Hematology News

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

More than half of research on homeopathic remedies is unpublished or unregistered, according to a new analysis.

Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.

The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.

The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.

The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.

“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.

Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.

According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.

Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
 

Study methods and findings

The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.

The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.

To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.

They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.

The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.

The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
 

Proceed with caution before recommending use of homeopathic remedies, says expert

Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.

The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.

“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”

Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.

Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.

“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.

At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.

“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.

Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.

“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”

The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.

Armed with data from multiple studies about how to implement goal-setting in hemophilia, a national nonprofit organization has released a free app designed to help patients track their illness and develop and monitor their objectives.

Robust Health, available for the iPhone and Android, “can really enhance the physician-patient relationship. This is a good approach to capture the many facets of what’s important to patients and help them improve their therapy management in their lives,” Jonathan C. Roberts, MD, a hematologist/oncologist at the University of Illinois at Peoria, said in an interview.

Working with colleagues, Dr. Roberts helped the app developer, the American Thrombosis and Hemostasis Network, devise the app’s goal-setting tool. Researchers reported their findings on the tool – known as Goal Attainment Scaling for Hemophilia, or “GOAL‐Hēm” – in a series of studies that emphasized the importance of including the “patient voice.”

The tool was developed to monitor patient outcomes in terms of “meaningful change,” beyond data points such as annualized bleed rate, Dr. Roberts said.

“Metrics like this are definitely important to joint health and quality of life,” he said, but researchers hoped to expand to more outcomes that matter to patients.

Consider a pediatric patient, for example, who may set a goal of preparing his or her clotting-factor treatment and making one attempt at a puncture. The tool allows a benchmark and timetable to be set up, Dr. Roberts said, and can provide both positive reinforcement and a score that reflects how well the patient is doing. “That really can help the multidisciplinary treatment team measure improvements in the patient’s overall treatment adherence.”

For the most recent study, published in the January 2022 issue of Research and Practice in Thrombosis and Haemostasis, researchers interviewed 19 adult patients with hemophilia (mean age 35, 68% male) and 19 caregivers of children with hemophilia (mean age of children 13, 83% male) about the language used in the tool. They responded in surveys, interviews, and focus groups.

“Thematic analysis indicated that participants were enthusiastic about patient‐centric language, empowered through the goal‐setting process, and recognized GOAL‐Hēm could measure clinically meaningful change,” the researchers reported.

They wrote that the participants kept 15 of 48 goals unchanged (32%), modified or deleted the others, and added three new goals. Their revisions included renaming one goal “bleeds,” instead of both“muscle bleeds” and “bleeds.” They renamed “work attendance” and “career planning” as simply “work.” “Depression,” “feelings of anger” and “self-esteem” were consolidated as a new heading: “emotional well-being.”

Each goal provides answers that patients can use to respond to queries about how they’re doing. For example, under the pediatric goal of “independent self-care management,” a descriptor could be “Always sets their own reminders to self‐infuse. Mother never needs to remind them.” This answer would be considered “much better than expected.”

Out of 635 responses, known as “descriptors,” most (75%) were revised or deleted in response to input from patients and caregivers. In the end, the total number of answers was reduced to 368 – 218 in the adult section, and 150 in the pediatric section.

“Our study highlights the importance of patient engagement in developing the tool and how it can be used in day-to-day practice,” Dr. Roberts said.

Going forward, he said, “we’re hoping this tool could potentially be an important player in studies of new therapeutic options for patients. The metrics could be used as kind of a common language to measure how our patients are doing on a particular therapy.”

Jayson Stoffman, MD, a pediatric hematologist/oncologist at Children’s Hospital of Winnipeg and the University of Manitoba, who was not involved in the research, welcomed the new app.

“The big challenge is always how to balance hemophilia and its management against the lifestyle needs and wants of the individual,” Dr. Stoffman said in an interview. “We don’t want people to be held back by their hemophilia, so it’s important to find the best ways to support them in their choices while optimizing their management.”

An app that helps patients define and delineate goals will be a “great benchmark to use in making treatment decisions and adjustments,” he said.

The study was funded by Takeda. Dr. Roberts disclosed grants and/or contracts from Takeda and consulting fees from Sanofi Genzyme, Takeda, Octapharma, uniQure, Novo Nordisk, Pfizer, Spark, and CSL Behring. The other authors reported various disclosures. Dr. Stoffman disclosed a consulting agreement with F. Hoffman La Roche AG.

Armed with data from multiple studies about how to implement goal-setting in hemophilia, a national nonprofit organization has released a free app designed to help patients track their illness and develop and monitor their objectives.

Robust Health, available for the iPhone and Android, “can really enhance the physician-patient relationship. This is a good approach to capture the many facets of what’s important to patients and help them improve their therapy management in their lives,” Jonathan C. Roberts, MD, a hematologist/oncologist at the University of Illinois at Peoria, said in an interview.

Working with colleagues, Dr. Roberts helped the app developer, the American Thrombosis and Hemostasis Network, devise the app’s goal-setting tool. Researchers reported their findings on the tool – known as Goal Attainment Scaling for Hemophilia, or “GOAL‐Hēm” – in a series of studies that emphasized the importance of including the “patient voice.”

The tool was developed to monitor patient outcomes in terms of “meaningful change,” beyond data points such as annualized bleed rate, Dr. Roberts said.

“Metrics like this are definitely important to joint health and quality of life,” he said, but researchers hoped to expand to more outcomes that matter to patients.

Consider a pediatric patient, for example, who may set a goal of preparing his or her clotting-factor treatment and making one attempt at a puncture. The tool allows a benchmark and timetable to be set up, Dr. Roberts said, and can provide both positive reinforcement and a score that reflects how well the patient is doing. “That really can help the multidisciplinary treatment team measure improvements in the patient’s overall treatment adherence.”

For the most recent study, published in the January 2022 issue of Research and Practice in Thrombosis and Haemostasis, researchers interviewed 19 adult patients with hemophilia (mean age 35, 68% male) and 19 caregivers of children with hemophilia (mean age of children 13, 83% male) about the language used in the tool. They responded in surveys, interviews, and focus groups.

“Thematic analysis indicated that participants were enthusiastic about patient‐centric language, empowered through the goal‐setting process, and recognized GOAL‐Hēm could measure clinically meaningful change,” the researchers reported.

They wrote that the participants kept 15 of 48 goals unchanged (32%), modified or deleted the others, and added three new goals. Their revisions included renaming one goal “bleeds,” instead of both“muscle bleeds” and “bleeds.” They renamed “work attendance” and “career planning” as simply “work.” “Depression,” “feelings of anger” and “self-esteem” were consolidated as a new heading: “emotional well-being.”

Each goal provides answers that patients can use to respond to queries about how they’re doing. For example, under the pediatric goal of “independent self-care management,” a descriptor could be “Always sets their own reminders to self‐infuse. Mother never needs to remind them.” This answer would be considered “much better than expected.”

Out of 635 responses, known as “descriptors,” most (75%) were revised or deleted in response to input from patients and caregivers. In the end, the total number of answers was reduced to 368 – 218 in the adult section, and 150 in the pediatric section.

“Our study highlights the importance of patient engagement in developing the tool and how it can be used in day-to-day practice,” Dr. Roberts said.

Going forward, he said, “we’re hoping this tool could potentially be an important player in studies of new therapeutic options for patients. The metrics could be used as kind of a common language to measure how our patients are doing on a particular therapy.”

Jayson Stoffman, MD, a pediatric hematologist/oncologist at Children’s Hospital of Winnipeg and the University of Manitoba, who was not involved in the research, welcomed the new app.

“The big challenge is always how to balance hemophilia and its management against the lifestyle needs and wants of the individual,” Dr. Stoffman said in an interview. “We don’t want people to be held back by their hemophilia, so it’s important to find the best ways to support them in their choices while optimizing their management.”

An app that helps patients define and delineate goals will be a “great benchmark to use in making treatment decisions and adjustments,” he said.

The study was funded by Takeda. Dr. Roberts disclosed grants and/or contracts from Takeda and consulting fees from Sanofi Genzyme, Takeda, Octapharma, uniQure, Novo Nordisk, Pfizer, Spark, and CSL Behring. The other authors reported various disclosures. Dr. Stoffman disclosed a consulting agreement with F. Hoffman La Roche AG.

Armed with data from multiple studies about how to implement goal-setting in hemophilia, a national nonprofit organization has released a free app designed to help patients track their illness and develop and monitor their objectives.

Robust Health, available for the iPhone and Android, “can really enhance the physician-patient relationship. This is a good approach to capture the many facets of what’s important to patients and help them improve their therapy management in their lives,” Jonathan C. Roberts, MD, a hematologist/oncologist at the University of Illinois at Peoria, said in an interview.

Working with colleagues, Dr. Roberts helped the app developer, the American Thrombosis and Hemostasis Network, devise the app’s goal-setting tool. Researchers reported their findings on the tool – known as Goal Attainment Scaling for Hemophilia, or “GOAL‐Hēm” – in a series of studies that emphasized the importance of including the “patient voice.”

The tool was developed to monitor patient outcomes in terms of “meaningful change,” beyond data points such as annualized bleed rate, Dr. Roberts said.

“Metrics like this are definitely important to joint health and quality of life,” he said, but researchers hoped to expand to more outcomes that matter to patients.

Consider a pediatric patient, for example, who may set a goal of preparing his or her clotting-factor treatment and making one attempt at a puncture. The tool allows a benchmark and timetable to be set up, Dr. Roberts said, and can provide both positive reinforcement and a score that reflects how well the patient is doing. “That really can help the multidisciplinary treatment team measure improvements in the patient’s overall treatment adherence.”

For the most recent study, published in the January 2022 issue of Research and Practice in Thrombosis and Haemostasis, researchers interviewed 19 adult patients with hemophilia (mean age 35, 68% male) and 19 caregivers of children with hemophilia (mean age of children 13, 83% male) about the language used in the tool. They responded in surveys, interviews, and focus groups.

“Thematic analysis indicated that participants were enthusiastic about patient‐centric language, empowered through the goal‐setting process, and recognized GOAL‐Hēm could measure clinically meaningful change,” the researchers reported.

They wrote that the participants kept 15 of 48 goals unchanged (32%), modified or deleted the others, and added three new goals. Their revisions included renaming one goal “bleeds,” instead of both“muscle bleeds” and “bleeds.” They renamed “work attendance” and “career planning” as simply “work.” “Depression,” “feelings of anger” and “self-esteem” were consolidated as a new heading: “emotional well-being.”

Each goal provides answers that patients can use to respond to queries about how they’re doing. For example, under the pediatric goal of “independent self-care management,” a descriptor could be “Always sets their own reminders to self‐infuse. Mother never needs to remind them.” This answer would be considered “much better than expected.”

Out of 635 responses, known as “descriptors,” most (75%) were revised or deleted in response to input from patients and caregivers. In the end, the total number of answers was reduced to 368 – 218 in the adult section, and 150 in the pediatric section.

“Our study highlights the importance of patient engagement in developing the tool and how it can be used in day-to-day practice,” Dr. Roberts said.

Going forward, he said, “we’re hoping this tool could potentially be an important player in studies of new therapeutic options for patients. The metrics could be used as kind of a common language to measure how our patients are doing on a particular therapy.”

Jayson Stoffman, MD, a pediatric hematologist/oncologist at Children’s Hospital of Winnipeg and the University of Manitoba, who was not involved in the research, welcomed the new app.

“The big challenge is always how to balance hemophilia and its management against the lifestyle needs and wants of the individual,” Dr. Stoffman said in an interview. “We don’t want people to be held back by their hemophilia, so it’s important to find the best ways to support them in their choices while optimizing their management.”

An app that helps patients define and delineate goals will be a “great benchmark to use in making treatment decisions and adjustments,” he said.

The study was funded by Takeda. Dr. Roberts disclosed grants and/or contracts from Takeda and consulting fees from Sanofi Genzyme, Takeda, Octapharma, uniQure, Novo Nordisk, Pfizer, Spark, and CSL Behring. The other authors reported various disclosures. Dr. Stoffman disclosed a consulting agreement with F. Hoffman La Roche AG.

Chernobyl. Fukushima. Three Mile Island.

The world knows these names all too well because of accidents there: complete or partial meltdowns of nuclear reactors that released massive amounts of cancer-causing radiation into the air, soil, and water.

The Santa Susana Field Lab is far less well-known, but no less infamous for what took place at this former rocket engine and nuclear energy test site just 28 miles northwest of downtown Los Angeles.

In July 1959, an accident involving one of 10 experimental nuclear reactors at the SSFL site released a cloud of harmful radiation and toxic chemicals over the surrounding area, including Simi Valley, San Gabriel Valley, Chatsworth, and Canoga Park. The small reactor had no containment vessel.

This accident resulted in a release of radioactive iodine estimated to be as much as 250 times that of the partial meltdown that would occur 2 decades later at Three Mile Island, a much larger commercial reactor that had a containment vessel.

Six decades later, hundreds of potentially carcinogenic chemicals remain in the surrounding environment. And local children are being diagnosed with rare cancers at a rate that far outpaces what experts would predict.
 

Decades-long cover-up

In 1959, the public knew nothing about what happened at the site.

According to John Pace, then an employee at SSFL, the accident was covered up. Mr. Pace recounted the cover-up in the documentary “In the Dark of the Valley,” which first aired in November 2021 on MSNBC.

In fact, the accident at SSFL remained under wraps for 2 decades, according to Daniel Hirsch, former director of the Program on Environmental and Nuclear Policy at the University of California, Santa Cruz, and now president of Committee to Bridge the Gap, a nuclear policy nongovernmental organization.

“Students working with me while I was teaching at UCLA in 1979 uncovered these Atomic Energy Commission reports from Atomics International,” he said in an interview. “We had to order the documents from the annex to the UCLA Engineering Library. They were stored offsite, and it took a few days, and when we got them, we opened them up, and there were these fold-out photographs of the fuel [rods]. As we folded out the photographs further, we saw one photo with an arrow labeled ‘longitudinal cracks,’ and then other arrows showing other kinds of cracks, and then another arrow labeled ‘melted blob.’ ”

Mr. Hirsch and his students found that other accidents had occurred at SSFL, including a fuel fabrication system that leached plutonium, fires in a “hot” lab where irradiated nuclear fuel from around the United States was handled, and open-air burn pits where radioactive and toxic chemical wastes were illegally torched.

According to the Committee to Bridge the Gap, when the 2,800-acre SSFL site was being developed under the name Rocketdyne by aircraft maker North American Aviation, the area was sparsely populated, with nearly as many grazing animals as people in its hills and valleys.

North American Aviation later became part of Rockwell International, which in turn sold its aerospace and defense business units to the Boeing Company in 1996. Boeing, now in charge of the site and the cleanup efforts, is doing everything in its power to shirk or diminish its responsibility, Mr. Hirsch and other critics say.
 

