To the Editor:

A 43-year-old woman presented with a mole on the central back that had been present since childhood and had changed and grown over the last few years. The patient reported that her 2-year-old rescue dog frequently sniffed the mole and would subsequently get agitated and try to scratch and bite the lesion. This behavior prompted the patient to visit a dermatologist.

She reported no personal history of melanoma or nonmelanoma skin cancer, tanning booth exposure, blistering sunburns, or use of immunosuppressant medications. Her family history was remarkable for basal cell carcinoma in her father but no family history of melanoma. Physical examination revealed a 1.2×1.5-cm brown patch along with a 1×1-cm ulcerated nodule on the lower aspect of the lesion (Figure 1). Dermoscopy showed a blue-white veil and an irregular vascular pattern (Figure 2). No cervical, axillary, or inguinal lymphadenopathy was appreciated on physical examination. Reflectance confocal microscopy showed pagetoid spread of atypical round melanocytes as well as melanocytes in the stratum corneum (Figure 3).

The patient was referred to a surgical oncologist for wide local excision and sentinel lymph node biopsy. Pathology showed a 4-mm-thick melanoma with numerous positive lymph nodes (Figure 4). The patient subsequently underwent a right axillary lymphadenectomy and was diagnosed with stage IIIB malignant melanoma. After surgery, the patient reported that her dog would now sniff her back and calmly rest his head in her lap.

Both anecdotal and systematic evidence have emerged on the role of canine olfaction in the detection of lung, breast, colorectal, ovarian, prostate, and skin cancers, including malignant melanoma.^1-6 A 1989 case report described a woman who was prompted to seek dermatologic evaluation of a pigmented lesion because her dog consistently targeted the lesion. Excision and subsequent histopathologic examination of the lesion revealed that it was malignant melanoma.⁵ Another case report described a patient whose dog, which was not trained to detect cancers in humans, persistently licked a lesion behind the patient’s ear that eventually was found to be malignant melanoma.⁶ These reports have inspired considerable research interest regarding canine olfaction as a potential method to noninvasively screen for and even diagnose malignant melanomas in humans.

Both physiologic and pathologic metabolic processes result in the production of volatile organic compounds (VOCs), or small odorant molecules that evaporate at normal temperatures and pressures.¹ Individual cells release VOCs in extremely low concentrations into the blood, urine, feces, and breath, as well as onto the skin’s surface, but there are methods for detecting these VOCs, including gas chromatography–mass spectrometry and canine olfaction.^7,8 Pathologic processes, such as infection and malignancy, result in irregular protein synthesis and metabolism, producing new VOCs or differing concentrations of VOCs as compared to normal processes.¹

Dimethyl disulfide and dimethyl trisulfide compounds have been identified in malignant melanoma, and these compounds are not produced by normal melanocytes.⁷ Furthermore, malignant melanoma produces differing quantities of these compounds as compared to normal melanocytes, including isovaleric acid, 2-methylbutyric acid, isoamyl alcohol (3-methyl-1-butanol), and 2-methyl-1-butanol, resulting in a distinct odorant profile that previously has been detected via canine olfaction.⁷ Canine olfaction can identify odorant molecules at up to 1 part per trillion (a magnitude more sensitive than the currently available gas chromatography–mass spectrometry technologies) and can detect the production of new VOCs or altered VOC ratios due to pathologic processes.¹ Systematic studies with dogs that are trained to detect cancers in humans have shown that canine olfaction correctly identified malignant melanomas against healthy skin, benign nevi, and even basal cell carcinomas at higher rates than what would have been expected by chance alone.^2,3

Canine olfaction can identify new or altered ratios of odorant VOCs associated with pathologic metabolic processes, and canines can be trained to target odor profiles associated with specific diseases.¹ Canine olfaction for melanoma screening and diagnosis may seem appealing, as it provides an easily transportable, real-time, low-cost method compared to other techniques such as gas chromatography–mass spectrometry.¹ Although preliminary results have shown that canine olfaction detects melanoma at higher rates than would be expected by chance alone, these findings have not approached clinical utility for the widespread use of canine olfaction as a screening method for melanoma.^2,3,9 Further studies are needed to understand the role of canine olfaction in melanoma screening and diagnosis as well as to explore methods to optimize sensitivity and specificity. Until then, patients and dermatologists should not ignore the behavior of dogs toward skin lesions. Dogs may be beneficial in the detection of melanoma and help save lives, as was seen in our case.

To the Editor:

A 43-year-old woman presented with a mole on the central back that had been present since childhood and had changed and grown over the last few years. The patient reported that her 2-year-old rescue dog frequently sniffed the mole and would subsequently get agitated and try to scratch and bite the lesion. This behavior prompted the patient to visit a dermatologist.

She reported no personal history of melanoma or nonmelanoma skin cancer, tanning booth exposure, blistering sunburns, or use of immunosuppressant medications. Her family history was remarkable for basal cell carcinoma in her father but no family history of melanoma. Physical examination revealed a 1.2×1.5-cm brown patch along with a 1×1-cm ulcerated nodule on the lower aspect of the lesion (Figure 1). Dermoscopy showed a blue-white veil and an irregular vascular pattern (Figure 2). No cervical, axillary, or inguinal lymphadenopathy was appreciated on physical examination. Reflectance confocal microscopy showed pagetoid spread of atypical round melanocytes as well as melanocytes in the stratum corneum (Figure 3).

The patient was referred to a surgical oncologist for wide local excision and sentinel lymph node biopsy. Pathology showed a 4-mm-thick melanoma with numerous positive lymph nodes (Figure 4). The patient subsequently underwent a right axillary lymphadenectomy and was diagnosed with stage IIIB malignant melanoma. After surgery, the patient reported that her dog would now sniff her back and calmly rest his head in her lap.

Both anecdotal and systematic evidence have emerged on the role of canine olfaction in the detection of lung, breast, colorectal, ovarian, prostate, and skin cancers, including malignant melanoma.^1-6 A 1989 case report described a woman who was prompted to seek dermatologic evaluation of a pigmented lesion because her dog consistently targeted the lesion. Excision and subsequent histopathologic examination of the lesion revealed that it was malignant melanoma.⁵ Another case report described a patient whose dog, which was not trained to detect cancers in humans, persistently licked a lesion behind the patient’s ear that eventually was found to be malignant melanoma.⁶ These reports have inspired considerable research interest regarding canine olfaction as a potential method to noninvasively screen for and even diagnose malignant melanomas in humans.

Both physiologic and pathologic metabolic processes result in the production of volatile organic compounds (VOCs), or small odorant molecules that evaporate at normal temperatures and pressures.¹ Individual cells release VOCs in extremely low concentrations into the blood, urine, feces, and breath, as well as onto the skin’s surface, but there are methods for detecting these VOCs, including gas chromatography–mass spectrometry and canine olfaction.^7,8 Pathologic processes, such as infection and malignancy, result in irregular protein synthesis and metabolism, producing new VOCs or differing concentrations of VOCs as compared to normal processes.¹

Dimethyl disulfide and dimethyl trisulfide compounds have been identified in malignant melanoma, and these compounds are not produced by normal melanocytes.⁷ Furthermore, malignant melanoma produces differing quantities of these compounds as compared to normal melanocytes, including isovaleric acid, 2-methylbutyric acid, isoamyl alcohol (3-methyl-1-butanol), and 2-methyl-1-butanol, resulting in a distinct odorant profile that previously has been detected via canine olfaction.⁷ Canine olfaction can identify odorant molecules at up to 1 part per trillion (a magnitude more sensitive than the currently available gas chromatography–mass spectrometry technologies) and can detect the production of new VOCs or altered VOC ratios due to pathologic processes.¹ Systematic studies with dogs that are trained to detect cancers in humans have shown that canine olfaction correctly identified malignant melanomas against healthy skin, benign nevi, and even basal cell carcinomas at higher rates than what would have been expected by chance alone.^2,3

Canine olfaction can identify new or altered ratios of odorant VOCs associated with pathologic metabolic processes, and canines can be trained to target odor profiles associated with specific diseases.¹ Canine olfaction for melanoma screening and diagnosis may seem appealing, as it provides an easily transportable, real-time, low-cost method compared to other techniques such as gas chromatography–mass spectrometry.¹ Although preliminary results have shown that canine olfaction detects melanoma at higher rates than would be expected by chance alone, these findings have not approached clinical utility for the widespread use of canine olfaction as a screening method for melanoma.^2,3,9 Further studies are needed to understand the role of canine olfaction in melanoma screening and diagnosis as well as to explore methods to optimize sensitivity and specificity. Until then, patients and dermatologists should not ignore the behavior of dogs toward skin lesions. Dogs may be beneficial in the detection of melanoma and help save lives, as was seen in our case.

To the Editor:

A 43-year-old woman presented with a mole on the central back that had been present since childhood and had changed and grown over the last few years. The patient reported that her 2-year-old rescue dog frequently sniffed the mole and would subsequently get agitated and try to scratch and bite the lesion. This behavior prompted the patient to visit a dermatologist.

