Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

When Jane Cooke Wright, MD, entered the medical profession in 1945, the notion that toxic drugs could target tumors struck many physicians and patients as outlandish. How could one poison be weaponized against another poison – a cancerous tumor – without creating more havoc? Let alone a combination of two or more chemicals?

Yet by the time Dr. Wright retired in 1987, chemotherapy treatments that she’d helped develop were routinely saving lives. In fact, she’d played key roles in the development of oncology, a new medical specialty, and of its most powerful agent to combat disease and death.

Courtesy of the Wright family

Dr. Wright’s story would be extraordinary enough if she’d looked like most of her colleagues, but this surgeon and researcher stood apart. An African American woman at a time when medicine and science – like politics and law – were almost entirely the domain of White men, Dr. Wright had determination in her blood. Her father, once honored by a crowd of dignitaries that included a First Lady, persevered despite his horrific encounters with racism. She shared her father’s commitment to progress and added her own personal twists. She balanced elegance and beauty with scientific savvy, fierce ambition, and a refusal to be defined by anything other than her accomplishments.

“She didn’t focus on race, not at all,” her daughter Alison Jones, PhD, a psychologist in East Lansing, Mich., said in an interview. “Wherever she was, she wanted to be the best, not the best Black person. It was not about how she performed in a category, and she would get upset if someone said she was good as a Black physician.”

On the road to being the best, Dr. Jones said, her mother set a goal of curing cancer. National Cancer Research Month is a fitting opportunity to look back on a scientist dedicated to bringing humanity closer to that elusive achievement.
 

Medical legacy blazed in toil and trauma

A strong case could be made that Dr. Jane C. Wright and her father Louis Tompkins Wright, MD, are the most accomplished father-and-daughter team in all of medicine.

The elder Dr. Wright, son of a formerly enslaved man turned physician and a stepson of the first African American to graduate from Yale University, New Haven, Conn., himself graduated from Harvard Medical School in 1915. He earned a Purple Heart while serving in World War I, then went on to become the first Black surgeon to join the staff at Harlem Hospital.

Dr. Wright, who had witnessed mob violence and the aftermath of a lynching as a young man, became a supporter of the Harlem Renaissance and a prominent advocate for civil rights and integration. He served as chairman of the National Association for the Advancement of Colored People and was only the second Black member of the American College of Surgeons.

According to the 2009 book “Black Genius: Inspirational Portraits of African American Leaders,” he successfully treated the rare but devastating venereal disease lymphogranuloma venereum with a new antibiotic developed by his former colleague Yellapragada SubbaRow, MD. Dr. Wright even tried the drug himself, “as a lot of doctors in the olden days did,” according to another of his daughters, the late Barbara Wright Pierce, MD, who was quoted in “Black Genius.” She, too, was a physician.

In 1948, Dr. Jane C. Wright joined her father at Harlem Hospital’s Cancer Research Foundation. There the duo explored the cancer-fighting possibilities of a nitrogen mustard–like chemical agent that had been known since World War I to kill white blood cells. Ironically, Dr. Louis Wright himself suffered lifelong health problems because of an attack from the poisonous gas phosgene during his wartime service.

“Remissions were observed in patients with sarcoma, Hodgkin disease, and chronic myelogenous leukemia, mycosis fungoides, and lymphoma,” reported a 2013 obituary in the journal Oncology of the younger Dr. Wright. “They also performed early research into the clinical efficacy and toxicity of folic acid antagonists, documenting responses in 93 patients with various forms of incurable blood cancers and solid tumors.”

This research appears in a study that was authored by three Dr. Wrights – Dr. Louis T. Wright and his daughters Jane and Barbara.

“The elder Dr. Wright died in 1952, just months after 1,000 people – including Eleanor Roosevelt – honored him at a dinner to dedicate a Harlem Hospital library named after him. He was 61.
 

Scientific savvy mixed with modesty and elegance

After her father’s death, Dr. Janet C. Wright became director of the hospital’s cancer foundation. From the 1950s to the 1970s, she “worked out ways to use pieces of a patient’s own tumor, removed by surgery and grown in a nutrient culture medium in the laboratory, as a ‘guinea pig for testing drugs,’ ” according to the 1991 book “Black Scientists.” Previously, researchers had focused on mice as test subjects.

This approach also allowed Dr. Wright to determine if specific drugs such as methotrexate, a folic acid antagonist, would help specific patients. “She was looking for predictive activity for chemotherapeutic efficacy in vitro at a time when no one had good predictive tests,” wrote James F. Holland, MD, the late Mount Sinai School of Medicine oncologist, who was quoted in Dr. Wright’s 2013 Oncology obituary.

“Her strict attention to detail and concern for her patients helped determine effective dosing levels and establish treatment guidelines,” the Oncology obituary reported. “She treated patients that other physicians had given up on, and she was among the first small cadre of researchers to carefully test the effects of drugs against cancer in a clinical trial setting.”

Dr. Wright also focused on developing ways to administer chemotherapy, such using a catheter to reach difficult-to-access organs like the spleen without surgery, according to “Black Scientists.”

Along with her work, Dr. Wright’s appearance set her apart. According to “Black Genius,” a newspaper columnist dubbed her one of the 10 most beautiful Back woman in America, and Ebony Magazine in 1966 honored her as one of the best-dressed women in America. It featured a photograph of her in a stunning ivory and yellow brocade gown, noting that she was “in private life Mrs. David J. Jones.” (She’d married the Harvard University Law School graduate in 1946.)

Dr. Wright had a sense of modesty despite her accomplishments, according to her daughter Alison Jones. She even downplayed her own mental powers in a newspaper interview. “I know I’m a member of two minority groups,” she told The New York Post in 1967, “but I don’t think of myself that way. Sure, a woman has to try twice as hard. But – racial prejudice? I’ve met very little of it. It could be I met it – and wasn’t intelligent enough to recognize it.”

Sharp-eyed readers might have glimpsed her modesty nearly 2 decades later. In a 1984 article for the Journal of the National Medical Association, a society of African American physicians, she wrote about the past, present, and future of chemotherapy without noting her own prominent role in its development.
 

‘Global medical pioneer’ cofounds ASCO – and more

In the 1960s, Dr. Wright joined the influential President’s Commission on Heart Disease, Cancer, and Stroke and was named associate dean at New York Medical College, her alma mater, a first for a black woman at a prominent U.S. medical school. Even more importantly, Dr. Wright was the sole woman among seven physicians who founded the American Society of Clinical Oncology in Chicago in 1964. She served as ASCO’s first Secretary-Treasurer and was honored as its longest surviving founder when she passed away 9 years ago.

“Jane Wright had the vision to see that oncology was an important separate discipline within medicine with far-reaching implications for research and discovery,” Georgetown University Medical Center, Washington, oncologist Sandra M. Swain, MD, a former president of the ASCO and author of the 2013 Oncology obituary of Dr. Wright, said in an interview. “It is truly remarkable that, as a woman and an African American woman, she had a seat at the very small table for the formation of such an important group.”

As her friend and fellow oncologist Edith Mitchell, MD, said in a eulogy, “Dr. Wright led delegations of oncologists to China and the Soviet Union, and countries in Africa and Eastern Europe. She led medical teams providing medical and cancer care and education to other nurses and physicians in Ghana in 1957 and Kenya in 1961. From 1973 to 1984, she served as vice-president of the African Research and Medical foundation.”

Dr. Wright also raised two daughters. A 1968 Ebony article devoted to her career and family declared that neither of her teenagers was interested in medical careers. Their perspectives shifted, however – as had Dr. Wright’s. An undergraduate at Smith College, Dr. Wright majored in art, swam on the varsity team, and had a special affinity for German language studies before she switched to premed.

Like their mother, Dr. Wright’s daughters also changed paths, and they ultimately became the fourth generation of their family to enter the medical field. Dr. Alison Jones, the psychologist, currently works in a prison, while Jane Jones, MD, became a clinical psychiatrist. She’s now retired and lives in Guttenberg, N.J.

Both fondly remember their mother as a supportive force who insisted on excellence. “There couldn’t be any excuses for you not getting where you wanted to go,” Dr. Jane Jones recalled in an interview.

Nevertheless, Dr. Wright was still keenly aware of society’s limits. “She told me I had to be a doctor or lawyer,” Dr. Alison Jones said, “because that’s how you need to survive when you’re Black in America.”

Dr. Wright passed away in 2013 at age 93. “Dr. Jane C. Wright truly has made contributions that have changed the practice of medicine,” noted her friend Dr. Mitchell, an oncologist and a retired brigadier general with the U.S. Air Force who now teaches at Thomas Jefferson University, Philadelphia. “A true pioneer. A concerned mentor. A renowned researcher. A global teacher. A global medical pioneer. A talented researcher, beloved sister, wife, and mother, and a beautiful, kind, and loving human being.”

When Jane Cooke Wright, MD, entered the medical profession in 1945, the notion that toxic drugs could target tumors struck many physicians and patients as outlandish. How could one poison be weaponized against another poison – a cancerous tumor – without creating more havoc? Let alone a combination of two or more chemicals?

Yet by the time Dr. Wright retired in 1987, chemotherapy treatments that she’d helped develop were routinely saving lives. In fact, she’d played key roles in the development of oncology, a new medical specialty, and of its most powerful agent to combat disease and death.

Courtesy of the Wright family

Dr. Wright’s story would be extraordinary enough if she’d looked like most of her colleagues, but this surgeon and researcher stood apart. An African American woman at a time when medicine and science – like politics and law – were almost entirely the domain of White men, Dr. Wright had determination in her blood. Her father, once honored by a crowd of dignitaries that included a First Lady, persevered despite his horrific encounters with racism. She shared her father’s commitment to progress and added her own personal twists. She balanced elegance and beauty with scientific savvy, fierce ambition, and a refusal to be defined by anything other than her accomplishments.

“She didn’t focus on race, not at all,” her daughter Alison Jones, PhD, a psychologist in East Lansing, Mich., said in an interview. “Wherever she was, she wanted to be the best, not the best Black person. It was not about how she performed in a category, and she would get upset if someone said she was good as a Black physician.”

On the road to being the best, Dr. Jones said, her mother set a goal of curing cancer. National Cancer Research Month is a fitting opportunity to look back on a scientist dedicated to bringing humanity closer to that elusive achievement.
 

Medical legacy blazed in toil and trauma

A strong case could be made that Dr. Jane C. Wright and her father Louis Tompkins Wright, MD, are the most accomplished father-and-daughter team in all of medicine.

The elder Dr. Wright, son of a formerly enslaved man turned physician and a stepson of the first African American to graduate from Yale University, New Haven, Conn., himself graduated from Harvard Medical School in 1915. He earned a Purple Heart while serving in World War I, then went on to become the first Black surgeon to join the staff at Harlem Hospital.

Dr. Wright, who had witnessed mob violence and the aftermath of a lynching as a young man, became a supporter of the Harlem Renaissance and a prominent advocate for civil rights and integration. He served as chairman of the National Association for the Advancement of Colored People and was only the second Black member of the American College of Surgeons.

According to the 2009 book “Black Genius: Inspirational Portraits of African American Leaders,” he successfully treated the rare but devastating venereal disease lymphogranuloma venereum with a new antibiotic developed by his former colleague Yellapragada SubbaRow, MD. Dr. Wright even tried the drug himself, “as a lot of doctors in the olden days did,” according to another of his daughters, the late Barbara Wright Pierce, MD, who was quoted in “Black Genius.” She, too, was a physician.

