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The leading independent newspaper covering dermatology news and commentary.
Golimumab approval extended to polyarticular-course JIA and juvenile PsA
after the Food and Drug Administration approved the tumor necrosis factor inhibitor for these indications on Sept. 30, according to an announcement from its manufacturer, Janssen.
Results from the open-label, single-arm, multicenter, phase 3, GO-VIVA clinical trial formed the basis for the agency’s approval of IV golimumab. GO-VIVA was conducted in 127 patients aged 2-17 years with JIA with arthritis in five or more joints (despite receiving treatment with methotrexate for at least 2 months) as part of a postmarketing requirement under the Pediatric Research Equity Act after the intravenous formulation of the biologic was approved for adults with rheumatoid arthritis in 2013. It demonstrated that pediatric patients had a level of pharmacokinetic exposure to golimumab that was similar to what was observed in two pivotal phase 3 trials in adults with moderately to severely active RA and active PsA, as well as efficacy that was generally consistent with responses seen in adult patients with RA, the manufacturer said.
Besides RA, intravenous golimumab was previously approved for adults with PsA and ankylosing spondylitis. As opposed to the IV dosing for adults with RA, PsA, and ankylosing spondylitis at 2 mg/kg infused over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter, dosing for pediatric patients with pJIA and PsA is based on body surface area at 80 mg/m2, also given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.
The adverse reactions observed in GO-VIVA were consistent with the established safety profile of intravenous golimumab in adult patients with RA and PsA, according to Janssen.
The full prescribing information for intravenous golimumab can be found on the FDA website.
after the Food and Drug Administration approved the tumor necrosis factor inhibitor for these indications on Sept. 30, according to an announcement from its manufacturer, Janssen.
Results from the open-label, single-arm, multicenter, phase 3, GO-VIVA clinical trial formed the basis for the agency’s approval of IV golimumab. GO-VIVA was conducted in 127 patients aged 2-17 years with JIA with arthritis in five or more joints (despite receiving treatment with methotrexate for at least 2 months) as part of a postmarketing requirement under the Pediatric Research Equity Act after the intravenous formulation of the biologic was approved for adults with rheumatoid arthritis in 2013. It demonstrated that pediatric patients had a level of pharmacokinetic exposure to golimumab that was similar to what was observed in two pivotal phase 3 trials in adults with moderately to severely active RA and active PsA, as well as efficacy that was generally consistent with responses seen in adult patients with RA, the manufacturer said.
Besides RA, intravenous golimumab was previously approved for adults with PsA and ankylosing spondylitis. As opposed to the IV dosing for adults with RA, PsA, and ankylosing spondylitis at 2 mg/kg infused over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter, dosing for pediatric patients with pJIA and PsA is based on body surface area at 80 mg/m2, also given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.
The adverse reactions observed in GO-VIVA were consistent with the established safety profile of intravenous golimumab in adult patients with RA and PsA, according to Janssen.
The full prescribing information for intravenous golimumab can be found on the FDA website.
after the Food and Drug Administration approved the tumor necrosis factor inhibitor for these indications on Sept. 30, according to an announcement from its manufacturer, Janssen.
Results from the open-label, single-arm, multicenter, phase 3, GO-VIVA clinical trial formed the basis for the agency’s approval of IV golimumab. GO-VIVA was conducted in 127 patients aged 2-17 years with JIA with arthritis in five or more joints (despite receiving treatment with methotrexate for at least 2 months) as part of a postmarketing requirement under the Pediatric Research Equity Act after the intravenous formulation of the biologic was approved for adults with rheumatoid arthritis in 2013. It demonstrated that pediatric patients had a level of pharmacokinetic exposure to golimumab that was similar to what was observed in two pivotal phase 3 trials in adults with moderately to severely active RA and active PsA, as well as efficacy that was generally consistent with responses seen in adult patients with RA, the manufacturer said.
Besides RA, intravenous golimumab was previously approved for adults with PsA and ankylosing spondylitis. As opposed to the IV dosing for adults with RA, PsA, and ankylosing spondylitis at 2 mg/kg infused over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter, dosing for pediatric patients with pJIA and PsA is based on body surface area at 80 mg/m2, also given as an IV infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.
The adverse reactions observed in GO-VIVA were consistent with the established safety profile of intravenous golimumab in adult patients with RA and PsA, according to Janssen.
The full prescribing information for intravenous golimumab can be found on the FDA website.
Tailoring cosmetic procedures for skin of color patients minimize risks
Based on the fact that hyperpigmentation and other adverse events associated with cosmetic dermatologic procedures are relevant to skin type, not racial identification, individualized strategies to minimize the risk of potential adverse events are always appropriate, according to an expert speaking at the virtual Skin of Color Update 2020.
There are many highly effective interventions that employ lasers, chemical peels, and topical agents to achieve excellent cosmetic results in darker skin, but results are highly dependent on first understanding the relative risks and treatment goals, Cheryl Burgess, MD, president and founder of the Center for Dermatology and Dermatologic Surgery, Washington, D.C., said at the meeting.
She stressed the importance of educating patients that “all cosmetic procedures are not for skin of color.” Her approach is to engage patients on what they are trying to accomplish and then seeking a solution that tailors treatment to skin type based on the Fitzpatrick scale, the Roberts Hyperpigmentation Scale, or other guidance.
“There are so many different methods that we can use, and these are not necessarily the ones that patients have read about in a magazine,” Dr. Burgess said.
Intense pulsed laser (IPL) for hair removal is an example. This technique is not appropriate in patients with Fitzpatrick skin type IV or higher, according to Dr. Burgess, who presented a case example of a bad outcome. In this case, a patient came to her for treatment after exposure to IPL resulted in first- and second-degree burns complicated by extensive hypopigmentation.
Ultimately, the solution in this case involved more laser therapy, but this time a strategy was selected appropriate to skin of color.
“It is hard to suggest to a patient that we are going to use a laser device” when the problem was caused by a laser, Dr. Burgess observed, but properly selected lasers are effective and should be considered in patients with dark skin.
In this case, triple cream containing 6% hydroquinone was the first step towards resolving the hyperpigmentation. Jessner’s peel was also applied to increase penetration.
Laser treatment using two different types of devices was also employed: A 1,927-nm thulium-fractionated erbium glass laser and a 650-microsecond 1,064-nm Nd:YAG laser. The excellent resolution of the hyperpigmentation demonstrates that lasers are effective in dark skin when used appropriately, she noted.
Dr. Burgess emphasized that tailored therapy is not just relevant to Black patients. She cited data indicating that the proportion of multiracial individuals in the United States is increasing, and when tailoring cosmetic procedures, she recommended considering skin characteristics, not just skin color.
Relative to white skin, pigmented skin typically has greater elasticity, greater amounts of collagen, and greater oil content. Importantly, darker skin has a greater propensity to darkening as a result of injury, she said.
In a review of the hyperpigmentation process that follows injury or other insults, Dr. Burgess reported that only three occur inside the melanocyte. There are now topically applied agents to intervene at many of these steps, including hydroquinone to reduce up-regulation of tyrosinase enzymes, and cysteamine to inhibit conversion of DOPA to dopaquinone. All of these, often used in combination, offer potential benefit in skin of color.
However, “you must understand skin of color,” Dr. Burgess emphasized. For example, most hyaluronic acid dermal fillers can be considered in patients with Fitzpatrick skin types IV or higher with low risks for hypo- or hyperpigmentation, scarring, or keloid formation, but technique is important.
“There is more postinflammatory hyperpigmentation with serial or multiple puncture injection techniques” in dark skin relative to lighter skin, according to Dr. Burgess. She recommended reducing this risk with relatively slow injection times.
When in doubt about the result with any cosmetic procedure, test spots are a reasonable strategy, Dr. Burgess said. When there is concern about risk for adverse events, she recommended using low doses and longer intervals between treatments than might otherwise be considered. Patients should participate in understanding the rationale for selecting one approach over another.
It helps for patients to know that “the desired outcome may take many more sessions than what they read about in that we might have to consider conservative measures in order to ensure that we accomplish the cosmetic effect than they want,” she said.
It is critical that clinicians who perform laser or other cosmetic procedures on darker skin be aware of these precautions, agreed Eliot F. Battle Jr., MD, CEO and cofounder of Cultura Dermatology and Laser Center, Washington, D.C. “Over the past 20 years, we have improved lasers that can safely and effectively treat patients with skin of color, but we still have a way to go,” he said at the meeting. Darker skin behaves differently in response to this energy.
“The pigment in the skin of patients of color competes for the laser light, which can cause heat-related side effects, like blistering and pigmentary changes. Skin of color also has an increased incidence of scarring and unwanted pigmentary changes from laser treatments that create irritation and inflammation,” he explained.
It is important to be aware of these differences, but practitioners also “need to treat conservatively to minimize these unwanted side effects,” Dr. Battle said.
Dr. Burgess reported financial relationships with Allergan, Merz Aesthetics, Revance Therapeutics, and Galderma. Dr. Battle had no commercial disclosures.
Based on the fact that hyperpigmentation and other adverse events associated with cosmetic dermatologic procedures are relevant to skin type, not racial identification, individualized strategies to minimize the risk of potential adverse events are always appropriate, according to an expert speaking at the virtual Skin of Color Update 2020.
There are many highly effective interventions that employ lasers, chemical peels, and topical agents to achieve excellent cosmetic results in darker skin, but results are highly dependent on first understanding the relative risks and treatment goals, Cheryl Burgess, MD, president and founder of the Center for Dermatology and Dermatologic Surgery, Washington, D.C., said at the meeting.
She stressed the importance of educating patients that “all cosmetic procedures are not for skin of color.” Her approach is to engage patients on what they are trying to accomplish and then seeking a solution that tailors treatment to skin type based on the Fitzpatrick scale, the Roberts Hyperpigmentation Scale, or other guidance.
“There are so many different methods that we can use, and these are not necessarily the ones that patients have read about in a magazine,” Dr. Burgess said.
Intense pulsed laser (IPL) for hair removal is an example. This technique is not appropriate in patients with Fitzpatrick skin type IV or higher, according to Dr. Burgess, who presented a case example of a bad outcome. In this case, a patient came to her for treatment after exposure to IPL resulted in first- and second-degree burns complicated by extensive hypopigmentation.
Ultimately, the solution in this case involved more laser therapy, but this time a strategy was selected appropriate to skin of color.
“It is hard to suggest to a patient that we are going to use a laser device” when the problem was caused by a laser, Dr. Burgess observed, but properly selected lasers are effective and should be considered in patients with dark skin.
In this case, triple cream containing 6% hydroquinone was the first step towards resolving the hyperpigmentation. Jessner’s peel was also applied to increase penetration.
Laser treatment using two different types of devices was also employed: A 1,927-nm thulium-fractionated erbium glass laser and a 650-microsecond 1,064-nm Nd:YAG laser. The excellent resolution of the hyperpigmentation demonstrates that lasers are effective in dark skin when used appropriately, she noted.
Dr. Burgess emphasized that tailored therapy is not just relevant to Black patients. She cited data indicating that the proportion of multiracial individuals in the United States is increasing, and when tailoring cosmetic procedures, she recommended considering skin characteristics, not just skin color.
Relative to white skin, pigmented skin typically has greater elasticity, greater amounts of collagen, and greater oil content. Importantly, darker skin has a greater propensity to darkening as a result of injury, she said.
In a review of the hyperpigmentation process that follows injury or other insults, Dr. Burgess reported that only three occur inside the melanocyte. There are now topically applied agents to intervene at many of these steps, including hydroquinone to reduce up-regulation of tyrosinase enzymes, and cysteamine to inhibit conversion of DOPA to dopaquinone. All of these, often used in combination, offer potential benefit in skin of color.
However, “you must understand skin of color,” Dr. Burgess emphasized. For example, most hyaluronic acid dermal fillers can be considered in patients with Fitzpatrick skin types IV or higher with low risks for hypo- or hyperpigmentation, scarring, or keloid formation, but technique is important.
“There is more postinflammatory hyperpigmentation with serial or multiple puncture injection techniques” in dark skin relative to lighter skin, according to Dr. Burgess. She recommended reducing this risk with relatively slow injection times.
When in doubt about the result with any cosmetic procedure, test spots are a reasonable strategy, Dr. Burgess said. When there is concern about risk for adverse events, she recommended using low doses and longer intervals between treatments than might otherwise be considered. Patients should participate in understanding the rationale for selecting one approach over another.
It helps for patients to know that “the desired outcome may take many more sessions than what they read about in that we might have to consider conservative measures in order to ensure that we accomplish the cosmetic effect than they want,” she said.
It is critical that clinicians who perform laser or other cosmetic procedures on darker skin be aware of these precautions, agreed Eliot F. Battle Jr., MD, CEO and cofounder of Cultura Dermatology and Laser Center, Washington, D.C. “Over the past 20 years, we have improved lasers that can safely and effectively treat patients with skin of color, but we still have a way to go,” he said at the meeting. Darker skin behaves differently in response to this energy.
“The pigment in the skin of patients of color competes for the laser light, which can cause heat-related side effects, like blistering and pigmentary changes. Skin of color also has an increased incidence of scarring and unwanted pigmentary changes from laser treatments that create irritation and inflammation,” he explained.
It is important to be aware of these differences, but practitioners also “need to treat conservatively to minimize these unwanted side effects,” Dr. Battle said.
Dr. Burgess reported financial relationships with Allergan, Merz Aesthetics, Revance Therapeutics, and Galderma. Dr. Battle had no commercial disclosures.
Based on the fact that hyperpigmentation and other adverse events associated with cosmetic dermatologic procedures are relevant to skin type, not racial identification, individualized strategies to minimize the risk of potential adverse events are always appropriate, according to an expert speaking at the virtual Skin of Color Update 2020.
There are many highly effective interventions that employ lasers, chemical peels, and topical agents to achieve excellent cosmetic results in darker skin, but results are highly dependent on first understanding the relative risks and treatment goals, Cheryl Burgess, MD, president and founder of the Center for Dermatology and Dermatologic Surgery, Washington, D.C., said at the meeting.
She stressed the importance of educating patients that “all cosmetic procedures are not for skin of color.” Her approach is to engage patients on what they are trying to accomplish and then seeking a solution that tailors treatment to skin type based on the Fitzpatrick scale, the Roberts Hyperpigmentation Scale, or other guidance.
