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Expert shares her tips for an effective cosmetic consultation
The way Kelly Stankiewicz, MD, sees it,
“I can’t tell you how many times I’ve walked into a room and thought the patient would say they’re concerned about one thing, but they’re concerned about something totally different,” Dr. Stankiewicz, a dermatologist in private practice in Park City, Utah, said during the annual conference of the American Society for Laser Medicine and Surgery. “The first question I ask is, ‘What would you like to improve?’ ‘What’s bothering you?’ ‘What would you like to make look better?’ Frequently, it’s not what you think.”
Next, she tries to get a sense of their lifestyle by asking patients about their occupation, hobbies, and outdoor activities they may engage in. “Here in Park City, it’s very sunny most all the time, so treatments need to be tailored to when those outdoor activities are being done, or perhaps they can be avoided for a period of time,” she said. “This gives you an idea of what kind of downtime people will tolerate. I also like to hear about their history of cosmetic procedures. If someone has had a lot of cosmetic procedures done, you can talk with them on a more detailed level. If someone is completely unaware of treatment options, you have to keep it simple.”
Dr. Stankiewicz also reviews their personal history of cosmetic procedures when considering safety of treatment. “For instance, if somebody has had a neck lift, you want to be very cautious doing any ablative procedures along the jawline,” she said. “I also like to know if anyone has had any reactions to dermal fillers or neuromodulators that they did not like. It’s very helpful to hear from patients what’s worked for them and what hasn’t. I also like to keep my ear open for pricing concerns. Not everyone will bring up the pricing issues, but sometimes they will, and it’s an important piece of information. Lastly, it’s important to look for any warning signs like irrational behavior or unrealistic expectations. These are patients you want to try to avoid treating.”
She shared four other key components to an effective cosmetic consultation, including the examination itself, which she prefers to separate from the discussion portion of the visit. “I lean the patient back in the exam chair and shine the light on their skin, which is important for evaluating for conditions you may not have discussed that could be easily improved,” Dr. Stankiewicz said.
“If the patient is concerned about pigmented lesions, I’ll pull out my dermatoscope to make sure there isn’t any concern for skin cancer. After the examination, I’ll sit the patient up again so that there is a very distinct start and finish to the examination portion of my cosmetic consultation.”
Surgery vs. noninvasive treatments
Step three in her consultative process is to review treatment options with patients. “I never hold back if surgery is their best treatment option,” she said. “I don’t perform surgery, but I have a list of people I can refer them to.”
Once she addresses the potential for surgery, she reviews noninvasive treatment options, including topical products, injectables, lasers, and chemical peels. “Everyone who comes in for a cosmetic consultation leaves with some sort of topical recommendation, even if it’s as simple as a sunscreen I think they would like or a prescription for generic tretinoin,” she said. “I always present options in a framework starting with those that require lower downtime, higher number of treatment options, and lower cost. Then I move up the scale to tell them more about treatments that require higher downtime, a lower number of treatments, but have a higher cost.”
Step four in her consultative process involves discussing her final treatment recommendations. She’ll say something like, “I’ve been through all these options with you and my final recommendation is X,” and the patient walks away with a clear understanding of the recommendations, she said. “When I leave the room after giving my final recommendation, I’ll write everything down outside of the room, or I’ll have a member of my staff write down everything I’ve said outside the room.”
Finally, she and her staff record all the relevant information for the patient as a customized handout, including the treatment options discussed, how many will be required, whether they have to come in early for numbing cream or not, and the per treatment price tag. “Once we’ve written down everything we’ve discussed, I’ll circle or I’ll star my recommended treatment,” Dr. Stankiewicz said. They also have a handout for topical products, and she checks off the topical products that she discussed with the patient. The third handout she provides to patients is a recommended skin care regimen.
Dr. Stankiewicz reported having no relevant financial disclosures.
The way Kelly Stankiewicz, MD, sees it,
“I can’t tell you how many times I’ve walked into a room and thought the patient would say they’re concerned about one thing, but they’re concerned about something totally different,” Dr. Stankiewicz, a dermatologist in private practice in Park City, Utah, said during the annual conference of the American Society for Laser Medicine and Surgery. “The first question I ask is, ‘What would you like to improve?’ ‘What’s bothering you?’ ‘What would you like to make look better?’ Frequently, it’s not what you think.”
Next, she tries to get a sense of their lifestyle by asking patients about their occupation, hobbies, and outdoor activities they may engage in. “Here in Park City, it’s very sunny most all the time, so treatments need to be tailored to when those outdoor activities are being done, or perhaps they can be avoided for a period of time,” she said. “This gives you an idea of what kind of downtime people will tolerate. I also like to hear about their history of cosmetic procedures. If someone has had a lot of cosmetic procedures done, you can talk with them on a more detailed level. If someone is completely unaware of treatment options, you have to keep it simple.”
Dr. Stankiewicz also reviews their personal history of cosmetic procedures when considering safety of treatment. “For instance, if somebody has had a neck lift, you want to be very cautious doing any ablative procedures along the jawline,” she said. “I also like to know if anyone has had any reactions to dermal fillers or neuromodulators that they did not like. It’s very helpful to hear from patients what’s worked for them and what hasn’t. I also like to keep my ear open for pricing concerns. Not everyone will bring up the pricing issues, but sometimes they will, and it’s an important piece of information. Lastly, it’s important to look for any warning signs like irrational behavior or unrealistic expectations. These are patients you want to try to avoid treating.”
She shared four other key components to an effective cosmetic consultation, including the examination itself, which she prefers to separate from the discussion portion of the visit. “I lean the patient back in the exam chair and shine the light on their skin, which is important for evaluating for conditions you may not have discussed that could be easily improved,” Dr. Stankiewicz said.
“If the patient is concerned about pigmented lesions, I’ll pull out my dermatoscope to make sure there isn’t any concern for skin cancer. After the examination, I’ll sit the patient up again so that there is a very distinct start and finish to the examination portion of my cosmetic consultation.”
Surgery vs. noninvasive treatments
Step three in her consultative process is to review treatment options with patients. “I never hold back if surgery is their best treatment option,” she said. “I don’t perform surgery, but I have a list of people I can refer them to.”
Once she addresses the potential for surgery, she reviews noninvasive treatment options, including topical products, injectables, lasers, and chemical peels. “Everyone who comes in for a cosmetic consultation leaves with some sort of topical recommendation, even if it’s as simple as a sunscreen I think they would like or a prescription for generic tretinoin,” she said. “I always present options in a framework starting with those that require lower downtime, higher number of treatment options, and lower cost. Then I move up the scale to tell them more about treatments that require higher downtime, a lower number of treatments, but have a higher cost.”
Step four in her consultative process involves discussing her final treatment recommendations. She’ll say something like, “I’ve been through all these options with you and my final recommendation is X,” and the patient walks away with a clear understanding of the recommendations, she said. “When I leave the room after giving my final recommendation, I’ll write everything down outside of the room, or I’ll have a member of my staff write down everything I’ve said outside the room.”
Finally, she and her staff record all the relevant information for the patient as a customized handout, including the treatment options discussed, how many will be required, whether they have to come in early for numbing cream or not, and the per treatment price tag. “Once we’ve written down everything we’ve discussed, I’ll circle or I’ll star my recommended treatment,” Dr. Stankiewicz said. They also have a handout for topical products, and she checks off the topical products that she discussed with the patient. The third handout she provides to patients is a recommended skin care regimen.
Dr. Stankiewicz reported having no relevant financial disclosures.
The way Kelly Stankiewicz, MD, sees it,
“I can’t tell you how many times I’ve walked into a room and thought the patient would say they’re concerned about one thing, but they’re concerned about something totally different,” Dr. Stankiewicz, a dermatologist in private practice in Park City, Utah, said during the annual conference of the American Society for Laser Medicine and Surgery. “The first question I ask is, ‘What would you like to improve?’ ‘What’s bothering you?’ ‘What would you like to make look better?’ Frequently, it’s not what you think.”
Next, she tries to get a sense of their lifestyle by asking patients about their occupation, hobbies, and outdoor activities they may engage in. “Here in Park City, it’s very sunny most all the time, so treatments need to be tailored to when those outdoor activities are being done, or perhaps they can be avoided for a period of time,” she said. “This gives you an idea of what kind of downtime people will tolerate. I also like to hear about their history of cosmetic procedures. If someone has had a lot of cosmetic procedures done, you can talk with them on a more detailed level. If someone is completely unaware of treatment options, you have to keep it simple.”
Dr. Stankiewicz also reviews their personal history of cosmetic procedures when considering safety of treatment. “For instance, if somebody has had a neck lift, you want to be very cautious doing any ablative procedures along the jawline,” she said. “I also like to know if anyone has had any reactions to dermal fillers or neuromodulators that they did not like. It’s very helpful to hear from patients what’s worked for them and what hasn’t. I also like to keep my ear open for pricing concerns. Not everyone will bring up the pricing issues, but sometimes they will, and it’s an important piece of information. Lastly, it’s important to look for any warning signs like irrational behavior or unrealistic expectations. These are patients you want to try to avoid treating.”
She shared four other key components to an effective cosmetic consultation, including the examination itself, which she prefers to separate from the discussion portion of the visit. “I lean the patient back in the exam chair and shine the light on their skin, which is important for evaluating for conditions you may not have discussed that could be easily improved,” Dr. Stankiewicz said.
“If the patient is concerned about pigmented lesions, I’ll pull out my dermatoscope to make sure there isn’t any concern for skin cancer. After the examination, I’ll sit the patient up again so that there is a very distinct start and finish to the examination portion of my cosmetic consultation.”
Surgery vs. noninvasive treatments
Step three in her consultative process is to review treatment options with patients. “I never hold back if surgery is their best treatment option,” she said. “I don’t perform surgery, but I have a list of people I can refer them to.”
Once she addresses the potential for surgery, she reviews noninvasive treatment options, including topical products, injectables, lasers, and chemical peels. “Everyone who comes in for a cosmetic consultation leaves with some sort of topical recommendation, even if it’s as simple as a sunscreen I think they would like or a prescription for generic tretinoin,” she said. “I always present options in a framework starting with those that require lower downtime, higher number of treatment options, and lower cost. Then I move up the scale to tell them more about treatments that require higher downtime, a lower number of treatments, but have a higher cost.”
Step four in her consultative process involves discussing her final treatment recommendations. She’ll say something like, “I’ve been through all these options with you and my final recommendation is X,” and the patient walks away with a clear understanding of the recommendations, she said. “When I leave the room after giving my final recommendation, I’ll write everything down outside of the room, or I’ll have a member of my staff write down everything I’ve said outside the room.”
Finally, she and her staff record all the relevant information for the patient as a customized handout, including the treatment options discussed, how many will be required, whether they have to come in early for numbing cream or not, and the per treatment price tag. “Once we’ve written down everything we’ve discussed, I’ll circle or I’ll star my recommended treatment,” Dr. Stankiewicz said. They also have a handout for topical products, and she checks off the topical products that she discussed with the patient. The third handout she provides to patients is a recommended skin care regimen.
Dr. Stankiewicz reported having no relevant financial disclosures.
FROM ASLMS 2021
Pilot study: Hybrid laser found effective for treating genitourinary syndrome of menopause
, results from a pilot trial showed.
“The genitourinary syndrome of menopause causes suffering in breast cancer survivors and postmenopausal women,” Jill S. Waibel, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. A common side effect for breast cancer survivors is early onset of menopause that is brought on by treatment, specifically aromatase-inhibitor therapies, she noted.
The symptoms of GSM include discomfort during sex, impaired sexual function, burning or sensation or irritation of the genital area, vaginal constriction, frequent urinary tract infections, urinary incontinence, and vaginal laxity, said Dr. Waibel, owner and medical director of the Miami Dermatology and Laser Institute. Nonhormonal treatments have included OTC vaginal lubricants, OTC moisturizers, low-dose vaginal estrogen – which increases the risk of breast cancer – and systemic estrogen therapy, which also can increase the risk of breast and endometrial cancer. “So, we need a healthy, nondrug option,” she said.
The objective of the pilot study was to determine the safety and efficacy of the diVa hybrid fractional laser as a treatment for symptoms of genitourinary syndrome of menopause, early menopause after breast cancer, or vaginal atrophy. The laser applies tunable nonablative (1,470-nm) and ablative (2,940-nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime. The device features a motorized precision guidance system and calibrated rotation for homogeneous pulsing.
“The 2,940-nm wavelength is used to ablate to a depth of 0-800 micrometers while the 1,470-nm wavelength is used to coagulate the epithelium and the lamina propria at a depth of 100-700 micrometers,” said Dr. Waibel, who is also subsection chief of dermatology at Baptist Hospital of Miami. “This combination is used for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen in tissue.” Each procedure is delivered via a single-use dilator, which expands the vaginal canal for increased treatment area. “The tip length is 5.5 cm and the diameter is 1 cm,” she said. “The clear tip acts as a hygienic barrier between the tip and the handpiece.”
Study participants included 25 women between the ages of 40 and 70 with early menopause after breast cancer or vaginal atrophy: 20 in the treatment arm and 5 in the sham-treatment arm. Dr. Waibel performed three procedures 2 weeks apart. An ob.gyn. assessed the primary endpoints, which included the Vaginal Health Index Scale (VHIS), the Vaginal Maturation Index (VMI), the Female Sexual Function Index (FSFI) questionnaire, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Secondary endpoints were histology and a satisfaction questionnaire.
Of the women in the treated group, there were data available for 19 at 3 months follow-up and 17 at 6 months follow-up. Based on the results in these patients, there were statistically significant improvements in nearly all domains of the FSFI treatment arm at 3 and 6 months when compared to baseline, especially arousal (P values of .05 at 3 months and .01 at 6 months) and lubrication (P values of .009 at three months and .001 at 6 months).
Between 3 and 6 months, patients in the treatment arm experienced improvements in four dimensions of the DIVA questionnaire: daily activities (P value of .01 at 3 months to .010 at 6 months), emotional well-being (P value of .06 at 3 months to .014 at 6 months), sexual function (P value of .30 at 3 months to .003 at 6 months), and self-concept/body image (P value of .002 at 3 months to .001 at 6 months).
As for satisfaction, a majority of those in the treatment arm were “somewhat satisfied” with the treatment and would “somewhat likely” repeat and recommend the treatment to friends and family, Dr. Waibel said. Results among the women in the control arm, who were also surveyed, were in the similar range, she noted. (No other results for women in the control arm were available.)
Following treatments, histology revealed that the collagen was denser, fibroblasts were more dense, and vascularity was more notable. No adverse events were observed. “The hybrid fractional laser is safe and effective for treating GSM, early menopause after breast cancer, or vaginal atrophy,” Dr. Waibel concluded. Further studies are important to improve the understanding of “laser dosimetry, frequency of treatments, and longevity of effect. Collaboration between ob.gyns. and dermatologists is important as we learn about laser therapy in GSM.”
Dr. Waibel disclosed that she is a member of the advisory board of Sciton, which manufactures the diVa laser. She has also conducted clinical trials for many other device and pharmaceutical companies.
, results from a pilot trial showed.
“The genitourinary syndrome of menopause causes suffering in breast cancer survivors and postmenopausal women,” Jill S. Waibel, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. A common side effect for breast cancer survivors is early onset of menopause that is brought on by treatment, specifically aromatase-inhibitor therapies, she noted.
The symptoms of GSM include discomfort during sex, impaired sexual function, burning or sensation or irritation of the genital area, vaginal constriction, frequent urinary tract infections, urinary incontinence, and vaginal laxity, said Dr. Waibel, owner and medical director of the Miami Dermatology and Laser Institute. Nonhormonal treatments have included OTC vaginal lubricants, OTC moisturizers, low-dose vaginal estrogen – which increases the risk of breast cancer – and systemic estrogen therapy, which also can increase the risk of breast and endometrial cancer. “So, we need a healthy, nondrug option,” she said.
The objective of the pilot study was to determine the safety and efficacy of the diVa hybrid fractional laser as a treatment for symptoms of genitourinary syndrome of menopause, early menopause after breast cancer, or vaginal atrophy. The laser applies tunable nonablative (1,470-nm) and ablative (2,940-nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime. The device features a motorized precision guidance system and calibrated rotation for homogeneous pulsing.
“The 2,940-nm wavelength is used to ablate to a depth of 0-800 micrometers while the 1,470-nm wavelength is used to coagulate the epithelium and the lamina propria at a depth of 100-700 micrometers,” said Dr. Waibel, who is also subsection chief of dermatology at Baptist Hospital of Miami. “This combination is used for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen in tissue.” Each procedure is delivered via a single-use dilator, which expands the vaginal canal for increased treatment area. “The tip length is 5.5 cm and the diameter is 1 cm,” she said. “The clear tip acts as a hygienic barrier between the tip and the handpiece.”
Study participants included 25 women between the ages of 40 and 70 with early menopause after breast cancer or vaginal atrophy: 20 in the treatment arm and 5 in the sham-treatment arm. Dr. Waibel performed three procedures 2 weeks apart. An ob.gyn. assessed the primary endpoints, which included the Vaginal Health Index Scale (VHIS), the Vaginal Maturation Index (VMI), the Female Sexual Function Index (FSFI) questionnaire, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Secondary endpoints were histology and a satisfaction questionnaire.
Of the women in the treated group, there were data available for 19 at 3 months follow-up and 17 at 6 months follow-up. Based on the results in these patients, there were statistically significant improvements in nearly all domains of the FSFI treatment arm at 3 and 6 months when compared to baseline, especially arousal (P values of .05 at 3 months and .01 at 6 months) and lubrication (P values of .009 at three months and .001 at 6 months).
Between 3 and 6 months, patients in the treatment arm experienced improvements in four dimensions of the DIVA questionnaire: daily activities (P value of .01 at 3 months to .010 at 6 months), emotional well-being (P value of .06 at 3 months to .014 at 6 months), sexual function (P value of .30 at 3 months to .003 at 6 months), and self-concept/body image (P value of .002 at 3 months to .001 at 6 months).
As for satisfaction, a majority of those in the treatment arm were “somewhat satisfied” with the treatment and would “somewhat likely” repeat and recommend the treatment to friends and family, Dr. Waibel said. Results among the women in the control arm, who were also surveyed, were in the similar range, she noted. (No other results for women in the control arm were available.)
Following treatments, histology revealed that the collagen was denser, fibroblasts were more dense, and vascularity was more notable. No adverse events were observed. “The hybrid fractional laser is safe and effective for treating GSM, early menopause after breast cancer, or vaginal atrophy,” Dr. Waibel concluded. Further studies are important to improve the understanding of “laser dosimetry, frequency of treatments, and longevity of effect. Collaboration between ob.gyns. and dermatologists is important as we learn about laser therapy in GSM.”
Dr. Waibel disclosed that she is a member of the advisory board of Sciton, which manufactures the diVa laser. She has also conducted clinical trials for many other device and pharmaceutical companies.
, results from a pilot trial showed.
