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12 state boards have disciplined docs for COVID misinformation
, according to a new survey from the Federation of State Medical Boards (FSMB).
The FSMB reports that in its 2021 annual survey two-thirds of its 71 member boards (which includes the United States, its territories, and Washington, DC) reported an increase in complaints about doctors spreading false or misleading information.
“The staggering number of state medical boards that have seen an increase in COVID-19 disinformation complaints is a sign of how widespread the issue has become,” said Humayun J. Chaudhry, DO, MACP, president and CEO of the FSMB, in a statement.
The FSMB board of directors warned physicians in July that they risked disciplinary action if they spread COVID-19 vaccine misinformation or disinformation.
The organization said 15 state boards have now adopted similar statements.
Dr. Chaudhry said the FSMB was “encouraged by the number of boards that have already taken action to combat COVID-19 disinformation by disciplining physicians who engage in that behavior and by reminding all physicians that their words and actions matter, and they should think twice before spreading disinformation that may harm patients.”
This news organization asked the FSMB for further comment on why more physicians have not been disciplined, but did not receive a response before publication.
Misinformation policies a new battleground
The FSMB and member board policies on COVID-19 around the country have become a new front in the war against mandates and restrictions.
The Tennessee Board of Medical Examiners voted just recently to remove its statement of policy against the spread of misinformation from its website after a Republican lawmaker allegedly threatened to dissolve the board.
The vote came just a few months after the board had approved the policy. The board did not rescind the policy, however, according to a report by the Associated Press.
In California, the president of the state’s medical board tweeted on December 8 about what she said was an incident of harassment by a group that has promoted “fake COVID-19 treatments.”Ms. Kristina Lawson said she observed four men sitting in front of her house in a truck. They flew a drone over her residence, and then followed her to work, parking nose-to-nose with her vehicle.
Ms. Lawson claimed that when she went to drive home the four men ambushed her in what was by then a dark parking garage. She said her “concern turned to terror” as they jumped out, cameras and recording equipment in hand.
The men told law enforcement called to the scene that they were just trying to interview her, according to a statement emailed by Ms. Lawson.
They had not made such a request to the California Medical Board.
Ms. Lawson tweeted that she would continue to volunteer for the board. “That means protecting Californians from bad doctors, and ensuring disinformation and misinformation do not detract from our work to protect patients and consumers,” she wrote.
The men who ambushed Ms. Larson allegedly identified themselves and were wearing clothing emblazoned with the logo of “America’s Frontline Doctors,” an organization that has trafficked in COVID-19 conspiracy theories and promoted unproven treatments like hydroxychloroquine and ivermectin, according to Time. It is led by Simone Gold, MD, who was arrested for breaching the U.S. Capitol on January 6.
Despite her activities, on November 30, the California Medical Board renewed Ms. Gold’s 2-year license to practice.
Who’s being disciplined, who’s not
Dr. Gold is not alone. An investigation by NPRin September found that 15 of 16 physicians who have spread false information in a high-profile manner have medical licenses in good standing.
Sherri Tenpenny, DO, who has claimed that COVID-19 vaccines magnetize people and “interface” with 5G cell phone towers, was able to renew her license with the Ohio State Medical Board on October 1, according to the Cincinnati Enquirer.
Some boards have acted. The Oregon Medical Board revoked the license of Steven LaTulippe, MD, and fined him $10,000 for spreading misinformation about masks and overprescribing opioids.
In August, Rhode Island’s Board of Medical Licensure suspended Mark Brody’s license for 5 years after finding that the doctor spread falsehoods about COVID-19 vaccines, according to board documents.
Maine physician Paul Gosselin, DO, is on temporary suspension until a February hearing, while the osteopathic board investigates his issuance of vaccine exemption letters and the promotion of unproven COVID-19 therapies.
The board found that Gosselin had “engaged in conduct that constitutes fraud or deceit,” according to official documents.
The Washington State Medical Board has opened an investigation into Ryan N. Cole, MD, a physician who has claimed that COVID vaccines are “fake,” and was appointed to a regional health board in Idaho in September, according to the Washington Post.
The Idaho Capital Sun reported that Dr. Cole claims he is licensed in 11 states, including Washington. The Idaho Medical Association has also filed a complaint about Dr. Cole with the Idaho Board of Medicine, according to the paper.
New FSMB guidance coming
The FSMB said it expects more disciplinary actions as investigations continue to unfold.
The organization is drafting a new policy document that will include further guidelines and recommendations for state medical boards “to help address the spread of disinformation,” it said. The final document would be released in April 2022.
In the meantime, some states, like Tennessee and others, are trying to find ways to counter the current policy — a development the FSMB called “troubling.”
“The FSMB strongly opposes any effort to restrict a board’s authority to evaluate the standard of care and assess risk for patient harm,” the organization said in its statement.
A version of this article was first published on Medscape.com.
, according to a new survey from the Federation of State Medical Boards (FSMB).
The FSMB reports that in its 2021 annual survey two-thirds of its 71 member boards (which includes the United States, its territories, and Washington, DC) reported an increase in complaints about doctors spreading false or misleading information.
“The staggering number of state medical boards that have seen an increase in COVID-19 disinformation complaints is a sign of how widespread the issue has become,” said Humayun J. Chaudhry, DO, MACP, president and CEO of the FSMB, in a statement.
The FSMB board of directors warned physicians in July that they risked disciplinary action if they spread COVID-19 vaccine misinformation or disinformation.
The organization said 15 state boards have now adopted similar statements.
Dr. Chaudhry said the FSMB was “encouraged by the number of boards that have already taken action to combat COVID-19 disinformation by disciplining physicians who engage in that behavior and by reminding all physicians that their words and actions matter, and they should think twice before spreading disinformation that may harm patients.”
This news organization asked the FSMB for further comment on why more physicians have not been disciplined, but did not receive a response before publication.
Misinformation policies a new battleground
The FSMB and member board policies on COVID-19 around the country have become a new front in the war against mandates and restrictions.
The Tennessee Board of Medical Examiners voted just recently to remove its statement of policy against the spread of misinformation from its website after a Republican lawmaker allegedly threatened to dissolve the board.
The vote came just a few months after the board had approved the policy. The board did not rescind the policy, however, according to a report by the Associated Press.
In California, the president of the state’s medical board tweeted on December 8 about what she said was an incident of harassment by a group that has promoted “fake COVID-19 treatments.”Ms. Kristina Lawson said she observed four men sitting in front of her house in a truck. They flew a drone over her residence, and then followed her to work, parking nose-to-nose with her vehicle.
Ms. Lawson claimed that when she went to drive home the four men ambushed her in what was by then a dark parking garage. She said her “concern turned to terror” as they jumped out, cameras and recording equipment in hand.
The men told law enforcement called to the scene that they were just trying to interview her, according to a statement emailed by Ms. Lawson.
They had not made such a request to the California Medical Board.
Ms. Lawson tweeted that she would continue to volunteer for the board. “That means protecting Californians from bad doctors, and ensuring disinformation and misinformation do not detract from our work to protect patients and consumers,” she wrote.
The men who ambushed Ms. Larson allegedly identified themselves and were wearing clothing emblazoned with the logo of “America’s Frontline Doctors,” an organization that has trafficked in COVID-19 conspiracy theories and promoted unproven treatments like hydroxychloroquine and ivermectin, according to Time. It is led by Simone Gold, MD, who was arrested for breaching the U.S. Capitol on January 6.
Despite her activities, on November 30, the California Medical Board renewed Ms. Gold’s 2-year license to practice.
Who’s being disciplined, who’s not
Dr. Gold is not alone. An investigation by NPRin September found that 15 of 16 physicians who have spread false information in a high-profile manner have medical licenses in good standing.
Sherri Tenpenny, DO, who has claimed that COVID-19 vaccines magnetize people and “interface” with 5G cell phone towers, was able to renew her license with the Ohio State Medical Board on October 1, according to the Cincinnati Enquirer.
Some boards have acted. The Oregon Medical Board revoked the license of Steven LaTulippe, MD, and fined him $10,000 for spreading misinformation about masks and overprescribing opioids.
In August, Rhode Island’s Board of Medical Licensure suspended Mark Brody’s license for 5 years after finding that the doctor spread falsehoods about COVID-19 vaccines, according to board documents.
Maine physician Paul Gosselin, DO, is on temporary suspension until a February hearing, while the osteopathic board investigates his issuance of vaccine exemption letters and the promotion of unproven COVID-19 therapies.
The board found that Gosselin had “engaged in conduct that constitutes fraud or deceit,” according to official documents.
The Washington State Medical Board has opened an investigation into Ryan N. Cole, MD, a physician who has claimed that COVID vaccines are “fake,” and was appointed to a regional health board in Idaho in September, according to the Washington Post.
The Idaho Capital Sun reported that Dr. Cole claims he is licensed in 11 states, including Washington. The Idaho Medical Association has also filed a complaint about Dr. Cole with the Idaho Board of Medicine, according to the paper.
New FSMB guidance coming
The FSMB said it expects more disciplinary actions as investigations continue to unfold.
The organization is drafting a new policy document that will include further guidelines and recommendations for state medical boards “to help address the spread of disinformation,” it said. The final document would be released in April 2022.
In the meantime, some states, like Tennessee and others, are trying to find ways to counter the current policy — a development the FSMB called “troubling.”
“The FSMB strongly opposes any effort to restrict a board’s authority to evaluate the standard of care and assess risk for patient harm,” the organization said in its statement.
A version of this article was first published on Medscape.com.
, according to a new survey from the Federation of State Medical Boards (FSMB).
The FSMB reports that in its 2021 annual survey two-thirds of its 71 member boards (which includes the United States, its territories, and Washington, DC) reported an increase in complaints about doctors spreading false or misleading information.
“The staggering number of state medical boards that have seen an increase in COVID-19 disinformation complaints is a sign of how widespread the issue has become,” said Humayun J. Chaudhry, DO, MACP, president and CEO of the FSMB, in a statement.
The FSMB board of directors warned physicians in July that they risked disciplinary action if they spread COVID-19 vaccine misinformation or disinformation.
The organization said 15 state boards have now adopted similar statements.
Dr. Chaudhry said the FSMB was “encouraged by the number of boards that have already taken action to combat COVID-19 disinformation by disciplining physicians who engage in that behavior and by reminding all physicians that their words and actions matter, and they should think twice before spreading disinformation that may harm patients.”
This news organization asked the FSMB for further comment on why more physicians have not been disciplined, but did not receive a response before publication.
Misinformation policies a new battleground
The FSMB and member board policies on COVID-19 around the country have become a new front in the war against mandates and restrictions.
The Tennessee Board of Medical Examiners voted just recently to remove its statement of policy against the spread of misinformation from its website after a Republican lawmaker allegedly threatened to dissolve the board.
The vote came just a few months after the board had approved the policy. The board did not rescind the policy, however, according to a report by the Associated Press.
In California, the president of the state’s medical board tweeted on December 8 about what she said was an incident of harassment by a group that has promoted “fake COVID-19 treatments.”Ms. Kristina Lawson said she observed four men sitting in front of her house in a truck. They flew a drone over her residence, and then followed her to work, parking nose-to-nose with her vehicle.
Ms. Lawson claimed that when she went to drive home the four men ambushed her in what was by then a dark parking garage. She said her “concern turned to terror” as they jumped out, cameras and recording equipment in hand.
The men told law enforcement called to the scene that they were just trying to interview her, according to a statement emailed by Ms. Lawson.
They had not made such a request to the California Medical Board.
Ms. Lawson tweeted that she would continue to volunteer for the board. “That means protecting Californians from bad doctors, and ensuring disinformation and misinformation do not detract from our work to protect patients and consumers,” she wrote.
The men who ambushed Ms. Larson allegedly identified themselves and were wearing clothing emblazoned with the logo of “America’s Frontline Doctors,” an organization that has trafficked in COVID-19 conspiracy theories and promoted unproven treatments like hydroxychloroquine and ivermectin, according to Time. It is led by Simone Gold, MD, who was arrested for breaching the U.S. Capitol on January 6.
Despite her activities, on November 30, the California Medical Board renewed Ms. Gold’s 2-year license to practice.
Who’s being disciplined, who’s not
Dr. Gold is not alone. An investigation by NPRin September found that 15 of 16 physicians who have spread false information in a high-profile manner have medical licenses in good standing.
Sherri Tenpenny, DO, who has claimed that COVID-19 vaccines magnetize people and “interface” with 5G cell phone towers, was able to renew her license with the Ohio State Medical Board on October 1, according to the Cincinnati Enquirer.
Some boards have acted. The Oregon Medical Board revoked the license of Steven LaTulippe, MD, and fined him $10,000 for spreading misinformation about masks and overprescribing opioids.
In August, Rhode Island’s Board of Medical Licensure suspended Mark Brody’s license for 5 years after finding that the doctor spread falsehoods about COVID-19 vaccines, according to board documents.
Maine physician Paul Gosselin, DO, is on temporary suspension until a February hearing, while the osteopathic board investigates his issuance of vaccine exemption letters and the promotion of unproven COVID-19 therapies.
The board found that Gosselin had “engaged in conduct that constitutes fraud or deceit,” according to official documents.
The Washington State Medical Board has opened an investigation into Ryan N. Cole, MD, a physician who has claimed that COVID vaccines are “fake,” and was appointed to a regional health board in Idaho in September, according to the Washington Post.
The Idaho Capital Sun reported that Dr. Cole claims he is licensed in 11 states, including Washington. The Idaho Medical Association has also filed a complaint about Dr. Cole with the Idaho Board of Medicine, according to the paper.
New FSMB guidance coming
The FSMB said it expects more disciplinary actions as investigations continue to unfold.
The organization is drafting a new policy document that will include further guidelines and recommendations for state medical boards “to help address the spread of disinformation,” it said. The final document would be released in April 2022.
In the meantime, some states, like Tennessee and others, are trying to find ways to counter the current policy — a development the FSMB called “troubling.”
“The FSMB strongly opposes any effort to restrict a board’s authority to evaluate the standard of care and assess risk for patient harm,” the organization said in its statement.
A version of this article was first published on Medscape.com.
Lung transplantation in the era of COVID-19: New issues and paradigms
Data is sparse thus far, but there is concern in lung transplant medicine about the long-term risk of chronic lung allograft dysfunction (CLAD) and a potentially shortened longevity of transplanted lungs in recipients who become ill with COVID-19.
“My fear is that we’re potentially sitting on this iceberg worth of people who, come 6 months or a year from [the acute phase of] their COVID illness, will in fact have earlier and progressive, chronic rejection,” said Cameron R. Wolfe, MBBS, MPH, associate professor of medicine in transplant infectious disease at Duke University, Durham, N.C.
Lower respiratory viral infections have long been concerning for lung transplant recipients given their propensity to cause scarring, a decline in lung function, and a heightened risk of allograft rejection. Time will tell whether lung transplant recipients who survive COVID-19 follow a similar path, or one that is worse, he said.
Short-term data
Outcomes beyond hospitalization and acute illness for lung transplant recipients affected by COVID-19 have been reported in the literature by only a few lung transplant programs. These reports – as well as anecdotal experiences being informally shared among transplant programs – have raised the specter of more severe dysfunction following the acute phase and more early CLAD, said Tathagat Narula, MD, assistant professor of medicine at the Mayo Medical School, Rochester, Minn., and a consultant in lung transplantation at the Mayo Clinic’s Jacksonville program.
“The available data cover only 3-6 months out. We don’t know what will happen in the next 6 months and beyond,” Dr. Narula said in an interview.
The risks of COVID-19 in already-transplanted patients and issues relating to the inadequate antibody responses to vaccination are just some of the challenges of lung transplant medicine in the era of SARS-CoV-2. “COVID-19,” said Dr. Narula, “has completely changed the way we practice lung transplant medicine – the way we’re looking both at our recipients and our donors.”
Potential donors are being evaluated with lower respiratory SARS-CoV-2 testing and an abundance of caution. And patients with severe COVID-19 affecting their own lungs are roundly expected to drive up lung transplant volume in the near future. “The whole paradigm has changed,” Dr. Narula said.
Post-acute trajectories
A chart review study published in October by the lung transplant team at the University of Texas Southwestern Medical Center, Dallas, covered 44 consecutive survivors at a median follow-up of 4.5 months from hospital discharge or acute illness (the survival rate was 83.3%). Patients had significantly impaired functional status, and 18 of the 44 (40.9%) had a significant and persistent loss of forced vital capacity or forced expiratory volume in 1 second (>10% from pre–COVID-19 baseline).
Three patients met the criteria for new CLAD after COVID-19 infection, with all three classified as restrictive allograft syndrome (RAS) phenotype.
Moreover, the majority of COVID-19 survivors who had CT chest scans (22 of 28) showed persistent parenchymal opacities – a finding that, regardless of symptomatology, suggests persistent allograft injury, said Amit Banga, MD, associate professor of medicine and medical director of the ex vivo lung perfusion program in UT Southwestern’s lung transplant program.
“The implication is that there may be long-term consequences of COVID-19, perhaps related to some degree of ongoing inflammation and damage,” said Dr. Banga, a coauthor of the postinfection outcomes paper.
The UT Southwestern lung transplant program, which normally performs 60-80 transplants a year, began routine CT scanning 4-5 months into the pandemic, after “stumbling into a few patients who had no symptoms indicative of COVID pneumonia and no changes on an x-ray but significant involvement on a CT,” he said.
Without routine scanning in the general population of COVID-19 patients, Dr. Banga noted, “we’re limited in convincingly saying that COVID is uniquely doing this to lung transplant recipients.” Nor can they conclude that SARS-CoV-2 is unique from other respiratory viruses such as respiratory syncytial virus (RSV) in this regard. (The program has added CT scanning to its protocol for lung transplant recipients afflicted with other respiratory viruses to learn more.)
However, in the big picture, COVID-19 has proven to be far worse for lung transplant recipients than illness with other respiratory viruses, including RSV. “Patients have more frequent and greater loss of lung function, and worse debility from the acute illness,” Dr. Banga said.
“The cornerstones of treatment of both these viruses are very similar, but both the in-hospital course and the postdischarge outcomes are significantly different.”
In an initial paper published in September 2021, Dr. Banga and colleagues compared their first 25 lung transplant patients testing positive for SARS-CoV-2 with a historical cohort of 36 patients with RSV treated during 2016-2018.
Patients with COVID-19 had significantly worse morbidity and mortality, including worse postinfection lung function loss, functional decline, and 3-month survival.
More time, he said, will shed light on the risks of CLAD and the long-term potential for recovery of lung function. Currently, at UT Southwestern, it appears that patients who survive acute illness and the “first 3-6 months after COVID-19, when we’re seeing all the postinfection morbidity, may [enter] a period of stability,” Dr. Banga said.
Overall, he said, patients in their initial cohort are “holding steady” without unusual morbidity, readmissions, or “other setbacks to their allografts.”
At the Mayo Clinic in Jacksonville, which normally performs 40-50 lung transplants a year, transplant physicians have similarly observed significant declines in lung function beyond the acute phase of COVID-19. “Anecdotally, we’re seeing that some patients are beginning to recover some of their lung function, while others have not,” said Dr. Narula. “And we don’t have predictors as to who will progress to CLAD. It’s a big knowledge gap.”
Dr. Narula noted that patients with restrictive allograft syndrome, such as those reported by the UT Southwestern team, “have scarring of the lung and a much worse prognosis than the obstructive type of chronic rejection.” Whether there’s a role for antifibrotic therapy is a question worthy of research.
In UT Southwestern’s analysis, persistently lower absolute lymphocyte counts (< 600/dL) and higher ferritin levels (>150 ng/mL) at the time of hospital discharge were independently associated with significant lung function loss. This finding, reported in their October paper, has helped guide their management practices, Dr. Banga said.
“Persistently elevated ferritin may indicate ongoing inflammation at the allograft level,” he said. “We now send [such patients] home on a longer course of oral corticosteroids.”
At the front end of care for infected lung transplant recipients, Dr. Banga said that his team and physicians at other lung transplant programs are holding the cell-cycle inhibitor component of patients’ maintenance immunosuppression therapy (commonly mycophenolate or azathioprine) once infection is diagnosed to maximize chances of a better outcome.
“There may be variation on how long [the regimens are adjusted],” he said. “We changed our duration from 4 weeks to 2 due to patients developing a rebound worsening in the third and fourth week of acute illness.”
There is significant variation from institution to institution in how viral infections are managed in lung transplant recipients, he and Dr. Narula said. “Our numbers are so small in lung transplant, and we don’t have standardized protocols – it’s one of the biggest challenges in our field,” said Dr. Narula.
Vaccination issues, evaluation of donors
Whether or not immunosuppression regimens should be adjusted prior to vaccination is a controversial question, but is “an absolutely valid one” and is currently being studied in at least one National Institutes of Health–funded trial involving solid organ transplant recipients, said Dr. Wolfe.
“Some have jumped to the conclusion [based on some earlier data] that they should reduce immunosuppression regimens for everyone at the time of vaccination ... but I don’t know the answer yet,” he said. “Balancing staying rejection free with potentially gaining more immune response is complicated ... and it may depend on where the pandemic is going in your area and other factors.”
Reductions aside, Dr. Wolfe tells lung transplant recipients that, based on his approximation of a number of different studies in solid organ transplant recipients, approximately 40%-50% of patients who are immunized with two doses of the COVID-19 mRNA vaccines will develop meaningful antibody levels – and that this rises to 50%-60% after a third dose.
It is difficult to glean from available studies the level of vaccine response for lung transplant recipients specifically. But given that their level of maintenance immunosuppression is higher than for recipients of other donor organs, “as a broad sweep, lung transplant recipients tend to be lower in the pecking order of response,” he said.
Still, “there’s a lot to gain,” he said, pointing to a recent study from the Morbidity and Mortality Weekly Report (2021 Nov 5. doi: 10.15585/mmwr.mm7044e3) showing that effectiveness of mRNA vaccination against COVID-19–associated hospitalization was 77% among immunocompromised adults (compared with 90% in immunocompetent adults).
“This is good vindication to keep vaccinating,” he said, “and perhaps speaks to how difficult it is to assess the vaccine response [through measurement of antibody only].”
Neither Duke University’s transplant program, which performed 100-120 lung transplants a year pre-COVID, nor the programs at UT Southwestern or the Mayo Clinic in Jacksonville require that solid organ transplant candidates be vaccinated against SARS-CoV-2 in order to receive transplants, as some other transplant programs have done. (When asked about the issue, Dr. Banga and Dr. Narula each said that they have had no or little trouble convincing patients awaiting lung transplants of the need for COVID-19 vaccination.)
In an August statement, the American Society of Transplantation recommended vaccination for all solid organ transplant recipients, preferably prior to transplantation, and said that it “support[s] the development of institutional policies regarding pretransplant vaccination.”
The Society is not tracking centers’ vaccination policies. But Kaiser Health News reported in October that a growing number of transplant programs, such as UCHealth in Denver and UW Medicine in Seattle, have decided to either bar patients who refuse to be vaccinated from receiving transplants or give them lower priority on waitlists.
Potential lung donors, meanwhile, must be evaluated with lower respiratory COVID-19 testing, with results available prior to transplantation, according to policy developed by the Organ Procurement and Transplantation Network and effective in May 2021. The policy followed three published cases of donor-derived COVID-19 in lung transplant recipients, said Dr. Wolfe, who wrote about use of COVID-positive donors in an editorial published in October.
In each case, the donor had a negative COVID-19 nasopharyngeal swab at the time of organ procurement but was later found to have the virus on bronchoalveolar lavage, he said.
(The use of other organs from COVID-positive donors is appearing thus far to be safe, Dr. Wolfe noted. In the editorial, he references 13 cases of solid organ transplantation from SARS-CoV-2–infected donors into noninfected recipients; none of the 13 transplant recipients developed COVID-19).
Some questions remain, such as how many lower respiratory tests should be run, and how donors should be evaluated in cases of discordant results. Dr. Banga shared the case of a donor with one positive lower respiratory test result followed by two negative results. After internal debate, and consideration of potential false positives and other issues, the team at UT Southwestern decided to decline the donor, Dr. Banga said.
Other programs are likely making similar, appropriately cautious decisions, said Dr. Wolfe. “There’s no way in real-time donor evaluation to know whether the positive test is active virus that could infect the recipient and replicate ... or whether it’s [picking up] inactive or dead fragments of virus that was there several weeks ago. Our tests don’t differentiate that.”
Transplants in COVID-19 patients
Decision-making about lung transplant candidacy among patients with COVID-19 acute respiratory distress syndrome is complex and in need of a new paradigm.
“Some of these patients have the potential to recover, and they’re going to recover way later than what we’re used to,” said Dr. Banga. “We can’t extrapolate for COVID ARDS what we’ve learned for any other virus-related ARDS.”
Dr. Narula also has recently seen at least one COVID-19 patient on ECMO and under evaluation for transplantation recover. “We do not want to transplant too early,” he said, noting that there is consensus that lung transplant should be pursued only when the damage is deemed irreversible clinically and radiologically in the best judgment of the team. Still, “for many of these patients the only exit route will be lung transplants. For the next 12-24 months, a significant proportion of our lung transplant patients will have had post-COVID–related lung damage.”
As of October 2021, 233 lung transplants had been performed in the United States in recipients whose primary diagnosis was reported as COVID related, said Anne Paschke, media relations specialist with the United Network for Organ Sharing.
Dr. Banga, Dr. Wolfe, and Dr. Narula reported that they have no relevant disclosures.
Data is sparse thus far, but there is concern in lung transplant medicine about the long-term risk of chronic lung allograft dysfunction (CLAD) and a potentially shortened longevity of transplanted lungs in recipients who become ill with COVID-19.
