperman then complained about Mr. McNaughton’s mother, whom he referred to as “this woman,” for “screaming and yelling” and “throwing tantrums” during calls with United.

The pair agreed that any appeal of the United doctor’s denial of the treatment would be a waste of the family’s time and money.

“We’re still gonna say no,” Mr. Opperman said.

More than 200 million Americans are covered by private health insurance. But data from state and federal regulators shows that insurers reject about 1 in 7 claims for treatment. Many people, faced with fighting insurance companies, simply give up: One study found that Americans file formal appeals on only 0.1% of claims denied by insurers under the Affordable Care Act.

Insurers have wide discretion in crafting what is covered by their policies, beyond some basic services mandated by federal and state law. They often deny claims for services that they deem not “medically necessary.”

When United refused to pay for Mr. McNaughton’s treatment for that reason, his family did something unusual. They fought back with a lawsuit, which uncovered a trove of materials, including internal emails and tape-recorded exchanges among company employees. Those records offer an extraordinary behind-the-scenes look at how one of America’s leading health care insurers relentlessly fought to reduce spending on care, even as its profits rose to record levels.

As United reviewed Mr. McNaughton’s treatment, he and his family were often in the dark about what was happening or their rights. Meanwhile, United employees misrepresented critical findings and ignored warnings from doctors about the risks of altering Mr. McNaughton’s drug plan.

At one point, court records show, United inaccurately reported to Penn State and the family that Mr. McNaughton’s doctor had agreed to lower the doses of his medication. Another time, a doctor paid by United concluded that denying payments for Mr. McNaughton’s treatment could put his health at risk, but the company buried his report and did not consider its findings. The insurer did, however, consider a report submitted by a company doctor who rubber-stamped the recommendation of a United nurse to reject paying for the treatment.

United declined to answer specific questions about the case, even after Mr. McNaughton signed a release provided by the insurer to allow it to discuss details of his interactions with the company. United noted that it ultimately paid for all of Mr. McNaughton’s treatments. In a written response, United spokesperson Maria Gordon Shydlo wrote that the company’s guiding concern was Mr. McNaughton’s well-being.

“Mr. McNaughton’s treatment involves medication dosages that far exceed [Food and Drug Administration] guidelines,” the statement said. “In cases like this, we review treatment plans based on current clinical guidelines to help ensure patient safety.”

But the records reviewed by ProPublica show that United had another, equally urgent goal in dealing with Mr. McNaughton. In emails, officials calculated what Mr. McNaughton was costing them to keep his crippling disease at bay and how much they would save if they forced him to undergo a cheaper treatment that had already failed him. As the family pressed the company to back down, first through Penn State and then through a lawsuit, the United officials handling the case bristled.

“This is just unbelievable,” Ms. Kavanaugh said of Mr. McNaughton’s family in one call to discuss his case. ”They’re just really pushing the envelope, and I’m surprised, like I don’t even know what to say.”
 

The same meal every day

Now 31, Mr. McNaughton grew up in State College, Pa., just blocks from the Penn State campus. Both of his parents are faculty members at the university.

In the winter of 2014, Mr. McNaughton was halfway through his junior year at Bard College in New York. At 6 feet, 4 inches tall, he was a guard on the basketball team and had started most of the team’s games since the start of his sophomore year. He was majoring in psychology.

When Mr. McNaughton returned to school after the winter holiday break, he started to experience frequent bouts of bloody diarrhea. After just a few days on campus, he went home to State College, where doctors diagnosed him with a severe case of ulcerative colitis.

A chronic inflammatory bowel disease that causes swelling and ulcers in the digestive tract, ulcerative colitis has no cure, and ongoing treatment is needed to alleviate symptoms and prevent serious health complications. The majority of cases produce mild to moderate symptoms. Mr. McNaughton’s case was severe.

Treatments for ulcerative colitis include steroids and special drugs known as biologics that work to reduce inflammation in the large intestine.

Mr. McNaughton, however, failed to get meaningful relief from the drugs his doctors initially prescribed. He was experiencing bloody diarrhea up to 20 times a day, with such severe stomach pain that he spent much of his day curled up on a couch. He had little appetite and lost 50 pounds. Severe anemia left him fatigued. He suffered from other conditions related to his colitis, including crippling arthritis. He was hospitalized several times to treat dangerous blood clots.

For 2 years, in an effort to help alleviate his symptoms, he ate the same meals every day: Rice Chex cereal and scrambled eggs for breakfast, a cup of white rice with plain chicken breast for lunch, and a similar meal for dinner, occasionally swapping in tilapia.

His hometown doctors referred him to a specialist at the University of Pittsburgh, who tried unsuccessfully to bring his disease under control. That doctor ended up referring Mr. McNaughton to Edward V. Loftus Jr., MD, at the Mayo Clinic in Rochester, Minn., which has been ranked as the best gastroenterology hospital in the country every year since 1990 by U.S. News & World Report.

For his first visit with Dr. Loftus in May 2015, Mr. McNaughton and his mother, Janice Light, charted hospitals along the 900-mile drive from Pennsylvania to Minnesota in case they needed medical help along the way.

Mornings were the hardest. Mr. McNaughton often spent several hours in the bathroom at the start of the day. To prepare for his meeting with Dr. Loftus, he set his alarm for 3:30 a.m. so he could be ready for the 7:30 a.m. appointment. Even with that preparation, he had to stop twice to use a bathroom on the 5-minute walk from the hotel to the clinic. When they met, Dr. Loftus looked at Mr. McNaughton and told him that he appeared incapacitated. It was, he told the student, as if Mr. McNaughton were chained to the bathroom, with no outside life. He had not been able to return to school and spent most days indoors, managing his symptoms as best he could.

Mr. McNaughton had tried a number of medications by this point, none of which worked. This pattern would repeat itself during the first couple of years that Dr. Loftus treated him.

In addition to trying to find a treatment that would bring Mr. McNaughton’s colitis into remission, Dr. Loftus wanted to wean him off the steroid prednisone, which he had been taking since his initial diagnosis in 2014. The drug is commonly prescribed to colitis patients to control inflammation, but prolonged use can lead to severe side effects including cataracts, osteoporosis, increased risk of infection, and fatigue. Mr. McNaughton also experienced “moon face,” a side effect caused by the shifting of fat deposits that results in the face becoming puffy and rounder.

In 2018, Dr. Loftus and Mr. McNaughton decided to try an unusual regimen. Many patients with inflammatory bowel diseases such as colitis take a single biologic drug as treatment. Whereas traditional drugs are chemically synthesized, biologics are manufactured in living systems, such as plant or animal cells. A year’s supply of an individual biologic drug can cost up to $500,000. They are often given through infusions in a medical facility, which adds to the cost.

Mr. McNaughton had tried individual biologics, and then two in combination, without much success. He and Dr. Loftus then agreed to try two biologic drugs together at doses well above those recommended by the Food and Drug Administration. The federal Agency for Healthcare Research and Quality estimates one in five prescriptions written today are for off-label uses.

There are drawbacks to the practice. Since some uses and doses of particular drugs have not been extensively studied, the risks and efficacy of using them off-label are not well known. Also, some drug manufacturers have improperly pushed off-label usage of their products to boost sales despite little or no evidence to support their use in those situations. Like many leading experts and researchers in his field, Dr. Loftus has been paid to do consulting related to the biologic drugs taken by Mr. McNaughton. The payments related to those drugs have ranged from a total of $1,440 in 2020 to $51,235 in 2018. Dr. Loftus said much of his work with pharmaceutical companies was related to conducting clinical trials on new drugs.

In cases of off-label prescribing, patients are depending upon their doctors’ expertise and experience with the drug. “In this case, I was comfortable that the potential benefits to Chris outweighed the risks,” Dr. Loftus said.

There was evidence that the treatment plan for Mr. McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe. The two drugs he takes, Entyvio and Remicade, have the same purpose – to reduce inflammation in the large intestine – but each works differently in the body. Remicade, marketed by Janssen Biotech, targets a protein that causes inflammation. Entyvio, made by Takeda Pharmaceuticals, works by preventing an excess of white blood cells from entering into the gastrointestinal tract.

As for any suggestion by United doctors that his treatment plan for Mr. McNaughton was out of bounds or dangerous, Dr. Loftus said “my treatment of Chris was not clinically inappropriate – as was shown by Chris’ positive outcome.”

The unusual high-dose combination of two biologic drugs produced a remarkable change in Mr. McNaughton. He no longer had blood in his stool, and his trips to the bathroom were cut from 20 times a day to 3 or 4. He was able to eat different foods and put on weight. He had more energy. He tapered off prednisone.

“If you told me in 2015 that I would be living like this, I would have asked where do I sign up,” Mr. McNaughton said of the change he experienced with the new drug regimen.

When he first started the new treatment, Mr. McNaughton was covered under his family’s plan, and all his bills were paid. Mr. McNaughton enrolled at the university in 2020. Before switching to United’s plan for students, Mr. McNaughton and his parents consulted with a health advocacy service offered to faculty members. A benefits specialist assured them the drugs taken by Mr. McNaughton would be covered by United.

Mr. McNaughton joined the student plan in July 2020, and his infusions that month and the following month were paid for by United. In September, the insurer indicated payment on his claims was “pending,” something it did for his other claims that came in during the rest of the year.

Mr. McNaughton and his family were worried. They called United to make sure there wasn’t a problem; the insurer told them, they said, that it only needed to check his medical records. When the family called again, United told them it had the documentation needed, they said. United, in a court filing last year, said it received two calls from the family and each time indicated that all of the necessary medical records had not yet been received.

In January 2021, Mr. McNaughton received a new explanation of benefits for the prior months. All of the claims for his care, beginning in September, were no longer “pending.” They were stamped “DENIED.” The total outstanding bill for his treatment was $807,086.

When Mr. McNaughton’s mother reached a United customer service representative the next day to ask why bills that had been paid in the summer were being denied for the fall, the representative told her the account was being reviewed because of “a high dollar amount on the claims,” according to a recording of the call.


 

Misrepresentations

With United refusing to pay, the family was terrified of being stuck with medical bills that would bankrupt them and deprive Mr. McNaughton of treatment that they considered miraculous.

They turned to Penn State for help. Ms. Light and Mr. McNaughton’s father, David McNaughton, hoped their position as faculty members would make the school more willing to intervene on their behalf.

“After more than 30 years on faculty, my husband and I know that this is not how Penn State would want its students to be treated,” Ms. Light wrote to a school official in February 2021.

In response to questions from ProPublica, Penn State spokesperson Lisa Powers wrote that “supporting the health and well-being of our students is always of primary importance” and that “our hearts go out to any student and family impacted by a serious medical condition.” The university, she wrote, does “not comment on students’ individual circumstances or disclose information from their records.” Mr. McNaughton offered to grant Penn State whatever permissions it needed to speak about his case with ProPublica. The school, however, wrote that it would not comment “even if confidentiality has been waived.”

The family appealed to school administrators. Because the effectiveness of biologics wanes in some patients if doses are skipped, Mr. McNaughton and his parents were worried about even a delay in treatment. His doctor wrote that if he missed scheduled infusions of the drugs, there was “a high likelihood they would no longer be effective.”

During a conference call arranged by Penn State officials on March 5, 2021, United agreed to pay for Mr. McNaughton’s care through the end of the plan year that August. Penn State immediately notified the family of the “wonderful news” while also apologizing for “the stress this has caused Chris and your family.”

Behind the scenes, Mr. McNaughton’s review had “gone all the way to the top” at United’s student health plan division, Ms. Kavanaugh, the nurse, said in a recorded conversation.

The family’s relief was short-lived. A month later, United started another review of Mr. McNaughton’s care, overseen by Ms. Kavanaugh, to determine if it would pay for the treatment in the upcoming plan year.

The nurse sent the Mr. McNaughton case to a company called Medical Review Institute of America. Insurers often turn to companies like MRIoA to review coverage decisions involving expensive treatments or specialized care.

Ms. Kavanaugh, who was assigned to a special investigations unit at United, let her feelings about the matter be known in a recorded telephone call with a representative of MRIoA.

“This school apparently is a big client of ours,” she said. She then shared her opinion of Mr. McNaughton’s treatment. “Really this is a case of a kid who’s getting a drug way too much, like too much of a dose,” Ms. Kavanaugh said. She said it was “insane that they would even think that this is reasonable” and “to be honest with you, they’re awfully pushy considering that we are paying through the end of this school year.”

On a call with an outside contractor, the United nurse claimed Mr. McNaughton was on a higher dose of medication than the FDA approved, which is a common practice.

MRIoA sent the case to Vikas Pabby, MD, a gastroenterologist at UCLA Health and a professor at the university’s medical school. His May 2021 review of Mr. McNaughton’s case was just one of more than 300 Dr. Pabby did for MRIoA that month, for which he was paid $23,000 in total, according to a log of his work produced in the lawsuit.

In a May 4, 2021, report, Dr. Pabby concluded Mr. McNaughton’s treatment was not medically necessary, because United’s policies for the two drugs taken by Mr. McNaughton did not support using them in combination.

Insurers spell out what services they cover in plan policies, lengthy documents that can be confusing and difficult to understand. Many policies, such as Mr. McNaughton’s, contain a provision that treatments and procedures must be “medically necessary” in order to be covered. The definition of medically necessary differs by plan. Some don’t even define the term. Mr. McNaughton’s policy contains a five-part definition, including that the treatment must be “in accordance with the standards of good medical policy” and “the most appropriate supply or level of service which can be safely provided.”

Behind the scenes at United, Mr. Opperman and Ms. Kavanaugh agreed that if Mr. McNaughton were to appeal Dr. Pabby’s decision, the insurer would simply rule against him. “I just think it’s a waste of money and time to appeal and send it to another one when we know we’re gonna get the same answer,” Mr. Opperman said, according to a recording in court files. At Mr. Opperman’s urging, United decided to skip the usual appeals process and arrange for Dr. Pabby to have a so-called “peer-to-peer” discussion with Dr. Loftus, the Mayo physician treating Mr. McNaughton. Such a conversation, in which a patient’s doctor talks with an insurance company’s doctor to advocate for the prescribed treatment, usually occurs only after a customer has appealed a denial and the appeal has been rejected.

When Ms. Kavanaugh called Dr. Loftus’ office to set up a conversation with Dr. Pabby, she explained it was an urgent matter and had been requested by Mr. McNaughton. “You know I’ve just gotten to know Christopher,” she explained, although she had never spoken with him. “We’re trying to advocate and help and get this peer-to-peer set up.”

Mr. McNaughton, meanwhile, had no idea at the time that a United doctor had decided his treatment was unnecessary and that the insurer was trying to set up a phone call with his physician.

In the peer-to-peer conversation, Dr. Loftus told Dr. Pabby that Mr. McNaughton had “a very complicated case” and that lower doses had not worked for him, according to an internal MRIoA memo.

Following his conversation with Dr. Loftus, Dr. Pabby created a second report for United. He recommended the insurer pay for both drugs, but at reduced doses. He added new language saying that the safety of using both drugs at the higher levels “is not established.”

When Ms. Kavanaugh shared the May 12 decision from Dr. Pabby with others at United, her boss responded with an email calling it “great news.”

Then Mr. Opperman sent an email that puzzled the McNaughtons.

In it, Mr. Opperman claimed that Dr. Loftus and Dr. Pabby had agreed that Mr. McNaughton should be on significantly lower doses of both drugs. He said Dr. Loftus “will work with the patient to start titrating them down to a normal dose range.” Mr. Opperman wrote that United would cover Mr. McNaughton’s treatment in the coming year, but only at the reduced doses. Mr. Opperman did not respond to emails and phone messages seeking comment.

Mr. McNaughton didn’t believe a word of it. He had already tried and failed treatment with those drugs at lower doses, and it was Dr. Loftus who had upped the doses, leading to his remission from severe colitis.

