Pediatric News

Poison control centers in the United States now receive more calls about adolescents abusing cannabis than alcohol or any other substance, according to a new study.

Many helpline calls about cannabis involve edible products, the researchers noted.

Over-the-counter medications – especially dextromethorphan-containing cough and cold medications and oral antihistamines, such as Benadryl – are other commonly abused substances.

But cannabis recently started topping the list.

“Since 2018, the most reported misused/abused substance involved exposure to marijuana,” according to the study, which was published online in Clinical Toxicology.  

Adrienne Hughes, MD, assistant professor of emergency medicine at Oregon Health & Science University, Portland, and colleagues analyzed calls to United States poison control centers between 2000 and 2020. They focused on 338,000 calls about intentional substance abuse or misuse, including for the purpose of getting high, in individuals aged 6-18 years.

The calls were made to 55 certified helplines for health professionals, public health agencies, and members of the public seeking guidance about exposures to various substances.
 

Cannabis vs. alcohol

In 2000, alcohol was the substance involved in the largest number of cases (1,318, or 9.8% of all calls). Between 2000 and 2013, cases of alcohol abuse exceeded the number of cannabis cases each year.

But that changed in 2014, when cannabis overtook alcohol.

Over the 20-year study period, calls about exposure to cannabis increased 245%, from 510 in 2000 to 1,761 in 2020.

Edibles played a key role.

“Edible marijuana preparations accounted for the highest increase in call rates, compared with all other forms of marijuana,” the researchers reported.

Edible products are “often marketed in ways that are attractive to young people, and they are considered more discrete and convenient,” Dr. Hughes said. But they can have “unpredictable” effects.

“Compared to smoking cannabis, which typically results in an immediate high, intoxication from edible forms usually takes several hours, which may lead some individuals to consume greater amounts and experience unexpected and unpredictable highs,” she said. 

For example, prior research has shown that edible cannabis consumption may lead to more acute psychiatric symptoms and cardiovascular events than does inhaled cannabis.

Trends in alcohol use may have held relatively steady, despite some minor declines in the poison center data, Dr. Hughes said.

“Anecdotally, there hasn’t been an obvious notable reduction in alcohol cases in the emergency department,” she said. “However, I wouldn’t expect a huge change given our data only found a slow mild decline in alcohol cases over the study period.”

The increase in cannabis-related calls coincides with more states legalizing or decriminalizing the drug for medical or recreational purposes. Currently, 21 states have approved recreational cannabis for adults who are at least 21 years old.
 

What are the risks?

Parents typically call a poison center about cannabis exposure after they see or suspect that their child has ingested loose cannabis leaves or edibles containing the substance, Dr. Hughes said.

“The poison center provides guidance to parents about whether or not their child can be watched at home or requires referral to a health care facility,” she said. “While marijuana carries a low risk for severe toxicity, it can be inebriating to the point of poor judgment, risk of falls or other injury, and occasionally a panic reaction in the novice user and unsuspecting children who accidentally ingest these products.”

Intentional misuse or abuse tends to occur in older children and teens.

Nonprescription drugs have a high potential for abuse because they are legal and may be perceived as safe, Dr. Hughes said.

If a child has a history of misusing or abusing substances or if a parent is worried that their child is at high risk for this behavior, they should consider securing medicines in a lock box, she advised.

That applies to cannabis too.

“I would recommend that parents also consider locking up their cannabis products,” she said.

The National Poison Data System relies on voluntary reporting, and the data are not expected to represent the actual number of intentional misuse and abuse exposures, the researchers noted.

Poison control centers in the United States are available for consultation about patients with known or suspected cannabis ingestion or other suspected poisonings (1-800-222-1222).

The researchers had no disclosures.

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

Poison control centers in the United States now receive more calls about adolescents abusing cannabis than alcohol or any other substance, according to a new study.

Many helpline calls about cannabis involve edible products, the researchers noted.

Over-the-counter medications – especially dextromethorphan-containing cough and cold medications and oral antihistamines, such as Benadryl – are other commonly abused substances.

But cannabis recently started topping the list.

“Since 2018, the most reported misused/abused substance involved exposure to marijuana,” according to the study, which was published online in Clinical Toxicology.  

Adrienne Hughes, MD, assistant professor of emergency medicine at Oregon Health & Science University, Portland, and colleagues analyzed calls to United States poison control centers between 2000 and 2020. They focused on 338,000 calls about intentional substance abuse or misuse, including for the purpose of getting high, in individuals aged 6-18 years.

The calls were made to 55 certified helplines for health professionals, public health agencies, and members of the public seeking guidance about exposures to various substances.
 

Cannabis vs. alcohol

In 2000, alcohol was the substance involved in the largest number of cases (1,318, or 9.8% of all calls). Between 2000 and 2013, cases of alcohol abuse exceeded the number of cannabis cases each year.

But that changed in 2014, when cannabis overtook alcohol.

Over the 20-year study period, calls about exposure to cannabis increased 245%, from 510 in 2000 to 1,761 in 2020.

Edibles played a key role.

“Edible marijuana preparations accounted for the highest increase in call rates, compared with all other forms of marijuana,” the researchers reported.

Edible products are “often marketed in ways that are attractive to young people, and they are considered more discrete and convenient,” Dr. Hughes said. But they can have “unpredictable” effects.

“Compared to smoking cannabis, which typically results in an immediate high, intoxication from edible forms usually takes several hours, which may lead some individuals to consume greater amounts and experience unexpected and unpredictable highs,” she said. 

For example, prior research has shown that edible cannabis consumption may lead to more acute psychiatric symptoms and cardiovascular events than does inhaled cannabis.

Trends in alcohol use may have held relatively steady, despite some minor declines in the poison center data, Dr. Hughes said.

“Anecdotally, there hasn’t been an obvious notable reduction in alcohol cases in the emergency department,” she said. “However, I wouldn’t expect a huge change given our data only found a slow mild decline in alcohol cases over the study period.”

The increase in cannabis-related calls coincides with more states legalizing or decriminalizing the drug for medical or recreational purposes. Currently, 21 states have approved recreational cannabis for adults who are at least 21 years old.
 

What are the risks?

Parents typically call a poison center about cannabis exposure after they see or suspect that their child has ingested loose cannabis leaves or edibles containing the substance, Dr. Hughes said.

“The poison center provides guidance to parents about whether or not their child can be watched at home or requires referral to a health care facility,” she said. “While marijuana carries a low risk for severe toxicity, it can be inebriating to the point of poor judgment, risk of falls or other injury, and occasionally a panic reaction in the novice user and unsuspecting children who accidentally ingest these products.”

Intentional misuse or abuse tends to occur in older children and teens.

Nonprescription drugs have a high potential for abuse because they are legal and may be perceived as safe, Dr. Hughes said.

If a child has a history of misusing or abusing substances or if a parent is worried that their child is at high risk for this behavior, they should consider securing medicines in a lock box, she advised.

That applies to cannabis too.

“I would recommend that parents also consider locking up their cannabis products,” she said.

The National Poison Data System relies on voluntary reporting, and the data are not expected to represent the actual number of intentional misuse and abuse exposures, the researchers noted.

Poison control centers in the United States are available for consultation about patients with known or suspected cannabis ingestion or other suspected poisonings (1-800-222-1222).

The researchers had no disclosures.

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

Poison control centers in the United States now receive more calls about adolescents abusing cannabis than alcohol or any other substance, according to a new study.

Many helpline calls about cannabis involve edible products, the researchers noted.

Over-the-counter medications – especially dextromethorphan-containing cough and cold medications and oral antihistamines, such as Benadryl – are other commonly abused substances.

But cannabis recently started topping the list.

“Since 2018, the most reported misused/abused substance involved exposure to marijuana,” according to the study, which was published online in Clinical Toxicology.  

Adrienne Hughes, MD, assistant professor of emergency medicine at Oregon Health & Science University, Portland, and colleagues analyzed calls to United States poison control centers between 2000 and 2020. They focused on 338,000 calls about intentional substance abuse or misuse, including for the purpose of getting high, in individuals aged 6-18 years.

The calls were made to 55 certified helplines for health professionals, public health agencies, and members of the public seeking guidance about exposures to various substances.
 

Cannabis vs. alcohol

In 2000, alcohol was the substance involved in the largest number of cases (1,318, or 9.8% of all calls). Between 2000 and 2013, cases of alcohol abuse exceeded the number of cannabis cases each year.

But that changed in 2014, when cannabis overtook alcohol.

Over the 20-year study period, calls about exposure to cannabis increased 245%, from 510 in 2000 to 1,761 in 2020.

Edibles played a key role.

“Edible marijuana preparations accounted for the highest increase in call rates, compared with all other forms of marijuana,” the researchers reported.

Edible products are “often marketed in ways that are attractive to young people, and they are considered more discrete and convenient,” Dr. Hughes said. But they can have “unpredictable” effects.

“Compared to smoking cannabis, which typically results in an immediate high, intoxication from edible forms usually takes several hours, which may lead some individuals to consume greater amounts and experience unexpected and unpredictable highs,” she said. 

For example, prior research has shown that edible cannabis consumption may lead to more acute psychiatric symptoms and cardiovascular events than does inhaled cannabis.

Trends in alcohol use may have held relatively steady, despite some minor declines in the poison center data, Dr. Hughes said.

“Anecdotally, there hasn’t been an obvious notable reduction in alcohol cases in the emergency department,” she said. “However, I wouldn’t expect a huge change given our data only found a slow mild decline in alcohol cases over the study period.”

The increase in cannabis-related calls coincides with more states legalizing or decriminalizing the drug for medical or recreational purposes. Currently, 21 states have approved recreational cannabis for adults who are at least 21 years old.
 

What are the risks?

Parents typically call a poison center about cannabis exposure after they see or suspect that their child has ingested loose cannabis leaves or edibles containing the substance, Dr. Hughes said.

“The poison center provides guidance to parents about whether or not their child can be watched at home or requires referral to a health care facility,” she said. “While marijuana carries a low risk for severe toxicity, it can be inebriating to the point of poor judgment, risk of falls or other injury, and occasionally a panic reaction in the novice user and unsuspecting children who accidentally ingest these products.”

Intentional misuse or abuse tends to occur in older children and teens.

Nonprescription drugs have a high potential for abuse because they are legal and may be perceived as safe, Dr. Hughes said.

If a child has a history of misusing or abusing substances or if a parent is worried that their child is at high risk for this behavior, they should consider securing medicines in a lock box, she advised.

That applies to cannabis too.

“I would recommend that parents also consider locking up their cannabis products,” she said.

The National Poison Data System relies on voluntary reporting, and the data are not expected to represent the actual number of intentional misuse and abuse exposures, the researchers noted.

Poison control centers in the United States are available for consultation about patients with known or suspected cannabis ingestion or other suspected poisonings (1-800-222-1222).

The researchers had no disclosures.

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

Adolescents later diagnosed with anorexia nervosa (AN) likely embark on the trajectory to AN with undisclosed dieting for weight loss at about age 14, a study of teens and parents found.

In the interview-based study, both adolescents and their parents described a similar prediagnosis sequence of behavioral changes occurring over roughly 1 year to 18 months, but parents lagged some 6 months behind in noticing their children’s disordered eating.

The findings suggest that even teens of normal weight should be asked about their eating habits and monitored more closely for contact with those who endorse these potentially harmful eating behaviors, according to Lisa M. Ranzenhofer, PhD, assistant professor of clinical psychology in psychiatry at Columbia University Medical Center in New York, and colleagues. Their report is in the Journal of Adolescent Health.

“We know that adolescents often have eating disorder behaviors long before they’re diagnosed, so we developed this interview as a tool to figure out how long a maladaptive behavior has been present,” Dr. Ranzenhofer said in an interview. “Most studies that report illness duration do so based on diagnosis, so this interview provides a more fine-grained assessment of the duration of problematic behavior, which may help improve understanding of the impact of duration on outcome, and hopefully facilitate better methods for early detection.” Since healthy adolescents are often seen once per year at an annual pediatrician visit, she added, teens engaging in significant dieting might benefit from more frequent monitoring since this behavior can evolve into an eating disorder over a relatively short time frame.

AN is associated with significant medical and psychiatric comorbidity and has a mortality rate among the highest of any psychiatric illness, the authors noted.
 

The study

The study cohort consisted of 71 girls ages 12-18 years participating in research from 2017 to 2021 at the Eating Disorders Research Unit of New York (N.Y.) State Psychiatric Institute. Patients had either the restricting or binge-eating/purging subtype of AN as diagnosed by the Eating Disorder Assessment–5 questionnaire. A semistructured 15-minute interview with the girls and their parents explored food restriction, dieting, loss of control/binge eating, purging, excessive/compulsive exercise, weight history, and amenorrhea.

Both parents and children were asked whether and when the children had been underweight or overweight, and whether and when primary amenorrhea (no menarche) or secondary amenorrhea (periods missed for 3 months) became evident. Dieting was defined as “deliberately changing eating patterns in any way to influence your shape or weight,” and restriction as “deliberately cutting down on the amount of food that you are eating, in order to change your shape or weight.” Loss-of-control eating was defined as “feeling unable to stop eating or control what or how much you are eating.”

In other characterizations, purging was defined as making yourself vomit on purpose, taking diuretics, or feeling driven to engage in these behaviors. Questions on exercise explored whether children might feel anxious when they do not exercise or inclined to exercise even if sick or injured, with excessive exercise defined as “Feeling like you must exercise, might continue exercising, sometimes in secret, if parents or doctors have told you to stop.”

Other questions focused on use of diuretics or laxatives and other strategies to compensate for calories consumed.

Responses revealed that restriction, underweight, dieting, and excessive exercise were present in most of the sample, while purging, loss-of-control eating, and overweight were reported by fewer than a third. With dieting typically emerging first around age 14, the other behaviors tended to manifest from age 14 to 14 and a half. The average age of formal diagnosis was just over 15 years. Parent-child dyads showed good agreement on the presence and timing of all behaviors except for dieting, for which children reported onset about 6 months earlier or longer duration compared with parents.

Although older age at the time of interview was associated with a lower body mass index percentile and higher eating disorder score, neither age of onset nor duration of disordered eating was associated with severity when researchers controlled for current age.
 

Telltale signs for parents

“For teens starting at a healthy weight, significant and intentional weight loss of more than 5-10 pounds can be a cause for concern,” Dr. Ranzenhofer said. Missed periods, refusing meals, skipping meals, fighting or arguing about eating, and withdrawal from normal activities and relationships are other signs of disordered eating. For overweight or obese teens, rapid weight loss and weight loss above and beyond that recommended are also concerning.

As for compulsive exercise, she said, “Altered exercise behavior might look like exercise that interferes with other activities, for example, being late to school or not doing homework in order to exercise.” Other red flags would be physical activity that varies considerably from that of peers, for instance, going running after a 2-hour sports practice and an inflexible routine that precludes being able to skip a day.

“All adolescents, male and female, should be screened regardless of weight trends – underweight, overweight, obese, or normal weight – regarding their body image and thoughts of dieting,” said Margaret E. Thew, DNP, FNP-BC, of the Medical College of Wisconsin, and medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, commenting on the study but not involved in it. “Most adolescents make decisions to lose weight after trying to ‘eat healthy’ but may take an aggressive approach when they don’t see the weight loss they hope to see.”

According to Ms. Thew, the study findings support the benefit of giving medical caregivers and parents training on the red flags regarding eating disorders to foster early detection. “These include starting a new fad diet, eliminating foods, ‘healthy eating,’ over-exercising, skipping meals, or no longer eating foods they previously loved.”

She added that times of transition are key junctures to watch: The transition from grade school to middle school, middle to high school, and high school to college. “These tend to provoke eating disorder onset or relapse of eating disorder thoughts and behaviors after diagnosis,” Ms. Thew said. “It would benefit the patient to screen for concerns about disordered eating and provide resources, including consultation with a dietitian, as appropriate.”

This study was supported by grants from the National Institute of Mental Health and the Hilda and Preston Davis Foundation. Coauthor Joanna E. Steinglass, MD, disclosed receiving royalties from UpToDate. Ms. Thew disclosed no competing interests with regard to her comments.

Adolescents later diagnosed with anorexia nervosa (AN) likely embark on the trajectory to AN with undisclosed dieting for weight loss at about age 14, a study of teens and parents found.

In the interview-based study, both adolescents and their parents described a similar prediagnosis sequence of behavioral changes occurring over roughly 1 year to 18 months, but parents lagged some 6 months behind in noticing their children’s disordered eating.

The findings suggest that even teens of normal weight should be asked about their eating habits and monitored more closely for contact with those who endorse these potentially harmful eating behaviors, according to Lisa M. Ranzenhofer, PhD, assistant professor of clinical psychology in psychiatry at Columbia University Medical Center in New York, and colleagues. Their report is in the Journal of Adolescent Health.

“We know that adolescents often have eating disorder behaviors long before they’re diagnosed, so we developed this interview as a tool to figure out how long a maladaptive behavior has been present,” Dr. Ranzenhofer said in an interview. “Most studies that report illness duration do so based on diagnosis, so this interview provides a more fine-grained assessment of the duration of problematic behavior, which may help improve understanding of the impact of duration on outcome, and hopefully facilitate better methods for early detection.” Since healthy adolescents are often seen once per year at an annual pediatrician visit, she added, teens engaging in significant dieting might benefit from more frequent monitoring since this behavior can evolve into an eating disorder over a relatively short time frame.

AN is associated with significant medical and psychiatric comorbidity and has a mortality rate among the highest of any psychiatric illness, the authors noted.
 

The study

The study cohort consisted of 71 girls ages 12-18 years participating in research from 2017 to 2021 at the Eating Disorders Research Unit of New York (N.Y.) State Psychiatric Institute. Patients had either the restricting or binge-eating/purging subtype of AN as diagnosed by the Eating Disorder Assessment–5 questionnaire. A semistructured 15-minute interview with the girls and their parents explored food restriction, dieting, loss of control/binge eating, purging, excessive/compulsive exercise, weight history, and amenorrhea.

Both parents and children were asked whether and when the children had been underweight or overweight, and whether and when primary amenorrhea (no menarche) or secondary amenorrhea (periods missed for 3 months) became evident. Dieting was defined as “deliberately changing eating patterns in any way to influence your shape or weight,” and restriction as “deliberately cutting down on the amount of food that you are eating, in order to change your shape or weight.” Loss-of-control eating was defined as “feeling unable to stop eating or control what or how much you are eating.”

In other characterizations, purging was defined as making yourself vomit on purpose, taking diuretics, or feeling driven to engage in these behaviors. Questions on exercise explored whether children might feel anxious when they do not exercise or inclined to exercise even if sick or injured, with excessive exercise defined as “Feeling like you must exercise, might continue exercising, sometimes in secret, if parents or doctors have told you to stop.”

Other questions focused on use of diuretics or laxatives and other strategies to compensate for calories consumed.

