MDedge Rheumatology

Key clinical point: The Internet-based Worry and Sadness program improved mental health in adults with rheumatoid arthritis over 3 months.

Major finding: At 3 months’ follow-up, measures of anxiety, depression, and emotional distress  improved significantly from baseline with effect sizes ranging from small to large; 44% of participants had normal scores for anxiety (medium effect size).

Study details: The data come from 28 adults (mean age 57 years, 86% women) with rheumatoid arthritis who completed an Internet-based cognitive-behavioral therapy intervention.

Disclosures: The study was supported in part by a University of Manitoba Graduate Fellowship and The Arthritis Society 2016 PhD Salary Award to lead author Dr. Blaney, and by the CIHR Chronic Pain SPOR Network and Health Sciences Centre. The researchers had no financial conflicts to disclose.

Source: Blaney C et al. Internet Interv. 2021 Mar 26. doi: 10.1016/j.invent.2021.100385.

Key clinical point: The Internet-based Worry and Sadness program improved mental health in adults with rheumatoid arthritis over 3 months.

Major finding: At 3 months’ follow-up, measures of anxiety, depression, and emotional distress  improved significantly from baseline with effect sizes ranging from small to large; 44% of participants had normal scores for anxiety (medium effect size).

Study details: The data come from 28 adults (mean age 57 years, 86% women) with rheumatoid arthritis who completed an Internet-based cognitive-behavioral therapy intervention.

Disclosures: The study was supported in part by a University of Manitoba Graduate Fellowship and The Arthritis Society 2016 PhD Salary Award to lead author Dr. Blaney, and by the CIHR Chronic Pain SPOR Network and Health Sciences Centre. The researchers had no financial conflicts to disclose.

Source: Blaney C et al. Internet Interv. 2021 Mar 26. doi: 10.1016/j.invent.2021.100385.

Key clinical point: The Internet-based Worry and Sadness program improved mental health in adults with rheumatoid arthritis over 3 months.

Major finding: At 3 months’ follow-up, measures of anxiety, depression, and emotional distress  improved significantly from baseline with effect sizes ranging from small to large; 44% of participants had normal scores for anxiety (medium effect size).

Study details: The data come from 28 adults (mean age 57 years, 86% women) with rheumatoid arthritis who completed an Internet-based cognitive-behavioral therapy intervention.

Disclosures: The study was supported in part by a University of Manitoba Graduate Fellowship and The Arthritis Society 2016 PhD Salary Award to lead author Dr. Blaney, and by the CIHR Chronic Pain SPOR Network and Health Sciences Centre. The researchers had no financial conflicts to disclose.

Source: Blaney C et al. Internet Interv. 2021 Mar 26. doi: 10.1016/j.invent.2021.100385.

Key clinical point: Use of beta blockers was significantly associated with remission in RA based on the Simplified Disease Activity Index and Clinical Disease Activity Index.

Major finding: Approximately 11% of the RA patients were using systemic beta blockers, and beta blocker use was associated with less frequent remission, both in the total study cohort and the cohort of patients with cardiovascular disease (adjusted hazard ratios 0.70 and 0.75, respectively).

Study details: The data come from a pooled cohort analysis of five randomized trials of tocilizumab and/or csDMARDs including 5,502 RA patients.

Disclosures: The study received no outside funding. Two researchers were supported by Beat Cancer Research Fellowships from Cancer Council South Australia and a Postdoctoral Fellowship from the National Breast Cancer Foundation, Australia. The lead author and other researchers had no financial conflicts to disclose. 

Source: Abuhelwa AY. Ther Adv Musculoskelet Dis. 2021 Apr 12. doi: 10.1177/1759720X211009020.

Key clinical point: Use of beta blockers was significantly associated with remission in RA based on the Simplified Disease Activity Index and Clinical Disease Activity Index.

Major finding: Approximately 11% of the RA patients were using systemic beta blockers, and beta blocker use was associated with less frequent remission, both in the total study cohort and the cohort of patients with cardiovascular disease (adjusted hazard ratios 0.70 and 0.75, respectively).

Study details: The data come from a pooled cohort analysis of five randomized trials of tocilizumab and/or csDMARDs including 5,502 RA patients.

Disclosures: The study received no outside funding. Two researchers were supported by Beat Cancer Research Fellowships from Cancer Council South Australia and a Postdoctoral Fellowship from the National Breast Cancer Foundation, Australia. The lead author and other researchers had no financial conflicts to disclose. 

Source: Abuhelwa AY. Ther Adv Musculoskelet Dis. 2021 Apr 12. doi: 10.1177/1759720X211009020.

Key clinical point: Use of beta blockers was significantly associated with remission in RA based on the Simplified Disease Activity Index and Clinical Disease Activity Index.

Major finding: Approximately 11% of the RA patients were using systemic beta blockers, and beta blocker use was associated with less frequent remission, both in the total study cohort and the cohort of patients with cardiovascular disease (adjusted hazard ratios 0.70 and 0.75, respectively).

Study details: The data come from a pooled cohort analysis of five randomized trials of tocilizumab and/or csDMARDs including 5,502 RA patients.

Disclosures: The study received no outside funding. Two researchers were supported by Beat Cancer Research Fellowships from Cancer Council South Australia and a Postdoctoral Fellowship from the National Breast Cancer Foundation, Australia. The lead author and other researchers had no financial conflicts to disclose. 

Source: Abuhelwa AY. Ther Adv Musculoskelet Dis. 2021 Apr 12. doi: 10.1177/1759720X211009020.

Key clinical point: Treatment of irradiated peripheral blood mononuclear cells (PBMCs) with filgotinib in particular correlated with enhanced foci in vitro; the study was a rare comparison of all four JAKis approved for RA: tofacitinib, baricitinib, and upadacitinib, and filgotinib.

Major finding: Lymphocyte proliferation was similar for tofacitinib, baricitinib, and upadacitinib, while dosage of filgotinib was two orders of magnitude higher when these JAKis were added to peripheral blood mononuclear cells from healthy donors.

Study details: The data come from an in vitro study of four JAK inhibitors currently approved for the treatment of RA: tofacitinib, baricitinib, upadacitinib, and filgotinib, in which increasing concentrations of the JAKis or methotrexate were added to peripheral blood mononuclear cells from healthy volunteers.

Disclosures: The study was supported by the European Union Program Regional Development Fund of the Ministry of Economy, Science and Digitalisation in Saxony-Anhalt. Lead author Dr. Reddig had no financial conflicts to disclose.

Source: Reddig A et al. J Clin Med. 2021 Apr 1. doi: 103390/jcm10071431.

Key clinical point: Treatment of irradiated peripheral blood mononuclear cells (PBMCs) with filgotinib in particular correlated with enhanced foci in vitro; the study was a rare comparison of all four JAKis approved for RA: tofacitinib, baricitinib, and upadacitinib, and filgotinib.

Major finding: Lymphocyte proliferation was similar for tofacitinib, baricitinib, and upadacitinib, while dosage of filgotinib was two orders of magnitude higher when these JAKis were added to peripheral blood mononuclear cells from healthy donors.

Study details: The data come from an in vitro study of four JAK inhibitors currently approved for the treatment of RA: tofacitinib, baricitinib, upadacitinib, and filgotinib, in which increasing concentrations of the JAKis or methotrexate were added to peripheral blood mononuclear cells from healthy volunteers.

Disclosures: The study was supported by the European Union Program Regional Development Fund of the Ministry of Economy, Science and Digitalisation in Saxony-Anhalt. Lead author Dr. Reddig had no financial conflicts to disclose.

Source: Reddig A et al. J Clin Med. 2021 Apr 1. doi: 103390/jcm10071431.

Key clinical point: Treatment of irradiated peripheral blood mononuclear cells (PBMCs) with filgotinib in particular correlated with enhanced foci in vitro; the study was a rare comparison of all four JAKis approved for RA: tofacitinib, baricitinib, and upadacitinib, and filgotinib.

Major finding: Lymphocyte proliferation was similar for tofacitinib, baricitinib, and upadacitinib, while dosage of filgotinib was two orders of magnitude higher when these JAKis were added to peripheral blood mononuclear cells from healthy donors.

Study details: The data come from an in vitro study of four JAK inhibitors currently approved for the treatment of RA: tofacitinib, baricitinib, upadacitinib, and filgotinib, in which increasing concentrations of the JAKis or methotrexate were added to peripheral blood mononuclear cells from healthy volunteers.

Disclosures: The study was supported by the European Union Program Regional Development Fund of the Ministry of Economy, Science and Digitalisation in Saxony-Anhalt. Lead author Dr. Reddig had no financial conflicts to disclose.

Source: Reddig A et al. J Clin Med. 2021 Apr 1. doi: 103390/jcm10071431.

The association of RA and cardiovascular disease has been extensively described. Beta adrenergic receptors are not known to be involved in RA, though Abuhelwa et al. suggest a potential role in “immunologic balance” in their study of beta blocker use and RA remission. In a pooled analysis of five tocilizumab trials, use of beta blockers was associated with lower proportions of CDAI remission. However, without information on beta blocker dose or duration of therapy as well as potential confounding by indication, the significance of this finding is uncertain.

Another known association of RA and its treatment is malignancy, perhaps due to decrease in immunosurveillance; it remains a concern in choice of therapy and long-term effects. Solipuram et al. performed a systematic review of combination JAK inhibitor and methotrexate therapy in RA to evaluate the evidence regarding malignancy risk. Among the 13 trials included for analysis, 40 cases of malignancy were reported for over 3,600 patient-years in patients receiving combination therapy, compared to 7 cases among nearly 1,000 patient-years in patients receiving methotrexate alone; no change in relative risk was seen in non-melanomatous skin cancer or other cancers. While this information is reassuring, it does not eliminate the possibility of increased malignancy given variations in duration of followup in different studies.  There is also a need for longer follow-up because of a potential latency period before the development of cancer. Ideally, long-term extension studies could help better define this risk, though those studies tend to be single-armed and without a control.

Though different JAK inhibitors generally are thought to have similar efficacy and class-associated side effects, few studies have compared immunomodulatory effects of the medications. Reddig et al compared the effects of baricitinib, upadicitinib, filgotinib, tofacitinib, and methotrexate on cell proliferation, cell activation, and apoptosis, as well as induction of DNA damage and repair in an in vitro study. The study authors used human peripheral blood monocytes treated with phytohemagglutinin to activate T cells and induce proliferation. Tofacitinib, baricitinib, and upadicitinib were associated with comparable dose-dependent inhibition of lymphocyte activation and proliferation. Higher doses of filgotinib were required to obtain the same effect. Filgotinib at high concentrations also were associated with higher levels of DNA damage markers. These findings are interesting as to the shared mechanism of action of JAK inhibitors, regardless of JAK specificity. However, given the lack of “universal” patterns in vitro, their clinical importance or relevance in distinguishing between the medications is unclear.