“The genitourinary syndrome of menopause causes suffering in breast cancer survivors and postmenopausal women,” Jill S. Waibel, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. A common side effect for breast cancer survivors is early onset of menopause that is brought on by treatment, specifically aromatase-inhibitor therapies, she noted.
The symptoms of GSM include discomfort during sex, impaired sexual function, burning or sensation or irritation of the genital area, vaginal constriction, frequent urinary tract infections, urinary incontinence, and vaginal laxity, said Dr. Waibel, owner and medical director of the Miami Dermatology and Laser Institute. Nonhormonal treatments have included OTC vaginal lubricants, OTC moisturizers, low-dose vaginal estrogen – which increases the risk of breast cancer – and systemic estrogen therapy, which also can increase the risk of breast and endometrial cancer. “So, we need a healthy, nondrug option,” she said.
The objective of the pilot study was to determine the safety and efficacy of the diVa hybrid fractional laser as a treatment for symptoms of genitourinary syndrome of menopause, early menopause after breast cancer, or vaginal atrophy. The laser applies tunable nonablative (1,470-nm) and ablative (2,940-nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime. The device features a motorized precision guidance system and calibrated rotation for homogeneous pulsing.
“The 2,940-nm wavelength is used to ablate to a depth of 0-800 micrometers while the 1,470-nm wavelength is used to coagulate the epithelium and the lamina propria at a depth of 100-700 micrometers,” said Dr. Waibel, who is also subsection chief of dermatology at Baptist Hospital of Miami. “This combination is used for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen in tissue.” Each procedure is delivered via a single-use dilator, which expands the vaginal canal for increased treatment area. “The tip length is 5.5 cm and the diameter is 1 cm,” she said. “The clear tip acts as a hygienic barrier between the tip and the handpiece.”
Study participants included 25 women between the ages of 40 and 70 with early menopause after breast cancer or vaginal atrophy: 20 in the treatment arm and 5 in the sham-treatment arm. Dr. Waibel performed three procedures 2 weeks apart. An ob.gyn. assessed the primary endpoints, which included the Vaginal Health Index Scale (VHIS), the Vaginal Maturation Index (VMI), the Female Sexual Function Index (FSFI) questionnaire, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Secondary endpoints were histology and a satisfaction questionnaire.
Of the women in the treated group, there were data available for 19 at 3 months follow-up and 17 at 6 months follow-up. Based on the results in these patients, there were statistically significant improvements in nearly all domains of the FSFI treatment arm at 3 and 6 months when compared to baseline, especially arousal (P values of .05 at 3 months and .01 at 6 months) and lubrication (P values of .009 at three months and .001 at 6 months).
Between 3 and 6 months, patients in the treatment arm experienced improvements in four dimensions of the DIVA questionnaire: daily activities (P value of .01 at 3 months to .010 at 6 months), emotional well-being (P value of .06 at 3 months to .014 at 6 months), sexual function (P value of .30 at 3 months to .003 at 6 months), and self-concept/body image (P value of .002 at 3 months to .001 at 6 months).
As for satisfaction, a majority of those in the treatment arm were “somewhat satisfied” with the treatment and would “somewhat likely” repeat and recommend the treatment to friends and family, Dr. Waibel said. Results among the women in the control arm, who were also surveyed, were in the similar range, she noted. (No other results for women in the control arm were available.)
Following treatments, histology revealed that the collagen was denser, fibroblasts were more dense, and vascularity was more notable. No adverse events were observed. “The hybrid fractional laser is safe and effective for treating GSM, early menopause after breast cancer, or vaginal atrophy,” Dr. Waibel concluded. Further studies are important to improve the understanding of “laser dosimetry, frequency of treatments, and longevity of effect. Collaboration between ob.gyns. and dermatologists is important as we learn about laser therapy in GSM.”
Dr. Waibel disclosed that she is a member of the advisory board of Sciton, which manufactures the diVa laser. She has also conducted clinical trials for many other device and pharmaceutical companies.
FROM ASLMS 2021
Cellular senescence, skin aging, and cosmeceuticals
I just completed the third edition of my Cosmetic Dermatology textbook (McGraw Hill), which will come out later this year. Although writing it is a huge effort, I really enjoy all the basic science. While I was working on the book, I was most surprised by the .
Right now, it is too early, and we don’t know enough yet, to have cosmeceuticals that affect cellular senescence and autophagy. But, it’s not too early to learn about this research, to avoid falling prey to any pseudoscience that invariably ends up affecting cosmeceuticals on the market. The following is a brief primer on cellular senescence, skin aging, and cosmeceuticals; it represents what we currently know.
Cell phases
Keratinocytes and fibroblasts go through five different phases: stem, proliferation, differentiation, senescence, and apoptosis. The difference between apoptotic cells and senescent cells is that apoptotic cells are not viable and are eliminated, while senescent cells, even though they have gone into cell cycle arrest, remain functional and are not eliminated from the skin.
What are senescent cells?
Senescent cells have lost the ability to proliferate but have not undergone apoptosis. Senescent human skin fibroblasts in cell culture lose the youthful spindlelike shape and become enlarged and flattened.1 Their lysosomes and mitochondria lose functionality.2 The presence of senescent cells is associated with increased aging and seems to speed aging.
Senescent cells and skin aging
Senescent cells are increased in the age-related phenotype3 because of an age-related decline of senescent cell removal systems, such as the immune system4 and the autophagy-lysosomal pathway.5 Senescent cells are deleterious because they develop into a senescence-associated secretory phenotype (SASP), which is believed to be one of the major causes of aging. SASP cells communicate with nearby cells using proinflammatory cytokines, which include catabolic modulators such as Matrix metalloproteinases. They are known to release growth factors, cytokines, chemokines, matrix-modeling enzymes, lipids, and extracellular vesicles. The last are lipid bilayer-lined vesicles that can transport functional RNA and microRNA and facilitate other modes of communication between cells.6
The SASP is likely a natural tumor suppressive mode employed by cells to prevent cells with cancerous mutations from undergoing replication;7 however, when it comes to aging, the deleterious effects of SASP outweigh the beneficial effects. For example, SASP contributes to a prolonged state of inflammation, known as “inflammaging,”8 which is detrimental to the skin’s appearance. Human fibroblasts that have assumed the SASP secrete proinflammatory cytokines and MMPs and release reactive oxygen species,9,10 resulting in degradation of the surrounding extracellular matrix (ECM). Loss of the ECM leads to fibroblast compaction and reduced DNA synthesis, all caused by SASPs.9
What causes cellular senescence?
Activation of the nuclear factor-erythroid 2-related transcription factor 2 (NRF2) induces cellular senescence via direct targeting of certain ECM genes. NRF2 is a key regulator of the skin’s antioxidant defense system, which controls the transcription of genes encoding reactive oxygen species–detoxifying enzymes and various other antioxidant proteins.11 Loss of mitochondrial autophagy also induces senescence, as do activation of the TP53 gene, inactivity of SIRT-1, and short telomeres.
Cellular senescence and skin aging
Timely clearance of senescent cells before they create too much damage postpones the onset and severity of age-related diseases and extends the life span of mice.12,6 Antiaging treatments should focus on decreasing the number of senescent cells and reverting senescent cells to the more juvenile forms: proliferating or differentiating cells as an approach to prevent skin aging.13 Restoration of the lysosomal-mitochondrial axis has been shown to revert SASP back to a juvenile status. Normalization of the lysosomal-mitochondrial axis is a prerequisite to reverse senescence.14
Cellular senescence, autophagy, the lysosomal-mitochondrial axis, and cosmeceuticals
Autophagy is the important process of organelles, like mitochondria,15 self-digesting their cytoplasmic material into lysosomes for degradation. Mitochondrial autophagy is very important in slowing the aging process because damaged mitochondria generate free radicals. As you can imagine, much research is focused on this area, but it is too early for any research to translate to efficacious cosmeceuticals.
Conclusion
To summarize, activation of sirtuin-1 (SIRT-1) has been shown to extend the lifespan of mammals, as does caloric restriction.16 This extension occurs because SIRT-1 decreases senescence and activates autophagy.
Although we do not yet know whether topical skincare products could affect senescence or autophagy, there are data to show that oral resveratrol16 and melatonin17 activate SIRT-1 and increase autophagy. I am closely watching this research and will let you know if there are any similar data on topical cosmeceuticals targeting senescence or autophagy. Stay tuned!
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Papadopoulou A et al. Biogerontology. 2020 Dec;21(6):695-708.
2. López-Otin C et al. Cell. 2013 June 6;153, 1194–217.
3. Yoon J E et al. Theranostics. 2018 Sep 9;8(17):4620-32.
4. Rodier F, Campisi J. J Cell Biol. 2011 Feb 21;192(4):547-56.
5. Dutta D et al. Circ Res. 2012 Apr 13;110(8):1125-38.
6. Terlecki-Zaniewicz L et al. J Invest Dermatol. 2019 Dec;139(12):2425-36.e5.
7. Campisi J et al. Nat Rev Mol Cell Biol. 2007 Sep;8(9):729-40.
8. Franceschi C and Campisi J. J Gerontol A Biol Sci Med Sci. 2014 Jun;69 Suppl 1:S4-9.
9. Nelson G et al. Aging Cell. 2012 Apr;11(2):345-9.
10. Passos JF et al. PLoS Biol. 2007 May;5(5):e110.
11. Hiebert P et al. Dev Cell. 2018 Jul 16;46(2):145-61.e10.
12. Baker DJ et al. Nature. 2016 Feb 11:530(7589):184-9.
13. Mavrogonatou E et al. Matrix Biol. 2019 Jan;75-76:27-42.
14. Park JT et al. Ageing Res Rev. 2018 Nov;47:176-82.
15. Levine B and Kroemer G. Cell. 2019 Jan 10;176(1-2):11-42.
16. Morselli E et al. Cell Death Dis. 2010;1(1):e10.
17. Lee JH et al. Oncotarget. 2016 Mar 15;7(11):12075-88.
I just completed the third edition of my Cosmetic Dermatology textbook (McGraw Hill), which will come out later this year. Although writing it is a huge effort, I really enjoy all the basic science. While I was working on the book, I was most surprised by the .
Right now, it is too early, and we don’t know enough yet, to have cosmeceuticals that affect cellular senescence and autophagy. But, it’s not too early to learn about this research, to avoid falling prey to any pseudoscience that invariably ends up affecting cosmeceuticals on the market. The following is a brief primer on cellular senescence, skin aging, and cosmeceuticals; it represents what we currently know.
Cell phases
Keratinocytes and fibroblasts go through five different phases: stem, proliferation, differentiation, senescence, and apoptosis. The difference between apoptotic cells and senescent cells is that apoptotic cells are not viable and are eliminated, while senescent cells, even though they have gone into cell cycle arrest, remain functional and are not eliminated from the skin.
What are senescent cells?
Senescent cells have lost the ability to proliferate but have not undergone apoptosis. Senescent human skin fibroblasts in cell culture lose the youthful spindlelike shape and become enlarged and flattened.1 Their lysosomes and mitochondria lose functionality.2 The presence of senescent cells is associated with increased aging and seems to speed aging.
Senescent cells and skin aging
Senescent cells are increased in the age-related phenotype3 because of an age-related decline of senescent cell removal systems, such as the immune system4 and the autophagy-lysosomal pathway.5 Senescent cells are deleterious because they develop into a senescence-associated secretory phenotype (SASP), which is believed to be one of the major causes of aging. SASP cells communicate with nearby cells using proinflammatory cytokines, which include catabolic modulators such as Matrix metalloproteinases. They are known to release growth factors, cytokines, chemokines, matrix-modeling enzymes, lipids, and extracellular vesicles. The last are lipid bilayer-lined vesicles that can transport functional RNA and microRNA and facilitate other modes of communication between cells.6
The SASP is likely a natural tumor suppressive mode employed by cells to prevent cells with cancerous mutations from undergoing replication;7 however, when it comes to aging, the deleterious effects of SASP outweigh the beneficial effects. For example, SASP contributes to a prolonged state of inflammation, known as “inflammaging,”8 which is detrimental to the skin’s appearance. Human fibroblasts that have assumed the SASP secrete proinflammatory cytokines and MMPs and release reactive oxygen species,9,10 resulting in degradation of the surrounding extracellular matrix (ECM). Loss of the ECM leads to fibroblast compaction and reduced DNA synthesis, all caused by SASPs.9
What causes cellular senescence?
Activation of the nuclear factor-erythroid 2-related transcription factor 2 (NRF2) induces cellular senescence via direct targeting of certain ECM genes. NRF2 is a key regulator of the skin’s antioxidant defense system, which controls the transcription of genes encoding reactive oxygen species–detoxifying enzymes and various other antioxidant proteins.11 Loss of mitochondrial autophagy also induces senescence, as do activation of the TP53 gene, inactivity of SIRT-1, and short telomeres.
Cellular senescence and skin aging
Timely clearance of senescent cells before they create too much damage postpones the onset and severity of age-related diseases and extends the life span of mice.12,6 Antiaging treatments should focus on decreasing the number of senescent cells and reverting senescent cells to the more juvenile forms: proliferating or differentiating cells as an approach to prevent skin aging.13 Restoration of the lysosomal-mitochondrial axis has been shown to revert SASP back to a juvenile status. Normalization of the lysosomal-mitochondrial axis is a prerequisite to reverse senescence.14
Cellular senescence, autophagy, the lysosomal-mitochondrial axis, and cosmeceuticals
Autophagy is the important process of organelles, like mitochondria,15 self-digesting their cytoplasmic material into lysosomes for degradation. Mitochondrial autophagy is very important in slowing the aging process because damaged mitochondria generate free radicals. As you can imagine, much research is focused on this area, but it is too early for any research to translate to efficacious cosmeceuticals.
Conclusion
To summarize, activation of sirtuin-1 (SIRT-1) has been shown to extend the lifespan of mammals, as does caloric restriction.16 This extension occurs because SIRT-1 decreases senescence and activates autophagy.
Although we do not yet know whether topical skincare products could affect senescence or autophagy, there are data to show that oral resveratrol16 and melatonin17 activate SIRT-1 and increase autophagy. I am closely watching this research and will let you know if there are any similar data on topical cosmeceuticals targeting senescence or autophagy. Stay tuned!
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Papadopoulou A et al. Biogerontology. 2020 Dec;21(6):695-708.
2. López-Otin C et al. Cell. 2013 June 6;153, 1194–217.
3. Yoon J E et al. Theranostics. 2018 Sep 9;8(17):4620-32.
4. Rodier F, Campisi J. J Cell Biol. 2011 Feb 21;192(4):547-56.
5. Dutta D et al. Circ Res. 2012 Apr 13;110(8):1125-38.
6. Terlecki-Zaniewicz L et al. J Invest Dermatol. 2019 Dec;139(12):2425-36.e5.
7. Campisi J et al. Nat Rev Mol Cell Biol. 2007 Sep;8(9):729-40.
8. Franceschi C and Campisi J. J Gerontol A Biol Sci Med Sci. 2014 Jun;69 Suppl 1:S4-9.
9. Nelson G et al. Aging Cell. 2012 Apr;11(2):345-9.
10. Passos JF et al. PLoS Biol. 2007 May;5(5):e110.
11. Hiebert P et al. Dev Cell. 2018 Jul 16;46(2):145-61.e10.
12. Baker DJ et al. Nature. 2016 Feb 11:530(7589):184-9.
13. Mavrogonatou E et al. Matrix Biol. 2019 Jan;75-76:27-42.
14. Park JT et al. Ageing Res Rev. 2018 Nov;47:176-82.
15. Levine B and Kroemer G. Cell. 2019 Jan 10;176(1-2):11-42.
16. Morselli E et al. Cell Death Dis. 2010;1(1):e10.
17. Lee JH et al. Oncotarget. 2016 Mar 15;7(11):12075-88.
I just completed the third edition of my Cosmetic Dermatology textbook (McGraw Hill), which will come out later this year. Although writing it is a huge effort, I really enjoy all the basic science. While I was working on the book, I was most surprised by the .
Right now, it is too early, and we don’t know enough yet, to have cosmeceuticals that affect cellular senescence and autophagy. But, it’s not too early to learn about this research, to avoid falling prey to any pseudoscience that invariably ends up affecting cosmeceuticals on the market. The following is a brief primer on cellular senescence, skin aging, and cosmeceuticals; it represents what we currently know.
Cell phases
Keratinocytes and fibroblasts go through five different phases: stem, proliferation, differentiation, senescence, and apoptosis. The difference between apoptotic cells and senescent cells is that apoptotic cells are not viable and are eliminated, while senescent cells, even though they have gone into cell cycle arrest, remain functional and are not eliminated from the skin.
What are senescent cells?
Senescent cells have lost the ability to proliferate but have not undergone apoptosis. Senescent human skin fibroblasts in cell culture lose the youthful spindlelike shape and become enlarged and flattened.1 Their lysosomes and mitochondria lose functionality.2 The presence of senescent cells is associated with increased aging and seems to speed aging.
Senescent cells and skin aging
Senescent cells are increased in the age-related phenotype3 because of an age-related decline of senescent cell removal systems, such as the immune system4 and the autophagy-lysosomal pathway.5 Senescent cells are deleterious because they develop into a senescence-associated secretory phenotype (SASP), which is believed to be one of the major causes of aging. SASP cells communicate with nearby cells using proinflammatory cytokines, which include catabolic modulators such as Matrix metalloproteinases. They are known to release growth factors, cytokines, chemokines, matrix-modeling enzymes, lipids, and extracellular vesicles. The last are lipid bilayer-lined vesicles that can transport functional RNA and microRNA and facilitate other modes of communication between cells.6
The SASP is likely a natural tumor suppressive mode employed by cells to prevent cells with cancerous mutations from undergoing replication;7 however, when it comes to aging, the deleterious effects of SASP outweigh the beneficial effects. For example, SASP contributes to a prolonged state of inflammation, known as “inflammaging,”8 which is detrimental to the skin’s appearance. Human fibroblasts that have assumed the SASP secrete proinflammatory cytokines and MMPs and release reactive oxygen species,9,10 resulting in degradation of the surrounding extracellular matrix (ECM). Loss of the ECM leads to fibroblast compaction and reduced DNA synthesis, all caused by SASPs.9
What causes cellular senescence?
Activation of the nuclear factor-erythroid 2-related transcription factor 2 (NRF2) induces cellular senescence via direct targeting of certain ECM genes. NRF2 is a key regulator of the skin’s antioxidant defense system, which controls the transcription of genes encoding reactive oxygen species–detoxifying enzymes and various other antioxidant proteins.11 Loss of mitochondrial autophagy also induces senescence, as do activation of the TP53 gene, inactivity of SIRT-1, and short telomeres.