The only thing that made sense to Mr. McNaughton was that the treatment United said it would now pay for was dramatically cheaper – saving the company at least hundreds of thousands of dollars a year – than his prescribed treatment because it sliced the size of the doses by more than half.

When the family contacted Dr. Loftus for an explanation, they were outraged by what they heard. Dr. Loftus told them that he had never recommended lowering the dosage. In a letter, Dr. Loftus wrote that changing Mr. McNaughton’s treatment “would have serious detrimental effects on both his short term and long term health and could potentially involve life threatening complications. This would ultimately incur far greater medical costs. Chris was on the doses suggested by United Healthcare before, and they were not at all effective.”

It would not be until the lawsuit that it would become clear how Dr. Loftus’ conversations had been so seriously misrepresented.

Under questioning by Mr. McNaughton’s lawyers, Ms. Kavanaugh acknowledged that she was the source of the incorrect claim that Mr. McNaughton’s doctor had agreed to a change in treatment.

“I incorrectly made an assumption that they had come to some sort of agreement,” she said in a deposition last August. “It was my first peer-to-peer. I did not realize that that simply does not occur.”

Ms. Kavanaugh did not respond to emails and telephone messages seeking comment.

When the McNaughtons first learned of Mr. Opperman’s inaccurate report of the phone call with Dr. Loftus, it unnerved them. They started to question if their case would be fairly reviewed.

“When we got the denial and they lied about what Dr. Loftus said, it just hit me that none of this matters,” Mr. McNaughton said. “They will just say or do anything to get rid of me. It delegitimized the entire review process. When I got that denial, I was crushed.”


 

A buried report

While the family tried to sort out the inaccurate report, United continued putting the McNaughton case in front of more company doctors.

On May 21, 2021, United sent the case to one of its own doctors, Nady Cates, MD, for an additional review. The review was marked “escalated issue.” Dr. Cates is a United medical director, a title used by many insurers for physicians who review cases. It is work he has been doing as an employee of health insurers since 1989 and at United since 2010. He has not practiced medicine since the early 1990s.

Dr. Cates, in a deposition, said he stopped seeing patients because of the long hours involved and because “AIDS was coming around then. I was seeing a lot of military folks who had venereal diseases, and I guess I was concerned about being exposed.” He transitioned to reviewing paperwork for the insurance industry, he said, because “I guess I was a chicken.”

When he had practiced, Dr. Cates said, he hadn’t treated patients with ulcerative colitis and had referred those cases to a gastroenterologist.

He said his review of Mr. McNaughton’s case primarily involved reading a United nurse’s recommendation to deny his care and making sure “that there wasn’t a decimal place that was out of line.” He said he copied and pasted the nurse’s recommendation and typed “agree” on his review of Mr. McNaughton’s case.

Dr. Cates said that he does about a hundred reviews a week. He said that in his reviews he typically checks to see if any medications are prescribed in accordance with the insurer’s guidelines, and if not, he denies it. United’s policies, he said, prevented him from considering that Mr. McNaughton had failed other treatments or that Dr. Loftus was a leading expert in his field.

“You are giving zero weight to the treating doctor’s opinion on the necessity of the treatment regimen?” a lawyer asked Dr. Cates in his deposition. He responded, “Yeah.”

Attempts to contact Dr. Cates for comment were unsuccessful.

At the same time Dr. Cates was looking at Mr. McNaughton’s case, yet another review was underway at MRIoA. United said it sent the case back to MRIoA after the insurer received the letter from Dr. Loftus warning of the life-threatening complications that might occur if the dosages were reduced.

On May 24, 2021, the new report requested by MRIoA arrived. It came to a completely different conclusion than all of the previous reviews.

Nitin Kumar, MD, a gastroenterologist in Illinois, concluded that Mr. McNaughton’s established treatment plan was not only medically necessary and appropriate but that lowering his doses “can result in a lack of effective therapy of Ulcerative Colitis, with complications of uncontrolled disease (including dysplasia leading to colorectal cancer), flare, hospitalization, need for surgery, and toxic megacolon.”

Unlike other doctors who produced reports for United, Dr. Kumar discussed the harm that Mr. McNaughton might suffer if United required him to change his treatment. “His disease is significantly severe, with diagnosis at a young age,” Dr. Kumar wrote. “He has failed every biologic medication class recommended by guidelines. Therefore, guidelines can no longer be applied in this case.” He cited six studies of patients using two biologic drugs together and wrote that they revealed no significant safety issues and found the therapy to be “broadly successful.”

When Ms. Kavanaugh learned of Dr. Kumar’s report, she quickly moved to quash it and get the case returned to Dr. Pabby, according to her deposition.

In a recorded telephone call, Ms. Kavanaugh told an MRIoA representative that “I had asked that this go back through Dr. Pabby, and it went through a different doctor and they had a much different result.” After further discussion, the MRIoA representative agreed to send the case back to Dr. Pabby. “I appreciate that,” Ms. Kavanaugh replied. “I just want to make sure, because, I mean, it’s obviously a very different result than what we’ve been getting on this case.”

MRIoA case notes show that at 7:04 a.m. on May 25, 2021, Dr. Pabby was assigned to take a look at the case for the third time. At 7:27 a.m., the notes indicate, Dr. Pabby again rejected Mr. McNaughton’s treatment plan. While noting it was “difficult to control” Mr. McNaughton’s ulcerative colitis, Dr. Pabby added that his doses “far exceed what is approved by literature” and that the “safety of the requested doses is not supported by literature.”

In a deposition, Ms. Kavanaugh said that after she opened the Kumar report and read that he was supporting Mr. McNaughton’s current treatment plan, she immediately spoke to her supervisor, who told her to call MRIoA and have the case sent back to Dr. Pabby for review.

Ms. Kavanaugh said she didn’t save a copy of the Kumar report, nor did she forward it to anyone at United or to officials at Penn State who had been inquiring about the McNaughton case. “I didn’t because it shouldn’t have existed,” she said. “It should have gone back to Dr. Pabby.”

When asked if the Kumar report caused her any concerns given his warning that Mr. McNaughton risked cancer or hospitalization if his regimen were changed, Ms. Kavanaugh said she didn’t read his full report. “I saw that it was not the correct doctor, I saw the initial outcome and I was asked to send it back,” she said. Ms. Kavanaugh added, “I have a lot of empathy for this member, but it needed to go back to the peer-to-peer reviewer.”

In a court filing, United said Ms. Kavanaugh was correct in insisting that Dr. Pabby conduct the review and that MRIoA confirmed that Dr. Pabby should have been the one doing the review.

The Kumar report was not provided to Mr. McNaughton when his lawyer, Jonathan M. Gesk, first asked United and MRIoA for any reviews of the case. Mr. Gesk discovered it by accident when he was listening to a recorded telephone call produced by United in which Ms. Kavanaugh mentioned a report number Mr. Gesk had not heard before. He then called MRIoA, which confirmed the report existed and eventually provided it to him.

Dr. Pabby asked ProPublica to direct any questions about his involvement in the matter to MRIoA. The company did not respond to questions from ProPublica about the case.
 

A sense of hopelessness

When Mr. McNaughton enrolled at Penn State in 2020, it brought a sense of normalcy that he had lost when he was first diagnosed with colitis. He still needed monthly hours-long infusions and suffered occasional flare-ups and symptoms, but he was attending classes in person and living a life similar to the one he had before his diagnosis.

It was a striking contrast to the previous 6 years, which he had spent largely confined to his parents’ house in State College. The frequent bouts of diarrhea made it difficult to go out. He didn’t talk much to friends and spent as much time as he could studying potential treatments and reviewing ongoing clinical trials. He tried to keep up with the occasional online course, but his disease made it difficult to make any real progress toward a degree.

United, in correspondence with Mr. McNaughton, noted that its review of his care was “not a treatment decision. Treatment decisions are made between you and your physician.” But by threatening not to pay for his medications, or only to pay for a different regimen, Mr. McNaughton said, United was in fact attempting to dictate his treatment. From his perspective, the insurer was playing doctor, making decisions without ever examining him or even speaking to him.

The idea of changing his treatment or stopping it altogether caused constant worry for Mr. McNaughton, exacerbating his colitis and triggering physical symptoms, according to his doctors. Those included a large ulcer on his leg and welts under his skin on his thighs and shin that made his leg muscles stiff and painful to the point where he couldn’t bend his leg or walk properly. There were daily migraines and severe stomach pain. “I was consumed with this situation,” Mr. McNaughton said. “My path was unconventional, but I was proud of myself for fighting back and finishing school and getting my life back on track. I thought they were singling me out. My biggest fear was going back to the hell.”

Mr. McNaughton said he contemplated suicide on several occasions, dreading a return to a life where he was housebound or hospitalized.

Mr. McNaughton and his parents talked about his possibly moving to Canada where his grandmother lived and seeking treatment there under the nation’s government health plan.

Dr. Loftus connected Mr. McNaughton with a psychologist who specializes in helping patients with chronic digestive diseases.

The psychologist, Tiffany Taft, PsyD, said Mr. McNaughton was not an unusual case. About one in three patients with diseases like colitis suffer from medical trauma or PTSD related to it, she said, often the result of issues related to getting appropriate treatment approved by insurers.

“You get into hopelessness,” she said of the depression that accompanies fighting with insurance companies over care. “They feel like ‘I can’t fix that. I am screwed.’ When you can’t control things with what an insurance company is doing, anxiety, PTSD and depression get mixed together.”

In the case of Mr. McNaughton, Dr. Taft said, he was being treated by one of the best gastroenterologists in the world, was doing well with his treatment, and then was suddenly notified he might be on the hook for nearly a million dollars in medical charges without access to his medications. “It sends you immediately into panic about all these horrific things that could happen,” Dr. Taft said. The physical and mental symptoms Mr. McNaughton suffered after his care was threatened were “triggered” by the stress he experienced, she said.

In early June 2021, United informed Mr. McNaughton in a letter that it would not cover the cost of his treatment regimen in the next academic year, starting in August. The insurer said it would pay only for a treatment plan that called for a significant reduction in the doses of the drugs he took.

United wrote that the decision came after his “records have been reviewed three times and the medical reviewers have concluded that the medication as prescribed does not meet the Medical Necessity requirement of the plan.”

In August 2021, Mr. McNaughton filed a federal lawsuit accusing United of acting in bad faith and unreasonably making treatment decisions based on financial concerns and not what was the best and most effective treatment. It claims United had a duty to find information that supported Mr. McNaughton’s claim for treatment rather than looking for ways to deny coverage.

United, in a court filing, said it did not breach any duty it owed to Mr. McNaughton and acted in good faith. On Sept. 20, 2021, a month after filing the lawsuit, and with United again balking at paying for his treatment, Mr. McNaughton asked a judge to grant a temporary restraining order requiring United to pay for his care. With the looming threat of a court hearing on the motion, United quickly agreed to cover the cost of Mr. McNaughton’s treatment through the end of the 2021-2022 academic year. It also dropped a demand requiring Mr. McNaughton to settle the matter as a condition of the insurer paying for his treatment as prescribed by Dr. Loftus, according to an email sent by United’s lawyer.
 

The cost of treatment

It is not surprising that insurers are carefully scrutinizing the care of patients treated with biologics, which are among the most expensive medications on the market. Biologics are considered specialty drugs, a class that includes the best-selling Humira, used to treat arthritis. Specialty drug spending in the United States is expected to reach $505 billion in 2023, according to an estimate from Optum, United’s health services division. The Institute for Clinical and Economic Review, a nonprofit that analyzes the value of drugs, found in 2020 that the biologic drugs used to treat patients like Mr. McNaughton are often effective but overpriced for their therapeutic benefit. To be judged cost-effective by ICER, the biologics should sell at a steep discount to their current market price, the panel found.

A panel convened by ICER to review its analysis cautioned that insurance coverage “should be structured to prevent situations in which patients are forced to choose a treatment approach on the basis of cost.” ICER also found examples where insurance company policies failed to keep pace with updates to clinical practice guidelines based on emerging research.

United officials did not make the cost of treatment an issue when discussing Mr. McNaughton’s care with Penn State administrators or the family.

Bill Truxal, the president of UnitedHealthcare StudentResources, the company’s student health plan division, told a Penn State official that the insurer wanted the “best for the student” and it had “nothing to do with cost,” according to notes the official took of the conversation.

Behind the scenes, however, the price of Mr. McNaughton’s care was front and center at United.

In one email, Mr. Opperman asked about the cost difference if the insurer insisted on paying only for greatly reduced doses of the biologic drugs. Ms. Kavanaugh responded that the insurer had paid $1.1 million in claims for Mr. McNaughton’s care as of the middle of May 2021. If the reduced doses had been in place, the amount would have been cut to $260,218, she wrote.

United was keeping close tabs on Mr. McNaughton at the highest levels of the company. On Aug. 2, 2021, Mr. Opperman notified Mr. Truxal and a United lawyer that Mr. McNaughton “has just purchased the plan again for the 21-22 school year.”

A month later, Ms. Kavanaugh shared another calculation with United executives showing that the insurer spent over $1.7 million on Mr. McNaughton in the prior plan year.

United officials strategized about how to best explain why it was reviewing Mr. McNaughton’s drug regimen, according to an internal email. They pointed to a justification often used by health insurers when denying claims. “As the cost of healthcare continues to climb to soaring heights, it has been determined that a judicious review of these drugs should be included” in order to “make healthcare more affordable for our members,” Ms. Kavanaugh offered as a potential talking point in an April 23, 2021, email.

Three days later, UnitedHealth Group filed an annual statement with the U.S. Securities and Exchange Commission disclosing its pay for top executives in the prior year. Then-CEO David Wichmann was paid $17.9 million in salary and other compensation in 2020. Wichmann retired early the following year, and his total compensation that year exceeded $140 million, according to calculations in a compensation database maintained by the Star Tribune in Minneapolis. The newspaper said the amount was the most paid to an executive in the state since it started tracking pay more than 2 decades ago. About $110 million of that total came from Wichmann exercising stock options accumulated during his stewardship.

The McNaughtons were well aware of the financial situation at United. They looked at publicly available financial results and annual reports. Last year, United reported a profit of $20.1 billion on revenues of $324.2 billion.

When discussing the case with Penn State, Ms. Light said, she told university administrators that United could pay for a year of her son’s treatment using just minutes’ worth of profit.
 

‘Betrayed’

Mr. McNaughton has been able to continue receiving his infusions for now, anyway. In October, United notified him it was once again reviewing his care, although the insurer quickly reversed course when his lawyer intervened. United, in a court filing, said the review was a mistake and that it had erred in putting Mr. McNaughton’s claims into pending status.

Mr. McNaughton said he is fortunate his parents were employed at the same school he was attending, which was critical in getting the attention of administrators there. But that help had its limits.

In June 2021, just a week after United told Mr. McNaughton it would not cover his treatment plan in the upcoming plan year, Penn State essentially walked away from the matter.

In an email to the McNaughtons and United, Penn State Associate Vice President for Student Affairs Andrea Dowhower wrote that administrators “have observed an unfortunate breakdown in communication” between Mr. McNaughton and his family and the university health insurance plan, “which appears from our perspective to have resulted in a standstill between the two parties.” While she proposed some potential steps to help settle the matter, she wrote that “Penn State’s role in this process is as a resource for students like Chris who, for whatever reason, have experienced difficulty navigating the complex world of health insurance.” The university’s role “is limited,” she wrote, and the school “simply must leave” the issue of the best treatment for Mr. McNaughton to “the appropriate health care professionals.”

In a statement, a Penn State spokesperson wrote that “as a third party in this arrangement, the University’s role is limited and Penn State officials can only help a student manage an issue based on information that a student/family, medical personnel, and/or insurance provider give – with the hope that all information is accurate and that the lines of communication remain open between the insured and the insurer.”

Penn State declined to provide financial information about the plan. However, the university and United share at least one tie that they have not publicly disclosed.