In 1948, Dr. Jane C. Wright joined her father at Harlem Hospital’s Cancer Research Foundation. There the duo explored the cancer-fighting possibilities of a nitrogen mustard–like chemical agent that had been known since World War I to kill white blood cells. Ironically, Dr. Louis Wright himself suffered lifelong health problems because of an attack from the poisonous gas phosgene during his wartime service.

“Remissions were observed in patients with sarcoma, Hodgkin disease, and chronic myelogenous leukemia, mycosis fungoides, and lymphoma,” reported a 2013 obituary in the journal Oncology of the younger Dr. Wright. “They also performed early research into the clinical efficacy and toxicity of folic acid antagonists, documenting responses in 93 patients with various forms of incurable blood cancers and solid tumors.”

This research appears in a study that was authored by three Dr. Wrights – Dr. Louis T. Wright and his daughters Jane and Barbara.

“The elder Dr. Wright died in 1952, just months after 1,000 people – including Eleanor Roosevelt – honored him at a dinner to dedicate a Harlem Hospital library named after him. He was 61.
 

Scientific savvy mixed with modesty and elegance

After her father’s death, Dr. Janet C. Wright became director of the hospital’s cancer foundation. From the 1950s to the 1970s, she “worked out ways to use pieces of a patient’s own tumor, removed by surgery and grown in a nutrient culture medium in the laboratory, as a ‘guinea pig for testing drugs,’ ” according to the 1991 book “Black Scientists.” Previously, researchers had focused on mice as test subjects.

This approach also allowed Dr. Wright to determine if specific drugs such as methotrexate, a folic acid antagonist, would help specific patients. “She was looking for predictive activity for chemotherapeutic efficacy in vitro at a time when no one had good predictive tests,” wrote James F. Holland, MD, the late Mount Sinai School of Medicine oncologist, who was quoted in Dr. Wright’s 2013 Oncology obituary.

“Her strict attention to detail and concern for her patients helped determine effective dosing levels and establish treatment guidelines,” the Oncology obituary reported. “She treated patients that other physicians had given up on, and she was among the first small cadre of researchers to carefully test the effects of drugs against cancer in a clinical trial setting.”

Dr. Wright also focused on developing ways to administer chemotherapy, such using a catheter to reach difficult-to-access organs like the spleen without surgery, according to “Black Scientists.”

Along with her work, Dr. Wright’s appearance set her apart. According to “Black Genius,” a newspaper columnist dubbed her one of the 10 most beautiful Back woman in America, and Ebony Magazine in 1966 honored her as one of the best-dressed women in America. It featured a photograph of her in a stunning ivory and yellow brocade gown, noting that she was “in private life Mrs. David J. Jones.” (She’d married the Harvard University Law School graduate in 1946.)

Dr. Wright had a sense of modesty despite her accomplishments, according to her daughter Alison Jones. She even downplayed her own mental powers in a newspaper interview. “I know I’m a member of two minority groups,” she told The New York Post in 1967, “but I don’t think of myself that way. Sure, a woman has to try twice as hard. But – racial prejudice? I’ve met very little of it. It could be I met it – and wasn’t intelligent enough to recognize it.”

Sharp-eyed readers might have glimpsed her modesty nearly 2 decades later. In a 1984 article for the Journal of the National Medical Association, a society of African American physicians, she wrote about the past, present, and future of chemotherapy without noting her own prominent role in its development.
 

‘Global medical pioneer’ cofounds ASCO – and more

In the 1960s, Dr. Wright joined the influential President’s Commission on Heart Disease, Cancer, and Stroke and was named associate dean at New York Medical College, her alma mater, a first for a black woman at a prominent U.S. medical school. Even more importantly, Dr. Wright was the sole woman among seven physicians who founded the American Society of Clinical Oncology in Chicago in 1964. She served as ASCO’s first Secretary-Treasurer and was honored as its longest surviving founder when she passed away 9 years ago.

“Jane Wright had the vision to see that oncology was an important separate discipline within medicine with far-reaching implications for research and discovery,” Georgetown University Medical Center, Washington, oncologist Sandra M. Swain, MD, a former president of the ASCO and author of the 2013 Oncology obituary of Dr. Wright, said in an interview. “It is truly remarkable that, as a woman and an African American woman, she had a seat at the very small table for the formation of such an important group.”

As her friend and fellow oncologist Edith Mitchell, MD, said in a eulogy, “Dr. Wright led delegations of oncologists to China and the Soviet Union, and countries in Africa and Eastern Europe. She led medical teams providing medical and cancer care and education to other nurses and physicians in Ghana in 1957 and Kenya in 1961. From 1973 to 1984, she served as vice-president of the African Research and Medical foundation.”

Dr. Wright also raised two daughters. A 1968 Ebony article devoted to her career and family declared that neither of her teenagers was interested in medical careers. Their perspectives shifted, however – as had Dr. Wright’s. An undergraduate at Smith College, Dr. Wright majored in art, swam on the varsity team, and had a special affinity for German language studies before she switched to premed.

Like their mother, Dr. Wright’s daughters also changed paths, and they ultimately became the fourth generation of their family to enter the medical field. Dr. Alison Jones, the psychologist, currently works in a prison, while Jane Jones, MD, became a clinical psychiatrist. She’s now retired and lives in Guttenberg, N.J.

Both fondly remember their mother as a supportive force who insisted on excellence. “There couldn’t be any excuses for you not getting where you wanted to go,” Dr. Jane Jones recalled in an interview.

Nevertheless, Dr. Wright was still keenly aware of society’s limits. “She told me I had to be a doctor or lawyer,” Dr. Alison Jones said, “because that’s how you need to survive when you’re Black in America.”

Dr. Wright passed away in 2013 at age 93. “Dr. Jane C. Wright truly has made contributions that have changed the practice of medicine,” noted her friend Dr. Mitchell, an oncologist and a retired brigadier general with the U.S. Air Force who now teaches at Thomas Jefferson University, Philadelphia. “A true pioneer. A concerned mentor. A renowned researcher. A global teacher. A global medical pioneer. A talented researcher, beloved sister, wife, and mother, and a beautiful, kind, and loving human being.”

When Jane Cooke Wright, MD, entered the medical profession in 1945, the notion that toxic drugs could target tumors struck many physicians and patients as outlandish. How could one poison be weaponized against another poison – a cancerous tumor – without creating more havoc? Let alone a combination of two or more chemicals?

Yet by the time Dr. Wright retired in 1987, chemotherapy treatments that she’d helped develop were routinely saving lives. In fact, she’d played key roles in the development of oncology, a new medical specialty, and of its most powerful agent to combat disease and death.

Courtesy of the Wright family

Dr. Wright’s story would be extraordinary enough if she’d looked like most of her colleagues, but this surgeon and researcher stood apart. An African American woman at a time when medicine and science – like politics and law – were almost entirely the domain of White men, Dr. Wright had determination in her blood. Her father, once honored by a crowd of dignitaries that included a First Lady, persevered despite his horrific encounters with racism. She shared her father’s commitment to progress and added her own personal twists. She balanced elegance and beauty with scientific savvy, fierce ambition, and a refusal to be defined by anything other than her accomplishments.

“She didn’t focus on race, not at all,” her daughter Alison Jones, PhD, a psychologist in East Lansing, Mich., said in an interview. “Wherever she was, she wanted to be the best, not the best Black person. It was not about how she performed in a category, and she would get upset if someone said she was good as a Black physician.”

On the road to being the best, Dr. Jones said, her mother set a goal of curing cancer. National Cancer Research Month is a fitting opportunity to look back on a scientist dedicated to bringing humanity closer to that elusive achievement.
 

Medical legacy blazed in toil and trauma

A strong case could be made that Dr. Jane C. Wright and her father Louis Tompkins Wright, MD, are the most accomplished father-and-daughter team in all of medicine.

The elder Dr. Wright, son of a formerly enslaved man turned physician and a stepson of the first African American to graduate from Yale University, New Haven, Conn., himself graduated from Harvard Medical School in 1915. He earned a Purple Heart while serving in World War I, then went on to become the first Black surgeon to join the staff at Harlem Hospital.

Dr. Wright, who had witnessed mob violence and the aftermath of a lynching as a young man, became a supporter of the Harlem Renaissance and a prominent advocate for civil rights and integration. He served as chairman of the National Association for the Advancement of Colored People and was only the second Black member of the American College of Surgeons.

According to the 2009 book “Black Genius: Inspirational Portraits of African American Leaders,” he successfully treated the rare but devastating venereal disease lymphogranuloma venereum with a new antibiotic developed by his former colleague Yellapragada SubbaRow, MD. Dr. Wright even tried the drug himself, “as a lot of doctors in the olden days did,” according to another of his daughters, the late Barbara Wright Pierce, MD, who was quoted in “Black Genius.” She, too, was a physician.

In 1948, Dr. Jane C. Wright joined her father at Harlem Hospital’s Cancer Research Foundation. There the duo explored the cancer-fighting possibilities of a nitrogen mustard–like chemical agent that had been known since World War I to kill white blood cells. Ironically, Dr. Louis Wright himself suffered lifelong health problems because of an attack from the poisonous gas phosgene during his wartime service.

“Remissions were observed in patients with sarcoma, Hodgkin disease, and chronic myelogenous leukemia, mycosis fungoides, and lymphoma,” reported a 2013 obituary in the journal Oncology of the younger Dr. Wright. “They also performed early research into the clinical efficacy and toxicity of folic acid antagonists, documenting responses in 93 patients with various forms of incurable blood cancers and solid tumors.”

This research appears in a study that was authored by three Dr. Wrights – Dr. Louis T. Wright and his daughters Jane and Barbara.

“The elder Dr. Wright died in 1952, just months after 1,000 people – including Eleanor Roosevelt – honored him at a dinner to dedicate a Harlem Hospital library named after him. He was 61.
 

Scientific savvy mixed with modesty and elegance

After her father’s death, Dr. Janet C. Wright became director of the hospital’s cancer foundation. From the 1950s to the 1970s, she “worked out ways to use pieces of a patient’s own tumor, removed by surgery and grown in a nutrient culture medium in the laboratory, as a ‘guinea pig for testing drugs,’ ” according to the 1991 book “Black Scientists.” Previously, researchers had focused on mice as test subjects.

This approach also allowed Dr. Wright to determine if specific drugs such as methotrexate, a folic acid antagonist, would help specific patients. “She was looking for predictive activity for chemotherapeutic efficacy in vitro at a time when no one had good predictive tests,” wrote James F. Holland, MD, the late Mount Sinai School of Medicine oncologist, who was quoted in Dr. Wright’s 2013 Oncology obituary.

“Her strict attention to detail and concern for her patients helped determine effective dosing levels and establish treatment guidelines,” the Oncology obituary reported. “She treated patients that other physicians had given up on, and she was among the first small cadre of researchers to carefully test the effects of drugs against cancer in a clinical trial setting.”

Dr. Wright also focused on developing ways to administer chemotherapy, such using a catheter to reach difficult-to-access organs like the spleen without surgery, according to “Black Scientists.”

Along with her work, Dr. Wright’s appearance set her apart. According to “Black Genius,” a newspaper columnist dubbed her one of the 10 most beautiful Back woman in America, and Ebony Magazine in 1966 honored her as one of the best-dressed women in America. It featured a photograph of her in a stunning ivory and yellow brocade gown, noting that she was “in private life Mrs. David J. Jones.” (She’d married the Harvard University Law School graduate in 1946.)

Dr. Wright had a sense of modesty despite her accomplishments, according to her daughter Alison Jones. She even downplayed her own mental powers in a newspaper interview. “I know I’m a member of two minority groups,” she told The New York Post in 1967, “but I don’t think of myself that way. Sure, a woman has to try twice as hard. But – racial prejudice? I’ve met very little of it. It could be I met it – and wasn’t intelligent enough to recognize it.”