“My fear is that we’re potentially sitting on this iceberg worth of people who, come 6 months or a year from [the acute phase of] their COVID illness, will in fact have earlier and progressive, chronic rejection,” said Cameron R. Wolfe, MBBS, MPH, associate professor of medicine in transplant infectious disease at Duke University, Durham, N.C.
Lower respiratory viral infections have long been concerning for lung transplant recipients given their propensity to cause scarring, a decline in lung function, and a heightened risk of allograft rejection. Time will tell whether lung transplant recipients who survive COVID-19 follow a similar path, or one that is worse, he said.
Short-term data
Outcomes beyond hospitalization and acute illness for lung transplant recipients affected by COVID-19 have been reported in the literature by only a few lung transplant programs. These reports – as well as anecdotal experiences being informally shared among transplant programs – have raised the specter of more severe dysfunction following the acute phase and more early CLAD, said Tathagat Narula, MD, assistant professor of medicine at the Mayo Medical School, Rochester, Minn., and a consultant in lung transplantation at the Mayo Clinic’s Jacksonville program.
“The available data cover only 3-6 months out. We don’t know what will happen in the next 6 months and beyond,” Dr. Narula said in an interview.
The risks of COVID-19 in already-transplanted patients and issues relating to the inadequate antibody responses to vaccination are just some of the challenges of lung transplant medicine in the era of SARS-CoV-2. “COVID-19,” said Dr. Narula, “has completely changed the way we practice lung transplant medicine – the way we’re looking both at our recipients and our donors.”
Potential donors are being evaluated with lower respiratory SARS-CoV-2 testing and an abundance of caution. And patients with severe COVID-19 affecting their own lungs are roundly expected to drive up lung transplant volume in the near future. “The whole paradigm has changed,” Dr. Narula said.
Post-acute trajectories
A chart review study published in October by the lung transplant team at the University of Texas Southwestern Medical Center, Dallas, covered 44 consecutive survivors at a median follow-up of 4.5 months from hospital discharge or acute illness (the survival rate was 83.3%). Patients had significantly impaired functional status, and 18 of the 44 (40.9%) had a significant and persistent loss of forced vital capacity or forced expiratory volume in 1 second (>10% from pre–COVID-19 baseline).
Three patients met the criteria for new CLAD after COVID-19 infection, with all three classified as restrictive allograft syndrome (RAS) phenotype.
Moreover, the majority of COVID-19 survivors who had CT chest scans (22 of 28) showed persistent parenchymal opacities – a finding that, regardless of symptomatology, suggests persistent allograft injury, said Amit Banga, MD, associate professor of medicine and medical director of the ex vivo lung perfusion program in UT Southwestern’s lung transplant program.
“The implication is that there may be long-term consequences of COVID-19, perhaps related to some degree of ongoing inflammation and damage,” said Dr. Banga, a coauthor of the postinfection outcomes paper.
The UT Southwestern lung transplant program, which normally performs 60-80 transplants a year, began routine CT scanning 4-5 months into the pandemic, after “stumbling into a few patients who had no symptoms indicative of COVID pneumonia and no changes on an x-ray but significant involvement on a CT,” he said.
Without routine scanning in the general population of COVID-19 patients, Dr. Banga noted, “we’re limited in convincingly saying that COVID is uniquely doing this to lung transplant recipients.” Nor can they conclude that SARS-CoV-2 is unique from other respiratory viruses such as respiratory syncytial virus (RSV) in this regard. (The program has added CT scanning to its protocol for lung transplant recipients afflicted with other respiratory viruses to learn more.)
However, in the big picture, COVID-19 has proven to be far worse for lung transplant recipients than illness with other respiratory viruses, including RSV. “Patients have more frequent and greater loss of lung function, and worse debility from the acute illness,” Dr. Banga said.
“The cornerstones of treatment of both these viruses are very similar, but both the in-hospital course and the postdischarge outcomes are significantly different.”
In an initial paper published in September 2021, Dr. Banga and colleagues compared their first 25 lung transplant patients testing positive for SARS-CoV-2 with a historical cohort of 36 patients with RSV treated during 2016-2018.
Patients with COVID-19 had significantly worse morbidity and mortality, including worse postinfection lung function loss, functional decline, and 3-month survival.
More time, he said, will shed light on the risks of CLAD and the long-term potential for recovery of lung function. Currently, at UT Southwestern, it appears that patients who survive acute illness and the “first 3-6 months after COVID-19, when we’re seeing all the postinfection morbidity, may [enter] a period of stability,” Dr. Banga said.
Overall, he said, patients in their initial cohort are “holding steady” without unusual morbidity, readmissions, or “other setbacks to their allografts.”
At the Mayo Clinic in Jacksonville, which normally performs 40-50 lung transplants a year, transplant physicians have similarly observed significant declines in lung function beyond the acute phase of COVID-19. “Anecdotally, we’re seeing that some patients are beginning to recover some of their lung function, while others have not,” said Dr. Narula. “And we don’t have predictors as to who will progress to CLAD. It’s a big knowledge gap.”
Dr. Narula noted that patients with restrictive allograft syndrome, such as those reported by the UT Southwestern team, “have scarring of the lung and a much worse prognosis than the obstructive type of chronic rejection.” Whether there’s a role for antifibrotic therapy is a question worthy of research.
In UT Southwestern’s analysis, persistently lower absolute lymphocyte counts (< 600/dL) and higher ferritin levels (>150 ng/mL) at the time of hospital discharge were independently associated with significant lung function loss. This finding, reported in their October paper, has helped guide their management practices, Dr. Banga said.
“Persistently elevated ferritin may indicate ongoing inflammation at the allograft level,” he said. “We now send [such patients] home on a longer course of oral corticosteroids.”
At the front end of care for infected lung transplant recipients, Dr. Banga said that his team and physicians at other lung transplant programs are holding the cell-cycle inhibitor component of patients’ maintenance immunosuppression therapy (commonly mycophenolate or azathioprine) once infection is diagnosed to maximize chances of a better outcome.
“There may be variation on how long [the regimens are adjusted],” he said. “We changed our duration from 4 weeks to 2 due to patients developing a rebound worsening in the third and fourth week of acute illness.”
There is significant variation from institution to institution in how viral infections are managed in lung transplant recipients, he and Dr. Narula said. “Our numbers are so small in lung transplant, and we don’t have standardized protocols – it’s one of the biggest challenges in our field,” said Dr. Narula.
Vaccination issues, evaluation of donors
Whether or not immunosuppression regimens should be adjusted prior to vaccination is a controversial question, but is “an absolutely valid one” and is currently being studied in at least one National Institutes of Health–funded trial involving solid organ transplant recipients, said Dr. Wolfe.
“Some have jumped to the conclusion [based on some earlier data] that they should reduce immunosuppression regimens for everyone at the time of vaccination ... but I don’t know the answer yet,” he said. “Balancing staying rejection free with potentially gaining more immune response is complicated ... and it may depend on where the pandemic is going in your area and other factors.”
Reductions aside, Dr. Wolfe tells lung transplant recipients that, based on his approximation of a number of different studies in solid organ transplant recipients, approximately 40%-50% of patients who are immunized with two doses of the COVID-19 mRNA vaccines will develop meaningful antibody levels – and that this rises to 50%-60% after a third dose.
It is difficult to glean from available studies the level of vaccine response for lung transplant recipients specifically. But given that their level of maintenance immunosuppression is higher than for recipients of other donor organs, “as a broad sweep, lung transplant recipients tend to be lower in the pecking order of response,” he said.
Still, “there’s a lot to gain,” he said, pointing to a recent study from the Morbidity and Mortality Weekly Report (2021 Nov 5. doi: 10.15585/mmwr.mm7044e3) showing that effectiveness of mRNA vaccination against COVID-19–associated hospitalization was 77% among immunocompromised adults (compared with 90% in immunocompetent adults).
“This is good vindication to keep vaccinating,” he said, “and perhaps speaks to how difficult it is to assess the vaccine response [through measurement of antibody only].”
Neither Duke University’s transplant program, which performed 100-120 lung transplants a year pre-COVID, nor the programs at UT Southwestern or the Mayo Clinic in Jacksonville require that solid organ transplant candidates be vaccinated against SARS-CoV-2 in order to receive transplants, as some other transplant programs have done. (When asked about the issue, Dr. Banga and Dr. Narula each said that they have had no or little trouble convincing patients awaiting lung transplants of the need for COVID-19 vaccination.)
In an August statement, the American Society of Transplantation recommended vaccination for all solid organ transplant recipients, preferably prior to transplantation, and said that it “support[s] the development of institutional policies regarding pretransplant vaccination.”
The Society is not tracking centers’ vaccination policies. But Kaiser Health News reported in October that a growing number of transplant programs, such as UCHealth in Denver and UW Medicine in Seattle, have decided to either bar patients who refuse to be vaccinated from receiving transplants or give them lower priority on waitlists.
Potential lung donors, meanwhile, must be evaluated with lower respiratory COVID-19 testing, with results available prior to transplantation, according to policy developed by the Organ Procurement and Transplantation Network and effective in May 2021. The policy followed three published cases of donor-derived COVID-19 in lung transplant recipients, said Dr. Wolfe, who wrote about use of COVID-positive donors in an editorial published in October.
In each case, the donor had a negative COVID-19 nasopharyngeal swab at the time of organ procurement but was later found to have the virus on bronchoalveolar lavage, he said.
(The use of other organs from COVID-positive donors is appearing thus far to be safe, Dr. Wolfe noted. In the editorial, he references 13 cases of solid organ transplantation from SARS-CoV-2–infected donors into noninfected recipients; none of the 13 transplant recipients developed COVID-19).
Some questions remain, such as how many lower respiratory tests should be run, and how donors should be evaluated in cases of discordant results. Dr. Banga shared the case of a donor with one positive lower respiratory test result followed by two negative results. After internal debate, and consideration of potential false positives and other issues, the team at UT Southwestern decided to decline the donor, Dr. Banga said.
Other programs are likely making similar, appropriately cautious decisions, said Dr. Wolfe. “There’s no way in real-time donor evaluation to know whether the positive test is active virus that could infect the recipient and replicate ... or whether it’s [picking up] inactive or dead fragments of virus that was there several weeks ago. Our tests don’t differentiate that.”
Transplants in COVID-19 patients
Decision-making about lung transplant candidacy among patients with COVID-19 acute respiratory distress syndrome is complex and in need of a new paradigm.
“Some of these patients have the potential to recover, and they’re going to recover way later than what we’re used to,” said Dr. Banga. “We can’t extrapolate for COVID ARDS what we’ve learned for any other virus-related ARDS.”
Dr. Narula also has recently seen at least one COVID-19 patient on ECMO and under evaluation for transplantation recover. “We do not want to transplant too early,” he said, noting that there is consensus that lung transplant should be pursued only when the damage is deemed irreversible clinically and radiologically in the best judgment of the team. Still, “for many of these patients the only exit route will be lung transplants. For the next 12-24 months, a significant proportion of our lung transplant patients will have had post-COVID–related lung damage.”
As of October 2021, 233 lung transplants had been performed in the United States in recipients whose primary diagnosis was reported as COVID related, said Anne Paschke, media relations specialist with the United Network for Organ Sharing.
Dr. Banga, Dr. Wolfe, and Dr. Narula reported that they have no relevant disclosures.
Data is sparse thus far, but there is concern in lung transplant medicine about the long-term risk of chronic lung allograft dysfunction (CLAD) and a potentially shortened longevity of transplanted lungs in recipients who become ill with COVID-19.
“My fear is that we’re potentially sitting on this iceberg worth of people who, come 6 months or a year from [the acute phase of] their COVID illness, will in fact have earlier and progressive, chronic rejection,” said Cameron R. Wolfe, MBBS, MPH, associate professor of medicine in transplant infectious disease at Duke University, Durham, N.C.
Lower respiratory viral infections have long been concerning for lung transplant recipients given their propensity to cause scarring, a decline in lung function, and a heightened risk of allograft rejection. Time will tell whether lung transplant recipients who survive COVID-19 follow a similar path, or one that is worse, he said.
Short-term data
Outcomes beyond hospitalization and acute illness for lung transplant recipients affected by COVID-19 have been reported in the literature by only a few lung transplant programs. These reports – as well as anecdotal experiences being informally shared among transplant programs – have raised the specter of more severe dysfunction following the acute phase and more early CLAD, said Tathagat Narula, MD, assistant professor of medicine at the Mayo Medical School, Rochester, Minn., and a consultant in lung transplantation at the Mayo Clinic’s Jacksonville program.
“The available data cover only 3-6 months out. We don’t know what will happen in the next 6 months and beyond,” Dr. Narula said in an interview.
The risks of COVID-19 in already-transplanted patients and issues relating to the inadequate antibody responses to vaccination are just some of the challenges of lung transplant medicine in the era of SARS-CoV-2. “COVID-19,” said Dr. Narula, “has completely changed the way we practice lung transplant medicine – the way we’re looking both at our recipients and our donors.”
Potential donors are being evaluated with lower respiratory SARS-CoV-2 testing and an abundance of caution. And patients with severe COVID-19 affecting their own lungs are roundly expected to drive up lung transplant volume in the near future. “The whole paradigm has changed,” Dr. Narula said.
Post-acute trajectories
A chart review study published in October by the lung transplant team at the University of Texas Southwestern Medical Center, Dallas, covered 44 consecutive survivors at a median follow-up of 4.5 months from hospital discharge or acute illness (the survival rate was 83.3%). Patients had significantly impaired functional status, and 18 of the 44 (40.9%) had a significant and persistent loss of forced vital capacity or forced expiratory volume in 1 second (>10% from pre–COVID-19 baseline).
Three patients met the criteria for new CLAD after COVID-19 infection, with all three classified as restrictive allograft syndrome (RAS) phenotype.
Moreover, the majority of COVID-19 survivors who had CT chest scans (22 of 28) showed persistent parenchymal opacities – a finding that, regardless of symptomatology, suggests persistent allograft injury, said Amit Banga, MD, associate professor of medicine and medical director of the ex vivo lung perfusion program in UT Southwestern’s lung transplant program.
“The implication is that there may be long-term consequences of COVID-19, perhaps related to some degree of ongoing inflammation and damage,” said Dr. Banga, a coauthor of the postinfection outcomes paper.
The UT Southwestern lung transplant program, which normally performs 60-80 transplants a year, began routine CT scanning 4-5 months into the pandemic, after “stumbling into a few patients who had no symptoms indicative of COVID pneumonia and no changes on an x-ray but significant involvement on a CT,” he said.
Without routine scanning in the general population of COVID-19 patients, Dr. Banga noted, “we’re limited in convincingly saying that COVID is uniquely doing this to lung transplant recipients.” Nor can they conclude that SARS-CoV-2 is unique from other respiratory viruses such as respiratory syncytial virus (RSV) in this regard. (The program has added CT scanning to its protocol for lung transplant recipients afflicted with other respiratory viruses to learn more.)
However, in the big picture, COVID-19 has proven to be far worse for lung transplant recipients than illness with other respiratory viruses, including RSV. “Patients have more frequent and greater loss of lung function, and worse debility from the acute illness,” Dr. Banga said.
“The cornerstones of treatment of both these viruses are very similar, but both the in-hospital course and the postdischarge outcomes are significantly different.”
In an initial paper published in September 2021, Dr. Banga and colleagues compared their first 25 lung transplant patients testing positive for SARS-CoV-2 with a historical cohort of 36 patients with RSV treated during 2016-2018.
Patients with COVID-19 had significantly worse morbidity and mortality, including worse postinfection lung function loss, functional decline, and 3-month survival.
More time, he said, will shed light on the risks of CLAD and the long-term potential for recovery of lung function. Currently, at UT Southwestern, it appears that patients who survive acute illness and the “first 3-6 months after COVID-19, when we’re seeing all the postinfection morbidity, may [enter] a period of stability,” Dr. Banga said.
Overall, he said, patients in their initial cohort are “holding steady” without unusual morbidity, readmissions, or “other setbacks to their allografts.”
At the Mayo Clinic in Jacksonville, which normally performs 40-50 lung transplants a year, transplant physicians have similarly observed significant declines in lung function beyond the acute phase of COVID-19. “Anecdotally, we’re seeing that some patients are beginning to recover some of their lung function, while others have not,” said Dr. Narula. “And we don’t have predictors as to who will progress to CLAD. It’s a big knowledge gap.”
Dr. Narula noted that patients with restrictive allograft syndrome, such as those reported by the UT Southwestern team, “have scarring of the lung and a much worse prognosis than the obstructive type of chronic rejection.” Whether there’s a role for antifibrotic therapy is a question worthy of research.
In UT Southwestern’s analysis, persistently lower absolute lymphocyte counts (< 600/dL) and higher ferritin levels (>150 ng/mL) at the time of hospital discharge were independently associated with significant lung function loss. This finding, reported in their October paper, has helped guide their management practices, Dr. Banga said.
“Persistently elevated ferritin may indicate ongoing inflammation at the allograft level,” he said. “We now send [such patients] home on a longer course of oral corticosteroids.”
At the front end of care for infected lung transplant recipients, Dr. Banga said that his team and physicians at other lung transplant programs are holding the cell-cycle inhibitor component of patients’ maintenance immunosuppression therapy (commonly mycophenolate or azathioprine) once infection is diagnosed to maximize chances of a better outcome.
“There may be variation on how long [the regimens are adjusted],” he said. “We changed our duration from 4 weeks to 2 due to patients developing a rebound worsening in the third and fourth week of acute illness.”
There is significant variation from institution to institution in how viral infections are managed in lung transplant recipients, he and Dr. Narula said. “Our numbers are so small in lung transplant, and we don’t have standardized protocols – it’s one of the biggest challenges in our field,” said Dr. Narula.
Vaccination issues, evaluation of donors
Whether or not immunosuppression regimens should be adjusted prior to vaccination is a controversial question, but is “an absolutely valid one” and is currently being studied in at least one National Institutes of Health–funded trial involving solid organ transplant recipients, said Dr. Wolfe.
“Some have jumped to the conclusion [based on some earlier data] that they should reduce immunosuppression regimens for everyone at the time of vaccination ... but I don’t know the answer yet,” he said. “Balancing staying rejection free with potentially gaining more immune response is complicated ... and it may depend on where the pandemic is going in your area and other factors.”
Reductions aside, Dr. Wolfe tells lung transplant recipients that, based on his approximation of a number of different studies in solid organ transplant recipients, approximately 40%-50% of patients who are immunized with two doses of the COVID-19 mRNA vaccines will develop meaningful antibody levels – and that this rises to 50%-60% after a third dose.
It is difficult to glean from available studies the level of vaccine response for lung transplant recipients specifically. But given that their level of maintenance immunosuppression is higher than for recipients of other donor organs, “as a broad sweep, lung transplant recipients tend to be lower in the pecking order of response,” he said.
Still, “there’s a lot to gain,” he said, pointing to a recent study from the Morbidity and Mortality Weekly Report (2021 Nov 5. doi: 10.15585/mmwr.mm7044e3) showing that effectiveness of mRNA vaccination against COVID-19–associated hospitalization was 77% among immunocompromised adults (compared with 90% in immunocompetent adults).
“This is good vindication to keep vaccinating,” he said, “and perhaps speaks to how difficult it is to assess the vaccine response [through measurement of antibody only].”
Neither Duke University’s transplant program, which performed 100-120 lung transplants a year pre-COVID, nor the programs at UT Southwestern or the Mayo Clinic in Jacksonville require that solid organ transplant candidates be vaccinated against SARS-CoV-2 in order to receive transplants, as some other transplant programs have done. (When asked about the issue, Dr. Banga and Dr. Narula each said that they have had no or little trouble convincing patients awaiting lung transplants of the need for COVID-19 vaccination.)
In an August statement, the American Society of Transplantation recommended vaccination for all solid organ transplant recipients, preferably prior to transplantation, and said that it “support[s] the development of institutional policies regarding pretransplant vaccination.”
The Society is not tracking centers’ vaccination policies. But Kaiser Health News reported in October that a growing number of transplant programs, such as UCHealth in Denver and UW Medicine in Seattle, have decided to either bar patients who refuse to be vaccinated from receiving transplants or give them lower priority on waitlists.
Potential lung donors, meanwhile, must be evaluated with lower respiratory COVID-19 testing, with results available prior to transplantation, according to policy developed by the Organ Procurement and Transplantation Network and effective in May 2021. The policy followed three published cases of donor-derived COVID-19 in lung transplant recipients, said Dr. Wolfe, who wrote about use of COVID-positive donors in an editorial published in October.
In each case, the donor had a negative COVID-19 nasopharyngeal swab at the time of organ procurement but was later found to have the virus on bronchoalveolar lavage, he said.
(The use of other organs from COVID-positive donors is appearing thus far to be safe, Dr. Wolfe noted. In the editorial, he references 13 cases of solid organ transplantation from SARS-CoV-2–infected donors into noninfected recipients; none of the 13 transplant recipients developed COVID-19).
Some questions remain, such as how many lower respiratory tests should be run, and how donors should be evaluated in cases of discordant results. Dr. Banga shared the case of a donor with one positive lower respiratory test result followed by two negative results. After internal debate, and consideration of potential false positives and other issues, the team at UT Southwestern decided to decline the donor, Dr. Banga said.
Other programs are likely making similar, appropriately cautious decisions, said Dr. Wolfe. “There’s no way in real-time donor evaluation to know whether the positive test is active virus that could infect the recipient and replicate ... or whether it’s [picking up] inactive or dead fragments of virus that was there several weeks ago. Our tests don’t differentiate that.”
Transplants in COVID-19 patients
Decision-making about lung transplant candidacy among patients with COVID-19 acute respiratory distress syndrome is complex and in need of a new paradigm.
“Some of these patients have the potential to recover, and they’re going to recover way later than what we’re used to,” said Dr. Banga. “We can’t extrapolate for COVID ARDS what we’ve learned for any other virus-related ARDS.”
Dr. Narula also has recently seen at least one COVID-19 patient on ECMO and under evaluation for transplantation recover. “We do not want to transplant too early,” he said, noting that there is consensus that lung transplant should be pursued only when the damage is deemed irreversible clinically and radiologically in the best judgment of the team. Still, “for many of these patients the only exit route will be lung transplants. For the next 12-24 months, a significant proportion of our lung transplant patients will have had post-COVID–related lung damage.”
As of October 2021, 233 lung transplants had been performed in the United States in recipients whose primary diagnosis was reported as COVID related, said Anne Paschke, media relations specialist with the United Network for Organ Sharing.
Dr. Banga, Dr. Wolfe, and Dr. Narula reported that they have no relevant disclosures.
The evolving HER2+ metastatic breast cancer landscape: Novel agents and promising combination therapies
Recent therapeutic advances in HER2-positive metastatic breast cancer (MBC) have begun to reshape the treatment landscape for patients. Since late 2019, the U.S. Food and Drug Administration (FDA) has approved a handful of novel agents for HER2-positive MBC — most notably, the antibody-drug conjugate (ADC) trastuzumab deruxtecan in December 2019 and the tyrosine kinase inhibitors (TKIs) tucatinib and neratinib in 2020. According to the National Cancer Institute›s Surveillance, Epidemiology, and End Results (SEER) program, the 5-year survival rate for patients with advanced disease was already on the rise between 2004 and 2018, and
“I’ve been involved in the HER2 space for a long time and have watched the field evolve,” said Adam Brufsky, MD, PhD, associate chief in the division of hematology/oncology and co-director of the Comprehensive Breast Cancer Center at the University of Pittsburgh School of Medicine. “The fact that we’re now talking about fourth- and fifth-line therapies for HER2-positive MBC represents a major advance in the management of these patients.”
Oncologists are still building on this progress, focusing on designing more targeted therapies as well as studying different combinations of available agents. The main goal of treatment, experts say, is to prolong patients’ systemic response and prevent recurrences, especially in the brain. This news organization spoke to Dr. Brufksy and others about promising agents and therapeutic strategies on the horizon to treat HER2-positive MBC.
Inside emerging ADCs
Because many patients develop resistance to trastuzumab emtansine (T-DM1) — the first FDA-approved ADC in breast cancer — researchers have focused on developing the next generation of ADCs with more potent payloads, different linkers, and distinct mechanisms of action, according to Sayeh Lavasani, MD, MS, a medical oncologist at City of Hope, a comprehensive cancer center in Los Angeles County.
The second-generation ADC trastuzumab deruxtecan showed “really dramatic” results in HER2-positive MBC, demonstrating progression-free survival of 16 months, remarked Kevin Kalinsky, MD, acting associate professor in the department of hematology and medical oncology at Emory University School of Medicine in Atlanta and director of the Glenn Family Breast Center at the Winship Cancer Institute of Emory University. “These outcomes further changed how we treat patients with metastatic disease and prompted considerable excitement over the potential to develop novel ADCs to treat HER2-positive MBC.”
Most recently, two investigational ADCs — trastuzumab duocarmazine (SYD985) and ARX788 — have stood out. The FDA granted fast-track designations to trastuzumab duocarmazine in January 2018 and ARX788 in January 2021. Trastuzumab duocarmazine, the furthest along the pipeline, has shown promising results so far. In June 2021, Netherlands-based biopharmaceutical company Byondis reported preliminary phase 3 data from the TULIP trial. The open-label, randomized phase 3 study enrolled 436 patients with HER2-positive locally advanced or metastatic disease that had progressed on previous anti-HER2 regimens. The company shared early results that trastuzumab duocarmazine achieved its progression-free survival primary endpoint, marking a significant improvement over physician’s choice of chemotherapy, and promised more detailed results to come later this year.