When the McNaughtons first reached out to the university for help, they were referred to the school’s student health insurance coordinator. The official, Heather Klinger, wrote in an email to the family in February 2021 that “I appreciate your trusting me to resolve this for you.”

In April 2022, United began paying Ms. Klinger’s salary, an arrangement which is not noted on the university website. Ms. Klinger appears in the online staff directory on the Penn State University Health Services web page, and has a university phone number, a university address, and a Penn State email listed as her contact. The school said she has maintained a part-time status with the university to allow her to access relevant data systems at both the university and United.

The university said students “benefit” from having a United employee to handle questions about insurance coverage and that the arrangement is “not uncommon” for student health plans.

The family was dismayed to learn that Ms. Klinger was now a full-time employee of United.

“We did feel betrayed,” Ms. Light said. Ms. Klinger did not respond to an email seeking comment.

Mr. McNaughton’s fight to maintain his treatment regimen has come at a cost of time, debilitating stress, and depression. “My biggest fear is realizing I might have to do this every year of my life,” he said.

Mr. McNaughton said one motivation for his lawsuit was to expose how insurers like United make decisions about what care they will pay for and what they will not. The case remains pending, a court docket shows.

He has been accepted to Penn State’s law school. He hopes to become a health care lawyer working for patients who find themselves in situations similar to his.

He plans to re-enroll in the United health care plan when he starts school next fall.

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

In May 2021, a nurse at UnitedHealthcare called a colleague to share some welcome news about a problem the two had been grappling with for weeks.

United provided the health insurance plan for students at Penn State University. It was a large and potentially lucrative account: lots of young, healthy students paying premiums in, not too many huge medical reimbursements going out.

But one student was costing United a lot of money. Christopher McNaughton suffered from a crippling case of ulcerative colitis – an ailment that caused him to develop severe arthritis, debilitating diarrhea, numbing fatigue, and life-threatening blood clots. His medical bills were running nearly $2 million a year.

United had flagged Mr. McNaughton’s case as a “high dollar account,” and the company was reviewing whether it needed to keep paying for the expensive cocktail of drugs crafted by a Mayo Clinic specialist that had brought Mr. McNaughton’s disease under control after he’d been through years of misery.

On the 2021 phone call, which was recorded by the company, nurse Victoria Kavanaugh told her colleague that a doctor contracted by United to review the case had concluded that Mr. McNaughton’s treatment was “not medically necessary.” Her colleague, Dave Opperman, reacted to the news with a long laugh.

“I knew that was coming,” said Mr. Opperman, who heads up a United subsidiary that brokered the health insurance contract between United and Penn State. “I did too,” Ms. Kavanaugh replied.

Mr. Opperman then complained about Mr. McNaughton’s mother, whom he referred to as “this woman,” for “screaming and yelling” and “throwing tantrums” during calls with United.

The pair agreed that any appeal of the United doctor’s denial of the treatment would be a waste of the family’s time and money.

“We’re still gonna say no,” Mr. Opperman said.

More than 200 million Americans are covered by private health insurance. But data from state and federal regulators shows that insurers reject about 1 in 7 claims for treatment. Many people, faced with fighting insurance companies, simply give up: One study found that Americans file formal appeals on only 0.1% of claims denied by insurers under the Affordable Care Act.

Insurers have wide discretion in crafting what is covered by their policies, beyond some basic services mandated by federal and state law. They often deny claims for services that they deem not “medically necessary.”

When United refused to pay for Mr. McNaughton’s treatment for that reason, his family did something unusual. They fought back with a lawsuit, which uncovered a trove of materials, including internal emails and tape-recorded exchanges among company employees. Those records offer an extraordinary behind-the-scenes look at how one of America’s leading health care insurers relentlessly fought to reduce spending on care, even as its profits rose to record levels.

As United reviewed Mr. McNaughton’s treatment, he and his family were often in the dark about what was happening or their rights. Meanwhile, United employees misrepresented critical findings and ignored warnings from doctors about the risks of altering Mr. McNaughton’s drug plan.

At one point, court records show, United inaccurately reported to Penn State and the family that Mr. McNaughton’s doctor had agreed to lower the doses of his medication. Another time, a doctor paid by United concluded that denying payments for Mr. McNaughton’s treatment could put his health at risk, but the company buried his report and did not consider its findings. The insurer did, however, consider a report submitted by a company doctor who rubber-stamped the recommendation of a United nurse to reject paying for the treatment.

United declined to answer specific questions about the case, even after Mr. McNaughton signed a release provided by the insurer to allow it to discuss details of his interactions with the company. United noted that it ultimately paid for all of Mr. McNaughton’s treatments. In a written response, United spokesperson Maria Gordon Shydlo wrote that the company’s guiding concern was Mr. McNaughton’s well-being.

“Mr. McNaughton’s treatment involves medication dosages that far exceed [Food and Drug Administration] guidelines,” the statement said. “In cases like this, we review treatment plans based on current clinical guidelines to help ensure patient safety.”

But the records reviewed by ProPublica show that United had another, equally urgent goal in dealing with Mr. McNaughton. In emails, officials calculated what Mr. McNaughton was costing them to keep his crippling disease at bay and how much they would save if they forced him to undergo a cheaper treatment that had already failed him. As the family pressed the company to back down, first through Penn State and then through a lawsuit, the United officials handling the case bristled.

“This is just unbelievable,” Ms. Kavanaugh said of Mr. McNaughton’s family in one call to discuss his case. ”They’re just really pushing the envelope, and I’m surprised, like I don’t even know what to say.”
 

The same meal every day

Now 31, Mr. McNaughton grew up in State College, Pa., just blocks from the Penn State campus. Both of his parents are faculty members at the university.

In the winter of 2014, Mr. McNaughton was halfway through his junior year at Bard College in New York. At 6 feet, 4 inches tall, he was a guard on the basketball team and had started most of the team’s games since the start of his sophomore year. He was majoring in psychology.

When Mr. McNaughton returned to school after the winter holiday break, he started to experience frequent bouts of bloody diarrhea. After just a few days on campus, he went home to State College, where doctors diagnosed him with a severe case of ulcerative colitis.

A chronic inflammatory bowel disease that causes swelling and ulcers in the digestive tract, ulcerative colitis has no cure, and ongoing treatment is needed to alleviate symptoms and prevent serious health complications. The majority of cases produce mild to moderate symptoms. Mr. McNaughton’s case was severe.

Treatments for ulcerative colitis include steroids and special drugs known as biologics that work to reduce inflammation in the large intestine.

Mr. McNaughton, however, failed to get meaningful relief from the drugs his doctors initially prescribed. He was experiencing bloody diarrhea up to 20 times a day, with such severe stomach pain that he spent much of his day curled up on a couch. He had little appetite and lost 50 pounds. Severe anemia left him fatigued. He suffered from other conditions related to his colitis, including crippling arthritis. He was hospitalized several times to treat dangerous blood clots.

For 2 years, in an effort to help alleviate his symptoms, he ate the same meals every day: Rice Chex cereal and scrambled eggs for breakfast, a cup of white rice with plain chicken breast for lunch, and a similar meal for dinner, occasionally swapping in tilapia.

His hometown doctors referred him to a specialist at the University of Pittsburgh, who tried unsuccessfully to bring his disease under control. That doctor ended up referring Mr. McNaughton to Edward V. Loftus Jr., MD, at the Mayo Clinic in Rochester, Minn., which has been ranked as the best gastroenterology hospital in the country every year since 1990 by U.S. News & World Report.

For his first visit with Dr. Loftus in May 2015, Mr. McNaughton and his mother, Janice Light, charted hospitals along the 900-mile drive from Pennsylvania to Minnesota in case they needed medical help along the way.

Mornings were the hardest. Mr. McNaughton often spent several hours in the bathroom at the start of the day. To prepare for his meeting with Dr. Loftus, he set his alarm for 3:30 a.m. so he could be ready for the 7:30 a.m. appointment. Even with that preparation, he had to stop twice to use a bathroom on the 5-minute walk from the hotel to the clinic. When they met, Dr. Loftus looked at Mr. McNaughton and told him that he appeared incapacitated. It was, he told the student, as if Mr. McNaughton were chained to the bathroom, with no outside life. He had not been able to return to school and spent most days indoors, managing his symptoms as best he could.

Mr. McNaughton had tried a number of medications by this point, none of which worked. This pattern would repeat itself during the first couple of years that Dr. Loftus treated him.

In addition to trying to find a treatment that would bring Mr. McNaughton’s colitis into remission, Dr. Loftus wanted to wean him off the steroid prednisone, which he had been taking since his initial diagnosis in 2014. The drug is commonly prescribed to colitis patients to control inflammation, but prolonged use can lead to severe side effects including cataracts, osteoporosis, increased risk of infection, and fatigue. Mr. McNaughton also experienced “moon face,” a side effect caused by the shifting of fat deposits that results in the face becoming puffy and rounder.

In 2018, Dr. Loftus and Mr. McNaughton decided to try an unusual regimen. Many patients with inflammatory bowel diseases such as colitis take a single biologic drug as treatment. Whereas traditional drugs are chemically synthesized, biologics are manufactured in living systems, such as plant or animal cells. A year’s supply of an individual biologic drug can cost up to $500,000. They are often given through infusions in a medical facility, which adds to the cost.

Mr. McNaughton had tried individual biologics, and then two in combination, without much success. He and Dr. Loftus then agreed to try two biologic drugs together at doses well above those recommended by the Food and Drug Administration. The federal Agency for Healthcare Research and Quality estimates one in five prescriptions written today are for off-label uses.

There are drawbacks to the practice. Since some uses and doses of particular drugs have not been extensively studied, the risks and efficacy of using them off-label are not well known. Also, some drug manufacturers have improperly pushed off-label usage of their products to boost sales despite little or no evidence to support their use in those situations. Like many leading experts and researchers in his field, Dr. Loftus has been paid to do consulting related to the biologic drugs taken by Mr. McNaughton. The payments related to those drugs have ranged from a total of $1,440 in 2020 to $51,235 in 2018. Dr. Loftus said much of his work with pharmaceutical companies was related to conducting clinical trials on new drugs.

In cases of off-label prescribing, patients are depending upon their doctors’ expertise and experience with the drug. “In this case, I was comfortable that the potential benefits to Chris outweighed the risks,” Dr. Loftus said.

There was evidence that the treatment plan for Mr. McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe. The two drugs he takes, Entyvio and Remicade, have the same purpose – to reduce inflammation in the large intestine – but each works differently in the body. Remicade, marketed by Janssen Biotech, targets a protein that causes inflammation. Entyvio, made by Takeda Pharmaceuticals, works by preventing an excess of white blood cells from entering into the gastrointestinal tract.

As for any suggestion by United doctors that his treatment plan for Mr. McNaughton was out of bounds or dangerous, Dr. Loftus said “my treatment of Chris was not clinically inappropriate – as was shown by Chris’ positive outcome.”

The unusual high-dose combination of two biologic drugs produced a remarkable change in Mr. McNaughton. He no longer had blood in his stool, and his trips to the bathroom were cut from 20 times a day to 3 or 4. He was able to eat different foods and put on weight. He had more energy. He tapered off prednisone.

“If you told me in 2015 that I would be living like this, I would have asked where do I sign up,” Mr. McNaughton said of the change he experienced with the new drug regimen.

When he first started the new treatment, Mr. McNaughton was covered under his family’s plan, and all his bills were paid. Mr. McNaughton enrolled at the university in 2020. Before switching to United’s plan for students, Mr. McNaughton and his parents consulted with a health advocacy service offered to faculty members. A benefits specialist assured them the drugs taken by Mr. McNaughton would be covered by United.

Mr. McNaughton joined the student plan in July 2020, and his infusions that month and the following month were paid for by United. In September, the insurer indicated payment on his claims was “pending,” something it did for his other claims that came in during the rest of the year.

Mr. McNaughton and his family were worried. They called United to make sure there wasn’t a problem; the insurer told them, they said, that it only needed to check his medical records. When the family called again, United told them it had the documentation needed, they said. United, in a court filing last year, said it received two calls from the family and each time indicated that all of the necessary medical records had not yet been received.

In January 2021, Mr. McNaughton received a new explanation of benefits for the prior months. All of the claims for his care, beginning in September, were no longer “pending.” They were stamped “DENIED.” The total outstanding bill for his treatment was $807,086.

When Mr. McNaughton’s mother reached a United customer service representative the next day to ask why bills that had been paid in the summer were being denied for the fall, the representative told her the account was being reviewed because of “a high dollar amount on the claims,” according to a recording of the call.


 

Misrepresentations

With United refusing to pay, the family was terrified of being stuck with medical bills that would bankrupt them and deprive Mr. McNaughton of treatment that they considered miraculous.

They turned to Penn State for help. Ms. Light and Mr. McNaughton’s father, David McNaughton, hoped their position as faculty members would make the school more willing to intervene on their behalf.

“After more than 30 years on faculty, my husband and I know that this is not how Penn State would want its students to be treated,” Ms. Light wrote to a school official in February 2021.

In response to questions from ProPublica, Penn State spokesperson Lisa Powers wrote that “supporting the health and well-being of our students is always of primary importance” and that “our hearts go out to any student and family impacted by a serious medical condition.” The university, she wrote, does “not comment on students’ individual circumstances or disclose information from their records.” Mr. McNaughton offered to grant Penn State whatever permissions it needed to speak about his case with ProPublica. The school, however, wrote that it would not comment “even if confidentiality has been waived.”

The family appealed to school administrators. Because the effectiveness of biologics wanes in some patients if doses are skipped, Mr. McNaughton and his parents were worried about even a delay in treatment. His doctor wrote that if he missed scheduled infusions of the drugs, there was “a high likelihood they would no longer be effective.”

During a conference call arranged by Penn State officials on March 5, 2021, United agreed to pay for Mr. McNaughton’s care through the end of the plan year that August. Penn State immediately notified the family of the “wonderful news” while also apologizing for “the stress this has caused Chris and your family.”

Behind the scenes, Mr. McNaughton’s review had “gone all the way to the top” at United’s student health plan division, Ms. Kavanaugh, the nurse, said in a recorded conversation.

The family’s relief was short-lived. A month later, United started another review of Mr. McNaughton’s care, overseen by Ms. Kavanaugh, to determine if it would pay for the treatment in the upcoming plan year.

The nurse sent the Mr. McNaughton case to a company called Medical Review Institute of America. Insurers often turn to companies like MRIoA to review coverage decisions involving expensive treatments or specialized care.

Ms. Kavanaugh, who was assigned to a special investigations unit at United, let her feelings about the matter be known in a recorded telephone call with a representative of MRIoA.

“This school apparently is a big client of ours,” she said. She then shared her opinion of Mr. McNaughton’s treatment. “Really this is a case of a kid who’s getting a drug way too much, like too much of a dose,” Ms. Kavanaugh said. She said it was “insane that they would even think that this is reasonable” and “to be honest with you, they’re awfully pushy considering that we are paying through the end of this school year.”

On a call with an outside contractor, the United nurse claimed Mr. McNaughton was on a higher dose of medication than the FDA approved, which is a common practice.

MRIoA sent the case to Vikas Pabby, MD, a gastroenterologist at UCLA Health and a professor at the university’s medical school. His May 2021 review of Mr. McNaughton’s case was just one of more than 300 Dr. Pabby did for MRIoA that month, for which he was paid $23,000 in total, according to a log of his work produced in the lawsuit.

In a May 4, 2021, report, Dr. Pabby concluded Mr. McNaughton’s treatment was not medically necessary, because United’s policies for the two drugs taken by Mr. McNaughton did not support using them in combination.