Sharp-eyed readers might have glimpsed her modesty nearly 2 decades later. In a 1984 article for the Journal of the National Medical Association, a society of African American physicians, she wrote about the past, present, and future of chemotherapy without noting her own prominent role in its development.
 

‘Global medical pioneer’ cofounds ASCO – and more

In the 1960s, Dr. Wright joined the influential President’s Commission on Heart Disease, Cancer, and Stroke and was named associate dean at New York Medical College, her alma mater, a first for a black woman at a prominent U.S. medical school. Even more importantly, Dr. Wright was the sole woman among seven physicians who founded the American Society of Clinical Oncology in Chicago in 1964. She served as ASCO’s first Secretary-Treasurer and was honored as its longest surviving founder when she passed away 9 years ago.

“Jane Wright had the vision to see that oncology was an important separate discipline within medicine with far-reaching implications for research and discovery,” Georgetown University Medical Center, Washington, oncologist Sandra M. Swain, MD, a former president of the ASCO and author of the 2013 Oncology obituary of Dr. Wright, said in an interview. “It is truly remarkable that, as a woman and an African American woman, she had a seat at the very small table for the formation of such an important group.”

As her friend and fellow oncologist Edith Mitchell, MD, said in a eulogy, “Dr. Wright led delegations of oncologists to China and the Soviet Union, and countries in Africa and Eastern Europe. She led medical teams providing medical and cancer care and education to other nurses and physicians in Ghana in 1957 and Kenya in 1961. From 1973 to 1984, she served as vice-president of the African Research and Medical foundation.”

Dr. Wright also raised two daughters. A 1968 Ebony article devoted to her career and family declared that neither of her teenagers was interested in medical careers. Their perspectives shifted, however – as had Dr. Wright’s. An undergraduate at Smith College, Dr. Wright majored in art, swam on the varsity team, and had a special affinity for German language studies before she switched to premed.

Like their mother, Dr. Wright’s daughters also changed paths, and they ultimately became the fourth generation of their family to enter the medical field. Dr. Alison Jones, the psychologist, currently works in a prison, while Jane Jones, MD, became a clinical psychiatrist. She’s now retired and lives in Guttenberg, N.J.

Both fondly remember their mother as a supportive force who insisted on excellence. “There couldn’t be any excuses for you not getting where you wanted to go,” Dr. Jane Jones recalled in an interview.

Nevertheless, Dr. Wright was still keenly aware of society’s limits. “She told me I had to be a doctor or lawyer,” Dr. Alison Jones said, “because that’s how you need to survive when you’re Black in America.”

Dr. Wright passed away in 2013 at age 93. “Dr. Jane C. Wright truly has made contributions that have changed the practice of medicine,” noted her friend Dr. Mitchell, an oncologist and a retired brigadier general with the U.S. Air Force who now teaches at Thomas Jefferson University, Philadelphia. “A true pioneer. A concerned mentor. A renowned researcher. A global teacher. A global medical pioneer. A talented researcher, beloved sister, wife, and mother, and a beautiful, kind, and loving human being.”

SAN DIEGO – An intestinal adsorbent, polymethylsiloxane polyhydrate (PMSPH), may relieve the diarrhea associated with irritable bowel syndrome (IBS), researchers say.

The adsorbent reduced abdominal pain, improved stool consistency, and won praise from patients, said Yan Yiannakou, MBChB, a consultant in gastroenterology at County Durham and Darlington (England) National Health Service Foundation Trust.

“It’s great to have something new for patients to try,” he told MDEdge. “And it’s great that this treatment is so safe, and easy to use.”

Dr. Yiannakou presented the finding at the annual Digestive Diseases Week^® (DDW).

Many people with irritable bowel syndrome find the currently available treatments and diets difficult to use or ineffective.

First developed 30 years ago in Eastern Europe, PMSPH is marketed over the counter in 30 European countries under the name Enterosgel as a treatment for diarrhea, said Dr. Yiannakou. It received conformité européenne (CE) mark in 2011.

Since PMSPH is not adsorbed by the body, it has been approved as a medical device rather than as a drug, said Dr. Yiannakou. Although its manufacturer is not yet marketing it in the United States, websites there are offering it as a dietary supplement for "toxin binding" and "cleansing the gut."*

Since the etiology of IBS is poorly understood, it is also not clear exactly how PMSPH improves IBS symptoms, Dr. Yiannakou said. “I think this is binding a whole range of molecules which are either irritant or induce diarrhea through secretion.” Fat, bile salts, immune chemicals, and bacterial breakdown products are possibilities, he said.

PMSPH’s approval in Europe rests largely on trials for other forms of diarrhea; it did not undergo a high-quality randomized, placebo-controlled trial for IBS, Dr. Yiannakou said.

To fill that gap, he and his colleagues recruited 440 people with IBS, aged 16-75 years, from 28 sites in England. They randomly assigned 219 to receive PMSPH and 221 to receive a placebo for 8 weeks. Following this blinded phase, both groups received PMSPH for another 8 weeks (a phase requested by the patients who helped design the trial). The investigators then followed up with a phone call 8 weeks later to those who responded to the treatment.

The subjects recorded their symptoms in an e-diary and completed questionnaires. Because of COVID-19 constraints imposed after the trial began, the researchers collected some of the data through virtual visits and online questionnaires.

On a U.S. Food and Drug Administration–recommended composite score for abdominal pain and stool consistency, 37.4% of the patients receiving PMSPH were defined as responders versus 24.3% of the patients receiving the placebo, a statistically significant difference.

However, that score does not accurately reflect the main concerns of people with IBS diarrhea, said Dr. Yiannakou. More important is how often they have diarrhea, and by that measure the difference between the placebo and treatment groups was larger.

There were also statistically significant differences in favor of the PMSPH group in separate scores for abdominal pain, stool frequency, bloating, and urgency.

Surveyed between week 5 and week 8, 69% of patients taking PMSPH reported that they were getting adequate relief, compared with 30% of those taking the placebo. Among the responders surveyed 8 weeks after the open-label phase ended, 74% said they were still benefiting from the treatment. And 81% said they were still using PMSPH, even though they had to buy it for themselves.

Only a handful of patients experienced any adverse events, and there were no significant differences in the number of these events between those taking the placebo and those taking PMSPH.

“I think we’re going to be eager to learn which patients that have irritable bowel syndrome would benefit from this particular treatment,” said session comoderator Eric Shah, MD, MBA, director of gastrointestinal motility at Dartmouth University in Hanover, N.H., who was not involved in the study. He also wanted to know how PMSPH compares to similar binding agents on the market.

Session comoderator Nikrad Shahnavaz, MD, an associate professor of medicine in the division of digestive diseases, department of medicine, at Emory University, Atlanta, said his patients complain two binding agents now prescribed for IBS in the United States, cholestyramine and colestipol, cause nausea and vomiting. That could be an advantage for PMSPH, he said. “It’s good to add to your tools.”

Dr. Yiannakou, Dr. Shahnavaz, and Dr. Shah reported no relevant financial interests.

*An earlier version of this article misstated PMSPH's mechanism of action. It is not adsorbed by the body. Additionally, the marketing status of PMSPH was misstated; it is not currently on the U.S. market. 

SAN DIEGO – An intestinal adsorbent, polymethylsiloxane polyhydrate (PMSPH), may relieve the diarrhea associated with irritable bowel syndrome (IBS), researchers say.

The adsorbent reduced abdominal pain, improved stool consistency, and won praise from patients, said Yan Yiannakou, MBChB, a consultant in gastroenterology at County Durham and Darlington (England) National Health Service Foundation Trust.

“It’s great to have something new for patients to try,” he told MDEdge. “And it’s great that this treatment is so safe, and easy to use.”

Dr. Yiannakou presented the finding at the annual Digestive Diseases Week^® (DDW).

Many people with irritable bowel syndrome find the currently available treatments and diets difficult to use or ineffective.

First developed 30 years ago in Eastern Europe, PMSPH is marketed over the counter in 30 European countries under the name Enterosgel as a treatment for diarrhea, said Dr. Yiannakou. It received conformité européenne (CE) mark in 2011.

Since PMSPH is not adsorbed by the body, it has been approved as a medical device rather than as a drug, said Dr. Yiannakou. Although its manufacturer is not yet marketing it in the United States, websites there are offering it as a dietary supplement for "toxin binding" and "cleansing the gut."*

Since the etiology of IBS is poorly understood, it is also not clear exactly how PMSPH improves IBS symptoms, Dr. Yiannakou said. “I think this is binding a whole range of molecules which are either irritant or induce diarrhea through secretion.” Fat, bile salts, immune chemicals, and bacterial breakdown products are possibilities, he said.

PMSPH’s approval in Europe rests largely on trials for other forms of diarrhea; it did not undergo a high-quality randomized, placebo-controlled trial for IBS, Dr. Yiannakou said.

To fill that gap, he and his colleagues recruited 440 people with IBS, aged 16-75 years, from 28 sites in England. They randomly assigned 219 to receive PMSPH and 221 to receive a placebo for 8 weeks. Following this blinded phase, both groups received PMSPH for another 8 weeks (a phase requested by the patients who helped design the trial). The investigators then followed up with a phone call 8 weeks later to those who responded to the treatment.

The subjects recorded their symptoms in an e-diary and completed questionnaires. Because of COVID-19 constraints imposed after the trial began, the researchers collected some of the data through virtual visits and online questionnaires.

On a U.S. Food and Drug Administration–recommended composite score for abdominal pain and stool consistency, 37.4% of the patients receiving PMSPH were defined as responders versus 24.3% of the patients receiving the placebo, a statistically significant difference.

However, that score does not accurately reflect the main concerns of people with IBS diarrhea, said Dr. Yiannakou. More important is how often they have diarrhea, and by that measure the difference between the placebo and treatment groups was larger.

There were also statistically significant differences in favor of the PMSPH group in separate scores for abdominal pain, stool frequency, bloating, and urgency.

Surveyed between week 5 and week 8, 69% of patients taking PMSPH reported that they were getting adequate relief, compared with 30% of those taking the placebo. Among the responders surveyed 8 weeks after the open-label phase ended, 74% said they were still benefiting from the treatment. And 81% said they were still using PMSPH, even though they had to buy it for themselves.

Only a handful of patients experienced any adverse events, and there were no significant differences in the number of these events between those taking the placebo and those taking PMSPH.

“I think we’re going to be eager to learn which patients that have irritable bowel syndrome would benefit from this particular treatment,” said session comoderator Eric Shah, MD, MBA, director of gastrointestinal motility at Dartmouth University in Hanover, N.H., who was not involved in the study. He also wanted to know how PMSPH compares to similar binding agents on the market.

Session comoderator Nikrad Shahnavaz, MD, an associate professor of medicine in the division of digestive diseases, department of medicine, at Emory University, Atlanta, said his patients complain two binding agents now prescribed for IBS in the United States, cholestyramine and colestipol, cause nausea and vomiting. That could be an advantage for PMSPH, he said. “It’s good to add to your tools.”

Dr. Yiannakou, Dr. Shahnavaz, and Dr. Shah reported no relevant financial interests.

*An earlier version of this article misstated PMSPH's mechanism of action. It is not adsorbed by the body. Additionally, the marketing status of PMSPH was misstated; it is not currently on the U.S. market. 

SAN DIEGO – An intestinal adsorbent, polymethylsiloxane polyhydrate (PMSPH), may relieve the diarrhea associated with irritable bowel syndrome (IBS), researchers say.

