Rheumatology News

Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.

Micah Young/istockphoto.com

Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.

On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.

As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:

• People aged 65 years and older.
• People aged 18 years and older in long-term care settings.
• People aged 50-64 years with underlying medical conditions.

The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:

• People aged 18-49 years with underlying medical conditions.
• People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

The CDC currently considers the following groups at increased risk for COVID-19:

• First responders (health care workers, firefighters, police, congregate care staff).
• Education staff (teachers, support staff, day care workers).
• Food and agriculture workers.
• Manufacturing workers.
• Corrections workers.
• U.S. Postal Service workers.
• Public transit workers.
• Grocery store workers.

Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.

“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.

“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.

To provide some initial answers, this news organization spoke with multiple COVID-19 experts.

1. What is the biggest concern you are hearing from patients about getting a booster?

“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.

“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”

Boosters for all COVID-19 vaccines are completely free.

“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.

2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?

“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.

Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”

3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer? 

The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.

More data will be needed before other vaccine boosters are authorized, she added.

“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.

4. When are the “mix-and-match” vaccine study results expected to come out?

“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.

5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization? 

“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.

“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.

”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”

“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”

6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial? 

“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”

“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”

It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.

“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”

7. What is the likelihood that one shot will combine COVID and flu protection in the near future? 

It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”

Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.

8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant? 

“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”

9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?

“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”

“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.

Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.

“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.

10. What does the future hold for booster shots?

“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said. 

“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
 

Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.

Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.

Micah Young/istockphoto.com

Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.

On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.

As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:

• People aged 65 years and older.
• People aged 18 years and older in long-term care settings.
• People aged 50-64 years with underlying medical conditions.

The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:

• People aged 18-49 years with underlying medical conditions.
• People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

The CDC currently considers the following groups at increased risk for COVID-19:

• First responders (health care workers, firefighters, police, congregate care staff).
• Education staff (teachers, support staff, day care workers).
• Food and agriculture workers.
• Manufacturing workers.
• Corrections workers.
• U.S. Postal Service workers.
• Public transit workers.
• Grocery store workers.

Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.

“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.

“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.

To provide some initial answers, this news organization spoke with multiple COVID-19 experts.

1. What is the biggest concern you are hearing from patients about getting a booster?

“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.

“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”

Boosters for all COVID-19 vaccines are completely free.

“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.

2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?

“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.

Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”

3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer? 

The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.

More data will be needed before other vaccine boosters are authorized, she added.

“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.

4. When are the “mix-and-match” vaccine study results expected to come out?

“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.

5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization? 

“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.

“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.

”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”

“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”

6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial? 

“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”

“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”

It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.

“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”

7. What is the likelihood that one shot will combine COVID and flu protection in the near future? 

It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”

Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.

8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant? 

“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”

9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?

“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”

“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.

Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.

“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.

10. What does the future hold for booster shots?

“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said. 

“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
 

Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.

Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.

Micah Young/istockphoto.com

Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.

On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.

As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:

• People aged 65 years and older.
• People aged 18 years and older in long-term care settings.
• People aged 50-64 years with underlying medical conditions.

The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:

• People aged 18-49 years with underlying medical conditions.
• People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

The CDC currently considers the following groups at increased risk for COVID-19:

• First responders (health care workers, firefighters, police, congregate care staff).
• Education staff (teachers, support staff, day care workers).
• Food and agriculture workers.
• Manufacturing workers.
• Corrections workers.
• U.S. Postal Service workers.
• Public transit workers.
• Grocery store workers.

Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.

“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.

“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.

To provide some initial answers, this news organization spoke with multiple COVID-19 experts.

1. What is the biggest concern you are hearing from patients about getting a booster?

“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.

“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”

Boosters for all COVID-19 vaccines are completely free.

“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.

2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?

“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.

Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”

3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer? 

The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.

More data will be needed before other vaccine boosters are authorized, she added.

“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.

4. When are the “mix-and-match” vaccine study results expected to come out?

“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.

5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization? 

“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.

“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.

”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”

“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”

6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial? 

“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”

“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”

It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.

“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”

7. What is the likelihood that one shot will combine COVID and flu protection in the near future? 

It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”

Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.

8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant? 

“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”

9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?

“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”

“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.

Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.

“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.

10. What does the future hold for booster shots?

“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said. 

“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
 

Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.

Patients with rheumatoid arthritis who were taking glucocorticoids and received short-term denosumab (Prolia) had lost any gains in bone mineral density at the spine or hip as well as any improvements in bone turnover markers a year later, according to findings from a post-hoc analysis of a phase 2 trial.

That is, stopping denosumab after a 12-month course resulted in a gradual increase in bone turnover markers and a concurrent return to baseline lumbar spine and total hip bone mineral density, Kenneth G. Saag, MD, professor of medicine and division director of clinical immunology and rheumatology at the University of Alabama at Birmingham, and colleagues reported in an article published online Sept. 17, 2021 in Arthritis & Rheumatology.

“These results provide further support for recommendations that patients discontinuing denosumab should transition to follow-on osteoporosis therapy to prevent or minimize remodeling-induced bone loss,” they concluded.

Like all nonbisphosphonate medications for osteoporosis, Dr. Saag and colleagues wrote, the pharmacologic effects of denosumab are readily reversible after discontinuation.

The current findings in glucocorticoid-treated patients are consistent with those observed in postmenopausal women 2 years after discontinuing denosumab therapy for osteoporosis. Denosumab is typically given for a longer time in such patients, compared with patients receiving glucocorticoids.

Invited to comment, Karen E. Hansen, MD, a rheumatologist and associate professor at the University of Wisconsin, Madison, who was not involved with the study, agreed that the results “highlight the need to prescribe another osteoporosis medication after stopping denosumab, in hopes of preventing loss of bone mineral density.”

Dr. Hansen, a coauthor of a review and meta-analysis of denosumab in the treatment of glucocorticoid-induced osteoporosis, noted that the American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis suggests the use of denosumab as fourth-line therapy, after oral bisphosphonates, intravenous bisphosphonates, and teriparatide (Forteo).