“There are so many different methods that we can use, and these are not necessarily the ones that patients have read about in a magazine,” Dr. Burgess said.
Intense pulsed laser (IPL) for hair removal is an example. This technique is not appropriate in patients with Fitzpatrick skin type IV or higher, according to Dr. Burgess, who presented a case example of a bad outcome. In this case, a patient came to her for treatment after exposure to IPL resulted in first- and second-degree burns complicated by extensive hypopigmentation.
Ultimately, the solution in this case involved more laser therapy, but this time a strategy was selected appropriate to skin of color.
“It is hard to suggest to a patient that we are going to use a laser device” when the problem was caused by a laser, Dr. Burgess observed, but properly selected lasers are effective and should be considered in patients with dark skin.
In this case, triple cream containing 6% hydroquinone was the first step towards resolving the hyperpigmentation. Jessner’s peel was also applied to increase penetration.
Laser treatment using two different types of devices was also employed: A 1,927-nm thulium-fractionated erbium glass laser and a 650-microsecond 1,064-nm Nd:YAG laser. The excellent resolution of the hyperpigmentation demonstrates that lasers are effective in dark skin when used appropriately, she noted.
Dr. Burgess emphasized that tailored therapy is not just relevant to Black patients. She cited data indicating that the proportion of multiracial individuals in the United States is increasing, and when tailoring cosmetic procedures, she recommended considering skin characteristics, not just skin color.
Relative to white skin, pigmented skin typically has greater elasticity, greater amounts of collagen, and greater oil content. Importantly, darker skin has a greater propensity to darkening as a result of injury, she said.
In a review of the hyperpigmentation process that follows injury or other insults, Dr. Burgess reported that only three occur inside the melanocyte. There are now topically applied agents to intervene at many of these steps, including hydroquinone to reduce up-regulation of tyrosinase enzymes, and cysteamine to inhibit conversion of DOPA to dopaquinone. All of these, often used in combination, offer potential benefit in skin of color.
However, “you must understand skin of color,” Dr. Burgess emphasized. For example, most hyaluronic acid dermal fillers can be considered in patients with Fitzpatrick skin types IV or higher with low risks for hypo- or hyperpigmentation, scarring, or keloid formation, but technique is important.
“There is more postinflammatory hyperpigmentation with serial or multiple puncture injection techniques” in dark skin relative to lighter skin, according to Dr. Burgess. She recommended reducing this risk with relatively slow injection times.
When in doubt about the result with any cosmetic procedure, test spots are a reasonable strategy, Dr. Burgess said. When there is concern about risk for adverse events, she recommended using low doses and longer intervals between treatments than might otherwise be considered. Patients should participate in understanding the rationale for selecting one approach over another.
It helps for patients to know that “the desired outcome may take many more sessions than what they read about in that we might have to consider conservative measures in order to ensure that we accomplish the cosmetic effect than they want,” she said.
It is critical that clinicians who perform laser or other cosmetic procedures on darker skin be aware of these precautions, agreed Eliot F. Battle Jr., MD, CEO and cofounder of Cultura Dermatology and Laser Center, Washington, D.C. “Over the past 20 years, we have improved lasers that can safely and effectively treat patients with skin of color, but we still have a way to go,” he said at the meeting. Darker skin behaves differently in response to this energy.
“The pigment in the skin of patients of color competes for the laser light, which can cause heat-related side effects, like blistering and pigmentary changes. Skin of color also has an increased incidence of scarring and unwanted pigmentary changes from laser treatments that create irritation and inflammation,” he explained.
It is important to be aware of these differences, but practitioners also “need to treat conservatively to minimize these unwanted side effects,” Dr. Battle said.
Dr. Burgess reported financial relationships with Allergan, Merz Aesthetics, Revance Therapeutics, and Galderma. Dr. Battle had no commercial disclosures.
FROM SOC 2020
New treatment options show promise for centrifugal cicatricial alopecia
according to a review of current strategies for this challenging disease, delivered at the virtual Skin of Color Update 2020.
Two case reports of favorable results with topical metformin were published earlier this year. A subsequent case in which metformin provided a major improvement in quality of life has provided further encouragement, according to Crystal Aguh, MD, director of the ethnic skin program at Johns Hopkins University, Baltimore.
In the subsequent case, there was complete scalp coverage, allowing the patient to no longer use a wig, which is “tough to achieve in patients with advanced disease,” Dr. Aguh said.
In the two published cases, 10% metformin compounded in Lipoderm (PCCA) produced notable hair growth within 6 months. Dr. Aguh said that the case studies were prompted by experimental evidence associating metformin with an antifibrotic effect.
This finding is potentially important. Most current treatments for CCCA are based on anti-inflammatory activity, according to Dr. Aguh, but fibrosis is strongly implicated in the pathogenesis of CCCA. Of several lines of evidence, one is the association between CCCA and other fibrosing conditions.
For example, women with CCCA “are several times more likely to have uterine fibroids than women without CCCA,” said Dr. Aguh, citing a study that she published in 2018. She suggested that there is an urgent need for new treatment options because of the “often-disappointing” responses to current standard therapies.
In the CCCA cases treated so far, topical metformin has been well tolerated, which is attributed to the low level of systemic absorption. No nausea or other gastrointestinal side effects common to oral metformin have been so far observed in Dr. Aguh’s cases.
“Some patients experience scalp dryness or irritation,” she said, but added that a light coating of emollient typically relieves this complaint.
Despite the promising results, topical metformin “is not a silver bullet,” Dr. Aguh cautioned. She estimated that only 10%-15% of patients respond, but this treatment can be considered “as an adjunctive option to avoid another round of intralesional steroids.”
Platelet-rich plasma (PRP) is another option that has demonstrated promise in a published case report for which Dr. Aguh served as a coauthor. In this series of two patients, only one had CCCA. The other had lichen planopilaris, but both patients experienced hair regrowth after failing standard therapies.
When treating alopecia with PRP, Dr. Aguh typically offers three or four sessions spaced 4 weeks apart. She does not start other treatments at the same time, but she does not discontinue topical treatments that patients are already taking, including topical minoxidil.
Again, like topical metformin, PRP is reasonably considered in patients who have failed standard therapies, according to Dr. Aguh. She cautioned that responses are not permanent. Patients who respond typically require retreatment a year or more later, but good responses have been seen after retreatment.
Appropriate hair care can help. Dr. Aguh recounted a case in which a patient with presumed CCCA was referred after failing intralesional triamcinolone injections. Ultimately, the patient was diagnosed with acquired trichorrhexis nodosa, but the large clinical improvements gained from better hair care practices, including avoidance of chemical relaxants and thermal styling, are relevant to CCCA, as well as other conditions resulting in hair loss.
In a book written by Dr. Aguh, titled “90 Days to Beautiful Hair,” strategies for better hair care practices include advice to reduce tension on hair follicles.
The role of increased traction is an issue in CCCA, agreed Amy McMichael, MD, chair of the department of dermatology, Wake Forest University, Winston-Salem, N.C. Although she provided data at the meeting suggesting that CCCA is a fibrosing disease linked to genetic susceptibility, she said there is also a “strong association” between the severity of CCCA and extensions, hair weaving, and other tension-associated hairstyles.
While there is an urgent need to develop therapies that address the underlying pathophysiology of CCCA, she concurred that patients with this or other conditions associated with hair loss, such as seborrheic dermatitis or frontal fibrosing alopecia, should not ignore appropriate hair care.
Dr. Aguh has financial relationships with LEO Pharma and UCB Pharma. Dr. McMichael’s disclosures included serving as an investigator and/or consultant for companies that included Allergan, Procter & Gamble, Nutrafol, Johnson & Johnson, and Aclaris.
according to a review of current strategies for this challenging disease, delivered at the virtual Skin of Color Update 2020.
Two case reports of favorable results with topical metformin were published earlier this year. A subsequent case in which metformin provided a major improvement in quality of life has provided further encouragement, according to Crystal Aguh, MD, director of the ethnic skin program at Johns Hopkins University, Baltimore.
In the subsequent case, there was complete scalp coverage, allowing the patient to no longer use a wig, which is “tough to achieve in patients with advanced disease,” Dr. Aguh said.
In the two published cases, 10% metformin compounded in Lipoderm (PCCA) produced notable hair growth within 6 months. Dr. Aguh said that the case studies were prompted by experimental evidence associating metformin with an antifibrotic effect.
This finding is potentially important. Most current treatments for CCCA are based on anti-inflammatory activity, according to Dr. Aguh, but fibrosis is strongly implicated in the pathogenesis of CCCA. Of several lines of evidence, one is the association between CCCA and other fibrosing conditions.
For example, women with CCCA “are several times more likely to have uterine fibroids than women without CCCA,” said Dr. Aguh, citing a study that she published in 2018. She suggested that there is an urgent need for new treatment options because of the “often-disappointing” responses to current standard therapies.
In the CCCA cases treated so far, topical metformin has been well tolerated, which is attributed to the low level of systemic absorption. No nausea or other gastrointestinal side effects common to oral metformin have been so far observed in Dr. Aguh’s cases.
“Some patients experience scalp dryness or irritation,” she said, but added that a light coating of emollient typically relieves this complaint.
Despite the promising results, topical metformin “is not a silver bullet,” Dr. Aguh cautioned. She estimated that only 10%-15% of patients respond, but this treatment can be considered “as an adjunctive option to avoid another round of intralesional steroids.”
Platelet-rich plasma (PRP) is another option that has demonstrated promise in a published case report for which Dr. Aguh served as a coauthor. In this series of two patients, only one had CCCA. The other had lichen planopilaris, but both patients experienced hair regrowth after failing standard therapies.
When treating alopecia with PRP, Dr. Aguh typically offers three or four sessions spaced 4 weeks apart. She does not start other treatments at the same time, but she does not discontinue topical treatments that patients are already taking, including topical minoxidil.
Again, like topical metformin, PRP is reasonably considered in patients who have failed standard therapies, according to Dr. Aguh. She cautioned that responses are not permanent. Patients who respond typically require retreatment a year or more later, but good responses have been seen after retreatment.
Appropriate hair care can help. Dr. Aguh recounted a case in which a patient with presumed CCCA was referred after failing intralesional triamcinolone injections. Ultimately, the patient was diagnosed with acquired trichorrhexis nodosa, but the large clinical improvements gained from better hair care practices, including avoidance of chemical relaxants and thermal styling, are relevant to CCCA, as well as other conditions resulting in hair loss.
In a book written by Dr. Aguh, titled “90 Days to Beautiful Hair,” strategies for better hair care practices include advice to reduce tension on hair follicles.
The role of increased traction is an issue in CCCA, agreed Amy McMichael, MD, chair of the department of dermatology, Wake Forest University, Winston-Salem, N.C. Although she provided data at the meeting suggesting that CCCA is a fibrosing disease linked to genetic susceptibility, she said there is also a “strong association” between the severity of CCCA and extensions, hair weaving, and other tension-associated hairstyles.
While there is an urgent need to develop therapies that address the underlying pathophysiology of CCCA, she concurred that patients with this or other conditions associated with hair loss, such as seborrheic dermatitis or frontal fibrosing alopecia, should not ignore appropriate hair care.
Dr. Aguh has financial relationships with LEO Pharma and UCB Pharma. Dr. McMichael’s disclosures included serving as an investigator and/or consultant for companies that included Allergan, Procter & Gamble, Nutrafol, Johnson & Johnson, and Aclaris.
according to a review of current strategies for this challenging disease, delivered at the virtual Skin of Color Update 2020.
Two case reports of favorable results with topical metformin were published earlier this year. A subsequent case in which metformin provided a major improvement in quality of life has provided further encouragement, according to Crystal Aguh, MD, director of the ethnic skin program at Johns Hopkins University, Baltimore.
In the subsequent case, there was complete scalp coverage, allowing the patient to no longer use a wig, which is “tough to achieve in patients with advanced disease,” Dr. Aguh said.
In the two published cases, 10% metformin compounded in Lipoderm (PCCA) produced notable hair growth within 6 months. Dr. Aguh said that the case studies were prompted by experimental evidence associating metformin with an antifibrotic effect.
This finding is potentially important. Most current treatments for CCCA are based on anti-inflammatory activity, according to Dr. Aguh, but fibrosis is strongly implicated in the pathogenesis of CCCA. Of several lines of evidence, one is the association between CCCA and other fibrosing conditions.
For example, women with CCCA “are several times more likely to have uterine fibroids than women without CCCA,” said Dr. Aguh, citing a study that she published in 2018. She suggested that there is an urgent need for new treatment options because of the “often-disappointing” responses to current standard therapies.
In the CCCA cases treated so far, topical metformin has been well tolerated, which is attributed to the low level of systemic absorption. No nausea or other gastrointestinal side effects common to oral metformin have been so far observed in Dr. Aguh’s cases.
“Some patients experience scalp dryness or irritation,” she said, but added that a light coating of emollient typically relieves this complaint.
Despite the promising results, topical metformin “is not a silver bullet,” Dr. Aguh cautioned. She estimated that only 10%-15% of patients respond, but this treatment can be considered “as an adjunctive option to avoid another round of intralesional steroids.”
Platelet-rich plasma (PRP) is another option that has demonstrated promise in a published case report for which Dr. Aguh served as a coauthor. In this series of two patients, only one had CCCA. The other had lichen planopilaris, but both patients experienced hair regrowth after failing standard therapies.
When treating alopecia with PRP, Dr. Aguh typically offers three or four sessions spaced 4 weeks apart. She does not start other treatments at the same time, but she does not discontinue topical treatments that patients are already taking, including topical minoxidil.
Again, like topical metformin, PRP is reasonably considered in patients who have failed standard therapies, according to Dr. Aguh. She cautioned that responses are not permanent. Patients who respond typically require retreatment a year or more later, but good responses have been seen after retreatment.
Appropriate hair care can help. Dr. Aguh recounted a case in which a patient with presumed CCCA was referred after failing intralesional triamcinolone injections. Ultimately, the patient was diagnosed with acquired trichorrhexis nodosa, but the large clinical improvements gained from better hair care practices, including avoidance of chemical relaxants and thermal styling, are relevant to CCCA, as well as other conditions resulting in hair loss.
