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The leading independent newspaper covering dermatology news and commentary.
Real-world data support adjuvant immunotherapy for stage III melanoma
Among patients with stage IIIC disease, the 2-year survival rate was 70% in those who received immunotherapy and 59% in those who did not (P < .01). The median overall survival in this group was 32.8 months with immunotherapy and 28 months without it (P < .01).
Among patients with stage IIIA disease, the 2-year survival rate was 94% with immunotherapy and 91% without it (P = .03).
There was a trend toward a 2-year survival benefit with immunotherapy in patients with stage IIIB disease and in all 4,094 stage III patients, but the differences were not significant. The 2-year survival rate was 84% with immunotherapy and 81% without it among patients with stage IIIB disease (P = .35). The survival rates were 83% and 80%, respectively, in all stage III patients (P = .051).
This was an early analysis, noted investigator Justin Moyers, MD, of Loma Linda (Calif.) University. Ipilimumab was approved as adjuvant therapy for stage III melanoma patients in 2015, the year patients from this analysis were diagnosed.
“There’s really only 2 full years of survival data,” Dr. Moyers said. “I think given time, we will see a benefit amongst all the substages.”
In the meantime, “I would definitely not use this data to say whether or not [immunotherapy] should be given,” Dr. Moyers said.
The researchers were just using the database – which captures 52% of U.S. melanoma cases – to see if “real-world data mimics the clinical trial data,” Dr. Moyers said.
Overall, the findings support “adjuvant immunotherapy in the real-world setting,” he said.
The researchers also looked at treatment patterns in 2015-2016 across 8,160 patients with stage III melanoma, 4,094 of whom were included in the aforementioned survival analysis. There were 2,260 patients (27.7%) who received immunotherapy after surgery during that time period.
Uptake of adjuvant immunotherapy “was low to start, but those patients did better than ones who did not get” it, said AACR president Antoni Ribas, MD, PhD, of the University of California, Los Angeles, who was not involved in the study.
Immunotherapy recipients were younger, on average (54.8 years vs. 62.4 years). Patients with Charlson comorbidity scores above zero and those on Medicare were less likely to receive immunotherapy (18.4% Medicare vs. over 30% with other payers). There also were trends of decreased use with lower income and lower high school graduation rates.
The finding “highlights the negative impact of socioeconomic [factors] on access to proven therapy,” Dr. Ribas said.
As for low use among Medicare patients, uptake of new treatments, in general, “seems to be faster with private insurance,” he noted.
The study excluded patients who received systemic therapies other than immunotherapy, as well as those who received immunotherapy before surgery. Among study limitations, the specific immunotherapies patients received was unknown.
There was no external funding for this study. Dr. Moyers reported travel compensation from Astellas Pharmaceuticals in 2018. Dr. Ribas disclosed relationships with Amgen, Chugai, Merck, Sanofi, Tango, Arcus, Bioncotech, Compugen, CytomX, FLX Bio, ImaginAb, Isoplexis, Merus, Rgenix, and PACT.
SOURCE: Moyers J et al. AACR 2020, Abstract 4338.
Among patients with stage IIIC disease, the 2-year survival rate was 70% in those who received immunotherapy and 59% in those who did not (P < .01). The median overall survival in this group was 32.8 months with immunotherapy and 28 months without it (P < .01).
Among patients with stage IIIA disease, the 2-year survival rate was 94% with immunotherapy and 91% without it (P = .03).
There was a trend toward a 2-year survival benefit with immunotherapy in patients with stage IIIB disease and in all 4,094 stage III patients, but the differences were not significant. The 2-year survival rate was 84% with immunotherapy and 81% without it among patients with stage IIIB disease (P = .35). The survival rates were 83% and 80%, respectively, in all stage III patients (P = .051).
This was an early analysis, noted investigator Justin Moyers, MD, of Loma Linda (Calif.) University. Ipilimumab was approved as adjuvant therapy for stage III melanoma patients in 2015, the year patients from this analysis were diagnosed.
“There’s really only 2 full years of survival data,” Dr. Moyers said. “I think given time, we will see a benefit amongst all the substages.”
In the meantime, “I would definitely not use this data to say whether or not [immunotherapy] should be given,” Dr. Moyers said.
The researchers were just using the database – which captures 52% of U.S. melanoma cases – to see if “real-world data mimics the clinical trial data,” Dr. Moyers said.
Overall, the findings support “adjuvant immunotherapy in the real-world setting,” he said.
The researchers also looked at treatment patterns in 2015-2016 across 8,160 patients with stage III melanoma, 4,094 of whom were included in the aforementioned survival analysis. There were 2,260 patients (27.7%) who received immunotherapy after surgery during that time period.
Uptake of adjuvant immunotherapy “was low to start, but those patients did better than ones who did not get” it, said AACR president Antoni Ribas, MD, PhD, of the University of California, Los Angeles, who was not involved in the study.
Immunotherapy recipients were younger, on average (54.8 years vs. 62.4 years). Patients with Charlson comorbidity scores above zero and those on Medicare were less likely to receive immunotherapy (18.4% Medicare vs. over 30% with other payers). There also were trends of decreased use with lower income and lower high school graduation rates.
The finding “highlights the negative impact of socioeconomic [factors] on access to proven therapy,” Dr. Ribas said.
As for low use among Medicare patients, uptake of new treatments, in general, “seems to be faster with private insurance,” he noted.
The study excluded patients who received systemic therapies other than immunotherapy, as well as those who received immunotherapy before surgery. Among study limitations, the specific immunotherapies patients received was unknown.
There was no external funding for this study. Dr. Moyers reported travel compensation from Astellas Pharmaceuticals in 2018. Dr. Ribas disclosed relationships with Amgen, Chugai, Merck, Sanofi, Tango, Arcus, Bioncotech, Compugen, CytomX, FLX Bio, ImaginAb, Isoplexis, Merus, Rgenix, and PACT.
SOURCE: Moyers J et al. AACR 2020, Abstract 4338.
Among patients with stage IIIC disease, the 2-year survival rate was 70% in those who received immunotherapy and 59% in those who did not (P < .01). The median overall survival in this group was 32.8 months with immunotherapy and 28 months without it (P < .01).
Among patients with stage IIIA disease, the 2-year survival rate was 94% with immunotherapy and 91% without it (P = .03).
There was a trend toward a 2-year survival benefit with immunotherapy in patients with stage IIIB disease and in all 4,094 stage III patients, but the differences were not significant. The 2-year survival rate was 84% with immunotherapy and 81% without it among patients with stage IIIB disease (P = .35). The survival rates were 83% and 80%, respectively, in all stage III patients (P = .051).
This was an early analysis, noted investigator Justin Moyers, MD, of Loma Linda (Calif.) University. Ipilimumab was approved as adjuvant therapy for stage III melanoma patients in 2015, the year patients from this analysis were diagnosed.
“There’s really only 2 full years of survival data,” Dr. Moyers said. “I think given time, we will see a benefit amongst all the substages.”
In the meantime, “I would definitely not use this data to say whether or not [immunotherapy] should be given,” Dr. Moyers said.
The researchers were just using the database – which captures 52% of U.S. melanoma cases – to see if “real-world data mimics the clinical trial data,” Dr. Moyers said.
Overall, the findings support “adjuvant immunotherapy in the real-world setting,” he said.
The researchers also looked at treatment patterns in 2015-2016 across 8,160 patients with stage III melanoma, 4,094 of whom were included in the aforementioned survival analysis. There were 2,260 patients (27.7%) who received immunotherapy after surgery during that time period.
Uptake of adjuvant immunotherapy “was low to start, but those patients did better than ones who did not get” it, said AACR president Antoni Ribas, MD, PhD, of the University of California, Los Angeles, who was not involved in the study.
Immunotherapy recipients were younger, on average (54.8 years vs. 62.4 years). Patients with Charlson comorbidity scores above zero and those on Medicare were less likely to receive immunotherapy (18.4% Medicare vs. over 30% with other payers). There also were trends of decreased use with lower income and lower high school graduation rates.
The finding “highlights the negative impact of socioeconomic [factors] on access to proven therapy,” Dr. Ribas said.
As for low use among Medicare patients, uptake of new treatments, in general, “seems to be faster with private insurance,” he noted.
The study excluded patients who received systemic therapies other than immunotherapy, as well as those who received immunotherapy before surgery. Among study limitations, the specific immunotherapies patients received was unknown.