The adsorbent reduced abdominal pain, improved stool consistency, and won praise from patients, said Yan Yiannakou, MBChB, a consultant in gastroenterology at County Durham and Darlington (England) National Health Service Foundation Trust.

“It’s great to have something new for patients to try,” he told MDEdge. “And it’s great that this treatment is so safe, and easy to use.”

Dr. Yiannakou presented the finding at the annual Digestive Diseases Week^® (DDW).

Many people with irritable bowel syndrome find the currently available treatments and diets difficult to use or ineffective.

First developed 30 years ago in Eastern Europe, PMSPH is marketed over the counter in 30 European countries under the name Enterosgel as a treatment for diarrhea, said Dr. Yiannakou. It received conformité européenne (CE) mark in 2011.

Since PMSPH is not adsorbed by the body, it has been approved as a medical device rather than as a drug, said Dr. Yiannakou. Although its manufacturer is not yet marketing it in the United States, websites there are offering it as a dietary supplement for "toxin binding" and "cleansing the gut."*

Since the etiology of IBS is poorly understood, it is also not clear exactly how PMSPH improves IBS symptoms, Dr. Yiannakou said. “I think this is binding a whole range of molecules which are either irritant or induce diarrhea through secretion.” Fat, bile salts, immune chemicals, and bacterial breakdown products are possibilities, he said.

PMSPH’s approval in Europe rests largely on trials for other forms of diarrhea; it did not undergo a high-quality randomized, placebo-controlled trial for IBS, Dr. Yiannakou said.

To fill that gap, he and his colleagues recruited 440 people with IBS, aged 16-75 years, from 28 sites in England. They randomly assigned 219 to receive PMSPH and 221 to receive a placebo for 8 weeks. Following this blinded phase, both groups received PMSPH for another 8 weeks (a phase requested by the patients who helped design the trial). The investigators then followed up with a phone call 8 weeks later to those who responded to the treatment.

The subjects recorded their symptoms in an e-diary and completed questionnaires. Because of COVID-19 constraints imposed after the trial began, the researchers collected some of the data through virtual visits and online questionnaires.

On a U.S. Food and Drug Administration–recommended composite score for abdominal pain and stool consistency, 37.4% of the patients receiving PMSPH were defined as responders versus 24.3% of the patients receiving the placebo, a statistically significant difference.

However, that score does not accurately reflect the main concerns of people with IBS diarrhea, said Dr. Yiannakou. More important is how often they have diarrhea, and by that measure the difference between the placebo and treatment groups was larger.

There were also statistically significant differences in favor of the PMSPH group in separate scores for abdominal pain, stool frequency, bloating, and urgency.

Surveyed between week 5 and week 8, 69% of patients taking PMSPH reported that they were getting adequate relief, compared with 30% of those taking the placebo. Among the responders surveyed 8 weeks after the open-label phase ended, 74% said they were still benefiting from the treatment. And 81% said they were still using PMSPH, even though they had to buy it for themselves.

Only a handful of patients experienced any adverse events, and there were no significant differences in the number of these events between those taking the placebo and those taking PMSPH.

“I think we’re going to be eager to learn which patients that have irritable bowel syndrome would benefit from this particular treatment,” said session comoderator Eric Shah, MD, MBA, director of gastrointestinal motility at Dartmouth University in Hanover, N.H., who was not involved in the study. He also wanted to know how PMSPH compares to similar binding agents on the market.

Session comoderator Nikrad Shahnavaz, MD, an associate professor of medicine in the division of digestive diseases, department of medicine, at Emory University, Atlanta, said his patients complain two binding agents now prescribed for IBS in the United States, cholestyramine and colestipol, cause nausea and vomiting. That could be an advantage for PMSPH, he said. “It’s good to add to your tools.”

Dr. Yiannakou, Dr. Shahnavaz, and Dr. Shah reported no relevant financial interests.

*An earlier version of this article misstated PMSPH's mechanism of action. It is not adsorbed by the body. Additionally, the marketing status of PMSPH was misstated; it is not currently on the U.S. market. 

Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.

“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.

“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.

“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.

In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.

Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.

Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.

Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).

“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.

“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”

The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.

“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
 

Make easy, effective contraception accessible to all

The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”

The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.

Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.

“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.

The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.

Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.

“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.

“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.

“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.

In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.

Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.

Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.

Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).

“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.

“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”

The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.

“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
 

Make easy, effective contraception accessible to all

The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”

The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.

Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.

“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.

The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.

Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.

“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.

“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.

“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.

In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.

Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.

Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.

Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).

“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.

“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”

The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.

“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
 

Make easy, effective contraception accessible to all

The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”

The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.

Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.

“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.

The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.

Different psychiatric disorders often share the same genetic architecture, which may help explain why many individuals diagnosed with one psychiatric disorder will be diagnosed with another in their lifetime, new research suggests.

Investigators conducted a genetic analysis of 11 major psychiatric disorders, including schizophrenia and bipolar disorder.

“Our findings confirm that high comorbidity across some disorders in part reflects overlapping pathways of genetic risk,” lead author Andrew Grotzinger, PhD, department of psychology and neuroscience, University of Colorado at Boulder, said in a press release.

The results could lead to the development of treatments that address multiple psychiatric disorders at once and help reshape the way diagnoses are established, the researchers note.

The findings were published online in Nature Genetics.
 

Common genetic patterns

Using the massive UK Biobank and the Psychiatric Genomics Consortium, the researchers applied novel statistical genetic methods to identify common patterns across 11 major psychiatric disorders: schizophrenia, bipolar disorder, major depressive disorder, anxiety disorder, anorexia nervosa, obsessive-compulsive disorder (OCD), Tourette syndrome, post traumatic stress disorder, problematic alcohol use, attention deficit hyperactive disorder, and autism. 

The average total sample size per disorder was 156,771 participants, with a range of 9,725 to 802,939 participants.

In all, the investigators identified 152 genetic variants shared across multiple disorders, including those already known to influence certain types of brain cells.

For example, they found that 70% of the genetic signal associated with schizophrenia was also associated with bipolar disorder. 

Results also showed that anorexia nervosa and OCD have a strong, shared genetic architecture and that individuals with a genetic predisposition to low body mass index also tend to have a genetic predisposition to these two disorders.

Not surprisingly, the researchers note, there was a large genetic overlap between anxiety disorder and major depressive disorder.

They also observed that psychiatric disorders that tend to cluster together also tend to share genes that influence how and when individuals are physically active during the day.

For example, patients with internalizing disorders such as anxiety and depression tend to have a genetic architecture associated with low movement throughout the day. On the other hand, those with OCD and anorexia tend to have genes associated with higher movement throughout the day. 

“When you think about it, it makes sense,” said Dr. Grotzinger. Depressed individuals often experience fatigue or low energy while those with compulsive disorders may have a tough time sitting still, he noted.
 

One treatment for multiple disorders?

“Collectively, these results offer key insights into the shared and disorder-specific mechanisms of genetic risk for psychiatric disease,” the investigators write.

Their research is also a first step toward developing therapies that can address multiple disorders with one treatment, they add.

“People are more likely today to be prescribed multiple medications intended to treat multiple diagnoses, and in some instances those medicines can have side effects,” Dr. Grotzinger said.

“By identifying what is shared across these issues, we can hopefully come up with ways to target them in a different way that doesn’t require four separate pills or four separate psychotherapy interventions,” he added.

Dr. Grotzinger noted that, for now, the knowledge that genetics are underlying their disorders may provide comfort to some patients.

“It’s important for people to know that they didn’t just get a terrible roll of the dice in life – that they are not facing multiple different issues but rather one set of risk factors bleeding into them all,” he said.

This research had no commercial funding. Dr. Grotzinger reported no relevant disclosures.

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

Different psychiatric disorders often share the same genetic architecture, which may help explain why many individuals diagnosed with one psychiatric disorder will be diagnosed with another in their lifetime, new research suggests.

Investigators conducted a genetic analysis of 11 major psychiatric disorders, including schizophrenia and bipolar disorder.

“Our findings confirm that high comorbidity across some disorders in part reflects overlapping pathways of genetic risk,” lead author Andrew Grotzinger, PhD, department of psychology and neuroscience, University of Colorado at Boulder, said in a press release.

The results could lead to the development of treatments that address multiple psychiatric disorders at once and help reshape the way diagnoses are established, the researchers note.

The findings were published online in Nature Genetics.
 

Common genetic patterns

Using the massive UK Biobank and the Psychiatric Genomics Consortium, the researchers applied novel statistical genetic methods to identify common patterns across 11 major psychiatric disorders: schizophrenia, bipolar disorder, major depressive disorder, anxiety disorder, anorexia nervosa, obsessive-compulsive disorder (OCD), Tourette syndrome, post traumatic stress disorder, problematic alcohol use, attention deficit hyperactive disorder, and autism. 

The average total sample size per disorder was 156,771 participants, with a range of 9,725 to 802,939 participants.

In all, the investigators identified 152 genetic variants shared across multiple disorders, including those already known to influence certain types of brain cells.

For example, they found that 70% of the genetic signal associated with schizophrenia was also associated with bipolar disorder. 

Results also showed that anorexia nervosa and OCD have a strong, shared genetic architecture and that individuals with a genetic predisposition to low body mass index also tend to have a genetic predisposition to these two disorders.

Not surprisingly, the researchers note, there was a large genetic overlap between anxiety disorder and major depressive disorder.

They also observed that psychiatric disorders that tend to cluster together also tend to share genes that influence how and when individuals are physically active during the day.

For example, patients with internalizing disorders such as anxiety and depression tend to have a genetic architecture associated with low movement throughout the day. On the other hand, those with OCD and anorexia tend to have genes associated with higher movement throughout the day. 

“When you think about it, it makes sense,” said Dr. Grotzinger. Depressed individuals often experience fatigue or low energy while those with compulsive disorders may have a tough time sitting still, he noted.
 

One treatment for multiple disorders?

“Collectively, these results offer key insights into the shared and disorder-specific mechanisms of genetic risk for psychiatric disease,” the investigators write.

Their research is also a first step toward developing therapies that can address multiple disorders with one treatment, they add.

“People are more likely today to be prescribed multiple medications intended to treat multiple diagnoses, and in some instances those medicines can have side effects,” Dr. Grotzinger said.

“By identifying what is shared across these issues, we can hopefully come up with ways to target them in a different way that doesn’t require four separate pills or four separate psychotherapy interventions,” he added.

Dr. Grotzinger noted that, for now, the knowledge that genetics are underlying their disorders may provide comfort to some patients.

“It’s important for people to know that they didn’t just get a terrible roll of the dice in life – that they are not facing multiple different issues but rather one set of risk factors bleeding into them all,” he said.

This research had no commercial funding. Dr. Grotzinger reported no relevant disclosures.

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

Different psychiatric disorders often share the same genetic architecture, which may help explain why many individuals diagnosed with one psychiatric disorder will be diagnosed with another in their lifetime, new research suggests.

Investigators conducted a genetic analysis of 11 major psychiatric disorders, including schizophrenia and bipolar disorder.

“Our findings confirm that high comorbidity across some disorders in part reflects overlapping pathways of genetic risk,” lead author Andrew Grotzinger, PhD, department of psychology and neuroscience, University of Colorado at Boulder, said in a press release.

The results could lead to the development of treatments that address multiple psychiatric disorders at once and help reshape the way diagnoses are established, the researchers note.

The findings were published online in Nature Genetics.
 

Common genetic patterns

Using the massive UK Biobank and the Psychiatric Genomics Consortium, the researchers applied novel statistical genetic methods to identify common patterns across 11 major psychiatric disorders: schizophrenia, bipolar disorder, major depressive disorder, anxiety disorder, anorexia nervosa, obsessive-compulsive disorder (OCD), Tourette syndrome, post traumatic stress disorder, problematic alcohol use, attention deficit hyperactive disorder, and autism. 

