Journal of Clinical Outcomes Management

New data shed light on the durability of antibody responses to SARS-CoV-2 vaccines and the impact of booster doses for patients with cancer undergoing systemic therapy or who have received a stem cell transplant (SCT).

In a cross-sectional study of 453 such patients, anti–SARS-CoV-2 spike protein receptor binding domain (anti-RBD) antibodies peaked 1 month after the second dose of an mRNA vaccine and remained stable over the next 6 months.

Notably, compared with the primary vaccine course, patients experienced a 20-fold increase in anti-RBD antibodies after the third vaccine dose, “indicative of a brisk anamnestic response from memory B cells,” Qamar Khan, MD, a medical oncologist at the University of Kansas Medical Center, Kansas City, and colleagues report.

The study appeared online in JAMA Oncology.

Given the risk of poor outcomes among patients with cancer and recipients of SCTs who get COVID, Dr. Khan and colleagues wanted to understand the durability of the antibody response to COVID vaccines in this population.

Among the 453 patients enrolled in the study, 70% had solid tumors and 30% had hematologic malignancies. Just over 40% were receiving chemotherapy, 16% were receiving immunotherapy, 14% were receiving a targeted oral agent, 5% were receiving chemoimmunotherapy, and 25% had received an SCT.

Regarding vaccine type, 61% received the Pfizer-BioNTech mRNA vaccine, 36% received the Moderna mRNA vaccine, and 4% got the Janssen/Johnson & Johnson vaccine. The mean age of the cohort was 60.4 years; 56% were women.

Prior to vaccination, the geometric mean titer (GMT) of anti-RBD antibodies for all patients was 1.7; it increased to 18.65 2 weeks after the first dose.

At 1 month after the second mRNA dose (or 2 months after the Johnson & Johnson vaccine), GMTs of anti-RBD antibodies reached 470.38 and then decreased to 425.8 at 3 months after the second dose (or 4 months after the Johnson & Johnson vaccine). Patients who were male, older than 65 years, and who had been diagnosed with a hematologic malignant tumor were more likely to have lower anti-RBD GMT 3 months after the second vaccine dose.

GMTs subsequently increased to 447.23 6 months after the second dose (7 months for Johnson & Johnson).

One month after the third dose, GMTs of anti-RBD antibodies rose to 9,224.85 – more than 20 times the previous GMT value.

According to the investigators, roughly 80% of these patients remained above the threshold of an anti-RBD level of 100 U/mL or higher at 6 months.

“While still an arbitrary cutoff, an anti-RBD level of 100 U/mL or higher has been associated with protection and has been used to evaluate the effectiveness of a third dose of an mRNA vaccine in a randomized clinical trial of patients who received a solid organ transplant,” Dr. Khan and colleagues write.

“Although more data are needed to confirm this level as protective, if established, anti-RBD can potentially be used to prioritize additional vaccine doses, especially in regions of the world with limited vaccine resources,” the authors conclude.

The study was supported in part by the University of Kansas Cancer Center and the Investigator Initiated Steering Committee, by a grant from the National Institute of General Medical Sciences, and a University of Kansas Cancer Center Support Grant from the National Cancer Institute. Dr. Khan reported no relevant financial relationships.

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

New data shed light on the durability of antibody responses to SARS-CoV-2 vaccines and the impact of booster doses for patients with cancer undergoing systemic therapy or who have received a stem cell transplant (SCT).

In a cross-sectional study of 453 such patients, anti–SARS-CoV-2 spike protein receptor binding domain (anti-RBD) antibodies peaked 1 month after the second dose of an mRNA vaccine and remained stable over the next 6 months.

Notably, compared with the primary vaccine course, patients experienced a 20-fold increase in anti-RBD antibodies after the third vaccine dose, “indicative of a brisk anamnestic response from memory B cells,” Qamar Khan, MD, a medical oncologist at the University of Kansas Medical Center, Kansas City, and colleagues report.

The study appeared online in JAMA Oncology.

Given the risk of poor outcomes among patients with cancer and recipients of SCTs who get COVID, Dr. Khan and colleagues wanted to understand the durability of the antibody response to COVID vaccines in this population.

Among the 453 patients enrolled in the study, 70% had solid tumors and 30% had hematologic malignancies. Just over 40% were receiving chemotherapy, 16% were receiving immunotherapy, 14% were receiving a targeted oral agent, 5% were receiving chemoimmunotherapy, and 25% had received an SCT.

Regarding vaccine type, 61% received the Pfizer-BioNTech mRNA vaccine, 36% received the Moderna mRNA vaccine, and 4% got the Janssen/Johnson & Johnson vaccine. The mean age of the cohort was 60.4 years; 56% were women.

Prior to vaccination, the geometric mean titer (GMT) of anti-RBD antibodies for all patients was 1.7; it increased to 18.65 2 weeks after the first dose.

At 1 month after the second mRNA dose (or 2 months after the Johnson & Johnson vaccine), GMTs of anti-RBD antibodies reached 470.38 and then decreased to 425.8 at 3 months after the second dose (or 4 months after the Johnson & Johnson vaccine). Patients who were male, older than 65 years, and who had been diagnosed with a hematologic malignant tumor were more likely to have lower anti-RBD GMT 3 months after the second vaccine dose.

GMTs subsequently increased to 447.23 6 months after the second dose (7 months for Johnson & Johnson).

One month after the third dose, GMTs of anti-RBD antibodies rose to 9,224.85 – more than 20 times the previous GMT value.

According to the investigators, roughly 80% of these patients remained above the threshold of an anti-RBD level of 100 U/mL or higher at 6 months.

“While still an arbitrary cutoff, an anti-RBD level of 100 U/mL or higher has been associated with protection and has been used to evaluate the effectiveness of a third dose of an mRNA vaccine in a randomized clinical trial of patients who received a solid organ transplant,” Dr. Khan and colleagues write.

“Although more data are needed to confirm this level as protective, if established, anti-RBD can potentially be used to prioritize additional vaccine doses, especially in regions of the world with limited vaccine resources,” the authors conclude.

The study was supported in part by the University of Kansas Cancer Center and the Investigator Initiated Steering Committee, by a grant from the National Institute of General Medical Sciences, and a University of Kansas Cancer Center Support Grant from the National Cancer Institute. Dr. Khan reported no relevant financial relationships.

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

New data shed light on the durability of antibody responses to SARS-CoV-2 vaccines and the impact of booster doses for patients with cancer undergoing systemic therapy or who have received a stem cell transplant (SCT).

In a cross-sectional study of 453 such patients, anti–SARS-CoV-2 spike protein receptor binding domain (anti-RBD) antibodies peaked 1 month after the second dose of an mRNA vaccine and remained stable over the next 6 months.

Notably, compared with the primary vaccine course, patients experienced a 20-fold increase in anti-RBD antibodies after the third vaccine dose, “indicative of a brisk anamnestic response from memory B cells,” Qamar Khan, MD, a medical oncologist at the University of Kansas Medical Center, Kansas City, and colleagues report.

The study appeared online in JAMA Oncology.

Given the risk of poor outcomes among patients with cancer and recipients of SCTs who get COVID, Dr. Khan and colleagues wanted to understand the durability of the antibody response to COVID vaccines in this population.

Among the 453 patients enrolled in the study, 70% had solid tumors and 30% had hematologic malignancies. Just over 40% were receiving chemotherapy, 16% were receiving immunotherapy, 14% were receiving a targeted oral agent, 5% were receiving chemoimmunotherapy, and 25% had received an SCT.

Regarding vaccine type, 61% received the Pfizer-BioNTech mRNA vaccine, 36% received the Moderna mRNA vaccine, and 4% got the Janssen/Johnson & Johnson vaccine. The mean age of the cohort was 60.4 years; 56% were women.

Prior to vaccination, the geometric mean titer (GMT) of anti-RBD antibodies for all patients was 1.7; it increased to 18.65 2 weeks after the first dose.

At 1 month after the second mRNA dose (or 2 months after the Johnson & Johnson vaccine), GMTs of anti-RBD antibodies reached 470.38 and then decreased to 425.8 at 3 months after the second dose (or 4 months after the Johnson & Johnson vaccine). Patients who were male, older than 65 years, and who had been diagnosed with a hematologic malignant tumor were more likely to have lower anti-RBD GMT 3 months after the second vaccine dose.

GMTs subsequently increased to 447.23 6 months after the second dose (7 months for Johnson & Johnson).

One month after the third dose, GMTs of anti-RBD antibodies rose to 9,224.85 – more than 20 times the previous GMT value.

According to the investigators, roughly 80% of these patients remained above the threshold of an anti-RBD level of 100 U/mL or higher at 6 months.

“While still an arbitrary cutoff, an anti-RBD level of 100 U/mL or higher has been associated with protection and has been used to evaluate the effectiveness of a third dose of an mRNA vaccine in a randomized clinical trial of patients who received a solid organ transplant,” Dr. Khan and colleagues write.

“Although more data are needed to confirm this level as protective, if established, anti-RBD can potentially be used to prioritize additional vaccine doses, especially in regions of the world with limited vaccine resources,” the authors conclude.

The study was supported in part by the University of Kansas Cancer Center and the Investigator Initiated Steering Committee, by a grant from the National Institute of General Medical Sciences, and a University of Kansas Cancer Center Support Grant from the National Cancer Institute. Dr. Khan reported no relevant financial relationships.

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

CHICAGO – Many physicians still hold beliefs despite the existence of clear evidence that they are incorrect, said a presenter at the annual meeting of the American College of Physicians.

These long-held pieces of dogma – or “medical myths” – were engraved during training or early in the careers of many physicians, and are difficult to overcome, noted Douglas Paauw, MD, professor of medicine at the University of Washington, Seattle.

“I think that myths persist because medical professionals get taught one way in training, given a ‘truth’ or ‘This is the way we do it,’ and then do not ever rethink, ‘Is it true?’ ” he said in an interview. “Studies pop up to question conventional wisdom, but unless the studies get highly publicized, they aren’t noticed.”

During his presentation, Dr. Paauw discussed three of what he considers to be some of the some of the medical myths that are in greatest need of being dispelled.
 

Shellfish allergy and radiocontrast

A myth persists that people with a shellfish allergy could have an allergic reaction when a contrast agent is used for a scan, he said.

This belief arose, because fish and shellfish contain iodine, and allergic reactions to seafood are fairly common, and contrast agents contain iodine, too, Dr. Paauw said.

The belief is widespread, with 65% of radiologists and 88.9% of interventional cardiologists saying they ask about seafood or shellfish allergies before administering contrast. And a third of radiologists and 50% of cardiologists said they would withhold contrast media or recommend a premedication for patients with such an allergy.

But the belief makes no sense, Dr. Pauuw said. Iodine is present in many other foods, including milk and bread, and allergies to shellfish are because of parvalbumin protein and tropomyosins, not iodine.
 

Colonoscopy dogma

It’s been long believed that people need to be on a clear, liquid diet for 1 or 2 days and need to drink a bowel-prep liquid before a colonoscopy, noted Dr. Paauw.

But the evidence shows this isn’t necessary, he said.

A 2020 study found that a low-residual diet, allowing foods such as meat, eggs, dairy, and bread, were comparable to the clear liquid diet in terms of bowel prep and detection of polyps during the exam. The patients on the low-residual diet had less nausea, less vomiting, and less hunger, and expressed more willingness to have a repeat colonoscopy.

“Let them eat,” Dr. Paauw said in his presentation.
 

Metronidazole and alcohol

There is a belief that patients shouldn’t drink alcohol if they are taking metronidazole, because of concerns about nausea, vomiting, flushing and other symptoms – also known as a disulfiramlike reaction, Dr. Paauw explained.

Case reports have been published, but the cases were presented as though a metronidazole-ethanol reaction was an established fact, and the authors didn’t provide evidence to justify this, Dr. Paauw said.

But it’s been shown in rat models that metronidazole can increase levels of acetaldehyde, the trigger of symptoms, in the colon, but not in the blood. And in a small placebo-controlled, randomized trial, six people were given metronidazole and ethanol and, after regular blood testing, no difference was seen in acetaldehyde blood levels, vital signs, or symptoms.