She reported no personal history of melanoma or nonmelanoma skin cancer, tanning booth exposure, blistering sunburns, or use of immunosuppressant medications. Her family history was remarkable for basal cell carcinoma in her father but no family history of melanoma. Physical examination revealed a 1.2×1.5-cm brown patch along with a 1×1-cm ulcerated nodule on the lower aspect of the lesion (Figure 1). Dermoscopy showed a blue-white veil and an irregular vascular pattern (Figure 2). No cervical, axillary, or inguinal lymphadenopathy was appreciated on physical examination. Reflectance confocal microscopy showed pagetoid spread of atypical round melanocytes as well as melanocytes in the stratum corneum (Figure 3).

The patient was referred to a surgical oncologist for wide local excision and sentinel lymph node biopsy. Pathology showed a 4-mm-thick melanoma with numerous positive lymph nodes (Figure 4). The patient subsequently underwent a right axillary lymphadenectomy and was diagnosed with stage IIIB malignant melanoma. After surgery, the patient reported that her dog would now sniff her back and calmly rest his head in her lap.

Both anecdotal and systematic evidence have emerged on the role of canine olfaction in the detection of lung, breast, colorectal, ovarian, prostate, and skin cancers, including malignant melanoma.^1-6 A 1989 case report described a woman who was prompted to seek dermatologic evaluation of a pigmented lesion because her dog consistently targeted the lesion. Excision and subsequent histopathologic examination of the lesion revealed that it was malignant melanoma.⁵ Another case report described a patient whose dog, which was not trained to detect cancers in humans, persistently licked a lesion behind the patient’s ear that eventually was found to be malignant melanoma.⁶ These reports have inspired considerable research interest regarding canine olfaction as a potential method to noninvasively screen for and even diagnose malignant melanomas in humans.

Both physiologic and pathologic metabolic processes result in the production of volatile organic compounds (VOCs), or small odorant molecules that evaporate at normal temperatures and pressures.¹ Individual cells release VOCs in extremely low concentrations into the blood, urine, feces, and breath, as well as onto the skin’s surface, but there are methods for detecting these VOCs, including gas chromatography–mass spectrometry and canine olfaction.^7,8 Pathologic processes, such as infection and malignancy, result in irregular protein synthesis and metabolism, producing new VOCs or differing concentrations of VOCs as compared to normal processes.¹

Dimethyl disulfide and dimethyl trisulfide compounds have been identified in malignant melanoma, and these compounds are not produced by normal melanocytes.⁷ Furthermore, malignant melanoma produces differing quantities of these compounds as compared to normal melanocytes, including isovaleric acid, 2-methylbutyric acid, isoamyl alcohol (3-methyl-1-butanol), and 2-methyl-1-butanol, resulting in a distinct odorant profile that previously has been detected via canine olfaction.⁷ Canine olfaction can identify odorant molecules at up to 1 part per trillion (a magnitude more sensitive than the currently available gas chromatography–mass spectrometry technologies) and can detect the production of new VOCs or altered VOC ratios due to pathologic processes.¹ Systematic studies with dogs that are trained to detect cancers in humans have shown that canine olfaction correctly identified malignant melanomas against healthy skin, benign nevi, and even basal cell carcinomas at higher rates than what would have been expected by chance alone.^2,3

Canine olfaction can identify new or altered ratios of odorant VOCs associated with pathologic metabolic processes, and canines can be trained to target odor profiles associated with specific diseases.¹ Canine olfaction for melanoma screening and diagnosis may seem appealing, as it provides an easily transportable, real-time, low-cost method compared to other techniques such as gas chromatography–mass spectrometry.¹ Although preliminary results have shown that canine olfaction detects melanoma at higher rates than would be expected by chance alone, these findings have not approached clinical utility for the widespread use of canine olfaction as a screening method for melanoma.^2,3,9 Further studies are needed to understand the role of canine olfaction in melanoma screening and diagnosis as well as to explore methods to optimize sensitivity and specificity. Until then, patients and dermatologists should not ignore the behavior of dogs toward skin lesions. Dogs may be beneficial in the detection of melanoma and help save lives, as was seen in our case.

PARIS – Middle-aged adults with a body mass index of 25-29 kg/m² had a significantly better adjusted survival during a median follow-up of nearly 10 years than did people with a “normal” body mass index of 20-24 kg/m² in a worldwide study of more than 140,000. This finding suggests the current, widely accepted definition of normal body mass index is wrong.*

Mitchel L. Zoler/MDedge News

The new findings suggest that the current definition of a “healthy” body mass index (BMI) “should be re-evaluated,” Darryl P. Leong, MBBS, said at the annual Congress of the European Society of Cardiology. The analysis also identified a BMI specifically of 27 kg/m² as associated with optimal survival among both women and men, “clearly outside the range of 20 to less than 25 kg/m² that is considered normal,” said Dr. Leong, a cardiologist at McMaster University and the Population Health Research Institute, both in Hamilton, Ont.

Dr. Leong cited three potential explanations for why the new study identified optimal survival with a BMI of 25 to less than 30 kg/m² among people who were 35-70 years old when they entered the study and were followed for a median of 9.5 years: The current study collected data and adjusted the results using a wider range of potential confounders than in prior studies, the data reflect the impact of contemporary interventions to reduce cardiovascular disease illness and death while past studies relied on data from earlier times when less cardiovascular disease protection occurred, and the current study included people from lower-income countries, although the finding is just as applicable to people who live in high-income countries, who were also included in the study population, noted Salim Yusuf, MBBS, principal investigator for the study.

A BMI of 20-24 kg/m² “is actually low and harmful,” noted Dr. Yusuf in an interview. Despite recent data consistently showing better survival among people with a BMI of 25-29 kg/m², panels that have recently written weight guidelines are “ossified” and “refuse to accept” the implications of these findings, said Dr. Yusuf, professor of medicine at McMaster and executive director of the Population Health Research Institute.

The results of the analyses that Dr. Leong reported also showed that BMI paled as a prognosticator for survival when compared with two other assessments of weight: waist/hip ratio, and even more powerful prognostically, a novel measure developed for this analysis that calculates the ratio of hand-grip strength/body weight. Waist/hip ratio adds the dimension of the location of body fat rather than just the amount, and the ratio of grip strength/body weight assesses the contribution of muscle mass to overall weight, noted Dr. Leong. He reported an optimal waist/hip ratio for survival of 0.83 in women and 0.93 in men, and an optimal strength/weight ratio of 0.42 in women and 0.50 in men. This means that a man whose hand-grip strength (measured in kg) is half of the person’s body weight has the best prospect for survival.
 
The study used data collected in PURE (Prospective Urban Rural Epidemiology Study) on 142,410 people aged 35-70 years from any one of four high-income countries, 12 middle-income countries, and five low-income countries. The study excluded people who had at baseline known coronary artery disease, stroke, heart failure, or cancer, and the adjusted analysis controlled for age, sex, region, education, activity, alcohol and tobacco use, and the baseline prevalence of hypertension and diabetes. During follow-up, 9,712 of these people died.

The researchers saw a nadir for mortality among people with a BMI of 25-29 kg/m² for both cardiovascular and noncardiovascular deaths. In addition, the link between total mortality and BMI was strongest in the subgroup of people on one or more treatments aimed at preventing cardiovascular disease, while it essentially disappeared among people not receiving any cardiovascular disease preventive measures, highlighting that the relationship now identified depends on a context of overall cardiovascular disease risk reduction, Dr. Leong said. The results also showed a very clear, direct, linear relationship between higher BMI and both the incidence of diabetes and cardiovascular disease, as well as increased all-cause and noncardiovascular mortality among people with a BMI of less than 20 kg/m².

Dr. Yusuf discussed the results of the analysis in a video interview.

The PURE study has received partial funding from unrestricted grants from several drug companies. Dr. Leong has been an advisor to Ferring Pharmaceuticals and has been a speaker on behalf of Janssen. Dr. Yusuf had no disclosures.

mzoler@mdedge.com

This story was updated 9/19/2019.

PARIS – Middle-aged adults with a body mass index of 25-29 kg/m² had a significantly better adjusted survival during a median follow-up of nearly 10 years than did people with a “normal” body mass index of 20-24 kg/m² in a worldwide study of more than 140,000. This finding suggests the current, widely accepted definition of normal body mass index is wrong.*

Mitchel L. Zoler/MDedge News

The new findings suggest that the current definition of a “healthy” body mass index (BMI) “should be re-evaluated,” Darryl P. Leong, MBBS, said at the annual Congress of the European Society of Cardiology. The analysis also identified a BMI specifically of 27 kg/m² as associated with optimal survival among both women and men, “clearly outside the range of 20 to less than 25 kg/m² that is considered normal,” said Dr. Leong, a cardiologist at McMaster University and the Population Health Research Institute, both in Hamilton, Ont.

Dr. Leong cited three potential explanations for why the new study identified optimal survival with a BMI of 25 to less than 30 kg/m² among people who were 35-70 years old when they entered the study and were followed for a median of 9.5 years: The current study collected data and adjusted the results using a wider range of potential confounders than in prior studies, the data reflect the impact of contemporary interventions to reduce cardiovascular disease illness and death while past studies relied on data from earlier times when less cardiovascular disease protection occurred, and the current study included people from lower-income countries, although the finding is just as applicable to people who live in high-income countries, who were also included in the study population, noted Salim Yusuf, MBBS, principal investigator for the study.