Parents against SSFL

Today, more than 150,000 people live within 5 miles of SSFL, and more than half a million live within 10 miles.

Melissa Bumstead is one of those residents. She and her family live 3.7 miles from the Santa Susana site. When her toddler Grace was diagnosed with a rare form of leukemia in 2014, doctors told Ms. Bumstead there were no known links between her daughter’s cancer and environmental contamination.

But during Grace’s treatment at Children’s Hospital Los Angeles, her mother began meeting other parents who lived near her and had children facing equally rare cancers.

Lauren Hammersley, whose daughter Hazel was diagnosed with a rare brain tumor called neuroblastoma at age 2, lived about 10 miles from Ms. Bumstead on the other side of a mountain and just over 4 miles from SSFL.

On her street alone, Ms. Bumstead discovered three cases of pediatric cancer, including two children in adjacent homes who had the same rare brain tumor as Hazel Hammersley.

As Ms. Bumstead told Los Angeles National Public Radio station KCRW in 2021, “I started to panic because I knew that childhood cancer is extremely rare. There’s only 15,000 new cases every year out of 72 million children in America. So, the chance of knowing your neighbors, especially at an internationally renowned hospital like Children’s Hospital Los Angeles – we knew something wasn’t right.”

After a relapse of her tumor, Hazel died in 2018, a few months after her seventh birthday.
 

Cancer clusters

Hoping to understand why their kids were getting so sick, Ms. Bumstead and the other parents formed a Facebook group. They plotted their homes on Google Maps and found that they all lived within roughly 10 miles of one another. It would take another year for them to realize that the SSFL site was at the center of the circle.

Once they realized that being close to SSFL could be their common thread, Ms. Bumstead and parents in her group began to gradually piece together the story, linking unusual or unexplained illnesses in their families to potential radiation or toxic chemical exposures from the lab.

“What really convinced me that this was absolutely a problem was when I learned about the epidemiological study by Dr. Hal Morgenstern that found that residents living within 2 miles of the Santa Susana Field Lab actually had a 60% higher cancer incidence rate and that over 1,500 workers have been diagnosed with cancer just from the Santa Susana Field Lab,” she told KCRW.

In 2015, Ms. Bumstead and other parents formed Parents Against Santa Susana Field Lab to hold SSFL site owner Boeing accountable for radiologic and toxic contamination and to ensure that Boeing cleans the site and surrounding areas. The group “seeks to reduce, to the greatest extent possible, the number of local families who have to hear the words, ‘Your child has cancer.’ ”
 

No longer quite so rare

Dr. Morgenstern, now retired from the University of Michigan, declined to be interviewed for this article. But as he and colleagues reported to the Centers for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry in 2007, there were strong signs of a link between contamination of the site and cancer.

The researchers compared cancer rates of adults living within 2 miles and 2-5 miles from SSFL with those of adults living more than 5 miles away, in Ventura and Los Angeles counties. They found that from 1988 through 1995, residents living within 2 miles of SSFL had a 60% higher rate of cancers than the control group. These included cancers of the thyroid, oral and nasal cavities, pharynx, larynx, esophagus, and bladder, as well as blood cancers such as leukemia, lymphoma, and multiple myeloma.

In separate studies, the investigators found higher rates of certain cancers among workers at SSFL who were exposed to radiation and to hydrazine, a chemical in rocket fuel.

In an interview, Dr. Saro Armenian, a pediatric hematologist-oncologist who was not involved in the studies, said the 60% increase in cancer incidence, which translated into a 1.6-fold increase in risk, merits more investigation.

“In epidemiologic studies, a 1.6-fold risk is actually a pretty strong signal because typically, most signals that you get are somewhere around 1.1- to 1.2-fold increased risk,” noted Dr. Armenian, a specialist in pediatric cancer survivorship and outcomes at City of Hope National Medical Center in Duarte, Calif.

However, Dr. Thomas Mack, former director of the Los Angeles County Cancer Surveillance Program, contends that there is insufficient evidence to support a direct link between the 1959 reactor accident and recent incident cancers. Dr. Mack is currently a professor of preventive medicine and pathology at the University of Southern California in Los Angeles.

“I have evaluated concerns about local excesses of cancer at least 100 times, usually from county residents, but for a while I represented the CDC and the California cancer registry,” Dr. Mack said, in response to an emailed request for comment.

“So far I have seen no evidence of carcinogenic radionucleotides or chemical carcinogens from Santa Susana found in any meaningful amount in any nearby community, but if someone has such evidence that would constitute evidence, that needs a response,” Dr. Mack added.
 

Boeing and California

Boeing has said problems at SSFL were not responsible for the high cancer rates among children in the community.

In April 2007, in a statement opposing a bill before the California State Legislature that would compel Boeing to pay for SSFL site cleanup, the company said that “in contrast to the accusations made against The Boeing Company that falsely claim increased cancer rates in the communities surrounding SSFL, a recent study conducted by the University of Michigan School of Public Health just concluded the opposite.”

Yet as Dr. Morgenstern wrote in 2007 to California state Sen. Joe Simitian, then chair of the Committee on Environmental Quality: “For the period 1996 through 2002, we found that the incidence rate of thyroid cancer was more than 60% greater among residents living within 2 miles of SSFL than for residents living more than 5 miles from SSFL. The magnitude and consistency of the thyroid finding for both periods is especially provocative because of evidence from other studies linking thyroid cancer with environmental exposures originating at SSFL and found in the surrounding communities.”

Boeing chose to ignore the results and instead focused on the methods used in the study, where the authors acknowledged that they measured distance from the site rather than environmental exposures and thus could not conclusively link excess cancer rates to exposures arising from SSFL.

But Dr. Morgenstern emphasized the conclusion of the report: “Despite the methodologic limitations of this study, the findings suggest there may be elevated incidence rates of certain cancers near SSFL that have been linked in previous studies with hazardous substances used at Rocketdyne, some of which have been observed or projected to exist offsite.”
 

Failure to come clean

In 2008, a law that set standards for cleanup of the site was passed. But the law was overturned in 2014 after a legal challenge by Boeing.

That left in place a 2007 order of consent between Boeing, NASA, the U.S. Department of Energy, and the California Department of Toxic Substances Control (DTSC) that required cleanup of SSFL to a much less stringent standard.

As of last year, Boeing and DTSC had begun confidential, nonbinding agreements regarding the 2007 order of consent, according to Parents Against SSFL.

Among the contaminants lingering at the site are radioactive particles, chemical compounds, heavy metals, and polluted water.

“In fact, over 300 contaminants of concern have been found at the site, and they are refusing to clean it,” Mr. Hirsch said. “This company releases large amounts of carcinogens, and perhaps significant numbers of people get sick with cancer, and the company doesn’t go to prison. They get more federal contracts.”

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

April 20, 2022 – Editor’s note: This article has been updated to include an interview with Dr. Thomas Mack, former director of the Los Angeles County Cancer Surveillance Program, who contends that there is insufficient evidence to support a direct link between the 1959 reactor accident and recent incident cancers.

Chernobyl. Fukushima. Three Mile Island.

The world knows these names all too well because of accidents there: complete or partial meltdowns of nuclear reactors that released massive amounts of cancer-causing radiation into the air, soil, and water.

The Santa Susana Field Lab is far less well-known, but no less infamous for what took place at this former rocket engine and nuclear energy test site just 28 miles northwest of downtown Los Angeles.

In July 1959, an accident involving one of 10 experimental nuclear reactors at the SSFL site released a cloud of harmful radiation and toxic chemicals over the surrounding area, including Simi Valley, San Gabriel Valley, Chatsworth, and Canoga Park. The small reactor had no containment vessel.

This accident resulted in a release of radioactive iodine estimated to be as much as 250 times that of the partial meltdown that would occur 2 decades later at Three Mile Island, a much larger commercial reactor that had a containment vessel.

Six decades later, hundreds of potentially carcinogenic chemicals remain in the surrounding environment. And local children are being diagnosed with rare cancers at a rate that far outpaces what experts would predict.
 

Decades-long cover-up

In 1959, the public knew nothing about what happened at the site.

According to John Pace, then an employee at SSFL, the accident was covered up. Mr. Pace recounted the cover-up in the documentary “In the Dark of the Valley,” which first aired in November 2021 on MSNBC.

In fact, the accident at SSFL remained under wraps for 2 decades, according to Daniel Hirsch, former director of the Program on Environmental and Nuclear Policy at the University of California, Santa Cruz, and now president of Committee to Bridge the Gap, a nuclear policy nongovernmental organization.

“Students working with me while I was teaching at UCLA in 1979 uncovered these Atomic Energy Commission reports from Atomics International,” he said in an interview. “We had to order the documents from the annex to the UCLA Engineering Library. They were stored offsite, and it took a few days, and when we got them, we opened them up, and there were these fold-out photographs of the fuel [rods]. As we folded out the photographs further, we saw one photo with an arrow labeled ‘longitudinal cracks,’ and then other arrows showing other kinds of cracks, and then another arrow labeled ‘melted blob.’ ”

Mr. Hirsch and his students found that other accidents had occurred at SSFL, including a fuel fabrication system that leached plutonium, fires in a “hot” lab where irradiated nuclear fuel from around the United States was handled, and open-air burn pits where radioactive and toxic chemical wastes were illegally torched.

According to the Committee to Bridge the Gap, when the 2,800-acre SSFL site was being developed under the name Rocketdyne by aircraft maker North American Aviation, the area was sparsely populated, with nearly as many grazing animals as people in its hills and valleys.

North American Aviation later became part of Rockwell International, which in turn sold its aerospace and defense business units to the Boeing Company in 1996. Boeing, now in charge of the site and the cleanup efforts, is doing everything in its power to shirk or diminish its responsibility, Mr. Hirsch and other critics say.
 

Parents against SSFL

Today, more than 150,000 people live within 5 miles of SSFL, and more than half a million live within 10 miles.

Melissa Bumstead is one of those residents. She and her family live 3.7 miles from the Santa Susana site. When her toddler Grace was diagnosed with a rare form of leukemia in 2014, doctors told Ms. Bumstead there were no known links between her daughter’s cancer and environmental contamination.

But during Grace’s treatment at Children’s Hospital Los Angeles, her mother began meeting other parents who lived near her and had children facing equally rare cancers.

Lauren Hammersley, whose daughter Hazel was diagnosed with a rare brain tumor called neuroblastoma at age 2, lived about 10 miles from Ms. Bumstead on the other side of a mountain and just over 4 miles from SSFL.

On her street alone, Ms. Bumstead discovered three cases of pediatric cancer, including two children in adjacent homes who had the same rare brain tumor as Hazel Hammersley.

As Ms. Bumstead told Los Angeles National Public Radio station KCRW in 2021, “I started to panic because I knew that childhood cancer is extremely rare. There’s only 15,000 new cases every year out of 72 million children in America. So, the chance of knowing your neighbors, especially at an internationally renowned hospital like Children’s Hospital Los Angeles – we knew something wasn’t right.”

After a relapse of her tumor, Hazel died in 2018, a few months after her seventh birthday.
 

Cancer clusters

Hoping to understand why their kids were getting so sick, Ms. Bumstead and the other parents formed a Facebook group. They plotted their homes on Google Maps and found that they all lived within roughly 10 miles of one another. It would take another year for them to realize that the SSFL site was at the center of the circle.

Once they realized that being close to SSFL could be their common thread, Ms. Bumstead and parents in her group began to gradually piece together the story, linking unusual or unexplained illnesses in their families to potential radiation or toxic chemical exposures from the lab.

“What really convinced me that this was absolutely a problem was when I learned about the epidemiological study by Dr. Hal Morgenstern that found that residents living within 2 miles of the Santa Susana Field Lab actually had a 60% higher cancer incidence rate and that over 1,500 workers have been diagnosed with cancer just from the Santa Susana Field Lab,” she told KCRW.

In 2015, Ms. Bumstead and other parents formed Parents Against Santa Susana Field Lab to hold SSFL site owner Boeing accountable for radiologic and toxic contamination and to ensure that Boeing cleans the site and surrounding areas. The group “seeks to reduce, to the greatest extent possible, the number of local families who have to hear the words, ‘Your child has cancer.’ ”
 

No longer quite so rare

Dr. Morgenstern, now retired from the University of Michigan, declined to be interviewed for this article. But as he and colleagues reported to the Centers for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry in 2007, there were strong signs of a link between contamination of the site and cancer.

The researchers compared cancer rates of adults living within 2 miles and 2-5 miles from SSFL with those of adults living more than 5 miles away, in Ventura and Los Angeles counties. They found that from 1988 through 1995, residents living within 2 miles of SSFL had a 60% higher rate of cancers than the control group. These included cancers of the thyroid, oral and nasal cavities, pharynx, larynx, esophagus, and bladder, as well as blood cancers such as leukemia, lymphoma, and multiple myeloma.

In separate studies, the investigators found higher rates of certain cancers among workers at SSFL who were exposed to radiation and to hydrazine, a chemical in rocket fuel.

In an interview, Dr. Saro Armenian, a pediatric hematologist-oncologist who was not involved in the studies, said the 60% increase in cancer incidence, which translated into a 1.6-fold increase in risk, merits more investigation.

“In epidemiologic studies, a 1.6-fold risk is actually a pretty strong signal because typically, most signals that you get are somewhere around 1.1- to 1.2-fold increased risk,” noted Dr. Armenian, a specialist in pediatric cancer survivorship and outcomes at City of Hope National Medical Center in Duarte, Calif.

However, Dr. Thomas Mack, former director of the Los Angeles County Cancer Surveillance Program, contends that there is insufficient evidence to support a direct link between the 1959 reactor accident and recent incident cancers. Dr. Mack is currently a professor of preventive medicine and pathology at the University of Southern California in Los Angeles.

“I have evaluated concerns about local excesses of cancer at least 100 times, usually from county residents, but for a while I represented the CDC and the California cancer registry,” Dr. Mack said, in response to an emailed request for comment.

“So far I have seen no evidence of carcinogenic radionucleotides or chemical carcinogens from Santa Susana found in any meaningful amount in any nearby community, but if someone has such evidence that would constitute evidence, that needs a response,” Dr. Mack added.
 

Boeing and California

Boeing has said problems at SSFL were not responsible for the high cancer rates among children in the community.

In April 2007, in a statement opposing a bill before the California State Legislature that would compel Boeing to pay for SSFL site cleanup, the company said that “in contrast to the accusations made against The Boeing Company that falsely claim increased cancer rates in the communities surrounding SSFL, a recent study conducted by the University of Michigan School of Public Health just concluded the opposite.”

Yet as Dr. Morgenstern wrote in 2007 to California state Sen. Joe Simitian, then chair of the Committee on Environmental Quality: “For the period 1996 through 2002, we found that the incidence rate of thyroid cancer was more than 60% greater among residents living within 2 miles of SSFL than for residents living more than 5 miles from SSFL. The magnitude and consistency of the thyroid finding for both periods is especially provocative because of evidence from other studies linking thyroid cancer with environmental exposures originating at SSFL and found in the surrounding communities.”