Cellular senescence and skin aging
Timely clearance of senescent cells before they create too much damage postpones the onset and severity of age-related diseases and extends the life span of mice.12,6 Antiaging treatments should focus on decreasing the number of senescent cells and reverting senescent cells to the more juvenile forms: proliferating or differentiating cells as an approach to prevent skin aging.13 Restoration of the lysosomal-mitochondrial axis has been shown to revert SASP back to a juvenile status. Normalization of the lysosomal-mitochondrial axis is a prerequisite to reverse senescence.14
Cellular senescence, autophagy, the lysosomal-mitochondrial axis, and cosmeceuticals
Autophagy is the important process of organelles, like mitochondria,15 self-digesting their cytoplasmic material into lysosomes for degradation. Mitochondrial autophagy is very important in slowing the aging process because damaged mitochondria generate free radicals. As you can imagine, much research is focused on this area, but it is too early for any research to translate to efficacious cosmeceuticals.
Conclusion
To summarize, activation of sirtuin-1 (SIRT-1) has been shown to extend the lifespan of mammals, as does caloric restriction.16 This extension occurs because SIRT-1 decreases senescence and activates autophagy.
Although we do not yet know whether topical skincare products could affect senescence or autophagy, there are data to show that oral resveratrol16 and melatonin17 activate SIRT-1 and increase autophagy. I am closely watching this research and will let you know if there are any similar data on topical cosmeceuticals targeting senescence or autophagy. Stay tuned!
Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].
References
1. Papadopoulou A et al. Biogerontology. 2020 Dec;21(6):695-708.
2. López-Otin C et al. Cell. 2013 June 6;153, 1194–217.
3. Yoon J E et al. Theranostics. 2018 Sep 9;8(17):4620-32.
4. Rodier F, Campisi J. J Cell Biol. 2011 Feb 21;192(4):547-56.
5. Dutta D et al. Circ Res. 2012 Apr 13;110(8):1125-38.
6. Terlecki-Zaniewicz L et al. J Invest Dermatol. 2019 Dec;139(12):2425-36.e5.
7. Campisi J et al. Nat Rev Mol Cell Biol. 2007 Sep;8(9):729-40.
8. Franceschi C and Campisi J. J Gerontol A Biol Sci Med Sci. 2014 Jun;69 Suppl 1:S4-9.
9. Nelson G et al. Aging Cell. 2012 Apr;11(2):345-9.
10. Passos JF et al. PLoS Biol. 2007 May;5(5):e110.
11. Hiebert P et al. Dev Cell. 2018 Jul 16;46(2):145-61.e10.
12. Baker DJ et al. Nature. 2016 Feb 11:530(7589):184-9.
13. Mavrogonatou E et al. Matrix Biol. 2019 Jan;75-76:27-42.
14. Park JT et al. Ageing Res Rev. 2018 Nov;47:176-82.
15. Levine B and Kroemer G. Cell. 2019 Jan 10;176(1-2):11-42.
16. Morselli E et al. Cell Death Dis. 2010;1(1):e10.
17. Lee JH et al. Oncotarget. 2016 Mar 15;7(11):12075-88.
Eat two fruits a day, ward off diabetes?
A new study supports the recommendation of eating two servings of fruit a day for health benefits – in this case a lower risk of diabetes.
Adults who ate two servings of fruit a day had 36% lower odds of developing diabetes within 5 years compared to those who ate less than a half serving of fruit a day, after adjusting for confounders, in a population-based Australian study.
The findings by Nicola P. Bondonno, PhD, and colleagues, based on data from the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab), were published online June 2 in the Journal of Clinical Endocrinology & Metabolism.
The study also showed that a higher fruit intake was associated with higher insulin sensitivity and lower pancreatic beta-cell function in a dose-response manner.
And a higher intake of apples – but not citrus fruit or bananas, the two other fruits studied – was associated with lower post-load serum insulin levels.
“This indicates that people who consumed more fruit [especially apples] had to produce less insulin to lower their blood glucose levels,” Dr. Bondonno, from the Institute for Nutrition Research, Edith Cowan University, Perth, Australia, explained in a statement from the Endocrine Society.
“This is important since high levels of circulating insulin (hyperinsulinemia) can damage blood vessels” and this is “related not only to diabetes, but also to high blood pressure, obesity, and heart disease,” she observed.
Fruit juice doesn’t have same effect
The study supports the recommendation of the Australian Dietary Guidelines – 2 servings of fruit a day, where one serving is 150 grams, which corresponds to a medium-sized apple, orange, or banana – Dr. Bondonno clarified in an email.
However, fruit juice was not associated with better glucose or insulin levels, or lower risk of diabetes, possibly because of its relatively high glycemic load and fewer beneficial fibers, the researchers speculate; added data suggest that even juice with added fiber does not trigger satiety.
The study findings “support encouragement of the consumption of whole fruits, but not fruit juice, to preserve insulin sensitivity and mitigate [type 2 diabetes] risk,” Dr. Bondonno and colleagues summarize.
“Promoting a healthy diet and lifestyle which includes the consumption of popular fruits such as apples, bananas, and oranges, with widespread geographical availability, may lower [type 2 diabetes] incidence,” they conclude.
Lower 5-year odds of diabetes
It is not clear how eating fruit may confer protection against developing diabetes, the researchers write.
They aimed to examine how consumption of total fruit, individual fruit, and fruit juice is related to glucose tolerance, insulin sensitivity, and incident diabetes at 5 years and 12 years in participants in the nationally representative AusDiab study.
They identified 7,675 adults aged 25 and older without diabetes who had undergone blood tests and completed a food frequency questionnaire in 1999-2000.
Participants had indicated how often they ate 10 different types of fruit, any type of fruit juice, and other foods on a scale of 0 (never) to 10 (three or more times/day).
Researchers divided participants into quartiles based on their median fruit consumption: 62 (range 0-95) g/day, 122 (95-162) g/day, 230 (162-283) g/day, and 372 (283-961) g/day.
The most commonly consumed fruit was apples (23% of total fruit intake), followed by bananas (20%) and citrus fruit (18%). Other fruits each accounted for less than 8% of total fruit intake, so they were not studied separately.
Participants in each quartile had a similar mean age (54 years) and body mass index (27 kg/m2).
However, compared with participants in quartile 1 (low fruit intake), those in quartiles 3 and 4 (moderate and high fruit intakes, respectively) were more likely to be female, do at least 150 minutes of physical activity a week, and less likely to smoke. They also ate more vegetables and less red meat and processed meat, but they consumed more sugar.
Of 4,674 participants who had 5-year follow-up, 179 participants developed diabetes.
Compared to participants with a low fruit intake (quartile 1), those with a moderate fruit intake (quartile 3) had a 36% lower odds of developing diabetes within 5 years (odds ratio, 0.64; 95% confidence interval, 0.44-0.92) after adjusting for age, sex, physical activity, education, socioeconomic status, income, body mass index, smoking, cardiovascular disease, parental history of diabetes, and consumption of alcohol, vegetables, red meat, processed meat, and calories.
Of the 3,518 participants with 12-year follow-up, 247 participants had diabetes, but there were no significant associations between fruit consumption and this longer-term risk of diabetes, possibly due to the small number of participants and events.
The study was supported by grants from the National Health and Medical Research Council of Australia and the National Heart Foundation of Australia. Dr. Bondonno has reported no relevant financial disclosures. Disclosures of the other authors are listed with the article.
A version of this article first appeared on Medscape.com.
A new study supports the recommendation of eating two servings of fruit a day for health benefits – in this case a lower risk of diabetes.
Adults who ate two servings of fruit a day had 36% lower odds of developing diabetes within 5 years compared to those who ate less than a half serving of fruit a day, after adjusting for confounders, in a population-based Australian study.
The findings by Nicola P. Bondonno, PhD, and colleagues, based on data from the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab), were published online June 2 in the Journal of Clinical Endocrinology & Metabolism.
The study also showed that a higher fruit intake was associated with higher insulin sensitivity and lower pancreatic beta-cell function in a dose-response manner.
And a higher intake of apples – but not citrus fruit or bananas, the two other fruits studied – was associated with lower post-load serum insulin levels.
“This indicates that people who consumed more fruit [especially apples] had to produce less insulin to lower their blood glucose levels,” Dr. Bondonno, from the Institute for Nutrition Research, Edith Cowan University, Perth, Australia, explained in a statement from the Endocrine Society.
“This is important since high levels of circulating insulin (hyperinsulinemia) can damage blood vessels” and this is “related not only to diabetes, but also to high blood pressure, obesity, and heart disease,” she observed.
Fruit juice doesn’t have same effect
The study supports the recommendation of the Australian Dietary Guidelines – 2 servings of fruit a day, where one serving is 150 grams, which corresponds to a medium-sized apple, orange, or banana – Dr. Bondonno clarified in an email.
However, fruit juice was not associated with better glucose or insulin levels, or lower risk of diabetes, possibly because of its relatively high glycemic load and fewer beneficial fibers, the researchers speculate; added data suggest that even juice with added fiber does not trigger satiety.
The study findings “support encouragement of the consumption of whole fruits, but not fruit juice, to preserve insulin sensitivity and mitigate [type 2 diabetes] risk,” Dr. Bondonno and colleagues summarize.
“Promoting a healthy diet and lifestyle which includes the consumption of popular fruits such as apples, bananas, and oranges, with widespread geographical availability, may lower [type 2 diabetes] incidence,” they conclude.
Lower 5-year odds of diabetes
It is not clear how eating fruit may confer protection against developing diabetes, the researchers write.
They aimed to examine how consumption of total fruit, individual fruit, and fruit juice is related to glucose tolerance, insulin sensitivity, and incident diabetes at 5 years and 12 years in participants in the nationally representative AusDiab study.
They identified 7,675 adults aged 25 and older without diabetes who had undergone blood tests and completed a food frequency questionnaire in 1999-2000.
Participants had indicated how often they ate 10 different types of fruit, any type of fruit juice, and other foods on a scale of 0 (never) to 10 (three or more times/day).
Researchers divided participants into quartiles based on their median fruit consumption: 62 (range 0-95) g/day, 122 (95-162) g/day, 230 (162-283) g/day, and 372 (283-961) g/day.
The most commonly consumed fruit was apples (23% of total fruit intake), followed by bananas (20%) and citrus fruit (18%). Other fruits each accounted for less than 8% of total fruit intake, so they were not studied separately.
Participants in each quartile had a similar mean age (54 years) and body mass index (27 kg/m2).
However, compared with participants in quartile 1 (low fruit intake), those in quartiles 3 and 4 (moderate and high fruit intakes, respectively) were more likely to be female, do at least 150 minutes of physical activity a week, and less likely to smoke. They also ate more vegetables and less red meat and processed meat, but they consumed more sugar.
Of 4,674 participants who had 5-year follow-up, 179 participants developed diabetes.
Compared to participants with a low fruit intake (quartile 1), those with a moderate fruit intake (quartile 3) had a 36% lower odds of developing diabetes within 5 years (odds ratio, 0.64; 95% confidence interval, 0.44-0.92) after adjusting for age, sex, physical activity, education, socioeconomic status, income, body mass index, smoking, cardiovascular disease, parental history of diabetes, and consumption of alcohol, vegetables, red meat, processed meat, and calories.
Of the 3,518 participants with 12-year follow-up, 247 participants had diabetes, but there were no significant associations between fruit consumption and this longer-term risk of diabetes, possibly due to the small number of participants and events.
The study was supported by grants from the National Health and Medical Research Council of Australia and the National Heart Foundation of Australia. Dr. Bondonno has reported no relevant financial disclosures. Disclosures of the other authors are listed with the article.
A version of this article first appeared on Medscape.com.
A new study supports the recommendation of eating two servings of fruit a day for health benefits – in this case a lower risk of diabetes.
Adults who ate two servings of fruit a day had 36% lower odds of developing diabetes within 5 years compared to those who ate less than a half serving of fruit a day, after adjusting for confounders, in a population-based Australian study.
The findings by Nicola P. Bondonno, PhD, and colleagues, based on data from the Australian Diabetes, Obesity, and Lifestyle Study (AusDiab), were published online June 2 in the Journal of Clinical Endocrinology & Metabolism.
The study also showed that a higher fruit intake was associated with higher insulin sensitivity and lower pancreatic beta-cell function in a dose-response manner.
And a higher intake of apples – but not citrus fruit or bananas, the two other fruits studied – was associated with lower post-load serum insulin levels.
“This indicates that people who consumed more fruit [especially apples] had to produce less insulin to lower their blood glucose levels,” Dr. Bondonno, from the Institute for Nutrition Research, Edith Cowan University, Perth, Australia, explained in a statement from the Endocrine Society.
“This is important since high levels of circulating insulin (hyperinsulinemia) can damage blood vessels” and this is “related not only to diabetes, but also to high blood pressure, obesity, and heart disease,” she observed.
Fruit juice doesn’t have same effect
The study supports the recommendation of the Australian Dietary Guidelines – 2 servings of fruit a day, where one serving is 150 grams, which corresponds to a medium-sized apple, orange, or banana – Dr. Bondonno clarified in an email.
However, fruit juice was not associated with better glucose or insulin levels, or lower risk of diabetes, possibly because of its relatively high glycemic load and fewer beneficial fibers, the researchers speculate; added data suggest that even juice with added fiber does not trigger satiety.
The study findings “support encouragement of the consumption of whole fruits, but not fruit juice, to preserve insulin sensitivity and mitigate [type 2 diabetes] risk,” Dr. Bondonno and colleagues summarize.
“Promoting a healthy diet and lifestyle which includes the consumption of popular fruits such as apples, bananas, and oranges, with widespread geographical availability, may lower [type 2 diabetes] incidence,” they conclude.
Lower 5-year odds of diabetes
It is not clear how eating fruit may confer protection against developing diabetes, the researchers write.
They aimed to examine how consumption of total fruit, individual fruit, and fruit juice is related to glucose tolerance, insulin sensitivity, and incident diabetes at 5 years and 12 years in participants in the nationally representative AusDiab study.
They identified 7,675 adults aged 25 and older without diabetes who had undergone blood tests and completed a food frequency questionnaire in 1999-2000.
Participants had indicated how often they ate 10 different types of fruit, any type of fruit juice, and other foods on a scale of 0 (never) to 10 (three or more times/day).
Researchers divided participants into quartiles based on their median fruit consumption: 62 (range 0-95) g/day, 122 (95-162) g/day, 230 (162-283) g/day, and 372 (283-961) g/day.
The most commonly consumed fruit was apples (23% of total fruit intake), followed by bananas (20%) and citrus fruit (18%). Other fruits each accounted for less than 8% of total fruit intake, so they were not studied separately.
Participants in each quartile had a similar mean age (54 years) and body mass index (27 kg/m2).
However, compared with participants in quartile 1 (low fruit intake), those in quartiles 3 and 4 (moderate and high fruit intakes, respectively) were more likely to be female, do at least 150 minutes of physical activity a week, and less likely to smoke. They also ate more vegetables and less red meat and processed meat, but they consumed more sugar.
Of 4,674 participants who had 5-year follow-up, 179 participants developed diabetes.
Compared to participants with a low fruit intake (quartile 1), those with a moderate fruit intake (quartile 3) had a 36% lower odds of developing diabetes within 5 years (odds ratio, 0.64; 95% confidence interval, 0.44-0.92) after adjusting for age, sex, physical activity, education, socioeconomic status, income, body mass index, smoking, cardiovascular disease, parental history of diabetes, and consumption of alcohol, vegetables, red meat, processed meat, and calories.
Of the 3,518 participants with 12-year follow-up, 247 participants had diabetes, but there were no significant associations between fruit consumption and this longer-term risk of diabetes, possibly due to the small number of participants and events.
The study was supported by grants from the National Health and Medical Research Council of Australia and the National Heart Foundation of Australia. Dr. Bondonno has reported no relevant financial disclosures. Disclosures of the other authors are listed with the article.
A version of this article first appeared on Medscape.com.
Screaming for screens: Digital well-being in the 2020s
Charlie is a 15-year-old male whose medical history includes overweight and autism spectrum disorder. While his autism symptoms are stable and he is doing fairly well in school, your sense is that he is underperforming and unhappy. His screening for anxiety and depression is not outstanding and you wonder whether to leave well enough alone.
Historically, pediatrician queries about media use happen in a minority of visits,1 overcrowded by the multitude of screening and acute care needs, let alone the pressures of electronic health record prompts, billing, and documentation. Yet the COVID-19 pandemic has emphasized what was already getting louder: screen life is becoming a ubiquitous, increasing, and normative function of child development. Digital well-being exhibits bidirectional interactions with most of the core indicators of child health: sleep, nutrition, safety, mood, relationships, and many other aspects of physical and mental health.1
The pandemic unveiled the blessings and curses of digital life by shifting many into remote work and school situations where screen time became both necessary and uncontrollable. Reeling with changes in employment, health, finances, and more, families struggled to forge a new screen-life balance that could bridge academic, professional, and recreational use.
Research has wavered in producing a verdict on the effects of screen time, in part because of limitations in methodology and follow-up time,2 and exacerbated by the quickly changing nature of screen use. Screen time may put youth at risk for obesity and behavior problems,3 but the latter may be mediated in part by loss of sleep because of late-night digital activity.4 While survey data at the population level show little link between screen time and well-being impairments,5 zooming in on individuals may tell a different story. Twenge and Campbell show light use of digital media (compared with nonuse) is associated with greater well-being while heavy use is associated with lower well-being and a higher risk for depression and suicidal behavior – especially in girls.6,7 Largely cross-sectional data show a small detriment to psychological well-being associated with digital technology, though this may be bidirectional and does not clearly differentiate types of technology.2
Recent neuroscience suggests that, compared with active play, sedentary screen time after school reduced impulse control and increased brain activity in regions associated with craving.8 This may explain some of the link between screen time and obesity. Brain imaging of preschoolers showed that greater screen time correlated with lower reading readiness as well as less integrity of white-matter tracts involved in language and executive function,9 whereas nurturing home reading practices were protective for language development and white matter integrity.10
Returning to the care of Charlie, providers may benefit from taking time to reflect on their own digital environment. What does the patient-side view of your office look like? Many offices use telephone reminders and patient portals, fill prescriptions electronically, and have waiting rooms with WiFi or devices for children’s use. Office visits share space with providers’ desktops, laptops, and smartphones, with EMRs guiding the visit. EMRs may come home for evening documentation. How does this affect provider digital well-being? How do you start the conversation with families about digital well-being?
The American Academy of Pediatrics recommends media screening be incorporated into routine pediatric care, with several tools available to support this. Adapting the HEADSSS model for psychosocial check-ins, Clark and colleagues propose an additional “S” to capture screen time.11 Their model queries which apps and social media are used, quantity of use, effects on self-confidence, and whether cyberbullying or sexting are occurring. Smartphones themselves provide an eye-opening and accessible dataset, with built-in features (for example, Screen Time for iOS) tracking not just daily duration of use, but also how frequently the phone is picked up and which apps get more use. Screening may be followed by motivational coaching, emphasizing nonjudgment, curiosity, empathy, and flexibility — for patient and provider.12
In Charlie’s case, screening reveals heavy use of social Internet games that connect him with like-minded peers. While he describes an inclusiveness and level of socialization that he has not found outside the home, the quantity of use is interfering with sleep, schoolwork, and physical activity.
