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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.
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
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.
Ignored by doctors, transgender people turn to DIY treatments
For the first 10 months of Christine’s gender transition, a progressive LGBT health clinic in Boston made getting on hormones easy. But after a year or so on estrogen and a testosterone-blocker, she found herself in financial trouble. She had just recently moved to the city, where she was unable to find a job, and her savings were starting to wear thin.
Finding employment as a transgender person, she says, was overwhelmingly difficult: “I was turned down for more jobs than I can count — 20 or 40 different positions in a couple of months.” She would land an interview, then wouldn’t hear back, she says, which she suspects happened because the company noticed she was “not like their other potential hires.”
Christine, a transgender woman, had been enrolled in the state’s Medicaid program, MassHealth, for four months, and her copay for hormone therapy was only $5. But without a job, she found herself torn between food, rent, and medication. For a while, she juggled all three expenses with donations from friends. But after several months, she felt guilty about asking for help and stopped treatment. (Undark has agreed to use only Christine's chosen name because she said she feared both online and in-person harassment for sharing her story.)
At first, Christine didn’t mind being off hormones. She marched in political protests alongside older trans people who assured her that starting and stopping hormones was a normal part of the trans experience. But eventually, Christine felt her body reverting back to the way it had been before her transition; her chest flattened and her fat moved from her hips to her stomach. She stopped wearing dresses and makeup.
“I wasn't looking at myself in the mirror anymore,” she says. “I existed for 10 months, and then I was gone.”
People who are visibly transgender often have trouble finding a job. Nearly a third live in poverty. Many don’t have health insurance, and those who do may have a plan that doesn’t cover hormones. Although testosterone and estrogen only cost $5 to $30 a month for patients with an insurance plan (and typically less than $100 per month for the uninsured), doctors often require consistent therapy and blood work, which ratchets up the cost. Even when trans people have the money, finding doctors willing to treat them can prove impossible. Trans people are also likely to have had bad experiences with the health care system and want to avoid it altogether.
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.
But those solutions aren’t available to most people who are seeking DIY treatments right now. Many doctors aren’t even aware that DIY transitioning exists, although the few experts who are following the community aren’t surprised. Self-treatment is “the reality for most trans people in the world,” says Ayden Scheim, an epidemiologist focusing on transgender health at Drexel University who is trans himself.
After Christine posted about her frustrations on Facebook, a trans friend offered a connection to a store in China that illicitly ships hormones to the United States. Christine didn’t follow up, not wanting to take the legal risk. But as time ticked by and job opportunities came and went, her mind started to change.
“I'm ready to throw all of this away and reach out to anyone — any underground black-market means — of getting what I need,” she thought after moving to the Cape. “If these systems put in place to help me have failed me over and over again, why would I go back to them?”
Transgender is an umbrella term that refers to a person who identifies with a gender that doesn’t match the one they were assigned at birth. For example, someone who has male written on their birth certificate, but who identifies as a woman, is a transgender woman. Many trans people experience distress over how their bodies relate to their gender identity, called gender dysphoria. But gender identity is deeply personal. A five o’clock shadow can spur an intense reaction in some trans women, for instance, while others may be fine with it.
To treat gender dysphoria, some trans people take sex hormones, spurring a sort of second puberty. Trans women — as well as people like Christine, who also identifies as nonbinary, meaning she doesn’t exclusively identify as being either a man or a woman — usually take estrogen with the testosterone-blocker spironolactone. Estrogen comes as a daily pill, by injection, or as a patch (recommended for women above the age of 40). The medications redistribute body fat, spur breast growth, decrease muscle mass, slow body hair growth, and shrink the testicles.
Transgender men and non-binary people who want to appear more traditionally masculine use testosterone, usually in the form of injections, which can be taken weekly, biweekly, or every three months depending on the medication. Others use a daily cream, gel, or patch applied to the skin. Testosterone therapy can redistribute body fat, increase strength, boost body hair growth, deepen the voice, stop menstruation, increase libido, and make the clitoris larger.
Some family members — especially those who are cisgender, which means their gender identity matches what they were assigned at birth — worry that people who are confused about their gender will begin hormones and accumulate permanent bodily changes before they realize they’re actually cisgender.
But many of the changes from taking hormones are reversible, and regret appears to be uncommon. Out of a group of nearly 3,400 trans people in the United Kingdom, only 16 regretted their gender transition, according to research presented at the 2019 biennial conference of the European Professional Association for Transgender Health. And although research on surgical transition is sparse, there are some hints that those who choose it are ultimately happy with the decision. According to a small 2018 study in Istanbul, post-operative trans people report a higher quality of life and fewer concerns about gender discrimination compared to those with dysphoria who haven’t had surgery.
And for trans people with dysphoria, hormones can be medically necessary. The treatments aren’t just cosmetic — transitioning literally saves lives, according to the American Academy of Pediatrics. In a 2019 review paper, researchers from the University of San Francisco found that hormone therapy is also linked to a higher quality of life and reduced anxiety and depression.
Despite the growing evidence that medical intervention can help, some trans people are wary of the health care system. According to the 2015 U.S. Transgender Survey, a third of trans people who saw a health care provider experienced mistreatment — from having to educate their doctor about transgender issues to being refused medical treatment to verbal abuse — and 23 percent avoided the doctor’s office because they feared mistreatment.
The health care system has a history of stigmatizing trans identity. Until recently, the World Health Organization and the American Psychiatric Association even considered it a mental disorder. And according to a 2015 study from researchers at the Lesbian, Gay, Bisexual, and Transgender Medical Education Research Group at the Stanford University School of Medicine, less than 35 percent of medical schools teach coursework related to transgender hormone therapy and surgery.
On June 12, the administration of President Donald J. Trump finalized a rule removing protections that had been put in place in 2016 to bar discrimination against transgender people by health care providers. Just three days later, the U.S. Supreme Court decided that the 1964 law that bans discrimination in the workplace based on sex, race, national origin, and religion also applies to sexual orientation and gender identity. While not directly touching on the new health care rule, some experts think the Supreme Court's decision may make legal challenges to it more likely to succeed.
Trans-friendly health care providers are rare, and booking an appointment can stretch out over many weeks. In England, for example, the average wait time from the referral to the first appointment is 18 months, according to an investigation by the BBC. Even those with hormone prescriptions face hurdles to get them filled. Scheim, who lived in Canada until recently, knows this firsthand. “As someone who just moved to the U.S., I’m keenly aware of the hoops one has to jump through,” he says.
“Even if it's theoretically possible to get a hormone prescription, and get it filled, and get it paid for, at a certain point people are going to want to go outside the system,” Scheim says. Navigating bureaucracy, being incorrectly identified — or misgendered — and facing outright transphobia from health care providers, he adds, “can just become too much for folks.”
Many of the health care barriers trans people face are amplified when it comes to surgery. Bottom surgery for trans feminine people, for example, costs about $25,000 and isn’t covered by most insurance plans in the U.S.
There are some signs that at least parts of the medical community have been rethinking their stance on transgender patients. “Clearly the medical professionals didn’t do the right thing. But things are changing now,” says Antonio Metastasio, a psychiatrist at the Camden and Islington NHS Foundation Trust in the U.K.
The Association of American Medical Colleges, for example, released their first curriculum guidelines for treating LGBT patients in 2014. In 2018, the American Academy of Pediatrics released a policy statement on transgender youth, encouraging gender-affirming models of treatment. And in 2019, the American College of Physicians released guidelines for primary care physicians on serving transgender patients.
The World Professional Association for Transgender Health (WPATH) — the international authority on transgender health care, according to a summary of clinical evidence on gender reassignment surgery prepared for the Centers for Medicare and Medicaid Services — has also changed its Standards of Care to make access to hormones easier. Previously, WPATH recommended that before a person could receive hormone treatment, they had to have “persistent, well-documented gender dysphoria,” as well as documented, real-life experiences covering at least three months. The newest guidelines, published in 2012, nix these stringent requirements, although they still strongly recommend mental health evaluations before allowing trans people to access gender-affirming medical care and require a referral letter from a mental health professional.
But the shift hasn’t stopped trans people from seeking DIY treatments.
Before Christine moved to Cape Cod, she secured about two weeks of estrogen from a trans friend. But she soon decided to end the DIY treatment and went off hormones for good. “I can only accept help for something like that for so long before I start to feel bad about it,” she says. “At that point, it was just like I gave up.”
But she didn’t give up for long. After the move, Christine tried to get back on hormones through a legitimate health care provider. First, she considered visiting a Planned Parenthood, but the closest one she could find was at least two hours away and she worried her old car couldn’t make the journey. Then she visited a local women’s health clinic. But she says they turned her away, refused to recognize her gender, and wouldn’t direct her to another provider or clinic. Instead of advice, Christine says, “I got ‘no, goodbye.’”
Left with few options and not wanting to take the risks of further DIY treatment, Christine accepted that she would be off hormones for the foreseeable future.
Many trans folks, however, start or extend their hormone use by turning to drugs that aren’t meant for transitioning, like birth control pills. Others buy hormones online, skirting the law to order from overseas pharmacies without a prescription. To figure out how best to take the drugs, people determine dosages from research online — they read academic literature, technical standards written for health care providers, or advice in blog posts and public forums like Reddit.
Then, they medicate themselves.