Responses revealed that restriction, underweight, dieting, and excessive exercise were present in most of the sample, while purging, loss-of-control eating, and overweight were reported by fewer than a third. With dieting typically emerging first around age 14, the other behaviors tended to manifest from age 14 to 14 and a half. The average age of formal diagnosis was just over 15 years. Parent-child dyads showed good agreement on the presence and timing of all behaviors except for dieting, for which children reported onset about 6 months earlier or longer duration compared with parents.

Although older age at the time of interview was associated with a lower body mass index percentile and higher eating disorder score, neither age of onset nor duration of disordered eating was associated with severity when researchers controlled for current age.
 

Telltale signs for parents

“For teens starting at a healthy weight, significant and intentional weight loss of more than 5-10 pounds can be a cause for concern,” Dr. Ranzenhofer said. Missed periods, refusing meals, skipping meals, fighting or arguing about eating, and withdrawal from normal activities and relationships are other signs of disordered eating. For overweight or obese teens, rapid weight loss and weight loss above and beyond that recommended are also concerning.

As for compulsive exercise, she said, “Altered exercise behavior might look like exercise that interferes with other activities, for example, being late to school or not doing homework in order to exercise.” Other red flags would be physical activity that varies considerably from that of peers, for instance, going running after a 2-hour sports practice and an inflexible routine that precludes being able to skip a day.

“All adolescents, male and female, should be screened regardless of weight trends – underweight, overweight, obese, or normal weight – regarding their body image and thoughts of dieting,” said Margaret E. Thew, DNP, FNP-BC, of the Medical College of Wisconsin, and medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, commenting on the study but not involved in it. “Most adolescents make decisions to lose weight after trying to ‘eat healthy’ but may take an aggressive approach when they don’t see the weight loss they hope to see.”

According to Ms. Thew, the study findings support the benefit of giving medical caregivers and parents training on the red flags regarding eating disorders to foster early detection. “These include starting a new fad diet, eliminating foods, ‘healthy eating,’ over-exercising, skipping meals, or no longer eating foods they previously loved.”

She added that times of transition are key junctures to watch: The transition from grade school to middle school, middle to high school, and high school to college. “These tend to provoke eating disorder onset or relapse of eating disorder thoughts and behaviors after diagnosis,” Ms. Thew said. “It would benefit the patient to screen for concerns about disordered eating and provide resources, including consultation with a dietitian, as appropriate.”

This study was supported by grants from the National Institute of Mental Health and the Hilda and Preston Davis Foundation. Coauthor Joanna E. Steinglass, MD, disclosed receiving royalties from UpToDate. Ms. Thew disclosed no competing interests with regard to her comments.

Adolescents later diagnosed with anorexia nervosa (AN) likely embark on the trajectory to AN with undisclosed dieting for weight loss at about age 14, a study of teens and parents found.

In the interview-based study, both adolescents and their parents described a similar prediagnosis sequence of behavioral changes occurring over roughly 1 year to 18 months, but parents lagged some 6 months behind in noticing their children’s disordered eating.

The findings suggest that even teens of normal weight should be asked about their eating habits and monitored more closely for contact with those who endorse these potentially harmful eating behaviors, according to Lisa M. Ranzenhofer, PhD, assistant professor of clinical psychology in psychiatry at Columbia University Medical Center in New York, and colleagues. Their report is in the Journal of Adolescent Health.

“We know that adolescents often have eating disorder behaviors long before they’re diagnosed, so we developed this interview as a tool to figure out how long a maladaptive behavior has been present,” Dr. Ranzenhofer said in an interview. “Most studies that report illness duration do so based on diagnosis, so this interview provides a more fine-grained assessment of the duration of problematic behavior, which may help improve understanding of the impact of duration on outcome, and hopefully facilitate better methods for early detection.” Since healthy adolescents are often seen once per year at an annual pediatrician visit, she added, teens engaging in significant dieting might benefit from more frequent monitoring since this behavior can evolve into an eating disorder over a relatively short time frame.

AN is associated with significant medical and psychiatric comorbidity and has a mortality rate among the highest of any psychiatric illness, the authors noted.
 

The study

The study cohort consisted of 71 girls ages 12-18 years participating in research from 2017 to 2021 at the Eating Disorders Research Unit of New York (N.Y.) State Psychiatric Institute. Patients had either the restricting or binge-eating/purging subtype of AN as diagnosed by the Eating Disorder Assessment–5 questionnaire. A semistructured 15-minute interview with the girls and their parents explored food restriction, dieting, loss of control/binge eating, purging, excessive/compulsive exercise, weight history, and amenorrhea.

Both parents and children were asked whether and when the children had been underweight or overweight, and whether and when primary amenorrhea (no menarche) or secondary amenorrhea (periods missed for 3 months) became evident. Dieting was defined as “deliberately changing eating patterns in any way to influence your shape or weight,” and restriction as “deliberately cutting down on the amount of food that you are eating, in order to change your shape or weight.” Loss-of-control eating was defined as “feeling unable to stop eating or control what or how much you are eating.”

In other characterizations, purging was defined as making yourself vomit on purpose, taking diuretics, or feeling driven to engage in these behaviors. Questions on exercise explored whether children might feel anxious when they do not exercise or inclined to exercise even if sick or injured, with excessive exercise defined as “Feeling like you must exercise, might continue exercising, sometimes in secret, if parents or doctors have told you to stop.”

Other questions focused on use of diuretics or laxatives and other strategies to compensate for calories consumed.

Responses revealed that restriction, underweight, dieting, and excessive exercise were present in most of the sample, while purging, loss-of-control eating, and overweight were reported by fewer than a third. With dieting typically emerging first around age 14, the other behaviors tended to manifest from age 14 to 14 and a half. The average age of formal diagnosis was just over 15 years. Parent-child dyads showed good agreement on the presence and timing of all behaviors except for dieting, for which children reported onset about 6 months earlier or longer duration compared with parents.

Although older age at the time of interview was associated with a lower body mass index percentile and higher eating disorder score, neither age of onset nor duration of disordered eating was associated with severity when researchers controlled for current age.
 

Telltale signs for parents

“For teens starting at a healthy weight, significant and intentional weight loss of more than 5-10 pounds can be a cause for concern,” Dr. Ranzenhofer said. Missed periods, refusing meals, skipping meals, fighting or arguing about eating, and withdrawal from normal activities and relationships are other signs of disordered eating. For overweight or obese teens, rapid weight loss and weight loss above and beyond that recommended are also concerning.

As for compulsive exercise, she said, “Altered exercise behavior might look like exercise that interferes with other activities, for example, being late to school or not doing homework in order to exercise.” Other red flags would be physical activity that varies considerably from that of peers, for instance, going running after a 2-hour sports practice and an inflexible routine that precludes being able to skip a day.

“All adolescents, male and female, should be screened regardless of weight trends – underweight, overweight, obese, or normal weight – regarding their body image and thoughts of dieting,” said Margaret E. Thew, DNP, FNP-BC, of the Medical College of Wisconsin, and medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, commenting on the study but not involved in it. “Most adolescents make decisions to lose weight after trying to ‘eat healthy’ but may take an aggressive approach when they don’t see the weight loss they hope to see.”

According to Ms. Thew, the study findings support the benefit of giving medical caregivers and parents training on the red flags regarding eating disorders to foster early detection. “These include starting a new fad diet, eliminating foods, ‘healthy eating,’ over-exercising, skipping meals, or no longer eating foods they previously loved.”

She added that times of transition are key junctures to watch: The transition from grade school to middle school, middle to high school, and high school to college. “These tend to provoke eating disorder onset or relapse of eating disorder thoughts and behaviors after diagnosis,” Ms. Thew said. “It would benefit the patient to screen for concerns about disordered eating and provide resources, including consultation with a dietitian, as appropriate.”

This study was supported by grants from the National Institute of Mental Health and the Hilda and Preston Davis Foundation. Coauthor Joanna E. Steinglass, MD, disclosed receiving royalties from UpToDate. Ms. Thew disclosed no competing interests with regard to her comments.

Researchers have identified pathogenic gene variations in 12% of cases of sudden unexplained death in children.

The new study, which involved 116 cases of sudden infant death syndrome or sudden unexplained deaths in children (SUDC), suggests that available methods of chromosome testing could be used to help screen for the conditions, which together account for roughly 1,800 fatalities a year in the United States.

“Even though the Back to Sleep campaign has been incredibly effective and safe sleep practices have been promoted for years, sudden unexplained death in pediatrics remains a leading cause of death for infants and children,” said Catherine Brownstein, MPH, PhD, of Boston Children’s Hospital, lead author of the new study.

The findings suggest that chromosomal microarray analysis (CMA), the method that the researchers used in the study, “should be considered in the genetic evaluation of SUDC,” Dr. Brownstein said. The approach is the first-line method of identifying conditions such as autism spectrum disorder, developmental disabilities, multiple congenital anomalies, and epilepsy, she noted.

In the study, published in Advanced Genetics, Dr. Brownstein and her colleagues used CMA to test genes from 116 deceased infants and toddlers up to age 28 months whose deaths were classified as SIDS or SUDC (the latter term applies to children older than 1 year).

The average age at the time of death was 5.7 months; 59% of the patients were boys. In 14 of the children (12%), the CMA test identified genetic variations in the form of deletions or duplications that were pathogenic (five cases) or uncertain but “favoring pathogenicity” (nine cases). Such deletions or duplications are known as copy number variants (CNVs).

CNVs are present in most people and are not necessarily associated with disease, according to the researchers. However, certain CNVs have been linked to ASD, attention-deficit/hyperactivity disorder, schizophrenia, Crohn’s disease, epilepsy, and various congenital abnormalities.

Dr. Brownstein’s group also compared pathogenicity in the SUDC group with that of a cohort of children with ASD and with healthy control persons. They found no significant difference in pathogenicity between SUDC and autism with regard to duplications. However, children in the SUDC group were significantly more likely to have higher pathogenicity scores for deletions, compared with control persons. Some of the CMVs did not appear connected to SIDS or SUDC; two cases in boys were undiagnosed cases of Klinefelter syndrome.

The study findings were limited by several factors, including the small sample size and the inability to conduct CMA analyses on parents or obtain family history, the researchers note. Other limitations were that phenotypic data were available only from autopsy material and medical records and that the study focused on younger children, the researchers add. They did not speculate about the causes of deaths in the other cases they examined.

In the current study, the other 88% of cases could involve nongenetic factors or genetic factors that aren’t measured by next-generation sequencing or chromosomal microarray, Dr. Brownstein said. “Undiagnosed disease programs looking for genetic causes for diseases in living patients identify a cause in about 1 in 4 cases,” she said. “While 12% is a modest percentage, the CNVs identified provide additional information. In the future, the goal would be to capture the full range of potential genetic changes.”

Previous research by Dr. Brownstein’s group at Robert’s Program, a clinical service for SUDC families at Boston Children’s Hospital, found genetic variants that might cause sudden death in children.

“We began this study with the simple question of whether, as a population, these children carry more copy number variation, which they do,” she said. “However, none of the CMA findings we identified are currently associated with SUDC, so much more investigation is necessary to find out if they are coincidental, risk factors, or causative.”

Looking ahead, she said, “Ideally, we would want every family affected by sudden unexplained death in pediatrics to have genetic testing, including a chromosomal microarray. Once we have more families enrolled and tested, we will be able to understand the risk factors for SIDS and SUDC much better.”

Benjamin Solomon, MD, clinical director at the National Human Genome Research Institute, Bethesda, Md., said the new research “may bring answers for individual situations as well as enable research to understand the overall biological underpinnings and causes of disease.”

The findings “help reinforce the heterogeneous nature of SUDC and related conditions,” Dr. Solomon said. “The results also highlight some of the challenges regarding how to interpret the possible clinical effects of genetic changes. That is, every person has genetic changes, and interpreting how certain genetic changes may or may not contribute to a disease or health care outcome can be challenging.”

Research is needed to understand not only the overall causes of SUDC but also how the different causes interact, Dr. Solomon said. “Eventually, better understanding of the causes could lead to knowledge that would enable interventions that could help prevent or reduce these devastating outcomes.”

The study was supported by the Robert’s Program on Sudden Unexplained Death in Pediatrics, the Jude Zayac Foundation, multiple grants from the Eunice Kennedy Shriver National Institutes of Health/National Institute of Child Health and Human Development, the Boston Children’s Hospital Intellectual and Developmental Disabilities Research Center Molecular Genetics Core Facility (supported by the NIH/NICHD), and by the NIH National Institute of Mental Health. The researchers and Dr. Solomon have disclosed no relevant financial relationships.

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

Researchers have identified pathogenic gene variations in 12% of cases of sudden unexplained death in children.

The new study, which involved 116 cases of sudden infant death syndrome or sudden unexplained deaths in children (SUDC), suggests that available methods of chromosome testing could be used to help screen for the conditions, which together account for roughly 1,800 fatalities a year in the United States.

“Even though the Back to Sleep campaign has been incredibly effective and safe sleep practices have been promoted for years, sudden unexplained death in pediatrics remains a leading cause of death for infants and children,” said Catherine Brownstein, MPH, PhD, of Boston Children’s Hospital, lead author of the new study.

The findings suggest that chromosomal microarray analysis (CMA), the method that the researchers used in the study, “should be considered in the genetic evaluation of SUDC,” Dr. Brownstein said. The approach is the first-line method of identifying conditions such as autism spectrum disorder, developmental disabilities, multiple congenital anomalies, and epilepsy, she noted.

In the study, published in Advanced Genetics, Dr. Brownstein and her colleagues used CMA to test genes from 116 deceased infants and toddlers up to age 28 months whose deaths were classified as SIDS or SUDC (the latter term applies to children older than 1 year).

The average age at the time of death was 5.7 months; 59% of the patients were boys. In 14 of the children (12%), the CMA test identified genetic variations in the form of deletions or duplications that were pathogenic (five cases) or uncertain but “favoring pathogenicity” (nine cases). Such deletions or duplications are known as copy number variants (CNVs).

CNVs are present in most people and are not necessarily associated with disease, according to the researchers. However, certain CNVs have been linked to ASD, attention-deficit/hyperactivity disorder, schizophrenia, Crohn’s disease, epilepsy, and various congenital abnormalities.

Dr. Brownstein’s group also compared pathogenicity in the SUDC group with that of a cohort of children with ASD and with healthy control persons. They found no significant difference in pathogenicity between SUDC and autism with regard to duplications. However, children in the SUDC group were significantly more likely to have higher pathogenicity scores for deletions, compared with control persons. Some of the CMVs did not appear connected to SIDS or SUDC; two cases in boys were undiagnosed cases of Klinefelter syndrome.

The study findings were limited by several factors, including the small sample size and the inability to conduct CMA analyses on parents or obtain family history, the researchers note. Other limitations were that phenotypic data were available only from autopsy material and medical records and that the study focused on younger children, the researchers add. They did not speculate about the causes of deaths in the other cases they examined.

In the current study, the other 88% of cases could involve nongenetic factors or genetic factors that aren’t measured by next-generation sequencing or chromosomal microarray, Dr. Brownstein said. “Undiagnosed disease programs looking for genetic causes for diseases in living patients identify a cause in about 1 in 4 cases,” she said. “While 12% is a modest percentage, the CNVs identified provide additional information. In the future, the goal would be to capture the full range of potential genetic changes.”

Previous research by Dr. Brownstein’s group at Robert’s Program, a clinical service for SUDC families at Boston Children’s Hospital, found genetic variants that might cause sudden death in children.

“We began this study with the simple question of whether, as a population, these children carry more copy number variation, which they do,” she said. “However, none of the CMA findings we identified are currently associated with SUDC, so much more investigation is necessary to find out if they are coincidental, risk factors, or causative.”

Looking ahead, she said, “Ideally, we would want every family affected by sudden unexplained death in pediatrics to have genetic testing, including a chromosomal microarray. Once we have more families enrolled and tested, we will be able to understand the risk factors for SIDS and SUDC much better.”

Benjamin Solomon, MD, clinical director at the National Human Genome Research Institute, Bethesda, Md., said the new research “may bring answers for individual situations as well as enable research to understand the overall biological underpinnings and causes of disease.”

The findings “help reinforce the heterogeneous nature of SUDC and related conditions,” Dr. Solomon said. “The results also highlight some of the challenges regarding how to interpret the possible clinical effects of genetic changes. That is, every person has genetic changes, and interpreting how certain genetic changes may or may not contribute to a disease or health care outcome can be challenging.”

Research is needed to understand not only the overall causes of SUDC but also how the different causes interact, Dr. Solomon said. “Eventually, better understanding of the causes could lead to knowledge that would enable interventions that could help prevent or reduce these devastating outcomes.”

The study was supported by the Robert’s Program on Sudden Unexplained Death in Pediatrics, the Jude Zayac Foundation, multiple grants from the Eunice Kennedy Shriver National Institutes of Health/National Institute of Child Health and Human Development, the Boston Children’s Hospital Intellectual and Developmental Disabilities Research Center Molecular Genetics Core Facility (supported by the NIH/NICHD), and by the NIH National Institute of Mental Health. The researchers and Dr. Solomon have disclosed no relevant financial relationships.

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

Researchers have identified pathogenic gene variations in 12% of cases of sudden unexplained death in children.

The new study, which involved 116 cases of sudden infant death syndrome or sudden unexplained deaths in children (SUDC), suggests that available methods of chromosome testing could be used to help screen for the conditions, which together account for roughly 1,800 fatalities a year in the United States.

“Even though the Back to Sleep campaign has been incredibly effective and safe sleep practices have been promoted for years, sudden unexplained death in pediatrics remains a leading cause of death for infants and children,” said Catherine Brownstein, MPH, PhD, of Boston Children’s Hospital, lead author of the new study.

The findings suggest that chromosomal microarray analysis (CMA), the method that the researchers used in the study, “should be considered in the genetic evaluation of SUDC,” Dr. Brownstein said. The approach is the first-line method of identifying conditions such as autism spectrum disorder, developmental disabilities, multiple congenital anomalies, and epilepsy, she noted.

In the study, published in Advanced Genetics, Dr. Brownstein and her colleagues used CMA to test genes from 116 deceased infants and toddlers up to age 28 months whose deaths were classified as SIDS or SUDC (the latter term applies to children older than 1 year).

The average age at the time of death was 5.7 months; 59% of the patients were boys. In 14 of the children (12%), the CMA test identified genetic variations in the form of deletions or duplications that were pathogenic (five cases) or uncertain but “favoring pathogenicity” (nine cases). Such deletions or duplications are known as copy number variants (CNVs).

CNVs are present in most people and are not necessarily associated with disease, according to the researchers. However, certain CNVs have been linked to ASD, attention-deficit/hyperactivity disorder, schizophrenia, Crohn’s disease, epilepsy, and various congenital abnormalities.

Dr. Brownstein’s group also compared pathogenicity in the SUDC group with that of a cohort of children with ASD and with healthy control persons. They found no significant difference in pathogenicity between SUDC and autism with regard to duplications. However, children in the SUDC group were significantly more likely to have higher pathogenicity scores for deletions, compared with control persons. Some of the CMVs did not appear connected to SIDS or SUDC; two cases in boys were undiagnosed cases of Klinefelter syndrome.