“Its use is particularly relevant in patients who have contraindications or side effects from bisphosphonates or anabolic therapy, or when patient compliance must be ensured,” she said in an interview.

“The type, timing, and effect of therapy after denosumab discontinuation, however, remain controversial,” Dr. Saag and colleagues noted.

However, ongoing trials that are investigating the optimal medication and dosing needed to prevent such losses in bone mineral density after stopping denosumab should provide greater insight, Dr. Hansen said.

Bone health after stopping denosumab

Patients with rheumatoid arthritis often have bone loss that can be worsened by their frequent use of glucocorticoids, leading to an increased risk of fragility fractures.

Denosumab, a monoclonal antibody that inhibits receptor activator of nuclear factor kappaB ligand (RANKL), was approved by the Food and Drug Administration in 2018 for treating patients with glucocorticoid-induced osteoporosis and a high risk of fracture.

Dr. Saag and colleagues performed a post-hoc analysis of a subgroup of 82 patients receiving glucocorticoids who were part of a larger phase 2 clinical trial of 218 patients with rheumatoid arthritis.

The patients had been randomized to receive placebo (n = 26), 60 mg denosumab (the approved dose, n = 27), or 180 mg denosumab (n = 29), given as two subcutaneous 6-month injections at baseline and 6 months, followed by 12 months without any bone-loss prevention therapy.

The patients had a mean age of 55, and 62% were women.

While receiving denosumab, their serum levels of the bone resorption marker C-terminal telopeptide of type I collagen (CTX) and the bone formation marker procollagen type I N-terminal propeptide (P1NP) decreased significantly from baseline.

In patients who received the 60-mg dose of denosumab, CTX levels had returned to baseline levels 6 months and 12 months after denosumab was discontinued.

Median levels of P1NP in these patients were 0.16% lower than baseline and 15% higher than baseline at 6 months and 12 months after denosumab was stopped, respectively.

In patients who received the 180-mg dose of denosumab, CTX levels also had returned to baseline levels 6 months and 12 months after denosumab was discontinued.

Median levels of P1NP in these patients were 9% and 76% higher than baseline levels, at 6 months and 12 months after denosumab was stopped, respectively.

Bone mineral density at the lumbar spine and total hip increased during the 12 months of denosumab treatment and then returned to baseline after 12 months of discontinuation of both doses of denosumab.

No osteoporotic fractures were reported during the 12-month denosumab treatment or the 12-month follow-up.

The study was funded by Amgen, which markets denosumab. Dr. Saag is an investigator with Amgen, Mereo, and Radius, and a consultant for Amgen and Roche. Four coauthors are employees of Amgen. The other six coauthors all reported a financial relationship with Amgen.

Patients with rheumatoid arthritis who were taking glucocorticoids and received short-term denosumab (Prolia) had lost any gains in bone mineral density at the spine or hip as well as any improvements in bone turnover markers a year later, according to findings from a post-hoc analysis of a phase 2 trial.

That is, stopping denosumab after a 12-month course resulted in a gradual increase in bone turnover markers and a concurrent return to baseline lumbar spine and total hip bone mineral density, Kenneth G. Saag, MD, professor of medicine and division director of clinical immunology and rheumatology at the University of Alabama at Birmingham, and colleagues reported in an article published online Sept. 17, 2021 in Arthritis & Rheumatology.

“These results provide further support for recommendations that patients discontinuing denosumab should transition to follow-on osteoporosis therapy to prevent or minimize remodeling-induced bone loss,” they concluded.

Like all nonbisphosphonate medications for osteoporosis, Dr. Saag and colleagues wrote, the pharmacologic effects of denosumab are readily reversible after discontinuation.

The current findings in glucocorticoid-treated patients are consistent with those observed in postmenopausal women 2 years after discontinuing denosumab therapy for osteoporosis. Denosumab is typically given for a longer time in such patients, compared with patients receiving glucocorticoids.

Invited to comment, Karen E. Hansen, MD, a rheumatologist and associate professor at the University of Wisconsin, Madison, who was not involved with the study, agreed that the results “highlight the need to prescribe another osteoporosis medication after stopping denosumab, in hopes of preventing loss of bone mineral density.”

Dr. Hansen, a coauthor of a review and meta-analysis of denosumab in the treatment of glucocorticoid-induced osteoporosis, noted that the American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis suggests the use of denosumab as fourth-line therapy, after oral bisphosphonates, intravenous bisphosphonates, and teriparatide (Forteo).

“Its use is particularly relevant in patients who have contraindications or side effects from bisphosphonates or anabolic therapy, or when patient compliance must be ensured,” she said in an interview.

“The type, timing, and effect of therapy after denosumab discontinuation, however, remain controversial,” Dr. Saag and colleagues noted.

However, ongoing trials that are investigating the optimal medication and dosing needed to prevent such losses in bone mineral density after stopping denosumab should provide greater insight, Dr. Hansen said.

Bone health after stopping denosumab

Patients with rheumatoid arthritis often have bone loss that can be worsened by their frequent use of glucocorticoids, leading to an increased risk of fragility fractures.

Denosumab, a monoclonal antibody that inhibits receptor activator of nuclear factor kappaB ligand (RANKL), was approved by the Food and Drug Administration in 2018 for treating patients with glucocorticoid-induced osteoporosis and a high risk of fracture.

Dr. Saag and colleagues performed a post-hoc analysis of a subgroup of 82 patients receiving glucocorticoids who were part of a larger phase 2 clinical trial of 218 patients with rheumatoid arthritis.

The patients had been randomized to receive placebo (n = 26), 60 mg denosumab (the approved dose, n = 27), or 180 mg denosumab (n = 29), given as two subcutaneous 6-month injections at baseline and 6 months, followed by 12 months without any bone-loss prevention therapy.

The patients had a mean age of 55, and 62% were women.

While receiving denosumab, their serum levels of the bone resorption marker C-terminal telopeptide of type I collagen (CTX) and the bone formation marker procollagen type I N-terminal propeptide (P1NP) decreased significantly from baseline.