In a book written by Dr. Aguh, titled “90 Days to Beautiful Hair,” strategies for better hair care practices include advice to reduce tension on hair follicles.
The role of increased traction is an issue in CCCA, agreed Amy McMichael, MD, chair of the department of dermatology, Wake Forest University, Winston-Salem, N.C. Although she provided data at the meeting suggesting that CCCA is a fibrosing disease linked to genetic susceptibility, she said there is also a “strong association” between the severity of CCCA and extensions, hair weaving, and other tension-associated hairstyles.
While there is an urgent need to develop therapies that address the underlying pathophysiology of CCCA, she concurred that patients with this or other conditions associated with hair loss, such as seborrheic dermatitis or frontal fibrosing alopecia, should not ignore appropriate hair care.
Dr. Aguh has financial relationships with LEO Pharma and UCB Pharma. Dr. McMichael’s disclosures included serving as an investigator and/or consultant for companies that included Allergan, Procter & Gamble, Nutrafol, Johnson & Johnson, and Aclaris.
FROM SOC 2020
How Kodak Gold contributed to bias in dermatology
A recent review looked at all articles describing skin manifestations associated with COVID-19 – 46 articles with a total of 130 clinical images – and found none that documented dermatologic conditions in people with dark skin. This was despite the disproportionate incidence of the disease in Black, Latino, and Native American/American Indian populations of color.
What’s going on? Temitayo Ogunleye, MD, an assistant professor of dermatology at the University of Pennsylvania, Philadelphia, spoke with lead investigator Jenna Lester, MD, a dermatologist and director of the Skin of Color Clinic at University of California, San Francisco, about the implications of her research.
Dr. Ogunleye: What prompted you to do this study in the first place?
Dr. Lester: It was actually driven by frustration. While we’re recognizing these COVID-related dermatologic manifestations, we’re still trying to figure out their clinical significance. We’ve learned what changes could be an early sign of infection and what might occur in people who are otherwise asymptomatic and should be tested. But in the process, we’re leaving out the group of people – dark-skinned populations – who are most heavily impacted by COVID. This is an injustice to the people who could benefit the most if found to have an early, visible sign of the disease on their skin. For example, pernio-like lesions and erythema, both of which have been seen in COVID patients, are harder to identify in darker skin.
As dermatologists, we know that the skin is the biggest organ and one that has the advantage of being visible. We partner with patients because they can see what we can see. We can explain what skin changes mean, and having examples to show them is really powerful. Because doctors typically respond best to numbers, I recognized that we needed data to prove that this lack of representation of persons of color in our COVID documentation was in fact true.
Can you tell us the key findings from your research?
We included any article that described the cutaneous manifestations of COVID – and also included a photograph – and was published over a period of 5 months. Then we categorized each image using the Fitzpatrick Skin Type Scale. We found that A handful, about 6%, depicted skin changes in patients with Fitzpatrick type IV skin.
Were you surprised by the findings?
No. I was not surprised at all, for a couple of reasons. First, many of the referrals that I had been getting to evaluate possible COVID manifestations were from primary care doctors. And as we both know, erythema, hyperpigmentation, and discoloration can be difficult for even a trained dermatologist to pick up on. So if these patients with skin changes potentially suggestive of COVID are presenting to their primary care doctor who could not determine what they were, perhaps because they had never seen them in someone with darker skin, it means those same clinicians are not likely to document these rashes. I suspect that a lot of these photos were sourced from primary care.
The other reason for my lack of surprise is that I have looked at this issue before. In a study I did in 2019 looking at images in dermatology textbooks, my coauthors and I found that there was a pretty dramatic underrepresentation of skin of color overall. Another analysis of images in core dermatology textbooks, published earlier this year by one of your colleagues at the University of Pennsylvania, Jules Lipoff, MD, showed that the percentage of images of dark skin ranged from as low as 4% to a high of about 18%.
So I wonder whether that makes us less likely to look for things in patients with darker skin, except for those conditions that we’re taught are more common in people with darker skin, like keloids, vitiligo, or certain types of hair loss. I wonder whether we just don’t think of other conditions because all the photos we ever see of psoriasis or rosacea, for example, are of people with lighter skin.
You bring up a good point about the cyclical nature of this process. If you don’t see skin conditions in darker skin, then you don’t know what to look for and so you never look for it.
Exactly. What if a Black patient says, for example: “This looks different on my skin; do you think this could be related to COVID?” And their doctor looks at their skin and says no. Not because it isn’t, but because they haven’t seen that before. Then they don’t take a picture of it and we’ll never know what that might have been.
The disturbing thing I have found is that there is an overrepresentation of dark skin in images of sexually transmitted infections. So based on what you are taught, you begin to create these powerful cognitive biases in your brain as a clinician and you start to put people in categories: “This person is more likely to get this because I’ve seen a lot of photos of it.”
Take the example of a 40ish Black woman with a cough who is presumed to have sarcoidosis, because we’ve all been taught that. But what we have not been taught, at least not as definitively, is that the highest prevalence of sarcoidosis is in Nordic countries, where there are not many Black people.
So these loops teach you things that don’t necessarily represent reality. We are taught to recognize patterns, but the patterns that we’ve created are not necessarily valid and carry the biases of the people who decided they were important for us to learn.
So the underrepresentation of persons of color in images depicting skin changes in COVID-19 is, in your perspective, a continuation of this pattern of bias?
I definitely think it is. It’s important to understand the history of photography and the development of color film in order to contextualize that question. Kodak Gold was one of the first color films made. To assist photographers, the company developed a Shirley card, which could be used for color balancing in developing this film. That card, which was distributed to film development labs across the country, depicted a fair-skinned White woman as the standard for how people should appear in the photograph. Film technology was built around this idea.
As a result, people with darker skin were never portrayed accurately and did not have a lot of detail to their features or their skin. A number of famous photographers boycotted by not using the film.
But it wasn’t until chocolate manufacturers and the furniture industries decided that Kodak Gold film was not showing their brown products in enough detail that Kodak was forced to change.
It took these big industries saying “we’re not going to use your film anymore” to spur the development of multicultural Shirley cards which included images of Asian, White, and Black women (a Latina was added later). That didn’t happen until 1995. By then, digital photography had already started to take off. Unfortunately, that advance built off of the original color film and still harbored some of the same issues.
So in addition to concerns about clinicians not recognizing a skin change in a darker-skinned person, if they do recognize it and do decide to photograph it, it just might not come out right. So then it’s possible that clinicians just decide to stop taking photos.
This is another example of structural racism – things that are just baked into the system about which people are unaware. I fear we’ll continue to perpetuate these unconscious biases with the development of augmented intelligence or various algorithms.
I think that this history – which I was unaware of – highlights what happens when White skin becomes the standard. It certainly explains the issue we’ve both seen of clinicians not recognizing erythema on dark skin.
That’s a big one. And I think it’s a big one because it’s a shared presenting sign of a lot of different rashes. It can also be a sign of a dermatologic emergency that requires rapid recognition and treatment. Erythema can be very subtle, especially in skin of color. It is one of the things that we use to grade severity of psoriasis, and as a result of it not being appreciated in people with darker skin, those patients have not been included in a lot of the clinical trials.
There has even been discussion of whether erythema is something we should deem to be an important finding in people with darker skin.
Maybe one of the problems is terminology. Erythema connotes pink or red coloration, and that does not really show up on dark skin as overtly.
Exactly. Emollient use is also different in people of color. So the “classic” scales of psoriasis often aren’t present in someone who uses a lot of lotion.
In addition to the different clinical appearance of many common skin conditions, cultural practices might be different in different groups, which may also alter your differential diagnoses and treatment recommendations – for instance, moisturizer use, shampooing frequency, or use of different hair styling products.
I totally agree. Hair is another big one. Identifying broken hairs, short hairs, texture changes, and variability in the size of the hair shaft is different in coiled, Black hair and is not really applicable to people with more textured hair patterns. People of different ethnicities and cultures do different things. Standards that we traditionally use, such as the hair-pull test, don’t work quite as well in different groups.
I think that speaks to the changes that we also need to make in educating both dermatologists and nondermatologists in diagnostic criteria and clinical findings.
Dermatology is the second least diverse specialty. And that means our experts – faculty, lecturers, mentors – are not likely to be people of color. You don’t know what you don’t know. You only have your own experiences. If you don’t have people who can explain why something may be different for a different group of people, you don’t have an opportunity to broaden your understanding. You and I noticed because we know what it’s like to have this type of hair. But it’s not something that other people who don’t share the same hair type would have the same perspective on.
It is even more reason to make sure that our dermatology workforce mirrors our population. About 3% of the dermatologists in the United States are Black; the numbers are equally bad for Latino and indigenous dermatologists. If you don’t have enough people in your immediate environment who can help broaden your perspective, that becomes a problem that can harm patients.
If we don’t have a diverse group of people in the field who are contributing to the literature, changing some of the ways that we think about practice, then everyone is just going to keep doing the wrong thing.
We need to build our evidence and pay more attention to the racial breakdown of patients included in studies. We are recognizing that we have blind spots but we don’t have people or data that can change that. If what we are publishing overrepresents a certain group, how will we ever learn to do things differently?
I recognize the fact that this is not a new idea. Others have worked on these issues for a long time. Your colleague, Susan Taylor, MD, a professor at University of Pennsylvania and a founder of the Skin of Color Society, used her energy and frustration about this issue and published a whole textbook on it: “Dermatology for Skin of Color.” When I tried to publish my first paper on this issue, I got a lot of pushback, but I’m happy that now it’s something that everyone is talking about. So just in the span of a couple of years, the acceptance of this idea has changed dramatically.
I hope that this is the start of sustainable, systemic changes that can have a real impact.
Let me ask a technical question. Is the excuse of not knowing how to photograph darker skin just that – an excuse? Or is that concern truly valid?
That’s a great question. There are certain techniques that one can employ. And yes, it can be more challenging if you are not used to taking photos of people with darker skin, but it certainly can be learned.
I think that an intelligent group of people who have faced things before that felt insurmountable could continue to push to figure out how to do it. But it is something that does require skills, and part of it is because there’s this bias built into the camera, so you have to make up for that.
I think every single dermatologist has that ability, and you just have to know that it’s worthwhile to do because your patient is that valuable.
A version of this article originally appeared on Medscape.com.
A recent review looked at all articles describing skin manifestations associated with COVID-19 – 46 articles with a total of 130 clinical images – and found none that documented dermatologic conditions in people with dark skin. This was despite the disproportionate incidence of the disease in Black, Latino, and Native American/American Indian populations of color.
What’s going on? Temitayo Ogunleye, MD, an assistant professor of dermatology at the University of Pennsylvania, Philadelphia, spoke with lead investigator Jenna Lester, MD, a dermatologist and director of the Skin of Color Clinic at University of California, San Francisco, about the implications of her research.
Dr. Ogunleye: What prompted you to do this study in the first place?
Dr. Lester: It was actually driven by frustration. While we’re recognizing these COVID-related dermatologic manifestations, we’re still trying to figure out their clinical significance. We’ve learned what changes could be an early sign of infection and what might occur in people who are otherwise asymptomatic and should be tested. But in the process, we’re leaving out the group of people – dark-skinned populations – who are most heavily impacted by COVID. This is an injustice to the people who could benefit the most if found to have an early, visible sign of the disease on their skin. For example, pernio-like lesions and erythema, both of which have been seen in COVID patients, are harder to identify in darker skin.
As dermatologists, we know that the skin is the biggest organ and one that has the advantage of being visible. We partner with patients because they can see what we can see. We can explain what skin changes mean, and having examples to show them is really powerful. Because doctors typically respond best to numbers, I recognized that we needed data to prove that this lack of representation of persons of color in our COVID documentation was in fact true.
Can you tell us the key findings from your research?
We included any article that described the cutaneous manifestations of COVID – and also included a photograph – and was published over a period of 5 months. Then we categorized each image using the Fitzpatrick Skin Type Scale. We found that A handful, about 6%, depicted skin changes in patients with Fitzpatrick type IV skin.
Were you surprised by the findings?
No. I was not surprised at all, for a couple of reasons. First, many of the referrals that I had been getting to evaluate possible COVID manifestations were from primary care doctors. And as we both know, erythema, hyperpigmentation, and discoloration can be difficult for even a trained dermatologist to pick up on. So if these patients with skin changes potentially suggestive of COVID are presenting to their primary care doctor who could not determine what they were, perhaps because they had never seen them in someone with darker skin, it means those same clinicians are not likely to document these rashes. I suspect that a lot of these photos were sourced from primary care.
The other reason for my lack of surprise is that I have looked at this issue before. In a study I did in 2019 looking at images in dermatology textbooks, my coauthors and I found that there was a pretty dramatic underrepresentation of skin of color overall. Another analysis of images in core dermatology textbooks, published earlier this year by one of your colleagues at the University of Pennsylvania, Jules Lipoff, MD, showed that the percentage of images of dark skin ranged from as low as 4% to a high of about 18%.
So I wonder whether that makes us less likely to look for things in patients with darker skin, except for those conditions that we’re taught are more common in people with darker skin, like keloids, vitiligo, or certain types of hair loss. I wonder whether we just don’t think of other conditions because all the photos we ever see of psoriasis or rosacea, for example, are of people with lighter skin.
You bring up a good point about the cyclical nature of this process. If you don’t see skin conditions in darker skin, then you don’t know what to look for and so you never look for it.
Exactly. What if a Black patient says, for example: “This looks different on my skin; do you think this could be related to COVID?” And their doctor looks at their skin and says no. Not because it isn’t, but because they haven’t seen that before. Then they don’t take a picture of it and we’ll never know what that might have been.
The disturbing thing I have found is that there is an overrepresentation of dark skin in images of sexually transmitted infections. So based on what you are taught, you begin to create these powerful cognitive biases in your brain as a clinician and you start to put people in categories: “This person is more likely to get this because I’ve seen a lot of photos of it.”
Take the example of a 40ish Black woman with a cough who is presumed to have sarcoidosis, because we’ve all been taught that. But what we have not been taught, at least not as definitively, is that the highest prevalence of sarcoidosis is in Nordic countries, where there are not many Black people.