Boeing chose to ignore the results and instead focused on the methods used in the study, where the authors acknowledged that they measured distance from the site rather than environmental exposures and thus could not conclusively link excess cancer rates to exposures arising from SSFL.

But Dr. Morgenstern emphasized the conclusion of the report: “Despite the methodologic limitations of this study, the findings suggest there may be elevated incidence rates of certain cancers near SSFL that have been linked in previous studies with hazardous substances used at Rocketdyne, some of which have been observed or projected to exist offsite.”
 

Failure to come clean

In 2008, a law that set standards for cleanup of the site was passed. But the law was overturned in 2014 after a legal challenge by Boeing.

That left in place a 2007 order of consent between Boeing, NASA, the U.S. Department of Energy, and the California Department of Toxic Substances Control (DTSC) that required cleanup of SSFL to a much less stringent standard.

As of last year, Boeing and DTSC had begun confidential, nonbinding agreements regarding the 2007 order of consent, according to Parents Against SSFL.

Among the contaminants lingering at the site are radioactive particles, chemical compounds, heavy metals, and polluted water.

“In fact, over 300 contaminants of concern have been found at the site, and they are refusing to clean it,” Mr. Hirsch said. “This company releases large amounts of carcinogens, and perhaps significant numbers of people get sick with cancer, and the company doesn’t go to prison. They get more federal contracts.”

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

April 20, 2022 – Editor’s note: This article has been updated to include an interview with Dr. Thomas Mack, former director of the Los Angeles County Cancer Surveillance Program, who contends that there is insufficient evidence to support a direct link between the 1959 reactor accident and recent incident cancers.

Chernobyl. Fukushima. Three Mile Island.

The world knows these names all too well because of accidents there: complete or partial meltdowns of nuclear reactors that released massive amounts of cancer-causing radiation into the air, soil, and water.

The Santa Susana Field Lab is far less well-known, but no less infamous for what took place at this former rocket engine and nuclear energy test site just 28 miles northwest of downtown Los Angeles.

In July 1959, an accident involving one of 10 experimental nuclear reactors at the SSFL site released a cloud of harmful radiation and toxic chemicals over the surrounding area, including Simi Valley, San Gabriel Valley, Chatsworth, and Canoga Park. The small reactor had no containment vessel.

This accident resulted in a release of radioactive iodine estimated to be as much as 250 times that of the partial meltdown that would occur 2 decades later at Three Mile Island, a much larger commercial reactor that had a containment vessel.

Six decades later, hundreds of potentially carcinogenic chemicals remain in the surrounding environment. And local children are being diagnosed with rare cancers at a rate that far outpaces what experts would predict.
 

Decades-long cover-up

In 1959, the public knew nothing about what happened at the site.

According to John Pace, then an employee at SSFL, the accident was covered up. Mr. Pace recounted the cover-up in the documentary “In the Dark of the Valley,” which first aired in November 2021 on MSNBC.

In fact, the accident at SSFL remained under wraps for 2 decades, according to Daniel Hirsch, former director of the Program on Environmental and Nuclear Policy at the University of California, Santa Cruz, and now president of Committee to Bridge the Gap, a nuclear policy nongovernmental organization.

“Students working with me while I was teaching at UCLA in 1979 uncovered these Atomic Energy Commission reports from Atomics International,” he said in an interview. “We had to order the documents from the annex to the UCLA Engineering Library. They were stored offsite, and it took a few days, and when we got them, we opened them up, and there were these fold-out photographs of the fuel [rods]. As we folded out the photographs further, we saw one photo with an arrow labeled ‘longitudinal cracks,’ and then other arrows showing other kinds of cracks, and then another arrow labeled ‘melted blob.’ ”

Mr. Hirsch and his students found that other accidents had occurred at SSFL, including a fuel fabrication system that leached plutonium, fires in a “hot” lab where irradiated nuclear fuel from around the United States was handled, and open-air burn pits where radioactive and toxic chemical wastes were illegally torched.

According to the Committee to Bridge the Gap, when the 2,800-acre SSFL site was being developed under the name Rocketdyne by aircraft maker North American Aviation, the area was sparsely populated, with nearly as many grazing animals as people in its hills and valleys.

North American Aviation later became part of Rockwell International, which in turn sold its aerospace and defense business units to the Boeing Company in 1996. Boeing, now in charge of the site and the cleanup efforts, is doing everything in its power to shirk or diminish its responsibility, Mr. Hirsch and other critics say.
 

Parents against SSFL

Today, more than 150,000 people live within 5 miles of SSFL, and more than half a million live within 10 miles.

Melissa Bumstead is one of those residents. She and her family live 3.7 miles from the Santa Susana site. When her toddler Grace was diagnosed with a rare form of leukemia in 2014, doctors told Ms. Bumstead there were no known links between her daughter’s cancer and environmental contamination.

But during Grace’s treatment at Children’s Hospital Los Angeles, her mother began meeting other parents who lived near her and had children facing equally rare cancers.

Lauren Hammersley, whose daughter Hazel was diagnosed with a rare brain tumor called neuroblastoma at age 2, lived about 10 miles from Ms. Bumstead on the other side of a mountain and just over 4 miles from SSFL.

On her street alone, Ms. Bumstead discovered three cases of pediatric cancer, including two children in adjacent homes who had the same rare brain tumor as Hazel Hammersley.

As Ms. Bumstead told Los Angeles National Public Radio station KCRW in 2021, “I started to panic because I knew that childhood cancer is extremely rare. There’s only 15,000 new cases every year out of 72 million children in America. So, the chance of knowing your neighbors, especially at an internationally renowned hospital like Children’s Hospital Los Angeles – we knew something wasn’t right.”

After a relapse of her tumor, Hazel died in 2018, a few months after her seventh birthday.
 

Cancer clusters

Hoping to understand why their kids were getting so sick, Ms. Bumstead and the other parents formed a Facebook group. They plotted their homes on Google Maps and found that they all lived within roughly 10 miles of one another. It would take another year for them to realize that the SSFL site was at the center of the circle.

Once they realized that being close to SSFL could be their common thread, Ms. Bumstead and parents in her group began to gradually piece together the story, linking unusual or unexplained illnesses in their families to potential radiation or toxic chemical exposures from the lab.

“What really convinced me that this was absolutely a problem was when I learned about the epidemiological study by Dr. Hal Morgenstern that found that residents living within 2 miles of the Santa Susana Field Lab actually had a 60% higher cancer incidence rate and that over 1,500 workers have been diagnosed with cancer just from the Santa Susana Field Lab,” she told KCRW.

In 2015, Ms. Bumstead and other parents formed Parents Against Santa Susana Field Lab to hold SSFL site owner Boeing accountable for radiologic and toxic contamination and to ensure that Boeing cleans the site and surrounding areas. The group “seeks to reduce, to the greatest extent possible, the number of local families who have to hear the words, ‘Your child has cancer.’ ”
 

No longer quite so rare

Dr. Morgenstern, now retired from the University of Michigan, declined to be interviewed for this article. But as he and colleagues reported to the Centers for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry in 2007, there were strong signs of a link between contamination of the site and cancer.

The researchers compared cancer rates of adults living within 2 miles and 2-5 miles from SSFL with those of adults living more than 5 miles away, in Ventura and Los Angeles counties. They found that from 1988 through 1995, residents living within 2 miles of SSFL had a 60% higher rate of cancers than the control group. These included cancers of the thyroid, oral and nasal cavities, pharynx, larynx, esophagus, and bladder, as well as blood cancers such as leukemia, lymphoma, and multiple myeloma.

In separate studies, the investigators found higher rates of certain cancers among workers at SSFL who were exposed to radiation and to hydrazine, a chemical in rocket fuel.

In an interview, Dr. Saro Armenian, a pediatric hematologist-oncologist who was not involved in the studies, said the 60% increase in cancer incidence, which translated into a 1.6-fold increase in risk, merits more investigation.

“In epidemiologic studies, a 1.6-fold risk is actually a pretty strong signal because typically, most signals that you get are somewhere around 1.1- to 1.2-fold increased risk,” noted Dr. Armenian, a specialist in pediatric cancer survivorship and outcomes at City of Hope National Medical Center in Duarte, Calif.

However, Dr. Thomas Mack, former director of the Los Angeles County Cancer Surveillance Program, contends that there is insufficient evidence to support a direct link between the 1959 reactor accident and recent incident cancers. Dr. Mack is currently a professor of preventive medicine and pathology at the University of Southern California in Los Angeles.

“I have evaluated concerns about local excesses of cancer at least 100 times, usually from county residents, but for a while I represented the CDC and the California cancer registry,” Dr. Mack said, in response to an emailed request for comment.

“So far I have seen no evidence of carcinogenic radionucleotides or chemical carcinogens from Santa Susana found in any meaningful amount in any nearby community, but if someone has such evidence that would constitute evidence, that needs a response,” Dr. Mack added.
 

Boeing and California

Boeing has said problems at SSFL were not responsible for the high cancer rates among children in the community.

In April 2007, in a statement opposing a bill before the California State Legislature that would compel Boeing to pay for SSFL site cleanup, the company said that “in contrast to the accusations made against The Boeing Company that falsely claim increased cancer rates in the communities surrounding SSFL, a recent study conducted by the University of Michigan School of Public Health just concluded the opposite.”

Yet as Dr. Morgenstern wrote in 2007 to California state Sen. Joe Simitian, then chair of the Committee on Environmental Quality: “For the period 1996 through 2002, we found that the incidence rate of thyroid cancer was more than 60% greater among residents living within 2 miles of SSFL than for residents living more than 5 miles from SSFL. The magnitude and consistency of the thyroid finding for both periods is especially provocative because of evidence from other studies linking thyroid cancer with environmental exposures originating at SSFL and found in the surrounding communities.”

Boeing chose to ignore the results and instead focused on the methods used in the study, where the authors acknowledged that they measured distance from the site rather than environmental exposures and thus could not conclusively link excess cancer rates to exposures arising from SSFL.

But Dr. Morgenstern emphasized the conclusion of the report: “Despite the methodologic limitations of this study, the findings suggest there may be elevated incidence rates of certain cancers near SSFL that have been linked in previous studies with hazardous substances used at Rocketdyne, some of which have been observed or projected to exist offsite.”
 

Failure to come clean

In 2008, a law that set standards for cleanup of the site was passed. But the law was overturned in 2014 after a legal challenge by Boeing.

That left in place a 2007 order of consent between Boeing, NASA, the U.S. Department of Energy, and the California Department of Toxic Substances Control (DTSC) that required cleanup of SSFL to a much less stringent standard.

As of last year, Boeing and DTSC had begun confidential, nonbinding agreements regarding the 2007 order of consent, according to Parents Against SSFL.

Among the contaminants lingering at the site are radioactive particles, chemical compounds, heavy metals, and polluted water.

“In fact, over 300 contaminants of concern have been found at the site, and they are refusing to clean it,” Mr. Hirsch said. “This company releases large amounts of carcinogens, and perhaps significant numbers of people get sick with cancer, and the company doesn’t go to prison. They get more federal contracts.”

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

April 20, 2022 – Editor’s note: This article has been updated to include an interview with Dr. Thomas Mack, former director of the Los Angeles County Cancer Surveillance Program, who contends that there is insufficient evidence to support a direct link between the 1959 reactor accident and recent incident cancers.

The Biden administration’s new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.

But the program is not that simple to groups representing physicians and pharmacists.

One large physicians’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are adverse effects from the medications. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.

Recently, the White House announced that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN. Ordering of the drugs is underway in many of these clinics, a White House official told the network.

Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to a statement from the U.S. Department of Health and Human Services.

The two antiviral pills authorized by the U.S. Food and Drug Administration include Pfizer’s Paxlovid, for people 12 and older, and Merck’s molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be effective in preventing serious illness.

The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have publicly criticized the administration’s approach.

The pharmacists’ groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups, including the NCPA and the APhA, have also sent a letter to the Biden administration urging it to remove barriers to pharmacies ordering the medications.

The groups also want permission as “clinically trained medication experts” to prescribe the drugs and ensure their safe use.

The AMA on March 4 took issue with the prescribing component, saying that “the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes.”

In the AMA’s view, prescribing Paxlovid without a patient’s physician being present poses a risk for adverse drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drug have full knowledge of a patient›s medical history.

The next day, the AMA released another statement, saying it was reassured by comments from administration officials “that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options.”
 

“Traditional doctor-only approach”

Having patients call their doctors after testing positive for COVID in a pharmacy “strikes me as unnecessary in the vast majority of cases, and it will delay treatment,” Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, said in an interview. “In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It’s much more of a team sport than an individual sport, the way it was years ago.”

Dr. Wachter said he has the utmost respect for pharmacists’ ability to screen prescriptions for adverse drug interactions. “We’re required to do medication reconciliation when patients see us,” he says. “And in many hospitals, we delegate that to pharmacists. They’re at least as good at it if not better than physicians are.”

While it’s essential to know what other medications a patient is taking, he noted, pharmacies have computer records of all the prescriptions they’ve filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
 

Drug interactions “not trivial”

Preeti Malani, MD, the chief health officer and a professor of medicine in the division of infectious diseases at the University of Michigan in Ann Arbor, told this news organization that the potential interactions between Paxlovid and some other medications are “not trivial.”

However, she said, “The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren’t individuals who are going to shop at a pharmacy.”

Besides the antirejection drugs, Dr. Wachter said, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, “Someone would have to make the decision on whether it’s ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody.”

Except for these potential drug interactions with Paxlovid, the antiviral medications are “quite safe,” he said, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor. That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.

Both Dr. Wachter and Dr. Malani said that the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can’t easily leave work or travel far to visit a physician.

Dr. Malani cautioned that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don’t have clinics on site.

Still, she said people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it’s not clear where the antivirals will be available in the near term.

“Right now, we’re playing catch-up,” Dr. Malani said. “But pharmacies are an important piece of the puzzle.”

Looking at the big picture, she said, “We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you’re talking about millions of cases, as we were having a few months ago, the health system can’t field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment.”

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

The Biden administration’s new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.

But the program is not that simple to groups representing physicians and pharmacists.

One large physicians’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are adverse effects from the medications. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.

Recently, the White House announced that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN. Ordering of the drugs is underway in many of these clinics, a White House official told the network.

Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to a statement from the U.S. Department of Health and Human Services.

The two antiviral pills authorized by the U.S. Food and Drug Administration include Pfizer’s Paxlovid, for people 12 and older, and Merck’s molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be effective in preventing serious illness.

The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have publicly criticized the administration’s approach.

The pharmacists’ groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups, including the NCPA and the APhA, have also sent a letter to the Biden administration urging it to remove barriers to pharmacies ordering the medications.