Insurers spell out what services they cover in plan policies, lengthy documents that can be confusing and difficult to understand. Many policies, such as Mr. McNaughton’s, contain a provision that treatments and procedures must be “medically necessary” in order to be covered. The definition of medically necessary differs by plan. Some don’t even define the term. Mr. McNaughton’s policy contains a five-part definition, including that the treatment must be “in accordance with the standards of good medical policy” and “the most appropriate supply or level of service which can be safely provided.”

Behind the scenes at United, Mr. Opperman and Ms. Kavanaugh agreed that if Mr. McNaughton were to appeal Dr. Pabby’s decision, the insurer would simply rule against him. “I just think it’s a waste of money and time to appeal and send it to another one when we know we’re gonna get the same answer,” Mr. Opperman said, according to a recording in court files. At Mr. Opperman’s urging, United decided to skip the usual appeals process and arrange for Dr. Pabby to have a so-called “peer-to-peer” discussion with Dr. Loftus, the Mayo physician treating Mr. McNaughton. Such a conversation, in which a patient’s doctor talks with an insurance company’s doctor to advocate for the prescribed treatment, usually occurs only after a customer has appealed a denial and the appeal has been rejected.

When Ms. Kavanaugh called Dr. Loftus’ office to set up a conversation with Dr. Pabby, she explained it was an urgent matter and had been requested by Mr. McNaughton. “You know I’ve just gotten to know Christopher,” she explained, although she had never spoken with him. “We’re trying to advocate and help and get this peer-to-peer set up.”

Mr. McNaughton, meanwhile, had no idea at the time that a United doctor had decided his treatment was unnecessary and that the insurer was trying to set up a phone call with his physician.

In the peer-to-peer conversation, Dr. Loftus told Dr. Pabby that Mr. McNaughton had “a very complicated case” and that lower doses had not worked for him, according to an internal MRIoA memo.

Following his conversation with Dr. Loftus, Dr. Pabby created a second report for United. He recommended the insurer pay for both drugs, but at reduced doses. He added new language saying that the safety of using both drugs at the higher levels “is not established.”

When Ms. Kavanaugh shared the May 12 decision from Dr. Pabby with others at United, her boss responded with an email calling it “great news.”

Then Mr. Opperman sent an email that puzzled the McNaughtons.

In it, Mr. Opperman claimed that Dr. Loftus and Dr. Pabby had agreed that Mr. McNaughton should be on significantly lower doses of both drugs. He said Dr. Loftus “will work with the patient to start titrating them down to a normal dose range.” Mr. Opperman wrote that United would cover Mr. McNaughton’s treatment in the coming year, but only at the reduced doses. Mr. Opperman did not respond to emails and phone messages seeking comment.

Mr. McNaughton didn’t believe a word of it. He had already tried and failed treatment with those drugs at lower doses, and it was Dr. Loftus who had upped the doses, leading to his remission from severe colitis.

The only thing that made sense to Mr. McNaughton was that the treatment United said it would now pay for was dramatically cheaper – saving the company at least hundreds of thousands of dollars a year – than his prescribed treatment because it sliced the size of the doses by more than half.

When the family contacted Dr. Loftus for an explanation, they were outraged by what they heard. Dr. Loftus told them that he had never recommended lowering the dosage. In a letter, Dr. Loftus wrote that changing Mr. McNaughton’s treatment “would have serious detrimental effects on both his short term and long term health and could potentially involve life threatening complications. This would ultimately incur far greater medical costs. Chris was on the doses suggested by United Healthcare before, and they were not at all effective.”

It would not be until the lawsuit that it would become clear how Dr. Loftus’ conversations had been so seriously misrepresented.

Under questioning by Mr. McNaughton’s lawyers, Ms. Kavanaugh acknowledged that she was the source of the incorrect claim that Mr. McNaughton’s doctor had agreed to a change in treatment.

“I incorrectly made an assumption that they had come to some sort of agreement,” she said in a deposition last August. “It was my first peer-to-peer. I did not realize that that simply does not occur.”

Ms. Kavanaugh did not respond to emails and telephone messages seeking comment.

When the McNaughtons first learned of Mr. Opperman’s inaccurate report of the phone call with Dr. Loftus, it unnerved them. They started to question if their case would be fairly reviewed.

“When we got the denial and they lied about what Dr. Loftus said, it just hit me that none of this matters,” Mr. McNaughton said. “They will just say or do anything to get rid of me. It delegitimized the entire review process. When I got that denial, I was crushed.”


 

A buried report

While the family tried to sort out the inaccurate report, United continued putting the McNaughton case in front of more company doctors.

On May 21, 2021, United sent the case to one of its own doctors, Nady Cates, MD, for an additional review. The review was marked “escalated issue.” Dr. Cates is a United medical director, a title used by many insurers for physicians who review cases. It is work he has been doing as an employee of health insurers since 1989 and at United since 2010. He has not practiced medicine since the early 1990s.

Dr. Cates, in a deposition, said he stopped seeing patients because of the long hours involved and because “AIDS was coming around then. I was seeing a lot of military folks who had venereal diseases, and I guess I was concerned about being exposed.” He transitioned to reviewing paperwork for the insurance industry, he said, because “I guess I was a chicken.”

When he had practiced, Dr. Cates said, he hadn’t treated patients with ulcerative colitis and had referred those cases to a gastroenterologist.

He said his review of Mr. McNaughton’s case primarily involved reading a United nurse’s recommendation to deny his care and making sure “that there wasn’t a decimal place that was out of line.” He said he copied and pasted the nurse’s recommendation and typed “agree” on his review of Mr. McNaughton’s case.

Dr. Cates said that he does about a hundred reviews a week. He said that in his reviews he typically checks to see if any medications are prescribed in accordance with the insurer’s guidelines, and if not, he denies it. United’s policies, he said, prevented him from considering that Mr. McNaughton had failed other treatments or that Dr. Loftus was a leading expert in his field.

“You are giving zero weight to the treating doctor’s opinion on the necessity of the treatment regimen?” a lawyer asked Dr. Cates in his deposition. He responded, “Yeah.”

Attempts to contact Dr. Cates for comment were unsuccessful.

At the same time Dr. Cates was looking at Mr. McNaughton’s case, yet another review was underway at MRIoA. United said it sent the case back to MRIoA after the insurer received the letter from Dr. Loftus warning of the life-threatening complications that might occur if the dosages were reduced.

On May 24, 2021, the new report requested by MRIoA arrived. It came to a completely different conclusion than all of the previous reviews.

Nitin Kumar, MD, a gastroenterologist in Illinois, concluded that Mr. McNaughton’s established treatment plan was not only medically necessary and appropriate but that lowering his doses “can result in a lack of effective therapy of Ulcerative Colitis, with complications of uncontrolled disease (including dysplasia leading to colorectal cancer), flare, hospitalization, need for surgery, and toxic megacolon.”

Unlike other doctors who produced reports for United, Dr. Kumar discussed the harm that Mr. McNaughton might suffer if United required him to change his treatment. “His disease is significantly severe, with diagnosis at a young age,” Dr. Kumar wrote. “He has failed every biologic medication class recommended by guidelines. Therefore, guidelines can no longer be applied in this case.” He cited six studies of patients using two biologic drugs together and wrote that they revealed no significant safety issues and found the therapy to be “broadly successful.”

When Ms. Kavanaugh learned of Dr. Kumar’s report, she quickly moved to quash it and get the case returned to Dr. Pabby, according to her deposition.

In a recorded telephone call, Ms. Kavanaugh told an MRIoA representative that “I had asked that this go back through Dr. Pabby, and it went through a different doctor and they had a much different result.” After further discussion, the MRIoA representative agreed to send the case back to Dr. Pabby. “I appreciate that,” Ms. Kavanaugh replied. “I just want to make sure, because, I mean, it’s obviously a very different result than what we’ve been getting on this case.”

MRIoA case notes show that at 7:04 a.m. on May 25, 2021, Dr. Pabby was assigned to take a look at the case for the third time. At 7:27 a.m., the notes indicate, Dr. Pabby again rejected Mr. McNaughton’s treatment plan. While noting it was “difficult to control” Mr. McNaughton’s ulcerative colitis, Dr. Pabby added that his doses “far exceed what is approved by literature” and that the “safety of the requested doses is not supported by literature.”

In a deposition, Ms. Kavanaugh said that after she opened the Kumar report and read that he was supporting Mr. McNaughton’s current treatment plan, she immediately spoke to her supervisor, who told her to call MRIoA and have the case sent back to Dr. Pabby for review.

Ms. Kavanaugh said she didn’t save a copy of the Kumar report, nor did she forward it to anyone at United or to officials at Penn State who had been inquiring about the McNaughton case. “I didn’t because it shouldn’t have existed,” she said. “It should have gone back to Dr. Pabby.”

When asked if the Kumar report caused her any concerns given his warning that Mr. McNaughton risked cancer or hospitalization if his regimen were changed, Ms. Kavanaugh said she didn’t read his full report. “I saw that it was not the correct doctor, I saw the initial outcome and I was asked to send it back,” she said. Ms. Kavanaugh added, “I have a lot of empathy for this member, but it needed to go back to the peer-to-peer reviewer.”

In a court filing, United said Ms. Kavanaugh was correct in insisting that Dr. Pabby conduct the review and that MRIoA confirmed that Dr. Pabby should have been the one doing the review.

The Kumar report was not provided to Mr. McNaughton when his lawyer, Jonathan M. Gesk, first asked United and MRIoA for any reviews of the case. Mr. Gesk discovered it by accident when he was listening to a recorded telephone call produced by United in which Ms. Kavanaugh mentioned a report number Mr. Gesk had not heard before. He then called MRIoA, which confirmed the report existed and eventually provided it to him.

Dr. Pabby asked ProPublica to direct any questions about his involvement in the matter to MRIoA. The company did not respond to questions from ProPublica about the case.
 

A sense of hopelessness

When Mr. McNaughton enrolled at Penn State in 2020, it brought a sense of normalcy that he had lost when he was first diagnosed with colitis. He still needed monthly hours-long infusions and suffered occasional flare-ups and symptoms, but he was attending classes in person and living a life similar to the one he had before his diagnosis.

It was a striking contrast to the previous 6 years, which he had spent largely confined to his parents’ house in State College. The frequent bouts of diarrhea made it difficult to go out. He didn’t talk much to friends and spent as much time as he could studying potential treatments and reviewing ongoing clinical trials. He tried to keep up with the occasional online course, but his disease made it difficult to make any real progress toward a degree.

United, in correspondence with Mr. McNaughton, noted that its review of his care was “not a treatment decision. Treatment decisions are made between you and your physician.” But by threatening not to pay for his medications, or only to pay for a different regimen, Mr. McNaughton said, United was in fact attempting to dictate his treatment. From his perspective, the insurer was playing doctor, making decisions without ever examining him or even speaking to him.

The idea of changing his treatment or stopping it altogether caused constant worry for Mr. McNaughton, exacerbating his colitis and triggering physical symptoms, according to his doctors. Those included a large ulcer on his leg and welts under his skin on his thighs and shin that made his leg muscles stiff and painful to the point where he couldn’t bend his leg or walk properly. There were daily migraines and severe stomach pain. “I was consumed with this situation,” Mr. McNaughton said. “My path was unconventional, but I was proud of myself for fighting back and finishing school and getting my life back on track. I thought they were singling me out. My biggest fear was going back to the hell.”

Mr. McNaughton said he contemplated suicide on several occasions, dreading a return to a life where he was housebound or hospitalized.

Mr. McNaughton and his parents talked about his possibly moving to Canada where his grandmother lived and seeking treatment there under the nation’s government health plan.

Dr. Loftus connected Mr. McNaughton with a psychologist who specializes in helping patients with chronic digestive diseases.

The psychologist, Tiffany Taft, PsyD, said Mr. McNaughton was not an unusual case. About one in three patients with diseases like colitis suffer from medical trauma or PTSD related to it, she said, often the result of issues related to getting appropriate treatment approved by insurers.

“You get into hopelessness,” she said of the depression that accompanies fighting with insurance companies over care. “They feel like ‘I can’t fix that. I am screwed.’ When you can’t control things with what an insurance company is doing, anxiety, PTSD and depression get mixed together.”

In the case of Mr. McNaughton, Dr. Taft said, he was being treated by one of the best gastroenterologists in the world, was doing well with his treatment, and then was suddenly notified he might be on the hook for nearly a million dollars in medical charges without access to his medications. “It sends you immediately into panic about all these horrific things that could happen,” Dr. Taft said. The physical and mental symptoms Mr. McNaughton suffered after his care was threatened were “triggered” by the stress he experienced, she said.

In early June 2021, United informed Mr. McNaughton in a letter that it would not cover the cost of his treatment regimen in the next academic year, starting in August. The insurer said it would pay only for a treatment plan that called for a significant reduction in the doses of the drugs he took.

United wrote that the decision came after his “records have been reviewed three times and the medical reviewers have concluded that the medication as prescribed does not meet the Medical Necessity requirement of the plan.”

In August 2021, Mr. McNaughton filed a federal lawsuit accusing United of acting in bad faith and unreasonably making treatment decisions based on financial concerns and not what was the best and most effective treatment. It claims United had a duty to find information that supported Mr. McNaughton’s claim for treatment rather than looking for ways to deny coverage.

United, in a court filing, said it did not breach any duty it owed to Mr. McNaughton and acted in good faith. On Sept. 20, 2021, a month after filing the lawsuit, and with United again balking at paying for his treatment, Mr. McNaughton asked a judge to grant a temporary restraining order requiring United to pay for his care. With the looming threat of a court hearing on the motion, United quickly agreed to cover the cost of Mr. McNaughton’s treatment through the end of the 2021-2022 academic year. It also dropped a demand requiring Mr. McNaughton to settle the matter as a condition of the insurer paying for his treatment as prescribed by Dr. Loftus, according to an email sent by United’s lawyer.
 

The cost of treatment

It is not surprising that insurers are carefully scrutinizing the care of patients treated with biologics, which are among the most expensive medications on the market. Biologics are considered specialty drugs, a class that includes the best-selling Humira, used to treat arthritis. Specialty drug spending in the United States is expected to reach $505 billion in 2023, according to an estimate from Optum, United’s health services division. The Institute for Clinical and Economic Review, a nonprofit that analyzes the value of drugs, found in 2020 that the biologic drugs used to treat patients like Mr. McNaughton are often effective but overpriced for their therapeutic benefit. To be judged cost-effective by ICER, the biologics should sell at a steep discount to their current market price, the panel found.

A panel convened by ICER to review its analysis cautioned that insurance coverage “should be structured to prevent situations in which patients are forced to choose a treatment approach on the basis of cost.” ICER also found examples where insurance company policies failed to keep pace with updates to clinical practice guidelines based on emerging research.

United officials did not make the cost of treatment an issue when discussing Mr. McNaughton’s care with Penn State administrators or the family.

Bill Truxal, the president of UnitedHealthcare StudentResources, the company’s student health plan division, told a Penn State official that the insurer wanted the “best for the student” and it had “nothing to do with cost,” according to notes the official took of the conversation.

Behind the scenes, however, the price of Mr. McNaughton’s care was front and center at United.

In one email, Mr. Opperman asked about the cost difference if the insurer insisted on paying only for greatly reduced doses of the biologic drugs. Ms. Kavanaugh responded that the insurer had paid $1.1 million in claims for Mr. McNaughton’s care as of the middle of May 2021. If the reduced doses had been in place, the amount would have been cut to $260,218, she wrote.

United was keeping close tabs on Mr. McNaughton at the highest levels of the company. On Aug. 2, 2021, Mr. Opperman notified Mr. Truxal and a United lawyer that Mr. McNaughton “has just purchased the plan again for the 21-22 school year.”

A month later, Ms. Kavanaugh shared another calculation with United executives showing that the insurer spent over $1.7 million on Mr. McNaughton in the prior plan year.