Significant problematic Internet use may lead to intervention or referral – addictive behaviors and mental health symptoms may warrant connection with mental health providers. Cyberbullying or unsafe behaviors may additionally benefit from parental and school-based support. There is early and limited evidence that psychological and educational interventions may be of benefit for problematic Internet use.13
When digital life is not so dramatically affecting well-being, providers may begin by working with families on a media use plan. The AAP offers its own website to support this. Other well-researched and well-designed sites include Digital Wellness Lab For Parents, with developmentally staged information and plentiful research, and Common Sense Media, which reviews apps, movies, and more; plus they have a knowledge/advice section under “Parents Need to Know.” Keep in mind that digital media can also support youth in managing psychiatric problems, e.g., a digital intervention promoting positive psychology practices looked very helpful for young people with psychosis.14
For Charlie, a health coaching approach is adopted. Using Gabrielli’s TECH parenting rubric,15 Charlie’s parents are coached to make space to talk about and coview media and apps, as well as creating a Family Media Use Plan for everyone – parents included. Alongside setting limits on screen time; health promotion activities like exercise, reading, and schoolwork are also rewarded with extra screen time. When Charlie returns 3 months later, the family reports that, in recognition of their collective digital overload, they preserved dinnertime and after 10 p.m. as screen-free downtime. While they still have concerns about Charlie’s gaming and social life, his sleep is somewhat improved and family tension is lower.
Attention to digital well-being stands to benefit provider and patient alike, and over time may gain from the scaffolding of handouts, standardized assessments, and health coaching providers that may be in place to support other important domains like sleep hygiene, food security, and parenting.
Dr. Rosenfeld is assistant professor, University of Vermont, Vermont Center for Children, Youth, and Families, Burlington. He has no relevant disclosures.
References
1. Chassiakos YR et al. Pediatrics. 2016;138(5)e20162593.
2. Orben A. Soc Psychiatry Psych Epi. 2020;55(4):407.
3. Fang K et al. Child Care Health Dev. 2019;45(5):744-53.
4. Janssen X et al. Sleep Med Rev. 2020;49:101226.
5. George MJ et al. J Ped. 2020;219:180.
6. Twenge JM and Campbell WK. Psychiatry Q. 2019;90(2):311-31.
7. Twenge JM and Martin GN. J Adolesc. 2020;79:91.
8. Efraim M et al. Brain Imaging Behav. 2021;15(1):177-89.
9. Hutton JS et al. JAMA Pediatr. 2020;174(1):e193869.
10. Hutton JS et al. Acta Paediatr. 2020;109(7):1376-86.
11. Clark DL et al. Pediatrics. 2018;141(6).
12. Jericho M and Elliot A. Clin Child Psychol Psychiatry. 2020;25(3):662.
13. Malinauskas R and Malinauskine V. J Behav Addict. 2019;8(4):613.
14. Lim MH et al. Soc Psychiatry Psychiatr Epi. 2020;55(7):877-89.
15. Gabrielli J et al. Pediatrics. 2018;142(1)e20173718.
Charlie is a 15-year-old male whose medical history includes overweight and autism spectrum disorder. While his autism symptoms are stable and he is doing fairly well in school, your sense is that he is underperforming and unhappy. His screening for anxiety and depression is not outstanding and you wonder whether to leave well enough alone.
Historically, pediatrician queries about media use happen in a minority of visits,1 overcrowded by the multitude of screening and acute care needs, let alone the pressures of electronic health record prompts, billing, and documentation. Yet the COVID-19 pandemic has emphasized what was already getting louder: screen life is becoming a ubiquitous, increasing, and normative function of child development. Digital well-being exhibits bidirectional interactions with most of the core indicators of child health: sleep, nutrition, safety, mood, relationships, and many other aspects of physical and mental health.1
The pandemic unveiled the blessings and curses of digital life by shifting many into remote work and school situations where screen time became both necessary and uncontrollable. Reeling with changes in employment, health, finances, and more, families struggled to forge a new screen-life balance that could bridge academic, professional, and recreational use.
Research has wavered in producing a verdict on the effects of screen time, in part because of limitations in methodology and follow-up time,2 and exacerbated by the quickly changing nature of screen use. Screen time may put youth at risk for obesity and behavior problems,3 but the latter may be mediated in part by loss of sleep because of late-night digital activity.4 While survey data at the population level show little link between screen time and well-being impairments,5 zooming in on individuals may tell a different story. Twenge and Campbell show light use of digital media (compared with nonuse) is associated with greater well-being while heavy use is associated with lower well-being and a higher risk for depression and suicidal behavior – especially in girls.6,7 Largely cross-sectional data show a small detriment to psychological well-being associated with digital technology, though this may be bidirectional and does not clearly differentiate types of technology.2
Recent neuroscience suggests that, compared with active play, sedentary screen time after school reduced impulse control and increased brain activity in regions associated with craving.8 This may explain some of the link between screen time and obesity. Brain imaging of preschoolers showed that greater screen time correlated with lower reading readiness as well as less integrity of white-matter tracts involved in language and executive function,9 whereas nurturing home reading practices were protective for language development and white matter integrity.10
Returning to the care of Charlie, providers may benefit from taking time to reflect on their own digital environment. What does the patient-side view of your office look like? Many offices use telephone reminders and patient portals, fill prescriptions electronically, and have waiting rooms with WiFi or devices for children’s use. Office visits share space with providers’ desktops, laptops, and smartphones, with EMRs guiding the visit. EMRs may come home for evening documentation. How does this affect provider digital well-being? How do you start the conversation with families about digital well-being?
The American Academy of Pediatrics recommends media screening be incorporated into routine pediatric care, with several tools available to support this. Adapting the HEADSSS model for psychosocial check-ins, Clark and colleagues propose an additional “S” to capture screen time.11 Their model queries which apps and social media are used, quantity of use, effects on self-confidence, and whether cyberbullying or sexting are occurring. Smartphones themselves provide an eye-opening and accessible dataset, with built-in features (for example, Screen Time for iOS) tracking not just daily duration of use, but also how frequently the phone is picked up and which apps get more use. Screening may be followed by motivational coaching, emphasizing nonjudgment, curiosity, empathy, and flexibility — for patient and provider.12
In Charlie’s case, screening reveals heavy use of social Internet games that connect him with like-minded peers. While he describes an inclusiveness and level of socialization that he has not found outside the home, the quantity of use is interfering with sleep, schoolwork, and physical activity.
Significant problematic Internet use may lead to intervention or referral – addictive behaviors and mental health symptoms may warrant connection with mental health providers. Cyberbullying or unsafe behaviors may additionally benefit from parental and school-based support. There is early and limited evidence that psychological and educational interventions may be of benefit for problematic Internet use.13
When digital life is not so dramatically affecting well-being, providers may begin by working with families on a media use plan. The AAP offers its own website to support this. Other well-researched and well-designed sites include Digital Wellness Lab For Parents, with developmentally staged information and plentiful research, and Common Sense Media, which reviews apps, movies, and more; plus they have a knowledge/advice section under “Parents Need to Know.” Keep in mind that digital media can also support youth in managing psychiatric problems, e.g., a digital intervention promoting positive psychology practices looked very helpful for young people with psychosis.14
For Charlie, a health coaching approach is adopted. Using Gabrielli’s TECH parenting rubric,15 Charlie’s parents are coached to make space to talk about and coview media and apps, as well as creating a Family Media Use Plan for everyone – parents included. Alongside setting limits on screen time; health promotion activities like exercise, reading, and schoolwork are also rewarded with extra screen time. When Charlie returns 3 months later, the family reports that, in recognition of their collective digital overload, they preserved dinnertime and after 10 p.m. as screen-free downtime. While they still have concerns about Charlie’s gaming and social life, his sleep is somewhat improved and family tension is lower.
Attention to digital well-being stands to benefit provider and patient alike, and over time may gain from the scaffolding of handouts, standardized assessments, and health coaching providers that may be in place to support other important domains like sleep hygiene, food security, and parenting.
Dr. Rosenfeld is assistant professor, University of Vermont, Vermont Center for Children, Youth, and Families, Burlington. He has no relevant disclosures.
References
1. Chassiakos YR et al. Pediatrics. 2016;138(5)e20162593.
2. Orben A. Soc Psychiatry Psych Epi. 2020;55(4):407.
3. Fang K et al. Child Care Health Dev. 2019;45(5):744-53.
4. Janssen X et al. Sleep Med Rev. 2020;49:101226.
5. George MJ et al. J Ped. 2020;219:180.
6. Twenge JM and Campbell WK. Psychiatry Q. 2019;90(2):311-31.
7. Twenge JM and Martin GN. J Adolesc. 2020;79:91.
8. Efraim M et al. Brain Imaging Behav. 2021;15(1):177-89.
9. Hutton JS et al. JAMA Pediatr. 2020;174(1):e193869.
10. Hutton JS et al. Acta Paediatr. 2020;109(7):1376-86.
11. Clark DL et al. Pediatrics. 2018;141(6).
12. Jericho M and Elliot A. Clin Child Psychol Psychiatry. 2020;25(3):662.
13. Malinauskas R and Malinauskine V. J Behav Addict. 2019;8(4):613.
14. Lim MH et al. Soc Psychiatry Psychiatr Epi. 2020;55(7):877-89.
15. Gabrielli J et al. Pediatrics. 2018;142(1)e20173718.
Charlie is a 15-year-old male whose medical history includes overweight and autism spectrum disorder. While his autism symptoms are stable and he is doing fairly well in school, your sense is that he is underperforming and unhappy. His screening for anxiety and depression is not outstanding and you wonder whether to leave well enough alone.
Historically, pediatrician queries about media use happen in a minority of visits,1 overcrowded by the multitude of screening and acute care needs, let alone the pressures of electronic health record prompts, billing, and documentation. Yet the COVID-19 pandemic has emphasized what was already getting louder: screen life is becoming a ubiquitous, increasing, and normative function of child development. Digital well-being exhibits bidirectional interactions with most of the core indicators of child health: sleep, nutrition, safety, mood, relationships, and many other aspects of physical and mental health.1
The pandemic unveiled the blessings and curses of digital life by shifting many into remote work and school situations where screen time became both necessary and uncontrollable. Reeling with changes in employment, health, finances, and more, families struggled to forge a new screen-life balance that could bridge academic, professional, and recreational use.
Research has wavered in producing a verdict on the effects of screen time, in part because of limitations in methodology and follow-up time,2 and exacerbated by the quickly changing nature of screen use. Screen time may put youth at risk for obesity and behavior problems,3 but the latter may be mediated in part by loss of sleep because of late-night digital activity.4 While survey data at the population level show little link between screen time and well-being impairments,5 zooming in on individuals may tell a different story. Twenge and Campbell show light use of digital media (compared with nonuse) is associated with greater well-being while heavy use is associated with lower well-being and a higher risk for depression and suicidal behavior – especially in girls.6,7 Largely cross-sectional data show a small detriment to psychological well-being associated with digital technology, though this may be bidirectional and does not clearly differentiate types of technology.2
Recent neuroscience suggests that, compared with active play, sedentary screen time after school reduced impulse control and increased brain activity in regions associated with craving.8 This may explain some of the link between screen time and obesity. Brain imaging of preschoolers showed that greater screen time correlated with lower reading readiness as well as less integrity of white-matter tracts involved in language and executive function,9 whereas nurturing home reading practices were protective for language development and white matter integrity.10
Returning to the care of Charlie, providers may benefit from taking time to reflect on their own digital environment. What does the patient-side view of your office look like? Many offices use telephone reminders and patient portals, fill prescriptions electronically, and have waiting rooms with WiFi or devices for children’s use. Office visits share space with providers’ desktops, laptops, and smartphones, with EMRs guiding the visit. EMRs may come home for evening documentation. How does this affect provider digital well-being? How do you start the conversation with families about digital well-being?
The American Academy of Pediatrics recommends media screening be incorporated into routine pediatric care, with several tools available to support this. Adapting the HEADSSS model for psychosocial check-ins, Clark and colleagues propose an additional “S” to capture screen time.11 Their model queries which apps and social media are used, quantity of use, effects on self-confidence, and whether cyberbullying or sexting are occurring. Smartphones themselves provide an eye-opening and accessible dataset, with built-in features (for example, Screen Time for iOS) tracking not just daily duration of use, but also how frequently the phone is picked up and which apps get more use. Screening may be followed by motivational coaching, emphasizing nonjudgment, curiosity, empathy, and flexibility — for patient and provider.12
In Charlie’s case, screening reveals heavy use of social Internet games that connect him with like-minded peers. While he describes an inclusiveness and level of socialization that he has not found outside the home, the quantity of use is interfering with sleep, schoolwork, and physical activity.
Significant problematic Internet use may lead to intervention or referral – addictive behaviors and mental health symptoms may warrant connection with mental health providers. Cyberbullying or unsafe behaviors may additionally benefit from parental and school-based support. There is early and limited evidence that psychological and educational interventions may be of benefit for problematic Internet use.13
When digital life is not so dramatically affecting well-being, providers may begin by working with families on a media use plan. The AAP offers its own website to support this. Other well-researched and well-designed sites include Digital Wellness Lab For Parents, with developmentally staged information and plentiful research, and Common Sense Media, which reviews apps, movies, and more; plus they have a knowledge/advice section under “Parents Need to Know.” Keep in mind that digital media can also support youth in managing psychiatric problems, e.g., a digital intervention promoting positive psychology practices looked very helpful for young people with psychosis.14
For Charlie, a health coaching approach is adopted. Using Gabrielli’s TECH parenting rubric,15 Charlie’s parents are coached to make space to talk about and coview media and apps, as well as creating a Family Media Use Plan for everyone – parents included. Alongside setting limits on screen time; health promotion activities like exercise, reading, and schoolwork are also rewarded with extra screen time. When Charlie returns 3 months later, the family reports that, in recognition of their collective digital overload, they preserved dinnertime and after 10 p.m. as screen-free downtime. While they still have concerns about Charlie’s gaming and social life, his sleep is somewhat improved and family tension is lower.
Attention to digital well-being stands to benefit provider and patient alike, and over time may gain from the scaffolding of handouts, standardized assessments, and health coaching providers that may be in place to support other important domains like sleep hygiene, food security, and parenting.
Dr. Rosenfeld is assistant professor, University of Vermont, Vermont Center for Children, Youth, and Families, Burlington. He has no relevant disclosures.
References
1. Chassiakos YR et al. Pediatrics. 2016;138(5)e20162593.
2. Orben A. Soc Psychiatry Psych Epi. 2020;55(4):407.
3. Fang K et al. Child Care Health Dev. 2019;45(5):744-53.
4. Janssen X et al. Sleep Med Rev. 2020;49:101226.
5. George MJ et al. J Ped. 2020;219:180.
6. Twenge JM and Campbell WK. Psychiatry Q. 2019;90(2):311-31.
7. Twenge JM and Martin GN. J Adolesc. 2020;79:91.
8. Efraim M et al. Brain Imaging Behav. 2021;15(1):177-89.
9. Hutton JS et al. JAMA Pediatr. 2020;174(1):e193869.
10. Hutton JS et al. Acta Paediatr. 2020;109(7):1376-86.
11. Clark DL et al. Pediatrics. 2018;141(6).
12. Jericho M and Elliot A. Clin Child Psychol Psychiatry. 2020;25(3):662.
13. Malinauskas R and Malinauskine V. J Behav Addict. 2019;8(4):613.
14. Lim MH et al. Soc Psychiatry Psychiatr Epi. 2020;55(7):877-89.
15. Gabrielli J et al. Pediatrics. 2018;142(1)e20173718.
Adjuvant capecitabine shown a less punishing option after NPC chemoradiation
Adjuvant capecitabine is an effective and better tolerated alternative to chemotherapy following chemoradiation for locoregionally advanced nasopharyngeal carcinoma, according to two phase 3 trials from China.
Despite using different dosing strategies, 3-year failure-free survival approached 90% in both trials, comparable to the standard approach with adjuvant platinum doublets, but with better compliance.
The study teams were looking for “a way to make adjuvant therapy more tolerable,” said oncologist Herbert Loong, MBBS, clinical associate professor at the Chinese University of Hong Kong, who discussed both trials after they were presented at the American Society for Clinical Oncology annual meeting.
Compliance is low with platinum doublets because of the toxicity. About 60%-70% of patients can tolerate 2-3 cycles after chemoradiation, and about a third can’t even start because of the toll chemoradiation took on their bodies, he said.
Induction chemotherapy is an alternative, but patients seem to derive more benefit form adjuvant therapy after chemoradiation. Indeed, “given the fact that we may now have a well established, well tolerated adjuvant therapy for our patients” – capecitabine – “the role of induction therapy” is in question, Dr. Loong said.
Metronomic dosing
One trial randomized 204 patients to metronomic dosing of capecitabine, 650 mg/m2 twice daily for 1 year within 12 to 16 weeks after the last radiation, and 202 others to observation.
The idea of metronomic dosing was to give a lower dose of the agent over a longer period to reduce side effects and perhaps improve efficacy.
Subjects had high-risk stage III to IVA disease with no locoregional disease or distant metastasis after chemoradiotherapy. Almost 80% in both arms also had induction chemotherapy, most commonly docetaxel and cisplatin.
Almost three-quarters of people in the treatment arm complied with capecitabine for an entire year.
At a median follow-up of 38 months, 3-year failure-free survival was 85.3% with metronomic capecitabine vs. 75.7% with observation (hazard ratio, .50, P = .002). Three-year overall survival was 93.3% with capecitabine and 88.6% with observation (HR .44, P = .018).
The incidence of grade 3/4 adverse events was 17.4% with metronomic capecitabine vs. 5.5% with observation. Hand-foot syndrome was the most common complication, occurring in 9% of capecitabine subjects. There were no treatment-related deaths, and there was no clinically meaningful deterioration in quality of life associated with treatment.
The approach “significantly improved” outcomes, “with a manageable safety profile and no compromise to quality of life ... Metronomic adjuvant capecitabine can be an option for first-line treatment in this high-risk” group, concluded investigators led by Jun Ma, MD, professor of radiation oncology and deputy president of Sun Yat-sen University Cancer Center in Guangzhou, China.
Standard dosing
The second trial used standard dosing. The researchers randomized 90 subjects to capecitabine 1,000 mg/m2 twice daily for 14 days in eight 21-day cycles after chemoradiation; 90 subjects were randomized to observation. None of the subjects received induction chemotherapy.
Patients had stage III-IVb disease plus at least one high-risk feature, such as high Epstein Barr virus DNA titers. The majority of patients in both arms had three or more high risk features.
Over 80% of capecitabine subjects completed all eight cycles of treatment.
At a median follow-up of 44.8 months, 3-year failure-free survival was 87.7% with capecitabine vs. 73.3% in the control arm (HR .52, P = .037). Three-year overall survival was 92.6% with capecitabine vs. 88.9% with observation, which wasn’t statistically significant.
The incidence of acute grade 3/4 adverse events was 57.8% with standard dose capecitabine. Rates of hand foot syndrome, mucositis, anemia, and other problems were substantially higher than with observation.