The study findings were limited by several factors, including the small sample size and the inability to conduct CMA analyses on parents or obtain family history, the researchers note. Other limitations were that phenotypic data were available only from autopsy material and medical records and that the study focused on younger children, the researchers add. They did not speculate about the causes of deaths in the other cases they examined.

In the current study, the other 88% of cases could involve nongenetic factors or genetic factors that aren’t measured by next-generation sequencing or chromosomal microarray, Dr. Brownstein said. “Undiagnosed disease programs looking for genetic causes for diseases in living patients identify a cause in about 1 in 4 cases,” she said. “While 12% is a modest percentage, the CNVs identified provide additional information. In the future, the goal would be to capture the full range of potential genetic changes.”

Previous research by Dr. Brownstein’s group at Robert’s Program, a clinical service for SUDC families at Boston Children’s Hospital, found genetic variants that might cause sudden death in children.

“We began this study with the simple question of whether, as a population, these children carry more copy number variation, which they do,” she said. “However, none of the CMA findings we identified are currently associated with SUDC, so much more investigation is necessary to find out if they are coincidental, risk factors, or causative.”

Looking ahead, she said, “Ideally, we would want every family affected by sudden unexplained death in pediatrics to have genetic testing, including a chromosomal microarray. Once we have more families enrolled and tested, we will be able to understand the risk factors for SIDS and SUDC much better.”

Benjamin Solomon, MD, clinical director at the National Human Genome Research Institute, Bethesda, Md., said the new research “may bring answers for individual situations as well as enable research to understand the overall biological underpinnings and causes of disease.”

The findings “help reinforce the heterogeneous nature of SUDC and related conditions,” Dr. Solomon said. “The results also highlight some of the challenges regarding how to interpret the possible clinical effects of genetic changes. That is, every person has genetic changes, and interpreting how certain genetic changes may or may not contribute to a disease or health care outcome can be challenging.”

Research is needed to understand not only the overall causes of SUDC but also how the different causes interact, Dr. Solomon said. “Eventually, better understanding of the causes could lead to knowledge that would enable interventions that could help prevent or reduce these devastating outcomes.”

The study was supported by the Robert’s Program on Sudden Unexplained Death in Pediatrics, the Jude Zayac Foundation, multiple grants from the Eunice Kennedy Shriver National Institutes of Health/National Institute of Child Health and Human Development, the Boston Children’s Hospital Intellectual and Developmental Disabilities Research Center Molecular Genetics Core Facility (supported by the NIH/NICHD), and by the NIH National Institute of Mental Health. The researchers and Dr. Solomon have disclosed no relevant financial relationships.

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

Amanda wanted to warn someone. In June 2021, her daughter – the one she and her husband had tried for 3 years to conceive – had died after only 28 hours. With an underdeveloped nose, she had battled for every breath.

Nobody knew why. Later, an autopsy report revealed their daughter had an extra 13th chromosome. The condition is nearly always fatal.

“But didn’t we test for that?” Amanda recalled asking herself. “That was kind of where the light bulb clicked.”

Through her doctor, Amanda had gotten a popular prenatal screening from a lab company. It had come back “negative.”

For three major conditions, including the one her baby had, the report gave the impression of near certainty. The likelihood that she would be born without them was “greater than 99%.”

As she recovered from a cesarean section, Amanda found herself facing a long maternity leave without a child. She shut the door to the empty nursery and began spending what seemed like endless hours of that hazy summer learning about the test.

It’s a simple blood draw designed to check for an array of genetic anomalies. But Amanda, a science researcher, read academic articles showing there was a higher risk of inaccurate results than she had realized. (She asked to be identified by only her first name to protect her privacy.)

On Reddit, she found other women reporting problems with the tests, too. She thought Labcorp, the company that made her test, would want to know about the screening that failed her. Maybe by alerting them, she could help other families. Maybe it would help her understand what happened.

“I was trying to gain answers,” said Amanda, now 32. She tried calling Labcorp’s customer service line, but she said she was passed along from one person to another. “It was just a circle,” she remembered.

She phoned Labcorp a second time. The call ended when an employee hung up on her.

Amanda was baffled. Why didn’t the company seem interested in her experience? Why, she wondered, wouldn’t it want to collect this data? Why wasn’t there someone who could answer her questions about how often this happens, and why?

If she had taken any number of other common commercial tests – including certain tests for COVID-19 or, say, pregnancy – the company would have been required to inform the U.S. Food and Drug Administration about reports of so-called adverse events.

But the test Amanda had falls into a regulatory void. No federal agency checks to make sure these prenatal screenings work the way they claim before they’re sold to health care providers. The FDA doesn’t ensure that marketing claims are backed up by evidence before screenings reach patients. And companies aren’t required to publicly report instances of when the tests get it wrong – sometimes catastrophically.

The broader lab testing industry and its lobbyists have successfully fought for years to keep it this way, cowing regulators into staying on the sidelines.

Worried about a growing variety of tests escaping scrutiny, the FDA was on the cusp of stepping in 6 years ago. But then it backed down.

Peter Lurie, then a top agency official, was at the meetings where the FDA tabled its plans. Not pushing harder, he told ProPublica, “remains one of my greatest regrets.”

The risk of false positives from prenatal screenings, in particular, has been known for years.

In 2014, the New England Center for Investigative Reporting detailed how some companies gave a misleading impression of the precision of the prenatal screenings. Women often didn’t understand they needed diagnostic testing to confirm the results. Some had gotten abortions based on false positive results, the story said. Earlier this year, the New York Times reported how companies sell optional extra screenings that are “usually wrong” when they predict a disorder.

Despite these stories and calls for reform by patient advocates, the government has done little to improve oversight of prenatal screenings. ProPublica set out to examine the forces that led to this inertia and left patients like Amanda feeling misled. Interviews with more than three dozen women revealed ongoing confusion about the screenings – and anger when their reliability proved to be overblown.

“This is a Wild West scenario where everybody is on their own,” said Lawrence Gostin, a Georgetown University, Washington, law professor specializing in bioethics.

The stakes for families are increasing. Upward of half of all pregnant people now receive one of these prenatal screenings. And with many states banning abortions or limiting them to early in pregnancies, the need for fast, accurate information has become more urgent.

The FDA itself acknowledges the problem. In correspondence with ProPublica, a spokesperson cited an “outdated policy” regarding the lack of vetting of many lab tests that the agency has “spent the better part of the last 2 decades trying to address.”

The screening industry, meanwhile, continues to expand, proving lucrative for those who lead it. The chief executive of Natera, which claims about 40% of the market share of prenatal screenings, received a $23 million compensation package last year, the highest of any executive at a publicly traded lab company.

Testing companies told ProPublica that, even without the FDA, there is significant oversight. Labs must abide by state regulations, and another federal agency, the Centers for Medicare and Medicaid Services, is charged with monitoring quality standards. It does not, however, check whether the tests the labs perform are clinically valid.

Companies also said the screenings offer important guidance to expectant families. Echoing others in the field, Labcorp said in a statement that the screenings, when used properly, “provide vital information about the presence of increased risk, but do not provide a definitive diagnosis.” (It declined to discuss the specifics of Amanda’s experience.)

Natera pointed out that its materials tell patients that “this test does not make a final diagnosis.” It reports results as “high-risk” or “low-risk,” not positive or negative.

Companies have stressed that, ultimately, it’s the responsibility of health care providers, who order the tests, to inform patients about the limits of screenings.

For all that, the statistical nuances of the test aren’t easy to parse for patients and even some doctors and nurses. For example, the test for trisomy 13, which doomed Amanda’s baby, is actually less likely to correctly predict the condition than other tests in the standard bundle of screenings offered to every patient.

When ProPublica asked readers to share their experiences with noninvasive prenatal screening tests, often referred to as NIPTs or NIPS, more than a thousand responded. Many said the tests had given them peace of mind. Some said they had provided an early warning about problems.

But others had more questions than answers. None more so than Amanda.

“What are these tests?” she wondered. “And how did mine end up in the margin of error?”
 

‘They started using it on humans, and then they went back and said: “Was our test accurate?” ’

Scientists have long tried to find ways to help parents and doctors understand what’s happening inside the womb. Amniocentesis was first used to reveal genetic anomalies in the late 1960s. But it didn’t become more popular until it began to be paired with ultrasound to precisely guide the procedure.

In the 1980s, doctors started using chorionic villus sampling, or CVS, an analysis of placental tissue that offers a diagnosis earlier in pregnancy. But, like amniocentesis, it is an invasive test that involves some risk to the fetus, though experts say it’s exceptionally low.

A breakthrough came in the late 1990s, when a scientist recognized that free-floating placental DNA could be detected in the mother’s blood. This meant that the fetus’s chromosomes could be examined by collecting a blood sample as soon as 9 weeks into pregnancy. This also provides an early opportunity to learn the likely fetal sex – a particularly popular feature.

Champions of the new science celebrated the arrival of a simple technique for patients that was particularly precise, at least for some conditions. Many favored it over other noninvasive options. But the industry that developed around NIPT has been marred by controversy from the beginning.

Dr. Ronald Wapner, director of reproductive genetics at Columbia University, described that time as “very chaotic.”

The tests had not been appropriately evaluated in clinical practice, said Dr. Wapner, whose research has sometimes been funded by testing companies. Because of this, he said, the industry “had very incomplete data on how well it worked.”

That didn’t stop the excitement. The chief executive of Sequenom, a biotechnology company that planned to release the first NIPT for Down syndrome, championed the company as the “Google of Molecular Diagnostics.” Its stock price soared.

Then, about 2 months before an expected launch in 2009, Sequenom killed the plan. The company’s research director, it turned out, had manipulated testing data and made misleading claims about how well the screening worked.

The U.S. Securities and Exchange Commission and Federal Bureau of Investigation opened investigations. Top executives were fired, and the research director pleaded guilty to conspiracy to commit securities fraud. Sequenom still managed to commercialize the test in 2011. (Labcorp, which later acquired Sequenom, said it uses a different kind of test.)

Other companies soon debuted their own tests. Still, there was little data on their clinical performance, researchers said.

As Megan Allyse, a bioethicist at the Mayo Clinic, put it, the companies “launched the test, they started using it on humans, and then they went back and said, ‘Was our test accurate?’ ” She also questioned the lack of attention to the ethics of how tests are presented to patients.

Despite missteps by the industry, the FDA didn’t scrutinize the screenings because they were considered lab-developed tests, which means they are created by the same laboratory that conducts them.

In 1976, Congress revamped oversight over medical devices. Since then, the FDA has effectively exempted such “home-brew” tests from key regulatory requirements. The idea was that when, say, a hospital lab wanted to create a simple test for its own patients, it was spared the time, money, and hassle of getting approval from Washington bureaucrats.

Today, lab-developed tests are vastly more numerous and complex. Because they aren’t registered with the federal government, nobody knows how many exist.

The distinction between tests the FDA actively regulates and those they don’t can seem nonsensical. It isn’t based on the complexity of the tests, or how people use them. It’s simply a matter of where the test is made.

The prenatal genetic screening industry took off almost immediately, powered by an army of aggressive sales representatives.

“At the very beginning, obstetricians in practice were being just completely inundated with visits from the sales reps,” said Dr. John Williams, director of reproductive health at Cedars-Sinai Medical Center in Los Angeles. The push left many ob.gyns. and patients thinking the screenings were accurate enough to substitute for diagnostic tests, such as amniocentesis or CVS.

In some cases, sales tactics escalated into lawbreaking.

Former Sequenom executives who exited during the fraud scandal created a new company that became Progenity, which also offered prenatal screening. Shortly after the company went public in 2020, it finalized a $49 million settlement with federal and state governments, where it admitted to falsifying insurance claims and giving kickbacks to physicians and their staff. According to a legal filing, one sales rep spent $65,658 on meals and alcohol for physicians in 1 year.

Now called Biora Therapeutics, the company said in a statement it no longer does any laboratory testing, including prenatal screenings.

Industry revenue continues to grow, but some testing companies are still fighting to make a profit, and competition to survive is fierce. “There’s a multibillion-dollar market, and they all want a piece of it,” said a former Progenity sales rep who quit in disgust after 5 months in 2016.

The rep, who requested anonymity because she continues to work in the field, said she still sees competitors from NIPT companies visiting medical practices “every week, buying breakfast or dinner, or taking them out for happy hour.”

Over time, companies pointed to new peer-reviewed studies, research the industry itself funded, to earn the confidence of doctors and other stakeholders. They showed that two tests – for Down syndrome and trisomy 18 – often performed better than other screening methods.

This research was valid, said Dr. Mary Norton, a perinatologist and clinical geneticist at the University of California, San Francisco, Medical Center’s prenatal diagnostic center. Considered a leading researcher in the field, she was an author of many of these key industry-funded studies.

But, she said, when research findings were presented publicly, the companies sometimes downplayed “inconvenient truths,” such as the exclusion of inconclusive results from accuracy estimates. Crucial caveats were also glossed over by some companies when they translated research into promotional copy aimed at health care providers and patients. Those materials didn’t always mention the many factors that can limit the performance of the screenings, including high body weight, the rarity of the condition tested, and younger maternal age.

Testing companies said they try to help patients understand the screenings through online resources and other materials. Some offer genetic counseling services.

The younger a person is, the lower the test’s positive predictive value – that is, the probability that a positive screening result will turn out to be correct – will be for some conditions. For instance, because Down syndrome is less prevalent in younger people’s pregnancies, a positive screening test is more likely to be a false positive for them.

Kristina was 30 years old in 2016, when her Progenity test came back positive for Down syndrome. She and her husband, who asked not to be fully named to protect their privacy, said they didn’t plan to carry a pregnancy with this condition to term.

But waiting to get an amniocentesis, and then waiting for the results, took 5 agonizing weeks, she said. It showed her son did not have Down syndrome.

Kristina, who lives in Texas, is still troubled by what she describes as a traumatic experience.

“I researched both late-term abortion providers and cemeteries,” she said. They even picked out a burial place, near their house.

She bought a blue baby blanket she intended to bury the baby’s tiny body in. She still has it. Her son, now 5, sleeps with it every night.
 

‘I can’t believe I didn’t say more’

As lab-developed tests became a bigger business, moving well past their home-brew origins, regulators looked for a way to assert oversight. In 2014, after years of study and debate, the time seemed right.

The FDA released plans proposing to regulate the tests, prioritizing those used to make major medical decisions. The agency has pointed to NIPTs as 1 of 20 concerning tests.

But, over the next 2 years, a coalition of power players urged the FDA to back off. Professional associations issued statements and hosted webinars devoted to the issue. Some created polished websites featuring sample letters to send to Washington.

Academic medical centers and pathology departments joined the fight, too. Scientists from 23 of them put it bluntly in a letter to the Office of Management and Budget: “FDA regulation of LDTs would be contrary to the public health,” it said, using a common acronym for the tests.

“Critical testing would be unavailable in the ‘lag time’ between development of new tests and FDA authorizing them,” the authors of the letter wrote, “and subsequent improvements on existing tests would slow significantly under the rigid, inflexible, and duplicative FDA regulatory scheme.”

This could delay essential care for patients. What’s more, opponents argued, existing lab reviews by the Centers for Medicare and Medicaid Services are sufficiently rigorous. Some have suggested modernizing the CMS review process to improve oversight.

An FDA spokesperson told ProPublica that the agency encountered “continued, negative feedback,” including a 25-page paper written by two legal heavyweights hired by the American Clinical Laboratory Association: Paul Clement, President George W. Bush’s former solicitor general, and Laurence Tribe, law professor at Harvard University.

Mr. Clement has reportedly commanded rates of $1,350 per hour. He and Mr. Tribe did not respond to ProPublica’s queries about their work.

Their brief argued that the FDA “lacked legal authority” to regulate lab-developed tests because they are properly seen as the practice of medicine: a service, rather than a product.

However, as lawyers representing the American Association of Bioanalysts countered, the FDA would vet tests before they reach the market, not control how doctors use them. The government proposal, they wrote, is “similar to imposing requirements to screen blood or label drugs.”

After the election of President Donald Trump, but before he took office, a handful of FDA officials discussed their battered proposal. It had represented a breakthrough in the decades of excruciating back-and-forth with industry. But now, with an incoming administration bent on deregulation, their efforts seemed futile.

The regulators feared anything they enacted would be undone by Congress – and, under the Congressional Review Act, they might not be able to reissue anything “substantially similar” in the future. So the FDA published a white paper instead, summarizing the issue “for further public discussion.”

After the meeting where officials made this call, Mr. Lurie, then the FDA’s associate commissioner, recalled a colleague approaching him: “I can’t believe you didn’t say more.”

“And I was like, ‘Yeah, actually, I can’t believe I didn’t say more either,’ ” Mr. Lurie later told ProPublica. (After leaving the agency, Mr. Lurie went on to lead the Center for Science in the Public Interest, a consumer advocacy nonprofit, which has pushed the FDA to finally assert oversight over lab-developed tests.)

Nancy Stade, an attorney and senior policy official who left the FDA in 2015, said the agency often moves slowly as it seeks to get buy-in from industry and professional groups. In her work on regulatory policy, she saw it happen with lab-developed tests.

The agency is “always testing the waters,” she said, “and always coming out with something a little bit softer.”

In 2020, the influential American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, representing doctors who handle pregnancies, gave the screening industry another huge boost.

In a bulletin updating their advice on the tests, the two groups described growing research on the performance of some of the standard tests and said people have the right to information about their pregnancies, so the tests should be offered to all patients. Previously, they recommended this only for those facing higher risk of genetic anomalies.

The bulletin said the coauthors had disclosed no conflicts of interest. But two of the four coauthors, including Mary Norton, had disclosed in prior publications that test-makers had provided funding for their research. A company had provided a third coauthor with laboratory services needed to run tests, according to that researcher, a connection she also disclosed in past papers.

ACOG, in a statement to ProPublica, said the organization “identified no conflicts because research funding is provided to academic institutions with institutional review boards, not to individual investigators.” Two of the three researchers responded to questions from ProPublica and said they maintained independence over their work.

One test-maker, Illumina, celebrated the ACOG guidance in a tweet, saying it “recognizes the superior performance of #NIPT and the benefit it provides expectant families.” Natera’s share prices doubled in 5 months. UnitedHealthcare, the nation’s largest private insurer and long a target of industry lobbying, told ProPublica it changed its stance to cover screenings for all patients, regardless of risk, because of the recommendation.

In a recent shareholder report, Natera stated that prenatal genetic and carrier screenings “represent the significant majority of our revenues,” which totaled $625.5 million in 2021. The company expects more growth to come.

“The NIPT market is still very underpenetrated, compared to the 4 to 5 million pregnancies in the U.S.,” Natera’s chief executive said on a 2021 earnings call, “so there’s a long way to go.”