The groups also want permission as “clinically trained medication experts” to prescribe the drugs and ensure their safe use.

The AMA on March 4 took issue with the prescribing component, saying that “the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes.”

In the AMA’s view, prescribing Paxlovid without a patient’s physician being present poses a risk for adverse drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drug have full knowledge of a patient›s medical history.

The next day, the AMA released another statement, saying it was reassured by comments from administration officials “that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options.”
 

“Traditional doctor-only approach”

Having patients call their doctors after testing positive for COVID in a pharmacy “strikes me as unnecessary in the vast majority of cases, and it will delay treatment,” Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, said in an interview. “In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It’s much more of a team sport than an individual sport, the way it was years ago.”

Dr. Wachter said he has the utmost respect for pharmacists’ ability to screen prescriptions for adverse drug interactions. “We’re required to do medication reconciliation when patients see us,” he says. “And in many hospitals, we delegate that to pharmacists. They’re at least as good at it if not better than physicians are.”

While it’s essential to know what other medications a patient is taking, he noted, pharmacies have computer records of all the prescriptions they’ve filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
 

Drug interactions “not trivial”

Preeti Malani, MD, the chief health officer and a professor of medicine in the division of infectious diseases at the University of Michigan in Ann Arbor, told this news organization that the potential interactions between Paxlovid and some other medications are “not trivial.”

However, she said, “The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren’t individuals who are going to shop at a pharmacy.”

Besides the antirejection drugs, Dr. Wachter said, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, “Someone would have to make the decision on whether it’s ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody.”

Except for these potential drug interactions with Paxlovid, the antiviral medications are “quite safe,” he said, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor. That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.

Both Dr. Wachter and Dr. Malani said that the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can’t easily leave work or travel far to visit a physician.

Dr. Malani cautioned that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don’t have clinics on site.

Still, she said people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it’s not clear where the antivirals will be available in the near term.

“Right now, we’re playing catch-up,” Dr. Malani said. “But pharmacies are an important piece of the puzzle.”

Looking at the big picture, she said, “We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you’re talking about millions of cases, as we were having a few months ago, the health system can’t field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment.”

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

The Biden administration’s new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.

But the program is not that simple to groups representing physicians and pharmacists.

One large physicians’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are adverse effects from the medications. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.

Recently, the White House announced that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN. Ordering of the drugs is underway in many of these clinics, a White House official told the network.

Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to a statement from the U.S. Department of Health and Human Services.

The two antiviral pills authorized by the U.S. Food and Drug Administration include Pfizer’s Paxlovid, for people 12 and older, and Merck’s molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be effective in preventing serious illness.

The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have publicly criticized the administration’s approach.

The pharmacists’ groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups, including the NCPA and the APhA, have also sent a letter to the Biden administration urging it to remove barriers to pharmacies ordering the medications.

The groups also want permission as “clinically trained medication experts” to prescribe the drugs and ensure their safe use.

The AMA on March 4 took issue with the prescribing component, saying that “the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes.”

In the AMA’s view, prescribing Paxlovid without a patient’s physician being present poses a risk for adverse drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drug have full knowledge of a patient›s medical history.

The next day, the AMA released another statement, saying it was reassured by comments from administration officials “that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options.”
 

“Traditional doctor-only approach”

Having patients call their doctors after testing positive for COVID in a pharmacy “strikes me as unnecessary in the vast majority of cases, and it will delay treatment,” Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, said in an interview. “In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It’s much more of a team sport than an individual sport, the way it was years ago.”

Dr. Wachter said he has the utmost respect for pharmacists’ ability to screen prescriptions for adverse drug interactions. “We’re required to do medication reconciliation when patients see us,” he says. “And in many hospitals, we delegate that to pharmacists. They’re at least as good at it if not better than physicians are.”

While it’s essential to know what other medications a patient is taking, he noted, pharmacies have computer records of all the prescriptions they’ve filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
 

Drug interactions “not trivial”

Preeti Malani, MD, the chief health officer and a professor of medicine in the division of infectious diseases at the University of Michigan in Ann Arbor, told this news organization that the potential interactions between Paxlovid and some other medications are “not trivial.”

However, she said, “The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren’t individuals who are going to shop at a pharmacy.”

Besides the antirejection drugs, Dr. Wachter said, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, “Someone would have to make the decision on whether it’s ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody.”

Except for these potential drug interactions with Paxlovid, the antiviral medications are “quite safe,” he said, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor. That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.

Both Dr. Wachter and Dr. Malani said that the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can’t easily leave work or travel far to visit a physician.

Dr. Malani cautioned that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don’t have clinics on site.

Still, she said people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it’s not clear where the antivirals will be available in the near term.

“Right now, we’re playing catch-up,” Dr. Malani said. “But pharmacies are an important piece of the puzzle.”

Looking at the big picture, she said, “We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you’re talking about millions of cases, as we were having a few months ago, the health system can’t field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment.”

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

Should pharmaceutical companies continue to do business in Russia, running ongoing clinical trials, starting new ones, or continuing to sell their products there?

Some argue that medicine and science must not get enmeshed in politics, staying above the fray to protect their independence and credibility. Other defenders of business-as-usual say the pharmaceutical industry deals in health and aids the vulnerable. Humanitarianism requires continued interaction with Russia.

I think both arguments fail. Pharma should follow the lead of other Western companies and suspend their involvement with Putin’s Russia.

We are fighting a war with Russia. It is a war of economic strangulation, social isolation, and pushing Russia as hard as we can to become a pariah state so that internal pressure on Putin will cause him to rethink his cruel, unjustified invasion or the Russian people to replace him. This pressure must be harsh and it must happen quickly. Why?

Having failed to rapidly defeat the Ukrainian army in the war’s first weeks, Russian commanders are now resorting to the horrible barbarism they used in previous wars in Chechnya and Syria: flattening cities, attacking civilians, killing children with massive and indiscriminate firepower.

To mention one recent horror among many, Russian shelling destroyed a maternity hospital in Mariupol. Ukraine’s president, Volodymyr Zelensky, in bemoaning the Russians for their continuing series of war crimes called on the world to act.

“Mariupol. Direct Strike of Russian troops at the maternity hospital,” he wrote in a Twitter post. “People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror?”

The Russian government’s response: “It is not the first time we have seen pathetic outcries concerning the so-called atrocities,” said Minister of Foreign Affairs Sergei Lavrov, claiming the hospital was being used as a base by an “ultra-radical” Ukrainian battalion.

Health and its preservation are key parts of the aim of medicine and science. There is no way that medicine and science can ignore what war does to health, what attacks on hospitals do to the sick and those who serve them there, the psychological toll that intentional terrorism takes on civilians and their defenders, and what the destruction of infrastructure means for the long-term well-being of Ukrainians.

There can be no collusion with war criminals. There can be no denial of the inextricable link between medicine, science, and politics. Medicine and science are controlled by political forces; their use for good or evil is driven by political considerations, and each doctor, scientist, and scientific society must take a stand when politics corrodes the underlying aims of research and healing.

How far does noncooperation with Russia go? Very, very far. All research, both ongoing and new, must cease immediately. Whatever can be done to minimize harm to existing subjects in a short period of time ought to be done, but that is it.

Similarly, no sale of medicines or therapies ought to be occurring, be they life-saving or consumer products. Putin will see to it that such shipments go to the military or are sold on the black market for revenue, and there is nothing pharma companies can do to stop that.

The Russian people need to be pinched not only by the loss of cheeseburgers and boutique coffee but by products they use to maintain their well-being. War is cruel that way, but if you tolerate a government that is bombing and shelling a peaceful neighbor to oblivion, then pharma must ensure that efforts to make Putin and his kleptocratic goons feel the wrath of their fellow citizens.

Given the realities of nuclear Armageddon, the civilized world must fight obvious barbarity as best it can with sanctions, financial assaults, property seizures, and forgoing commerce, including important raw materials and health products. War, even in a fiscal form, is not without terrible costs; but achieving a rapid, just resolution against tyranny permits no exceptions for pharma or any other business if it is a war that must be fought.

Dr. Caplan is director of the division of medical ethics at New York University. He has consulted with Johnson & Johnson’s Panel for Compassionate Drug Use.



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

Should pharmaceutical companies continue to do business in Russia, running ongoing clinical trials, starting new ones, or continuing to sell their products there?

Some argue that medicine and science must not get enmeshed in politics, staying above the fray to protect their independence and credibility. Other defenders of business-as-usual say the pharmaceutical industry deals in health and aids the vulnerable. Humanitarianism requires continued interaction with Russia.

I think both arguments fail. Pharma should follow the lead of other Western companies and suspend their involvement with Putin’s Russia.

We are fighting a war with Russia. It is a war of economic strangulation, social isolation, and pushing Russia as hard as we can to become a pariah state so that internal pressure on Putin will cause him to rethink his cruel, unjustified invasion or the Russian people to replace him. This pressure must be harsh and it must happen quickly. Why?

Having failed to rapidly defeat the Ukrainian army in the war’s first weeks, Russian commanders are now resorting to the horrible barbarism they used in previous wars in Chechnya and Syria: flattening cities, attacking civilians, killing children with massive and indiscriminate firepower.

To mention one recent horror among many, Russian shelling destroyed a maternity hospital in Mariupol. Ukraine’s president, Volodymyr Zelensky, in bemoaning the Russians for their continuing series of war crimes called on the world to act.

“Mariupol. Direct Strike of Russian troops at the maternity hospital,” he wrote in a Twitter post. “People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror?”

The Russian government’s response: “It is not the first time we have seen pathetic outcries concerning the so-called atrocities,” said Minister of Foreign Affairs Sergei Lavrov, claiming the hospital was being used as a base by an “ultra-radical” Ukrainian battalion.

Health and its preservation are key parts of the aim of medicine and science. There is no way that medicine and science can ignore what war does to health, what attacks on hospitals do to the sick and those who serve them there, the psychological toll that intentional terrorism takes on civilians and their defenders, and what the destruction of infrastructure means for the long-term well-being of Ukrainians.

There can be no collusion with war criminals. There can be no denial of the inextricable link between medicine, science, and politics. Medicine and science are controlled by political forces; their use for good or evil is driven by political considerations, and each doctor, scientist, and scientific society must take a stand when politics corrodes the underlying aims of research and healing.

How far does noncooperation with Russia go? Very, very far. All research, both ongoing and new, must cease immediately. Whatever can be done to minimize harm to existing subjects in a short period of time ought to be done, but that is it.

Similarly, no sale of medicines or therapies ought to be occurring, be they life-saving or consumer products. Putin will see to it that such shipments go to the military or are sold on the black market for revenue, and there is nothing pharma companies can do to stop that.

The Russian people need to be pinched not only by the loss of cheeseburgers and boutique coffee but by products they use to maintain their well-being. War is cruel that way, but if you tolerate a government that is bombing and shelling a peaceful neighbor to oblivion, then pharma must ensure that efforts to make Putin and his kleptocratic goons feel the wrath of their fellow citizens.

Given the realities of nuclear Armageddon, the civilized world must fight obvious barbarity as best it can with sanctions, financial assaults, property seizures, and forgoing commerce, including important raw materials and health products. War, even in a fiscal form, is not without terrible costs; but achieving a rapid, just resolution against tyranny permits no exceptions for pharma or any other business if it is a war that must be fought.

Dr. Caplan is director of the division of medical ethics at New York University. He has consulted with Johnson & Johnson’s Panel for Compassionate Drug Use.



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

Should pharmaceutical companies continue to do business in Russia, running ongoing clinical trials, starting new ones, or continuing to sell their products there?

Some argue that medicine and science must not get enmeshed in politics, staying above the fray to protect their independence and credibility. Other defenders of business-as-usual say the pharmaceutical industry deals in health and aids the vulnerable. Humanitarianism requires continued interaction with Russia.

I think both arguments fail. Pharma should follow the lead of other Western companies and suspend their involvement with Putin’s Russia.

We are fighting a war with Russia. It is a war of economic strangulation, social isolation, and pushing Russia as hard as we can to become a pariah state so that internal pressure on Putin will cause him to rethink his cruel, unjustified invasion or the Russian people to replace him. This pressure must be harsh and it must happen quickly. Why?

Having failed to rapidly defeat the Ukrainian army in the war’s first weeks, Russian commanders are now resorting to the horrible barbarism they used in previous wars in Chechnya and Syria: flattening cities, attacking civilians, killing children with massive and indiscriminate firepower.

To mention one recent horror among many, Russian shelling destroyed a maternity hospital in Mariupol. Ukraine’s president, Volodymyr Zelensky, in bemoaning the Russians for their continuing series of war crimes called on the world to act.

“Mariupol. Direct Strike of Russian troops at the maternity hospital,” he wrote in a Twitter post. “People, children are under the wreckage. Atrocity! How much longer will the world be an accomplice ignoring terror?”

The Russian government’s response: “It is not the first time we have seen pathetic outcries concerning the so-called atrocities,” said Minister of Foreign Affairs Sergei Lavrov, claiming the hospital was being used as a base by an “ultra-radical” Ukrainian battalion.

Health and its preservation are key parts of the aim of medicine and science. There is no way that medicine and science can ignore what war does to health, what attacks on hospitals do to the sick and those who serve them there, the psychological toll that intentional terrorism takes on civilians and their defenders, and what the destruction of infrastructure means for the long-term well-being of Ukrainians.

There can be no collusion with war criminals. There can be no denial of the inextricable link between medicine, science, and politics. Medicine and science are controlled by political forces; their use for good or evil is driven by political considerations, and each doctor, scientist, and scientific society must take a stand when politics corrodes the underlying aims of research and healing.

How far does noncooperation with Russia go? Very, very far. All research, both ongoing and new, must cease immediately. Whatever can be done to minimize harm to existing subjects in a short period of time ought to be done, but that is it.

Similarly, no sale of medicines or therapies ought to be occurring, be they life-saving or consumer products. Putin will see to it that such shipments go to the military or are sold on the black market for revenue, and there is nothing pharma companies can do to stop that.

The Russian people need to be pinched not only by the loss of cheeseburgers and boutique coffee but by products they use to maintain their well-being. War is cruel that way, but if you tolerate a government that is bombing and shelling a peaceful neighbor to oblivion, then pharma must ensure that efforts to make Putin and his kleptocratic goons feel the wrath of their fellow citizens.

Given the realities of nuclear Armageddon, the civilized world must fight obvious barbarity as best it can with sanctions, financial assaults, property seizures, and forgoing commerce, including important raw materials and health products. War, even in a fiscal form, is not without terrible costs; but achieving a rapid, just resolution against tyranny permits no exceptions for pharma or any other business if it is a war that must be fought.

Dr. Caplan is director of the division of medical ethics at New York University. He has consulted with Johnson & Johnson’s Panel for Compassionate Drug Use.



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

Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.

The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.

The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.

At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.

AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.