In patients who received the 60-mg dose of denosumab, CTX levels had returned to baseline levels 6 months and 12 months after denosumab was discontinued.

Median levels of P1NP in these patients were 0.16% lower than baseline and 15% higher than baseline at 6 months and 12 months after denosumab was stopped, respectively.

In patients who received the 180-mg dose of denosumab, CTX levels also had returned to baseline levels 6 months and 12 months after denosumab was discontinued.

Median levels of P1NP in these patients were 9% and 76% higher than baseline levels, at 6 months and 12 months after denosumab was stopped, respectively.

Bone mineral density at the lumbar spine and total hip increased during the 12 months of denosumab treatment and then returned to baseline after 12 months of discontinuation of both doses of denosumab.

No osteoporotic fractures were reported during the 12-month denosumab treatment or the 12-month follow-up.

The study was funded by Amgen, which markets denosumab. Dr. Saag is an investigator with Amgen, Mereo, and Radius, and a consultant for Amgen and Roche. Four coauthors are employees of Amgen. The other six coauthors all reported a financial relationship with Amgen.

Patients with rheumatoid arthritis who were taking glucocorticoids and received short-term denosumab (Prolia) had lost any gains in bone mineral density at the spine or hip as well as any improvements in bone turnover markers a year later, according to findings from a post-hoc analysis of a phase 2 trial.

That is, stopping denosumab after a 12-month course resulted in a gradual increase in bone turnover markers and a concurrent return to baseline lumbar spine and total hip bone mineral density, Kenneth G. Saag, MD, professor of medicine and division director of clinical immunology and rheumatology at the University of Alabama at Birmingham, and colleagues reported in an article published online Sept. 17, 2021 in Arthritis & Rheumatology.

“These results provide further support for recommendations that patients discontinuing denosumab should transition to follow-on osteoporosis therapy to prevent or minimize remodeling-induced bone loss,” they concluded.

Like all nonbisphosphonate medications for osteoporosis, Dr. Saag and colleagues wrote, the pharmacologic effects of denosumab are readily reversible after discontinuation.

The current findings in glucocorticoid-treated patients are consistent with those observed in postmenopausal women 2 years after discontinuing denosumab therapy for osteoporosis. Denosumab is typically given for a longer time in such patients, compared with patients receiving glucocorticoids.

Invited to comment, Karen E. Hansen, MD, a rheumatologist and associate professor at the University of Wisconsin, Madison, who was not involved with the study, agreed that the results “highlight the need to prescribe another osteoporosis medication after stopping denosumab, in hopes of preventing loss of bone mineral density.”

Dr. Hansen, a coauthor of a review and meta-analysis of denosumab in the treatment of glucocorticoid-induced osteoporosis, noted that the American College of Rheumatology guideline for the prevention and treatment of glucocorticoid-induced osteoporosis suggests the use of denosumab as fourth-line therapy, after oral bisphosphonates, intravenous bisphosphonates, and teriparatide (Forteo).

“Its use is particularly relevant in patients who have contraindications or side effects from bisphosphonates or anabolic therapy, or when patient compliance must be ensured,” she said in an interview.

“The type, timing, and effect of therapy after denosumab discontinuation, however, remain controversial,” Dr. Saag and colleagues noted.

However, ongoing trials that are investigating the optimal medication and dosing needed to prevent such losses in bone mineral density after stopping denosumab should provide greater insight, Dr. Hansen said.

Bone health after stopping denosumab

Patients with rheumatoid arthritis often have bone loss that can be worsened by their frequent use of glucocorticoids, leading to an increased risk of fragility fractures.

Denosumab, a monoclonal antibody that inhibits receptor activator of nuclear factor kappaB ligand (RANKL), was approved by the Food and Drug Administration in 2018 for treating patients with glucocorticoid-induced osteoporosis and a high risk of fracture.

Dr. Saag and colleagues performed a post-hoc analysis of a subgroup of 82 patients receiving glucocorticoids who were part of a larger phase 2 clinical trial of 218 patients with rheumatoid arthritis.

The patients had been randomized to receive placebo (n = 26), 60 mg denosumab (the approved dose, n = 27), or 180 mg denosumab (n = 29), given as two subcutaneous 6-month injections at baseline and 6 months, followed by 12 months without any bone-loss prevention therapy.

The patients had a mean age of 55, and 62% were women.

While receiving denosumab, their serum levels of the bone resorption marker C-terminal telopeptide of type I collagen (CTX) and the bone formation marker procollagen type I N-terminal propeptide (P1NP) decreased significantly from baseline.

In patients who received the 60-mg dose of denosumab, CTX levels had returned to baseline levels 6 months and 12 months after denosumab was discontinued.

Median levels of P1NP in these patients were 0.16% lower than baseline and 15% higher than baseline at 6 months and 12 months after denosumab was stopped, respectively.

In patients who received the 180-mg dose of denosumab, CTX levels also had returned to baseline levels 6 months and 12 months after denosumab was discontinued.

Median levels of P1NP in these patients were 9% and 76% higher than baseline levels, at 6 months and 12 months after denosumab was stopped, respectively.

Bone mineral density at the lumbar spine and total hip increased during the 12 months of denosumab treatment and then returned to baseline after 12 months of discontinuation of both doses of denosumab.

No osteoporotic fractures were reported during the 12-month denosumab treatment or the 12-month follow-up.

The study was funded by Amgen, which markets denosumab. Dr. Saag is an investigator with Amgen, Mereo, and Radius, and a consultant for Amgen and Roche. Four coauthors are employees of Amgen. The other six coauthors all reported a financial relationship with Amgen.

Slips and falls are a major source of injuries, especially among the elderly, but they’re also a way for schemers to rake in big bucks, as a story in the New York Daily News, among other news outlets, indicates.

In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.

These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.

In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.

Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.

According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.

If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.

This isn’t the first time such a scheme has been hatched and carried out in New York City.

In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)

Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”

Sales reps in the OR — helpful or harmful?

Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.

In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.

Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.

In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.

The defendants have each denied any wrongdoing.