But even Dr. Norton, who coauthored the ACOG recommendation and favors NIPTs for patients 40 and over, has concerns about screenings becoming widespread among those who are younger. In most cases, she prefers other screening methods that catch the nongenetic problems younger moms are more likely to face. Negative results from an NIPT, she said, can be “falsely reassuring.”

In the years after the FDA set aside its regulatory proposal, the agency has assisted members of Congress on a proposed legislative solution. That effort, dubbed the VALID Act, aims to end any debate over the agency’s authority over lab-developed tests. An FDA press officer said the legislation would ensure the prenatal screening tests and others are “accurate and reliable.”

But, as in the past, intense lobbying followed the proposal. The VALID Act was a rider to a funding reauthorization bill, but in September the House and Senate agreed to remove it. Advocates now hope to attach it to proposed end-of-year legislation.

Meanwhile, earlier this year, 4 months after the New York Times story on the usefulness of some screenings, the FDA took a step toward more public awareness about prenatal genetic screening. It issued its first safety communication on them, noting the potential for false results.

It cautioned patients about making “critical health care decisions based on results from these screening tests alone.”

Cara Tenenbaum, a former FDA policy advisor, was pleased to see the statement. Still, she said, it was long overdue.

“This has been known – known, or should have been known – for 10 years,” she said.
 

‘It had me so messed up’

With the demise of Roe v. Wade, restrictive and ever-changing abortion laws can pressure people to act quickly with limited information, heightening the stakes of prenatal screening.

Julia, a mom from Mississippi’s Gulf Coast, knows what it’s like to face harrowing consequences while navigating state-imposed time limits – and doing so with little guidance. Last fall, she was pregnant with her fourth child when, she said, a nurse practitioner suggested prenatal genetic screening.

At 33, Julia had no risk factors. Her previous pregnancies hadn’t been screened with an NIPT. But with three sons and 18 nephews, she and her husband were curious about the baby’s sex. And the screening seemed like it had no downside.

Julia figured it would only be offered if it was reliable, so her nurse practitioner ordered her both the basic bundle of screenings and the extra tests. (The medical practice didn’t respond to interview requests. Julia is a family nickname that’s used here to protect her privacy.)

The screenings showed the baby was a girl – but the extra tests also detected trisomy 16, a condition caused by an extra chromosome that is so rare, the nurse didn’t know what it was, Julia recalled.

The nurse borrowed Julia’s phone, using it to search online and read aloud what she found. Julia was stunned to hear trisomy 16 was incompatible with life.

“I was utterly devastated,” she said. “I made it out of my doctor’s office but completely broke down in the car.”

But ACOG does not recommend the trisomy 16 screening, saying “its accuracy with regard to detection and the false-positive rate is not established.” Julia wasn’t informed of this, she said, and she’s not sure if her health care providers knew it either.

The lab report recommended diagnostic testing to confirm the results, but time was short. She had her amniocentesis at 17 weeks. It could take up to 4 more weeks to receive results.

That would be too late for a legal abortion in Mississippi. So she made an appointment for one in Florida, where the cutoff was 24 weeks. (It’s now 15 weeks in Florida, while Mississippi went from 15 weeks for legal procedures to a ban on nearly all abortions.)

The wait was excruciating. Julia was driving twice a week to New Orleans for specialized care. With work and child care, it was too hard. She quit the teaching job she loved.

One winter night, she felt the fetus move for the first time – ordinarily a milestone, but now, facing a fatal prognosis, she didn’t want to get attached. “It had me so messed up,” she said.

On the way to the amniocentesis, Julia and her husband chose a name. Drawing from a language conjured by J.R.R. Tolkien in the fantasy novels they love, it means “hope.”

More than halfway through her pregnancy, the amnio results arrived. The prenatal screening had given a false positive. The baby would be fine. In May, Julia gave birth to a healthy daughter.

Julia and her husband are upset about the needless anguish brought on by the screening. “They like to have it both ways,” said Julia’s husband. “They say they are 99% accurate, but when there’s a false positive, they say, ‘Well, we’re not diagnostic.’ ”

Believing the prenatal screening was likely accurate, they had seriously considered canceling the amniocentesis, saving their limited funds for an abortion in Florida, hundreds of miles away.

Their dilemma points to a longtime concern: ending pregnancies based on false positives. The FDA cited it as a risk as far back as 2015. Now, those with positive results are facing an even tighter time crunch. They must consider whether waiting for a definitive test, and possibly traveling to another state for an abortion later in pregnancy, is worth it.

In their promotional material, some companies not only sidestep the variability of the standard tests, they fail to distinguish them from the least reliable ones – those for exceptionally rare conditions. They tout the extra screenings as “premium,” “plus,” or “advanced” options.

“Going to greater lengths for the answers that matter most,” says a brochure aimed at health care providers from test-maker Illumina. Elsewhere it states that the “expanded” panel of tests provides “confident results” and “the additional insights you need.”

But the companies themselves know the accuracy of some of their tests has yet to be established in the research. Natera acknowledged in a recent shareholder report that many insurers won’t pay for screenings for missing chromosomal fragments, known as microdeletions, in part because there isn’t enough published data behind them.

The company, responding to ProPublica, stressed the quality of the data over the quantity, saying the research so far has been favorable. “Natera’s microdeletion testing was thoroughly validated with results published in peer-reviewed publications,” it said in a statement.

Natera pointed to a recent study that looked at DiGeorge syndrome, one of several chromosomal anomalies it checks for with its microdeletion screenings. Researchers found the positive predictive value (PPV) of the test to be 52.6%, meaning that nearly half of positive results are false positives. (For many patients, PPVs for more common conditions can exceed 90%.)

Natera said the performance of the diGeorge syndrome test “is excellent and not considered a low PPV,” because of the condition being extremely rare.

Companies also play up the danger of diagnostic tests like amnio. They “can cause miscarriages,” warns the marketing from Labcorp, which made Amanda’s screening, while its test “does not cause miscarriages.” But medical experts emphasize that diagnostic tests, such as amniocentesis, are more accurate and, in fact, carry little risk to the pregnancy.

Labcorp, in a statement, said the company “acknowledges the well-documented risk associated with amniocentesis and CVS in our literature. It is the patient’s prerogative to decide which risks they are willing or unwilling to take.”

Marketing claims also sometimes skate over the nuances in the guidance from the leading professional societies. On a webpage targeting health care providers, for example, a Labcorp chart said groups such as ACOG “endorse and/or recognize” prenatal screenings as an option for all pregnancies. But the chart listed screenings ACOG does not recommend, including trisomy 16.

When asked about it, Labcorp said in a statement that ACOG “endorses NIPS for all pregnancies.” In fact, the guidance is not so sweeping. It says only that the basic bundle of tests should be offered to all, alongside other screening options. It explicitly advises providers to not offer patients the extra tests.

Soon after ProPublica’s query, the Labcorp webpage was updated to remove any mention of the professional societies.

Patients say they often don’t know where to turn for informed and unbiased information. That’s why the r/NIPT Reddit page became such a robust community. Facing difficult news, Julia turned to it for counsel from other prospective parents. Kristina in Texas found the same community. Amanda, too.
 

‘The margin of error is a human life’

On a warm and cloudy day this past June, on what would have been their daughter’s first birthday, Amanda and her husband visited her grave. They brought a unicorn balloon and vanilla cake, which they ate nearby on the grass. Her husband read a poem.

To them, their baby had been perfect. She had fingers and toes. A thatch of dark hair. While in intensive care, peering up at her parents, she grabbed for her mother’s hand.

Had her condition been known, they would’ve spared her futile medical interventions, as doctors tried to save her life. Their family priest would have been able to baptize her. As it was, they never got to hold their child while she was alive.

These days, when Amanda and her husband say grace before dinner, they give thanks for the 28 hours of their daughter’s life.

They’re also thinking about making comfort boxes the hospital could give to other parents who lose a child. It might include books on grief. Softer tissues. Something that says, as Amanda puts it, “This is to help you get through.”

Amid their grief, they had a prayer answered: Amanda is pregnant again.

It’s frightening to go through this again. She barely sleeps the night before visiting the doctor. It feels like she never stopped being pregnant. It will feel that way, she said, until she brings a baby home – one who lives past the first 2 nights.

Amanda planned to get another genetic screening test. At first she couldn’t bear it, wasn’t sure she could trust it. “The margin of error is a human life,” Amanda said.

The 10-week appointment passed. Then the 12-week appointment. After her 13th week, she took the plunge. The test she was given was from Labcorp.

Around this time, more than a year after Amanda had desperately tried to alert the company about what had happened to her and her first baby, she finally heard back. Labcorp’s vice president of genetic counseling and services reached out – after ProPublica contacted the company and shared Amanda’s story.

The executive would only speak to Amanda without a reporter present.

Amanda said that during the call, the executive told her that prenatal genetic tests are evolving, and doctors should be clear about what the screenings can and cannot do. By the end of the conversation, the executive offered Amanda her cell number.

Amanda said she appreciated the call. “I feel better. I feel like I got something.”

The same day, her screening results came back. They were negative.
 

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

Amanda wanted to warn someone. In June 2021, her daughter – the one she and her husband had tried for 3 years to conceive – had died after only 28 hours. With an underdeveloped nose, she had battled for every breath.

Nobody knew why. Later, an autopsy report revealed their daughter had an extra 13th chromosome. The condition is nearly always fatal.

“But didn’t we test for that?” Amanda recalled asking herself. “That was kind of where the light bulb clicked.”

Through her doctor, Amanda had gotten a popular prenatal screening from a lab company. It had come back “negative.”

For three major conditions, including the one her baby had, the report gave the impression of near certainty. The likelihood that she would be born without them was “greater than 99%.”

As she recovered from a cesarean section, Amanda found herself facing a long maternity leave without a child. She shut the door to the empty nursery and began spending what seemed like endless hours of that hazy summer learning about the test.

It’s a simple blood draw designed to check for an array of genetic anomalies. But Amanda, a science researcher, read academic articles showing there was a higher risk of inaccurate results than she had realized. (She asked to be identified by only her first name to protect her privacy.)

On Reddit, she found other women reporting problems with the tests, too. She thought Labcorp, the company that made her test, would want to know about the screening that failed her. Maybe by alerting them, she could help other families. Maybe it would help her understand what happened.

“I was trying to gain answers,” said Amanda, now 32. She tried calling Labcorp’s customer service line, but she said she was passed along from one person to another. “It was just a circle,” she remembered.

She phoned Labcorp a second time. The call ended when an employee hung up on her.

Amanda was baffled. Why didn’t the company seem interested in her experience? Why, she wondered, wouldn’t it want to collect this data? Why wasn’t there someone who could answer her questions about how often this happens, and why?

If she had taken any number of other common commercial tests – including certain tests for COVID-19 or, say, pregnancy – the company would have been required to inform the U.S. Food and Drug Administration about reports of so-called adverse events.

But the test Amanda had falls into a regulatory void. No federal agency checks to make sure these prenatal screenings work the way they claim before they’re sold to health care providers. The FDA doesn’t ensure that marketing claims are backed up by evidence before screenings reach patients. And companies aren’t required to publicly report instances of when the tests get it wrong – sometimes catastrophically.

The broader lab testing industry and its lobbyists have successfully fought for years to keep it this way, cowing regulators into staying on the sidelines.

Worried about a growing variety of tests escaping scrutiny, the FDA was on the cusp of stepping in 6 years ago. But then it backed down.

Peter Lurie, then a top agency official, was at the meetings where the FDA tabled its plans. Not pushing harder, he told ProPublica, “remains one of my greatest regrets.”

The risk of false positives from prenatal screenings, in particular, has been known for years.

In 2014, the New England Center for Investigative Reporting detailed how some companies gave a misleading impression of the precision of the prenatal screenings. Women often didn’t understand they needed diagnostic testing to confirm the results. Some had gotten abortions based on false positive results, the story said. Earlier this year, the New York Times reported how companies sell optional extra screenings that are “usually wrong” when they predict a disorder.

Despite these stories and calls for reform by patient advocates, the government has done little to improve oversight of prenatal screenings. ProPublica set out to examine the forces that led to this inertia and left patients like Amanda feeling misled. Interviews with more than three dozen women revealed ongoing confusion about the screenings – and anger when their reliability proved to be overblown.

“This is a Wild West scenario where everybody is on their own,” said Lawrence Gostin, a Georgetown University, Washington, law professor specializing in bioethics.

The stakes for families are increasing. Upward of half of all pregnant people now receive one of these prenatal screenings. And with many states banning abortions or limiting them to early in pregnancies, the need for fast, accurate information has become more urgent.

The FDA itself acknowledges the problem. In correspondence with ProPublica, a spokesperson cited an “outdated policy” regarding the lack of vetting of many lab tests that the agency has “spent the better part of the last 2 decades trying to address.”

The screening industry, meanwhile, continues to expand, proving lucrative for those who lead it. The chief executive of Natera, which claims about 40% of the market share of prenatal screenings, received a $23 million compensation package last year, the highest of any executive at a publicly traded lab company.

Testing companies told ProPublica that, even without the FDA, there is significant oversight. Labs must abide by state regulations, and another federal agency, the Centers for Medicare and Medicaid Services, is charged with monitoring quality standards. It does not, however, check whether the tests the labs perform are clinically valid.

Companies also said the screenings offer important guidance to expectant families. Echoing others in the field, Labcorp said in a statement that the screenings, when used properly, “provide vital information about the presence of increased risk, but do not provide a definitive diagnosis.” (It declined to discuss the specifics of Amanda’s experience.)

Natera pointed out that its materials tell patients that “this test does not make a final diagnosis.” It reports results as “high-risk” or “low-risk,” not positive or negative.

Companies have stressed that, ultimately, it’s the responsibility of health care providers, who order the tests, to inform patients about the limits of screenings.

For all that, the statistical nuances of the test aren’t easy to parse for patients and even some doctors and nurses. For example, the test for trisomy 13, which doomed Amanda’s baby, is actually less likely to correctly predict the condition than other tests in the standard bundle of screenings offered to every patient.

When ProPublica asked readers to share their experiences with noninvasive prenatal screening tests, often referred to as NIPTs or NIPS, more than a thousand responded. Many said the tests had given them peace of mind. Some said they had provided an early warning about problems.

But others had more questions than answers. None more so than Amanda.

“What are these tests?” she wondered. “And how did mine end up in the margin of error?”
 

‘They started using it on humans, and then they went back and said: “Was our test accurate?” ’

Scientists have long tried to find ways to help parents and doctors understand what’s happening inside the womb. Amniocentesis was first used to reveal genetic anomalies in the late 1960s. But it didn’t become more popular until it began to be paired with ultrasound to precisely guide the procedure.

In the 1980s, doctors started using chorionic villus sampling, or CVS, an analysis of placental tissue that offers a diagnosis earlier in pregnancy. But, like amniocentesis, it is an invasive test that involves some risk to the fetus, though experts say it’s exceptionally low.

A breakthrough came in the late 1990s, when a scientist recognized that free-floating placental DNA could be detected in the mother’s blood. This meant that the fetus’s chromosomes could be examined by collecting a blood sample as soon as 9 weeks into pregnancy. This also provides an early opportunity to learn the likely fetal sex – a particularly popular feature.

Champions of the new science celebrated the arrival of a simple technique for patients that was particularly precise, at least for some conditions. Many favored it over other noninvasive options. But the industry that developed around NIPT has been marred by controversy from the beginning.

Dr. Ronald Wapner, director of reproductive genetics at Columbia University, described that time as “very chaotic.”

The tests had not been appropriately evaluated in clinical practice, said Dr. Wapner, whose research has sometimes been funded by testing companies. Because of this, he said, the industry “had very incomplete data on how well it worked.”

That didn’t stop the excitement. The chief executive of Sequenom, a biotechnology company that planned to release the first NIPT for Down syndrome, championed the company as the “Google of Molecular Diagnostics.” Its stock price soared.

Then, about 2 months before an expected launch in 2009, Sequenom killed the plan. The company’s research director, it turned out, had manipulated testing data and made misleading claims about how well the screening worked.

The U.S. Securities and Exchange Commission and Federal Bureau of Investigation opened investigations. Top executives were fired, and the research director pleaded guilty to conspiracy to commit securities fraud. Sequenom still managed to commercialize the test in 2011. (Labcorp, which later acquired Sequenom, said it uses a different kind of test.)

Other companies soon debuted their own tests. Still, there was little data on their clinical performance, researchers said.

As Megan Allyse, a bioethicist at the Mayo Clinic, put it, the companies “launched the test, they started using it on humans, and then they went back and said, ‘Was our test accurate?’ ” She also questioned the lack of attention to the ethics of how tests are presented to patients.

Despite missteps by the industry, the FDA didn’t scrutinize the screenings because they were considered lab-developed tests, which means they are created by the same laboratory that conducts them.

In 1976, Congress revamped oversight over medical devices. Since then, the FDA has effectively exempted such “home-brew” tests from key regulatory requirements. The idea was that when, say, a hospital lab wanted to create a simple test for its own patients, it was spared the time, money, and hassle of getting approval from Washington bureaucrats.

Today, lab-developed tests are vastly more numerous and complex. Because they aren’t registered with the federal government, nobody knows how many exist.

The distinction between tests the FDA actively regulates and those they don’t can seem nonsensical. It isn’t based on the complexity of the tests, or how people use them. It’s simply a matter of where the test is made.

The prenatal genetic screening industry took off almost immediately, powered by an army of aggressive sales representatives.

“At the very beginning, obstetricians in practice were being just completely inundated with visits from the sales reps,” said Dr. John Williams, director of reproductive health at Cedars-Sinai Medical Center in Los Angeles. The push left many ob.gyns. and patients thinking the screenings were accurate enough to substitute for diagnostic tests, such as amniocentesis or CVS.

In some cases, sales tactics escalated into lawbreaking.

Former Sequenom executives who exited during the fraud scandal created a new company that became Progenity, which also offered prenatal screening. Shortly after the company went public in 2020, it finalized a $49 million settlement with federal and state governments, where it admitted to falsifying insurance claims and giving kickbacks to physicians and their staff. According to a legal filing, one sales rep spent $65,658 on meals and alcohol for physicians in 1 year.

Now called Biora Therapeutics, the company said in a statement it no longer does any laboratory testing, including prenatal screenings.

Industry revenue continues to grow, but some testing companies are still fighting to make a profit, and competition to survive is fierce. “There’s a multibillion-dollar market, and they all want a piece of it,” said a former Progenity sales rep who quit in disgust after 5 months in 2016.

The rep, who requested anonymity because she continues to work in the field, said she still sees competitors from NIPT companies visiting medical practices “every week, buying breakfast or dinner, or taking them out for happy hour.”

Over time, companies pointed to new peer-reviewed studies, research the industry itself funded, to earn the confidence of doctors and other stakeholders. They showed that two tests – for Down syndrome and trisomy 18 – often performed better than other screening methods.

This research was valid, said Dr. Mary Norton, a perinatologist and clinical geneticist at the University of California, San Francisco, Medical Center’s prenatal diagnostic center. Considered a leading researcher in the field, she was an author of many of these key industry-funded studies.