The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.

They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.

“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”

AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
 

Triggered by cost cutting

The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”

Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”

There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”

Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”

As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.

“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”

Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”

The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).

This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”

“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.

In fact, the medical center hired seven new oncologists to replace them.
 

Noncompete covenant

In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.

“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”

The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.

“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “

In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.

Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.

“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”

Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.

“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
 

Telemedicine added to the mix

Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.

As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.

“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.

Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.

One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.

A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.

“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”

Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.

Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.

“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.

Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.

“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.

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

Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.

The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.

The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.

At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.

AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.

The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.

They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.

“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”

AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
 

Triggered by cost cutting

The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”

Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”

There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”

Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”

As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.

“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”

Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”

The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).

This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”

“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.

In fact, the medical center hired seven new oncologists to replace them.
 

Noncompete covenant

In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.

“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”

The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.

“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “

In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.

Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.

“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”

Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.

“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
 

Telemedicine added to the mix

Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.

As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.

“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.

Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.

One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.

A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.

“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”

Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.

Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.

“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.

Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.

“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.

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

Last year, nine oncologists filed a lawsuit against the Anne Arundel Medical Center (AAMC), in Annapolis, Md., alleging that the hospital had fired them and had refused to allow them privileges to see their patients.

The oncologists said that the hospital chose profit over the needs of cancer patients, as it slashed oncology care services to cut costs.

The hospital denied any wrongdoing and alleged that the oncologists were not fired but that they had quit because they had been offered a more profitable opportunity.

At that time, the oncologists were not free to respond because of the ongoing litigation. But now that the lawsuit is over and the dust has settled, they are free to speak, and they contacted this news organization to tell their side of the story.

AAMC is a private, not-for-profit corporation that operates a large acute care hospital in Annapolis. It is affiliated with Luminis Health, the parent company of the medical center. Until October 23, 2020, the nine oncologists were employed by the AA Physician Group.

The doctors are Jason Taksey, MD, Benjamin Bridges, MD, Ravin Garg, MD, Adam Goldrich, MD, Carol Tweed, MD, Peter Graze, MD, Stuart Selonick, MD, David Weng, MD, and Jeanine Werner, MD.

They are all “highly respected, board certified oncologists and hematologists, with regional and, for some, national reputations in their medical specialty. The oncologists have had privileges at AAMC for many years and their capability as physicians is unquestioned,” according to the court filing made on behalf of the oncologists.

“Most of us have been in this town for decades,” said Dr. Tweed, who served as the unofficial spokesperson for the group. “Some of us are faculty members at Johns Hopkins, and this hospital’s oncology service was historically defined by our group.”

AAMC has a good reputation for providing high-quality medicine, “which is what brought many of us there in the first place,” Dr. Tweed said in an interview.
 

Triggered by cost cutting

The situation began when the hospital began cutting services to curtail costs, which directly affected the delivery of oncology care, Dr. Tweed explained. “They were also creating a very toxic and difficult interpersonal work environment, and that made it difficult to do patient care,” she said. “We would go to them and let them know that we were having difficulty delivering optimal patient care because we didn’t have enough staff or the resources we needed for safety — and it got to the point where we were being ignored and our input was no longer welcome.”

Dr. Tweed explained that the administrators announced which patient-care services would be cut without asking for their input as to the safety of those decisions. “Perhaps the most notorious was when they shut down the oncology lab,” she said. “That lab to an oncologist/hematologist is like a scalpel to a surgeon. I need lab results immediately — I need to know if I can give chemotherapy right now, or do I need to hold a dose. The lab is intrinsic to oncology care anywhere.”

There was a continuing cascade of events, and the oncology group mulled over some ideas as to how to provide optimal patient care in this increasingly difficult environment. The decision they reached was to discuss running their own practice with the hospital administrators as a means of making up for the gaps that they were now having to contend with. “As physicians, we do a lot of non-billable work, such as patient education, nighttime rounds for our cancer patients, and so on, and we told them that we would continue doing that,” said Dr. Tweed. “They said that they would talk to us, but they didn’t.”

Within a week of sending their proposal for setting up their own practice, all nine physicians were fired. “Instead of arranging a discussion, we received termination letters,” she explained. “We were terminated without cause.”

As physicians, Dr. Tweed explained that they were by contract obligated to arbitrate. It dragged on for weeks and months, to the tune of hundreds of thousands of dollars in legal fees.

“The only thing we wanted was to be able to practice in this town,” said Dr. Tweed. “And what is important to know is that it was never for money, and that was never our motivation for wanting to form our own practice.”

Dr. Tweed was referring to the hospital’s allegations that the oncologists had left their employment for monetary gain. A statement given to this news organization by the Luminis Health Anne Arundel Medical Center at the time stated that “this dispute started after nine oncologists left their employment to join a for-profit organization. We tried repeatedly to remain aligned with them.”

The oncologists had resigned during the height of the coronavirus pandemic to “pursue lucrative contracts” with a “major pharmaceutical distribution,” according to Todd M. Reinecker, attorney for Luminis Health, as reported by the Capital Gazette (this news organization reached out to Mr. Reinecker at that time but did not receive a response).

This was not the case, Dr. Tweed emphasized. “We took a great financial risk in doing this for patient care. It was pretty disgusting that was in print from the hospital’s lawyer.”

“The doctors anticipated Luminis Health would be unable to recruit new physicians and be forced to continue to use their services,” Mr. Reinecker maintained.

In fact, the medical center hired seven new oncologists to replace them.
 

Noncompete covenant

In filing their lawsuit, the nine oncologists put before the arbitrator the issue of the enforceability of the noncompete provision in their employment agreement, which prohibited the oncologists from working in the geographic area that includes the hospital. Their position was that the agreement was overly broad and thus unenforceable.

“We sign noncompete restrictive covenant contracts and we’re told that they are nonenforceable, and that’s the general discourse,” said Dr. Tweed. “Some states don’t even allow them. Well, we found out that they are very enforceable.”

The arbitrator eventually determined that three of the oncologists, including Dr. Tweed, had enforceable noncompete contracts.

“During the year or so while this was all going on, I would say that 90% of my patients wanted to stay with me,” said Dr. Tweed. “Patients were looking all over the place for us because, in many cases, the hospital did not tell them where to find us. In fact, they told us that we couldn’t contact the patients — they said it was ‘solicitation of a patient.’ “

In addition, the hospital continued to put more restrictions on the doctors. Six of the nine oncologists were able to continue practicing in Annapolis, and the remaining three will be able to join them in October 2022 when their noncompete contracts expire.

Now that the hospital has seen that there was a new oncology practice in town, Dr. Tweed noted, they changed their bylaws, and they now forbid hospital privileges to every physician in that group.

“The new bylaws do not restrict all private oncologists, just specifically our group, which prevents us from being able to do rounds in the hospital,” said Dr. Tweed. “If I want to see any of my patients, I have to get a visitor badge.”

Dr. Tweed contends that this move was purely for financial and business reasons to keep the oncologists from their patients. This is the primary hospital where their patients would be admitted if they need hospital care. AAMC is the only hospital within a 15-mile radius, and it serves as the regional hospital for the greater Annapolis area and for many Eastern Shore communities, whose hospitals do not offer various specialty services, such as oncology care.

“This was done purely because they were finance focused and not patient care focused,” Dr. Tweed emphasized. “We basically had to bargain with the hospital to let us even transfuse our patients.”
 

Telemedicine added to the mix

Yet another restriction that surfaced during the arbitration involved telemedicine. Dr. Tweed explained that as soon as the hospital realized that the three oncologists planned to stay in town and that their patients wanted to continue receiving care with them, they put telemedicine on the chopping block.

As if the restrictions and removal of hospital privileges wasn’t enough, the hospital decided to go after telemedicine during arbitration, Dr. Tweed said. If patients lived in any of the restricted ZIP codes, they were forbidden to conduct virtual visits with them.

“This isn’t ethical, but they tried to do everything to keep us from seeing our patients,” she said. “This is patient choice, but they were telling patients that if you live in any of these ZIP codes, you cannot do telemedicine if you choose Carol Tweed as your doctor,” Dr. Tweed said.

Of course, a patient isn’t bound by the arbitration and can see any doctor, but Dr. Tweed explained that the hospital threatened to come after her with a lawsuit.

One of the other physicians, Stuart Selonick, MD, said in an interview that he wasn’t quite sure how the idea of prohibiting telemedicine even came up. “There is little precedence for telemedicine in the U.S.,” he said. “They’ve extended the restrictions to telemedicine, and this is a new legal boundary, and it was new to the judge. But they made it part of the definition of the restrictive covenant. But to fight it would mean another lawsuit,” he added.

A separate lawsuit had previously been filed in an effort to regain hospital privileges, but the decision was made not to continue, owing to the amount of litigation it would involve.

“We can’t spend a lifetime and millions on another legal battle,” said Dr. Tweed. “We don’t have the corporate legal pool that the hospital has, and they know it.”

Patients have written endless letters supporting the doctors, Dr. Tweed said, but to no avail, as the hospital did not change course.

Litigation is now completed, and in about 9 months, the remaining three physicians will be able to rejoin their colleagues and put this behind them as best they can.

“The hospital knows that they harmed patient care for financial gain -- that’s the tagline,” said Tweed.

Approached for a response, Justin McLeod, spokesperson for Luminis Health, said that they are “pleased with the outcome of the case and the resolution agreed to by both sides. This agreement ensures patient access and continuity of care for patients with cancer. These providers have access to their patients’ electronic medical records, can order outpatient services, and attend quarterly cancer committee meetings with other providers.

“Our focus is the future of cancer care for our community. Luminis Health Anne Arundel Medical Center is committed to providing patients with high quality, comprehensive cancer care that is accessible to all,” he added.

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

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

People taking immunosuppressive drugs benefit significantly from SARS-CoV-2 vaccines approved in the United States to prevent and reduce the severity of COVID-19, according to the first study to quantify the vaccines’ real-world effectiveness in this population.

Researchers’ analysis of the electronic medical records of more than 150,000 people in the University of Michigan’s health care system showed that even after becoming fully vaccinated, immunosuppressed individuals remain at higher risk for COVID-19 than are vaccinated people in the wider population who aren’t receiving immunosuppressive therapy. However, they still derive benefit from vaccination, particularly when bolstered with a booster dose.

BrianAJackson/Thinkstock

The study, published online in Annals of the Rheumatic Diseases, also claims to be the first to show that the Moderna (mRNA-1273) vaccine is as effective as the Pfizer-BioNTech (BNT162b2) vaccine for people taking immunosuppressants.

“Booster doses are effective and important for individuals on immunosuppressants,” corresponding author Lili Zhao, PhD, a research associate professor in biostatistics at the University of Michigan, Ann Arbor, said in an interview. “Previous studies focused mostly on the Pfizer vaccine, whereas our study is the first that also investigates the Moderna vaccine in a large, immunosuppressed population.”

The epidemiologic study included 154,519 fully vaccinated and unvaccinated adults in the Michigan Medicine electronic health record database. Participants were considered fully vaccinated if they were within 2 weeks of having received a second dose of the Pfizer-BioNTech and Moderna vaccines or the single-dose Johnson & Johnson (Ad26.COV2.S) vaccine. The study population included 5,536 immunosuppressed patients; of those, 4,283 were fully vaccinated, and 1,253 were unvaccinated.

The researchers focused on data collected from Jan. 1 to Dec. 7, 2021, so the study doesn’t cover the Omicron variant. “The conclusions for immunosuppressed individuals are likely to remain the same during the Omicron period,” Dr. Zhao said. “We are currently investigating this.” Johnson & Johnson paused production of its vaccine in February.

The researchers found that, among unvaccinated individuals, the immunosuppressed group had about a 40% higher risk of infection than did the immunocompetent patients (hazard ratio, 1.398; 95% confidence interval, 1.068-1.829; P = .0075) but a similar risk of COVID-19 hospitalization (HR, 0.951; 95% CI, 0.435-2.080; P = .9984). For the fully vaccinated, the gap was significantly wider: Immunosuppressed patients had more than double the risk of infection (HR, 2.173; 95% CI, 1.690-2.794; P < .0001) and almost five times the risk of hospitalization (HR, 4.861; 95% CI, 2.238-10.56; P < .0001), compared with immunocompetent patients.

However, among immunosuppressed individuals, the vaccinations significantly lowered risks, compared with not being vaccinated. There was a statistically significant 45% lower risk of infection (HR, 0.550; 95% CI, 0.387-0.781; P = .001) and similarly lower risk of hospitalization that did not reach statistical significance (HR, 0.534; 95% CI, 0.196-1.452; P = .3724).

When those immunosuppressed patients received a booster dose, their protection against COVID-19 improved, compared with their immunosuppressed counterparts who didn’t get a booster, with a 58% lower risk of infection after adjustment for age, gender, race, and Charlson Comorbidity Index (adjusted HR, 0.42; 95% CI, 0.24-0.76; P = .0037). The study included nearly 4 months of data after the Centers for Disease Control and Prevention recommended a booster dose of the Moderna and Pfizer-BioNTech vaccines for immunocompromised individuals in August 2021. Among the immunosuppressed patients, 38.5% had received a booster dose.

There also was no apparent difference in the effectiveness between the Moderna and Pfizer-BioNTech vaccines, with adjusted hazard ratios showing 41%-48% lower risk of infection. Too few individuals in the study were vaccinated with the Johnson & Johnson vaccine to enable a sufficiently powered calculation of its effectiveness.

Other studies reach similar conclusions

The study findings fall into line with other studies of patient populations on immunosuppressants. A retrospective cohort study of Veterans Affairs patients with inflammatory bowel disease who were taking immunosuppressants, published in Gastroenterology, found that full vaccination with either Moderna and Pfizer-BioNTech vaccines was about 80% effective. Another retrospective cohort study of data from the National COVID Cohort Collaborative, published in JAMA Internal Medicine, reported that full vaccination significantly reduced the risk of COVID-19 breakthrough infection regardless of immune status. Immunosuppressed patients in this study had higher rates of breakthrough infections than immunocompetent patients, but the disparities were in line with what Dr. Zhao and the University of Michigan researchers reported.

A review of 23 studies of COVID-19 vaccinations, published in Lancet Global Health, found that immunocompromised people – 1,722 of whom were included in the studies – had lower rates of producing antibodies after two vaccine doses than did immunocompetent people, ranging from 27% to 92%, depending on the nature of their immunocompromised status, compared with 99% for the immunocompetent.
 

Strengths and limitations

One strength of the Michigan study is the quality of data, which were drawn from the Michigan Medicine electronic health record, Dr. Zhao said. “So, we know who received the vaccine and who didn’t. We also have access to data on patient health conditions, such as comorbidities, in addition to demographic variables (age, gender, and race), which were controlled in making fair comparisons between immunosuppressants and immunocompetent groups.”