The Centers for Disease Control and Prevention has said that avoiding alcohol while taking metronidazole is unnecessary, said Dr. Paauw.
 

Sinus headaches

Contrary to common belief, headaches thought to be “sinus headaches” are usually migraine headaches, Dr. Paauw said.

In one study, 2,991 patients with six headaches in the previous 6 months were self-diagnosed or were physician-diagnosed with sinus headaches. But 88% of these headaches met the International Headache Society criteria for migraine headache.

Dr. Paauw said he hopes that clinicians reconsider the evidence regularly when deciding how to treat their patients, and not rely on bits of dogma.

“They stay with us,” he said, “and sometimes there are other ways to do it.”

Shien Tze, MD, an internist in Fargo, N,D,, said that patients sometimes also hold misconceptions, based on outdated dogma, that he needs to dispel.

“I try to convince them that this is a myth that is not based on evidence, not based on science,” he said. “I think it depends on the way you say it. If you say it in a calm, firm, not wishy-washy way, the patients believe you.”

Dr. Paauw reported no relevant financial disclosures. He serves on the editorial advisory board of Internal Medicine News, and he contributes “Myth of the Month” and “Pearl of the Month” columns to this publication.

CHICAGO – Many physicians still hold beliefs despite the existence of clear evidence that they are incorrect, said a presenter at the annual meeting of the American College of Physicians.

These long-held pieces of dogma – or “medical myths” – were engraved during training or early in the careers of many physicians, and are difficult to overcome, noted Douglas Paauw, MD, professor of medicine at the University of Washington, Seattle.

“I think that myths persist because medical professionals get taught one way in training, given a ‘truth’ or ‘This is the way we do it,’ and then do not ever rethink, ‘Is it true?’ ” he said in an interview. “Studies pop up to question conventional wisdom, but unless the studies get highly publicized, they aren’t noticed.”

During his presentation, Dr. Paauw discussed three of what he considers to be some of the some of the medical myths that are in greatest need of being dispelled.
 

Shellfish allergy and radiocontrast

A myth persists that people with a shellfish allergy could have an allergic reaction when a contrast agent is used for a scan, he said.

This belief arose, because fish and shellfish contain iodine, and allergic reactions to seafood are fairly common, and contrast agents contain iodine, too, Dr. Paauw said.

The belief is widespread, with 65% of radiologists and 88.9% of interventional cardiologists saying they ask about seafood or shellfish allergies before administering contrast. And a third of radiologists and 50% of cardiologists said they would withhold contrast media or recommend a premedication for patients with such an allergy.

But the belief makes no sense, Dr. Pauuw said. Iodine is present in many other foods, including milk and bread, and allergies to shellfish are because of parvalbumin protein and tropomyosins, not iodine.
 

Colonoscopy dogma

It’s been long believed that people need to be on a clear, liquid diet for 1 or 2 days and need to drink a bowel-prep liquid before a colonoscopy, noted Dr. Paauw.

But the evidence shows this isn’t necessary, he said.

A 2020 study found that a low-residual diet, allowing foods such as meat, eggs, dairy, and bread, were comparable to the clear liquid diet in terms of bowel prep and detection of polyps during the exam. The patients on the low-residual diet had less nausea, less vomiting, and less hunger, and expressed more willingness to have a repeat colonoscopy.

“Let them eat,” Dr. Paauw said in his presentation.
 

Metronidazole and alcohol

There is a belief that patients shouldn’t drink alcohol if they are taking metronidazole, because of concerns about nausea, vomiting, flushing and other symptoms – also known as a disulfiramlike reaction, Dr. Paauw explained.

Case reports have been published, but the cases were presented as though a metronidazole-ethanol reaction was an established fact, and the authors didn’t provide evidence to justify this, Dr. Paauw said.

But it’s been shown in rat models that metronidazole can increase levels of acetaldehyde, the trigger of symptoms, in the colon, but not in the blood. And in a small placebo-controlled, randomized trial, six people were given metronidazole and ethanol and, after regular blood testing, no difference was seen in acetaldehyde blood levels, vital signs, or symptoms.

The Centers for Disease Control and Prevention has said that avoiding alcohol while taking metronidazole is unnecessary, said Dr. Paauw.
 

Sinus headaches

Contrary to common belief, headaches thought to be “sinus headaches” are usually migraine headaches, Dr. Paauw said.

In one study, 2,991 patients with six headaches in the previous 6 months were self-diagnosed or were physician-diagnosed with sinus headaches. But 88% of these headaches met the International Headache Society criteria for migraine headache.

Dr. Paauw said he hopes that clinicians reconsider the evidence regularly when deciding how to treat their patients, and not rely on bits of dogma.

“They stay with us,” he said, “and sometimes there are other ways to do it.”

Shien Tze, MD, an internist in Fargo, N,D,, said that patients sometimes also hold misconceptions, based on outdated dogma, that he needs to dispel.

“I try to convince them that this is a myth that is not based on evidence, not based on science,” he said. “I think it depends on the way you say it. If you say it in a calm, firm, not wishy-washy way, the patients believe you.”

Dr. Paauw reported no relevant financial disclosures. He serves on the editorial advisory board of Internal Medicine News, and he contributes “Myth of the Month” and “Pearl of the Month” columns to this publication.

CHICAGO – Many physicians still hold beliefs despite the existence of clear evidence that they are incorrect, said a presenter at the annual meeting of the American College of Physicians.

These long-held pieces of dogma – or “medical myths” – were engraved during training or early in the careers of many physicians, and are difficult to overcome, noted Douglas Paauw, MD, professor of medicine at the University of Washington, Seattle.

“I think that myths persist because medical professionals get taught one way in training, given a ‘truth’ or ‘This is the way we do it,’ and then do not ever rethink, ‘Is it true?’ ” he said in an interview. “Studies pop up to question conventional wisdom, but unless the studies get highly publicized, they aren’t noticed.”

During his presentation, Dr. Paauw discussed three of what he considers to be some of the some of the medical myths that are in greatest need of being dispelled.
 

Shellfish allergy and radiocontrast

A myth persists that people with a shellfish allergy could have an allergic reaction when a contrast agent is used for a scan, he said.

This belief arose, because fish and shellfish contain iodine, and allergic reactions to seafood are fairly common, and contrast agents contain iodine, too, Dr. Paauw said.

The belief is widespread, with 65% of radiologists and 88.9% of interventional cardiologists saying they ask about seafood or shellfish allergies before administering contrast. And a third of radiologists and 50% of cardiologists said they would withhold contrast media or recommend a premedication for patients with such an allergy.

But the belief makes no sense, Dr. Pauuw said. Iodine is present in many other foods, including milk and bread, and allergies to shellfish are because of parvalbumin protein and tropomyosins, not iodine.
 

Colonoscopy dogma

It’s been long believed that people need to be on a clear, liquid diet for 1 or 2 days and need to drink a bowel-prep liquid before a colonoscopy, noted Dr. Paauw.

But the evidence shows this isn’t necessary, he said.

A 2020 study found that a low-residual diet, allowing foods such as meat, eggs, dairy, and bread, were comparable to the clear liquid diet in terms of bowel prep and detection of polyps during the exam. The patients on the low-residual diet had less nausea, less vomiting, and less hunger, and expressed more willingness to have a repeat colonoscopy.

“Let them eat,” Dr. Paauw said in his presentation.
 

Metronidazole and alcohol

There is a belief that patients shouldn’t drink alcohol if they are taking metronidazole, because of concerns about nausea, vomiting, flushing and other symptoms – also known as a disulfiramlike reaction, Dr. Paauw explained.

Case reports have been published, but the cases were presented as though a metronidazole-ethanol reaction was an established fact, and the authors didn’t provide evidence to justify this, Dr. Paauw said.

But it’s been shown in rat models that metronidazole can increase levels of acetaldehyde, the trigger of symptoms, in the colon, but not in the blood. And in a small placebo-controlled, randomized trial, six people were given metronidazole and ethanol and, after regular blood testing, no difference was seen in acetaldehyde blood levels, vital signs, or symptoms.

The Centers for Disease Control and Prevention has said that avoiding alcohol while taking metronidazole is unnecessary, said Dr. Paauw.
 

Sinus headaches

Contrary to common belief, headaches thought to be “sinus headaches” are usually migraine headaches, Dr. Paauw said.

In one study, 2,991 patients with six headaches in the previous 6 months were self-diagnosed or were physician-diagnosed with sinus headaches. But 88% of these headaches met the International Headache Society criteria for migraine headache.

Dr. Paauw said he hopes that clinicians reconsider the evidence regularly when deciding how to treat their patients, and not rely on bits of dogma.

“They stay with us,” he said, “and sometimes there are other ways to do it.”

Shien Tze, MD, an internist in Fargo, N,D,, said that patients sometimes also hold misconceptions, based on outdated dogma, that he needs to dispel.

“I try to convince them that this is a myth that is not based on evidence, not based on science,” he said. “I think it depends on the way you say it. If you say it in a calm, firm, not wishy-washy way, the patients believe you.”

Dr. Paauw reported no relevant financial disclosures. He serves on the editorial advisory board of Internal Medicine News, and he contributes “Myth of the Month” and “Pearl of the Month” columns to this publication.

The Food and Drug Administration is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.

The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.

The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.

Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.

The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.

The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.

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

The Food and Drug Administration is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.

The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.

The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.

Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.

The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.

The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.

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

The Food and Drug Administration is limiting who can receive the Johnson & Johnson COVID-19 vaccine because of concerns about the risk of a rare blood clotting condition.

In a statement issued May 5, the FDA said the J&J vaccine should only be given to people 18 and older who don’t have access to other vaccines or for whom other vaccines are not clinically appropriate. People 18 and older can also get the J&J vaccine if they choose to because they wouldn’t otherwise receive any vaccine, the FDA said.

The FDA statement was similar to the recommendation made in December by a Centers for Disease Control and Prevention committee of experts.

The FDA said the decision was made after more information was shared about the occurrence of a rare blood clotting condition, thrombosis with thrombocytopenia syndrome (TTS), 1 or 2 weeks after people received the J&J vaccine. The finding “warrants limiting the authorized use of the vaccine,” the FDA said.

“We recognize that the Janssen COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals.”

The CDC says 16.9 million people are fully vaccinated with the J&J vaccine, compared with 76.5 million with Moderna and 126.3 million with Pfizer.

Through March 18, the CDC and FDA have detected 60 confirmed cases of TTS, including 9 fatal cases, ABC News reported.

The J&J vaccine was granted emergency authorization in February 2021. Health authorities hoped it would help spread vaccines across the nation because it only required one initial dose and didn’t need to be stored at extremely cold temperatures, unlike the two-dose Pfizer and Moderna vaccines.

But 2 months after authorization, the government paused its use for 10 days because of reports of TTS. In December 2021, the CDC’s Advisory Committee on Immunization Practices said the Pfizer and Moderna vaccines were preferred over J&J because J&J carried the rare risk of blood clots and bleeding in the brain.

The FDA said the cause of the blood clotting is not known. But the “known and potential benefits of the vaccine” outweigh the risks for those people now allowed to receive it, the FDA said.

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

Researchers in Scotland have developed a risk calculator using a large electronic health records database that has shown a high reliability in predicting the risk of death for patients hospitalized for chronic occlusive pulmonary disease (COPD), providing another potential tool for improving postdischarge survival in these patients.

In a study published online in the journal Pharmacological Research, Pierpalo Pellicori, MD, and colleagues reported that a few variables, including prescriptions and laboratory data in routine EHRs, could help predict a patient’s risk of dying within 90 days after a hospital stay for COPD. Dr. Pellicori is a clinical cardiologist and research fellow at the Robertson Center for Biostatistics at the University of Glasgow.

“Identification of patients at high risk is valuable information for multidisciplinary teams,” Dr. Pellicori said in a written comment. “It allows the most vulnerable patients to be highlighted and prioritized for consideration of optimized value-based care, and for anticipatory care plan discussions.”

The retrospective cohort study analyzed EHR records of 17,973 patients who had an unplanned hospitalization for COPD in the Glasgow area from 2011 to 2017. The risk calculator model achieved a potential accuracy of 80%.