But, she said, when research findings were presented publicly, the companies sometimes downplayed “inconvenient truths,” such as the exclusion of inconclusive results from accuracy estimates. Crucial caveats were also glossed over by some companies when they translated research into promotional copy aimed at health care providers and patients. Those materials didn’t always mention the many factors that can limit the performance of the screenings, including high body weight, the rarity of the condition tested, and younger maternal age.

Testing companies said they try to help patients understand the screenings through online resources and other materials. Some offer genetic counseling services.

The younger a person is, the lower the test’s positive predictive value – that is, the probability that a positive screening result will turn out to be correct – will be for some conditions. For instance, because Down syndrome is less prevalent in younger people’s pregnancies, a positive screening test is more likely to be a false positive for them.

Kristina was 30 years old in 2016, when her Progenity test came back positive for Down syndrome. She and her husband, who asked not to be fully named to protect their privacy, said they didn’t plan to carry a pregnancy with this condition to term.

But waiting to get an amniocentesis, and then waiting for the results, took 5 agonizing weeks, she said. It showed her son did not have Down syndrome.

Kristina, who lives in Texas, is still troubled by what she describes as a traumatic experience.

“I researched both late-term abortion providers and cemeteries,” she said. They even picked out a burial place, near their house.

She bought a blue baby blanket she intended to bury the baby’s tiny body in. She still has it. Her son, now 5, sleeps with it every night.
 

‘I can’t believe I didn’t say more’

As lab-developed tests became a bigger business, moving well past their home-brew origins, regulators looked for a way to assert oversight. In 2014, after years of study and debate, the time seemed right.

The FDA released plans proposing to regulate the tests, prioritizing those used to make major medical decisions. The agency has pointed to NIPTs as 1 of 20 concerning tests.

But, over the next 2 years, a coalition of power players urged the FDA to back off. Professional associations issued statements and hosted webinars devoted to the issue. Some created polished websites featuring sample letters to send to Washington.

Academic medical centers and pathology departments joined the fight, too. Scientists from 23 of them put it bluntly in a letter to the Office of Management and Budget: “FDA regulation of LDTs would be contrary to the public health,” it said, using a common acronym for the tests.

“Critical testing would be unavailable in the ‘lag time’ between development of new tests and FDA authorizing them,” the authors of the letter wrote, “and subsequent improvements on existing tests would slow significantly under the rigid, inflexible, and duplicative FDA regulatory scheme.”

This could delay essential care for patients. What’s more, opponents argued, existing lab reviews by the Centers for Medicare and Medicaid Services are sufficiently rigorous. Some have suggested modernizing the CMS review process to improve oversight.

An FDA spokesperson told ProPublica that the agency encountered “continued, negative feedback,” including a 25-page paper written by two legal heavyweights hired by the American Clinical Laboratory Association: Paul Clement, President George W. Bush’s former solicitor general, and Laurence Tribe, law professor at Harvard University.

Mr. Clement has reportedly commanded rates of $1,350 per hour. He and Mr. Tribe did not respond to ProPublica’s queries about their work.

Their brief argued that the FDA “lacked legal authority” to regulate lab-developed tests because they are properly seen as the practice of medicine: a service, rather than a product.

However, as lawyers representing the American Association of Bioanalysts countered, the FDA would vet tests before they reach the market, not control how doctors use them. The government proposal, they wrote, is “similar to imposing requirements to screen blood or label drugs.”

After the election of President Donald Trump, but before he took office, a handful of FDA officials discussed their battered proposal. It had represented a breakthrough in the decades of excruciating back-and-forth with industry. But now, with an incoming administration bent on deregulation, their efforts seemed futile.

The regulators feared anything they enacted would be undone by Congress – and, under the Congressional Review Act, they might not be able to reissue anything “substantially similar” in the future. So the FDA published a white paper instead, summarizing the issue “for further public discussion.”

After the meeting where officials made this call, Mr. Lurie, then the FDA’s associate commissioner, recalled a colleague approaching him: “I can’t believe you didn’t say more.”

“And I was like, ‘Yeah, actually, I can’t believe I didn’t say more either,’ ” Mr. Lurie later told ProPublica. (After leaving the agency, Mr. Lurie went on to lead the Center for Science in the Public Interest, a consumer advocacy nonprofit, which has pushed the FDA to finally assert oversight over lab-developed tests.)

Nancy Stade, an attorney and senior policy official who left the FDA in 2015, said the agency often moves slowly as it seeks to get buy-in from industry and professional groups. In her work on regulatory policy, she saw it happen with lab-developed tests.

The agency is “always testing the waters,” she said, “and always coming out with something a little bit softer.”

In 2020, the influential American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, representing doctors who handle pregnancies, gave the screening industry another huge boost.

In a bulletin updating their advice on the tests, the two groups described growing research on the performance of some of the standard tests and said people have the right to information about their pregnancies, so the tests should be offered to all patients. Previously, they recommended this only for those facing higher risk of genetic anomalies.

The bulletin said the coauthors had disclosed no conflicts of interest. But two of the four coauthors, including Mary Norton, had disclosed in prior publications that test-makers had provided funding for their research. A company had provided a third coauthor with laboratory services needed to run tests, according to that researcher, a connection she also disclosed in past papers.

ACOG, in a statement to ProPublica, said the organization “identified no conflicts because research funding is provided to academic institutions with institutional review boards, not to individual investigators.” Two of the three researchers responded to questions from ProPublica and said they maintained independence over their work.

One test-maker, Illumina, celebrated the ACOG guidance in a tweet, saying it “recognizes the superior performance of #NIPT and the benefit it provides expectant families.” Natera’s share prices doubled in 5 months. UnitedHealthcare, the nation’s largest private insurer and long a target of industry lobbying, told ProPublica it changed its stance to cover screenings for all patients, regardless of risk, because of the recommendation.

In a recent shareholder report, Natera stated that prenatal genetic and carrier screenings “represent the significant majority of our revenues,” which totaled $625.5 million in 2021. The company expects more growth to come.

“The NIPT market is still very underpenetrated, compared to the 4 to 5 million pregnancies in the U.S.,” Natera’s chief executive said on a 2021 earnings call, “so there’s a long way to go.”

But even Dr. Norton, who coauthored the ACOG recommendation and favors NIPTs for patients 40 and over, has concerns about screenings becoming widespread among those who are younger. In most cases, she prefers other screening methods that catch the nongenetic problems younger moms are more likely to face. Negative results from an NIPT, she said, can be “falsely reassuring.”

In the years after the FDA set aside its regulatory proposal, the agency has assisted members of Congress on a proposed legislative solution. That effort, dubbed the VALID Act, aims to end any debate over the agency’s authority over lab-developed tests. An FDA press officer said the legislation would ensure the prenatal screening tests and others are “accurate and reliable.”

But, as in the past, intense lobbying followed the proposal. The VALID Act was a rider to a funding reauthorization bill, but in September the House and Senate agreed to remove it. Advocates now hope to attach it to proposed end-of-year legislation.

Meanwhile, earlier this year, 4 months after the New York Times story on the usefulness of some screenings, the FDA took a step toward more public awareness about prenatal genetic screening. It issued its first safety communication on them, noting the potential for false results.

It cautioned patients about making “critical health care decisions based on results from these screening tests alone.”

Cara Tenenbaum, a former FDA policy advisor, was pleased to see the statement. Still, she said, it was long overdue.

“This has been known – known, or should have been known – for 10 years,” she said.
 

‘It had me so messed up’

With the demise of Roe v. Wade, restrictive and ever-changing abortion laws can pressure people to act quickly with limited information, heightening the stakes of prenatal screening.

Julia, a mom from Mississippi’s Gulf Coast, knows what it’s like to face harrowing consequences while navigating state-imposed time limits – and doing so with little guidance. Last fall, she was pregnant with her fourth child when, she said, a nurse practitioner suggested prenatal genetic screening.

At 33, Julia had no risk factors. Her previous pregnancies hadn’t been screened with an NIPT. But with three sons and 18 nephews, she and her husband were curious about the baby’s sex. And the screening seemed like it had no downside.

Julia figured it would only be offered if it was reliable, so her nurse practitioner ordered her both the basic bundle of screenings and the extra tests. (The medical practice didn’t respond to interview requests. Julia is a family nickname that’s used here to protect her privacy.)

The screenings showed the baby was a girl – but the extra tests also detected trisomy 16, a condition caused by an extra chromosome that is so rare, the nurse didn’t know what it was, Julia recalled.

The nurse borrowed Julia’s phone, using it to search online and read aloud what she found. Julia was stunned to hear trisomy 16 was incompatible with life.

“I was utterly devastated,” she said. “I made it out of my doctor’s office but completely broke down in the car.”

But ACOG does not recommend the trisomy 16 screening, saying “its accuracy with regard to detection and the false-positive rate is not established.” Julia wasn’t informed of this, she said, and she’s not sure if her health care providers knew it either.

The lab report recommended diagnostic testing to confirm the results, but time was short. She had her amniocentesis at 17 weeks. It could take up to 4 more weeks to receive results.

That would be too late for a legal abortion in Mississippi. So she made an appointment for one in Florida, where the cutoff was 24 weeks. (It’s now 15 weeks in Florida, while Mississippi went from 15 weeks for legal procedures to a ban on nearly all abortions.)

The wait was excruciating. Julia was driving twice a week to New Orleans for specialized care. With work and child care, it was too hard. She quit the teaching job she loved.

One winter night, she felt the fetus move for the first time – ordinarily a milestone, but now, facing a fatal prognosis, she didn’t want to get attached. “It had me so messed up,” she said.

On the way to the amniocentesis, Julia and her husband chose a name. Drawing from a language conjured by J.R.R. Tolkien in the fantasy novels they love, it means “hope.”

More than halfway through her pregnancy, the amnio results arrived. The prenatal screening had given a false positive. The baby would be fine. In May, Julia gave birth to a healthy daughter.

Julia and her husband are upset about the needless anguish brought on by the screening. “They like to have it both ways,” said Julia’s husband. “They say they are 99% accurate, but when there’s a false positive, they say, ‘Well, we’re not diagnostic.’ ”

Believing the prenatal screening was likely accurate, they had seriously considered canceling the amniocentesis, saving their limited funds for an abortion in Florida, hundreds of miles away.

Their dilemma points to a longtime concern: ending pregnancies based on false positives. The FDA cited it as a risk as far back as 2015. Now, those with positive results are facing an even tighter time crunch. They must consider whether waiting for a definitive test, and possibly traveling to another state for an abortion later in pregnancy, is worth it.

In their promotional material, some companies not only sidestep the variability of the standard tests, they fail to distinguish them from the least reliable ones – those for exceptionally rare conditions. They tout the extra screenings as “premium,” “plus,” or “advanced” options.

“Going to greater lengths for the answers that matter most,” says a brochure aimed at health care providers from test-maker Illumina. Elsewhere it states that the “expanded” panel of tests provides “confident results” and “the additional insights you need.”

But the companies themselves know the accuracy of some of their tests has yet to be established in the research. Natera acknowledged in a recent shareholder report that many insurers won’t pay for screenings for missing chromosomal fragments, known as microdeletions, in part because there isn’t enough published data behind them.

The company, responding to ProPublica, stressed the quality of the data over the quantity, saying the research so far has been favorable. “Natera’s microdeletion testing was thoroughly validated with results published in peer-reviewed publications,” it said in a statement.

Natera pointed to a recent study that looked at DiGeorge syndrome, one of several chromosomal anomalies it checks for with its microdeletion screenings. Researchers found the positive predictive value (PPV) of the test to be 52.6%, meaning that nearly half of positive results are false positives. (For many patients, PPVs for more common conditions can exceed 90%.)

Natera said the performance of the diGeorge syndrome test “is excellent and not considered a low PPV,” because of the condition being extremely rare.

Companies also play up the danger of diagnostic tests like amnio. They “can cause miscarriages,” warns the marketing from Labcorp, which made Amanda’s screening, while its test “does not cause miscarriages.” But medical experts emphasize that diagnostic tests, such as amniocentesis, are more accurate and, in fact, carry little risk to the pregnancy.

Labcorp, in a statement, said the company “acknowledges the well-documented risk associated with amniocentesis and CVS in our literature. It is the patient’s prerogative to decide which risks they are willing or unwilling to take.”

Marketing claims also sometimes skate over the nuances in the guidance from the leading professional societies. On a webpage targeting health care providers, for example, a Labcorp chart said groups such as ACOG “endorse and/or recognize” prenatal screenings as an option for all pregnancies. But the chart listed screenings ACOG does not recommend, including trisomy 16.

When asked about it, Labcorp said in a statement that ACOG “endorses NIPS for all pregnancies.” In fact, the guidance is not so sweeping. It says only that the basic bundle of tests should be offered to all, alongside other screening options. It explicitly advises providers to not offer patients the extra tests.

Soon after ProPublica’s query, the Labcorp webpage was updated to remove any mention of the professional societies.

Patients say they often don’t know where to turn for informed and unbiased information. That’s why the r/NIPT Reddit page became such a robust community. Facing difficult news, Julia turned to it for counsel from other prospective parents. Kristina in Texas found the same community. Amanda, too.
 

‘The margin of error is a human life’

On a warm and cloudy day this past June, on what would have been their daughter’s first birthday, Amanda and her husband visited her grave. They brought a unicorn balloon and vanilla cake, which they ate nearby on the grass. Her husband read a poem.

To them, their baby had been perfect. She had fingers and toes. A thatch of dark hair. While in intensive care, peering up at her parents, she grabbed for her mother’s hand.

Had her condition been known, they would’ve spared her futile medical interventions, as doctors tried to save her life. Their family priest would have been able to baptize her. As it was, they never got to hold their child while she was alive.

These days, when Amanda and her husband say grace before dinner, they give thanks for the 28 hours of their daughter’s life.

They’re also thinking about making comfort boxes the hospital could give to other parents who lose a child. It might include books on grief. Softer tissues. Something that says, as Amanda puts it, “This is to help you get through.”

Amid their grief, they had a prayer answered: Amanda is pregnant again.

It’s frightening to go through this again. She barely sleeps the night before visiting the doctor. It feels like she never stopped being pregnant. It will feel that way, she said, until she brings a baby home – one who lives past the first 2 nights.

Amanda planned to get another genetic screening test. At first she couldn’t bear it, wasn’t sure she could trust it. “The margin of error is a human life,” Amanda said.

The 10-week appointment passed. Then the 12-week appointment. After her 13th week, she took the plunge. The test she was given was from Labcorp.

Around this time, more than a year after Amanda had desperately tried to alert the company about what had happened to her and her first baby, she finally heard back. Labcorp’s vice president of genetic counseling and services reached out – after ProPublica contacted the company and shared Amanda’s story.

The executive would only speak to Amanda without a reporter present.

Amanda said that during the call, the executive told her that prenatal genetic tests are evolving, and doctors should be clear about what the screenings can and cannot do. By the end of the conversation, the executive offered Amanda her cell number.

Amanda said she appreciated the call. “I feel better. I feel like I got something.”

The same day, her screening results came back. They were negative.
 

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Amanda wanted to warn someone. In June 2021, her daughter – the one she and her husband had tried for 3 years to conceive – had died after only 28 hours. With an underdeveloped nose, she had battled for every breath.

Nobody knew why. Later, an autopsy report revealed their daughter had an extra 13th chromosome. The condition is nearly always fatal.

“But didn’t we test for that?” Amanda recalled asking herself. “That was kind of where the light bulb clicked.”

Through her doctor, Amanda had gotten a popular prenatal screening from a lab company. It had come back “negative.”

For three major conditions, including the one her baby had, the report gave the impression of near certainty. The likelihood that she would be born without them was “greater than 99%.”

As she recovered from a cesarean section, Amanda found herself facing a long maternity leave without a child. She shut the door to the empty nursery and began spending what seemed like endless hours of that hazy summer learning about the test.

It’s a simple blood draw designed to check for an array of genetic anomalies. But Amanda, a science researcher, read academic articles showing there was a higher risk of inaccurate results than she had realized. (She asked to be identified by only her first name to protect her privacy.)

On Reddit, she found other women reporting problems with the tests, too. She thought Labcorp, the company that made her test, would want to know about the screening that failed her. Maybe by alerting them, she could help other families. Maybe it would help her understand what happened.

“I was trying to gain answers,” said Amanda, now 32. She tried calling Labcorp’s customer service line, but she said she was passed along from one person to another. “It was just a circle,” she remembered.

She phoned Labcorp a second time. The call ended when an employee hung up on her.

Amanda was baffled. Why didn’t the company seem interested in her experience? Why, she wondered, wouldn’t it want to collect this data? Why wasn’t there someone who could answer her questions about how often this happens, and why?

If she had taken any number of other common commercial tests – including certain tests for COVID-19 or, say, pregnancy – the company would have been required to inform the U.S. Food and Drug Administration about reports of so-called adverse events.

But the test Amanda had falls into a regulatory void. No federal agency checks to make sure these prenatal screenings work the way they claim before they’re sold to health care providers. The FDA doesn’t ensure that marketing claims are backed up by evidence before screenings reach patients. And companies aren’t required to publicly report instances of when the tests get it wrong – sometimes catastrophically.

The broader lab testing industry and its lobbyists have successfully fought for years to keep it this way, cowing regulators into staying on the sidelines.

Worried about a growing variety of tests escaping scrutiny, the FDA was on the cusp of stepping in 6 years ago. But then it backed down.

Peter Lurie, then a top agency official, was at the meetings where the FDA tabled its plans. Not pushing harder, he told ProPublica, “remains one of my greatest regrets.”

The risk of false positives from prenatal screenings, in particular, has been known for years.

In 2014, the New England Center for Investigative Reporting detailed how some companies gave a misleading impression of the precision of the prenatal screenings. Women often didn’t understand they needed diagnostic testing to confirm the results. Some had gotten abortions based on false positive results, the story said. Earlier this year, the New York Times reported how companies sell optional extra screenings that are “usually wrong” when they predict a disorder.

Despite these stories and calls for reform by patient advocates, the government has done little to improve oversight of prenatal screenings. ProPublica set out to examine the forces that led to this inertia and left patients like Amanda feeling misled. Interviews with more than three dozen women revealed ongoing confusion about the screenings – and anger when their reliability proved to be overblown.

“This is a Wild West scenario where everybody is on their own,” said Lawrence Gostin, a Georgetown University, Washington, law professor specializing in bioethics.

The stakes for families are increasing. Upward of half of all pregnant people now receive one of these prenatal screenings. And with many states banning abortions or limiting them to early in pregnancies, the need for fast, accurate information has become more urgent.

The FDA itself acknowledges the problem. In correspondence with ProPublica, a spokesperson cited an “outdated policy” regarding the lack of vetting of many lab tests that the agency has “spent the better part of the last 2 decades trying to address.”

The screening industry, meanwhile, continues to expand, proving lucrative for those who lead it. The chief executive of Natera, which claims about 40% of the market share of prenatal screenings, received a $23 million compensation package last year, the highest of any executive at a publicly traded lab company.