There was no external funding for this study. Dr. Moyers reported travel compensation from Astellas Pharmaceuticals in 2018. Dr. Ribas disclosed relationships with Amgen, Chugai, Merck, Sanofi, Tango, Arcus, Bioncotech, Compugen, CytomX, FLX Bio, ImaginAb, Isoplexis, Merus, Rgenix, and PACT.
SOURCE: Moyers J et al. AACR 2020, Abstract 4338.
FROM AACR 2020
Daily Recap: Docs are good at saving money; SARS-CoV-2 vaccine trials advance
Here are the stories our MDedge editors across specialties think you need to know about today:
Many physicians live within their means and save
Although about two of five physicians report a net worth of between $1 million and $5 million, about half report that they are living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.
Net worth figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%). Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000. Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.
Asked about saving habits, 43% of physicians reported they live below their means. Just 7% said they live above their means. How do they save money? Survey respondents reported putting bonus money into an investment account, putting extra money toward paying down the mortgage, and bringing lunch to work everyday.
The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic. Read more.
Phase 3 COVID-19 vaccine trials launching in July
There are now 120 Investigational New Drug applications to the Food and Drug Administration for a SARS-CoV-2 vaccine, and researchers at more than 70 companies across the globe are interested in making a vaccine, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.” Read more.
FDA approves in-home breast cancer treatment
The Food and Drug Administration has approved a combination of subcutaneous breast cancer treatments that could be administered at home, following completion of chemotherapy.
The agency gave the green light to pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche), administered subcutaneously rather than intravenously, for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete. Read more.
Could a visual tool aid migraine management?
A new visual tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines.
The tool is still just a prototype, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors from depression to insomnia.
Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” lead researcher Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, said in an interview.
Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Many physicians live within their means and save
Although about two of five physicians report a net worth of between $1 million and $5 million, about half report that they are living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.
Net worth figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%). Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000. Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.
Asked about saving habits, 43% of physicians reported they live below their means. Just 7% said they live above their means. How do they save money? Survey respondents reported putting bonus money into an investment account, putting extra money toward paying down the mortgage, and bringing lunch to work everyday.
The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic. Read more.
Phase 3 COVID-19 vaccine trials launching in July
There are now 120 Investigational New Drug applications to the Food and Drug Administration for a SARS-CoV-2 vaccine, and researchers at more than 70 companies across the globe are interested in making a vaccine, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.” Read more.
FDA approves in-home breast cancer treatment
The Food and Drug Administration has approved a combination of subcutaneous breast cancer treatments that could be administered at home, following completion of chemotherapy.
The agency gave the green light to pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche), administered subcutaneously rather than intravenously, for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete. Read more.
Could a visual tool aid migraine management?
A new visual tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines.
The tool is still just a prototype, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors from depression to insomnia.
Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” lead researcher Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, said in an interview.
Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Many physicians live within their means and save
Although about two of five physicians report a net worth of between $1 million and $5 million, about half report that they are living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.
Net worth figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%). Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000. Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.
Asked about saving habits, 43% of physicians reported they live below their means. Just 7% said they live above their means. How do they save money? Survey respondents reported putting bonus money into an investment account, putting extra money toward paying down the mortgage, and bringing lunch to work everyday.
The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic. Read more.
Phase 3 COVID-19 vaccine trials launching in July
There are now 120 Investigational New Drug applications to the Food and Drug Administration for a SARS-CoV-2 vaccine, and researchers at more than 70 companies across the globe are interested in making a vaccine, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.” Read more.
FDA approves in-home breast cancer treatment
The Food and Drug Administration has approved a combination of subcutaneous breast cancer treatments that could be administered at home, following completion of chemotherapy.
The agency gave the green light to pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche), administered subcutaneously rather than intravenously, for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete. Read more.
Could a visual tool aid migraine management?
A new visual tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines.
The tool is still just a prototype, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors from depression to insomnia.
Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” lead researcher Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, said in an interview.
Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Phase 3 COVID-19 vaccine trials launching in July, expert says
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.
According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.
“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”
Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”
Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”
Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”
Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”
“Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”
The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”
A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”
Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”
Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”
Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”
FROM PEDIATRIC DERMATOLOGY 2020
Many physicians live within their means and save, survey shows
Although about two of five physicians report a net worth of between $1 million and $5 million, half are under the million dollars and about half believe in living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.
Along with that somewhat prudent lifestyle comes savings, with
Those habits may help some navigate the financial upheaval in medicine brought about by COVID-19.
The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic.
The authors of the report note that by some estimates, primary care offices have seen a 55% drop in revenue because of the pandemic, and specialists have been hard hit with the suspension of most elective procedures.
Primary care offices are seeing fewer patients and are limiting hours, and some offices have been forced to close. Others have stemmed the losses by introducing telemedicine options.
Before COVID-19, average incomes had continued to rise – this year to $243,000 (a 2.5% boost from last year’s $237,000) for primary care physicians and $346,000 for specialists (a 1.5% rise from last year’s $341,000).
About half of physicians (42%) reported a net worth of $1 million to $5 million, and 8% reported a net worth of more than $5 million. Fifty percent of physicians had a net worth of less than $1 million.
Those figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%).
Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000.
Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.
43% live below their means
Asked about habits regarding saving, 43% of physicians reported they live below their means. Half said they live at their means, and 7% said they live above their means.
Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minn., recommends in the report trying to save 20% of annual gross salary.
More than a third of physicians who responded (39%) said they put more than $2,000/month into tax-deferred retirement or college savings, but Dr. Greenwald acknowledged that this may become more challenging.
“Many have seen the employer match in their retirement plans reduced or eliminated through the end of 2020, with what comes in 2021 as yet undefined,” he said.
A smaller percentage (26%) answered that they put more than $2,000 a month into a taxable retirement or college savings account each month.
Home size by specialty
Mortgages on a primary residence were the top reasons for debt (63%), followed by car loans (37%), personal education loans (26%), and credit card balances (25%).
Half of specialists and 61% of primary care physicians live in homes with up to 3,000 square feet. Only 7% of PCPs and 12% of specialists live in homes with 5000 square feet or more.
At 22%, plastic surgeons and orthopedists were the most likely groups to have houses with the largest square footage, according to the survey.
About one in four physicians in five specialties (urology, cardiology, plastic surgery, otolaryngology, and critical care) reported that they had mortgages of more than $500,000.
Standard financial advice, the report authors note, is that a mortgage should take up no more than 28% of monthly gross income.
Another large source of debt came from student loans. Close to 80% of graduating medical students have educational debt. The average balance for graduating students in 2018 was $196,520, the report authors state.
Those in physical medicine/rehabilitation and family medicine were most likely to still be paying off student debt (34% said they were). Conversely, half as many nephrologists and rheumatologists (15%) and gastroenterologists (14%) reported that they were paying off educational debt.
Only 11% of physicians said they were currently free of any debt.
Most physicians in the survey (72%) reported that they had not experienced a significant financial loss in the past year.
For those who did experience such a loss, the top reason given was related to a bad investment or the stock market (9%).
Cost-cutting strategies
Revenue reduction will likely lead to spending less this year as the pandemic challenges continue.
Survey respondents offered their most effective cost-cutting strategies.
A hospitalist said, “Half of every bonus goes into the investment account, no matter how much.”
“We add an extra amount to the principal of our monthly mortgage payment,” an internist said.
A pediatrician offered, “I bring my lunch to work every day and don’t eat in restaurants often.”
This article first appeared on Medscape.com.
Although about two of five physicians report a net worth of between $1 million and $5 million, half are under the million dollars and about half believe in living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.
Along with that somewhat prudent lifestyle comes savings, with
Those habits may help some navigate the financial upheaval in medicine brought about by COVID-19.
The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic.
The authors of the report note that by some estimates, primary care offices have seen a 55% drop in revenue because of the pandemic, and specialists have been hard hit with the suspension of most elective procedures.
Primary care offices are seeing fewer patients and are limiting hours, and some offices have been forced to close. Others have stemmed the losses by introducing telemedicine options.
Before COVID-19, average incomes had continued to rise – this year to $243,000 (a 2.5% boost from last year’s $237,000) for primary care physicians and $346,000 for specialists (a 1.5% rise from last year’s $341,000).
About half of physicians (42%) reported a net worth of $1 million to $5 million, and 8% reported a net worth of more than $5 million. Fifty percent of physicians had a net worth of less than $1 million.
Those figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%).
Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000.
Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.
43% live below their means
Asked about habits regarding saving, 43% of physicians reported they live below their means. Half said they live at their means, and 7% said they live above their means.
Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minn., recommends in the report trying to save 20% of annual gross salary.