The study noted that, while a number of models have been developed to calculate the risk of exacerbations, inpatient death and prognosis in patients hospitalized for COPD, most of those models were based on cohorts of 1000 patients or less.

“Older age, male sex, and a longer hospital stay were important predictors of mortality in patients with COPD,” Dr. Pellicori said. “We also found that use of commonly prescribed medications such as digoxin identify patients with COPD more likely to die, perhaps because many have underlying heart failure, a highly prevalent but frequently missed diagnosis.”

He noted that heart failure and COPD share many risk factors, signs, and symptoms, such as smoking history, peripheral edema, and breathlessness. “Distinguishing between COPD and heart failure can be difficult, but is very important, as appropriate treatment for heart failure can improve a patient’s quality of life and survival substantially in many cases.”

The study also found that routinely collected and inexpensive blood markers – such as hemoglobin, neutrophil/lymphocyte ratio, serum chloride, urea, creatinine, and albumin – can also improve predictability of outcomes.

For example, the study found a linear increase in mortality of blood hemoglobin concentration less than 14 g/dL, but higher levels posed no greater risk. Higher white blood cell and neutrophil counts and lower lymphocyte and eosinophil counts were associated with a worse prognosis.

The study also found a linear increase in mortality with serum sodium less than 140 mmol/L or serum chloride less than 105 mmol/L –  but that higher concentrations of each were associated with a worse outcome.

“Interestingly,” Pellicori added, “social deprivation was not associated with mortality in this cohort.”

The final predictive model included age, sex, length of stay, and just nine other variables. “The model can be applied easily in clinical practice, even if electronic records are not available, because there are only 12 variables,” Dr. Pellicori said. “These could easily be entered manually into the risk calculator that we provide.”

“What is notable about this risk calculator is that it uses some of the techniques of machine learning, although it’s not specifically machine learning,” Angel Coz, MD, a pulmonologist at the Cleveland Clinic Respiratory Institute, said in an interview. “But it’s a retrospective data analysis, and actually by doing that it may catch some factors that we may not have necessarily paid attention to on a regular basis.”

While he called it a “well-done study,” Dr. Coz cautioned that “we have to be conservative in how to interpret and apply this because it is retrospective,” adding that future research should also use a prospective cohort.

For future consideration, Dr. Pellicori said that, while EHRs provide a “rich source” of data for such risk calculators, systems differ greatly across hospitals and health care systems and don’t link easily.

Future research would focus on validating the model in other large national datasets and seeing if machine learning can improve its predictability, Dr. Pellicori said. “Whether such models can provide a real-time, refined risk assessment for all patients in both primary or secondary care settings and improve the efficacy, efficiency, and quality of health care is our long-term goal.”

Dr. Pellicori and Dr. Coz disclosed no relevant financial relationships.

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

Researchers in Scotland have developed a risk calculator using a large electronic health records database that has shown a high reliability in predicting the risk of death for patients hospitalized for chronic occlusive pulmonary disease (COPD), providing another potential tool for improving postdischarge survival in these patients.

In a study published online in the journal Pharmacological Research, Pierpalo Pellicori, MD, and colleagues reported that a few variables, including prescriptions and laboratory data in routine EHRs, could help predict a patient’s risk of dying within 90 days after a hospital stay for COPD. Dr. Pellicori is a clinical cardiologist and research fellow at the Robertson Center for Biostatistics at the University of Glasgow.

“Identification of patients at high risk is valuable information for multidisciplinary teams,” Dr. Pellicori said in a written comment. “It allows the most vulnerable patients to be highlighted and prioritized for consideration of optimized value-based care, and for anticipatory care plan discussions.”

The retrospective cohort study analyzed EHR records of 17,973 patients who had an unplanned hospitalization for COPD in the Glasgow area from 2011 to 2017. The risk calculator model achieved a potential accuracy of 80%.

The study noted that, while a number of models have been developed to calculate the risk of exacerbations, inpatient death and prognosis in patients hospitalized for COPD, most of those models were based on cohorts of 1000 patients or less.

“Older age, male sex, and a longer hospital stay were important predictors of mortality in patients with COPD,” Dr. Pellicori said. “We also found that use of commonly prescribed medications such as digoxin identify patients with COPD more likely to die, perhaps because many have underlying heart failure, a highly prevalent but frequently missed diagnosis.”

He noted that heart failure and COPD share many risk factors, signs, and symptoms, such as smoking history, peripheral edema, and breathlessness. “Distinguishing between COPD and heart failure can be difficult, but is very important, as appropriate treatment for heart failure can improve a patient’s quality of life and survival substantially in many cases.”

The study also found that routinely collected and inexpensive blood markers – such as hemoglobin, neutrophil/lymphocyte ratio, serum chloride, urea, creatinine, and albumin – can also improve predictability of outcomes.

For example, the study found a linear increase in mortality of blood hemoglobin concentration less than 14 g/dL, but higher levels posed no greater risk. Higher white blood cell and neutrophil counts and lower lymphocyte and eosinophil counts were associated with a worse prognosis.

The study also found a linear increase in mortality with serum sodium less than 140 mmol/L or serum chloride less than 105 mmol/L –  but that higher concentrations of each were associated with a worse outcome.

“Interestingly,” Pellicori added, “social deprivation was not associated with mortality in this cohort.”

The final predictive model included age, sex, length of stay, and just nine other variables. “The model can be applied easily in clinical practice, even if electronic records are not available, because there are only 12 variables,” Dr. Pellicori said. “These could easily be entered manually into the risk calculator that we provide.”

“What is notable about this risk calculator is that it uses some of the techniques of machine learning, although it’s not specifically machine learning,” Angel Coz, MD, a pulmonologist at the Cleveland Clinic Respiratory Institute, said in an interview. “But it’s a retrospective data analysis, and actually by doing that it may catch some factors that we may not have necessarily paid attention to on a regular basis.”

While he called it a “well-done study,” Dr. Coz cautioned that “we have to be conservative in how to interpret and apply this because it is retrospective,” adding that future research should also use a prospective cohort.

For future consideration, Dr. Pellicori said that, while EHRs provide a “rich source” of data for such risk calculators, systems differ greatly across hospitals and health care systems and don’t link easily.

Future research would focus on validating the model in other large national datasets and seeing if machine learning can improve its predictability, Dr. Pellicori said. “Whether such models can provide a real-time, refined risk assessment for all patients in both primary or secondary care settings and improve the efficacy, efficiency, and quality of health care is our long-term goal.”

Dr. Pellicori and Dr. Coz disclosed no relevant financial relationships.

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

Researchers in Scotland have developed a risk calculator using a large electronic health records database that has shown a high reliability in predicting the risk of death for patients hospitalized for chronic occlusive pulmonary disease (COPD), providing another potential tool for improving postdischarge survival in these patients.

In a study published online in the journal Pharmacological Research, Pierpalo Pellicori, MD, and colleagues reported that a few variables, including prescriptions and laboratory data in routine EHRs, could help predict a patient’s risk of dying within 90 days after a hospital stay for COPD. Dr. Pellicori is a clinical cardiologist and research fellow at the Robertson Center for Biostatistics at the University of Glasgow.

“Identification of patients at high risk is valuable information for multidisciplinary teams,” Dr. Pellicori said in a written comment. “It allows the most vulnerable patients to be highlighted and prioritized for consideration of optimized value-based care, and for anticipatory care plan discussions.”

The retrospective cohort study analyzed EHR records of 17,973 patients who had an unplanned hospitalization for COPD in the Glasgow area from 2011 to 2017. The risk calculator model achieved a potential accuracy of 80%.

The study noted that, while a number of models have been developed to calculate the risk of exacerbations, inpatient death and prognosis in patients hospitalized for COPD, most of those models were based on cohorts of 1000 patients or less.

“Older age, male sex, and a longer hospital stay were important predictors of mortality in patients with COPD,” Dr. Pellicori said. “We also found that use of commonly prescribed medications such as digoxin identify patients with COPD more likely to die, perhaps because many have underlying heart failure, a highly prevalent but frequently missed diagnosis.”

He noted that heart failure and COPD share many risk factors, signs, and symptoms, such as smoking history, peripheral edema, and breathlessness. “Distinguishing between COPD and heart failure can be difficult, but is very important, as appropriate treatment for heart failure can improve a patient’s quality of life and survival substantially in many cases.”

The study also found that routinely collected and inexpensive blood markers – such as hemoglobin, neutrophil/lymphocyte ratio, serum chloride, urea, creatinine, and albumin – can also improve predictability of outcomes.

For example, the study found a linear increase in mortality of blood hemoglobin concentration less than 14 g/dL, but higher levels posed no greater risk. Higher white blood cell and neutrophil counts and lower lymphocyte and eosinophil counts were associated with a worse prognosis.

The study also found a linear increase in mortality with serum sodium less than 140 mmol/L or serum chloride less than 105 mmol/L –  but that higher concentrations of each were associated with a worse outcome.

“Interestingly,” Pellicori added, “social deprivation was not associated with mortality in this cohort.”

The final predictive model included age, sex, length of stay, and just nine other variables. “The model can be applied easily in clinical practice, even if electronic records are not available, because there are only 12 variables,” Dr. Pellicori said. “These could easily be entered manually into the risk calculator that we provide.”

“What is notable about this risk calculator is that it uses some of the techniques of machine learning, although it’s not specifically machine learning,” Angel Coz, MD, a pulmonologist at the Cleveland Clinic Respiratory Institute, said in an interview. “But it’s a retrospective data analysis, and actually by doing that it may catch some factors that we may not have necessarily paid attention to on a regular basis.”

While he called it a “well-done study,” Dr. Coz cautioned that “we have to be conservative in how to interpret and apply this because it is retrospective,” adding that future research should also use a prospective cohort.

For future consideration, Dr. Pellicori said that, while EHRs provide a “rich source” of data for such risk calculators, systems differ greatly across hospitals and health care systems and don’t link easily.

Future research would focus on validating the model in other large national datasets and seeing if machine learning can improve its predictability, Dr. Pellicori said. “Whether such models can provide a real-time, refined risk assessment for all patients in both primary or secondary care settings and improve the efficacy, efficiency, and quality of health care is our long-term goal.”

Dr. Pellicori and Dr. Coz disclosed no relevant financial relationships.

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

I’m often in the position of caring for patients after they’ve stopped active cancer treatments, but before they’ve made the decision to enroll in hospice. They remain under my care until they feel emotionally ready, or until their care needs have escalated to the point in which hospice is unavoidable.

Jenny, a mom in her 50s with metastatic pancreatic cancer, stopped coming to the clinic. She lived about 40 minutes away from the clinic and was no longer receiving treatment. The car rides were painful and difficult for her. I held weekly video visits with her for 2 months before she eventually went to hospice and passed away. Before she died, she shared with me her sadness that her oncologist – who had taken care of her for 3 years – had “washed his hands of [me].” She rarely heard from him after their final conversation in the clinic when he informed her that she was no longer a candidate for further therapy. The sense of abandonment Jenny described was visceral and devastating. With her permission, I let her oncology team know how she felt and they reached out to her just 1 week before her death. After she died, her husband told me how meaningful it had been for the whole family to hear from Jenny’s oncologist who told them that she had done everything possible to fight her cancer and that “no stone was left unturned.” Her husband felt this final conversation provided Jenny with the closure she needed to pass away peacefully.

Transitioning from active therapy to symptom management

Switching gears from an all-out pursuit of active therapy to focusing on cancer symptoms is often a scary transition for patients and their families. The transition is often viewed as a movement away from hope and optimism to “giving up the fight.” Whether you agree with the warrior language or not, many patients still describe their journey in these terms and thus, experience enrollment in hospice as a sense of having failed.

The sense of failure can be compounded by feelings of abandonment by oncology providers when they are referred without much guidance or continuity through the hospice enrollment process. Unfortunately, the consequences of suboptimal hospice transitions can be damaging, especially for the mental health and well-being of the patient and their surviving loved ones. Hospice transitions seem to reside in an area of clinical practice that is overlooked or, in my experience they are considered an afterthought by many oncologists.