The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”

The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.

A trial is scheduled for this November.

But was the Houston incident typical?

Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.

Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.

The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.

Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.

Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.

Device makers have denied these and other allegations. Many of their cases have been settled confidentially.

This high-risk specialty found a way to lower its claim rates

Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.

Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.

The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.

Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)

For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)

“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
 

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

Slips and falls are a major source of injuries, especially among the elderly, but they’re also a way for schemers to rake in big bucks, as a story in the New York Daily News, among other news outlets, indicates.

In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.

These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.

In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.

Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.

According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.

If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.

This isn’t the first time such a scheme has been hatched and carried out in New York City.

In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)

Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”

Sales reps in the OR — helpful or harmful?

Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.

In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.

Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.

In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.

The defendants have each denied any wrongdoing.

The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”

The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.

A trial is scheduled for this November.

But was the Houston incident typical?

Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.

Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.

The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.

Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.

Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.

Device makers have denied these and other allegations. Many of their cases have been settled confidentially.

This high-risk specialty found a way to lower its claim rates

Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.

Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.

The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.

Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)

For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)

“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
 

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

Slips and falls are a major source of injuries, especially among the elderly, but they’re also a way for schemers to rake in big bucks, as a story in the New York Daily News, among other news outlets, indicates.

In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.

These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.

In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.

Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.

According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.

If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.

This isn’t the first time such a scheme has been hatched and carried out in New York City.

In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)

Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”

Sales reps in the OR — helpful or harmful?

Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.

In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.

Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.

In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.

The defendants have each denied any wrongdoing.

The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”

The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.

A trial is scheduled for this November.

But was the Houston incident typical?

Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.

Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.

The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.

Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.

Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.

Device makers have denied these and other allegations. Many of their cases have been settled confidentially.

This high-risk specialty found a way to lower its claim rates

Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.

Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.

The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.

Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)

For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)

“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
 

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

Withholding mycophenolate around the time of vaccination against SARS-CoV-2 proved safe and augmented the humoral response to vaccination among a group of patients at one center who were taking the immunosuppressive drug for a variety of rheumatic and musculoskeletal diseases (RMDs).

Previous studies have shown that use of mycophenolate attenuates the humoral response to SARS-CoV-2 vaccination, and the most up-to-date recommendations from the American College of Rheumatology on SARS-CoV-2 vaccination in patients with RMDs advise that mycophenolate should be withheld for a week after receiving the vaccine.

To understand better how withholding mycophenolate would affect immune response to SARS-CoV-2 vaccination, rheumatology fellow Caoilfhionn M. Connolly, MD, and coauthors at Johns Hopkins University, Baltimore, described in their report – published online Sept. 23, 2021, in Annals of the Rheumatic Diseases – how they compared the immune responses to vaccination in 24 patients who withheld mycophenolate and 171 patients who did not stop taking it. All but 1 of the 24 patients who withheld mycophenolate were female, with a median age of 51 years, and they had mostly systemic lupus erythematosus (6 patients), myositis (5), scleroderma (4), or overlap connective tissue disease (4). Three patients received the Janssen/Johnson & Johnson vaccine; all others received either the two-dose Moderna or Pfizer/BioNTech mRNA series.

At a median of 32 days after vaccination, all but two of the patients (92%) who withheld mycophenolate had detectable antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, compared with 65% of those who continued the drug (P = .01). This calculated to patients who withheld the drug as having nearly sixfold higher odds for a positive antibody response (odds ratio, 5.8; 95% CI, 1.3-25.5; P = .02). The association remained statistically significant in an logistic regression analysis that was adjusted for age, sex, race, vaccine type, and use of rituximab and glucocorticoids.

The withholding group also had significantly higher median anti-RBD immunoglobulin titers than did the group that continued therapy (125 vs. 7 U/L; P = .004).

Two patients who reported a flare of their underlying disease during the perivaccination period were treated with topical and oral glucocorticoids.

The patients who withdrew mycophenolate had taken it with twice daily dosing at a median total daily dose of 2,000 mg. They ended up withholding a median of 20 doses around the time of vaccination, with 54% withholding before, 38% both before and after, and 8% only after vaccination.

The researchers said that the conclusions that can be drawn from the study were limited by its small sample size, which “did not allow for evaluation of optimal duration of withholding therapy,” and also its “nonrandomized design, lack of data on cellular response, and limited information on dosing of other immunosuppressive agents.”

Three of the authors disclosed receiving consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. A fourth author has received consulting fees from Janssen, Boehringer Ingelheim, Mallinckrodt, EMD Serono, Allogene, and ArgenX.

jevans@mdedge.com

Withholding mycophenolate around the time of vaccination against SARS-CoV-2 proved safe and augmented the humoral response to vaccination among a group of patients at one center who were taking the immunosuppressive drug for a variety of rheumatic and musculoskeletal diseases (RMDs).

Previous studies have shown that use of mycophenolate attenuates the humoral response to SARS-CoV-2 vaccination, and the most up-to-date recommendations from the American College of Rheumatology on SARS-CoV-2 vaccination in patients with RMDs advise that mycophenolate should be withheld for a week after receiving the vaccine.

To understand better how withholding mycophenolate would affect immune response to SARS-CoV-2 vaccination, rheumatology fellow Caoilfhionn M. Connolly, MD, and coauthors at Johns Hopkins University, Baltimore, described in their report – published online Sept. 23, 2021, in Annals of the Rheumatic Diseases – how they compared the immune responses to vaccination in 24 patients who withheld mycophenolate and 171 patients who did not stop taking it. All but 1 of the 24 patients who withheld mycophenolate were female, with a median age of 51 years, and they had mostly systemic lupus erythematosus (6 patients), myositis (5), scleroderma (4), or overlap connective tissue disease (4). Three patients received the Janssen/Johnson & Johnson vaccine; all others received either the two-dose Moderna or Pfizer/BioNTech mRNA series.