More than a third of physicians who responded (39%) said they put more than $2,000/month into tax-deferred retirement or college savings, but Dr. Greenwald acknowledged that this may become more challenging.
“Many have seen the employer match in their retirement plans reduced or eliminated through the end of 2020, with what comes in 2021 as yet undefined,” he said.
A smaller percentage (26%) answered that they put more than $2,000 a month into a taxable retirement or college savings account each month.
Home size by specialty
Mortgages on a primary residence were the top reasons for debt (63%), followed by car loans (37%), personal education loans (26%), and credit card balances (25%).
Half of specialists and 61% of primary care physicians live in homes with up to 3,000 square feet. Only 7% of PCPs and 12% of specialists live in homes with 5000 square feet or more.
At 22%, plastic surgeons and orthopedists were the most likely groups to have houses with the largest square footage, according to the survey.
About one in four physicians in five specialties (urology, cardiology, plastic surgery, otolaryngology, and critical care) reported that they had mortgages of more than $500,000.
Standard financial advice, the report authors note, is that a mortgage should take up no more than 28% of monthly gross income.
Another large source of debt came from student loans. Close to 80% of graduating medical students have educational debt. The average balance for graduating students in 2018 was $196,520, the report authors state.
Those in physical medicine/rehabilitation and family medicine were most likely to still be paying off student debt (34% said they were). Conversely, half as many nephrologists and rheumatologists (15%) and gastroenterologists (14%) reported that they were paying off educational debt.
Only 11% of physicians said they were currently free of any debt.
Most physicians in the survey (72%) reported that they had not experienced a significant financial loss in the past year.
For those who did experience such a loss, the top reason given was related to a bad investment or the stock market (9%).
Cost-cutting strategies
Revenue reduction will likely lead to spending less this year as the pandemic challenges continue.
Survey respondents offered their most effective cost-cutting strategies.
A hospitalist said, “Half of every bonus goes into the investment account, no matter how much.”
“We add an extra amount to the principal of our monthly mortgage payment,” an internist said.
A pediatrician offered, “I bring my lunch to work every day and don’t eat in restaurants often.”
This article first appeared on Medscape.com.
Although about two of five physicians report a net worth of between $1 million and $5 million, half are under the million dollars and about half believe in living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.
Along with that somewhat prudent lifestyle comes savings, with
Those habits may help some navigate the financial upheaval in medicine brought about by COVID-19.
The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic.
The authors of the report note that by some estimates, primary care offices have seen a 55% drop in revenue because of the pandemic, and specialists have been hard hit with the suspension of most elective procedures.
Primary care offices are seeing fewer patients and are limiting hours, and some offices have been forced to close. Others have stemmed the losses by introducing telemedicine options.
Before COVID-19, average incomes had continued to rise – this year to $243,000 (a 2.5% boost from last year’s $237,000) for primary care physicians and $346,000 for specialists (a 1.5% rise from last year’s $341,000).
About half of physicians (42%) reported a net worth of $1 million to $5 million, and 8% reported a net worth of more than $5 million. Fifty percent of physicians had a net worth of less than $1 million.
Those figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%).
Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000.
Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.
43% live below their means
Asked about habits regarding saving, 43% of physicians reported they live below their means. Half said they live at their means, and 7% said they live above their means.
Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minn., recommends in the report trying to save 20% of annual gross salary.
More than a third of physicians who responded (39%) said they put more than $2,000/month into tax-deferred retirement or college savings, but Dr. Greenwald acknowledged that this may become more challenging.
“Many have seen the employer match in their retirement plans reduced or eliminated through the end of 2020, with what comes in 2021 as yet undefined,” he said.
A smaller percentage (26%) answered that they put more than $2,000 a month into a taxable retirement or college savings account each month.
Home size by specialty
Mortgages on a primary residence were the top reasons for debt (63%), followed by car loans (37%), personal education loans (26%), and credit card balances (25%).
Half of specialists and 61% of primary care physicians live in homes with up to 3,000 square feet. Only 7% of PCPs and 12% of specialists live in homes with 5000 square feet or more.
At 22%, plastic surgeons and orthopedists were the most likely groups to have houses with the largest square footage, according to the survey.
About one in four physicians in five specialties (urology, cardiology, plastic surgery, otolaryngology, and critical care) reported that they had mortgages of more than $500,000.
Standard financial advice, the report authors note, is that a mortgage should take up no more than 28% of monthly gross income.
Another large source of debt came from student loans. Close to 80% of graduating medical students have educational debt. The average balance for graduating students in 2018 was $196,520, the report authors state.
Those in physical medicine/rehabilitation and family medicine were most likely to still be paying off student debt (34% said they were). Conversely, half as many nephrologists and rheumatologists (15%) and gastroenterologists (14%) reported that they were paying off educational debt.
Only 11% of physicians said they were currently free of any debt.
Most physicians in the survey (72%) reported that they had not experienced a significant financial loss in the past year.
For those who did experience such a loss, the top reason given was related to a bad investment or the stock market (9%).
Cost-cutting strategies
Revenue reduction will likely lead to spending less this year as the pandemic challenges continue.
Survey respondents offered their most effective cost-cutting strategies.
A hospitalist said, “Half of every bonus goes into the investment account, no matter how much.”
“We add an extra amount to the principal of our monthly mortgage payment,” an internist said.
A pediatrician offered, “I bring my lunch to work every day and don’t eat in restaurants often.”
This article first appeared on Medscape.com.
Two pandemics
This column is adapted from Dr. Eleryan’s speech at the George Washington University dermatology residency program’s virtual graduation ceremony on June 12.
I’ve been reflecting on my entire residency and the last 2 weeks have stood out the most. I have to admit that I’ve been angry, and so are numerous others who look like me. However, after conversations with a few important people in my life, I’ve realized that people care and are open to listening and changing if I give them the opportunity to see through my lens. I don’t want my legacy to be one of anger, but to be one of change, one of activism, one of heroism, and one of taking a stand in the midst of adversity.
So thank you to everyone who has played a part in my residency and is here to celebrate as I transition to the next step in my career.
But I must pause for a moment to say “I can’t breathe.” I can’t breathe because while I sit here in a place of honor for my accomplishments, I can’t forget that I’m standing in the gap for all of the black men and women who will never have the opportunity to experience a moment like this.
I can’t breathe because George Floyd, Breonna Taylor, Ahmaud Arbery, Tony McDade, Trayvon Martin, Philando Castile, Sandra Bland, Eric Garner, Tamir Rice, Mike Brown, Emmett Till, and so many others will never get to experience a celebratory occasion such as this because of their senseless executions as a likely result of racial bias.
As a black person in “the land of the free,” I have to live with the fact that my life may be taken for simply taking a stroll through a park, jogging through a neighborhood, driving down the street, walking back home from the store, or even sitting in my own home!
As a black physician, I must contend with the very notion that my privilege as a physician does not shield me from discrimination and bias. I recognize that my race walks into the room before I ever do. I know that many of my patients will question my abilities or my title – thinking I am the receptionist, food services worker, or even part of the janitorial staff – simply because of the color of my skin. And what’s even more disturbing is that some of my colleagues will confuse me with another black woman whom I look nothing like or challenge my intelligence and abilities and how I got my position.
All of this boils down to racism – pure and simple. Black people in this country don’t have the privilege of ignoring this truth. We know that this world is not colorblind; neither is anyone in it. We know that this is entrenched racism that for generations has created racial disparities in health care, education, housing, employment, and law enforcement. We weren’t born into a fragile or vulnerable state, yet we were born into a system of dis-enfranchisement, dis-investment, dis-crimination, dis-advantage, and dis-respect.
As physicians, we must recognize and acknowledge the lived experiences that walk through the door with our black patients. And we must understand that black patients walk around with the effects of trauma and toxic stress from just being black in America. That trauma and stress show up in very real ways that contribute to black people experiencing the brunt of chronic diseases and poorer health outcomes. There is no better example than the current COVID-19 pandemic. We are in the midst of a global pandemic from a virus that does not discriminate based on race, but black people are almost three times as likely to be hospitalized as are white people with COVID-19 . And why is that? Because of the “comorbidity” of racism that black people in this country live with. It is not a mere coincidence that the black population is overrepresented in essential jobs and black people are more likely to work in health care than are white people – all positions that increase the risk of infection and death from the virus. So, if we call COVID-19 a pandemic, racism most certainly has been a pandemic that this country has refused to acknowledge, treat, and vaccinate for centuries. We cannot ignore that both have tragically affected black people.