United officials strategized about how to best explain why it was reviewing Mr. McNaughton’s drug regimen, according to an internal email. They pointed to a justification often used by health insurers when denying claims. “As the cost of healthcare continues to climb to soaring heights, it has been determined that a judicious review of these drugs should be included” in order to “make healthcare more affordable for our members,” Ms. Kavanaugh offered as a potential talking point in an April 23, 2021, email.

Three days later, UnitedHealth Group filed an annual statement with the U.S. Securities and Exchange Commission disclosing its pay for top executives in the prior year. Then-CEO David Wichmann was paid $17.9 million in salary and other compensation in 2020. Wichmann retired early the following year, and his total compensation that year exceeded $140 million, according to calculations in a compensation database maintained by the Star Tribune in Minneapolis. The newspaper said the amount was the most paid to an executive in the state since it started tracking pay more than 2 decades ago. About $110 million of that total came from Wichmann exercising stock options accumulated during his stewardship.

The McNaughtons were well aware of the financial situation at United. They looked at publicly available financial results and annual reports. Last year, United reported a profit of $20.1 billion on revenues of $324.2 billion.

When discussing the case with Penn State, Ms. Light said, she told university administrators that United could pay for a year of her son’s treatment using just minutes’ worth of profit.
 

‘Betrayed’

Mr. McNaughton has been able to continue receiving his infusions for now, anyway. In October, United notified him it was once again reviewing his care, although the insurer quickly reversed course when his lawyer intervened. United, in a court filing, said the review was a mistake and that it had erred in putting Mr. McNaughton’s claims into pending status.

Mr. McNaughton said he is fortunate his parents were employed at the same school he was attending, which was critical in getting the attention of administrators there. But that help had its limits.

In June 2021, just a week after United told Mr. McNaughton it would not cover his treatment plan in the upcoming plan year, Penn State essentially walked away from the matter.

In an email to the McNaughtons and United, Penn State Associate Vice President for Student Affairs Andrea Dowhower wrote that administrators “have observed an unfortunate breakdown in communication” between Mr. McNaughton and his family and the university health insurance plan, “which appears from our perspective to have resulted in a standstill between the two parties.” While she proposed some potential steps to help settle the matter, she wrote that “Penn State’s role in this process is as a resource for students like Chris who, for whatever reason, have experienced difficulty navigating the complex world of health insurance.” The university’s role “is limited,” she wrote, and the school “simply must leave” the issue of the best treatment for Mr. McNaughton to “the appropriate health care professionals.”

In a statement, a Penn State spokesperson wrote that “as a third party in this arrangement, the University’s role is limited and Penn State officials can only help a student manage an issue based on information that a student/family, medical personnel, and/or insurance provider give – with the hope that all information is accurate and that the lines of communication remain open between the insured and the insurer.”

Penn State declined to provide financial information about the plan. However, the university and United share at least one tie that they have not publicly disclosed.

When the McNaughtons first reached out to the university for help, they were referred to the school’s student health insurance coordinator. The official, Heather Klinger, wrote in an email to the family in February 2021 that “I appreciate your trusting me to resolve this for you.”

In April 2022, United began paying Ms. Klinger’s salary, an arrangement which is not noted on the university website. Ms. Klinger appears in the online staff directory on the Penn State University Health Services web page, and has a university phone number, a university address, and a Penn State email listed as her contact. The school said she has maintained a part-time status with the university to allow her to access relevant data systems at both the university and United.

The university said students “benefit” from having a United employee to handle questions about insurance coverage and that the arrangement is “not uncommon” for student health plans.

The family was dismayed to learn that Ms. Klinger was now a full-time employee of United.

“We did feel betrayed,” Ms. Light said. Ms. Klinger did not respond to an email seeking comment.

Mr. McNaughton’s fight to maintain his treatment regimen has come at a cost of time, debilitating stress, and depression. “My biggest fear is realizing I might have to do this every year of my life,” he said.

Mr. McNaughton said one motivation for his lawsuit was to expose how insurers like United make decisions about what care they will pay for and what they will not. The case remains pending, a court docket shows.

He has been accepted to Penn State’s law school. He hopes to become a health care lawyer working for patients who find themselves in situations similar to his.

He plans to re-enroll in the United health care plan when he starts school next fall.

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

In May 2021, a nurse at UnitedHealthcare called a colleague to share some welcome news about a problem the two had been grappling with for weeks.

United provided the health insurance plan for students at Penn State University. It was a large and potentially lucrative account: lots of young, healthy students paying premiums in, not too many huge medical reimbursements going out.

But one student was costing United a lot of money. Christopher McNaughton suffered from a crippling case of ulcerative colitis – an ailment that caused him to develop severe arthritis, debilitating diarrhea, numbing fatigue, and life-threatening blood clots. His medical bills were running nearly $2 million a year.

United had flagged Mr. McNaughton’s case as a “high dollar account,” and the company was reviewing whether it needed to keep paying for the expensive cocktail of drugs crafted by a Mayo Clinic specialist that had brought Mr. McNaughton’s disease under control after he’d been through years of misery.

On the 2021 phone call, which was recorded by the company, nurse Victoria Kavanaugh told her colleague that a doctor contracted by United to review the case had concluded that Mr. McNaughton’s treatment was “not medically necessary.” Her colleague, Dave Opperman, reacted to the news with a long laugh.

“I knew that was coming,” said Mr. Opperman, who heads up a United subsidiary that brokered the health insurance contract between United and Penn State. “I did too,” Ms. Kavanaugh replied.

Mr. Opperman then complained about Mr. McNaughton’s mother, whom he referred to as “this woman,” for “screaming and yelling” and “throwing tantrums” during calls with United.

The pair agreed that any appeal of the United doctor’s denial of the treatment would be a waste of the family’s time and money.

“We’re still gonna say no,” Mr. Opperman said.

More than 200 million Americans are covered by private health insurance. But data from state and federal regulators shows that insurers reject about 1 in 7 claims for treatment. Many people, faced with fighting insurance companies, simply give up: One study found that Americans file formal appeals on only 0.1% of claims denied by insurers under the Affordable Care Act.

Insurers have wide discretion in crafting what is covered by their policies, beyond some basic services mandated by federal and state law. They often deny claims for services that they deem not “medically necessary.”

When United refused to pay for Mr. McNaughton’s treatment for that reason, his family did something unusual. They fought back with a lawsuit, which uncovered a trove of materials, including internal emails and tape-recorded exchanges among company employees. Those records offer an extraordinary behind-the-scenes look at how one of America’s leading health care insurers relentlessly fought to reduce spending on care, even as its profits rose to record levels.

As United reviewed Mr. McNaughton’s treatment, he and his family were often in the dark about what was happening or their rights. Meanwhile, United employees misrepresented critical findings and ignored warnings from doctors about the risks of altering Mr. McNaughton’s drug plan.

At one point, court records show, United inaccurately reported to Penn State and the family that Mr. McNaughton’s doctor had agreed to lower the doses of his medication. Another time, a doctor paid by United concluded that denying payments for Mr. McNaughton’s treatment could put his health at risk, but the company buried his report and did not consider its findings. The insurer did, however, consider a report submitted by a company doctor who rubber-stamped the recommendation of a United nurse to reject paying for the treatment.

United declined to answer specific questions about the case, even after Mr. McNaughton signed a release provided by the insurer to allow it to discuss details of his interactions with the company. United noted that it ultimately paid for all of Mr. McNaughton’s treatments. In a written response, United spokesperson Maria Gordon Shydlo wrote that the company’s guiding concern was Mr. McNaughton’s well-being.

“Mr. McNaughton’s treatment involves medication dosages that far exceed [Food and Drug Administration] guidelines,” the statement said. “In cases like this, we review treatment plans based on current clinical guidelines to help ensure patient safety.”

But the records reviewed by ProPublica show that United had another, equally urgent goal in dealing with Mr. McNaughton. In emails, officials calculated what Mr. McNaughton was costing them to keep his crippling disease at bay and how much they would save if they forced him to undergo a cheaper treatment that had already failed him. As the family pressed the company to back down, first through Penn State and then through a lawsuit, the United officials handling the case bristled.

“This is just unbelievable,” Ms. Kavanaugh said of Mr. McNaughton’s family in one call to discuss his case. ”They’re just really pushing the envelope, and I’m surprised, like I don’t even know what to say.”
 

The same meal every day

Now 31, Mr. McNaughton grew up in State College, Pa., just blocks from the Penn State campus. Both of his parents are faculty members at the university.

In the winter of 2014, Mr. McNaughton was halfway through his junior year at Bard College in New York. At 6 feet, 4 inches tall, he was a guard on the basketball team and had started most of the team’s games since the start of his sophomore year. He was majoring in psychology.

When Mr. McNaughton returned to school after the winter holiday break, he started to experience frequent bouts of bloody diarrhea. After just a few days on campus, he went home to State College, where doctors diagnosed him with a severe case of ulcerative colitis.

A chronic inflammatory bowel disease that causes swelling and ulcers in the digestive tract, ulcerative colitis has no cure, and ongoing treatment is needed to alleviate symptoms and prevent serious health complications. The majority of cases produce mild to moderate symptoms. Mr. McNaughton’s case was severe.

Treatments for ulcerative colitis include steroids and special drugs known as biologics that work to reduce inflammation in the large intestine.

Mr. McNaughton, however, failed to get meaningful relief from the drugs his doctors initially prescribed. He was experiencing bloody diarrhea up to 20 times a day, with such severe stomach pain that he spent much of his day curled up on a couch. He had little appetite and lost 50 pounds. Severe anemia left him fatigued. He suffered from other conditions related to his colitis, including crippling arthritis. He was hospitalized several times to treat dangerous blood clots.

For 2 years, in an effort to help alleviate his symptoms, he ate the same meals every day: Rice Chex cereal and scrambled eggs for breakfast, a cup of white rice with plain chicken breast for lunch, and a similar meal for dinner, occasionally swapping in tilapia.

His hometown doctors referred him to a specialist at the University of Pittsburgh, who tried unsuccessfully to bring his disease under control. That doctor ended up referring Mr. McNaughton to Edward V. Loftus Jr., MD, at the Mayo Clinic in Rochester, Minn., which has been ranked as the best gastroenterology hospital in the country every year since 1990 by U.S. News & World Report.

For his first visit with Dr. Loftus in May 2015, Mr. McNaughton and his mother, Janice Light, charted hospitals along the 900-mile drive from Pennsylvania to Minnesota in case they needed medical help along the way.

Mornings were the hardest. Mr. McNaughton often spent several hours in the bathroom at the start of the day. To prepare for his meeting with Dr. Loftus, he set his alarm for 3:30 a.m. so he could be ready for the 7:30 a.m. appointment. Even with that preparation, he had to stop twice to use a bathroom on the 5-minute walk from the hotel to the clinic. When they met, Dr. Loftus looked at Mr. McNaughton and told him that he appeared incapacitated. It was, he told the student, as if Mr. McNaughton were chained to the bathroom, with no outside life. He had not been able to return to school and spent most days indoors, managing his symptoms as best he could.

Mr. McNaughton had tried a number of medications by this point, none of which worked. This pattern would repeat itself during the first couple of years that Dr. Loftus treated him.

In addition to trying to find a treatment that would bring Mr. McNaughton’s colitis into remission, Dr. Loftus wanted to wean him off the steroid prednisone, which he had been taking since his initial diagnosis in 2014. The drug is commonly prescribed to colitis patients to control inflammation, but prolonged use can lead to severe side effects including cataracts, osteoporosis, increased risk of infection, and fatigue. Mr. McNaughton also experienced “moon face,” a side effect caused by the shifting of fat deposits that results in the face becoming puffy and rounder.

In 2018, Dr. Loftus and Mr. McNaughton decided to try an unusual regimen. Many patients with inflammatory bowel diseases such as colitis take a single biologic drug as treatment. Whereas traditional drugs are chemically synthesized, biologics are manufactured in living systems, such as plant or animal cells. A year’s supply of an individual biologic drug can cost up to $500,000. They are often given through infusions in a medical facility, which adds to the cost.

Mr. McNaughton had tried individual biologics, and then two in combination, without much success. He and Dr. Loftus then agreed to try two biologic drugs together at doses well above those recommended by the Food and Drug Administration. The federal Agency for Healthcare Research and Quality estimates one in five prescriptions written today are for off-label uses.

There are drawbacks to the practice. Since some uses and doses of particular drugs have not been extensively studied, the risks and efficacy of using them off-label are not well known. Also, some drug manufacturers have improperly pushed off-label usage of their products to boost sales despite little or no evidence to support their use in those situations. Like many leading experts and researchers in his field, Dr. Loftus has been paid to do consulting related to the biologic drugs taken by Mr. McNaughton. The payments related to those drugs have ranged from a total of $1,440 in 2020 to $51,235 in 2018. Dr. Loftus said much of his work with pharmaceutical companies was related to conducting clinical trials on new drugs.

In cases of off-label prescribing, patients are depending upon their doctors’ expertise and experience with the drug. “In this case, I was comfortable that the potential benefits to Chris outweighed the risks,” Dr. Loftus said.

There was evidence that the treatment plan for Mr. McNaughton might work, including studies that had found dual biologic therapy to be efficacious and safe. The two drugs he takes, Entyvio and Remicade, have the same purpose – to reduce inflammation in the large intestine – but each works differently in the body. Remicade, marketed by Janssen Biotech, targets a protein that causes inflammation. Entyvio, made by Takeda Pharmaceuticals, works by preventing an excess of white blood cells from entering into the gastrointestinal tract.

As for any suggestion by United doctors that his treatment plan for Mr. McNaughton was out of bounds or dangerous, Dr. Loftus said “my treatment of Chris was not clinically inappropriate – as was shown by Chris’ positive outcome.”

The unusual high-dose combination of two biologic drugs produced a remarkable change in Mr. McNaughton. He no longer had blood in his stool, and his trips to the bathroom were cut from 20 times a day to 3 or 4. He was able to eat different foods and put on weight. He had more energy. He tapered off prednisone.

“If you told me in 2015 that I would be living like this, I would have asked where do I sign up,” Mr. McNaughton said of the change he experienced with the new drug regimen.

When he first started the new treatment, Mr. McNaughton was covered under his family’s plan, and all his bills were paid. Mr. McNaughton enrolled at the university in 2020. Before switching to United’s plan for students, Mr. McNaughton and his parents consulted with a health advocacy service offered to faculty members. A benefits specialist assured them the drugs taken by Mr. McNaughton would be covered by United.

Mr. McNaughton joined the student plan in July 2020, and his infusions that month and the following month were paid for by United. In September, the insurer indicated payment on his claims was “pending,” something it did for his other claims that came in during the rest of the year.

Mr. McNaughton and his family were worried. They called United to make sure there wasn’t a problem; the insurer told them, they said, that it only needed to check his medical records. When the family called again, United told them it had the documentation needed, they said. United, in a court filing last year, said it received two calls from the family and each time indicated that all of the necessary medical records had not yet been received.

In January 2021, Mr. McNaughton received a new explanation of benefits for the prior months. All of the claims for his care, beginning in September, were no longer “pending.” They were stamped “DENIED.” The total outstanding bill for his treatment was $807,086.

When Mr. McNaughton’s mother reached a United customer service representative the next day to ask why bills that had been paid in the summer were being denied for the fall, the representative told her the account was being reviewed because of “a high dollar amount on the claims,” according to a recording of the call.


 

Misrepresentations

With United refusing to pay, the family was terrified of being stuck with medical bills that would bankrupt them and deprive Mr. McNaughton of treatment that they considered miraculous.

They turned to Penn State for help. Ms. Light and Mr. McNaughton’s father, David McNaughton, hoped their position as faculty members would make the school more willing to intervene on their behalf.

“After more than 30 years on faculty, my husband and I know that this is not how Penn State would want its students to be treated,” Ms. Light wrote to a school official in February 2021.