Alfred Kim, MD, PhD, an assistant professor of internal medicine and rheumatology at Washington University in St. Louis, who was not involved with the study, credited Dr. Zhao and associates for delivering the first data that specifically quantified COVID-19 risk reduction in a large study population. Although he noted that the large sample size and the design reduced the chances of confounding and were strengths, he said in an interview that “lumping” the patients taking immunosuppressive drugs into one group was a weakness of the study.

“Clearly, there are certain medications (B-cell depleters, mycophenolate, for example) that carry the greatest risk of poor antibody responses post vaccination,” he said. “One would have to guess that the greatest risk of breakthrough infections continues to be in those patients taking these high-risk medications.”

Another possible problem, which the authors acknowledged, is spotty SARS-CoV-2 testing of study participants – “a systemic issue,” Dr. Kim noted.

“The easiest and most durable way to reduce the risk of getting COVID-19 is through vaccination, period,” he said. “Now we have infection-rates data from a real-world study cohort to prove this. Furthermore, boosting clearly provides additional benefit to this population.”

The National Institute of Allergy and Infectious Diseases provided funding for the study. Dr. Zhao, Dr. Zhao’s coauthors, and Kim disclosed no relevant financial relationships.

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

People taking immunosuppressive drugs benefit significantly from SARS-CoV-2 vaccines approved in the United States to prevent and reduce the severity of COVID-19, according to the first study to quantify the vaccines’ real-world effectiveness in this population.

Researchers’ analysis of the electronic medical records of more than 150,000 people in the University of Michigan’s health care system showed that even after becoming fully vaccinated, immunosuppressed individuals remain at higher risk for COVID-19 than are vaccinated people in the wider population who aren’t receiving immunosuppressive therapy. However, they still derive benefit from vaccination, particularly when bolstered with a booster dose.

BrianAJackson/Thinkstock

The study, published online in Annals of the Rheumatic Diseases, also claims to be the first to show that the Moderna (mRNA-1273) vaccine is as effective as the Pfizer-BioNTech (BNT162b2) vaccine for people taking immunosuppressants.

“Booster doses are effective and important for individuals on immunosuppressants,” corresponding author Lili Zhao, PhD, a research associate professor in biostatistics at the University of Michigan, Ann Arbor, said in an interview. “Previous studies focused mostly on the Pfizer vaccine, whereas our study is the first that also investigates the Moderna vaccine in a large, immunosuppressed population.”

The epidemiologic study included 154,519 fully vaccinated and unvaccinated adults in the Michigan Medicine electronic health record database. Participants were considered fully vaccinated if they were within 2 weeks of having received a second dose of the Pfizer-BioNTech and Moderna vaccines or the single-dose Johnson & Johnson (Ad26.COV2.S) vaccine. The study population included 5,536 immunosuppressed patients; of those, 4,283 were fully vaccinated, and 1,253 were unvaccinated.

The researchers focused on data collected from Jan. 1 to Dec. 7, 2021, so the study doesn’t cover the Omicron variant. “The conclusions for immunosuppressed individuals are likely to remain the same during the Omicron period,” Dr. Zhao said. “We are currently investigating this.” Johnson & Johnson paused production of its vaccine in February.

The researchers found that, among unvaccinated individuals, the immunosuppressed group had about a 40% higher risk of infection than did the immunocompetent patients (hazard ratio, 1.398; 95% confidence interval, 1.068-1.829; P = .0075) but a similar risk of COVID-19 hospitalization (HR, 0.951; 95% CI, 0.435-2.080; P = .9984). For the fully vaccinated, the gap was significantly wider: Immunosuppressed patients had more than double the risk of infection (HR, 2.173; 95% CI, 1.690-2.794; P < .0001) and almost five times the risk of hospitalization (HR, 4.861; 95% CI, 2.238-10.56; P < .0001), compared with immunocompetent patients.

However, among immunosuppressed individuals, the vaccinations significantly lowered risks, compared with not being vaccinated. There was a statistically significant 45% lower risk of infection (HR, 0.550; 95% CI, 0.387-0.781; P = .001) and similarly lower risk of hospitalization that did not reach statistical significance (HR, 0.534; 95% CI, 0.196-1.452; P = .3724).

When those immunosuppressed patients received a booster dose, their protection against COVID-19 improved, compared with their immunosuppressed counterparts who didn’t get a booster, with a 58% lower risk of infection after adjustment for age, gender, race, and Charlson Comorbidity Index (adjusted HR, 0.42; 95% CI, 0.24-0.76; P = .0037). The study included nearly 4 months of data after the Centers for Disease Control and Prevention recommended a booster dose of the Moderna and Pfizer-BioNTech vaccines for immunocompromised individuals in August 2021. Among the immunosuppressed patients, 38.5% had received a booster dose.

There also was no apparent difference in the effectiveness between the Moderna and Pfizer-BioNTech vaccines, with adjusted hazard ratios showing 41%-48% lower risk of infection. Too few individuals in the study were vaccinated with the Johnson & Johnson vaccine to enable a sufficiently powered calculation of its effectiveness.

Other studies reach similar conclusions

The study findings fall into line with other studies of patient populations on immunosuppressants. A retrospective cohort study of Veterans Affairs patients with inflammatory bowel disease who were taking immunosuppressants, published in Gastroenterology, found that full vaccination with either Moderna and Pfizer-BioNTech vaccines was about 80% effective. Another retrospective cohort study of data from the National COVID Cohort Collaborative, published in JAMA Internal Medicine, reported that full vaccination significantly reduced the risk of COVID-19 breakthrough infection regardless of immune status. Immunosuppressed patients in this study had higher rates of breakthrough infections than immunocompetent patients, but the disparities were in line with what Dr. Zhao and the University of Michigan researchers reported.

A review of 23 studies of COVID-19 vaccinations, published in Lancet Global Health, found that immunocompromised people – 1,722 of whom were included in the studies – had lower rates of producing antibodies after two vaccine doses than did immunocompetent people, ranging from 27% to 92%, depending on the nature of their immunocompromised status, compared with 99% for the immunocompetent.
 

Strengths and limitations

One strength of the Michigan study is the quality of data, which were drawn from the Michigan Medicine electronic health record, Dr. Zhao said. “So, we know who received the vaccine and who didn’t. We also have access to data on patient health conditions, such as comorbidities, in addition to demographic variables (age, gender, and race), which were controlled in making fair comparisons between immunosuppressants and immunocompetent groups.”

Alfred Kim, MD, PhD, an assistant professor of internal medicine and rheumatology at Washington University in St. Louis, who was not involved with the study, credited Dr. Zhao and associates for delivering the first data that specifically quantified COVID-19 risk reduction in a large study population. Although he noted that the large sample size and the design reduced the chances of confounding and were strengths, he said in an interview that “lumping” the patients taking immunosuppressive drugs into one group was a weakness of the study.

“Clearly, there are certain medications (B-cell depleters, mycophenolate, for example) that carry the greatest risk of poor antibody responses post vaccination,” he said. “One would have to guess that the greatest risk of breakthrough infections continues to be in those patients taking these high-risk medications.”

Another possible problem, which the authors acknowledged, is spotty SARS-CoV-2 testing of study participants – “a systemic issue,” Dr. Kim noted.

“The easiest and most durable way to reduce the risk of getting COVID-19 is through vaccination, period,” he said. “Now we have infection-rates data from a real-world study cohort to prove this. Furthermore, boosting clearly provides additional benefit to this population.”

The National Institute of Allergy and Infectious Diseases provided funding for the study. Dr. Zhao, Dr. Zhao’s coauthors, and Kim disclosed no relevant financial relationships.

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

People taking immunosuppressive drugs benefit significantly from SARS-CoV-2 vaccines approved in the United States to prevent and reduce the severity of COVID-19, according to the first study to quantify the vaccines’ real-world effectiveness in this population.

Researchers’ analysis of the electronic medical records of more than 150,000 people in the University of Michigan’s health care system showed that even after becoming fully vaccinated, immunosuppressed individuals remain at higher risk for COVID-19 than are vaccinated people in the wider population who aren’t receiving immunosuppressive therapy. However, they still derive benefit from vaccination, particularly when bolstered with a booster dose.

BrianAJackson/Thinkstock

The study, published online in Annals of the Rheumatic Diseases, also claims to be the first to show that the Moderna (mRNA-1273) vaccine is as effective as the Pfizer-BioNTech (BNT162b2) vaccine for people taking immunosuppressants.

“Booster doses are effective and important for individuals on immunosuppressants,” corresponding author Lili Zhao, PhD, a research associate professor in biostatistics at the University of Michigan, Ann Arbor, said in an interview. “Previous studies focused mostly on the Pfizer vaccine, whereas our study is the first that also investigates the Moderna vaccine in a large, immunosuppressed population.”

The epidemiologic study included 154,519 fully vaccinated and unvaccinated adults in the Michigan Medicine electronic health record database. Participants were considered fully vaccinated if they were within 2 weeks of having received a second dose of the Pfizer-BioNTech and Moderna vaccines or the single-dose Johnson & Johnson (Ad26.COV2.S) vaccine. The study population included 5,536 immunosuppressed patients; of those, 4,283 were fully vaccinated, and 1,253 were unvaccinated.

The researchers focused on data collected from Jan. 1 to Dec. 7, 2021, so the study doesn’t cover the Omicron variant. “The conclusions for immunosuppressed individuals are likely to remain the same during the Omicron period,” Dr. Zhao said. “We are currently investigating this.” Johnson & Johnson paused production of its vaccine in February.

The researchers found that, among unvaccinated individuals, the immunosuppressed group had about a 40% higher risk of infection than did the immunocompetent patients (hazard ratio, 1.398; 95% confidence interval, 1.068-1.829; P = .0075) but a similar risk of COVID-19 hospitalization (HR, 0.951; 95% CI, 0.435-2.080; P = .9984). For the fully vaccinated, the gap was significantly wider: Immunosuppressed patients had more than double the risk of infection (HR, 2.173; 95% CI, 1.690-2.794; P < .0001) and almost five times the risk of hospitalization (HR, 4.861; 95% CI, 2.238-10.56; P < .0001), compared with immunocompetent patients.

However, among immunosuppressed individuals, the vaccinations significantly lowered risks, compared with not being vaccinated. There was a statistically significant 45% lower risk of infection (HR, 0.550; 95% CI, 0.387-0.781; P = .001) and similarly lower risk of hospitalization that did not reach statistical significance (HR, 0.534; 95% CI, 0.196-1.452; P = .3724).

When those immunosuppressed patients received a booster dose, their protection against COVID-19 improved, compared with their immunosuppressed counterparts who didn’t get a booster, with a 58% lower risk of infection after adjustment for age, gender, race, and Charlson Comorbidity Index (adjusted HR, 0.42; 95% CI, 0.24-0.76; P = .0037). The study included nearly 4 months of data after the Centers for Disease Control and Prevention recommended a booster dose of the Moderna and Pfizer-BioNTech vaccines for immunocompromised individuals in August 2021. Among the immunosuppressed patients, 38.5% had received a booster dose.

There also was no apparent difference in the effectiveness between the Moderna and Pfizer-BioNTech vaccines, with adjusted hazard ratios showing 41%-48% lower risk of infection. Too few individuals in the study were vaccinated with the Johnson & Johnson vaccine to enable a sufficiently powered calculation of its effectiveness.

Other studies reach similar conclusions

The study findings fall into line with other studies of patient populations on immunosuppressants. A retrospective cohort study of Veterans Affairs patients with inflammatory bowel disease who were taking immunosuppressants, published in Gastroenterology, found that full vaccination with either Moderna and Pfizer-BioNTech vaccines was about 80% effective. Another retrospective cohort study of data from the National COVID Cohort Collaborative, published in JAMA Internal Medicine, reported that full vaccination significantly reduced the risk of COVID-19 breakthrough infection regardless of immune status. Immunosuppressed patients in this study had higher rates of breakthrough infections than immunocompetent patients, but the disparities were in line with what Dr. Zhao and the University of Michigan researchers reported.

A review of 23 studies of COVID-19 vaccinations, published in Lancet Global Health, found that immunocompromised people – 1,722 of whom were included in the studies – had lower rates of producing antibodies after two vaccine doses than did immunocompetent people, ranging from 27% to 92%, depending on the nature of their immunocompromised status, compared with 99% for the immunocompetent.
 

Strengths and limitations

One strength of the Michigan study is the quality of data, which were drawn from the Michigan Medicine electronic health record, Dr. Zhao said. “So, we know who received the vaccine and who didn’t. We also have access to data on patient health conditions, such as comorbidities, in addition to demographic variables (age, gender, and race), which were controlled in making fair comparisons between immunosuppressants and immunocompetent groups.”

Alfred Kim, MD, PhD, an assistant professor of internal medicine and rheumatology at Washington University in St. Louis, who was not involved with the study, credited Dr. Zhao and associates for delivering the first data that specifically quantified COVID-19 risk reduction in a large study population. Although he noted that the large sample size and the design reduced the chances of confounding and were strengths, he said in an interview that “lumping” the patients taking immunosuppressive drugs into one group was a weakness of the study.

“Clearly, there are certain medications (B-cell depleters, mycophenolate, for example) that carry the greatest risk of poor antibody responses post vaccination,” he said. “One would have to guess that the greatest risk of breakthrough infections continues to be in those patients taking these high-risk medications.”

Another possible problem, which the authors acknowledged, is spotty SARS-CoV-2 testing of study participants – “a systemic issue,” Dr. Kim noted.

“The easiest and most durable way to reduce the risk of getting COVID-19 is through vaccination, period,” he said. “Now we have infection-rates data from a real-world study cohort to prove this. Furthermore, boosting clearly provides additional benefit to this population.”

The National Institute of Allergy and Infectious Diseases provided funding for the study. Dr. Zhao, Dr. Zhao’s coauthors, and Kim disclosed no relevant financial relationships.

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

Patients who have a rare subtype of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with isolated Hodgkin/Reed–Sternberg-like cells (CLL-HRS) may benefit from Hodgkin-directed therapy, based on data from 46 individuals.

Those patients who progress to classic Hodgkin lymphoma (CHL) from CLL/SLL are generally diagnosed based on straightforward pathology and treated with HRS cells in the same way as patients with de novo CHL, wrote lead author Dr. Rebecca L. King, a pathologist at the Mayo Clinic in Rochester, Minn.

However, in a small subset of patients, HRS cells occur in a background of CLL/SLL, in a condition known as CLL-HRS, and these patients do not progress to overt CHL, the researchers wrote.

Given the rarity of CLL-HRS, data on patient management are limited, they noted.

In a retrospective study published in Blood Cancer Journal, researchers reviewed outcome data from 15 adults with CLL-HRS and 31 adults with CLL/SLL who had overtly transformed to CLL-HL. The median age of the participants at the time of CLL-HL or CLL-HRS transformation diagnosis was 72 years; 71% and 87% of the CLL-HL and CLL-HRS patients, respectively, were male.