So these loops teach you things that don’t necessarily represent reality. We are taught to recognize patterns, but the patterns that we’ve created are not necessarily valid and carry the biases of the people who decided they were important for us to learn.
So the underrepresentation of persons of color in images depicting skin changes in COVID-19 is, in your perspective, a continuation of this pattern of bias?
I definitely think it is. It’s important to understand the history of photography and the development of color film in order to contextualize that question. Kodak Gold was one of the first color films made. To assist photographers, the company developed a Shirley card, which could be used for color balancing in developing this film. That card, which was distributed to film development labs across the country, depicted a fair-skinned White woman as the standard for how people should appear in the photograph. Film technology was built around this idea.
As a result, people with darker skin were never portrayed accurately and did not have a lot of detail to their features or their skin. A number of famous photographers boycotted by not using the film.
But it wasn’t until chocolate manufacturers and the furniture industries decided that Kodak Gold film was not showing their brown products in enough detail that Kodak was forced to change.
It took these big industries saying “we’re not going to use your film anymore” to spur the development of multicultural Shirley cards which included images of Asian, White, and Black women (a Latina was added later). That didn’t happen until 1995. By then, digital photography had already started to take off. Unfortunately, that advance built off of the original color film and still harbored some of the same issues.
So in addition to concerns about clinicians not recognizing a skin change in a darker-skinned person, if they do recognize it and do decide to photograph it, it just might not come out right. So then it’s possible that clinicians just decide to stop taking photos.
This is another example of structural racism – things that are just baked into the system about which people are unaware. I fear we’ll continue to perpetuate these unconscious biases with the development of augmented intelligence or various algorithms.
I think that this history – which I was unaware of – highlights what happens when White skin becomes the standard. It certainly explains the issue we’ve both seen of clinicians not recognizing erythema on dark skin.
That’s a big one. And I think it’s a big one because it’s a shared presenting sign of a lot of different rashes. It can also be a sign of a dermatologic emergency that requires rapid recognition and treatment. Erythema can be very subtle, especially in skin of color. It is one of the things that we use to grade severity of psoriasis, and as a result of it not being appreciated in people with darker skin, those patients have not been included in a lot of the clinical trials.
There has even been discussion of whether erythema is something we should deem to be an important finding in people with darker skin.
Maybe one of the problems is terminology. Erythema connotes pink or red coloration, and that does not really show up on dark skin as overtly.
Exactly. Emollient use is also different in people of color. So the “classic” scales of psoriasis often aren’t present in someone who uses a lot of lotion.
In addition to the different clinical appearance of many common skin conditions, cultural practices might be different in different groups, which may also alter your differential diagnoses and treatment recommendations – for instance, moisturizer use, shampooing frequency, or use of different hair styling products.
I totally agree. Hair is another big one. Identifying broken hairs, short hairs, texture changes, and variability in the size of the hair shaft is different in coiled, Black hair and is not really applicable to people with more textured hair patterns. People of different ethnicities and cultures do different things. Standards that we traditionally use, such as the hair-pull test, don’t work quite as well in different groups.
I think that speaks to the changes that we also need to make in educating both dermatologists and nondermatologists in diagnostic criteria and clinical findings.
Dermatology is the second least diverse specialty. And that means our experts – faculty, lecturers, mentors – are not likely to be people of color. You don’t know what you don’t know. You only have your own experiences. If you don’t have people who can explain why something may be different for a different group of people, you don’t have an opportunity to broaden your understanding. You and I noticed because we know what it’s like to have this type of hair. But it’s not something that other people who don’t share the same hair type would have the same perspective on.
It is even more reason to make sure that our dermatology workforce mirrors our population. About 3% of the dermatologists in the United States are Black; the numbers are equally bad for Latino and indigenous dermatologists. If you don’t have enough people in your immediate environment who can help broaden your perspective, that becomes a problem that can harm patients.
If we don’t have a diverse group of people in the field who are contributing to the literature, changing some of the ways that we think about practice, then everyone is just going to keep doing the wrong thing.
We need to build our evidence and pay more attention to the racial breakdown of patients included in studies. We are recognizing that we have blind spots but we don’t have people or data that can change that. If what we are publishing overrepresents a certain group, how will we ever learn to do things differently?
I recognize the fact that this is not a new idea. Others have worked on these issues for a long time. Your colleague, Susan Taylor, MD, a professor at University of Pennsylvania and a founder of the Skin of Color Society, used her energy and frustration about this issue and published a whole textbook on it: “Dermatology for Skin of Color.” When I tried to publish my first paper on this issue, I got a lot of pushback, but I’m happy that now it’s something that everyone is talking about. So just in the span of a couple of years, the acceptance of this idea has changed dramatically.
I hope that this is the start of sustainable, systemic changes that can have a real impact.
Let me ask a technical question. Is the excuse of not knowing how to photograph darker skin just that – an excuse? Or is that concern truly valid?
That’s a great question. There are certain techniques that one can employ. And yes, it can be more challenging if you are not used to taking photos of people with darker skin, but it certainly can be learned.
I think that an intelligent group of people who have faced things before that felt insurmountable could continue to push to figure out how to do it. But it is something that does require skills, and part of it is because there’s this bias built into the camera, so you have to make up for that.
I think every single dermatologist has that ability, and you just have to know that it’s worthwhile to do because your patient is that valuable.
A version of this article originally appeared on Medscape.com.
A recent review looked at all articles describing skin manifestations associated with COVID-19 – 46 articles with a total of 130 clinical images – and found none that documented dermatologic conditions in people with dark skin. This was despite the disproportionate incidence of the disease in Black, Latino, and Native American/American Indian populations of color.
What’s going on? Temitayo Ogunleye, MD, an assistant professor of dermatology at the University of Pennsylvania, Philadelphia, spoke with lead investigator Jenna Lester, MD, a dermatologist and director of the Skin of Color Clinic at University of California, San Francisco, about the implications of her research.
Dr. Ogunleye: What prompted you to do this study in the first place?
Dr. Lester: It was actually driven by frustration. While we’re recognizing these COVID-related dermatologic manifestations, we’re still trying to figure out their clinical significance. We’ve learned what changes could be an early sign of infection and what might occur in people who are otherwise asymptomatic and should be tested. But in the process, we’re leaving out the group of people – dark-skinned populations – who are most heavily impacted by COVID. This is an injustice to the people who could benefit the most if found to have an early, visible sign of the disease on their skin. For example, pernio-like lesions and erythema, both of which have been seen in COVID patients, are harder to identify in darker skin.
As dermatologists, we know that the skin is the biggest organ and one that has the advantage of being visible. We partner with patients because they can see what we can see. We can explain what skin changes mean, and having examples to show them is really powerful. Because doctors typically respond best to numbers, I recognized that we needed data to prove that this lack of representation of persons of color in our COVID documentation was in fact true.
Can you tell us the key findings from your research?
We included any article that described the cutaneous manifestations of COVID – and also included a photograph – and was published over a period of 5 months. Then we categorized each image using the Fitzpatrick Skin Type Scale. We found that A handful, about 6%, depicted skin changes in patients with Fitzpatrick type IV skin.
Were you surprised by the findings?
No. I was not surprised at all, for a couple of reasons. First, many of the referrals that I had been getting to evaluate possible COVID manifestations were from primary care doctors. And as we both know, erythema, hyperpigmentation, and discoloration can be difficult for even a trained dermatologist to pick up on. So if these patients with skin changes potentially suggestive of COVID are presenting to their primary care doctor who could not determine what they were, perhaps because they had never seen them in someone with darker skin, it means those same clinicians are not likely to document these rashes. I suspect that a lot of these photos were sourced from primary care.
The other reason for my lack of surprise is that I have looked at this issue before. In a study I did in 2019 looking at images in dermatology textbooks, my coauthors and I found that there was a pretty dramatic underrepresentation of skin of color overall. Another analysis of images in core dermatology textbooks, published earlier this year by one of your colleagues at the University of Pennsylvania, Jules Lipoff, MD, showed that the percentage of images of dark skin ranged from as low as 4% to a high of about 18%.
So I wonder whether that makes us less likely to look for things in patients with darker skin, except for those conditions that we’re taught are more common in people with darker skin, like keloids, vitiligo, or certain types of hair loss. I wonder whether we just don’t think of other conditions because all the photos we ever see of psoriasis or rosacea, for example, are of people with lighter skin.
You bring up a good point about the cyclical nature of this process. If you don’t see skin conditions in darker skin, then you don’t know what to look for and so you never look for it.
Exactly. What if a Black patient says, for example: “This looks different on my skin; do you think this could be related to COVID?” And their doctor looks at their skin and says no. Not because it isn’t, but because they haven’t seen that before. Then they don’t take a picture of it and we’ll never know what that might have been.
The disturbing thing I have found is that there is an overrepresentation of dark skin in images of sexually transmitted infections. So based on what you are taught, you begin to create these powerful cognitive biases in your brain as a clinician and you start to put people in categories: “This person is more likely to get this because I’ve seen a lot of photos of it.”
Take the example of a 40ish Black woman with a cough who is presumed to have sarcoidosis, because we’ve all been taught that. But what we have not been taught, at least not as definitively, is that the highest prevalence of sarcoidosis is in Nordic countries, where there are not many Black people.
So these loops teach you things that don’t necessarily represent reality. We are taught to recognize patterns, but the patterns that we’ve created are not necessarily valid and carry the biases of the people who decided they were important for us to learn.
So the underrepresentation of persons of color in images depicting skin changes in COVID-19 is, in your perspective, a continuation of this pattern of bias?
I definitely think it is. It’s important to understand the history of photography and the development of color film in order to contextualize that question. Kodak Gold was one of the first color films made. To assist photographers, the company developed a Shirley card, which could be used for color balancing in developing this film. That card, which was distributed to film development labs across the country, depicted a fair-skinned White woman as the standard for how people should appear in the photograph. Film technology was built around this idea.
As a result, people with darker skin were never portrayed accurately and did not have a lot of detail to their features or their skin. A number of famous photographers boycotted by not using the film.
But it wasn’t until chocolate manufacturers and the furniture industries decided that Kodak Gold film was not showing their brown products in enough detail that Kodak was forced to change.
It took these big industries saying “we’re not going to use your film anymore” to spur the development of multicultural Shirley cards which included images of Asian, White, and Black women (a Latina was added later). That didn’t happen until 1995. By then, digital photography had already started to take off. Unfortunately, that advance built off of the original color film and still harbored some of the same issues.
So in addition to concerns about clinicians not recognizing a skin change in a darker-skinned person, if they do recognize it and do decide to photograph it, it just might not come out right. So then it’s possible that clinicians just decide to stop taking photos.
This is another example of structural racism – things that are just baked into the system about which people are unaware. I fear we’ll continue to perpetuate these unconscious biases with the development of augmented intelligence or various algorithms.
I think that this history – which I was unaware of – highlights what happens when White skin becomes the standard. It certainly explains the issue we’ve both seen of clinicians not recognizing erythema on dark skin.
That’s a big one. And I think it’s a big one because it’s a shared presenting sign of a lot of different rashes. It can also be a sign of a dermatologic emergency that requires rapid recognition and treatment. Erythema can be very subtle, especially in skin of color. It is one of the things that we use to grade severity of psoriasis, and as a result of it not being appreciated in people with darker skin, those patients have not been included in a lot of the clinical trials.
There has even been discussion of whether erythema is something we should deem to be an important finding in people with darker skin.
Maybe one of the problems is terminology. Erythema connotes pink or red coloration, and that does not really show up on dark skin as overtly.
Exactly. Emollient use is also different in people of color. So the “classic” scales of psoriasis often aren’t present in someone who uses a lot of lotion.
In addition to the different clinical appearance of many common skin conditions, cultural practices might be different in different groups, which may also alter your differential diagnoses and treatment recommendations – for instance, moisturizer use, shampooing frequency, or use of different hair styling products.
I totally agree. Hair is another big one. Identifying broken hairs, short hairs, texture changes, and variability in the size of the hair shaft is different in coiled, Black hair and is not really applicable to people with more textured hair patterns. People of different ethnicities and cultures do different things. Standards that we traditionally use, such as the hair-pull test, don’t work quite as well in different groups.
I think that speaks to the changes that we also need to make in educating both dermatologists and nondermatologists in diagnostic criteria and clinical findings.
Dermatology is the second least diverse specialty. And that means our experts – faculty, lecturers, mentors – are not likely to be people of color. You don’t know what you don’t know. You only have your own experiences. If you don’t have people who can explain why something may be different for a different group of people, you don’t have an opportunity to broaden your understanding. You and I noticed because we know what it’s like to have this type of hair. But it’s not something that other people who don’t share the same hair type would have the same perspective on.
It is even more reason to make sure that our dermatology workforce mirrors our population. About 3% of the dermatologists in the United States are Black; the numbers are equally bad for Latino and indigenous dermatologists. If you don’t have enough people in your immediate environment who can help broaden your perspective, that becomes a problem that can harm patients.
If we don’t have a diverse group of people in the field who are contributing to the literature, changing some of the ways that we think about practice, then everyone is just going to keep doing the wrong thing.
We need to build our evidence and pay more attention to the racial breakdown of patients included in studies. We are recognizing that we have blind spots but we don’t have people or data that can change that. If what we are publishing overrepresents a certain group, how will we ever learn to do things differently?
I recognize the fact that this is not a new idea. Others have worked on these issues for a long time. Your colleague, Susan Taylor, MD, a professor at University of Pennsylvania and a founder of the Skin of Color Society, used her energy and frustration about this issue and published a whole textbook on it: “Dermatology for Skin of Color.” When I tried to publish my first paper on this issue, I got a lot of pushback, but I’m happy that now it’s something that everyone is talking about. So just in the span of a couple of years, the acceptance of this idea has changed dramatically.
I hope that this is the start of sustainable, systemic changes that can have a real impact.
Let me ask a technical question. Is the excuse of not knowing how to photograph darker skin just that – an excuse? Or is that concern truly valid?
That’s a great question. There are certain techniques that one can employ. And yes, it can be more challenging if you are not used to taking photos of people with darker skin, but it certainly can be learned.
I think that an intelligent group of people who have faced things before that felt insurmountable could continue to push to figure out how to do it. But it is something that does require skills, and part of it is because there’s this bias built into the camera, so you have to make up for that.