Kim et al. investigates the pathogenesis of RA in their in vitro study of mast cells. Though previously identified in RA synovial fluid and tissue and not in OA synovium, their role is not entirely clear. Though normally associated with allergic responses, mast cells have been postulated to have pro- and anti-inflammatory effects, and release inflammatory cytokines and mediators, such as histamine. Synovial fluid and serum samples from RA and OA patients, as well as healthy volunteers, were analyzed for tryptase, chymase, and histamine; serum levels of all three were higher in RA than in OA patients and healthy volunteers. Synovial fluid levels of histamine were higher in RA. Cell culture studies were performed using IL-33 to activate human mast cells, causing an increase in tryptase –positive cells, as well as an increased expression of RANKL and MMP-9. This suggests a role for mast cells in osteoclastogenesis and tissue degradation. In addition to providing more information about the involvement of mast cells in RA pathogenesis, these findings suggest mast cells as a potential therapeutic target.

The association of RA and cardiovascular disease has been extensively described. Beta adrenergic receptors are not known to be involved in RA, though Abuhelwa et al. suggest a potential role in “immunologic balance” in their study of beta blocker use and RA remission. In a pooled analysis of five tocilizumab trials, use of beta blockers was associated with lower proportions of CDAI remission. However, without information on beta blocker dose or duration of therapy as well as potential confounding by indication, the significance of this finding is uncertain.

Another known association of RA and its treatment is malignancy, perhaps due to decrease in immunosurveillance; it remains a concern in choice of therapy and long-term effects. Solipuram et al. performed a systematic review of combination JAK inhibitor and methotrexate therapy in RA to evaluate the evidence regarding malignancy risk. Among the 13 trials included for analysis, 40 cases of malignancy were reported for over 3,600 patient-years in patients receiving combination therapy, compared to 7 cases among nearly 1,000 patient-years in patients receiving methotrexate alone; no change in relative risk was seen in non-melanomatous skin cancer or other cancers. While this information is reassuring, it does not eliminate the possibility of increased malignancy given variations in duration of followup in different studies.  There is also a need for longer follow-up because of a potential latency period before the development of cancer. Ideally, long-term extension studies could help better define this risk, though those studies tend to be single-armed and without a control.

Though different JAK inhibitors generally are thought to have similar efficacy and class-associated side effects, few studies have compared immunomodulatory effects of the medications. Reddig et al compared the effects of baricitinib, upadicitinib, filgotinib, tofacitinib, and methotrexate on cell proliferation, cell activation, and apoptosis, as well as induction of DNA damage and repair in an in vitro study. The study authors used human peripheral blood monocytes treated with phytohemagglutinin to activate T cells and induce proliferation. Tofacitinib, baricitinib, and upadicitinib were associated with comparable dose-dependent inhibition of lymphocyte activation and proliferation. Higher doses of filgotinib were required to obtain the same effect. Filgotinib at high concentrations also were associated with higher levels of DNA damage markers. These findings are interesting as to the shared mechanism of action of JAK inhibitors, regardless of JAK specificity. However, given the lack of “universal” patterns in vitro, their clinical importance or relevance in distinguishing between the medications is unclear.

Kim et al. investigates the pathogenesis of RA in their in vitro study of mast cells. Though previously identified in RA synovial fluid and tissue and not in OA synovium, their role is not entirely clear. Though normally associated with allergic responses, mast cells have been postulated to have pro- and anti-inflammatory effects, and release inflammatory cytokines and mediators, such as histamine. Synovial fluid and serum samples from RA and OA patients, as well as healthy volunteers, were analyzed for tryptase, chymase, and histamine; serum levels of all three were higher in RA than in OA patients and healthy volunteers. Synovial fluid levels of histamine were higher in RA. Cell culture studies were performed using IL-33 to activate human mast cells, causing an increase in tryptase –positive cells, as well as an increased expression of RANKL and MMP-9. This suggests a role for mast cells in osteoclastogenesis and tissue degradation. In addition to providing more information about the involvement of mast cells in RA pathogenesis, these findings suggest mast cells as a potential therapeutic target.

The association of RA and cardiovascular disease has been extensively described. Beta adrenergic receptors are not known to be involved in RA, though Abuhelwa et al. suggest a potential role in “immunologic balance” in their study of beta blocker use and RA remission. In a pooled analysis of five tocilizumab trials, use of beta blockers was associated with lower proportions of CDAI remission. However, without information on beta blocker dose or duration of therapy as well as potential confounding by indication, the significance of this finding is uncertain.

Another known association of RA and its treatment is malignancy, perhaps due to decrease in immunosurveillance; it remains a concern in choice of therapy and long-term effects. Solipuram et al. performed a systematic review of combination JAK inhibitor and methotrexate therapy in RA to evaluate the evidence regarding malignancy risk. Among the 13 trials included for analysis, 40 cases of malignancy were reported for over 3,600 patient-years in patients receiving combination therapy, compared to 7 cases among nearly 1,000 patient-years in patients receiving methotrexate alone; no change in relative risk was seen in non-melanomatous skin cancer or other cancers. While this information is reassuring, it does not eliminate the possibility of increased malignancy given variations in duration of followup in different studies.  There is also a need for longer follow-up because of a potential latency period before the development of cancer. Ideally, long-term extension studies could help better define this risk, though those studies tend to be single-armed and without a control.

Though different JAK inhibitors generally are thought to have similar efficacy and class-associated side effects, few studies have compared immunomodulatory effects of the medications. Reddig et al compared the effects of baricitinib, upadicitinib, filgotinib, tofacitinib, and methotrexate on cell proliferation, cell activation, and apoptosis, as well as induction of DNA damage and repair in an in vitro study. The study authors used human peripheral blood monocytes treated with phytohemagglutinin to activate T cells and induce proliferation. Tofacitinib, baricitinib, and upadicitinib were associated with comparable dose-dependent inhibition of lymphocyte activation and proliferation. Higher doses of filgotinib were required to obtain the same effect. Filgotinib at high concentrations also were associated with higher levels of DNA damage markers. These findings are interesting as to the shared mechanism of action of JAK inhibitors, regardless of JAK specificity. However, given the lack of “universal” patterns in vitro, their clinical importance or relevance in distinguishing between the medications is unclear.

Kim et al. investigates the pathogenesis of RA in their in vitro study of mast cells. Though previously identified in RA synovial fluid and tissue and not in OA synovium, their role is not entirely clear. Though normally associated with allergic responses, mast cells have been postulated to have pro- and anti-inflammatory effects, and release inflammatory cytokines and mediators, such as histamine. Synovial fluid and serum samples from RA and OA patients, as well as healthy volunteers, were analyzed for tryptase, chymase, and histamine; serum levels of all three were higher in RA than in OA patients and healthy volunteers. Synovial fluid levels of histamine were higher in RA. Cell culture studies were performed using IL-33 to activate human mast cells, causing an increase in tryptase –positive cells, as well as an increased expression of RANKL and MMP-9. This suggests a role for mast cells in osteoclastogenesis and tissue degradation. In addition to providing more information about the involvement of mast cells in RA pathogenesis, these findings suggest mast cells as a potential therapeutic target.

Patients who receive the mRNA COVID-19 vaccines are experiencing a variety of skin rashes, a dermatologist told colleagues, and some lesions don’t appear until several days after an injection. The good news is that these side effects tend to be minor and vanish within a few days, Esther Freeman, MD, PhD, said in a presentation at the American Academy of Dermatology Virtual Meeting Experience.

“The reality is actually very reassuring,” Dr. Freeman said, especially in light of what is currently known about when the rashes occur and how anaphylaxis is extremely uncommon. Now, she added, dermatologists can tell patients who had reactions to their initial vaccination that “we know you had this big reaction, and we know that it was upsetting and uncomfortable. But it may not happen the second time around. And if it does, [the reaction is] probably going to be smaller.”

Dr. Freeman, associate professor of dermatology at Harvard Medical School, Boston, highlighted a study published in the Journal of the American Academy of Dermatology that she coauthored with dermatologists across the United States. The researchers tracked 414 cutaneous reactions to the Moderna (83%) and Pfizer (17%) COVID-19 vaccines in a group of patients, which was 90% female, 78% White, and mostly from the United States. Their average age was 44 years. The cases were reported to the AAD–International League of Dermatological Societies registry of COVID-19 cutaneous manifestations.

While most were women, “it’s a little hard to know if this is really going to end up being a true finding,” said Dr. Freeman, the registry’s principal investigator and a member of the AAD’s COVID-19 Ad Hoc Task Force. “If you think about who got vaccinated early, it was health care providers, and the American health care workforce is over 70% female. So I think there’s a little bit of bias here. There may also be a bias because women may be slightly more likely to report or go to their health care provider for a rash.”

Delayed large local reactions were the most common, accounting for 66% (175 cases) of the 267 skin reactions reported after the first Moderna vaccine dose and 30% (31 cases) of the 102 reactions reported after the second dose. These reactions represented 15% (5 cases) of the 34 skin reactions reported after the first Pfizer vaccine dose and 18% (7 cases) of the 40 reactions after the second dose.

There are two peaks with that first dose, Dr. Freeman said. “There’s a peak around day 2 or 3. And there’s another peak around day 7 or 8 with some of these reactions. Only 27% who had a reaction with the first dose had the same reaction with the second.” She added that these reactions “are not cellulitis and don’t require antibiotics.”

Other more common reactions included local injection-site reactions (swelling, erythema, and pain), urticaria (after 24 hours in almost all cases, occurring at a higher rate in patients who received the Pfizer vaccine), and morbilliform eruptions.

Dr. Freeman said that patients may experience redness and swelling in the hands and feet that can be “very uncomfortable.” She described one patient “who was having a hard time actually closing his fist, just because of the amount of swelling and redness in his hand. It did resolve, and it’s important to reassure your patients it will go away.”

According to this study, less common reports of other cutaneous findings with both vaccines included 9 reports of swelling at the site of cosmetic fillers, 8 reports of pernio/chilblains, 10 reports of varicella zoster, 4 reports of herpes simplex flares, 4 pityriasis rosea–like reactions, and 4 rashes in infants of vaccinated breastfeeding mothers.

The study noted that “patients responded well to topical corticosteroids, oral antihistamines, and/or pain-relieving medications. These reactions resolved after a median of 3-4 days.”

It’s important to understand that none of the patients developed anaphylaxis after the second dose even if they’d had a reaction to the first dose, Dr. Freeman said. “But I should point out that we’re talking about reactions that have started more than 4 hours after the vaccine. If a rash such as a urticaria specifically starts within 4 hours of vaccination, that’s in a different category. Those are considered more immediate allergic reactions, and those patients need to be seen by allergy before a second dose.”

Dr. Freeman added that “it’s really interesting to think about how our bodies are really reacting to the vaccine in a way that’s mimicking our body’s reactions to COVID-19.” For example, some patients who got vaccinated developed chilblains similar to the “COVID toes” described in infected patients, apparently as part of the body’s immune response to the virus. “We’ve seen this in patients who actually had COVID and had prior COVID toes and then actually got a flare with their vaccine. And then we’ve also seen it in patients who never had COVID.”