So as Pastor Reginald Sharpe Jr. in Chicago recently said, we’re dealing with two pandemics: One has no vaccination and one has no explanation; one can physiologically take your breath away because it affects the respiratory system, while the second can also take your breath away. Just ask Eric Garner and George Floyd.
As physicians, we must recognize that the mechanisms that tragically resulted in the deaths of George Floyd, Breonna Taylor, Ahmaud Arbery, and so many other black men and women are the same mechanisms that are harming and killing black people in our health care system. It’s not acceptable for institutions that built themselves on black and brown bodies to offer condolences, but to continue to do nothing about the racism that still runs rampant within. It’s not acceptable to do nothing. It’s important to note: Racist systems do not perpetuate themselves – the individuals operating within them do.
Martin Luther King Jr. once said, “He who passively accepts evil is as much involved in it as he who helps to perpetuate it. He who accepts evil without protesting against it is really cooperating with it.” Being well-intentioned, good-hearted, sad, or disheartened is not enough. We won’t be able to tear down the systems and institutions that have been a breeding ground for racism until outrage is met by action, not just from black people and people of color, but also by the white majority.
As physicians it’s time for us to look at how our health care institution – an institution instrumental in the victimization of black people – is affecting the health and well-being of our black patients. (For example, increased maternal mortality among black women.)
Are they being seen and heard? Are they receiving culturally relevant and sensitive care? Are their needs and concerns receiving the same amount of time and attention as other patients? It’s time to understand that, for many black patients, the health care system is another place of injustice that has not proved itself to be trustworthy or inclusive of black culture.
As physicians, we must affirm that the lives and health of black and brown people matter to us, that we see the racism they experience, and that we will use our platform as physicians to eliminate racism not just in the hospitals but in the world our patients live in.
So while I didn’t choose the body that I was born into, I fully embrace it and the challenges that come with it. I’m not here to make people feel comfortable, I’m here to continue the work of my ancestors, accomplish the dreams that they fought and lost their lives for, and most importantly, I’m here to continue the fight against the systems that work to prevent other marginalized persons from getting to where I am and even further.
The author James Baldwin once wrote, “Not everything that is faced can be changed, but nothing can be changed until it is faced.” So, I urge you to be loudly antiracist in every space that you hold. I urge you to educate yourselves about racism and white supremacy and privilege and how it permeates our health care system. I urge you to stand beside black people rather than in front of them. Use your privilege to amplify underheard voices and to challenge the biases of your peers, friends, and family members. Use your platform as physicians to advocate for a more just and equitable health care system.
So let me repeat ... we as physicians have the responsibility to eliminate racial bias in the practice of medicine and recognize racism as a threat to the health and well-being of black people and other people of color.
How do we do this? We are beyond lengthy dialogue and “Black History Month” talks. Now is the time for action. Taking action includes the following:
1. Medical academic institutions committing to having a diverse and inclusive faculty. We know it is critical and vital to the recruitment, success, and matriculation of medical students and residents of color to see faculty, particularly senior level faculty in their specialty, who look like them and can serve as mentors. Every year, these institutions need to set a goal that they will take additional steps to have at least one-third of their faculty be black and another third persons of color. In addition, senior faculty positions – those setting curricula, selecting incoming students and residents – must include at least one-third from underrepresented backgrounds (black, Hispanic, Native American/Indigenous).
2. Hospital administration has to resemble the communities in which the hospital serves. Unfortunately, all too often, we know this is not the case, and as a result, decisions that affect the care of black and brown people are often to their detriment because they perpetuate the racism within the existing system. In order to dismantle racism in the hospital system, hospital administrations must consist of diverse individuals. Therefore, hospitals need to commit to hiring and promoting black and brown staff to ensure one-third of its senior leaderships consists of individuals from underrepresented backgrounds.
3. Improving the pipeline that matriculates black and brown students into medical school and residency programs. Lack of access to mentors within the medical field, lack of funding for travel to/from interviews, and lack of knowledge of the overall application process are a few barriers faced by students of color seeking to enter into the medical field. In addition to current scholarship opportunities, medical schools need to allocate funds to connect underrepresented minority students with a range of lived experiences (not just those from impoverished backgrounds but also those from middle class backgrounds who face difficulty gaining acceptance into medical school and residency programs), such as connecting them with mentors by opening opportunities for them to shadow professionals at a conference, travel to residency interviews with most, if not all, expenses covered up front, and have access to local programs that expose them to physicians in several specialties.
These are just a few examples of the active steps we can take to dismantle racism and reconcile the effects of it in the medical field. So if I may borrow from other movements, “Time’s Up” for silence regarding the existence of racism and white supremacy, and now it’s time to truly show that “We are all in this together.”
It is not just my duty but yours also – to ensure that we never have to hear another black man, woman, or child say “I can’t breathe” at the hands of injustice.
Dr. Eleryan (@skinclusionMD) is a social justice activist and was co-chief resident in dermatology (2019-2020) at George Washington University, Washington, DC, and is an Alpha Omega Alpha inductee (2020). She will be a micrographic surgery and dermatologic oncology fellow at the University of California, Los Angeles, in July 2020.
This column is adapted from Dr. Eleryan’s speech at the George Washington University dermatology residency program’s virtual graduation ceremony on June 12.
I’ve been reflecting on my entire residency and the last 2 weeks have stood out the most. I have to admit that I’ve been angry, and so are numerous others who look like me. However, after conversations with a few important people in my life, I’ve realized that people care and are open to listening and changing if I give them the opportunity to see through my lens. I don’t want my legacy to be one of anger, but to be one of change, one of activism, one of heroism, and one of taking a stand in the midst of adversity.
So thank you to everyone who has played a part in my residency and is here to celebrate as I transition to the next step in my career.
But I must pause for a moment to say “I can’t breathe.” I can’t breathe because while I sit here in a place of honor for my accomplishments, I can’t forget that I’m standing in the gap for all of the black men and women who will never have the opportunity to experience a moment like this.
I can’t breathe because George Floyd, Breonna Taylor, Ahmaud Arbery, Tony McDade, Trayvon Martin, Philando Castile, Sandra Bland, Eric Garner, Tamir Rice, Mike Brown, Emmett Till, and so many others will never get to experience a celebratory occasion such as this because of their senseless executions as a likely result of racial bias.
As a black person in “the land of the free,” I have to live with the fact that my life may be taken for simply taking a stroll through a park, jogging through a neighborhood, driving down the street, walking back home from the store, or even sitting in my own home!
As a black physician, I must contend with the very notion that my privilege as a physician does not shield me from discrimination and bias. I recognize that my race walks into the room before I ever do. I know that many of my patients will question my abilities or my title – thinking I am the receptionist, food services worker, or even part of the janitorial staff – simply because of the color of my skin. And what’s even more disturbing is that some of my colleagues will confuse me with another black woman whom I look nothing like or challenge my intelligence and abilities and how I got my position.
All of this boils down to racism – pure and simple. Black people in this country don’t have the privilege of ignoring this truth. We know that this world is not colorblind; neither is anyone in it. We know that this is entrenched racism that for generations has created racial disparities in health care, education, housing, employment, and law enforcement. We weren’t born into a fragile or vulnerable state, yet we were born into a system of dis-enfranchisement, dis-investment, dis-crimination, dis-advantage, and dis-respect.
As physicians, we must recognize and acknowledge the lived experiences that walk through the door with our black patients. And we must understand that black patients walk around with the effects of trauma and toxic stress from just being black in America. That trauma and stress show up in very real ways that contribute to black people experiencing the brunt of chronic diseases and poorer health outcomes. There is no better example than the current COVID-19 pandemic. We are in the midst of a global pandemic from a virus that does not discriminate based on race, but black people are almost three times as likely to be hospitalized as are white people with COVID-19 . And why is that? Because of the “comorbidity” of racism that black people in this country live with. It is not a mere coincidence that the black population is overrepresented in essential jobs and black people are more likely to work in health care than are white people – all positions that increase the risk of infection and death from the virus. So, if we call COVID-19 a pandemic, racism most certainly has been a pandemic that this country has refused to acknowledge, treat, and vaccinate for centuries. We cannot ignore that both have tragically affected black people.
So as Pastor Reginald Sharpe Jr. in Chicago recently said, we’re dealing with two pandemics: One has no vaccination and one has no explanation; one can physiologically take your breath away because it affects the respiratory system, while the second can also take your breath away. Just ask Eric Garner and George Floyd.