I think every single dermatologist has that ability, and you just have to know that it’s worthwhile to do because your patient is that valuable.
A version of this article originally appeared on Medscape.com.
‘Celebration’ will be ‘short-lived’ if COVID vaccine rushed: Experts
on Wednesday.
The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.
FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.
“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”
Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.
“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.
President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.
In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.
Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.
In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.
In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
Pushback on politics
Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.
“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”
Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.
Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.
Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.
“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.
Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.
“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.
Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.
COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.
Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
Debate on approaches for vaccine effectiveness
In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.
Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”
There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.
“Do you agree with those concerns? And either way, tell me why,” Griffith asked.
“I don’t agree,” Offit responded.
“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”
But other researchers also question the approaches used with the current crop of COVID-19 vaccines.
“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.
He fears consumers will not get what they might expect from the vaccines being tested.
“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.
This article first appeared on Medscape.com.
on Wednesday.
The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.
FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.
“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”
Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.
“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.
President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.
In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.
Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.
In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.
In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
Pushback on politics
Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.
“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”
Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.
Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.
Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.
“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.
Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.
“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.
Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.
COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.
Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
Debate on approaches for vaccine effectiveness
In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.
Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”
There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.
“Do you agree with those concerns? And either way, tell me why,” Griffith asked.
“I don’t agree,” Offit responded.
“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”
But other researchers also question the approaches used with the current crop of COVID-19 vaccines.
“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.
He fears consumers will not get what they might expect from the vaccines being tested.
“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.
This article first appeared on Medscape.com.
on Wednesday.
The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.
FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.
“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”
Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.
“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.
President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.
In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.
Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.
In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.
In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
Pushback on politics
Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.
“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”
Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.
Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.
Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.
“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.
Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.
“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.
Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.
COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.
Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
Debate on approaches for vaccine effectiveness
In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.
Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”
There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.
“Do you agree with those concerns? And either way, tell me why,” Griffith asked.
“I don’t agree,” Offit responded.
“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”
But other researchers also question the approaches used with the current crop of COVID-19 vaccines.
“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.
He fears consumers will not get what they might expect from the vaccines being tested.
“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.
This article first appeared on Medscape.com.
Trump signs Medicare loan relief bill delaying repayments
President Trump on Oct. 1 signed a bill to keep the federal government running through December 11. This “continuing resolution” (CR), which was approved by the Senate Wednesday on an 84-10 vote, according to The New York Times, includes provisions to delay repayment by physicians of pandemic-related Medicare loans and to reduce the loans’ interest rate.
In an earlier news release, the American Medical Association reported that Congress and the White House had agreed to include the provisions on Medicare loans in the CR.
Under the Medicare Accelerated and Advance Payments (AAP) program, the Centers for Medicare & Medicaid Services advanced money to physicians who were financially impacted by the pandemic. The program, created in March, was suspended in late April.
Physicians who received the Medicare loans were supposed to start paying them back 120 days after they were made. CMS planned to recoup the advances by offsetting them against Medicare claims payments due to physicians. Practices had up to 210 days (7 months) to repay the loans through this process before being asked to repay them directly with interest of 10.25%.
For the practices that received these advances, that meant their Medicare cash flow was scheduled to dry up, starting in August. However, CMS quietly abstained from collecting these payments when they came due, according to Modern Healthcare.
New terms
The amount to be recouped from each claim is reduced from 100% to 25% of the claim for the first 11 months and to 50% of claims withheld for an additional 6 months. If the loan is not repaid in full by then, the provider must pay the balance with interest of 4%.
More than 80% of the $100 billion that CMS loaned to healthcare providers through May 2 went to hospitals, Modern Healthcare calculated. Of the remainder, specialty or multispecialty practices received $3.5 billion, internal medicine specialists got $24 million, family physicians were loaned $15 million, and federally qualified health centers received $20 million.
In the AMA’s news release, AMA President Susan Bailey, MD, who assumed the post in June, called the original loan repayment plan an “economic sword hanging over physician practices.”
This article first appeared on Medscape.com.
President Trump on Oct. 1 signed a bill to keep the federal government running through December 11. This “continuing resolution” (CR), which was approved by the Senate Wednesday on an 84-10 vote, according to The New York Times, includes provisions to delay repayment by physicians of pandemic-related Medicare loans and to reduce the loans’ interest rate.
In an earlier news release, the American Medical Association reported that Congress and the White House had agreed to include the provisions on Medicare loans in the CR.
Under the Medicare Accelerated and Advance Payments (AAP) program, the Centers for Medicare & Medicaid Services advanced money to physicians who were financially impacted by the pandemic. The program, created in March, was suspended in late April.
Physicians who received the Medicare loans were supposed to start paying them back 120 days after they were made. CMS planned to recoup the advances by offsetting them against Medicare claims payments due to physicians. Practices had up to 210 days (7 months) to repay the loans through this process before being asked to repay them directly with interest of 10.25%.
For the practices that received these advances, that meant their Medicare cash flow was scheduled to dry up, starting in August. However, CMS quietly abstained from collecting these payments when they came due, according to Modern Healthcare.
New terms
The amount to be recouped from each claim is reduced from 100% to 25% of the claim for the first 11 months and to 50% of claims withheld for an additional 6 months. If the loan is not repaid in full by then, the provider must pay the balance with interest of 4%.
More than 80% of the $100 billion that CMS loaned to healthcare providers through May 2 went to hospitals, Modern Healthcare calculated. Of the remainder, specialty or multispecialty practices received $3.5 billion, internal medicine specialists got $24 million, family physicians were loaned $15 million, and federally qualified health centers received $20 million.
In the AMA’s news release, AMA President Susan Bailey, MD, who assumed the post in June, called the original loan repayment plan an “economic sword hanging over physician practices.”
This article first appeared on Medscape.com.
President Trump on Oct. 1 signed a bill to keep the federal government running through December 11. This “continuing resolution” (CR), which was approved by the Senate Wednesday on an 84-10 vote, according to The New York Times, includes provisions to delay repayment by physicians of pandemic-related Medicare loans and to reduce the loans’ interest rate.
In an earlier news release, the American Medical Association reported that Congress and the White House had agreed to include the provisions on Medicare loans in the CR.
Under the Medicare Accelerated and Advance Payments (AAP) program, the Centers for Medicare & Medicaid Services advanced money to physicians who were financially impacted by the pandemic. The program, created in March, was suspended in late April.
Physicians who received the Medicare loans were supposed to start paying them back 120 days after they were made. CMS planned to recoup the advances by offsetting them against Medicare claims payments due to physicians. Practices had up to 210 days (7 months) to repay the loans through this process before being asked to repay them directly with interest of 10.25%.
For the practices that received these advances, that meant their Medicare cash flow was scheduled to dry up, starting in August. However, CMS quietly abstained from collecting these payments when they came due, according to Modern Healthcare.
New terms
The amount to be recouped from each claim is reduced from 100% to 25% of the claim for the first 11 months and to 50% of claims withheld for an additional 6 months. If the loan is not repaid in full by then, the provider must pay the balance with interest of 4%.
More than 80% of the $100 billion that CMS loaned to healthcare providers through May 2 went to hospitals, Modern Healthcare calculated. Of the remainder, specialty or multispecialty practices received $3.5 billion, internal medicine specialists got $24 million, family physicians were loaned $15 million, and federally qualified health centers received $20 million.
In the AMA’s news release, AMA President Susan Bailey, MD, who assumed the post in June, called the original loan repayment plan an “economic sword hanging over physician practices.”
This article first appeared on Medscape.com.
Pregnancy studies on psoriasis, PsA medications pick up
Christina Chambers, PhD, MPH, who runs the MotherToBaby Pregnancy Studies research center at the University of California, San Diego, has found most pregnant women to be “entirely altruistic” about sharing their experiences with drug treatment during pregnancy.
– but dermatologists, rheumatologists, and their female patients with psoriasis and psoriatic arthritis (PsA) want much more.
And women’s participation in the MotherToBaby studies conducted by the nonprofit Organization of Teratology Information Specialists (OTIS) is key, say physicians who are treating women of reproductive age. OTIS is now listed in drug labeling as the “pregnancy registry” contact for many of the medications they may be discussing with patients.
Dr. Chambers said that most women appreciate “that participating in a study may not help her with her pregnancy, but it can help her sister or her friend or someone else who has these same questions in planning a pregnancy of ‘Can I stay on my treatment?’ or, in the case of an unplanned pregnancy, ‘Should I be concerned?’ ”
OTIS has enrolled women with psoriasis and/or PsA in studies of nine medications, most of them biologics (both TNF-alpha blockers and newer anti-interleukin agents).
Four of the studies – those evaluating etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), and ustekinumab (Stelara) – are now closed to enrollment with analyses either underway or completed. The other five are currently enrolling patients and involve treatment with certolizumab pegol (Cimzia), tildrakizumab (Ilumya), apremilast (Otezla), guselkumab (Tremfya), and tofacitinib (Xeljanz).
Lisa R. Sammaritano, MD, a rheumatologist at the Hospital for Special Surgery, New York, who led the development of the American College of Rheumatology’s first guideline for the management of reproductive health in rheumatic and musculoskeletal diseases, recommends to some of her patients that they contact OTIS. “Their pregnancy registry studies have added important information to the field over the years,” she said.
Most recently, a study of the anti–TNF-alpha medication adalimumab that began in 2004 in pregnant patients with RA and Crohn’s disease culminated in a 2019 PLOS ONE paper reporting no associations between exposure to the medication and an increased risk of adverse outcomes. The outcomes studied were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, and malignancies.
An analysis is underway of adalimumab exposure in women with PsA – a patient subset that was added after the study started. But in the meantime, Dr. Chambers said, the 2019 research article is relevant to questions of drug safety across indications.
OTIS’s MothertoBaby studies are structured as prospective cohort studies. Dr. Chambers, a perinatal epidemiologist, is president of OTIS, which recruits women who have an exposure to the medication under study – at least one dose, for any length of time. And in most cases, it also recruits women with the underlying condition but no exposure and healthy women without the condition to represent the general population.
It’s the disease-matched comparison group that makes OTIS’s studies different from traditional pregnancy registries involving “a simple exposure series and outcomes that are described in the context of what you’d expect in the general population,” said Dr. Chambers, professor in the department of pediatrics, as well as family and preventative medicine, at UCSD and codirector of the Center for Better Beginnings at that university. “Many maternal conditions themselves [or their comorbidities] carry some risk of adverse outcomes in pregnancy.”
The OTIS studies typically involve at least 100 exposed pregnancies and a similar number of unexposed pregnancies; some have cohorts of 200-300.
The recently published study of adalimumab, for instance, included 257 women with exposure to the drug and 120 women in a disease comparison group with no exposure. In addition to finding no associations between drug exposure and adverse outcomes, the study found that women with RA or Crohn’s were at increased risk of preterm delivery, irrespective of adalimumab exposure.
“There’s insufficient [power with any of these numbers] to come to the conclusion that a drug is safe,” she said. “But what we have been able to say [through our studies] is that we’ve looked carefully at the whole array of outcomes ... and we don’t see anything unusual. That early view can be reassuring” until large population-based studies or claims analyses become possible.
Dr. Sammaritano, also with Weill Cornell Medicine, New York, said that she does not recommend registry participation for patients who stop biologics at the diagnosis of pregnancy. Since “the start of IgG antibody transfer during pregnancy is about 16 weeks,” she worries that including these patients might lead to falsely reassuring findings. “We are most interested in [knowing the outcomes of] patients who must continue the drugs through pregnancy,” she said.
Dr. Chambers, however, said that in her view, placental transfer is not a requirement for a medication to have some effect on the outcome of pregnancy. “The outcome could be influenced by an effect of the medication that doesn’t require placental transfer or require placental transfer in large amounts,” she said. “So it’s relevant to examine exposures that have occurred only in the first trimester, and this is especially true for the outcome of major birth defects, most of which are initiated in the first trimester.”
The MotherToBaby studies typically include both early, short exposures and longer exposures, she said. “And certainly, duration of use is a factor that we do consider in looking at specific outcomes such as growth, preterm delivery, and risk of serious or opportunistic infections.”
(In the published study of adalimumab, 65.3% of women in the medication-exposed cohort used the medication in all three trimesters, 10.5% in the first and second trimesters, and 22.4% in the first trimester only.)
Women participating in the MotherToBaby studies complete two to four interviews during pregnancy and may be interviewed again after delivery. They are asked for their permission to share a copy of their medical records – and their baby’s medical records – and their babies receive a follow-up pediatric exam by a pediatrician with expertise in dysmorphology/genetics (who is blinded to exposure status), most commonly in the participant’s home. Providers are not asked to enter any data.
Eliza Chakravarty, MD, a rheumatologist with the Oklahoma Medical Research Foundation in Oklahoma City who treats patients with PsA who are pregnant or considering pregnancy, said that her referrals for research participation “have been mostly to MothertoBaby.”
“Most drug companies [in the autoimmune space] are now contracting with them [for their pregnancy exposure research],” she said. “I really like that it’s become so centralized.”
She tells patients that many questions can be answered through research, that their experience matters, and that “there are benefits” to the extra pediatric examination. “I give them the information and let them decide whether or not they want to call [MotherToBaby],” she said. “I don’t want to impose. I want to make them aware.”
Dr. Chambers emphasizes to patients and physicians that the studies are strictly observational and do not require any changes in personal or medical regimens. “When people hear the word ‘research’ they think of clinical trials. We’re saying, you and your provider do everything you normally would do, just let us observe what happens during your pregnancy.”
Physicians should assure patients, moreover, that “just because the drug is being studied doesn’t mean there’s a known risk or even a suspected risk,” she said.
The MotherToBaby studies receive funding from the pharmaceutical companies, which are required by the Food and Drug Administration to conduct pregnancy exposure registries for medications used during pregnancy or in women of reproductive age. OTIS has an independent advisory board, however, and independently analyzes and publishes its findings. Progress reports are shared with the pharmaceutical companies, and in turn, the FDA, Dr. Chambers said.
To refer patients for MotherToBaby studies, physicians can use an online referral form found on the MothertoBaby web site, a service of OTIS, or call the pregnancy studies team at 877-311-8972 to provide them with the patient’s name or number. Patients may also be given the number and advised to consider calling. MotherToBaby offers medication fact sheets that answer questions about exposures during pregnancy and breastfeeding, and runs a free and confidential teratogen counseling service: 866-626-6847.