The average total sample size per disorder was 156,771 participants, with a range of 9,725 to 802,939 participants.

In all, the investigators identified 152 genetic variants shared across multiple disorders, including those already known to influence certain types of brain cells.

For example, they found that 70% of the genetic signal associated with schizophrenia was also associated with bipolar disorder. 

Results also showed that anorexia nervosa and OCD have a strong, shared genetic architecture and that individuals with a genetic predisposition to low body mass index also tend to have a genetic predisposition to these two disorders.

Not surprisingly, the researchers note, there was a large genetic overlap between anxiety disorder and major depressive disorder.

They also observed that psychiatric disorders that tend to cluster together also tend to share genes that influence how and when individuals are physically active during the day.

For example, patients with internalizing disorders such as anxiety and depression tend to have a genetic architecture associated with low movement throughout the day. On the other hand, those with OCD and anorexia tend to have genes associated with higher movement throughout the day. 

“When you think about it, it makes sense,” said Dr. Grotzinger. Depressed individuals often experience fatigue or low energy while those with compulsive disorders may have a tough time sitting still, he noted.
 

One treatment for multiple disorders?

“Collectively, these results offer key insights into the shared and disorder-specific mechanisms of genetic risk for psychiatric disease,” the investigators write.

Their research is also a first step toward developing therapies that can address multiple disorders with one treatment, they add.

“People are more likely today to be prescribed multiple medications intended to treat multiple diagnoses, and in some instances those medicines can have side effects,” Dr. Grotzinger said.

“By identifying what is shared across these issues, we can hopefully come up with ways to target them in a different way that doesn’t require four separate pills or four separate psychotherapy interventions,” he added.

Dr. Grotzinger noted that, for now, the knowledge that genetics are underlying their disorders may provide comfort to some patients.

“It’s important for people to know that they didn’t just get a terrible roll of the dice in life – that they are not facing multiple different issues but rather one set of risk factors bleeding into them all,” he said.

This research had no commercial funding. Dr. Grotzinger reported no relevant disclosures.

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

Children who have first-degree relatives with celiac disease (CD) may be at higher risk of developing CD before age 10 than previously thought, according to results of an analysis of 10-year follow-up data. This analysis also yielded a web-based prediction model to help with screening for CD in children.

Screening is recommended for children who have a first-degree relative with celiac disease (CD) because they have a much higher risk for CD, but it has been unclear when to screen such children and how frequently. The researchers, led by Caroline Meijer, MD, in the department of pediatrics and medical statistics at Leiden (the Netherlands) University Medical Center, wrote in Gastroenterology that a prediction model they developed can help parents and providers with those questions.

NormaF/ThinkStock

The researchers analyzed prospective data from 10 years of follow-up from the PreventCD birth cohort with 944 children genetically predisposed to celiac disease with at least one first-degree relative affected. The children were enrolled at birth between 2007 and 2010 in Croatia, Germany, Hungary, Israel, Italy, the Netherlands, Poland, and Spain.

“The data of the follow-up of the PreventCD cohort at the mean age of 10 years offers a unique opportunity to study the natural development of CD in children from high risk families,” the authors wrote.

Children were assessed regularly from birth for CD development at specific intervals, including seven times during the first 3 years of age and once a year after that or at least once between March 2016 and March 2019.

The researchers monitored parent-reported health status, recorded weight and height and gluten consumption and serum IgA against anti-transglutaminase. They found that risk for CD differs by gender, age, and human leukocyte antigen (HLA-DQ) genes. Variables that significantly affected the risk were combined to develop a risk score.

The noted that CD affects as many as 1%-3% of the general population. Until recently, the lifetime risk of CD when a child has a first-degree CD connection was considered to be 5%-10%, with one review indicating a pooled prevalence of 7.5%. However, the investigators found that the cumulative incidence of CD was 7.5%, 16.6%, and 17.5% at 3, 8, and 10 years of age, respectively.

“Our data show that, at the age of 8 years, this is as high as 17%, emphasizing the importance of a sound advice for early screening,” Dr. Meijer and coauthors wrote. “We also confirm that CD develops in children with affected FDR at a very young age, as the mean age of diagnosis in our cohort was 4 years of age.”

They found that CD developed more often in girls (P = .0005). Data show that, at the age of 10 years, girls in the cohort have a 7.7% higher cumulative incidence compared to boys (21.5% vs 13.8%). CD also developed more often in HLA-DQ2 homozygous participants than in other HLA-risk groups (8-year cumulative incidence of 35.4% vs. the maximum of the other groups of 18.2%; P < .001).

Benjamin Lebwohl, MD, MS, said the study provides data that can help parents of a child with a family history of celiac disease.

“The results of the study include an estimate of celiac disease risk over time, based on the child’s age, number of affected relatives, and genetic test results. Using this information, the web-based prediction model provides advice on how often to test the child for celiac disease, based on the child’s risk of developing the condition in the years ahead,” said Dr. Lebwohl, director of clinical research at the Celiac Disease Center at Columbia University Medical Center, New York, said in an interview.

“Overall,” he said, “the study advances our understanding of the natural history of celiac disease among children with a family history and gives clinicians and families practical advice on when to test.”

Validation of the prediction model was done with data from the independent NeoCel cohort. In that cohort, all children were assessed regularly from birth for CD development at predefined intervals, in a similar way as in the PreventCD cohort.

The investigators concluded that children should be screened early in life and that screening should include HLA-DQ2/8-typing. If children are genetically predisposed to CD, they should get further personalized screening advice using the web-based prediction “app” developed by the investigators.

“If the prediction for CD development [according to the app] is higher than 10% in the next 2 years, we advice to repeat the screening after 6 months. If the prediction is between 5%-10%, the advice is to repeat the screening after 1 year and if the prediction is lower than 5%, to repeat the screening after 2 years.”

The study authors reported no relevant financial relationships. The work is supported by funding from the European Commission; the Azrieli Foundation; Deutsche Zöliakie Gesellschaft; Eurospital; Fondazione Celiachia; Fria Bröd Sweden; Instituto de Salud Carlos III; Spanish Society for Pediatric Gastroenterology, Hepatology, and Nutrition; Komitet Badań Naukowych; Fundacja Nutricia; Hungarian Scientific Research Funds; and TAMOP; Stichting Coeliakie Onderzoek Nederland; Thermo Fisher Scientific; and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Dr. Lebwohl reported having no relevant disclosures.

AGA offers guidance on celiac disease to help patients maintain a gluten free diet in the AGA GI Patient Center: www.gastro.org/celiac

Children who have first-degree relatives with celiac disease (CD) may be at higher risk of developing CD before age 10 than previously thought, according to results of an analysis of 10-year follow-up data. This analysis also yielded a web-based prediction model to help with screening for CD in children.

Screening is recommended for children who have a first-degree relative with celiac disease (CD) because they have a much higher risk for CD, but it has been unclear when to screen such children and how frequently. The researchers, led by Caroline Meijer, MD, in the department of pediatrics and medical statistics at Leiden (the Netherlands) University Medical Center, wrote in Gastroenterology that a prediction model they developed can help parents and providers with those questions.

NormaF/ThinkStock

The researchers analyzed prospective data from 10 years of follow-up from the PreventCD birth cohort with 944 children genetically predisposed to celiac disease with at least one first-degree relative affected. The children were enrolled at birth between 2007 and 2010 in Croatia, Germany, Hungary, Israel, Italy, the Netherlands, Poland, and Spain.

“The data of the follow-up of the PreventCD cohort at the mean age of 10 years offers a unique opportunity to study the natural development of CD in children from high risk families,” the authors wrote.

Children were assessed regularly from birth for CD development at specific intervals, including seven times during the first 3 years of age and once a year after that or at least once between March 2016 and March 2019.

The researchers monitored parent-reported health status, recorded weight and height and gluten consumption and serum IgA against anti-transglutaminase. They found that risk for CD differs by gender, age, and human leukocyte antigen (HLA-DQ) genes. Variables that significantly affected the risk were combined to develop a risk score.

The noted that CD affects as many as 1%-3% of the general population. Until recently, the lifetime risk of CD when a child has a first-degree CD connection was considered to be 5%-10%, with one review indicating a pooled prevalence of 7.5%. However, the investigators found that the cumulative incidence of CD was 7.5%, 16.6%, and 17.5% at 3, 8, and 10 years of age, respectively.

“Our data show that, at the age of 8 years, this is as high as 17%, emphasizing the importance of a sound advice for early screening,” Dr. Meijer and coauthors wrote. “We also confirm that CD develops in children with affected FDR at a very young age, as the mean age of diagnosis in our cohort was 4 years of age.”

They found that CD developed more often in girls (P = .0005). Data show that, at the age of 10 years, girls in the cohort have a 7.7% higher cumulative incidence compared to boys (21.5% vs 13.8%). CD also developed more often in HLA-DQ2 homozygous participants than in other HLA-risk groups (8-year cumulative incidence of 35.4% vs. the maximum of the other groups of 18.2%; P < .001).

Benjamin Lebwohl, MD, MS, said the study provides data that can help parents of a child with a family history of celiac disease.

“The results of the study include an estimate of celiac disease risk over time, based on the child’s age, number of affected relatives, and genetic test results. Using this information, the web-based prediction model provides advice on how often to test the child for celiac disease, based on the child’s risk of developing the condition in the years ahead,” said Dr. Lebwohl, director of clinical research at the Celiac Disease Center at Columbia University Medical Center, New York, said in an interview.

“Overall,” he said, “the study advances our understanding of the natural history of celiac disease among children with a family history and gives clinicians and families practical advice on when to test.”

Validation of the prediction model was done with data from the independent NeoCel cohort. In that cohort, all children were assessed regularly from birth for CD development at predefined intervals, in a similar way as in the PreventCD cohort.

The investigators concluded that children should be screened early in life and that screening should include HLA-DQ2/8-typing. If children are genetically predisposed to CD, they should get further personalized screening advice using the web-based prediction “app” developed by the investigators.

“If the prediction for CD development [according to the app] is higher than 10% in the next 2 years, we advice to repeat the screening after 6 months. If the prediction is between 5%-10%, the advice is to repeat the screening after 1 year and if the prediction is lower than 5%, to repeat the screening after 2 years.”

The study authors reported no relevant financial relationships. The work is supported by funding from the European Commission; the Azrieli Foundation; Deutsche Zöliakie Gesellschaft; Eurospital; Fondazione Celiachia; Fria Bröd Sweden; Instituto de Salud Carlos III; Spanish Society for Pediatric Gastroenterology, Hepatology, and Nutrition; Komitet Badań Naukowych; Fundacja Nutricia; Hungarian Scientific Research Funds; and TAMOP; Stichting Coeliakie Onderzoek Nederland; Thermo Fisher Scientific; and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Dr. Lebwohl reported having no relevant disclosures.

AGA offers guidance on celiac disease to help patients maintain a gluten free diet in the AGA GI Patient Center: www.gastro.org/celiac

Children who have first-degree relatives with celiac disease (CD) may be at higher risk of developing CD before age 10 than previously thought, according to results of an analysis of 10-year follow-up data. This analysis also yielded a web-based prediction model to help with screening for CD in children.

Screening is recommended for children who have a first-degree relative with celiac disease (CD) because they have a much higher risk for CD, but it has been unclear when to screen such children and how frequently. The researchers, led by Caroline Meijer, MD, in the department of pediatrics and medical statistics at Leiden (the Netherlands) University Medical Center, wrote in Gastroenterology that a prediction model they developed can help parents and providers with those questions.