In regard to general advice for patients, she said, “I do still encourage my patients who previously had COVID to go ahead and get the vaccine even if they had a skin manifestation with COVID.”

Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, said she has have seen only a handful of cases of delayed large local reactions and local injection site reactions after COVID-19 vaccination. “I have seen a significant number of cases of acute urticaria following the first and second doses,” she said in an interview. “However, it is important to keep in mind that we cannot determine cause and effect for the cases of acute urticaria. They may or may not be vaccine related.”

Fortunately, none of the adverse effects she’s seen have been severe. “It is important that dermatologists educate the public and their patients that most people do not develop any skin reaction in response to the vaccine,” she said. In the minority who do, “reactions tend to be mild and are not life-threatening. Many of these skin reactions resolve on their own without treatment.”

She added that “patients with pernio/chilblains or herpes zoster following vaccination should be referred by a board-certified dermatologist for prompt treatment and to avoid sequelae.”


 

‘COVID vaccine arm’

Delayed local reactions to the Moderna vaccine were also described in a report published online on May 12, 2021, in JAMA Dermatology, after the AAD meeting, in 16 patients referred to the Yale New Haven (Conn.) Hospital Dermatology service who experienced delayed localized cutaneous hypersensitivity reactions a median of 7 days after receiving the vaccine (range, 2-12 days), from Jan. 20 to Feb. 12, 2021. No such cases were reported in Pfizer vaccine recipients.

Of the 16 patients, whose median age was 38 years and who were mostly women, 15 developed the reaction after the first dose, described as “pruritic and variably painful erythematous reactions near the injection site,” which lasted a median of 5 days (range, 1-21 days). After the second dose, 12 of the 16 patients developed injection-site reactions (including one patient who had no reaction after dose 1), a median of 2 days after the vaccine was administered (range, 0-5 days). Histologic results of a biopsy in one patient with a reaction to the second dose “ demonstrated mild predominantly perivascular and focal interstitial mixed infiltrate with lymphocytes and eosinophils consistent with a dermal hypersensitivity reaction,” wrote Alicia J. Little, MD, PhD, of the department of dermatology, Yale University, New Haven, and coauthors.

Compared with immediate hypersensitivity reactions, occurring within 4 hours of vaccination, such as anaphylaxis and urticaria, they concluded that “these delayed localized hypersensitivity reactions are not a contraindication to subsequent vaccination,” and they proposed that they be named “COVID vaccine arm.”

Dr. Freeman reported no disclosures. Dr. Lipner also had no relevant disclosures. Dr. Little reported receiving a grant from the National Center for Advancing Translational Science and a Women’s Health Career Development Award from the Dermatology Foundation while the study was conducted; another author reported equity in Johnson & Johnson in his spouse’s retirement fund outside the submitted work.
 

Patients who receive the mRNA COVID-19 vaccines are experiencing a variety of skin rashes, a dermatologist told colleagues, and some lesions don’t appear until several days after an injection. The good news is that these side effects tend to be minor and vanish within a few days, Esther Freeman, MD, PhD, said in a presentation at the American Academy of Dermatology Virtual Meeting Experience.

“The reality is actually very reassuring,” Dr. Freeman said, especially in light of what is currently known about when the rashes occur and how anaphylaxis is extremely uncommon. Now, she added, dermatologists can tell patients who had reactions to their initial vaccination that “we know you had this big reaction, and we know that it was upsetting and uncomfortable. But it may not happen the second time around. And if it does, [the reaction is] probably going to be smaller.”

Dr. Freeman, associate professor of dermatology at Harvard Medical School, Boston, highlighted a study published in the Journal of the American Academy of Dermatology that she coauthored with dermatologists across the United States. The researchers tracked 414 cutaneous reactions to the Moderna (83%) and Pfizer (17%) COVID-19 vaccines in a group of patients, which was 90% female, 78% White, and mostly from the United States. Their average age was 44 years. The cases were reported to the AAD–International League of Dermatological Societies registry of COVID-19 cutaneous manifestations.

While most were women, “it’s a little hard to know if this is really going to end up being a true finding,” said Dr. Freeman, the registry’s principal investigator and a member of the AAD’s COVID-19 Ad Hoc Task Force. “If you think about who got vaccinated early, it was health care providers, and the American health care workforce is over 70% female. So I think there’s a little bit of bias here. There may also be a bias because women may be slightly more likely to report or go to their health care provider for a rash.”

Delayed large local reactions were the most common, accounting for 66% (175 cases) of the 267 skin reactions reported after the first Moderna vaccine dose and 30% (31 cases) of the 102 reactions reported after the second dose. These reactions represented 15% (5 cases) of the 34 skin reactions reported after the first Pfizer vaccine dose and 18% (7 cases) of the 40 reactions after the second dose.

There are two peaks with that first dose, Dr. Freeman said. “There’s a peak around day 2 or 3. And there’s another peak around day 7 or 8 with some of these reactions. Only 27% who had a reaction with the first dose had the same reaction with the second.” She added that these reactions “are not cellulitis and don’t require antibiotics.”

Other more common reactions included local injection-site reactions (swelling, erythema, and pain), urticaria (after 24 hours in almost all cases, occurring at a higher rate in patients who received the Pfizer vaccine), and morbilliform eruptions.

Dr. Freeman said that patients may experience redness and swelling in the hands and feet that can be “very uncomfortable.” She described one patient “who was having a hard time actually closing his fist, just because of the amount of swelling and redness in his hand. It did resolve, and it’s important to reassure your patients it will go away.”

According to this study, less common reports of other cutaneous findings with both vaccines included 9 reports of swelling at the site of cosmetic fillers, 8 reports of pernio/chilblains, 10 reports of varicella zoster, 4 reports of herpes simplex flares, 4 pityriasis rosea–like reactions, and 4 rashes in infants of vaccinated breastfeeding mothers.

The study noted that “patients responded well to topical corticosteroids, oral antihistamines, and/or pain-relieving medications. These reactions resolved after a median of 3-4 days.”

It’s important to understand that none of the patients developed anaphylaxis after the second dose even if they’d had a reaction to the first dose, Dr. Freeman said. “But I should point out that we’re talking about reactions that have started more than 4 hours after the vaccine. If a rash such as a urticaria specifically starts within 4 hours of vaccination, that’s in a different category. Those are considered more immediate allergic reactions, and those patients need to be seen by allergy before a second dose.”

Dr. Freeman added that “it’s really interesting to think about how our bodies are really reacting to the vaccine in a way that’s mimicking our body’s reactions to COVID-19.” For example, some patients who got vaccinated developed chilblains similar to the “COVID toes” described in infected patients, apparently as part of the body’s immune response to the virus. “We’ve seen this in patients who actually had COVID and had prior COVID toes and then actually got a flare with their vaccine. And then we’ve also seen it in patients who never had COVID.”

In regard to general advice for patients, she said, “I do still encourage my patients who previously had COVID to go ahead and get the vaccine even if they had a skin manifestation with COVID.”

Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, said she has have seen only a handful of cases of delayed large local reactions and local injection site reactions after COVID-19 vaccination. “I have seen a significant number of cases of acute urticaria following the first and second doses,” she said in an interview. “However, it is important to keep in mind that we cannot determine cause and effect for the cases of acute urticaria. They may or may not be vaccine related.”

Fortunately, none of the adverse effects she’s seen have been severe. “It is important that dermatologists educate the public and their patients that most people do not develop any skin reaction in response to the vaccine,” she said. In the minority who do, “reactions tend to be mild and are not life-threatening. Many of these skin reactions resolve on their own without treatment.”

She added that “patients with pernio/chilblains or herpes zoster following vaccination should be referred by a board-certified dermatologist for prompt treatment and to avoid sequelae.”


 

‘COVID vaccine arm’

Delayed local reactions to the Moderna vaccine were also described in a report published online on May 12, 2021, in JAMA Dermatology, after the AAD meeting, in 16 patients referred to the Yale New Haven (Conn.) Hospital Dermatology service who experienced delayed localized cutaneous hypersensitivity reactions a median of 7 days after receiving the vaccine (range, 2-12 days), from Jan. 20 to Feb. 12, 2021. No such cases were reported in Pfizer vaccine recipients.

Of the 16 patients, whose median age was 38 years and who were mostly women, 15 developed the reaction after the first dose, described as “pruritic and variably painful erythematous reactions near the injection site,” which lasted a median of 5 days (range, 1-21 days). After the second dose, 12 of the 16 patients developed injection-site reactions (including one patient who had no reaction after dose 1), a median of 2 days after the vaccine was administered (range, 0-5 days). Histologic results of a biopsy in one patient with a reaction to the second dose “ demonstrated mild predominantly perivascular and focal interstitial mixed infiltrate with lymphocytes and eosinophils consistent with a dermal hypersensitivity reaction,” wrote Alicia J. Little, MD, PhD, of the department of dermatology, Yale University, New Haven, and coauthors.

Compared with immediate hypersensitivity reactions, occurring within 4 hours of vaccination, such as anaphylaxis and urticaria, they concluded that “these delayed localized hypersensitivity reactions are not a contraindication to subsequent vaccination,” and they proposed that they be named “COVID vaccine arm.”

Dr. Freeman reported no disclosures. Dr. Lipner also had no relevant disclosures. Dr. Little reported receiving a grant from the National Center for Advancing Translational Science and a Women’s Health Career Development Award from the Dermatology Foundation while the study was conducted; another author reported equity in Johnson & Johnson in his spouse’s retirement fund outside the submitted work.
 

Patients who receive the mRNA COVID-19 vaccines are experiencing a variety of skin rashes, a dermatologist told colleagues, and some lesions don’t appear until several days after an injection. The good news is that these side effects tend to be minor and vanish within a few days, Esther Freeman, MD, PhD, said in a presentation at the American Academy of Dermatology Virtual Meeting Experience.

“The reality is actually very reassuring,” Dr. Freeman said, especially in light of what is currently known about when the rashes occur and how anaphylaxis is extremely uncommon. Now, she added, dermatologists can tell patients who had reactions to their initial vaccination that “we know you had this big reaction, and we know that it was upsetting and uncomfortable. But it may not happen the second time around. And if it does, [the reaction is] probably going to be smaller.”

Dr. Freeman, associate professor of dermatology at Harvard Medical School, Boston, highlighted a study published in the Journal of the American Academy of Dermatology that she coauthored with dermatologists across the United States. The researchers tracked 414 cutaneous reactions to the Moderna (83%) and Pfizer (17%) COVID-19 vaccines in a group of patients, which was 90% female, 78% White, and mostly from the United States. Their average age was 44 years. The cases were reported to the AAD–International League of Dermatological Societies registry of COVID-19 cutaneous manifestations.

While most were women, “it’s a little hard to know if this is really going to end up being a true finding,” said Dr. Freeman, the registry’s principal investigator and a member of the AAD’s COVID-19 Ad Hoc Task Force. “If you think about who got vaccinated early, it was health care providers, and the American health care workforce is over 70% female. So I think there’s a little bit of bias here. There may also be a bias because women may be slightly more likely to report or go to their health care provider for a rash.”