When managed poorly, hospice transitions can easily lead to patient and family harm, which is a claim supported by research. A qualitative study published in 2019 included 92 caregivers of patients with terminal cancer. The authors found three common pathways for end-of-life transitions – a frictionless transition in which the patient and family are well prepared in advance by their oncologist; a more turbulent transition in which patient and family had direct conversations with their oncologist about the incurability of the disease and the lack of efficacy of further treatments, but were given no guidance on prognosis; and a third type of transition marked by abrupt shifts toward end-of-life care occurring in extremis and typically in the hospital.

In the latter two groups, caregivers felt their loved ones died very quickly after stopping treatment, taking them by surprise and leaving them rushing to put end-of-life care plans in place without much support from their oncologists. In the last group, caregivers shared they received their first prognostic information from the hospital or ICU doctor caring for their actively dying loved one, leaving them with a sense of anger and betrayal toward their oncologist for allowing them to be so ill-prepared.

A Japanese survey published in 2018 in The Oncologist of families of cancer patients who had passed away under hospice care over a 2-year period (2012-2014), found that about one-quarter felt abandoned by oncologists. Several factors that were associated with feeling either more or less abandonment. Spouses of patients, patients aged less than 60 years, and patients whose oncologists informed them that there was “nothing more to do” felt more abandoned by oncologists; whereas families for whom the oncologist provided reassurance about the trajectory of care, recommended hospice, and engaged with a palliative care team felt less abandoned by oncologists. Families who felt more abandoned had higher levels of depression and grief when measured with standardized instruments.
 

‘Don’t just put in the hospice order and walk away’

Fortunately, there are a few low-resource interventions that can improve the quality of care-to-hospice transitions and prevent the sense of abandonment felt by many patients and families.

First, don’t just put in the hospice order and walk away. Designate a staffer in your office to contact hospice directly, ensure all medical records are faxed and received, and update the patient and family on this progress throughout the transition. Taking care of details like these ensures the patient enrolls in hospice in a timely manner and reduces the chance the patient, who is likely to be quite sick at this point, will end up in the hospital despite your best efforts to get hospice involved.

Make sure the patient and family understand that you are still their oncologist and still available to them. If they want to continue care with you, have them name you as the “non–hospice-attending physician” so that you can continue to bill for telemedicine and office visits using the terminal diagnosis (with a billing modifier). This does not mean that you will be expected to manage the patient’s hospice problem list or respond to hospice nurse calls at 2 a.m. – the hospice doctor will still do this. It just ensures that patients do not receive a bill if you continue to see them.

If ongoing office or video visits are too much for the patient and family, consider assigning a member of your team to call the patient and family on a weekly basis to check in and offer support. A small 2018 pilot study aimed at improving communication found that when caregivers of advanced cancer patients transitioning to hospice received weekly supportive phone calls by a member of their oncology team (typically a nurse or nurse practitioner), they felt emotionally supported, had good continuity of care throughout the hospice enrollment, and appreciated the ability to have closure with their oncology team. In other words, a sense of abandonment was prevented and the patient-provider relationship was actually deepened through the transition.

These suggestions are not rocket science – they are simple, obvious ways to try to restore patient-centeredness to a transition that for providers can seem routine, but for patients and families is often the first time they have confronted the reality that death is approaching. That reality is terrifying and overwhelming. Patients and caregivers need our support more during hospice transitions than at any other point during their cancer journey – except perhaps at diagnosis.

As with Jenny, my patient who felt abandoned, all it took was a single call by her oncology team to restore the trust and heal the sense of feeling forsaken by the people who cared for her for years. Sometimes, even just one more phone call can feel like a lot to a chronically overburdened provider – but what a difference a simple call can make.

Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.

I’m often in the position of caring for patients after they’ve stopped active cancer treatments, but before they’ve made the decision to enroll in hospice. They remain under my care until they feel emotionally ready, or until their care needs have escalated to the point in which hospice is unavoidable.

Jenny, a mom in her 50s with metastatic pancreatic cancer, stopped coming to the clinic. She lived about 40 minutes away from the clinic and was no longer receiving treatment. The car rides were painful and difficult for her. I held weekly video visits with her for 2 months before she eventually went to hospice and passed away. Before she died, she shared with me her sadness that her oncologist – who had taken care of her for 3 years – had “washed his hands of [me].” She rarely heard from him after their final conversation in the clinic when he informed her that she was no longer a candidate for further therapy. The sense of abandonment Jenny described was visceral and devastating. With her permission, I let her oncology team know how she felt and they reached out to her just 1 week before her death. After she died, her husband told me how meaningful it had been for the whole family to hear from Jenny’s oncologist who told them that she had done everything possible to fight her cancer and that “no stone was left unturned.” Her husband felt this final conversation provided Jenny with the closure she needed to pass away peacefully.

Transitioning from active therapy to symptom management

Switching gears from an all-out pursuit of active therapy to focusing on cancer symptoms is often a scary transition for patients and their families. The transition is often viewed as a movement away from hope and optimism to “giving up the fight.” Whether you agree with the warrior language or not, many patients still describe their journey in these terms and thus, experience enrollment in hospice as a sense of having failed.

The sense of failure can be compounded by feelings of abandonment by oncology providers when they are referred without much guidance or continuity through the hospice enrollment process. Unfortunately, the consequences of suboptimal hospice transitions can be damaging, especially for the mental health and well-being of the patient and their surviving loved ones. Hospice transitions seem to reside in an area of clinical practice that is overlooked or, in my experience they are considered an afterthought by many oncologists.

When managed poorly, hospice transitions can easily lead to patient and family harm, which is a claim supported by research. A qualitative study published in 2019 included 92 caregivers of patients with terminal cancer. The authors found three common pathways for end-of-life transitions – a frictionless transition in which the patient and family are well prepared in advance by their oncologist; a more turbulent transition in which patient and family had direct conversations with their oncologist about the incurability of the disease and the lack of efficacy of further treatments, but were given no guidance on prognosis; and a third type of transition marked by abrupt shifts toward end-of-life care occurring in extremis and typically in the hospital.

In the latter two groups, caregivers felt their loved ones died very quickly after stopping treatment, taking them by surprise and leaving them rushing to put end-of-life care plans in place without much support from their oncologists. In the last group, caregivers shared they received their first prognostic information from the hospital or ICU doctor caring for their actively dying loved one, leaving them with a sense of anger and betrayal toward their oncologist for allowing them to be so ill-prepared.

A Japanese survey published in 2018 in The Oncologist of families of cancer patients who had passed away under hospice care over a 2-year period (2012-2014), found that about one-quarter felt abandoned by oncologists. Several factors that were associated with feeling either more or less abandonment. Spouses of patients, patients aged less than 60 years, and patients whose oncologists informed them that there was “nothing more to do” felt more abandoned by oncologists; whereas families for whom the oncologist provided reassurance about the trajectory of care, recommended hospice, and engaged with a palliative care team felt less abandoned by oncologists. Families who felt more abandoned had higher levels of depression and grief when measured with standardized instruments.
 

‘Don’t just put in the hospice order and walk away’

Fortunately, there are a few low-resource interventions that can improve the quality of care-to-hospice transitions and prevent the sense of abandonment felt by many patients and families.

First, don’t just put in the hospice order and walk away. Designate a staffer in your office to contact hospice directly, ensure all medical records are faxed and received, and update the patient and family on this progress throughout the transition. Taking care of details like these ensures the patient enrolls in hospice in a timely manner and reduces the chance the patient, who is likely to be quite sick at this point, will end up in the hospital despite your best efforts to get hospice involved.

Make sure the patient and family understand that you are still their oncologist and still available to them. If they want to continue care with you, have them name you as the “non–hospice-attending physician” so that you can continue to bill for telemedicine and office visits using the terminal diagnosis (with a billing modifier). This does not mean that you will be expected to manage the patient’s hospice problem list or respond to hospice nurse calls at 2 a.m. – the hospice doctor will still do this. It just ensures that patients do not receive a bill if you continue to see them.

If ongoing office or video visits are too much for the patient and family, consider assigning a member of your team to call the patient and family on a weekly basis to check in and offer support. A small 2018 pilot study aimed at improving communication found that when caregivers of advanced cancer patients transitioning to hospice received weekly supportive phone calls by a member of their oncology team (typically a nurse or nurse practitioner), they felt emotionally supported, had good continuity of care throughout the hospice enrollment, and appreciated the ability to have closure with their oncology team. In other words, a sense of abandonment was prevented and the patient-provider relationship was actually deepened through the transition.

These suggestions are not rocket science – they are simple, obvious ways to try to restore patient-centeredness to a transition that for providers can seem routine, but for patients and families is often the first time they have confronted the reality that death is approaching. That reality is terrifying and overwhelming. Patients and caregivers need our support more during hospice transitions than at any other point during their cancer journey – except perhaps at diagnosis.

As with Jenny, my patient who felt abandoned, all it took was a single call by her oncology team to restore the trust and heal the sense of feeling forsaken by the people who cared for her for years. Sometimes, even just one more phone call can feel like a lot to a chronically overburdened provider – but what a difference a simple call can make.

Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.

I’m often in the position of caring for patients after they’ve stopped active cancer treatments, but before they’ve made the decision to enroll in hospice. They remain under my care until they feel emotionally ready, or until their care needs have escalated to the point in which hospice is unavoidable.

Jenny, a mom in her 50s with metastatic pancreatic cancer, stopped coming to the clinic. She lived about 40 minutes away from the clinic and was no longer receiving treatment. The car rides were painful and difficult for her. I held weekly video visits with her for 2 months before she eventually went to hospice and passed away. Before she died, she shared with me her sadness that her oncologist – who had taken care of her for 3 years – had “washed his hands of [me].” She rarely heard from him after their final conversation in the clinic when he informed her that she was no longer a candidate for further therapy. The sense of abandonment Jenny described was visceral and devastating. With her permission, I let her oncology team know how she felt and they reached out to her just 1 week before her death. After she died, her husband told me how meaningful it had been for the whole family to hear from Jenny’s oncologist who told them that she had done everything possible to fight her cancer and that “no stone was left unturned.” Her husband felt this final conversation provided Jenny with the closure she needed to pass away peacefully.

Transitioning from active therapy to symptom management

Switching gears from an all-out pursuit of active therapy to focusing on cancer symptoms is often a scary transition for patients and their families. The transition is often viewed as a movement away from hope and optimism to “giving up the fight.” Whether you agree with the warrior language or not, many patients still describe their journey in these terms and thus, experience enrollment in hospice as a sense of having failed.

The sense of failure can be compounded by feelings of abandonment by oncology providers when they are referred without much guidance or continuity through the hospice enrollment process. Unfortunately, the consequences of suboptimal hospice transitions can be damaging, especially for the mental health and well-being of the patient and their surviving loved ones. Hospice transitions seem to reside in an area of clinical practice that is overlooked or, in my experience they are considered an afterthought by many oncologists.

When managed poorly, hospice transitions can easily lead to patient and family harm, which is a claim supported by research. A qualitative study published in 2019 included 92 caregivers of patients with terminal cancer. The authors found three common pathways for end-of-life transitions – a frictionless transition in which the patient and family are well prepared in advance by their oncologist; a more turbulent transition in which patient and family had direct conversations with their oncologist about the incurability of the disease and the lack of efficacy of further treatments, but were given no guidance on prognosis; and a third type of transition marked by abrupt shifts toward end-of-life care occurring in extremis and typically in the hospital.

In the latter two groups, caregivers felt their loved ones died very quickly after stopping treatment, taking them by surprise and leaving them rushing to put end-of-life care plans in place without much support from their oncologists. In the last group, caregivers shared they received their first prognostic information from the hospital or ICU doctor caring for their actively dying loved one, leaving them with a sense of anger and betrayal toward their oncologist for allowing them to be so ill-prepared.

A Japanese survey published in 2018 in The Oncologist of families of cancer patients who had passed away under hospice care over a 2-year period (2012-2014), found that about one-quarter felt abandoned by oncologists. Several factors that were associated with feeling either more or less abandonment. Spouses of patients, patients aged less than 60 years, and patients whose oncologists informed them that there was “nothing more to do” felt more abandoned by oncologists; whereas families for whom the oncologist provided reassurance about the trajectory of care, recommended hospice, and engaged with a palliative care team felt less abandoned by oncologists. Families who felt more abandoned had higher levels of depression and grief when measured with standardized instruments.
 