A BMI of 20-24 kg/m² “is actually low and harmful,” noted Dr. Yusuf in an interview. Despite recent data consistently showing better survival among people with a BMI of 25-29 kg/m², panels that have recently written weight guidelines are “ossified” and “refuse to accept” the implications of these findings, said Dr. Yusuf, professor of medicine at McMaster and executive director of the Population Health Research Institute.

The results of the analyses that Dr. Leong reported also showed that BMI paled as a prognosticator for survival when compared with two other assessments of weight: waist/hip ratio, and even more powerful prognostically, a novel measure developed for this analysis that calculates the ratio of hand-grip strength/body weight. Waist/hip ratio adds the dimension of the location of body fat rather than just the amount, and the ratio of grip strength/body weight assesses the contribution of muscle mass to overall weight, noted Dr. Leong. He reported an optimal waist/hip ratio for survival of 0.83 in women and 0.93 in men, and an optimal strength/weight ratio of 0.42 in women and 0.50 in men. This means that a man whose hand-grip strength (measured in kg) is half of the person’s body weight has the best prospect for survival.
 
The study used data collected in PURE (Prospective Urban Rural Epidemiology Study) on 142,410 people aged 35-70 years from any one of four high-income countries, 12 middle-income countries, and five low-income countries. The study excluded people who had at baseline known coronary artery disease, stroke, heart failure, or cancer, and the adjusted analysis controlled for age, sex, region, education, activity, alcohol and tobacco use, and the baseline prevalence of hypertension and diabetes. During follow-up, 9,712 of these people died.

The researchers saw a nadir for mortality among people with a BMI of 25-29 kg/m² for both cardiovascular and noncardiovascular deaths. In addition, the link between total mortality and BMI was strongest in the subgroup of people on one or more treatments aimed at preventing cardiovascular disease, while it essentially disappeared among people not receiving any cardiovascular disease preventive measures, highlighting that the relationship now identified depends on a context of overall cardiovascular disease risk reduction, Dr. Leong said. The results also showed a very clear, direct, linear relationship between higher BMI and both the incidence of diabetes and cardiovascular disease, as well as increased all-cause and noncardiovascular mortality among people with a BMI of less than 20 kg/m².

Dr. Yusuf discussed the results of the analysis in a video interview.

The PURE study has received partial funding from unrestricted grants from several drug companies. Dr. Leong has been an advisor to Ferring Pharmaceuticals and has been a speaker on behalf of Janssen. Dr. Yusuf had no disclosures.

mzoler@mdedge.com

This story was updated 9/19/2019.

PARIS – Middle-aged adults with a body mass index of 25-29 kg/m² had a significantly better adjusted survival during a median follow-up of nearly 10 years than did people with a “normal” body mass index of 20-24 kg/m² in a worldwide study of more than 140,000. This finding suggests the current, widely accepted definition of normal body mass index is wrong.*

Mitchel L. Zoler/MDedge News

The new findings suggest that the current definition of a “healthy” body mass index (BMI) “should be re-evaluated,” Darryl P. Leong, MBBS, said at the annual Congress of the European Society of Cardiology. The analysis also identified a BMI specifically of 27 kg/m² as associated with optimal survival among both women and men, “clearly outside the range of 20 to less than 25 kg/m² that is considered normal,” said Dr. Leong, a cardiologist at McMaster University and the Population Health Research Institute, both in Hamilton, Ont.

Dr. Leong cited three potential explanations for why the new study identified optimal survival with a BMI of 25 to less than 30 kg/m² among people who were 35-70 years old when they entered the study and were followed for a median of 9.5 years: The current study collected data and adjusted the results using a wider range of potential confounders than in prior studies, the data reflect the impact of contemporary interventions to reduce cardiovascular disease illness and death while past studies relied on data from earlier times when less cardiovascular disease protection occurred, and the current study included people from lower-income countries, although the finding is just as applicable to people who live in high-income countries, who were also included in the study population, noted Salim Yusuf, MBBS, principal investigator for the study.

A BMI of 20-24 kg/m² “is actually low and harmful,” noted Dr. Yusuf in an interview. Despite recent data consistently showing better survival among people with a BMI of 25-29 kg/m², panels that have recently written weight guidelines are “ossified” and “refuse to accept” the implications of these findings, said Dr. Yusuf, professor of medicine at McMaster and executive director of the Population Health Research Institute.

The results of the analyses that Dr. Leong reported also showed that BMI paled as a prognosticator for survival when compared with two other assessments of weight: waist/hip ratio, and even more powerful prognostically, a novel measure developed for this analysis that calculates the ratio of hand-grip strength/body weight. Waist/hip ratio adds the dimension of the location of body fat rather than just the amount, and the ratio of grip strength/body weight assesses the contribution of muscle mass to overall weight, noted Dr. Leong. He reported an optimal waist/hip ratio for survival of 0.83 in women and 0.93 in men, and an optimal strength/weight ratio of 0.42 in women and 0.50 in men. This means that a man whose hand-grip strength (measured in kg) is half of the person’s body weight has the best prospect for survival.
 
The study used data collected in PURE (Prospective Urban Rural Epidemiology Study) on 142,410 people aged 35-70 years from any one of four high-income countries, 12 middle-income countries, and five low-income countries. The study excluded people who had at baseline known coronary artery disease, stroke, heart failure, or cancer, and the adjusted analysis controlled for age, sex, region, education, activity, alcohol and tobacco use, and the baseline prevalence of hypertension and diabetes. During follow-up, 9,712 of these people died.

The researchers saw a nadir for mortality among people with a BMI of 25-29 kg/m² for both cardiovascular and noncardiovascular deaths. In addition, the link between total mortality and BMI was strongest in the subgroup of people on one or more treatments aimed at preventing cardiovascular disease, while it essentially disappeared among people not receiving any cardiovascular disease preventive measures, highlighting that the relationship now identified depends on a context of overall cardiovascular disease risk reduction, Dr. Leong said. The results also showed a very clear, direct, linear relationship between higher BMI and both the incidence of diabetes and cardiovascular disease, as well as increased all-cause and noncardiovascular mortality among people with a BMI of less than 20 kg/m².

Dr. Yusuf discussed the results of the analysis in a video interview.

The PURE study has received partial funding from unrestricted grants from several drug companies. Dr. Leong has been an advisor to Ferring Pharmaceuticals and has been a speaker on behalf of Janssen. Dr. Yusuf had no disclosures.

mzoler@mdedge.com

This story was updated 9/19/2019.

BARCELONA – Adding a blood microRNA (miRNA) assay to low-dose computed tomography (LDCT)–based lung cancer screening in heavy smokers bolsters lung cancer prevention efforts, according to findings from the prospective bioMILD trial.

Specifically, the addition of the miRNA assay appears to reduce unnecessary repeat LDCT scans based on individual risk profiles without adversely affecting lung cancer detection or mortality, Ugo Pastorino, MD, director of thoracic surgery at the Istituto Nazionale dei Tumori Foundation, Milan, reported at the World Conference on Lung Cancer.

Of 4,119 volunteers with a median age of 60 years and a median of 42 pack-years who were enrolled between January 2013 and March 2016, 2,384 (58%) were assigned a 3-year LDCT repeat according to their double-negative baseline LDCT and miRNA profile, whereas 1,526 (37%) with a single-positive screen (either a positive miRNA or indeterminate/positive LDCT) and 209 (5%) with double positive (both a positive miRNA and indeterminate/positive LDCT) were assigned to annual or shorter LDCT repeat.

After four screening runs, a total of 115 lung cancers were diagnosed. The cumulative lung cancer rates “were enormously different” in the 3 groups, despite similar group composition with respect to age, gender, and tobacco consumption (0.6% for double-negative screening, 3.8% for single-positive screening, and 20.1% for double-positive screening), and lung cancer mortality was 0.1%, 0.6%, and 3.8% in the groups, respectively, Dr. Pastorino said at the conference, which is sponsored by the International Association for the Study of Lung Cancer.

However, no significant differences were seen in the proportion of stage I lung cancers, resection rates, or interval cancer incidence in subjects sent to 3-year LDCT repeat, he noted.

The bioMILD trial was designed in the wake of the National Lung Screening Trial (NLST), which showed that three annual LDCT rounds for lung cancer screening reduced lung cancer mortality, and the Multicentric Italian Lung Detection (MILD) trial, which provided additional evidence that intervention beyond 5 years with annual or biennial rounds enhanced the benefit of screening.

Dr. Pastorino, the lead author on the MILD trial, previously reported that miRNA expression profiles in tumors and in normal lung tissue indicate aggressive lung cancer development and that specific miRNA signatures can be identified in plasma samples up to 2 years before spiral-CT detection of the disease.

The bioMILD trial tested the additional value of an miRNA assay at the time of LDCT.