As physicians, we must recognize that the mechanisms that tragically resulted in the deaths of George Floyd, Breonna Taylor, Ahmaud Arbery, and so many other black men and women are the same mechanisms that are harming and killing black people in our health care system. It’s not acceptable for institutions that built themselves on black and brown bodies to offer condolences, but to continue to do nothing about the racism that still runs rampant within. It’s not acceptable to do nothing. It’s important to note: Racist systems do not perpetuate themselves – the individuals operating within them do.
Martin Luther King Jr. once said, “He who passively accepts evil is as much involved in it as he who helps to perpetuate it. He who accepts evil without protesting against it is really cooperating with it.” Being well-intentioned, good-hearted, sad, or disheartened is not enough. We won’t be able to tear down the systems and institutions that have been a breeding ground for racism until outrage is met by action, not just from black people and people of color, but also by the white majority.
As physicians it’s time for us to look at how our health care institution – an institution instrumental in the victimization of black people – is affecting the health and well-being of our black patients. (For example, increased maternal mortality among black women.)
Are they being seen and heard? Are they receiving culturally relevant and sensitive care? Are their needs and concerns receiving the same amount of time and attention as other patients? It’s time to understand that, for many black patients, the health care system is another place of injustice that has not proved itself to be trustworthy or inclusive of black culture.
As physicians, we must affirm that the lives and health of black and brown people matter to us, that we see the racism they experience, and that we will use our platform as physicians to eliminate racism not just in the hospitals but in the world our patients live in.
So while I didn’t choose the body that I was born into, I fully embrace it and the challenges that come with it. I’m not here to make people feel comfortable, I’m here to continue the work of my ancestors, accomplish the dreams that they fought and lost their lives for, and most importantly, I’m here to continue the fight against the systems that work to prevent other marginalized persons from getting to where I am and even further.
The author James Baldwin once wrote, “Not everything that is faced can be changed, but nothing can be changed until it is faced.” So, I urge you to be loudly antiracist in every space that you hold. I urge you to educate yourselves about racism and white supremacy and privilege and how it permeates our health care system. I urge you to stand beside black people rather than in front of them. Use your privilege to amplify underheard voices and to challenge the biases of your peers, friends, and family members. Use your platform as physicians to advocate for a more just and equitable health care system.
So let me repeat ... we as physicians have the responsibility to eliminate racial bias in the practice of medicine and recognize racism as a threat to the health and well-being of black people and other people of color.
How do we do this? We are beyond lengthy dialogue and “Black History Month” talks. Now is the time for action. Taking action includes the following:
1. Medical academic institutions committing to having a diverse and inclusive faculty. We know it is critical and vital to the recruitment, success, and matriculation of medical students and residents of color to see faculty, particularly senior level faculty in their specialty, who look like them and can serve as mentors. Every year, these institutions need to set a goal that they will take additional steps to have at least one-third of their faculty be black and another third persons of color. In addition, senior faculty positions – those setting curricula, selecting incoming students and residents – must include at least one-third from underrepresented backgrounds (black, Hispanic, Native American/Indigenous).
2. Hospital administration has to resemble the communities in which the hospital serves. Unfortunately, all too often, we know this is not the case, and as a result, decisions that affect the care of black and brown people are often to their detriment because they perpetuate the racism within the existing system. In order to dismantle racism in the hospital system, hospital administrations must consist of diverse individuals. Therefore, hospitals need to commit to hiring and promoting black and brown staff to ensure one-third of its senior leaderships consists of individuals from underrepresented backgrounds.
3. Improving the pipeline that matriculates black and brown students into medical school and residency programs. Lack of access to mentors within the medical field, lack of funding for travel to/from interviews, and lack of knowledge of the overall application process are a few barriers faced by students of color seeking to enter into the medical field. In addition to current scholarship opportunities, medical schools need to allocate funds to connect underrepresented minority students with a range of lived experiences (not just those from impoverished backgrounds but also those from middle class backgrounds who face difficulty gaining acceptance into medical school and residency programs), such as connecting them with mentors by opening opportunities for them to shadow professionals at a conference, travel to residency interviews with most, if not all, expenses covered up front, and have access to local programs that expose them to physicians in several specialties.
These are just a few examples of the active steps we can take to dismantle racism and reconcile the effects of it in the medical field. So if I may borrow from other movements, “Time’s Up” for silence regarding the existence of racism and white supremacy, and now it’s time to truly show that “We are all in this together.”
It is not just my duty but yours also – to ensure that we never have to hear another black man, woman, or child say “I can’t breathe” at the hands of injustice.
Dr. Eleryan (@skinclusionMD) is a social justice activist and was co-chief resident in dermatology (2019-2020) at George Washington University, Washington, DC, and is an Alpha Omega Alpha inductee (2020). She will be a micrographic surgery and dermatologic oncology fellow at the University of California, Los Angeles, in July 2020.
This column is adapted from Dr. Eleryan’s speech at the George Washington University dermatology residency program’s virtual graduation ceremony on June 12.
I’ve been reflecting on my entire residency and the last 2 weeks have stood out the most. I have to admit that I’ve been angry, and so are numerous others who look like me. However, after conversations with a few important people in my life, I’ve realized that people care and are open to listening and changing if I give them the opportunity to see through my lens. I don’t want my legacy to be one of anger, but to be one of change, one of activism, one of heroism, and one of taking a stand in the midst of adversity.
So thank you to everyone who has played a part in my residency and is here to celebrate as I transition to the next step in my career.
But I must pause for a moment to say “I can’t breathe.” I can’t breathe because while I sit here in a place of honor for my accomplishments, I can’t forget that I’m standing in the gap for all of the black men and women who will never have the opportunity to experience a moment like this.
I can’t breathe because George Floyd, Breonna Taylor, Ahmaud Arbery, Tony McDade, Trayvon Martin, Philando Castile, Sandra Bland, Eric Garner, Tamir Rice, Mike Brown, Emmett Till, and so many others will never get to experience a celebratory occasion such as this because of their senseless executions as a likely result of racial bias.
As a black person in “the land of the free,” I have to live with the fact that my life may be taken for simply taking a stroll through a park, jogging through a neighborhood, driving down the street, walking back home from the store, or even sitting in my own home!
As a black physician, I must contend with the very notion that my privilege as a physician does not shield me from discrimination and bias. I recognize that my race walks into the room before I ever do. I know that many of my patients will question my abilities or my title – thinking I am the receptionist, food services worker, or even part of the janitorial staff – simply because of the color of my skin. And what’s even more disturbing is that some of my colleagues will confuse me with another black woman whom I look nothing like or challenge my intelligence and abilities and how I got my position.
All of this boils down to racism – pure and simple. Black people in this country don’t have the privilege of ignoring this truth. We know that this world is not colorblind; neither is anyone in it. We know that this is entrenched racism that for generations has created racial disparities in health care, education, housing, employment, and law enforcement. We weren’t born into a fragile or vulnerable state, yet we were born into a system of dis-enfranchisement, dis-investment, dis-crimination, dis-advantage, and dis-respect.
As physicians, we must recognize and acknowledge the lived experiences that walk through the door with our black patients. And we must understand that black patients walk around with the effects of trauma and toxic stress from just being black in America. That trauma and stress show up in very real ways that contribute to black people experiencing the brunt of chronic diseases and poorer health outcomes. There is no better example than the current COVID-19 pandemic. We are in the midst of a global pandemic from a virus that does not discriminate based on race, but black people are almost three times as likely to be hospitalized as are white people with COVID-19 . And why is that? Because of the “comorbidity” of racism that black people in this country live with. It is not a mere coincidence that the black population is overrepresented in essential jobs and black people are more likely to work in health care than are white people – all positions that increase the risk of infection and death from the virus. So, if we call COVID-19 a pandemic, racism most certainly has been a pandemic that this country has refused to acknowledge, treat, and vaccinate for centuries. We cannot ignore that both have tragically affected black people.
So as Pastor Reginald Sharpe Jr. in Chicago recently said, we’re dealing with two pandemics: One has no vaccination and one has no explanation; one can physiologically take your breath away because it affects the respiratory system, while the second can also take your breath away. Just ask Eric Garner and George Floyd.
As physicians, we must recognize that the mechanisms that tragically resulted in the deaths of George Floyd, Breonna Taylor, Ahmaud Arbery, and so many other black men and women are the same mechanisms that are harming and killing black people in our health care system. It’s not acceptable for institutions that built themselves on black and brown bodies to offer condolences, but to continue to do nothing about the racism that still runs rampant within. It’s not acceptable to do nothing. It’s important to note: Racist systems do not perpetuate themselves – the individuals operating within them do.