‘Don’t just put in the hospice order and walk away’

Fortunately, there are a few low-resource interventions that can improve the quality of care-to-hospice transitions and prevent the sense of abandonment felt by many patients and families.

First, don’t just put in the hospice order and walk away. Designate a staffer in your office to contact hospice directly, ensure all medical records are faxed and received, and update the patient and family on this progress throughout the transition. Taking care of details like these ensures the patient enrolls in hospice in a timely manner and reduces the chance the patient, who is likely to be quite sick at this point, will end up in the hospital despite your best efforts to get hospice involved.

Make sure the patient and family understand that you are still their oncologist and still available to them. If they want to continue care with you, have them name you as the “non–hospice-attending physician” so that you can continue to bill for telemedicine and office visits using the terminal diagnosis (with a billing modifier). This does not mean that you will be expected to manage the patient’s hospice problem list or respond to hospice nurse calls at 2 a.m. – the hospice doctor will still do this. It just ensures that patients do not receive a bill if you continue to see them.

If ongoing office or video visits are too much for the patient and family, consider assigning a member of your team to call the patient and family on a weekly basis to check in and offer support. A small 2018 pilot study aimed at improving communication found that when caregivers of advanced cancer patients transitioning to hospice received weekly supportive phone calls by a member of their oncology team (typically a nurse or nurse practitioner), they felt emotionally supported, had good continuity of care throughout the hospice enrollment, and appreciated the ability to have closure with their oncology team. In other words, a sense of abandonment was prevented and the patient-provider relationship was actually deepened through the transition.

These suggestions are not rocket science – they are simple, obvious ways to try to restore patient-centeredness to a transition that for providers can seem routine, but for patients and families is often the first time they have confronted the reality that death is approaching. That reality is terrifying and overwhelming. Patients and caregivers need our support more during hospice transitions than at any other point during their cancer journey – except perhaps at diagnosis.

As with Jenny, my patient who felt abandoned, all it took was a single call by her oncology team to restore the trust and heal the sense of feeling forsaken by the people who cared for her for years. Sometimes, even just one more phone call can feel like a lot to a chronically overburdened provider – but what a difference a simple call can make.

Ms. D’Ambruoso is a hospice and palliative care nurse practitioner for UCLA Health Cancer Care, Santa Monica, Calif.

CHICAGO – Both physicians and patients like the idea of having health care delivered virtually, and telehealth will likely continue to be prominent in the U.S. medical landscape, according to the medical director for digital health and telemedicine at Johns Hopkins Medicine, Baltimore.

This physician, Brian Hasselfeld, MD, said his university’s health system did 50-80 telemedicine visits a month before COVID, during a presentation at the annual meeting of the American College of Physicians. This soared to close to 100,000 a month in the pandemic, and now the health system does close to 40,000 a month, he continued.

“Life is definitely different in how we engage with our patients on a day-to-day basis,” said Dr. Hasselfeld, who oversees the telehealth for six hospitals and 50 ambulatory-care locations in Maryland and three other states.

Attitudes gauged in Johns Hopkins surveys suggest that a lot of medical care will continue to be provided by telemedicine. Nine out of 10 patients said they would likely recommend telemedicine to friends and family, and 88% said it would be either moderately, very, or extremely important to have video visit options in the future, he said.

A survey of the Hopkins system’s 3,600 physicians, which generated about 1,300 responses, found that physicians would like to have a considerable chunk of time set aside for telemedicine visits – the median response was 30%.
 

Virtual care is in ‘early-adopter phase’

But Dr. Hasselfeld said virtual care is still in the “early-adopter phase.” While many physicians said they would like more than half of their time devoted to telehealth, a larger proportion was more likely to say they wanted very little time devoted to it, Dr. Hasselfeld said. Among those wanting to do it are some who want to do all of their visits virtually, he said.

Those who are eager to do it will be those guiding the change, Dr. Hasselfeld said.

“As we move forward – and thinking about how to optimize virtual-care options for your patients – it’s not going to be a forced issue,” he said.

Providing better access to certain patient groups continues to be a challenge. A dashboard developed at Hopkins to identify groups who are at a technological disadvantage and don’t have ready access to telemedicine found that those living in low-income zip codes, African-Americans, and those on Medicaid and Medicare tend to have higher percentages of “audio-only” visits, mainly because of lack of connectivity allowing video visits, Dr. Hasselfeld said.

The lower share of video visits in the inner city suggests that access to telemedicine isn’t just a problem in remote rural areas, as the conventional wisdom has gone, he said.

“It doesn’t matter how many towers we have in downtown Baltimore, or how much fiber we have in the ground,” he said. “If you can’t have a data plan to access that high-speed Internet, or have a home with high-speed Internet, it doesn’t matter.”

Hopkins has developed a tool to assess how likely it is that someone will have trouble connecting for a telemedicine visit – if they’ve previously had an audio-only visit, for instance – and try to get in touch with those patients shortly before a visit so that it runs smoothly, Dr. Hasselfeld said.

The explosion of telemedicine has led to the rise of companies providing care through apps on phones and tablets, he said.

“This is real care being provided to our patients through nontraditional routes, and this is a new force, one our patients see out in the marketplace,” he said. “We have to acknowledge and wrestle with the fact that convenience is a new part of what it means to [provide] access [to] care for patients.”

Heather Hirsch, MD, an internist with Brigham and Women’s Hospital in Boston, said in an interview after the session that telemedicine is poised to improve care.

“I think the good is definitely going to outweigh the bad so long as the infrastructure and the legislation will allow it,” said Dr. Hirsch, who does about half of her visits in person and half through telemedicine, which she performs while at the office. “It does allow for a lot of flexibility for both patients and providers.”

But health care at academic medical centers, she said, needs to adjust to the times.

“We need [academic medicine] for so many reasons,” she said, “but the reality is that it moves very slowly, and the old infrastructure and the slowness to catch up with technology is the worry.”

Dr. Hasselfeld reported financial relationships with Humana and TRUE-See Systems.

CHICAGO – Both physicians and patients like the idea of having health care delivered virtually, and telehealth will likely continue to be prominent in the U.S. medical landscape, according to the medical director for digital health and telemedicine at Johns Hopkins Medicine, Baltimore.

This physician, Brian Hasselfeld, MD, said his university’s health system did 50-80 telemedicine visits a month before COVID, during a presentation at the annual meeting of the American College of Physicians. This soared to close to 100,000 a month in the pandemic, and now the health system does close to 40,000 a month, he continued.

“Life is definitely different in how we engage with our patients on a day-to-day basis,” said Dr. Hasselfeld, who oversees the telehealth for six hospitals and 50 ambulatory-care locations in Maryland and three other states.

Attitudes gauged in Johns Hopkins surveys suggest that a lot of medical care will continue to be provided by telemedicine. Nine out of 10 patients said they would likely recommend telemedicine to friends and family, and 88% said it would be either moderately, very, or extremely important to have video visit options in the future, he said.

A survey of the Hopkins system’s 3,600 physicians, which generated about 1,300 responses, found that physicians would like to have a considerable chunk of time set aside for telemedicine visits – the median response was 30%.
 

Virtual care is in ‘early-adopter phase’

But Dr. Hasselfeld said virtual care is still in the “early-adopter phase.” While many physicians said they would like more than half of their time devoted to telehealth, a larger proportion was more likely to say they wanted very little time devoted to it, Dr. Hasselfeld said. Among those wanting to do it are some who want to do all of their visits virtually, he said.

Those who are eager to do it will be those guiding the change, Dr. Hasselfeld said.

“As we move forward – and thinking about how to optimize virtual-care options for your patients – it’s not going to be a forced issue,” he said.

Providing better access to certain patient groups continues to be a challenge. A dashboard developed at Hopkins to identify groups who are at a technological disadvantage and don’t have ready access to telemedicine found that those living in low-income zip codes, African-Americans, and those on Medicaid and Medicare tend to have higher percentages of “audio-only” visits, mainly because of lack of connectivity allowing video visits, Dr. Hasselfeld said.

The lower share of video visits in the inner city suggests that access to telemedicine isn’t just a problem in remote rural areas, as the conventional wisdom has gone, he said.

“It doesn’t matter how many towers we have in downtown Baltimore, or how much fiber we have in the ground,” he said. “If you can’t have a data plan to access that high-speed Internet, or have a home with high-speed Internet, it doesn’t matter.”

Hopkins has developed a tool to assess how likely it is that someone will have trouble connecting for a telemedicine visit – if they’ve previously had an audio-only visit, for instance – and try to get in touch with those patients shortly before a visit so that it runs smoothly, Dr. Hasselfeld said.

The explosion of telemedicine has led to the rise of companies providing care through apps on phones and tablets, he said.

“This is real care being provided to our patients through nontraditional routes, and this is a new force, one our patients see out in the marketplace,” he said. “We have to acknowledge and wrestle with the fact that convenience is a new part of what it means to [provide] access [to] care for patients.”

Heather Hirsch, MD, an internist with Brigham and Women’s Hospital in Boston, said in an interview after the session that telemedicine is poised to improve care.

“I think the good is definitely going to outweigh the bad so long as the infrastructure and the legislation will allow it,” said Dr. Hirsch, who does about half of her visits in person and half through telemedicine, which she performs while at the office. “It does allow for a lot of flexibility for both patients and providers.”

But health care at academic medical centers, she said, needs to adjust to the times.

“We need [academic medicine] for so many reasons,” she said, “but the reality is that it moves very slowly, and the old infrastructure and the slowness to catch up with technology is the worry.”

Dr. Hasselfeld reported financial relationships with Humana and TRUE-See Systems.

CHICAGO – Both physicians and patients like the idea of having health care delivered virtually, and telehealth will likely continue to be prominent in the U.S. medical landscape, according to the medical director for digital health and telemedicine at Johns Hopkins Medicine, Baltimore.

This physician, Brian Hasselfeld, MD, said his university’s health system did 50-80 telemedicine visits a month before COVID, during a presentation at the annual meeting of the American College of Physicians. This soared to close to 100,000 a month in the pandemic, and now the health system does close to 40,000 a month, he continued.

“Life is definitely different in how we engage with our patients on a day-to-day basis,” said Dr. Hasselfeld, who oversees the telehealth for six hospitals and 50 ambulatory-care locations in Maryland and three other states.

Attitudes gauged in Johns Hopkins surveys suggest that a lot of medical care will continue to be provided by telemedicine. Nine out of 10 patients said they would likely recommend telemedicine to friends and family, and 88% said it would be either moderately, very, or extremely important to have video visit options in the future, he said.

A survey of the Hopkins system’s 3,600 physicians, which generated about 1,300 responses, found that physicians would like to have a considerable chunk of time set aside for telemedicine visits – the median response was 30%.
 

Virtual care is in ‘early-adopter phase’

But Dr. Hasselfeld said virtual care is still in the “early-adopter phase.” While many physicians said they would like more than half of their time devoted to telehealth, a larger proportion was more likely to say they wanted very little time devoted to it, Dr. Hasselfeld said. Among those wanting to do it are some who want to do all of their visits virtually, he said.

Those who are eager to do it will be those guiding the change, Dr. Hasselfeld said.

“As we move forward – and thinking about how to optimize virtual-care options for your patients – it’s not going to be a forced issue,” he said.

Providing better access to certain patient groups continues to be a challenge. A dashboard developed at Hopkins to identify groups who are at a technological disadvantage and don’t have ready access to telemedicine found that those living in low-income zip codes, African-Americans, and those on Medicaid and Medicare tend to have higher percentages of “audio-only” visits, mainly because of lack of connectivity allowing video visits, Dr. Hasselfeld said.

The lower share of video visits in the inner city suggests that access to telemedicine isn’t just a problem in remote rural areas, as the conventional wisdom has gone, he said.

“It doesn’t matter how many towers we have in downtown Baltimore, or how much fiber we have in the ground,” he said. “If you can’t have a data plan to access that high-speed Internet, or have a home with high-speed Internet, it doesn’t matter.”

Hopkins has developed a tool to assess how likely it is that someone will have trouble connecting for a telemedicine visit – if they’ve previously had an audio-only visit, for instance – and try to get in touch with those patients shortly before a visit so that it runs smoothly, Dr. Hasselfeld said.