Although only in early-phase trials, ARX788 has also shown robust anti-HER2 activity as well as low toxicity in HER2-positive tumors, according to recent data. The findings from two phase 1 studies, presented at the June 2021 virtual American Society for Clinical Oncology meeting (abstract 1038), revealed an overall response rate of 74% in the breast cancer cohort, but the investigators acknowledged it was too early to report median progression-free survival outcomes. Preclinical data also showed activity in HER2-low and T-DM1–resistant tumors.
Despite the encouraging initial findings, Dr. Kalinsky remains cautiously optimistic about long-term outcomes for both ADCs. “These data are hot off the press, but it’s too soon to know how these two ADCs and others in the pipeline will measure up to approved therapies,” he commented. As experts learn more about the efficacy of these novel ADCs, Dr. Brufsky would also like to better understand resistance mechanisms and how to integrate these agents into current treatment strategies. “The cellular biology of HER2-positive MBC is complicated, and many factors in these tumor cells affect where ADCs are released, how resistance develops, and whether or not resistance to one ADC applies to others,” Dr. Brufsky remarked. “As we gather more data, we’ll understand resistance mechanisms better and begin to figure out where to go with treatment sequencing.”
TKIs and beyond
In addition to ADCs, TKIs continue to make their mark in the targeted HER2 therapeutic space. The approvals of tucatinib and neratinib last year represented an important advance in treating HER2-positive MBC, particularly for patients with brain metastases. The HER2CLIMB trial, for instance, found that tucatinib combined with trastuzumab and capecitabine had a 4.5-month overall survival advantage compared with placebo (21.9 vs 17.4) and a median progression-free survival advantage of 5.4 months in patients with active brain metastases (9.5 vs 4.1) and 8.3 months in patients with stable metastases (13.9 vs 5.6).
Given this progress, experts are looking to add new TKIs to the armamentarium. In particular, pyrotinib — already approved in China for treating HER2-positive MBC — has demonstrated significantly longer progression-free survival compared with a standard TKI, lapatinib. The phase 3 PHOEBE trial results, published in The Lancet in early 2021, found a median progression-free survival of 12.5 months in patients randomly assigned to receive pyrotinib plus capecitabine compared with 6.8 months in those receiving lapatinib plus capecitabine. The investigators also reported “manageable toxicity”; diarrhea was the most common grade 3 adverse event, occurring in 31% of the pyrotinib group vs. 8% of the lapatinib group, and overall serious adverse events occurred in 10% of patients receiving pyrotinib vs. 8% of those receiving lapatinib.
More recent data on pyrotinib come from the phase 2 PERMEATE trial, which focused on the safety and efficacy of the agent in patients with advanced disease and brain metastases. The investigators, who presented their findings at the 2021 virtual ASCO meeting (abstract 1037), reported that radiation therapy–naive patients receiving pyrotinib plus capecitabine had an overall response rate of 74.6% in the central nervous system. Patients experiencing progression after whole-brain or stereotactic radiation therapy, however, had a comparatively lower overall response rate of 42.1%.
Similarly, median progression-free survival was much higher in the radiation therapy–naive patients (12.1 vs 5.6 months in the radiation therapy cohort). Similar to the PHOEBE trial, the most common grade 3 adverse event was diarrhea (23.1%), followed by decreased neutrophil and white blood cell counts (12.8% for both), anemia (9%), and hand-foot syndrome (7.7%). The main question for Dr. Kalinsky is how well pyrotinib will ultimately stack up to tucatinib and neratinib. “Pyrotinib — like neratinib — was shown to be superior to lapatinib plus capecitabine , but its role may be limited by its gastrointestinal toxicity,” he said. In addition to research focused on expanding the selection of novel ADCs and TKIs, researchers are also exploring new combinations of approved treatments and whether these combinations can be used earlier in treatment sequencing.
Take the CompassHER2 trials. The ongoing phase 3 trial in patients with high-risk HER2-positive breast cancer and residual disease will explore whether tucatinib plus T-DM1 compared with T-DM1 alone improves overall survival and recurrence-free survival and prevents brain metastases. Another possibility currently under investigation is pairing tucatinib and trastuzumab deruxtecan, instead of T-DM1. “Overall, it’s exciting that we are increasing the number of therapeutic options and combinations,” commented Debu Tripathy, MD, professor and chairman in the department of breast medical oncology at the University of Texas MD Anderson Cancer Center in Houston. “Having more choices allows us to tailor therapies to manage resistance and prolong patients’ responses.”
Curbing brain metastasis, according to Dr. Brufksy, is particularly important, and experts need to explore the extent to which ADCs can penetrate the blood-brain barrier. Already, a subgroup analysis of the DESTINY-Breast01 trial found that trastuzumab deruxtecan appeared to be active in patients with brain metastases. Investigators reported an overall response rate of 58.3% and a median progression-free survival of 18.1 months — results in line with those in the general study cohort — but the study population did not include patients with untreated or progressive brain metastases. A phase 2 study currently under way will examine whether patients with HER2-positive and HER2-low breast cancer who have untreated or progressive brain metastases respond to trastuzumab deruxtecan as well. Ultimately, Dr. Brufksy hopes the recent successes with preventing brain metastases in pediatric acute lymphoblastic leukemia (ALL) foreshadow what›s to come in HER2-positive MBC.
“When we figured out how to treat brain metastases prophylactically in childhood ALL, we saw a huge improvement in the cure rate, which is ultimately my vision for HER2-positive disease,” Dr. Brufsky remarked. “Are there cures for HER2-positive MBC on the horizon? We don’t know yet, but the field has really exploded in recent years.”
A version of this article first appeared on Medscape.com.
Recent therapeutic advances in HER2-positive metastatic breast cancer (MBC) have begun to reshape the treatment landscape for patients. Since late 2019, the U.S. Food and Drug Administration (FDA) has approved a handful of novel agents for HER2-positive MBC — most notably, the antibody-drug conjugate (ADC) trastuzumab deruxtecan in December 2019 and the tyrosine kinase inhibitors (TKIs) tucatinib and neratinib in 2020. According to the National Cancer Institute›s Surveillance, Epidemiology, and End Results (SEER) program, the 5-year survival rate for patients with advanced disease was already on the rise between 2004 and 2018, and
“I’ve been involved in the HER2 space for a long time and have watched the field evolve,” said Adam Brufsky, MD, PhD, associate chief in the division of hematology/oncology and co-director of the Comprehensive Breast Cancer Center at the University of Pittsburgh School of Medicine. “The fact that we’re now talking about fourth- and fifth-line therapies for HER2-positive MBC represents a major advance in the management of these patients.”
Oncologists are still building on this progress, focusing on designing more targeted therapies as well as studying different combinations of available agents. The main goal of treatment, experts say, is to prolong patients’ systemic response and prevent recurrences, especially in the brain. This news organization spoke to Dr. Brufksy and others about promising agents and therapeutic strategies on the horizon to treat HER2-positive MBC.
Inside emerging ADCs
Because many patients develop resistance to trastuzumab emtansine (T-DM1) — the first FDA-approved ADC in breast cancer — researchers have focused on developing the next generation of ADCs with more potent payloads, different linkers, and distinct mechanisms of action, according to Sayeh Lavasani, MD, MS, a medical oncologist at City of Hope, a comprehensive cancer center in Los Angeles County.
The second-generation ADC trastuzumab deruxtecan showed “really dramatic” results in HER2-positive MBC, demonstrating progression-free survival of 16 months, remarked Kevin Kalinsky, MD, acting associate professor in the department of hematology and medical oncology at Emory University School of Medicine in Atlanta and director of the Glenn Family Breast Center at the Winship Cancer Institute of Emory University. “These outcomes further changed how we treat patients with metastatic disease and prompted considerable excitement over the potential to develop novel ADCs to treat HER2-positive MBC.”
Most recently, two investigational ADCs — trastuzumab duocarmazine (SYD985) and ARX788 — have stood out. The FDA granted fast-track designations to trastuzumab duocarmazine in January 2018 and ARX788 in January 2021. Trastuzumab duocarmazine, the furthest along the pipeline, has shown promising results so far. In June 2021, Netherlands-based biopharmaceutical company Byondis reported preliminary phase 3 data from the TULIP trial. The open-label, randomized phase 3 study enrolled 436 patients with HER2-positive locally advanced or metastatic disease that had progressed on previous anti-HER2 regimens. The company shared early results that trastuzumab duocarmazine achieved its progression-free survival primary endpoint, marking a significant improvement over physician’s choice of chemotherapy, and promised more detailed results to come later this year.
Although only in early-phase trials, ARX788 has also shown robust anti-HER2 activity as well as low toxicity in HER2-positive tumors, according to recent data. The findings from two phase 1 studies, presented at the June 2021 virtual American Society for Clinical Oncology meeting (abstract 1038), revealed an overall response rate of 74% in the breast cancer cohort, but the investigators acknowledged it was too early to report median progression-free survival outcomes. Preclinical data also showed activity in HER2-low and T-DM1–resistant tumors.
Despite the encouraging initial findings, Dr. Kalinsky remains cautiously optimistic about long-term outcomes for both ADCs. “These data are hot off the press, but it’s too soon to know how these two ADCs and others in the pipeline will measure up to approved therapies,” he commented. As experts learn more about the efficacy of these novel ADCs, Dr. Brufsky would also like to better understand resistance mechanisms and how to integrate these agents into current treatment strategies. “The cellular biology of HER2-positive MBC is complicated, and many factors in these tumor cells affect where ADCs are released, how resistance develops, and whether or not resistance to one ADC applies to others,” Dr. Brufsky remarked. “As we gather more data, we’ll understand resistance mechanisms better and begin to figure out where to go with treatment sequencing.”
TKIs and beyond
In addition to ADCs, TKIs continue to make their mark in the targeted HER2 therapeutic space. The approvals of tucatinib and neratinib last year represented an important advance in treating HER2-positive MBC, particularly for patients with brain metastases. The HER2CLIMB trial, for instance, found that tucatinib combined with trastuzumab and capecitabine had a 4.5-month overall survival advantage compared with placebo (21.9 vs 17.4) and a median progression-free survival advantage of 5.4 months in patients with active brain metastases (9.5 vs 4.1) and 8.3 months in patients with stable metastases (13.9 vs 5.6).
Given this progress, experts are looking to add new TKIs to the armamentarium. In particular, pyrotinib — already approved in China for treating HER2-positive MBC — has demonstrated significantly longer progression-free survival compared with a standard TKI, lapatinib. The phase 3 PHOEBE trial results, published in The Lancet in early 2021, found a median progression-free survival of 12.5 months in patients randomly assigned to receive pyrotinib plus capecitabine compared with 6.8 months in those receiving lapatinib plus capecitabine. The investigators also reported “manageable toxicity”; diarrhea was the most common grade 3 adverse event, occurring in 31% of the pyrotinib group vs. 8% of the lapatinib group, and overall serious adverse events occurred in 10% of patients receiving pyrotinib vs. 8% of those receiving lapatinib.
More recent data on pyrotinib come from the phase 2 PERMEATE trial, which focused on the safety and efficacy of the agent in patients with advanced disease and brain metastases. The investigators, who presented their findings at the 2021 virtual ASCO meeting (abstract 1037), reported that radiation therapy–naive patients receiving pyrotinib plus capecitabine had an overall response rate of 74.6% in the central nervous system. Patients experiencing progression after whole-brain or stereotactic radiation therapy, however, had a comparatively lower overall response rate of 42.1%.
Similarly, median progression-free survival was much higher in the radiation therapy–naive patients (12.1 vs 5.6 months in the radiation therapy cohort). Similar to the PHOEBE trial, the most common grade 3 adverse event was diarrhea (23.1%), followed by decreased neutrophil and white blood cell counts (12.8% for both), anemia (9%), and hand-foot syndrome (7.7%). The main question for Dr. Kalinsky is how well pyrotinib will ultimately stack up to tucatinib and neratinib. “Pyrotinib — like neratinib — was shown to be superior to lapatinib plus capecitabine , but its role may be limited by its gastrointestinal toxicity,” he said. In addition to research focused on expanding the selection of novel ADCs and TKIs, researchers are also exploring new combinations of approved treatments and whether these combinations can be used earlier in treatment sequencing.
Take the CompassHER2 trials. The ongoing phase 3 trial in patients with high-risk HER2-positive breast cancer and residual disease will explore whether tucatinib plus T-DM1 compared with T-DM1 alone improves overall survival and recurrence-free survival and prevents brain metastases. Another possibility currently under investigation is pairing tucatinib and trastuzumab deruxtecan, instead of T-DM1. “Overall, it’s exciting that we are increasing the number of therapeutic options and combinations,” commented Debu Tripathy, MD, professor and chairman in the department of breast medical oncology at the University of Texas MD Anderson Cancer Center in Houston. “Having more choices allows us to tailor therapies to manage resistance and prolong patients’ responses.”
Curbing brain metastasis, according to Dr. Brufksy, is particularly important, and experts need to explore the extent to which ADCs can penetrate the blood-brain barrier. Already, a subgroup analysis of the DESTINY-Breast01 trial found that trastuzumab deruxtecan appeared to be active in patients with brain metastases. Investigators reported an overall response rate of 58.3% and a median progression-free survival of 18.1 months — results in line with those in the general study cohort — but the study population did not include patients with untreated or progressive brain metastases. A phase 2 study currently under way will examine whether patients with HER2-positive and HER2-low breast cancer who have untreated or progressive brain metastases respond to trastuzumab deruxtecan as well. Ultimately, Dr. Brufksy hopes the recent successes with preventing brain metastases in pediatric acute lymphoblastic leukemia (ALL) foreshadow what›s to come in HER2-positive MBC.
“When we figured out how to treat brain metastases prophylactically in childhood ALL, we saw a huge improvement in the cure rate, which is ultimately my vision for HER2-positive disease,” Dr. Brufsky remarked. “Are there cures for HER2-positive MBC on the horizon? We don’t know yet, but the field has really exploded in recent years.”
A version of this article first appeared on Medscape.com.
Recent therapeutic advances in HER2-positive metastatic breast cancer (MBC) have begun to reshape the treatment landscape for patients. Since late 2019, the U.S. Food and Drug Administration (FDA) has approved a handful of novel agents for HER2-positive MBC — most notably, the antibody-drug conjugate (ADC) trastuzumab deruxtecan in December 2019 and the tyrosine kinase inhibitors (TKIs) tucatinib and neratinib in 2020. According to the National Cancer Institute›s Surveillance, Epidemiology, and End Results (SEER) program, the 5-year survival rate for patients with advanced disease was already on the rise between 2004 and 2018, and
“I’ve been involved in the HER2 space for a long time and have watched the field evolve,” said Adam Brufsky, MD, PhD, associate chief in the division of hematology/oncology and co-director of the Comprehensive Breast Cancer Center at the University of Pittsburgh School of Medicine. “The fact that we’re now talking about fourth- and fifth-line therapies for HER2-positive MBC represents a major advance in the management of these patients.”
Oncologists are still building on this progress, focusing on designing more targeted therapies as well as studying different combinations of available agents. The main goal of treatment, experts say, is to prolong patients’ systemic response and prevent recurrences, especially in the brain. This news organization spoke to Dr. Brufksy and others about promising agents and therapeutic strategies on the horizon to treat HER2-positive MBC.
Inside emerging ADCs
Because many patients develop resistance to trastuzumab emtansine (T-DM1) — the first FDA-approved ADC in breast cancer — researchers have focused on developing the next generation of ADCs with more potent payloads, different linkers, and distinct mechanisms of action, according to Sayeh Lavasani, MD, MS, a medical oncologist at City of Hope, a comprehensive cancer center in Los Angeles County.
The second-generation ADC trastuzumab deruxtecan showed “really dramatic” results in HER2-positive MBC, demonstrating progression-free survival of 16 months, remarked Kevin Kalinsky, MD, acting associate professor in the department of hematology and medical oncology at Emory University School of Medicine in Atlanta and director of the Glenn Family Breast Center at the Winship Cancer Institute of Emory University. “These outcomes further changed how we treat patients with metastatic disease and prompted considerable excitement over the potential to develop novel ADCs to treat HER2-positive MBC.”
Most recently, two investigational ADCs — trastuzumab duocarmazine (SYD985) and ARX788 — have stood out. The FDA granted fast-track designations to trastuzumab duocarmazine in January 2018 and ARX788 in January 2021. Trastuzumab duocarmazine, the furthest along the pipeline, has shown promising results so far. In June 2021, Netherlands-based biopharmaceutical company Byondis reported preliminary phase 3 data from the TULIP trial. The open-label, randomized phase 3 study enrolled 436 patients with HER2-positive locally advanced or metastatic disease that had progressed on previous anti-HER2 regimens. The company shared early results that trastuzumab duocarmazine achieved its progression-free survival primary endpoint, marking a significant improvement over physician’s choice of chemotherapy, and promised more detailed results to come later this year.
Although only in early-phase trials, ARX788 has also shown robust anti-HER2 activity as well as low toxicity in HER2-positive tumors, according to recent data. The findings from two phase 1 studies, presented at the June 2021 virtual American Society for Clinical Oncology meeting (abstract 1038), revealed an overall response rate of 74% in the breast cancer cohort, but the investigators acknowledged it was too early to report median progression-free survival outcomes. Preclinical data also showed activity in HER2-low and T-DM1–resistant tumors.
Despite the encouraging initial findings, Dr. Kalinsky remains cautiously optimistic about long-term outcomes for both ADCs. “These data are hot off the press, but it’s too soon to know how these two ADCs and others in the pipeline will measure up to approved therapies,” he commented. As experts learn more about the efficacy of these novel ADCs, Dr. Brufsky would also like to better understand resistance mechanisms and how to integrate these agents into current treatment strategies. “The cellular biology of HER2-positive MBC is complicated, and many factors in these tumor cells affect where ADCs are released, how resistance develops, and whether or not resistance to one ADC applies to others,” Dr. Brufsky remarked. “As we gather more data, we’ll understand resistance mechanisms better and begin to figure out where to go with treatment sequencing.”
TKIs and beyond
In addition to ADCs, TKIs continue to make their mark in the targeted HER2 therapeutic space. The approvals of tucatinib and neratinib last year represented an important advance in treating HER2-positive MBC, particularly for patients with brain metastases. The HER2CLIMB trial, for instance, found that tucatinib combined with trastuzumab and capecitabine had a 4.5-month overall survival advantage compared with placebo (21.9 vs 17.4) and a median progression-free survival advantage of 5.4 months in patients with active brain metastases (9.5 vs 4.1) and 8.3 months in patients with stable metastases (13.9 vs 5.6).
Given this progress, experts are looking to add new TKIs to the armamentarium. In particular, pyrotinib — already approved in China for treating HER2-positive MBC — has demonstrated significantly longer progression-free survival compared with a standard TKI, lapatinib. The phase 3 PHOEBE trial results, published in The Lancet in early 2021, found a median progression-free survival of 12.5 months in patients randomly assigned to receive pyrotinib plus capecitabine compared with 6.8 months in those receiving lapatinib plus capecitabine. The investigators also reported “manageable toxicity”; diarrhea was the most common grade 3 adverse event, occurring in 31% of the pyrotinib group vs. 8% of the lapatinib group, and overall serious adverse events occurred in 10% of patients receiving pyrotinib vs. 8% of those receiving lapatinib.
More recent data on pyrotinib come from the phase 2 PERMEATE trial, which focused on the safety and efficacy of the agent in patients with advanced disease and brain metastases. The investigators, who presented their findings at the 2021 virtual ASCO meeting (abstract 1037), reported that radiation therapy–naive patients receiving pyrotinib plus capecitabine had an overall response rate of 74.6% in the central nervous system. Patients experiencing progression after whole-brain or stereotactic radiation therapy, however, had a comparatively lower overall response rate of 42.1%.
Similarly, median progression-free survival was much higher in the radiation therapy–naive patients (12.1 vs 5.6 months in the radiation therapy cohort). Similar to the PHOEBE trial, the most common grade 3 adverse event was diarrhea (23.1%), followed by decreased neutrophil and white blood cell counts (12.8% for both), anemia (9%), and hand-foot syndrome (7.7%). The main question for Dr. Kalinsky is how well pyrotinib will ultimately stack up to tucatinib and neratinib. “Pyrotinib — like neratinib — was shown to be superior to lapatinib plus capecitabine , but its role may be limited by its gastrointestinal toxicity,” he said. In addition to research focused on expanding the selection of novel ADCs and TKIs, researchers are also exploring new combinations of approved treatments and whether these combinations can be used earlier in treatment sequencing.
Take the CompassHER2 trials. The ongoing phase 3 trial in patients with high-risk HER2-positive breast cancer and residual disease will explore whether tucatinib plus T-DM1 compared with T-DM1 alone improves overall survival and recurrence-free survival and prevents brain metastases. Another possibility currently under investigation is pairing tucatinib and trastuzumab deruxtecan, instead of T-DM1. “Overall, it’s exciting that we are increasing the number of therapeutic options and combinations,” commented Debu Tripathy, MD, professor and chairman in the department of breast medical oncology at the University of Texas MD Anderson Cancer Center in Houston. “Having more choices allows us to tailor therapies to manage resistance and prolong patients’ responses.”
Curbing brain metastasis, according to Dr. Brufksy, is particularly important, and experts need to explore the extent to which ADCs can penetrate the blood-brain barrier. Already, a subgroup analysis of the DESTINY-Breast01 trial found that trastuzumab deruxtecan appeared to be active in patients with brain metastases. Investigators reported an overall response rate of 58.3% and a median progression-free survival of 18.1 months — results in line with those in the general study cohort — but the study population did not include patients with untreated or progressive brain metastases. A phase 2 study currently under way will examine whether patients with HER2-positive and HER2-low breast cancer who have untreated or progressive brain metastases respond to trastuzumab deruxtecan as well. Ultimately, Dr. Brufksy hopes the recent successes with preventing brain metastases in pediatric acute lymphoblastic leukemia (ALL) foreshadow what›s to come in HER2-positive MBC.
“When we figured out how to treat brain metastases prophylactically in childhood ALL, we saw a huge improvement in the cure rate, which is ultimately my vision for HER2-positive disease,” Dr. Brufsky remarked. “Are there cures for HER2-positive MBC on the horizon? We don’t know yet, but the field has really exploded in recent years.”
A version of this article first appeared on Medscape.com.
IDF Atlas: 1 in 10 adults worldwide now has diabetes
One in 10 adults worldwide currently has diabetes, accounting for an estimated global health expenditure of $966 billion in U.S. dollars in 2021, according to the new International Diabetes Federation Diabetes Atlas.
The IDF Atlas, 10th edition, was published online Dec. 6, 2021.
Highlights from it were presented during two sessions at the IDF Virtual Congress 2021, covering global diabetes incidence and prevalence, mortality, and costs, as well as new sections in this edition devoted to adult-onset type 1 diabetes, childhood-onset type 2 diabetes, and the interactions between diabetes and COVID-19.
More detailed data from some of the Atlas chapters were also published Dec. 6, 2021, in separate papers in the IDF journal Diabetes Research and Clinical Practice, with more publications planned.
Information for the Atlas comes from peer-reviewed literature, unpublished reports, and national registries. This latest edition includes 219 data sources from 144 countries, with figures for other countries extrapolated.
Atlas cochair Dianna Magliano, PhD, reviewed some of the highlights. Half of those currently with diabetes, or about 240 million adults, are undiagnosed, and another 319 million have impaired fasting glucose. Over three-quarters of all adults with diabetes now live in low- and middle-income countries. And about 6.7 million deaths in 2021 can be attributed to diabetes.
The Atlas also predicts increases in these numbers over the coming decades if current trends continue.
“Our data and projections tell a sobering story. Diabetes prevalence is expected to increase globally. The number of adults with diabetes will rise from 537 million in 2021 to 786 million ... by the year 2045, an increase of 46%. Rises are expected in every region of the world, with the largest increases expected to occur in the regions of Africa, the Middle East, and Southeast Asia,” said Dr. Magliano, head of diabetes and population health at the Baker Heart and Diabetes Institute, Melbourne.
Since 2019, when the last Atlas was published, the 2021 numbers represent increases of 73.6 million more adults with diabetes including 7.8 million more undiagnosed, 2.5 million more deaths attributed to diabetes, and an additional global expenditure of $206 billion.
Increases have also occurred in the number of people with prediabetes, children with type 1 diabetes, and pregnancies affected by diabetes, Dr. Magliano reported.
“There is a strong need for effective intervention strategies and policies to stall the increase in the number of people developing diabetes across the world,” she added.
Projected rise in expenditures for diabetes will be ‘unsustainable’
The current $966 billion global health expenditure caused by diabetes represents a 316% increase from the $232 billion reported in 2006, according to William H. Herman, MD, professor of internal medicine and epidemiology at the University of Michigan, Ann Arbor.
By region, 43% of current diabetes-related global expenditures are in North America, 25% in the Western Pacific, and 20% in Europe, while 12% are from the regions of South and Central America, North Africa, Africa, and Southeast Asia combined, Herman said.
The direct costs of diabetes are projected to grow to $1054 billion in 2045, an increase of just 9% over 25 years. The reason for the far lower increase going forward, compared with the tripling in the 15 years prior, is because of the anticipated diabetes rise in regions of the world where per-person spending on diabetes is low, a situation Dr. Herman called “unsustainable.”
“The keys to controlling the global costs of diabetes care are diabetes prevention and providing effective care to the largest number of people at the lowest possible cost,” he said.
Diabetes-related mortality: Some shifts since 2019
One third of the current 6.7 million diabetes-related deaths in 2021 were in people younger than 60 years, said Elbert S. Huang, MD, professor of medicine and public health sciences at the University of Chicago.