Martin Luther King Jr. once said, “He who passively accepts evil is as much involved in it as he who helps to perpetuate it. He who accepts evil without protesting against it is really cooperating with it.” Being well-intentioned, good-hearted, sad, or disheartened is not enough. We won’t be able to tear down the systems and institutions that have been a breeding ground for racism until outrage is met by action, not just from black people and people of color, but also by the white majority.
As physicians it’s time for us to look at how our health care institution – an institution instrumental in the victimization of black people – is affecting the health and well-being of our black patients. (For example, increased maternal mortality among black women.)
Are they being seen and heard? Are they receiving culturally relevant and sensitive care? Are their needs and concerns receiving the same amount of time and attention as other patients? It’s time to understand that, for many black patients, the health care system is another place of injustice that has not proved itself to be trustworthy or inclusive of black culture.
As physicians, we must affirm that the lives and health of black and brown people matter to us, that we see the racism they experience, and that we will use our platform as physicians to eliminate racism not just in the hospitals but in the world our patients live in.
So while I didn’t choose the body that I was born into, I fully embrace it and the challenges that come with it. I’m not here to make people feel comfortable, I’m here to continue the work of my ancestors, accomplish the dreams that they fought and lost their lives for, and most importantly, I’m here to continue the fight against the systems that work to prevent other marginalized persons from getting to where I am and even further.
The author James Baldwin once wrote, “Not everything that is faced can be changed, but nothing can be changed until it is faced.” So, I urge you to be loudly antiracist in every space that you hold. I urge you to educate yourselves about racism and white supremacy and privilege and how it permeates our health care system. I urge you to stand beside black people rather than in front of them. Use your privilege to amplify underheard voices and to challenge the biases of your peers, friends, and family members. Use your platform as physicians to advocate for a more just and equitable health care system.
So let me repeat ... we as physicians have the responsibility to eliminate racial bias in the practice of medicine and recognize racism as a threat to the health and well-being of black people and other people of color.
How do we do this? We are beyond lengthy dialogue and “Black History Month” talks. Now is the time for action. Taking action includes the following:
1. Medical academic institutions committing to having a diverse and inclusive faculty. We know it is critical and vital to the recruitment, success, and matriculation of medical students and residents of color to see faculty, particularly senior level faculty in their specialty, who look like them and can serve as mentors. Every year, these institutions need to set a goal that they will take additional steps to have at least one-third of their faculty be black and another third persons of color. In addition, senior faculty positions – those setting curricula, selecting incoming students and residents – must include at least one-third from underrepresented backgrounds (black, Hispanic, Native American/Indigenous).
2. Hospital administration has to resemble the communities in which the hospital serves. Unfortunately, all too often, we know this is not the case, and as a result, decisions that affect the care of black and brown people are often to their detriment because they perpetuate the racism within the existing system. In order to dismantle racism in the hospital system, hospital administrations must consist of diverse individuals. Therefore, hospitals need to commit to hiring and promoting black and brown staff to ensure one-third of its senior leaderships consists of individuals from underrepresented backgrounds.
3. Improving the pipeline that matriculates black and brown students into medical school and residency programs. Lack of access to mentors within the medical field, lack of funding for travel to/from interviews, and lack of knowledge of the overall application process are a few barriers faced by students of color seeking to enter into the medical field. In addition to current scholarship opportunities, medical schools need to allocate funds to connect underrepresented minority students with a range of lived experiences (not just those from impoverished backgrounds but also those from middle class backgrounds who face difficulty gaining acceptance into medical school and residency programs), such as connecting them with mentors by opening opportunities for them to shadow professionals at a conference, travel to residency interviews with most, if not all, expenses covered up front, and have access to local programs that expose them to physicians in several specialties.
These are just a few examples of the active steps we can take to dismantle racism and reconcile the effects of it in the medical field. So if I may borrow from other movements, “Time’s Up” for silence regarding the existence of racism and white supremacy, and now it’s time to truly show that “We are all in this together.”
It is not just my duty but yours also – to ensure that we never have to hear another black man, woman, or child say “I can’t breathe” at the hands of injustice.
Dr. Eleryan (@skinclusionMD) is a social justice activist and was co-chief resident in dermatology (2019-2020) at George Washington University, Washington, DC, and is an Alpha Omega Alpha inductee (2020). She will be a micrographic surgery and dermatologic oncology fellow at the University of California, Los Angeles, in July 2020.
Skin patterns of COVID-19 vary widely
according to Christine Ko, MD.
“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”
Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.
On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”
Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.
A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).
“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).
“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.
according to Christine Ko, MD.
“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”
Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.
On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”
Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.
A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).
“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).
“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.
according to Christine Ko, MD.
“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”
Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.
On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”
Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.
A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).
“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).
“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.
FROM AAD 20
Novel rapid acoustic pulse device shows promise for treating cellulite
After a single treatment, it provided a roughly 1.16 point reduction in the five-point Cellulite Severity Scale at 12 weeks, which corresponds to a roughly 32.5% reduction in cellulite.
“In cellulite, we know that the septa within the fat – those fibrous bands that pull down the skin and tether – lead to the traditional look of cellulite dimples and ridges,” lead study author Elizabeth Tanzi, MD, said during a late-breaking abstract session at the virtual annual meeting of the American Academy of Dermatology. A rapid acoustic pulse (RAP) device being developed by Soliton emits rapid acoustic pulses and shock waves at 50 Hz that are transmitted through the skin. The pulses “rupture and shear the fibrotic septa, which causes release of the septa and smoothing of the skin dimples,” explained Dr. Tanzi, director of Capital Laser & Skin Care in Chevy Chase, Md.
She added that the repetition rate of the RAP device makes it stand out from other technologies currently on the market for cellulite treatment. “The repetition rate and very short rise times provide microscopic mechanical destruction to the targeted cellular level structures and the vacuoles,” Dr. Tanzi said. “The high peak pressure and fast repetition rate exploit the viscoelastic nature of the tissue. It’s the rapid rate at which the energy is being delivered, as well as the very short times that energy is being delivered, that makes the technology an entirely different device-tissue interaction.”
The physical effects observed occur in the extracellular matrix and in the destruction of fibrous septa. “That’s the acoustic subcision,” she continued. “But also, there’s no cavitation and there are nonthermal physical effects. There is some investigational research going into what biologic effects those shock waves have on the rest of the tissue, looking into neocollagenesis, potential angiogenesis, potential lymphangiogenesis, as well as inflammation inhibition.”
In a prospective pivotal clinical trial conducted at four sites, Dr. Tanzi and her colleagues evaluated the safety and effectiveness of the RAP device in 62 female patients who were treated with a single, rapid acoustic pulse treatment comprised of 1-2 minutes on each identified dimple or large ridge of cellulite. This amounted to a 19- to 33-minute treatment session for each patient. No anesthesia was required, and photographs were taken on all sites with QuantifiCare medical imaging software.
“It’s completely noninvasive and it’s truly an incisionless treatment,” Dr. Tanzi said of the procedure. “The skin’s never punctured. There’s physician oversight, but it is highly delegatable, and there is no recovery time for the patient.”
Following treatment, adverse effects and tolerability were reported, and safety and efficacy were assessed at 12 weeks. Efficacy was determined by photographic assessment by three blinded independent physicians who used a validated, simplified version of the Cellulite Severity Scale (CSS), a 0-5 scale based on the number of cellulite depressions, as well as the average depth of those depressions.
The mean age of patients was 43 years, 92% were white, and their mean body mass index was 24.5 kg/m2. The average time of treatment was 28 minutes. Based on the CSS scores, the researchers found that 87% of the study subjects had some improvement of their cellulite after a single RAP treatment. “If you break the data down further, half of patients had at least a 30% reduction of their CSS, and almost one-quarter had a 50% improvement of their CSS,” Dr. Tanzi said. “Overall, we saw a reduction of a 1.16 level on that six-point scale, which translates roughly into 32.5% reduction of the look of their cellulite from the baseline score.”
In addition, 84% of the time, the blinded assessors were able to correctly identify pre- and posttreatment unlabeled photos that they were presented at the 3-month mark. Those same blinded assessors graded about 86% of the treated cellulite areas as appearing either improved, much improved, or very much improved on the Global Aesthetic Improvement Scale (GAIS).
“We found a very favorable side-effect profile, although 95% of patients had some redness to their skin,” Dr. Tanzi added. “They had some erythema and folliculitis, but it was transient and very mild. In addition, 98% of patients said that the procedure was tolerable.”