In response to questions from ProPublica, Penn State spokesperson Lisa Powers wrote that “supporting the health and well-being of our students is always of primary importance” and that “our hearts go out to any student and family impacted by a serious medical condition.” The university, she wrote, does “not comment on students’ individual circumstances or disclose information from their records.” Mr. McNaughton offered to grant Penn State whatever permissions it needed to speak about his case with ProPublica. The school, however, wrote that it would not comment “even if confidentiality has been waived.”

The family appealed to school administrators. Because the effectiveness of biologics wanes in some patients if doses are skipped, Mr. McNaughton and his parents were worried about even a delay in treatment. His doctor wrote that if he missed scheduled infusions of the drugs, there was “a high likelihood they would no longer be effective.”

During a conference call arranged by Penn State officials on March 5, 2021, United agreed to pay for Mr. McNaughton’s care through the end of the plan year that August. Penn State immediately notified the family of the “wonderful news” while also apologizing for “the stress this has caused Chris and your family.”

Behind the scenes, Mr. McNaughton’s review had “gone all the way to the top” at United’s student health plan division, Ms. Kavanaugh, the nurse, said in a recorded conversation.

The family’s relief was short-lived. A month later, United started another review of Mr. McNaughton’s care, overseen by Ms. Kavanaugh, to determine if it would pay for the treatment in the upcoming plan year.

The nurse sent the Mr. McNaughton case to a company called Medical Review Institute of America. Insurers often turn to companies like MRIoA to review coverage decisions involving expensive treatments or specialized care.

Ms. Kavanaugh, who was assigned to a special investigations unit at United, let her feelings about the matter be known in a recorded telephone call with a representative of MRIoA.

“This school apparently is a big client of ours,” she said. She then shared her opinion of Mr. McNaughton’s treatment. “Really this is a case of a kid who’s getting a drug way too much, like too much of a dose,” Ms. Kavanaugh said. She said it was “insane that they would even think that this is reasonable” and “to be honest with you, they’re awfully pushy considering that we are paying through the end of this school year.”

On a call with an outside contractor, the United nurse claimed Mr. McNaughton was on a higher dose of medication than the FDA approved, which is a common practice.

MRIoA sent the case to Vikas Pabby, MD, a gastroenterologist at UCLA Health and a professor at the university’s medical school. His May 2021 review of Mr. McNaughton’s case was just one of more than 300 Dr. Pabby did for MRIoA that month, for which he was paid $23,000 in total, according to a log of his work produced in the lawsuit.

In a May 4, 2021, report, Dr. Pabby concluded Mr. McNaughton’s treatment was not medically necessary, because United’s policies for the two drugs taken by Mr. McNaughton did not support using them in combination.

Insurers spell out what services they cover in plan policies, lengthy documents that can be confusing and difficult to understand. Many policies, such as Mr. McNaughton’s, contain a provision that treatments and procedures must be “medically necessary” in order to be covered. The definition of medically necessary differs by plan. Some don’t even define the term. Mr. McNaughton’s policy contains a five-part definition, including that the treatment must be “in accordance with the standards of good medical policy” and “the most appropriate supply or level of service which can be safely provided.”

Behind the scenes at United, Mr. Opperman and Ms. Kavanaugh agreed that if Mr. McNaughton were to appeal Dr. Pabby’s decision, the insurer would simply rule against him. “I just think it’s a waste of money and time to appeal and send it to another one when we know we’re gonna get the same answer,” Mr. Opperman said, according to a recording in court files. At Mr. Opperman’s urging, United decided to skip the usual appeals process and arrange for Dr. Pabby to have a so-called “peer-to-peer” discussion with Dr. Loftus, the Mayo physician treating Mr. McNaughton. Such a conversation, in which a patient’s doctor talks with an insurance company’s doctor to advocate for the prescribed treatment, usually occurs only after a customer has appealed a denial and the appeal has been rejected.

When Ms. Kavanaugh called Dr. Loftus’ office to set up a conversation with Dr. Pabby, she explained it was an urgent matter and had been requested by Mr. McNaughton. “You know I’ve just gotten to know Christopher,” she explained, although she had never spoken with him. “We’re trying to advocate and help and get this peer-to-peer set up.”

Mr. McNaughton, meanwhile, had no idea at the time that a United doctor had decided his treatment was unnecessary and that the insurer was trying to set up a phone call with his physician.

In the peer-to-peer conversation, Dr. Loftus told Dr. Pabby that Mr. McNaughton had “a very complicated case” and that lower doses had not worked for him, according to an internal MRIoA memo.

Following his conversation with Dr. Loftus, Dr. Pabby created a second report for United. He recommended the insurer pay for both drugs, but at reduced doses. He added new language saying that the safety of using both drugs at the higher levels “is not established.”

When Ms. Kavanaugh shared the May 12 decision from Dr. Pabby with others at United, her boss responded with an email calling it “great news.”

Then Mr. Opperman sent an email that puzzled the McNaughtons.

In it, Mr. Opperman claimed that Dr. Loftus and Dr. Pabby had agreed that Mr. McNaughton should be on significantly lower doses of both drugs. He said Dr. Loftus “will work with the patient to start titrating them down to a normal dose range.” Mr. Opperman wrote that United would cover Mr. McNaughton’s treatment in the coming year, but only at the reduced doses. Mr. Opperman did not respond to emails and phone messages seeking comment.

Mr. McNaughton didn’t believe a word of it. He had already tried and failed treatment with those drugs at lower doses, and it was Dr. Loftus who had upped the doses, leading to his remission from severe colitis.

The only thing that made sense to Mr. McNaughton was that the treatment United said it would now pay for was dramatically cheaper – saving the company at least hundreds of thousands of dollars a year – than his prescribed treatment because it sliced the size of the doses by more than half.

When the family contacted Dr. Loftus for an explanation, they were outraged by what they heard. Dr. Loftus told them that he had never recommended lowering the dosage. In a letter, Dr. Loftus wrote that changing Mr. McNaughton’s treatment “would have serious detrimental effects on both his short term and long term health and could potentially involve life threatening complications. This would ultimately incur far greater medical costs. Chris was on the doses suggested by United Healthcare before, and they were not at all effective.”

It would not be until the lawsuit that it would become clear how Dr. Loftus’ conversations had been so seriously misrepresented.

Under questioning by Mr. McNaughton’s lawyers, Ms. Kavanaugh acknowledged that she was the source of the incorrect claim that Mr. McNaughton’s doctor had agreed to a change in treatment.

“I incorrectly made an assumption that they had come to some sort of agreement,” she said in a deposition last August. “It was my first peer-to-peer. I did not realize that that simply does not occur.”

Ms. Kavanaugh did not respond to emails and telephone messages seeking comment.

When the McNaughtons first learned of Mr. Opperman’s inaccurate report of the phone call with Dr. Loftus, it unnerved them. They started to question if their case would be fairly reviewed.

“When we got the denial and they lied about what Dr. Loftus said, it just hit me that none of this matters,” Mr. McNaughton said. “They will just say or do anything to get rid of me. It delegitimized the entire review process. When I got that denial, I was crushed.”


 

A buried report

While the family tried to sort out the inaccurate report, United continued putting the McNaughton case in front of more company doctors.

On May 21, 2021, United sent the case to one of its own doctors, Nady Cates, MD, for an additional review. The review was marked “escalated issue.” Dr. Cates is a United medical director, a title used by many insurers for physicians who review cases. It is work he has been doing as an employee of health insurers since 1989 and at United since 2010. He has not practiced medicine since the early 1990s.

Dr. Cates, in a deposition, said he stopped seeing patients because of the long hours involved and because “AIDS was coming around then. I was seeing a lot of military folks who had venereal diseases, and I guess I was concerned about being exposed.” He transitioned to reviewing paperwork for the insurance industry, he said, because “I guess I was a chicken.”

When he had practiced, Dr. Cates said, he hadn’t treated patients with ulcerative colitis and had referred those cases to a gastroenterologist.

He said his review of Mr. McNaughton’s case primarily involved reading a United nurse’s recommendation to deny his care and making sure “that there wasn’t a decimal place that was out of line.” He said he copied and pasted the nurse’s recommendation and typed “agree” on his review of Mr. McNaughton’s case.

Dr. Cates said that he does about a hundred reviews a week. He said that in his reviews he typically checks to see if any medications are prescribed in accordance with the insurer’s guidelines, and if not, he denies it. United’s policies, he said, prevented him from considering that Mr. McNaughton had failed other treatments or that Dr. Loftus was a leading expert in his field.

“You are giving zero weight to the treating doctor’s opinion on the necessity of the treatment regimen?” a lawyer asked Dr. Cates in his deposition. He responded, “Yeah.”

Attempts to contact Dr. Cates for comment were unsuccessful.

At the same time Dr. Cates was looking at Mr. McNaughton’s case, yet another review was underway at MRIoA. United said it sent the case back to MRIoA after the insurer received the letter from Dr. Loftus warning of the life-threatening complications that might occur if the dosages were reduced.

On May 24, 2021, the new report requested by MRIoA arrived. It came to a completely different conclusion than all of the previous reviews.

Nitin Kumar, MD, a gastroenterologist in Illinois, concluded that Mr. McNaughton’s established treatment plan was not only medically necessary and appropriate but that lowering his doses “can result in a lack of effective therapy of Ulcerative Colitis, with complications of uncontrolled disease (including dysplasia leading to colorectal cancer), flare, hospitalization, need for surgery, and toxic megacolon.”

Unlike other doctors who produced reports for United, Dr. Kumar discussed the harm that Mr. McNaughton might suffer if United required him to change his treatment. “His disease is significantly severe, with diagnosis at a young age,” Dr. Kumar wrote. “He has failed every biologic medication class recommended by guidelines. Therefore, guidelines can no longer be applied in this case.” He cited six studies of patients using two biologic drugs together and wrote that they revealed no significant safety issues and found the therapy to be “broadly successful.”

When Ms. Kavanaugh learned of Dr. Kumar’s report, she quickly moved to quash it and get the case returned to Dr. Pabby, according to her deposition.

In a recorded telephone call, Ms. Kavanaugh told an MRIoA representative that “I had asked that this go back through Dr. Pabby, and it went through a different doctor and they had a much different result.” After further discussion, the MRIoA representative agreed to send the case back to Dr. Pabby. “I appreciate that,” Ms. Kavanaugh replied. “I just want to make sure, because, I mean, it’s obviously a very different result than what we’ve been getting on this case.”

MRIoA case notes show that at 7:04 a.m. on May 25, 2021, Dr. Pabby was assigned to take a look at the case for the third time. At 7:27 a.m., the notes indicate, Dr. Pabby again rejected Mr. McNaughton’s treatment plan. While noting it was “difficult to control” Mr. McNaughton’s ulcerative colitis, Dr. Pabby added that his doses “far exceed what is approved by literature” and that the “safety of the requested doses is not supported by literature.”

In a deposition, Ms. Kavanaugh said that after she opened the Kumar report and read that he was supporting Mr. McNaughton’s current treatment plan, she immediately spoke to her supervisor, who told her to call MRIoA and have the case sent back to Dr. Pabby for review.

Ms. Kavanaugh said she didn’t save a copy of the Kumar report, nor did she forward it to anyone at United or to officials at Penn State who had been inquiring about the McNaughton case. “I didn’t because it shouldn’t have existed,” she said. “It should have gone back to Dr. Pabby.”

When asked if the Kumar report caused her any concerns given his warning that Mr. McNaughton risked cancer or hospitalization if his regimen were changed, Ms. Kavanaugh said she didn’t read his full report. “I saw that it was not the correct doctor, I saw the initial outcome and I was asked to send it back,” she said. Ms. Kavanaugh added, “I have a lot of empathy for this member, but it needed to go back to the peer-to-peer reviewer.”

In a court filing, United said Ms. Kavanaugh was correct in insisting that Dr. Pabby conduct the review and that MRIoA confirmed that Dr. Pabby should have been the one doing the review.

The Kumar report was not provided to Mr. McNaughton when his lawyer, Jonathan M. Gesk, first asked United and MRIoA for any reviews of the case. Mr. Gesk discovered it by accident when he was listening to a recorded telephone call produced by United in which Ms. Kavanaugh mentioned a report number Mr. Gesk had not heard before. He then called MRIoA, which confirmed the report existed and eventually provided it to him.

Dr. Pabby asked ProPublica to direct any questions about his involvement in the matter to MRIoA. The company did not respond to questions from ProPublica about the case.
 

A sense of hopelessness

When Mr. McNaughton enrolled at Penn State in 2020, it brought a sense of normalcy that he had lost when he was first diagnosed with colitis. He still needed monthly hours-long infusions and suffered occasional flare-ups and symptoms, but he was attending classes in person and living a life similar to the one he had before his diagnosis.

It was a striking contrast to the previous 6 years, which he had spent largely confined to his parents’ house in State College. The frequent bouts of diarrhea made it difficult to go out. He didn’t talk much to friends and spent as much time as he could studying potential treatments and reviewing ongoing clinical trials. He tried to keep up with the occasional online course, but his disease made it difficult to make any real progress toward a degree.

United, in correspondence with Mr. McNaughton, noted that its review of his care was “not a treatment decision. Treatment decisions are made between you and your physician.” But by threatening not to pay for his medications, or only to pay for a different regimen, Mr. McNaughton said, United was in fact attempting to dictate his treatment. From his perspective, the insurer was playing doctor, making decisions without ever examining him or even speaking to him.

The idea of changing his treatment or stopping it altogether caused constant worry for Mr. McNaughton, exacerbating his colitis and triggering physical symptoms, according to his doctors. Those included a large ulcer on his leg and welts under his skin on his thighs and shin that made his leg muscles stiff and painful to the point where he couldn’t bend his leg or walk properly. There were daily migraines and severe stomach pain. “I was consumed with this situation,” Mr. McNaughton said. “My path was unconventional, but I was proud of myself for fighting back and finishing school and getting my life back on track. I thought they were singling me out. My biggest fear was going back to the hell.”

Mr. McNaughton said he contemplated suicide on several occasions, dreading a return to a life where he was housebound or hospitalized.

Mr. McNaughton and his parents talked about his possibly moving to Canada where his grandmother lived and seeking treatment there under the nation’s government health plan.

Dr. Loftus connected Mr. McNaughton with a psychologist who specializes in helping patients with chronic digestive diseases.

The psychologist, Tiffany Taft, PsyD, said Mr. McNaughton was not an unusual case. About one in three patients with diseases like colitis suffer from medical trauma or PTSD related to it, she said, often the result of issues related to getting appropriate treatment approved by insurers.

“You get into hopelessness,” she said of the depression that accompanies fighting with insurance companies over care. “They feel like ‘I can’t fix that. I am screwed.’ When you can’t control things with what an insurance company is doing, anxiety, PTSD and depression get mixed together.”

In the case of Mr. McNaughton, Dr. Taft said, he was being treated by one of the best gastroenterologists in the world, was doing well with his treatment, and then was suddenly notified he might be on the hook for nearly a million dollars in medical charges without access to his medications. “It sends you immediately into panic about all these horrific things that could happen,” Dr. Taft said. The physical and mental symptoms Mr. McNaughton suffered after his care was threatened were “triggered” by the stress he experienced, she said.

In early June 2021, United informed Mr. McNaughton in a letter that it would not cover the cost of his treatment regimen in the next academic year, starting in August. The insurer said it would pay only for a treatment plan that called for a significant reduction in the doses of the drugs he took.

United wrote that the decision came after his “records have been reviewed three times and the medical reviewers have concluded that the medication as prescribed does not meet the Medical Necessity requirement of the plan.”

In August 2021, Mr. McNaughton filed a federal lawsuit accusing United of acting in bad faith and unreasonably making treatment decisions based on financial concerns and not what was the best and most effective treatment. It claims United had a duty to find information that supported Mr. McNaughton’s claim for treatment rather than looking for ways to deny coverage.