Overall, diabetes accounted for 11.8% of total global deaths in people younger than 60 years, but that varied widely, from 24.5% in the Middle East/North Africa to just 6.9% in Southeast Asia.
The regions with the highest number of diabetes-related deaths in people younger than 60 years in 2021 were the Western Pacific and the Middle East/North Africa, a major change from just 2 years ago, when Southeast Asia and Africa saw the greatest numbers of diabetes-related deaths in working-age adults.
“These findings mirror recent reports on inadequate uptake of diabetes prevention programs as well as stagnant quality of care trends for the past decade and reemphasize the need to address noncommunicable diseases across the globe,” Dr. Huang said.
Diabetes and COVID-19: Other factors partly explain the increased risk
Gillian Booth, MD, summarized the current literature on COVID-19 and diabetes including a meta-analysis her group conducted of 300 studies from around the world, with 58% from high-income countries.
The risk for increased COVID-19 severity in people with diabetes could be at least partly explained by factors such as age, sex, and comorbidities, said Dr. Booth, professor in the department of medicine and the Institute of Health Policy, Management, and Evaluation at the University of Toronto.
For example, the unadjusted pooled odds of hospitalization with COVID-19 in patients with diabetes, compared with those without diabetes, was 3.69, but dropped to 1.73 after adjustment for age, sex, and having one or more comorbidities. For COVID-19–related death, those odds ratios were 2.32 unadjusted versus 1.59 adjusted. In both cases, the values were still significant after adjustment, she emphasized.
Overall, hyperglycemia and hemoglobin A1c at admission emerged as significant independent predictors of severe outcomes.
“Further research is needed to understand the interplay between COVID-19 and diabetes and how best to address the disproportionate burden of COVID-19 among people living with diabetes,” she stressed.
Adult-onset type 1 diabetes: Growing recognition of the burden
Ascertainment of data for both adult-onset type 1 and type 2 diabetes in youth was subject to significant limitations.
For adult-onset type 1 diabetes, Jessica Harding, PhD, pointed to the fact that the epidemiology of adult-onset type 1 diabetes hasn’t been well characterized because of the historical focus on children, the difficulty of distinguishing it from type 2 diabetes in adults, and that many registries simply don’t include incident data across the lifespan for type 1 diabetes.
Nonetheless, she said, “there is growing recognition of the burden of adult-onset type 1,” noting that the American Diabetes Association and European Association for the Study of Diabetes just published a consensus statement addressing the topic.
A systematic review of 46 studies representing 32 countries or regions revealed that countries with the highest incidence of type 1 diabetes onset per population of 100,000 ages 20 or above were Eritrea, at 46.2, followed by Sweden and Ireland, both at 30.6, and Finland, at 0. The lowest rates were in Asian countries.
While the Nordic countries (Finland, Sweden, and Norway) are among the top for incidence of both childhood-onset (0-14 years) and adult-onset type 1 diabetes, Eritrea isn’t even among the top 10 for childhood onset.
The unusual situation in Eritrea is the subject of current study but the reasons aren’t yet clear, noted Dr. Magliano, of Emory University, Atlanta, during the question-and-answer period.
And only seven studies, 15%, used biomarkers to determine type 1 diabetes status, suggesting “there is a pressing need to improve the quality and quantity of information on adult-onset type 1 diabetes, particularly in those low- and middle-income countries,” Dr. Harding said.
Type 2 diabetes in youth: A call for better data
When presenting the data for childhood-onset type 2 diabetes, Andrea Luk, MD, noted: “The onset of advanced complications during the most productive time of life has significant impact on individuals, communities, and health economies.”
In 19 studies, the highest reported prevalence of type 2 diabetes in youth was in Brazil, Mexico, indigenous populations of the United States and Canada, and the Black population in the United States, with rates ranging from 160 per 100,000 to 3300 per 100,000. The lowest prevalence rates of 0.6 per 100,000 to 2.7 per 100,000 were reported in Europe. Incidence data were similar, with the highest rates from 31 per 100,000 to 94 per 100,000 and the lowest 0.1 per 100,000 to 0.8 per 100,000 per year.
Of note, Dr. Luk pointed out that childhood obesity is an important factor but not the only one.
“Some populations that have a low prevalence of obesity, such as East Asians, reported higher incidence rates of youth-onset type 2 diabetes than populations with a greater burden of childhood obesity.”
There was variability in incidence rates for youth of similar ethnic background but from different countries. “Apart from genetic predisposition and background obesogenic environment, disparity in socioeconomic status, access to health care, and cultural practices are other contributors to differences in risk of type 2 diabetes in youth,” noted Dr. Luk, associate professor in the division of endocrinology, Department of Medicine and Therapeutics, Chinese University of Hong Kong.
She also noted that the incidence of type 2 diabetes was extremely low in prepubertal children and rises gradually during puberty, and that the incidence is higher in girls than boys but that reverses in adulthood.
Compared with adults with type 2 diabetes, youth with type 2 diabetes had a more adverse glycemic trajectory and higher rates of metformin failure.
And compared with youth with type 1 diabetes, those with type 2 diabetes had more adverse metabolic profiles and higher rates of vascular complications.
“A strong call must be made for the collection of trend data to assess global burden of type 2 diabetes in youth,” she concluded.
Dr. Luk reported serving as an advisory panel member for and/or receiving research support from Amgen, AstraZeneca, Boehringer Ingelheim, Sanofi, the Asia Diabetes Foundation, Bayer, Lee’s Pharmaceutical, MSD, Novo Nordisk, Roche, Sugardown, and Takeda. The other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One in 10 adults worldwide currently has diabetes, accounting for an estimated global health expenditure of $966 billion in U.S. dollars in 2021, according to the new International Diabetes Federation Diabetes Atlas.
The IDF Atlas, 10th edition, was published online Dec. 6, 2021.
Highlights from it were presented during two sessions at the IDF Virtual Congress 2021, covering global diabetes incidence and prevalence, mortality, and costs, as well as new sections in this edition devoted to adult-onset type 1 diabetes, childhood-onset type 2 diabetes, and the interactions between diabetes and COVID-19.
More detailed data from some of the Atlas chapters were also published Dec. 6, 2021, in separate papers in the IDF journal Diabetes Research and Clinical Practice, with more publications planned.
Information for the Atlas comes from peer-reviewed literature, unpublished reports, and national registries. This latest edition includes 219 data sources from 144 countries, with figures for other countries extrapolated.
Atlas cochair Dianna Magliano, PhD, reviewed some of the highlights. Half of those currently with diabetes, or about 240 million adults, are undiagnosed, and another 319 million have impaired fasting glucose. Over three-quarters of all adults with diabetes now live in low- and middle-income countries. And about 6.7 million deaths in 2021 can be attributed to diabetes.
The Atlas also predicts increases in these numbers over the coming decades if current trends continue.
“Our data and projections tell a sobering story. Diabetes prevalence is expected to increase globally. The number of adults with diabetes will rise from 537 million in 2021 to 786 million ... by the year 2045, an increase of 46%. Rises are expected in every region of the world, with the largest increases expected to occur in the regions of Africa, the Middle East, and Southeast Asia,” said Dr. Magliano, head of diabetes and population health at the Baker Heart and Diabetes Institute, Melbourne.
Since 2019, when the last Atlas was published, the 2021 numbers represent increases of 73.6 million more adults with diabetes including 7.8 million more undiagnosed, 2.5 million more deaths attributed to diabetes, and an additional global expenditure of $206 billion.
Increases have also occurred in the number of people with prediabetes, children with type 1 diabetes, and pregnancies affected by diabetes, Dr. Magliano reported.
“There is a strong need for effective intervention strategies and policies to stall the increase in the number of people developing diabetes across the world,” she added.
Projected rise in expenditures for diabetes will be ‘unsustainable’
The current $966 billion global health expenditure caused by diabetes represents a 316% increase from the $232 billion reported in 2006, according to William H. Herman, MD, professor of internal medicine and epidemiology at the University of Michigan, Ann Arbor.
By region, 43% of current diabetes-related global expenditures are in North America, 25% in the Western Pacific, and 20% in Europe, while 12% are from the regions of South and Central America, North Africa, Africa, and Southeast Asia combined, Herman said.
The direct costs of diabetes are projected to grow to $1054 billion in 2045, an increase of just 9% over 25 years. The reason for the far lower increase going forward, compared with the tripling in the 15 years prior, is because of the anticipated diabetes rise in regions of the world where per-person spending on diabetes is low, a situation Dr. Herman called “unsustainable.”
“The keys to controlling the global costs of diabetes care are diabetes prevention and providing effective care to the largest number of people at the lowest possible cost,” he said.
Diabetes-related mortality: Some shifts since 2019
One third of the current 6.7 million diabetes-related deaths in 2021 were in people younger than 60 years, said Elbert S. Huang, MD, professor of medicine and public health sciences at the University of Chicago.
Overall, diabetes accounted for 11.8% of total global deaths in people younger than 60 years, but that varied widely, from 24.5% in the Middle East/North Africa to just 6.9% in Southeast Asia.
The regions with the highest number of diabetes-related deaths in people younger than 60 years in 2021 were the Western Pacific and the Middle East/North Africa, a major change from just 2 years ago, when Southeast Asia and Africa saw the greatest numbers of diabetes-related deaths in working-age adults.
“These findings mirror recent reports on inadequate uptake of diabetes prevention programs as well as stagnant quality of care trends for the past decade and reemphasize the need to address noncommunicable diseases across the globe,” Dr. Huang said.
Diabetes and COVID-19: Other factors partly explain the increased risk
Gillian Booth, MD, summarized the current literature on COVID-19 and diabetes including a meta-analysis her group conducted of 300 studies from around the world, with 58% from high-income countries.
The risk for increased COVID-19 severity in people with diabetes could be at least partly explained by factors such as age, sex, and comorbidities, said Dr. Booth, professor in the department of medicine and the Institute of Health Policy, Management, and Evaluation at the University of Toronto.
For example, the unadjusted pooled odds of hospitalization with COVID-19 in patients with diabetes, compared with those without diabetes, was 3.69, but dropped to 1.73 after adjustment for age, sex, and having one or more comorbidities. For COVID-19–related death, those odds ratios were 2.32 unadjusted versus 1.59 adjusted. In both cases, the values were still significant after adjustment, she emphasized.
Overall, hyperglycemia and hemoglobin A1c at admission emerged as significant independent predictors of severe outcomes.
“Further research is needed to understand the interplay between COVID-19 and diabetes and how best to address the disproportionate burden of COVID-19 among people living with diabetes,” she stressed.
Adult-onset type 1 diabetes: Growing recognition of the burden
Ascertainment of data for both adult-onset type 1 and type 2 diabetes in youth was subject to significant limitations.
For adult-onset type 1 diabetes, Jessica Harding, PhD, pointed to the fact that the epidemiology of adult-onset type 1 diabetes hasn’t been well characterized because of the historical focus on children, the difficulty of distinguishing it from type 2 diabetes in adults, and that many registries simply don’t include incident data across the lifespan for type 1 diabetes.
Nonetheless, she said, “there is growing recognition of the burden of adult-onset type 1,” noting that the American Diabetes Association and European Association for the Study of Diabetes just published a consensus statement addressing the topic.
A systematic review of 46 studies representing 32 countries or regions revealed that countries with the highest incidence of type 1 diabetes onset per population of 100,000 ages 20 or above were Eritrea, at 46.2, followed by Sweden and Ireland, both at 30.6, and Finland, at 0. The lowest rates were in Asian countries.
While the Nordic countries (Finland, Sweden, and Norway) are among the top for incidence of both childhood-onset (0-14 years) and adult-onset type 1 diabetes, Eritrea isn’t even among the top 10 for childhood onset.
The unusual situation in Eritrea is the subject of current study but the reasons aren’t yet clear, noted Dr. Magliano, of Emory University, Atlanta, during the question-and-answer period.
And only seven studies, 15%, used biomarkers to determine type 1 diabetes status, suggesting “there is a pressing need to improve the quality and quantity of information on adult-onset type 1 diabetes, particularly in those low- and middle-income countries,” Dr. Harding said.
Type 2 diabetes in youth: A call for better data
When presenting the data for childhood-onset type 2 diabetes, Andrea Luk, MD, noted: “The onset of advanced complications during the most productive time of life has significant impact on individuals, communities, and health economies.”
In 19 studies, the highest reported prevalence of type 2 diabetes in youth was in Brazil, Mexico, indigenous populations of the United States and Canada, and the Black population in the United States, with rates ranging from 160 per 100,000 to 3300 per 100,000. The lowest prevalence rates of 0.6 per 100,000 to 2.7 per 100,000 were reported in Europe. Incidence data were similar, with the highest rates from 31 per 100,000 to 94 per 100,000 and the lowest 0.1 per 100,000 to 0.8 per 100,000 per year.
Of note, Dr. Luk pointed out that childhood obesity is an important factor but not the only one.
“Some populations that have a low prevalence of obesity, such as East Asians, reported higher incidence rates of youth-onset type 2 diabetes than populations with a greater burden of childhood obesity.”
There was variability in incidence rates for youth of similar ethnic background but from different countries. “Apart from genetic predisposition and background obesogenic environment, disparity in socioeconomic status, access to health care, and cultural practices are other contributors to differences in risk of type 2 diabetes in youth,” noted Dr. Luk, associate professor in the division of endocrinology, Department of Medicine and Therapeutics, Chinese University of Hong Kong.
She also noted that the incidence of type 2 diabetes was extremely low in prepubertal children and rises gradually during puberty, and that the incidence is higher in girls than boys but that reverses in adulthood.
Compared with adults with type 2 diabetes, youth with type 2 diabetes had a more adverse glycemic trajectory and higher rates of metformin failure.
And compared with youth with type 1 diabetes, those with type 2 diabetes had more adverse metabolic profiles and higher rates of vascular complications.
“A strong call must be made for the collection of trend data to assess global burden of type 2 diabetes in youth,” she concluded.
Dr. Luk reported serving as an advisory panel member for and/or receiving research support from Amgen, AstraZeneca, Boehringer Ingelheim, Sanofi, the Asia Diabetes Foundation, Bayer, Lee’s Pharmaceutical, MSD, Novo Nordisk, Roche, Sugardown, and Takeda. The other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One in 10 adults worldwide currently has diabetes, accounting for an estimated global health expenditure of $966 billion in U.S. dollars in 2021, according to the new International Diabetes Federation Diabetes Atlas.
The IDF Atlas, 10th edition, was published online Dec. 6, 2021.
Highlights from it were presented during two sessions at the IDF Virtual Congress 2021, covering global diabetes incidence and prevalence, mortality, and costs, as well as new sections in this edition devoted to adult-onset type 1 diabetes, childhood-onset type 2 diabetes, and the interactions between diabetes and COVID-19.
More detailed data from some of the Atlas chapters were also published Dec. 6, 2021, in separate papers in the IDF journal Diabetes Research and Clinical Practice, with more publications planned.
Information for the Atlas comes from peer-reviewed literature, unpublished reports, and national registries. This latest edition includes 219 data sources from 144 countries, with figures for other countries extrapolated.
Atlas cochair Dianna Magliano, PhD, reviewed some of the highlights. Half of those currently with diabetes, or about 240 million adults, are undiagnosed, and another 319 million have impaired fasting glucose. Over three-quarters of all adults with diabetes now live in low- and middle-income countries. And about 6.7 million deaths in 2021 can be attributed to diabetes.
The Atlas also predicts increases in these numbers over the coming decades if current trends continue.
“Our data and projections tell a sobering story. Diabetes prevalence is expected to increase globally. The number of adults with diabetes will rise from 537 million in 2021 to 786 million ... by the year 2045, an increase of 46%. Rises are expected in every region of the world, with the largest increases expected to occur in the regions of Africa, the Middle East, and Southeast Asia,” said Dr. Magliano, head of diabetes and population health at the Baker Heart and Diabetes Institute, Melbourne.
Since 2019, when the last Atlas was published, the 2021 numbers represent increases of 73.6 million more adults with diabetes including 7.8 million more undiagnosed, 2.5 million more deaths attributed to diabetes, and an additional global expenditure of $206 billion.
Increases have also occurred in the number of people with prediabetes, children with type 1 diabetes, and pregnancies affected by diabetes, Dr. Magliano reported.
“There is a strong need for effective intervention strategies and policies to stall the increase in the number of people developing diabetes across the world,” she added.
Projected rise in expenditures for diabetes will be ‘unsustainable’
The current $966 billion global health expenditure caused by diabetes represents a 316% increase from the $232 billion reported in 2006, according to William H. Herman, MD, professor of internal medicine and epidemiology at the University of Michigan, Ann Arbor.
By region, 43% of current diabetes-related global expenditures are in North America, 25% in the Western Pacific, and 20% in Europe, while 12% are from the regions of South and Central America, North Africa, Africa, and Southeast Asia combined, Herman said.
The direct costs of diabetes are projected to grow to $1054 billion in 2045, an increase of just 9% over 25 years. The reason for the far lower increase going forward, compared with the tripling in the 15 years prior, is because of the anticipated diabetes rise in regions of the world where per-person spending on diabetes is low, a situation Dr. Herman called “unsustainable.”
“The keys to controlling the global costs of diabetes care are diabetes prevention and providing effective care to the largest number of people at the lowest possible cost,” he said.
Diabetes-related mortality: Some shifts since 2019
One third of the current 6.7 million diabetes-related deaths in 2021 were in people younger than 60 years, said Elbert S. Huang, MD, professor of medicine and public health sciences at the University of Chicago.
Overall, diabetes accounted for 11.8% of total global deaths in people younger than 60 years, but that varied widely, from 24.5% in the Middle East/North Africa to just 6.9% in Southeast Asia.
The regions with the highest number of diabetes-related deaths in people younger than 60 years in 2021 were the Western Pacific and the Middle East/North Africa, a major change from just 2 years ago, when Southeast Asia and Africa saw the greatest numbers of diabetes-related deaths in working-age adults.
“These findings mirror recent reports on inadequate uptake of diabetes prevention programs as well as stagnant quality of care trends for the past decade and reemphasize the need to address noncommunicable diseases across the globe,” Dr. Huang said.
Diabetes and COVID-19: Other factors partly explain the increased risk
Gillian Booth, MD, summarized the current literature on COVID-19 and diabetes including a meta-analysis her group conducted of 300 studies from around the world, with 58% from high-income countries.
The risk for increased COVID-19 severity in people with diabetes could be at least partly explained by factors such as age, sex, and comorbidities, said Dr. Booth, professor in the department of medicine and the Institute of Health Policy, Management, and Evaluation at the University of Toronto.
For example, the unadjusted pooled odds of hospitalization with COVID-19 in patients with diabetes, compared with those without diabetes, was 3.69, but dropped to 1.73 after adjustment for age, sex, and having one or more comorbidities. For COVID-19–related death, those odds ratios were 2.32 unadjusted versus 1.59 adjusted. In both cases, the values were still significant after adjustment, she emphasized.
Overall, hyperglycemia and hemoglobin A1c at admission emerged as significant independent predictors of severe outcomes.
“Further research is needed to understand the interplay between COVID-19 and diabetes and how best to address the disproportionate burden of COVID-19 among people living with diabetes,” she stressed.
Adult-onset type 1 diabetes: Growing recognition of the burden
Ascertainment of data for both adult-onset type 1 and type 2 diabetes in youth was subject to significant limitations.
For adult-onset type 1 diabetes, Jessica Harding, PhD, pointed to the fact that the epidemiology of adult-onset type 1 diabetes hasn’t been well characterized because of the historical focus on children, the difficulty of distinguishing it from type 2 diabetes in adults, and that many registries simply don’t include incident data across the lifespan for type 1 diabetes.
Nonetheless, she said, “there is growing recognition of the burden of adult-onset type 1,” noting that the American Diabetes Association and European Association for the Study of Diabetes just published a consensus statement addressing the topic.
A systematic review of 46 studies representing 32 countries or regions revealed that countries with the highest incidence of type 1 diabetes onset per population of 100,000 ages 20 or above were Eritrea, at 46.2, followed by Sweden and Ireland, both at 30.6, and Finland, at 0. The lowest rates were in Asian countries.
While the Nordic countries (Finland, Sweden, and Norway) are among the top for incidence of both childhood-onset (0-14 years) and adult-onset type 1 diabetes, Eritrea isn’t even among the top 10 for childhood onset.
The unusual situation in Eritrea is the subject of current study but the reasons aren’t yet clear, noted Dr. Magliano, of Emory University, Atlanta, during the question-and-answer period.
And only seven studies, 15%, used biomarkers to determine type 1 diabetes status, suggesting “there is a pressing need to improve the quality and quantity of information on adult-onset type 1 diabetes, particularly in those low- and middle-income countries,” Dr. Harding said.
Type 2 diabetes in youth: A call for better data
When presenting the data for childhood-onset type 2 diabetes, Andrea Luk, MD, noted: “The onset of advanced complications during the most productive time of life has significant impact on individuals, communities, and health economies.”
In 19 studies, the highest reported prevalence of type 2 diabetes in youth was in Brazil, Mexico, indigenous populations of the United States and Canada, and the Black population in the United States, with rates ranging from 160 per 100,000 to 3300 per 100,000. The lowest prevalence rates of 0.6 per 100,000 to 2.7 per 100,000 were reported in Europe. Incidence data were similar, with the highest rates from 31 per 100,000 to 94 per 100,000 and the lowest 0.1 per 100,000 to 0.8 per 100,000 per year.
Of note, Dr. Luk pointed out that childhood obesity is an important factor but not the only one.
“Some populations that have a low prevalence of obesity, such as East Asians, reported higher incidence rates of youth-onset type 2 diabetes than populations with a greater burden of childhood obesity.”
There was variability in incidence rates for youth of similar ethnic background but from different countries. “Apart from genetic predisposition and background obesogenic environment, disparity in socioeconomic status, access to health care, and cultural practices are other contributors to differences in risk of type 2 diabetes in youth,” noted Dr. Luk, associate professor in the division of endocrinology, Department of Medicine and Therapeutics, Chinese University of Hong Kong.
She also noted that the incidence of type 2 diabetes was extremely low in prepubertal children and rises gradually during puberty, and that the incidence is higher in girls than boys but that reverses in adulthood.
Compared with adults with type 2 diabetes, youth with type 2 diabetes had a more adverse glycemic trajectory and higher rates of metformin failure.
And compared with youth with type 1 diabetes, those with type 2 diabetes had more adverse metabolic profiles and higher rates of vascular complications.
“A strong call must be made for the collection of trend data to assess global burden of type 2 diabetes in youth,” she concluded.
Dr. Luk reported serving as an advisory panel member for and/or receiving research support from Amgen, AstraZeneca, Boehringer Ingelheim, Sanofi, the Asia Diabetes Foundation, Bayer, Lee’s Pharmaceutical, MSD, Novo Nordisk, Roche, Sugardown, and Takeda. The other authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Risk for severe COVID-19 and death plummets with Pfizer booster
Both studies were completed before the advent of the Omicron variant.
In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.
This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).
The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).
Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).
Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.
In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.
The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
Death risk down by 90%
A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.
Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.
The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.
The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.
The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”
The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.
None of the authors involved in both studies reported relevant financial relationships.
A version of this article first appeared on Medscape.com.
Both studies were completed before the advent of the Omicron variant.
In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.
This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).
The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).
Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).
Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.
In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.
The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
Death risk down by 90%
A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.
Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.
The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.
The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.
The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”
The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.
None of the authors involved in both studies reported relevant financial relationships.
A version of this article first appeared on Medscape.com.
Both studies were completed before the advent of the Omicron variant.
In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.
This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).
The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).
Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).
Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.
In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.
The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
Death risk down by 90%
A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.
Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.
The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.
The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.
The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”
The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.
None of the authors involved in both studies reported relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Dracunculiasis – guinea worm disease – is close to eradication. But will we ever reach the finish line?
When in 1988 former U.S. President Jimmy Carter toured Denchira and Elevanyo, two villages near Accra, Ghana, he noticed a young woman who appeared to be cradling a baby. Carter approached her for a chat, but was stopped in his tracks by a disquieting sight.
“It was not a baby. It was her right breast, which was about a foot long, and it had a guinea worm coming out of its nipple,” Mr. Carter later recalled. During his tour of Ghana that year, Mr. Carter saw hundreds of people affected by the guinea worm, an infection known as dracunculiasis – a disease caused by the nematode parasite Dracunculus medinensis. It’s a condition that can cause fever, severe pain, and even permanent damage to affected limbs.
In the late 1980s the country reported as many as 180,000 cases of guinea worm disease per year. Across the globe, that number was a staggering 3.5 million. However, by 2020, the world was down to just 27 cases, all of them in Africa.
This enormous reduction in prevalence is a direct effect of campaigns by endemic countries assisted by organizations such as the Centers for Disease Control and Prevention, the World Health Organization, and the Carter Center (a not-for-profit founded in 1982 by Jimmy Carter), which have strived since the 1980s to eradicate dracunculiasis, hoping to make it the second human disease purposefully wiped off the face of Earth. (Smallpox was the first.)
“That’s an extraordinary public health achievement,” David Molyneux, PhD, parasitologist at the Liverpool School of Tropical Medicine, said in an interview. Yet the eradication goal, currently set for 2030, seems unlikely to be met. What’s more, some experts argue that chasing eradication may be altogether a misguided idea.
Humanity has known dracunculiasis for millennia. Well-preserved specimens of Dracunculus medinensis were discovered in Egyptian mummies, while some researchers claim that the Old Testament’s “fiery serpents” that descended upon the Israelites near the Red Sea were in fact guinea worms, as the parasite was endemic to the area in the past. Even the serpent coiled around the staff of Asclepius, the god of medicine, might have been a guinea worm, according to some historians.