As for pain, on a 0-10 scale, with 10 being the worst, subjects rated their pain level at 2.4 during the treatment and 0.3 immediately afterward. On subject satisfaction surveys, 92% of the patient said that they “agree” or “strongly agree” that their cellulite appeared improved.
“Patients with moderate cellulite seem to respond [to this treatment], too,” Dr. Tanzi said. “I don’t think there’s a ceiling or a floor to which we have to pigeonhole patients into potentially treating with this device. I think the key is [targeting] cellulite and not necessarily skin laxity.”
She emphasized that much remains to be known about the RAP device for treating cellulite. “What happens if we do multiple treatments to the tissue?” she asked. “Also, we need to further investigate what’s happening in the tissue, because not only does it seem like we’re getting a cleaving of the fibrous septa, but what is happening to the fibroblasts? What’s really happening in the tissue on a molecular level when those rapid acoustic pulses are going through the skin? There’s a lot of unanswered questions, but this is exciting technology.”
According to a news release from Soliton, the company is further reviewing and analyzing these results for inclusion in a marketing application to the Food and Drug Administration.
Soliton sponsored the trial. Dr. Tanzi disclosed that she is either a consultant for or is a member of the scientific advisory board for Allergan/Coolsculpting, Beiersdorf, Cutera, Merz/Ulthera, Pulse Biosciences, Sciton, Soliton, Solta, and Syneron/Candela.
After a single treatment, it provided a roughly 1.16 point reduction in the five-point Cellulite Severity Scale at 12 weeks, which corresponds to a roughly 32.5% reduction in cellulite.
“In cellulite, we know that the septa within the fat – those fibrous bands that pull down the skin and tether – lead to the traditional look of cellulite dimples and ridges,” lead study author Elizabeth Tanzi, MD, said during a late-breaking abstract session at the virtual annual meeting of the American Academy of Dermatology. A rapid acoustic pulse (RAP) device being developed by Soliton emits rapid acoustic pulses and shock waves at 50 Hz that are transmitted through the skin. The pulses “rupture and shear the fibrotic septa, which causes release of the septa and smoothing of the skin dimples,” explained Dr. Tanzi, director of Capital Laser & Skin Care in Chevy Chase, Md.
She added that the repetition rate of the RAP device makes it stand out from other technologies currently on the market for cellulite treatment. “The repetition rate and very short rise times provide microscopic mechanical destruction to the targeted cellular level structures and the vacuoles,” Dr. Tanzi said. “The high peak pressure and fast repetition rate exploit the viscoelastic nature of the tissue. It’s the rapid rate at which the energy is being delivered, as well as the very short times that energy is being delivered, that makes the technology an entirely different device-tissue interaction.”
The physical effects observed occur in the extracellular matrix and in the destruction of fibrous septa. “That’s the acoustic subcision,” she continued. “But also, there’s no cavitation and there are nonthermal physical effects. There is some investigational research going into what biologic effects those shock waves have on the rest of the tissue, looking into neocollagenesis, potential angiogenesis, potential lymphangiogenesis, as well as inflammation inhibition.”
In a prospective pivotal clinical trial conducted at four sites, Dr. Tanzi and her colleagues evaluated the safety and effectiveness of the RAP device in 62 female patients who were treated with a single, rapid acoustic pulse treatment comprised of 1-2 minutes on each identified dimple or large ridge of cellulite. This amounted to a 19- to 33-minute treatment session for each patient. No anesthesia was required, and photographs were taken on all sites with QuantifiCare medical imaging software.
“It’s completely noninvasive and it’s truly an incisionless treatment,” Dr. Tanzi said of the procedure. “The skin’s never punctured. There’s physician oversight, but it is highly delegatable, and there is no recovery time for the patient.”
Following treatment, adverse effects and tolerability were reported, and safety and efficacy were assessed at 12 weeks. Efficacy was determined by photographic assessment by three blinded independent physicians who used a validated, simplified version of the Cellulite Severity Scale (CSS), a 0-5 scale based on the number of cellulite depressions, as well as the average depth of those depressions.
The mean age of patients was 43 years, 92% were white, and their mean body mass index was 24.5 kg/m2. The average time of treatment was 28 minutes. Based on the CSS scores, the researchers found that 87% of the study subjects had some improvement of their cellulite after a single RAP treatment. “If you break the data down further, half of patients had at least a 30% reduction of their CSS, and almost one-quarter had a 50% improvement of their CSS,” Dr. Tanzi said. “Overall, we saw a reduction of a 1.16 level on that six-point scale, which translates roughly into 32.5% reduction of the look of their cellulite from the baseline score.”
In addition, 84% of the time, the blinded assessors were able to correctly identify pre- and posttreatment unlabeled photos that they were presented at the 3-month mark. Those same blinded assessors graded about 86% of the treated cellulite areas as appearing either improved, much improved, or very much improved on the Global Aesthetic Improvement Scale (GAIS).
“We found a very favorable side-effect profile, although 95% of patients had some redness to their skin,” Dr. Tanzi added. “They had some erythema and folliculitis, but it was transient and very mild. In addition, 98% of patients said that the procedure was tolerable.”
As for pain, on a 0-10 scale, with 10 being the worst, subjects rated their pain level at 2.4 during the treatment and 0.3 immediately afterward. On subject satisfaction surveys, 92% of the patient said that they “agree” or “strongly agree” that their cellulite appeared improved.
“Patients with moderate cellulite seem to respond [to this treatment], too,” Dr. Tanzi said. “I don’t think there’s a ceiling or a floor to which we have to pigeonhole patients into potentially treating with this device. I think the key is [targeting] cellulite and not necessarily skin laxity.”
She emphasized that much remains to be known about the RAP device for treating cellulite. “What happens if we do multiple treatments to the tissue?” she asked. “Also, we need to further investigate what’s happening in the tissue, because not only does it seem like we’re getting a cleaving of the fibrous septa, but what is happening to the fibroblasts? What’s really happening in the tissue on a molecular level when those rapid acoustic pulses are going through the skin? There’s a lot of unanswered questions, but this is exciting technology.”
According to a news release from Soliton, the company is further reviewing and analyzing these results for inclusion in a marketing application to the Food and Drug Administration.
Soliton sponsored the trial. Dr. Tanzi disclosed that she is either a consultant for or is a member of the scientific advisory board for Allergan/Coolsculpting, Beiersdorf, Cutera, Merz/Ulthera, Pulse Biosciences, Sciton, Soliton, Solta, and Syneron/Candela.
After a single treatment, it provided a roughly 1.16 point reduction in the five-point Cellulite Severity Scale at 12 weeks, which corresponds to a roughly 32.5% reduction in cellulite.
“In cellulite, we know that the septa within the fat – those fibrous bands that pull down the skin and tether – lead to the traditional look of cellulite dimples and ridges,” lead study author Elizabeth Tanzi, MD, said during a late-breaking abstract session at the virtual annual meeting of the American Academy of Dermatology. A rapid acoustic pulse (RAP) device being developed by Soliton emits rapid acoustic pulses and shock waves at 50 Hz that are transmitted through the skin. The pulses “rupture and shear the fibrotic septa, which causes release of the septa and smoothing of the skin dimples,” explained Dr. Tanzi, director of Capital Laser & Skin Care in Chevy Chase, Md.
She added that the repetition rate of the RAP device makes it stand out from other technologies currently on the market for cellulite treatment. “The repetition rate and very short rise times provide microscopic mechanical destruction to the targeted cellular level structures and the vacuoles,” Dr. Tanzi said. “The high peak pressure and fast repetition rate exploit the viscoelastic nature of the tissue. It’s the rapid rate at which the energy is being delivered, as well as the very short times that energy is being delivered, that makes the technology an entirely different device-tissue interaction.”
The physical effects observed occur in the extracellular matrix and in the destruction of fibrous septa. “That’s the acoustic subcision,” she continued. “But also, there’s no cavitation and there are nonthermal physical effects. There is some investigational research going into what biologic effects those shock waves have on the rest of the tissue, looking into neocollagenesis, potential angiogenesis, potential lymphangiogenesis, as well as inflammation inhibition.”
In a prospective pivotal clinical trial conducted at four sites, Dr. Tanzi and her colleagues evaluated the safety and effectiveness of the RAP device in 62 female patients who were treated with a single, rapid acoustic pulse treatment comprised of 1-2 minutes on each identified dimple or large ridge of cellulite. This amounted to a 19- to 33-minute treatment session for each patient. No anesthesia was required, and photographs were taken on all sites with QuantifiCare medical imaging software.