For high-risk patients unable to tolerate chemotherapy, adjuvant capecitabine is a “suitable alternative treatment option,” said lead investigator Jingjing Miao, MD, of the department of nasopharyngeal carcinoma at Sun Yat-sen University Cancer Center, Guangzhou, China.
The trials were funded by Sun Yat-sen University and others. The investigators had no disclosures. Dr. Loong is an adviser, speaker, and/or researcher for a number of companies, including Novartis, Pfizer, and Lilly.
Adjuvant capecitabine is an effective and better tolerated alternative to chemotherapy following chemoradiation for locoregionally advanced nasopharyngeal carcinoma, according to two phase 3 trials from China.
Despite using different dosing strategies, 3-year failure-free survival approached 90% in both trials, comparable to the standard approach with adjuvant platinum doublets, but with better compliance.
The study teams were looking for “a way to make adjuvant therapy more tolerable,” said oncologist Herbert Loong, MBBS, clinical associate professor at the Chinese University of Hong Kong, who discussed both trials after they were presented at the American Society for Clinical Oncology annual meeting.
Compliance is low with platinum doublets because of the toxicity. About 60%-70% of patients can tolerate 2-3 cycles after chemoradiation, and about a third can’t even start because of the toll chemoradiation took on their bodies, he said.
Induction chemotherapy is an alternative, but patients seem to derive more benefit form adjuvant therapy after chemoradiation. Indeed, “given the fact that we may now have a well established, well tolerated adjuvant therapy for our patients” – capecitabine – “the role of induction therapy” is in question, Dr. Loong said.
Metronomic dosing
One trial randomized 204 patients to metronomic dosing of capecitabine, 650 mg/m2 twice daily for 1 year within 12 to 16 weeks after the last radiation, and 202 others to observation.
The idea of metronomic dosing was to give a lower dose of the agent over a longer period to reduce side effects and perhaps improve efficacy.
Subjects had high-risk stage III to IVA disease with no locoregional disease or distant metastasis after chemoradiotherapy. Almost 80% in both arms also had induction chemotherapy, most commonly docetaxel and cisplatin.
Almost three-quarters of people in the treatment arm complied with capecitabine for an entire year.
At a median follow-up of 38 months, 3-year failure-free survival was 85.3% with metronomic capecitabine vs. 75.7% with observation (hazard ratio, .50, P = .002). Three-year overall survival was 93.3% with capecitabine and 88.6% with observation (HR .44, P = .018).
The incidence of grade 3/4 adverse events was 17.4% with metronomic capecitabine vs. 5.5% with observation. Hand-foot syndrome was the most common complication, occurring in 9% of capecitabine subjects. There were no treatment-related deaths, and there was no clinically meaningful deterioration in quality of life associated with treatment.
The approach “significantly improved” outcomes, “with a manageable safety profile and no compromise to quality of life ... Metronomic adjuvant capecitabine can be an option for first-line treatment in this high-risk” group, concluded investigators led by Jun Ma, MD, professor of radiation oncology and deputy president of Sun Yat-sen University Cancer Center in Guangzhou, China.
Standard dosing
The second trial used standard dosing. The researchers randomized 90 subjects to capecitabine 1,000 mg/m2 twice daily for 14 days in eight 21-day cycles after chemoradiation; 90 subjects were randomized to observation. None of the subjects received induction chemotherapy.
Patients had stage III-IVb disease plus at least one high-risk feature, such as high Epstein Barr virus DNA titers. The majority of patients in both arms had three or more high risk features.
Over 80% of capecitabine subjects completed all eight cycles of treatment.
At a median follow-up of 44.8 months, 3-year failure-free survival was 87.7% with capecitabine vs. 73.3% in the control arm (HR .52, P = .037). Three-year overall survival was 92.6% with capecitabine vs. 88.9% with observation, which wasn’t statistically significant.
The incidence of acute grade 3/4 adverse events was 57.8% with standard dose capecitabine. Rates of hand foot syndrome, mucositis, anemia, and other problems were substantially higher than with observation.
For high-risk patients unable to tolerate chemotherapy, adjuvant capecitabine is a “suitable alternative treatment option,” said lead investigator Jingjing Miao, MD, of the department of nasopharyngeal carcinoma at Sun Yat-sen University Cancer Center, Guangzhou, China.
The trials were funded by Sun Yat-sen University and others. The investigators had no disclosures. Dr. Loong is an adviser, speaker, and/or researcher for a number of companies, including Novartis, Pfizer, and Lilly.
Adjuvant capecitabine is an effective and better tolerated alternative to chemotherapy following chemoradiation for locoregionally advanced nasopharyngeal carcinoma, according to two phase 3 trials from China.
Despite using different dosing strategies, 3-year failure-free survival approached 90% in both trials, comparable to the standard approach with adjuvant platinum doublets, but with better compliance.
The study teams were looking for “a way to make adjuvant therapy more tolerable,” said oncologist Herbert Loong, MBBS, clinical associate professor at the Chinese University of Hong Kong, who discussed both trials after they were presented at the American Society for Clinical Oncology annual meeting.
Compliance is low with platinum doublets because of the toxicity. About 60%-70% of patients can tolerate 2-3 cycles after chemoradiation, and about a third can’t even start because of the toll chemoradiation took on their bodies, he said.
Induction chemotherapy is an alternative, but patients seem to derive more benefit form adjuvant therapy after chemoradiation. Indeed, “given the fact that we may now have a well established, well tolerated adjuvant therapy for our patients” – capecitabine – “the role of induction therapy” is in question, Dr. Loong said.
Metronomic dosing
One trial randomized 204 patients to metronomic dosing of capecitabine, 650 mg/m2 twice daily for 1 year within 12 to 16 weeks after the last radiation, and 202 others to observation.
The idea of metronomic dosing was to give a lower dose of the agent over a longer period to reduce side effects and perhaps improve efficacy.
Subjects had high-risk stage III to IVA disease with no locoregional disease or distant metastasis after chemoradiotherapy. Almost 80% in both arms also had induction chemotherapy, most commonly docetaxel and cisplatin.
Almost three-quarters of people in the treatment arm complied with capecitabine for an entire year.
At a median follow-up of 38 months, 3-year failure-free survival was 85.3% with metronomic capecitabine vs. 75.7% with observation (hazard ratio, .50, P = .002). Three-year overall survival was 93.3% with capecitabine and 88.6% with observation (HR .44, P = .018).
The incidence of grade 3/4 adverse events was 17.4% with metronomic capecitabine vs. 5.5% with observation. Hand-foot syndrome was the most common complication, occurring in 9% of capecitabine subjects. There were no treatment-related deaths, and there was no clinically meaningful deterioration in quality of life associated with treatment.
The approach “significantly improved” outcomes, “with a manageable safety profile and no compromise to quality of life ... Metronomic adjuvant capecitabine can be an option for first-line treatment in this high-risk” group, concluded investigators led by Jun Ma, MD, professor of radiation oncology and deputy president of Sun Yat-sen University Cancer Center in Guangzhou, China.
Standard dosing
The second trial used standard dosing. The researchers randomized 90 subjects to capecitabine 1,000 mg/m2 twice daily for 14 days in eight 21-day cycles after chemoradiation; 90 subjects were randomized to observation. None of the subjects received induction chemotherapy.
Patients had stage III-IVb disease plus at least one high-risk feature, such as high Epstein Barr virus DNA titers. The majority of patients in both arms had three or more high risk features.
Over 80% of capecitabine subjects completed all eight cycles of treatment.
At a median follow-up of 44.8 months, 3-year failure-free survival was 87.7% with capecitabine vs. 73.3% in the control arm (HR .52, P = .037). Three-year overall survival was 92.6% with capecitabine vs. 88.9% with observation, which wasn’t statistically significant.
The incidence of acute grade 3/4 adverse events was 57.8% with standard dose capecitabine. Rates of hand foot syndrome, mucositis, anemia, and other problems were substantially higher than with observation.
For high-risk patients unable to tolerate chemotherapy, adjuvant capecitabine is a “suitable alternative treatment option,” said lead investigator Jingjing Miao, MD, of the department of nasopharyngeal carcinoma at Sun Yat-sen University Cancer Center, Guangzhou, China.
The trials were funded by Sun Yat-sen University and others. The investigators had no disclosures. Dr. Loong is an adviser, speaker, and/or researcher for a number of companies, including Novartis, Pfizer, and Lilly.
FROM ASCO 2021
Cabozantinib gains ground for salvage in differentiated thyroid cancer
The vascular endothelial growth factor receptor 2 blocker cabozantinib prolonged progression-free survival in radioiodine-refractory differentiated thyroid cancer following progression on first-line VEGFR inhibitors in a phase 3 trial from cabozantinib maker, Exelixis.
After a median follow up of 6.2 months, the 125 subjects on cabozantinib 60 mg every day had not reached median progression-free survival, but among the 62 randomized to placebo, mPFS was only 1.9 months.
The results led the Food and Drug Administration to grant cabozantinib breakthrough therapy status for salvage after progression on lenvatinib or sorafenib, the two VEGFR inhibitors approved for first-line treatment in radioiodine refractory differentiated thyroid cancer. Cabozantinib already carries a first-line indication for progressive, metastatic medullary thyroid cancer.
“We were all so excited to have sorafenib and lenvatinib,” but patients need another option after they develop resistance. “Cabozantinib is positioned to be the next in line,” said lead investigator Marcia Brose, MD, PhD, a thyroid specialist and professor at the University of Pennsylvania, Philadelphia, who presented the findings at the American Society of Clinical Oncology Annual Meeting.
The trial discussant, medical oncologist Nicole Chau, MD, clinical associate professor at the University of British Columbia, Vancouver, said the results “support cabozantinib as a potential second- or third-line” option, but its impact on quality of life and financial toxicity “should be evaluated.”
Subjects in the trial – dubbed COSMIC-311 – had locally advanced or metastatic disease that had progressed during or after first-line VEGFR treatment, including about 40% with lenvatinib, almost 40% with sorafenib, and over 20% with both.
The median age in the study was 66 years, and 55% of the subjects were women. Bone and liver metastases were more common in the cabozantinib arm.
Promising results
The robust of mPFS benefit (hazard ratio, 0.22; P < .0001) held across subgroups. The mPFS in the placebo arm of 1.9 months demonstrates that “these patients [progress rapidly], so you have to be ready with the next thing in line” to start it quickly, Dr. Brose said.
Overall survival favored cabozantinib (HR, 0.54) but didn’t reach statistical significance perhaps because placebo patients were allowed to cross over to cabozantinib after progression.
The overall response rate was 15% with cabozantinib versus no responders with placebo, which also didn’t meet the study’s criteria for clinical significance. Even so, the disease control rate of 60% with cabozantinib versus 27% with placebo, “is clinically meaningful in this heavily pretreated population,” Dr. Chau said.
Adverse events
Safety was consistent with previous reports and included diarrhea in 51% of cabozantinib subjects, hand-foot skin reaction in 46%, hypertension in 28%, fatigue in 27%, and nausea in 24%, all substantially higher than with placebo. Over half of cabozantinib subjects had grade 3-4 adverse events versus 26% on placebo. There were no treatment related deaths.
Adverse events led to dose reductions or holds in the majority of cabozantinib subjects, but only 5% discontinued the drug; the number might have been higher with longer follow-up, Dr. Chau said.
Genotype-targeted therapy is an option for patients with fusion alterations, but whether it should come before or after VEGFR inhibition is unclear, Dr. Brose noted.
Biomarkers to help with such treatment decisions will become “increasingly important as we move beyond the era of single-agent” VEGFR inhibitors, Dr. Chau said.
The study was funded by cabozantinib maker Exelixis, and three investigators were employees. Dr. Brose disclosed research funding and honoraria from the company, and is an adviser. Dr. Chau has no involvement with Exelixis.
The vascular endothelial growth factor receptor 2 blocker cabozantinib prolonged progression-free survival in radioiodine-refractory differentiated thyroid cancer following progression on first-line VEGFR inhibitors in a phase 3 trial from cabozantinib maker, Exelixis.
After a median follow up of 6.2 months, the 125 subjects on cabozantinib 60 mg every day had not reached median progression-free survival, but among the 62 randomized to placebo, mPFS was only 1.9 months.
The results led the Food and Drug Administration to grant cabozantinib breakthrough therapy status for salvage after progression on lenvatinib or sorafenib, the two VEGFR inhibitors approved for first-line treatment in radioiodine refractory differentiated thyroid cancer. Cabozantinib already carries a first-line indication for progressive, metastatic medullary thyroid cancer.
“We were all so excited to have sorafenib and lenvatinib,” but patients need another option after they develop resistance. “Cabozantinib is positioned to be the next in line,” said lead investigator Marcia Brose, MD, PhD, a thyroid specialist and professor at the University of Pennsylvania, Philadelphia, who presented the findings at the American Society of Clinical Oncology Annual Meeting.
The trial discussant, medical oncologist Nicole Chau, MD, clinical associate professor at the University of British Columbia, Vancouver, said the results “support cabozantinib as a potential second- or third-line” option, but its impact on quality of life and financial toxicity “should be evaluated.”
Subjects in the trial – dubbed COSMIC-311 – had locally advanced or metastatic disease that had progressed during or after first-line VEGFR treatment, including about 40% with lenvatinib, almost 40% with sorafenib, and over 20% with both.
The median age in the study was 66 years, and 55% of the subjects were women. Bone and liver metastases were more common in the cabozantinib arm.
Promising results
The robust of mPFS benefit (hazard ratio, 0.22; P < .0001) held across subgroups. The mPFS in the placebo arm of 1.9 months demonstrates that “these patients [progress rapidly], so you have to be ready with the next thing in line” to start it quickly, Dr. Brose said.
Overall survival favored cabozantinib (HR, 0.54) but didn’t reach statistical significance perhaps because placebo patients were allowed to cross over to cabozantinib after progression.
The overall response rate was 15% with cabozantinib versus no responders with placebo, which also didn’t meet the study’s criteria for clinical significance. Even so, the disease control rate of 60% with cabozantinib versus 27% with placebo, “is clinically meaningful in this heavily pretreated population,” Dr. Chau said.
Adverse events
Safety was consistent with previous reports and included diarrhea in 51% of cabozantinib subjects, hand-foot skin reaction in 46%, hypertension in 28%, fatigue in 27%, and nausea in 24%, all substantially higher than with placebo. Over half of cabozantinib subjects had grade 3-4 adverse events versus 26% on placebo. There were no treatment related deaths.
Adverse events led to dose reductions or holds in the majority of cabozantinib subjects, but only 5% discontinued the drug; the number might have been higher with longer follow-up, Dr. Chau said.
Genotype-targeted therapy is an option for patients with fusion alterations, but whether it should come before or after VEGFR inhibition is unclear, Dr. Brose noted.
Biomarkers to help with such treatment decisions will become “increasingly important as we move beyond the era of single-agent” VEGFR inhibitors, Dr. Chau said.
The study was funded by cabozantinib maker Exelixis, and three investigators were employees. Dr. Brose disclosed research funding and honoraria from the company, and is an adviser. Dr. Chau has no involvement with Exelixis.
The vascular endothelial growth factor receptor 2 blocker cabozantinib prolonged progression-free survival in radioiodine-refractory differentiated thyroid cancer following progression on first-line VEGFR inhibitors in a phase 3 trial from cabozantinib maker, Exelixis.
After a median follow up of 6.2 months, the 125 subjects on cabozantinib 60 mg every day had not reached median progression-free survival, but among the 62 randomized to placebo, mPFS was only 1.9 months.
The results led the Food and Drug Administration to grant cabozantinib breakthrough therapy status for salvage after progression on lenvatinib or sorafenib, the two VEGFR inhibitors approved for first-line treatment in radioiodine refractory differentiated thyroid cancer. Cabozantinib already carries a first-line indication for progressive, metastatic medullary thyroid cancer.
“We were all so excited to have sorafenib and lenvatinib,” but patients need another option after they develop resistance. “Cabozantinib is positioned to be the next in line,” said lead investigator Marcia Brose, MD, PhD, a thyroid specialist and professor at the University of Pennsylvania, Philadelphia, who presented the findings at the American Society of Clinical Oncology Annual Meeting.
The trial discussant, medical oncologist Nicole Chau, MD, clinical associate professor at the University of British Columbia, Vancouver, said the results “support cabozantinib as a potential second- or third-line” option, but its impact on quality of life and financial toxicity “should be evaluated.”
Subjects in the trial – dubbed COSMIC-311 – had locally advanced or metastatic disease that had progressed during or after first-line VEGFR treatment, including about 40% with lenvatinib, almost 40% with sorafenib, and over 20% with both.
The median age in the study was 66 years, and 55% of the subjects were women. Bone and liver metastases were more common in the cabozantinib arm.
Promising results
The robust of mPFS benefit (hazard ratio, 0.22; P < .0001) held across subgroups. The mPFS in the placebo arm of 1.9 months demonstrates that “these patients [progress rapidly], so you have to be ready with the next thing in line” to start it quickly, Dr. Brose said.
Overall survival favored cabozantinib (HR, 0.54) but didn’t reach statistical significance perhaps because placebo patients were allowed to cross over to cabozantinib after progression.
The overall response rate was 15% with cabozantinib versus no responders with placebo, which also didn’t meet the study’s criteria for clinical significance. Even so, the disease control rate of 60% with cabozantinib versus 27% with placebo, “is clinically meaningful in this heavily pretreated population,” Dr. Chau said.
Adverse events
Safety was consistent with previous reports and included diarrhea in 51% of cabozantinib subjects, hand-foot skin reaction in 46%, hypertension in 28%, fatigue in 27%, and nausea in 24%, all substantially higher than with placebo. Over half of cabozantinib subjects had grade 3-4 adverse events versus 26% on placebo. There were no treatment related deaths.
Adverse events led to dose reductions or holds in the majority of cabozantinib subjects, but only 5% discontinued the drug; the number might have been higher with longer follow-up, Dr. Chau said.
Genotype-targeted therapy is an option for patients with fusion alterations, but whether it should come before or after VEGFR inhibition is unclear, Dr. Brose noted.
Biomarkers to help with such treatment decisions will become “increasingly important as we move beyond the era of single-agent” VEGFR inhibitors, Dr. Chau said.
The study was funded by cabozantinib maker Exelixis, and three investigators were employees. Dr. Brose disclosed research funding and honoraria from the company, and is an adviser. Dr. Chau has no involvement with Exelixis.
FROM ASCO 2021
Judge tosses hospital staff suit over vaccine mandate
A federal judge in Texas has dismissed a lawsuit from 117 Houston Methodist Hospital workers who refused to get a COVID-19 vaccine and said it was illegal to require them to do so.
In the ruling issued June 12, U.S. District Judge Lynn Hughes upheld the hospital’s policy and said the vaccination requirement didn’t break any federal laws.
“This is not coercion,” Judge Hughes wrote in the ruling.
“Methodist is trying to do their business of saving lives without giving them the COVID-19 virus,” he wrote. “It is a choice made to keep staff, patients, and their families safer.”