Metastasio is one of the few scientists who have studied the practice. He learned about it in 2014, when one of his transgender patients admitted they were taking non-prescribed hormones. Metastasio asked his colleagues if they’d heard similar stories, but none had. So he started asking all his trans patients about DIY hormones and tracked those who were involved in the practice, ultimately publishing a report of seven case studies in 2018.
While there isn’t a lot of other existing research on DIY hormone treatment, and some of it may be outdated, the available studies suggest it is fairly common and researchers may in fact be underestimating the prevalence of DIY hormone use because they miss people who avoid the medical system completely. In 2014, researchers in the U.K. found that at the time of their first gender clinic visit, 17 percent of transgender people were already taking hormones that they had bought online or from a friend. In Canada, a quarter of trans people on hormones had self-medicated, according to a 2013 study in the American Journal of Public Health. And in a survey of trans people in Washington, D.C. in 2000, 58 percent said they used non-prescribed hormones.
People cite all sorts of reasons for ordering the drugs online or acquiring them by other means. In addition to distrust of doctors and a lack of insurance or access to health care, some simply don’t want to endure long waits for medications. That’s the case for Emma, a trans woman in college in the Netherlands, where it can take two to three years to receive a physician prescription. (Emma is only using her first name to avoid online harassment, which she says she’s experienced in the past.)
As for surgery, far fewer people turn to DIY versions compared to those who try hormones. A 2012 study in the Journal of Sexual Medicine reported that only 109 cases of self-castration or self-mutilation of the genitals appear in the scientific literature, and not all are related to gender identity. “But one is too many,” Scheim says. “No one should be in a position where they feel like they need to do that.”
The individual cases reveal a practice that is dangerous and devastating. In Hangzhou, China, a 30-year-old transgender woman feared rejection from her family, so she hid her true gender, according to a 2019 Amnesty International report. She also tried to transition in secret. At first, the woman tried putting ice on her genitals to stop them from functioning. When that didn’t work, she booked an appointment with a black-market surgeon, but the doctor was arrested before her session. She attempted surgery on herself, the report says, and after losing a profuse amount of blood, hailed a taxi to the emergency room. There, she asked the doctor to tell her family she had been in an accident.
When it comes to self-surgery, the dangers of DIY transitioning are obvious. The dangers of DIY hormones are more far-ranging, from “not ideal to serious,” Scheim says. Some DIY users take a more-is-better approach, but taking too much testosterone too quickly can fry the vocal cords. Even buying hormones from an online pharmacy is risky. In 2010, more than half of all treatments from illicit websites — not only of hormones, but of any drug — were counterfeit, according to a bulletin from the World Health Organization.
Still, Charley isn’t worried about the legitimacy of the drugs he’s taking. The packaging his estrogen comes in matches what he would get from a pharmacy with a doctor’s prescription, he says. He’s also unconcerned about the side effects. “I just did a metric century” — a 100-kilometer bike ride — “in under four hours and walked away from it feeling great. I’m healthy,” he says. “So, yeah, there might be a few side effects. But I know where the local hospital is.”
Yet waiting to see if a seemingly minor side effect leads to a health emergency may mean a patient gets help too late. “I don’t want to say that the risks are incredibly high and there is a high mortality,” Metastasio says. “I am saying, though, that this is a procedure best to be monitored.” Metastasio and others recommend seeing a doctor regularly to catch any health issues that arise as quickly as possible.
But even when doctors prescribe the drugs, the risks are unclear because of a lack of research on trans health, says Scheim: “There’s so much we don’t know about hormone use.”
Researchers do know a little bit, though. Even when a doctor weighs in on the proper dosages, there is an increased risk of heart attack. Taking testosterone increases the chances of developing acne, headaches and migraines, and anger and irritability, according to the Trans Care Project, a program of the Transcend Transgender Support and Education Society and Vancouver Coastal Health’s Transgender Health Program in Canada. Testosterone also increases the risk of having abnormally high levels of red blood cells, or polycythemia, which thickens the blood and can lead to clotting. Meanwhile, studies suggest estrogen can up the risk for breast cancer, stroke, blood clots, gallstones, and a range of heart issues. And the most common testosterone-blocker, spironolactone, can cause dehydration and weaken the kidneys.
All of these risks make it especially important for trans people to have the support of a medical provider, Metastasio says. Specialists are in short supply, but general practitioners and family doctors should be able to fill the gap. After all, they already sign off on the hormone medications for cisgender people for birth control and conditions such as menopause and male pattern baldness — which come with similar side effects and warnings as when trans people use them.
Some doctors have already realized the connection. “People can increasingly get hormone therapy from their pre-existing family doctor,” Scheim says, “which is really ideal because people should be able to have a sort of continuity of health care.”
Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City, would like to see more of this. Treating gender dysphoria, she says, 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,’” she says. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.”
Another way to increase access to hormones is through informed consent, a system which received a green light from the newest WPATH guidelines. That’s how Christine received her hormones from Fenway Health before she moved from Boston to Cape Cod. Under informed consent, if someone has a blood test to assess personal health risks of treatment, they can receive a diagnosis of gender dysphoria, sign off on knowing the risks and benefits of hormone therapy, and get a prescription — all in one day.
And Jaime Lynn Gilmour, a trans woman using the full name she chose to match her gender identity, turned to informed consent after struggling to find DIY hormones. In 2017, Jaime realized she was trans while serving in the military, and says she felt she had to keep her gender a secret. When her service ended, she was ready to start taking hormones right away. So she tried to find them online, but her order wouldn’t go through on three different websites. Instead, she visited a Planned Parenthood clinic. After blood work and a few questions, she walked out with three months of estrogen and spironolactone.
But Goldstein says even informed consent doesn’t go far enough: “If I have someone who's diabetic, I don't make them sign a document eliciting their informed consent before starting insulin.”
For trans people, hormone treatments “are life-saving therapies,” Goldstein adds, “and we shouldn’t delay or stigmatize.”
For now Christine still lives with her parents in Cape Cod. She’s also still off hormones. But she found a job. After she stashes a bit more cash in the bank, she plans to move closer to Boston and find a physician.
Despite the positive shifts in her life, it’s been a difficult few months. After moving to Cape Cod, Christine lost most of her social life and support system — particularly since her parents don’t understand or accept her gender identity. Though she has reconnected with a few friends in the past several weeks, she says she’s in a tough place emotionally. In public, she typically dresses and styles herself to look more masculine to avoid rude stares, and she is experiencing self-hatred that she fears won’t go away when she restarts treatment. Transitioning again isn’t going to be easy, as she explained to Undark in a private message on Facebook: “I've been beaten down enough that now I don't wanna get back up most of the time.”
Even worse is the fear that she might not be able to restart treatment at all. Earlier this year, Christine suffered two health emergencies within the span of a week, in which she says her blood pressure spiked, potentially causing organ damage. Christine has had one similar episode in the past and her family has a history of heart issues.
Christine may not be able to get back on estrogen despite the hard work she’s done to be able to afford it, she says, since it can increase the risk of heart attack and stroke. Because she has so far resisted trying DIY treatments again, she may have saved herself from additional health problems.
But Christine doesn’t see it that way. “Even if it was unsafe, even if I risked health concerns making myself a guinea pig, I wish I followed through,” she wrote. “Being off hormones is hell. And now that I face potentially never taking them again, I wish I had.”
Tara Santora is a science journalist based out of Denver. They have written for Psychology Today, Live Science, Fatherly, Audubon, and more.
This article was originally published on Undark. Read the original article.
For the first 10 months of Christine’s gender transition, a progressive LGBT health clinic in Boston made getting on hormones easy. But after a year or so on estrogen and a testosterone-blocker, she found herself in financial trouble. She had just recently moved to the city, where she was unable to find a job, and her savings were starting to wear thin.
Finding employment as a transgender person, she says, was overwhelmingly difficult: “I was turned down for more jobs than I can count — 20 or 40 different positions in a couple of months.” She would land an interview, then wouldn’t hear back, she says, which she suspects happened because the company noticed she was “not like their other potential hires.”
Christine, a transgender woman, had been enrolled in the state’s Medicaid program, MassHealth, for four months, and her copay for hormone therapy was only $5. But without a job, she found herself torn between food, rent, and medication. For a while, she juggled all three expenses with donations from friends. But after several months, she felt guilty about asking for help and stopped treatment. (Undark has agreed to use only Christine's chosen name because she said she feared both online and in-person harassment for sharing her story.)
At first, Christine didn’t mind being off hormones. She marched in political protests alongside older trans people who assured her that starting and stopping hormones was a normal part of the trans experience. But eventually, Christine felt her body reverting back to the way it had been before her transition; her chest flattened and her fat moved from her hips to her stomach. She stopped wearing dresses and makeup.
“I wasn't looking at myself in the mirror anymore,” she says. “I existed for 10 months, and then I was gone.”
People who are visibly transgender often have trouble finding a job. Nearly a third live in poverty. Many don’t have health insurance, and those who do may have a plan that doesn’t cover hormones. Although testosterone and estrogen only cost $5 to $30 a month for patients with an insurance plan (and typically less than $100 per month for the uninsured), doctors often require consistent therapy and blood work, which ratchets up the cost. Even when trans people have the money, finding doctors willing to treat them can prove impossible. Trans people are also likely to have had bad experiences with the health care system and want to avoid it altogether.