At a median of 32 days after vaccination, all but two of the patients (92%) who withheld mycophenolate had detectable antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, compared with 65% of those who continued the drug (P = .01). This calculated to patients who withheld the drug as having nearly sixfold higher odds for a positive antibody response (odds ratio, 5.8; 95% CI, 1.3-25.5; P = .02). The association remained statistically significant in an logistic regression analysis that was adjusted for age, sex, race, vaccine type, and use of rituximab and glucocorticoids.

The withholding group also had significantly higher median anti-RBD immunoglobulin titers than did the group that continued therapy (125 vs. 7 U/L; P = .004).

Two patients who reported a flare of their underlying disease during the perivaccination period were treated with topical and oral glucocorticoids.

The patients who withdrew mycophenolate had taken it with twice daily dosing at a median total daily dose of 2,000 mg. They ended up withholding a median of 20 doses around the time of vaccination, with 54% withholding before, 38% both before and after, and 8% only after vaccination.

The researchers said that the conclusions that can be drawn from the study were limited by its small sample size, which “did not allow for evaluation of optimal duration of withholding therapy,” and also its “nonrandomized design, lack of data on cellular response, and limited information on dosing of other immunosuppressive agents.”

Three of the authors disclosed receiving consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. A fourth author has received consulting fees from Janssen, Boehringer Ingelheim, Mallinckrodt, EMD Serono, Allogene, and ArgenX.

jevans@mdedge.com

Withholding mycophenolate around the time of vaccination against SARS-CoV-2 proved safe and augmented the humoral response to vaccination among a group of patients at one center who were taking the immunosuppressive drug for a variety of rheumatic and musculoskeletal diseases (RMDs).

Previous studies have shown that use of mycophenolate attenuates the humoral response to SARS-CoV-2 vaccination, and the most up-to-date recommendations from the American College of Rheumatology on SARS-CoV-2 vaccination in patients with RMDs advise that mycophenolate should be withheld for a week after receiving the vaccine.

To understand better how withholding mycophenolate would affect immune response to SARS-CoV-2 vaccination, rheumatology fellow Caoilfhionn M. Connolly, MD, and coauthors at Johns Hopkins University, Baltimore, described in their report – published online Sept. 23, 2021, in Annals of the Rheumatic Diseases – how they compared the immune responses to vaccination in 24 patients who withheld mycophenolate and 171 patients who did not stop taking it. All but 1 of the 24 patients who withheld mycophenolate were female, with a median age of 51 years, and they had mostly systemic lupus erythematosus (6 patients), myositis (5), scleroderma (4), or overlap connective tissue disease (4). Three patients received the Janssen/Johnson & Johnson vaccine; all others received either the two-dose Moderna or Pfizer/BioNTech mRNA series.

At a median of 32 days after vaccination, all but two of the patients (92%) who withheld mycophenolate had detectable antibodies against the receptor binding domain (RBD) of the SARS-CoV-2 spike protein, compared with 65% of those who continued the drug (P = .01). This calculated to patients who withheld the drug as having nearly sixfold higher odds for a positive antibody response (odds ratio, 5.8; 95% CI, 1.3-25.5; P = .02). The association remained statistically significant in an logistic regression analysis that was adjusted for age, sex, race, vaccine type, and use of rituximab and glucocorticoids.

The withholding group also had significantly higher median anti-RBD immunoglobulin titers than did the group that continued therapy (125 vs. 7 U/L; P = .004).

Two patients who reported a flare of their underlying disease during the perivaccination period were treated with topical and oral glucocorticoids.

The patients who withdrew mycophenolate had taken it with twice daily dosing at a median total daily dose of 2,000 mg. They ended up withholding a median of 20 doses around the time of vaccination, with 54% withholding before, 38% both before and after, and 8% only after vaccination.

The researchers said that the conclusions that can be drawn from the study were limited by its small sample size, which “did not allow for evaluation of optimal duration of withholding therapy,” and also its “nonrandomized design, lack of data on cellular response, and limited information on dosing of other immunosuppressive agents.”

Three of the authors disclosed receiving consulting and speaking honoraria from Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallincrodt, and Thermo Fisher Scientific. A fourth author has received consulting fees from Janssen, Boehringer Ingelheim, Mallinckrodt, EMD Serono, Allogene, and ArgenX.

jevans@mdedge.com

Older age, higher subjective disease activity, and exercising for more than 120 minutes per week were three factors linked to patients with ankylosing spondylitis (AS) who switched from their original tumor necrosis factor inhibitor (TNFi) treatment within 2 years in a U.S.-based study.

Data from the Prospective Study of Outcomes in Ankylosing Spondylitis (PSOAS) also found that higher levels of inflammation, but not radiographic disease, were linked to patients changing from one TNFi to another, or to an interleukin (IL)-17 inhibitor or Janus kinase (JAK) inhibitor.

“Different factors were associated in AS patients who switch from their initial TNF inhibitor to another TNF inhibitor, IL-17 inhibitor, or JAK inhibitor within 2 years versus after 2 years of treatment,” John D. Reveille, MD, professor and vice chair of rheumatology and clinical immunogenetics with McGovern Medical School at UTHealth Houston, said at the 12th International Congress on Spondyloarthritides.

“We’re currently looking at different approaches to analyzing these data. And, certainly, this needs need to be looked at in other cohorts,” Dr. Reveille said.

PSOAS is a prospective observational cohort study that has been looking at predictors of AS severity for almost 20 years. Started in 2002, the study has routinely collected a whole host of data on various demographic and disease-related factors.

The reasoning behind the current analysis of PSOAS data was that a relatively recent study based on a commercial claims database had found that many patients with AS do not remain on their initial TNFi 2 years after initiation. So, Dr. Reveille and associates decided to look at the factors that could be influencing whether patients who started a TNFi would remain on their original drug in the PSOAS cohort.

In all, 533 patients from the PSOAS cohort who had at least 2 years of follow-up were included in the analysis. The majority (n = 496) were treated with a TNFi, 34 had received an IL-17 inhibitor, and 3 had received a JAK inhibitor.

Of the 496 patients treated with a TNFi, almost 70% (n = 344) persisted with this treatment for the duration of the study. Of those that switched to another TNFi or IL-17 or JAK inhibitor treatment, 20% (n = 101) did so within 2 years and the remaining 10% (n = 51) after 2 years.