United, in a court filing, said it did not breach any duty it owed to Mr. McNaughton and acted in good faith. On Sept. 20, 2021, a month after filing the lawsuit, and with United again balking at paying for his treatment, Mr. McNaughton asked a judge to grant a temporary restraining order requiring United to pay for his care. With the looming threat of a court hearing on the motion, United quickly agreed to cover the cost of Mr. McNaughton’s treatment through the end of the 2021-2022 academic year. It also dropped a demand requiring Mr. McNaughton to settle the matter as a condition of the insurer paying for his treatment as prescribed by Dr. Loftus, according to an email sent by United’s lawyer.
 

The cost of treatment

It is not surprising that insurers are carefully scrutinizing the care of patients treated with biologics, which are among the most expensive medications on the market. Biologics are considered specialty drugs, a class that includes the best-selling Humira, used to treat arthritis. Specialty drug spending in the United States is expected to reach $505 billion in 2023, according to an estimate from Optum, United’s health services division. The Institute for Clinical and Economic Review, a nonprofit that analyzes the value of drugs, found in 2020 that the biologic drugs used to treat patients like Mr. McNaughton are often effective but overpriced for their therapeutic benefit. To be judged cost-effective by ICER, the biologics should sell at a steep discount to their current market price, the panel found.

A panel convened by ICER to review its analysis cautioned that insurance coverage “should be structured to prevent situations in which patients are forced to choose a treatment approach on the basis of cost.” ICER also found examples where insurance company policies failed to keep pace with updates to clinical practice guidelines based on emerging research.

United officials did not make the cost of treatment an issue when discussing Mr. McNaughton’s care with Penn State administrators or the family.

Bill Truxal, the president of UnitedHealthcare StudentResources, the company’s student health plan division, told a Penn State official that the insurer wanted the “best for the student” and it had “nothing to do with cost,” according to notes the official took of the conversation.

Behind the scenes, however, the price of Mr. McNaughton’s care was front and center at United.

In one email, Mr. Opperman asked about the cost difference if the insurer insisted on paying only for greatly reduced doses of the biologic drugs. Ms. Kavanaugh responded that the insurer had paid $1.1 million in claims for Mr. McNaughton’s care as of the middle of May 2021. If the reduced doses had been in place, the amount would have been cut to $260,218, she wrote.

United was keeping close tabs on Mr. McNaughton at the highest levels of the company. On Aug. 2, 2021, Mr. Opperman notified Mr. Truxal and a United lawyer that Mr. McNaughton “has just purchased the plan again for the 21-22 school year.”

A month later, Ms. Kavanaugh shared another calculation with United executives showing that the insurer spent over $1.7 million on Mr. McNaughton in the prior plan year.

United officials strategized about how to best explain why it was reviewing Mr. McNaughton’s drug regimen, according to an internal email. They pointed to a justification often used by health insurers when denying claims. “As the cost of healthcare continues to climb to soaring heights, it has been determined that a judicious review of these drugs should be included” in order to “make healthcare more affordable for our members,” Ms. Kavanaugh offered as a potential talking point in an April 23, 2021, email.

Three days later, UnitedHealth Group filed an annual statement with the U.S. Securities and Exchange Commission disclosing its pay for top executives in the prior year. Then-CEO David Wichmann was paid $17.9 million in salary and other compensation in 2020. Wichmann retired early the following year, and his total compensation that year exceeded $140 million, according to calculations in a compensation database maintained by the Star Tribune in Minneapolis. The newspaper said the amount was the most paid to an executive in the state since it started tracking pay more than 2 decades ago. About $110 million of that total came from Wichmann exercising stock options accumulated during his stewardship.

The McNaughtons were well aware of the financial situation at United. They looked at publicly available financial results and annual reports. Last year, United reported a profit of $20.1 billion on revenues of $324.2 billion.

When discussing the case with Penn State, Ms. Light said, she told university administrators that United could pay for a year of her son’s treatment using just minutes’ worth of profit.
 

‘Betrayed’

Mr. McNaughton has been able to continue receiving his infusions for now, anyway. In October, United notified him it was once again reviewing his care, although the insurer quickly reversed course when his lawyer intervened. United, in a court filing, said the review was a mistake and that it had erred in putting Mr. McNaughton’s claims into pending status.

Mr. McNaughton said he is fortunate his parents were employed at the same school he was attending, which was critical in getting the attention of administrators there. But that help had its limits.

In June 2021, just a week after United told Mr. McNaughton it would not cover his treatment plan in the upcoming plan year, Penn State essentially walked away from the matter.

In an email to the McNaughtons and United, Penn State Associate Vice President for Student Affairs Andrea Dowhower wrote that administrators “have observed an unfortunate breakdown in communication” between Mr. McNaughton and his family and the university health insurance plan, “which appears from our perspective to have resulted in a standstill between the two parties.” While she proposed some potential steps to help settle the matter, she wrote that “Penn State’s role in this process is as a resource for students like Chris who, for whatever reason, have experienced difficulty navigating the complex world of health insurance.” The university’s role “is limited,” she wrote, and the school “simply must leave” the issue of the best treatment for Mr. McNaughton to “the appropriate health care professionals.”

In a statement, a Penn State spokesperson wrote that “as a third party in this arrangement, the University’s role is limited and Penn State officials can only help a student manage an issue based on information that a student/family, medical personnel, and/or insurance provider give – with the hope that all information is accurate and that the lines of communication remain open between the insured and the insurer.”

Penn State declined to provide financial information about the plan. However, the university and United share at least one tie that they have not publicly disclosed.

When the McNaughtons first reached out to the university for help, they were referred to the school’s student health insurance coordinator. The official, Heather Klinger, wrote in an email to the family in February 2021 that “I appreciate your trusting me to resolve this for you.”

In April 2022, United began paying Ms. Klinger’s salary, an arrangement which is not noted on the university website. Ms. Klinger appears in the online staff directory on the Penn State University Health Services web page, and has a university phone number, a university address, and a Penn State email listed as her contact. The school said she has maintained a part-time status with the university to allow her to access relevant data systems at both the university and United.

The university said students “benefit” from having a United employee to handle questions about insurance coverage and that the arrangement is “not uncommon” for student health plans.

The family was dismayed to learn that Ms. Klinger was now a full-time employee of United.

“We did feel betrayed,” Ms. Light said. Ms. Klinger did not respond to an email seeking comment.

Mr. McNaughton’s fight to maintain his treatment regimen has come at a cost of time, debilitating stress, and depression. “My biggest fear is realizing I might have to do this every year of my life,” he said.

Mr. McNaughton said one motivation for his lawsuit was to expose how insurers like United make decisions about what care they will pay for and what they will not. The case remains pending, a court docket shows.

He has been accepted to Penn State’s law school. He hopes to become a health care lawyer working for patients who find themselves in situations similar to his.

He plans to re-enroll in the United health care plan when he starts school next fall.

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

In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.

The FDA has scheduled a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee for March 28-29 to discuss proposed changes to the iPLEDGE risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

Ocskay Bence/Fotolia.com

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.

Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.

However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.

(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)

Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.

In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.

The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.

“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.

As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.


The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.

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

In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.

The FDA has scheduled a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee for March 28-29 to discuss proposed changes to the iPLEDGE risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

Ocskay Bence/Fotolia.com

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.

Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.

However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.

(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)

Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.

In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.

The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.

“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.

As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.


The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.

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

In December 2021, major changes took effect in the iPLEDGE program, the Food and Drug Administration–required safety program for managing the risks of isotretinoin’s teratogenicity and preventing exposure during pregnancy. Now, more modifications may be coming to the acne drug’s safety program.

The FDA has scheduled a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee for March 28-29 to discuss proposed changes to the iPLEDGE risk evaluation and mitigation strategy (REMS) requirements. The aim, according to the FDA meeting announcement, is “to minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

Ocskay Bence/Fotolia.com

Isotretinoin is marketed as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane. Its former brand name was Accutane.

Problems began to surface days after a new, gender-neutral approach to the risk mitigation program was launched on Dec. 13, 2021. That program had been approved earlier by the FDA.

However, the problems that were encountered were a result of glitches in changes in the platform that had been planned, and were not related to the gender-neutral changes. The iPLEDGE program had transitioned to the new platform, and the rollout was far from smooth. Dermatologists, pharmacists, patients, parents of patients, and others were frustrated and angry that they could not access the new platform and obtain the medication promptly. Reaching the help line to sort out problems was another exercise in frustration. Wait times while on hold were unbearably long, or problems were not resolved over the phone.

(The new gender-neutral approach, which advocates said was needed to preserve inclusiveness of their patients, including transgender patients, places potential patients into two categories: those who can become pregnant, and those who cannot. Previously, there were three categories into which patients were classified: females who have reproductive potential, females who do not have reproductive potential, and males.)

Before pharmacists can fill a prescription for isotretinoin, a medical provider must confirm a patient’s negative pregnancy test and inform a patient with reproductive potential of the risks of the medication.

In January 2022, to deal with the chaotic launch and subsequent problems, the FDA said it would continue to meet with the Isotretinoin Products Manufacturers Group (IPMG) to resolve the problems reported by clinicians, pharmacists, and patients.

The American Academy of Dermatology Association formed an iPLEDGE work group to address the issues and suggest solutions. It has made several requests of and suggestions for the IPMG, which manages the program, according to Andrea L. Zaenglein, MD, professor of dermatology and pediatrics at Penn State Hershey (Pa.) Medical Center, and a member of the work group.

“We are asking them to eliminate the monthly attestation for patients who can’t get pregnant and to review and modify restrictive and punitive waiting and lockout periods for all patients,” she told this news organization.

As of February 2023, most of the platform glitches had been smoothed out, Dr. Zaenglein said. Still, “improvements to the design of the website could improve the user interface,” she added.


The FDA has established a docket for the public to submit comments before the meeting. The docket number is FDA-2022-N-3071. The electronic filing system will accept comments until 11:59 p.m. Eastern time on March 27. Background material and a link to the live webcast of the panel meeting will be available to the public no later than 2 days before the meeting and will be posted on the FDA web page or at the time of the meeting.

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

The U.S. Food and Drug Administration today expanded the indication for Pfizer’s oral Janus kinase (JAK) inhibitor for atopic dermatitis (AD), abrocitinib (Cibinqo), to include adolescents aged 12 through 17 years.

Abrocitinib, taken once daily, previously was approved only for treating adults aged 18 and older.

It joins upadacitinib (Rinvoq), previously the only oral JAK inhibitor to be approved for use by adolescents aged 12 through 17 with refractory moderate to severe AD.

The indication has been expanded for teens whose disease is not adequately controlled with other systemic drugs, including biologics, or those for whom use of those drugs is not advised.

Prescribing information was updated to reflect data from JADE TEEN, a phase 3, randomized, placebo-controlled trial that supported the indication for adolescents. That trial evaluated both the 100-mg and 200-mg doses of abrocitinib in comparison with placebo in 285 adolescents aged 12-18 who had moderate to severe AD and who were also receiving background therapy with topical medications.

The most common toxicities that were reported in at least 1% of patients treated with abrocitinib for up to 16 weeks included nasopharyngitis, nausea, and headache.

Efficacy measures included improvements in itch, skin clearance, and disease severity using the Investigator Global Assessment (IGA), the Peak Pruritus Numerical Rating Scale (PP-NRS), and the Eczema Area and Severity Index (EASI), according to the Pfizer statement announcing the expanded approval.

Select JADE TEEN findings include the following:

• IGA response rate of 0 or 1 at week 12: 39% with abrocitinib 100 mg; 46% with abrocitinib 200 mg; and 24% with placebo.
• EASI-75 response rate at week 12: 64%, 71%, and 41%, respectively.
• Proportion of participants achieving PP-NRS with at least a 4-point decrease from baseline at week 2: 13%, 25%, and 8%, respectively.

Data included in the prescribing information now encompass five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with abrocitinib, according to the statement from Pfizer.

In a 2021 story, when JADE TEEN trial results were presented, Lawrence Eichenfield, MD, professor of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego, told this news organization that he welcomed oral JAKs as a weapon against atopic dermatitis.

He noted that moderate to severe AD can have a tremendous impact on adolescents. “Traditionally, we have treated it with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control,” he said.

Abrocitinib is not recommended for use with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

AD, one of the most common inflammatory skin diseases, affects approximately 5%-10% of adults in the United States and approximately 11% of children. About one in three adults and one in three children and adolescents aged 17 and younger with AD have moderate to severe disease.

JAK inhibition is thought to modulate multiple cytokines involved in AD, including interleukin (IL)–4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin.

Prescribing information includes a warning that use of abrocitinib should be avoided by patients with an active, serious infection, including localized infections. A boxed warning is included in the labels of JAK inhibitors regarding the risk of serious infections, mortality, major cardiovascular events, and thrombosis.

Treatment risks and benefits should be carefully considered for patients with chronic or recurrent infections or those who have lived in or traveled in areas of endemic tuberculosis or endemic mycoses, the information states.

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

The U.S. Food and Drug Administration today expanded the indication for Pfizer’s oral Janus kinase (JAK) inhibitor for atopic dermatitis (AD), abrocitinib (Cibinqo), to include adolescents aged 12 through 17 years.

Abrocitinib, taken once daily, previously was approved only for treating adults aged 18 and older.

It joins upadacitinib (Rinvoq), previously the only oral JAK inhibitor to be approved for use by adolescents aged 12 through 17 with refractory moderate to severe AD.

The indication has been expanded for teens whose disease is not adequately controlled with other systemic drugs, including biologics, or those for whom use of those drugs is not advised.

Prescribing information was updated to reflect data from JADE TEEN, a phase 3, randomized, placebo-controlled trial that supported the indication for adolescents. That trial evaluated both the 100-mg and 200-mg doses of abrocitinib in comparison with placebo in 285 adolescents aged 12-18 who had moderate to severe AD and who were also receiving background therapy with topical medications.

The most common toxicities that were reported in at least 1% of patients treated with abrocitinib for up to 16 weeks included nasopharyngitis, nausea, and headache.

Efficacy measures included improvements in itch, skin clearance, and disease severity using the Investigator Global Assessment (IGA), the Peak Pruritus Numerical Rating Scale (PP-NRS), and the Eczema Area and Severity Index (EASI), according to the Pfizer statement announcing the expanded approval.

Select JADE TEEN findings include the following:

• IGA response rate of 0 or 1 at week 12: 39% with abrocitinib 100 mg; 46% with abrocitinib 200 mg; and 24% with placebo.
• EASI-75 response rate at week 12: 64%, 71%, and 41%, respectively.
• Proportion of participants achieving PP-NRS with at least a 4-point decrease from baseline at week 2: 13%, 25%, and 8%, respectively.

Data included in the prescribing information now encompass five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with abrocitinib, according to the statement from Pfizer.

In a 2021 story, when JADE TEEN trial results were presented, Lawrence Eichenfield, MD, professor of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego, told this news organization that he welcomed oral JAKs as a weapon against atopic dermatitis.

He noted that moderate to severe AD can have a tremendous impact on adolescents. “Traditionally, we have treated it with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control,” he said.

Abrocitinib is not recommended for use with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

AD, one of the most common inflammatory skin diseases, affects approximately 5%-10% of adults in the United States and approximately 11% of children. About one in three adults and one in three children and adolescents aged 17 and younger with AD have moderate to severe disease.

JAK inhibition is thought to modulate multiple cytokines involved in AD, including interleukin (IL)–4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin.

Prescribing information includes a warning that use of abrocitinib should be avoided by patients with an active, serious infection, including localized infections. A boxed warning is included in the labels of JAK inhibitors regarding the risk of serious infections, mortality, major cardiovascular events, and thrombosis.

Treatment risks and benefits should be carefully considered for patients with chronic or recurrent infections or those who have lived in or traveled in areas of endemic tuberculosis or endemic mycoses, the information states.