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.
But those solutions aren’t available to most people who are seeking DIY treatments right now. Many doctors aren’t even aware that DIY transitioning exists, although the few experts who are following the community aren’t surprised. Self-treatment is “the reality for most trans people in the world,” says Ayden Scheim, an epidemiologist focusing on transgender health at Drexel University who is trans himself.
After Christine posted about her frustrations on Facebook, a trans friend offered a connection to a store in China that illicitly ships hormones to the United States. Christine didn’t follow up, not wanting to take the legal risk. But as time ticked by and job opportunities came and went, her mind started to change.
“I'm ready to throw all of this away and reach out to anyone — any underground black-market means — of getting what I need,” she thought after moving to the Cape. “If these systems put in place to help me have failed me over and over again, why would I go back to them?”
Transgender is an umbrella term that refers to a person who identifies with a gender that doesn’t match the one they were assigned at birth. For example, someone who has male written on their birth certificate, but who identifies as a woman, is a transgender woman. Many trans people experience distress over how their bodies relate to their gender identity, called gender dysphoria. But gender identity is deeply personal. A five o’clock shadow can spur an intense reaction in some trans women, for instance, while others may be fine with it.
To treat gender dysphoria, some trans people take sex hormones, spurring a sort of second puberty. Trans women — as well as people like Christine, who also identifies as nonbinary, meaning she doesn’t exclusively identify as being either a man or a woman — usually take estrogen with the testosterone-blocker spironolactone. Estrogen comes as a daily pill, by injection, or as a patch (recommended for women above the age of 40). The medications redistribute body fat, spur breast growth, decrease muscle mass, slow body hair growth, and shrink the testicles.
Transgender men and non-binary people who want to appear more traditionally masculine use testosterone, usually in the form of injections, which can be taken weekly, biweekly, or every three months depending on the medication. Others use a daily cream, gel, or patch applied to the skin. Testosterone therapy can redistribute body fat, increase strength, boost body hair growth, deepen the voice, stop menstruation, increase libido, and make the clitoris larger.
Some family members — especially those who are cisgender, which means their gender identity matches what they were assigned at birth — worry that people who are confused about their gender will begin hormones and accumulate permanent bodily changes before they realize they’re actually cisgender.
But many of the changes from taking hormones are reversible, and regret appears to be uncommon. Out of a group of nearly 3,400 trans people in the United Kingdom, only 16 regretted their gender transition, according to research presented at the 2019 biennial conference of the European Professional Association for Transgender Health. And although research on surgical transition is sparse, there are some hints that those who choose it are ultimately happy with the decision. According to a small 2018 study in Istanbul, post-operative trans people report a higher quality of life and fewer concerns about gender discrimination compared to those with dysphoria who haven’t had surgery.
And for trans people with dysphoria, hormones can be medically necessary. The treatments aren’t just cosmetic — transitioning literally saves lives, according to the American Academy of Pediatrics. In a 2019 review paper, researchers from the University of San Francisco found that hormone therapy is also linked to a higher quality of life and reduced anxiety and depression.
Despite the growing evidence that medical intervention can help, some trans people are wary of the health care system. According to the 2015 U.S. Transgender Survey, a third of trans people who saw a health care provider experienced mistreatment — from having to educate their doctor about transgender issues to being refused medical treatment to verbal abuse — and 23 percent avoided the doctor’s office because they feared mistreatment.
The health care system has a history of stigmatizing trans identity. Until recently, the World Health Organization and the American Psychiatric Association even considered it a mental disorder. And according to a 2015 study from researchers at the Lesbian, Gay, Bisexual, and Transgender Medical Education Research Group at the Stanford University School of Medicine, less than 35 percent of medical schools teach coursework related to transgender hormone therapy and surgery.
On June 12, the administration of President Donald J. Trump finalized a rule removing protections that had been put in place in 2016 to bar discrimination against transgender people by health care providers. Just three days later, the U.S. Supreme Court decided that the 1964 law that bans discrimination in the workplace based on sex, race, national origin, and religion also applies to sexual orientation and gender identity. While not directly touching on the new health care rule, some experts think the Supreme Court's decision may make legal challenges to it more likely to succeed.
Trans-friendly health care providers are rare, and booking an appointment can stretch out over many weeks. In England, for example, the average wait time from the referral to the first appointment is 18 months, according to an investigation by the BBC. Even those with hormone prescriptions face hurdles to get them filled. Scheim, who lived in Canada until recently, knows this firsthand. “As someone who just moved to the U.S., I’m keenly aware of the hoops one has to jump through,” he says.
“Even if it's theoretically possible to get a hormone prescription, and get it filled, and get it paid for, at a certain point people are going to want to go outside the system,” Scheim says. Navigating bureaucracy, being incorrectly identified — or misgendered — and facing outright transphobia from health care providers, he adds, “can just become too much for folks.”
Many of the health care barriers trans people face are amplified when it comes to surgery. Bottom surgery for trans feminine people, for example, costs about $25,000 and isn’t covered by most insurance plans in the U.S.
There are some signs that at least parts of the medical community have been rethinking their stance on transgender patients. “Clearly the medical professionals didn’t do the right thing. But things are changing now,” says Antonio Metastasio, a psychiatrist at the Camden and Islington NHS Foundation Trust in the U.K.
The Association of American Medical Colleges, for example, released their first curriculum guidelines for treating LGBT patients in 2014. In 2018, the American Academy of Pediatrics released a policy statement on transgender youth, encouraging gender-affirming models of treatment. And in 2019, the American College of Physicians released guidelines for primary care physicians on serving transgender patients.
The World Professional Association for Transgender Health (WPATH) — the international authority on transgender health care, according to a summary of clinical evidence on gender reassignment surgery prepared for the Centers for Medicare and Medicaid Services — has also changed its Standards of Care to make access to hormones easier. Previously, WPATH recommended that before a person could receive hormone treatment, they had to have “persistent, well-documented gender dysphoria,” as well as documented, real-life experiences covering at least three months. The newest guidelines, published in 2012, nix these stringent requirements, although they still strongly recommend mental health evaluations before allowing trans people to access gender-affirming medical care and require a referral letter from a mental health professional.
But the shift hasn’t stopped trans people from seeking DIY treatments.
Before Christine moved to Cape Cod, she secured about two weeks of estrogen from a trans friend. But she soon decided to end the DIY treatment and went off hormones for good. “I can only accept help for something like that for so long before I start to feel bad about it,” she says. “At that point, it was just like I gave up.”
But she didn’t give up for long. After the move, Christine tried to get back on hormones through a legitimate health care provider. First, she considered visiting a Planned Parenthood, but the closest one she could find was at least two hours away and she worried her old car couldn’t make the journey. Then she visited a local women’s health clinic. But she says they turned her away, refused to recognize her gender, and wouldn’t direct her to another provider or clinic. Instead of advice, Christine says, “I got ‘no, goodbye.’”
Left with few options and not wanting to take the risks of further DIY treatment, Christine accepted that she would be off hormones for the foreseeable future.
Many trans folks, however, start or extend their hormone use by turning to drugs that aren’t meant for transitioning, like birth control pills. Others buy hormones online, skirting the law to order from overseas pharmacies without a prescription. To figure out how best to take the drugs, people determine dosages from research online — they read academic literature, technical standards written for health care providers, or advice in blog posts and public forums like Reddit.
Then, they medicate themselves.
Metastasio is one of the few scientists who have studied the practice. He learned about it in 2014, when one of his transgender patients admitted they were taking non-prescribed hormones. Metastasio asked his colleagues if they’d heard similar stories, but none had. So he started asking all his trans patients about DIY hormones and tracked those who were involved in the practice, ultimately publishing a report of seven case studies in 2018.
While there isn’t a lot of other existing research on DIY hormone treatment, and some of it may be outdated, the available studies suggest it is fairly common and researchers may in fact be underestimating the prevalence of DIY hormone use because they miss people who avoid the medical system completely. In 2014, researchers in the U.K. found that at the time of their first gender clinic visit, 17 percent of transgender people were already taking hormones that they had bought online or from a friend. In Canada, a quarter of trans people on hormones had self-medicated, according to a 2013 study in the American Journal of Public Health. And in a survey of trans people in Washington, D.C. in 2000, 58 percent said they used non-prescribed hormones.
People cite all sorts of reasons for ordering the drugs online or acquiring them by other means. In addition to distrust of doctors and a lack of insurance or access to health care, some simply don’t want to endure long waits for medications. That’s the case for Emma, a trans woman in college in the Netherlands, where it can take two to three years to receive a physician prescription. (Emma is only using her first name to avoid online harassment, which she says she’s experienced in the past.)
As for surgery, far fewer people turn to DIY versions compared to those who try hormones. A 2012 study in the Journal of Sexual Medicine reported that only 109 cases of self-castration or self-mutilation of the genitals appear in the scientific literature, and not all are related to gender identity. “But one is too many,” Scheim says. “No one should be in a position where they feel like they need to do that.”
The individual cases reveal a practice that is dangerous and devastating. In Hangzhou, China, a 30-year-old transgender woman feared rejection from her family, so she hid her true gender, according to a 2019 Amnesty International report. She also tried to transition in secret. At first, the woman tried putting ice on her genitals to stop them from functioning. When that didn’t work, she booked an appointment with a black-market surgeon, but the doctor was arrested before her session. She attempted surgery on herself, the report says, and after losing a profuse amount of blood, hailed a taxi to the emergency room. There, she asked the doctor to tell her family she had been in an accident.