Delayed large local reactions were the most common, accounting for 66% (175 cases) of the 267 skin reactions reported after the first Moderna vaccine dose and 30% (31 cases) of the 102 reactions reported after the second dose. These reactions represented 15% (5 cases) of the 34 skin reactions reported after the first Pfizer vaccine dose and 18% (7 cases) of the 40 reactions after the second dose.

There are two peaks with that first dose, Dr. Freeman said. “There’s a peak around day 2 or 3. And there’s another peak around day 7 or 8 with some of these reactions. Only 27% who had a reaction with the first dose had the same reaction with the second.” She added that these reactions “are not cellulitis and don’t require antibiotics.”

Other more common reactions included local injection-site reactions (swelling, erythema, and pain), urticaria (after 24 hours in almost all cases, occurring at a higher rate in patients who received the Pfizer vaccine), and morbilliform eruptions.

Dr. Freeman said that patients may experience redness and swelling in the hands and feet that can be “very uncomfortable.” She described one patient “who was having a hard time actually closing his fist, just because of the amount of swelling and redness in his hand. It did resolve, and it’s important to reassure your patients it will go away.”

According to this study, less common reports of other cutaneous findings with both vaccines included 9 reports of swelling at the site of cosmetic fillers, 8 reports of pernio/chilblains, 10 reports of varicella zoster, 4 reports of herpes simplex flares, 4 pityriasis rosea–like reactions, and 4 rashes in infants of vaccinated breastfeeding mothers.

The study noted that “patients responded well to topical corticosteroids, oral antihistamines, and/or pain-relieving medications. These reactions resolved after a median of 3-4 days.”

It’s important to understand that none of the patients developed anaphylaxis after the second dose even if they’d had a reaction to the first dose, Dr. Freeman said. “But I should point out that we’re talking about reactions that have started more than 4 hours after the vaccine. If a rash such as a urticaria specifically starts within 4 hours of vaccination, that’s in a different category. Those are considered more immediate allergic reactions, and those patients need to be seen by allergy before a second dose.”

Dr. Freeman added that “it’s really interesting to think about how our bodies are really reacting to the vaccine in a way that’s mimicking our body’s reactions to COVID-19.” For example, some patients who got vaccinated developed chilblains similar to the “COVID toes” described in infected patients, apparently as part of the body’s immune response to the virus. “We’ve seen this in patients who actually had COVID and had prior COVID toes and then actually got a flare with their vaccine. And then we’ve also seen it in patients who never had COVID.”

In regard to general advice for patients, she said, “I do still encourage my patients who previously had COVID to go ahead and get the vaccine even if they had a skin manifestation with COVID.”

Shari Lipner, MD, PhD, associate professor of clinical dermatology, Weill Cornell Medicine, New York, said she has have seen only a handful of cases of delayed large local reactions and local injection site reactions after COVID-19 vaccination. “I have seen a significant number of cases of acute urticaria following the first and second doses,” she said in an interview. “However, it is important to keep in mind that we cannot determine cause and effect for the cases of acute urticaria. They may or may not be vaccine related.”

Fortunately, none of the adverse effects she’s seen have been severe. “It is important that dermatologists educate the public and their patients that most people do not develop any skin reaction in response to the vaccine,” she said. In the minority who do, “reactions tend to be mild and are not life-threatening. Many of these skin reactions resolve on their own without treatment.”

She added that “patients with pernio/chilblains or herpes zoster following vaccination should be referred by a board-certified dermatologist for prompt treatment and to avoid sequelae.”


 

‘COVID vaccine arm’

Delayed local reactions to the Moderna vaccine were also described in a report published online on May 12, 2021, in JAMA Dermatology, after the AAD meeting, in 16 patients referred to the Yale New Haven (Conn.) Hospital Dermatology service who experienced delayed localized cutaneous hypersensitivity reactions a median of 7 days after receiving the vaccine (range, 2-12 days), from Jan. 20 to Feb. 12, 2021. No such cases were reported in Pfizer vaccine recipients.

Of the 16 patients, whose median age was 38 years and who were mostly women, 15 developed the reaction after the first dose, described as “pruritic and variably painful erythematous reactions near the injection site,” which lasted a median of 5 days (range, 1-21 days). After the second dose, 12 of the 16 patients developed injection-site reactions (including one patient who had no reaction after dose 1), a median of 2 days after the vaccine was administered (range, 0-5 days). Histologic results of a biopsy in one patient with a reaction to the second dose “ demonstrated mild predominantly perivascular and focal interstitial mixed infiltrate with lymphocytes and eosinophils consistent with a dermal hypersensitivity reaction,” wrote Alicia J. Little, MD, PhD, of the department of dermatology, Yale University, New Haven, and coauthors.

Compared with immediate hypersensitivity reactions, occurring within 4 hours of vaccination, such as anaphylaxis and urticaria, they concluded that “these delayed localized hypersensitivity reactions are not a contraindication to subsequent vaccination,” and they proposed that they be named “COVID vaccine arm.”

Dr. Freeman reported no disclosures. Dr. Lipner also had no relevant disclosures. Dr. Little reported receiving a grant from the National Center for Advancing Translational Science and a Women’s Health Career Development Award from the Dermatology Foundation while the study was conducted; another author reported equity in Johnson & Johnson in his spouse’s retirement fund outside the submitted work.
 

Federal guidance on indoor mask use may change soon, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on May 9.

He was asked whether it’s time to start relaxing indoor mask requirements.

“I think so, and I think you’re going to probably be seeing that as we go along and as more people get vaccinated,” Dr. Fauci said on ABC News’s This Week.Nearly 150 million adults in the United States – or about 58% of the adult population – have received at least one COVID-19 vaccine dose, according to the latest CDC tally. About 113 million adults, or 44%, are considered fully vaccinated.

“The CDC will be, you know, almost in real time … updating their recommendations and their guidelines,” Dr. Fauci said.

In April, the CDC relaxed its guidance for those who have been vaccinated against COVID-19. Those who have gotten a shot don’t need to wear a mask outdoors or in small indoor gatherings with other vaccinated people, but both vaccinated and unvaccinated people are still advised to wear masks in indoor public spaces.

“We do need to start being more liberal as we get more people vaccinated,” Dr. Fauci said. “As you get more people vaccinated, the number of cases per day will absolutely go down.”

The United States is averaging about 43,000 cases per day, he said, adding that the cases need to be “much, much lower.” When the case numbers drop and vaccination numbers increase, the risk of infection will fall dramatically indoors and outdoors, he said.

Even after the pandemic, though, wearing masks could become a seasonal habit, Dr. Fauci said May 9 on NBC News’s Meet the Press.“I think people have gotten used to the fact that wearing masks, clearly if you look at the data, it diminishes respiratory diseases. We’ve had practically a nonexistent flu season this year,” he said.

“So it is conceivable that as we go on, a year or 2 or more from now, that during certain seasonal periods when you have respiratory-borne viruses like the flu, people might actually elect to wear masks to diminish the likelihood that you’ll spread these respiratory-borne diseases,” he said.

Dr. Fauci was asked about indoor mask guidelines on May 9 after former FDA Commissioner Scott Gottlieb, MD, said face mask requirements should be relaxed.

“Certainly outdoors, we shouldn’t be putting limits on gatherings anymore,” Dr. Gottlieb said on CBS News’s Face the Nation.“The states where prevalence is low, vaccination rates are high, we have good testing in place, and we’re identifying infections, I think we could start lifting these restrictions indoors as well, on a broad basis,” he said.

Lifting pandemic-related restrictions in areas where they’re no longer necessary could also encourage people to implement them again if cases increase during future surges, such as this fall or winter, Dr. Gottlieb said.

At the same time, Americans should continue to follow CDC guidance and wait for new guidelines before changing their indoor mask use, Jeffrey Zients, the White House COVID-19 response coordinator, said on CNN’s State of the Union on May 9.

“We all want to get back to a normal lifestyle,” he said. “I think we’re on the path to do that, but stay disciplined, and let’s take advantage of the new privilege of being vaccinated and not wearing masks outdoors, for example, unless you’re in a crowded place.”

Mr. Zients pointed to President Joe Biden’s goal for 70% of adults to receive at least one vaccine dose by July 4.

“As we all move toward that 70% goal, there will be more and more advantages to being vaccinated,” he said. “And if you’re not vaccinated, you’re not protected.”

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

Federal guidance on indoor mask use may change soon, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on May 9.

He was asked whether it’s time to start relaxing indoor mask requirements.

“I think so, and I think you’re going to probably be seeing that as we go along and as more people get vaccinated,” Dr. Fauci said on ABC News’s This Week.Nearly 150 million adults in the United States – or about 58% of the adult population – have received at least one COVID-19 vaccine dose, according to the latest CDC tally. About 113 million adults, or 44%, are considered fully vaccinated.

“The CDC will be, you know, almost in real time … updating their recommendations and their guidelines,” Dr. Fauci said.

In April, the CDC relaxed its guidance for those who have been vaccinated against COVID-19. Those who have gotten a shot don’t need to wear a mask outdoors or in small indoor gatherings with other vaccinated people, but both vaccinated and unvaccinated people are still advised to wear masks in indoor public spaces.

“We do need to start being more liberal as we get more people vaccinated,” Dr. Fauci said. “As you get more people vaccinated, the number of cases per day will absolutely go down.”

The United States is averaging about 43,000 cases per day, he said, adding that the cases need to be “much, much lower.” When the case numbers drop and vaccination numbers increase, the risk of infection will fall dramatically indoors and outdoors, he said.

Even after the pandemic, though, wearing masks could become a seasonal habit, Dr. Fauci said May 9 on NBC News’s Meet the Press.“I think people have gotten used to the fact that wearing masks, clearly if you look at the data, it diminishes respiratory diseases. We’ve had practically a nonexistent flu season this year,” he said.

“So it is conceivable that as we go on, a year or 2 or more from now, that during certain seasonal periods when you have respiratory-borne viruses like the flu, people might actually elect to wear masks to diminish the likelihood that you’ll spread these respiratory-borne diseases,” he said.

Dr. Fauci was asked about indoor mask guidelines on May 9 after former FDA Commissioner Scott Gottlieb, MD, said face mask requirements should be relaxed.

“Certainly outdoors, we shouldn’t be putting limits on gatherings anymore,” Dr. Gottlieb said on CBS News’s Face the Nation.“The states where prevalence is low, vaccination rates are high, we have good testing in place, and we’re identifying infections, I think we could start lifting these restrictions indoors as well, on a broad basis,” he said.

Lifting pandemic-related restrictions in areas where they’re no longer necessary could also encourage people to implement them again if cases increase during future surges, such as this fall or winter, Dr. Gottlieb said.

At the same time, Americans should continue to follow CDC guidance and wait for new guidelines before changing their indoor mask use, Jeffrey Zients, the White House COVID-19 response coordinator, said on CNN’s State of the Union on May 9.