NormaF/ThinkStock

The researchers analyzed prospective data from 10 years of follow-up from the PreventCD birth cohort with 944 children genetically predisposed to celiac disease with at least one first-degree relative affected. The children were enrolled at birth between 2007 and 2010 in Croatia, Germany, Hungary, Israel, Italy, the Netherlands, Poland, and Spain.

“The data of the follow-up of the PreventCD cohort at the mean age of 10 years offers a unique opportunity to study the natural development of CD in children from high risk families,” the authors wrote.

Children were assessed regularly from birth for CD development at specific intervals, including seven times during the first 3 years of age and once a year after that or at least once between March 2016 and March 2019.

The researchers monitored parent-reported health status, recorded weight and height and gluten consumption and serum IgA against anti-transglutaminase. They found that risk for CD differs by gender, age, and human leukocyte antigen (HLA-DQ) genes. Variables that significantly affected the risk were combined to develop a risk score.

The noted that CD affects as many as 1%-3% of the general population. Until recently, the lifetime risk of CD when a child has a first-degree CD connection was considered to be 5%-10%, with one review indicating a pooled prevalence of 7.5%. However, the investigators found that the cumulative incidence of CD was 7.5%, 16.6%, and 17.5% at 3, 8, and 10 years of age, respectively.

“Our data show that, at the age of 8 years, this is as high as 17%, emphasizing the importance of a sound advice for early screening,” Dr. Meijer and coauthors wrote. “We also confirm that CD develops in children with affected FDR at a very young age, as the mean age of diagnosis in our cohort was 4 years of age.”

They found that CD developed more often in girls (P = .0005). Data show that, at the age of 10 years, girls in the cohort have a 7.7% higher cumulative incidence compared to boys (21.5% vs 13.8%). CD also developed more often in HLA-DQ2 homozygous participants than in other HLA-risk groups (8-year cumulative incidence of 35.4% vs. the maximum of the other groups of 18.2%; P < .001).

Benjamin Lebwohl, MD, MS, said the study provides data that can help parents of a child with a family history of celiac disease.

“The results of the study include an estimate of celiac disease risk over time, based on the child’s age, number of affected relatives, and genetic test results. Using this information, the web-based prediction model provides advice on how often to test the child for celiac disease, based on the child’s risk of developing the condition in the years ahead,” said Dr. Lebwohl, director of clinical research at the Celiac Disease Center at Columbia University Medical Center, New York, said in an interview.

“Overall,” he said, “the study advances our understanding of the natural history of celiac disease among children with a family history and gives clinicians and families practical advice on when to test.”

Validation of the prediction model was done with data from the independent NeoCel cohort. In that cohort, all children were assessed regularly from birth for CD development at predefined intervals, in a similar way as in the PreventCD cohort.

The investigators concluded that children should be screened early in life and that screening should include HLA-DQ2/8-typing. If children are genetically predisposed to CD, they should get further personalized screening advice using the web-based prediction “app” developed by the investigators.

“If the prediction for CD development [according to the app] is higher than 10% in the next 2 years, we advice to repeat the screening after 6 months. If the prediction is between 5%-10%, the advice is to repeat the screening after 1 year and if the prediction is lower than 5%, to repeat the screening after 2 years.”

The study authors reported no relevant financial relationships. The work is supported by funding from the European Commission; the Azrieli Foundation; Deutsche Zöliakie Gesellschaft; Eurospital; Fondazione Celiachia; Fria Bröd Sweden; Instituto de Salud Carlos III; Spanish Society for Pediatric Gastroenterology, Hepatology, and Nutrition; Komitet Badań Naukowych; Fundacja Nutricia; Hungarian Scientific Research Funds; and TAMOP; Stichting Coeliakie Onderzoek Nederland; Thermo Fisher Scientific; and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Dr. Lebwohl reported having no relevant disclosures.

AGA offers guidance on celiac disease to help patients maintain a gluten free diet in the AGA GI Patient Center: www.gastro.org/celiac

President Joe Biden said Monday that he didn’t believe quarantines to prevent the spread of monkeypox in the United States would be necessary.

He said the United States has enough vaccine doses available to stop any serious outbreaks and to “deal with the likelihood of the problem,” according to The Washington Post .

“I just don’t think it rises to the level of the kind of concern that existed with COVID-19, and the smallpox vaccine works for it,” Biden said during a news conference in Japan.

The World Health Organization has identified monkeypox cases in at least a dozen countries where the disease isn’t typically considered endemic. Generally found in Central and West Africa, the illness has been reported in several European countries, as well as the United States, Canada, and Australia.

On Sunday, Biden told reporters that monkeypox is a “concern in that if it were to spread, it would be consequential.” Administration officials have said the president has been briefed on the disease, the newspaper reported.

Monkeypox spreads through droplets and bodily fluids but doesn’t pass easily between humans and is less contagious than the coronavirus, the Post reported. The CDC has reported that the smallpox vaccine is 85% effective against monkeypox, and the U.S. has licensed two smallpox vaccines that could help in potential outbreaks, including one that specifically targets monkeypox.

Mandatory monkeypox quarantine in Belgium

Belgium is the first country to put a mandatory 21-day quarantine in place for monkeypox patients as cases spread globally, according to CNBC. Health authorities announced the quarantine on Friday after the country recorded its third case.

The quarantine only applies to patients with a confirmed infection. Close contacts aren’t required to self-isolate but are encouraged to be careful and watch for symptoms, especially if they spend time with vulnerable people who could contract a serious illness, CNBC reported.

The United Kingdom has published guidelines to assess risks of monkeypox infection and provide guidance on self-isolation and monitoring. Health officials have said that those who have high exposure risks should self-isolate for 21 days, which includes household contacts or medical professionals who have worked with infected patients.

As of Saturday, the WHO has received reports of 92 confirmed monkeypox cases and 28 suspected cases across 12 countries where the virus isn’t typically found. No deaths linked to the cases have been reported so far.

The outbreaks have caused concern among health officials because most cases don’t have travel links to endemic countries. So far, many cases have spread between men who have sex with men, and the cases have been identified as patients seek care in primary care and sexual health clinics, the WHO reported.

“The identification of confirmed and suspected cases of monkeypox with no direct travel links to an endemic area represents a highly unusual event,” the WHO said. “Available information suggests that human-to-human transmission is occurring among people in close physical contact with cases who are symptomatic.”

White House health official doesn’t foresee major outbreak

Ashish Jha, MD, a top Biden administration health official who serves as the White House COVID-19 response coordinator, said Sunday that he doesn’t expect monkeypox to have widespread effects in the U.S.

“I feel like this is a virus we understand,” he said on ABC News’s This Week.

The virus has been monitored for decades, and there are treatments for it, Dr. Jha said.

“We have vaccines against it. We have treatments against it,” he said. “It’s not as contagious as COVID. So, I am confident we’re going to be able to keep our arms around it.”

At the same time, Dr. Jha agreed that health officials should keep an eye on the situation. Cases have been confirmed in recent days in several countries, as well as the United States.

“I would not be surprised if we see a few more cases in the upcoming days,” he said. “Any time we have an infectious outbreak like this, we should all be paying attention.”

Dr. Jha also stressed ongoing caution amid the COVID-19 pandemic as cases once again surpass 100,000 daily infections. Variants will continue to evolve, he said, and ongoing outbreaks will reinfect people who have been vaccinated or had a previous infection.

“What we know is that this virus is evolving very quickly, and every iteration of it has more and more immune escape,” he said. “That makes it harder for this virus to be contained unless we continue vaccinating people and keeping people up to date.”

Third possible U.S. monkeypox case found in Florida

The CDC said Sunday that it may have found a third monkeypox case in the United States and is running tests on a patient in South Florida, according to Reuters.

The person is in Broward County and remains isolated. The case appears to be related to international travel, the CDC told Reuters.

Health officials are doing tests to confirm if the patient has the disease, with results expected “soon.” No other cases have been identified in Florida so far.

The first monkeypox case in the United States was reported in Massachusetts last week. The patient had recently traveled to Canada.

The second U.S. case was reported in a New York City resident who tested positive on Friday.

The disease, which is like human smallpox but milder, is a viral infection that was first found in the Democratic Republic of Congo in the 1970s. Symptoms include fever, headaches, and a skin rash across the body.


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

President Joe Biden said Monday that he didn’t believe quarantines to prevent the spread of monkeypox in the United States would be necessary.

He said the United States has enough vaccine doses available to stop any serious outbreaks and to “deal with the likelihood of the problem,” according to The Washington Post .

“I just don’t think it rises to the level of the kind of concern that existed with COVID-19, and the smallpox vaccine works for it,” Biden said during a news conference in Japan.

The World Health Organization has identified monkeypox cases in at least a dozen countries where the disease isn’t typically considered endemic. Generally found in Central and West Africa, the illness has been reported in several European countries, as well as the United States, Canada, and Australia.

On Sunday, Biden told reporters that monkeypox is a “concern in that if it were to spread, it would be consequential.” Administration officials have said the president has been briefed on the disease, the newspaper reported.

Monkeypox spreads through droplets and bodily fluids but doesn’t pass easily between humans and is less contagious than the coronavirus, the Post reported. The CDC has reported that the smallpox vaccine is 85% effective against monkeypox, and the U.S. has licensed two smallpox vaccines that could help in potential outbreaks, including one that specifically targets monkeypox.

Mandatory monkeypox quarantine in Belgium

Belgium is the first country to put a mandatory 21-day quarantine in place for monkeypox patients as cases spread globally, according to CNBC. Health authorities announced the quarantine on Friday after the country recorded its third case.

The quarantine only applies to patients with a confirmed infection. Close contacts aren’t required to self-isolate but are encouraged to be careful and watch for symptoms, especially if they spend time with vulnerable people who could contract a serious illness, CNBC reported.

The United Kingdom has published guidelines to assess risks of monkeypox infection and provide guidance on self-isolation and monitoring. Health officials have said that those who have high exposure risks should self-isolate for 21 days, which includes household contacts or medical professionals who have worked with infected patients.

As of Saturday, the WHO has received reports of 92 confirmed monkeypox cases and 28 suspected cases across 12 countries where the virus isn’t typically found. No deaths linked to the cases have been reported so far.

The outbreaks have caused concern among health officials because most cases don’t have travel links to endemic countries. So far, many cases have spread between men who have sex with men, and the cases have been identified as patients seek care in primary care and sexual health clinics, the WHO reported.

“The identification of confirmed and suspected cases of monkeypox with no direct travel links to an endemic area represents a highly unusual event,” the WHO said. “Available information suggests that human-to-human transmission is occurring among people in close physical contact with cases who are symptomatic.”

White House health official doesn’t foresee major outbreak

Ashish Jha, MD, a top Biden administration health official who serves as the White House COVID-19 response coordinator, said Sunday that he doesn’t expect monkeypox to have widespread effects in the U.S.

“I feel like this is a virus we understand,” he said on ABC News’s This Week.

The virus has been monitored for decades, and there are treatments for it, Dr. Jha said.

“We have vaccines against it. We have treatments against it,” he said. “It’s not as contagious as COVID. So, I am confident we’re going to be able to keep our arms around it.”

At the same time, Dr. Jha agreed that health officials should keep an eye on the situation. Cases have been confirmed in recent days in several countries, as well as the United States.

“I would not be surprised if we see a few more cases in the upcoming days,” he said. “Any time we have an infectious outbreak like this, we should all be paying attention.”

Dr. Jha also stressed ongoing caution amid the COVID-19 pandemic as cases once again surpass 100,000 daily infections. Variants will continue to evolve, he said, and ongoing outbreaks will reinfect people who have been vaccinated or had a previous infection.