Subjects were current (79%) or former heavy smokers, and 39% were women.

The findings suggest that adding the miRNA assay to LDCT for lung cancer screening is a “valuable and safe tool to assess individual risk profile and reduce unnecessary LDCT repeats in lung cancer screening,” Dr. Pastorino said.

“But what is more important for us [is that] the knowledge of individual biologic risk can improve the efficacy of screening, but can [also] guide prevention strategies because the problem in a heavy smoker is not to just detect lung cancer, it’s to reduce mortality,” he said at a press conference highlighting the findings. “And so, personalized prevention is a real option now, and that means diagnosis, but also preventive measures [such as] smoking cessation and chemoprevention.”

Invited discussant Harry J. de Koning, MD, PhD, professor of public health and screening evaluation at Erasmus Medical Center, Rotterdam, the Netherlands, noted that no other studies have evaluated screening intervals longer than 2 years, but he agreed that “reducing regular follow-up scans based on additional risk information is a way forward.”

However, the approach would increase costs, he said, adding that large, prospective, randomized, controlled trials are needed to confirm the safety of such approaches in nationwide programs.

Dr. Pastorino and Dr. de Koning each reported having no disclosures.

SOURCE: Pastorino U et al. WCLC 2019, Abstract PL02.04

BARCELONA – Adding a blood microRNA (miRNA) assay to low-dose computed tomography (LDCT)–based lung cancer screening in heavy smokers bolsters lung cancer prevention efforts, according to findings from the prospective bioMILD trial.

Specifically, the addition of the miRNA assay appears to reduce unnecessary repeat LDCT scans based on individual risk profiles without adversely affecting lung cancer detection or mortality, Ugo Pastorino, MD, director of thoracic surgery at the Istituto Nazionale dei Tumori Foundation, Milan, reported at the World Conference on Lung Cancer.

Of 4,119 volunteers with a median age of 60 years and a median of 42 pack-years who were enrolled between January 2013 and March 2016, 2,384 (58%) were assigned a 3-year LDCT repeat according to their double-negative baseline LDCT and miRNA profile, whereas 1,526 (37%) with a single-positive screen (either a positive miRNA or indeterminate/positive LDCT) and 209 (5%) with double positive (both a positive miRNA and indeterminate/positive LDCT) were assigned to annual or shorter LDCT repeat.

After four screening runs, a total of 115 lung cancers were diagnosed. The cumulative lung cancer rates “were enormously different” in the 3 groups, despite similar group composition with respect to age, gender, and tobacco consumption (0.6% for double-negative screening, 3.8% for single-positive screening, and 20.1% for double-positive screening), and lung cancer mortality was 0.1%, 0.6%, and 3.8% in the groups, respectively, Dr. Pastorino said at the conference, which is sponsored by the International Association for the Study of Lung Cancer.

However, no significant differences were seen in the proportion of stage I lung cancers, resection rates, or interval cancer incidence in subjects sent to 3-year LDCT repeat, he noted.

The bioMILD trial was designed in the wake of the National Lung Screening Trial (NLST), which showed that three annual LDCT rounds for lung cancer screening reduced lung cancer mortality, and the Multicentric Italian Lung Detection (MILD) trial, which provided additional evidence that intervention beyond 5 years with annual or biennial rounds enhanced the benefit of screening.

Dr. Pastorino, the lead author on the MILD trial, previously reported that miRNA expression profiles in tumors and in normal lung tissue indicate aggressive lung cancer development and that specific miRNA signatures can be identified in plasma samples up to 2 years before spiral-CT detection of the disease.

The bioMILD trial tested the additional value of an miRNA assay at the time of LDCT.

Subjects were current (79%) or former heavy smokers, and 39% were women.

The findings suggest that adding the miRNA assay to LDCT for lung cancer screening is a “valuable and safe tool to assess individual risk profile and reduce unnecessary LDCT repeats in lung cancer screening,” Dr. Pastorino said.

“But what is more important for us [is that] the knowledge of individual biologic risk can improve the efficacy of screening, but can [also] guide prevention strategies because the problem in a heavy smoker is not to just detect lung cancer, it’s to reduce mortality,” he said at a press conference highlighting the findings. “And so, personalized prevention is a real option now, and that means diagnosis, but also preventive measures [such as] smoking cessation and chemoprevention.”

Invited discussant Harry J. de Koning, MD, PhD, professor of public health and screening evaluation at Erasmus Medical Center, Rotterdam, the Netherlands, noted that no other studies have evaluated screening intervals longer than 2 years, but he agreed that “reducing regular follow-up scans based on additional risk information is a way forward.”

However, the approach would increase costs, he said, adding that large, prospective, randomized, controlled trials are needed to confirm the safety of such approaches in nationwide programs.

Dr. Pastorino and Dr. de Koning each reported having no disclosures.

SOURCE: Pastorino U et al. WCLC 2019, Abstract PL02.04

BARCELONA – Adding a blood microRNA (miRNA) assay to low-dose computed tomography (LDCT)–based lung cancer screening in heavy smokers bolsters lung cancer prevention efforts, according to findings from the prospective bioMILD trial.

Specifically, the addition of the miRNA assay appears to reduce unnecessary repeat LDCT scans based on individual risk profiles without adversely affecting lung cancer detection or mortality, Ugo Pastorino, MD, director of thoracic surgery at the Istituto Nazionale dei Tumori Foundation, Milan, reported at the World Conference on Lung Cancer.

Of 4,119 volunteers with a median age of 60 years and a median of 42 pack-years who were enrolled between January 2013 and March 2016, 2,384 (58%) were assigned a 3-year LDCT repeat according to their double-negative baseline LDCT and miRNA profile, whereas 1,526 (37%) with a single-positive screen (either a positive miRNA or indeterminate/positive LDCT) and 209 (5%) with double positive (both a positive miRNA and indeterminate/positive LDCT) were assigned to annual or shorter LDCT repeat.

After four screening runs, a total of 115 lung cancers were diagnosed. The cumulative lung cancer rates “were enormously different” in the 3 groups, despite similar group composition with respect to age, gender, and tobacco consumption (0.6% for double-negative screening, 3.8% for single-positive screening, and 20.1% for double-positive screening), and lung cancer mortality was 0.1%, 0.6%, and 3.8% in the groups, respectively, Dr. Pastorino said at the conference, which is sponsored by the International Association for the Study of Lung Cancer.

However, no significant differences were seen in the proportion of stage I lung cancers, resection rates, or interval cancer incidence in subjects sent to 3-year LDCT repeat, he noted.

The bioMILD trial was designed in the wake of the National Lung Screening Trial (NLST), which showed that three annual LDCT rounds for lung cancer screening reduced lung cancer mortality, and the Multicentric Italian Lung Detection (MILD) trial, which provided additional evidence that intervention beyond 5 years with annual or biennial rounds enhanced the benefit of screening.

Dr. Pastorino, the lead author on the MILD trial, previously reported that miRNA expression profiles in tumors and in normal lung tissue indicate aggressive lung cancer development and that specific miRNA signatures can be identified in plasma samples up to 2 years before spiral-CT detection of the disease.

The bioMILD trial tested the additional value of an miRNA assay at the time of LDCT.

Subjects were current (79%) or former heavy smokers, and 39% were women.

The findings suggest that adding the miRNA assay to LDCT for lung cancer screening is a “valuable and safe tool to assess individual risk profile and reduce unnecessary LDCT repeats in lung cancer screening,” Dr. Pastorino said.

“But what is more important for us [is that] the knowledge of individual biologic risk can improve the efficacy of screening, but can [also] guide prevention strategies because the problem in a heavy smoker is not to just detect lung cancer, it’s to reduce mortality,” he said at a press conference highlighting the findings. “And so, personalized prevention is a real option now, and that means diagnosis, but also preventive measures [such as] smoking cessation and chemoprevention.”

Invited discussant Harry J. de Koning, MD, PhD, professor of public health and screening evaluation at Erasmus Medical Center, Rotterdam, the Netherlands, noted that no other studies have evaluated screening intervals longer than 2 years, but he agreed that “reducing regular follow-up scans based on additional risk information is a way forward.”

However, the approach would increase costs, he said, adding that large, prospective, randomized, controlled trials are needed to confirm the safety of such approaches in nationwide programs.

Dr. Pastorino and Dr. de Koning each reported having no disclosures.

SOURCE: Pastorino U et al. WCLC 2019, Abstract PL02.04

The number of measles cases reported in the United States dropped for the fourth month in a row in August after reaching a peak of 341 in April, according to the Centers for Disease Control and Prevention.

A total of 24 measles cases were confirmed in August, and the total for the year is now 1,241 cases in 31 states. Only seven of those cases were added during the most recent reporting week, which ended Sept. 5, but five were older cases that had just been reported, the CDC said Sept. 9.

With the ending of the measles outbreak in New York, announced Sept. 3, the largest of the three remaining active outbreaks in the country is in Rockland County, N.Y., just north of the city, which has reported 312 cases since it began in 2018.