“We all want to get back to a normal lifestyle,” he said. “I think we’re on the path to do that, but stay disciplined, and let’s take advantage of the new privilege of being vaccinated and not wearing masks outdoors, for example, unless you’re in a crowded place.”

Mr. Zients pointed to President Joe Biden’s goal for 70% of adults to receive at least one vaccine dose by July 4.

“As we all move toward that 70% goal, there will be more and more advantages to being vaccinated,” he said. “And if you’re not vaccinated, you’re not protected.”

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

Federal guidance on indoor mask use may change soon, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on May 9.

He was asked whether it’s time to start relaxing indoor mask requirements.

“I think so, and I think you’re going to probably be seeing that as we go along and as more people get vaccinated,” Dr. Fauci said on ABC News’s This Week.Nearly 150 million adults in the United States – or about 58% of the adult population – have received at least one COVID-19 vaccine dose, according to the latest CDC tally. About 113 million adults, or 44%, are considered fully vaccinated.

“The CDC will be, you know, almost in real time … updating their recommendations and their guidelines,” Dr. Fauci said.

In April, the CDC relaxed its guidance for those who have been vaccinated against COVID-19. Those who have gotten a shot don’t need to wear a mask outdoors or in small indoor gatherings with other vaccinated people, but both vaccinated and unvaccinated people are still advised to wear masks in indoor public spaces.

“We do need to start being more liberal as we get more people vaccinated,” Dr. Fauci said. “As you get more people vaccinated, the number of cases per day will absolutely go down.”

The United States is averaging about 43,000 cases per day, he said, adding that the cases need to be “much, much lower.” When the case numbers drop and vaccination numbers increase, the risk of infection will fall dramatically indoors and outdoors, he said.

Even after the pandemic, though, wearing masks could become a seasonal habit, Dr. Fauci said May 9 on NBC News’s Meet the Press.“I think people have gotten used to the fact that wearing masks, clearly if you look at the data, it diminishes respiratory diseases. We’ve had practically a nonexistent flu season this year,” he said.

“So it is conceivable that as we go on, a year or 2 or more from now, that during certain seasonal periods when you have respiratory-borne viruses like the flu, people might actually elect to wear masks to diminish the likelihood that you’ll spread these respiratory-borne diseases,” he said.

Dr. Fauci was asked about indoor mask guidelines on May 9 after former FDA Commissioner Scott Gottlieb, MD, said face mask requirements should be relaxed.

“Certainly outdoors, we shouldn’t be putting limits on gatherings anymore,” Dr. Gottlieb said on CBS News’s Face the Nation.“The states where prevalence is low, vaccination rates are high, we have good testing in place, and we’re identifying infections, I think we could start lifting these restrictions indoors as well, on a broad basis,” he said.

Lifting pandemic-related restrictions in areas where they’re no longer necessary could also encourage people to implement them again if cases increase during future surges, such as this fall or winter, Dr. Gottlieb said.

At the same time, Americans should continue to follow CDC guidance and wait for new guidelines before changing their indoor mask use, Jeffrey Zients, the White House COVID-19 response coordinator, said on CNN’s State of the Union on May 9.

“We all want to get back to a normal lifestyle,” he said. “I think we’re on the path to do that, but stay disciplined, and let’s take advantage of the new privilege of being vaccinated and not wearing masks outdoors, for example, unless you’re in a crowded place.”

Mr. Zients pointed to President Joe Biden’s goal for 70% of adults to receive at least one vaccine dose by July 4.

“As we all move toward that 70% goal, there will be more and more advantages to being vaccinated,” he said. “And if you’re not vaccinated, you’re not protected.”

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

The Food and Drug Administration on May 10 granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.  

The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.

Acting FDA Commissioner Janet Woodcock, MD, called the decision “a significant step” in “returning to a sense of normalcy.”

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

The Pfizer adolescent vaccine is not yet a done deal, though.

Next, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide on May 12 whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.

The FDA action on May 10 amends the Dec. 11, 2020, emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.

The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna also has launched clinical trials in children.

Most health experts have said the United States needs to vaccinate children before the COVID-19 pandemic can truly be brought under control. The 12- to 15-year-old group represents 17 million people, about 5% of the population. Thus far, 58% of U.S. adults have had at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.

American Academy of Pediatrics President Lee Savio Beers, MD, praised the agency’s decision, calling it a “critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”

President Joe Biden recently announced a new strategy for expanding vaccinations in which vaccinating 12- to 15-year-olds was a key component. He said the administration was ready to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.

In March, Anthony S. Fauci, MD, told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. … We ultimately would like to get and have to get children into that mix.” 

Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12-15 in clinical trials.

Though most children have milder symptoms when infected with the coronavirus, about 1.5 million cases in children aged 11-17 were reported to the CDC between March 1, 2020, and April 30 of this year, the FDA news release said.

Albert Bourla, CEO of Pfizer, tweeted that “today brings very encouraging news for families and adolescents across the United States.

“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world. In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts,” he said. 

“It’s essential for children to be vaccinated against COVID-19. According to data compiled by the AAP and Children’s Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic,” said Dr. Savio Beers. “While fewer children than adults have suffered the most severe disease, this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatricians about how to get the vaccine for their adolescents as soon as they are eligible.”

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

The Food and Drug Administration on May 10 granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.  

The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.

Acting FDA Commissioner Janet Woodcock, MD, called the decision “a significant step” in “returning to a sense of normalcy.”

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

The Pfizer adolescent vaccine is not yet a done deal, though.

Next, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide on May 12 whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.

The FDA action on May 10 amends the Dec. 11, 2020, emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.

The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna also has launched clinical trials in children.

Most health experts have said the United States needs to vaccinate children before the COVID-19 pandemic can truly be brought under control. The 12- to 15-year-old group represents 17 million people, about 5% of the population. Thus far, 58% of U.S. adults have had at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.

American Academy of Pediatrics President Lee Savio Beers, MD, praised the agency’s decision, calling it a “critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”

President Joe Biden recently announced a new strategy for expanding vaccinations in which vaccinating 12- to 15-year-olds was a key component. He said the administration was ready to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.

In March, Anthony S. Fauci, MD, told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. … We ultimately would like to get and have to get children into that mix.” 

Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12-15 in clinical trials.

Though most children have milder symptoms when infected with the coronavirus, about 1.5 million cases in children aged 11-17 were reported to the CDC between March 1, 2020, and April 30 of this year, the FDA news release said.

Albert Bourla, CEO of Pfizer, tweeted that “today brings very encouraging news for families and adolescents across the United States.

“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world. In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts,” he said. 

“It’s essential for children to be vaccinated against COVID-19. According to data compiled by the AAP and Children’s Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic,” said Dr. Savio Beers. “While fewer children than adults have suffered the most severe disease, this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatricians about how to get the vaccine for their adolescents as soon as they are eligible.”

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

The Food and Drug Administration on May 10 granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.  

The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.

Acting FDA Commissioner Janet Woodcock, MD, called the decision “a significant step” in “returning to a sense of normalcy.”

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

The Pfizer adolescent vaccine is not yet a done deal, though.

Next, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide on May 12 whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.

The FDA action on May 10 amends the Dec. 11, 2020, emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.

The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna also has launched clinical trials in children.

Most health experts have said the United States needs to vaccinate children before the COVID-19 pandemic can truly be brought under control. The 12- to 15-year-old group represents 17 million people, about 5% of the population. Thus far, 58% of U.S. adults have had at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.

American Academy of Pediatrics President Lee Savio Beers, MD, praised the agency’s decision, calling it a “critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”

President Joe Biden recently announced a new strategy for expanding vaccinations in which vaccinating 12- to 15-year-olds was a key component. He said the administration was ready to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.

In March, Anthony S. Fauci, MD, told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. … We ultimately would like to get and have to get children into that mix.” 

Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12-15 in clinical trials.

Though most children have milder symptoms when infected with the coronavirus, about 1.5 million cases in children aged 11-17 were reported to the CDC between March 1, 2020, and April 30 of this year, the FDA news release said.

Albert Bourla, CEO of Pfizer, tweeted that “today brings very encouraging news for families and adolescents across the United States.

“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world. In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts,” he said. 

“It’s essential for children to be vaccinated against COVID-19. According to data compiled by the AAP and Children’s Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic,” said Dr. Savio Beers. “While fewer children than adults have suffered the most severe disease, this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatricians about how to get the vaccine for their adolescents as soon as they are eligible.”

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

NSAIDs don’t boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.

Denise Fulton/MDedge News

“To our knowledge, our prospective study includes the largest number of patients admitted to hospital with COVID-19 to date, and adds to the literature on the safety of NSAIDs and in-hospital outcomes. NSAIDs do not appear to increase the risk of worse in-hospital outcomes ...” the study authors wrote. “NSAIDs are an important analgesic modality and have a vital opioid-sparing role in pain management. Patients and clinicians should be reassured by these findings that NSAIDs are safe in the context of the pandemic.”

The report was published online May 7 in The Lancet Rheumatology and led by clinical research fellow Thomas M. Drake, MBChB, of the University of Edinburgh’s Usher Institute.

For more than a year, researchers worldwide have debated about whether NSAIDs spell trouble for people at risk of COVID-19. In March 2020, French health officials announced that use of the painkillers such as NSAIDs may increase the severity of the disease, and they recommended that patients take acetaminophen instead. The National Health Service in the United Kingdom made a similar recommendation. But other agencies didn’t believe there was enough evidence to support ditching NSAIDs, and recent research studies published in Annals of the Rheumatic Diseases and PLoS Medicine suggested they may be right.

For the new study, researchers identified 72,179 patients who were treated for COVID-19 in British hospitals during January-August 2020. About 56% were men, 74% were White, and 6% took NSAIDs on a regular basis before they entered the hospital. The average age was 70.

The researchers examined whether the patients in either group were more or less likely to die in the hospital, be admitted into a critical care unit, need oxygen treatment, need a ventilator, or suffer kidney injury.

In terms of outcomes, there weren’t any major gaps between the groups overall. The differences in most comparisons were statistically insignificant. For example, 31% of those who didn’t take NSAIDs died vs. 30% of those who did (P = .227). In both groups, 14% required critical care admission (P = .476).

The researchers then focused on two matched groups of 4,205 patients: One group used NSAIDs regularly, and the other group didn’t. The difference in risk of death in those who took NSAIDs vs. those who didn’t was statistically insignificant (odds ratio, 0.95; 95% confidence interval, 0.84-1.07; P = .35). Other comparisons were also statistically insignificant.

The findings offer insight into whether the use of NSAIDs might actually be helpful for patients who develop COVID-19. Scientists believe that COVID-19 is linked to inflammation in the body, and NSAIDs, of course, reduce inflammation. But the researchers didn’t turn up any sign of a benefit.

The new study has some weaknesses: It doesn’t say anything about whether NSAIDs have an impact on whether people get COVID-19 in the first place. Researchers don’t know if high use of NSAIDs may affect the severity of the disease. And it doesn’t examine the potential effect of acetaminophen, although other research suggests the drug also may not cause harm in patients with COVID-19.