In April, the Houston Methodist Hospital system announced a policy that required employees to be vaccinated by June 7 or request an exemption. After the deadline, 178 of 26,000 employees refused to get inoculated and were placed on suspension without pay. The employees said the vaccine was unsafe and “experimental.” In his ruling, Judge Hughes said their claim was false and irrelevant.
“Texas law only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” he wrote. “Receiving a COVID-19 vaccination is not an illegal act, and it carries no criminal penalties.”
He denounced the “press-release style of the complaint” and the comparison of the hospital’s vaccine policy to forced experimentation by the Nazis against Jewish people during the Holocaust.
“Equating the injection requirement to medical experimentation in concentration camps is reprehensible,” he wrote. “Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.”
Judge Hughes also said that employees can “freely choose” to accept or refuse a COVID-19 vaccine. If they refuse, they “simply need to work somewhere else,” he wrote.
“If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired,” Judge Hughes said. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”
The ruling could set a precedent for similar COVID-19 vaccine lawsuits across the country, NPR reported. Houston Methodist was one of the first hospitals to require staff to be vaccinated. After the ruling on June 12, the hospital system wrote in a statement that it was “pleased and reassured” that Judge Hughes dismissed a “frivolous lawsuit.”
The hospital system will begin to terminate the 178 employees who were suspended if they don’t get a vaccine by June 21.
Jennifer Bridges, a nurse who has led the campaign against the vaccine policy, said she and the other plaintiffs will appeal the decision, according to KHOU.
“We’re OK with this decision. We are appealing. This will be taken all the way to the Supreme Court,” she told the news station. “This is far from over. This is literally only the beginning.”
A version of this article first appeared on WebMD.com.
A federal judge in Texas has dismissed a lawsuit from 117 Houston Methodist Hospital workers who refused to get a COVID-19 vaccine and said it was illegal to require them to do so.
In the ruling issued June 12, U.S. District Judge Lynn Hughes upheld the hospital’s policy and said the vaccination requirement didn’t break any federal laws.
“This is not coercion,” Judge Hughes wrote in the ruling.
“Methodist is trying to do their business of saving lives without giving them the COVID-19 virus,” he wrote. “It is a choice made to keep staff, patients, and their families safer.”
In April, the Houston Methodist Hospital system announced a policy that required employees to be vaccinated by June 7 or request an exemption. After the deadline, 178 of 26,000 employees refused to get inoculated and were placed on suspension without pay. The employees said the vaccine was unsafe and “experimental.” In his ruling, Judge Hughes said their claim was false and irrelevant.
“Texas law only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” he wrote. “Receiving a COVID-19 vaccination is not an illegal act, and it carries no criminal penalties.”
He denounced the “press-release style of the complaint” and the comparison of the hospital’s vaccine policy to forced experimentation by the Nazis against Jewish people during the Holocaust.
“Equating the injection requirement to medical experimentation in concentration camps is reprehensible,” he wrote. “Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.”
Judge Hughes also said that employees can “freely choose” to accept or refuse a COVID-19 vaccine. If they refuse, they “simply need to work somewhere else,” he wrote.
“If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired,” Judge Hughes said. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”
The ruling could set a precedent for similar COVID-19 vaccine lawsuits across the country, NPR reported. Houston Methodist was one of the first hospitals to require staff to be vaccinated. After the ruling on June 12, the hospital system wrote in a statement that it was “pleased and reassured” that Judge Hughes dismissed a “frivolous lawsuit.”
The hospital system will begin to terminate the 178 employees who were suspended if they don’t get a vaccine by June 21.
Jennifer Bridges, a nurse who has led the campaign against the vaccine policy, said she and the other plaintiffs will appeal the decision, according to KHOU.
“We’re OK with this decision. We are appealing. This will be taken all the way to the Supreme Court,” she told the news station. “This is far from over. This is literally only the beginning.”
A version of this article first appeared on WebMD.com.
A federal judge in Texas has dismissed a lawsuit from 117 Houston Methodist Hospital workers who refused to get a COVID-19 vaccine and said it was illegal to require them to do so.
In the ruling issued June 12, U.S. District Judge Lynn Hughes upheld the hospital’s policy and said the vaccination requirement didn’t break any federal laws.
“This is not coercion,” Judge Hughes wrote in the ruling.
“Methodist is trying to do their business of saving lives without giving them the COVID-19 virus,” he wrote. “It is a choice made to keep staff, patients, and their families safer.”
In April, the Houston Methodist Hospital system announced a policy that required employees to be vaccinated by June 7 or request an exemption. After the deadline, 178 of 26,000 employees refused to get inoculated and were placed on suspension without pay. The employees said the vaccine was unsafe and “experimental.” In his ruling, Judge Hughes said their claim was false and irrelevant.
“Texas law only protects employees from being terminated for refusing to commit an act carrying criminal penalties to the worker,” he wrote. “Receiving a COVID-19 vaccination is not an illegal act, and it carries no criminal penalties.”
He denounced the “press-release style of the complaint” and the comparison of the hospital’s vaccine policy to forced experimentation by the Nazis against Jewish people during the Holocaust.
“Equating the injection requirement to medical experimentation in concentration camps is reprehensible,” he wrote. “Nazi doctors conducted medical experiments on victims that caused pain, mutilation, permanent disability, and in many cases, death.”
Judge Hughes also said that employees can “freely choose” to accept or refuse a COVID-19 vaccine. If they refuse, they “simply need to work somewhere else,” he wrote.
“If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired,” Judge Hughes said. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. This is all part of the bargain.”
The ruling could set a precedent for similar COVID-19 vaccine lawsuits across the country, NPR reported. Houston Methodist was one of the first hospitals to require staff to be vaccinated. After the ruling on June 12, the hospital system wrote in a statement that it was “pleased and reassured” that Judge Hughes dismissed a “frivolous lawsuit.”
The hospital system will begin to terminate the 178 employees who were suspended if they don’t get a vaccine by June 21.
Jennifer Bridges, a nurse who has led the campaign against the vaccine policy, said she and the other plaintiffs will appeal the decision, according to KHOU.
“We’re OK with this decision. We are appealing. This will be taken all the way to the Supreme Court,” she told the news station. “This is far from over. This is literally only the beginning.”
A version of this article first appeared on WebMD.com.
Is your patient having an existential crisis?
The news is portraying our modern time as an existential crisis as though our very existence is threatened. An existential crisis is a profound feeling of lack of meaning, choice, or freedom in one’s life that makes even existing seem worthless. It can emerge as early as 5 years old, especially in introspective, gifted children, when they realize that death is permanent and universal, after a real loss or a story of a loss or failure, or from a sense of guilt.
The past 18 months of COVID-19 have been a perfect storm for developing an existential crisis. One of the main sources of life meaning for children is friendships. COVID-19 has reduced or blocked access to old and new friends. Younger children, when asked what makes a friend, will say “we like to do the same things.” Virtual play dates help but don’t replace shared experiences.
School provides meaning for children not only from socializing but also from accomplishing academic tasks – fulfilling Erickson’s stages of “mastery” and “productivity.” Teachers were better able to carry out hands-on activities, group assignments, and field trips in person so that all children and learning styles were engaged and successful. Not having in-person school has also meant loss of extracurricular activities, sports, and clubs as sources of mastery.
Loss of the structure of daily life, common during COVID-19, for waking, dressing, meals, chores, homework time, bathing, or bedtime can be profoundly disorienting.
For adolescents, opportunities to contribute to society and become productive by volunteering or being employed have been stunted by quarantine and social distancing. Some teens have had to care for relatives at home so that parents can earn a living, which, while meaningful, blocks age-essential socializing.
Meaning can also be created at any age by community structures and agreed upon beliefs such as religion. While religious membership is low in the United States, members have been largely unable to attend services. Following sports teams, an alternate “religion” and source of identity, was on hold for many months.
Existential despair can also come from major life losses. COVID-19 has taken a terrible toll of lives, homes, and jobs for millions. As short-term thinkers, when children see so many of their plans and dreams for making the team, having a girlfriend, going to prom, attending summer camp, or graduating, it feels like the end of the world they had imagined. Even the most important source of meaning – connection to family – has been disrupted by lockdown, illness, or loss.
The loss of choice and freedom goes beyond being stuck indoors. Advanced classes and exams, as well as resume-building jobs or volunteering, which teens saw as essential to college, disappeared; sometimes also the money needed was exhausted by COVID-19 unemployment. Work-at-home parents supervising virtual school see their children’s malaise or panic and pressure them to work harder, which is impossible for despairing children. Observing a parent losing his or her job makes a teen’s own career aspirations uncertain. Teen depression and suicidal ideation/acts have shot up from hopelessness, with loss of meaning at the core.
A profound sense of powerlessness has taken over. COVID-19, an invisible threat, has taken down lives. Even with amazingly effective vaccines available, fear and helplessness have burned into our brains. Helplessness to stop structural racism and the arbitrary killings of our own Black citizens by police has finally registered. And climate change is now reported as an impending disaster that may not be stoppable.
So this must be the worst time in history, right? Actually, no. The past 60 years have been a period of historically remarkable stability of government, economy, and natural forces. Perhaps knowing no other world has made these problems appear unsolvable to the parents of our patients. Their own sense of meaning has been challenged in a way similar to that of their children. Perhaps from lack of privacy or peers, parents have been sharing their own sense of powerlessness with their children directly or indirectly, making it harder to reassure them.
With COVID-19 waning in the United States, many of the sources of meaning just discussed can be reinstated by way of in-person play dates, school, sports, socializing, practicing religion, volunteering, and getting jobs. Although there is “existential therapy,” what our children need most is adult leadership showing confidence in life’s meaning, even if we have to hide our own worries. Parents can point out that, even if it takes years, people have made it through difficult times in the past, and there are many positive alternatives for education and employment.
Children need to repeatedly hear about ways they are valued that are not dependent on accomplishments. Thanking them for and telling others about their effort, ideas, curiosity, integrity, love, and kindness point out meaning for their existence independent of world events. Parents need to establish routines and rules for children to demonstrate that life goes on as usual. Chores helpful to the family are a practical contribution. Family activities that are challenging and unpredictable set up for discussing, modeling, and building resilience; for example, visiting new places, camping, hiking, trying a new sport, or adopting a pet give opportunities to say: “Oh, well, we’ll find another way.”
Parents can share stories or books about people who made it through tougher times, such as Abraham Lincoln, or better, personal, or family experiences overcoming challenges. Recalling and nicknaming instances of the child’s own resilience is valuable. Books such as “The Little Engine That Could,” “Chicken Little,” and fairy tales of overcoming doubts when facing challenges can be helpful. “Stay calm and carry on,” a saying from the British when they were being bombed during World War II, has become a meme.
As clinicians we need to sort out significant complicated grief, anxiety, obsessive compulsive disorder, depression, or suicidal ideation, and provide assessment and treatment. But when children get stuck in existential futility, in addition to engaging them in meaningful activities, we can advise parents to coach them to distract themselves, “put the thoughts in a box in your head” to consider later, and/or write down or photograph things that make them grateful. Good lessons for us all to reinvent meaning in our lives.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].
The news is portraying our modern time as an existential crisis as though our very existence is threatened. An existential crisis is a profound feeling of lack of meaning, choice, or freedom in one’s life that makes even existing seem worthless. It can emerge as early as 5 years old, especially in introspective, gifted children, when they realize that death is permanent and universal, after a real loss or a story of a loss or failure, or from a sense of guilt.
The past 18 months of COVID-19 have been a perfect storm for developing an existential crisis. One of the main sources of life meaning for children is friendships. COVID-19 has reduced or blocked access to old and new friends. Younger children, when asked what makes a friend, will say “we like to do the same things.” Virtual play dates help but don’t replace shared experiences.
School provides meaning for children not only from socializing but also from accomplishing academic tasks – fulfilling Erickson’s stages of “mastery” and “productivity.” Teachers were better able to carry out hands-on activities, group assignments, and field trips in person so that all children and learning styles were engaged and successful. Not having in-person school has also meant loss of extracurricular activities, sports, and clubs as sources of mastery.
Loss of the structure of daily life, common during COVID-19, for waking, dressing, meals, chores, homework time, bathing, or bedtime can be profoundly disorienting.
For adolescents, opportunities to contribute to society and become productive by volunteering or being employed have been stunted by quarantine and social distancing. Some teens have had to care for relatives at home so that parents can earn a living, which, while meaningful, blocks age-essential socializing.
Meaning can also be created at any age by community structures and agreed upon beliefs such as religion. While religious membership is low in the United States, members have been largely unable to attend services. Following sports teams, an alternate “religion” and source of identity, was on hold for many months.
Existential despair can also come from major life losses. COVID-19 has taken a terrible toll of lives, homes, and jobs for millions. As short-term thinkers, when children see so many of their plans and dreams for making the team, having a girlfriend, going to prom, attending summer camp, or graduating, it feels like the end of the world they had imagined. Even the most important source of meaning – connection to family – has been disrupted by lockdown, illness, or loss.
The loss of choice and freedom goes beyond being stuck indoors. Advanced classes and exams, as well as resume-building jobs or volunteering, which teens saw as essential to college, disappeared; sometimes also the money needed was exhausted by COVID-19 unemployment. Work-at-home parents supervising virtual school see their children’s malaise or panic and pressure them to work harder, which is impossible for despairing children. Observing a parent losing his or her job makes a teen’s own career aspirations uncertain. Teen depression and suicidal ideation/acts have shot up from hopelessness, with loss of meaning at the core.
A profound sense of powerlessness has taken over. COVID-19, an invisible threat, has taken down lives. Even with amazingly effective vaccines available, fear and helplessness have burned into our brains. Helplessness to stop structural racism and the arbitrary killings of our own Black citizens by police has finally registered. And climate change is now reported as an impending disaster that may not be stoppable.
So this must be the worst time in history, right? Actually, no. The past 60 years have been a period of historically remarkable stability of government, economy, and natural forces. Perhaps knowing no other world has made these problems appear unsolvable to the parents of our patients. Their own sense of meaning has been challenged in a way similar to that of their children. Perhaps from lack of privacy or peers, parents have been sharing their own sense of powerlessness with their children directly or indirectly, making it harder to reassure them.
With COVID-19 waning in the United States, many of the sources of meaning just discussed can be reinstated by way of in-person play dates, school, sports, socializing, practicing religion, volunteering, and getting jobs. Although there is “existential therapy,” what our children need most is adult leadership showing confidence in life’s meaning, even if we have to hide our own worries. Parents can point out that, even if it takes years, people have made it through difficult times in the past, and there are many positive alternatives for education and employment.
Children need to repeatedly hear about ways they are valued that are not dependent on accomplishments. Thanking them for and telling others about their effort, ideas, curiosity, integrity, love, and kindness point out meaning for their existence independent of world events. Parents need to establish routines and rules for children to demonstrate that life goes on as usual. Chores helpful to the family are a practical contribution. Family activities that are challenging and unpredictable set up for discussing, modeling, and building resilience; for example, visiting new places, camping, hiking, trying a new sport, or adopting a pet give opportunities to say: “Oh, well, we’ll find another way.”
Parents can share stories or books about people who made it through tougher times, such as Abraham Lincoln, or better, personal, or family experiences overcoming challenges. Recalling and nicknaming instances of the child’s own resilience is valuable. Books such as “The Little Engine That Could,” “Chicken Little,” and fairy tales of overcoming doubts when facing challenges can be helpful. “Stay calm and carry on,” a saying from the British when they were being bombed during World War II, has become a meme.
As clinicians we need to sort out significant complicated grief, anxiety, obsessive compulsive disorder, depression, or suicidal ideation, and provide assessment and treatment. But when children get stuck in existential futility, in addition to engaging them in meaningful activities, we can advise parents to coach them to distract themselves, “put the thoughts in a box in your head” to consider later, and/or write down or photograph things that make them grateful. Good lessons for us all to reinvent meaning in our lives.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].
The news is portraying our modern time as an existential crisis as though our very existence is threatened. An existential crisis is a profound feeling of lack of meaning, choice, or freedom in one’s life that makes even existing seem worthless. It can emerge as early as 5 years old, especially in introspective, gifted children, when they realize that death is permanent and universal, after a real loss or a story of a loss or failure, or from a sense of guilt.
The past 18 months of COVID-19 have been a perfect storm for developing an existential crisis. One of the main sources of life meaning for children is friendships. COVID-19 has reduced or blocked access to old and new friends. Younger children, when asked what makes a friend, will say “we like to do the same things.” Virtual play dates help but don’t replace shared experiences.
School provides meaning for children not only from socializing but also from accomplishing academic tasks – fulfilling Erickson’s stages of “mastery” and “productivity.” Teachers were better able to carry out hands-on activities, group assignments, and field trips in person so that all children and learning styles were engaged and successful. Not having in-person school has also meant loss of extracurricular activities, sports, and clubs as sources of mastery.
Loss of the structure of daily life, common during COVID-19, for waking, dressing, meals, chores, homework time, bathing, or bedtime can be profoundly disorienting.
For adolescents, opportunities to contribute to society and become productive by volunteering or being employed have been stunted by quarantine and social distancing. Some teens have had to care for relatives at home so that parents can earn a living, which, while meaningful, blocks age-essential socializing.
Meaning can also be created at any age by community structures and agreed upon beliefs such as religion. While religious membership is low in the United States, members have been largely unable to attend services. Following sports teams, an alternate “religion” and source of identity, was on hold for many months.
Existential despair can also come from major life losses. COVID-19 has taken a terrible toll of lives, homes, and jobs for millions. As short-term thinkers, when children see so many of their plans and dreams for making the team, having a girlfriend, going to prom, attending summer camp, or graduating, it feels like the end of the world they had imagined. Even the most important source of meaning – connection to family – has been disrupted by lockdown, illness, or loss.
The loss of choice and freedom goes beyond being stuck indoors. Advanced classes and exams, as well as resume-building jobs or volunteering, which teens saw as essential to college, disappeared; sometimes also the money needed was exhausted by COVID-19 unemployment. Work-at-home parents supervising virtual school see their children’s malaise or panic and pressure them to work harder, which is impossible for despairing children. Observing a parent losing his or her job makes a teen’s own career aspirations uncertain. Teen depression and suicidal ideation/acts have shot up from hopelessness, with loss of meaning at the core.
A profound sense of powerlessness has taken over. COVID-19, an invisible threat, has taken down lives. Even with amazingly effective vaccines available, fear and helplessness have burned into our brains. Helplessness to stop structural racism and the arbitrary killings of our own Black citizens by police has finally registered. And climate change is now reported as an impending disaster that may not be stoppable.
So this must be the worst time in history, right? Actually, no. The past 60 years have been a period of historically remarkable stability of government, economy, and natural forces. Perhaps knowing no other world has made these problems appear unsolvable to the parents of our patients. Their own sense of meaning has been challenged in a way similar to that of their children. Perhaps from lack of privacy or peers, parents have been sharing their own sense of powerlessness with their children directly or indirectly, making it harder to reassure them.