The median times from CLL to CLL-HL transformation and from CLL to CLL-HRS transformation were 6.6 years and 4.9 years, respectively; the difference was not statistically significant. The phenotypic features of Reed-Sternberg cells and Epstein-Barr virus status were similar in both patient groups. Two patients had biopsies in which both CLL-HRS and CLL-HL were present in the same tissue at initial diagnosis; they were included in the CLL-HL group for clinical analysis and in both groups for pathology analysis.

The median overall survival of CLL-HRS patients was 17.5 months, compared with 33.5 months for CLL-HL patients (P = .24), a nonsignificant difference. However, patients with CLL-HRS who received Hodgkin-directed therapy had a significantly longer median overall survival, compared with those who received CLL-directed therapy (57 months vs. 8.4 months, P = .02).

CLL-directed therapy included rituximab with or without corticosteroids, chemoimmunotherapy, or acalabrutinib; HL-directed therapy included doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine–based treatment; radiotherapy; or BCVPP (carmustine, cyclophosphamide, vinblastine, procarbazine, and prednisone).

Histopathology findings showed that CLL-HL patients had a background of mixed inflammation that was distinct from findings in CLL/SLL. CLL-HRS patients had a minimal inflammatory background, compared with CLL-HL cases, but researchers identified rosetting of T cells around the HRS cells in 56% of these patients.

“Our findings suggest that, clinically and pathologically, these patients show a spectrum of findings, and these two entities likely exist on a biologic continuum. Furthermore, our findings suggest that CLL-HRS patients managed with Hodgkin-directed therapy, rather than CLL-directed therapy, may have superior outcomes,” the researchers wrote.

The study findings were limited by several factors, including the retrospective design and the use of data from a single center. Therefore, the results should be validated in other cohorts, the researchers noted. In addition, the study participants were diagnosed over three decades, and management of the condition has significantly improved.

However, the results were strengthened by a review of data by three pathologists who were blinded to the clinical outcomes, they said.

“These findings have important implications for a scenario in which clinical guidelines are lacking and suggest that hematologists treating patients with CLL-HRS should consider HL-directed therapy,” the researchers concluded.

In an interview, Jennifer A. Woyach, MD, a hematologist at Ohio State University, Columbus, commented on the study findings: “Hodgkin transformation and CLL with Hodgkin-like cells likely represent a biologic continuum, and care should be taken to obtain adequate biopsies, so that the diagnosis of Hodgkin transformation can be made when appropriate.”

“Interestingly, the authors noted a trend toward improved survival when CLL with Hodgkin-like cells was treated with standard Hodgkin regimens,” said Dr. Woyach. “With the small patient numbers, this certainly cannot be a general recommendation, but should be considered by treating physicians on a case-by-case basis.”

“While we know that patients with Hodgkin transformation can in many cases be successfully treated with standard Hodgkin regimen, the natural history and optimal treatment for CLL with Hodgkin-like cells have been unknown. This analysis helps understand the biologic difference between these two clinicopathologic entities to understand how to better treat patients,” she noted. Going forward, “it would be extremely helpful to see these data validated by other centers to be sure that these results are reproducible,” Dr. Woyach added.

The study was supported by the Mayo Clinic, Rochester, Minn., and by the Henry J. Predolin Foundation. Lead author Dr. King disclosed research support to her institution from Bristol-Myers Squibb/Celgene. Dr. Woyach had no financial disclosures relevant to this study, but she has received laboratory research funding from Schrodinger and has consulted for AbbVie, Pharmacyclics, Janssen, AstraZeneca, Genentech, Beigene, Loxo, and Newave.
 

This article was updated 3/11/22.

Patients who have a rare subtype of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with isolated Hodgkin/Reed–Sternberg-like cells (CLL-HRS) may benefit from Hodgkin-directed therapy, based on data from 46 individuals.

Those patients who progress to classic Hodgkin lymphoma (CHL) from CLL/SLL are generally diagnosed based on straightforward pathology and treated with HRS cells in the same way as patients with de novo CHL, wrote lead author Dr. Rebecca L. King, a pathologist at the Mayo Clinic in Rochester, Minn.

However, in a small subset of patients, HRS cells occur in a background of CLL/SLL, in a condition known as CLL-HRS, and these patients do not progress to overt CHL, the researchers wrote.

Given the rarity of CLL-HRS, data on patient management are limited, they noted.

In a retrospective study published in Blood Cancer Journal, researchers reviewed outcome data from 15 adults with CLL-HRS and 31 adults with CLL/SLL who had overtly transformed to CLL-HL. The median age of the participants at the time of CLL-HL or CLL-HRS transformation diagnosis was 72 years; 71% and 87% of the CLL-HL and CLL-HRS patients, respectively, were male.

The median times from CLL to CLL-HL transformation and from CLL to CLL-HRS transformation were 6.6 years and 4.9 years, respectively; the difference was not statistically significant. The phenotypic features of Reed-Sternberg cells and Epstein-Barr virus status were similar in both patient groups. Two patients had biopsies in which both CLL-HRS and CLL-HL were present in the same tissue at initial diagnosis; they were included in the CLL-HL group for clinical analysis and in both groups for pathology analysis.

The median overall survival of CLL-HRS patients was 17.5 months, compared with 33.5 months for CLL-HL patients (P = .24), a nonsignificant difference. However, patients with CLL-HRS who received Hodgkin-directed therapy had a significantly longer median overall survival, compared with those who received CLL-directed therapy (57 months vs. 8.4 months, P = .02).

CLL-directed therapy included rituximab with or without corticosteroids, chemoimmunotherapy, or acalabrutinib; HL-directed therapy included doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine–based treatment; radiotherapy; or BCVPP (carmustine, cyclophosphamide, vinblastine, procarbazine, and prednisone).

Histopathology findings showed that CLL-HL patients had a background of mixed inflammation that was distinct from findings in CLL/SLL. CLL-HRS patients had a minimal inflammatory background, compared with CLL-HL cases, but researchers identified rosetting of T cells around the HRS cells in 56% of these patients.

“Our findings suggest that, clinically and pathologically, these patients show a spectrum of findings, and these two entities likely exist on a biologic continuum. Furthermore, our findings suggest that CLL-HRS patients managed with Hodgkin-directed therapy, rather than CLL-directed therapy, may have superior outcomes,” the researchers wrote.

The study findings were limited by several factors, including the retrospective design and the use of data from a single center. Therefore, the results should be validated in other cohorts, the researchers noted. In addition, the study participants were diagnosed over three decades, and management of the condition has significantly improved.

However, the results were strengthened by a review of data by three pathologists who were blinded to the clinical outcomes, they said.

“These findings have important implications for a scenario in which clinical guidelines are lacking and suggest that hematologists treating patients with CLL-HRS should consider HL-directed therapy,” the researchers concluded.

In an interview, Jennifer A. Woyach, MD, a hematologist at Ohio State University, Columbus, commented on the study findings: “Hodgkin transformation and CLL with Hodgkin-like cells likely represent a biologic continuum, and care should be taken to obtain adequate biopsies, so that the diagnosis of Hodgkin transformation can be made when appropriate.”

“Interestingly, the authors noted a trend toward improved survival when CLL with Hodgkin-like cells was treated with standard Hodgkin regimens,” said Dr. Woyach. “With the small patient numbers, this certainly cannot be a general recommendation, but should be considered by treating physicians on a case-by-case basis.”

“While we know that patients with Hodgkin transformation can in many cases be successfully treated with standard Hodgkin regimen, the natural history and optimal treatment for CLL with Hodgkin-like cells have been unknown. This analysis helps understand the biologic difference between these two clinicopathologic entities to understand how to better treat patients,” she noted. Going forward, “it would be extremely helpful to see these data validated by other centers to be sure that these results are reproducible,” Dr. Woyach added.

The study was supported by the Mayo Clinic, Rochester, Minn., and by the Henry J. Predolin Foundation. Lead author Dr. King disclosed research support to her institution from Bristol-Myers Squibb/Celgene. Dr. Woyach had no financial disclosures relevant to this study, but she has received laboratory research funding from Schrodinger and has consulted for AbbVie, Pharmacyclics, Janssen, AstraZeneca, Genentech, Beigene, Loxo, and Newave.
 

This article was updated 3/11/22.

Patients who have a rare subtype of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with isolated Hodgkin/Reed–Sternberg-like cells (CLL-HRS) may benefit from Hodgkin-directed therapy, based on data from 46 individuals.

Those patients who progress to classic Hodgkin lymphoma (CHL) from CLL/SLL are generally diagnosed based on straightforward pathology and treated with HRS cells in the same way as patients with de novo CHL, wrote lead author Dr. Rebecca L. King, a pathologist at the Mayo Clinic in Rochester, Minn.

However, in a small subset of patients, HRS cells occur in a background of CLL/SLL, in a condition known as CLL-HRS, and these patients do not progress to overt CHL, the researchers wrote.

Given the rarity of CLL-HRS, data on patient management are limited, they noted.

In a retrospective study published in Blood Cancer Journal, researchers reviewed outcome data from 15 adults with CLL-HRS and 31 adults with CLL/SLL who had overtly transformed to CLL-HL. The median age of the participants at the time of CLL-HL or CLL-HRS transformation diagnosis was 72 years; 71% and 87% of the CLL-HL and CLL-HRS patients, respectively, were male.

The median times from CLL to CLL-HL transformation and from CLL to CLL-HRS transformation were 6.6 years and 4.9 years, respectively; the difference was not statistically significant. The phenotypic features of Reed-Sternberg cells and Epstein-Barr virus status were similar in both patient groups. Two patients had biopsies in which both CLL-HRS and CLL-HL were present in the same tissue at initial diagnosis; they were included in the CLL-HL group for clinical analysis and in both groups for pathology analysis.

The median overall survival of CLL-HRS patients was 17.5 months, compared with 33.5 months for CLL-HL patients (P = .24), a nonsignificant difference. However, patients with CLL-HRS who received Hodgkin-directed therapy had a significantly longer median overall survival, compared with those who received CLL-directed therapy (57 months vs. 8.4 months, P = .02).

CLL-directed therapy included rituximab with or without corticosteroids, chemoimmunotherapy, or acalabrutinib; HL-directed therapy included doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine–based treatment; radiotherapy; or BCVPP (carmustine, cyclophosphamide, vinblastine, procarbazine, and prednisone).

Histopathology findings showed that CLL-HL patients had a background of mixed inflammation that was distinct from findings in CLL/SLL. CLL-HRS patients had a minimal inflammatory background, compared with CLL-HL cases, but researchers identified rosetting of T cells around the HRS cells in 56% of these patients.

“Our findings suggest that, clinically and pathologically, these patients show a spectrum of findings, and these two entities likely exist on a biologic continuum. Furthermore, our findings suggest that CLL-HRS patients managed with Hodgkin-directed therapy, rather than CLL-directed therapy, may have superior outcomes,” the researchers wrote.

The study findings were limited by several factors, including the retrospective design and the use of data from a single center. Therefore, the results should be validated in other cohorts, the researchers noted. In addition, the study participants were diagnosed over three decades, and management of the condition has significantly improved.

However, the results were strengthened by a review of data by three pathologists who were blinded to the clinical outcomes, they said.

“These findings have important implications for a scenario in which clinical guidelines are lacking and suggest that hematologists treating patients with CLL-HRS should consider HL-directed therapy,” the researchers concluded.

In an interview, Jennifer A. Woyach, MD, a hematologist at Ohio State University, Columbus, commented on the study findings: “Hodgkin transformation and CLL with Hodgkin-like cells likely represent a biologic continuum, and care should be taken to obtain adequate biopsies, so that the diagnosis of Hodgkin transformation can be made when appropriate.”

“Interestingly, the authors noted a trend toward improved survival when CLL with Hodgkin-like cells was treated with standard Hodgkin regimens,” said Dr. Woyach. “With the small patient numbers, this certainly cannot be a general recommendation, but should be considered by treating physicians on a case-by-case basis.”

“While we know that patients with Hodgkin transformation can in many cases be successfully treated with standard Hodgkin regimen, the natural history and optimal treatment for CLL with Hodgkin-like cells have been unknown. This analysis helps understand the biologic difference between these two clinicopathologic entities to understand how to better treat patients,” she noted. Going forward, “it would be extremely helpful to see these data validated by other centers to be sure that these results are reproducible,” Dr. Woyach added.

The study was supported by the Mayo Clinic, Rochester, Minn., and by the Henry J. Predolin Foundation. Lead author Dr. King disclosed research support to her institution from Bristol-Myers Squibb/Celgene. Dr. Woyach had no financial disclosures relevant to this study, but she has received laboratory research funding from Schrodinger and has consulted for AbbVie, Pharmacyclics, Janssen, AstraZeneca, Genentech, Beigene, Loxo, and Newave.
 

This article was updated 3/11/22.

Drink a day could age your brain

There are many things we can do daily to improve our health: Exercise, read a book, eat an apple (supposedly). Not drink a glass of red wine. Wait, not drink? That’s right. We were told that a glass of red wine each night was doing something good for our hearts, but it’s doing something bad to our brains: Aging them prematurely.

According to a recent study in Nature Communications, drinking half a pint of beer a day could age the brain of a 50-year-old by 6 months. A pint of beer equaled 2 years of aging and a pint and a half aged participants’ brains by 3.5 years.

Courtesy Debora Cartagena, USCDCP

Compared with people who didn’t drink, those who averaged about two pints of beer or two glasses of wine daily had brains aged 10 years older!

The researchers’ analysis included MRI scans of about 37,000 middle-aged men in the United Kingdom, along with their medical information and drinking habits, Everyday Health reported. They determined volume reductions in two parts of the brain potentially impacted by daily consumption of alcohol: White matter, which controls the senses and communication, and gray matter, which controls cognitive functions such as movement, emotions, and memories.

Normal brain aging is bad enough: Stuff like forgetting why we walked into the kitchen or having a word we want to use on the tips of our tongues. Who knew that happy hour could be speeding up the process?

Bartender, make that mimosa a virgin.
 

A big dose of meta-cine

The metaverse is big news in the tech world. For those who are less technologically inclined or haven’t thrown a few hundred dollars at a clunky virtual reality headset, the metaverse is a vaguely defined artificial reality world, brought to you by Facebo-, excuse us, Meta, where you hang out with people using a virtual avatar and do various activities, all from the comfort of your own home.

Piqsels

That’s not the most helpful definition, if we’re being honest, and that’s partially because the metaverse, as it’s being pushed by companies such as Meta, is very new and kind of a Wild West. No one really knows what it’ll be used for, but that’s not going to stop big business from pushing to secure their own corners of a new and exciting market, and that brings us to CVS, which is looking to become the first pharmacy in the metaverse.