“What we know is that this virus is evolving very quickly, and every iteration of it has more and more immune escape,” he said. “That makes it harder for this virus to be contained unless we continue vaccinating people and keeping people up to date.”

Third possible U.S. monkeypox case found in Florida

The CDC said Sunday that it may have found a third monkeypox case in the United States and is running tests on a patient in South Florida, according to Reuters.

The person is in Broward County and remains isolated. The case appears to be related to international travel, the CDC told Reuters.

Health officials are doing tests to confirm if the patient has the disease, with results expected “soon.” No other cases have been identified in Florida so far.

The first monkeypox case in the United States was reported in Massachusetts last week. The patient had recently traveled to Canada.

The second U.S. case was reported in a New York City resident who tested positive on Friday.

The disease, which is like human smallpox but milder, is a viral infection that was first found in the Democratic Republic of Congo in the 1970s. Symptoms include fever, headaches, and a skin rash across the body.


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

President Joe Biden said Monday that he didn’t believe quarantines to prevent the spread of monkeypox in the United States would be necessary.

He said the United States has enough vaccine doses available to stop any serious outbreaks and to “deal with the likelihood of the problem,” according to The Washington Post .

“I just don’t think it rises to the level of the kind of concern that existed with COVID-19, and the smallpox vaccine works for it,” Biden said during a news conference in Japan.

The World Health Organization has identified monkeypox cases in at least a dozen countries where the disease isn’t typically considered endemic. Generally found in Central and West Africa, the illness has been reported in several European countries, as well as the United States, Canada, and Australia.

On Sunday, Biden told reporters that monkeypox is a “concern in that if it were to spread, it would be consequential.” Administration officials have said the president has been briefed on the disease, the newspaper reported.

Monkeypox spreads through droplets and bodily fluids but doesn’t pass easily between humans and is less contagious than the coronavirus, the Post reported. The CDC has reported that the smallpox vaccine is 85% effective against monkeypox, and the U.S. has licensed two smallpox vaccines that could help in potential outbreaks, including one that specifically targets monkeypox.

Mandatory monkeypox quarantine in Belgium

Belgium is the first country to put a mandatory 21-day quarantine in place for monkeypox patients as cases spread globally, according to CNBC. Health authorities announced the quarantine on Friday after the country recorded its third case.

The quarantine only applies to patients with a confirmed infection. Close contacts aren’t required to self-isolate but are encouraged to be careful and watch for symptoms, especially if they spend time with vulnerable people who could contract a serious illness, CNBC reported.

The United Kingdom has published guidelines to assess risks of monkeypox infection and provide guidance on self-isolation and monitoring. Health officials have said that those who have high exposure risks should self-isolate for 21 days, which includes household contacts or medical professionals who have worked with infected patients.

As of Saturday, the WHO has received reports of 92 confirmed monkeypox cases and 28 suspected cases across 12 countries where the virus isn’t typically found. No deaths linked to the cases have been reported so far.

The outbreaks have caused concern among health officials because most cases don’t have travel links to endemic countries. So far, many cases have spread between men who have sex with men, and the cases have been identified as patients seek care in primary care and sexual health clinics, the WHO reported.

“The identification of confirmed and suspected cases of monkeypox with no direct travel links to an endemic area represents a highly unusual event,” the WHO said. “Available information suggests that human-to-human transmission is occurring among people in close physical contact with cases who are symptomatic.”

White House health official doesn’t foresee major outbreak

Ashish Jha, MD, a top Biden administration health official who serves as the White House COVID-19 response coordinator, said Sunday that he doesn’t expect monkeypox to have widespread effects in the U.S.

“I feel like this is a virus we understand,” he said on ABC News’s This Week.

The virus has been monitored for decades, and there are treatments for it, Dr. Jha said.

“We have vaccines against it. We have treatments against it,” he said. “It’s not as contagious as COVID. So, I am confident we’re going to be able to keep our arms around it.”

At the same time, Dr. Jha agreed that health officials should keep an eye on the situation. Cases have been confirmed in recent days in several countries, as well as the United States.

“I would not be surprised if we see a few more cases in the upcoming days,” he said. “Any time we have an infectious outbreak like this, we should all be paying attention.”

Dr. Jha also stressed ongoing caution amid the COVID-19 pandemic as cases once again surpass 100,000 daily infections. Variants will continue to evolve, he said, and ongoing outbreaks will reinfect people who have been vaccinated or had a previous infection.

“What we know is that this virus is evolving very quickly, and every iteration of it has more and more immune escape,” he said. “That makes it harder for this virus to be contained unless we continue vaccinating people and keeping people up to date.”

Third possible U.S. monkeypox case found in Florida

The CDC said Sunday that it may have found a third monkeypox case in the United States and is running tests on a patient in South Florida, according to Reuters.

The person is in Broward County and remains isolated. The case appears to be related to international travel, the CDC told Reuters.

Health officials are doing tests to confirm if the patient has the disease, with results expected “soon.” No other cases have been identified in Florida so far.

The first monkeypox case in the United States was reported in Massachusetts last week. The patient had recently traveled to Canada.

The second U.S. case was reported in a New York City resident who tested positive on Friday.

The disease, which is like human smallpox but milder, is a viral infection that was first found in the Democratic Republic of Congo in the 1970s. Symptoms include fever, headaches, and a skin rash across the body.


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

I live in New Orleans and recently became aware of a piece of state legislation that would create a “gold card” system for prior authorizations in Louisiana. Before delving into what is a gold card and how it works, let’s take a look at the evolution of prior authorizations (PAs).

Commercial health insurance and Medicare/Medicaid had their beginnings in the 1950s and 1960s. Because the government would now be paying for medical services for seniors, there was a concern that there might be an “overutilization” of services. This concern resulted in the concepts of utilization review and “medical necessity.” These utilization reviews morphed into what are now known as utilization management tools (UMTs). The original intent of these tools was to link cost containment to quality assurance.

PAs are one of a number of UMTs, along with formulary step therapy and nonmedical switching, that are used by health insurance companies and pharmacy benefit managers to determine whether a prescribed product or service is medically necessary and cost effective. Originally, it also meant that the service/treatment would be reimbursed. That is not the case anymore.

Today, physicians face many frivolous PAs for generic medications, such as methotrexate and prednisone, and ironically sometimes higher-priced drugs are preferred over lower-priced ones.

A number of surveys, including a recent one of more than 1,000 specialty physicians by the Alliance of Specialty Medicine, show that PAs are not only a significant administrative burden on practices but also harm patients with significant delays in accessing needed treatments and diagnostic services.

The often-cited study by Zachary Wallace et al. clearly demonstrates significant harm to rheumatology patients whose treatments were delayed because of PAs. These delays caused a substantial increase in steroid dosages in patients whose PA was initially denied and even in those patients whose PAs were initially approved. These data and others support the urgent need to address the entire spectrum of PAs.

Over the last few years, we have seen many states passing laws, adding common-sense protections to mitigate the harmful consequences of UMTs. Such reforms are needed now to stop the indiscriminate use of PAs. Suggestions have included completely eliminating PAs for medications and services that are consistently approved, standardizing electronic forms across all health plans with real-time approval, and others, including “gold card” legislation. In addition to states’ efforts, Congress proposed H.R. 3173, the Improving Seniors’ Timely Access to Care Act of 2021, to protect seniors from the harm caused by PAs that are required by Medicare Advantage programs.

This brings us to the topic of gold card legislation, in which physicians would be given a gold card exempting them from PA for specific services (hopefully including prescription drugs). However, the criteria a physician needs to qualify for a gold card could vary from state to state. For example, it could be based on a physician’s PA approval rate during a specified review period, or it could be completely up to the insurance company to decide the criteria.

Texas is the only state that has passed gold card legislation thus far, although there is an active gold card bill in Louisiana (as of this writing). There are a few other states that have introduced gold card bills that have not yet passed, but there is definite interest throughout the country in this concept. In the Texas legislation, physicians would qualify for a gold card if they had a PA approval threshold of 90% for specific medications or services over a 6-month review period.

A few of the concerns about how this will be implemented and the potential unintended consequences of the legislation include:

• Would one gold card cover all drugs, a specific drug, or just a specific drug for a specific diagnosis?
• Will clinicians get bogged down appealing gold card denials/rescissions?
• Will health plans begin denying more requests up front to keep clinicians from qualifying for an exemption?

Unfortunately, the Louisiana gold card legislation has been amended from its original form to exclude “pharmacy services” and qualification for the gold card “shall be at the sole discretion of the health insurance issuer.”

Consequently, my initial excitement surrounding the Louisiana gold card legislation, for our specialty, has for the most part disappeared. Nonetheless, there is clear excitement behind the gold card concept throughout the country.

What is clear is that health insurance companies and pharmacy benefit managers have lost sight of the original purpose of UMTs, which is to ensure that patients have access to cost-effective quality care. Over the years, the aggressive use of PAs and other UMTs has led to a significant increase in administrative burden for our offices, and more importantly, a loss of disease control in many of our patients, resulting in an increase in overall health care costs.

While it is extremely disturbing that we need legislation to force health plans to keep our patients safe and ensure quality of care, it certainly proves that now, more than ever, we must make our voices be heard.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is president of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

I live in New Orleans and recently became aware of a piece of state legislation that would create a “gold card” system for prior authorizations in Louisiana. Before delving into what is a gold card and how it works, let’s take a look at the evolution of prior authorizations (PAs).

Commercial health insurance and Medicare/Medicaid had their beginnings in the 1950s and 1960s. Because the government would now be paying for medical services for seniors, there was a concern that there might be an “overutilization” of services. This concern resulted in the concepts of utilization review and “medical necessity.” These utilization reviews morphed into what are now known as utilization management tools (UMTs). The original intent of these tools was to link cost containment to quality assurance.

PAs are one of a number of UMTs, along with formulary step therapy and nonmedical switching, that are used by health insurance companies and pharmacy benefit managers to determine whether a prescribed product or service is medically necessary and cost effective. Originally, it also meant that the service/treatment would be reimbursed. That is not the case anymore.

Today, physicians face many frivolous PAs for generic medications, such as methotrexate and prednisone, and ironically sometimes higher-priced drugs are preferred over lower-priced ones.

A number of surveys, including a recent one of more than 1,000 specialty physicians by the Alliance of Specialty Medicine, show that PAs are not only a significant administrative burden on practices but also harm patients with significant delays in accessing needed treatments and diagnostic services.

The often-cited study by Zachary Wallace et al. clearly demonstrates significant harm to rheumatology patients whose treatments were delayed because of PAs. These delays caused a substantial increase in steroid dosages in patients whose PA was initially denied and even in those patients whose PAs were initially approved. These data and others support the urgent need to address the entire spectrum of PAs.

Over the last few years, we have seen many states passing laws, adding common-sense protections to mitigate the harmful consequences of UMTs. Such reforms are needed now to stop the indiscriminate use of PAs. Suggestions have included completely eliminating PAs for medications and services that are consistently approved, standardizing electronic forms across all health plans with real-time approval, and others, including “gold card” legislation. In addition to states’ efforts, Congress proposed H.R. 3173, the Improving Seniors’ Timely Access to Care Act of 2021, to protect seniors from the harm caused by PAs that are required by Medicare Advantage programs.

This brings us to the topic of gold card legislation, in which physicians would be given a gold card exempting them from PA for specific services (hopefully including prescription drugs). However, the criteria a physician needs to qualify for a gold card could vary from state to state. For example, it could be based on a physician’s PA approval rate during a specified review period, or it could be completely up to the insurance company to decide the criteria.