Still, the researchers say the study is the largest of its kind to look at the use of NSAIDs by patients who are admitted to the hospital with COVID-19. “Considering all the evidence, if there was an extreme effect of NSAIDs on COVID-19 outcomes or severity, this would have been observed in one or more of the studies that have been done, including the present study,” they wrote.

In a commentary that accompanied the study, three physicians from hospitals in Denmark, led by Kristian Kragholm, MD, of Aalborg University Hospital, praised the research and wrote that it adds to “a growing body of evidence” that NSAIDs don’t make things worse for patients with COVID-19.

The study was funded by the U.K. National Institute for Health Research and the U.K. Medical Research Council. The study and commentary authors reported no relevant disclosures.

NSAIDs don’t boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.

Denise Fulton/MDedge News

“To our knowledge, our prospective study includes the largest number of patients admitted to hospital with COVID-19 to date, and adds to the literature on the safety of NSAIDs and in-hospital outcomes. NSAIDs do not appear to increase the risk of worse in-hospital outcomes ...” the study authors wrote. “NSAIDs are an important analgesic modality and have a vital opioid-sparing role in pain management. Patients and clinicians should be reassured by these findings that NSAIDs are safe in the context of the pandemic.”

The report was published online May 7 in The Lancet Rheumatology and led by clinical research fellow Thomas M. Drake, MBChB, of the University of Edinburgh’s Usher Institute.

For more than a year, researchers worldwide have debated about whether NSAIDs spell trouble for people at risk of COVID-19. In March 2020, French health officials announced that use of the painkillers such as NSAIDs may increase the severity of the disease, and they recommended that patients take acetaminophen instead. The National Health Service in the United Kingdom made a similar recommendation. But other agencies didn’t believe there was enough evidence to support ditching NSAIDs, and recent research studies published in Annals of the Rheumatic Diseases and PLoS Medicine suggested they may be right.

For the new study, researchers identified 72,179 patients who were treated for COVID-19 in British hospitals during January-August 2020. About 56% were men, 74% were White, and 6% took NSAIDs on a regular basis before they entered the hospital. The average age was 70.

The researchers examined whether the patients in either group were more or less likely to die in the hospital, be admitted into a critical care unit, need oxygen treatment, need a ventilator, or suffer kidney injury.

In terms of outcomes, there weren’t any major gaps between the groups overall. The differences in most comparisons were statistically insignificant. For example, 31% of those who didn’t take NSAIDs died vs. 30% of those who did (P = .227). In both groups, 14% required critical care admission (P = .476).

The researchers then focused on two matched groups of 4,205 patients: One group used NSAIDs regularly, and the other group didn’t. The difference in risk of death in those who took NSAIDs vs. those who didn’t was statistically insignificant (odds ratio, 0.95; 95% confidence interval, 0.84-1.07; P = .35). Other comparisons were also statistically insignificant.

The findings offer insight into whether the use of NSAIDs might actually be helpful for patients who develop COVID-19. Scientists believe that COVID-19 is linked to inflammation in the body, and NSAIDs, of course, reduce inflammation. But the researchers didn’t turn up any sign of a benefit.

The new study has some weaknesses: It doesn’t say anything about whether NSAIDs have an impact on whether people get COVID-19 in the first place. Researchers don’t know if high use of NSAIDs may affect the severity of the disease. And it doesn’t examine the potential effect of acetaminophen, although other research suggests the drug also may not cause harm in patients with COVID-19.

Still, the researchers say the study is the largest of its kind to look at the use of NSAIDs by patients who are admitted to the hospital with COVID-19. “Considering all the evidence, if there was an extreme effect of NSAIDs on COVID-19 outcomes or severity, this would have been observed in one or more of the studies that have been done, including the present study,” they wrote.

In a commentary that accompanied the study, three physicians from hospitals in Denmark, led by Kristian Kragholm, MD, of Aalborg University Hospital, praised the research and wrote that it adds to “a growing body of evidence” that NSAIDs don’t make things worse for patients with COVID-19.

The study was funded by the U.K. National Institute for Health Research and the U.K. Medical Research Council. The study and commentary authors reported no relevant disclosures.

NSAIDs don’t boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.

Denise Fulton/MDedge News

“To our knowledge, our prospective study includes the largest number of patients admitted to hospital with COVID-19 to date, and adds to the literature on the safety of NSAIDs and in-hospital outcomes. NSAIDs do not appear to increase the risk of worse in-hospital outcomes ...” the study authors wrote. “NSAIDs are an important analgesic modality and have a vital opioid-sparing role in pain management. Patients and clinicians should be reassured by these findings that NSAIDs are safe in the context of the pandemic.”

The report was published online May 7 in The Lancet Rheumatology and led by clinical research fellow Thomas M. Drake, MBChB, of the University of Edinburgh’s Usher Institute.

For more than a year, researchers worldwide have debated about whether NSAIDs spell trouble for people at risk of COVID-19. In March 2020, French health officials announced that use of the painkillers such as NSAIDs may increase the severity of the disease, and they recommended that patients take acetaminophen instead. The National Health Service in the United Kingdom made a similar recommendation. But other agencies didn’t believe there was enough evidence to support ditching NSAIDs, and recent research studies published in Annals of the Rheumatic Diseases and PLoS Medicine suggested they may be right.

For the new study, researchers identified 72,179 patients who were treated for COVID-19 in British hospitals during January-August 2020. About 56% were men, 74% were White, and 6% took NSAIDs on a regular basis before they entered the hospital. The average age was 70.

The researchers examined whether the patients in either group were more or less likely to die in the hospital, be admitted into a critical care unit, need oxygen treatment, need a ventilator, or suffer kidney injury.

In terms of outcomes, there weren’t any major gaps between the groups overall. The differences in most comparisons were statistically insignificant. For example, 31% of those who didn’t take NSAIDs died vs. 30% of those who did (P = .227). In both groups, 14% required critical care admission (P = .476).

The researchers then focused on two matched groups of 4,205 patients: One group used NSAIDs regularly, and the other group didn’t. The difference in risk of death in those who took NSAIDs vs. those who didn’t was statistically insignificant (odds ratio, 0.95; 95% confidence interval, 0.84-1.07; P = .35). Other comparisons were also statistically insignificant.

The findings offer insight into whether the use of NSAIDs might actually be helpful for patients who develop COVID-19. Scientists believe that COVID-19 is linked to inflammation in the body, and NSAIDs, of course, reduce inflammation. But the researchers didn’t turn up any sign of a benefit.

The new study has some weaknesses: It doesn’t say anything about whether NSAIDs have an impact on whether people get COVID-19 in the first place. Researchers don’t know if high use of NSAIDs may affect the severity of the disease. And it doesn’t examine the potential effect of acetaminophen, although other research suggests the drug also may not cause harm in patients with COVID-19.

Still, the researchers say the study is the largest of its kind to look at the use of NSAIDs by patients who are admitted to the hospital with COVID-19. “Considering all the evidence, if there was an extreme effect of NSAIDs on COVID-19 outcomes or severity, this would have been observed in one or more of the studies that have been done, including the present study,” they wrote.

In a commentary that accompanied the study, three physicians from hospitals in Denmark, led by Kristian Kragholm, MD, of Aalborg University Hospital, praised the research and wrote that it adds to “a growing body of evidence” that NSAIDs don’t make things worse for patients with COVID-19.

The study was funded by the U.K. National Institute for Health Research and the U.K. Medical Research Council. The study and commentary authors reported no relevant disclosures.

The use of braces or insoles in combination with nonbiomechanical treatments appear to deliver the greatest pain relief for patients with medial tibiofemoral osteoarthritis, although the evidence supporting these interventions has a high degree of uncertainty, according findings from a large meta-analysis of randomized, controlled trials presented at the OARSI 2021 World Congress.

Thinkstock/Zinkevych

“It’s been highlighted for several years now that due to the high rate of joint replacement, we need to promote more effective nonsurgical treatments,” Ans van Ginckel, PhD, of Ghent (Belgium) University, told the conference.

However, guidelines on the use of biomechanical treatments for knee OA pain vary widely, and there are few studies that compare the effectiveness of different interventions.

To address this, Dr. van Ginckel and colleagues conducted a network meta-analysis of 27 randomized, controlled trials – involving a total of 2,413 participants – of biomechanical treatments for knee OA pain. The treatments included were valgus braces, combined brace treatment (with added nonbiomechanical treatment), lateral or medial wedged insoles, combined insole treatment (with added nonbiomechanical treatment), contralateral cane use, gait retraining, and modified shoes.

“These treatments are mainly based on the premise that people with knee osteoarthritis likely experience a higher external knee adduction moment during walking, compared to healthy people,” Dr. van Ginckel told the conference, which is sponsored by the Osteoarthritis Research Society International. “This has been associated to some extent with disease onset, severity, and progression.”

When compared to nonbiomechanical controls, walking sticks and canes were the only intervention that showed a benefit in reducing pain, although the authors described the data supporting this as “high risk.”

When all the treatments were ranked according to the degree of pain relief seen in studies, combined insole and/or combined brace treatments showed the greatest degree of benefit.

However, Dr. van Ginckel said the evidence supporting even these treatments was of low to very low certainty, there was significant variation in the control treatments used in the studies, and the confidence intervals were wide. This also reflected the multifactorial nature of pain in knee OA, she said.

“A plausible explanation is the partial role in the biomechanics of the pathogenesis of pain and the multifactorial nature of pain,” she said.

Commenting on the study, Rik Lories, MD, PhD, head of the division of rheumatology at University Hospitals Leuven (Belgium) and of the department of development and regeneration at Catholic University Leuven, said the findings of the analysis show how difficult it is to study biomechanical interventions for knee OA.

“It was a smart approach to try to get some more information about a wide array of studies that have been performed, being selective with regards to what to include,” Dr. Lories said. “It’s still a big challenge in terms of how do you control for confounders.”

Dr. Lories said that he took a positive view of the findings, suggesting that these interventions are unlikely to cause harm, and are therefore “not a road to avoid” in helping to reduce knee OA pain. But he also argued that the analysis pointed to a clear need for better studies of biomechanical interventions for knee OA. “I think that’s an important message that somehow the field has to improve the quality of their trials,” he said in an interview, although he acknowledged that such trials may be difficult to run and get funding for.

Dr. van Ginckel was supported by an EU Horizon 2020 fellowship, and a coauthor was supported by the Australian National Health and Medical Research Council. No conflicts of interest were declared.

The use of braces or insoles in combination with nonbiomechanical treatments appear to deliver the greatest pain relief for patients with medial tibiofemoral osteoarthritis, although the evidence supporting these interventions has a high degree of uncertainty, according findings from a large meta-analysis of randomized, controlled trials presented at the OARSI 2021 World Congress.

Thinkstock/Zinkevych

“It’s been highlighted for several years now that due to the high rate of joint replacement, we need to promote more effective nonsurgical treatments,” Ans van Ginckel, PhD, of Ghent (Belgium) University, told the conference.