This would make sense considering how the disease is treated. When an adult worm emerges through the skin, a painful and crippling occurrence, it is wound up around a stick or a piece of gauze, a little at a time, to slowly draw it out of the skin. As the worm can be over 3 feet long, this procedure may take weeks. What you end up with is a stick with a long, snake-like animal coiled around it. Asclepius’s staff.
The first step in the infection is when a person drinks water contaminated with copepods, or water fleas, which contain the larvae of Dracunculus medinensis. Next, the larvae are freed in the stomach and start migrating through the body, looking to mate. The fertilized female worm is the one that causes the debilitating symptoms.
About a year after the initial infection, the pregnant female worm looks for exit points from the body, usually through legs or feet, ready to release new larvae. If the unlucky sufferer steps into a pond or a river, the immature larvae escape into the water, where they are eaten by water fleas. “People are fetching water to drink, and they walk into the water thinking they can get cleaner water not along the edge,” Adam Weiss, MPH, director of the Carter Center’s Guinea Worm Eradication Program, said in an interview. The vicious cycle begins anew.
Dracunculiasis may not be a killer disease, but it is painful and disabling. A study on school attendance in Nigeria showed that in 1995 when guinea worm infection prevalence among schoolchildren was as high as 27.7%, it was responsible for almost all school absences. As the result of the infection, children were seen wandering and sitting around the village helplessly. If it was the parents who got infected, children stayed out of school to help around the home. The dracunculiasis’ impact on work and earning capacity is so profound, in fact, that in Mali the infliction is known as “the disease of the empty granary.”
When in 1986 the Carter Center took the reins of the global dracunculiasis eradication campaign, India was the only country with a national program to get rid of the disease. Yet, once other nations joined the struggle, the results rapidly became visible. By 1993, the American Journal of Tropical Medicine and Hygiene published a paper titled, “Dracunculiasis Eradication: Beginning of the End.” The cases plummeted from 3.5 million in 1986 to 221,000 in 1993 and 32,000 in 2003, then to a mere 22 cases in 2015. What worked was a combination of surveillance, education campaigns, safe water provision, and treating potentially contaminated water with a chemical called Abate, a potent larvicide.
Today, many endemic countries, from Chad and Ethiopia to Mali and South Sudan, follow similar procedures. First and foremost is the supply of clean drinking water. However, Mr. Weiss said, this is not a “silver bullet, given how people live.” Those who are seminomadic or otherwise take care of livestock often fetch water outside of the village, from ponds or rivers. This is why dracunculiasis eradication programs include handing out portable water filters, which can be worn around the neck.
But if you don’t know why you should filter water, in all likelihood you won’t do it – cloth filters distributed for home water purification sometimes ended up as decorations or sewn into wedding dresses. That’s why education is key, too. Poster campaigns, comic books, radio broadcasts, instructions by volunteers, even t-shirts with health messages slowly but surely did change behaviors.
Cash rewards for reporting cases of dracunculiasis, which can be as high as $100, also work well to boost surveillance systems. Once a case is identified, patients may be moved to a containment center, both to treat the wound and to prevent patients from spreading the disease. Local water sources, meanwhile, may be sprayed with Abate.
1995 was the first year set as a target date for the eradication of dracunculiasis. Yet the goal wasn’t met – even though the total number of cases did decline by 97%. Next goals followed: 2009, 2020, and now, finally, 2030. For well over a decade now the world has been down to a trickle of cases per year, but the numbers don’t seem to want to budge lower. Mr. Weiss calls it a “limbo period” – we are almost there, but not quite. The final push, it seems, may be the one that’s the most difficult, especially now that we have two further complications: increasing conflicts in some endemic areas and zoonotic transmission.
According to WHO, in places like the Democratic Republic of the Congo, Mali, South Sudan, and Sudan, insecurity “hinders eradication efforts.” Not only does this insecurity make it difficult for health workers to reach endemic areas, but wars and violence also displace people, pushing those infected with guinea worm to walk far distances in search of safety, and spreading the disease during their travels. Case containment and contact tracing become challenging. A recent study by Dr. Molyneux and colleagues showed that, in the 3 years since 2018, conflicts in the endemic areas have increased dramatically.
And then there are the animals. Up until 2012, eradication of guinea worm seemed fairly simple, at least from a biological perspective: Stop infected humans from contaminating drinking water and the parasites won’t be able to continue their life cycle. But in 2012, news came from Chad that a significant number of local dogs were found infected with the Dracunculus medinensis parasite, the very same one that attacks humans. In 2020, close to 1,600 dogs were reported to be infected with guinea worm, most of them in Chad. This left scientists scratching their heads: Dracunculiasis was supposed to be a purely human infliction. How were the dogs getting infected? Did the parasite jump to a new species because we were so efficient at eliminating it from humans?
“I have first seen a guinea worm transmission in dogs back in 2003,” Teshome Gebre, PhD, said in an interview. Dr. Gebre is regional director for Africa at International Trachoma Initiative and has spent more than 40 years fighting to eradicate various diseases, including smallpox and guinea worm. Yet in 2003, Dr. Gebre’s report was dismissed: it couldn’t have been the same species of the parasite, the reasoning went, since Dracunculus medinensis was exclusive to humans.
“I think it’s fair to say that there were infections in dogs before 2012. I find it difficult to believe, logically, that it just came out of nowhere,” Mr. Weiss said. A 2018 genetic study showed that a novel host switch is an unlikely scenario – the parasites must have been infecting dogs in the past, we just haven’t been looking. By 2012, Chad had a very efficient guinea worm surveillance system, with generous cash rewards for human cases, and people started reporting the dogs, too. Soon money was also offered for news on infected animals, and the cases exploded. This was then followed by accounts of afflicted cats and baboons.
To announce the eradication of dracunculiasis in 2030, the requirement will be no more transmission of the parasite for at least 4 years prior anywhere in the world – not only zero human cases, but also no infections in dogs, cats, or baboons. Seven countries remain to be certified as guinea worm free, all of them in Africa. “We have to be a 100% sure that there is no transmission of the parasite in a country,” said Dr. Molyneux, who participated in country certification teams – a rigorous process to validate country reports. He believes that the presence of animal hosts as well as growing insecurities in the region make such certification extremely challenging over the next few years.
“Eradication as it is defined does not seem feasible by 2030 as things stand, [considering] political and resource constraints, the unknowns of the ecology of dogs, and the possible impact of climate change and geopolitical instability and with countries having other health priorities, including COVID,” Dr. Molyneux said.
For Mr. Weiss, dogs are not that much of a problem – since they can be tethered to prevent the spread of the disease. But you can’t tether baboons. “That does raise that more existential threat–related question of: Is this scientifically possible?” he said. Mr. Weiss and colleagues at the Centers for Disease Control and Prevention are currently working on a serologic assay to test whether baboons are important for human transmission.
For some experts, such as Dr. Gebre, the current struggles to bring cases down to zero put a spotlight on a bigger question: is it worthwhile to strive for eradication at all? That last stretch of the eradication campaign can appear a bit like a game of whack-a-mole. “There were times when we’ve achieved zero cases [in Ethiopia]. Zero. And then, it just reemerges,” Dr. Gebre said. Programs aimed at certification are costly, running up to $1.6 million per year in Nigeria. The funds often come from the same donor pockets that pay for the fight against malaria, HIV, polio, as well as other neglected tropical diseases. Dr. Gebre believed it would be more cost and time efficient to switch the effort from total eradication to elimination as a public health care problem.
Of course, there is the risk that the cases would go up again once we ease up on the pressure to eradicate dracunculiasis. “Do we want to be fighting guinea worm in perpetuity?” Mr. Weiss asked. However, Dr. Gebre believed the cases are unlikely to explode anymore.
“The situation in the countries is not the way it was 30 years ago,” Dr. Gebre said, pointing out increased awareness, higher education levels, and better community-based health facilities. “You can cap it around a trickle number of cases a year – 10, 15, 20 maybe.”
The keys, Dr. Gebre and Dr. Molyneux both said, include the provision of safe drinking water and strengthening the healthcare systems of endemic countries in general, so they can deal with whatever cases may come up. “Water, sanitation, surveillance, good public education – and the maintenance of the guinea worm–specific reward system to maintain awareness, as well as continuing research” are all needed, Dr. Molyneux said.
Getting out of the dracunculiasis limbo period won’t be easy. We certainly need more data on animal transmission to better understand what challenges we might be facing. The experts agree that what’s important is to follow the science and stay flexible. “We have made an incredible progress, our investment has been worthwhile,” Dr. Molyneux said. But “you have to adapt to the changing realities.”
Dr. Gebre received no financial support for the review article and has no other conflicts of interest to declare. Dr. Molyneux is a member of the WHO International Commission for the Certification of Dracunculus Eradication, an independent body appointed by the director general of WHO. He acts as a rapporteur for the ICCDE as a paid consultant. He declared he does not receive any financial support for other related activities. Mr. Weiss receives support from the nonprofit Carter Center.
A version of this article first appeared on Medscape.com.
When in 1988 former U.S. President Jimmy Carter toured Denchira and Elevanyo, two villages near Accra, Ghana, he noticed a young woman who appeared to be cradling a baby. Carter approached her for a chat, but was stopped in his tracks by a disquieting sight.
“It was not a baby. It was her right breast, which was about a foot long, and it had a guinea worm coming out of its nipple,” Mr. Carter later recalled. During his tour of Ghana that year, Mr. Carter saw hundreds of people affected by the guinea worm, an infection known as dracunculiasis – a disease caused by the nematode parasite Dracunculus medinensis. It’s a condition that can cause fever, severe pain, and even permanent damage to affected limbs.
In the late 1980s the country reported as many as 180,000 cases of guinea worm disease per year. Across the globe, that number was a staggering 3.5 million. However, by 2020, the world was down to just 27 cases, all of them in Africa.
This enormous reduction in prevalence is a direct effect of campaigns by endemic countries assisted by organizations such as the Centers for Disease Control and Prevention, the World Health Organization, and the Carter Center (a not-for-profit founded in 1982 by Jimmy Carter), which have strived since the 1980s to eradicate dracunculiasis, hoping to make it the second human disease purposefully wiped off the face of Earth. (Smallpox was the first.)
“That’s an extraordinary public health achievement,” David Molyneux, PhD, parasitologist at the Liverpool School of Tropical Medicine, said in an interview. Yet the eradication goal, currently set for 2030, seems unlikely to be met. What’s more, some experts argue that chasing eradication may be altogether a misguided idea.
Humanity has known dracunculiasis for millennia. Well-preserved specimens of Dracunculus medinensis were discovered in Egyptian mummies, while some researchers claim that the Old Testament’s “fiery serpents” that descended upon the Israelites near the Red Sea were in fact guinea worms, as the parasite was endemic to the area in the past. Even the serpent coiled around the staff of Asclepius, the god of medicine, might have been a guinea worm, according to some historians.
This would make sense considering how the disease is treated. When an adult worm emerges through the skin, a painful and crippling occurrence, it is wound up around a stick or a piece of gauze, a little at a time, to slowly draw it out of the skin. As the worm can be over 3 feet long, this procedure may take weeks. What you end up with is a stick with a long, snake-like animal coiled around it. Asclepius’s staff.
The first step in the infection is when a person drinks water contaminated with copepods, or water fleas, which contain the larvae of Dracunculus medinensis. Next, the larvae are freed in the stomach and start migrating through the body, looking to mate. The fertilized female worm is the one that causes the debilitating symptoms.
About a year after the initial infection, the pregnant female worm looks for exit points from the body, usually through legs or feet, ready to release new larvae. If the unlucky sufferer steps into a pond or a river, the immature larvae escape into the water, where they are eaten by water fleas. “People are fetching water to drink, and they walk into the water thinking they can get cleaner water not along the edge,” Adam Weiss, MPH, director of the Carter Center’s Guinea Worm Eradication Program, said in an interview. The vicious cycle begins anew.
Dracunculiasis may not be a killer disease, but it is painful and disabling. A study on school attendance in Nigeria showed that in 1995 when guinea worm infection prevalence among schoolchildren was as high as 27.7%, it was responsible for almost all school absences. As the result of the infection, children were seen wandering and sitting around the village helplessly. If it was the parents who got infected, children stayed out of school to help around the home. The dracunculiasis’ impact on work and earning capacity is so profound, in fact, that in Mali the infliction is known as “the disease of the empty granary.”
When in 1986 the Carter Center took the reins of the global dracunculiasis eradication campaign, India was the only country with a national program to get rid of the disease. Yet, once other nations joined the struggle, the results rapidly became visible. By 1993, the American Journal of Tropical Medicine and Hygiene published a paper titled, “Dracunculiasis Eradication: Beginning of the End.” The cases plummeted from 3.5 million in 1986 to 221,000 in 1993 and 32,000 in 2003, then to a mere 22 cases in 2015. What worked was a combination of surveillance, education campaigns, safe water provision, and treating potentially contaminated water with a chemical called Abate, a potent larvicide.
Today, many endemic countries, from Chad and Ethiopia to Mali and South Sudan, follow similar procedures. First and foremost is the supply of clean drinking water. However, Mr. Weiss said, this is not a “silver bullet, given how people live.” Those who are seminomadic or otherwise take care of livestock often fetch water outside of the village, from ponds or rivers. This is why dracunculiasis eradication programs include handing out portable water filters, which can be worn around the neck.
But if you don’t know why you should filter water, in all likelihood you won’t do it – cloth filters distributed for home water purification sometimes ended up as decorations or sewn into wedding dresses. That’s why education is key, too. Poster campaigns, comic books, radio broadcasts, instructions by volunteers, even t-shirts with health messages slowly but surely did change behaviors.
Cash rewards for reporting cases of dracunculiasis, which can be as high as $100, also work well to boost surveillance systems. Once a case is identified, patients may be moved to a containment center, both to treat the wound and to prevent patients from spreading the disease. Local water sources, meanwhile, may be sprayed with Abate.
1995 was the first year set as a target date for the eradication of dracunculiasis. Yet the goal wasn’t met – even though the total number of cases did decline by 97%. Next goals followed: 2009, 2020, and now, finally, 2030. For well over a decade now the world has been down to a trickle of cases per year, but the numbers don’t seem to want to budge lower. Mr. Weiss calls it a “limbo period” – we are almost there, but not quite. The final push, it seems, may be the one that’s the most difficult, especially now that we have two further complications: increasing conflicts in some endemic areas and zoonotic transmission.
According to WHO, in places like the Democratic Republic of the Congo, Mali, South Sudan, and Sudan, insecurity “hinders eradication efforts.” Not only does this insecurity make it difficult for health workers to reach endemic areas, but wars and violence also displace people, pushing those infected with guinea worm to walk far distances in search of safety, and spreading the disease during their travels. Case containment and contact tracing become challenging. A recent study by Dr. Molyneux and colleagues showed that, in the 3 years since 2018, conflicts in the endemic areas have increased dramatically.
And then there are the animals. Up until 2012, eradication of guinea worm seemed fairly simple, at least from a biological perspective: Stop infected humans from contaminating drinking water and the parasites won’t be able to continue their life cycle. But in 2012, news came from Chad that a significant number of local dogs were found infected with the Dracunculus medinensis parasite, the very same one that attacks humans. In 2020, close to 1,600 dogs were reported to be infected with guinea worm, most of them in Chad. This left scientists scratching their heads: Dracunculiasis was supposed to be a purely human infliction. How were the dogs getting infected? Did the parasite jump to a new species because we were so efficient at eliminating it from humans?
“I have first seen a guinea worm transmission in dogs back in 2003,” Teshome Gebre, PhD, said in an interview. Dr. Gebre is regional director for Africa at International Trachoma Initiative and has spent more than 40 years fighting to eradicate various diseases, including smallpox and guinea worm. Yet in 2003, Dr. Gebre’s report was dismissed: it couldn’t have been the same species of the parasite, the reasoning went, since Dracunculus medinensis was exclusive to humans.
“I think it’s fair to say that there were infections in dogs before 2012. I find it difficult to believe, logically, that it just came out of nowhere,” Mr. Weiss said. A 2018 genetic study showed that a novel host switch is an unlikely scenario – the parasites must have been infecting dogs in the past, we just haven’t been looking. By 2012, Chad had a very efficient guinea worm surveillance system, with generous cash rewards for human cases, and people started reporting the dogs, too. Soon money was also offered for news on infected animals, and the cases exploded. This was then followed by accounts of afflicted cats and baboons.
To announce the eradication of dracunculiasis in 2030, the requirement will be no more transmission of the parasite for at least 4 years prior anywhere in the world – not only zero human cases, but also no infections in dogs, cats, or baboons. Seven countries remain to be certified as guinea worm free, all of them in Africa. “We have to be a 100% sure that there is no transmission of the parasite in a country,” said Dr. Molyneux, who participated in country certification teams – a rigorous process to validate country reports. He believes that the presence of animal hosts as well as growing insecurities in the region make such certification extremely challenging over the next few years.
“Eradication as it is defined does not seem feasible by 2030 as things stand, [considering] political and resource constraints, the unknowns of the ecology of dogs, and the possible impact of climate change and geopolitical instability and with countries having other health priorities, including COVID,” Dr. Molyneux said.
For Mr. Weiss, dogs are not that much of a problem – since they can be tethered to prevent the spread of the disease. But you can’t tether baboons. “That does raise that more existential threat–related question of: Is this scientifically possible?” he said. Mr. Weiss and colleagues at the Centers for Disease Control and Prevention are currently working on a serologic assay to test whether baboons are important for human transmission.
For some experts, such as Dr. Gebre, the current struggles to bring cases down to zero put a spotlight on a bigger question: is it worthwhile to strive for eradication at all? That last stretch of the eradication campaign can appear a bit like a game of whack-a-mole. “There were times when we’ve achieved zero cases [in Ethiopia]. Zero. And then, it just reemerges,” Dr. Gebre said. Programs aimed at certification are costly, running up to $1.6 million per year in Nigeria. The funds often come from the same donor pockets that pay for the fight against malaria, HIV, polio, as well as other neglected tropical diseases. Dr. Gebre believed it would be more cost and time efficient to switch the effort from total eradication to elimination as a public health care problem.
Of course, there is the risk that the cases would go up again once we ease up on the pressure to eradicate dracunculiasis. “Do we want to be fighting guinea worm in perpetuity?” Mr. Weiss asked. However, Dr. Gebre believed the cases are unlikely to explode anymore.
“The situation in the countries is not the way it was 30 years ago,” Dr. Gebre said, pointing out increased awareness, higher education levels, and better community-based health facilities. “You can cap it around a trickle number of cases a year – 10, 15, 20 maybe.”
The keys, Dr. Gebre and Dr. Molyneux both said, include the provision of safe drinking water and strengthening the healthcare systems of endemic countries in general, so they can deal with whatever cases may come up. “Water, sanitation, surveillance, good public education – and the maintenance of the guinea worm–specific reward system to maintain awareness, as well as continuing research” are all needed, Dr. Molyneux said.
Getting out of the dracunculiasis limbo period won’t be easy. We certainly need more data on animal transmission to better understand what challenges we might be facing. The experts agree that what’s important is to follow the science and stay flexible. “We have made an incredible progress, our investment has been worthwhile,” Dr. Molyneux said. But “you have to adapt to the changing realities.”
Dr. Gebre received no financial support for the review article and has no other conflicts of interest to declare. Dr. Molyneux is a member of the WHO International Commission for the Certification of Dracunculus Eradication, an independent body appointed by the director general of WHO. He acts as a rapporteur for the ICCDE as a paid consultant. He declared he does not receive any financial support for other related activities. Mr. Weiss receives support from the nonprofit Carter Center.
A version of this article first appeared on Medscape.com.
When in 1988 former U.S. President Jimmy Carter toured Denchira and Elevanyo, two villages near Accra, Ghana, he noticed a young woman who appeared to be cradling a baby. Carter approached her for a chat, but was stopped in his tracks by a disquieting sight.
“It was not a baby. It was her right breast, which was about a foot long, and it had a guinea worm coming out of its nipple,” Mr. Carter later recalled. During his tour of Ghana that year, Mr. Carter saw hundreds of people affected by the guinea worm, an infection known as dracunculiasis – a disease caused by the nematode parasite Dracunculus medinensis. It’s a condition that can cause fever, severe pain, and even permanent damage to affected limbs.
In the late 1980s the country reported as many as 180,000 cases of guinea worm disease per year. Across the globe, that number was a staggering 3.5 million. However, by 2020, the world was down to just 27 cases, all of them in Africa.
This enormous reduction in prevalence is a direct effect of campaigns by endemic countries assisted by organizations such as the Centers for Disease Control and Prevention, the World Health Organization, and the Carter Center (a not-for-profit founded in 1982 by Jimmy Carter), which have strived since the 1980s to eradicate dracunculiasis, hoping to make it the second human disease purposefully wiped off the face of Earth. (Smallpox was the first.)
“That’s an extraordinary public health achievement,” David Molyneux, PhD, parasitologist at the Liverpool School of Tropical Medicine, said in an interview. Yet the eradication goal, currently set for 2030, seems unlikely to be met. What’s more, some experts argue that chasing eradication may be altogether a misguided idea.
Humanity has known dracunculiasis for millennia. Well-preserved specimens of Dracunculus medinensis were discovered in Egyptian mummies, while some researchers claim that the Old Testament’s “fiery serpents” that descended upon the Israelites near the Red Sea were in fact guinea worms, as the parasite was endemic to the area in the past. Even the serpent coiled around the staff of Asclepius, the god of medicine, might have been a guinea worm, according to some historians.
This would make sense considering how the disease is treated. When an adult worm emerges through the skin, a painful and crippling occurrence, it is wound up around a stick or a piece of gauze, a little at a time, to slowly draw it out of the skin. As the worm can be over 3 feet long, this procedure may take weeks. What you end up with is a stick with a long, snake-like animal coiled around it. Asclepius’s staff.
The first step in the infection is when a person drinks water contaminated with copepods, or water fleas, which contain the larvae of Dracunculus medinensis. Next, the larvae are freed in the stomach and start migrating through the body, looking to mate. The fertilized female worm is the one that causes the debilitating symptoms.
About a year after the initial infection, the pregnant female worm looks for exit points from the body, usually through legs or feet, ready to release new larvae. If the unlucky sufferer steps into a pond or a river, the immature larvae escape into the water, where they are eaten by water fleas. “People are fetching water to drink, and they walk into the water thinking they can get cleaner water not along the edge,” Adam Weiss, MPH, director of the Carter Center’s Guinea Worm Eradication Program, said in an interview. The vicious cycle begins anew.
Dracunculiasis may not be a killer disease, but it is painful and disabling. A study on school attendance in Nigeria showed that in 1995 when guinea worm infection prevalence among schoolchildren was as high as 27.7%, it was responsible for almost all school absences. As the result of the infection, children were seen wandering and sitting around the village helplessly. If it was the parents who got infected, children stayed out of school to help around the home. The dracunculiasis’ impact on work and earning capacity is so profound, in fact, that in Mali the infliction is known as “the disease of the empty granary.”
When in 1986 the Carter Center took the reins of the global dracunculiasis eradication campaign, India was the only country with a national program to get rid of the disease. Yet, once other nations joined the struggle, the results rapidly became visible. By 1993, the American Journal of Tropical Medicine and Hygiene published a paper titled, “Dracunculiasis Eradication: Beginning of the End.” The cases plummeted from 3.5 million in 1986 to 221,000 in 1993 and 32,000 in 2003, then to a mere 22 cases in 2015. What worked was a combination of surveillance, education campaigns, safe water provision, and treating potentially contaminated water with a chemical called Abate, a potent larvicide.
Today, many endemic countries, from Chad and Ethiopia to Mali and South Sudan, follow similar procedures. First and foremost is the supply of clean drinking water. However, Mr. Weiss said, this is not a “silver bullet, given how people live.” Those who are seminomadic or otherwise take care of livestock often fetch water outside of the village, from ponds or rivers. This is why dracunculiasis eradication programs include handing out portable water filters, which can be worn around the neck.
But if you don’t know why you should filter water, in all likelihood you won’t do it – cloth filters distributed for home water purification sometimes ended up as decorations or sewn into wedding dresses. That’s why education is key, too. Poster campaigns, comic books, radio broadcasts, instructions by volunteers, even t-shirts with health messages slowly but surely did change behaviors.
Cash rewards for reporting cases of dracunculiasis, which can be as high as $100, also work well to boost surveillance systems. Once a case is identified, patients may be moved to a containment center, both to treat the wound and to prevent patients from spreading the disease. Local water sources, meanwhile, may be sprayed with Abate.
1995 was the first year set as a target date for the eradication of dracunculiasis. Yet the goal wasn’t met – even though the total number of cases did decline by 97%. Next goals followed: 2009, 2020, and now, finally, 2030. For well over a decade now the world has been down to a trickle of cases per year, but the numbers don’t seem to want to budge lower. Mr. Weiss calls it a “limbo period” – we are almost there, but not quite. The final push, it seems, may be the one that’s the most difficult, especially now that we have two further complications: increasing conflicts in some endemic areas and zoonotic transmission.
According to WHO, in places like the Democratic Republic of the Congo, Mali, South Sudan, and Sudan, insecurity “hinders eradication efforts.” Not only does this insecurity make it difficult for health workers to reach endemic areas, but wars and violence also displace people, pushing those infected with guinea worm to walk far distances in search of safety, and spreading the disease during their travels. Case containment and contact tracing become challenging. A recent study by Dr. Molyneux and colleagues showed that, in the 3 years since 2018, conflicts in the endemic areas have increased dramatically.