Texas is the only state that has passed gold card legislation thus far, although there is an active gold card bill in Louisiana (as of this writing). There are a few other states that have introduced gold card bills that have not yet passed, but there is definite interest throughout the country in this concept. In the Texas legislation, physicians would qualify for a gold card if they had a PA approval threshold of 90% for specific medications or services over a 6-month review period.

A few of the concerns about how this will be implemented and the potential unintended consequences of the legislation include:

• Would one gold card cover all drugs, a specific drug, or just a specific drug for a specific diagnosis?
• Will clinicians get bogged down appealing gold card denials/rescissions?
• Will health plans begin denying more requests up front to keep clinicians from qualifying for an exemption?

Unfortunately, the Louisiana gold card legislation has been amended from its original form to exclude “pharmacy services” and qualification for the gold card “shall be at the sole discretion of the health insurance issuer.”

Consequently, my initial excitement surrounding the Louisiana gold card legislation, for our specialty, has for the most part disappeared. Nonetheless, there is clear excitement behind the gold card concept throughout the country.

What is clear is that health insurance companies and pharmacy benefit managers have lost sight of the original purpose of UMTs, which is to ensure that patients have access to cost-effective quality care. Over the years, the aggressive use of PAs and other UMTs has led to a significant increase in administrative burden for our offices, and more importantly, a loss of disease control in many of our patients, resulting in an increase in overall health care costs.

While it is extremely disturbing that we need legislation to force health plans to keep our patients safe and ensure quality of care, it certainly proves that now, more than ever, we must make our voices be heard.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is president of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

I live in New Orleans and recently became aware of a piece of state legislation that would create a “gold card” system for prior authorizations in Louisiana. Before delving into what is a gold card and how it works, let’s take a look at the evolution of prior authorizations (PAs).

Commercial health insurance and Medicare/Medicaid had their beginnings in the 1950s and 1960s. Because the government would now be paying for medical services for seniors, there was a concern that there might be an “overutilization” of services. This concern resulted in the concepts of utilization review and “medical necessity.” These utilization reviews morphed into what are now known as utilization management tools (UMTs). The original intent of these tools was to link cost containment to quality assurance.

PAs are one of a number of UMTs, along with formulary step therapy and nonmedical switching, that are used by health insurance companies and pharmacy benefit managers to determine whether a prescribed product or service is medically necessary and cost effective. Originally, it also meant that the service/treatment would be reimbursed. That is not the case anymore.

Today, physicians face many frivolous PAs for generic medications, such as methotrexate and prednisone, and ironically sometimes higher-priced drugs are preferred over lower-priced ones.

A number of surveys, including a recent one of more than 1,000 specialty physicians by the Alliance of Specialty Medicine, show that PAs are not only a significant administrative burden on practices but also harm patients with significant delays in accessing needed treatments and diagnostic services.

The often-cited study by Zachary Wallace et al. clearly demonstrates significant harm to rheumatology patients whose treatments were delayed because of PAs. These delays caused a substantial increase in steroid dosages in patients whose PA was initially denied and even in those patients whose PAs were initially approved. These data and others support the urgent need to address the entire spectrum of PAs.

Over the last few years, we have seen many states passing laws, adding common-sense protections to mitigate the harmful consequences of UMTs. Such reforms are needed now to stop the indiscriminate use of PAs. Suggestions have included completely eliminating PAs for medications and services that are consistently approved, standardizing electronic forms across all health plans with real-time approval, and others, including “gold card” legislation. In addition to states’ efforts, Congress proposed H.R. 3173, the Improving Seniors’ Timely Access to Care Act of 2021, to protect seniors from the harm caused by PAs that are required by Medicare Advantage programs.

This brings us to the topic of gold card legislation, in which physicians would be given a gold card exempting them from PA for specific services (hopefully including prescription drugs). However, the criteria a physician needs to qualify for a gold card could vary from state to state. For example, it could be based on a physician’s PA approval rate during a specified review period, or it could be completely up to the insurance company to decide the criteria.

Texas is the only state that has passed gold card legislation thus far, although there is an active gold card bill in Louisiana (as of this writing). There are a few other states that have introduced gold card bills that have not yet passed, but there is definite interest throughout the country in this concept. In the Texas legislation, physicians would qualify for a gold card if they had a PA approval threshold of 90% for specific medications or services over a 6-month review period.

A few of the concerns about how this will be implemented and the potential unintended consequences of the legislation include:

• Would one gold card cover all drugs, a specific drug, or just a specific drug for a specific diagnosis?
• Will clinicians get bogged down appealing gold card denials/rescissions?
• Will health plans begin denying more requests up front to keep clinicians from qualifying for an exemption?

Unfortunately, the Louisiana gold card legislation has been amended from its original form to exclude “pharmacy services” and qualification for the gold card “shall be at the sole discretion of the health insurance issuer.”

Consequently, my initial excitement surrounding the Louisiana gold card legislation, for our specialty, has for the most part disappeared. Nonetheless, there is clear excitement behind the gold card concept throughout the country.

What is clear is that health insurance companies and pharmacy benefit managers have lost sight of the original purpose of UMTs, which is to ensure that patients have access to cost-effective quality care. Over the years, the aggressive use of PAs and other UMTs has led to a significant increase in administrative burden for our offices, and more importantly, a loss of disease control in many of our patients, resulting in an increase in overall health care costs.

While it is extremely disturbing that we need legislation to force health plans to keep our patients safe and ensure quality of care, it certainly proves that now, more than ever, we must make our voices be heard.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is president of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

Everything in medicine, and pretty much the universe, is based on averages. Average reduction of seizures, average blood levels, average response to treatment, average insurance reimbursement, average time spent with a new consult.

Statistics are helpful in working through large amounts of data, but on a smaller scale, like my practice, statistics aren’t quite as helpful.

I see, on average, maybe 10 patients per day, consisting of new ones, follow-ups, and electromyography and nerve conduction velocity (EMG/NCV) studies. That is, by far, a smaller number of patients than my colleagues in primary care see, and probably other neurology practices as well. But it works for me.

But that’s on averages and not always. Sometimes we all hit slumps. Who knows why? Everyone is on vacation, or the holidays are coming, or they’ve been abducted by aliens. Whatever the reason, I get the occasional week where I’m pretty bored. Maybe one or two patients in a day. I start to feel like the lonely Maytag repairman behind my desk. I check to see if any drug samples have expired. I wonder if people are actually reading my online reviews and going elsewhere.

Years ago weeks like that terrified me. I was worried my little practice might fail (granted, it still could). But as years – and cycles that make up the averages – go by, they don’t bother me as much.

After 23 years I’ve learned that it’s just part of the normal fluctuations that make up an average. One morning I’ll roll the phones and the lines will explode (figuratively, I hope) with calls. At times like these my secretary seems to grow another pair of arms as she frantically schedules callers, puts others on hold, copies insurance cards, and gives the evil eye to drug reps who step in and ask her if she’s busy.

Then my schedule gets packed. My secretary crams patients in my emergency slots of 7:00, 8:00, and 12:00. MRI results come in that require me to see people sooner rather than later. My “average” of 10 patients per day suddenly doesn’t exist. I go home with a pile of dictations to do and work away into the night to catch up.

With experience we learn to take this in stride. Now, when I hit a slow patch, I remind myself that it’s not the average, and to enjoy it while I can. Read a book, take a long lunch, go home early and nap.

Worrying about where the patients are isn’t productive, or good for your mental health. They know where I am, and will find me when they need me.

Learning to ride out the highs and lows that make up an average patient load is just another part of the job. Enjoy the slow times while you can.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Everything in medicine, and pretty much the universe, is based on averages. Average reduction of seizures, average blood levels, average response to treatment, average insurance reimbursement, average time spent with a new consult.

Statistics are helpful in working through large amounts of data, but on a smaller scale, like my practice, statistics aren’t quite as helpful.

I see, on average, maybe 10 patients per day, consisting of new ones, follow-ups, and electromyography and nerve conduction velocity (EMG/NCV) studies. That is, by far, a smaller number of patients than my colleagues in primary care see, and probably other neurology practices as well. But it works for me.

But that’s on averages and not always. Sometimes we all hit slumps. Who knows why? Everyone is on vacation, or the holidays are coming, or they’ve been abducted by aliens. Whatever the reason, I get the occasional week where I’m pretty bored. Maybe one or two patients in a day. I start to feel like the lonely Maytag repairman behind my desk. I check to see if any drug samples have expired. I wonder if people are actually reading my online reviews and going elsewhere.

Years ago weeks like that terrified me. I was worried my little practice might fail (granted, it still could). But as years – and cycles that make up the averages – go by, they don’t bother me as much.

After 23 years I’ve learned that it’s just part of the normal fluctuations that make up an average. One morning I’ll roll the phones and the lines will explode (figuratively, I hope) with calls. At times like these my secretary seems to grow another pair of arms as she frantically schedules callers, puts others on hold, copies insurance cards, and gives the evil eye to drug reps who step in and ask her if she’s busy.

Then my schedule gets packed. My secretary crams patients in my emergency slots of 7:00, 8:00, and 12:00. MRI results come in that require me to see people sooner rather than later. My “average” of 10 patients per day suddenly doesn’t exist. I go home with a pile of dictations to do and work away into the night to catch up.

With experience we learn to take this in stride. Now, when I hit a slow patch, I remind myself that it’s not the average, and to enjoy it while I can. Read a book, take a long lunch, go home early and nap.

Worrying about where the patients are isn’t productive, or good for your mental health. They know where I am, and will find me when they need me.

Learning to ride out the highs and lows that make up an average patient load is just another part of the job. Enjoy the slow times while you can.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Everything in medicine, and pretty much the universe, is based on averages. Average reduction of seizures, average blood levels, average response to treatment, average insurance reimbursement, average time spent with a new consult.

Statistics are helpful in working through large amounts of data, but on a smaller scale, like my practice, statistics aren’t quite as helpful.

I see, on average, maybe 10 patients per day, consisting of new ones, follow-ups, and electromyography and nerve conduction velocity (EMG/NCV) studies. That is, by far, a smaller number of patients than my colleagues in primary care see, and probably other neurology practices as well. But it works for me.

But that’s on averages and not always. Sometimes we all hit slumps. Who knows why? Everyone is on vacation, or the holidays are coming, or they’ve been abducted by aliens. Whatever the reason, I get the occasional week where I’m pretty bored. Maybe one or two patients in a day. I start to feel like the lonely Maytag repairman behind my desk. I check to see if any drug samples have expired. I wonder if people are actually reading my online reviews and going elsewhere.

Years ago weeks like that terrified me. I was worried my little practice might fail (granted, it still could). But as years – and cycles that make up the averages – go by, they don’t bother me as much.

After 23 years I’ve learned that it’s just part of the normal fluctuations that make up an average. One morning I’ll roll the phones and the lines will explode (figuratively, I hope) with calls. At times like these my secretary seems to grow another pair of arms as she frantically schedules callers, puts others on hold, copies insurance cards, and gives the evil eye to drug reps who step in and ask her if she’s busy.

Then my schedule gets packed. My secretary crams patients in my emergency slots of 7:00, 8:00, and 12:00. MRI results come in that require me to see people sooner rather than later. My “average” of 10 patients per day suddenly doesn’t exist. I go home with a pile of dictations to do and work away into the night to catch up.

With experience we learn to take this in stride. Now, when I hit a slow patch, I remind myself that it’s not the average, and to enjoy it while I can. Read a book, take a long lunch, go home early and nap.

Worrying about where the patients are isn’t productive, or good for your mental health. They know where I am, and will find me when they need me.

Learning to ride out the highs and lows that make up an average patient load is just another part of the job. Enjoy the slow times while you can.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.