The explosion of telemedicine has led to the rise of companies providing care through apps on phones and tablets, he said.

“This is real care being provided to our patients through nontraditional routes, and this is a new force, one our patients see out in the marketplace,” he said. “We have to acknowledge and wrestle with the fact that convenience is a new part of what it means to [provide] access [to] care for patients.”

Heather Hirsch, MD, an internist with Brigham and Women’s Hospital in Boston, said in an interview after the session that telemedicine is poised to improve care.

“I think the good is definitely going to outweigh the bad so long as the infrastructure and the legislation will allow it,” said Dr. Hirsch, who does about half of her visits in person and half through telemedicine, which she performs while at the office. “It does allow for a lot of flexibility for both patients and providers.”

But health care at academic medical centers, she said, needs to adjust to the times.

“We need [academic medicine] for so many reasons,” she said, “but the reality is that it moves very slowly, and the old infrastructure and the slowness to catch up with technology is the worry.”

Dr. Hasselfeld reported financial relationships with Humana and TRUE-See Systems.

Just in time for Memorial Day outings, a new report on sunscreens is out.

The news isn’t all sunny. About 75% of more than 1,850 sunscreen products evaluated offer inferior sun protection or have worrisome ingredients, according to the Environmental Working Group, a nonprofit research and advocacy group that just issued its 16th annual Guide to Sunscreens.

In response, dermatologists, including the president of the American Academy of Dermatology, say that although some concerns have been raised about the safety of some sunscreen ingredients, sunscreens themselves remain an important tool in the fight against skin cancer. According to the Skin Cancer Foundation, 1 in 5 Americans will get skin cancer by age 70. Melanoma, the most deadly, has a 5-year survival rate of 99% if caught early.
 

2022 report

Overall, the Environmental Working Group found that about 1 in 4 sunscreens, or about 500 products, met their standards for providing adequate sun protection and avoiding ingredients linked to known health harms. Products meant for babies and children did slightly better, with about 1 in 3 meeting the standards. The group evaluated mineral sunscreens, also called physical sunscreens, and non-mineral sunscreens, also called chemical sunscreens. Mineral sunscreens contain zinc oxide or titanium dioxide and sit on the skin to deflect the sun’s rays. Chemical sunscreens, with ingredients such as oxybenzone or avobenzone, are partially absorbed into the skin.

Among the group’s concerns:

• The use of oxybenzone in the non-mineral sunscreens. About 30% of the non-mineral sunscreens have it, says Carla Burns, senior director for cosmetic science for the Environmental Working Group. Oxybenzone is a potential hormone disrupter and a skin sensitizer that may harm children and adults, she says. Some progress has been made, as the group found oxybenzone in 66% of the non-mineral sunscreens it reviewed in 2019. (The FDA is seeking more information on oxybenzone and many other sunscreen ingredients.)
• Contamination of sunscreens with benzene, which has been linked to leukemia and other blood disorders, according to the National Cancer Institute. But industry experts stress that that chemical is found in trace amounts in personal care products and does not pose a safety concern. “Benzene is a chemical that is ubiquitous in the environment and not an intentionally added ingredient in personal care products. People worldwide are exposed daily to benzene from indoor and outdoor sources, including air, drinking water, and food and beverages,” the Personal Care Products Council, an industry group, said in a statement.
• Protection from ultraviolet A (UVA) rays is often inadequate, according to research published last year by the Environmental Working Group.

Products on the ‘best’ list

The Environmental Working Group found that 282 recreational sunscreens met its criteria. Among them:

• Coral Safe Sunscreen Lotion, SPF 30
• Neutrogena Sheer Zinc Mineral Sunscreen Lotion, SPF 30
• Mad Hippie Facial Sunscreen Lotion, SPF 30+

The group chose 86 non-mineral sunscreens as better options, including:

• Alba Botanica Hawaiian Sunscreen Lotion, Aloe Vera, SPF 30
• Banana Boat Sport Ultra Sunscreen Stick, SPF 50+
• Black Girl Sunscreen Melanin Boosting Moisturizing Sunscreen Lotion, SPF 30

And 70 sunscreens made the kids’ best list, including:

• True Baby Everyday Play Sunscreen Lotion, SPF 30+
• Sun Biologic Kids’ Sunscreen Stick, SPF 30+
• Kiss My Face Organic Kids’ Defense Sunscreen Lotion, SPF 30

Industry response, FDA actions

In a statement, Alexandra Kowcz, chief scientist at the Personal Care Products Council, pointed out that “as part of a daily safe-sun regimen, sunscreen products help prevent sunburn and reduce skin cancer risk. It is unfortunate that as Americans spend more time outdoors, the Environmental Working Group’s (EWG) 2022 Guide to Sunscreens resorts to fear-mongering with misleading information that could keep consumers from using sunscreens altogether.”

The FDA has asked for more information about certain ingredients to further evaluate products, she says, and industry is working with the agency. The FDA says it is attempting to improve the quality, safety and effectiveness of over-the-counter sunscreen products. In September, 2021, the FDA issued a proposal for regulating OTC sunscreen products, as required under the CARES (Coronavirus Aid, Relief and Economic Security) Act. The effective date for the final order can’t be earlier than September 2022, the CARES Act says.
 

Dermatologists weigh in

“Every time something like this gets published, my patients come in hysterical,” says Michele Green, MD, a New York City dermatologist who reviewed the report for WebMD. She acknowledges that more research is needed on some sunscreen ingredients. “We really do not know the long-term consequence of oxybenzone,” she says.

Her advice: If her patients have melasma (a skin condition with brown patches on the face), she advises them to use both a chemical and a mineral sunscreen. “I don’t tell my patients in general not to use the chemical [sunscreens].”

For children, she says, the mineral sunscreens may be preferred. On her own children, who are teens, she uses the mineral sunscreens, due to possible concern about hormone disruption.

In a statement, Mark D. Kaufmann, MD, president of the American Academy of Dermatology, says that “sunscreen is an important part of a comprehensive sun protection strategy.”

Besides a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher for exposed skin, the academy recommends seeking shade and wearing sun-protective clothing to reduce skin cancer risk.

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

Just in time for Memorial Day outings, a new report on sunscreens is out.

The news isn’t all sunny. About 75% of more than 1,850 sunscreen products evaluated offer inferior sun protection or have worrisome ingredients, according to the Environmental Working Group, a nonprofit research and advocacy group that just issued its 16th annual Guide to Sunscreens.

In response, dermatologists, including the president of the American Academy of Dermatology, say that although some concerns have been raised about the safety of some sunscreen ingredients, sunscreens themselves remain an important tool in the fight against skin cancer. According to the Skin Cancer Foundation, 1 in 5 Americans will get skin cancer by age 70. Melanoma, the most deadly, has a 5-year survival rate of 99% if caught early.
 

2022 report

Overall, the Environmental Working Group found that about 1 in 4 sunscreens, or about 500 products, met their standards for providing adequate sun protection and avoiding ingredients linked to known health harms. Products meant for babies and children did slightly better, with about 1 in 3 meeting the standards. The group evaluated mineral sunscreens, also called physical sunscreens, and non-mineral sunscreens, also called chemical sunscreens. Mineral sunscreens contain zinc oxide or titanium dioxide and sit on the skin to deflect the sun’s rays. Chemical sunscreens, with ingredients such as oxybenzone or avobenzone, are partially absorbed into the skin.

Among the group’s concerns:

• The use of oxybenzone in the non-mineral sunscreens. About 30% of the non-mineral sunscreens have it, says Carla Burns, senior director for cosmetic science for the Environmental Working Group. Oxybenzone is a potential hormone disrupter and a skin sensitizer that may harm children and adults, she says. Some progress has been made, as the group found oxybenzone in 66% of the non-mineral sunscreens it reviewed in 2019. (The FDA is seeking more information on oxybenzone and many other sunscreen ingredients.)
• Contamination of sunscreens with benzene, which has been linked to leukemia and other blood disorders, according to the National Cancer Institute. But industry experts stress that that chemical is found in trace amounts in personal care products and does not pose a safety concern. “Benzene is a chemical that is ubiquitous in the environment and not an intentionally added ingredient in personal care products. People worldwide are exposed daily to benzene from indoor and outdoor sources, including air, drinking water, and food and beverages,” the Personal Care Products Council, an industry group, said in a statement.
• Protection from ultraviolet A (UVA) rays is often inadequate, according to research published last year by the Environmental Working Group.

Products on the ‘best’ list

The Environmental Working Group found that 282 recreational sunscreens met its criteria. Among them:

• Coral Safe Sunscreen Lotion, SPF 30
• Neutrogena Sheer Zinc Mineral Sunscreen Lotion, SPF 30
• Mad Hippie Facial Sunscreen Lotion, SPF 30+

The group chose 86 non-mineral sunscreens as better options, including:

• Alba Botanica Hawaiian Sunscreen Lotion, Aloe Vera, SPF 30
• Banana Boat Sport Ultra Sunscreen Stick, SPF 50+
• Black Girl Sunscreen Melanin Boosting Moisturizing Sunscreen Lotion, SPF 30

And 70 sunscreens made the kids’ best list, including:

• True Baby Everyday Play Sunscreen Lotion, SPF 30+
• Sun Biologic Kids’ Sunscreen Stick, SPF 30+
• Kiss My Face Organic Kids’ Defense Sunscreen Lotion, SPF 30

Industry response, FDA actions

In a statement, Alexandra Kowcz, chief scientist at the Personal Care Products Council, pointed out that “as part of a daily safe-sun regimen, sunscreen products help prevent sunburn and reduce skin cancer risk. It is unfortunate that as Americans spend more time outdoors, the Environmental Working Group’s (EWG) 2022 Guide to Sunscreens resorts to fear-mongering with misleading information that could keep consumers from using sunscreens altogether.”

The FDA has asked for more information about certain ingredients to further evaluate products, she says, and industry is working with the agency. The FDA says it is attempting to improve the quality, safety and effectiveness of over-the-counter sunscreen products. In September, 2021, the FDA issued a proposal for regulating OTC sunscreen products, as required under the CARES (Coronavirus Aid, Relief and Economic Security) Act. The effective date for the final order can’t be earlier than September 2022, the CARES Act says.
 

Dermatologists weigh in

“Every time something like this gets published, my patients come in hysterical,” says Michele Green, MD, a New York City dermatologist who reviewed the report for WebMD. She acknowledges that more research is needed on some sunscreen ingredients. “We really do not know the long-term consequence of oxybenzone,” she says.

Her advice: If her patients have melasma (a skin condition with brown patches on the face), she advises them to use both a chemical and a mineral sunscreen. “I don’t tell my patients in general not to use the chemical [sunscreens].”

For children, she says, the mineral sunscreens may be preferred. On her own children, who are teens, she uses the mineral sunscreens, due to possible concern about hormone disruption.

In a statement, Mark D. Kaufmann, MD, president of the American Academy of Dermatology, says that “sunscreen is an important part of a comprehensive sun protection strategy.”

Besides a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher for exposed skin, the academy recommends seeking shade and wearing sun-protective clothing to reduce skin cancer risk.

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

Just in time for Memorial Day outings, a new report on sunscreens is out.

The news isn’t all sunny. About 75% of more than 1,850 sunscreen products evaluated offer inferior sun protection or have worrisome ingredients, according to the Environmental Working Group, a nonprofit research and advocacy group that just issued its 16th annual Guide to Sunscreens.

In response, dermatologists, including the president of the American Academy of Dermatology, say that although some concerns have been raised about the safety of some sunscreen ingredients, sunscreens themselves remain an important tool in the fight against skin cancer. According to the Skin Cancer Foundation, 1 in 5 Americans will get skin cancer by age 70. Melanoma, the most deadly, has a 5-year survival rate of 99% if caught early.
 

2022 report

Overall, the Environmental Working Group found that about 1 in 4 sunscreens, or about 500 products, met their standards for providing adequate sun protection and avoiding ingredients linked to known health harms. Products meant for babies and children did slightly better, with about 1 in 3 meeting the standards. The group evaluated mineral sunscreens, also called physical sunscreens, and non-mineral sunscreens, also called chemical sunscreens. Mineral sunscreens contain zinc oxide or titanium dioxide and sit on the skin to deflect the sun’s rays. Chemical sunscreens, with ingredients such as oxybenzone or avobenzone, are partially absorbed into the skin.