With COVID-19 waning in the United States, many of the sources of meaning just discussed can be reinstated by way of in-person play dates, school, sports, socializing, practicing religion, volunteering, and getting jobs. Although there is “existential therapy,” what our children need most is adult leadership showing confidence in life’s meaning, even if we have to hide our own worries. Parents can point out that, even if it takes years, people have made it through difficult times in the past, and there are many positive alternatives for education and employment.
Children need to repeatedly hear about ways they are valued that are not dependent on accomplishments. Thanking them for and telling others about their effort, ideas, curiosity, integrity, love, and kindness point out meaning for their existence independent of world events. Parents need to establish routines and rules for children to demonstrate that life goes on as usual. Chores helpful to the family are a practical contribution. Family activities that are challenging and unpredictable set up for discussing, modeling, and building resilience; for example, visiting new places, camping, hiking, trying a new sport, or adopting a pet give opportunities to say: “Oh, well, we’ll find another way.”
Parents can share stories or books about people who made it through tougher times, such as Abraham Lincoln, or better, personal, or family experiences overcoming challenges. Recalling and nicknaming instances of the child’s own resilience is valuable. Books such as “The Little Engine That Could,” “Chicken Little,” and fairy tales of overcoming doubts when facing challenges can be helpful. “Stay calm and carry on,” a saying from the British when they were being bombed during World War II, has become a meme.
As clinicians we need to sort out significant complicated grief, anxiety, obsessive compulsive disorder, depression, or suicidal ideation, and provide assessment and treatment. But when children get stuck in existential futility, in addition to engaging them in meaningful activities, we can advise parents to coach them to distract themselves, “put the thoughts in a box in your head” to consider later, and/or write down or photograph things that make them grateful. Good lessons for us all to reinvent meaning in our lives.
Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].
Conflicting medical opinions: Black lungs, Big Coal, and bias
In 2008, the U.S. Department of Labor (DOL) paid for Tony Adams, a 48-year-old coal miner, to have a chest x-ray. His doctor found stage I black lung disease. Yet Mr. Adams’ claim for medical benefits was denied. This was because the insurance group that represented his employer hired a different – more credentialed – doctor as its medical expert. That doctor said he saw no such evidence. The judge ruled in favor of the mining company on the basis of the latter’s “expertise.”
Before he died 5 years later, at age 53, Mr. Adams went through this process again. In fact, he did it four more times. Each time, his doctor found evidence of black lung, but the company’s medical expert did not. He died without receiving benefits. Among the causes of death listed on his autopsy were cardiopulmonary arrest and coal worker’s pneumoconiosis (CWP): black lung.
Since his death in 2013, two judges have awarded Mr. Adams’ benefits to his widow, Linda. Both times, the mining company appealed the decision, most recently in December 2020. She’s not giving up. “Two weeks before he died, he told me, ‘I’m going to die of black lung,’ ” Linda recalled. “‘But I don’t want you to give up on black lung. There are too many people screwing these miners out of what they deserve.’”
There has long been suspicion among miners and their advocates that doctors used by coal companies to fight claims like Mr. Adams’ are in the pocket of “Big Coal.” At the very least, some say these physicians are swayed by their client’s preference when reading a coal miner’s chest x-ray. A recent study published in Annals of the American Thoracic Society provides empirical evidence that these doctors’ conflict of interest – namely, that parties representing coal companies hired them – appears to influence their medical opinion.
Proof of a ‘broken system’
The Annals study examined 63,780 radiograph classifications made by 264 physicians – all certified as B-readers, a certification by the National Institute for Occupational Safety and Health (NIOSH) for physicians who demonstrate proficiency in classifying radiographs of pneumoconiosis. The results showed that doctors hired by miners identified black lung 49% of the time; those hired by coal companies identified black lung only 15% of the time.
The study also found that B-readers contracted by employers read results differently for different clients. The same doctors were significantly less likely to say a miner’s lungs were negative for CWP when they were hired by the DOL (77.2%) than when they were hired by a coal company or its insurers (90.2%).
The bias does appear to work both ways: B-readers hired by miners and miners’ attorneys were more likely to find evidence of black lung when they worked with plaintiffs. However, a much higher number of doctors appeared to be biased in favor of the companies. “There were 3X more B-readers providing 8X more classifications among those affiliated with employers compared to those affiliated with miners,” the study concluded.
The authors suggest that one reason for this was the difference in pay. Some company-hired doctors made as much as $750 per reading, about 10 times what miner-hired doctors were paid.
“We knew [about the potential bias] from our work over the decades taking care of these guys,” said Robert A. Cohen, MD, a pulmonologist and the study’s senior author. “But then you see it with P values that are incredibly statistically significant ...”
The study finally put numbers to a problem that many working with black lung claims had always assumed. Those within the system are accustomed to seeing names of the same doctors on documents and reports, with little to no overlap between those hired by the defense and the plaintiffs.
“The vast majority of the time, we know what a report will say based on the doctor’s name,” said Evan Smith, JD, advocacy director at AppalReD Legal Aid, in Prestonsburg, Ky.. It is far more surprising, he said, when a defense-hired doctor agrees with a miner-hired doctor.
Over the years, Katherine DePonte, MD, a radiologist and B-reader in West Virginia, has often seen an “almost textbook appearance” of CWP, only to later learn that “another radiologist read it as negative.” She explained, “They would use some other term, like ‘old granulomatous disease.’”
Employer-hired doctors often do acknowledge the same lung damage on the radiograph as miner-hired docs; they simply don’t attribute it to coal dust. Common “alternative diagnoses” include chronic obstructive pulmonary disease or histoplasmosis. “I know a number don’t believe this disease of coal worker pneumoconiosis exists [at all],” Dr. DePonte said.
What’s inarguable is that, even as coal mining in Appalachia is on the decline, black lung disease is on the rise. NIOSH now estimates that it affects over 20% of long-term (25+ years) coal workers in central Appalachia. That’s the highest prevalence in a quarter of a century.
Mr. Smith said that at its most basic level, these doctors’ conflicts of interest “lead to people who have the disease that these benefits are for, having them denied.” People like Tony Adams. Whether the doctors involved are complicit or just conservative, critics say they have become a fixture of a broken system.
Financial bias or difference of opinion?
Broken system or not, evidence suggests that the problem can’t be blamed solely on medical experts. Dr. DePonte primarily reads for the DOL and miners. “Not that I necessarily chose that,” she said. “You get pigeonholed.”
Some say that the bias demonstrated by the Annals study is at least partially driven by the litigation process itself. It is an adversarial system. As such, attorneys on both sides are naturally inclined to seek out doctors who will best support their clients’ cases. Doctors with a legitimately conservative perspective on what constitutes black lung are more sought after by the coal companies’ attorneys.
“It can often be impossible to tell whether the money is driving a change in the behavior or if the behavior is causing them to be sought out,” said Matt McCoy, PhD, a medical ethicist who specializes in conflicts of interest at the University of Pennsylvania, Philadelphia.
Although some believe that certain doctors are driven purely by financial incentive and offer a specific reading to secure repeat business, B-readers can end up working exclusively for companies because of other reasons. Wes Addington, JD, an attorney at the Appalachian Citizens’ Law Center, Whitesburg, Ky., said some doctors appear to have an authentically different – often antiquated – view of the disease.
Perhaps the most extreme example is Paul Wheeler, MD, a highly credentialed Johns Hopkins radiologist who was exposed for false medical testimony in Chris Hamby’s 2013 Pulitzer Prize reporting. In 1,500 readings, Dr. Wheeler never diagnosed a single case of severe black lung. And yet, Dr. Cohen, Mr. Addington, Mr. Smith, and other experts all agree that Dr. Wheeler appeared to wholeheartedly believe that his view of black lung was accurate. That made him a valuable asset to mining companies.
Since Dr. Wheeler’s exposure, there has been a greater sense of accountability among B-readers, said John Cline, JD, a West Virginia–based attorney who represents miners with federal black lung claims. “Radiologists were thinking, ‘Somebody could be watching me.’ Even if they thought they were doing this in the shadows, it made people more cautious,” he said.
The data used in the Annals study predate Mr. Hamby’s investigation, going back to 2000. Thus, it is possible that, as Mr. Cline argues, things may be different now. However, Lee S. Friedman, PhD, associate professor at the University of Illinois at Chicago, who is the lead author of the study, remains skeptical.
“While the Wheeler case might have dampened some physicians [who were] completely skewing their readings always negative, I think it’s premature or incorrect” to say it resolved the issue, he said. “Did they all change their behavior the morning after? It doesn’t seem likely, given the evidence of financial conflicts of interest and behavior that’s been demonstrated.”
Skewing the evidence?
Mr. Hamby’s 2013 reporting also revealed that even when company-hired doctors did diagnose CWP, law firms were burying those readings. In 2016, the DOL attempted to stop this practice. The agency made suppression of written evidence illegal – emphasis on written.
Law firms can’t hide positive reports, but they can prevent them. Dr. Cohen explained that now, “a doctor on the phone says, ‘I will read this as positive.’ Then the company says, ‘No, thank you,’ we will send you a check.”
This practice was confirmed by Kim Adcock, MD, a retired radiologist and B-reader in Littleton, Colo., who primarily reads for 26 law firms. Some of his clients want a report no matter how he reads the radiograph. However, some want him to call them first if he’s going to read the radiograph as positive. Dr. Adcock said this practice skews the dataset to make company-hired docs appear to read more negatively than they actually do.
Because the dataset used in the study is from the Federal Black Lung Program (FBLP), it includes only readings that made it to court. Dr. Adcock said he reads approximately 2,000 radiographs a year, although only a few of his readings appeared in the study’s dataset, according to a search by Dr. Friedman. This difference is likely because the study evaluated only readings between 2000 and 2013, the year Dr. Adcock started B-reading.
“I think it’s important to get a message that, to a certain extent, contravenes this paper. Yes, we should have some reservations about the conclusions,” Dr. Adcock explained. “There are people out there attempting to do the best job they could do.”
Law firms shopping for the reading they want and censoring the ones they don’t might alter the FBLP data, but experts say that doesn’t change the underlying problem. “In any case like this, where you’re looking at individuals going up against corporations,” Dr. McCoy said, “[corporations] are able to marshal their resources and hire more officials in a way claimants can’t, and that’s a baseline concern here.”
Battling bias
Admitting bias is notoriously difficult; thus, it isn’t surprising that many doctors involved refuse to believe they are influenced by money, incentives, or other biases. Dr. DePonte said she’s not swayed by money, nor does she actively take a pro-miner stance. She views herself as more of an advocate for accuracy. However, she did say that it has traditionally been far more difficult for miners to prove their cases, a problem that has improved with new regulations in recent years.
In Colorado, Dr. Adcock’s approach is to stay as far removed from the litigation process as possible. He said he has limited understanding of how his reports are used or how claims are filed and awarded. He leans heavily on his initial – almost instantaneous – impression of a chest x-ray.
Dr. DePonte and Dr. Adcock were both hired as experts on Tony Adams’ case. In 2008, Dr. DePonte read his chest x-ray as positive for early-stage black lung (1/0). Dr. Adcock also read two of Adams’ four chest x-rays, one in 2009 and the other in 2013. He read them as negative. When asked about the case, which autopsy confirmed as black lung, Dr. Adcock explained that positive histopathology doesn’t mean the radiograph reading was wrong, only that the disease didn’t show on that radiograph. He said his “highest ambition” is to be “an objective finder of fact” and that he trusts the process to work out the truth.
That process didn’t work in time for Tony Adams. Dr. Friedman argues that people who provide expert testimony have an ethical responsibility to know how their testimony is being used; to do otherwise, he says, is “willful ignorance.” Still, the Annals study authors, along with Dr. DePonte, Mr. Cline, and West Virginia attorney Sam Petsonk, say that the process is getting fairer, thanks to new policies developed over the past 5 years by the DOL.
“The DOL has worked very hard to reconcile the final award rate (around 30%) with the incidence of disease in the population (between 20% and 25%),” Mr. Petsonk said. Although the study calls into question the integrity of the system and the doctors within it, it’s critical for miners to know that the system is working and that they can get benefits, he explained. Many fear that cynicism about the system drives miners away and causes them to resort to Social Security or long-term disability.
Fixing what’s broken
The Annals study’s authors propose some solutions to the problems they quantified. The first is a sort of “super panel” that collectively evaluates readings. Although a completely unbiased panel would be nice, such impartiality is likely unsustainable, Mr. Smith said. He believes that over time, the panel would become vulnerable to politics and would work in favor of the companies.
Even without a panel, a method to provide greater transparency could be a great start, some suggest. The DOL could make the entire FBLP database public and analyze it annually. The authors also propose a flat fee for readings. Even now, Dr. Adcock said he doesn’t make anywhere close to the upper limit of $750 per readings. “My understanding is around $125 is a pretty characteristic fee [for reading a chest x-ray],” he elaborated. “Everyone I’ve had a conversation with is within 25 bucks [of that].”
That said, Dr. Adcock is not currently listed among the heavy readers who appear in the data used for the study; it’s possible that his experience is not representative. Some readers who were included in that dataset read more than 10 times the average number of classifications per reader – the average was 242 classifications – and read 95% of chest x-rays as negative, according to Dr. Friedman. This news organization obtained the names of two doctors whose readings were 95% negative on a high volume of cases. Neither agreed to an interview.
It’s possible that if the dataset had included readings from more recent years, Dr. Adcock would have appeared more frequently, given his personal estimates. That’s why the study authors recommend that the DOL conduct this kind of analysis annually in order to get an accurate picture of who is contributing to these cases, in what way, and how often. By doing so, readers who appear biased could be identified and addressed with more regularity, Dr. Friedman said.
Even if the rate were more consistent and the data were more frequently analyzed, the very nature of the adversarial system will put any potential solution at risk. “I’m not sure there’s a foolproof system that can be devised that can’t be corrupted in time,” Mr. Cline said.
A version of this article first appeared on Medscape.com.
In 2008, the U.S. Department of Labor (DOL) paid for Tony Adams, a 48-year-old coal miner, to have a chest x-ray. His doctor found stage I black lung disease. Yet Mr. Adams’ claim for medical benefits was denied. This was because the insurance group that represented his employer hired a different – more credentialed – doctor as its medical expert. That doctor said he saw no such evidence. The judge ruled in favor of the mining company on the basis of the latter’s “expertise.”
Before he died 5 years later, at age 53, Mr. Adams went through this process again. In fact, he did it four more times. Each time, his doctor found evidence of black lung, but the company’s medical expert did not. He died without receiving benefits. Among the causes of death listed on his autopsy were cardiopulmonary arrest and coal worker’s pneumoconiosis (CWP): black lung.
Since his death in 2013, two judges have awarded Mr. Adams’ benefits to his widow, Linda. Both times, the mining company appealed the decision, most recently in December 2020. She’s not giving up. “Two weeks before he died, he told me, ‘I’m going to die of black lung,’ ” Linda recalled. “‘But I don’t want you to give up on black lung. There are too many people screwing these miners out of what they deserve.’”
There has long been suspicion among miners and their advocates that doctors used by coal companies to fight claims like Mr. Adams’ are in the pocket of “Big Coal.” At the very least, some say these physicians are swayed by their client’s preference when reading a coal miner’s chest x-ray. A recent study published in Annals of the American Thoracic Society provides empirical evidence that these doctors’ conflict of interest – namely, that parties representing coal companies hired them – appears to influence their medical opinion.
Proof of a ‘broken system’
The Annals study examined 63,780 radiograph classifications made by 264 physicians – all certified as B-readers, a certification by the National Institute for Occupational Safety and Health (NIOSH) for physicians who demonstrate proficiency in classifying radiographs of pneumoconiosis. The results showed that doctors hired by miners identified black lung 49% of the time; those hired by coal companies identified black lung only 15% of the time.
The study also found that B-readers contracted by employers read results differently for different clients. The same doctors were significantly less likely to say a miner’s lungs were negative for CWP when they were hired by the DOL (77.2%) than when they were hired by a coal company or its insurers (90.2%).
The bias does appear to work both ways: B-readers hired by miners and miners’ attorneys were more likely to find evidence of black lung when they worked with plaintiffs. However, a much higher number of doctors appeared to be biased in favor of the companies. “There were 3X more B-readers providing 8X more classifications among those affiliated with employers compared to those affiliated with miners,” the study concluded.
The authors suggest that one reason for this was the difference in pay. Some company-hired doctors made as much as $750 per reading, about 10 times what miner-hired doctors were paid.
“We knew [about the potential bias] from our work over the decades taking care of these guys,” said Robert A. Cohen, MD, a pulmonologist and the study’s senior author. “But then you see it with P values that are incredibly statistically significant ...”
The study finally put numbers to a problem that many working with black lung claims had always assumed. Those within the system are accustomed to seeing names of the same doctors on documents and reports, with little to no overlap between those hired by the defense and the plaintiffs.
“The vast majority of the time, we know what a report will say based on the doctor’s name,” said Evan Smith, JD, advocacy director at AppalReD Legal Aid, in Prestonsburg, Ky.. It is far more surprising, he said, when a defense-hired doctor agrees with a miner-hired doctor.
Over the years, Katherine DePonte, MD, a radiologist and B-reader in West Virginia, has often seen an “almost textbook appearance” of CWP, only to later learn that “another radiologist read it as negative.” She explained, “They would use some other term, like ‘old granulomatous disease.’”
Employer-hired doctors often do acknowledge the same lung damage on the radiograph as miner-hired docs; they simply don’t attribute it to coal dust. Common “alternative diagnoses” include chronic obstructive pulmonary disease or histoplasmosis. “I know a number don’t believe this disease of coal worker pneumoconiosis exists [at all],” Dr. DePonte said.
What’s inarguable is that, even as coal mining in Appalachia is on the decline, black lung disease is on the rise. NIOSH now estimates that it affects over 20% of long-term (25+ years) coal workers in central Appalachia. That’s the highest prevalence in a quarter of a century.
Mr. Smith said that at its most basic level, these doctors’ conflicts of interest “lead to people who have the disease that these benefits are for, having them denied.” People like Tony Adams. Whether the doctors involved are complicit or just conservative, critics say they have become a fixture of a broken system.
Financial bias or difference of opinion?
Broken system or not, evidence suggests that the problem can’t be blamed solely on medical experts. Dr. DePonte primarily reads for the DOL and miners. “Not that I necessarily chose that,” she said. “You get pigeonholed.”
Some say that the bias demonstrated by the Annals study is at least partially driven by the litigation process itself. It is an adversarial system. As such, attorneys on both sides are naturally inclined to seek out doctors who will best support their clients’ cases. Doctors with a legitimately conservative perspective on what constitutes black lung are more sought after by the coal companies’ attorneys.
“It can often be impossible to tell whether the money is driving a change in the behavior or if the behavior is causing them to be sought out,” said Matt McCoy, PhD, a medical ethicist who specializes in conflicts of interest at the University of Pennsylvania, Philadelphia.