Christina Chambers, PhD, MPH, who runs the MotherToBaby Pregnancy Studies research center at the University of California, San Diego, has found most pregnant women to be “entirely altruistic” about sharing their experiences with drug treatment during pregnancy.
– but dermatologists, rheumatologists, and their female patients with psoriasis and psoriatic arthritis (PsA) want much more.
And women’s participation in the MotherToBaby studies conducted by the nonprofit Organization of Teratology Information Specialists (OTIS) is key, say physicians who are treating women of reproductive age. OTIS is now listed in drug labeling as the “pregnancy registry” contact for many of the medications they may be discussing with patients.
Dr. Chambers said that most women appreciate “that participating in a study may not help her with her pregnancy, but it can help her sister or her friend or someone else who has these same questions in planning a pregnancy of ‘Can I stay on my treatment?’ or, in the case of an unplanned pregnancy, ‘Should I be concerned?’ ”
OTIS has enrolled women with psoriasis and/or PsA in studies of nine medications, most of them biologics (both TNF-alpha blockers and newer anti-interleukin agents).
Four of the studies – those evaluating etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), and ustekinumab (Stelara) – are now closed to enrollment with analyses either underway or completed. The other five are currently enrolling patients and involve treatment with certolizumab pegol (Cimzia), tildrakizumab (Ilumya), apremilast (Otezla), guselkumab (Tremfya), and tofacitinib (Xeljanz).
Lisa R. Sammaritano, MD, a rheumatologist at the Hospital for Special Surgery, New York, who led the development of the American College of Rheumatology’s first guideline for the management of reproductive health in rheumatic and musculoskeletal diseases, recommends to some of her patients that they contact OTIS. “Their pregnancy registry studies have added important information to the field over the years,” she said.
Most recently, a study of the anti–TNF-alpha medication adalimumab that began in 2004 in pregnant patients with RA and Crohn’s disease culminated in a 2019 PLOS ONE paper reporting no associations between exposure to the medication and an increased risk of adverse outcomes. The outcomes studied were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, and malignancies.
An analysis is underway of adalimumab exposure in women with PsA – a patient subset that was added after the study started. But in the meantime, Dr. Chambers said, the 2019 research article is relevant to questions of drug safety across indications.
OTIS’s MothertoBaby studies are structured as prospective cohort studies. Dr. Chambers, a perinatal epidemiologist, is president of OTIS, which recruits women who have an exposure to the medication under study – at least one dose, for any length of time. And in most cases, it also recruits women with the underlying condition but no exposure and healthy women without the condition to represent the general population.
It’s the disease-matched comparison group that makes OTIS’s studies different from traditional pregnancy registries involving “a simple exposure series and outcomes that are described in the context of what you’d expect in the general population,” said Dr. Chambers, professor in the department of pediatrics, as well as family and preventative medicine, at UCSD and codirector of the Center for Better Beginnings at that university. “Many maternal conditions themselves [or their comorbidities] carry some risk of adverse outcomes in pregnancy.”
The OTIS studies typically involve at least 100 exposed pregnancies and a similar number of unexposed pregnancies; some have cohorts of 200-300.
The recently published study of adalimumab, for instance, included 257 women with exposure to the drug and 120 women in a disease comparison group with no exposure. In addition to finding no associations between drug exposure and adverse outcomes, the study found that women with RA or Crohn’s were at increased risk of preterm delivery, irrespective of adalimumab exposure.
“There’s insufficient [power with any of these numbers] to come to the conclusion that a drug is safe,” she said. “But what we have been able to say [through our studies] is that we’ve looked carefully at the whole array of outcomes ... and we don’t see anything unusual. That early view can be reassuring” until large population-based studies or claims analyses become possible.
Dr. Sammaritano, also with Weill Cornell Medicine, New York, said that she does not recommend registry participation for patients who stop biologics at the diagnosis of pregnancy. Since “the start of IgG antibody transfer during pregnancy is about 16 weeks,” she worries that including these patients might lead to falsely reassuring findings. “We are most interested in [knowing the outcomes of] patients who must continue the drugs through pregnancy,” she said.
Dr. Chambers, however, said that in her view, placental transfer is not a requirement for a medication to have some effect on the outcome of pregnancy. “The outcome could be influenced by an effect of the medication that doesn’t require placental transfer or require placental transfer in large amounts,” she said. “So it’s relevant to examine exposures that have occurred only in the first trimester, and this is especially true for the outcome of major birth defects, most of which are initiated in the first trimester.”
The MotherToBaby studies typically include both early, short exposures and longer exposures, she said. “And certainly, duration of use is a factor that we do consider in looking at specific outcomes such as growth, preterm delivery, and risk of serious or opportunistic infections.”
(In the published study of adalimumab, 65.3% of women in the medication-exposed cohort used the medication in all three trimesters, 10.5% in the first and second trimesters, and 22.4% in the first trimester only.)
Women participating in the MotherToBaby studies complete two to four interviews during pregnancy and may be interviewed again after delivery. They are asked for their permission to share a copy of their medical records – and their baby’s medical records – and their babies receive a follow-up pediatric exam by a pediatrician with expertise in dysmorphology/genetics (who is blinded to exposure status), most commonly in the participant’s home. Providers are not asked to enter any data.
Eliza Chakravarty, MD, a rheumatologist with the Oklahoma Medical Research Foundation in Oklahoma City who treats patients with PsA who are pregnant or considering pregnancy, said that her referrals for research participation “have been mostly to MothertoBaby.”
“Most drug companies [in the autoimmune space] are now contracting with them [for their pregnancy exposure research],” she said. “I really like that it’s become so centralized.”
She tells patients that many questions can be answered through research, that their experience matters, and that “there are benefits” to the extra pediatric examination. “I give them the information and let them decide whether or not they want to call [MotherToBaby],” she said. “I don’t want to impose. I want to make them aware.”
Dr. Chambers emphasizes to patients and physicians that the studies are strictly observational and do not require any changes in personal or medical regimens. “When people hear the word ‘research’ they think of clinical trials. We’re saying, you and your provider do everything you normally would do, just let us observe what happens during your pregnancy.”
Physicians should assure patients, moreover, that “just because the drug is being studied doesn’t mean there’s a known risk or even a suspected risk,” she said.
The MotherToBaby studies receive funding from the pharmaceutical companies, which are required by the Food and Drug Administration to conduct pregnancy exposure registries for medications used during pregnancy or in women of reproductive age. OTIS has an independent advisory board, however, and independently analyzes and publishes its findings. Progress reports are shared with the pharmaceutical companies, and in turn, the FDA, Dr. Chambers said.
To refer patients for MotherToBaby studies, physicians can use an online referral form found on the MothertoBaby web site, a service of OTIS, or call the pregnancy studies team at 877-311-8972 to provide them with the patient’s name or number. Patients may also be given the number and advised to consider calling. MotherToBaby offers medication fact sheets that answer questions about exposures during pregnancy and breastfeeding, and runs a free and confidential teratogen counseling service: 866-626-6847.
Christina Chambers, PhD, MPH, who runs the MotherToBaby Pregnancy Studies research center at the University of California, San Diego, has found most pregnant women to be “entirely altruistic” about sharing their experiences with drug treatment during pregnancy.
– but dermatologists, rheumatologists, and their female patients with psoriasis and psoriatic arthritis (PsA) want much more.
And women’s participation in the MotherToBaby studies conducted by the nonprofit Organization of Teratology Information Specialists (OTIS) is key, say physicians who are treating women of reproductive age. OTIS is now listed in drug labeling as the “pregnancy registry” contact for many of the medications they may be discussing with patients.
Dr. Chambers said that most women appreciate “that participating in a study may not help her with her pregnancy, but it can help her sister or her friend or someone else who has these same questions in planning a pregnancy of ‘Can I stay on my treatment?’ or, in the case of an unplanned pregnancy, ‘Should I be concerned?’ ”
OTIS has enrolled women with psoriasis and/or PsA in studies of nine medications, most of them biologics (both TNF-alpha blockers and newer anti-interleukin agents).
Four of the studies – those evaluating etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), and ustekinumab (Stelara) – are now closed to enrollment with analyses either underway or completed. The other five are currently enrolling patients and involve treatment with certolizumab pegol (Cimzia), tildrakizumab (Ilumya), apremilast (Otezla), guselkumab (Tremfya), and tofacitinib (Xeljanz).
Lisa R. Sammaritano, MD, a rheumatologist at the Hospital for Special Surgery, New York, who led the development of the American College of Rheumatology’s first guideline for the management of reproductive health in rheumatic and musculoskeletal diseases, recommends to some of her patients that they contact OTIS. “Their pregnancy registry studies have added important information to the field over the years,” she said.
Most recently, a study of the anti–TNF-alpha medication adalimumab that began in 2004 in pregnant patients with RA and Crohn’s disease culminated in a 2019 PLOS ONE paper reporting no associations between exposure to the medication and an increased risk of adverse outcomes. The outcomes studied were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, and malignancies.
An analysis is underway of adalimumab exposure in women with PsA – a patient subset that was added after the study started. But in the meantime, Dr. Chambers said, the 2019 research article is relevant to questions of drug safety across indications.
OTIS’s MothertoBaby studies are structured as prospective cohort studies. Dr. Chambers, a perinatal epidemiologist, is president of OTIS, which recruits women who have an exposure to the medication under study – at least one dose, for any length of time. And in most cases, it also recruits women with the underlying condition but no exposure and healthy women without the condition to represent the general population.
It’s the disease-matched comparison group that makes OTIS’s studies different from traditional pregnancy registries involving “a simple exposure series and outcomes that are described in the context of what you’d expect in the general population,” said Dr. Chambers, professor in the department of pediatrics, as well as family and preventative medicine, at UCSD and codirector of the Center for Better Beginnings at that university. “Many maternal conditions themselves [or their comorbidities] carry some risk of adverse outcomes in pregnancy.”
The OTIS studies typically involve at least 100 exposed pregnancies and a similar number of unexposed pregnancies; some have cohorts of 200-300.
The recently published study of adalimumab, for instance, included 257 women with exposure to the drug and 120 women in a disease comparison group with no exposure. In addition to finding no associations between drug exposure and adverse outcomes, the study found that women with RA or Crohn’s were at increased risk of preterm delivery, irrespective of adalimumab exposure.
“There’s insufficient [power with any of these numbers] to come to the conclusion that a drug is safe,” she said. “But what we have been able to say [through our studies] is that we’ve looked carefully at the whole array of outcomes ... and we don’t see anything unusual. That early view can be reassuring” until large population-based studies or claims analyses become possible.
Dr. Sammaritano, also with Weill Cornell Medicine, New York, said that she does not recommend registry participation for patients who stop biologics at the diagnosis of pregnancy. Since “the start of IgG antibody transfer during pregnancy is about 16 weeks,” she worries that including these patients might lead to falsely reassuring findings. “We are most interested in [knowing the outcomes of] patients who must continue the drugs through pregnancy,” she said.
Dr. Chambers, however, said that in her view, placental transfer is not a requirement for a medication to have some effect on the outcome of pregnancy. “The outcome could be influenced by an effect of the medication that doesn’t require placental transfer or require placental transfer in large amounts,” she said. “So it’s relevant to examine exposures that have occurred only in the first trimester, and this is especially true for the outcome of major birth defects, most of which are initiated in the first trimester.”
The MotherToBaby studies typically include both early, short exposures and longer exposures, she said. “And certainly, duration of use is a factor that we do consider in looking at specific outcomes such as growth, preterm delivery, and risk of serious or opportunistic infections.”
(In the published study of adalimumab, 65.3% of women in the medication-exposed cohort used the medication in all three trimesters, 10.5% in the first and second trimesters, and 22.4% in the first trimester only.)
Women participating in the MotherToBaby studies complete two to four interviews during pregnancy and may be interviewed again after delivery. They are asked for their permission to share a copy of their medical records – and their baby’s medical records – and their babies receive a follow-up pediatric exam by a pediatrician with expertise in dysmorphology/genetics (who is blinded to exposure status), most commonly in the participant’s home. Providers are not asked to enter any data.
Eliza Chakravarty, MD, a rheumatologist with the Oklahoma Medical Research Foundation in Oklahoma City who treats patients with PsA who are pregnant or considering pregnancy, said that her referrals for research participation “have been mostly to MothertoBaby.”
“Most drug companies [in the autoimmune space] are now contracting with them [for their pregnancy exposure research],” she said. “I really like that it’s become so centralized.”
She tells patients that many questions can be answered through research, that their experience matters, and that “there are benefits” to the extra pediatric examination. “I give them the information and let them decide whether or not they want to call [MotherToBaby],” she said. “I don’t want to impose. I want to make them aware.”
Dr. Chambers emphasizes to patients and physicians that the studies are strictly observational and do not require any changes in personal or medical regimens. “When people hear the word ‘research’ they think of clinical trials. We’re saying, you and your provider do everything you normally would do, just let us observe what happens during your pregnancy.”
Physicians should assure patients, moreover, that “just because the drug is being studied doesn’t mean there’s a known risk or even a suspected risk,” she said.
The MotherToBaby studies receive funding from the pharmaceutical companies, which are required by the Food and Drug Administration to conduct pregnancy exposure registries for medications used during pregnancy or in women of reproductive age. OTIS has an independent advisory board, however, and independently analyzes and publishes its findings. Progress reports are shared with the pharmaceutical companies, and in turn, the FDA, Dr. Chambers said.
To refer patients for MotherToBaby studies, physicians can use an online referral form found on the MothertoBaby web site, a service of OTIS, or call the pregnancy studies team at 877-311-8972 to provide them with the patient’s name or number. Patients may also be given the number and advised to consider calling. MotherToBaby offers medication fact sheets that answer questions about exposures during pregnancy and breastfeeding, and runs a free and confidential teratogen counseling service: 866-626-6847.
Children’s share of new COVID-19 cases is on the rise
The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.
As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.
Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. Dr. Sisk and associates wrote.
Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.
Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.
Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.
The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.
SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.
The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.
As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.
Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. Dr. Sisk and associates wrote.
Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.
Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.
Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.
The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.
SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.
The cumulative percentage of COVID-19 cases reported in children continues to climb, but “the history behind that cumulative number shows substantial change,” according to a new analysis of state health department data.