Multinominal logistic regression modeling revealed a number of different factors that were associated with switching within 2 years versus switching after 2 years.

Compared to patients who persisted with treatment throughout the study period, patients who switched from their original TNFi within 2 years were more likely to be older (odds ratio [OR], 2.0 for ≥ 40 vs. < 40 years; P = .002), have a higher Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) score at baseline (OR, 1.73 for ≥ 4 vs. < 4; P = .03), higher C-reactive protein levels (OR, 1.94 for ≥ 0.8 mg/dL vs. < 0.8 mg/dL, P = .004), and greater weekly duration of exercise (OR, 1.95 for ≥ 120 minutes per week vs. < 120; P <.001).

Switchers also were less likely to have severe radiographic disease at baseline, as determined by the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS, OR, 0.63; P = .03), and less likely to be current smokers (OR, 0.69; P < .001).

Factors associated with switching after 2 years versus persisting with treatment were higher baseline BASDAI (OR, 2.31; P = .01), exercising more than 120 minutes per week (OR, 1.66; P = .03), and having more comorbidities (OR, 1.63 for ≥ 2 vs. < 2, P = .04).

However, patients who switched after 2 years were less likely to be depressed (OR, 0.35; P = .002) or to have a longer baseline disease duration (OR, 0.27 for ≥ 20 years vs. < 20 years P < .001).

The association observed between switching within 2 years and lower likelihood of currently smoking was a “little bit puzzling,” one delegate said after Dr. Reveille’s presentation. “The opposite has been shown in the literature, and current smokers seem to be refractory to TNF inhibitor therapy,” the delegate observed.

“I was confounded when I saw the data,” Dr. Reveille acknowledged. Because this was an observational study, this finding needs more investigation, he agreed. “Interestingly, we have seen this negative association with some other parameters, too,” he added.

The HLA-B27 carrier and radiographic status were carefully checked, so there should not be a problem with the diagnosis, Dr. Reveille reassured. Further analyses of the findings are now warranted.

Funding for the study was provided by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Additional funding was received from the Spondyloarthritis Association of America and Eli Lilly.

Dr. Reveille made no personal disclosures; a coauthor of the abstract was an employee of Eli Lilly.

Older age, higher subjective disease activity, and exercising for more than 120 minutes per week were three factors linked to patients with ankylosing spondylitis (AS) who switched from their original tumor necrosis factor inhibitor (TNFi) treatment within 2 years in a U.S.-based study.

Data from the Prospective Study of Outcomes in Ankylosing Spondylitis (PSOAS) also found that higher levels of inflammation, but not radiographic disease, were linked to patients changing from one TNFi to another, or to an interleukin (IL)-17 inhibitor or Janus kinase (JAK) inhibitor.

“Different factors were associated in AS patients who switch from their initial TNF inhibitor to another TNF inhibitor, IL-17 inhibitor, or JAK inhibitor within 2 years versus after 2 years of treatment,” John D. Reveille, MD, professor and vice chair of rheumatology and clinical immunogenetics with McGovern Medical School at UTHealth Houston, said at the 12th International Congress on Spondyloarthritides.

“We’re currently looking at different approaches to analyzing these data. And, certainly, this needs need to be looked at in other cohorts,” Dr. Reveille said.

PSOAS is a prospective observational cohort study that has been looking at predictors of AS severity for almost 20 years. Started in 2002, the study has routinely collected a whole host of data on various demographic and disease-related factors.

The reasoning behind the current analysis of PSOAS data was that a relatively recent study based on a commercial claims database had found that many patients with AS do not remain on their initial TNFi 2 years after initiation. So, Dr. Reveille and associates decided to look at the factors that could be influencing whether patients who started a TNFi would remain on their original drug in the PSOAS cohort.

In all, 533 patients from the PSOAS cohort who had at least 2 years of follow-up were included in the analysis. The majority (n = 496) were treated with a TNFi, 34 had received an IL-17 inhibitor, and 3 had received a JAK inhibitor.

Of the 496 patients treated with a TNFi, almost 70% (n = 344) persisted with this treatment for the duration of the study. Of those that switched to another TNFi or IL-17 or JAK inhibitor treatment, 20% (n = 101) did so within 2 years and the remaining 10% (n = 51) after 2 years.

Multinominal logistic regression modeling revealed a number of different factors that were associated with switching within 2 years versus switching after 2 years.

Compared to patients who persisted with treatment throughout the study period, patients who switched from their original TNFi within 2 years were more likely to be older (odds ratio [OR], 2.0 for ≥ 40 vs. < 40 years; P = .002), have a higher Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) score at baseline (OR, 1.73 for ≥ 4 vs. < 4; P = .03), higher C-reactive protein levels (OR, 1.94 for ≥ 0.8 mg/dL vs. < 0.8 mg/dL, P = .004), and greater weekly duration of exercise (OR, 1.95 for ≥ 120 minutes per week vs. < 120; P <.001).

Switchers also were less likely to have severe radiographic disease at baseline, as determined by the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS, OR, 0.63; P = .03), and less likely to be current smokers (OR, 0.69; P < .001).

Factors associated with switching after 2 years versus persisting with treatment were higher baseline BASDAI (OR, 2.31; P = .01), exercising more than 120 minutes per week (OR, 1.66; P = .03), and having more comorbidities (OR, 1.63 for ≥ 2 vs. < 2, P = .04).

However, patients who switched after 2 years were less likely to be depressed (OR, 0.35; P = .002) or to have a longer baseline disease duration (OR, 0.27 for ≥ 20 years vs. < 20 years P < .001).

The association observed between switching within 2 years and lower likelihood of currently smoking was a “little bit puzzling,” one delegate said after Dr. Reveille’s presentation. “The opposite has been shown in the literature, and current smokers seem to be refractory to TNF inhibitor therapy,” the delegate observed.

“I was confounded when I saw the data,” Dr. Reveille acknowledged. Because this was an observational study, this finding needs more investigation, he agreed. “Interestingly, we have seen this negative association with some other parameters, too,” he added.