The two other outbreaks are located in El Paso, Tex., where six cases have been reported so far, and Wyoming County in western New York State, where five cases have occurred.

rfranki@mdedge.com

The number of measles cases reported in the United States dropped for the fourth month in a row in August after reaching a peak of 341 in April, according to the Centers for Disease Control and Prevention.

A total of 24 measles cases were confirmed in August, and the total for the year is now 1,241 cases in 31 states. Only seven of those cases were added during the most recent reporting week, which ended Sept. 5, but five were older cases that had just been reported, the CDC said Sept. 9.

With the ending of the measles outbreak in New York, announced Sept. 3, the largest of the three remaining active outbreaks in the country is in Rockland County, N.Y., just north of the city, which has reported 312 cases since it began in 2018.

The two other outbreaks are located in El Paso, Tex., where six cases have been reported so far, and Wyoming County in western New York State, where five cases have occurred.

rfranki@mdedge.com

The number of measles cases reported in the United States dropped for the fourth month in a row in August after reaching a peak of 341 in April, according to the Centers for Disease Control and Prevention.

A total of 24 measles cases were confirmed in August, and the total for the year is now 1,241 cases in 31 states. Only seven of those cases were added during the most recent reporting week, which ended Sept. 5, but five were older cases that had just been reported, the CDC said Sept. 9.

With the ending of the measles outbreak in New York, announced Sept. 3, the largest of the three remaining active outbreaks in the country is in Rockland County, N.Y., just north of the city, which has reported 312 cases since it began in 2018.

The two other outbreaks are located in El Paso, Tex., where six cases have been reported so far, and Wyoming County in western New York State, where five cases have occurred.

rfranki@mdedge.com

NEW YORK – The most recently approved therapy for acne, sarecycline, as well as several agents in late stages of clinical testing, might represent a particular advance for treating black patients or others with darker skin tones due to a reduced risk of irritation, according to a review presented at the Skin of Color Update 2019.

Hulldude30/Getty Images

Acne is an inflammatory skin disease, but patients with darker skin tones are at a high risk of postinflammatory hyperpigmentation (PIH), a complication many consider worse than the acne itself, according to Andrew Alexis, MD, director of the Skin of Color Center and chair of the department of dermatology at Mount Sinai St. Luke’s, New York.

“The importance of PIH is that it alters our endpoint in patients of color. Not only are we treating the pustules, comedones, and other classic features of acne, but we have to treat all the way through to the resolution of the PIH if we want a satisfied patient,” he said.

There are data to back this up. In one of the surveys cited by Dr. Alexis, 42% of nonwhite patients identified resolution of PIH as the most important goal in the treatment of their acne.

As in those with light skin, acute acne lesions in darker skin can resolve relatively rapidly after initiating an effective regimen that includes established therapies such as retinoids or antibiotics. However, PIH, once it develops, might take 6-12 months to resolve, according to Dr. Alexis, who is a professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

Ted Bosworth/MDedge News

“You have to keep in mind the subclinical inflammation, which can be a slow burning process beneath the surface of the skin,” he said. He cited a biopsy study that demonstrated inflammation even in nonlesional skin of black patients with acne.

Because of the slow reversal of PIH, it is imperative in skin of color patients to employ therapies with the least risk of exacerbating PIH. While this includes judicious use of currently available agents, Dr. Alexis believes that newer agents might have a larger therapeutic window, reducing the potential for inflammation at effective doses.

This advantage has yet to be confirmed in head-to-head studies, but Dr. Alexis is optimistic. In the case of sarecycline, which became the first antibiotic approved specifically for acne when it was approved by the Food and Drug Administration in 2018, about 20% of those included in the phase 3 registration trial were nonwhite, he said.

The results were “impressive” regardless of skin color in the phase 3 study, according to Dr. Alexis. He conceded that this is not the only antibiotic with anti-inflammatory activity, but he suggested that a high degree of efficacy might be relevant for early acne control and a reduced risk of PIH.

The same can be said for trifarotene, a novel topical retinoid that was associated with highly significant reductions in both inflammatory and noninflammatory lesion counts in a recently published phase 3 trial (J Am Acad Dermatol. 2019 Jun;80[6]:1691-9). According to Dr. Alexis, the impact of this therapy on PIH has not been specifically tested, but he expects those data to be forthcoming.

A new 0.045% lotion formulation of tazarotene might also widen the therapeutic window relative to current tazarotene formulations based on clinical trials he cited. Despite a concentration that is about half that of the currently available tazarotene cream, the efficacy of this product appeared to be at least as good “without the baggage of a greater potential for irritation,” he said.

After “a few years of drought” regarding new options for treatment of acne, these are not the only promising agents in clinical trials, according to Dr. Alexis. If these agents prove to offer greater efficacy with less irritation, their increased clinical value might prove most meaningful to patients with darker skin.

“There is a delicate balance between maximizing efficacy without causing irritation that leads to PIH in patients with skin of color,” he cautioned. He is hopeful that the newer agents will make this balance easier to achieve.

Dr. Alexis has financial relationships with many pharmaceutical companies, including many that market drugs for acne.


 

NEW YORK – The most recently approved therapy for acne, sarecycline, as well as several agents in late stages of clinical testing, might represent a particular advance for treating black patients or others with darker skin tones due to a reduced risk of irritation, according to a review presented at the Skin of Color Update 2019.

Hulldude30/Getty Images

Acne is an inflammatory skin disease, but patients with darker skin tones are at a high risk of postinflammatory hyperpigmentation (PIH), a complication many consider worse than the acne itself, according to Andrew Alexis, MD, director of the Skin of Color Center and chair of the department of dermatology at Mount Sinai St. Luke’s, New York.

“The importance of PIH is that it alters our endpoint in patients of color. Not only are we treating the pustules, comedones, and other classic features of acne, but we have to treat all the way through to the resolution of the PIH if we want a satisfied patient,” he said.

There are data to back this up. In one of the surveys cited by Dr. Alexis, 42% of nonwhite patients identified resolution of PIH as the most important goal in the treatment of their acne.

As in those with light skin, acute acne lesions in darker skin can resolve relatively rapidly after initiating an effective regimen that includes established therapies such as retinoids or antibiotics. However, PIH, once it develops, might take 6-12 months to resolve, according to Dr. Alexis, who is a professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

Ted Bosworth/MDedge News

“You have to keep in mind the subclinical inflammation, which can be a slow burning process beneath the surface of the skin,” he said. He cited a biopsy study that demonstrated inflammation even in nonlesional skin of black patients with acne.

Because of the slow reversal of PIH, it is imperative in skin of color patients to employ therapies with the least risk of exacerbating PIH. While this includes judicious use of currently available agents, Dr. Alexis believes that newer agents might have a larger therapeutic window, reducing the potential for inflammation at effective doses.

This advantage has yet to be confirmed in head-to-head studies, but Dr. Alexis is optimistic. In the case of sarecycline, which became the first antibiotic approved specifically for acne when it was approved by the Food and Drug Administration in 2018, about 20% of those included in the phase 3 registration trial were nonwhite, he said.

The results were “impressive” regardless of skin color in the phase 3 study, according to Dr. Alexis. He conceded that this is not the only antibiotic with anti-inflammatory activity, but he suggested that a high degree of efficacy might be relevant for early acne control and a reduced risk of PIH.

The same can be said for trifarotene, a novel topical retinoid that was associated with highly significant reductions in both inflammatory and noninflammatory lesion counts in a recently published phase 3 trial (J Am Acad Dermatol. 2019 Jun;80[6]:1691-9). According to Dr. Alexis, the impact of this therapy on PIH has not been specifically tested, but he expects those data to be forthcoming.

A new 0.045% lotion formulation of tazarotene might also widen the therapeutic window relative to current tazarotene formulations based on clinical trials he cited. Despite a concentration that is about half that of the currently available tazarotene cream, the efficacy of this product appeared to be at least as good “without the baggage of a greater potential for irritation,” he said.

After “a few years of drought” regarding new options for treatment of acne, these are not the only promising agents in clinical trials, according to Dr. Alexis. If these agents prove to offer greater efficacy with less irritation, their increased clinical value might prove most meaningful to patients with darker skin.

“There is a delicate balance between maximizing efficacy without causing irritation that leads to PIH in patients with skin of color,” he cautioned. He is hopeful that the newer agents will make this balance easier to achieve.

Dr. Alexis has financial relationships with many pharmaceutical companies, including many that market drugs for acne.


 

NEW YORK – The most recently approved therapy for acne, sarecycline, as well as several agents in late stages of clinical testing, might represent a particular advance for treating black patients or others with darker skin tones due to a reduced risk of irritation, according to a review presented at the Skin of Color Update 2019.

Hulldude30/Getty Images

Acne is an inflammatory skin disease, but patients with darker skin tones are at a high risk of postinflammatory hyperpigmentation (PIH), a complication many consider worse than the acne itself, according to Andrew Alexis, MD, director of the Skin of Color Center and chair of the department of dermatology at Mount Sinai St. Luke’s, New York.

“The importance of PIH is that it alters our endpoint in patients of color. Not only are we treating the pustules, comedones, and other classic features of acne, but we have to treat all the way through to the resolution of the PIH if we want a satisfied patient,” he said.