However, guidelines on the use of biomechanical treatments for knee OA pain vary widely, and there are few studies that compare the effectiveness of different interventions.

To address this, Dr. van Ginckel and colleagues conducted a network meta-analysis of 27 randomized, controlled trials – involving a total of 2,413 participants – of biomechanical treatments for knee OA pain. The treatments included were valgus braces, combined brace treatment (with added nonbiomechanical treatment), lateral or medial wedged insoles, combined insole treatment (with added nonbiomechanical treatment), contralateral cane use, gait retraining, and modified shoes.

“These treatments are mainly based on the premise that people with knee osteoarthritis likely experience a higher external knee adduction moment during walking, compared to healthy people,” Dr. van Ginckel told the conference, which is sponsored by the Osteoarthritis Research Society International. “This has been associated to some extent with disease onset, severity, and progression.”

When compared to nonbiomechanical controls, walking sticks and canes were the only intervention that showed a benefit in reducing pain, although the authors described the data supporting this as “high risk.”

When all the treatments were ranked according to the degree of pain relief seen in studies, combined insole and/or combined brace treatments showed the greatest degree of benefit.

However, Dr. van Ginckel said the evidence supporting even these treatments was of low to very low certainty, there was significant variation in the control treatments used in the studies, and the confidence intervals were wide. This also reflected the multifactorial nature of pain in knee OA, she said.

“A plausible explanation is the partial role in the biomechanics of the pathogenesis of pain and the multifactorial nature of pain,” she said.

Commenting on the study, Rik Lories, MD, PhD, head of the division of rheumatology at University Hospitals Leuven (Belgium) and of the department of development and regeneration at Catholic University Leuven, said the findings of the analysis show how difficult it is to study biomechanical interventions for knee OA.

“It was a smart approach to try to get some more information about a wide array of studies that have been performed, being selective with regards to what to include,” Dr. Lories said. “It’s still a big challenge in terms of how do you control for confounders.”

Dr. Lories said that he took a positive view of the findings, suggesting that these interventions are unlikely to cause harm, and are therefore “not a road to avoid” in helping to reduce knee OA pain. But he also argued that the analysis pointed to a clear need for better studies of biomechanical interventions for knee OA. “I think that’s an important message that somehow the field has to improve the quality of their trials,” he said in an interview, although he acknowledged that such trials may be difficult to run and get funding for.

Dr. van Ginckel was supported by an EU Horizon 2020 fellowship, and a coauthor was supported by the Australian National Health and Medical Research Council. No conflicts of interest were declared.

The use of braces or insoles in combination with nonbiomechanical treatments appear to deliver the greatest pain relief for patients with medial tibiofemoral osteoarthritis, although the evidence supporting these interventions has a high degree of uncertainty, according findings from a large meta-analysis of randomized, controlled trials presented at the OARSI 2021 World Congress.

Thinkstock/Zinkevych

“It’s been highlighted for several years now that due to the high rate of joint replacement, we need to promote more effective nonsurgical treatments,” Ans van Ginckel, PhD, of Ghent (Belgium) University, told the conference.

However, guidelines on the use of biomechanical treatments for knee OA pain vary widely, and there are few studies that compare the effectiveness of different interventions.

To address this, Dr. van Ginckel and colleagues conducted a network meta-analysis of 27 randomized, controlled trials – involving a total of 2,413 participants – of biomechanical treatments for knee OA pain. The treatments included were valgus braces, combined brace treatment (with added nonbiomechanical treatment), lateral or medial wedged insoles, combined insole treatment (with added nonbiomechanical treatment), contralateral cane use, gait retraining, and modified shoes.

“These treatments are mainly based on the premise that people with knee osteoarthritis likely experience a higher external knee adduction moment during walking, compared to healthy people,” Dr. van Ginckel told the conference, which is sponsored by the Osteoarthritis Research Society International. “This has been associated to some extent with disease onset, severity, and progression.”

When compared to nonbiomechanical controls, walking sticks and canes were the only intervention that showed a benefit in reducing pain, although the authors described the data supporting this as “high risk.”

When all the treatments were ranked according to the degree of pain relief seen in studies, combined insole and/or combined brace treatments showed the greatest degree of benefit.

However, Dr. van Ginckel said the evidence supporting even these treatments was of low to very low certainty, there was significant variation in the control treatments used in the studies, and the confidence intervals were wide. This also reflected the multifactorial nature of pain in knee OA, she said.

“A plausible explanation is the partial role in the biomechanics of the pathogenesis of pain and the multifactorial nature of pain,” she said.

Commenting on the study, Rik Lories, MD, PhD, head of the division of rheumatology at University Hospitals Leuven (Belgium) and of the department of development and regeneration at Catholic University Leuven, said the findings of the analysis show how difficult it is to study biomechanical interventions for knee OA.

“It was a smart approach to try to get some more information about a wide array of studies that have been performed, being selective with regards to what to include,” Dr. Lories said. “It’s still a big challenge in terms of how do you control for confounders.”

Dr. Lories said that he took a positive view of the findings, suggesting that these interventions are unlikely to cause harm, and are therefore “not a road to avoid” in helping to reduce knee OA pain. But he also argued that the analysis pointed to a clear need for better studies of biomechanical interventions for knee OA. “I think that’s an important message that somehow the field has to improve the quality of their trials,” he said in an interview, although he acknowledged that such trials may be difficult to run and get funding for.

Dr. van Ginckel was supported by an EU Horizon 2020 fellowship, and a coauthor was supported by the Australian National Health and Medical Research Council. No conflicts of interest were declared.

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

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

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

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

Cardiothoracic surgeon J. Marvin Smith III, MD, had always thrived on a busy practice schedule, often performing 20-30 surgeries a week. A practicing surgeon for more than 40 years, Dr. Smith said he had no plans to slow down anytime soon.

But Dr. Smith said his career was derailed when leaders at Methodist Healthcare System of San Antonio initiated a sudden peer review proceeding against him. The hospital system alleged certain surgeries performed by Dr. Smith had excessive mortality rates. When he proved the data inaccurate, Dr. Smith said administrators next claimed he was cognitively impaired and wasn’t safe to practice.

Dr. Smith has now been embroiled in a peer review dispute with the hospital system for more than 2 years and says the conflict has essentially forced him out of surgical practice. He believes the peer review was “malicious” and was really launched because of complaints he made about nurse staffing and other issues at the hospital.

“I think it is absolutely in bad faith and is disingenuous what they’ve told me along the way,” said Dr. Smith, 73. “It’s because I pointed out deficiencies in nursing care, and they want to get rid of me. It would be a lot easier for them if I had a contract and they could control me better. But the fact that I was independent, meant they had to resort to a malicious peer review to try and push me out.”

Dr. Smith had a peer review hearing with Methodist in March 2021, and in April, a panel found in Dr. Smith’s favor, according to Dr. Smith. The findings were sent to the hospital’s medical board for review, which issued a decision in early May.

Eric A. Pullen, an attorney for Dr. Smith, said he could not go into detail about the board’s decision for legal reasons, but that “the medical board’s decision did not completely resolve the matter, and Dr. Smith intends to exercise his procedural rights, which could include an appeal.”

Methodist Hospital Texsan and its parent company, Methodist Health System of San Antonio, did not respond to messages seeking comment about the case. Without hearing from the hospital system, its side is unknown and it is unclear if there is more to the story from Methodist’s view.

Malicious peer review – also called sham peer review – is defined as misusing the medical peer review process for malevolent purposes, such as to silence or to remove a physician. The problem is not new, but some experts, such as Lawrence Huntoon, MD, PhD, say the practice has become more common in recent years, particularly against independent doctors.

Dr. Huntoon believes there is a nationwide trend at many hospitals to get rid of independent physicians and replace them with employed doctors, he said.

However, because most sham peer reviews go on behind closed doors, there are no data to pinpoint its prevalence or measure its growth.

“Independent physicians are basically being purged from medical staffs across the United States,” said Dr. Huntoon, who is chair of the Association of American Physicians and Surgeons’ Committee to Combat Sham Peer Review. “The hospitals want more control over how physicians practice and who they refer to, and they do that by having employees.”

Anthony P. Weiss, MD, MBA, chief medical officer for Beth Israel Deaconess Medical Center said it has not been his experience that independent physicians are being targeted in such a way. Dr. Weiss responded to an inquiry sent to the American Hospital Association for this story.

“As the authority for peer review rests with the organized medical staff (i.e., physicians), and not formally with the hospital per se, the peer review lever is not typically available as a management tool for hospital administration,” said Dr. Weiss, who is a former member of the AHA’s Committee on Clinical Leadership, but who was speaking on behalf of himself.

A spokesman for the AHA said the organization stands behinds Dr. Weiss’ comments.

Peer review remains a foundational aspect of overseeing the safety and appropriateness of healthcare provided by physicians, Dr. Weiss said. Peer review likely varies from hospital to hospital, he added, although the Healthcare Quality Improvement Act provides some level of guidance as does the American Medical Association Code of Medical Ethics (section 9.4.1).

“In essence, both require that the evaluation be conducted in good faith with the intention to improve care, by physicians with adequate training and knowledge, using a process that is fair and inclusive of the physician under review,” he said. “I believe that most medical staffs abide by these ethical principles, but we have little data to confirm this supposition.”
 

Did hospital target doc for being vocal?

When members of Methodist’s medical staff first approached Dr. Smith with concerns about his surgery outcomes in November 2018, the physician says he was surprised, but that he was open to an assessment.

“They came to me and said they thought my numbers were bad, and I said: ‘Well my gosh, I certainly don’t want that to be the case. I need to see what numbers you are talking about,’ ” Dr. Smith recalled. “I’ve been president of the Bexar County Medical Society; I’ve been involved with standards and ethics for the Society of Thoracic Surgeons. Quality health care means a whole lot to me.”

The statistical information provided by hospital administrators indicated that Dr. Smith’s mortality rates for coronary artery surgery in 2018 were “excessive” and that his rates for aortic surgery were “unacceptable,” according to a lawsuit Dr. Smith filed against the hospital system. Dr. Smith, who is double boarded with the American Board of Surgery and the American Board of Thoracic Surgery, said his outcomes had never come into question in the past. Dr. Smith said the timing was suspicious to him, however, considering he had recently raised concerns with the hospital through letters about nursing performance, staffing, and compensation.

A peer review investigation was initiated. In the meantime, Dr. Smith agreed to intensivist consults on his postoperative patients and consults with the hospital’s “Heart Team” on all preoperative cardiac, valve, and aortic cases. A vocal critic of the Heart Team, Dr. Smith had long contended the entity provided no meaningful benefit to his patients in most cases and, rather, increased hospital stays and raised medical expenses. Despite his agreement, Dr. Smith was later asked to voluntarily stop performing surgeries at the hospital.

“I agreed, convinced that we’d get this all settled,” he said.