Testing companies told ProPublica that, even without the FDA, there is significant oversight. Labs must abide by state regulations, and another federal agency, the Centers for Medicare and Medicaid Services, is charged with monitoring quality standards. It does not, however, check whether the tests the labs perform are clinically valid.

Companies also said the screenings offer important guidance to expectant families. Echoing others in the field, Labcorp said in a statement that the screenings, when used properly, “provide vital information about the presence of increased risk, but do not provide a definitive diagnosis.” (It declined to discuss the specifics of Amanda’s experience.)

Natera pointed out that its materials tell patients that “this test does not make a final diagnosis.” It reports results as “high-risk” or “low-risk,” not positive or negative.

Companies have stressed that, ultimately, it’s the responsibility of health care providers, who order the tests, to inform patients about the limits of screenings.

For all that, the statistical nuances of the test aren’t easy to parse for patients and even some doctors and nurses. For example, the test for trisomy 13, which doomed Amanda’s baby, is actually less likely to correctly predict the condition than other tests in the standard bundle of screenings offered to every patient.

When ProPublica asked readers to share their experiences with noninvasive prenatal screening tests, often referred to as NIPTs or NIPS, more than a thousand responded. Many said the tests had given them peace of mind. Some said they had provided an early warning about problems.

But others had more questions than answers. None more so than Amanda.

“What are these tests?” she wondered. “And how did mine end up in the margin of error?”
 

‘They started using it on humans, and then they went back and said: “Was our test accurate?” ’

Scientists have long tried to find ways to help parents and doctors understand what’s happening inside the womb. Amniocentesis was first used to reveal genetic anomalies in the late 1960s. But it didn’t become more popular until it began to be paired with ultrasound to precisely guide the procedure.

In the 1980s, doctors started using chorionic villus sampling, or CVS, an analysis of placental tissue that offers a diagnosis earlier in pregnancy. But, like amniocentesis, it is an invasive test that involves some risk to the fetus, though experts say it’s exceptionally low.

A breakthrough came in the late 1990s, when a scientist recognized that free-floating placental DNA could be detected in the mother’s blood. This meant that the fetus’s chromosomes could be examined by collecting a blood sample as soon as 9 weeks into pregnancy. This also provides an early opportunity to learn the likely fetal sex – a particularly popular feature.

Champions of the new science celebrated the arrival of a simple technique for patients that was particularly precise, at least for some conditions. Many favored it over other noninvasive options. But the industry that developed around NIPT has been marred by controversy from the beginning.

Dr. Ronald Wapner, director of reproductive genetics at Columbia University, described that time as “very chaotic.”

The tests had not been appropriately evaluated in clinical practice, said Dr. Wapner, whose research has sometimes been funded by testing companies. Because of this, he said, the industry “had very incomplete data on how well it worked.”

That didn’t stop the excitement. The chief executive of Sequenom, a biotechnology company that planned to release the first NIPT for Down syndrome, championed the company as the “Google of Molecular Diagnostics.” Its stock price soared.

Then, about 2 months before an expected launch in 2009, Sequenom killed the plan. The company’s research director, it turned out, had manipulated testing data and made misleading claims about how well the screening worked.

The U.S. Securities and Exchange Commission and Federal Bureau of Investigation opened investigations. Top executives were fired, and the research director pleaded guilty to conspiracy to commit securities fraud. Sequenom still managed to commercialize the test in 2011. (Labcorp, which later acquired Sequenom, said it uses a different kind of test.)

Other companies soon debuted their own tests. Still, there was little data on their clinical performance, researchers said.

As Megan Allyse, a bioethicist at the Mayo Clinic, put it, the companies “launched the test, they started using it on humans, and then they went back and said, ‘Was our test accurate?’ ” She also questioned the lack of attention to the ethics of how tests are presented to patients.

Despite missteps by the industry, the FDA didn’t scrutinize the screenings because they were considered lab-developed tests, which means they are created by the same laboratory that conducts them.

In 1976, Congress revamped oversight over medical devices. Since then, the FDA has effectively exempted such “home-brew” tests from key regulatory requirements. The idea was that when, say, a hospital lab wanted to create a simple test for its own patients, it was spared the time, money, and hassle of getting approval from Washington bureaucrats.

Today, lab-developed tests are vastly more numerous and complex. Because they aren’t registered with the federal government, nobody knows how many exist.

The distinction between tests the FDA actively regulates and those they don’t can seem nonsensical. It isn’t based on the complexity of the tests, or how people use them. It’s simply a matter of where the test is made.

The prenatal genetic screening industry took off almost immediately, powered by an army of aggressive sales representatives.

“At the very beginning, obstetricians in practice were being just completely inundated with visits from the sales reps,” said Dr. John Williams, director of reproductive health at Cedars-Sinai Medical Center in Los Angeles. The push left many ob.gyns. and patients thinking the screenings were accurate enough to substitute for diagnostic tests, such as amniocentesis or CVS.

In some cases, sales tactics escalated into lawbreaking.

Former Sequenom executives who exited during the fraud scandal created a new company that became Progenity, which also offered prenatal screening. Shortly after the company went public in 2020, it finalized a $49 million settlement with federal and state governments, where it admitted to falsifying insurance claims and giving kickbacks to physicians and their staff. According to a legal filing, one sales rep spent $65,658 on meals and alcohol for physicians in 1 year.

Now called Biora Therapeutics, the company said in a statement it no longer does any laboratory testing, including prenatal screenings.

Industry revenue continues to grow, but some testing companies are still fighting to make a profit, and competition to survive is fierce. “There’s a multibillion-dollar market, and they all want a piece of it,” said a former Progenity sales rep who quit in disgust after 5 months in 2016.

The rep, who requested anonymity because she continues to work in the field, said she still sees competitors from NIPT companies visiting medical practices “every week, buying breakfast or dinner, or taking them out for happy hour.”

Over time, companies pointed to new peer-reviewed studies, research the industry itself funded, to earn the confidence of doctors and other stakeholders. They showed that two tests – for Down syndrome and trisomy 18 – often performed better than other screening methods.

This research was valid, said Dr. Mary Norton, a perinatologist and clinical geneticist at the University of California, San Francisco, Medical Center’s prenatal diagnostic center. Considered a leading researcher in the field, she was an author of many of these key industry-funded studies.

But, she said, when research findings were presented publicly, the companies sometimes downplayed “inconvenient truths,” such as the exclusion of inconclusive results from accuracy estimates. Crucial caveats were also glossed over by some companies when they translated research into promotional copy aimed at health care providers and patients. Those materials didn’t always mention the many factors that can limit the performance of the screenings, including high body weight, the rarity of the condition tested, and younger maternal age.

Testing companies said they try to help patients understand the screenings through online resources and other materials. Some offer genetic counseling services.

The younger a person is, the lower the test’s positive predictive value – that is, the probability that a positive screening result will turn out to be correct – will be for some conditions. For instance, because Down syndrome is less prevalent in younger people’s pregnancies, a positive screening test is more likely to be a false positive for them.

Kristina was 30 years old in 2016, when her Progenity test came back positive for Down syndrome. She and her husband, who asked not to be fully named to protect their privacy, said they didn’t plan to carry a pregnancy with this condition to term.

But waiting to get an amniocentesis, and then waiting for the results, took 5 agonizing weeks, she said. It showed her son did not have Down syndrome.

Kristina, who lives in Texas, is still troubled by what she describes as a traumatic experience.

“I researched both late-term abortion providers and cemeteries,” she said. They even picked out a burial place, near their house.

She bought a blue baby blanket she intended to bury the baby’s tiny body in. She still has it. Her son, now 5, sleeps with it every night.
 

‘I can’t believe I didn’t say more’

As lab-developed tests became a bigger business, moving well past their home-brew origins, regulators looked for a way to assert oversight. In 2014, after years of study and debate, the time seemed right.

The FDA released plans proposing to regulate the tests, prioritizing those used to make major medical decisions. The agency has pointed to NIPTs as 1 of 20 concerning tests.

But, over the next 2 years, a coalition of power players urged the FDA to back off. Professional associations issued statements and hosted webinars devoted to the issue. Some created polished websites featuring sample letters to send to Washington.

Academic medical centers and pathology departments joined the fight, too. Scientists from 23 of them put it bluntly in a letter to the Office of Management and Budget: “FDA regulation of LDTs would be contrary to the public health,” it said, using a common acronym for the tests.

“Critical testing would be unavailable in the ‘lag time’ between development of new tests and FDA authorizing them,” the authors of the letter wrote, “and subsequent improvements on existing tests would slow significantly under the rigid, inflexible, and duplicative FDA regulatory scheme.”

This could delay essential care for patients. What’s more, opponents argued, existing lab reviews by the Centers for Medicare and Medicaid Services are sufficiently rigorous. Some have suggested modernizing the CMS review process to improve oversight.

An FDA spokesperson told ProPublica that the agency encountered “continued, negative feedback,” including a 25-page paper written by two legal heavyweights hired by the American Clinical Laboratory Association: Paul Clement, President George W. Bush’s former solicitor general, and Laurence Tribe, law professor at Harvard University.

Mr. Clement has reportedly commanded rates of $1,350 per hour. He and Mr. Tribe did not respond to ProPublica’s queries about their work.

Their brief argued that the FDA “lacked legal authority” to regulate lab-developed tests because they are properly seen as the practice of medicine: a service, rather than a product.

However, as lawyers representing the American Association of Bioanalysts countered, the FDA would vet tests before they reach the market, not control how doctors use them. The government proposal, they wrote, is “similar to imposing requirements to screen blood or label drugs.”

After the election of President Donald Trump, but before he took office, a handful of FDA officials discussed their battered proposal. It had represented a breakthrough in the decades of excruciating back-and-forth with industry. But now, with an incoming administration bent on deregulation, their efforts seemed futile.

The regulators feared anything they enacted would be undone by Congress – and, under the Congressional Review Act, they might not be able to reissue anything “substantially similar” in the future. So the FDA published a white paper instead, summarizing the issue “for further public discussion.”

After the meeting where officials made this call, Mr. Lurie, then the FDA’s associate commissioner, recalled a colleague approaching him: “I can’t believe you didn’t say more.”

“And I was like, ‘Yeah, actually, I can’t believe I didn’t say more either,’ ” Mr. Lurie later told ProPublica. (After leaving the agency, Mr. Lurie went on to lead the Center for Science in the Public Interest, a consumer advocacy nonprofit, which has pushed the FDA to finally assert oversight over lab-developed tests.)

Nancy Stade, an attorney and senior policy official who left the FDA in 2015, said the agency often moves slowly as it seeks to get buy-in from industry and professional groups. In her work on regulatory policy, she saw it happen with lab-developed tests.

The agency is “always testing the waters,” she said, “and always coming out with something a little bit softer.”

In 2020, the influential American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine, representing doctors who handle pregnancies, gave the screening industry another huge boost.

In a bulletin updating their advice on the tests, the two groups described growing research on the performance of some of the standard tests and said people have the right to information about their pregnancies, so the tests should be offered to all patients. Previously, they recommended this only for those facing higher risk of genetic anomalies.

The bulletin said the coauthors had disclosed no conflicts of interest. But two of the four coauthors, including Mary Norton, had disclosed in prior publications that test-makers had provided funding for their research. A company had provided a third coauthor with laboratory services needed to run tests, according to that researcher, a connection she also disclosed in past papers.

ACOG, in a statement to ProPublica, said the organization “identified no conflicts because research funding is provided to academic institutions with institutional review boards, not to individual investigators.” Two of the three researchers responded to questions from ProPublica and said they maintained independence over their work.

One test-maker, Illumina, celebrated the ACOG guidance in a tweet, saying it “recognizes the superior performance of #NIPT and the benefit it provides expectant families.” Natera’s share prices doubled in 5 months. UnitedHealthcare, the nation’s largest private insurer and long a target of industry lobbying, told ProPublica it changed its stance to cover screenings for all patients, regardless of risk, because of the recommendation.

In a recent shareholder report, Natera stated that prenatal genetic and carrier screenings “represent the significant majority of our revenues,” which totaled $625.5 million in 2021. The company expects more growth to come.

“The NIPT market is still very underpenetrated, compared to the 4 to 5 million pregnancies in the U.S.,” Natera’s chief executive said on a 2021 earnings call, “so there’s a long way to go.”

But even Dr. Norton, who coauthored the ACOG recommendation and favors NIPTs for patients 40 and over, has concerns about screenings becoming widespread among those who are younger. In most cases, she prefers other screening methods that catch the nongenetic problems younger moms are more likely to face. Negative results from an NIPT, she said, can be “falsely reassuring.”

In the years after the FDA set aside its regulatory proposal, the agency has assisted members of Congress on a proposed legislative solution. That effort, dubbed the VALID Act, aims to end any debate over the agency’s authority over lab-developed tests. An FDA press officer said the legislation would ensure the prenatal screening tests and others are “accurate and reliable.”

But, as in the past, intense lobbying followed the proposal. The VALID Act was a rider to a funding reauthorization bill, but in September the House and Senate agreed to remove it. Advocates now hope to attach it to proposed end-of-year legislation.

Meanwhile, earlier this year, 4 months after the New York Times story on the usefulness of some screenings, the FDA took a step toward more public awareness about prenatal genetic screening. It issued its first safety communication on them, noting the potential for false results.

It cautioned patients about making “critical health care decisions based on results from these screening tests alone.”

Cara Tenenbaum, a former FDA policy advisor, was pleased to see the statement. Still, she said, it was long overdue.

“This has been known – known, or should have been known – for 10 years,” she said.
 

‘It had me so messed up’

With the demise of Roe v. Wade, restrictive and ever-changing abortion laws can pressure people to act quickly with limited information, heightening the stakes of prenatal screening.

Julia, a mom from Mississippi’s Gulf Coast, knows what it’s like to face harrowing consequences while navigating state-imposed time limits – and doing so with little guidance. Last fall, she was pregnant with her fourth child when, she said, a nurse practitioner suggested prenatal genetic screening.

At 33, Julia had no risk factors. Her previous pregnancies hadn’t been screened with an NIPT. But with three sons and 18 nephews, she and her husband were curious about the baby’s sex. And the screening seemed like it had no downside.

Julia figured it would only be offered if it was reliable, so her nurse practitioner ordered her both the basic bundle of screenings and the extra tests. (The medical practice didn’t respond to interview requests. Julia is a family nickname that’s used here to protect her privacy.)

The screenings showed the baby was a girl – but the extra tests also detected trisomy 16, a condition caused by an extra chromosome that is so rare, the nurse didn’t know what it was, Julia recalled.

The nurse borrowed Julia’s phone, using it to search online and read aloud what she found. Julia was stunned to hear trisomy 16 was incompatible with life.

“I was utterly devastated,” she said. “I made it out of my doctor’s office but completely broke down in the car.”

But ACOG does not recommend the trisomy 16 screening, saying “its accuracy with regard to detection and the false-positive rate is not established.” Julia wasn’t informed of this, she said, and she’s not sure if her health care providers knew it either.

The lab report recommended diagnostic testing to confirm the results, but time was short. She had her amniocentesis at 17 weeks. It could take up to 4 more weeks to receive results.

That would be too late for a legal abortion in Mississippi. So she made an appointment for one in Florida, where the cutoff was 24 weeks. (It’s now 15 weeks in Florida, while Mississippi went from 15 weeks for legal procedures to a ban on nearly all abortions.)

The wait was excruciating. Julia was driving twice a week to New Orleans for specialized care. With work and child care, it was too hard. She quit the teaching job she loved.

One winter night, she felt the fetus move for the first time – ordinarily a milestone, but now, facing a fatal prognosis, she didn’t want to get attached. “It had me so messed up,” she said.

On the way to the amniocentesis, Julia and her husband chose a name. Drawing from a language conjured by J.R.R. Tolkien in the fantasy novels they love, it means “hope.”

More than halfway through her pregnancy, the amnio results arrived. The prenatal screening had given a false positive. The baby would be fine. In May, Julia gave birth to a healthy daughter.

Julia and her husband are upset about the needless anguish brought on by the screening. “They like to have it both ways,” said Julia’s husband. “They say they are 99% accurate, but when there’s a false positive, they say, ‘Well, we’re not diagnostic.’ ”

Believing the prenatal screening was likely accurate, they had seriously considered canceling the amniocentesis, saving their limited funds for an abortion in Florida, hundreds of miles away.

Their dilemma points to a longtime concern: ending pregnancies based on false positives. The FDA cited it as a risk as far back as 2015. Now, those with positive results are facing an even tighter time crunch. They must consider whether waiting for a definitive test, and possibly traveling to another state for an abortion later in pregnancy, is worth it.

In their promotional material, some companies not only sidestep the variability of the standard tests, they fail to distinguish them from the least reliable ones – those for exceptionally rare conditions. They tout the extra screenings as “premium,” “plus,” or “advanced” options.

“Going to greater lengths for the answers that matter most,” says a brochure aimed at health care providers from test-maker Illumina. Elsewhere it states that the “expanded” panel of tests provides “confident results” and “the additional insights you need.”

But the companies themselves know the accuracy of some of their tests has yet to be established in the research. Natera acknowledged in a recent shareholder report that many insurers won’t pay for screenings for missing chromosomal fragments, known as microdeletions, in part because there isn’t enough published data behind them.

The company, responding to ProPublica, stressed the quality of the data over the quantity, saying the research so far has been favorable. “Natera’s microdeletion testing was thoroughly validated with results published in peer-reviewed publications,” it said in a statement.

Natera pointed to a recent study that looked at DiGeorge syndrome, one of several chromosomal anomalies it checks for with its microdeletion screenings. Researchers found the positive predictive value (PPV) of the test to be 52.6%, meaning that nearly half of positive results are false positives. (For many patients, PPVs for more common conditions can exceed 90%.)

Natera said the performance of the diGeorge syndrome test “is excellent and not considered a low PPV,” because of the condition being extremely rare.

Companies also play up the danger of diagnostic tests like amnio. They “can cause miscarriages,” warns the marketing from Labcorp, which made Amanda’s screening, while its test “does not cause miscarriages.” But medical experts emphasize that diagnostic tests, such as amniocentesis, are more accurate and, in fact, carry little risk to the pregnancy.

Labcorp, in a statement, said the company “acknowledges the well-documented risk associated with amniocentesis and CVS in our literature. It is the patient’s prerogative to decide which risks they are willing or unwilling to take.”

Marketing claims also sometimes skate over the nuances in the guidance from the leading professional societies. On a webpage targeting health care providers, for example, a Labcorp chart said groups such as ACOG “endorse and/or recognize” prenatal screenings as an option for all pregnancies. But the chart listed screenings ACOG does not recommend, including trisomy 16.

When asked about it, Labcorp said in a statement that ACOG “endorses NIPS for all pregnancies.” In fact, the guidance is not so sweeping. It says only that the basic bundle of tests should be offered to all, alongside other screening options. It explicitly advises providers to not offer patients the extra tests.