Among the group’s concerns:

• The use of oxybenzone in the non-mineral sunscreens. About 30% of the non-mineral sunscreens have it, says Carla Burns, senior director for cosmetic science for the Environmental Working Group. Oxybenzone is a potential hormone disrupter and a skin sensitizer that may harm children and adults, she says. Some progress has been made, as the group found oxybenzone in 66% of the non-mineral sunscreens it reviewed in 2019. (The FDA is seeking more information on oxybenzone and many other sunscreen ingredients.)
• Contamination of sunscreens with benzene, which has been linked to leukemia and other blood disorders, according to the National Cancer Institute. But industry experts stress that that chemical is found in trace amounts in personal care products and does not pose a safety concern. “Benzene is a chemical that is ubiquitous in the environment and not an intentionally added ingredient in personal care products. People worldwide are exposed daily to benzene from indoor and outdoor sources, including air, drinking water, and food and beverages,” the Personal Care Products Council, an industry group, said in a statement.
• Protection from ultraviolet A (UVA) rays is often inadequate, according to research published last year by the Environmental Working Group.

Products on the ‘best’ list

The Environmental Working Group found that 282 recreational sunscreens met its criteria. Among them:

• Coral Safe Sunscreen Lotion, SPF 30
• Neutrogena Sheer Zinc Mineral Sunscreen Lotion, SPF 30
• Mad Hippie Facial Sunscreen Lotion, SPF 30+

The group chose 86 non-mineral sunscreens as better options, including:

• Alba Botanica Hawaiian Sunscreen Lotion, Aloe Vera, SPF 30
• Banana Boat Sport Ultra Sunscreen Stick, SPF 50+
• Black Girl Sunscreen Melanin Boosting Moisturizing Sunscreen Lotion, SPF 30

And 70 sunscreens made the kids’ best list, including:

• True Baby Everyday Play Sunscreen Lotion, SPF 30+
• Sun Biologic Kids’ Sunscreen Stick, SPF 30+
• Kiss My Face Organic Kids’ Defense Sunscreen Lotion, SPF 30

Industry response, FDA actions

In a statement, Alexandra Kowcz, chief scientist at the Personal Care Products Council, pointed out that “as part of a daily safe-sun regimen, sunscreen products help prevent sunburn and reduce skin cancer risk. It is unfortunate that as Americans spend more time outdoors, the Environmental Working Group’s (EWG) 2022 Guide to Sunscreens resorts to fear-mongering with misleading information that could keep consumers from using sunscreens altogether.”

The FDA has asked for more information about certain ingredients to further evaluate products, she says, and industry is working with the agency. The FDA says it is attempting to improve the quality, safety and effectiveness of over-the-counter sunscreen products. In September, 2021, the FDA issued a proposal for regulating OTC sunscreen products, as required under the CARES (Coronavirus Aid, Relief and Economic Security) Act. The effective date for the final order can’t be earlier than September 2022, the CARES Act says.
 

Dermatologists weigh in

“Every time something like this gets published, my patients come in hysterical,” says Michele Green, MD, a New York City dermatologist who reviewed the report for WebMD. She acknowledges that more research is needed on some sunscreen ingredients. “We really do not know the long-term consequence of oxybenzone,” she says.

Her advice: If her patients have melasma (a skin condition with brown patches on the face), she advises them to use both a chemical and a mineral sunscreen. “I don’t tell my patients in general not to use the chemical [sunscreens].”

For children, she says, the mineral sunscreens may be preferred. On her own children, who are teens, she uses the mineral sunscreens, due to possible concern about hormone disruption.

In a statement, Mark D. Kaufmann, MD, president of the American Academy of Dermatology, says that “sunscreen is an important part of a comprehensive sun protection strategy.”

Besides a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher for exposed skin, the academy recommends seeking shade and wearing sun-protective clothing to reduce skin cancer risk.

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

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

Counting calories, joining a gym, and taking part in exercise programs are popular methods used by people in the United Kingdom who want to shed some pounds, but they seem to be fairly ineffective strategies, according to an investigation.

A survey of adults with obesity from six countries in western Europe found that most who set out to reduce a meaningful amount of weight failed in their attempt.

The preliminary results, presented in two posters at the European Congress on Obesity, underlined the need for better support and solutions for weight management, the authors suggested.

Marc Evans, MB, BCh, a consultant physician in diabetes and endocrinology, from University Hospital, Cardiff, Wales, who led the analysis, said that, “while obesity’s impact on health is well known, our finding that a sizable proportion of adults with obesity appear at elevated risk of hospitalization or surgery due to multiple underlying illnesses, undoubtedly adds a sense of urgency to tackling Europe’s growing obesity epidemic.”

The study, which also involved analytics consultancy firm Lane Clark & Peacock, conducted a cross-sectional survey of 1,850 adults. Of those 500 were from the UK, and the remainder from France, Germany, Italy, Spain, and Sweden.

All participants had a body mass index of 30 kg/m², or higher. More specifically, 56.3%; were classified as obesity class I, 26.8% obesity class II, and 16.9% obesity class III.
 

Obesity-related conditions

In total, 25.7% of participants reported no obesity-related health conditions, 28.4% had one condition, 19.6% had two, and 26.3% had three or more. The most common comorbidities were hypertension, dyslipidemia, and type 2 diabetes.

Overall, 78.6% of respondents reported having tried to lose weight in the previous year. Asked in a questionnaire about how they had tried to achieve this, the responses indicated that the most common strategies were:

• Calorie-controlled/restricted diet (71.9%)
• Exercise program course (21.9%)
• Pharmaceutical treatment/medication (12.3%)
• Joined a gym (12%)
• Digital health app (9.7%)

Among other participants, 8.1% said they had used alternative treatments, 7.6% a weight loss service, and 2.1% cognitive-behavioral therapy.

Analysis of the survey results showed that 78% of the individuals who attempted to lose weight did not achieve a clinically meaningful loss of 5% or more of their body weight, while some actually weighed more afterward.

Exercise and restricted diet

Notably, while exercise and calorie-controlled or restricted diets were among the most popular weight-loss methods in U.K. participants, they were amongst the least successful strategies. For instance, while 26.5% of adults who controlled their diet said they had lost weight, 17.1% reported their weight had increased. For those who took part in an exercise program, 33.3% said they lost weight, but 15.5% said they gained weight.

Signing up for gym membership also scored poorly, with 27% shedding weight, compared with 32.4% who put weight on.

“Our survey results indicate that, while the majority of adults with obesity are actively trying to reduce their weight, using a variety of strategies, most are unsuccessful,” said Dr. Evans.

Further studies were needed to assess whether people who lose weight succeed in maintaining their weight loss, the authors said.

The conference posters have yet to be published in a journal but were peer reviewed by the ECO selection committee.

The studies were sponsored by Novo Nordisk, a researcher into and manufacturer of diabetes and obesity medications, and employer of several of the coauthors.

A version of this article first appeared on Medscape UK/Univadis.

The U.S. Food and Drug Administration has approved two vonoprazan-based treatments for Helicobacter pylori infection: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.

Vonoprazan is an oral potassium-competitive acid blocker and “the first innovative acid suppressant from a new drug class approved in the United States in over 30 years,” the company said in a news release announcing the approval.

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

The U.S. Food and Drug Administration has approved two vonoprazan-based treatments for Helicobacter pylori infection: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.

Vonoprazan is an oral potassium-competitive acid blocker and “the first innovative acid suppressant from a new drug class approved in the United States in over 30 years,” the company said in a news release announcing the approval.

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

The U.S. Food and Drug Administration has approved two vonoprazan-based treatments for Helicobacter pylori infection: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.

Vonoprazan is an oral potassium-competitive acid blocker and “the first innovative acid suppressant from a new drug class approved in the United States in over 30 years,” the company said in a news release announcing the approval.

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

The more boosters the better? Data from Israel show that immune protection in elderly people is strengthened even further after a fourth dose. Karl Lauterbach, MD, German minister of health, recently pleaded for a second booster for those aged 18 years and older, and he pushed for a European Union–wide recommendation. He has not been able to implement this yet.

Just as before, Germany’s Standing Committee on Vaccination (STIKO) is only recommending the second booster for people aged 70 years and older, the European Medicines Agency (EMA) is recommending the fourth vaccination for everyone aged 80 years and older, and the United States has set the general age limit at 50 years.

Specialists remain skeptical about expanding the availability of the second booster. “From an immunologic perspective, people under the age of 70 with a healthy immune system do not need this fourth vaccination,” said Christiane Falk, PhD, head of the Institute for Transplantation Immunology of the Hannover Medical School (Germany) and member of the German Federal Government COVID Expert Panel, at a Science Media Center press briefing.

After the second vaccination, young healthy people are sufficiently protected against a severe course of the disease. Dr. Falk sees the STIKO recommendation as feasible, since it can be worked with. People in nursing facilities or those with additional underlying conditions would be considered for a fourth vaccination, explained Dr. Falk.
 

Complete protection unrealistic

Achieving complete protection against infection through multiple boosters is not realistic, said Christoph Neumann-Haefelin, MD, head of the Working Group for Translational Virus Immunology at the Clinic for Internal Medicine II, University Hospital Freiburg, Germany. Therefore, this should not be pursued when discussing boosters. “The aim of the booster vaccination should be to protect different groups of people against severe courses of the disease,” said Dr. Neumann-Haefelin.

Neutralizing antibodies that are only present in high concentrations for a few weeks after infection or vaccination are sometimes able to prevent the infection on their own. The immunologic memory of B cells and T cells, which ensures long-lasting protection against severe courses of the disease, is at a high level after two doses, and a third dose increases the protection more.

While people with a weak immune system need significantly more vaccinations in a shorter period to receive the same protection, too many booster vaccinations against SARS-CoV-2 are not sensible for young healthy people.
 

Immune saturation effect

A recent study in macaques showed that an adjusted Omicron booster did not lead to higher antibody titers, compared with a usual booster. In January 2022, the EMA warned against frequent consecutive boosters that may no longer produce the desired immune response.

If someone receives a booster too early, a saturation effect can occur, warned Andreas Radbruch, PhD, scientific director of the German Rheumatism Research Center Berlin. “We know this from lots of experimental studies but also from lots of other vaccinations. For example, you cannot be vaccinated against tetanus twice at 3- or 4-week intervals. Nothing at all will happen the second time,” explained Dr. Radbruch.

If the same antigen is applied again and again at the same dose, the immune system is made so active that the antigen is directly intercepted and cannot have any new effect on the immune system. This mechanism has been known for a long time, said Dr. Radbruch.
 

‘Original antigenic sin’

Premature boosting could even be a handicap in the competition between immune response and virus, said Dr. Radbruch. This is due to the principle of “original antigenic sin.” If the immune system has already come into contact with a virus, contact with a new virus variant will cause it to form antibodies predominantly against those epitopes that were already present in the original virus. As a result of this, too many boosters can weaken protection against different variants.

“We have not actually observed this with SARS-CoV-2, however,” said Dr. Radbruch. “Immunity is always extremely broad. With a double or triple vaccination, all previously existing variants are covered by an affinity-matured immune system.”

Dr. Neumann-Haefelin confirmed this and added that all virus mutations, including Omicron, have different epitopes that affect the antibody response, but the T-cell response does not differ.

Dr. Radbruch said that the vaccine protection probably lasts for decades. Following an infection or vaccination, the antibody concentration in the bone marrow is similar to that achieved after a measles or tetanus vaccination. “The vaccination is already extremely efficient. You have protection at the same magnitude as for other infectious diseases or vaccinations, which is expected to last decades,” said Dr. Radbruch.

He clarified that the decrease in antibodies after vaccination and infection is normal and does not indicate a drop in protection. “Quantity and quality must not be confused here. There is simply less mass, but the grade of remaining antibody increases.”

In the competition around the virus antigens (referred to as affinity maturation), antibodies develop that bind 10 to 100 times better and are particularly protective against the virus. The immune system is thereby sustainably effective.
 

For whom and when?