Another report issued by the hospital in 2019 also indicated elevated mortality rates associated with some of Smith’s surgeries, although the document differed from the first report, according to the lawsuit. Dr. Smith says he was ignored when he pointed out problems with the data, including a lack of appropriate risk stratification in the report, departure from Society of Thoracic Surgeons data rules, and improper inclusion of his cases in the denominator of the ratio when a comparison was made of his outcomes with those hospitalwide. A subsequent report from Methodist in March 2019 indicated Dr. Smith’s surgery outcomes were “within the expected parameters of performance,” according to court documents.

The surgery accusations were dropped, but the peer review proceeding against Dr. Smith wasn’t over. The hospital next requested that Dr. Smith undergo a competency evaluation.

“When they realized the data was bad, they then changed their argument in the peer review proceeding and essentially started to argue that Dr. Smith had some sort of cognitive disability that prevented him from continuing to practice,” said Mr. Pullen. “The way I look at it, when the initial basis for the peer review was proven false, the hospital found something else and some other reason to try to keep Dr. Smith from practicing.”

Thus began a lengthy disagreement about which entity would conduct the evaluation, who would pay, and the type of acceptable assessment. An evaluation by the hospital’s preferred organization resulted in a finding of mild cognitive impairment, Dr. Smith said. He hired his own experts who conducted separate evaluations, finding no impairment and no basis for the former evaluation’s conclusion.

“Literally, the determinant as to whether I was normal or below normal on their test was one point, which was associated with a finding that I didn’t draw a clock correctly,” Dr. Smith claimed. “The reviewer said my minute hand was a little too short and docked me a point. It was purely subjective. To me, the gold standard of whether you are learned in thoracic surgery is the American Board of Thoracic Surgery’s test. The board’s test shows my cognitive ability is entirely in keeping with my practice. That contrasts with the one point off I got for drawing a clock wrong in somebody’s estimation.”
 

Conflict leads to legal case

In September 2020, Dr. Smith filed a lawsuit against Methodist Healthcare System of San Antonio, alleging business disparagement by Methodist for allegedly publishing false and disparaging information about Dr. Smith and tortious interference with business relations. The latter claim stems from Methodist refusing to provide documents to other hospitals about the status of Dr. Smith’s privileges at Methodist, Mr. Pullen said.

Because Methodist refused to confirm his status, the renewal process for Baptist Health System could not be completed and Dr. Smith lost his privileges at Baptist Health System facilities, according to the lawsuit.

Notably, Dr. Smith’s legal challenge also asks the court to take a stance against alleged amendments by Methodist to its Unified Medical Staff Bylaws. The hospital allegedly proposed changes that would prevent physicians from seeking legal action against the hospital for malicious peer review, according to Dr. Smith’s lawsuit.

The amendments would make the peer review process itself the “sole and exclusive remedy with respect to any action or recommendation taken at the hospital affecting medical staff appointment and/or clinical privileges,” according to an excerpt of the proposed amendments included in Dr. Smith’s lawsuit. In addition, the changes would hold practitioners liable for lost revenues if the doctor initiates “any type of legal action challenging credentialing, privileging, or other medical peer review or professional review activity,” according to the lawsuit.

Dr. Smith’s lawsuit seeks a declaration that the proposed amendments to the bylaws are “void as against public policy,” and a declaration that the proposed amendments to the bylaws cannot take away physicians’ statutory right to bring litigation against Methodist for malicious peer review.

“The proposed amendments have a tendency to and will injure the public good,” Dr. Smith argued in the lawsuit. “The proposed amendments allow Methodist to act with malice and in bad faith in conducting peer review proceedings and face no legal repercussions.”

Regardless of the final outcome of the peer review proceeding, Mr. Pullen said the harm Dr. Smith has already endured cannot be reversed.

“Even if comes out in his favor, the damage is already done,” he said. “It will not remedy the damage Dr. Smith has incurred.”
 

Fighting sham peer review is difficult

Battling a malicious peer review has long been an uphill battle for physicians, according to Dr. Huntoon. That’s because the Health Care Quality Improvement Act (HCQIA), a federal law passed in 1986, provides near absolute immunity to hospitals and peer reviewers in legal disputes.

The HCQIA was created by Congress to extend immunity to good-faith peer review of doctors and to increase overall participation in peer review by removing fear of litigation. However, the act has also enabled abuse of peer review by shielding bad-faith reviewers from accountability, said Dr. Huntoon.

“The Health Care Quality Improvement Act presumes that what the hospital did was warranted and reasonable and shifts the burden to the physician to prove his innocence by a preponderance of evidence,” he said. “That’s an entirely foreign concept to most people who think a person should be considered innocent until proven guilty. Here, it’s the exact opposite.”

The HCQIA has been challenged numerous times over the years and tested at the appellate level, but continues to survive and remain settled law, added Richard B. Willner, DPM, founder and director of the Center for Peer Review Justice, which assists and counsels physicians about sham peer review.

In 2011, former Rep. Joe Heck, DO, (R-Nev.) introduced a bill that would have amended the HCQIA to prohibit a professional review entity from submitting a report to the National Practitioner Data Bank (NPDB) while the doctor was still under investigation and before the doctor was afforded adequate notice and a hearing. Although the measure had 16 cosponsors and plenty of support from the physician community, it failed.

In addition to a heavy legal burden, physicians who experience malicious peer reviews also face ramifications from being reported to the NPDB. Peer review organizations are required to report certain negative actions or findings to the NPDB.

“A databank entry is a scarlet letter on your forehead,” Dr. Willner said. “The rules at a lot of institutions are not to take anyone who has been databanked, rightfully or wrongfully. And what is the evidence necessary to databank you? None. There’s no evidence needed to databank somebody.”

Despite the bleak landscape, experts say progress has been made on a case-by-case basis by physicians who have succeeded in fighting back against questionable peer reviews in recent years.

In January 2020, Indiana ob.gyn. Rebecca Denman, MD, prevailed in her defamation lawsuit against St Vincent Carmel Hospital and St Vincent Carmel Medical Group, winning $4.75 million in damages. Dr. Denman alleged administrators failed to conduct a proper peer review investigation after a false allegation by a nurse that she was under the influence while on the job.

Indianapolis attorney Kathleen A. DeLaney, who represented Dr. Denman, said hospital leaders misled Dr. Denman into believing a peer review had occurred when no formal peer review hearing or proceeding took place.

“The CMO of the medical group claimed that he performed a peer review ‘screening,’ but he never informed the other members of the peer review executive committee of the matter until after he had placed Dr. Denman on administrative leave,” Ms. DeLaney said. “He also neglected to tell the peer review executive committee that the substance abuse policy had not been followed, or that Dr. Denman had not been tested for alcohol use – due to the 12-hour delay in report.”

Dr. Denman was ultimately required to undergo an alcohol abuse evaluation, enter a treatment program, and sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit. She claimed repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

She sued the hospital in July 2018, alleging fraud, defamation, tortious interference with an employment relationship, and negligent misrepresentation. After a 4-day trial, jurors found in her favor, awarding Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

A hospital spokesperson said Ascension St Vincent is pursuing an appeal, and that it looks “forward to the opportunity to bring this matter before the Indiana Court of Appeals in June.”

In another case, South Dakota surgeon Linda Miller, MD, was awarded $1.1 million in 2017 after a federal jury found Huron Regional Medical Center breached her contract and violated her due process rights. Dr. Miller became the subject of a peer review at Huron Regional Medical Center when the hospital began analyzing some of her surgery outcomes.

Ken Barker, an attorney for Dr. Miller, said he feels it became evident at trial that the campaign to force Dr. Miller to either resign or lose her privileges was led by the lay board of directors of the hospital and upper-level administration at the hospital.

“They began the process by ordering an unprecedented 90-day review of her medical charts, looking for errors in the medical care she provided patients,” he said. “They could find nothing, so they did a second 90-day review, waiting for a patient’s ‘bad outcome.’ As any general surgeon will say, a ‘bad outcome’ is inevitable. And so it was. Upon that occurrence, they had a medical review committee review the patient’s chart and use it as an excuse to force her to reduce her privileges. Unbeknown to Dr. Miller, an external review had been conducted on another patient’s chart, in which the external review found her care above the standards and, in some measure, ‘exemplary.’ ”

Dr. Miller was eventually pressured to resign, according to her claim. Because of reports made to the NPDB by the medical center, including a patient complication that was allegedly falsified by the hospital, Dr. Miller said she was unable to find work as a general surgeon and went to work as a wound care doctor. At trial, jurors awarded Dr. Miller $586,617 in lost wages, $343,640 for lost future earning capacity, and $250,000 for mental anguish. (The mental anguish award was subsequently struck by a district court.)

Attorneys for Huron Regional Medical Center argued the jury improperly awarded damages and requested a new trial, which was denied by an appeals court.

In the end, the evidence came to light and the jury’s verdict spoke loudly that the hospital had taken unfair advantage of Dr. Miller, Mr. Barker said. But he emphasized that such cases often end differently.

“There are a handful of cases in which physicians like Dr. Miller have challenged the system and won,” he said. “In most cases, however, it is a ‘David vs. Goliath’ scenario where the giant prevails.”
 

What to do if faced with malicious peer review

An important step when doctors encounter a peer review that they believe is malicious is to consult with an experienced attorney as early as possible, Dr. Huntoon said. “Not all attorneys who set themselves out to be health law attorneys necessarily have knowledge and expertise in sham peer review. And before such a thing happens, I always encourage physicians to read their medical staff bylaws. That’s where everything is set forth, [such as] the corrective action section that tells how peer review is to take place.”

Mr. Barker added that documentation is also key in the event of a potential malicious peer review.

“When a physician senses [the] administration has targeted them, they should start documenting their conversations and actions very carefully, and if possible, recruit another ‘observer’ who can provide a third-party perspective, if necessary,” Mr. Barker said.

Dr. Huntoon recently wrote an article with advice about preparedness and defense of sham peer reviews. The guidance includes that physicians educate themselves about the tactics used by some hospitals to conduct sham peer reviews and the factors that place doctors more at risk. Factors that may raise a doctor’s danger of being targeted include being in solo practice or a small group, being new on staff, or being an older physician approaching retirement as some bad-actor hospitals may view older physicians as being less likely to fight back, said Dr. Huntoon.

Doctors should also keep detailed records and a timeline in the event of a malicious peer review and insist that an independent court reporter record all peer review hearings, even if that means the physician has to pay for the reporter him or herself, according to the guidance. An independent record is invaluable should the physician ultimately issue a future legal challenge against the hospital.

Mr. Willner encourages physicians to call the Center for Peer Review Justice hotline at (504) 621-1670 or visit the website for help with peer review and NPDB issues.

As for Dr. Smith, his days are much quieter and slower today, compared with the active practice he was accustomed to for more than half his life. He misses the fast pace, the patients, and the work that always brought him great joy.

“I hope to get back to doing surgeries eventually,” he said. “I graduated medical school in 1972. Practicing surgery has been my whole life and my career. They have taken my identity and my livelihood away from me based on false numbers and false premises. I want it back.”

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