And then there are the animals. Up until 2012, eradication of guinea worm seemed fairly simple, at least from a biological perspective: Stop infected humans from contaminating drinking water and the parasites won’t be able to continue their life cycle. But in 2012, news came from Chad that a significant number of local dogs were found infected with the Dracunculus medinensis parasite, the very same one that attacks humans. In 2020, close to 1,600 dogs were reported to be infected with guinea worm, most of them in Chad. This left scientists scratching their heads: Dracunculiasis was supposed to be a purely human infliction. How were the dogs getting infected? Did the parasite jump to a new species because we were so efficient at eliminating it from humans?
“I have first seen a guinea worm transmission in dogs back in 2003,” Teshome Gebre, PhD, said in an interview. Dr. Gebre is regional director for Africa at International Trachoma Initiative and has spent more than 40 years fighting to eradicate various diseases, including smallpox and guinea worm. Yet in 2003, Dr. Gebre’s report was dismissed: it couldn’t have been the same species of the parasite, the reasoning went, since Dracunculus medinensis was exclusive to humans.
“I think it’s fair to say that there were infections in dogs before 2012. I find it difficult to believe, logically, that it just came out of nowhere,” Mr. Weiss said. A 2018 genetic study showed that a novel host switch is an unlikely scenario – the parasites must have been infecting dogs in the past, we just haven’t been looking. By 2012, Chad had a very efficient guinea worm surveillance system, with generous cash rewards for human cases, and people started reporting the dogs, too. Soon money was also offered for news on infected animals, and the cases exploded. This was then followed by accounts of afflicted cats and baboons.
To announce the eradication of dracunculiasis in 2030, the requirement will be no more transmission of the parasite for at least 4 years prior anywhere in the world – not only zero human cases, but also no infections in dogs, cats, or baboons. Seven countries remain to be certified as guinea worm free, all of them in Africa. “We have to be a 100% sure that there is no transmission of the parasite in a country,” said Dr. Molyneux, who participated in country certification teams – a rigorous process to validate country reports. He believes that the presence of animal hosts as well as growing insecurities in the region make such certification extremely challenging over the next few years.
“Eradication as it is defined does not seem feasible by 2030 as things stand, [considering] political and resource constraints, the unknowns of the ecology of dogs, and the possible impact of climate change and geopolitical instability and with countries having other health priorities, including COVID,” Dr. Molyneux said.
For Mr. Weiss, dogs are not that much of a problem – since they can be tethered to prevent the spread of the disease. But you can’t tether baboons. “That does raise that more existential threat–related question of: Is this scientifically possible?” he said. Mr. Weiss and colleagues at the Centers for Disease Control and Prevention are currently working on a serologic assay to test whether baboons are important for human transmission.
For some experts, such as Dr. Gebre, the current struggles to bring cases down to zero put a spotlight on a bigger question: is it worthwhile to strive for eradication at all? That last stretch of the eradication campaign can appear a bit like a game of whack-a-mole. “There were times when we’ve achieved zero cases [in Ethiopia]. Zero. And then, it just reemerges,” Dr. Gebre said. Programs aimed at certification are costly, running up to $1.6 million per year in Nigeria. The funds often come from the same donor pockets that pay for the fight against malaria, HIV, polio, as well as other neglected tropical diseases. Dr. Gebre believed it would be more cost and time efficient to switch the effort from total eradication to elimination as a public health care problem.
Of course, there is the risk that the cases would go up again once we ease up on the pressure to eradicate dracunculiasis. “Do we want to be fighting guinea worm in perpetuity?” Mr. Weiss asked. However, Dr. Gebre believed the cases are unlikely to explode anymore.
“The situation in the countries is not the way it was 30 years ago,” Dr. Gebre said, pointing out increased awareness, higher education levels, and better community-based health facilities. “You can cap it around a trickle number of cases a year – 10, 15, 20 maybe.”
The keys, Dr. Gebre and Dr. Molyneux both said, include the provision of safe drinking water and strengthening the healthcare systems of endemic countries in general, so they can deal with whatever cases may come up. “Water, sanitation, surveillance, good public education – and the maintenance of the guinea worm–specific reward system to maintain awareness, as well as continuing research” are all needed, Dr. Molyneux said.
Getting out of the dracunculiasis limbo period won’t be easy. We certainly need more data on animal transmission to better understand what challenges we might be facing. The experts agree that what’s important is to follow the science and stay flexible. “We have made an incredible progress, our investment has been worthwhile,” Dr. Molyneux said. But “you have to adapt to the changing realities.”
Dr. Gebre received no financial support for the review article and has no other conflicts of interest to declare. Dr. Molyneux is a member of the WHO International Commission for the Certification of Dracunculus Eradication, an independent body appointed by the director general of WHO. He acts as a rapporteur for the ICCDE as a paid consultant. He declared he does not receive any financial support for other related activities. Mr. Weiss receives support from the nonprofit Carter Center.
A version of this article first appeared on Medscape.com.
Advocating for children’s health, one page at a time
Everyone can remember a book from their childhood that helped transform them, reinvent them, or turned the world on its head. Characters such as Harry Potter, Franklin the Turtle, Matilda, the Very Hungry Caterpillar, Corduroy, and Nancy Drew, among others, continue to exist in the cultural zeitgeist because they remind us of our childhood and the experience of discovering something innovative and exciting for the first time.
For many young children, introductions to these timeless characters first come from an adult reading to them. Those interactions, starting with watching mouths form words, to exploring pictures, to eventually reading along, leave a lasting impression. “Adults remember being read to,” says pediatrician Perri Klass, MD. “It’s a very powerful thing.”
Dr. Klass serves as national medical director of Reach Out and Read, a nonprofit organization that champions the positive effects of reading and other language-rich activities with young children.
And what better partners to involve in this mission than pediatricians? Before a child reaches the age of 4, the U.S. Department of Health and Human Services recommends that a child visit the pediatrician at least seven times. The Bright Futures/American Academy of Pediatrics suggests as many as 13 pediatrician visits before the child reaches that same milestone. Regardless of the exact number, almost all children are encountering a pediatrician multiple times during the most crucial years of their brain development.
In 1989, physicians Barry Zuckerman, MD, and Robert Needleman, MD, at Boston City Hospital (now Boston Medical Center) realized that they could reach a large population of children and parents, especially those coming from disadvantaged backgrounds, in the pediatrics ward of offices and hospitals all over the country.
The design of Reach Out and Read, the organization they founded, is to work with pediatricians in how they can best support parents in making reading to their children a part of their daily routine, advocating for the importance of books for children, and making sure that a child leaves the office with a book to take home.
Rather than just dumping books onto nervous or busy parents, the organization trains doctors on how to teach parents to read to their children: how to hold the books, how to make it as active as possible, how to point to the pictures and make them come to life, and how to make sure the child is grasping the language.
“You don’t just prop a baby up and read to them,” Dr. Klass told this news organization. “You have to make it interactive.”
Physician-driven success
Now an international organization, Dr. Klass has watched the nonprofit grow tremendously since it began during her fellowship in Boston over three decades ago. The initiative has over 6,100 sites in all 50 states and is able to get books into the hands of 4.2 million children every single year through government aid, individual contributions, and in-kind donations. On average, the organization is able to give parents 6.4 million books annually. Half of the children served every year by the program come from low-income backgrounds.
Dr. Klass ascribed some of the organization’s longevity and success to “practical realism,” its “mission-driven” approach, and its creation by people in primary care who understood the constraints, the upkeep, and the scaling.
“Our organization isn’t looking to pile 10 more things on to the hands of pediatricians who are already very busy,” she said. “We understand that conversation is important with our care providers. We always hear that watching children happily interacting with literature is one of the most rewarding parts of their job. So, we’re saying to them, ‘I want to help you do what you enjoy most.’”
Both Dr. Klass, who is also a presidential appointee to the Advisory Board of the National Institute For Literacy, and Brian Gallagher, MPA, the CEO of Reach Out and Read, said one of the most rewarding parts of their attachment to the organization is working with dedicated physicians all over the country.
“We hear all the time that physicians say working with these tools [from Reach Out and Read] is the most joyful part of their day,” said Mr. Gallagher. “Children are hope for the future and books help them grow.”
Amy Shriver, MD, an Iowa pediatrician and medical director of the Reach Out and Read Iowa Board, admitted that at first she just thought of the organization as a book drive. As Dr. Shriver got closer to the organization, though, she realized how she could utilize the book as a surveillance tool.
“At 6 months through 2 years, I hand the book to the patient, and I can always tell which children are familiar with books by their responses,” she said. After learning about and implementing Reach Out and Read’s ‘model, observe, coach’ methodology, Dr. Shriver said she was wowed by how much it helped families who weren’t reading to their child understand not only how to read with their children but why it’s so important.”
Dr. Shriver said that her clinic has purchased more diverse books to meet the needs of its patient population and has partnered with local libraries and a science center to promote early brain development. The biggest change is that Dr. Shriver finds herself spending more time observing and talking about parent/child relationships since starting with Reach Out and Read.
Mr. Gallagher attributed the organization’s success to the massive amounts of research that back up the practices of the organization. “Our model isn’t just a nice thing to do,” Mr. Gallagher said. “Our practice has been proven to be effective, and that’s why pediatricians continue to work with us. We’ve heard experts say that when they’re advocating for children’s health, they say ‘vaccines, sleep, and Reach Out and Read.’”
Nineteen independent studies have been done profiling the work of Reach Out and Read since its inception. The research has shown that exposure to the organization results in parents reading more often to their children, higher language scores, as well as an improvement in clinic culture and clinician well-being.
In 2014, the American Academy of Pediatrics quoted the research of Reach Out and Read in its policy statement “Literacy Promotion: An Essential Component of Primary Care Pediatric Practice,” which argued that pediatrics should advocate for literacy from birth. The abstract of the study suggests that practicing pediatricians “advise all parents that reading aloud with young children can enhance parent-child relationships and prepare young minds to learn language and early literacy skills ... provide developmentally appropriate books given at health supervision visits for all high-risk, low-income young children ... partnering with other child advocates to influence national messaging and policies that support and promote these key, early shared-reading experiences.”
Adapting to benefit children and parents
Reach Out and Read is not afraid to change with the times. When it began in 1989, there was no guidance for pediatricians on the importance of reading. Mr. Gallagher said that a common question Reach Out and Read received was, “Why not focus on physical health?” The organization was more interested in the shift in pediatric practice overtime.
“We used to advocate starting off kids with books at 6 months old, but we always listen to the research,” Mr. Gallagher said. Now, the organization as well as the American Academy of Pediatrics advocate for beginning at birth. Other publications such as Green Child Magazine and Psychology Today speak of the importance of reading to babies still in the womb. The Proceedings of the National Academy of Sciences published an article in 2013 that suggests that third-trimester babies can not only pick up on language patterns but also can identify words first heard in the womb.
“We aren’t afraid to adjust our practice if it will be more effective and beneficial for children,” Mr. Gallagher said, “We follow the research and share the work that we are doing. It’s important to stay as up to date as possible.”
Although the focus is largely on the health of children, the impact on parents is crucial as well. Mr. Gallagher described the books at the center of the mission as “a vehicle for bonding” between parents and their children. “The relationship-building we see between families is truly quite magical,” he said.
“Parents will say it’s a respite in their day,” Dr. Klass said of the daily practice of reading aloud. She recalled a memory of talking to a mother with two rowdy young boys, who would sit down and read to them, immediately calming them down.
“When parents sit down to read to their children they don’t have to make anything up. It’s a script, it’s a prompt. You have this story, a picture to show. And kids get preferences,” she said. “When they pick a book that they want you to read, they get to exercise some control. It’s a satisfying routine for parents. It helps open up the world to your child. And when kids come over and hand a book to you for you to read together, it’s them saying, ‘I like the way you look, sound, and interact with me when we do this together.’”
A study from Ambulatory Pediatrics demonstrated that families working with Reach Out and Read were more likely to report reading aloud at bedtime, to read aloud three or more days per week, to mention reading aloud as a favorite parenting activity, and to own 10 or more children’s books. The American Journal of Diseases for Children, in a 1991 article co-authored by Needleman and Zuckerman, noted that the effects of Reach Out and Read were greater for those families who were receiving Aid to Families with Dependent Children. In 2015, the Pew Research Center unveiled a report, “Parenting in America” on raising a child in the modern age, the first generation in American history expected, on average, to make less than their parents.
The report stated that “a broad, demographically-based look at the landscape of American families reveals stark parenting divides linked less to philosophies or values and more to economic circumstances and changing family structure.”
As questions of access and privilege loom over the growing world of education, Reach Out and Read is trying to shorten the gap one book at a time. They are hoping, in time, that their model will be able to reach 90% of children in the United States and foster a relationship with reading and protecting children from toxic stress.
“Every time I look at a newborn, I think about the power of relationships,” said Dr. Shriver, the Iowa-based pediatrician. “I think about how much love passes between infants and their parents, and how shared reading is such a powerful way to show our children we love them. I know from my own experiences how good it feels to snuggle every night and read together. Those moments when the world falls away, and it’s just you, your child, and a book are magical.”
“I want every parent and child to have that experience and create those loving memories. I want all children to feel safe, secure, and loved. I want every child to have the opportunity to use books as a mirror to see themselves and as a window to see the world.”
A version of this article first appeared on Medscape.com.
Everyone can remember a book from their childhood that helped transform them, reinvent them, or turned the world on its head. Characters such as Harry Potter, Franklin the Turtle, Matilda, the Very Hungry Caterpillar, Corduroy, and Nancy Drew, among others, continue to exist in the cultural zeitgeist because they remind us of our childhood and the experience of discovering something innovative and exciting for the first time.
For many young children, introductions to these timeless characters first come from an adult reading to them. Those interactions, starting with watching mouths form words, to exploring pictures, to eventually reading along, leave a lasting impression. “Adults remember being read to,” says pediatrician Perri Klass, MD. “It’s a very powerful thing.”
Dr. Klass serves as national medical director of Reach Out and Read, a nonprofit organization that champions the positive effects of reading and other language-rich activities with young children.
And what better partners to involve in this mission than pediatricians? Before a child reaches the age of 4, the U.S. Department of Health and Human Services recommends that a child visit the pediatrician at least seven times. The Bright Futures/American Academy of Pediatrics suggests as many as 13 pediatrician visits before the child reaches that same milestone. Regardless of the exact number, almost all children are encountering a pediatrician multiple times during the most crucial years of their brain development.
In 1989, physicians Barry Zuckerman, MD, and Robert Needleman, MD, at Boston City Hospital (now Boston Medical Center) realized that they could reach a large population of children and parents, especially those coming from disadvantaged backgrounds, in the pediatrics ward of offices and hospitals all over the country.
The design of Reach Out and Read, the organization they founded, is to work with pediatricians in how they can best support parents in making reading to their children a part of their daily routine, advocating for the importance of books for children, and making sure that a child leaves the office with a book to take home.
Rather than just dumping books onto nervous or busy parents, the organization trains doctors on how to teach parents to read to their children: how to hold the books, how to make it as active as possible, how to point to the pictures and make them come to life, and how to make sure the child is grasping the language.
“You don’t just prop a baby up and read to them,” Dr. Klass told this news organization. “You have to make it interactive.”
Physician-driven success
Now an international organization, Dr. Klass has watched the nonprofit grow tremendously since it began during her fellowship in Boston over three decades ago. The initiative has over 6,100 sites in all 50 states and is able to get books into the hands of 4.2 million children every single year through government aid, individual contributions, and in-kind donations. On average, the organization is able to give parents 6.4 million books annually. Half of the children served every year by the program come from low-income backgrounds.
Dr. Klass ascribed some of the organization’s longevity and success to “practical realism,” its “mission-driven” approach, and its creation by people in primary care who understood the constraints, the upkeep, and the scaling.
“Our organization isn’t looking to pile 10 more things on to the hands of pediatricians who are already very busy,” she said. “We understand that conversation is important with our care providers. We always hear that watching children happily interacting with literature is one of the most rewarding parts of their job. So, we’re saying to them, ‘I want to help you do what you enjoy most.’”
Both Dr. Klass, who is also a presidential appointee to the Advisory Board of the National Institute For Literacy, and Brian Gallagher, MPA, the CEO of Reach Out and Read, said one of the most rewarding parts of their attachment to the organization is working with dedicated physicians all over the country.
“We hear all the time that physicians say working with these tools [from Reach Out and Read] is the most joyful part of their day,” said Mr. Gallagher. “Children are hope for the future and books help them grow.”
Amy Shriver, MD, an Iowa pediatrician and medical director of the Reach Out and Read Iowa Board, admitted that at first she just thought of the organization as a book drive. As Dr. Shriver got closer to the organization, though, she realized how she could utilize the book as a surveillance tool.
“At 6 months through 2 years, I hand the book to the patient, and I can always tell which children are familiar with books by their responses,” she said. After learning about and implementing Reach Out and Read’s ‘model, observe, coach’ methodology, Dr. Shriver said she was wowed by how much it helped families who weren’t reading to their child understand not only how to read with their children but why it’s so important.”
Dr. Shriver said that her clinic has purchased more diverse books to meet the needs of its patient population and has partnered with local libraries and a science center to promote early brain development. The biggest change is that Dr. Shriver finds herself spending more time observing and talking about parent/child relationships since starting with Reach Out and Read.
Mr. Gallagher attributed the organization’s success to the massive amounts of research that back up the practices of the organization. “Our model isn’t just a nice thing to do,” Mr. Gallagher said. “Our practice has been proven to be effective, and that’s why pediatricians continue to work with us. We’ve heard experts say that when they’re advocating for children’s health, they say ‘vaccines, sleep, and Reach Out and Read.’”
Nineteen independent studies have been done profiling the work of Reach Out and Read since its inception. The research has shown that exposure to the organization results in parents reading more often to their children, higher language scores, as well as an improvement in clinic culture and clinician well-being.
In 2014, the American Academy of Pediatrics quoted the research of Reach Out and Read in its policy statement “Literacy Promotion: An Essential Component of Primary Care Pediatric Practice,” which argued that pediatrics should advocate for literacy from birth. The abstract of the study suggests that practicing pediatricians “advise all parents that reading aloud with young children can enhance parent-child relationships and prepare young minds to learn language and early literacy skills ... provide developmentally appropriate books given at health supervision visits for all high-risk, low-income young children ... partnering with other child advocates to influence national messaging and policies that support and promote these key, early shared-reading experiences.”
Adapting to benefit children and parents
Reach Out and Read is not afraid to change with the times. When it began in 1989, there was no guidance for pediatricians on the importance of reading. Mr. Gallagher said that a common question Reach Out and Read received was, “Why not focus on physical health?” The organization was more interested in the shift in pediatric practice overtime.
“We used to advocate starting off kids with books at 6 months old, but we always listen to the research,” Mr. Gallagher said. Now, the organization as well as the American Academy of Pediatrics advocate for beginning at birth. Other publications such as Green Child Magazine and Psychology Today speak of the importance of reading to babies still in the womb. The Proceedings of the National Academy of Sciences published an article in 2013 that suggests that third-trimester babies can not only pick up on language patterns but also can identify words first heard in the womb.
“We aren’t afraid to adjust our practice if it will be more effective and beneficial for children,” Mr. Gallagher said, “We follow the research and share the work that we are doing. It’s important to stay as up to date as possible.”
Although the focus is largely on the health of children, the impact on parents is crucial as well. Mr. Gallagher described the books at the center of the mission as “a vehicle for bonding” between parents and their children. “The relationship-building we see between families is truly quite magical,” he said.
“Parents will say it’s a respite in their day,” Dr. Klass said of the daily practice of reading aloud. She recalled a memory of talking to a mother with two rowdy young boys, who would sit down and read to them, immediately calming them down.
“When parents sit down to read to their children they don’t have to make anything up. It’s a script, it’s a prompt. You have this story, a picture to show. And kids get preferences,” she said. “When they pick a book that they want you to read, they get to exercise some control. It’s a satisfying routine for parents. It helps open up the world to your child. And when kids come over and hand a book to you for you to read together, it’s them saying, ‘I like the way you look, sound, and interact with me when we do this together.’”
A study from Ambulatory Pediatrics demonstrated that families working with Reach Out and Read were more likely to report reading aloud at bedtime, to read aloud three or more days per week, to mention reading aloud as a favorite parenting activity, and to own 10 or more children’s books. The American Journal of Diseases for Children, in a 1991 article co-authored by Needleman and Zuckerman, noted that the effects of Reach Out and Read were greater for those families who were receiving Aid to Families with Dependent Children. In 2015, the Pew Research Center unveiled a report, “Parenting in America” on raising a child in the modern age, the first generation in American history expected, on average, to make less than their parents.
The report stated that “a broad, demographically-based look at the landscape of American families reveals stark parenting divides linked less to philosophies or values and more to economic circumstances and changing family structure.”
As questions of access and privilege loom over the growing world of education, Reach Out and Read is trying to shorten the gap one book at a time. They are hoping, in time, that their model will be able to reach 90% of children in the United States and foster a relationship with reading and protecting children from toxic stress.
“Every time I look at a newborn, I think about the power of relationships,” said Dr. Shriver, the Iowa-based pediatrician. “I think about how much love passes between infants and their parents, and how shared reading is such a powerful way to show our children we love them. I know from my own experiences how good it feels to snuggle every night and read together. Those moments when the world falls away, and it’s just you, your child, and a book are magical.”
“I want every parent and child to have that experience and create those loving memories. I want all children to feel safe, secure, and loved. I want every child to have the opportunity to use books as a mirror to see themselves and as a window to see the world.”
A version of this article first appeared on Medscape.com.
Everyone can remember a book from their childhood that helped transform them, reinvent them, or turned the world on its head. Characters such as Harry Potter, Franklin the Turtle, Matilda, the Very Hungry Caterpillar, Corduroy, and Nancy Drew, among others, continue to exist in the cultural zeitgeist because they remind us of our childhood and the experience of discovering something innovative and exciting for the first time.
For many young children, introductions to these timeless characters first come from an adult reading to them. Those interactions, starting with watching mouths form words, to exploring pictures, to eventually reading along, leave a lasting impression. “Adults remember being read to,” says pediatrician Perri Klass, MD. “It’s a very powerful thing.”
Dr. Klass serves as national medical director of Reach Out and Read, a nonprofit organization that champions the positive effects of reading and other language-rich activities with young children.
And what better partners to involve in this mission than pediatricians? Before a child reaches the age of 4, the U.S. Department of Health and Human Services recommends that a child visit the pediatrician at least seven times. The Bright Futures/American Academy of Pediatrics suggests as many as 13 pediatrician visits before the child reaches that same milestone. Regardless of the exact number, almost all children are encountering a pediatrician multiple times during the most crucial years of their brain development.
In 1989, physicians Barry Zuckerman, MD, and Robert Needleman, MD, at Boston City Hospital (now Boston Medical Center) realized that they could reach a large population of children and parents, especially those coming from disadvantaged backgrounds, in the pediatrics ward of offices and hospitals all over the country.
The design of Reach Out and Read, the organization they founded, is to work with pediatricians in how they can best support parents in making reading to their children a part of their daily routine, advocating for the importance of books for children, and making sure that a child leaves the office with a book to take home.
Rather than just dumping books onto nervous or busy parents, the organization trains doctors on how to teach parents to read to their children: how to hold the books, how to make it as active as possible, how to point to the pictures and make them come to life, and how to make sure the child is grasping the language.
“You don’t just prop a baby up and read to them,” Dr. Klass told this news organization. “You have to make it interactive.”
Physician-driven success
Now an international organization, Dr. Klass has watched the nonprofit grow tremendously since it began during her fellowship in Boston over three decades ago. The initiative has over 6,100 sites in all 50 states and is able to get books into the hands of 4.2 million children every single year through government aid, individual contributions, and in-kind donations. On average, the organization is able to give parents 6.4 million books annually. Half of the children served every year by the program come from low-income backgrounds.
Dr. Klass ascribed some of the organization’s longevity and success to “practical realism,” its “mission-driven” approach, and its creation by people in primary care who understood the constraints, the upkeep, and the scaling.
“Our organization isn’t looking to pile 10 more things on to the hands of pediatricians who are already very busy,” she said. “We understand that conversation is important with our care providers. We always hear that watching children happily interacting with literature is one of the most rewarding parts of their job. So, we’re saying to them, ‘I want to help you do what you enjoy most.’”
Both Dr. Klass, who is also a presidential appointee to the Advisory Board of the National Institute For Literacy, and Brian Gallagher, MPA, the CEO of Reach Out and Read, said one of the most rewarding parts of their attachment to the organization is working with dedicated physicians all over the country.
“We hear all the time that physicians say working with these tools [from Reach Out and Read] is the most joyful part of their day,” said Mr. Gallagher. “Children are hope for the future and books help them grow.”
Amy Shriver, MD, an Iowa pediatrician and medical director of the Reach Out and Read Iowa Board, admitted that at first she just thought of the organization as a book drive. As Dr. Shriver got closer to the organization, though, she realized how she could utilize the book as a surveillance tool.
“At 6 months through 2 years, I hand the book to the patient, and I can always tell which children are familiar with books by their responses,” she said. After learning about and implementing Reach Out and Read’s ‘model, observe, coach’ methodology, Dr. Shriver said she was wowed by how much it helped families who weren’t reading to their child understand not only how to read with their children but why it’s so important.”
Dr. Shriver said that her clinic has purchased more diverse books to meet the needs of its patient population and has partnered with local libraries and a science center to promote early brain development. The biggest change is that Dr. Shriver finds herself spending more time observing and talking about parent/child relationships since starting with Reach Out and Read.