Soon after ProPublica’s query, the Labcorp webpage was updated to remove any mention of the professional societies.

Patients say they often don’t know where to turn for informed and unbiased information. That’s why the r/NIPT Reddit page became such a robust community. Facing difficult news, Julia turned to it for counsel from other prospective parents. Kristina in Texas found the same community. Amanda, too.
 

‘The margin of error is a human life’

On a warm and cloudy day this past June, on what would have been their daughter’s first birthday, Amanda and her husband visited her grave. They brought a unicorn balloon and vanilla cake, which they ate nearby on the grass. Her husband read a poem.

To them, their baby had been perfect. She had fingers and toes. A thatch of dark hair. While in intensive care, peering up at her parents, she grabbed for her mother’s hand.

Had her condition been known, they would’ve spared her futile medical interventions, as doctors tried to save her life. Their family priest would have been able to baptize her. As it was, they never got to hold their child while she was alive.

These days, when Amanda and her husband say grace before dinner, they give thanks for the 28 hours of their daughter’s life.

They’re also thinking about making comfort boxes the hospital could give to other parents who lose a child. It might include books on grief. Softer tissues. Something that says, as Amanda puts it, “This is to help you get through.”

Amid their grief, they had a prayer answered: Amanda is pregnant again.

It’s frightening to go through this again. She barely sleeps the night before visiting the doctor. It feels like she never stopped being pregnant. It will feel that way, she said, until she brings a baby home – one who lives past the first 2 nights.

Amanda planned to get another genetic screening test. At first she couldn’t bear it, wasn’t sure she could trust it. “The margin of error is a human life,” Amanda said.

The 10-week appointment passed. Then the 12-week appointment. After her 13th week, she took the plunge. The test she was given was from Labcorp.

Around this time, more than a year after Amanda had desperately tried to alert the company about what had happened to her and her first baby, she finally heard back. Labcorp’s vice president of genetic counseling and services reached out – after ProPublica contacted the company and shared Amanda’s story.

The executive would only speak to Amanda without a reporter present.

Amanda said that during the call, the executive told her that prenatal genetic tests are evolving, and doctors should be clear about what the screenings can and cannot do. By the end of the conversation, the executive offered Amanda her cell number.

Amanda said she appreciated the call. “I feel better. I feel like I got something.”

The same day, her screening results came back. They were negative.
 

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

NASHVILLE, TENN. – There is no negative impact of in utero exposure to antiseizure medications on children’s creativity, new research shows.

The results of this study, along with other research, suggest the risk for cognitive problems “is fairly low” overall for children of women with epilepsy taking lamotrigine or levetiracetam, study investigator, Kimford J. Meador, MD, professor, department of neurology & neurological sciences, Stanford (Calif.) University School of Medicine, told this news organization.

“This is another encouraging piece that’s showing these new drugs are safe with regard to cognition.”

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Capturing creativity

Fetal exposure to antiseizure medications can produce adverse neurodevelopmental effects. These are typically assessed using measures such as general intelligence, verbal/nonverbal abilities, or additional educational needs.

However, these measures don’t capture creativity, which “is related to intelligence but not completely,” said Dr. Meador. “I have seen wonderful examples of creativity in people who have a lot of cognitive impairment.”

He referred to one of his patients with epilepsy who is “spectacularly good” at painting with watercolors, even though she has significant cognitive impairment.

The new analysis is part of the MONEAD study, a prospective, observational multicenter study examining pregnancy outcomes for both mother and child. It included pregnant women who were enrolled at under 20 weeks’ gestational age.

The women with epilepsy in the study were primarily on monotherapy (73%), and of these, 82% were on lamotrigine or levetiracetam. About 22% were on polytherapy, of which 42% were on dual therapy with lamotrigine and levetiracetam.
 

Fluency, originality

Researchers assessed the children of these women at age 4½ years using the Torrance Test of Creative Thinking-Figural (TTCT-F). This is a standardized assessment of creative thinking with index scores measuring such things as fluency, originality, abstractness, and elaboration.

Dr. Meador noted the research team used a shorter version of the test battery “so as to not wear out the families and kids.”

During the test, children were given lines of different shapes and asked to draw a picture using these lines. Dr. Meador pointed out the drawings ranged from quite basic to more intricate.

One child cleverly turned a few squiggly lines into a car. “I can look at this and say this kid’s going to do very well,” said Dr. Meador.

Investigators compared scores between 241 children of women with epilepsy (WWE) and 65 children of healthy women (HW). They adjusted for the mother’s IQ, education level, age at enrollment, gestation age at enrollment, post-birth average anxiety score, and the child’s ethnicity and sex.

Investigators found the mean TTCT-F scores did not differ significantly between the two groups: adjusted least squares mean of 89.5 (95% confidence interval, 86.7-92.3) for children of WWE, compared with adjusted least square mean of 92.0 (95% CI, 86.4-97.6) for children of HW.
 

Balancing act

The researchers haven’t looked at a dose effect in this current study, but Dr. Meador said it’s always “a balancing act” between giving enough of the drug to keep mothers from seizing, which affect both the mother and fetus, and giving as low a dose as possible to protect the fetus.

In addition, as medication levels change during pregnancy, he said he recommends that drug levels are monitored monthly so that medication can be adjusted as necessary.

Looking at what factors might predict creativity scores, researchers found children did less well creatively if their mother didn’t have a college degree (estimate –9.5; 95% CI, –17.9 to –1.2; P = .025).

“It looks like being in a home where the mother has had more education is going to have an impact on the kid’s thinking and creativity,” said Dr. Meador.

These new findings are consistent with a lack of differences in other cognitive abilities that Dr. Meador and his team found when the children were younger.

“At age 3, we did not find an overall difference in cognitive and verbal abilities and intelligence between the children of mothers with epilepsy and those of healthy women,” he said.

The researchers aim to assess cognitive and behavioral outcomes in these children when they are 6 years old.
 

Helpful information

Commenting on the findings, Stéphane Auvin, MD, PhD, chair of the department of pediatric neurology at the University of Paris, who co-moderated a platform session featuring the research, said the study “is an interesting measure of the impact of being exposed to antiseizure medications.”

Creativity is “complex,” he said. “It’s not only cognition; it could be things like behavior and impulsivity.”

The new information is “very helpful.” Focusing on something broader than just IQ “gives you a better picture of what’s going on.”

The study received funding from NIH, NINDS, and NICH. Dr. Meador has received grants from NIH/NINDS, NIH/NICHD, Veterans Administration, and Eisai. He has been a consultant for Epilepsy Consortium, Novartis, Supernus, Upsher Smith Labs, and UCB Pharma. Dr. Auvin reports no relevant financial relationships.

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

NASHVILLE, TENN. – There is no negative impact of in utero exposure to antiseizure medications on children’s creativity, new research shows.

The results of this study, along with other research, suggest the risk for cognitive problems “is fairly low” overall for children of women with epilepsy taking lamotrigine or levetiracetam, study investigator, Kimford J. Meador, MD, professor, department of neurology & neurological sciences, Stanford (Calif.) University School of Medicine, told this news organization.

“This is another encouraging piece that’s showing these new drugs are safe with regard to cognition.”

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Capturing creativity

Fetal exposure to antiseizure medications can produce adverse neurodevelopmental effects. These are typically assessed using measures such as general intelligence, verbal/nonverbal abilities, or additional educational needs.

However, these measures don’t capture creativity, which “is related to intelligence but not completely,” said Dr. Meador. “I have seen wonderful examples of creativity in people who have a lot of cognitive impairment.”

He referred to one of his patients with epilepsy who is “spectacularly good” at painting with watercolors, even though she has significant cognitive impairment.

The new analysis is part of the MONEAD study, a prospective, observational multicenter study examining pregnancy outcomes for both mother and child. It included pregnant women who were enrolled at under 20 weeks’ gestational age.

The women with epilepsy in the study were primarily on monotherapy (73%), and of these, 82% were on lamotrigine or levetiracetam. About 22% were on polytherapy, of which 42% were on dual therapy with lamotrigine and levetiracetam.
 

Fluency, originality

Researchers assessed the children of these women at age 4½ years using the Torrance Test of Creative Thinking-Figural (TTCT-F). This is a standardized assessment of creative thinking with index scores measuring such things as fluency, originality, abstractness, and elaboration.

Dr. Meador noted the research team used a shorter version of the test battery “so as to not wear out the families and kids.”

During the test, children were given lines of different shapes and asked to draw a picture using these lines. Dr. Meador pointed out the drawings ranged from quite basic to more intricate.

One child cleverly turned a few squiggly lines into a car. “I can look at this and say this kid’s going to do very well,” said Dr. Meador.

Investigators compared scores between 241 children of women with epilepsy (WWE) and 65 children of healthy women (HW). They adjusted for the mother’s IQ, education level, age at enrollment, gestation age at enrollment, post-birth average anxiety score, and the child’s ethnicity and sex.

Investigators found the mean TTCT-F scores did not differ significantly between the two groups: adjusted least squares mean of 89.5 (95% confidence interval, 86.7-92.3) for children of WWE, compared with adjusted least square mean of 92.0 (95% CI, 86.4-97.6) for children of HW.
 

Balancing act

The researchers haven’t looked at a dose effect in this current study, but Dr. Meador said it’s always “a balancing act” between giving enough of the drug to keep mothers from seizing, which affect both the mother and fetus, and giving as low a dose as possible to protect the fetus.

In addition, as medication levels change during pregnancy, he said he recommends that drug levels are monitored monthly so that medication can be adjusted as necessary.

Looking at what factors might predict creativity scores, researchers found children did less well creatively if their mother didn’t have a college degree (estimate –9.5; 95% CI, –17.9 to –1.2; P = .025).

“It looks like being in a home where the mother has had more education is going to have an impact on the kid’s thinking and creativity,” said Dr. Meador.

These new findings are consistent with a lack of differences in other cognitive abilities that Dr. Meador and his team found when the children were younger.

“At age 3, we did not find an overall difference in cognitive and verbal abilities and intelligence between the children of mothers with epilepsy and those of healthy women,” he said.

The researchers aim to assess cognitive and behavioral outcomes in these children when they are 6 years old.
 

Helpful information

Commenting on the findings, Stéphane Auvin, MD, PhD, chair of the department of pediatric neurology at the University of Paris, who co-moderated a platform session featuring the research, said the study “is an interesting measure of the impact of being exposed to antiseizure medications.”

Creativity is “complex,” he said. “It’s not only cognition; it could be things like behavior and impulsivity.”

The new information is “very helpful.” Focusing on something broader than just IQ “gives you a better picture of what’s going on.”

The study received funding from NIH, NINDS, and NICH. Dr. Meador has received grants from NIH/NINDS, NIH/NICHD, Veterans Administration, and Eisai. He has been a consultant for Epilepsy Consortium, Novartis, Supernus, Upsher Smith Labs, and UCB Pharma. Dr. Auvin reports no relevant financial relationships.

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

NASHVILLE, TENN. – There is no negative impact of in utero exposure to antiseizure medications on children’s creativity, new research shows.

The results of this study, along with other research, suggest the risk for cognitive problems “is fairly low” overall for children of women with epilepsy taking lamotrigine or levetiracetam, study investigator, Kimford J. Meador, MD, professor, department of neurology & neurological sciences, Stanford (Calif.) University School of Medicine, told this news organization.

“This is another encouraging piece that’s showing these new drugs are safe with regard to cognition.”

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Capturing creativity

Fetal exposure to antiseizure medications can produce adverse neurodevelopmental effects. These are typically assessed using measures such as general intelligence, verbal/nonverbal abilities, or additional educational needs.

However, these measures don’t capture creativity, which “is related to intelligence but not completely,” said Dr. Meador. “I have seen wonderful examples of creativity in people who have a lot of cognitive impairment.”

He referred to one of his patients with epilepsy who is “spectacularly good” at painting with watercolors, even though she has significant cognitive impairment.

The new analysis is part of the MONEAD study, a prospective, observational multicenter study examining pregnancy outcomes for both mother and child. It included pregnant women who were enrolled at under 20 weeks’ gestational age.

The women with epilepsy in the study were primarily on monotherapy (73%), and of these, 82% were on lamotrigine or levetiracetam. About 22% were on polytherapy, of which 42% were on dual therapy with lamotrigine and levetiracetam.
 

Fluency, originality

Researchers assessed the children of these women at age 4½ years using the Torrance Test of Creative Thinking-Figural (TTCT-F). This is a standardized assessment of creative thinking with index scores measuring such things as fluency, originality, abstractness, and elaboration.

Dr. Meador noted the research team used a shorter version of the test battery “so as to not wear out the families and kids.”

During the test, children were given lines of different shapes and asked to draw a picture using these lines. Dr. Meador pointed out the drawings ranged from quite basic to more intricate.

One child cleverly turned a few squiggly lines into a car. “I can look at this and say this kid’s going to do very well,” said Dr. Meador.

Investigators compared scores between 241 children of women with epilepsy (WWE) and 65 children of healthy women (HW). They adjusted for the mother’s IQ, education level, age at enrollment, gestation age at enrollment, post-birth average anxiety score, and the child’s ethnicity and sex.

Investigators found the mean TTCT-F scores did not differ significantly between the two groups: adjusted least squares mean of 89.5 (95% confidence interval, 86.7-92.3) for children of WWE, compared with adjusted least square mean of 92.0 (95% CI, 86.4-97.6) for children of HW.
 

Balancing act

The researchers haven’t looked at a dose effect in this current study, but Dr. Meador said it’s always “a balancing act” between giving enough of the drug to keep mothers from seizing, which affect both the mother and fetus, and giving as low a dose as possible to protect the fetus.

In addition, as medication levels change during pregnancy, he said he recommends that drug levels are monitored monthly so that medication can be adjusted as necessary.

Looking at what factors might predict creativity scores, researchers found children did less well creatively if their mother didn’t have a college degree (estimate –9.5; 95% CI, –17.9 to –1.2; P = .025).

“It looks like being in a home where the mother has had more education is going to have an impact on the kid’s thinking and creativity,” said Dr. Meador.

These new findings are consistent with a lack of differences in other cognitive abilities that Dr. Meador and his team found when the children were younger.

“At age 3, we did not find an overall difference in cognitive and verbal abilities and intelligence between the children of mothers with epilepsy and those of healthy women,” he said.

The researchers aim to assess cognitive and behavioral outcomes in these children when they are 6 years old.
 

Helpful information

Commenting on the findings, Stéphane Auvin, MD, PhD, chair of the department of pediatric neurology at the University of Paris, who co-moderated a platform session featuring the research, said the study “is an interesting measure of the impact of being exposed to antiseizure medications.”

Creativity is “complex,” he said. “It’s not only cognition; it could be things like behavior and impulsivity.”

The new information is “very helpful.” Focusing on something broader than just IQ “gives you a better picture of what’s going on.”

The study received funding from NIH, NINDS, and NICH. Dr. Meador has received grants from NIH/NINDS, NIH/NICHD, Veterans Administration, and Eisai. He has been a consultant for Epilepsy Consortium, Novartis, Supernus, Upsher Smith Labs, and UCB Pharma. Dr. Auvin reports no relevant financial relationships.

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

Sunscreens marketed to individuals with skin of color are generally more expensive than products broadly marketed to consumers, and more than 40% contain a UV blocker that may create a white cast.

Ridofranz / iStock / Getty Images

Those are among the findings from a study by Michelle Xiong, a medical student at Brown University, Providence, R.I., and Erin M. Warshaw, MD, of the department of dermatology at Park Nicollet/Health Partners Health Services, Minneapolis, which was published online in the Journal of the American Academy of Dermatology.

“There is increasing awareness of the negative effects of ultraviolet (UV) light in individuals with skin of color (SOC), especially in regards to pigmentation disorders induced and/or exacerbated by UV exposure,” the authors wrote. “As a result, there has been a surge in sunscreens marketed to this population. We aimed to characterize cost, marketing claims, and potential allergenic ingredients in sunscreens marketed to individuals with SOC.”

Between December 2021 and October 2022, the researchers used the following search terms on Google: “sunscreen” plus “skin of 36 color,” “dark skin,” “brown skin,” “LatinX skin,” and/or “Black skin.” They extracted price, marketing claims, and ingredients from manufacturers’ websites and used 90 allergens contained in the American Contact Dermatitis Society 2020 Core series to identify potential allergens. Next, they combined cross-reactors/synonyms into allergen categories based on ACDS Contact Allergen Management Plan (CAMP) cross-reactor classification. If multiple ingredients in a sunscreen were represented by a single allergen category, it was counted only once. A similar approach was utilized for marketing categories.

A total of 12 sunscreens were included in the analysis: Absolute Joi, Black Girl Sunscreen, Black Girl Sunscreen Make It Matte, Bolden SPF Brightening Moisturizer, Eleven on the Defense Unrivaled Sun Serum, Kinlo Golden Rays Sunscreen, Live Tinted Hueguard 3-in-1 Mineral Sunscreen, Mele Dew The Most Sheer Moisturizer SPF30 Broad Spectrum Sunscreen, Mele No Shade Sunscreen Oil, Specific Beauty Active Radiance Day Moi, Unsun Mineral Sunscreen, and Urban Skin Rx Complexion Protection. Their average cost was $19.30 per ounce (range, $6.33-$50.00) and common marketing claims for these products were “no white cast” (91.7%), being free of an ingredient (83.3%), and “moisturizing” (75%).

Of the 12 sunscreens, 7 (58.3%) contained a chemical sunscreen agent, 5 (41.7%) contained a physical UV blocker, and all contained at least one allergen. The average number of allergens per product was 4.7, most commonly fragrance/botanicals (83.3%), tocopherol (83.3%), sodium benzoates/derivatives (58.3%), and sorbitan sesquiolate/derivatives (58.3%).

“Average cost of sunscreens marketed to individuals with SOC was $19.30/oz, much higher than the median price of $3.32/oz reported in a separate study of 65 popular sunscreens,” the study authors wrote. “As many of the sunscreens in our study were sold by smaller businesses, higher prices may be due to higher production costs or a perceived smaller market.”

The authors expressed surprise that five sunscreens marketed to individuals with SOC contained a physical UV blocker which may create a white cast. They contacted the manufacturers of these five sunscreens and confirmed that three used micronized formulations. “While ingested/inhaled nanoparticles of titanium dioxide may cause tissue effects, most studies of topical products show excellent safety,” they wrote.

They also noted that the average of 4.7 allergens per product observed in the analysis was similar to the average of 4.9 seen in a separate study of 52 popular sunscreens. “However, that study only included 34 allergens while this study evaluated 90 allergens,” the authors wrote. “Consumers and providers should be aware sunscreens marketed to individuals with SOC may cause allergic contact dermatitis,” they commented.