There are data to back this up. In one of the surveys cited by Dr. Alexis, 42% of nonwhite patients identified resolution of PIH as the most important goal in the treatment of their acne.

As in those with light skin, acute acne lesions in darker skin can resolve relatively rapidly after initiating an effective regimen that includes established therapies such as retinoids or antibiotics. However, PIH, once it develops, might take 6-12 months to resolve, according to Dr. Alexis, who is a professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York.

Ted Bosworth/MDedge News

“You have to keep in mind the subclinical inflammation, which can be a slow burning process beneath the surface of the skin,” he said. He cited a biopsy study that demonstrated inflammation even in nonlesional skin of black patients with acne.

Because of the slow reversal of PIH, it is imperative in skin of color patients to employ therapies with the least risk of exacerbating PIH. While this includes judicious use of currently available agents, Dr. Alexis believes that newer agents might have a larger therapeutic window, reducing the potential for inflammation at effective doses.

This advantage has yet to be confirmed in head-to-head studies, but Dr. Alexis is optimistic. In the case of sarecycline, which became the first antibiotic approved specifically for acne when it was approved by the Food and Drug Administration in 2018, about 20% of those included in the phase 3 registration trial were nonwhite, he said.

The results were “impressive” regardless of skin color in the phase 3 study, according to Dr. Alexis. He conceded that this is not the only antibiotic with anti-inflammatory activity, but he suggested that a high degree of efficacy might be relevant for early acne control and a reduced risk of PIH.

The same can be said for trifarotene, a novel topical retinoid that was associated with highly significant reductions in both inflammatory and noninflammatory lesion counts in a recently published phase 3 trial (J Am Acad Dermatol. 2019 Jun;80[6]:1691-9). According to Dr. Alexis, the impact of this therapy on PIH has not been specifically tested, but he expects those data to be forthcoming.

A new 0.045% lotion formulation of tazarotene might also widen the therapeutic window relative to current tazarotene formulations based on clinical trials he cited. Despite a concentration that is about half that of the currently available tazarotene cream, the efficacy of this product appeared to be at least as good “without the baggage of a greater potential for irritation,” he said.

After “a few years of drought” regarding new options for treatment of acne, these are not the only promising agents in clinical trials, according to Dr. Alexis. If these agents prove to offer greater efficacy with less irritation, their increased clinical value might prove most meaningful to patients with darker skin.

“There is a delicate balance between maximizing efficacy without causing irritation that leads to PIH in patients with skin of color,” he cautioned. He is hopeful that the newer agents will make this balance easier to achieve.

Dr. Alexis has financial relationships with many pharmaceutical companies, including many that market drugs for acne.


 

The Center for Tobacco Products, part of the Food and Drug Administration, has issued a warning letter to JUUL Labs Inc. for illegal marketing of unauthorized modified-risk tobacco products, citing violation of the Federal Food, Drug, and Cosmetic Act.

According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.

As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”

In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”

In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”

The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.

lfranki@mdedge.com

The Center for Tobacco Products, part of the Food and Drug Administration, has issued a warning letter to JUUL Labs Inc. for illegal marketing of unauthorized modified-risk tobacco products, citing violation of the Federal Food, Drug, and Cosmetic Act.

According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.

As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”

In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”

In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”

The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.

lfranki@mdedge.com

The Center for Tobacco Products, part of the Food and Drug Administration, has issued a warning letter to JUUL Labs Inc. for illegal marketing of unauthorized modified-risk tobacco products, citing violation of the Federal Food, Drug, and Cosmetic Act.

According to the letter, JUUL has marketed its e-cigarettes and e-liquids as modified-risk tobacco products without receiving FDA authorization to do so. JUUL’s labeling, advertising, and other consumer-oriented activities to this effect could reasonably lead consumers to believe that JUUL products represent a lower risk of tobacco-related disease, compared with other tobacco products; that they contain a reduced level of a substance; and that they are free of a particular substance or substances.

As evidence, the letter cited testimony given at a July 2019 hearing held by the Subcommittee on Economic and Consumer Policy of the Committee on Oversight and Reform of the House of Representatives, in which a representative from JUUL, speaking to students at a school presentation, said that JUUL products were “much safer than cigarettes” and that the “FDA would approve it any day,” that JUUL products were “totally safe,” that a student “should mention JUUL to his [nicotine-addicted] friend ... because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use,” and that the FDA “was about to come out and say it [JUUL] was 99% safer than cigarettes ... and that ... would happen very soon.”

In addition, a “Letter from the CEO” that appeared on the JUUL website and was emailed to a parent in response to her complaint that the company sold JUUL products to her child stated that “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”

In a related press release, acting FDA Commissioner Ned Sharpless, MD, said that “regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”

The FDA has requested a response from JUUL within 15 working days of the letter’s issue. Failure to comply with the Federal Food, Drug, and Cosmetic Act could result in the FDA’s initiating further actions such as civil money penalties, seizure, and/or injunction.

lfranki@mdedge.com

Vidyard Video

Vidyard Video

Vidyard Video

 Videos courtesy of Mayo Clinic

Read the related article: Native tissue repair of POP: Surgical techniques to improve outcomes

Vidyard Video

Vidyard Video

Vidyard Video

 Videos courtesy of Mayo Clinic

Read the related article: Native tissue repair of POP: Surgical techniques to improve outcomes

Vidyard Video

Vidyard Video

Vidyard Video

 Videos courtesy of Mayo Clinic

Read the related article: Native tissue repair of POP: Surgical techniques to improve outcomes

Screening for colorectal cancer in patients with cystic fibrosis is cost effective, and should be started at a younger age and performed more often, new research suggests.

While colorectal cancer (CRC) screening traditionally begins at age 50 years in people at average risk for the disease, those at high risk usually begin undergoing colonoscopies at an earlier age. Patients with cystic fibrosis fall under the latter category, wrote Andrea Gini, of the department of public health at Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues, with an incidence of CRC up to 30 times higher than the general population, but their shorter lifespan has led to a “different trade-off between the benefits and harms of CRC screening.”

Between 2000 and 2015, the median predicted survival age for patients with cystic fibrosis increased from 33.3 years to 41.7 years; this increased survival has brought increased risk for other diseases, particularly in the GI tract, Mr. Gini and colleagues wrote in Gastroenterology. By using the Microsimulation Screening Analysis–Colon model – a joint project between Erasmus Medical Center and Memorial Sloan Kettering Cancer Center in New York – the investigators assessed the cost-effectiveness of CRC screening in patients with cystic fibrosis.

Three cohorts of 10 million patients each were simulated, with one cohort having undergone transplant, one cohort not having transplant, and one cohort of individuals without cystic fibrosis. The simulated patient age was 30 years in 2017. A total of 76 different colonoscopy-screening strategies were assessed, with each differing in screening interval (3, 5, or 10 years for colonoscopy), age to start screening (30, 35, 40, 45, or 50 years), and age to end screening (55, 60, 65, 70, or 75 years). The optimal screening strategy was determined based on a willingness-to-pay threshold of $100,000 per life-year gained, the investigators wrote.

In the absence of screening, the mortality rate for nontransplant cystic fibrosis patients was 19.1 per 1,000 people, and the rate for cystic fibrosis patients who had undergone transplant was 22.3 per 1,000 people. The standard screening strategy prevented more than 73% of CRC deaths in the general population, 66% of deaths in nontransplant cystic fibrosis patients, and 36% of deaths in cystic fibrosis patients with transplant; however, the model predicted that only 22% of individuals who received a transplant and 36% of those who did not would reach the age of 50 years.

According to the model, the optimal colonoscopy-screening strategy for nontransplant patients was one screen every 5 years, starting at 40 and screening until the age of 75. The incremental cost-effectiveness ratio (ICER) was $84,000 per life-year gained; CRC incidence was reduced by 52% and CRC mortality was reduced by 79%. For transplant patients, the best strategy was one screen every 3 years between the ages of 35 and 55, which reduced CRC mortality by 82% at an ICER of $71,000 per life-year gained.

In a separate analysis of fecal immunochemical testing, a less-demanding alternative to colonoscopy, the optimal screening strategy was an annual test between the age of 35 and 75 years for nontransplant cystic fibrosis patients, for an ICER of $47,000 per life-year gained and a CRC mortality reduction of 78%. The best strategy for transplant patients was once a year between the ages of 30 and 60, which reduced CRC mortality by 77% at an ICER of $86,000 per life-year gained. While fecal immunochemical testing may be more cost effective than colonoscopy, “specific evidence of its performance in the cystic fibrosis population is required before considering this screening modality,” the investigators noted.

“This study indicates that there is benefit to earlier CRC screening in the cystic fibrosis population and [that it] can be done at acceptable costs,” the investigators wrote. “The findings of this analysis support clinicians, researchers, and policy makers who aim to define a tailored CRC screening for individuals with cystic fibrosis in the United States.”

The study was funded by the Cystic Fibrosis Foundation, the Cancer Intervention and Surveillance Modeling Network consortium, and Memorial Sloan Kettering Cancer Center. The investigators reported no conflicts of interest.

lfranki@mdedge.com

SOURCE: Gini A et al. Gastroenterology. 2017 Dec 27. doi: 10.1053/j.gastro.2017.12.011.