When it comes to self-surgery, the dangers of DIY transitioning are obvious. The dangers of DIY hormones are more far-ranging, from “not ideal to serious,” Scheim says. Some DIY users take a more-is-better approach, but taking too much testosterone too quickly can fry the vocal cords. Even buying hormones from an online pharmacy is risky. In 2010, more than half of all treatments from illicit websites — not only of hormones, but of any drug — were counterfeit, according to a bulletin from the World Health Organization.
Still, Charley isn’t worried about the legitimacy of the drugs he’s taking. The packaging his estrogen comes in matches what he would get from a pharmacy with a doctor’s prescription, he says. He’s also unconcerned about the side effects. “I just did a metric century” — a 100-kilometer bike ride — “in under four hours and walked away from it feeling great. I’m healthy,” he says. “So, yeah, there might be a few side effects. But I know where the local hospital is.”
Yet waiting to see if a seemingly minor side effect leads to a health emergency may mean a patient gets help too late. “I don’t want to say that the risks are incredibly high and there is a high mortality,” Metastasio says. “I am saying, though, that this is a procedure best to be monitored.” Metastasio and others recommend seeing a doctor regularly to catch any health issues that arise as quickly as possible.
But even when doctors prescribe the drugs, the risks are unclear because of a lack of research on trans health, says Scheim: “There’s so much we don’t know about hormone use.”
Researchers do know a little bit, though. Even when a doctor weighs in on the proper dosages, there is an increased risk of heart attack. Taking testosterone increases the chances of developing acne, headaches and migraines, and anger and irritability, according to the Trans Care Project, a program of the Transcend Transgender Support and Education Society and Vancouver Coastal Health’s Transgender Health Program in Canada. Testosterone also increases the risk of having abnormally high levels of red blood cells, or polycythemia, which thickens the blood and can lead to clotting. Meanwhile, studies suggest estrogen can up the risk for breast cancer, stroke, blood clots, gallstones, and a range of heart issues. And the most common testosterone-blocker, spironolactone, can cause dehydration and weaken the kidneys.
All of these risks make it especially important for trans people to have the support of a medical provider, Metastasio says. Specialists are in short supply, but general practitioners and family doctors should be able to fill the gap. After all, they already sign off on the hormone medications for cisgender people for birth control and conditions such as menopause and male pattern baldness — which come with similar side effects and warnings as when trans people use them.
Some doctors have already realized the connection. “People can increasingly get hormone therapy from their pre-existing family doctor,” Scheim says, “which is really ideal because people should be able to have a sort of continuity of health care.”
Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City, would like to see more of this. Treating gender dysphoria, she says, 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,’” she says. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.”
Another way to increase access to hormones is through informed consent, a system which received a green light from the newest WPATH guidelines. That’s how Christine received her hormones from Fenway Health before she moved from Boston to Cape Cod. Under informed consent, if someone has a blood test to assess personal health risks of treatment, they can receive a diagnosis of gender dysphoria, sign off on knowing the risks and benefits of hormone therapy, and get a prescription — all in one day.
And Jaime Lynn Gilmour, a trans woman using the full name she chose to match her gender identity, turned to informed consent after struggling to find DIY hormones. In 2017, Jaime realized she was trans while serving in the military, and says she felt she had to keep her gender a secret. When her service ended, she was ready to start taking hormones right away. So she tried to find them online, but her order wouldn’t go through on three different websites. Instead, she visited a Planned Parenthood clinic. After blood work and a few questions, she walked out with three months of estrogen and spironolactone.
But Goldstein says even informed consent doesn’t go far enough: “If I have someone who's diabetic, I don't make them sign a document eliciting their informed consent before starting insulin.”
For trans people, hormone treatments “are life-saving therapies,” Goldstein adds, “and we shouldn’t delay or stigmatize.”
For now Christine still lives with her parents in Cape Cod. She’s also still off hormones. But she found a job. After she stashes a bit more cash in the bank, she plans to move closer to Boston and find a physician.
Despite the positive shifts in her life, it’s been a difficult few months. After moving to Cape Cod, Christine lost most of her social life and support system — particularly since her parents don’t understand or accept her gender identity. Though she has reconnected with a few friends in the past several weeks, she says she’s in a tough place emotionally. In public, she typically dresses and styles herself to look more masculine to avoid rude stares, and she is experiencing self-hatred that she fears won’t go away when she restarts treatment. Transitioning again isn’t going to be easy, as she explained to Undark in a private message on Facebook: “I've been beaten down enough that now I don't wanna get back up most of the time.”
Even worse is the fear that she might not be able to restart treatment at all. Earlier this year, Christine suffered two health emergencies within the span of a week, in which she says her blood pressure spiked, potentially causing organ damage. Christine has had one similar episode in the past and her family has a history of heart issues.
Christine may not be able to get back on estrogen despite the hard work she’s done to be able to afford it, she says, since it can increase the risk of heart attack and stroke. Because she has so far resisted trying DIY treatments again, she may have saved herself from additional health problems.
But Christine doesn’t see it that way. “Even if it was unsafe, even if I risked health concerns making myself a guinea pig, I wish I followed through,” she wrote. “Being off hormones is hell. And now that I face potentially never taking them again, I wish I had.”
Tara Santora is a science journalist based out of Denver. They have written for Psychology Today, Live Science, Fatherly, Audubon, and more.
This article was originally published on Undark. Read the original article.
For the first 10 months of Christine’s gender transition, a progressive LGBT health clinic in Boston made getting on hormones easy. But after a year or so on estrogen and a testosterone-blocker, she found herself in financial trouble. She had just recently moved to the city, where she was unable to find a job, and her savings were starting to wear thin.
Finding employment as a transgender person, she says, was overwhelmingly difficult: “I was turned down for more jobs than I can count — 20 or 40 different positions in a couple of months.” She would land an interview, then wouldn’t hear back, she says, which she suspects happened because the company noticed she was “not like their other potential hires.”
Christine, a transgender woman, had been enrolled in the state’s Medicaid program, MassHealth, for four months, and her copay for hormone therapy was only $5. But without a job, she found herself torn between food, rent, and medication. For a while, she juggled all three expenses with donations from friends. But after several months, she felt guilty about asking for help and stopped treatment. (Undark has agreed to use only Christine's chosen name because she said she feared both online and in-person harassment for sharing her story.)
At first, Christine didn’t mind being off hormones. She marched in political protests alongside older trans people who assured her that starting and stopping hormones was a normal part of the trans experience. But eventually, Christine felt her body reverting back to the way it had been before her transition; her chest flattened and her fat moved from her hips to her stomach. She stopped wearing dresses and makeup.
“I wasn't looking at myself in the mirror anymore,” she says. “I existed for 10 months, and then I was gone.”
People who are visibly transgender often have trouble finding a job. Nearly a third live in poverty. Many don’t have health insurance, and those who do may have a plan that doesn’t cover hormones. Although testosterone and estrogen only cost $5 to $30 a month for patients with an insurance plan (and typically less than $100 per month for the uninsured), doctors often require consistent therapy and blood work, which ratchets up the cost. Even when trans people have the money, finding doctors willing to treat them can prove impossible. Trans people are also likely to have had bad experiences with the health care system and want to avoid it altogether.
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.
But those solutions aren’t available to most people who are seeking DIY treatments right now. Many doctors aren’t even aware that DIY transitioning exists, although the few experts who are following the community aren’t surprised. Self-treatment is “the reality for most trans people in the world,” says Ayden Scheim, an epidemiologist focusing on transgender health at Drexel University who is trans himself.
After Christine posted about her frustrations on Facebook, a trans friend offered a connection to a store in China that illicitly ships hormones to the United States. Christine didn’t follow up, not wanting to take the legal risk. But as time ticked by and job opportunities came and went, her mind started to change.
“I'm ready to throw all of this away and reach out to anyone — any underground black-market means — of getting what I need,” she thought after moving to the Cape. “If these systems put in place to help me have failed me over and over again, why would I go back to them?”
Transgender is an umbrella term that refers to a person who identifies with a gender that doesn’t match the one they were assigned at birth. For example, someone who has male written on their birth certificate, but who identifies as a woman, is a transgender woman. Many trans people experience distress over how their bodies relate to their gender identity, called gender dysphoria. But gender identity is deeply personal. A five o’clock shadow can spur an intense reaction in some trans women, for instance, while others may be fine with it.
To treat gender dysphoria, some trans people take sex hormones, spurring a sort of second puberty. Trans women — as well as people like Christine, who also identifies as nonbinary, meaning she doesn’t exclusively identify as being either a man or a woman — usually take estrogen with the testosterone-blocker spironolactone. Estrogen comes as a daily pill, by injection, or as a patch (recommended for women above the age of 40). The medications redistribute body fat, spur breast growth, decrease muscle mass, slow body hair growth, and shrink the testicles.
Transgender men and non-binary people who want to appear more traditionally masculine use testosterone, usually in the form of injections, which can be taken weekly, biweekly, or every three months depending on the medication. Others use a daily cream, gel, or patch applied to the skin. Testosterone therapy can redistribute body fat, increase strength, boost body hair growth, deepen the voice, stop menstruation, increase libido, and make the clitoris larger.