As of Sept. 10, the 549,432 cases in children represented 10.0% of all reported COVID-19 cases in the United States following a substantial rise over the course of the pandemic – the figure was 7.7% on July 16 and 3.2% on May 7, Blake Sisk, PhD, of the American Academy of Pediatrics and associates reported Sept. 29 in Pediatrics.
Unlike the cumulative number, the weekly proportion of cases in children fell early in the summer but then started climbing again in late July. Dr. Sisk and associates wrote.
Despite the increase, however, the proportion of pediatric COVID-19 cases is still well below children’s share of the overall population (22.6%). Also, “it is unclear how much of the increase in child cases is due to increased testing capacity, although CDC data from public and commercial laboratories show the share of all tests administered to children ages 0-17 has remained stable at 5%-7% since late April,” they said.
Data for the current report were drawn from 49 state health department websites (New York state does not report ages for COVID-19 cases), along with New York City, the District of Columbia, Puerto Rico, and Guam. Alabama changed its definition of a child case in August and was not included in the trend analysis (see graph), the investigators explained.
Those data show “substantial variation in case growth by region: in April, a preponderance of cases was in the Northeast. In June, cases surged in the South and West, followed by mid-July increases in the Midwest,” Dr. Sisk and associates said.
The increase among children in Midwest states is ongoing with the number of new cases reaching its highest level yet during the week ending Sept. 10, they reported.
SOURCE: Sisk B et al. Pediatrics. 2020 Sep 29. doi: 10.1542/peds.2020-027425.
FROM PEDIATRICS
Pandemic poses new challenges for rural doctors
These include struggling with seeing patients virtually and treating patients who have politicized the virus. Additionally, the pandemic has exposed rural practices to greater financial difficulties.
Before the pandemic some rurally based primary care physicians were already working through big challenges, such as having few local medical colleagues to consult and working in small practices with lean budgets. In fact, data gathered by the National Rural Health Association showed that there are only 40 primary care physicians per 100,000 patients in rural regions, compared with 53 in urban areas – and the number of physicians overall is 13 per 10,000 in rural areas, compared with 31 in cities.
In the prepandemic world, for some doctors, the challenges were balanced by the benefits of practicing in these sparsely populated communities with scenic, low-traffic roads. Some perks of practicing in rural areas touted by doctors included having a fast commute, being able to swim in a lake near the office before work, having a low cost of living, and feeling like they are making a difference in their communities as they treat generations of the families they see around town.
But today, new hurdles to practicing medicine in rural America created by the COVID-19 pandemic have caused the hardships to feel heavier than the joys at times for some physicians interviewed by MDedge.
Many independent rural practices in need of assistance were not able to get much from the federal Provider Relief Funds, said John M. Westfall, MD, who is director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, in an interview.
“Rural primary care doctors function independently or in smaller critical access hospitals and community health centers,” said Dr. Westfall, who previously practiced family medicine in a small town in Colorado. “Many of these have much less financial reserves so are at risk of cutbacks and closure.”
Jacqueline W. Fincher, MD, an internist based in a tiny Georgia community along the highway between Atlanta and Augusta, said her small practice works on really thin margins and doesn’t have much cushion. At the beginning of the pandemic, all visits were down, and her practice operated at a loss. To help, Dr. Fincher and her colleagues applied for funding from the Small Business Administration’s Paycheck Protection Program (PPP) through the CARES Act.
“COVID-19 has had a tremendous impact especially on primary care practices. We live and die by volume. … Our volume in mid-March to mid-May really dropped dramatically,” explained Dr. Fincher, who is also president of the American College of Physicians. “The PPP sustained us for 2 months, enabling us to pay our staff and to remain open and get us up and running on telehealth.”
Starting up telemedicine
Experiencing spotty or no access to broadband Internet is nothing new to rural physicians, but having this problem interfere with their ability to provide care to patients is.
As much of the American health system rapidly embraced telehealth during the pandemic, obtaining access to high-speed Internet has been a major challenge for rural patients, noted Dr. Westfall.
“Some practices were able to quickly adopt some telehealth capacity with phone and video. Changes in payment for telehealth helped. But in some rural communities there was not adequate Internet bandwidth for quality video connections. And some patients did not have the means for high-speed video connections,” Dr. Westfall said.
Indeed, according to a 2019 Pew Research Center survey, 63% of rural Americans say they can access the Internet through a broadband connection at home, compared with 75% and 79% in suburban and urban areas, respectively.
In the Appalachian town of Zanesville, Ohio, for example, family physician Shelly L. Dunmyer, MD, and her colleagues discovered that many patients don’t have Internet access at home. Dr. Fincher has to go to the office to conduct telehealth visits because her own Internet access at home is unpredictable. As for patients, it may take 15 minutes for them to work out technical glitches and find good Internet reception, said Dr. Fincher. For internist Y. Ki Shin, MD, who practices in the coastal town of Montesano in Washington state, about 25% of his practice’s telehealth visits must be conducted by phone because of limitations on video, such as lack of high-speed access.
But telephone visits are often insufficient replacements for appointments via video, according to several rural physicians interviewed for this piece.
“Telehealth can be frustrating at times due to connectivity issues which can be difficult at times in the rural areas,” said Dr. Fincher. “In order for telehealth to be reasonably helpful to patients and physicians to care for people with chronic problems, the patients must have things like blood pressure monitors, glucometers, and scales to address problems like hypertension, diabetes myelitis, and congestive heart failure.”
“If you have the audio and video and the data from these devices, you’re good. If you don’t have these data, and/or don’t have the video you just can’t provide good care,” she explained.
Dr. Dunmyer and her colleagues at Medical Home Primary Care Center in Zanesville, Ohio, found a way to get around the problem of patients not being able to access Internet to participate in video visits from their homes. This involved having her patients drive into her practice’s parking lot to participate in modified telehealth visits. Staffers gave iPads to patients in their cars, and Dr. Dunmyer conducted visits from her office, about 50 yards away.
“We were even doing Medicare wellness visits: Instead of asking them to get up and move around the room, we would sit at the window and wave at them, ask them to get out, walk around the car. We were able to check mobility and all kinds of things that we’d normally do in the office,” Dr. Dunmyer explained in an interview.
The family physician noted that her practice is now conducting fewer parking lot visits since her office is allowing in-person appointments, but that they’re still an option for her patients.
Treating political adversaries
Some rural physicians have experienced strained relationships with patients for reasons other than technology – stark differences in opinion over the pandemic itself. Certain patients are following President Trump’s lead and questioning everything from the pandemic death toll to preventive measures recommended by scientists and medical experts, physicians interviewed by MDedge said.
Patients everywhere share these viewpoints, of course, but research and election results confirm that rural areas are more receptive to conservative viewpoints. In 2018, a Pew Research Center survey reported that rural and urban areas are “becoming more polarized politically,” and “rural areas tend to have a higher concentration of Republicans and Republican-leaning independents.” For example, 40% of rural respondents reported “very warm” or “somewhat warm” feelings toward Donald Trump, compared with just 19% in urban areas.
Dr. Shin has struggled to cope with patients who want to argue about pandemic safety precautions like wearing masks and seem to question whether systemic racism exists.
“We are seeing a lot more people who feel that this pandemic is not real, that it’s a political and not-true infection,” he said in an interview. “We’ve had patients who were angry at us because we made them wear masks, and some were demanding hydroxychloroquine and wanted to have an argument because we’re not going to prescribe it for them.”
In one situation, which he found especially disturbing, Dr. Shin had to leave the exam room because a patient wouldn’t stop challenging him regarding the pandemic. Things have gotten so bad that Dr. Shin has even questioned whether he wants to continue his long career in his small town because of local political attitudes such as opposition to mask-wearing and social distancing.
“Mr. Trump’s misinformation on this pandemic made my job much more difficult. As a minority, I feel less safe in my community than ever,” said Dr. Shin, who described himself as Asian American.
Despite these new stressors, Dr. Shin has experienced some joyful moments while practicing medicine in the pandemic.
He said a recent home visit to a patient who had been hospitalized for over 3 months and nearly died helped him put political disputes with his patients into perspective.
“He was discharged home but is bedbound. He had gangrene on his toes, and I could not fully examine him using video,” Dr. Shin recalled. “It was tricky to find the house, but a very large Trump sign was very helpful in locating it. It was a good visit: He was happy to see me, and I was happy to see that he was doing okay at home.”
“I need to remind myself that supporting Mr. Trump does not always mean that my patient supports Mr. Trump’s view on the pandemic and the race issues in our country,” Dr. Shin added.
The Washington-based internist said he also tells himself that, even if his patients refuse to follow his strong advice regarding pandemic precautions, it does not mean he has failed as a doctor.
“I need to continue to educate patients about the dangers of COVID infection but cannot be angry if they don’t choose to follow my recommendations,” he noted.
Dr. Fincher says her close connection with patients has allowed her to smooth over politically charged claims about the pandemic in the town of Thomson, Georgia, with a population 6,800.
“I have a sense that, even though we may differ in our understanding of some basic facts, they appreciate what I say since we have a long-term relationship built on trust,” she said. This kind of trust, Dr. Fincher suggested, may be more common than in urban areas where there’s a larger supply of physicians, and patients don’t see the same doctors for long periods of time.
“It’s more meaningful when it comes from me, rather than doctors who are [new to patients] every year when their employer changes their insurance,” she noted.
These include struggling with seeing patients virtually and treating patients who have politicized the virus. Additionally, the pandemic has exposed rural practices to greater financial difficulties.
Before the pandemic some rurally based primary care physicians were already working through big challenges, such as having few local medical colleagues to consult and working in small practices with lean budgets. In fact, data gathered by the National Rural Health Association showed that there are only 40 primary care physicians per 100,000 patients in rural regions, compared with 53 in urban areas – and the number of physicians overall is 13 per 10,000 in rural areas, compared with 31 in cities.
In the prepandemic world, for some doctors, the challenges were balanced by the benefits of practicing in these sparsely populated communities with scenic, low-traffic roads. Some perks of practicing in rural areas touted by doctors included having a fast commute, being able to swim in a lake near the office before work, having a low cost of living, and feeling like they are making a difference in their communities as they treat generations of the families they see around town.
But today, new hurdles to practicing medicine in rural America created by the COVID-19 pandemic have caused the hardships to feel heavier than the joys at times for some physicians interviewed by MDedge.
Many independent rural practices in need of assistance were not able to get much from the federal Provider Relief Funds, said John M. Westfall, MD, who is director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, in an interview.
“Rural primary care doctors function independently or in smaller critical access hospitals and community health centers,” said Dr. Westfall, who previously practiced family medicine in a small town in Colorado. “Many of these have much less financial reserves so are at risk of cutbacks and closure.”
Jacqueline W. Fincher, MD, an internist based in a tiny Georgia community along the highway between Atlanta and Augusta, said her small practice works on really thin margins and doesn’t have much cushion. At the beginning of the pandemic, all visits were down, and her practice operated at a loss. To help, Dr. Fincher and her colleagues applied for funding from the Small Business Administration’s Paycheck Protection Program (PPP) through the CARES Act.
“COVID-19 has had a tremendous impact especially on primary care practices. We live and die by volume. … Our volume in mid-March to mid-May really dropped dramatically,” explained Dr. Fincher, who is also president of the American College of Physicians. “The PPP sustained us for 2 months, enabling us to pay our staff and to remain open and get us up and running on telehealth.”
Starting up telemedicine
Experiencing spotty or no access to broadband Internet is nothing new to rural physicians, but having this problem interfere with their ability to provide care to patients is.
As much of the American health system rapidly embraced telehealth during the pandemic, obtaining access to high-speed Internet has been a major challenge for rural patients, noted Dr. Westfall.
“Some practices were able to quickly adopt some telehealth capacity with phone and video. Changes in payment for telehealth helped. But in some rural communities there was not adequate Internet bandwidth for quality video connections. And some patients did not have the means for high-speed video connections,” Dr. Westfall said.
Indeed, according to a 2019 Pew Research Center survey, 63% of rural Americans say they can access the Internet through a broadband connection at home, compared with 75% and 79% in suburban and urban areas, respectively.
In the Appalachian town of Zanesville, Ohio, for example, family physician Shelly L. Dunmyer, MD, and her colleagues discovered that many patients don’t have Internet access at home. Dr. Fincher has to go to the office to conduct telehealth visits because her own Internet access at home is unpredictable. As for patients, it may take 15 minutes for them to work out technical glitches and find good Internet reception, said Dr. Fincher. For internist Y. Ki Shin, MD, who practices in the coastal town of Montesano in Washington state, about 25% of his practice’s telehealth visits must be conducted by phone because of limitations on video, such as lack of high-speed access.
But telephone visits are often insufficient replacements for appointments via video, according to several rural physicians interviewed for this piece.
“Telehealth can be frustrating at times due to connectivity issues which can be difficult at times in the rural areas,” said Dr. Fincher. “In order for telehealth to be reasonably helpful to patients and physicians to care for people with chronic problems, the patients must have things like blood pressure monitors, glucometers, and scales to address problems like hypertension, diabetes myelitis, and congestive heart failure.”
“If you have the audio and video and the data from these devices, you’re good. If you don’t have these data, and/or don’t have the video you just can’t provide good care,” she explained.
Dr. Dunmyer and her colleagues at Medical Home Primary Care Center in Zanesville, Ohio, found a way to get around the problem of patients not being able to access Internet to participate in video visits from their homes. This involved having her patients drive into her practice’s parking lot to participate in modified telehealth visits. Staffers gave iPads to patients in their cars, and Dr. Dunmyer conducted visits from her office, about 50 yards away.
“We were even doing Medicare wellness visits: Instead of asking them to get up and move around the room, we would sit at the window and wave at them, ask them to get out, walk around the car. We were able to check mobility and all kinds of things that we’d normally do in the office,” Dr. Dunmyer explained in an interview.
The family physician noted that her practice is now conducting fewer parking lot visits since her office is allowing in-person appointments, but that they’re still an option for her patients.
Treating political adversaries
Some rural physicians have experienced strained relationships with patients for reasons other than technology – stark differences in opinion over the pandemic itself. Certain patients are following President Trump’s lead and questioning everything from the pandemic death toll to preventive measures recommended by scientists and medical experts, physicians interviewed by MDedge said.