Since the immune response is age dependent, it makes more sense to administer an additional booster to elderly people than to young people. Also included in this group, however, are people whose immune system still does not provide the same level of protection after the second or even third vaccination as that of younger, healthy people.

Dr. Radbruch noted that 4% of people older than 70 years exhibited autoantibodies against interferons. The effects are huge. “That is 20% of patients in an intensive care unit – and they all have a very poor prognosis,” said Dr. Radbruch. These people are extremely threatened by the virus. Multiple vaccinations are sensible for them.

Even people with a weak immune response benefit from multiple vaccinations, confirmed Dr. Neumann-Haefelin. “We are not seeing the antibody responses here that we see in young people with healthy immune systems until the third or fourth vaccination sometimes.”

Although for young healthy people, it is particularly important to ensure a sufficient period between vaccinations so that the affinity maturation is not impaired, those with a weak immune response can be vaccinated again as soon as after 3 months.

The “optimum minimum period of time” for people with healthy immune systems is 6 months, according to Dr. Neumann-Haefelin. “This is true for everyone in whom a proper response is expected.” The vaccine protection probably lasts significantly longer, and therefore, frequent boosting may not be necessary in the future, he said. The time separation also applies for medical personnel, for whom the Robert Koch Institute also recommends a second booster.

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

The more boosters the better? Data from Israel show that immune protection in elderly people is strengthened even further after a fourth dose. Karl Lauterbach, MD, German minister of health, recently pleaded for a second booster for those aged 18 years and older, and he pushed for a European Union–wide recommendation. He has not been able to implement this yet.

Just as before, Germany’s Standing Committee on Vaccination (STIKO) is only recommending the second booster for people aged 70 years and older, the European Medicines Agency (EMA) is recommending the fourth vaccination for everyone aged 80 years and older, and the United States has set the general age limit at 50 years.

Specialists remain skeptical about expanding the availability of the second booster. “From an immunologic perspective, people under the age of 70 with a healthy immune system do not need this fourth vaccination,” said Christiane Falk, PhD, head of the Institute for Transplantation Immunology of the Hannover Medical School (Germany) and member of the German Federal Government COVID Expert Panel, at a Science Media Center press briefing.

After the second vaccination, young healthy people are sufficiently protected against a severe course of the disease. Dr. Falk sees the STIKO recommendation as feasible, since it can be worked with. People in nursing facilities or those with additional underlying conditions would be considered for a fourth vaccination, explained Dr. Falk.
 

Complete protection unrealistic

Achieving complete protection against infection through multiple boosters is not realistic, said Christoph Neumann-Haefelin, MD, head of the Working Group for Translational Virus Immunology at the Clinic for Internal Medicine II, University Hospital Freiburg, Germany. Therefore, this should not be pursued when discussing boosters. “The aim of the booster vaccination should be to protect different groups of people against severe courses of the disease,” said Dr. Neumann-Haefelin.

Neutralizing antibodies that are only present in high concentrations for a few weeks after infection or vaccination are sometimes able to prevent the infection on their own. The immunologic memory of B cells and T cells, which ensures long-lasting protection against severe courses of the disease, is at a high level after two doses, and a third dose increases the protection more.

While people with a weak immune system need significantly more vaccinations in a shorter period to receive the same protection, too many booster vaccinations against SARS-CoV-2 are not sensible for young healthy people.
 

Immune saturation effect

A recent study in macaques showed that an adjusted Omicron booster did not lead to higher antibody titers, compared with a usual booster. In January 2022, the EMA warned against frequent consecutive boosters that may no longer produce the desired immune response.

If someone receives a booster too early, a saturation effect can occur, warned Andreas Radbruch, PhD, scientific director of the German Rheumatism Research Center Berlin. “We know this from lots of experimental studies but also from lots of other vaccinations. For example, you cannot be vaccinated against tetanus twice at 3- or 4-week intervals. Nothing at all will happen the second time,” explained Dr. Radbruch.

If the same antigen is applied again and again at the same dose, the immune system is made so active that the antigen is directly intercepted and cannot have any new effect on the immune system. This mechanism has been known for a long time, said Dr. Radbruch.
 

‘Original antigenic sin’

Premature boosting could even be a handicap in the competition between immune response and virus, said Dr. Radbruch. This is due to the principle of “original antigenic sin.” If the immune system has already come into contact with a virus, contact with a new virus variant will cause it to form antibodies predominantly against those epitopes that were already present in the original virus. As a result of this, too many boosters can weaken protection against different variants.

“We have not actually observed this with SARS-CoV-2, however,” said Dr. Radbruch. “Immunity is always extremely broad. With a double or triple vaccination, all previously existing variants are covered by an affinity-matured immune system.”

Dr. Neumann-Haefelin confirmed this and added that all virus mutations, including Omicron, have different epitopes that affect the antibody response, but the T-cell response does not differ.

Dr. Radbruch said that the vaccine protection probably lasts for decades. Following an infection or vaccination, the antibody concentration in the bone marrow is similar to that achieved after a measles or tetanus vaccination. “The vaccination is already extremely efficient. You have protection at the same magnitude as for other infectious diseases or vaccinations, which is expected to last decades,” said Dr. Radbruch.

He clarified that the decrease in antibodies after vaccination and infection is normal and does not indicate a drop in protection. “Quantity and quality must not be confused here. There is simply less mass, but the grade of remaining antibody increases.”

In the competition around the virus antigens (referred to as affinity maturation), antibodies develop that bind 10 to 100 times better and are particularly protective against the virus. The immune system is thereby sustainably effective.
 

For whom and when?

Since the immune response is age dependent, it makes more sense to administer an additional booster to elderly people than to young people. Also included in this group, however, are people whose immune system still does not provide the same level of protection after the second or even third vaccination as that of younger, healthy people.

Dr. Radbruch noted that 4% of people older than 70 years exhibited autoantibodies against interferons. The effects are huge. “That is 20% of patients in an intensive care unit – and they all have a very poor prognosis,” said Dr. Radbruch. These people are extremely threatened by the virus. Multiple vaccinations are sensible for them.

Even people with a weak immune response benefit from multiple vaccinations, confirmed Dr. Neumann-Haefelin. “We are not seeing the antibody responses here that we see in young people with healthy immune systems until the third or fourth vaccination sometimes.”

Although for young healthy people, it is particularly important to ensure a sufficient period between vaccinations so that the affinity maturation is not impaired, those with a weak immune response can be vaccinated again as soon as after 3 months.

The “optimum minimum period of time” for people with healthy immune systems is 6 months, according to Dr. Neumann-Haefelin. “This is true for everyone in whom a proper response is expected.” The vaccine protection probably lasts significantly longer, and therefore, frequent boosting may not be necessary in the future, he said. The time separation also applies for medical personnel, for whom the Robert Koch Institute also recommends a second booster.

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

The more boosters the better? Data from Israel show that immune protection in elderly people is strengthened even further after a fourth dose. Karl Lauterbach, MD, German minister of health, recently pleaded for a second booster for those aged 18 years and older, and he pushed for a European Union–wide recommendation. He has not been able to implement this yet.

Just as before, Germany’s Standing Committee on Vaccination (STIKO) is only recommending the second booster for people aged 70 years and older, the European Medicines Agency (EMA) is recommending the fourth vaccination for everyone aged 80 years and older, and the United States has set the general age limit at 50 years.

Specialists remain skeptical about expanding the availability of the second booster. “From an immunologic perspective, people under the age of 70 with a healthy immune system do not need this fourth vaccination,” said Christiane Falk, PhD, head of the Institute for Transplantation Immunology of the Hannover Medical School (Germany) and member of the German Federal Government COVID Expert Panel, at a Science Media Center press briefing.

After the second vaccination, young healthy people are sufficiently protected against a severe course of the disease. Dr. Falk sees the STIKO recommendation as feasible, since it can be worked with. People in nursing facilities or those with additional underlying conditions would be considered for a fourth vaccination, explained Dr. Falk.
 

Complete protection unrealistic

Achieving complete protection against infection through multiple boosters is not realistic, said Christoph Neumann-Haefelin, MD, head of the Working Group for Translational Virus Immunology at the Clinic for Internal Medicine II, University Hospital Freiburg, Germany. Therefore, this should not be pursued when discussing boosters. “The aim of the booster vaccination should be to protect different groups of people against severe courses of the disease,” said Dr. Neumann-Haefelin.

Neutralizing antibodies that are only present in high concentrations for a few weeks after infection or vaccination are sometimes able to prevent the infection on their own. The immunologic memory of B cells and T cells, which ensures long-lasting protection against severe courses of the disease, is at a high level after two doses, and a third dose increases the protection more.

While people with a weak immune system need significantly more vaccinations in a shorter period to receive the same protection, too many booster vaccinations against SARS-CoV-2 are not sensible for young healthy people.
 

Immune saturation effect

A recent study in macaques showed that an adjusted Omicron booster did not lead to higher antibody titers, compared with a usual booster. In January 2022, the EMA warned against frequent consecutive boosters that may no longer produce the desired immune response.

If someone receives a booster too early, a saturation effect can occur, warned Andreas Radbruch, PhD, scientific director of the German Rheumatism Research Center Berlin. “We know this from lots of experimental studies but also from lots of other vaccinations. For example, you cannot be vaccinated against tetanus twice at 3- or 4-week intervals. Nothing at all will happen the second time,” explained Dr. Radbruch.

If the same antigen is applied again and again at the same dose, the immune system is made so active that the antigen is directly intercepted and cannot have any new effect on the immune system. This mechanism has been known for a long time, said Dr. Radbruch.
 

‘Original antigenic sin’

Premature boosting could even be a handicap in the competition between immune response and virus, said Dr. Radbruch. This is due to the principle of “original antigenic sin.” If the immune system has already come into contact with a virus, contact with a new virus variant will cause it to form antibodies predominantly against those epitopes that were already present in the original virus. As a result of this, too many boosters can weaken protection against different variants.

“We have not actually observed this with SARS-CoV-2, however,” said Dr. Radbruch. “Immunity is always extremely broad. With a double or triple vaccination, all previously existing variants are covered by an affinity-matured immune system.”

Dr. Neumann-Haefelin confirmed this and added that all virus mutations, including Omicron, have different epitopes that affect the antibody response, but the T-cell response does not differ.

Dr. Radbruch said that the vaccine protection probably lasts for decades. Following an infection or vaccination, the antibody concentration in the bone marrow is similar to that achieved after a measles or tetanus vaccination. “The vaccination is already extremely efficient. You have protection at the same magnitude as for other infectious diseases or vaccinations, which is expected to last decades,” said Dr. Radbruch.

He clarified that the decrease in antibodies after vaccination and infection is normal and does not indicate a drop in protection. “Quantity and quality must not be confused here. There is simply less mass, but the grade of remaining antibody increases.”

In the competition around the virus antigens (referred to as affinity maturation), antibodies develop that bind 10 to 100 times better and are particularly protective against the virus. The immune system is thereby sustainably effective.
 

For whom and when?

Since the immune response is age dependent, it makes more sense to administer an additional booster to elderly people than to young people. Also included in this group, however, are people whose immune system still does not provide the same level of protection after the second or even third vaccination as that of younger, healthy people.

Dr. Radbruch noted that 4% of people older than 70 years exhibited autoantibodies against interferons. The effects are huge. “That is 20% of patients in an intensive care unit – and they all have a very poor prognosis,” said Dr. Radbruch. These people are extremely threatened by the virus. Multiple vaccinations are sensible for them.

Even people with a weak immune response benefit from multiple vaccinations, confirmed Dr. Neumann-Haefelin. “We are not seeing the antibody responses here that we see in young people with healthy immune systems until the third or fourth vaccination sometimes.”

Although for young healthy people, it is particularly important to ensure a sufficient period between vaccinations so that the affinity maturation is not impaired, those with a weak immune response can be vaccinated again as soon as after 3 months.

The “optimum minimum period of time” for people with healthy immune systems is 6 months, according to Dr. Neumann-Haefelin. “This is true for everyone in whom a proper response is expected.” The vaccine protection probably lasts significantly longer, and therefore, frequent boosting may not be necessary in the future, he said. The time separation also applies for medical personnel, for whom the Robert Koch Institute also recommends a second booster.

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