Some family members — especially those who are cisgender, which means their gender identity matches what they were assigned at birth — worry that people who are confused about their gender will begin hormones and accumulate permanent bodily changes before they realize they’re actually cisgender.
But many of the changes from taking hormones are reversible, and regret appears to be uncommon. Out of a group of nearly 3,400 trans people in the United Kingdom, only 16 regretted their gender transition, according to research presented at the 2019 biennial conference of the European Professional Association for Transgender Health. And although research on surgical transition is sparse, there are some hints that those who choose it are ultimately happy with the decision. According to a small 2018 study in Istanbul, post-operative trans people report a higher quality of life and fewer concerns about gender discrimination compared to those with dysphoria who haven’t had surgery.
And for trans people with dysphoria, hormones can be medically necessary. The treatments aren’t just cosmetic — transitioning literally saves lives, according to the American Academy of Pediatrics. In a 2019 review paper, researchers from the University of San Francisco found that hormone therapy is also linked to a higher quality of life and reduced anxiety and depression.
Despite the growing evidence that medical intervention can help, some trans people are wary of the health care system. According to the 2015 U.S. Transgender Survey, a third of trans people who saw a health care provider experienced mistreatment — from having to educate their doctor about transgender issues to being refused medical treatment to verbal abuse — and 23 percent avoided the doctor’s office because they feared mistreatment.
The health care system has a history of stigmatizing trans identity. Until recently, the World Health Organization and the American Psychiatric Association even considered it a mental disorder. And according to a 2015 study from researchers at the Lesbian, Gay, Bisexual, and Transgender Medical Education Research Group at the Stanford University School of Medicine, less than 35 percent of medical schools teach coursework related to transgender hormone therapy and surgery.
On June 12, the administration of President Donald J. Trump finalized a rule removing protections that had been put in place in 2016 to bar discrimination against transgender people by health care providers. Just three days later, the U.S. Supreme Court decided that the 1964 law that bans discrimination in the workplace based on sex, race, national origin, and religion also applies to sexual orientation and gender identity. While not directly touching on the new health care rule, some experts think the Supreme Court's decision may make legal challenges to it more likely to succeed.
Trans-friendly health care providers are rare, and booking an appointment can stretch out over many weeks. In England, for example, the average wait time from the referral to the first appointment is 18 months, according to an investigation by the BBC. Even those with hormone prescriptions face hurdles to get them filled. Scheim, who lived in Canada until recently, knows this firsthand. “As someone who just moved to the U.S., I’m keenly aware of the hoops one has to jump through,” he says.
“Even if it's theoretically possible to get a hormone prescription, and get it filled, and get it paid for, at a certain point people are going to want to go outside the system,” Scheim says. Navigating bureaucracy, being incorrectly identified — or misgendered — and facing outright transphobia from health care providers, he adds, “can just become too much for folks.”
Many of the health care barriers trans people face are amplified when it comes to surgery. Bottom surgery for trans feminine people, for example, costs about $25,000 and isn’t covered by most insurance plans in the U.S.
There are some signs that at least parts of the medical community have been rethinking their stance on transgender patients. “Clearly the medical professionals didn’t do the right thing. But things are changing now,” says Antonio Metastasio, a psychiatrist at the Camden and Islington NHS Foundation Trust in the U.K.
The Association of American Medical Colleges, for example, released their first curriculum guidelines for treating LGBT patients in 2014. In 2018, the American Academy of Pediatrics released a policy statement on transgender youth, encouraging gender-affirming models of treatment. And in 2019, the American College of Physicians released guidelines for primary care physicians on serving transgender patients.
The World Professional Association for Transgender Health (WPATH) — the international authority on transgender health care, according to a summary of clinical evidence on gender reassignment surgery prepared for the Centers for Medicare and Medicaid Services — has also changed its Standards of Care to make access to hormones easier. Previously, WPATH recommended that before a person could receive hormone treatment, they had to have “persistent, well-documented gender dysphoria,” as well as documented, real-life experiences covering at least three months. The newest guidelines, published in 2012, nix these stringent requirements, although they still strongly recommend mental health evaluations before allowing trans people to access gender-affirming medical care and require a referral letter from a mental health professional.
But the shift hasn’t stopped trans people from seeking DIY treatments.
Before Christine moved to Cape Cod, she secured about two weeks of estrogen from a trans friend. But she soon decided to end the DIY treatment and went off hormones for good. “I can only accept help for something like that for so long before I start to feel bad about it,” she says. “At that point, it was just like I gave up.”
But she didn’t give up for long. After the move, Christine tried to get back on hormones through a legitimate health care provider. First, she considered visiting a Planned Parenthood, but the closest one she could find was at least two hours away and she worried her old car couldn’t make the journey. Then she visited a local women’s health clinic. But she says they turned her away, refused to recognize her gender, and wouldn’t direct her to another provider or clinic. Instead of advice, Christine says, “I got ‘no, goodbye.’”
Left with few options and not wanting to take the risks of further DIY treatment, Christine accepted that she would be off hormones for the foreseeable future.
Many trans folks, however, start or extend their hormone use by turning to drugs that aren’t meant for transitioning, like birth control pills. Others buy hormones online, skirting the law to order from overseas pharmacies without a prescription. To figure out how best to take the drugs, people determine dosages from research online — they read academic literature, technical standards written for health care providers, or advice in blog posts and public forums like Reddit.
Then, they medicate themselves.
Metastasio is one of the few scientists who have studied the practice. He learned about it in 2014, when one of his transgender patients admitted they were taking non-prescribed hormones. Metastasio asked his colleagues if they’d heard similar stories, but none had. So he started asking all his trans patients about DIY hormones and tracked those who were involved in the practice, ultimately publishing a report of seven case studies in 2018.
While there isn’t a lot of other existing research on DIY hormone treatment, and some of it may be outdated, the available studies suggest it is fairly common and researchers may in fact be underestimating the prevalence of DIY hormone use because they miss people who avoid the medical system completely. In 2014, researchers in the U.K. found that at the time of their first gender clinic visit, 17 percent of transgender people were already taking hormones that they had bought online or from a friend. In Canada, a quarter of trans people on hormones had self-medicated, according to a 2013 study in the American Journal of Public Health. And in a survey of trans people in Washington, D.C. in 2000, 58 percent said they used non-prescribed hormones.
People cite all sorts of reasons for ordering the drugs online or acquiring them by other means. In addition to distrust of doctors and a lack of insurance or access to health care, some simply don’t want to endure long waits for medications. That’s the case for Emma, a trans woman in college in the Netherlands, where it can take two to three years to receive a physician prescription. (Emma is only using her first name to avoid online harassment, which she says she’s experienced in the past.)
As for surgery, far fewer people turn to DIY versions compared to those who try hormones. A 2012 study in the Journal of Sexual Medicine reported that only 109 cases of self-castration or self-mutilation of the genitals appear in the scientific literature, and not all are related to gender identity. “But one is too many,” Scheim says. “No one should be in a position where they feel like they need to do that.”
The individual cases reveal a practice that is dangerous and devastating. In Hangzhou, China, a 30-year-old transgender woman feared rejection from her family, so she hid her true gender, according to a 2019 Amnesty International report. She also tried to transition in secret. At first, the woman tried putting ice on her genitals to stop them from functioning. When that didn’t work, she booked an appointment with a black-market surgeon, but the doctor was arrested before her session. She attempted surgery on herself, the report says, and after losing a profuse amount of blood, hailed a taxi to the emergency room. There, she asked the doctor to tell her family she had been in an accident.
When it comes to self-surgery, the dangers of DIY transitioning are obvious. The dangers of DIY hormones are more far-ranging, from “not ideal to serious,” Scheim says. Some DIY users take a more-is-better approach, but taking too much testosterone too quickly can fry the vocal cords. Even buying hormones from an online pharmacy is risky. In 2010, more than half of all treatments from illicit websites — not only of hormones, but of any drug — were counterfeit, according to a bulletin from the World Health Organization.
Still, Charley isn’t worried about the legitimacy of the drugs he’s taking. The packaging his estrogen comes in matches what he would get from a pharmacy with a doctor’s prescription, he says. He’s also unconcerned about the side effects. “I just did a metric century” — a 100-kilometer bike ride — “in under four hours and walked away from it feeling great. I’m healthy,” he says. “So, yeah, there might be a few side effects. But I know where the local hospital is.”
Yet waiting to see if a seemingly minor side effect leads to a health emergency may mean a patient gets help too late. “I don’t want to say that the risks are incredibly high and there is a high mortality,” Metastasio says. “I am saying, though, that this is a procedure best to be monitored.” Metastasio and others recommend seeing a doctor regularly to catch any health issues that arise as quickly as possible.
But even when doctors prescribe the drugs, the risks are unclear because of a lack of research on trans health, says Scheim: “There’s so much we don’t know about hormone use.”
Researchers do know a little bit, though. Even when a doctor weighs in on the proper dosages, there is an increased risk of heart attack. Taking testosterone increases the chances of developing acne, headaches and migraines, and anger and irritability, according to the Trans Care Project, a program of the Transcend Transgender Support and Education Society and Vancouver Coastal Health’s Transgender Health Program in Canada. Testosterone also increases the risk of having abnormally high levels of red blood cells, or polycythemia, which thickens the blood and can lead to clotting. Meanwhile, studies suggest estrogen can up the risk for breast cancer, stroke, blood clots, gallstones, and a range of heart issues. And the most common testosterone-blocker, spironolactone, can cause dehydration and weaken the kidneys.