Patients everywhere share these viewpoints, of course, but research and election results confirm that rural areas are more receptive to conservative viewpoints. In 2018, a Pew Research Center survey reported that rural and urban areas are “becoming more polarized politically,” and “rural areas tend to have a higher concentration of Republicans and Republican-leaning independents.” For example, 40% of rural respondents reported “very warm” or “somewhat warm” feelings toward Donald Trump, compared with just 19% in urban areas.
Dr. Shin has struggled to cope with patients who want to argue about pandemic safety precautions like wearing masks and seem to question whether systemic racism exists.
“We are seeing a lot more people who feel that this pandemic is not real, that it’s a political and not-true infection,” he said in an interview. “We’ve had patients who were angry at us because we made them wear masks, and some were demanding hydroxychloroquine and wanted to have an argument because we’re not going to prescribe it for them.”
In one situation, which he found especially disturbing, Dr. Shin had to leave the exam room because a patient wouldn’t stop challenging him regarding the pandemic. Things have gotten so bad that Dr. Shin has even questioned whether he wants to continue his long career in his small town because of local political attitudes such as opposition to mask-wearing and social distancing.
“Mr. Trump’s misinformation on this pandemic made my job much more difficult. As a minority, I feel less safe in my community than ever,” said Dr. Shin, who described himself as Asian American.
Despite these new stressors, Dr. Shin has experienced some joyful moments while practicing medicine in the pandemic.
He said a recent home visit to a patient who had been hospitalized for over 3 months and nearly died helped him put political disputes with his patients into perspective.
“He was discharged home but is bedbound. He had gangrene on his toes, and I could not fully examine him using video,” Dr. Shin recalled. “It was tricky to find the house, but a very large Trump sign was very helpful in locating it. It was a good visit: He was happy to see me, and I was happy to see that he was doing okay at home.”
“I need to remind myself that supporting Mr. Trump does not always mean that my patient supports Mr. Trump’s view on the pandemic and the race issues in our country,” Dr. Shin added.
The Washington-based internist said he also tells himself that, even if his patients refuse to follow his strong advice regarding pandemic precautions, it does not mean he has failed as a doctor.
“I need to continue to educate patients about the dangers of COVID infection but cannot be angry if they don’t choose to follow my recommendations,” he noted.
Dr. Fincher says her close connection with patients has allowed her to smooth over politically charged claims about the pandemic in the town of Thomson, Georgia, with a population 6,800.
“I have a sense that, even though we may differ in our understanding of some basic facts, they appreciate what I say since we have a long-term relationship built on trust,” she said. This kind of trust, Dr. Fincher suggested, may be more common than in urban areas where there’s a larger supply of physicians, and patients don’t see the same doctors for long periods of time.
“It’s more meaningful when it comes from me, rather than doctors who are [new to patients] every year when their employer changes their insurance,” she noted.
These include struggling with seeing patients virtually and treating patients who have politicized the virus. Additionally, the pandemic has exposed rural practices to greater financial difficulties.
Before the pandemic some rurally based primary care physicians were already working through big challenges, such as having few local medical colleagues to consult and working in small practices with lean budgets. In fact, data gathered by the National Rural Health Association showed that there are only 40 primary care physicians per 100,000 patients in rural regions, compared with 53 in urban areas – and the number of physicians overall is 13 per 10,000 in rural areas, compared with 31 in cities.
In the prepandemic world, for some doctors, the challenges were balanced by the benefits of practicing in these sparsely populated communities with scenic, low-traffic roads. Some perks of practicing in rural areas touted by doctors included having a fast commute, being able to swim in a lake near the office before work, having a low cost of living, and feeling like they are making a difference in their communities as they treat generations of the families they see around town.
But today, new hurdles to practicing medicine in rural America created by the COVID-19 pandemic have caused the hardships to feel heavier than the joys at times for some physicians interviewed by MDedge.
Many independent rural practices in need of assistance were not able to get much from the federal Provider Relief Funds, said John M. Westfall, MD, who is director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, in an interview.
“Rural primary care doctors function independently or in smaller critical access hospitals and community health centers,” said Dr. Westfall, who previously practiced family medicine in a small town in Colorado. “Many of these have much less financial reserves so are at risk of cutbacks and closure.”
Jacqueline W. Fincher, MD, an internist based in a tiny Georgia community along the highway between Atlanta and Augusta, said her small practice works on really thin margins and doesn’t have much cushion. At the beginning of the pandemic, all visits were down, and her practice operated at a loss. To help, Dr. Fincher and her colleagues applied for funding from the Small Business Administration’s Paycheck Protection Program (PPP) through the CARES Act.
“COVID-19 has had a tremendous impact especially on primary care practices. We live and die by volume. … Our volume in mid-March to mid-May really dropped dramatically,” explained Dr. Fincher, who is also president of the American College of Physicians. “The PPP sustained us for 2 months, enabling us to pay our staff and to remain open and get us up and running on telehealth.”
Starting up telemedicine
Experiencing spotty or no access to broadband Internet is nothing new to rural physicians, but having this problem interfere with their ability to provide care to patients is.
As much of the American health system rapidly embraced telehealth during the pandemic, obtaining access to high-speed Internet has been a major challenge for rural patients, noted Dr. Westfall.
“Some practices were able to quickly adopt some telehealth capacity with phone and video. Changes in payment for telehealth helped. But in some rural communities there was not adequate Internet bandwidth for quality video connections. And some patients did not have the means for high-speed video connections,” Dr. Westfall said.
Indeed, according to a 2019 Pew Research Center survey, 63% of rural Americans say they can access the Internet through a broadband connection at home, compared with 75% and 79% in suburban and urban areas, respectively.
In the Appalachian town of Zanesville, Ohio, for example, family physician Shelly L. Dunmyer, MD, and her colleagues discovered that many patients don’t have Internet access at home. Dr. Fincher has to go to the office to conduct telehealth visits because her own Internet access at home is unpredictable. As for patients, it may take 15 minutes for them to work out technical glitches and find good Internet reception, said Dr. Fincher. For internist Y. Ki Shin, MD, who practices in the coastal town of Montesano in Washington state, about 25% of his practice’s telehealth visits must be conducted by phone because of limitations on video, such as lack of high-speed access.
But telephone visits are often insufficient replacements for appointments via video, according to several rural physicians interviewed for this piece.
“Telehealth can be frustrating at times due to connectivity issues which can be difficult at times in the rural areas,” said Dr. Fincher. “In order for telehealth to be reasonably helpful to patients and physicians to care for people with chronic problems, the patients must have things like blood pressure monitors, glucometers, and scales to address problems like hypertension, diabetes myelitis, and congestive heart failure.”
“If you have the audio and video and the data from these devices, you’re good. If you don’t have these data, and/or don’t have the video you just can’t provide good care,” she explained.
Dr. Dunmyer and her colleagues at Medical Home Primary Care Center in Zanesville, Ohio, found a way to get around the problem of patients not being able to access Internet to participate in video visits from their homes. This involved having her patients drive into her practice’s parking lot to participate in modified telehealth visits. Staffers gave iPads to patients in their cars, and Dr. Dunmyer conducted visits from her office, about 50 yards away.
“We were even doing Medicare wellness visits: Instead of asking them to get up and move around the room, we would sit at the window and wave at them, ask them to get out, walk around the car. We were able to check mobility and all kinds of things that we’d normally do in the office,” Dr. Dunmyer explained in an interview.
The family physician noted that her practice is now conducting fewer parking lot visits since her office is allowing in-person appointments, but that they’re still an option for her patients.
Treating political adversaries
Some rural physicians have experienced strained relationships with patients for reasons other than technology – stark differences in opinion over the pandemic itself. Certain patients are following President Trump’s lead and questioning everything from the pandemic death toll to preventive measures recommended by scientists and medical experts, physicians interviewed by MDedge said.
Patients everywhere share these viewpoints, of course, but research and election results confirm that rural areas are more receptive to conservative viewpoints. In 2018, a Pew Research Center survey reported that rural and urban areas are “becoming more polarized politically,” and “rural areas tend to have a higher concentration of Republicans and Republican-leaning independents.” For example, 40% of rural respondents reported “very warm” or “somewhat warm” feelings toward Donald Trump, compared with just 19% in urban areas.
Dr. Shin has struggled to cope with patients who want to argue about pandemic safety precautions like wearing masks and seem to question whether systemic racism exists.
“We are seeing a lot more people who feel that this pandemic is not real, that it’s a political and not-true infection,” he said in an interview. “We’ve had patients who were angry at us because we made them wear masks, and some were demanding hydroxychloroquine and wanted to have an argument because we’re not going to prescribe it for them.”
In one situation, which he found especially disturbing, Dr. Shin had to leave the exam room because a patient wouldn’t stop challenging him regarding the pandemic. Things have gotten so bad that Dr. Shin has even questioned whether he wants to continue his long career in his small town because of local political attitudes such as opposition to mask-wearing and social distancing.
“Mr. Trump’s misinformation on this pandemic made my job much more difficult. As a minority, I feel less safe in my community than ever,” said Dr. Shin, who described himself as Asian American.
Despite these new stressors, Dr. Shin has experienced some joyful moments while practicing medicine in the pandemic.
He said a recent home visit to a patient who had been hospitalized for over 3 months and nearly died helped him put political disputes with his patients into perspective.
“He was discharged home but is bedbound. He had gangrene on his toes, and I could not fully examine him using video,” Dr. Shin recalled. “It was tricky to find the house, but a very large Trump sign was very helpful in locating it. It was a good visit: He was happy to see me, and I was happy to see that he was doing okay at home.”
“I need to remind myself that supporting Mr. Trump does not always mean that my patient supports Mr. Trump’s view on the pandemic and the race issues in our country,” Dr. Shin added.
The Washington-based internist said he also tells himself that, even if his patients refuse to follow his strong advice regarding pandemic precautions, it does not mean he has failed as a doctor.
“I need to continue to educate patients about the dangers of COVID infection but cannot be angry if they don’t choose to follow my recommendations,” he noted.
Dr. Fincher says her close connection with patients has allowed her to smooth over politically charged claims about the pandemic in the town of Thomson, Georgia, with a population 6,800.
“I have a sense that, even though we may differ in our understanding of some basic facts, they appreciate what I say since we have a long-term relationship built on trust,” she said. This kind of trust, Dr. Fincher suggested, may be more common than in urban areas where there’s a larger supply of physicians, and patients don’t see the same doctors for long periods of time.
“It’s more meaningful when it comes from me, rather than doctors who are [new to patients] every year when their employer changes their insurance,” she noted.
Revamping mentorship in medicine
Why the current system fails underrepresented physicians — and tips to improve it
Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?
For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”
Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.
At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?
One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise, 
Below are three recommendations to consider for improving mentorship within departments:
1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.
2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.
3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.
If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.
Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.
Why the current system fails underrepresented physicians — and tips to improve it
Why the current system fails underrepresented physicians — and tips to improve it
Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?
For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”
Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.
At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?
One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise,
Below are three recommendations to consider for improving mentorship within departments:
1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.
2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.
3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.
If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.
Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.
Mentoring is often promoted as an organizational practice to promote diversity and inclusion. New or established group members who want to further their careers look for a mentor to guide them toward success within a system by amplifying their strengths and accomplishments and defending and promoting them when necessary. But how can mentoring work if there isn’t a mentor?
For underrepresented groups or marginalized physicians, it too often looks as if there are no mentors who understand the struggles of being a racial or ethnic minority group member or mentors who are even cognizant of those struggles. Mentoring is a practice that occurs within the overarching systems of practice groups, academic departments, hospitals, medicine, and society at large. These systems frequently carry the legacies of bias, discrimination, and exclusion. The mentoring itself that takes place within a biased system risks perpetuating institutional bias, exclusion, or a sense of unworthiness in the mentee. It is stressful for any person with a minority background or even a minority interest to feel that there’s no one to emulate in their immediate working environment. When that is the case, a natural question follows: “Do I even belong here?”
Before departments and psychiatric practices turn to old, surface-level solutions like using mentorship to appear more welcoming to underrepresented groups, leaders must explicitly evaluate their track record of mentorship within their system and determine whether mentorship has been used to protect the status quo or move the culture forward. As mentorship is inherently an imbalanced relationship, there must be department- or group-level reflection about the diversity of mentors and also their examinations of mentors’ own preconceived notions of who will make a “good” mentee.
At the most basic level, leaders can examine whether there are gaps in who is mentored and who is not. Other parts of mentoring relationships should also be examined: a) How can mentoring happen if there is a dearth of underrepresented groups in the department? b) What type of mentoring style is favored? Do departments/groups look for a natural fit between mentor and mentee or are they matched based on interests, ideals, and goals? and c) How is the worthiness for mentorship determined?
One example is the fraught process of evaluating “worthiness” among residents. Prospective mentors frequently divide trainees unofficially into a top-tier candidates, middle-tier performers who may be overlooked, and a bottom tier who are avoided when it comes to mentorship. Because this division is informal and usually based on extremely early perceptions of trainees’ aptitude and openness, the process can be subject to an individual mentor’s conscious and unconscious bias, which then plays a large role in perpetuating systemic racism. When it comes to these informal but often rigid divisions, it can be hard to fall from the top when mentees are buoyed by good will, frequent opportunities to shine, and the mentor’s reputation. Likewise,
Below are three recommendations to consider for improving mentorship within departments:
1) Consider opportunities for senior mentors and potential mentees to interact with one another outside of assigned duties so that some mentorship relationships can be formed organically.
2) Review when mentorship relationships have been ineffective or unsuccessful versus productive and useful for both participants.
3) Increase opportunities for adjunct or former faculty who remain connected to the institution to also be mentors. This approach would open up more possibilities and could increase the diversity of available mentors.
If mentorship is to be part of the armamentarium for promoting equity within academia and workplaces alike, it must be examined and changed to meet the new reality.
Dr. Posada is assistant clinical professor, department of psychiatry and behavioral sciences at George Washington University in Washington. She also serves as staff physician at George Washington Medical Faculty Associates, also in Washington. She disclosed no relevant financial relationships. Dr. Forrester is consultation-liaison psychiatry fellowship training director at the University of Maryland, Baltimore. She disclosed no relevant financial relationships.