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

The U.S. Food and Drug Administration today expanded the indication for Pfizer’s oral Janus kinase (JAK) inhibitor for atopic dermatitis (AD), abrocitinib (Cibinqo), to include adolescents aged 12 through 17 years.

Abrocitinib, taken once daily, previously was approved only for treating adults aged 18 and older.

It joins upadacitinib (Rinvoq), previously the only oral JAK inhibitor to be approved for use by adolescents aged 12 through 17 with refractory moderate to severe AD.

The indication has been expanded for teens whose disease is not adequately controlled with other systemic drugs, including biologics, or those for whom use of those drugs is not advised.

Prescribing information was updated to reflect data from JADE TEEN, a phase 3, randomized, placebo-controlled trial that supported the indication for adolescents. That trial evaluated both the 100-mg and 200-mg doses of abrocitinib in comparison with placebo in 285 adolescents aged 12-18 who had moderate to severe AD and who were also receiving background therapy with topical medications.

The most common toxicities that were reported in at least 1% of patients treated with abrocitinib for up to 16 weeks included nasopharyngitis, nausea, and headache.

Efficacy measures included improvements in itch, skin clearance, and disease severity using the Investigator Global Assessment (IGA), the Peak Pruritus Numerical Rating Scale (PP-NRS), and the Eczema Area and Severity Index (EASI), according to the Pfizer statement announcing the expanded approval.

Select JADE TEEN findings include the following:

• IGA response rate of 0 or 1 at week 12: 39% with abrocitinib 100 mg; 46% with abrocitinib 200 mg; and 24% with placebo.
• EASI-75 response rate at week 12: 64%, 71%, and 41%, respectively.
• Proportion of participants achieving PP-NRS with at least a 4-point decrease from baseline at week 2: 13%, 25%, and 8%, respectively.

Data included in the prescribing information now encompass five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with abrocitinib, according to the statement from Pfizer.

In a 2021 story, when JADE TEEN trial results were presented, Lawrence Eichenfield, MD, professor of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego, told this news organization that he welcomed oral JAKs as a weapon against atopic dermatitis.

He noted that moderate to severe AD can have a tremendous impact on adolescents. “Traditionally, we have treated it with intermittent topical corticosteroids, but this has left a significant percentage of patients without long-term disease control,” he said.

Abrocitinib is not recommended for use with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

AD, one of the most common inflammatory skin diseases, affects approximately 5%-10% of adults in the United States and approximately 11% of children. About one in three adults and one in three children and adolescents aged 17 and younger with AD have moderate to severe disease.

JAK inhibition is thought to modulate multiple cytokines involved in AD, including interleukin (IL)–4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin.

Prescribing information includes a warning that use of abrocitinib should be avoided by patients with an active, serious infection, including localized infections. A boxed warning is included in the labels of JAK inhibitors regarding the risk of serious infections, mortality, major cardiovascular events, and thrombosis.

Treatment risks and benefits should be carefully considered for patients with chronic or recurrent infections or those who have lived in or traveled in areas of endemic tuberculosis or endemic mycoses, the information states.

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

Only 56% of children enrolled in Medicaid received any outpatient follow-up within 30 days after a mental health emergency department discharge, according to results of a large study released in Pediatrics.

Fewer than one-third (31.2%) had an outpatient visit within a week after a mental health ED discharge.

Researchers conducted a retrospective study of 28,551 children ages 6-17 years old who had mental health discharges from EDs from January 2018 to June 2019.

The researchers, led by Jennifer A. Hoffmann, MD, MS, with the division of emergency medicine, Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, Chicago, also analyzed the effect that having a timely follow-up had on whether the child was likely to return to the ED.
 

Follow-up within 30 days cuts risk of quick return to ED

They found that follow-up within 30 days was linked with a 26% decreased risk of return within 5 days of the initial ED discharge (hazard ratio, 0.74; 95% confidence interval, 0.63-0.91).

The researchers also found racial disparities in the data. The odds for getting follow-up outpatient care were lower for non-Hispanic Black children, for children with fee-for-service insurance, and for children with no previous mental health outpatient visits.

The numbers were particularly striking for Black children, who were 10% less likely to get outpatient follow-up than their White counterparts.

In addition, 27% of all children in this sample returned to the ED for mental health-related symptoms within 6 months, 20% spent more than 48 hours in the ED for their initial mental health visit, and children with 14 or more mental health outpatient visits had five times higher adjusted odds of follow-up within 7 days and 9.5 times higher adjusted odds of follow-up within 30 days, compared with children with no outpatient mental health visits in the previous year.

A ‘mental health system of care in crisis’

In an accompanying editorial, Hannah E. Karpman, MSW, PhD, with the department of pediatrics, University of Massachusetts, Worcester, and colleagues said those statistics help expose other signs of “a pediatric mental health system of care in crisis.”

If one in five children are spending more than 2 days in the ED for their initial mental health visit, they wrote, that signals the follow-up care they need is not readily available.

The 27% returning to the ED shows that, even if the children are getting outpatient services, that environment is failing them, they noted.

Additionally, 28% of children presented with more than four mental health diagnoses, “suggesting poor diagnostic specificity or perhaps inadequate diagnostic categories to characterize their needs.”

The authors called for interventions that link patients to outpatient care within 5 days of a mental health ED discharge.

The editorialists wrote: “We believe it is time for a “child mental health moonshot,” and call on the field and its funders to come together to launch the next wave of bold mental health research for the benefit of these children and their families who so desperately need our support.”
 

Things may even be worse in light of COVID

David Rettew, MD, a child and adolescent psychiatrist with Lane County Behavioral Health in Eugene, Ore., and Oregon Health & Science University, Portland, said in an interview the numbers won’t surprise clinicians who support these children or the patients’ families.

He added that he wouldn’t be surprised if things are even worse now after this study’s data collection, “as COVID and other factors have driven more mental health professionals away from many of the people who need them the most.”

The study does present new evidence that quick access to care is particularly tough for young people who aren’t already established in care, he noted.

“As wait lists grow at outpatient clinics, we are seeing ever stronger need for centers willing and able to provide actual mental health assessment and treatment for people right ‘off the street,’” he said.

Dr. Rettew emphasized that, because mental health conditions rarely improve quickly, having a timely follow-up appointment is important, but won’t likely bring quick improvement.

He agreed with the editorialists’ argument and emphasized, “not only do we need to focus on more rapid care, but also more comprehensive and effective care.

“For an adolescent in crisis, achieving stability often involves more than a medication tweak and a supportive conversation,” Dr. Rettew said. “Rather, it can require an intensive multimodal approach that addresses things like family financial stressors, parental mental health and substance use concerns, school supports, and health promotion or lifestyle changes. What we desperately need are more teams that can quickly intervene on all these levels.”
 

Addressing problems before crisis is essential

Ideally, teams would address these issues before a crisis. That helps support the “moonshot” charge the editorialists suggest, which “would significantly disrupt the current way we value different components of our health care system,” Dr. Rettew said.

He highlighted a statistic that may get lost in the data: Nearly 40% of youth in enough danger to need an ED visit had no more than one health-related appointment of any kind in the previous year.

“To me, this speaks volumes about the need for earlier involvement before things escalate to the level of an emergency,” Dr. Rettew said.

The authors and editorialists declared no relevant financial relationships. Dr. Rettew is author of the book, “Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.”

Only 56% of children enrolled in Medicaid received any outpatient follow-up within 30 days after a mental health emergency department discharge, according to results of a large study released in Pediatrics.

Fewer than one-third (31.2%) had an outpatient visit within a week after a mental health ED discharge.

Researchers conducted a retrospective study of 28,551 children ages 6-17 years old who had mental health discharges from EDs from January 2018 to June 2019.

The researchers, led by Jennifer A. Hoffmann, MD, MS, with the division of emergency medicine, Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, Chicago, also analyzed the effect that having a timely follow-up had on whether the child was likely to return to the ED.
 

Follow-up within 30 days cuts risk of quick return to ED

They found that follow-up within 30 days was linked with a 26% decreased risk of return within 5 days of the initial ED discharge (hazard ratio, 0.74; 95% confidence interval, 0.63-0.91).

The researchers also found racial disparities in the data. The odds for getting follow-up outpatient care were lower for non-Hispanic Black children, for children with fee-for-service insurance, and for children with no previous mental health outpatient visits.

The numbers were particularly striking for Black children, who were 10% less likely to get outpatient follow-up than their White counterparts.

In addition, 27% of all children in this sample returned to the ED for mental health-related symptoms within 6 months, 20% spent more than 48 hours in the ED for their initial mental health visit, and children with 14 or more mental health outpatient visits had five times higher adjusted odds of follow-up within 7 days and 9.5 times higher adjusted odds of follow-up within 30 days, compared with children with no outpatient mental health visits in the previous year.

A ‘mental health system of care in crisis’

In an accompanying editorial, Hannah E. Karpman, MSW, PhD, with the department of pediatrics, University of Massachusetts, Worcester, and colleagues said those statistics help expose other signs of “a pediatric mental health system of care in crisis.”

If one in five children are spending more than 2 days in the ED for their initial mental health visit, they wrote, that signals the follow-up care they need is not readily available.

The 27% returning to the ED shows that, even if the children are getting outpatient services, that environment is failing them, they noted.

Additionally, 28% of children presented with more than four mental health diagnoses, “suggesting poor diagnostic specificity or perhaps inadequate diagnostic categories to characterize their needs.”

The authors called for interventions that link patients to outpatient care within 5 days of a mental health ED discharge.

The editorialists wrote: “We believe it is time for a “child mental health moonshot,” and call on the field and its funders to come together to launch the next wave of bold mental health research for the benefit of these children and their families who so desperately need our support.”
 

Things may even be worse in light of COVID

David Rettew, MD, a child and adolescent psychiatrist with Lane County Behavioral Health in Eugene, Ore., and Oregon Health & Science University, Portland, said in an interview the numbers won’t surprise clinicians who support these children or the patients’ families.

He added that he wouldn’t be surprised if things are even worse now after this study’s data collection, “as COVID and other factors have driven more mental health professionals away from many of the people who need them the most.”

The study does present new evidence that quick access to care is particularly tough for young people who aren’t already established in care, he noted.

“As wait lists grow at outpatient clinics, we are seeing ever stronger need for centers willing and able to provide actual mental health assessment and treatment for people right ‘off the street,’” he said.

Dr. Rettew emphasized that, because mental health conditions rarely improve quickly, having a timely follow-up appointment is important, but won’t likely bring quick improvement.

He agreed with the editorialists’ argument and emphasized, “not only do we need to focus on more rapid care, but also more comprehensive and effective care.

“For an adolescent in crisis, achieving stability often involves more than a medication tweak and a supportive conversation,” Dr. Rettew said. “Rather, it can require an intensive multimodal approach that addresses things like family financial stressors, parental mental health and substance use concerns, school supports, and health promotion or lifestyle changes. What we desperately need are more teams that can quickly intervene on all these levels.”
 

Addressing problems before crisis is essential

Ideally, teams would address these issues before a crisis. That helps support the “moonshot” charge the editorialists suggest, which “would significantly disrupt the current way we value different components of our health care system,” Dr. Rettew said.

He highlighted a statistic that may get lost in the data: Nearly 40% of youth in enough danger to need an ED visit had no more than one health-related appointment of any kind in the previous year.

“To me, this speaks volumes about the need for earlier involvement before things escalate to the level of an emergency,” Dr. Rettew said.

The authors and editorialists declared no relevant financial relationships. Dr. Rettew is author of the book, “Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.”

Only 56% of children enrolled in Medicaid received any outpatient follow-up within 30 days after a mental health emergency department discharge, according to results of a large study released in Pediatrics.

Fewer than one-third (31.2%) had an outpatient visit within a week after a mental health ED discharge.

Researchers conducted a retrospective study of 28,551 children ages 6-17 years old who had mental health discharges from EDs from January 2018 to June 2019.

The researchers, led by Jennifer A. Hoffmann, MD, MS, with the division of emergency medicine, Ann & Robert H. Lurie Children’s Hospital of Chicago and Northwestern University, Chicago, also analyzed the effect that having a timely follow-up had on whether the child was likely to return to the ED.
 

Follow-up within 30 days cuts risk of quick return to ED

They found that follow-up within 30 days was linked with a 26% decreased risk of return within 5 days of the initial ED discharge (hazard ratio, 0.74; 95% confidence interval, 0.63-0.91).

The researchers also found racial disparities in the data. The odds for getting follow-up outpatient care were lower for non-Hispanic Black children, for children with fee-for-service insurance, and for children with no previous mental health outpatient visits.

The numbers were particularly striking for Black children, who were 10% less likely to get outpatient follow-up than their White counterparts.

In addition, 27% of all children in this sample returned to the ED for mental health-related symptoms within 6 months, 20% spent more than 48 hours in the ED for their initial mental health visit, and children with 14 or more mental health outpatient visits had five times higher adjusted odds of follow-up within 7 days and 9.5 times higher adjusted odds of follow-up within 30 days, compared with children with no outpatient mental health visits in the previous year.

A ‘mental health system of care in crisis’

In an accompanying editorial, Hannah E. Karpman, MSW, PhD, with the department of pediatrics, University of Massachusetts, Worcester, and colleagues said those statistics help expose other signs of “a pediatric mental health system of care in crisis.”

If one in five children are spending more than 2 days in the ED for their initial mental health visit, they wrote, that signals the follow-up care they need is not readily available.

The 27% returning to the ED shows that, even if the children are getting outpatient services, that environment is failing them, they noted.

Additionally, 28% of children presented with more than four mental health diagnoses, “suggesting poor diagnostic specificity or perhaps inadequate diagnostic categories to characterize their needs.”

The authors called for interventions that link patients to outpatient care within 5 days of a mental health ED discharge.

The editorialists wrote: “We believe it is time for a “child mental health moonshot,” and call on the field and its funders to come together to launch the next wave of bold mental health research for the benefit of these children and their families who so desperately need our support.”
 

Things may even be worse in light of COVID

David Rettew, MD, a child and adolescent psychiatrist with Lane County Behavioral Health in Eugene, Ore., and Oregon Health & Science University, Portland, said in an interview the numbers won’t surprise clinicians who support these children or the patients’ families.

He added that he wouldn’t be surprised if things are even worse now after this study’s data collection, “as COVID and other factors have driven more mental health professionals away from many of the people who need them the most.”

The study does present new evidence that quick access to care is particularly tough for young people who aren’t already established in care, he noted.

“As wait lists grow at outpatient clinics, we are seeing ever stronger need for centers willing and able to provide actual mental health assessment and treatment for people right ‘off the street,’” he said.

Dr. Rettew emphasized that, because mental health conditions rarely improve quickly, having a timely follow-up appointment is important, but won’t likely bring quick improvement.

He agreed with the editorialists’ argument and emphasized, “not only do we need to focus on more rapid care, but also more comprehensive and effective care.

“For an adolescent in crisis, achieving stability often involves more than a medication tweak and a supportive conversation,” Dr. Rettew said. “Rather, it can require an intensive multimodal approach that addresses things like family financial stressors, parental mental health and substance use concerns, school supports, and health promotion or lifestyle changes. What we desperately need are more teams that can quickly intervene on all these levels.”
 

Addressing problems before crisis is essential

Ideally, teams would address these issues before a crisis. That helps support the “moonshot” charge the editorialists suggest, which “would significantly disrupt the current way we value different components of our health care system,” Dr. Rettew said.

He highlighted a statistic that may get lost in the data: Nearly 40% of youth in enough danger to need an ED visit had no more than one health-related appointment of any kind in the previous year.

“To me, this speaks volumes about the need for earlier involvement before things escalate to the level of an emergency,” Dr. Rettew said.

The authors and editorialists declared no relevant financial relationships. Dr. Rettew is author of the book, “Parenting Made Complicated: What Science Really Knows about the Greatest Debates of Early Childhood.”