The HLA-B27 carrier and radiographic status were carefully checked, so there should not be a problem with the diagnosis, Dr. Reveille reassured. Further analyses of the findings are now warranted.

Funding for the study was provided by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Additional funding was received from the Spondyloarthritis Association of America and Eli Lilly.

Dr. Reveille made no personal disclosures; a coauthor of the abstract was an employee of Eli Lilly.

Older age, higher subjective disease activity, and exercising for more than 120 minutes per week were three factors linked to patients with ankylosing spondylitis (AS) who switched from their original tumor necrosis factor inhibitor (TNFi) treatment within 2 years in a U.S.-based study.

Data from the Prospective Study of Outcomes in Ankylosing Spondylitis (PSOAS) also found that higher levels of inflammation, but not radiographic disease, were linked to patients changing from one TNFi to another, or to an interleukin (IL)-17 inhibitor or Janus kinase (JAK) inhibitor.

“Different factors were associated in AS patients who switch from their initial TNF inhibitor to another TNF inhibitor, IL-17 inhibitor, or JAK inhibitor within 2 years versus after 2 years of treatment,” John D. Reveille, MD, professor and vice chair of rheumatology and clinical immunogenetics with McGovern Medical School at UTHealth Houston, said at the 12th International Congress on Spondyloarthritides.

“We’re currently looking at different approaches to analyzing these data. And, certainly, this needs need to be looked at in other cohorts,” Dr. Reveille said.

PSOAS is a prospective observational cohort study that has been looking at predictors of AS severity for almost 20 years. Started in 2002, the study has routinely collected a whole host of data on various demographic and disease-related factors.

The reasoning behind the current analysis of PSOAS data was that a relatively recent study based on a commercial claims database had found that many patients with AS do not remain on their initial TNFi 2 years after initiation. So, Dr. Reveille and associates decided to look at the factors that could be influencing whether patients who started a TNFi would remain on their original drug in the PSOAS cohort.

In all, 533 patients from the PSOAS cohort who had at least 2 years of follow-up were included in the analysis. The majority (n = 496) were treated with a TNFi, 34 had received an IL-17 inhibitor, and 3 had received a JAK inhibitor.

Of the 496 patients treated with a TNFi, almost 70% (n = 344) persisted with this treatment for the duration of the study. Of those that switched to another TNFi or IL-17 or JAK inhibitor treatment, 20% (n = 101) did so within 2 years and the remaining 10% (n = 51) after 2 years.

Multinominal logistic regression modeling revealed a number of different factors that were associated with switching within 2 years versus switching after 2 years.

Compared to patients who persisted with treatment throughout the study period, patients who switched from their original TNFi within 2 years were more likely to be older (odds ratio [OR], 2.0 for ≥ 40 vs. < 40 years; P = .002), have a higher Bath Ankylosing Spondyloarthritis Disease Activity Index (BASDAI) score at baseline (OR, 1.73 for ≥ 4 vs. < 4; P = .03), higher C-reactive protein levels (OR, 1.94 for ≥ 0.8 mg/dL vs. < 0.8 mg/dL, P = .004), and greater weekly duration of exercise (OR, 1.95 for ≥ 120 minutes per week vs. < 120; P <.001).

Switchers also were less likely to have severe radiographic disease at baseline, as determined by the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS, OR, 0.63; P = .03), and less likely to be current smokers (OR, 0.69; P < .001).

Factors associated with switching after 2 years versus persisting with treatment were higher baseline BASDAI (OR, 2.31; P = .01), exercising more than 120 minutes per week (OR, 1.66; P = .03), and having more comorbidities (OR, 1.63 for ≥ 2 vs. < 2, P = .04).

However, patients who switched after 2 years were less likely to be depressed (OR, 0.35; P = .002) or to have a longer baseline disease duration (OR, 0.27 for ≥ 20 years vs. < 20 years P < .001).

The association observed between switching within 2 years and lower likelihood of currently smoking was a “little bit puzzling,” one delegate said after Dr. Reveille’s presentation. “The opposite has been shown in the literature, and current smokers seem to be refractory to TNF inhibitor therapy,” the delegate observed.

“I was confounded when I saw the data,” Dr. Reveille acknowledged. Because this was an observational study, this finding needs more investigation, he agreed. “Interestingly, we have seen this negative association with some other parameters, too,” he added.

The HLA-B27 carrier and radiographic status were carefully checked, so there should not be a problem with the diagnosis, Dr. Reveille reassured. Further analyses of the findings are now warranted.

Funding for the study was provided by the U.S. Department of Health and Human Services, the National Institutes of Health, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Additional funding was received from the Spondyloarthritis Association of America and Eli Lilly.

Dr. Reveille made no personal disclosures; a coauthor of the abstract was an employee of Eli Lilly.

The director of the Centers for Disease Control and Prevention late Thursday overruled the recommendation of the agency’s advisory panel to broaden the number of Americans who are now eligible for a third dose of the Pfizer COVID-19 vaccine.

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and up and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose.  About 13.6 million of them are over the age of 65.  Another 5.3 million are ages 50 to 64.

In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.

This is the group Dr. Walensky added to the eligible list on her own.

Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville.  Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.

“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”

The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
 

How much will the U.S. benefit from boosters?

Some felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

Others agreed.

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.

“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
 

Next steps

People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.

While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.

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

The director of the Centers for Disease Control and Prevention late Thursday overruled the recommendation of the agency’s advisory panel to broaden the number of Americans who are now eligible for a third dose of the Pfizer COVID-19 vaccine.

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and up and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose.  About 13.6 million of them are over the age of 65.  Another 5.3 million are ages 50 to 64.

In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.

This is the group Dr. Walensky added to the eligible list on her own.

Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville.  Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.

“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”

The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
 

How much will the U.S. benefit from boosters?

Some felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

Others agreed.

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.

“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
 

Next steps

People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.

While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.