Mr. Gallagher attributed the organization’s success to the massive amounts of research that back up the practices of the organization. “Our model isn’t just a nice thing to do,” Mr. Gallagher said. “Our practice has been proven to be effective, and that’s why pediatricians continue to work with us. We’ve heard experts say that when they’re advocating for children’s health, they say ‘vaccines, sleep, and Reach Out and Read.’”
Nineteen independent studies have been done profiling the work of Reach Out and Read since its inception. The research has shown that exposure to the organization results in parents reading more often to their children, higher language scores, as well as an improvement in clinic culture and clinician well-being.
In 2014, the American Academy of Pediatrics quoted the research of Reach Out and Read in its policy statement “Literacy Promotion: An Essential Component of Primary Care Pediatric Practice,” which argued that pediatrics should advocate for literacy from birth. The abstract of the study suggests that practicing pediatricians “advise all parents that reading aloud with young children can enhance parent-child relationships and prepare young minds to learn language and early literacy skills ... provide developmentally appropriate books given at health supervision visits for all high-risk, low-income young children ... partnering with other child advocates to influence national messaging and policies that support and promote these key, early shared-reading experiences.”
Adapting to benefit children and parents
Reach Out and Read is not afraid to change with the times. When it began in 1989, there was no guidance for pediatricians on the importance of reading. Mr. Gallagher said that a common question Reach Out and Read received was, “Why not focus on physical health?” The organization was more interested in the shift in pediatric practice overtime.
“We used to advocate starting off kids with books at 6 months old, but we always listen to the research,” Mr. Gallagher said. Now, the organization as well as the American Academy of Pediatrics advocate for beginning at birth. Other publications such as Green Child Magazine and Psychology Today speak of the importance of reading to babies still in the womb. The Proceedings of the National Academy of Sciences published an article in 2013 that suggests that third-trimester babies can not only pick up on language patterns but also can identify words first heard in the womb.
“We aren’t afraid to adjust our practice if it will be more effective and beneficial for children,” Mr. Gallagher said, “We follow the research and share the work that we are doing. It’s important to stay as up to date as possible.”
Although the focus is largely on the health of children, the impact on parents is crucial as well. Mr. Gallagher described the books at the center of the mission as “a vehicle for bonding” between parents and their children. “The relationship-building we see between families is truly quite magical,” he said.
“Parents will say it’s a respite in their day,” Dr. Klass said of the daily practice of reading aloud. She recalled a memory of talking to a mother with two rowdy young boys, who would sit down and read to them, immediately calming them down.
“When parents sit down to read to their children they don’t have to make anything up. It’s a script, it’s a prompt. You have this story, a picture to show. And kids get preferences,” she said. “When they pick a book that they want you to read, they get to exercise some control. It’s a satisfying routine for parents. It helps open up the world to your child. And when kids come over and hand a book to you for you to read together, it’s them saying, ‘I like the way you look, sound, and interact with me when we do this together.’”
A study from Ambulatory Pediatrics demonstrated that families working with Reach Out and Read were more likely to report reading aloud at bedtime, to read aloud three or more days per week, to mention reading aloud as a favorite parenting activity, and to own 10 or more children’s books. The American Journal of Diseases for Children, in a 1991 article co-authored by Needleman and Zuckerman, noted that the effects of Reach Out and Read were greater for those families who were receiving Aid to Families with Dependent Children. In 2015, the Pew Research Center unveiled a report, “Parenting in America” on raising a child in the modern age, the first generation in American history expected, on average, to make less than their parents.
The report stated that “a broad, demographically-based look at the landscape of American families reveals stark parenting divides linked less to philosophies or values and more to economic circumstances and changing family structure.”
As questions of access and privilege loom over the growing world of education, Reach Out and Read is trying to shorten the gap one book at a time. They are hoping, in time, that their model will be able to reach 90% of children in the United States and foster a relationship with reading and protecting children from toxic stress.
“Every time I look at a newborn, I think about the power of relationships,” said Dr. Shriver, the Iowa-based pediatrician. “I think about how much love passes between infants and their parents, and how shared reading is such a powerful way to show our children we love them. I know from my own experiences how good it feels to snuggle every night and read together. Those moments when the world falls away, and it’s just you, your child, and a book are magical.”
“I want every parent and child to have that experience and create those loving memories. I want all children to feel safe, secure, and loved. I want every child to have the opportunity to use books as a mirror to see themselves and as a window to see the world.”
A version of this article first appeared on Medscape.com.
A very strange place to find a tooth
A nose for the tooth
Have you ever had a stuffy nose that just wouldn’t go away? Those irritating head colds have nothing on the stuffy nose a man in New York recently had to go through. A stuffy nose to top all stuffy noses. One stuffy nose to rule them all, as it were.
This man went to a Mount Sinai clinic with difficulty breathing through his right nostril, a problem that had been going on for years. Let us repeat that: A stuffy nose that lasted for years. The exam revealed a white mass jutting through the back of the septum and a CT scan confirmed the diagnosis. Perhaps you’ve already guessed, since the headline does give things away. Yes, this man had a tooth growing into his nose.
The problem was a half-inch-long ectopic tooth. Ectopic teeth are rare, occurring in less than 1% of people, but an ectopic tooth growing backward into the nasal cavity? Well, that’s so uncommon that this man got a case report in the New England Journal of Medicine.
This story does have a happy ending. Not all ectopic teeth need to be treated, but this one really did have to go. The offending tooth was surgically removed and, at a 3-month follow-up, the stuffy nose issue was completely resolved. So our friend gets the best of both worlds: His issue gets cured and he gets a case report in a major medical publication. If that’s not living the dream, we don’t know what is, and that’s the tooth.
Lettuce recommend you a sleep aid
Lettuce is great for many things. The star in a salad? Of course. The fresh element in a BLT? Yep. A sleep aid? According to a TikTok hack with almost 5 million views, the pinch hitter in a sandwich is switching leagues to be used like a tea for faster sleep. But, does it really work? Researchers say yes and no, according to a recent report at Tyla.com.
Studies conducted in 2013 and 2017 pointed toward a compound called lactucin, which is found in the plant’s n-butanol fraction. In the 2013 study, mice that received n-butanol fraction fell asleep faster and stayed asleep longer. In 2017, researchers found that lettuce made mice sleep longer and helped protect against cell inflammation and damage.
OK, so it works on mice. But what about humans? In the TikTok video, user Shapla Hoque pours hot water on a few lettuce leaves in a mug with a peppermint tea bag (for flavor). After 10 minutes, when the leaves are soaked and soggy, she removes them and drinks the lettuce tea. By the end of the video she’s visibly drowsy and ready to crash. Does this hold water?
Here’s the no. Dr. Charlotte Norton of the Slimming Clinic told Tyla.com that yeah, there are some properties in lettuce that will help you fall asleep, such as lactucarium, which is prominent in romaine. But you would need a massive amount of lettuce to get any effect. The TikTok video, she said, is an example of the placebo effect.
Brains get a rise out of Viagra
A lot of medications are used off label. Antidepressants for COVID have taken the cake recently, but here’s a new one: Viagra for Alzheimer’s disease.
Although there’s no definite link yet between the two, neuron models derived from induced pluripotent stem cells from patients with Alzheimer’s suggest that sildenafil increases neurite growth and decreases phospho-tau expression, Jiansong Fang, PhD, of the Cleveland Clinic, and associates said in Nature Aging.
Their research is an attempt to find untapped sources of new treatments among existing drugs. They began the search with 1,600 approved drugs and focused on those that target the buildup of beta amyloid and tau proteins in the brain, according to the Daily Beast.
Since sildenafil is obviously for men, more research will need to be done on how this drug affects women. Don’t start stocking up just yet.
Omicron is not a social-distancing robot
COVID, safe to say, has not been your typical, run-of-the-mill pandemic. People have protested social distancing. People have protested lockdowns. People have protested mask mandates. People have protested vaccine mandates. People have protested people protesting vaccine mandates.
Someone used a fake arm to get a COVID vaccine card. People have tried to reverse their COVID vaccinations. People had COVID contamination parties.
The common denominator? People. Humans. Maybe what we need is a nonhuman intervention. To fight COVID, we need a hero. A robotic hero.
And where can we find such a hero? The University of Maryland, of course, where computer scientists and engineers are working on an autonomous mobile robot to enforce indoor social-distancing rules.
Their robot can detect lapses in social distancing using cameras, both thermal and visual, along with a LiDAR (Light Detection and Ranging) sensor. It then sorts the offenders into various groups depending on whether they are standing still or moving and predicts their future movement using a state-of-the-art hybrid collision avoidance method known as Frozone, Adarsh Jagan Sathyamoorthy and associates explained in PLOS One.
“Once it reaches the breach, the robot encourages people to move apart via text that appears on a mounted display,” ScienceDaily said.
Maybe you were expecting a Terminator-type robot coming to enforce social distancing requirements rather than a simple text message. Let’s just hope that all COVID guidelines are followed, including social distancing, so the pandemic will finally end and won’t “be back.”
A nose for the tooth
Have you ever had a stuffy nose that just wouldn’t go away? Those irritating head colds have nothing on the stuffy nose a man in New York recently had to go through. A stuffy nose to top all stuffy noses. One stuffy nose to rule them all, as it were.
This man went to a Mount Sinai clinic with difficulty breathing through his right nostril, a problem that had been going on for years. Let us repeat that: A stuffy nose that lasted for years. The exam revealed a white mass jutting through the back of the septum and a CT scan confirmed the diagnosis. Perhaps you’ve already guessed, since the headline does give things away. Yes, this man had a tooth growing into his nose.
The problem was a half-inch-long ectopic tooth. Ectopic teeth are rare, occurring in less than 1% of people, but an ectopic tooth growing backward into the nasal cavity? Well, that’s so uncommon that this man got a case report in the New England Journal of Medicine.
This story does have a happy ending. Not all ectopic teeth need to be treated, but this one really did have to go. The offending tooth was surgically removed and, at a 3-month follow-up, the stuffy nose issue was completely resolved. So our friend gets the best of both worlds: His issue gets cured and he gets a case report in a major medical publication. If that’s not living the dream, we don’t know what is, and that’s the tooth.
Lettuce recommend you a sleep aid
Lettuce is great for many things. The star in a salad? Of course. The fresh element in a BLT? Yep. A sleep aid? According to a TikTok hack with almost 5 million views, the pinch hitter in a sandwich is switching leagues to be used like a tea for faster sleep. But, does it really work? Researchers say yes and no, according to a recent report at Tyla.com.
Studies conducted in 2013 and 2017 pointed toward a compound called lactucin, which is found in the plant’s n-butanol fraction. In the 2013 study, mice that received n-butanol fraction fell asleep faster and stayed asleep longer. In 2017, researchers found that lettuce made mice sleep longer and helped protect against cell inflammation and damage.
OK, so it works on mice. But what about humans? In the TikTok video, user Shapla Hoque pours hot water on a few lettuce leaves in a mug with a peppermint tea bag (for flavor). After 10 minutes, when the leaves are soaked and soggy, she removes them and drinks the lettuce tea. By the end of the video she’s visibly drowsy and ready to crash. Does this hold water?
Here’s the no. Dr. Charlotte Norton of the Slimming Clinic told Tyla.com that yeah, there are some properties in lettuce that will help you fall asleep, such as lactucarium, which is prominent in romaine. But you would need a massive amount of lettuce to get any effect. The TikTok video, she said, is an example of the placebo effect.
Brains get a rise out of Viagra
A lot of medications are used off label. Antidepressants for COVID have taken the cake recently, but here’s a new one: Viagra for Alzheimer’s disease.
Although there’s no definite link yet between the two, neuron models derived from induced pluripotent stem cells from patients with Alzheimer’s suggest that sildenafil increases neurite growth and decreases phospho-tau expression, Jiansong Fang, PhD, of the Cleveland Clinic, and associates said in Nature Aging.
Their research is an attempt to find untapped sources of new treatments among existing drugs. They began the search with 1,600 approved drugs and focused on those that target the buildup of beta amyloid and tau proteins in the brain, according to the Daily Beast.
Since sildenafil is obviously for men, more research will need to be done on how this drug affects women. Don’t start stocking up just yet.
Omicron is not a social-distancing robot
COVID, safe to say, has not been your typical, run-of-the-mill pandemic. People have protested social distancing. People have protested lockdowns. People have protested mask mandates. People have protested vaccine mandates. People have protested people protesting vaccine mandates.
Someone used a fake arm to get a COVID vaccine card. People have tried to reverse their COVID vaccinations. People had COVID contamination parties.
The common denominator? People. Humans. Maybe what we need is a nonhuman intervention. To fight COVID, we need a hero. A robotic hero.
And where can we find such a hero? The University of Maryland, of course, where computer scientists and engineers are working on an autonomous mobile robot to enforce indoor social-distancing rules.
Their robot can detect lapses in social distancing using cameras, both thermal and visual, along with a LiDAR (Light Detection and Ranging) sensor. It then sorts the offenders into various groups depending on whether they are standing still or moving and predicts their future movement using a state-of-the-art hybrid collision avoidance method known as Frozone, Adarsh Jagan Sathyamoorthy and associates explained in PLOS One.
“Once it reaches the breach, the robot encourages people to move apart via text that appears on a mounted display,” ScienceDaily said.
Maybe you were expecting a Terminator-type robot coming to enforce social distancing requirements rather than a simple text message. Let’s just hope that all COVID guidelines are followed, including social distancing, so the pandemic will finally end and won’t “be back.”
A nose for the tooth
Have you ever had a stuffy nose that just wouldn’t go away? Those irritating head colds have nothing on the stuffy nose a man in New York recently had to go through. A stuffy nose to top all stuffy noses. One stuffy nose to rule them all, as it were.
This man went to a Mount Sinai clinic with difficulty breathing through his right nostril, a problem that had been going on for years. Let us repeat that: A stuffy nose that lasted for years. The exam revealed a white mass jutting through the back of the septum and a CT scan confirmed the diagnosis. Perhaps you’ve already guessed, since the headline does give things away. Yes, this man had a tooth growing into his nose.
The problem was a half-inch-long ectopic tooth. Ectopic teeth are rare, occurring in less than 1% of people, but an ectopic tooth growing backward into the nasal cavity? Well, that’s so uncommon that this man got a case report in the New England Journal of Medicine.
This story does have a happy ending. Not all ectopic teeth need to be treated, but this one really did have to go. The offending tooth was surgically removed and, at a 3-month follow-up, the stuffy nose issue was completely resolved. So our friend gets the best of both worlds: His issue gets cured and he gets a case report in a major medical publication. If that’s not living the dream, we don’t know what is, and that’s the tooth.
Lettuce recommend you a sleep aid
Lettuce is great for many things. The star in a salad? Of course. The fresh element in a BLT? Yep. A sleep aid? According to a TikTok hack with almost 5 million views, the pinch hitter in a sandwich is switching leagues to be used like a tea for faster sleep. But, does it really work? Researchers say yes and no, according to a recent report at Tyla.com.
Studies conducted in 2013 and 2017 pointed toward a compound called lactucin, which is found in the plant’s n-butanol fraction. In the 2013 study, mice that received n-butanol fraction fell asleep faster and stayed asleep longer. In 2017, researchers found that lettuce made mice sleep longer and helped protect against cell inflammation and damage.
OK, so it works on mice. But what about humans? In the TikTok video, user Shapla Hoque pours hot water on a few lettuce leaves in a mug with a peppermint tea bag (for flavor). After 10 minutes, when the leaves are soaked and soggy, she removes them and drinks the lettuce tea. By the end of the video she’s visibly drowsy and ready to crash. Does this hold water?
Here’s the no. Dr. Charlotte Norton of the Slimming Clinic told Tyla.com that yeah, there are some properties in lettuce that will help you fall asleep, such as lactucarium, which is prominent in romaine. But you would need a massive amount of lettuce to get any effect. The TikTok video, she said, is an example of the placebo effect.
Brains get a rise out of Viagra
A lot of medications are used off label. Antidepressants for COVID have taken the cake recently, but here’s a new one: Viagra for Alzheimer’s disease.
Although there’s no definite link yet between the two, neuron models derived from induced pluripotent stem cells from patients with Alzheimer’s suggest that sildenafil increases neurite growth and decreases phospho-tau expression, Jiansong Fang, PhD, of the Cleveland Clinic, and associates said in Nature Aging.
Their research is an attempt to find untapped sources of new treatments among existing drugs. They began the search with 1,600 approved drugs and focused on those that target the buildup of beta amyloid and tau proteins in the brain, according to the Daily Beast.
Since sildenafil is obviously for men, more research will need to be done on how this drug affects women. Don’t start stocking up just yet.
Omicron is not a social-distancing robot
COVID, safe to say, has not been your typical, run-of-the-mill pandemic. People have protested social distancing. People have protested lockdowns. People have protested mask mandates. People have protested vaccine mandates. People have protested people protesting vaccine mandates.
Someone used a fake arm to get a COVID vaccine card. People have tried to reverse their COVID vaccinations. People had COVID contamination parties.
The common denominator? People. Humans. Maybe what we need is a nonhuman intervention. To fight COVID, we need a hero. A robotic hero.
And where can we find such a hero? The University of Maryland, of course, where computer scientists and engineers are working on an autonomous mobile robot to enforce indoor social-distancing rules.
Their robot can detect lapses in social distancing using cameras, both thermal and visual, along with a LiDAR (Light Detection and Ranging) sensor. It then sorts the offenders into various groups depending on whether they are standing still or moving and predicts their future movement using a state-of-the-art hybrid collision avoidance method known as Frozone, Adarsh Jagan Sathyamoorthy and associates explained in PLOS One.
“Once it reaches the breach, the robot encourages people to move apart via text that appears on a mounted display,” ScienceDaily said.
Maybe you were expecting a Terminator-type robot coming to enforce social distancing requirements rather than a simple text message. Let’s just hope that all COVID guidelines are followed, including social distancing, so the pandemic will finally end and won’t “be back.”
AHA challenges diet doctor’s study alleging COVID vax risks
An abstract and poster presentation questioning the safety of mRNA-based COVID-19 vaccines, embraced by some and lambasted by others, has drawn an “expression of concern” from the American Heart Association, along with a bid for correction.
The abstract in question concludes that COVID vaccines “dramatically increase” levels of certain inflammatory biomarkers, and therefore, the 5-year risk of acute coronary syndromes (ACS), based on pre- and post-vaccination results of an obscure blood panel called the PULS Cardiac Test (GD Biosciences). The findings were presented at the AHA’s 2021 Scientific Sessionsas, an uncontrolled observational study of 566 patients in a preventive cardiology practice.
Some on social media have seized on the abstract as evidence of serious potential harm from the two available mRNA-based SARS-CoV-2 vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). But others contend that the study’s described design and findings are specious and its conclusions overstated.
They also point to the notoriety of its one listed author, Steven R. Gundry, MD, who promotes his diet books and supplements as well as fringe, highly criticized theories about diet and disease on several websites, including drgundry.com. Dr. Gundry has not responded to requests for an interview.
Dr. Gundry’s abstract from the AHA Scientific Sessions 2021, available on the meeting’s program planner, was marked with an “expression of concern” by the AHA that is to stand “until a suitable correction is published, to indicate that the abstract in its current version may not be reliable.”
The expression of concern statement, also published online Nov. 24 in Circulation, says “potential errors in the abstract” were brought to the attention of the meeting planners. “Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used.”
The biomarker elevations on which the abstract’s conclusions are based included hepatocyte growth factor, “which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue,” it states.
“The expression of concern about the abstract will remain in place until a correction is accepted and published” in Circulation, AHA spokesperson Suzanne Grant told this news organization by email.
“The specific data needed will be up to the abstract author to determine and supply,” she said, noting that Dr. Gundry “has been in communication with the journal throughout this process.”
Submitting researchers “must always attest to the validity of the abstract,” Ms. Grant said. “Abstracts are then curated by independent review panels, blinded to the identities of the abstract authors, and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting.”
Regarding the AHA’s system for vetting abstracts vying for acceptance to the scientific sessions, she said it is not primarily intended to “evaluate scientific validity” and that the organization is “currently reviewing its existing abstract submission processes.”
A recent Reuters report reviews the controversy and provides links to criticisms of the study on social media.
A version of this article first appeared on Medscape.com.
An abstract and poster presentation questioning the safety of mRNA-based COVID-19 vaccines, embraced by some and lambasted by others, has drawn an “expression of concern” from the American Heart Association, along with a bid for correction.
The abstract in question concludes that COVID vaccines “dramatically increase” levels of certain inflammatory biomarkers, and therefore, the 5-year risk of acute coronary syndromes (ACS), based on pre- and post-vaccination results of an obscure blood panel called the PULS Cardiac Test (GD Biosciences). The findings were presented at the AHA’s 2021 Scientific Sessionsas, an uncontrolled observational study of 566 patients in a preventive cardiology practice.
Some on social media have seized on the abstract as evidence of serious potential harm from the two available mRNA-based SARS-CoV-2 vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). But others contend that the study’s described design and findings are specious and its conclusions overstated.
They also point to the notoriety of its one listed author, Steven R. Gundry, MD, who promotes his diet books and supplements as well as fringe, highly criticized theories about diet and disease on several websites, including drgundry.com. Dr. Gundry has not responded to requests for an interview.
Dr. Gundry’s abstract from the AHA Scientific Sessions 2021, available on the meeting’s program planner, was marked with an “expression of concern” by the AHA that is to stand “until a suitable correction is published, to indicate that the abstract in its current version may not be reliable.”
The expression of concern statement, also published online Nov. 24 in Circulation, says “potential errors in the abstract” were brought to the attention of the meeting planners. “Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used.”
The biomarker elevations on which the abstract’s conclusions are based included hepatocyte growth factor, “which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue,” it states.
“The expression of concern about the abstract will remain in place until a correction is accepted and published” in Circulation, AHA spokesperson Suzanne Grant told this news organization by email.
“The specific data needed will be up to the abstract author to determine and supply,” she said, noting that Dr. Gundry “has been in communication with the journal throughout this process.”
Submitting researchers “must always attest to the validity of the abstract,” Ms. Grant said. “Abstracts are then curated by independent review panels, blinded to the identities of the abstract authors, and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting.”
Regarding the AHA’s system for vetting abstracts vying for acceptance to the scientific sessions, she said it is not primarily intended to “evaluate scientific validity” and that the organization is “currently reviewing its existing abstract submission processes.”
A recent Reuters report reviews the controversy and provides links to criticisms of the study on social media.
A version of this article first appeared on Medscape.com.
An abstract and poster presentation questioning the safety of mRNA-based COVID-19 vaccines, embraced by some and lambasted by others, has drawn an “expression of concern” from the American Heart Association, along with a bid for correction.
The abstract in question concludes that COVID vaccines “dramatically increase” levels of certain inflammatory biomarkers, and therefore, the 5-year risk of acute coronary syndromes (ACS), based on pre- and post-vaccination results of an obscure blood panel called the PULS Cardiac Test (GD Biosciences). The findings were presented at the AHA’s 2021 Scientific Sessionsas, an uncontrolled observational study of 566 patients in a preventive cardiology practice.
Some on social media have seized on the abstract as evidence of serious potential harm from the two available mRNA-based SARS-CoV-2 vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna). But others contend that the study’s described design and findings are specious and its conclusions overstated.
They also point to the notoriety of its one listed author, Steven R. Gundry, MD, who promotes his diet books and supplements as well as fringe, highly criticized theories about diet and disease on several websites, including drgundry.com. Dr. Gundry has not responded to requests for an interview.
Dr. Gundry’s abstract from the AHA Scientific Sessions 2021, available on the meeting’s program planner, was marked with an “expression of concern” by the AHA that is to stand “until a suitable correction is published, to indicate that the abstract in its current version may not be reliable.”
The expression of concern statement, also published online Nov. 24 in Circulation, says “potential errors in the abstract” were brought to the attention of the meeting planners. “Specifically, there are several typographical errors, there is no data in the abstract regarding myocardial T-cell infiltration, there are no statistical analyses for significance provided, and the author is not clear that only anecdotal data was used.”
The biomarker elevations on which the abstract’s conclusions are based included hepatocyte growth factor, “which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue,” it states.
“The expression of concern about the abstract will remain in place until a correction is accepted and published” in Circulation, AHA spokesperson Suzanne Grant told this news organization by email.
“The specific data needed will be up to the abstract author to determine and supply,” she said, noting that Dr. Gundry “has been in communication with the journal throughout this process.”
Submitting researchers “must always attest to the validity of the abstract,” Ms. Grant said. “Abstracts are then curated by independent review panels, blinded to the identities of the abstract authors, and are considered based on the potential to add to the diversity of scientific issues and views discussed at the meeting.”
Regarding the AHA’s system for vetting abstracts vying for acceptance to the scientific sessions, she said it is not primarily intended to “evaluate scientific validity” and that the organization is “currently reviewing its existing abstract submission processes.”
A recent Reuters report reviews the controversy and provides links to criticisms of the study on social media.
A version of this article first appeared on Medscape.com.
Is mindfulness key to helping physicians with mental health?
In 2011, the Mayo Clinic began surveying physicians about burnout and found 45% of physicians experienced at least one symptom, such as emotional exhaustion, finding work no longer meaningful, feelings of ineffectiveness, and depersonalizing patients. Associated manifestations can range from headache and insomnia to impaired memory and decreased attention.
Fast forward 10 years to the Medscape National Physician Burnout and Suicide Report, which found that a similar number of physicians (42%) feel burned out. The COVID-19 pandemic only added insult to injury. A Medscape survey that included nearly 5,000 U.S. physicians revealed that about two-thirds (64%) of them reported burnout had intensified during the crisis.