All of these risks make it especially important for trans people to have the support of a medical provider, Metastasio says. Specialists are in short supply, but general practitioners and family doctors should be able to fill the gap. After all, they already sign off on the hormone medications for cisgender people for birth control and conditions such as menopause and male pattern baldness — which come with similar side effects and warnings as when trans people use them.
Some doctors have already realized the connection. “People can increasingly get hormone therapy from their pre-existing family doctor,” Scheim says, “which is really ideal because people should be able to have a sort of continuity of health care.”
Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City, would like to see more of this. Treating gender dysphoria, she says, 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,’” she says. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.”
Another way to increase access to hormones is through informed consent, a system which received a green light from the newest WPATH guidelines. That’s how Christine received her hormones from Fenway Health before she moved from Boston to Cape Cod. Under informed consent, if someone has a blood test to assess personal health risks of treatment, they can receive a diagnosis of gender dysphoria, sign off on knowing the risks and benefits of hormone therapy, and get a prescription — all in one day.
And Jaime Lynn Gilmour, a trans woman using the full name she chose to match her gender identity, turned to informed consent after struggling to find DIY hormones. In 2017, Jaime realized she was trans while serving in the military, and says she felt she had to keep her gender a secret. When her service ended, she was ready to start taking hormones right away. So she tried to find them online, but her order wouldn’t go through on three different websites. Instead, she visited a Planned Parenthood clinic. After blood work and a few questions, she walked out with three months of estrogen and spironolactone.
But Goldstein says even informed consent doesn’t go far enough: “If I have someone who's diabetic, I don't make them sign a document eliciting their informed consent before starting insulin.”
For trans people, hormone treatments “are life-saving therapies,” Goldstein adds, “and we shouldn’t delay or stigmatize.”
For now Christine still lives with her parents in Cape Cod. She’s also still off hormones. But she found a job. After she stashes a bit more cash in the bank, she plans to move closer to Boston and find a physician.
Despite the positive shifts in her life, it’s been a difficult few months. After moving to Cape Cod, Christine lost most of her social life and support system — particularly since her parents don’t understand or accept her gender identity. Though she has reconnected with a few friends in the past several weeks, she says she’s in a tough place emotionally. In public, she typically dresses and styles herself to look more masculine to avoid rude stares, and she is experiencing self-hatred that she fears won’t go away when she restarts treatment. Transitioning again isn’t going to be easy, as she explained to Undark in a private message on Facebook: “I've been beaten down enough that now I don't wanna get back up most of the time.”
Even worse is the fear that she might not be able to restart treatment at all. Earlier this year, Christine suffered two health emergencies within the span of a week, in which she says her blood pressure spiked, potentially causing organ damage. Christine has had one similar episode in the past and her family has a history of heart issues.
Christine may not be able to get back on estrogen despite the hard work she’s done to be able to afford it, she says, since it can increase the risk of heart attack and stroke. Because she has so far resisted trying DIY treatments again, she may have saved herself from additional health problems.
But Christine doesn’t see it that way. “Even if it was unsafe, even if I risked health concerns making myself a guinea pig, I wish I followed through,” she wrote. “Being off hormones is hell. And now that I face potentially never taking them again, I wish I had.”
Tara Santora is a science journalist based out of Denver. They have written for Psychology Today, Live Science, Fatherly, Audubon, and more.
This article was originally published on Undark. Read the original article.
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.
Report describes intoxication with new psychoactive substance
When evaluated at local emergency departments, lethargy and slurred speech were the most common clinical findings.
One student had mild respiratory depression with a respiratory rate of 10 breaths per minute.
“All patients had sufficient clinical improvement within 6 hours such that they could be discharged from the hospital,” according to a description of the cases that was published online in Pediatrics.
The report is the first to detail clinical toxicity from flualprazolam, and “it is likely that physicians will again encounter patients” with intoxication from this new psychoactive drug, said Adam Blumenberg, MD, of Oregon Health & Science University in Portland and colleagues.
Internet purchasing has increased rates of exposure to new psychoactive substances since the early 2000s, and law enforcement agents have seized tons of these drugs. “In the United States, the incidence of exposures to designer benzodiazepines in particular has been rising since 2014,” the authors said.
According to an addiction researcher, the COVID-19 pandemic may exacerbate abuse of designer benzodiazepines.
“This is an important paper describing what medical examiners, pathologists, and emergency rooms have been seeing recently – an increase in designer benzodiazepines,” commented Mark S. Gold, MD, adjunct professor of psychiatry at Washington University in St. Louis. “Recent increases in these drugs have started to be seen in many locations as the traditional drugs of abuse, grown and distributed in bulk, have been disrupted” by the pandemic, he said in an interview. Although it may be too early for such cases to appear in Centers for Disease Control and Prevention reports, they can be described in studies like this one and, “I suspect, sadly, in medical examiner case reports.”
Flualprazolam, known colloquially as Hulk, is structurally related to the Food and Drug Administration–approved drugs alprazolam and triazolam. During 1 week in June 2019, the patients in Oregon received the drug as a free sample from another student from their Oregon high school. They believed it was commercial Xanax (alprazolam). “The flualprazolam tablets were identical in appearance and labeling to 2-mg tablets of alprazolam,” according to the report. “This indicates an intentionally counterfeit product entering the drug supply chain.”
Five of the six patients were boys, and they ranged in age from 14 to 16 years. The patient with mild respiratory depression received 0.4-mg naloxone, which physicians gave empirically because of the unknown identity of the drug, but did not respond. Two of the six patients initially felt drowsy but were asymptomatic during the clinical evaluation.
A urine immunoassay was performed in five of the patients, and all tested positive for benzodiazepines. One patient also tested positive for cannabinoids. Analysis of a tablet fragment revealed that it contained flualprazolam.
“Although flualprazolam intoxication cannot be clinically differentiated from that of other benzodiazepines without advanced testing, patient management should be the same,” Dr. Blumenberg and coauthors said. “For mild to moderate intoxication, patients should be treated with close monitoring and supportive care until symptom resolution. The benzodiazepine antidote flumazenil may be considered a safe and effective antidote in pediatric patients with significant CNS or respiratory depression. In patients for whom there is a concern of benzodiazepine dependence and flumazenil-induced seizures, airway protection and mechanical ventilation may be considered.”
Although patients rarely die from isolated benzodiazepine toxicity, death from respiratory depression or aspiration is more common when benzodiazepine toxicity occurs “in combination with alcohol, opioids, or other sedatives,” the authors noted. In addition, counterfeit alprazolam tablets have contained adulterants such as fentanyl and the opioid U-47700, which can be deadly.
The authors had no relevant financial disclosures, and there was no external funding for the study.
SOURCE: Blumenberg A et al. Pediatrics. 2020 Jun 24. doi: 10.1542/peds.2019-2953.
When evaluated at local emergency departments, lethargy and slurred speech were the most common clinical findings.
One student had mild respiratory depression with a respiratory rate of 10 breaths per minute.
“All patients had sufficient clinical improvement within 6 hours such that they could be discharged from the hospital,” according to a description of the cases that was published online in Pediatrics.
The report is the first to detail clinical toxicity from flualprazolam, and “it is likely that physicians will again encounter patients” with intoxication from this new psychoactive drug, said Adam Blumenberg, MD, of Oregon Health & Science University in Portland and colleagues.
Internet purchasing has increased rates of exposure to new psychoactive substances since the early 2000s, and law enforcement agents have seized tons of these drugs. “In the United States, the incidence of exposures to designer benzodiazepines in particular has been rising since 2014,” the authors said.
According to an addiction researcher, the COVID-19 pandemic may exacerbate abuse of designer benzodiazepines.
“This is an important paper describing what medical examiners, pathologists, and emergency rooms have been seeing recently – an increase in designer benzodiazepines,” commented Mark S. Gold, MD, adjunct professor of psychiatry at Washington University in St. Louis. “Recent increases in these drugs have started to be seen in many locations as the traditional drugs of abuse, grown and distributed in bulk, have been disrupted” by the pandemic, he said in an interview. Although it may be too early for such cases to appear in Centers for Disease Control and Prevention reports, they can be described in studies like this one and, “I suspect, sadly, in medical examiner case reports.”
Flualprazolam, known colloquially as Hulk, is structurally related to the Food and Drug Administration–approved drugs alprazolam and triazolam. During 1 week in June 2019, the patients in Oregon received the drug as a free sample from another student from their Oregon high school. They believed it was commercial Xanax (alprazolam). “The flualprazolam tablets were identical in appearance and labeling to 2-mg tablets of alprazolam,” according to the report. “This indicates an intentionally counterfeit product entering the drug supply chain.”
Five of the six patients were boys, and they ranged in age from 14 to 16 years. The patient with mild respiratory depression received 0.4-mg naloxone, which physicians gave empirically because of the unknown identity of the drug, but did not respond. Two of the six patients initially felt drowsy but were asymptomatic during the clinical evaluation.
A urine immunoassay was performed in five of the patients, and all tested positive for benzodiazepines. One patient also tested positive for cannabinoids. Analysis of a tablet fragment revealed that it contained flualprazolam.