Screening for colorectal cancer in patients with cystic fibrosis is cost effective, and should be started at a younger age and performed more often, new research suggests.

While colorectal cancer (CRC) screening traditionally begins at age 50 years in people at average risk for the disease, those at high risk usually begin undergoing colonoscopies at an earlier age. Patients with cystic fibrosis fall under the latter category, wrote Andrea Gini, of the department of public health at Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues, with an incidence of CRC up to 30 times higher than the general population, but their shorter lifespan has led to a “different trade-off between the benefits and harms of CRC screening.”

Between 2000 and 2015, the median predicted survival age for patients with cystic fibrosis increased from 33.3 years to 41.7 years; this increased survival has brought increased risk for other diseases, particularly in the GI tract, Mr. Gini and colleagues wrote in Gastroenterology. By using the Microsimulation Screening Analysis–Colon model – a joint project between Erasmus Medical Center and Memorial Sloan Kettering Cancer Center in New York – the investigators assessed the cost-effectiveness of CRC screening in patients with cystic fibrosis.

Three cohorts of 10 million patients each were simulated, with one cohort having undergone transplant, one cohort not having transplant, and one cohort of individuals without cystic fibrosis. The simulated patient age was 30 years in 2017. A total of 76 different colonoscopy-screening strategies were assessed, with each differing in screening interval (3, 5, or 10 years for colonoscopy), age to start screening (30, 35, 40, 45, or 50 years), and age to end screening (55, 60, 65, 70, or 75 years). The optimal screening strategy was determined based on a willingness-to-pay threshold of $100,000 per life-year gained, the investigators wrote.

In the absence of screening, the mortality rate for nontransplant cystic fibrosis patients was 19.1 per 1,000 people, and the rate for cystic fibrosis patients who had undergone transplant was 22.3 per 1,000 people. The standard screening strategy prevented more than 73% of CRC deaths in the general population, 66% of deaths in nontransplant cystic fibrosis patients, and 36% of deaths in cystic fibrosis patients with transplant; however, the model predicted that only 22% of individuals who received a transplant and 36% of those who did not would reach the age of 50 years.

According to the model, the optimal colonoscopy-screening strategy for nontransplant patients was one screen every 5 years, starting at 40 and screening until the age of 75. The incremental cost-effectiveness ratio (ICER) was $84,000 per life-year gained; CRC incidence was reduced by 52% and CRC mortality was reduced by 79%. For transplant patients, the best strategy was one screen every 3 years between the ages of 35 and 55, which reduced CRC mortality by 82% at an ICER of $71,000 per life-year gained.

In a separate analysis of fecal immunochemical testing, a less-demanding alternative to colonoscopy, the optimal screening strategy was an annual test between the age of 35 and 75 years for nontransplant cystic fibrosis patients, for an ICER of $47,000 per life-year gained and a CRC mortality reduction of 78%. The best strategy for transplant patients was once a year between the ages of 30 and 60, which reduced CRC mortality by 77% at an ICER of $86,000 per life-year gained. While fecal immunochemical testing may be more cost effective than colonoscopy, “specific evidence of its performance in the cystic fibrosis population is required before considering this screening modality,” the investigators noted.

“This study indicates that there is benefit to earlier CRC screening in the cystic fibrosis population and [that it] can be done at acceptable costs,” the investigators wrote. “The findings of this analysis support clinicians, researchers, and policy makers who aim to define a tailored CRC screening for individuals with cystic fibrosis in the United States.”

The study was funded by the Cystic Fibrosis Foundation, the Cancer Intervention and Surveillance Modeling Network consortium, and Memorial Sloan Kettering Cancer Center. The investigators reported no conflicts of interest.

lfranki@mdedge.com

SOURCE: Gini A et al. Gastroenterology. 2017 Dec 27. doi: 10.1053/j.gastro.2017.12.011.

Screening for colorectal cancer in patients with cystic fibrosis is cost effective, and should be started at a younger age and performed more often, new research suggests.

While colorectal cancer (CRC) screening traditionally begins at age 50 years in people at average risk for the disease, those at high risk usually begin undergoing colonoscopies at an earlier age. Patients with cystic fibrosis fall under the latter category, wrote Andrea Gini, of the department of public health at Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues, with an incidence of CRC up to 30 times higher than the general population, but their shorter lifespan has led to a “different trade-off between the benefits and harms of CRC screening.”

Between 2000 and 2015, the median predicted survival age for patients with cystic fibrosis increased from 33.3 years to 41.7 years; this increased survival has brought increased risk for other diseases, particularly in the GI tract, Mr. Gini and colleagues wrote in Gastroenterology. By using the Microsimulation Screening Analysis–Colon model – a joint project between Erasmus Medical Center and Memorial Sloan Kettering Cancer Center in New York – the investigators assessed the cost-effectiveness of CRC screening in patients with cystic fibrosis.

Three cohorts of 10 million patients each were simulated, with one cohort having undergone transplant, one cohort not having transplant, and one cohort of individuals without cystic fibrosis. The simulated patient age was 30 years in 2017. A total of 76 different colonoscopy-screening strategies were assessed, with each differing in screening interval (3, 5, or 10 years for colonoscopy), age to start screening (30, 35, 40, 45, or 50 years), and age to end screening (55, 60, 65, 70, or 75 years). The optimal screening strategy was determined based on a willingness-to-pay threshold of $100,000 per life-year gained, the investigators wrote.

In the absence of screening, the mortality rate for nontransplant cystic fibrosis patients was 19.1 per 1,000 people, and the rate for cystic fibrosis patients who had undergone transplant was 22.3 per 1,000 people. The standard screening strategy prevented more than 73% of CRC deaths in the general population, 66% of deaths in nontransplant cystic fibrosis patients, and 36% of deaths in cystic fibrosis patients with transplant; however, the model predicted that only 22% of individuals who received a transplant and 36% of those who did not would reach the age of 50 years.

According to the model, the optimal colonoscopy-screening strategy for nontransplant patients was one screen every 5 years, starting at 40 and screening until the age of 75. The incremental cost-effectiveness ratio (ICER) was $84,000 per life-year gained; CRC incidence was reduced by 52% and CRC mortality was reduced by 79%. For transplant patients, the best strategy was one screen every 3 years between the ages of 35 and 55, which reduced CRC mortality by 82% at an ICER of $71,000 per life-year gained.

In a separate analysis of fecal immunochemical testing, a less-demanding alternative to colonoscopy, the optimal screening strategy was an annual test between the age of 35 and 75 years for nontransplant cystic fibrosis patients, for an ICER of $47,000 per life-year gained and a CRC mortality reduction of 78%. The best strategy for transplant patients was once a year between the ages of 30 and 60, which reduced CRC mortality by 77% at an ICER of $86,000 per life-year gained. While fecal immunochemical testing may be more cost effective than colonoscopy, “specific evidence of its performance in the cystic fibrosis population is required before considering this screening modality,” the investigators noted.

“This study indicates that there is benefit to earlier CRC screening in the cystic fibrosis population and [that it] can be done at acceptable costs,” the investigators wrote. “The findings of this analysis support clinicians, researchers, and policy makers who aim to define a tailored CRC screening for individuals with cystic fibrosis in the United States.”

The study was funded by the Cystic Fibrosis Foundation, the Cancer Intervention and Surveillance Modeling Network consortium, and Memorial Sloan Kettering Cancer Center. The investigators reported no conflicts of interest.

lfranki@mdedge.com

SOURCE: Gini A et al. Gastroenterology. 2017 Dec 27. doi: 10.1053/j.gastro.2017.12.011.

CASE Patient has adverse effects from halted estrogen pills

JR twists her hands nervously as you step into the room. “They stopped my hormones,” she sighs as you pull up her lab results.

JR recently had been admitted to an inpatient cardiology unit for several days for a heart failure exacerbation. Her ankles are still swollen beneath her floral print skirt, but she is breathing much easier now. She is back at your primary care office, hoping to get clearance to restart her estrogen pills.

JR reports having mood swings and terrible nightmares while not taking her hormones, which she has been taking for more than 3 years. She hesitates before sharing, “One of the doctors kept asking me questions about my sex life that had nothing to do with my heart condition. I don’t want to go back there.”