Although some believe that certain doctors are driven purely by financial incentive and offer a specific reading to secure repeat business, B-readers can end up working exclusively for companies because of other reasons. Wes Addington, JD, an attorney at the Appalachian Citizens’ Law Center, Whitesburg, Ky., said some doctors appear to have an authentically different – often antiquated – view of the disease.
Perhaps the most extreme example is Paul Wheeler, MD, a highly credentialed Johns Hopkins radiologist who was exposed for false medical testimony in Chris Hamby’s 2013 Pulitzer Prize reporting. In 1,500 readings, Dr. Wheeler never diagnosed a single case of severe black lung. And yet, Dr. Cohen, Mr. Addington, Mr. Smith, and other experts all agree that Dr. Wheeler appeared to wholeheartedly believe that his view of black lung was accurate. That made him a valuable asset to mining companies.
Since Dr. Wheeler’s exposure, there has been a greater sense of accountability among B-readers, said John Cline, JD, a West Virginia–based attorney who represents miners with federal black lung claims. “Radiologists were thinking, ‘Somebody could be watching me.’ Even if they thought they were doing this in the shadows, it made people more cautious,” he said.
The data used in the Annals study predate Mr. Hamby’s investigation, going back to 2000. Thus, it is possible that, as Mr. Cline argues, things may be different now. However, Lee S. Friedman, PhD, associate professor at the University of Illinois at Chicago, who is the lead author of the study, remains skeptical.
“While the Wheeler case might have dampened some physicians [who were] completely skewing their readings always negative, I think it’s premature or incorrect” to say it resolved the issue, he said. “Did they all change their behavior the morning after? It doesn’t seem likely, given the evidence of financial conflicts of interest and behavior that’s been demonstrated.”
Skewing the evidence?
Mr. Hamby’s 2013 reporting also revealed that even when company-hired doctors did diagnose CWP, law firms were burying those readings. In 2016, the DOL attempted to stop this practice. The agency made suppression of written evidence illegal – emphasis on written.
Law firms can’t hide positive reports, but they can prevent them. Dr. Cohen explained that now, “a doctor on the phone says, ‘I will read this as positive.’ Then the company says, ‘No, thank you,’ we will send you a check.”
This practice was confirmed by Kim Adcock, MD, a retired radiologist and B-reader in Littleton, Colo., who primarily reads for 26 law firms. Some of his clients want a report no matter how he reads the radiograph. However, some want him to call them first if he’s going to read the radiograph as positive. Dr. Adcock said this practice skews the dataset to make company-hired docs appear to read more negatively than they actually do.
Because the dataset used in the study is from the Federal Black Lung Program (FBLP), it includes only readings that made it to court. Dr. Adcock said he reads approximately 2,000 radiographs a year, although only a few of his readings appeared in the study’s dataset, according to a search by Dr. Friedman. This difference is likely because the study evaluated only readings between 2000 and 2013, the year Dr. Adcock started B-reading.
“I think it’s important to get a message that, to a certain extent, contravenes this paper. Yes, we should have some reservations about the conclusions,” Dr. Adcock explained. “There are people out there attempting to do the best job they could do.”
Law firms shopping for the reading they want and censoring the ones they don’t might alter the FBLP data, but experts say that doesn’t change the underlying problem. “In any case like this, where you’re looking at individuals going up against corporations,” Dr. McCoy said, “[corporations] are able to marshal their resources and hire more officials in a way claimants can’t, and that’s a baseline concern here.”
Battling bias
Admitting bias is notoriously difficult; thus, it isn’t surprising that many doctors involved refuse to believe they are influenced by money, incentives, or other biases. Dr. DePonte said she’s not swayed by money, nor does she actively take a pro-miner stance. She views herself as more of an advocate for accuracy. However, she did say that it has traditionally been far more difficult for miners to prove their cases, a problem that has improved with new regulations in recent years.
In Colorado, Dr. Adcock’s approach is to stay as far removed from the litigation process as possible. He said he has limited understanding of how his reports are used or how claims are filed and awarded. He leans heavily on his initial – almost instantaneous – impression of a chest x-ray.
Dr. DePonte and Dr. Adcock were both hired as experts on Tony Adams’ case. In 2008, Dr. DePonte read his chest x-ray as positive for early-stage black lung (1/0). Dr. Adcock also read two of Adams’ four chest x-rays, one in 2009 and the other in 2013. He read them as negative. When asked about the case, which autopsy confirmed as black lung, Dr. Adcock explained that positive histopathology doesn’t mean the radiograph reading was wrong, only that the disease didn’t show on that radiograph. He said his “highest ambition” is to be “an objective finder of fact” and that he trusts the process to work out the truth.
That process didn’t work in time for Tony Adams. Dr. Friedman argues that people who provide expert testimony have an ethical responsibility to know how their testimony is being used; to do otherwise, he says, is “willful ignorance.” Still, the Annals study authors, along with Dr. DePonte, Mr. Cline, and West Virginia attorney Sam Petsonk, say that the process is getting fairer, thanks to new policies developed over the past 5 years by the DOL.
“The DOL has worked very hard to reconcile the final award rate (around 30%) with the incidence of disease in the population (between 20% and 25%),” Mr. Petsonk said. Although the study calls into question the integrity of the system and the doctors within it, it’s critical for miners to know that the system is working and that they can get benefits, he explained. Many fear that cynicism about the system drives miners away and causes them to resort to Social Security or long-term disability.
Fixing what’s broken
The Annals study’s authors propose some solutions to the problems they quantified. The first is a sort of “super panel” that collectively evaluates readings. Although a completely unbiased panel would be nice, such impartiality is likely unsustainable, Mr. Smith said. He believes that over time, the panel would become vulnerable to politics and would work in favor of the companies.
Even without a panel, a method to provide greater transparency could be a great start, some suggest. The DOL could make the entire FBLP database public and analyze it annually. The authors also propose a flat fee for readings. Even now, Dr. Adcock said he doesn’t make anywhere close to the upper limit of $750 per readings. “My understanding is around $125 is a pretty characteristic fee [for reading a chest x-ray],” he elaborated. “Everyone I’ve had a conversation with is within 25 bucks [of that].”
That said, Dr. Adcock is not currently listed among the heavy readers who appear in the data used for the study; it’s possible that his experience is not representative. Some readers who were included in that dataset read more than 10 times the average number of classifications per reader – the average was 242 classifications – and read 95% of chest x-rays as negative, according to Dr. Friedman. This news organization obtained the names of two doctors whose readings were 95% negative on a high volume of cases. Neither agreed to an interview.
It’s possible that if the dataset had included readings from more recent years, Dr. Adcock would have appeared more frequently, given his personal estimates. That’s why the study authors recommend that the DOL conduct this kind of analysis annually in order to get an accurate picture of who is contributing to these cases, in what way, and how often. By doing so, readers who appear biased could be identified and addressed with more regularity, Dr. Friedman said.
Even if the rate were more consistent and the data were more frequently analyzed, the very nature of the adversarial system will put any potential solution at risk. “I’m not sure there’s a foolproof system that can be devised that can’t be corrupted in time,” Mr. Cline said.
A version of this article first appeared on Medscape.com.
In 2008, the U.S. Department of Labor (DOL) paid for Tony Adams, a 48-year-old coal miner, to have a chest x-ray. His doctor found stage I black lung disease. Yet Mr. Adams’ claim for medical benefits was denied. This was because the insurance group that represented his employer hired a different – more credentialed – doctor as its medical expert. That doctor said he saw no such evidence. The judge ruled in favor of the mining company on the basis of the latter’s “expertise.”
Before he died 5 years later, at age 53, Mr. Adams went through this process again. In fact, he did it four more times. Each time, his doctor found evidence of black lung, but the company’s medical expert did not. He died without receiving benefits. Among the causes of death listed on his autopsy were cardiopulmonary arrest and coal worker’s pneumoconiosis (CWP): black lung.
Since his death in 2013, two judges have awarded Mr. Adams’ benefits to his widow, Linda. Both times, the mining company appealed the decision, most recently in December 2020. She’s not giving up. “Two weeks before he died, he told me, ‘I’m going to die of black lung,’ ” Linda recalled. “‘But I don’t want you to give up on black lung. There are too many people screwing these miners out of what they deserve.’”
There has long been suspicion among miners and their advocates that doctors used by coal companies to fight claims like Mr. Adams’ are in the pocket of “Big Coal.” At the very least, some say these physicians are swayed by their client’s preference when reading a coal miner’s chest x-ray. A recent study published in Annals of the American Thoracic Society provides empirical evidence that these doctors’ conflict of interest – namely, that parties representing coal companies hired them – appears to influence their medical opinion.
Proof of a ‘broken system’
The Annals study examined 63,780 radiograph classifications made by 264 physicians – all certified as B-readers, a certification by the National Institute for Occupational Safety and Health (NIOSH) for physicians who demonstrate proficiency in classifying radiographs of pneumoconiosis. The results showed that doctors hired by miners identified black lung 49% of the time; those hired by coal companies identified black lung only 15% of the time.
The study also found that B-readers contracted by employers read results differently for different clients. The same doctors were significantly less likely to say a miner’s lungs were negative for CWP when they were hired by the DOL (77.2%) than when they were hired by a coal company or its insurers (90.2%).
The bias does appear to work both ways: B-readers hired by miners and miners’ attorneys were more likely to find evidence of black lung when they worked with plaintiffs. However, a much higher number of doctors appeared to be biased in favor of the companies. “There were 3X more B-readers providing 8X more classifications among those affiliated with employers compared to those affiliated with miners,” the study concluded.
The authors suggest that one reason for this was the difference in pay. Some company-hired doctors made as much as $750 per reading, about 10 times what miner-hired doctors were paid.
“We knew [about the potential bias] from our work over the decades taking care of these guys,” said Robert A. Cohen, MD, a pulmonologist and the study’s senior author. “But then you see it with P values that are incredibly statistically significant ...”
The study finally put numbers to a problem that many working with black lung claims had always assumed. Those within the system are accustomed to seeing names of the same doctors on documents and reports, with little to no overlap between those hired by the defense and the plaintiffs.
“The vast majority of the time, we know what a report will say based on the doctor’s name,” said Evan Smith, JD, advocacy director at AppalReD Legal Aid, in Prestonsburg, Ky.. It is far more surprising, he said, when a defense-hired doctor agrees with a miner-hired doctor.
Over the years, Katherine DePonte, MD, a radiologist and B-reader in West Virginia, has often seen an “almost textbook appearance” of CWP, only to later learn that “another radiologist read it as negative.” She explained, “They would use some other term, like ‘old granulomatous disease.’”
Employer-hired doctors often do acknowledge the same lung damage on the radiograph as miner-hired docs; they simply don’t attribute it to coal dust. Common “alternative diagnoses” include chronic obstructive pulmonary disease or histoplasmosis. “I know a number don’t believe this disease of coal worker pneumoconiosis exists [at all],” Dr. DePonte said.
What’s inarguable is that, even as coal mining in Appalachia is on the decline, black lung disease is on the rise. NIOSH now estimates that it affects over 20% of long-term (25+ years) coal workers in central Appalachia. That’s the highest prevalence in a quarter of a century.
Mr. Smith said that at its most basic level, these doctors’ conflicts of interest “lead to people who have the disease that these benefits are for, having them denied.” People like Tony Adams. Whether the doctors involved are complicit or just conservative, critics say they have become a fixture of a broken system.
Financial bias or difference of opinion?
Broken system or not, evidence suggests that the problem can’t be blamed solely on medical experts. Dr. DePonte primarily reads for the DOL and miners. “Not that I necessarily chose that,” she said. “You get pigeonholed.”
Some say that the bias demonstrated by the Annals study is at least partially driven by the litigation process itself. It is an adversarial system. As such, attorneys on both sides are naturally inclined to seek out doctors who will best support their clients’ cases. Doctors with a legitimately conservative perspective on what constitutes black lung are more sought after by the coal companies’ attorneys.
“It can often be impossible to tell whether the money is driving a change in the behavior or if the behavior is causing them to be sought out,” said Matt McCoy, PhD, a medical ethicist who specializes in conflicts of interest at the University of Pennsylvania, Philadelphia.
Although some believe that certain doctors are driven purely by financial incentive and offer a specific reading to secure repeat business, B-readers can end up working exclusively for companies because of other reasons. Wes Addington, JD, an attorney at the Appalachian Citizens’ Law Center, Whitesburg, Ky., said some doctors appear to have an authentically different – often antiquated – view of the disease.
Perhaps the most extreme example is Paul Wheeler, MD, a highly credentialed Johns Hopkins radiologist who was exposed for false medical testimony in Chris Hamby’s 2013 Pulitzer Prize reporting. In 1,500 readings, Dr. Wheeler never diagnosed a single case of severe black lung. And yet, Dr. Cohen, Mr. Addington, Mr. Smith, and other experts all agree that Dr. Wheeler appeared to wholeheartedly believe that his view of black lung was accurate. That made him a valuable asset to mining companies.
Since Dr. Wheeler’s exposure, there has been a greater sense of accountability among B-readers, said John Cline, JD, a West Virginia–based attorney who represents miners with federal black lung claims. “Radiologists were thinking, ‘Somebody could be watching me.’ Even if they thought they were doing this in the shadows, it made people more cautious,” he said.
The data used in the Annals study predate Mr. Hamby’s investigation, going back to 2000. Thus, it is possible that, as Mr. Cline argues, things may be different now. However, Lee S. Friedman, PhD, associate professor at the University of Illinois at Chicago, who is the lead author of the study, remains skeptical.
“While the Wheeler case might have dampened some physicians [who were] completely skewing their readings always negative, I think it’s premature or incorrect” to say it resolved the issue, he said. “Did they all change their behavior the morning after? It doesn’t seem likely, given the evidence of financial conflicts of interest and behavior that’s been demonstrated.”
Skewing the evidence?
Mr. Hamby’s 2013 reporting also revealed that even when company-hired doctors did diagnose CWP, law firms were burying those readings. In 2016, the DOL attempted to stop this practice. The agency made suppression of written evidence illegal – emphasis on written.
Law firms can’t hide positive reports, but they can prevent them. Dr. Cohen explained that now, “a doctor on the phone says, ‘I will read this as positive.’ Then the company says, ‘No, thank you,’ we will send you a check.”
This practice was confirmed by Kim Adcock, MD, a retired radiologist and B-reader in Littleton, Colo., who primarily reads for 26 law firms. Some of his clients want a report no matter how he reads the radiograph. However, some want him to call them first if he’s going to read the radiograph as positive. Dr. Adcock said this practice skews the dataset to make company-hired docs appear to read more negatively than they actually do.
Because the dataset used in the study is from the Federal Black Lung Program (FBLP), it includes only readings that made it to court. Dr. Adcock said he reads approximately 2,000 radiographs a year, although only a few of his readings appeared in the study’s dataset, according to a search by Dr. Friedman. This difference is likely because the study evaluated only readings between 2000 and 2013, the year Dr. Adcock started B-reading.
“I think it’s important to get a message that, to a certain extent, contravenes this paper. Yes, we should have some reservations about the conclusions,” Dr. Adcock explained. “There are people out there attempting to do the best job they could do.”
Law firms shopping for the reading they want and censoring the ones they don’t might alter the FBLP data, but experts say that doesn’t change the underlying problem. “In any case like this, where you’re looking at individuals going up against corporations,” Dr. McCoy said, “[corporations] are able to marshal their resources and hire more officials in a way claimants can’t, and that’s a baseline concern here.”
Battling bias
Admitting bias is notoriously difficult; thus, it isn’t surprising that many doctors involved refuse to believe they are influenced by money, incentives, or other biases. Dr. DePonte said she’s not swayed by money, nor does she actively take a pro-miner stance. She views herself as more of an advocate for accuracy. However, she did say that it has traditionally been far more difficult for miners to prove their cases, a problem that has improved with new regulations in recent years.
In Colorado, Dr. Adcock’s approach is to stay as far removed from the litigation process as possible. He said he has limited understanding of how his reports are used or how claims are filed and awarded. He leans heavily on his initial – almost instantaneous – impression of a chest x-ray.
Dr. DePonte and Dr. Adcock were both hired as experts on Tony Adams’ case. In 2008, Dr. DePonte read his chest x-ray as positive for early-stage black lung (1/0). Dr. Adcock also read two of Adams’ four chest x-rays, one in 2009 and the other in 2013. He read them as negative. When asked about the case, which autopsy confirmed as black lung, Dr. Adcock explained that positive histopathology doesn’t mean the radiograph reading was wrong, only that the disease didn’t show on that radiograph. He said his “highest ambition” is to be “an objective finder of fact” and that he trusts the process to work out the truth.
That process didn’t work in time for Tony Adams. Dr. Friedman argues that people who provide expert testimony have an ethical responsibility to know how their testimony is being used; to do otherwise, he says, is “willful ignorance.” Still, the Annals study authors, along with Dr. DePonte, Mr. Cline, and West Virginia attorney Sam Petsonk, say that the process is getting fairer, thanks to new policies developed over the past 5 years by the DOL.
“The DOL has worked very hard to reconcile the final award rate (around 30%) with the incidence of disease in the population (between 20% and 25%),” Mr. Petsonk said. Although the study calls into question the integrity of the system and the doctors within it, it’s critical for miners to know that the system is working and that they can get benefits, he explained. Many fear that cynicism about the system drives miners away and causes them to resort to Social Security or long-term disability.
Fixing what’s broken
The Annals study’s authors propose some solutions to the problems they quantified. The first is a sort of “super panel” that collectively evaluates readings. Although a completely unbiased panel would be nice, such impartiality is likely unsustainable, Mr. Smith said. He believes that over time, the panel would become vulnerable to politics and would work in favor of the companies.
Even without a panel, a method to provide greater transparency could be a great start, some suggest. The DOL could make the entire FBLP database public and analyze it annually. The authors also propose a flat fee for readings. Even now, Dr. Adcock said he doesn’t make anywhere close to the upper limit of $750 per readings. “My understanding is around $125 is a pretty characteristic fee [for reading a chest x-ray],” he elaborated. “Everyone I’ve had a conversation with is within 25 bucks [of that].”
That said, Dr. Adcock is not currently listed among the heavy readers who appear in the data used for the study; it’s possible that his experience is not representative. Some readers who were included in that dataset read more than 10 times the average number of classifications per reader – the average was 242 classifications – and read 95% of chest x-rays as negative, according to Dr. Friedman. This news organization obtained the names of two doctors whose readings were 95% negative on a high volume of cases. Neither agreed to an interview.
It’s possible that if the dataset had included readings from more recent years, Dr. Adcock would have appeared more frequently, given his personal estimates. That’s why the study authors recommend that the DOL conduct this kind of analysis annually in order to get an accurate picture of who is contributing to these cases, in what way, and how often. By doing so, readers who appear biased could be identified and addressed with more regularity, Dr. Friedman said.
Even if the rate were more consistent and the data were more frequently analyzed, the very nature of the adversarial system will put any potential solution at risk. “I’m not sure there’s a foolproof system that can be devised that can’t be corrupted in time,” Mr. Cline said.
A version of this article first appeared on Medscape.com.