“Although flualprazolam intoxication cannot be clinically differentiated from that of other benzodiazepines without advanced testing, patient management should be the same,” Dr. Blumenberg and coauthors said. “For mild to moderate intoxication, patients should be treated with close monitoring and supportive care until symptom resolution. The benzodiazepine antidote flumazenil may be considered a safe and effective antidote in pediatric patients with significant CNS or respiratory depression. In patients for whom there is a concern of benzodiazepine dependence and flumazenil-induced seizures, airway protection and mechanical ventilation may be considered.”
Although patients rarely die from isolated benzodiazepine toxicity, death from respiratory depression or aspiration is more common when benzodiazepine toxicity occurs “in combination with alcohol, opioids, or other sedatives,” the authors noted. In addition, counterfeit alprazolam tablets have contained adulterants such as fentanyl and the opioid U-47700, which can be deadly.
The authors had no relevant financial disclosures, and there was no external funding for the study.
SOURCE: Blumenberg A et al. Pediatrics. 2020 Jun 24. doi: 10.1542/peds.2019-2953.
When evaluated at local emergency departments, lethargy and slurred speech were the most common clinical findings.
One student had mild respiratory depression with a respiratory rate of 10 breaths per minute.
“All patients had sufficient clinical improvement within 6 hours such that they could be discharged from the hospital,” according to a description of the cases that was published online in Pediatrics.
The report is the first to detail clinical toxicity from flualprazolam, and “it is likely that physicians will again encounter patients” with intoxication from this new psychoactive drug, said Adam Blumenberg, MD, of Oregon Health & Science University in Portland and colleagues.
Internet purchasing has increased rates of exposure to new psychoactive substances since the early 2000s, and law enforcement agents have seized tons of these drugs. “In the United States, the incidence of exposures to designer benzodiazepines in particular has been rising since 2014,” the authors said.
According to an addiction researcher, the COVID-19 pandemic may exacerbate abuse of designer benzodiazepines.
“This is an important paper describing what medical examiners, pathologists, and emergency rooms have been seeing recently – an increase in designer benzodiazepines,” commented Mark S. Gold, MD, adjunct professor of psychiatry at Washington University in St. Louis. “Recent increases in these drugs have started to be seen in many locations as the traditional drugs of abuse, grown and distributed in bulk, have been disrupted” by the pandemic, he said in an interview. Although it may be too early for such cases to appear in Centers for Disease Control and Prevention reports, they can be described in studies like this one and, “I suspect, sadly, in medical examiner case reports.”
Flualprazolam, known colloquially as Hulk, is structurally related to the Food and Drug Administration–approved drugs alprazolam and triazolam. During 1 week in June 2019, the patients in Oregon received the drug as a free sample from another student from their Oregon high school. They believed it was commercial Xanax (alprazolam). “The flualprazolam tablets were identical in appearance and labeling to 2-mg tablets of alprazolam,” according to the report. “This indicates an intentionally counterfeit product entering the drug supply chain.”
Five of the six patients were boys, and they ranged in age from 14 to 16 years. The patient with mild respiratory depression received 0.4-mg naloxone, which physicians gave empirically because of the unknown identity of the drug, but did not respond. Two of the six patients initially felt drowsy but were asymptomatic during the clinical evaluation.
A urine immunoassay was performed in five of the patients, and all tested positive for benzodiazepines. One patient also tested positive for cannabinoids. Analysis of a tablet fragment revealed that it contained flualprazolam.
“Although flualprazolam intoxication cannot be clinically differentiated from that of other benzodiazepines without advanced testing, patient management should be the same,” Dr. Blumenberg and coauthors said. “For mild to moderate intoxication, patients should be treated with close monitoring and supportive care until symptom resolution. The benzodiazepine antidote flumazenil may be considered a safe and effective antidote in pediatric patients with significant CNS or respiratory depression. In patients for whom there is a concern of benzodiazepine dependence and flumazenil-induced seizures, airway protection and mechanical ventilation may be considered.”
Although patients rarely die from isolated benzodiazepine toxicity, death from respiratory depression or aspiration is more common when benzodiazepine toxicity occurs “in combination with alcohol, opioids, or other sedatives,” the authors noted. In addition, counterfeit alprazolam tablets have contained adulterants such as fentanyl and the opioid U-47700, which can be deadly.
The authors had no relevant financial disclosures, and there was no external funding for the study.
SOURCE: Blumenberg A et al. Pediatrics. 2020 Jun 24. doi: 10.1542/peds.2019-2953.
FROM PEDIATRICS
Encourage parents to follow pediatric plans for vaccination
Outpatient medical care has been severely disrupted during the COVID-19 pandemic with a reduction of nearly 70% in outpatient visits since March before starting to rebound, Melinda Wharton, MD, said at the virtual meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Pediatrics was among the hardest hit specialties, with a 62% reduction in outpatient visits by April 5, said Dr. Wharton, director of the immunization services division at the CDC’s National Center for Immunization and Respiratory Diseases. However, visits for all pediatric age groups increased in May, compared with April, and the CDC emphasized the need to educate families about the importance of routine vaccination and well-child visits, Dr. Wharton said.
The CDC strategies to support routine childhood vaccination include monitoring vaccination service delivery to inform targeted interventions, said Dr. Wharton. In addition, the CDC will continue to support providers by identifying gaps in the Vaccines For Children (VFC) program network, increasing VFC funding, developing guidance materials, and identifying policy interventions.
Many small practices have struggled during the pandemic, and financial support is available through the Provider Relief Fund, which is now available to all Medicaid and Children’s Health Insurance Program (CHIP) providers, said Dr. Wharton.
because more families may now qualify for the program because of changes in job status and income, and parents may not be aware that their children may be eligible, she said.
“Vaccination is an essential medical service for all children and adolescents, ideally in the medical home,” Dr. Wharton said. The CDC’s interim guidance for immunization during the COVID-19 pandemic calls for administering all current or overdue vaccines according to the routine immunization schedule during the same visit, and implementing strategies to get patients caught up, prioritizing newborns, infants, and children up to age 24 months. The guidance includes details on safe delivery of vaccines, including physical distance and the use of personal protective equipment.
In addition, encourage parents to return for well-child visits, and use reminder systems to help keep patients current on visits and vaccines. “Discuss the safety protocols that have been put in place,” Dr. Wharton emphasized. The CDC also offers resources for providers to help communicate with parents about routine vaccination.
Looking ahead, back-to-school vaccination requirements “provide a critical checkpoint for children’s vaccination status,” Dr. Wharton said. Catch-up vaccination during the summer will help clinical capacity manage back-to-school and influenza vaccination in the fall, she emphasized. “Influenza vaccination will be an important strategy to decrease stress on our health care system.”
Flu vaccination strategies should focus on adults at higher risk for COVID-19 infections, such as health care providers. In addition, identifying and reducing disparities will be important for future COVID-19 vaccines, as well as for the flu this season, she noted.
View the complete guidance online.
Dr. Wharton had no relevant financial disclosures.
Outpatient medical care has been severely disrupted during the COVID-19 pandemic with a reduction of nearly 70% in outpatient visits since March before starting to rebound, Melinda Wharton, MD, said at the virtual meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Pediatrics was among the hardest hit specialties, with a 62% reduction in outpatient visits by April 5, said Dr. Wharton, director of the immunization services division at the CDC’s National Center for Immunization and Respiratory Diseases. However, visits for all pediatric age groups increased in May, compared with April, and the CDC emphasized the need to educate families about the importance of routine vaccination and well-child visits, Dr. Wharton said.
The CDC strategies to support routine childhood vaccination include monitoring vaccination service delivery to inform targeted interventions, said Dr. Wharton. In addition, the CDC will continue to support providers by identifying gaps in the Vaccines For Children (VFC) program network, increasing VFC funding, developing guidance materials, and identifying policy interventions.
Many small practices have struggled during the pandemic, and financial support is available through the Provider Relief Fund, which is now available to all Medicaid and Children’s Health Insurance Program (CHIP) providers, said Dr. Wharton.
because more families may now qualify for the program because of changes in job status and income, and parents may not be aware that their children may be eligible, she said.
“Vaccination is an essential medical service for all children and adolescents, ideally in the medical home,” Dr. Wharton said. The CDC’s interim guidance for immunization during the COVID-19 pandemic calls for administering all current or overdue vaccines according to the routine immunization schedule during the same visit, and implementing strategies to get patients caught up, prioritizing newborns, infants, and children up to age 24 months. The guidance includes details on safe delivery of vaccines, including physical distance and the use of personal protective equipment.
In addition, encourage parents to return for well-child visits, and use reminder systems to help keep patients current on visits and vaccines. “Discuss the safety protocols that have been put in place,” Dr. Wharton emphasized. The CDC also offers resources for providers to help communicate with parents about routine vaccination.
Looking ahead, back-to-school vaccination requirements “provide a critical checkpoint for children’s vaccination status,” Dr. Wharton said. Catch-up vaccination during the summer will help clinical capacity manage back-to-school and influenza vaccination in the fall, she emphasized. “Influenza vaccination will be an important strategy to decrease stress on our health care system.”
Flu vaccination strategies should focus on adults at higher risk for COVID-19 infections, such as health care providers. In addition, identifying and reducing disparities will be important for future COVID-19 vaccines, as well as for the flu this season, she noted.