These elevated numbers are being labeled as “a public health crisis” for the impact widespread physician burnout could have on the health of the doctor and patient safety. The relatively consistent levels across the decade seem to suggest that, if health organizations are attempting to improve physician well-being, it doesn’t appear to be working, forcing doctors to find solutions for themselves.
Jill Wener, MD, considers herself part of the 45% burned out 10 years ago. She was working as an internist at Rush University Medical Center in Chicago, but the “existential reality of being a doctor in this world” was wearing on her. “Staying up with the literature, knowing that every day you’re going to go into work without knowing what you’re going to find, threats of lawsuits, the pressure of perfectionism,” Dr. Wener told this news organization. “By the time I hit burnout, everything made me feel like the world was crashing down on me.”
When Dr. Wener encountered someone who meditated twice a day, she was intrigued, even though the self-described “most Type-A, inside-the-box, nonspiritual type, anxious, linear-path doctor” didn’t think people like her could meditate. Dr. Wener is not alone in her hesitation to explore meditation as a means to help prevent burnout because the causes of burnout are primarily linked to external rather than internal factors. Issues including a loss of autonomy, the burden and distraction of electronic health records, and the intense pressure to comply with rules from the government are not things mindfulness can fix.
And because the sources of burnout are primarily environmental and inherent to the current medical system, the suggestion that physicians need to fix themselves with meditation can come as a slap in the face. However, when up against a system slow to change, mindfulness can provide physicians access to the one thing they can control: How they perceive and react to what’s in front of them.
At the recommendation of an acquaintance, Dr. Wener enrolled in a Vedic Meditation (also known as Conscious Health Meditation) course taught by Light Watkins, a well-known traveling instructor, author, and speaker. By the second meeting she was successfully practicing 20 minutes twice a day. This form of mediation traces its roots to the Vedas, ancient Indian texts (also the foundation for yoga), and uses a mantra to settle the mind, transitioning to an awake state of inner contentment.
Three weeks later, Dr. Wener’s daily crying jags ended as did her propensity for road rage. “I felt like I was on the cusp of something life-changing, I just didn’t understand it,” she recalled. “But I knew I was never going to give it up.”
Defining mindfulness
“Mindfulness is being able to be present in the moment that you’re in with acceptance of what it is and without judging it,” said Donna Rockwell, PsyD, a leading mindfulness meditation teacher. The practice of mindfulness is really meditation. Dr. Rockwell explained that the noise of our mind is most often focused on either the past or the future. “We’re either bemoaning something that happened earlier or we’re catastrophizing the future,” she said, which prevents us from being present in the moment.
Meditation allows you to notice when your mind has drifted from the present moment into the past or future. “You gently notice it, label it with a lot of self-compassion, and then bring your mind back by focusing on your breath – going out, going in – and the incoming stimuli through your five senses,” said Dr. Rockwell. “When you’re doing that, you can’t be in the past or future.”
Dr. Rockwell also pointed out that we constantly categorize incoming data of the moment as either “good for me or bad for me,” which gets in the way of simply being present for what you’re facing. “When you’re more fully present, you become more skillful and able to do what this moment is asking of you,” she said. Being mindful allows us to better navigate incoming stimuli, which could be a “code blue” in the ED or a patient who needs another 2 minutes during an office visit.
When Dr. Wener was burned out, she felt unable to adapt whenever something unexpected happened. “When you have no emotional reserves, everything feels like a big deal,” she said. “The meditation gave me what we call adaptation energy; it filled up my tank and kept me from feeling like I was going to lose it at 10 o’clock in the morning.”
Dr. Rockwell explained burnout as an overactive fight or flight response activated by the amygdala. It starts pumping cortisol, our pupils dilate, and our pores open. The prefrontal cortex is offline when we’re experiencing this physiological response because they both can’t be operational at the same time. “When we’re constantly in a ‘fight or flight’ response and don’t have any access to our prefrontal cortex, we are coming from a brain that is pumping cortisol and that leads to burnout,” said Dr. Rockwell.
“Any fight or flight response leaves a mark on your body,” Dr. Wener echoed. “When we go into our state of deep rest in the meditation practice, which is two to five times more restful than sleep, it heals those stress scars.”
Making time for mindfulness
Prescribing mindfulness for physicians is not new. Molecular biologist Jon Kabat-Zinn, PhD, developed Mindfulness-Based Stress Reduction (MBSR) in 1979, a practice that incorporates mindfulness exercises to help people become familiar with their behavior patterns in stressful situations. Thus, instead of reacting, they can respond with a clearer understanding of the circumstance. Dr. Kabat-Zinn initially targeted people with chronic health problems to help them cope with the effects of pain and the condition of their illness, but it has expanded to anyone experiencing challenges in their life, including physicians. A standard MBSR course runs 8 weeks, making it a commitment for most people.
Mindfulness training requires that physicians use what they already have so little of: time.
Dr. Wener was able to take a sabbatical, embarking on a 3-month trip to India to immerse herself in the study of Vedic Meditation. Upon her return, Dr. Wener took a position at Emory University, Atlanta, and has launched a number of CME-accredited meditation courses and retreats. Unlike Dr. Kabat-Zinn, her programs are by physicians and for physicians. She also created an online version of the meditation course to make it more accessible.
For these reasons, Kara Pepper, MD, an internist in outpatient primary care in Atlanta, was drawn to the meditation course. Dr. Pepper was 7 years into practice when she burned out. “The program dovetailed into my burnout recovery,” she said. “It allowed me space to separate myself from the thoughts I was having about work and just recognize them as just that – as thoughts.”
In the course, Dr. Wener teaches the REST Technique, which she says is different than mindfulness in that she encourages the mind to run rampant. “Trying to control the mind can feel very uncomfortable because we always have thoughts,” she says. “We can’t tell the mind to stop thinking just like we can’t tell the heart to stop beating.” Dr. Wener said the REST Technique lets “the mind swim downstream,” allowing the brain to go into a deep state of rest and start to heal from the scars caused by stress.
Dr. Pepper said the self-paced online course gave her all the tools she needed, and it was pragmatic and evidence based. “I didn’t feel ‘woo’ or like another gimmick,” she said. Pepper, who continues to practice medicine, became a life coach in 2019 to teach others the skills she uses daily.
An integrated strategy
In a review published in The American Journal of Medicine in 2019, Scott Yates, MD, MBA, from the Center for Executive Medicine in Plano, Tex., found that physicians who had adopted mediation and mindfulness training to decrease anxiety and perceived work stress only experienced modest benefits. In fact, Dr. Yates claims that there’s little data to suggest the long-term benefit of any particular stress management intervention in the prevention of burnout symptoms.
“The often-repeated goals of the Triple Aim [enhancing patient experience, improving population health, and reducing costs] may be unreachable until we recognize and address burnout in health care providers,” Dr. Yates wrote. He recommends adding a fourth goal to specifically address physician wellness, which certainly could include mindfulness training and meditation.
Burnout coach, trainer, and consultant Dike Drummond, MD, also professes that physician wellness must be added as the key fourth ingredient to improving health care. “Burnout is a dilemma, a balancing act,” he said. “It takes an integrated strategy.” The CEO and founder of TheHappyMD.com, Dr. Drummond’s integrated strategy to stop physician burnout has been taught to more than 40,000 physicians in 175 organizations, and one element of that strategy can be mindfulness training.
Dr. Drummond said he doesn’t use the word meditation “because that scares most people”; it takes a commitment and isn’t accessible for a lot of doctors. Instead, he coaches doctors to use a ‘single-breath’ technique to help them reset multiple times throughout the day. “I teach people how to breathe up to the top of their head and then down to the bottom of their feet,” Dr. Drummond said. He calls it the Squeegee Breath Technique because when they exhale, they “wipe away” anything that doesn’t need to be there right now. “If you happen to have a mindfulness practice like meditation, they work synergistically because the calmness you feel in your mediation is available to you at the bottom of these releasing breaths.”
Various studies and surveys provide great detail as to the “why” of physician burnout. And while mindfulness is not the sole answer, it’s something physicians can explore for themselves while health care as an industry looks for a more comprehensive solution.
“It’s not rocket science,” Dr. Drummond insisted. “You want a different result? You’re not satisfied with the way things are now and you want to feel different? You absolutely must do something different.”
A version of this article first appeared on Medscape.com.
In 2011, the Mayo Clinic began surveying physicians about burnout and found 45% of physicians experienced at least one symptom, such as emotional exhaustion, finding work no longer meaningful, feelings of ineffectiveness, and depersonalizing patients. Associated manifestations can range from headache and insomnia to impaired memory and decreased attention.
Fast forward 10 years to the Medscape National Physician Burnout and Suicide Report, which found that a similar number of physicians (42%) feel burned out. The COVID-19 pandemic only added insult to injury. A Medscape survey that included nearly 5,000 U.S. physicians revealed that about two-thirds (64%) of them reported burnout had intensified during the crisis.
These elevated numbers are being labeled as “a public health crisis” for the impact widespread physician burnout could have on the health of the doctor and patient safety. The relatively consistent levels across the decade seem to suggest that, if health organizations are attempting to improve physician well-being, it doesn’t appear to be working, forcing doctors to find solutions for themselves.
Jill Wener, MD, considers herself part of the 45% burned out 10 years ago. She was working as an internist at Rush University Medical Center in Chicago, but the “existential reality of being a doctor in this world” was wearing on her. “Staying up with the literature, knowing that every day you’re going to go into work without knowing what you’re going to find, threats of lawsuits, the pressure of perfectionism,” Dr. Wener told this news organization. “By the time I hit burnout, everything made me feel like the world was crashing down on me.”
When Dr. Wener encountered someone who meditated twice a day, she was intrigued, even though the self-described “most Type-A, inside-the-box, nonspiritual type, anxious, linear-path doctor” didn’t think people like her could meditate. Dr. Wener is not alone in her hesitation to explore meditation as a means to help prevent burnout because the causes of burnout are primarily linked to external rather than internal factors. Issues including a loss of autonomy, the burden and distraction of electronic health records, and the intense pressure to comply with rules from the government are not things mindfulness can fix.
And because the sources of burnout are primarily environmental and inherent to the current medical system, the suggestion that physicians need to fix themselves with meditation can come as a slap in the face. However, when up against a system slow to change, mindfulness can provide physicians access to the one thing they can control: How they perceive and react to what’s in front of them.
At the recommendation of an acquaintance, Dr. Wener enrolled in a Vedic Meditation (also known as Conscious Health Meditation) course taught by Light Watkins, a well-known traveling instructor, author, and speaker. By the second meeting she was successfully practicing 20 minutes twice a day. This form of mediation traces its roots to the Vedas, ancient Indian texts (also the foundation for yoga), and uses a mantra to settle the mind, transitioning to an awake state of inner contentment.
Three weeks later, Dr. Wener’s daily crying jags ended as did her propensity for road rage. “I felt like I was on the cusp of something life-changing, I just didn’t understand it,” she recalled. “But I knew I was never going to give it up.”
Defining mindfulness
“Mindfulness is being able to be present in the moment that you’re in with acceptance of what it is and without judging it,” said Donna Rockwell, PsyD, a leading mindfulness meditation teacher. The practice of mindfulness is really meditation. Dr. Rockwell explained that the noise of our mind is most often focused on either the past or the future. “We’re either bemoaning something that happened earlier or we’re catastrophizing the future,” she said, which prevents us from being present in the moment.
Meditation allows you to notice when your mind has drifted from the present moment into the past or future. “You gently notice it, label it with a lot of self-compassion, and then bring your mind back by focusing on your breath – going out, going in – and the incoming stimuli through your five senses,” said Dr. Rockwell. “When you’re doing that, you can’t be in the past or future.”
Dr. Rockwell also pointed out that we constantly categorize incoming data of the moment as either “good for me or bad for me,” which gets in the way of simply being present for what you’re facing. “When you’re more fully present, you become more skillful and able to do what this moment is asking of you,” she said. Being mindful allows us to better navigate incoming stimuli, which could be a “code blue” in the ED or a patient who needs another 2 minutes during an office visit.
When Dr. Wener was burned out, she felt unable to adapt whenever something unexpected happened. “When you have no emotional reserves, everything feels like a big deal,” she said. “The meditation gave me what we call adaptation energy; it filled up my tank and kept me from feeling like I was going to lose it at 10 o’clock in the morning.”
Dr. Rockwell explained burnout as an overactive fight or flight response activated by the amygdala. It starts pumping cortisol, our pupils dilate, and our pores open. The prefrontal cortex is offline when we’re experiencing this physiological response because they both can’t be operational at the same time. “When we’re constantly in a ‘fight or flight’ response and don’t have any access to our prefrontal cortex, we are coming from a brain that is pumping cortisol and that leads to burnout,” said Dr. Rockwell.
“Any fight or flight response leaves a mark on your body,” Dr. Wener echoed. “When we go into our state of deep rest in the meditation practice, which is two to five times more restful than sleep, it heals those stress scars.”
Making time for mindfulness
Prescribing mindfulness for physicians is not new. Molecular biologist Jon Kabat-Zinn, PhD, developed Mindfulness-Based Stress Reduction (MBSR) in 1979, a practice that incorporates mindfulness exercises to help people become familiar with their behavior patterns in stressful situations. Thus, instead of reacting, they can respond with a clearer understanding of the circumstance. Dr. Kabat-Zinn initially targeted people with chronic health problems to help them cope with the effects of pain and the condition of their illness, but it has expanded to anyone experiencing challenges in their life, including physicians. A standard MBSR course runs 8 weeks, making it a commitment for most people.
Mindfulness training requires that physicians use what they already have so little of: time.
Dr. Wener was able to take a sabbatical, embarking on a 3-month trip to India to immerse herself in the study of Vedic Meditation. Upon her return, Dr. Wener took a position at Emory University, Atlanta, and has launched a number of CME-accredited meditation courses and retreats. Unlike Dr. Kabat-Zinn, her programs are by physicians and for physicians. She also created an online version of the meditation course to make it more accessible.
For these reasons, Kara Pepper, MD, an internist in outpatient primary care in Atlanta, was drawn to the meditation course. Dr. Pepper was 7 years into practice when she burned out. “The program dovetailed into my burnout recovery,” she said. “It allowed me space to separate myself from the thoughts I was having about work and just recognize them as just that – as thoughts.”
In the course, Dr. Wener teaches the REST Technique, which she says is different than mindfulness in that she encourages the mind to run rampant. “Trying to control the mind can feel very uncomfortable because we always have thoughts,” she says. “We can’t tell the mind to stop thinking just like we can’t tell the heart to stop beating.” Dr. Wener said the REST Technique lets “the mind swim downstream,” allowing the brain to go into a deep state of rest and start to heal from the scars caused by stress.
Dr. Pepper said the self-paced online course gave her all the tools she needed, and it was pragmatic and evidence based. “I didn’t feel ‘woo’ or like another gimmick,” she said. Pepper, who continues to practice medicine, became a life coach in 2019 to teach others the skills she uses daily.
An integrated strategy
In a review published in The American Journal of Medicine in 2019, Scott Yates, MD, MBA, from the Center for Executive Medicine in Plano, Tex., found that physicians who had adopted mediation and mindfulness training to decrease anxiety and perceived work stress only experienced modest benefits. In fact, Dr. Yates claims that there’s little data to suggest the long-term benefit of any particular stress management intervention in the prevention of burnout symptoms.
“The often-repeated goals of the Triple Aim [enhancing patient experience, improving population health, and reducing costs] may be unreachable until we recognize and address burnout in health care providers,” Dr. Yates wrote. He recommends adding a fourth goal to specifically address physician wellness, which certainly could include mindfulness training and meditation.
Burnout coach, trainer, and consultant Dike Drummond, MD, also professes that physician wellness must be added as the key fourth ingredient to improving health care. “Burnout is a dilemma, a balancing act,” he said. “It takes an integrated strategy.” The CEO and founder of TheHappyMD.com, Dr. Drummond’s integrated strategy to stop physician burnout has been taught to more than 40,000 physicians in 175 organizations, and one element of that strategy can be mindfulness training.
Dr. Drummond said he doesn’t use the word meditation “because that scares most people”; it takes a commitment and isn’t accessible for a lot of doctors. Instead, he coaches doctors to use a ‘single-breath’ technique to help them reset multiple times throughout the day. “I teach people how to breathe up to the top of their head and then down to the bottom of their feet,” Dr. Drummond said. He calls it the Squeegee Breath Technique because when they exhale, they “wipe away” anything that doesn’t need to be there right now. “If you happen to have a mindfulness practice like meditation, they work synergistically because the calmness you feel in your mediation is available to you at the bottom of these releasing breaths.”
Various studies and surveys provide great detail as to the “why” of physician burnout. And while mindfulness is not the sole answer, it’s something physicians can explore for themselves while health care as an industry looks for a more comprehensive solution.
“It’s not rocket science,” Dr. Drummond insisted. “You want a different result? You’re not satisfied with the way things are now and you want to feel different? You absolutely must do something different.”
A version of this article first appeared on Medscape.com.
In 2011, the Mayo Clinic began surveying physicians about burnout and found 45% of physicians experienced at least one symptom, such as emotional exhaustion, finding work no longer meaningful, feelings of ineffectiveness, and depersonalizing patients. Associated manifestations can range from headache and insomnia to impaired memory and decreased attention.
Fast forward 10 years to the Medscape National Physician Burnout and Suicide Report, which found that a similar number of physicians (42%) feel burned out. The COVID-19 pandemic only added insult to injury. A Medscape survey that included nearly 5,000 U.S. physicians revealed that about two-thirds (64%) of them reported burnout had intensified during the crisis.
These elevated numbers are being labeled as “a public health crisis” for the impact widespread physician burnout could have on the health of the doctor and patient safety. The relatively consistent levels across the decade seem to suggest that, if health organizations are attempting to improve physician well-being, it doesn’t appear to be working, forcing doctors to find solutions for themselves.
Jill Wener, MD, considers herself part of the 45% burned out 10 years ago. She was working as an internist at Rush University Medical Center in Chicago, but the “existential reality of being a doctor in this world” was wearing on her. “Staying up with the literature, knowing that every day you’re going to go into work without knowing what you’re going to find, threats of lawsuits, the pressure of perfectionism,” Dr. Wener told this news organization. “By the time I hit burnout, everything made me feel like the world was crashing down on me.”
When Dr. Wener encountered someone who meditated twice a day, she was intrigued, even though the self-described “most Type-A, inside-the-box, nonspiritual type, anxious, linear-path doctor” didn’t think people like her could meditate. Dr. Wener is not alone in her hesitation to explore meditation as a means to help prevent burnout because the causes of burnout are primarily linked to external rather than internal factors. Issues including a loss of autonomy, the burden and distraction of electronic health records, and the intense pressure to comply with rules from the government are not things mindfulness can fix.
And because the sources of burnout are primarily environmental and inherent to the current medical system, the suggestion that physicians need to fix themselves with meditation can come as a slap in the face. However, when up against a system slow to change, mindfulness can provide physicians access to the one thing they can control: How they perceive and react to what’s in front of them.
At the recommendation of an acquaintance, Dr. Wener enrolled in a Vedic Meditation (also known as Conscious Health Meditation) course taught by Light Watkins, a well-known traveling instructor, author, and speaker. By the second meeting she was successfully practicing 20 minutes twice a day. This form of mediation traces its roots to the Vedas, ancient Indian texts (also the foundation for yoga), and uses a mantra to settle the mind, transitioning to an awake state of inner contentment.
Three weeks later, Dr. Wener’s daily crying jags ended as did her propensity for road rage. “I felt like I was on the cusp of something life-changing, I just didn’t understand it,” she recalled. “But I knew I was never going to give it up.”
Defining mindfulness
“Mindfulness is being able to be present in the moment that you’re in with acceptance of what it is and without judging it,” said Donna Rockwell, PsyD, a leading mindfulness meditation teacher. The practice of mindfulness is really meditation. Dr. Rockwell explained that the noise of our mind is most often focused on either the past or the future. “We’re either bemoaning something that happened earlier or we’re catastrophizing the future,” she said, which prevents us from being present in the moment.
Meditation allows you to notice when your mind has drifted from the present moment into the past or future. “You gently notice it, label it with a lot of self-compassion, and then bring your mind back by focusing on your breath – going out, going in – and the incoming stimuli through your five senses,” said Dr. Rockwell. “When you’re doing that, you can’t be in the past or future.”
Dr. Rockwell also pointed out that we constantly categorize incoming data of the moment as either “good for me or bad for me,” which gets in the way of simply being present for what you’re facing. “When you’re more fully present, you become more skillful and able to do what this moment is asking of you,” she said. Being mindful allows us to better navigate incoming stimuli, which could be a “code blue” in the ED or a patient who needs another 2 minutes during an office visit.
When Dr. Wener was burned out, she felt unable to adapt whenever something unexpected happened. “When you have no emotional reserves, everything feels like a big deal,” she said. “The meditation gave me what we call adaptation energy; it filled up my tank and kept me from feeling like I was going to lose it at 10 o’clock in the morning.”
Dr. Rockwell explained burnout as an overactive fight or flight response activated by the amygdala. It starts pumping cortisol, our pupils dilate, and our pores open. The prefrontal cortex is offline when we’re experiencing this physiological response because they both can’t be operational at the same time. “When we’re constantly in a ‘fight or flight’ response and don’t have any access to our prefrontal cortex, we are coming from a brain that is pumping cortisol and that leads to burnout,” said Dr. Rockwell.
“Any fight or flight response leaves a mark on your body,” Dr. Wener echoed. “When we go into our state of deep rest in the meditation practice, which is two to five times more restful than sleep, it heals those stress scars.”
Making time for mindfulness
Prescribing mindfulness for physicians is not new. Molecular biologist Jon Kabat-Zinn, PhD, developed Mindfulness-Based Stress Reduction (MBSR) in 1979, a practice that incorporates mindfulness exercises to help people become familiar with their behavior patterns in stressful situations. Thus, instead of reacting, they can respond with a clearer understanding of the circumstance. Dr. Kabat-Zinn initially targeted people with chronic health problems to help them cope with the effects of pain and the condition of their illness, but it has expanded to anyone experiencing challenges in their life, including physicians. A standard MBSR course runs 8 weeks, making it a commitment for most people.
Mindfulness training requires that physicians use what they already have so little of: time.
Dr. Wener was able to take a sabbatical, embarking on a 3-month trip to India to immerse herself in the study of Vedic Meditation. Upon her return, Dr. Wener took a position at Emory University, Atlanta, and has launched a number of CME-accredited meditation courses and retreats. Unlike Dr. Kabat-Zinn, her programs are by physicians and for physicians. She also created an online version of the meditation course to make it more accessible.
For these reasons, Kara Pepper, MD, an internist in outpatient primary care in Atlanta, was drawn to the meditation course. Dr. Pepper was 7 years into practice when she burned out. “The program dovetailed into my burnout recovery,” she said. “It allowed me space to separate myself from the thoughts I was having about work and just recognize them as just that – as thoughts.”
In the course, Dr. Wener teaches the REST Technique, which she says is different than mindfulness in that she encourages the mind to run rampant. “Trying to control the mind can feel very uncomfortable because we always have thoughts,” she says. “We can’t tell the mind to stop thinking just like we can’t tell the heart to stop beating.” Dr. Wener said the REST Technique lets “the mind swim downstream,” allowing the brain to go into a deep state of rest and start to heal from the scars caused by stress.
Dr. Pepper said the self-paced online course gave her all the tools she needed, and it was pragmatic and evidence based. “I didn’t feel ‘woo’ or like another gimmick,” she said. Pepper, who continues to practice medicine, became a life coach in 2019 to teach others the skills she uses daily.
An integrated strategy
In a review published in The American Journal of Medicine in 2019, Scott Yates, MD, MBA, from the Center for Executive Medicine in Plano, Tex., found that physicians who had adopted mediation and mindfulness training to decrease anxiety and perceived work stress only experienced modest benefits. In fact, Dr. Yates claims that there’s little data to suggest the long-term benefit of any particular stress management intervention in the prevention of burnout symptoms.
“The often-repeated goals of the Triple Aim [enhancing patient experience, improving population health, and reducing costs] may be unreachable until we recognize and address burnout in health care providers,” Dr. Yates wrote. He recommends adding a fourth goal to specifically address physician wellness, which certainly could include mindfulness training and meditation.
Burnout coach, trainer, and consultant Dike Drummond, MD, also professes that physician wellness must be added as the key fourth ingredient to improving health care. “Burnout is a dilemma, a balancing act,” he said. “It takes an integrated strategy.” The CEO and founder of TheHappyMD.com, Dr. Drummond’s integrated strategy to stop physician burnout has been taught to more than 40,000 physicians in 175 organizations, and one element of that strategy can be mindfulness training.
Dr. Drummond said he doesn’t use the word meditation “because that scares most people”; it takes a commitment and isn’t accessible for a lot of doctors. Instead, he coaches doctors to use a ‘single-breath’ technique to help them reset multiple times throughout the day. “I teach people how to breathe up to the top of their head and then down to the bottom of their feet,” Dr. Drummond said. He calls it the Squeegee Breath Technique because when they exhale, they “wipe away” anything that doesn’t need to be there right now. “If you happen to have a mindfulness practice like meditation, they work synergistically because the calmness you feel in your mediation is available to you at the bottom of these releasing breaths.”
Various studies and surveys provide great detail as to the “why” of physician burnout. And while mindfulness is not the sole answer, it’s something physicians can explore for themselves while health care as an industry looks for a more comprehensive solution.
“It’s not rocket science,” Dr. Drummond insisted. “You want a different result? You’re not satisfied with the way things are now and you want to feel different? You absolutely must do something different.”
A version of this article first appeared on Medscape.com.