“It is interesting to see how costly these products are now compared to store bought and general commercially available sunscreens several years ago,” said Lawrence J. Green, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “However, to me that is not surprising as products marketed and targeted to specific populations are often priced at a premium. It wasn’t clear to me how many of these specialized online SOC sunscreens are tinted. I wish the authors had compared the cost of tinted sunscreens in general to nontinted sunscreens because tinted ones are more useful for SOC, because when rubbed in, they can readily match SOC and can also offer protection in the visible light spectrum.”

The authors reported having no financial disclosures; the study had no funding source. Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies.

Sunscreens marketed to individuals with skin of color are generally more expensive than products broadly marketed to consumers, and more than 40% contain a UV blocker that may create a white cast.

Ridofranz / iStock / Getty Images

Those are among the findings from a study by Michelle Xiong, a medical student at Brown University, Providence, R.I., and Erin M. Warshaw, MD, of the department of dermatology at Park Nicollet/Health Partners Health Services, Minneapolis, which was published online in the Journal of the American Academy of Dermatology.

“There is increasing awareness of the negative effects of ultraviolet (UV) light in individuals with skin of color (SOC), especially in regards to pigmentation disorders induced and/or exacerbated by UV exposure,” the authors wrote. “As a result, there has been a surge in sunscreens marketed to this population. We aimed to characterize cost, marketing claims, and potential allergenic ingredients in sunscreens marketed to individuals with SOC.”

Between December 2021 and October 2022, the researchers used the following search terms on Google: “sunscreen” plus “skin of 36 color,” “dark skin,” “brown skin,” “LatinX skin,” and/or “Black skin.” They extracted price, marketing claims, and ingredients from manufacturers’ websites and used 90 allergens contained in the American Contact Dermatitis Society 2020 Core series to identify potential allergens. Next, they combined cross-reactors/synonyms into allergen categories based on ACDS Contact Allergen Management Plan (CAMP) cross-reactor classification. If multiple ingredients in a sunscreen were represented by a single allergen category, it was counted only once. A similar approach was utilized for marketing categories.

A total of 12 sunscreens were included in the analysis: Absolute Joi, Black Girl Sunscreen, Black Girl Sunscreen Make It Matte, Bolden SPF Brightening Moisturizer, Eleven on the Defense Unrivaled Sun Serum, Kinlo Golden Rays Sunscreen, Live Tinted Hueguard 3-in-1 Mineral Sunscreen, Mele Dew The Most Sheer Moisturizer SPF30 Broad Spectrum Sunscreen, Mele No Shade Sunscreen Oil, Specific Beauty Active Radiance Day Moi, Unsun Mineral Sunscreen, and Urban Skin Rx Complexion Protection. Their average cost was $19.30 per ounce (range, $6.33-$50.00) and common marketing claims for these products were “no white cast” (91.7%), being free of an ingredient (83.3%), and “moisturizing” (75%).

Of the 12 sunscreens, 7 (58.3%) contained a chemical sunscreen agent, 5 (41.7%) contained a physical UV blocker, and all contained at least one allergen. The average number of allergens per product was 4.7, most commonly fragrance/botanicals (83.3%), tocopherol (83.3%), sodium benzoates/derivatives (58.3%), and sorbitan sesquiolate/derivatives (58.3%).

“Average cost of sunscreens marketed to individuals with SOC was $19.30/oz, much higher than the median price of $3.32/oz reported in a separate study of 65 popular sunscreens,” the study authors wrote. “As many of the sunscreens in our study were sold by smaller businesses, higher prices may be due to higher production costs or a perceived smaller market.”

The authors expressed surprise that five sunscreens marketed to individuals with SOC contained a physical UV blocker which may create a white cast. They contacted the manufacturers of these five sunscreens and confirmed that three used micronized formulations. “While ingested/inhaled nanoparticles of titanium dioxide may cause tissue effects, most studies of topical products show excellent safety,” they wrote.

They also noted that the average of 4.7 allergens per product observed in the analysis was similar to the average of 4.9 seen in a separate study of 52 popular sunscreens. “However, that study only included 34 allergens while this study evaluated 90 allergens,” the authors wrote. “Consumers and providers should be aware sunscreens marketed to individuals with SOC may cause allergic contact dermatitis,” they commented.

“It is interesting to see how costly these products are now compared to store bought and general commercially available sunscreens several years ago,” said Lawrence J. Green, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “However, to me that is not surprising as products marketed and targeted to specific populations are often priced at a premium. It wasn’t clear to me how many of these specialized online SOC sunscreens are tinted. I wish the authors had compared the cost of tinted sunscreens in general to nontinted sunscreens because tinted ones are more useful for SOC, because when rubbed in, they can readily match SOC and can also offer protection in the visible light spectrum.”

The authors reported having no financial disclosures; the study had no funding source. Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies.

Sunscreens marketed to individuals with skin of color are generally more expensive than products broadly marketed to consumers, and more than 40% contain a UV blocker that may create a white cast.

Ridofranz / iStock / Getty Images

Those are among the findings from a study by Michelle Xiong, a medical student at Brown University, Providence, R.I., and Erin M. Warshaw, MD, of the department of dermatology at Park Nicollet/Health Partners Health Services, Minneapolis, which was published online in the Journal of the American Academy of Dermatology.

“There is increasing awareness of the negative effects of ultraviolet (UV) light in individuals with skin of color (SOC), especially in regards to pigmentation disorders induced and/or exacerbated by UV exposure,” the authors wrote. “As a result, there has been a surge in sunscreens marketed to this population. We aimed to characterize cost, marketing claims, and potential allergenic ingredients in sunscreens marketed to individuals with SOC.”

Between December 2021 and October 2022, the researchers used the following search terms on Google: “sunscreen” plus “skin of 36 color,” “dark skin,” “brown skin,” “LatinX skin,” and/or “Black skin.” They extracted price, marketing claims, and ingredients from manufacturers’ websites and used 90 allergens contained in the American Contact Dermatitis Society 2020 Core series to identify potential allergens. Next, they combined cross-reactors/synonyms into allergen categories based on ACDS Contact Allergen Management Plan (CAMP) cross-reactor classification. If multiple ingredients in a sunscreen were represented by a single allergen category, it was counted only once. A similar approach was utilized for marketing categories.

A total of 12 sunscreens were included in the analysis: Absolute Joi, Black Girl Sunscreen, Black Girl Sunscreen Make It Matte, Bolden SPF Brightening Moisturizer, Eleven on the Defense Unrivaled Sun Serum, Kinlo Golden Rays Sunscreen, Live Tinted Hueguard 3-in-1 Mineral Sunscreen, Mele Dew The Most Sheer Moisturizer SPF30 Broad Spectrum Sunscreen, Mele No Shade Sunscreen Oil, Specific Beauty Active Radiance Day Moi, Unsun Mineral Sunscreen, and Urban Skin Rx Complexion Protection. Their average cost was $19.30 per ounce (range, $6.33-$50.00) and common marketing claims for these products were “no white cast” (91.7%), being free of an ingredient (83.3%), and “moisturizing” (75%).

Of the 12 sunscreens, 7 (58.3%) contained a chemical sunscreen agent, 5 (41.7%) contained a physical UV blocker, and all contained at least one allergen. The average number of allergens per product was 4.7, most commonly fragrance/botanicals (83.3%), tocopherol (83.3%), sodium benzoates/derivatives (58.3%), and sorbitan sesquiolate/derivatives (58.3%).

“Average cost of sunscreens marketed to individuals with SOC was $19.30/oz, much higher than the median price of $3.32/oz reported in a separate study of 65 popular sunscreens,” the study authors wrote. “As many of the sunscreens in our study were sold by smaller businesses, higher prices may be due to higher production costs or a perceived smaller market.”

The authors expressed surprise that five sunscreens marketed to individuals with SOC contained a physical UV blocker which may create a white cast. They contacted the manufacturers of these five sunscreens and confirmed that three used micronized formulations. “While ingested/inhaled nanoparticles of titanium dioxide may cause tissue effects, most studies of topical products show excellent safety,” they wrote.

They also noted that the average of 4.7 allergens per product observed in the analysis was similar to the average of 4.9 seen in a separate study of 52 popular sunscreens. “However, that study only included 34 allergens while this study evaluated 90 allergens,” the authors wrote. “Consumers and providers should be aware sunscreens marketed to individuals with SOC may cause allergic contact dermatitis,” they commented.

“It is interesting to see how costly these products are now compared to store bought and general commercially available sunscreens several years ago,” said Lawrence J. Green, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “However, to me that is not surprising as products marketed and targeted to specific populations are often priced at a premium. It wasn’t clear to me how many of these specialized online SOC sunscreens are tinted. I wish the authors had compared the cost of tinted sunscreens in general to nontinted sunscreens because tinted ones are more useful for SOC, because when rubbed in, they can readily match SOC and can also offer protection in the visible light spectrum.”

The authors reported having no financial disclosures; the study had no funding source. Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.

One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.

You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.

I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But I do want to tell you about a paper that, unlike so many that came before, lays out the argument for a potential COVID preventive so thoroughly and so rigorously, that it has convinced me that this little drug, ursodeoxycholic acid (UDCA) – you may know it as Actigall, used for an uncommon form of liver disease – may actually be useful to prevent COVID infection.

How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.

All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.

Courtesy Innovative Genomics

Courtesy Nature

Courtesy Nature

Courtesy Nature

Courtesy Nature

Courtesy Dr. F. Perry Wilson

courtesy Nature

Courtesy Nature

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.

A version of this video transcript first appeared on Medscape.com.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.

One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.

You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.

I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But I do want to tell you about a paper that, unlike so many that came before, lays out the argument for a potential COVID preventive so thoroughly and so rigorously, that it has convinced me that this little drug, ursodeoxycholic acid (UDCA) – you may know it as Actigall, used for an uncommon form of liver disease – may actually be useful to prevent COVID infection.

How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.

All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.

Courtesy Innovative Genomics

Courtesy Nature

Courtesy Nature

Courtesy Nature

Courtesy Nature

Courtesy Dr. F. Perry Wilson

courtesy Nature

Courtesy Nature

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.

A version of this video transcript first appeared on Medscape.com.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.

As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.

One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.

You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.

I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But I do want to tell you about a paper that, unlike so many that came before, lays out the argument for a potential COVID preventive so thoroughly and so rigorously, that it has convinced me that this little drug, ursodeoxycholic acid (UDCA) – you may know it as Actigall, used for an uncommon form of liver disease – may actually be useful to prevent COVID infection.

How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.

All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.

Courtesy Innovative Genomics

Courtesy Nature

Courtesy Nature

Courtesy Nature

Courtesy Nature

Courtesy Dr. F. Perry Wilson

courtesy Nature

Courtesy Nature

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.

A version of this video transcript first appeared on Medscape.com.

Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID. But the government plans to stop footing the bill within months, and millions of people who are at the highest risk of severe illness and are least able to afford the drug – the uninsured and seniors – may have to pay the full price.

And that means fewer people will get the potentially lifesaving treatments, experts said.

“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.

In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.

But soon the Department of Health & Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.

The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to Kaiser Health News, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year – those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.

Mr. Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”

Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D – the prescription drug program that covers nearly 50 million seniors – from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.

Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.

Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare – the very people who would benefit most from the drug, wrote federal health experts.

“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’s Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.

In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved – the Senate voted that same day to end the public health emergency and denied similar requests in recent months.

Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than White patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.

People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates – instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.

About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available 7 days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.

States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.

“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Ms. Rosenthal said.

People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.

Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.

And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Ms. Corlette said.

One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.

HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.

Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.

HHS did not make officials available for an interview or answer written questions about the commercialization plans.

The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.

Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.

“The medications are so worthwhile,” said Dr. Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID. But the government plans to stop footing the bill within months, and millions of people who are at the highest risk of severe illness and are least able to afford the drug – the uninsured and seniors – may have to pay the full price.

And that means fewer people will get the potentially lifesaving treatments, experts said.

“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.

In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.

But soon the Department of Health & Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.

The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to Kaiser Health News, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year – those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.

Mr. Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”

Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D – the prescription drug program that covers nearly 50 million seniors – from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.

Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.

Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare – the very people who would benefit most from the drug, wrote federal health experts.

“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’s Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.

In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved – the Senate voted that same day to end the public health emergency and denied similar requests in recent months.

Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than White patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.

People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates – instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.

About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available 7 days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.

States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.

“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Ms. Rosenthal said.

People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.

Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.

And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Ms. Corlette said.

One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.

HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.

Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.

HHS did not make officials available for an interview or answer written questions about the commercialization plans.

The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.

Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.

“The medications are so worthwhile,” said Dr. Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID. But the government plans to stop footing the bill within months, and millions of people who are at the highest risk of severe illness and are least able to afford the drug – the uninsured and seniors – may have to pay the full price.

And that means fewer people will get the potentially lifesaving treatments, experts said.

“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.

In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.

But soon the Department of Health & Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.

The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to Kaiser Health News, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year – those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.

Mr. Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”

Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D – the prescription drug program that covers nearly 50 million seniors – from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.

Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.

Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare – the very people who would benefit most from the drug, wrote federal health experts.

“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’s Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.

In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved – the Senate voted that same day to end the public health emergency and denied similar requests in recent months.

Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than White patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.

People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates – instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.

About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available 7 days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.

States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.

“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Ms. Rosenthal said.

People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.

Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.

And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Ms. Corlette said.

One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.

HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.

Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.

HHS did not make officials available for an interview or answer written questions about the commercialization plans.

The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.

Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.

“The medications are so worthwhile,” said Dr. Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

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If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Measles has sickened 59 children in an outbreak that began in November and now spans four Ohio counties.

None of the children had been fully vaccinated against measles, and 23 of them have been hospitalized, local officials report.

“Measles can be very serious, especially for children under age 5,” Columbus Public Health spokesperson Kelli Newman told CNN.

Nearly all of the infected children are under age 5, with 12 of them being under 1 year old. 

“Many children are hospitalized for dehydration,” Ms. Newman told CNN in an email. “Other serious complications also can include pneumonia and neurological conditions such as encephalitis. There’s no way of knowing which children will become so sick they have to be hospitalized. The safest way to protect children from measles is to make sure they are vaccinated with MMR.”

Of the 59 infected children, 56 were unvaccinated and three had been partially vaccinated. The MMR (measles, mumps, and rubella) vaccine is recommended for children beginning at 12 months old, according to the Centers for Disease Control and American Academy of Pediatrics. Two doses are needed to be considered fully vaccinated, and the second dose is usually given between 4 and 6 years old.

Measles “is one of the most infectious agents known to man,” the academy says.

It is so contagious that if one person has it, up to 9 out of 10 people around that person will also become infected if they are not protected, the CDC explains. Measles infection causes a rash and a fever that can spike beyond 104° F. Sometimes, the illness can lead to brain swelling, brain damage, or death.

Last month, the World Health Organization and CDC warned that 40 million children worldwide missed their measles vaccinations in 2021, partly due to pandemic disruptions. The American Academy of Pediatrics also notes that many parents choose not to vaccinate their children due to misinformation.

Infants are at heightened risk because they are too young to be vaccinated.

The academy offered several tips for protecting unvaccinated infants during a measles outbreak:

• Limit your baby’s exposure to crowds, other children, and people with cold symptoms.
• Disinfect objects and surfaces at home regularly, because the measles virus can live on surfaces or suspended in the air for 2 hours.
• If possible, feed your baby breast milk, because it has antibodies to prevent and fight infections.

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

Measles has sickened 59 children in an outbreak that began in November and now spans four Ohio counties.

None of the children had been fully vaccinated against measles, and 23 of them have been hospitalized, local officials report.

“Measles can be very serious, especially for children under age 5,” Columbus Public Health spokesperson Kelli Newman told CNN.

Nearly all of the infected children are under age 5, with 12 of them being under 1 year old. 

“Many children are hospitalized for dehydration,” Ms. Newman told CNN in an email. “Other serious complications also can include pneumonia and neurological conditions such as encephalitis. There’s no way of knowing which children will become so sick they have to be hospitalized. The safest way to protect children from measles is to make sure they are vaccinated with MMR.”

Of the 59 infected children, 56 were unvaccinated and three had been partially vaccinated. The MMR (measles, mumps, and rubella) vaccine is recommended for children beginning at 12 months old, according to the Centers for Disease Control and American Academy of Pediatrics. Two doses are needed to be considered fully vaccinated, and the second dose is usually given between 4 and 6 years old.

Measles “is one of the most infectious agents known to man,” the academy says.

It is so contagious that if one person has it, up to 9 out of 10 people around that person will also become infected if they are not protected, the CDC explains. Measles infection causes a rash and a fever that can spike beyond 104° F. Sometimes, the illness can lead to brain swelling, brain damage, or death.

Last month, the World Health Organization and CDC warned that 40 million children worldwide missed their measles vaccinations in 2021, partly due to pandemic disruptions. The American Academy of Pediatrics also notes that many parents choose not to vaccinate their children due to misinformation.

Infants are at heightened risk because they are too young to be vaccinated.

The academy offered several tips for protecting unvaccinated infants during a measles outbreak:

• Limit your baby’s exposure to crowds, other children, and people with cold symptoms.
• Disinfect objects and surfaces at home regularly, because the measles virus can live on surfaces or suspended in the air for 2 hours.
• If possible, feed your baby breast milk, because it has antibodies to prevent and fight infections.

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

Measles has sickened 59 children in an outbreak that began in November and now spans four Ohio counties.

None of the children had been fully vaccinated against measles, and 23 of them have been hospitalized, local officials report.

“Measles can be very serious, especially for children under age 5,” Columbus Public Health spokesperson Kelli Newman told CNN.

Nearly all of the infected children are under age 5, with 12 of them being under 1 year old. 

“Many children are hospitalized for dehydration,” Ms. Newman told CNN in an email. “Other serious complications also can include pneumonia and neurological conditions such as encephalitis. There’s no way of knowing which children will become so sick they have to be hospitalized. The safest way to protect children from measles is to make sure they are vaccinated with MMR.”

Of the 59 infected children, 56 were unvaccinated and three had been partially vaccinated. The MMR (measles, mumps, and rubella) vaccine is recommended for children beginning at 12 months old, according to the Centers for Disease Control and American Academy of Pediatrics. Two doses are needed to be considered fully vaccinated, and the second dose is usually given between 4 and 6 years old.

Measles “is one of the most infectious agents known to man,” the academy says.

It is so contagious that if one person has it, up to 9 out of 10 people around that person will also become infected if they are not protected, the CDC explains. Measles infection causes a rash and a fever that can spike beyond 104° F. Sometimes, the illness can lead to brain swelling, brain damage, or death.

Last month, the World Health Organization and CDC warned that 40 million children worldwide missed their measles vaccinations in 2021, partly due to pandemic disruptions. The American Academy of Pediatrics also notes that many parents choose not to vaccinate their children due to misinformation.

Infants are at heightened risk because they are too young to be vaccinated.

The academy offered several tips for protecting unvaccinated infants during a measles outbreak:

• Limit your baby’s exposure to crowds, other children, and people with cold symptoms.
• Disinfect objects and surfaces at home regularly, because the measles virus can live on surfaces or suspended in the air for 2 hours.
• If possible, feed your baby breast milk, because it has antibodies to prevent and fight infections.

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