Specifically, the company is looking to provide the entirety of its health care services – nonemergency medical care, wellness programs, nutrition advice, and counseling – to the metaverse. That makes sense. Telemedicine has become big during the pandemic, and bringing that care to the metaverse could work. Probably overcomplicated, since the sort of person who couldn’t figure out a video call to a doctor probably won’t be spending much time in the metaverse, but hey, if they can make it work, more power to them.

Where things get a bit silly is the online store. CVS looking to sell not only NFTs (because of course it is), but also downloadable virtual goods, including “prescription drugs, health, wellness, beauty, and personal care products,” according to the company’s claim to the U.S. Patent Trade Office. What exactly is a downloadable virtual prescription drug? Excellent question. We’re picturing holographic meatloaf, but the true answer is bound to be sillier than anything SpongeBob and friends could conjure.
 

Please don’t eat the winner

Hello friends. LOTME Sports welcomes you to the University of Toledo’s Glass Bowl for the wackiest virtual sporting event since Usain Bolt raced against a cheetah.

Frank_P_AJJ74/Pixabay

Hi, I’m Jim Nantz, and we’re here to witness the brainchild of Toledo physics professor Scott Lee, PhD, who posed an unusual question to his students: Is Usain Bolt faster than a 900-pound dinosaur?

Before we get started, though, I’ve got a quick question for my partner in today’s broadcast, Hall of Fame quarterback Peyton Manning: Why is someone who practices physics called a physicist when someone who practices medicine is known as a physician?

Jim, I’m prepared to talk about how Dr. Lee’s students used the concepts of 1D kinematics – displacement, speed, velocity, and acceleration – to determine if a Jamaican sprinter could beat Dilophosaurus wetherilli in a hypothetical race. Heck, it took me 2 days to be able to pronounce Dilophosaurus wetherilli. Don’t get me started on etymology.

Fair enough, my friend. What else can you tell us?

In his article in The Physics Teacher, Dr. Lee noted that recent musculoskeletal models of vertebrate animals have shown that a dinosaur like Dilophosaurus could run about as fast as Usain Bolt when he set the world record of 9.58 seconds for 100 meters in 2009. You might remember Dilophosaurus from “Jurassic Park.” It was the one that attacked the guy who played Newman on “Seinfeld.”

Fascinating stuff, Peyton, but it looks like the race is about to start. And they’re off! Newton’s second law, which says that acceleration is determined by a combination of mass and force, gives the smaller Bolt an early advantage. The dinosaur takes longer to reach maximum running velocity and crosses the line 2 seconds behind the world’s fastest human. Amazing!

Be sure to tune in again next week, when tennis legend Serena Williams takes the court against a hungry velociraptor.
 

Turning back the egg timer

The idea of getting older can be scary. Wouldn’t it be nice if we could reverse the aging process? Nice, sure, but not possible. Well, it may just be possible for women undergoing assisted reproductive treatment.

Gerd Altmann/Pixabay

It’s generally known that oocytes accumulate DNA damage over time as well, hindering fertility, but a lab in Jerusalem has found a way to reverse the age of eggs.

If you’re wondering how on Earth that was possible, here’s how. Scientists from the Hebrew University of Jerusalem said that they found a previously unknown aging mechanism, which they were able to reverse using antiviral medications, they reported in Aging Cell.

The experiment started on mice eggs, but soon real human eggs were donated. After the procedure, the treated eggs appeared younger, with less of the DNA damage that comes from age. Sperm has not yet been used to test fertility so it is unclear if this will result in something game changing, but the investigators have high hopes.

“Many women are trying to get pregnant aged 40 or over, and we think this could actually increase their level of fertility,” senior investigator Michael Klutstein, PhD, told the Times of Israel. “Within 10 years, we hope to use antiviral drugs to increase fertility among older women.”

We’re counting on you, science! Do your thing!

Drink a day could age your brain

There are many things we can do daily to improve our health: Exercise, read a book, eat an apple (supposedly). Not drink a glass of red wine. Wait, not drink? That’s right. We were told that a glass of red wine each night was doing something good for our hearts, but it’s doing something bad to our brains: Aging them prematurely.

According to a recent study in Nature Communications, drinking half a pint of beer a day could age the brain of a 50-year-old by 6 months. A pint of beer equaled 2 years of aging and a pint and a half aged participants’ brains by 3.5 years.

Courtesy Debora Cartagena, USCDCP

Compared with people who didn’t drink, those who averaged about two pints of beer or two glasses of wine daily had brains aged 10 years older!

The researchers’ analysis included MRI scans of about 37,000 middle-aged men in the United Kingdom, along with their medical information and drinking habits, Everyday Health reported. They determined volume reductions in two parts of the brain potentially impacted by daily consumption of alcohol: White matter, which controls the senses and communication, and gray matter, which controls cognitive functions such as movement, emotions, and memories.

Normal brain aging is bad enough: Stuff like forgetting why we walked into the kitchen or having a word we want to use on the tips of our tongues. Who knew that happy hour could be speeding up the process?

Bartender, make that mimosa a virgin.
 

A big dose of meta-cine

The metaverse is big news in the tech world. For those who are less technologically inclined or haven’t thrown a few hundred dollars at a clunky virtual reality headset, the metaverse is a vaguely defined artificial reality world, brought to you by Facebo-, excuse us, Meta, where you hang out with people using a virtual avatar and do various activities, all from the comfort of your own home.

Piqsels

That’s not the most helpful definition, if we’re being honest, and that’s partially because the metaverse, as it’s being pushed by companies such as Meta, is very new and kind of a Wild West. No one really knows what it’ll be used for, but that’s not going to stop big business from pushing to secure their own corners of a new and exciting market, and that brings us to CVS, which is looking to become the first pharmacy in the metaverse.

Specifically, the company is looking to provide the entirety of its health care services – nonemergency medical care, wellness programs, nutrition advice, and counseling – to the metaverse. That makes sense. Telemedicine has become big during the pandemic, and bringing that care to the metaverse could work. Probably overcomplicated, since the sort of person who couldn’t figure out a video call to a doctor probably won’t be spending much time in the metaverse, but hey, if they can make it work, more power to them.

Where things get a bit silly is the online store. CVS looking to sell not only NFTs (because of course it is), but also downloadable virtual goods, including “prescription drugs, health, wellness, beauty, and personal care products,” according to the company’s claim to the U.S. Patent Trade Office. What exactly is a downloadable virtual prescription drug? Excellent question. We’re picturing holographic meatloaf, but the true answer is bound to be sillier than anything SpongeBob and friends could conjure.
 

Please don’t eat the winner

Hello friends. LOTME Sports welcomes you to the University of Toledo’s Glass Bowl for the wackiest virtual sporting event since Usain Bolt raced against a cheetah.

Frank_P_AJJ74/Pixabay

Hi, I’m Jim Nantz, and we’re here to witness the brainchild of Toledo physics professor Scott Lee, PhD, who posed an unusual question to his students: Is Usain Bolt faster than a 900-pound dinosaur?

Before we get started, though, I’ve got a quick question for my partner in today’s broadcast, Hall of Fame quarterback Peyton Manning: Why is someone who practices physics called a physicist when someone who practices medicine is known as a physician?

Jim, I’m prepared to talk about how Dr. Lee’s students used the concepts of 1D kinematics – displacement, speed, velocity, and acceleration – to determine if a Jamaican sprinter could beat Dilophosaurus wetherilli in a hypothetical race. Heck, it took me 2 days to be able to pronounce Dilophosaurus wetherilli. Don’t get me started on etymology.

Fair enough, my friend. What else can you tell us?

In his article in The Physics Teacher, Dr. Lee noted that recent musculoskeletal models of vertebrate animals have shown that a dinosaur like Dilophosaurus could run about as fast as Usain Bolt when he set the world record of 9.58 seconds for 100 meters in 2009. You might remember Dilophosaurus from “Jurassic Park.” It was the one that attacked the guy who played Newman on “Seinfeld.”

Fascinating stuff, Peyton, but it looks like the race is about to start. And they’re off! Newton’s second law, which says that acceleration is determined by a combination of mass and force, gives the smaller Bolt an early advantage. The dinosaur takes longer to reach maximum running velocity and crosses the line 2 seconds behind the world’s fastest human. Amazing!

Be sure to tune in again next week, when tennis legend Serena Williams takes the court against a hungry velociraptor.
 

Turning back the egg timer

The idea of getting older can be scary. Wouldn’t it be nice if we could reverse the aging process? Nice, sure, but not possible. Well, it may just be possible for women undergoing assisted reproductive treatment.

Gerd Altmann/Pixabay

It’s generally known that oocytes accumulate DNA damage over time as well, hindering fertility, but a lab in Jerusalem has found a way to reverse the age of eggs.

If you’re wondering how on Earth that was possible, here’s how. Scientists from the Hebrew University of Jerusalem said that they found a previously unknown aging mechanism, which they were able to reverse using antiviral medications, they reported in Aging Cell.

The experiment started on mice eggs, but soon real human eggs were donated. After the procedure, the treated eggs appeared younger, with less of the DNA damage that comes from age. Sperm has not yet been used to test fertility so it is unclear if this will result in something game changing, but the investigators have high hopes.

“Many women are trying to get pregnant aged 40 or over, and we think this could actually increase their level of fertility,” senior investigator Michael Klutstein, PhD, told the Times of Israel. “Within 10 years, we hope to use antiviral drugs to increase fertility among older women.”

We’re counting on you, science! Do your thing!

Drink a day could age your brain

There are many things we can do daily to improve our health: Exercise, read a book, eat an apple (supposedly). Not drink a glass of red wine. Wait, not drink? That’s right. We were told that a glass of red wine each night was doing something good for our hearts, but it’s doing something bad to our brains: Aging them prematurely.

According to a recent study in Nature Communications, drinking half a pint of beer a day could age the brain of a 50-year-old by 6 months. A pint of beer equaled 2 years of aging and a pint and a half aged participants’ brains by 3.5 years.

Courtesy Debora Cartagena, USCDCP

Compared with people who didn’t drink, those who averaged about two pints of beer or two glasses of wine daily had brains aged 10 years older!

The researchers’ analysis included MRI scans of about 37,000 middle-aged men in the United Kingdom, along with their medical information and drinking habits, Everyday Health reported. They determined volume reductions in two parts of the brain potentially impacted by daily consumption of alcohol: White matter, which controls the senses and communication, and gray matter, which controls cognitive functions such as movement, emotions, and memories.

Normal brain aging is bad enough: Stuff like forgetting why we walked into the kitchen or having a word we want to use on the tips of our tongues. Who knew that happy hour could be speeding up the process?

Bartender, make that mimosa a virgin.
 

A big dose of meta-cine

The metaverse is big news in the tech world. For those who are less technologically inclined or haven’t thrown a few hundred dollars at a clunky virtual reality headset, the metaverse is a vaguely defined artificial reality world, brought to you by Facebo-, excuse us, Meta, where you hang out with people using a virtual avatar and do various activities, all from the comfort of your own home.

Piqsels

That’s not the most helpful definition, if we’re being honest, and that’s partially because the metaverse, as it’s being pushed by companies such as Meta, is very new and kind of a Wild West. No one really knows what it’ll be used for, but that’s not going to stop big business from pushing to secure their own corners of a new and exciting market, and that brings us to CVS, which is looking to become the first pharmacy in the metaverse.

Specifically, the company is looking to provide the entirety of its health care services – nonemergency medical care, wellness programs, nutrition advice, and counseling – to the metaverse. That makes sense. Telemedicine has become big during the pandemic, and bringing that care to the metaverse could work. Probably overcomplicated, since the sort of person who couldn’t figure out a video call to a doctor probably won’t be spending much time in the metaverse, but hey, if they can make it work, more power to them.

Where things get a bit silly is the online store. CVS looking to sell not only NFTs (because of course it is), but also downloadable virtual goods, including “prescription drugs, health, wellness, beauty, and personal care products,” according to the company’s claim to the U.S. Patent Trade Office. What exactly is a downloadable virtual prescription drug? Excellent question. We’re picturing holographic meatloaf, but the true answer is bound to be sillier than anything SpongeBob and friends could conjure.
 

Please don’t eat the winner

Hello friends. LOTME Sports welcomes you to the University of Toledo’s Glass Bowl for the wackiest virtual sporting event since Usain Bolt raced against a cheetah.

Frank_P_AJJ74/Pixabay

Hi, I’m Jim Nantz, and we’re here to witness the brainchild of Toledo physics professor Scott Lee, PhD, who posed an unusual question to his students: Is Usain Bolt faster than a 900-pound dinosaur?

Before we get started, though, I’ve got a quick question for my partner in today’s broadcast, Hall of Fame quarterback Peyton Manning: Why is someone who practices physics called a physicist when someone who practices medicine is known as a physician?

Jim, I’m prepared to talk about how Dr. Lee’s students used the concepts of 1D kinematics – displacement, speed, velocity, and acceleration – to determine if a Jamaican sprinter could beat Dilophosaurus wetherilli in a hypothetical race. Heck, it took me 2 days to be able to pronounce Dilophosaurus wetherilli. Don’t get me started on etymology.

Fair enough, my friend. What else can you tell us?

In his article in The Physics Teacher, Dr. Lee noted that recent musculoskeletal models of vertebrate animals have shown that a dinosaur like Dilophosaurus could run about as fast as Usain Bolt when he set the world record of 9.58 seconds for 100 meters in 2009. You might remember Dilophosaurus from “Jurassic Park.” It was the one that attacked the guy who played Newman on “Seinfeld.”

Fascinating stuff, Peyton, but it looks like the race is about to start. And they’re off! Newton’s second law, which says that acceleration is determined by a combination of mass and force, gives the smaller Bolt an early advantage. The dinosaur takes longer to reach maximum running velocity and crosses the line 2 seconds behind the world’s fastest human. Amazing!

Be sure to tune in again next week, when tennis legend Serena Williams takes the court against a hungry velociraptor.
 

Turning back the egg timer

The idea of getting older can be scary. Wouldn’t it be nice if we could reverse the aging process? Nice, sure, but not possible. Well, it may just be possible for women undergoing assisted reproductive treatment.

Gerd Altmann/Pixabay

It’s generally known that oocytes accumulate DNA damage over time as well, hindering fertility, but a lab in Jerusalem has found a way to reverse the age of eggs.

If you’re wondering how on Earth that was possible, here’s how. Scientists from the Hebrew University of Jerusalem said that they found a previously unknown aging mechanism, which they were able to reverse using antiviral medications, they reported in Aging Cell.

The experiment started on mice eggs, but soon real human eggs were donated. After the procedure, the treated eggs appeared younger, with less of the DNA damage that comes from age. Sperm has not yet been used to test fertility so it is unclear if this will result in something game changing, but the investigators have high hopes.

“Many women are trying to get pregnant aged 40 or over, and we think this could actually increase their level of fertility,” senior investigator Michael Klutstein, PhD, told the Times of Israel. “Within 10 years, we hope to use antiviral drugs to increase fertility among older women.”

We’re counting on you, science! Do your thing!