Providing compassionate and comprehensive care to gender-nonconforming individuals is challenging for a multitude of reasons, from clinician ignorance to systemic discrimination. About 33% of transgender patients reported being harassed, denied care, or even being assaulted when seeking health care, while 23% reported avoiding going to the doctor altogether when sick or injured out of fear of discrimination.¹

Unfortunately, now, further increases to barriers to care may be put in place. In late May of this year, the Department of Health and Human Services (HHS) proposed new regulations that would reverse previous regulations granted through section 1557 of the Affordable Care Act (ACA)—the Health Care Rights Law—which affirmed the rights of gender nonbinary persons to medical care. Among the proposed changes is the elimination of protections against discrimination in health care based on gender identity.² The proposed regulation changes come on the heels of a federal court case, which seeks to declare that hospital systems may turn away patients based on gender identity.³

Unraveling rights afforded under the ACA

The Health Care Rights Law was passed under the ACA; it prohibits discrimination based on race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance. Multiple lower courts have supported that the rights of transgender individuals is included within these protections against discrimination on the basis of sex.⁴ These court rulings not only have ensured the ability of gender-diverse individuals to access care but also have enforced insurance coverage of therapies for gender dysphoria. It was only in 2014 that Medicaid began providing coverage for gender-affirming surgeries and eliminating language that such procedures were “experimental” or “cosmetic.” The 2016 passage of the ACA mandated that private insurance companies follow suit. Unfortunately, the recent proposed regulation changes to the Health Care Rights Law may spark a reversal from insurance companies as well. Such a setback would affect gender-diverse individuals’ hormone treatments as well as their ability to access a full spectrum of care within the health care system.

Continue to: ACOG urges nondiscriminatory practices...

ACOG urges nondiscriminatory practices

The proposed regulation changes to the Health Care Rights Law are from the Conscience and Religious Freedom Division of the HHS Office for Civil Rights, which was established in 2018 and has been advocating for the rights of health care providers to refuse to treat patients based on their own religious beliefs.⁵ We argue, however, that providing care to persons of varying backgrounds is not an assault on our individual liberties but rather a privilege as providers. As obstetrician-gynecologists, it may be easy to only consider cis-gendered women our responsibility. But our field also emphasizes individual empowerment above all else—we fight every day for our patients’ rights to contraception, fertility, pregnancy, parenthood, and sexual freedoms. Let us continue speaking up for the rights of all those who need gynecologic care, regardless of the pronouns they use.

“The American College of Obstetricians and Gynecologists urges health care providers to foster nondiscriminatory practices and policies to increase identification and to facilitate quality health care for transgender individuals, both in assisting with the transition if desired as well as providing long-term preventive health care.”⁶

We urge you to take action

• Reach out to your local representatives about protecting transgender health access
• Educate yourself on the unique needs of transgender individuals
• Read personal accounts
• Share your personal story
• Find referring providers near your practice

CASE Patient has adverse effects from halted estrogen pills

JR twists her hands nervously as you step into the room. “They stopped my hormones,” she sighs as you pull up her lab results.

JR recently had been admitted to an inpatient cardiology unit for several days for a heart failure exacerbation. Her ankles are still swollen beneath her floral print skirt, but she is breathing much easier now. She is back at your primary care office, hoping to get clearance to restart her estrogen pills.

JR reports having mood swings and terrible nightmares while not taking her hormones, which she has been taking for more than 3 years. She hesitates before sharing, “One of the doctors kept asking me questions about my sex life that had nothing to do with my heart condition. I don’t want to go back there.”

Providing compassionate and comprehensive care to gender-nonconforming individuals is challenging for a multitude of reasons, from clinician ignorance to systemic discrimination. About 33% of transgender patients reported being harassed, denied care, or even being assaulted when seeking health care, while 23% reported avoiding going to the doctor altogether when sick or injured out of fear of discrimination.¹

Unfortunately, now, further increases to barriers to care may be put in place. In late May of this year, the Department of Health and Human Services (HHS) proposed new regulations that would reverse previous regulations granted through section 1557 of the Affordable Care Act (ACA)—the Health Care Rights Law—which affirmed the rights of gender nonbinary persons to medical care. Among the proposed changes is the elimination of protections against discrimination in health care based on gender identity.² The proposed regulation changes come on the heels of a federal court case, which seeks to declare that hospital systems may turn away patients based on gender identity.³

Unraveling rights afforded under the ACA

The Health Care Rights Law was passed under the ACA; it prohibits discrimination based on race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance. Multiple lower courts have supported that the rights of transgender individuals is included within these protections against discrimination on the basis of sex.⁴ These court rulings not only have ensured the ability of gender-diverse individuals to access care but also have enforced insurance coverage of therapies for gender dysphoria. It was only in 2014 that Medicaid began providing coverage for gender-affirming surgeries and eliminating language that such procedures were “experimental” or “cosmetic.” The 2016 passage of the ACA mandated that private insurance companies follow suit. Unfortunately, the recent proposed regulation changes to the Health Care Rights Law may spark a reversal from insurance companies as well. Such a setback would affect gender-diverse individuals’ hormone treatments as well as their ability to access a full spectrum of care within the health care system.

Continue to: ACOG urges nondiscriminatory practices...

ACOG urges nondiscriminatory practices

The proposed regulation changes to the Health Care Rights Law are from the Conscience and Religious Freedom Division of the HHS Office for Civil Rights, which was established in 2018 and has been advocating for the rights of health care providers to refuse to treat patients based on their own religious beliefs.⁵ We argue, however, that providing care to persons of varying backgrounds is not an assault on our individual liberties but rather a privilege as providers. As obstetrician-gynecologists, it may be easy to only consider cis-gendered women our responsibility. But our field also emphasizes individual empowerment above all else—we fight every day for our patients’ rights to contraception, fertility, pregnancy, parenthood, and sexual freedoms. Let us continue speaking up for the rights of all those who need gynecologic care, regardless of the pronouns they use.

“The American College of Obstetricians and Gynecologists urges health care providers to foster nondiscriminatory practices and policies to increase identification and to facilitate quality health care for transgender individuals, both in assisting with the transition if desired as well as providing long-term preventive health care.”⁶

We urge you to take action

• Reach out to your local representatives about protecting transgender health access
• Educate yourself on the unique needs of transgender individuals
• Read personal accounts
• Share your personal story
• Find referring providers near your practice

CASE Patient has adverse effects from halted estrogen pills

JR twists her hands nervously as you step into the room. “They stopped my hormones,” she sighs as you pull up her lab results.

JR recently had been admitted to an inpatient cardiology unit for several days for a heart failure exacerbation. Her ankles are still swollen beneath her floral print skirt, but she is breathing much easier now. She is back at your primary care office, hoping to get clearance to restart her estrogen pills.

JR reports having mood swings and terrible nightmares while not taking her hormones, which she has been taking for more than 3 years. She hesitates before sharing, “One of the doctors kept asking me questions about my sex life that had nothing to do with my heart condition. I don’t want to go back there.”

Providing compassionate and comprehensive care to gender-nonconforming individuals is challenging for a multitude of reasons, from clinician ignorance to systemic discrimination. About 33% of transgender patients reported being harassed, denied care, or even being assaulted when seeking health care, while 23% reported avoiding going to the doctor altogether when sick or injured out of fear of discrimination.¹

Unfortunately, now, further increases to barriers to care may be put in place. In late May of this year, the Department of Health and Human Services (HHS) proposed new regulations that would reverse previous regulations granted through section 1557 of the Affordable Care Act (ACA)—the Health Care Rights Law—which affirmed the rights of gender nonbinary persons to medical care. Among the proposed changes is the elimination of protections against discrimination in health care based on gender identity.² The proposed regulation changes come on the heels of a federal court case, which seeks to declare that hospital systems may turn away patients based on gender identity.³

Unraveling rights afforded under the ACA

The Health Care Rights Law was passed under the ACA; it prohibits discrimination based on race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance. Multiple lower courts have supported that the rights of transgender individuals is included within these protections against discrimination on the basis of sex.⁴ These court rulings not only have ensured the ability of gender-diverse individuals to access care but also have enforced insurance coverage of therapies for gender dysphoria. It was only in 2014 that Medicaid began providing coverage for gender-affirming surgeries and eliminating language that such procedures were “experimental” or “cosmetic.” The 2016 passage of the ACA mandated that private insurance companies follow suit. Unfortunately, the recent proposed regulation changes to the Health Care Rights Law may spark a reversal from insurance companies as well. Such a setback would affect gender-diverse individuals’ hormone treatments as well as their ability to access a full spectrum of care within the health care system.

Continue to: ACOG urges nondiscriminatory practices...

ACOG urges nondiscriminatory practices

The proposed regulation changes to the Health Care Rights Law are from the Conscience and Religious Freedom Division of the HHS Office for Civil Rights, which was established in 2018 and has been advocating for the rights of health care providers to refuse to treat patients based on their own religious beliefs.⁵ We argue, however, that providing care to persons of varying backgrounds is not an assault on our individual liberties but rather a privilege as providers. As obstetrician-gynecologists, it may be easy to only consider cis-gendered women our responsibility. But our field also emphasizes individual empowerment above all else—we fight every day for our patients’ rights to contraception, fertility, pregnancy, parenthood, and sexual freedoms. Let us continue speaking up for the rights of all those who need gynecologic care, regardless of the pronouns they use.

“The American College of Obstetricians and Gynecologists urges health care providers to foster nondiscriminatory practices and policies to increase identification and to facilitate quality health care for transgender individuals, both in assisting with the transition if desired as well as providing long-term preventive health care.”⁶

We urge you to take action

• Reach out to your local representatives about protecting transgender health access
• Educate yourself on the unique needs of transgender individuals
• Read personal accounts
• Share your personal story
• Find referring providers near your practice