“It’s completely noninvasive and it’s truly an incisionless treatment,” Dr. Tanzi said of the procedure. “The skin’s never punctured. There’s physician oversight, but it is highly delegatable, and there is no recovery time for the patient.”
Following treatment, adverse effects and tolerability were reported, and safety and efficacy were assessed at 12 weeks. Efficacy was determined by photographic assessment by three blinded independent physicians who used a validated, simplified version of the Cellulite Severity Scale (CSS), a 0-5 scale based on the number of cellulite depressions, as well as the average depth of those depressions.
The mean age of patients was 43 years, 92% were white, and their mean body mass index was 24.5 kg/m2. The average time of treatment was 28 minutes. Based on the CSS scores, the researchers found that 87% of the study subjects had some improvement of their cellulite after a single RAP treatment. “If you break the data down further, half of patients had at least a 30% reduction of their CSS, and almost one-quarter had a 50% improvement of their CSS,” Dr. Tanzi said. “Overall, we saw a reduction of a 1.16 level on that six-point scale, which translates roughly into 32.5% reduction of the look of their cellulite from the baseline score.”
In addition, 84% of the time, the blinded assessors were able to correctly identify pre- and posttreatment unlabeled photos that they were presented at the 3-month mark. Those same blinded assessors graded about 86% of the treated cellulite areas as appearing either improved, much improved, or very much improved on the Global Aesthetic Improvement Scale (GAIS).
“We found a very favorable side-effect profile, although 95% of patients had some redness to their skin,” Dr. Tanzi added. “They had some erythema and folliculitis, but it was transient and very mild. In addition, 98% of patients said that the procedure was tolerable.”
As for pain, on a 0-10 scale, with 10 being the worst, subjects rated their pain level at 2.4 during the treatment and 0.3 immediately afterward. On subject satisfaction surveys, 92% of the patient said that they “agree” or “strongly agree” that their cellulite appeared improved.
“Patients with moderate cellulite seem to respond [to this treatment], too,” Dr. Tanzi said. “I don’t think there’s a ceiling or a floor to which we have to pigeonhole patients into potentially treating with this device. I think the key is [targeting] cellulite and not necessarily skin laxity.”
She emphasized that much remains to be known about the RAP device for treating cellulite. “What happens if we do multiple treatments to the tissue?” she asked. “Also, we need to further investigate what’s happening in the tissue, because not only does it seem like we’re getting a cleaving of the fibrous septa, but what is happening to the fibroblasts? What’s really happening in the tissue on a molecular level when those rapid acoustic pulses are going through the skin? There’s a lot of unanswered questions, but this is exciting technology.”
According to a news release from Soliton, the company is further reviewing and analyzing these results for inclusion in a marketing application to the Food and Drug Administration.
Soliton sponsored the trial. Dr. Tanzi disclosed that she is either a consultant for or is a member of the scientific advisory board for Allergan/Coolsculpting, Beiersdorf, Cutera, Merz/Ulthera, Pulse Biosciences, Sciton, Soliton, Solta, and Syneron/Candela.
FROM AAD 20
Daily Recap: Transgender patients turn to DIY treatments; ACIP plans priority vaccine groups
Here are the stories our MDedge editors across specialties think you need to know about today:
Ignored by doctors, transgender patients turn to DIY treatments
Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.
Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.
Treating gender dysphoria should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.” Read more.
ACIP plans priority groups in advance of COVID-19 vaccine
Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.
‘Nietzsche was wrong’: Past stressors do not create psychological resilience.
The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.
Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.
The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.
“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.
High-impact training can build bone in older women
Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.
Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.
“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Ignored by doctors, transgender patients turn to DIY treatments
Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.
Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.
Treating gender dysphoria should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.” Read more.
ACIP plans priority groups in advance of COVID-19 vaccine
Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.
‘Nietzsche was wrong’: Past stressors do not create psychological resilience.
The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.
Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.
The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.
“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.
High-impact training can build bone in older women
Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.
Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.
“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
Ignored by doctors, transgender patients turn to DIY treatments
Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.
Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.
Treating gender dysphoria should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.” Read more.
ACIP plans priority groups in advance of COVID-19 vaccine
Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.
‘Nietzsche was wrong’: Past stressors do not create psychological resilience.
The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.
Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.
The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.
“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.
High-impact training can build bone in older women
Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.
Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.
“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
How racism contributes to the effects of SARS-CoV-2
It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19.
Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.
Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.
A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.
Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?
That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.
Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.
As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.
As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.
Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.
With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.
In my limited time in Brooklyn, taking care of almost exclusively black and Hispanic patients, I saw one physician assistant and one nurse who were black; one nurse practitioner was Hispanic. This mismatch is sadly common. Although 13% of the population of the United States is black, only 5% of physicians in the United States are black. Hispanic people, who make up 18% of the US population, are only 6% of physicians. This undoubtedly contributes to poorer outcomes for underrepresented minority patients who have a hard time finding physicians who look like them and understand them.
So while SARS-CoV-2 may not discriminate, the effects it has on patients depends on all of these other factors. If it flies through the air and lands on the mucosal tract of a person who works from home, has effective health insurance and a primary care physician, and lives in a community with no toxic exposures, that person may be more likely to kick it out before it has a chance to settle in. The reason we have such a huge disparity in outcomes related to COVID-19 by race is that a person meeting that description is less likely to be black or Hispanic. Race is not an independent risk factor; structural racism is.
When I drive by the mall that is now open or the restaurants that are now open with indoor dining, my heart rate quickens just a bit with anxiety. The pandemic fatigue people are experiencing is leading them to act in unsafe ways – gathering with more people, not wearing masks, not keeping a safe distance. I worry about everyone, sure, but I really worry about black and Hispanic people who are most vulnerable as a result of everyone else’s refusal to follow guidelines.
Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.
It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19.
Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.
Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.
A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.
Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?
That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.
Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.
As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.
As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.
Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.
With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.
In my limited time in Brooklyn, taking care of almost exclusively black and Hispanic patients, I saw one physician assistant and one nurse who were black; one nurse practitioner was Hispanic. This mismatch is sadly common. Although 13% of the population of the United States is black, only 5% of physicians in the United States are black. Hispanic people, who make up 18% of the US population, are only 6% of physicians. This undoubtedly contributes to poorer outcomes for underrepresented minority patients who have a hard time finding physicians who look like them and understand them.
So while SARS-CoV-2 may not discriminate, the effects it has on patients depends on all of these other factors. If it flies through the air and lands on the mucosal tract of a person who works from home, has effective health insurance and a primary care physician, and lives in a community with no toxic exposures, that person may be more likely to kick it out before it has a chance to settle in. The reason we have such a huge disparity in outcomes related to COVID-19 by race is that a person meeting that description is less likely to be black or Hispanic. Race is not an independent risk factor; structural racism is.
When I drive by the mall that is now open or the restaurants that are now open with indoor dining, my heart rate quickens just a bit with anxiety. The pandemic fatigue people are experiencing is leading them to act in unsafe ways – gathering with more people, not wearing masks, not keeping a safe distance. I worry about everyone, sure, but I really worry about black and Hispanic people who are most vulnerable as a result of everyone else’s refusal to follow guidelines.
Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.
It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19.
Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.
Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.
A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.
Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?
That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.
Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.
As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.
As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.
Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.
With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.
In my limited time in Brooklyn, taking care of almost exclusively black and Hispanic patients, I saw one physician assistant and one nurse who were black; one nurse practitioner was Hispanic. This mismatch is sadly common. Although 13% of the population of the United States is black, only 5% of physicians in the United States are black. Hispanic people, who make up 18% of the US population, are only 6% of physicians. This undoubtedly contributes to poorer outcomes for underrepresented minority patients who have a hard time finding physicians who look like them and understand them.
So while SARS-CoV-2 may not discriminate, the effects it has on patients depends on all of these other factors. If it flies through the air and lands on the mucosal tract of a person who works from home, has effective health insurance and a primary care physician, and lives in a community with no toxic exposures, that person may be more likely to kick it out before it has a chance to settle in. The reason we have such a huge disparity in outcomes related to COVID-19 by race is that a person meeting that description is less likely to be black or Hispanic. Race is not an independent risk factor; structural racism is.
When I drive by the mall that is now open or the restaurants that are now open with indoor dining, my heart rate quickens just a bit with anxiety. The pandemic fatigue people are experiencing is leading them to act in unsafe ways – gathering with more people, not wearing masks, not keeping a safe distance. I worry about everyone, sure, but I really worry about black and Hispanic people who are most vulnerable as a result of everyone else’s refusal to follow guidelines.
Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.
ACIP plans priority groups in advance of COVID-19 vaccine
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.