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

The director of the Centers for Disease Control and Prevention late Thursday overruled the recommendation of the agency’s advisory panel to broaden the number of Americans who are now eligible for a third dose of the Pfizer COVID-19 vaccine.

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and up and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose.  About 13.6 million of them are over the age of 65.  Another 5.3 million are ages 50 to 64.

In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.

This is the group Dr. Walensky added to the eligible list on her own.

Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville.  Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.

“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”

The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
 

How much will the U.S. benefit from boosters?

Some felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

Others agreed.

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.

“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
 

Next steps

People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.

While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.

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

Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.

Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.

Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.

Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.

The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.

A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
 

Use of remdesivir controversial

Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.

However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.

The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”

The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.

The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.

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

Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.

Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.

Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.

Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.

The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.

A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
 

Use of remdesivir controversial

Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.

However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.

The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”

The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.

The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.

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

Remdesivir (Veklury, Gilead) was found to reduce some COVID-19 patients’ risk of hospitalization by 87% in a phase 3 trial, the drug’s manufacturer announced Sept. 22 in a press release.

The randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a 3-day course of intravenous remdesivir in an analysis of 562 nonhospitalized patients at high risk for disease progression.

Remdesivir demonstrated a statistically significant 87% reduction in risk for COVID-19–related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) P = .008. Participants were assigned 1:1 to remdesivir or the placebo group.

Researchers also found an 81% reduction in risk for the composite secondary endpoint – medical visits due to COVID-19 or all-cause death by Day 28. Only 1.6% had COVID-19 medical visits ([4/246]) compared with those in the placebo group (8.3% [21/252]) P = .002. No deaths were observed in either arm by Day 28.

“These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether,” coauthor Robert L. Gottlieb, MD, PhD, from Baylor University Medical Center, Houston, said in the press release.

Remdesivir is the only drug approved by the U.S. Food and Drug Administration for hospitalized COVID-19 patients at least 12 years old. Its treatment of nonhospitalized patients with 3 days of dosing is investigational, and the safety and efficacy for this use and dosing duration have not been established or approved by any regulatory agency, the Gilead press release notes.

The patients in this study were considered high-risk for disease progression based on comorbidities – commonly obesity, hypertension, and diabetes – and age, but had not recently been hospitalized due to COVID-19.

A third of the participants were at least 60 years old. Participants in the study must have received a positive diagnosis within 4 days of starting treatment and experienced symptoms for 7 days or less.
 

Use of remdesivir controversial

Results from the Adaptive COVID-19 Treatment Trial (ACTT-1) showed remdesivir was superior to placebo in shortening time to recovery in adults hospitalized with COVID-19 with evidence of lower respiratory tract infection.

However, a large trial of more than 11,000 people in 30 countries, sponsored by the World Health Organization, did not show any benefit for the drug in reducing COVID deaths.

The WHO has conditionally recommended against using remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.”

The drug also is given intravenously, and this study tested three infusions over 3 days, a difficult treatment for nonhospitalized patients.

The study results were released ahead of IDWeek, where the late-breaking abstract will be presented at the virtual conference in full at the end of next week.

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

A strain of COVID-19 first reported in Japan surfaced at a Kentucky nursing home in the spring.

Deadline, citing a Centers for Disease Control and Prevention report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.

On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have “mutations aligning with the R.1 lineage,” Deadline said.

About 90% of the facility’s residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about “reduced protective immunity” in relation to the R.1 variant, the CDC said.

However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.

“Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19,” the CDC said. The vaccination of nursing home residents and health care workers “is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices,” the CDC said.

Since being reported in Kentucky, R.1 has been detected more than 10,000 times in the United States, Forbes reported, basing that number on entries in the GISAID SARS-CoV-2 database.

Overall, more than 42 million cases of COVID have been reported since the start of the pandemic.

Deadline reported that the R.1 strain was first detected in Japan in January among three members of one family. The family members had no history of traveling abroad, Deadline said, citing an National Institutes of Health report.

The CDC has not classified R.1 as a variant of concern yet but noted it has “several mutations of importance” and “demonstrates evidence of increasing virus transmissibility.”

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

A strain of COVID-19 first reported in Japan surfaced at a Kentucky nursing home in the spring.

Deadline, citing a Centers for Disease Control and Prevention report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.

On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have “mutations aligning with the R.1 lineage,” Deadline said.

About 90% of the facility’s residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about “reduced protective immunity” in relation to the R.1 variant, the CDC said.

However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.

“Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19,” the CDC said. The vaccination of nursing home residents and health care workers “is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices,” the CDC said.

Since being reported in Kentucky, R.1 has been detected more than 10,000 times in the United States, Forbes reported, basing that number on entries in the GISAID SARS-CoV-2 database.

Overall, more than 42 million cases of COVID have been reported since the start of the pandemic.

Deadline reported that the R.1 strain was first detected in Japan in January among three members of one family. The family members had no history of traveling abroad, Deadline said, citing an National Institutes of Health report.

The CDC has not classified R.1 as a variant of concern yet but noted it has “several mutations of importance” and “demonstrates evidence of increasing virus transmissibility.”

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

A strain of COVID-19 first reported in Japan surfaced at a Kentucky nursing home in the spring.

Deadline, citing a Centers for Disease Control and Prevention report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.

On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have “mutations aligning with the R.1 lineage,” Deadline said.

About 90% of the facility’s residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about “reduced protective immunity” in relation to the R.1 variant, the CDC said.

However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.

“Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19,” the CDC said. The vaccination of nursing home residents and health care workers “is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices,” the CDC said.

Since being reported in Kentucky, R.1 has been detected more than 10,000 times in the United States, Forbes reported, basing that number on entries in the GISAID SARS-CoV-2 database.

Overall, more than 42 million cases of COVID have been reported since the start of the pandemic.

Deadline reported that the R.1 strain was first detected in Japan in January among three members of one family. The family members had no history of traveling abroad, Deadline said, citing an National Institutes of Health report.

The CDC has not classified R.1 as a variant of concern yet but noted it has “several mutations of importance” and “demonstrates evidence of increasing virus transmissibility.”

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