View the complete guidance online.
Dr. Wharton had no relevant financial disclosures.
Outpatient medical care has been severely disrupted during the COVID-19 pandemic with a reduction of nearly 70% in outpatient visits since March before starting to rebound, Melinda Wharton, MD, said at the virtual meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Pediatrics was among the hardest hit specialties, with a 62% reduction in outpatient visits by April 5, said Dr. Wharton, director of the immunization services division at the CDC’s National Center for Immunization and Respiratory Diseases. However, visits for all pediatric age groups increased in May, compared with April, and the CDC emphasized the need to educate families about the importance of routine vaccination and well-child visits, Dr. Wharton said.
The CDC strategies to support routine childhood vaccination include monitoring vaccination service delivery to inform targeted interventions, said Dr. Wharton. In addition, the CDC will continue to support providers by identifying gaps in the Vaccines For Children (VFC) program network, increasing VFC funding, developing guidance materials, and identifying policy interventions.
Many small practices have struggled during the pandemic, and financial support is available through the Provider Relief Fund, which is now available to all Medicaid and Children’s Health Insurance Program (CHIP) providers, said Dr. Wharton.
because more families may now qualify for the program because of changes in job status and income, and parents may not be aware that their children may be eligible, she said.
“Vaccination is an essential medical service for all children and adolescents, ideally in the medical home,” Dr. Wharton said. The CDC’s interim guidance for immunization during the COVID-19 pandemic calls for administering all current or overdue vaccines according to the routine immunization schedule during the same visit, and implementing strategies to get patients caught up, prioritizing newborns, infants, and children up to age 24 months. The guidance includes details on safe delivery of vaccines, including physical distance and the use of personal protective equipment.
In addition, encourage parents to return for well-child visits, and use reminder systems to help keep patients current on visits and vaccines. “Discuss the safety protocols that have been put in place,” Dr. Wharton emphasized. The CDC also offers resources for providers to help communicate with parents about routine vaccination.
Looking ahead, back-to-school vaccination requirements “provide a critical checkpoint for children’s vaccination status,” Dr. Wharton said. Catch-up vaccination during the summer will help clinical capacity manage back-to-school and influenza vaccination in the fall, she emphasized. “Influenza vaccination will be an important strategy to decrease stress on our health care system.”
Flu vaccination strategies should focus on adults at higher risk for COVID-19 infections, such as health care providers. In addition, identifying and reducing disparities will be important for future COVID-19 vaccines, as well as for the flu this season, she noted.
View the complete guidance online.
Dr. Wharton had no relevant financial disclosures.
Daily Recap: Higher risk of severe COVID-19 seen in pregnancy, primary care practices at risk
Here are the stories our MDedge editors across specialties think you need to know about today:
Pregnant women at higher risk for severe COVID-19
Pregnant women may be at increased risk for severe COVID-19 illness, according to a report published online June 26 in Morbidity and Mortality Weekly Report.
Among reproductive-aged women (15-44 years) infected with SARS-CoV-2, pregnancy was associated with a greater likelihood of hospitalization, admission to the intensive care unit (ICU), and mechanical ventilation, but not death. Pregnant women were 5.4 times more likely to be hospitalized, 1.5 times more likely to be admitted to the ICU, and 1.7 times more likely to need mechanical ventilation, after adjustment for age, underlying conditions, and race/ethnicity.
CDC researchers said that preventing COVID-19 infection in pregnant women should be a priority and any potential barriers to compliance with preventive measures need to be removed.
“During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections,” they wrote. Read more.
Going out of business: Primary care practices at risk
In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. In an interview with Kenny Lin, MD, MPH, a family physician, Dr. Frieden discussed the future of primary care.
Here is a sample of Dr. Frieden’s observations:
“When I’ve looked around the United States, I’ve been extremely concerned about both the risk that primary care practitioners are subjected to in their everyday practice and the economic risk that we could lose many of our primary care practices around the country. It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.” Read more.
Surge in out-of-hospital cardiac arrests
The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests that placed a huge burden on first responders, according to a new analysis.
During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.
In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.
“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.
The study was published online June 19 in JAMA Cardiology.
Read more.
Fenfluramine approved for Dravet syndrome
The U.S. Food and Drug Administration has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in children age 2 years and older.
Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy.
Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release. 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:
Pregnant women at higher risk for severe COVID-19
Pregnant women may be at increased risk for severe COVID-19 illness, according to a report published online June 26 in Morbidity and Mortality Weekly Report.
Among reproductive-aged women (15-44 years) infected with SARS-CoV-2, pregnancy was associated with a greater likelihood of hospitalization, admission to the intensive care unit (ICU), and mechanical ventilation, but not death. Pregnant women were 5.4 times more likely to be hospitalized, 1.5 times more likely to be admitted to the ICU, and 1.7 times more likely to need mechanical ventilation, after adjustment for age, underlying conditions, and race/ethnicity.
CDC researchers said that preventing COVID-19 infection in pregnant women should be a priority and any potential barriers to compliance with preventive measures need to be removed.
“During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections,” they wrote. Read more.
Going out of business: Primary care practices at risk
In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. In an interview with Kenny Lin, MD, MPH, a family physician, Dr. Frieden discussed the future of primary care.
Here is a sample of Dr. Frieden’s observations:
“When I’ve looked around the United States, I’ve been extremely concerned about both the risk that primary care practitioners are subjected to in their everyday practice and the economic risk that we could lose many of our primary care practices around the country. It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.” Read more.
Surge in out-of-hospital cardiac arrests
The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests that placed a huge burden on first responders, according to a new analysis.
During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.
In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.
“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.
The study was published online June 19 in JAMA Cardiology.
Read more.
Fenfluramine approved for Dravet syndrome
The U.S. Food and Drug Administration has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in children age 2 years and older.
Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy.
Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release. 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:
Pregnant women at higher risk for severe COVID-19
Pregnant women may be at increased risk for severe COVID-19 illness, according to a report published online June 26 in Morbidity and Mortality Weekly Report.
Among reproductive-aged women (15-44 years) infected with SARS-CoV-2, pregnancy was associated with a greater likelihood of hospitalization, admission to the intensive care unit (ICU), and mechanical ventilation, but not death. Pregnant women were 5.4 times more likely to be hospitalized, 1.5 times more likely to be admitted to the ICU, and 1.7 times more likely to need mechanical ventilation, after adjustment for age, underlying conditions, and race/ethnicity.
CDC researchers said that preventing COVID-19 infection in pregnant women should be a priority and any potential barriers to compliance with preventive measures need to be removed.
“During pregnancy, women experience immunologic and physiologic changes that could increase their risk for more severe illness from respiratory infections,” they wrote. Read more.
Going out of business: Primary care practices at risk
In a recently published editorial, Tom Frieden, MD, MPH, former head of the Centers for Disease Control and Prevention, argued that primary care is in deep trouble, its long-standing financial problems exacerbated by the fallout from the COVID-19 pandemic. In an interview with Kenny Lin, MD, MPH, a family physician, Dr. Frieden discussed the future of primary care.
Here is a sample of Dr. Frieden’s observations:
“When I’ve looked around the United States, I’ve been extremely concerned about both the risk that primary care practitioners are subjected to in their everyday practice and the economic risk that we could lose many of our primary care practices around the country. It’s really striking to see that the number of visits has plummeted. Because of our payment structure, that means incomes have plummeted. We’re hearing about doctors’ offices getting boarded up and shuttering. As I write in the piece, it’s one thing for a theater or a restaurant or another important community entity to shut because of economic downturn, and these are real losses, but to lose their only primary care practice or one of the few in an area really is a matter of life and death for many communities.” Read more.
Surge in out-of-hospital cardiac arrests
The COVID-19 pandemic in New York City led to a surge in out-of-hospital cardiac arrests that placed a huge burden on first responders, according to a new analysis.
During the height of the pandemic in New York, there was a “dramatic increase in cardiopulmonary arrests, nearly all presented in non-shockable cardiac rhythms (> 90% fatality rate) and vulnerable patient populations were most affected,” David J. Prezant, MD, chief medical officer, Fire Department of New York (FDNY), said in an interview.
In a news release, Dr. Prezant noted that “relatively few, if any, patients were tested to confirm the presence of COVID-19,” making it impossible to distinguish between cardiac arrests as a result of COVID-19 and those that may have resulted from other health conditions.
“We also can’t rule out the possibility that some people may have died from delays in seeking or receiving treatment for non–COVID-19-related conditions. However, the dramatic increase in cardiac arrests compared to the same period in 2019 strongly indicates that the pandemic was directly or indirectly responsible for that surge in cardiac arrests and deaths,” said Dr. Prezant.
The study was published online June 19 in JAMA Cardiology.
Read more.
Fenfluramine approved for Dravet syndrome
The U.S. Food and Drug Administration has approved fenfluramine (Fintepla, Zogenix) oral solution, a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in children age 2 years and older.
Dravet syndrome is a rare childhood-onset epilepsy characterized by frequent, drug-resistant convulsive seizures that may contribute to intellectual disability and impairments in motor control, behavior, and cognition, as well as an increased risk of sudden unexpected death in epilepsy.
Dravet syndrome takes a “tremendous toll on both patients and their families. Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome,” Billy Dunn, MD, director, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a news release. Read more.
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